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Align Technology

algn · NASDAQ Healthcare
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FY2025 Annual Report · Align Technology
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________________________________________________________
FORM 10-K
 ________________________________________________________________________
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2025
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                     to                    
Commission file number: 000-32259
________________________________________________________________________
ALIGN TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
________________________________________________________________________
Delaware
94-3267295
(State or other jurisdiction of

incorporation or organization)
(I.R.S. Employer
Identification No.)
410 North Scottsdale Road, Suite 1300
Tempe, Arizona 85288
(Address of principal executive offices, including zip code)
(602) 742-2000
(Registrant’s telephone number, including area code)
________________________________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, $0.0001 par value
ALGN
The Nasdaq Stock Market LLC
(Nasdaq Global Select Market)
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☒    No  ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ☐    No  ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12  months (or for such shorter period that the registrant was required to file such reports), and (2)  has been subject to such filing requirements for the past
90 days.    Yes  ☒    No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☒
Accelerated filer  
☐
Non-accelerated filer  
☐
Smaller reporting company  
☐
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the
correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the
registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ☐    No  ☒
The aggregate market value of the common stock held by non-affiliates of the registrant was approximately $11.1 billion as of June 30, 2025, based on the closing sales price
of the registrant’s common stock on the Nasdaq Global Select Market on such date. Shares held by persons who may be deemed affiliates have been excluded. This determination
of affiliate status is not necessarily a conclusive determination for other purposes.
On February 20, 2026, 71,282,132 shares of the registrant’s common stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement relating to its 2026 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on
Form 10-K where indicated. The registrant’s definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal
year to which this report relates.
1

ALIGN TECHNOLOGY, INC.
FORM 10-K
For the Year Ended December 31, 2025
TABLE OF CONTENTS
 
 
 
Page
PART I  
3
Item 1.
Business
3
Information about our Executive Officers
22
Item 1A.
Risk Factors
22
Item 1B.
Unresolved Staff Comments
36
Item 1C.
Cybersecurity
36
Item 2.
Properties
38
Item 3.
Legal Proceedings
38
Item 4.
Mine Safety Disclosures
38
PART II
39
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
39
Item 6.
[Reserved]
41
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
41
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
54
Item 8.
Financial Statements and Supplementary Data
56
Item 9.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
97
Item 9A.
Controls and Procedures
97
Item 9B.
Other Information
97
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
97
PART III
97
Item 10.
Directors, Executive Officers and Corporate Governance
97
Item 11.
Executive Compensation
98
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
98
Item 13.
Certain Relationships and Related Transactions, and Director Independence
99
Item 14.
Principal Accountant Fees and Services
99
PART IV
100
Item 15.
Exhibits and Financial Statement Schedules
100
Item 16.
Form 10-K Summary
102
Signatures
103
Invisalign, Align, the Invisalign logo, ClinCheck, Invisalign Assist, Invisalign First, Invisalign Go, the Invisalign sonic logo, Vivera, SmartForce, SmartTrack,
SmartStage, SmileView, iTero, iTero Element, iTero Lumina, Orthocad, exocad, Align Digital Platform, Align Oral Health Suite, Invisalign Smile Architect, iTero
exocad Connector, exocad Dental CAD, and Cubicure, among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries
or affiliated companies and may be registered in the United States and/or other countries.
2

In addition to historical information, this Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include, among other
things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our beliefs and expectations regarding
macroeconomic conditions, including fluctuations in foreign currency exchange rates, inflation, higher interest rates, market volatility, actual or proposed
tariffs, customs duties or fees, and any retaliatory tariffs or protectionist trade measures taken in response to such tariffs, actual or potential economic
slowdowns or recessions, effects of geopolitical events, our expectations and beliefs regarding customer and consumer purchasing behavior and changes in
consumer spending habits, our expectations regarding product mix, product launches, product pilots and product adoption, our expectations regarding
competition and our ability to compete in our target markets, our expectations regarding the sales growth of our intraoral scanners, clear aligners and other
products, our expectations regarding the impact of the military conflicts in the Middle East and Ukraine and our operations and assets in Israel and Russia, our
marketing and efforts to build our brand awareness, our estimates regarding the size and opportunities of the markets we are targeting along with our
expectations for growth in those markets and potential collaboration opportunities, our beliefs regarding the impact of technological innovation in general, and
in our solutions and products in particular, on target markets and patient care, our beliefs regarding digital dentistry and its potential to impact our business,
our intentions regarding expanding our business, including its impact on our operational flexibility and responsiveness to customer demand, our expectations
regarding our tax positions and the judgments we make related to our tax obligations, our beliefs regarding the importance of our manufacturing operations on
our success, our beliefs regarding the need for and benefits of our technological development on Invisalign treatment, the areas of development in which we
focus our efforts, and the advantages of our intellectual property portfolio, our beliefs regarding our business strategy and growth drivers, our expectations
regarding the utilization rates for our products, including the impact of marketing on those rates and causes for periodic fluctuations of the rates, our
expectations regarding the existence and impact of seasonality, our expectations regarding the continued expansion of our international markets and their
growth, our expectations regarding impacts or staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our
business both in the United States and internationally, our beliefs regarding our culture and commitment and its impact on our financial and operational
performance and its importance to our future success, our expectations for future investments in and benefits from sales and marketing activities, our
preparedness and our customers’ preparedness to react to changing circumstances and demand, our expectations for our expenses and capital obligations and
expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of and ability to repatriate foreign
earnings, our belief regarding the sufficiency of our cash and investment balances and borrowing capacity, our judgments regarding the estimates used in our
revenue recognition and assessment of goodwill and intangible assets, our predicted level of operating expenses and gross margins and other factors beyond
our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.

In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,”
“plans,” and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to
such differences include, but are not limited to, those discussed in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of
Operations,” and in particular, the risks discussed below in Part I, Item 1A “Risk Factors.” We undertake no obligation to revise or update these forward-
looking statements. Given these risks and uncertainties, you should not to place undue reliance on such forward-looking statements. Also, these forward-looking
statements represent our estimates and assumptions only as of the date of this filing.
PART I
 
Item 1. Business.
Our Company
Align Technology, Inc. (“we,” “us,” “our,” “Align” or the “Company”) is a global medical device company primarily engaged in the design, manufacture
and marketing of Invisalign  clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners
(“GPs”), Vivera
 retainers for retention, iTero
 intraoral scanners and services for dentistry, and exocad
 computer-aided design and computer-aided
manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners. Our vision and strategy is to revolutionize orthodontic and restorative
dentistry through digital treatment planning and implementation using the Align
Digital Platform, an integrated suite of proprietary technologies and services
designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs and lab partners. We strive to achieve our vision and strategy
through key objectives made possible with the proprietary technologies and services of the Align
 Digital Platform to establish: clear aligners as the principal
solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients
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globally, our iTero intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative
solution of choice for dental labs.
Our corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85288. Our telephone number is 602-742-2000. Our
internet address is www.aligntech.com. Our Americas regional headquarters is located in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa
(“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific (“APAC”) regional headquarters is located in Singapore.
We have two operating segments: (1) Clear Aligner and (2) Imaging Systems and CAD/CAM Services (“Systems and Services”). For the year ended
December  31, 2025, Clear Aligner net revenues represented approximately 80% of worldwide net revenues, while Systems and Services net revenues
represented the remaining 20%. We sell the majority of our products and services directly through a dedicated and specialized sales force to our customers:
orthodontists, GPs, including prosthodontists, periodontists, oral surgeons and dental laboratories. We also sell through sales agents and distributors in certain
countries. In addition, we sell directly to dental support organizations (“DSOs”) who contract with dental practices to provide critical business management and
support, including non-clinical operations. We also sell our products to dental laboratories who use our products to manufacture or customize their own products
for licensed dentists. We furthermore market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under
the Invisalign  and other brand names, including retainers, dental supplies, clear aligner cases (clamshells), ultrasonic and UV electronic cleaning devices, teeth
whitening products and cleaning solutions (collectively, “Invisalign Accessory Products”). Depending on the product, our Invisalign Accessory Products are
sold through a variety of channels, including online through large e-commerce websites, our doctor portal and in-store through large retailers and pharmacy
stores.
Our clear aligners are sold under the Invisalign  brand name. Our Invisalign System is intended mainly for the treatment of malocclusions and is designed
to help dental professionals achieve the clinical outcomes they expect and the results patients desire. To date, over 22 million people worldwide have been
treated with the Invisalign System. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training
course. Our iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures, Invisalign
case submissions, and comprehensive digital dentistry diagnosis, treatment planning and treatment monitoring. Our exocad CAD/CAM software products
provide restorative dentistry, implantology, guided surgery and smile design to dental labs and dental practices through fully integrated workflows, with the goal
to provide cross-disciplinary dentistry in labs and at chairside.
Our Products, Services and Technologies
Align
 Digital Platform
For nearly 30 years, Align has been transforming smiles and changing lives; driving innovation in digital orthodontics and dentistry, helping doctors
transform their practices using digital tools and technology to deliver exceptional, modern treatment
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experiences and outcomes to over 22 million people worldwide. The Align
 Digital Platform is the foundation of our goal to lead the digital revolution in
orthodontics, restorative dentistry and comprehensive digital dentistry by delivering seamless workflows in dental practices, on mobile devices, and through
remote monitoring, as well as diagnostic and treatment solutions designed to improve all aspects of assessment and treatment, from initial consultations to final
smiles with our doctor-centered treatment model.
The Align
 Digital Platform is an end-to-end digital platform that combines software, systems and services designed to provide a seamless experience and
end-to-end workflow that integrates and connects those critical to successful treatment outcomes – doctors, labs, patients and consumers. At the center of the
Align
 Digital Platform are Invisalign clear aligners, iTero intraoral scanners and exocad CAD/CAM software.
The Align
 Digital Platform utilizes the Align
 Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected
workflows and treatment solutions. The Align
 Digital Workflow includes dedicated tools and capabilities for each stage of the Invisalign treatment journey:
•
Connect: The initial stage of the platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign
providers. Some of the tools that support this stage are Invisalign.com, Invisalign  Doctor Locator, Invisalign SmileView
 tool, Invisalign  Practice
App, Invisalign  Virtual Appointment and My Invisalign
 app.
•
Scan: During this stage, patient data is captured through intraoral scanning. Doctors and their staffs use intraoral scanning tools designed to support
diagnosis of a patient’s oral conditions and health and support doctors to develop appropriate treatment pathways. Visualization of their potential smiles
helps patients understand the benefits of treatment and increases patient conversion. The tools that support this stage include iTero intraoral scanners
and exocad CAD/CAM imaging systems, Invisalign  Outcome Simulator Pro, iTero Element
5D auto-upload feature, iTero
Near Infra-Red
Imaging (NIRI) technology, iTero
 Scan Report, iTero
 TimeLapse Technology and iTero-exocad Connector
.
•
Diagnose: Doctors can access and use tools that support diagnosis of a patient’s oral health and develop an appropriate treatment pathway. The Align
Digital Platform facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations. Some of the tools that
support this stage include Align
 Oral Health Suite, Align X-ray Insights, iTero
 intraoral scanners, including those with NIRI technology, iTero
TimeLapse technology and iTero
 Occlusogram.
•
Plan: Doctors digitally visualize and plan orthodontic and restorative treatments. Orthodontists and GPs can use our products to design, build and share
their vision for treatment planning and agree on a customized plan with their patients to reach the desired outcomes. Some of the tools that support this
stage are ClinCheck® Pro Software, 3D Controls in ClinCheck® Pro, ClinCheck® Plan Editor, Invisalign® Personalized Plan, CBCT integration for
ClinCheck®, and Invisalign Smile Architect™.
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•
Treat: During this stage, doctors treat their patients with our Invisalign  clear aligners and may offer teeth whitening using the Invisalign
Professional Whitening System. The Invisalign  Palatal Expander System and the Invisalign  System with mandibular advancement with occlusal
blocks and enhanced precision wings, and SmartTrack™ material, SmartForce™ features and SmartStage™ technology are additional products that
support patient treatment.
•
Monitor: Doctors can remotely track their patients’ treatment between visits, and orthodontists and GPs can more easily track treatment progress and
communicate issues, results and recommendations to their patients. Some of the tools that support this stage include Invisalign  Progress Assessment,
Invisalign  Virtual Care AI and My Invisalign
 app.
•
Retain: Following completion of their orthodontic treatment, patients can retain the final position of their teeth using Vivera
 retainers.
New Products/Feature Enhancement
As we further evolve the treatment planning experience for doctors through new technological research and development innovations, we expect to
introduce new technologies, features and functionality that improve personalization of treatment planning, predictability, clinical preferences, and 2D/3D
imaging, including digital tools for faster and more accurate final tooth positions.
In 2025, we announced several new enhancements to the Align
 Digital Platform.
•
In March 2025, we announced the addition of restorative capabilities to our iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the
new iTero Lumina™ Pro dental imaging system (with iTero NIRI technology).
•
In March 2025, we also announced the launch in European Union countries and the United Kingdom of Align X-ray Insights, a new software-based
(CADe*) computer aided detection solution that uses artificial intelligence (“AI”) to automatically analyze 2D radiographs.
•
In October 2025, we announced a series of new innovations for iTero Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and
integrated software tools, including enhancements to the Align™ Oral Health Suite, Invisalign  Outcome Simulator Pro with ClinCheck Smile Video,
and the iTero™ Design Suite.
•
In December 2025, we announced limited commercial availability of the Invisalign  System with mandibular advancement featuring occlusal blocks
(“MAOB”), the latest clinical innovation that expands Align’s Class II treatment portfolio by offering practitioners a comprehensive solution for
treating growing patients with Class II malocclusions caused by mandibular retrusion.
Clear Aligner Segment
Malocclusion and Traditional Orthodontic Treatment
Malocclusion is one of the most prevalent clinical dental conditions in the world, affecting approximately 60% to 75% of the global population. We
estimate that there are approximately 600 million people globally with malocclusion who could benefit from straightening their teeth. However, most people
afflicted by malocclusion do not seek orthodontic treatment for various reasons, including negative perceptions of traditional wires and brackets, affordability of
treatment, and accessibility to doctors. Annually, only approximately 22  million people globally elect treatment by orthodontists. Today, most orthodontic
patients continue to have their malocclusions treated with the use of traditional corrective methods such as metal arch wires and brackets, referred to as braces,
augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary devices as needed. Upon completion of a patient’s treatment,
their dental professional may recommend the patient use a retainer appliance to preserve the benefits of their treatment. Of the 22 million cases started each
year, we estimate that almost all can be treated using our Invisalign System, yet we estimate our share of the 22 million case starts through orthodontists is
approximately 10% globally. Our business strategy remains focused on increasing our share of the existing market of orthodontic case starts compared to wires
and brackets, especially among teens, and expand the market for digital orthodontics, especially among adults. By training more doctors, including GPs as well
as orthodontists, increasing utilization of existing doctors using our products, educating more consumers about the benefits of straighter teeth using the
Invisalign System and connecting consumers with an Invisalign-trained doctor of their choice, we are helping drive adoption of digital orthodontics and
restorative dentistry globally.
The Invisalign System
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The Invisalign System is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of
doctor-prescribed, custom manufactured, clear polymer removable aligners. We received 510(k) clearance from the U.S. Food and Drug Administration
(“FDA”) to market the Invisalign System in 1998.
The Invisalign System offers a range of treatment options, specialized services and access to proprietary software for treatment visualization and is
comprised of the following phases:
Diagnosis and transmission of treatment data. As part of the Align™ Digital Workflow, we have developed solutions to enable doctor diagnosis and drive
patient adoption – providing tools to support diagnosis of a patient’s oral health and support to identify an appropriate treatment pathway, facilitating the doctor-
patient conversation, education and clinical needs and expectations. An Invisalign trained dental professional prepares an online prescription form on our
Invisalign Doctor Site and securely submits the patient’s records, which include a digital intraoral scan or a polyvinyl-siloxane (“PVS”) impression of the
relevant dental arches, photographs of the patient and, at the dental professional’s election, x-rays of the patient’s dentition. Intraoral digital scans may be
submitted through Align’s iTero scanner or certain third-party scanners capable of accurately interfacing with our systems and processes. Globally, more than
95% of Invisalign System prescription orders are now submitted via digital scan, increasing the accuracy of treatment plans, reducing the time from when the
doctor submits the prescription to the time the patient receives the clear aligners, and helping to decrease the carbon footprint resulting from elimination of the
initial or upfront shipment of the patient’s PVS impressions to the doctors and shipping those PVS impressions back to us.
Computer-simulated treatment plan. Our ClinCheck  treatment planning software is the cornerstone of the Align
 Digital Platform. ClinCheck Pro
treatment planning software uses proprietary algorithms based on the insights from data from our over 22 million patients treated worldwide. Using the digital
scans or PVS impressions, certain doctor preferences and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a
ClinCheck  treatment plan, using proprietary software developed through significant, ongoing research and development investments spanning more than two
decades. A patient’s ClinCheck treatment plan simulates 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 shapes that are sometimes used to increase the biomechanical force on a specific tooth or teeth in
order to affect the desired movement(s).
Review and approval of the treatment plan by an Invisalign-trained doctor. The patient’s ClinCheck treatment plan is then made available to the
prescribing dental professional via our Invisalign Doctor Site, enabling the dental professional to evaluate projected tooth movement from initial to final
position and compare, modify or choose from multiple treatment plan options to best meet the dental professional’s treatment objectives. By reviewing,
modifying as needed and approving the treatment plan, the dental professional retains control of the patient’s treatment.
Manufacture of custom clear aligners. Following the dental professional’s approval of a ClinCheck treatment plan, we use the data underlying the
simulation as input for stereolithography technology (a form of 3D printing technology) to construct a series of molds. Each mold is a replica of the patient’s
teeth at each stage of the simulated course of treatment. From these molds, clear aligners are fabricated by pressure-forming polymeric sheets over each mold.
Clear aligners are thin, clear polymer, removable dental appliances that are custom manufactured in a series designed to correspond to each stage of the patient’s
ClinCheck treatment plan.
Shipment to the dental professional and patient clear aligner wear. Once manufactured, all the clear aligners for a patient’s doctor-approved treatment plan
are typically shipped directly to the dental professional. The majority of doctors then dispense all of the clear aligners to the patient. Clear aligners are generally
worn for one week or for a short period of time corresponding to the stages of the patient’s approved ClinCheck treatment plan and their doctor’s discretion. The
patient replaces their current set of clear aligners with the next set in the series when prescribed, advancing tooth movement through each stage. At various
points in each patient’s treatment, their doctor may place attachments or use other auxiliaries to achieve desired tooth movements, per the doctor’s original
prescription and the approved ClinCheck treatment plan.
Clear Aligner Products
We offer our Invisalign System in a variety of treatment packages designed to correspond with the case-by-case treatment needs of our doctors and their
patients and any nonclinical requirements. The table below provides a general description of the categories of products in our Invisalign System offered in
various regions as they typically correspond to the severity of malocclusion and length of anticipated treatment.
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Malocclusion
Very Mild to Mild
Mild to Moderate
Moderate to Severe
Product
Invisalign  Express Package Invisalign  Lite Package
Invisalign Go
Package
Limited Movement
(GP)
Invisalign  Moderate
Package
Invisalign  Comprehensive
Packages
Treatment Stages*
7
14
20
20-26
As many as required
Clinical Scope
Relapse and minor
movement, anterior esthetic
alignment
Class I, mild
crowding/spacing, non-
extraction, pre-restorative
Class I, no AP
correction, mild to
moderate
crowding/spacing, non-
extraction, pre-
restorative.

Tooth movement from
second pre-molar to
second pre-molar (5x5)
Class I, mild Class II,
mild to moderate
crowding/spacing, mild
AP and vertical
discrepancies, pre-
restorative
Class I, II, III, moderate to severe
crowding/spacing, AP and
vertical discrepancies,
extractions, complex pre-
restorative
Most of our Invisalign System products described above provide dental professionals with the option to order additional clear aligners if the patient’s
treatment progress or needs deviate from the original treatment plan. The number and timing of additional clear aligner orders are subject to certain
requirements noted in our terms and conditions. In certain regions, we offer streamlined configurations with limited or no additional aligners, including the
option to separately purchase additional aligners under applicable terms, and we anticipate offering these configurations in additional markets over time.
Comprehensive Products - Invisalign Treatment Options
Invisalign Comprehensive Packages. Invisalign Comprehensive Packages are used to treat adults and teens over a wide spectrum of mild to severe
malocclusion and contains a broad variety of features to achieve desired treatment goals. They also address the frequently complex orthodontic needs of teenage
or younger patients with advanced features such as mandibular advancement, compliance indicators and compensation for tooth eruption. These packages
include Invisalign Comprehensive, Invisalign First
 Phase 1 and Invisalign First
 Comprehensive Phase 2. 
Invisalign First Phase 1 and Invisalign First Comprehensive Phase 2 Packages. Invisalign First Phase 1 Package is designed specifically for younger
patients generally between the ages of six and ten, who frequently have a mixture of primary/baby and permanent teeth. Invisalign First Phase 1 treatment
provides early interceptive orthodontic treatment, traditionally done through arch expansion, or partial metal braces, before all permanent teeth have erupted.
Invisalign First Phase 1 clear aligners are designed specifically to address a wide range of younger patients’ malocclusions, including shorter clinical crowns,
management of erupting dentition and predictable dental arch expansion. Our Invisalign First Comprehensive Phase 2 Package complements Invisalign First
Phase 1 and is generally consistent with our Invisalign Comprehensive Package. After a patient completes Invisalign First Phase 1, doctors have the option to
purchase a Comprehensive Phase 2 Package for that same patient.
Invisalign Comprehensive 3in3 Package. The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration
date and three sets of additional clear aligners included prior to the treatment expiration date, rather than the five-year treatment expiration date with unlimited
additional clear aligner sets prior to the treatment end date offered under the Invisalign Comprehensive Package.
Invisalign  System With Mandibular Advancement Featuring Occlusal Blocks for Class II Skeletal and Dental Correction. The Invisalign System with
mandibular advancement featuring occlusal blocks expands our Class II treatment portfolio by offering practitioners a comprehensive solution for treating
growing patients with late mixed or early permanent dentition (ages 10-16) with Class II malocclusions caused by mandibular retrusion. Class II malocclusion is
one of the most common orthodontic problems, characterized by a discrepancy in jaw alignment where the lower jaw (mandible) is positioned too far back
relative to the upper jaw (maxilla) and represents approximately 30%-45% of malocclusions globally. By leveraging the natural growth potential during pre-
adolescence and adolescence, the Invisalign System with mandibular advancement featuring occlusal blocks facilitates effective correction of Class II
malocclusions, helping to improve occlusal relationships, enhance facial aesthetics, and provides long-term functional benefits.
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Non-Comprehensive Products - Invisalign Treatment Options
Invisalign Non-comprehensive Packages. We offer a variety of lower-priced treatment packages for less complex orthodontic cases, non-comprehensive
relapse cases, or teeth straightening prior to restorative or cosmetic treatments, such as veneers. These treatment packages include Invisalign Express, Invisalign
Lite, and Invisalign  Moderate. These packages may be offered in select countries and/or may differ from region to region.
Invisalign Doctor Subscription Program (“DSP”) is our monthly subscription-based clear aligner program which includes retainers and low-stage “touch-
up” clear aligner treatment. DSP is currently available in North America, Latin America, and certain countries in Europe.
Invisalign Go Packages. In various markets we also offer Invisalign Go
, Invisalign Go
 Express and Invisalign Go
 Plus, which are streamlined non-
comprehensive packages designed for GPs to more easily identify and treat patients with mild-to-moderate malocclusion cases, expand arch width, align
anterior teeth prior to restorative treatment, and move teeth from second pre-molar to second pre-molar. These packages include case assessment support,
simplified ClinCheck treatment plans and a progress assessment feature for case monitoring.
Invisalign® Palatal Expander System. In December 2023, we received 510(k) clearance in the United States for the Invisalign Palatal Expander System, a
direct 3D printed orthodontic appliance design based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid
expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent
dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it is designed to be used in conjunction with surgery or other
interventions when necessary. The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to
expand a patient’s narrow maxilla to a position determined by their treating doctor. Each direct 3D printed device is customized to the patient’s unique anatomy
based on an iTero™ intraoral digital scan. A palatal expansion treatment plan and device design are then developed using our proprietary orthodontic software.
The Invisalign Palatal Expander is our first direct 3D printed orthodontic device that provides doctors with a solution set to treat the most common skeletal and
dental malocclusions in growing children. Together with Invisalign First™ clear aligners, Invisalign Palatal Expanders can address early intervention treatment,
such as Phase 1, an early interceptive orthodontic treatment for young patients. The Invisalign Palatal Expander System is currently available in the United
States, Canada, Australia, New Zealand, Hong Kong, Singapore, Vietnam, Japan, Thailand, India and certain countries in EMEA. The Invisalign Palatal
Expander System is expected to be commercially available in additional markets, pending regulatory approvals.
Non-Case Products
The Comprehensive and Non-Comprehensive clear aligner packages described above are distributed in cases, meaning that all the sets of clear aligners
required for all the stages of a doctor-approved treatment plan are delivered in a case. We also sell non-case products. Clear aligner non-case products include
retention products, Invisalign training, adjusting tools used by dental professionals during the course of treatment, ancillary Invisalign Accessory Products and
other oral health products available in certain e-commerce and retail channels in the United States.
Vivera™ Retainers for Retention. We offer up to four sets of Vivera retainers, which are custom clear aligners made with proprietary material strong
enough to maintain tooth position and correct minor relapse, if necessary, as well as Invisalign retainers. 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 select markets, we also offer single set retainers.
Invisalign Professional Whitening System. The Invisalign™ Professional Whitening System, powered by Opalescence™, is the only professional teeth
whitening system approved by Align for combined use with Invisalign® aligners and Vivera™ retainers.
Direct Fabrication
In January 2024, we completed the acquisition of Cubicure GmbH (“Cubicure”), a company that develops, produces and distributes proprietary direct 3D
printing technologies that enable us to efficiently and sustainably manufacture our devices without the added step of first creating a mold. We believe Cubicure
provides direct fabrication capabilities that will support and scale our strategic innovation roadmap and strengthen the Align Digital Platform by enabling us to
scale our 3D printing operations to eventually print millions of custom devices per day. We expect this technology will ultimately extend and scale our printing,
materials and manufacturing capabilities for our 3D printed product portfolio while concurrently materially reducing the amount of resin used in our
manufacturing process. Direct fabrication offers the transformative potential of design flexibility that goes beyond what the current thermoforming technology
allows. This will potentially allow us to design unique appliances that may perform even better than existing appliances and address unmet market needs. We
have begun limited
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manufacturing of certain appliances already, and expect to pilot additional devices, including retainers and certain pre-fab attachments, in limited releases in
2026.
Smart Technology: SmartTrack
, SmartForce
and SmartStage
Smart technology is applied in the development of Invisalign treatments and leads to more precise control of individual and multiple tooth movements. We
use a force driven system in our Invisalign clear aligners such that the next clear aligner is shaped so that when inserted, the clear aligner stretches and applies
the desired force to the surface of the tooth, resulting in the desired tooth movement. Smart technology allows us to find the right thickness, the right elasticity,
and the right force application over a period of time. Smart technology includes the use of SmartTrack, SmartForce and SmartStage Technology.
SmartTrack Material. SmartTrack clear aligner material is a patented, custom-engineered Invisalign clear aligner material that provides gentle, more
constant force to improve control of tooth movements. Conventional clear aligner materials relax and lose a substantial percentage of the force applied in the
initial days of wear. SmartTrack material maintains more constant force over a longer period of time. The flexible SmartTrack material also more precisely
conforms to tooth morphology, attachments and interproximal spaces to improve control of tooth movement throughout treatment.
SmartForce Attachments. SmartForce attachments are small tooth-colored shapes that attach to teeth before or during Invisalign treatment. Invisalign clear
aligners fit smoothly and tightly around the attachments and give the clear aligners something to gently push on. SmartForce attachments make complex tooth
movements possible without braces by helping clear aligners apply the right amount of force in the right direction.
SmartStage Technology. SmartStage is an advanced algorithm that determines the optimal path of tooth movement and the shape of the clear aligner at
every stage of an Invisalign treatment. The programming determines tooth movement in a certain sequence, at the right time to achieve optimal outcomes with
greater predictability and fewer undesirable interferences.
Systems and Services Segment
Intraoral scanning is a rapidly evolving technology substantially impacting the practice of dentistry. By enabling the dental practitioner to create a 3D
image (digital scan) of a patient’s teeth using a handheld intraoral scanner, digital scanning is faster, more efficient, precise and comfortable for patients.
Beginning patient care with the early use 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 helps patients decide to undergo treatment and improve
treatment outcomes and satisfaction. The accuracy of digitally scanned models substantially reduces the rate of restoration “remakes,” which results in patients
being recalled to dental offices less often and experiencing shorter treatment times for the restoration work because fewer procedures are required after teeth are
aligned and spaced optimally, increasing overall patient satisfaction. Digital models also reduce the carbon footprint associated with the shipping of the
materials used to create PVS impressions, the shipping of those impressions and their disposal. Moreover, the digital model file can be used for various
procedures and services including fabrication of physical dental models for use by labs to create restorative units such as veneers, inlays, onlays, crowns,
bridges and implant abutments; digital records storage; aid to caries detection; orthodontic diagnosis; orthodontic retainers and appliances; and Invisalign
digital impression submission.
iTero Element™ Scanner. The iTero Element™ portfolio of intraoral scanners includes the iTero Element™ 2, the iTero Element™ Flex, iTero Element™
5D imaging system, iTero Element™ Plus Series and the iTero Lumina™ which are each available in select regions and countries. These products build on the
existing high precision, full-color imaging and fast scan times of the iTero Element portfolio and are available with software options for orthodontic and
restorative procedures. The iTero scanner is interoperable with our Invisalign system such that a full arch or full mouth digital scan can be submitted as part of
the Invisalign system prescription order submission process.
Our iTero Element 5D imaging system is the first integrated dental imaging system that simultaneously records 3D, intraoral color camera images, NIRI
technology and enables comparison over time using the iTero™ TimeLapse technology. NIRI technology, included in our iTero Element 5D and 5D Plus
imaging systems, aids in detection and monitoring of interproximal caries above the gingiva in real time, without using harmful radiation. The iTero Element 5D
imaging system is available in the United States, Canada, China, and the majority of EMEA and select APAC and LATAM countries and is pending regulatory
approval in others. The findings of a clinical study we sponsored were published in the peer-reviewed Journal of Dentistry which demonstrated that the NIRI
technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing x-ray radiography for detection of interproximal lesions, without the
use of harmful radiation. We received 510(k) clearance in the United States for the caries detection feature of the iTero Element 5D imaging system in 2020.
The iTero Element Plus Series of intraoral scanners and imaging systems offers restorative and orthodontic digital workflows that include enhanced
visualization for optimized patient experience, including a fully integrated 3D intraoral camera in certain
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models, seamless scanning with reduced processing time, artificial intelligence (“AI”)-based features, and, in certain models, NIRI 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 scanner and have a service period of 1 to 5 years. 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. Our iTero software is designed for orthodontists for digital records storage, orthodontic diagnosis, and for
the fabrication of printed models and retainers. Our restorative software is designed for GPs, prosthodontists, periodontists and oral surgeons and includes
restorative workflows providing the ability to send digital impressions to the lab of their choice and communicate seamlessly with external treatment planning,
custom implant abutment, chairside milling and laboratory CAD/CAM systems such as through our iTero-exocad Connector
.
Invisalign® Progress Assessment Tool. The Invisalign Progress Assessment tool provides the ability to compare a patient’s new scan with a specific stage
of their ClinCheck  treatment plan, allowing doctors to visually assess and communicate Invisalign treatment progress with an easy-to-read, color-coded, tooth
movement report.
iTero
 TimeLapse Technology. Our iTero
 TimeLapse technology allows doctors or practitioners to compare a patient’s historic 3D scans to the present-
day scan, enabling clinicians to identify and measure orthodontic movement, tooth wear, and gingival recession. This highlights areas of diagnostic interest to
dental professionals and helps foster a proactive conversation with the patient regarding potential restorative or orthodontic solutions.
iTero Lumina™ Intraoral Scanner and iTero Lumina™ Pro Dental Imaging System
In January 2024, we launched the iTero Lumina intraoral scanner. The iTero Lumina intraoral scanner is designed with iTero Multi-Direct Capture
technology that captures more data quickly and accurately while delivering exceptional scan quality and photorealistic images that remove the need for intraoral
photos. iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models. It has a wider field of capture and multi-angled
scanning that enables simultaneous capture from multiple angles. Additionally, the iTero Lumina scanner has a capture distance of up to 25mm, making it easier
to scan complex oral regions such as narrow or deep palates, edentulous spaces, and partially erupted teeth with minimal maneuvering. It has a 50% smaller and
45% lighter wand (as compared to iTero Element™ 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids
and teen patients. The iTero Lumina scanner has photorealistic scans that are clinically comparable to intra-oral photography and its advanced software enables
scanning at two times the speed.
In March 2025, we announced the addition of restorative capabilities to our next generation iTero Lumina™  intraoral scanner (without iTero NIRI
technology) and the new iTero Lumina™  Pro dental imaging system (with NIRI technology)  to enable efficient restorative and multidisciplinary ortho-
restorative workflows and support diagnostic of interproximal caries above the gingiva, helping GPs reach new levels of practice efficiency and growth while
delivering exceptional clinical outcomes.
Since October 2025, our portfolio of intraoral scanners have included a PC configuration (desktop and laptop) that extends the performance found in the
cart and mobile configurations into a compact and adaptable format that integrates easily into existing practices.
The enhanced capabilities of the iTero Lumina solutions provide an improved scanning experience and performance, optimal for the simplest to the most
challenging restorative cases. These capabilities are complemented by simplified restorative workflows that include the capture of single unit dental crowns to
full dental arch with multiple preparations in a single pass, with a wave of an iTero Lumina wand.
iTero™ Digital Solutions
In October 2025, we announced a series of new product innovations for iTero™ Digital Solutions, a comprehensive ecosystem that includes intraoral
scanners and integrated software tools designed to transform dental consultations into a modern, multi-modal oral health assessment that helps doctors and their
teams deliver exceptional chairside experiences. These new capabilities span across key practice workflows that underline the Align™ Digital Workflow
including Diagnose, Plan, Treat, and Monitor steps. From dynamic and personalized visualization and patient engagement tools at chairside, to expanded
compatibility with 3D printers and milling machines, these new innovations are designed to simplify workflows, increase patient acceptance, and drive practice
growth.
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Align
 Oral Health Suite. The Align™ Oral Health Suite is designed to be an intuitive and visually engaging digital interface intended to enhance patient-
driven interest and engagement with iTero Element™ Plus and iTero Lumina™ scan images to help drive doctor-patient conversations about treatment options
earlier in the patient journey. The all-in-one chairside consultation can help patients see their oral health conditions, discuss potential root causes with their
doctors and evaluate treatment options.
Invisalign® Outcome Simulator Pro. Invisalign Outcome Simulator Pro is a patient communication tool on iTero Element™ Plus Series and iTero
Lumina™ imaging systems, that generates highly realistic, simulated in-face visualizations of a patient’s potential future smile after an orthodontic or ortho-
restorative treatment. Invisalign Outcome Simulation Pro with multi treatment simulations offers two types of simulations chairside: Invisalign for ortho-only,
and Invisalign Smile Architect™ for ortho-restorative. The new Invisalign  Outcome Simulator Pro with Smile Video offers dynamic in-face visualization at
chairside designed to improve patient conversion.
iTero™ Design Suite. iTero™ Design Suite offers doctors and dental staff a simple and intuitive digital chairside design workflow for 3D printing and
milling of models, bite splints, mock-ups, and restorations to enable single-visit dentistry and better patient experiences. It includes comprehensive printing and
milling compatibility, a new mock-up workflow that drives patient engagement and treatment acceptance, and the integration of iTero NIRI and HD intraoral
images into the Suite to help trace the margin line and support detailed restoration design.
CAD/CAM Services. Our exocad CAD/CAM software platform addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-
restorative and comprehensive dentistry. The platform provides doctors and dental labs with digital clinical solutions that aid GPs and dental labs in planning
and delivering restorative dental treatments, adding restorative functionality to our comprehensive digital platform to deliver digital ortho-restorative workflows
and interdisciplinary dentistry. Our exocad software is licensed and sold separately.
Other proprietary software mentioned in this Annual Report on Form 10-K, such as software embedded in our iTero intraoral scanners, ClinCheck and
ClinCheck Pro software, the Invisalign Doctor Site, Align X-Ray Insights and feature enhancements included as part of the Invisalign System are not sold
separately, nor do they contribute as individual items to revenues.
Business Strategy
Over the past 28 years, Align has helped doctors treat over 22 million patients with the Invisalign System and is driving the evolution in digital dentistry
through the Align
 Digital Platform. Our technology and innovations are designed to meet the demands of today’s patients with advanced technologies
improving doctors’ diagnostic capabilities along with treatment options that are effective, convenient, comfortable and affordable to improve overall oral health.
We strive to help doctors and lab technicians move their businesses forward by connecting them with new patients, providing digital solutions that increase
operational speed and efficiency and provide solutions that allow them to deliver exceptional treatment outcomes and experiences to millions of people around
the world. We achieve this by focusing on and executing our strategic growth drivers:
•
International Expansion. We continue growing our global presence by increasing awareness of our products and making them available in more
countries to more customers and consumers. We continue expansion of our sales and marketing by reaching into new countries and regions, including
new areas in Africa, Asia and Latin America. As of the end of 2025, we are selling directly or through authorized distributors in more than 100
countries. We support our growth through targeted investments in clinical support, product improvements, technological innovations, clinical education
and advertising. In addition, we are scaling and expanding our operations and facilities to better support the growing numbers of global customers. As
of the end of 2025, we have 11 fabrication and treatment planning locations throughout the world. We have a manufacturing facility in each of our
three key regions: Americas (Mexico), APAC (China), and EMEA (Poland). Each of these facilities form the foundation of our manufacturing strategy,
which continues to evolve to increase flexibility and optimize our capacity and cost structure. We also 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 are creating an infrastructure that allows us to be responsive to local
and regional needs, while providing global operational flexibility and scale needed for variations in global and regional demand. We expect to continue
expanding our business by investing in resources, infrastructure and initiatives that help drive Invisalign treatment growth, position our iTero intraoral
scanners as the preferred scanning technology for digital dental scans, and establish our exocad CAD/CAM software as the solution of choice for
dental labs in existing and new markets.
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•
GP Dentist Treatment. We strive to enable GPs, who treat the general patient population, to more easily identify potential cases they can treat with the
Invisalign System, monitor patient progress or, if needed, help refer cases to orthodontists while providing high-quality restorative, orthodontic and
dental hygiene care. We believe success with GPs can be achieved through doctor training and clinical education, by offering digital tools such as the
iTero intraoral scanner and products like Invisalign Go™ treatment that address the distinctive needs of GP patients, all delivered by sales and
marketing personnel specifically focused on the unique needs of this customer category. We encourage GPs to scan every patient with intraoral
scanners as a means to diagnose and treat patients over time and as an opportunity to drive future demand for their services and the Invisalign System.
DSOs represent a large and growing opportunity to help drive adoption of digital technology across the dental industry. We have well established
relationships with many DSOs globally that recognize the benefits of digital workflows enabled by our portfolio of products and services that make up
the Align
 Digital Platform, including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter
cycle times and customer proximity. We have and may continue to financially invest in or explore collaborations with key ecosystem partners,
including DSOs, whose missions and visions align with our vision, strategy, business model and goals.
•
Patient Demand. Our goal is to make the Invisalign brand a highly recognized name brand worldwide by creating awareness for Invisalign treatment
among consumers and motivating the potential 600  million patients who can benefit from treatment of malocclusion to seek treatment using the
Invisalign System. We accomplish this 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 trained doctors. To further drive consumer awareness, we continue to offer additional dental-related Invisalign Accessory Products under the
Invisalign brand name available in certain e-commerce channels in the United States. The initial stage of the Align
 Digital Platform drives consumer
demand and connects potential patients to our websites and the websites of Invisalign providers. Some of the tools that support this stage are
Invisalign.com, Doctor Locator, Invisalign SmileView
 tool, Invisalign  Practice App, Invisalign  Virtual Appointment and My Invisalign
 app.
The Align
 Digital Platform also facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations.
Further to our commitment to diagnostic innovation and our ongoing efforts to expand our digital platform, we launched the Align™ Oral Health Suite
in 2025, which integrates iTero diagnostic aid and visualization tools, and broadens the holistic approach we offer to GP dentists and orthodontists to
support earlier patient interaction for diverse treatment options in oral health, restorative and aesthetic dentistry.
•
Orthodontic Utilization. We continue to innovate and increase product applicability and predictability to address a wide range of cases, from simple to
complex, thereby enabling doctors to confidently diagnose and treat children and adults with the Invisalign System. This is especially important to
treating teenage patients who make up the largest portion of the 22 million annual orthodontic case starts. We also continue to make improvements to
our Invisalign treatment software, ClinCheck Pro, designed to deliver an exceptional user experience and increase treatment control to help doctors
achieve their treatment goals. In combination with the new Invisalign System innovations that are part of the Align
 Digital Platform, we are
enhancing the digital treatment planning experience for orthodontics by providing doctors with greater flexibility, consistency of treatment preferences
and real-time treatment plan access and modification capabilities.
Manufacturing and Suppliers
We have regional fabrication facilities in our main markets for clear aligners, which are located in Juarez, Mexico; Ziyang, China; and Wroclaw, Poland.
We believe this allows us to better serve our global customer base by being closer to our customers and driving efficiencies in the business. We produce our
handheld intraoral scanner wand, perform final scanner assembly and repair our scanners at our facilities in Ziyang, China and Petah Tikva, Israel and also
perform final scanner assembly in Blonie, Poland and Juarez, Mexico; as well as service and repair certain scanners in Juarez, Mexico.
We also perform digital treatment planning and interpretation for restorative cases based on digital scans generated by our iTero intraoral scanners. Our
digital treatment planning facilities are located worldwide, including in Costa Rica, China, Germany, Spain, Poland and Japan, among other international
locations.
Our quality system is required to be in compliance with the Quality System regulations enforced by the FDA, and similar regulations of other worldwide
regulatory authorities. We are certified to ISO 13485:2016, an internationally recognized standard for medical device quality. We are routinely audited by third-
party certification bodies as well as global health authorities for compliance to this standard and other international regulations. We maintain a formal,
documented quality system by which quality objectives are defined, understood and achieved. Systems, processes and procedures are implemented to ensure
high levels of product and service quality. We monitor the effectiveness of the quality system based on internal data
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and direct customer feedback and strive to continually improve our systems and processes, taking corrective action, as needed.
Since the mass-customized treatment planning and manufacturing processes of our products require substantial and varied technical expertise, we believe
our manufacturing capacity and capabilities are important to our success. In order to produce our highly-customized, highly-precise, medical quality products in
volume, we have developed a number of proprietary processes and technologies. These include complex software algorithms and solutions, including AI and
machine-learning based CAD/CAM software, vision systems, CT scanning, stereolithography and automated custom clear aligner fabrication equipment. To
increase the efficiency and yield of our manufacturing processes, we continue to focus our efforts on software development, equipment development and the
improvement of rate-limiting processes or bottlenecks. In addition, we have invested in developing technologies that allow us to directly print the devices to
improve and streamline the processes as well as the performance of devices. We continuously upgrade our proprietary, three-dimensional treatment planning
software to enhance computer analysis of treatment data and reduce time spent on manual and judgmental tasks for each case, thereby increasing the efficiency
of our technicians. Moreover, to improve efficiency and increase the scale of our operations, we continue to invest in the development of automated systems for
the fabrication and packaging of clear aligners.
In addition, predictable and consistent production is essential to timely deliver products to our customers efficiently and profitably. Our production can be
disrupted by such things as supply chain and shipping issues, production manufacturing software system issues, quality and safety issues, and production
equipment downtime. Accordingly, as we have grown our operations, we have included flexibility and resiliency in our overall manufacturing design to mitigate
against risks of production downtime. Our manufacturing facilities include backup generators and systems and each facility has an emergency response plan that
is part of ongoing employee training and testing through recurring cross functional scenario-based simulation exercises. Likewise, having manufacturing
facilities in key regions provides greater flexibility and capacity to adjust and redirect production as needed.
As part of our manufacturing resiliency design efforts, we have also considered climate change related risks such as higher average global temperatures,
rising sea levels and more frequent and severe wildfires, hurricanes, floods, storms, heat waves and other events and natural disasters (collectively, “climate-
related risks”). We view climate-related risks to be one of many operational challenges we face and factor them into our business continuity planning and
strategic risk mitigation efforts.
For instance, our manufacturing plants and operations may be impacted by extreme temperatures and weather, subjecting us to potential brownouts and
blackouts, increased energy costs and capital investments needed to maintain ideal operating temperatures. Our manufacturing facility in Juarez, Mexico is
located in an area classified as high-water stress and our operations could be impacted by water shortages, rationing and droughts. Our California, Costa Rica,
Mexico and North Carolina operations are located in areas that have historically been impacted by extreme weather events such as hurricanes, tornados,
wildfires or flooding.
In part to help mitigate risks to our manufacturing operations, we have strategically located our clear aligner production facilities on three different
continents. This allows us to both respond more quickly to customer demand while also offering redundancy in the event natural disasters or climate-related
events affect operations at one or more facilities. Moreover, each of our key clear aligner manufacturing facilities are located at elevations less likely to be
impacted by rising sea levels and at least two hundred miles inland.
Moreover, we are highly dependent on manufacturers of specialized scanning equipment, rapid prototyping machines, resin and other advanced materials
for our clear aligners, as well as the optics, electronic and other mechanical components of our intraoral scanners. We maintain single or sole source supplier
relationships for many of these machines and materials technologies. In particular, our CT scanning and stereolithography equipment used in our clear aligner
manufacturing and many of the critical components for the optics of our intraoral scanners are provided by single or sole source suppliers. We also currently
purchase our resin and polymer, the primary raw materials used in our manufacturing process for clear aligners, from a single source. A discussion of the risks
of our supply and manufacturing operations, including foreign operations, may be found in Item 1A of this Annual Report on Form 10-K under the heading
“Risk Factors.”
Sales and Marketing
Our sales and marketing efforts are focused on increasing adoption and utilization of the Invisalign System and Vivera retainers by orthodontists and GPs
and integrating the iTero scanner and services and exocad CAD/CAM products into dental labs and practices. The iTero scanner is an important component to
the customer experience and is central to a digital approach as well as overall customer utilization of Invisalign clear aligners. In each region, we have direct
sales, marketing and support organizations, which include quota carrying sales representatives, sales management and sales administration. We also have
distribution partners in certain markets. Our sales and marketing personnel are organized primarily to support orthodontists and GPs, allowing highly trained
and specialized personnel to serve each customer channel, thereby increasing our focus and
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effectiveness on both. We continue to expand in existing markets through targeted investments in sales resources, professional marketing and education
programs. Additionally, our consumer marketing programs are designed to create awareness and educate consumers on the benefits of Invisalign treatment and
Vivera retainers, including where they can find trained doctors to provide treatment.
We provide training, marketing and clinical support to orthodontists and GPs. As of December 31, 2025, we had approximately 130,015 active Invisalign-
trained doctors. We define doctors as active if they have submitted at least one Invisalign case in the prior 12-month period. To drive further adoption by
additional doctors and increase utilization by existing doctors, we are, among other things, continuing to move key operations closer to our customers,
simplifying our Advantage rebate program, launching new offerings, expanding our zero AA configuration, aligning our sales teams to market demographics,
and deepening our commitment to consumer marketing.
Research and Development
We are committed to investing in world-class digital and clinical technology development, which we believe is critical to achieving our goal of
establishing the Invisalign System as the standard method for treating malocclusion, our iTero intraoral scanners as the preferred scanning technology for digital
dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.
Our research and development activities are directed toward developing digital technology innovations we believe will deliver our next generation of
products and solutions as part of the Align
 Digital Platform. These activities range from accelerating product and clinical innovation, to developing treatment
planning and manufacturing process improvements, to researching future technologies, products and software.
The treatment capabilities of the Invisalign System have been demonstrated by more than 800 peer-reviewed publications and various clinical case studies
and articles have been published that highlight the clinical applicability of Invisalign treatment as a means to effectively treat a broad spectrum of malocclusions
across permanent and mixed dentitions, including addressing malocclusions of severe complexity. Similarly, various studies have been published demonstrating
the capabilities of our iTero Lumina solutions, including advanced features such as our NIRI technology, and we have conducted internal clinical validation
research supporting the conclusion that iTero Lumina photorealistic scans are clinically comparable to intra-oral photography. We undertake pre-
commercialization trials and testing of our technological improvements to our products and manufacturing process. In September 2025, we launched an
enhanced clinical evidence webpage containing an expansive library of peer-reviewed clinical research publications and the Align Global Gallery™, a
searchable database of more than 1,500 real-world Invisalign treatment cases by doctors from around the world. We furthermore fund research in the field of
orthodontics and dentistry through initiatives such as our Annual Research Award Program, which was in its 16th year in 2025 and donations to the American
Association of Orthodontists Foundation.
Intellectual Property
We believe our intellectual property portfolio represents a substantial business advantage. As of December 31, 2025, we had 1,137 active U.S. patents,
1,147 active foreign patents, and 1,070 pending global patent applications. Our active U.S. patents expire between 2026 and 2044. When patents expire, we lose
the protection and competitive advantages they provide, which could negatively impact our operating results; however, as we continue to pursue new
innovations, we seek intellectual property protection for new inventions and know-how through U.S. and foreign patent applications and non-disclosure
agreements. We also seek to protect our software, documentation and other written materials under trade secret and copyright laws. We furthermore have a
broad and diverse trademark portfolio that we use to highlight and protect universally recognized brands. Information regarding risks associated with our
proprietary technology and our intellectual property rights may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “Risk
Factors.”
Seasonal Fluctuations
General economic conditions impact our business and financial results, and we have historically experienced seasonal trends within our two operating
segments, customer channels and geographic locations we serve. Sales of the Invisalign System are often weaker in Europe, especially southern European
countries during the summer months and seasonally higher in China during the third quarter. Similarly, other international holidays like Lunar New Year can
impact our sales in APAC in the first quarter. In North America, summer is typically the busiest season for orthodontists that have a high percentage of
adolescent and teenage patients as many parents start their children in treatment before the school year begins. Conversely, many GPs are on vacation during
this time and therefore tend to start fewer cases. For our Systems and Services segment, capital equipment sales are often stronger in the fourth calendar
quarter. However, many of these typical seasonal patterns have been impacted by changes in foreign exchange rates, military conflicts, inflation, trade policies
and other macroeconomic challenges. It remains
TM
15

unclear when or the extent to which these seasonal fluctuations will return to historical norms. Consequently, seasonal trends have and may continue to cause
fluctuations in our quarterly results, including fluctuations in sequential revenue growth rates.
Competition
Our clear aligner products compete directly against traditional orthodontic treatments that use wires and brackets and increasingly against clear aligner
products manufactured and distributed by various companies, both within and outside the United States. Although the number of competitors varies by segment,
product, geography and customer, they include new and well-established regional competitors in certain foreign markets, as well as larger companies, divisions
of larger companies or well-capitalized new entrants with substantial sales, marketing, research and financial capabilities at cost-effective rates. We also
compete with direct-to-consumer (“DTC”) companies that provide clear aligners directly to consumers requiring little or no in-office care from doctors and also
from doctors who manufacture retainers and custom clear aligners using 3D printing technology.
Additionally, we face competition in the rapidly evolving markets for intraoral scanners and software solutions, including CAD/CAM. The global intraoral
scanner market is very dynamic with participants spanning from traditional dental conglomerates to companies dedicated primarily to scanner development and
sales with new entrants playing larger roles. The iTero intraoral scanner also competes with traditional PVS impressions that doctors use for clear aligner
therapy or other dental procedures, as well as other intraoral scanners. It also competes with traditional bite wing 2D dental x-rays for detecting interproximal
caries. Information regarding risks associated with increased competition may be found in Part I, Item 1A of this Annual Report on Form 10-K under the
heading “Risk Factors.”
We believe we are well positioned to compete in the markets we target. We have thousands of dedicated, highly skilled sales force employees who are
focused on key portions of our target markets that allow us to uniquely address customer needs and thereby enhance the customer experience. Our significant
historical and ongoing investments in research and development and design around the movement of teeth, SmartTrack aligner materials and design, intraoral
scanning, 3D manufacturing, global scale of manufacturing and treatment planning, strong brand name recognition, strong workforce, diversified and
knowledgeable customer base, geographic expansion, reliable financial results, leading digital platform, technology and IP, next wave of innovation with direct
3D printing and innovations powered by AI enabling more personalized care, and regulatory clearance of our products are among a few of our key competitive
factors that compare favorably with our competitors’ products and services.
Government Regulations
Many countries have established regulatory frameworks for commercialization of medical devices. As a designer, manufacturer, and marketer of medical
devices, we are obligated to comply with the respective frameworks of these countries to obtain and maintain access to these global markets.
The frameworks often define requirements for marketing authorizations which vary by country. Failure to obtain appropriate marketing authorization and
meet all local requirements, including specific quality and safety standards and new software and AI standards in any country in which we market our products,
could cause commercial disruption and/or subject us to sanctions and fines. Delays in receipt of, or a failure to receive, such marketing authorizations, or the
loss of any previously received authorizations, could have a material adverse effect on our business, financial condition and results of operations.
With regards to premarket authorization in the United States, many of our products are classified as medical devices under the U.S. Food, Drug, and
Cosmetic Act (“FD&C Act”). The FD&C Act requires these products, when sold in the United States, to be safe and effective for their intended use and to
comply with medical device regulations defined by the FDA. The regulatory framework depends on a set of written processes for ensuring consistent quality
called a Quality Management System (“QMS”) coupled with a product marketing authorization which depends on the risk classification of the product. This
regulatory framework is comparable to the framework established in the European Union (“EU”). Within the EU, our products are subject to the requirements
defined by the Medical Device Regulation EU 2017/745 which replaced the Medical Device Directive 93/42/EEC with a final transition date of May 26, 2021.
Similar market access regulations exist in Brazil, China, Japan and other countries. Our QMS is routinely audited by certification bodies as well as country
regulators for compliance with applicable regulations. We believe we are in material compliance with all state, federal, and international regulatory requirements
applicable to our products.
We are also subject to various laws around the world that govern interactions with our customers as healthcare professionals or government officials. The
laws govern different interactions and may include: prohibiting improper influence of or payments to healthcare professionals, other decision makers or
purchasers of medical devices and government officials;
16

setting out rules for when and how to engage healthcare professionals; marketing our products within the regulatory approval (e.g., on label) promotion, sale and
marketing of our products and services; the importing and exporting of our products; the operation of our facilities and distribution of our products; and
disclosure of payments to healthcare professionals and institutions. As we expand our operations, compliance with applicable laws in countries in which we sell
and invest in new business models becomes more complex and the general trend is toward increasingly stringent oversight and enforcement.
Initiatives sponsored by government agencies, legislative bodies, and the private sector to limit the growth of healthcare expenses generally are ongoing in
markets where we do business. It is not possible to predict whether these trends will impact our business or the potential cost containment measures on our
future business.
Our customers are healthcare providers who may be reimbursed by state or federal funded programs such as Medicaid, a foreign national healthcare
program, or private pay insurance, each of which may offer some degree of oversight. As a medical device manufacturer and seller, we are subject to
transparency reporting laws (also known as sunshine laws) that in certain countries and U.S. states require us to report transfers of value to healthcare
professionals that perform services or receive other items from us (e.g., meals, travel, branded promotional or educational items, or other benefits of value).
Enforcement actions and associated efforts to respond or defend against enforcement actions can be expensive, and any resulting findings carry the risk of
significant civil and criminal penalties.
In addition, we must comply with numerous laws and regulations addressing privacy, data protection, artificial intelligence, data governance and
cybersecurity. We are subject to the European Union General Data Protection Regulation 2016/679 and any applicable national implementing laws (together, the
“EU GDPR”), as well as the United Kingdom General Data Protection Regulation and the Data Protection Act 2018 (together, the “UK GDPR”). Collectively,
these are referred to as the “GDPR.” The GDPR establishes broad data privacy requirements regarding our collection, processing, sharing, disclosure, transfer,
and other uses of information relating to identifiable living individuals. These requirements include principles of accountability and the obligation to
demonstrate compliance through the implementation of appropriate policies, procedures, training, and audits. Many of these laws and regulations do or will
soon regulate or restrict cross-border data transfers, such as in the United States, the EU, Switzerland, Brazil, China, Vietnam, Japan, Korea, Australia, New
Zealand, the Kingdom of Saudi Arabia, Hong Kong and other countries. Further, in the United States, we may be required to comply with laws and regulations
addressing the collection, use, security and processing of protected health information and other information relating to individuals, including the Health
Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing rules. Additionally, many U.S. states maintain laws and regulations
addressing privacy, data protection, data governance and cybersecurity. Like many other companies, we must work to ensure our global privacy program
framework incorporates applicable requirements of new and modified laws and regulations in relevant jurisdictions to support our efforts to ensure our product
innovations and associated practices comply with these increasingly complex laws and regulations.
Legislatures and regulators globally are proposing, and in certain cases have enacted, new laws or regulations regarding privacy, data protection, artificial
intelligence, data governance and cybersecurity that could require us to modify our policies and practices in order to comply with new and evolving obligations
relating to these matters. Information regarding risks associated with data security and privacy may be found in Part I, Item 1A of this Annual Report on Form
10-K under the heading “Risk Factors.”
Environmental Laws and Regulations
We are subject to numerous international, federal, state and local environmental laws, including provisions that regulate the purchase, use, distribution, and
environmental impact of hazardous substances used in our operations, contained within our products and the packaging associated with our products. We are
also subject to environmental laws applicable to our manufacturing facilities and operations, including environmental health, safety and sustainability
regulations. The number and rate at which these regulations are being proposed and implemented are increasing at the regional, country and local territorial
levels, requiring greater diligence, governance and skills to manage. We may be required to incur significant costs to comply with existing and new laws and
regulations in the future. Information regarding risks associated with environmental laws and regulations may be found in Part I, Item 1A of this Annual Report
on Form 10-K under the heading “Risk Factors.”
Human Capital
We believe our culture and commitment to employees provide unique value that benefits Align, its stockholders and the communities and other
stakeholders we serve. Every employee, and every job, is important to our success and helps us achieve our purpose of transforming smiles and changing lives.
Align is committed to building a global workforce with varied cultural backgrounds and life experiences. Fostering a culture of dignity, integrity, open dialogue,
open-mindedness, compassion,
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fairness, recognition, and shared goals allows us to attract and retain the best talent, and provide a safe and supportive environment that allows our employees to
excel.
As of December  31, 2025, we had approximately 20,290 employees, a decrease of approximately 3.1% and 6.1% over December  31, 2024, and
December 31, 2023, respectively. The number of employees for each of the last five years and our employees’ roles as of December 31, 2025 are as follows:
 
We are fundamentally a global organization with approximately 91% of our employees located internationally, primarily in direct-labor roles in our
manufacturing and clinical treatment planning facilities. Set forth in the following paragraphs are some of the most important elements of our culture and
commitment to our employees.
Governance. Our commitment to improving the lives of our employees and the communities in which we live and work, including conducting our
business ethically, responsibly and transparently through open and clear disclosures that allow us and others to hold us accountable, begins with our Board of
Directors (“Board”) and management team. They set the tone for our organization by establishing and clearly communicating our core values of Agility,
Customer and Accountability that inform our culture. Our Global Code of Conduct (“Code”) and quality policies are designed to enable us to operate with
integrity and deliver superior treatment outcomes and experiences to patients. We seek to create an environment that values the health, safety and well-being of
our teams, and we work to equip them with the knowledge and skills to serve our business and develop their careers. We believe that by effectively managing
our business founded on these values, we are driving long-term value for our stockholders and all stakeholders.
As part of our commitment to our employees and communities, our Board has delegated oversight responsibility of our policies and practices that foster
Align’s sustainability and cultural initiatives, policies, practices, and programs to our Nominating and Governance Committee. Additionally, our Compensation
and Human Capital Committee has oversight responsibilities of all human capital management strategies, programs and policies. Our Compensation and Human
Capital Committee regularly reviews and discusses key performance indicators regarding human capital management that allow it to monitor trends on issues
such as total headcount, employee hiring, recruiting, attrition, career development, compensation, benefits, workplace culture, and other measures of employee
engagement and interest to management and the committee.
We believe our success continues to be driven by our focus on integrating and welcoming employees across the globe and of all different backgrounds,
orientations, beliefs, perspectives and capabilities into our workforce. Our employees bring a positive mix of ethnic and culturally diverse backgrounds to the 48
different countries in which we operate. Our largest population of employees work in Mexico followed by Costa Rica and China. Employees in the United
States represent approximately 9% of our global population.
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Our management team is comprised of individuals from varying countries and nationalities who are committed to promoting and encouraging the health
and well-being of our employees at work, at home and in society in general.
Our work culture is designed to create financial, health, career and personal benefits for our employees and organization. We sponsor cultural recognition
events to increase awareness of inclusion and belonging, including its importance in creating an environment where every employee feels safe, supported and
can thrive.
Our employees have also established and manage employee groups including employee resource groups based on shared characteristics or life
experiences. These are open to all employees, including those who do not directly identify with other members.
Talent Recruitment and Engagement. We employ a variety of career development, employee benefits, compensation and other policies and programs
designed to attract, develop and retain employees. We focus on building a talent pipeline that nurtures those early in their careers, encourages continuous
learning and growth, and incentivizes employees to stay and contribute to our success over the long term. Our programs include early recruitment at high
schools and universities, initiatives such as internships, co-ops, apprenticeships, and training programs, quarterly performance management check-ins focused
on individual goals and commitment to values and conducting regular employee surveys to build trust and strengthen relationships.
Our efforts have resulted in numerous awards for our positive work environment and culture. Some of the certifications, awards and recognitions
recognized or received include:
•
Best Workplaces for Women, China
•
Best Workplaces for Parents, Korea
•
Great Places to Work and Best Places to Work based on our employee-validated great workplaces in the following countries: Australia, Brazil, Canada,
China, India, Israel, Korea, Singapore, Taiwan, Thailand, Turkey, Vietnam and Raleigh, North Carolina (United States)
•
Forbes America’s Best Employers: Dream Employers, Best Midsize Employers, Best Employers for Engineers, Best Employers for New Grads, Best
Employers for Company Culture
•
LinkedIn Top Companies, Israel
•
Mercer China, Healthiest Workplace Award for Outstanding Women Care
•
Newsweek, America’s Greatest Workplaces: Overall, By State (California), Gen Z, Inclusion, Mental Well-Being, Parents & Families
We believe it is imperative to provide a vibrant employee experience and we value our employees’ collective voices. Accordingly, we conduct recurring
employee surveys that utilize a continuous employee listening strategy to collect employee feedback critical to improving our culture. This includes globally
managed pulse surveys, employee lifecycle surveys, and a self-service feature to support listening efforts. We use what we learn from the surveys to improve the
employee experience, including enhancements to our workplaces, focus on employee connections, increased career development opportunities, support for
relocated employees, and growth in our recognition programs and experiences. Our global response rates are consistently high, reflecting strong engagement by
our employees.
Training and Professional Development. Training is an integral part of developing and retaining our employees and creating a culture of leadership within
Align.
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Training at Align begins with our Code and our strong commitment to ethical business practices in all aspects of our operations. Every employee and
contractor is required to review the Code and confirm they understand and will comply with it. We routinely reference the Code in presentations and as part of
everyday operations.
As a further part of our standard onboarding program, we train employees on important environmental health and safety topics to protect them and the
environment. As a general practice, employees are trained to perform their jobs in accordance with all applicable statutory and regulatory requirements and that
training is routinely refreshed and re-administered.
At Align, we believe employees learn best when skill development is driven by the changing and immediate needs of our employees and by empowering
all employees to take action and ownership of their careers. We also believe learning should be relevant and actionable as well as rooted in our purpose and
values. develop@Align, our global online learning hub, enables our global employee population to access a diverse portfolio of approximately 2,100 self-
directed courses in up to 23 languages. We also offer a full suite of custom leadership development programs, beginning with aspiring leaders, continuing with
managers and directors, and culminating with executive development opportunities.
We also recognize we must continually evolve by providing employees with the resources they need to continue to learn, grow, and thrive. To this end, we
created Voyage. Voyage is a global initiative that offers a set of tools, resources and a new mindset, empowering employees to start thinking differently about
career growth by embracing development opportunities in new and sometimes unexpected ways. Our Voyage Compass helps employees experience their career
through four distinct lenses: self, networks, experience and skills. Since its launch in 2022, over 70% of the employee population has interacted with Voyage,
and there have been over 164,000 visits to the Voyage website. In addition to our navigation site, we annually host a Voyage Set Sail Month, where we offer
experiential learning for individuals and teams utilizing activities that keep professional development front and center in employees’ minds.
Compensation and Benefits. Our benefit and compensation programs reflect the value and contributions our employees make. In addition to competitive
base pay, we offer an assortment of benefits that vary by country, roles and contributions, including performance-based variable compensation programs, health
and welfare benefit plans, retirement planning services and benefits, holiday and leave policies, equity participation programs such as our 2005 Annual
Incentive Plan and Employee Stock Purchase Plan, and charitable and community service opportunities. We also offer discounts to our employees and their
dependents who undergo Invisalign treatment.
We are furthermore committed to pay equity practices. We exceed minimum pay requirements for our manufacturing employees and regularly review our
pay equity practices globally and locally for compliance with applicable laws and work to address discrepancies identified.
Health, Wellness and Safety. Our employees’ health and well-being is critical to our success and their continuing achievements. We therefore offer a wide
variety of robust programs and initiatives designed to promote the overall health and welfare of all our employees and their families. Every year, we promote a
Month of Wellness, a month dedicated to well-being and a worldwide movement fostering employee health across our organization. Throughout the Month of
Wellness, employees participate in a variety of activities such as informational sessions and health fairs and receive useful resources aligned to our wellness
pillars - mental resilience, physical well-being and healthy living, social/family connections, and financial wellness. This provides employees with a variety of
meaningful ways to embrace wellness and well-being through mindfulness, meditation, nutrition and mental wellness activities, exercise, hikes, yoga, volunteer
activities, financial education sessions, social events and stress management.
Additionally, a primary objective is to prevent injuries and occupational diseases by focusing first and foremost on creating and maintaining safe
environments. We have environmental, health, safety and sustainability personnel who are responsible for ensuring health and safety programs and processes are
maintained and effective at each of our locations. Major worksites, such as our clear aligner fabrication sites, and large offices have dedicated Environmental
Health and Safety (“EHS”) departments dedicated to ensuring our health and safety programs are maintained while contributing Best Management Practices and
general input to corporate-wide programs. Each EHS department is responsible for ensuring all employees at their location are properly trained on various EHS
topics and at the appropriate frequencies. A training suite is determined for each employee depending on their responsibilities and function modeled off ISO
45001.

Community. We actively encourage employees to support charitable organizations by providing opportunities for volunteerism, team building, and
donation and matching programs. In 2025, our employees continued to make us proud through their generosity and dedication, especially during our annual
Month of Smiles initiative in October where we encouraged them to make a difference individually and as teams through volunteer activities, charitable
donations, fundraising, and intentional acts of goodness. In addition, through our Align Foundation, we support organizations whose visions closely align with
our
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mission to improve smiles, supporting and educating teens, and empowering our customers through partnerships with learning institutions and foundations.
Below are some of our key community initiatives in 2025:
•
Since 2013, we have been a proud supporter of Operation Smile, a global medical nonprofit that has provided hundreds of thousands of free surgeries
for people born with cleft lips and cleft palates in low and middle-income countries. For a fifth year, we were the title sponsor of Operation Smile’s
International Student Leadership Conference, a powerful opportunity for youth in high schools and colleges around the world to develop leadership
skills and impact their communities. As part of our 2025 sponsorship, we provided scholarships for 90 students, including those born with cleft
conditions and those facing financial barriers. As of December 31, 2025, we had donated approximately $3.4 million to Operation Smile.
•
As part of Align’s commitment to improving oral health, we partnered with the INCAE Business School as part of the CAHI Jeffe Fellowship in Health
and Innovation to improve health services in Latin America. The CAHI Jeffe Fellowship brought together 19 leaders from nine Latin American
countries and focused on enhancing the quality, accessibility, and affordability of health services through a variety of programs. Align provided
scholarships to two leaders from the program who focused on oral health education and expansion of dental health for low-income populations.
•
For 18 years we have supported America’s ToothFairy, an organization with a mission to ensure underserved children in the United States have access
to dental care and learn about oral health by supporting nonprofit clinics and community partners. As of December 31, 2025, we have provided almost
$2 million for the foundation’s operational expenses and children’s oral health programs. As Title Sponsor of the HERO Program since 2019, we have
helped the program reach an estimated 2.87 million children, caregivers, and parents. During America’s ToothFairy’s 2025 fiscal year, which ended
June 30th, the HERO Program positively impacted 1,082,150 children and caregivers  using downloadable resources, which are also available in
multiple languages. With Align’s support, America’s ToothFairy’s Dental Resource Program (DRP) member clinics provided clinical care to 213,675
children—on average, a 25% increase over 2024. Among these:
◦
191,204 children received fluoride varnish, nearly 36% more than in 2024
◦
75% of patients served live at or below the poverty line
◦
44% of children treated live in rural communities where access to care is limited
◦
52% of care was delivered through school-based programs
◦
85% of patients rely on state-funded insurance
We also provide product donations to the dental community to help patients in need of healthy, beautiful smiles. For more information on our charitable
and 
community 
efforts, 
please 
refer 
to 
the 
Corporate 
Accountability 
portion 
of 
our 
corporate 
website 
located 
at
https://www.aligntech.com/about/corporate_accountability.
Available Information
Our corporate website address is www.aligntech.com, and our investor relations website address is http://investor.aligntech.com. The information on or
accessible through either of these websites is not incorporated by reference into this Annual Report on Form 10-K, and all website URLs in this Annual Report
on Form 10-K are intended to be inactive textual references only. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, our proxy statements on Schedule 14A for our annual stockholders’ meetings and amendments to reports filed pursuant to Sections 13(a) and 15(d)
of the Exchange Act are available, free of charge, on our investor relations website as soon as reasonably practicable after we electronically file with or furnish
such material to the Securities and Exchange Commission (“SEC”). Further, the SEC maintains an internet site (http://www.sec.gov) that contains reports, proxy
and information statements and other information regarding our filings with the SEC.
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Information about our Executive Officers
The following table sets forth certain information regarding our executive officers as of February 27, 2026:
 
Name
Age
Position
Period
Joseph M. Hogan
68
President and Chief Executive Officer of Align
• Chief Executive Officer of ABB
• Chief Executive Officer of GE Healthcare
2015-Present

2008-2013

2000-2008
John F. Morici
59
Chief Financial Officer and Executive Vice President, Global Finance of Align
• Chief Financial Officer and Senior Vice President, Global Finance of Align
• Chief Financial Officer of Align
• EVP and Managing Director of NBC Universal North America Home Entertainment
• CFO/Chief Operating Officer of NBC Universal North America Home Entertainment
• Senior Vice President and Chief Financial Officer of NBC Universal North America Home Entertainment
2022-Present
2018-2022
2016-2018
2014-2016
2011-2014
2007-2011
Julie Coletti
58
Executive Vice President, Chief Legal and Regulatory Officer of Align
• Senior Vice President, Chief Legal and Regulatory Officer of Align
• Vice President, Associate General Counsel, Strategic Commercial Affairs of Align
• Vice President, Global General Counsel and Chief Compliance Officer of Danaher
• Vice President, Chief Legal Officer and Corporate Secretary of Bayer HealthCare's MEDRAD/Radiology and
Interventional Division
2022-Present

2019-2022

2018-2019

2013-2017

2007-2013
Stuart Hockridge
54
Executive Vice President, Global Human Resources of Align
• Senior Vice Present, Global Human Resources of Align
• Vice President, Global Human Resources of Align
• Vice President of Talent of Visa
2022-Present

2018-2022

2016-2018

2013-2016
Item 1A. Risk Factors.
Our business, reputation, results of operations, financial condition, cash flows and stock price can be affected by a number of factors, whether currently
known or unknown, or that we currently believe to be material. including those described below. When any one or more of these risks materialize from time to
time, our business, reputation, results of operations, financial condition, cash flows and stock price can be materially and adversely affected. The risks below
are not the only ones we face. Because of the following factors, as well as other factors affecting our results of operations and financial condition, past financial
performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or
trends in future periods. Therefore, you should review this section carefully, as well as our consolidated financial statements and notes thereto and other
information appearing in this Annual Report on Form 10-K, for important information regarding these and other risks that may affect us. Additionally, you
should consider these risk factors in connection with evaluating the forward-looking statements contained in this Annual Report on Form 10-K.
Macroeconomic and External Risks
Global and regional economic conditions have and could in the future materially affect our business, financial condition and results of operations.
Macroeconomic conditions impact consumer confidence and discretionary spending, which can reduce or shift spending away from elective procedures,
drive patients to pursue less costly orthodontic treatments, decrease the number of orthodontic case starts, reduce patient traffic in dental offices, or reduce
demand for dental services generally. Consumer spending habits are affected by, among other things, fluctuations in foreign currency exchange rates, changes in
consumer confidence and demand, inflation, general economic weakness, actual or potential slowdowns or recessions, employment levels, health insurance
coverage, wages, debt obligations, discretionary income, interest rates, cultural and social influences, market volatility and perceptions of current and future
economic conditions. For instance, decreased demand for dental services has and may in the future cause doctors and labs to revert to wires and brackets and
postpone investments in capital equipment. Uncertain economic outlooks for, or declines in the economic outlooks of, the United States, Chinese, European and
other economies have and could in the future materially adversely affect consumer demand and dental practice spending. Higher interest rates have and could in
the future reduce consumers’ disposable income, which could cause a decrease in discretionary spending for our products.
Inflation has and may continue to adversely impact spending and trade activities, and may unpredictably impact global and regional economies. Efforts by
central banks and federal, state and local governments to combat inflation could result in an economic recession or slowdown or adversely impact consumer
spending for a prolonged period of time. Higher inflation, as well as the cost of fuel, energy and domestic and international shipping costs, food and other
essential or discretionary items,
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raw material prices and labor rates, has and may continue to rise, which could adversely impact the costs of producing, procuring and shipping our products. We
may not be able to fully mitigate the impact of the increased costs or pass price increases on to our customers, which could result in downward pressure on our
operating results. Attempts to offset cost increases with price increases may reduce sales, increase customer dissatisfaction or otherwise harm our reputation.
Any of these events could materially affect our business, financial condition or results of operations.
We are subject to foreign currency exchange fluctuations, which could have a material adverse effect on our financial condition or results of
operations.
We have significant international operations and sales and are therefore exposed to fluctuations in foreign currencies that have and may continue to
adversely impact our business, financial condition or results of operations. Although the U.S. dollar is our reporting currency, a large portion of our net revenues
and expenses are generated in foreign currencies. While we forecast our balance sheet exposures to foreign currency fluctuations and utilize foreign currency
forward contracts to moderate the impact of currency fluctuations on certain assets and liabilities, these contracts may not eliminate our exposure. Currency
exchange rate fluctuations have and may continue to materially adversely affect our results of operations and cash flows.
Geopolitical events, tariffs and trade policies, and military conflicts have and could in the future materially affect our business, financial condition and
results of operations.
Geopolitical events, wars, military actions, terrorism, or major public health crises have and could in the future harm or disrupt international commerce and
the global economy, and could materially adversely affect our business. Such events have and could result in, among other things, supply chain and trade
disruptions, changes in diplomatic and trade relationships, new and retaliatory tariffs, trade protection measures, quotas, embargoes, trade sanctions and
countersanctions, customs investigations or restrictions, boycotts, reduced consumer spending, government shutdowns, cyberattacks, energy shortages or power
outages, energy rationing that adversely impacts our manufacturing facilities, rising fuel or rising costs of producing, procuring, and shipping our products,
constraints, volatility or disruption in the financial markets, employee deaths or injuries, restrictions and shortages of food, water, shelter and medical supplies,
data or information exchange, disruptions, interruptions or limitations in telecommunication services, critical systems or applications reliant on a stable and
uninterrupted communications infrastructure, and protests that may impact delivery of our products to customers or destruction of property. Such events may
also cause a shift in public opinion about companies based in the United States or in the regions where we operate or plan to operate, which could adversely
impact our reputation and business.
Tariffs or proposed tariffs, customs duties, or fees, and any retaliatory tariffs, international trade disputes, or protectionist trade measures taken in response
to such tariffs may increase the cost of our products and the components or the raw materials used to make them, reduce demand for our products and adversely
impact our gross margin and results of operations, limit our ability to sell to certain customers, limit or prohibit the availability of certain raw materials,
components and parts necessary for our products or the products of our suppliers, or impede or slow the movement of our goods across borders. For example,
the U.S. Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects on
the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices. A significant portion
of the products we sell, and the components and raw materials used in our products are originally manufactured or sourced outside the United States. For
example, we manufacture clear aligners in our facility in Mexico and ship them to the United States, primarily for our United States customers, with the
remainder eventually shipped to other international locations. Tariffs have and could in the future result in additional costs for our products, which may reduce
demand for our products and adversely impact our gross margin and results of operations, and we may not be able to fully or substantially mitigate the impact of
any new or increased tariffs or pass price increases on to our customers and to the extent we do, we may experience reduced demand for our products. The
extent and duration of any tariffs and the resulting impact on general economic conditions and on our business, financial condition and results of operations are
uncertain.
Foreign countries have and may continue to adopt other measures such as controls on the import or export of goods, technology or data, including personal
data, which could adversely impact our operations and supply chains or limit our ability to offer certain products or services. We may take various actions in
response to these measures, including changing suppliers, where we manufacture our products, or restructuring business relationships. Such actions may be
expensive, time-consuming, disruptive to our logistics and operations, irreversible, and more costly for us and our customers. Trade restrictions may be
announced with little or no advance notice and we may be unable to effectively mitigate any adverse impacts in a timely manner or at all.
Military conflicts, wars, and escalation of terrorist or gang activities have and may in the future materially adversely impact the economies in which we
operate. Our iTero operations, headquartered in Israel, are close to areas that have been affected by the conflict between Israel and Hamas. Our supply chains
and demand for our products could be impaired as a result of political instability, drug trafficking, the continuation or escalation of terrorist or gang activities
(particularly with respect to our manufacturing operations in Mexico), hostilities, export and import restrictions, sanctions or boycotts. These events could
disrupt ongoing operations and may materially impact the logistics, timing and cost of shipping of our products and materials or our ability to operate out of
impacted areas, and our ongoing contingency planning and business continuity measures to mitigate these risks may not be sufficient. Additionally, China’s
territorial conflicts with other neighboring countries may impact our operations and sales in China. We cannot predict the progress or outcome of these events or
the reactions by governments, businesses or consumers and each event could, individually or in the aggregate, materially adversely affect our business, financial
condition and results of operations.
Natural disasters may adversely impact our business, financial condition and results of operations, as well as those of our customers and consumers,
suppliers, contract manufacturers, commercial intermediaries and other business partners.
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Natural disasters and extreme weather conditions (including those caused by climate change) can cause deaths, injuries and major public health crises,
power outages, property damage, restrictions and shortages of food, water, shelter and medical supplies, telecommunications failures, materials scarcity, price
volatility and other adverse consequences. If a natural disaster occurs in a region where one of our facilities or those of our customers or suppliers are located,
our or their employees or facilities could be impacted, valuable research could be lost, and our ability to create treatment plans, respond to customer inquiries or
manufacture and ship our products could be compromised, causing significant delays and reputational harm. Climate change could increase the frequency and
severity of natural disasters such as hurricanes, tornadoes, earthquakes, wildfires, droughts, extreme temperatures, or flooding which could cause supply chain
interruptions, increase demand and negatively impact availability of sources of energy or resources material to manufacturing our products and operations, or
cause damage to our products and facilities. It could also affect the availability or cost of materials, goods, and services on which we and our suppliers, contract
manufacturers, commercial intermediaries and other business partners rely, which could materially adversely impact our business, financial condition and results
of operations.
Business and Industry Risks
Demand for our products and services may not increase or may decrease for many reasons, including resistance to the innovative and business-model-
disruptive nature of some of our products and services.
Our products and services require our customers and consumers to forego traditional treatment methods. For example, Invisalign treatment is a significant
departure from traditional orthodontic wires and brackets, and our customers and consumers may not find it cost-effective or preferable. A number of dental
professionals believe Invisalign treatment is only appropriate for a limited percentage of patients. Additionally, our clear aligners and iTero products utilize
digital technology and some dental professionals have and may continue to resist moving to a digital platform. Increased acceptance of our products and
services depends in part on the recommendations of dental professionals, professional associations, societies and organizations, as well as other factors,
including efficacy, safety, ease of use, reliability, aesthetics, third-party reimbursement, price compared to traditional treatment methods and competing
products, and perceptions regarding single-use or non-recyclable plastics. Additionally, negative experiences with clear aligner products manufactured or
distributed by competitors may adversely affect our reputation and demand for the Invisalign System if consumers or dental professionals attribute these
negative experiences to clear aligner therapy generally, even if our products differ significantly in design, quality, and clinical effectiveness. If demand for our
products or services fails to increase, or decreases, our business, financial condition and results of operations may be materially adversely affected.
Our net revenues depend primarily on sales of the Invisalign System and iTero intraoral scanners and declines in volume or the average selling price
(“ASP”) may adversely affect net revenues, gross profit, operating profit and net income.
Our net revenues are primarily dependent on sales of the Invisalign System and iTero intraoral scanners. Of the two, we expect the Invisalign System to
continue to represent the majority of our net revenues and remain critical to our success.
The ASPs of our products, particularly the Invisalign System, are influenced by numerous factors, including the mix of product treatment packages,
geographical mix, channel mix and timing of products sold, promotions and discounts, inflation and foreign currency exchange rates. In addition, we sell our
products at different prices and with varying shipping and handling charges or processing fees that may differ by country. Our ASPs for the Invisalign System
and iTero intraoral scanners have been and could in the future be adversely affected if:
•
we offer promotions or general or volume-based discount programs, product or services bundles, large account sales or consumer rebate programs;
•
participation in promotions or programs unexpectedly increases, decreases or changes demand in material ways;
•
our geographic, channel or product mix shifts to lower-priced products or to products with a higher percentage of deferred revenue;
•
we decrease prices or are unable to increase prices on one or more products or services in response to increasing competitive pricing pressures;
•
we introduce new or change existing products or services, or modify how we market, lease or sell any of our new or existing products or services;
•
we modify our pricing strategies for certain products or adjust pricing for certain items based on cancellation fees, shipping and handling charges or
processing fees;
•
we participate in government tenders, such as volume-based procurement in China; or
•
our critical accounting estimates materially differ from actual results.
We have a history of offering volume discounts, price reductions and other promotions to targeted customers and consumers and releasing lower priced
products which have had, and may in the future have, unexpected and unintended consequences, including reduced net revenues, gross profit, operating profit
and net income.
Competition in the markets for our products and services is increasing.
The dental industry is experiencing immense and rapid digital transformation and we may be unable to compete with existing competitors and emerging
companies that introduce new technologies, products or services, and customers who alone or with others create orthodontic appliances and solutions or other
products or services that compete with us. While our product portfolio facilitates this transition, our competitors may render our technology or products obsolete
or economically unattractive, particularly as competitors incorporate AI and machine learning into new or existing services and technologies that facilitate
changes in doctor-patient interactions, expectations and treatment workflows. We may be unable to devote adequate
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financial resources to develop or acquire new AI technologies and systems in the future and sufficiently meet evolving industry trends and consumer demands.
We also face competition from traditional products and services, such as wires and brackets, which doctors have historically been able to purchase at a
lower price point. We have and will likely continue to experience price-focused competition as we continue to expand into new markets, which could contribute
to the commoditization of our products or services if we are unable to otherwise differentiate our offerings from those of our competitors.
The number and types of competitors we face are diverse and growing rapidly. The Invisalign System competes primarily against traditional wires and
brackets and increasingly with clear aligners manufactured and distributed by new market entrants and existing competitors, including traditional medical device
companies, laboratories, startups and, in some cases, doctors and DSOs. Our competitors also include DTC companies that provide clear aligners using a
business model requiring little to no in-office care from trained and licensed doctors, and doctors and DSOs who manufacture custom aligners or procure
products from third-party white-label providers. Large consumer product companies may also start supplying orthodontic products. Orthodontists, GPs and
DSOs have and may continue to sample competitive and alternative products, take advantage of competitive promotions and sale opportunities, or engage in
“bait and switch,” “margin steering” or similar practices that take advantage of the significant brand recognition of Invisalign to offer alternative products.
Our iTero intraoral scanners compete with polyvinyl siloxane impressions and numerous new and existing intraoral scanners and traditional impression
methods, as well as traditional bite wing 2D dental X-rays and dental imaging systems that leverage NIRI technology and AI for detecting interproximal caries.
We have and may continue to experience competition with respect to our scanners and software solutions from competitors who introduce products at lower
prices or with enhanced features or functionalities that better meets customer demand, including expansion of their portfolios in the digital ecosystem. If we are
unable to compete effectively with existing products, existing competitors, new market entrants, or respond effectively to new technologies, our business,
financial condition, and results of operations could be materially adversely impacted.
Our success depends on our ability to quickly and profitably develop, manufacture, market, and obtain and maintain regulatory approvals or clearances
of new, improved or refurbished products and services.
The extent and rate at which our products or services achieve market acceptance and penetration depends on many factors, including our ability to:
•
cost-effectively and efficiently predict, timely innovate, develop, manufacture, quality test, market, launch, dispose of and sell new or improved
technologies, applications, features, products and services to meet market demand and keep pace with changes in technology, customers’ demands and
industry standards;
•
successfully and timely obtain and maintain regulatory approvals or clearances of new or improved products or services from government agencies
such as the FDA and analogous agencies in other countries;
•
properly forecast the amount and timing of new or improved product and services demand;
•
allocate our research and development funding to products and services with higher growth prospects;
•
ensure the compatibility of our technology, services and systems with those of our customers;
•
anticipate and rapidly innovate in response to new competitive offerings and technologies;
•
differentiate our products and services from those of our competitors as well as other products and services in our own portfolio and successfully
articulate the benefits to potential customers;
•
design and manufacture products that achieve the clinical and practice outcomes necessary for market acceptance;
•
manage the impact of nationalism or initiatives encouraging consumer purchases from domestic vendors;
•
qualify for third-party reimbursement for procedures involving our products or services;
•
offer attractive and competitive products, services and subscription plans;
•
encourage customers to adopt new or improved technologies and provide the needed technical, sales and marketing support to make new or improved
product and services launches successful;
•
manage government procurement program restrictions; and
•
source and receive quality raw materials or parts from our suppliers.
If we fail to accurately predict the needs and preferences of customers and their patients, or fail to offer viable products or services, we may invest heavily
in research and development that does not lead to significant revenues. Even if we successfully innovate and develop new or improved products and services,
we may incur substantial costs doing so and our profitability may suffer. Introduction and acceptance of any products and services may take significant time and
effort, particularly if they require doctor education and training to understand their benefits or doctors choose to withhold judgment on a product or service until
patients complete their treatments. In addition, we periodically introduce new business and sales initiatives to meet customers’ needs and demands, which may
not be successful and may involve short-term execution challenges. Should these initiatives fail, our business, financial condition and results of operations could
be materially adversely impacted.
We may not realize the anticipated benefits of acquisitions, investments or other strategic transactions, and they may require significant management
attention, disrupt our business, dilute stockholder value or adversely affect our business, financial condition and results of operations.
We have and may in the future acquire, or make investments in, companies, businesses, products, technologies or other assets, which may not ultimately
strengthen our competitive position or achieve our desired synergies and integration. Alternatively, we may be unable to find suitable investment or acquisition
opportunities or be unable to complete investments or acquisitions on favorable terms. We are subject to various risks when making a strategic investment or
acquisition and integrating the operations and cultures of acquired businesses within our own, including that we may:
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•
ultimately own less than a majority of the outstanding shares of the company and be unable to control or have significant influence over critical issues
that could harm the value of our investment;
•
fail to perform proper due diligence and inherit unexpected material issues or assets, including intellectual property (“IP”) or other litigation or ongoing
investigations, accounting irregularities or compliance liabilities;
•
experience information technology (“IT”) security and privacy compliance issues;
•
invest in companies that generate net losses or are slow or fail to develop;
•
not realize a positive return on our investment or determine that investments have declined in value, which could require recording impairments;
•
need to pay cash, incur debt or issue equity securities to pay for an acquisition, adversely affecting our liquidity, financial condition or the trading price
of our common stock;
•
find it difficult to implement and harmonize company-wide financial reporting, forecasting and budgeting, accounting, billing, IT and other systems
due to inconsistencies in standards, internal controls, procedures and policies;
•
require significant time and resources to effectuate the integration;
•
fail to retain key personnel or harm our existing culture or the culture of an acquired entity;
•
not realize material portions of the expected synergies and benefits of the investment or acquisition; or
•
unsuccessfully evaluate or utilize the acquired technology or acquired company’s know-how or fail to successfully integrate the technologies acquired.
Operational Risks
Our quarterly and annual results of operations have and will continue to fluctuate in the future, and we may not accurately predict the timing and
amount of customer demand and our revenues, costs, and expenditures.
Some of the factors that have and could in the future cause our operating results to fluctuate include:
•
changes in consumer, customer and industry demand;
•
changes in manufacturing, packaging, delivery and inventory costs;
•
the creditworthiness, liquidity and solvency of our customers and their ability to timely make payments when due;
•
our ability to collect payments;
•
our acceptance of longer customer payment cycles;
•
changes in the timing of revenue recognition and our ASPs as a result of changes to the amount allocated to the standalone selling price of the distinct
performance obligations under sales contracts;
•
seasonal fluctuations;
•
geographic, channel or product mix shifts to lower priced products or to products with a higher percentage of deferred revenue;
•
improvements to or changes in our products, capabilities or technologies that replace or shorten the life cycles of legacy products or cause customers to
defer or stop purchasing legacy products until new products become available;
•
changes in costs and expenditures, including in connection with new treatment planning and fabrication facilities and the hiring and deployment of
personnel;
•
the timing of clear aligner treatment order submissions, acceptance, processing and fulfillment, which can cause fluctuations in our backlog;
•
new, proposed or retaliatory tariffs; and
•
timing and fluctuation of spending around marketing and brand awareness campaigns and industry trade shows.
If we fail to accurately predict product demand, our manufacturing capacity, staffing, supplies, components, or materials, or those of one or more of our
suppliers may be inadequate. If we fail to timely manufacture and deliver products to meet demand, this could damage our relationships with existing customers
or harm our ability to attract new customers and adversely affect our business, financial condition and results of operations.
We may make business decisions that adversely affect our operating results such as modifications to our pricing policies and payment terms, promotions,
development efforts, product releases, business structure or operations. The majority of our expenses, such as employee compensation and lease obligations, are
relatively fixed in the short term. Moreover, our expense levels are based, in part, on expectations for future revenues. As a result, if our net revenues for a
particular period are below expectations, we may be unable to timely or effectively reduce spending to offset any shortfalls.
Our results of operations may be adversely affected if doctors at DSOs, orthodontic service organizations (“OSOs”) or other large group practices
reduce, delay, or do not increase their purchasing of our products and services in ways that reduce adoption of our products and services.
DSOs, OSOs and other large group practices have become an increasingly important channel for adoption of our products and services. If doctors at DSOs,
OSOs or other large group practices reduce, delay, or do not expand their purchasing of our products and services, or otherwise change priorities, protocols, or
workflows in ways that reduce utilization of our products, demand for our products and services may not increase or may decrease, which could have a material
impact on our business, financial condition and results of operations. In addition, on behalf of the doctors in their affiliated practices, DSOs and other large
group practices may have greater leverage to negotiate pricing, volume‑based discounts, rebates, extended payment terms, or other commercial concessions,
which could adversely affect our ASPs, gross margins and profitability.
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We are subject to operating risks, including excess or constrained capacity, operational inefficiencies and pressure on our internal systems, personnel
and suppliers, including as a result of our past and any future restructuring efforts, which could adversely affect our results of operations.
To manage current and anticipated future operations effectively, we must continually implement and improve our operational, financial and management
information systems, hire, train, motivate, manage and retain employees, and ensure our suppliers remain diverse and capable of meeting demand for the
systems, raw materials, parts and components essential to product manufacturing and delivery. We may fail to balance near-term efforts to meet existing demand
with future demand, including adding personnel, creating scalable, secure and robust systems and operations, and automating processes for long-term
efficiencies. Production of the Invisalign System and iTero intraoral scanners could also be limited by capacity constraints due to a variety of factors, including
labor shortages, shipping delays, our dependency on third-party vendors for key materials, parts, components and equipment, the quality of or changes in
product components, and limited production yields. Any such failure could materially impact our business, financial condition and results of operations.
Additionally, we have established treatment planning and manufacturing facilities closer to our international customers to provide better experiences, create
efficiencies and provide redundancy should other facilities become unavailable. If one of these facilities is temporarily, partially or fully shut down, we may be
unable to timely fulfill orders, which may negatively impact our reputation, business, financial condition and results of operations.
Security breaches, data breaches, cybersecurity attacks, or other cybersecurity incidents could materially adversely impact our operations and patient
care, and our reputation, business, financial condition and results of operations could be harmed.
Our IT systems, policies and contracts and the policies of our third-party vendors, and their IT systems safeguard employee, applicant and customer
personal, health and financial, and our own proprietary information and data essential to our operations. Our cybersecurity controls also depend on our
customers, many of whom are individual or small healthcare providers with limited IT experience and inadequate or untested security protocols, to successfully
manage data privacy and security requirements. We and our service providers, third-party vendors and other third parties could be targeted by or subject to
physical break-ins, computer viruses and other malicious code, unauthorized or fraudulent access, programming errors or other technical malfunctions, hacking
attacks, phishing, vishing, deepfakes, and other social engineering attacks, malware, ransomware, employee noncompliance, error or malfeasance, cybersecurity
attacks, malicious code, and other breaches of, or incidents impacting, IT systems or similar malicious or otherwise disruptive actions, including by organized
groups and nation-state actors, which may disrupt or limit the availability of, or result in damage to, our IT systems and result in loss or unavailability of,
damage to, or the unauthorized acquisition, use, disclosure, or other processing of confidential information. We have experienced, and may again experience in
the future, cybersecurity incidents, data incidents, and unauthorized internal employee exfiltration of information.
Our cybersecurity risk management program and processes, including our policies, controls or procedures, may not be successfully implemented, complied
with or effective in protecting our systems and information or any other information we maintain or otherwise process. Further, the frequency and sophistication
of third-party cybersecurity attacks are increasing, particularly with the advancement of AI technologies. Significant service disruptions, breaches, incidents,
interruptions or other disruptive events impacting our infrastructure and IT systems, or other cybersecurity incidents, or any belief or reporting that any of the
foregoing has occurred, could expose us to regulatory investigations, private claims, demands, litigation or other proceedings, impair our reputation and
competitive position, distract management and require significant time and resources to address. In addition, patient care could suffer, and we could be liable if
our products, services or IT systems fail to timely deliver accurate and complete information.
Additionally, our iTero intraoral scanners may be independently or collectively the target of cybersecurity incidents or attacks or subject to security
vulnerabilities, bugs, errors, defects, or viruses or other malicious code. Due to the large and growing number of these decentralized devices, we may be unable,
or not have the capacity, knowledge or infrastructure, to respond to or remedy a cybersecurity incident in a timely manner. Any such cybersecurity incident may
cause loss or damage to us, our customers or strategic business partners or may cause further malfunctions in, or damage to, our products, services, or IT
systems, damage to, or loss, unavailability, or unauthorized acquisition, use, or other processing of our data, or disruption, interruption or temporary cessation of
our operations. Further, any such security breach or incident, or other cybersecurity incident, or any belief or reporting that any of the foregoing has occurred,
may otherwise have a negative impact upon our business or reputation.
Issues with IT system and software integration, implementation, updates, and upgrades, or third-party software have previously and could again in the
future disrupt our operations.
We rely on the efficient, uninterrupted, and secure operation of complex IT systems and are dependent on key third-party software embedded in IT systems
as well as third-party hosted IT systems to support our operations, including third-party cloud platforms. To effectively manage and improve our operations, our
IT systems and applications require an ongoing commitment of significant expenditures and resources to maintain, protect, upgrade, enhance, and restore
existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving industry and regulatory
standards, and changing customer preferences. Usage of online and hosted technology platforms by us, our customers, and suppliers, including remote working,
teledentistry, and new or expanded use of online service platforms, products, and solutions such as doctor, consumer, and patient apps have increased the
demands on and risks to our IT systems and personnel. Moreover, we continue to transform business processes, extend established processes to new
subsidiaries, and implement additional functionality in our enterprise resource planning, product development, manufacturing, and other software and IT
systems. This entails certain risks, including operational disruptions, such as our ability to continue developing and updating
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products while addressing safety and security, track orders and timely ship products, manage our supply chain, and aggregate financial and operational data.
Failure to adequately protect and maintain the integrity of our products, IT systems and data in those systems, and those of our suppliers and customers may
materially impact our reputation, business, financial condition, and results of operations.
Additionally, we continuously upgrade and issue new software releases upon which customer facing manufacturing and treatment planning operations
depend. Software applications and products containing software may contain errors or defects, especially when first introduced or released. The discovery of a
defect, error, or security vulnerability in our products, software applications or IT systems, incompatibility with customers’ computer operating systems and
hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems, that we are unable to timely cure, may
cause adverse consequences. These may include delays, loss of revenues, significant remediation costs, market acceptance delays, data damage, loss, or
unavailability, unintended disclosure or other processing of financial, health or other information relating to individuals, product recalls, loss of market share or
increased service costs, any of which could have a material effect on our reputation, business, financial condition or results of our operations and those of our
customers or our business partners.
Products in our Systems and Services segment, such as our iTero intraoral scanners, are subject to software and hardware risks that, if improperly
managed, could have a material adverse impact on our business and financial results.
Our Systems and Services segment is subject to software and hardware risks related to the manufacturing, design, quality and safety of our complex, global
installed base of iTero intraoral scanners, which are continually updated to add, expand or improve features with new hardware or software, to integrate new or
existing software or other components manufactured by third parties, or to provide repair or replacement parts, any of which may contain errors or exhibit
failures, especially when products are first introduced. We may be unable to ensure that third-party components or changes to them will be completely
compatible with our scanners, which could cause our scanners to fail to perform as anticipated. Additionally, the third-party software integrated into or
interoperable with our scanners routinely reach end of life, and as a consequence, certain applications and models may be exposed to additional vulnerabilities,
including security risks, errors, and malfunctions that may be irreparable or difficult to repair. We may not timely and adequately remediate or implement
corrective measures for such failures, including due to reliance on third-party providers or suppliers. Consequently, any remediation may be time-consuming or
difficult to achieve, which may materially impact our customers and business partners, damage our reputation, and result in lost business and revenue
opportunities, and could be materially costly. If our products experience component aging, errors, or performance problems, or do not otherwise satisfy our
stringent quality processes and controls we may choose to or be compelled to recall certain products, which may include, product withdrawals from the market,
labeling changes, design changes, customer notifications, and notifications to global regulatory bodies.
A significant portion of our clear aligner production is dependent on digital scans from our globally dispersed and decentralized installed base of iTero and
third-party intraoral scanners, and if we or third parties discontinue commercial availability or support for older versions of these scanners, our clear aligner
revenues could be adversely impacted. Failures of all or any portion of our or third-party software or other components or systems to interoperate with iTero or
third-party scanners, termination of interoperability with third-party scanners, product or system vulnerabilities or defects, interference or disruptions for us, our
customers, labs or other business partners in the use of our products or the transmission or processing of data needed for the use or ordering of our products, or
system outages, regardless of cause, have harmed our operations previously and in the future could materially and adversely affect our ability to accept scans,
manufacture clear aligners or restorative procedures or treatments and services, or otherwise service our customers. Any of these events could harm our sales,
damage our reputation, adversely impact our strategic partners, or result in claims, demands, litigation, and liabilities, which could have a material effect on our
reputation, business, financial condition or results of our operations and the operations of our customers or business partners.
We are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and
our business, financial condition and results of operations could be materially adversely affected if supply is restricted or ends or the price materially
increases.
We are highly dependent on our supply chain, particularly manufacturers of specialized and customized scanning equipment, rapid prototyping machines,
resin and other advanced materials, as well as the optics, electronic and other mechanical components of our iTero scanners. We maintain single and sole supply
relationships in limited locations for materials and manufacturing, which exposes us to multiple supply chain vulnerabilities. We are reliant upon manufacturers
that we contract with for quality and stability and any failures on their part may have an impact on our ability to supply our products.
Because of our dependence on our suppliers, changes in key relationships can materially disrupt our supply chain. For instance, we may be unable to
quickly establish or qualify replacement suppliers, which could create production interruptions, delays and inefficiencies. Finding substitute manufacturers may
be expensive, time-consuming or impossible and could result in significant interruptions in the supply of one or more products, product retesting or additional
product registration, causing us to lose revenues and damage customer relationships. Technology changes by our service providers, vendors and other third
parties could disrupt access to required manufacturing capacity or require expensive, time-consuming development efforts to adapt and integrate new equipment
or processes. In the event of technology changes, delivery delays, labor stoppages or shortages, or increases in price for these items, sales may decrease and our
business and prospects may be harmed.
We contract with commercial intermediaries to distribute a portion of the importation, marketing and sales of our products and services, which exposes
us to risks to our sales, operations and reputation, including the risk these intermediaries do not comply with applicable laws or our internal procedures.
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In addition to our direct sales force, we have and expect to continue to use distributors, resellers or other commercial intermediaries to import, market, sell,
service and support our products and services. Our distribution agreements are generally non-exclusive and terminable by either party with customary notice. If
qualified and acceptable alternative commercial intermediaries cannot be quickly found and trained in the use, marketing, sales and support of our products and
services, our revenues and ability to sell or service our products and services in key markets could be adversely affected. These commercial intermediaries may
also choose to sell alternative or competing products or services. In addition, we may be held responsible for the actions of these commercial intermediaries,
their employees and commercial intermediaries for non-compliance with laws and regulations, including fair competition, bribery and corruption, import and
export compliance, safety, data privacy, false advertising or unfair and deceptive trade practices, and marketing and sales activities. If these commercial
intermediaries fail to satisfy customers, our reputation and brand loyalty could be harmed. An intermediary may also affect our ability to effectively market our
products in certain foreign countries or regulatory jurisdictions if it holds the regulatory authorization in such countries or within such regions and causes, by
action or inaction, the suspension of such marketing authorization or sanctions for non-compliance or prevents us from taking control of any such authorization.
It may be difficult, expensive, and time-consuming for us to re-establish market access or regulatory compliance.
A disruption in the operations of a primary freight carrier, higher shipping costs or shipping delays could disrupt our supply chain and impact our
operating and financial results.
We depend on commercial freight carriers, primarily United Parcel Service, Inc., to deliver our products. If the operations of commercial freight carriers are
disrupted or we fail to mitigate any disruptions, we may be unable to timely deliver products to our customers who may choose alternative products, causing our
net revenues and gross margin to decline, possibly materially. Moreover, when fuel costs increase, our freight costs generally do as well. In addition, we earn an
increasingly larger portion of our total revenues from international sales, which carry higher shipping costs that negatively impact our gross margin and results
of operations. If freight costs materially increase and we are unable to successfully pass all or significant portions of the increases along to our customers, or we
cannot otherwise offset such increases, our gross margin and financial results could be materially affected.
If we cannot attract, motivate, train or retain personnel, it will be difficult to achieve our strategic priorities, which could materially adversely affect our
business, financial condition and results of operations.
The loss of the services and knowledge of any key personnel, particularly executive management, research and development, or sales personnel, could harm
our business and prospects and impede the achievement of our research and development, operational or strategic objectives. Competition for highly skilled
personnel, particularly technical and digital talent, is intense, and traditional and emerging competitors have and are likely to continue to recruit our personnel as
the dental industry undergoes rapid digital transformation on a global scale. Various internal and external factors can impact our ability to hire and retain talent,
including our compensation and benefit arrangements, advancement or career opportunities at our organization, and our past and any future restructuring efforts,
such as the restructuring plans we have implemented in each of the past three fiscal years, and most recently in the third quarter of 2025. Additionally,
approximately 91% of our employees are located internationally, and restrictive immigration or travel policies or legal or regulatory developments relating to
immigration in the United States and other countries may negatively affect our efforts to attract, motivate, train or retain qualified personnel.
Seamless leadership transitions for key positions are critical to sustaining our culture and organizational success. If our succession planning is ineffective, it
could adversely impact our business. Organizational changes, such as our past and any future restructuring efforts, such as the restructuring plans we have
implemented in each of the past three fiscal years, and most recently in the third quarter of 2025, may increase attrition and adversely impact our ability to
successfully attract, motivate, and retain key personnel. In September, 2025, we required most of our employees to return to working five days per week in the
office for most locations, which could impact our ability to attract and retain qualified personnel, particularly if companies that we compete with for talent have
adopted work policies and arrangements that our employees may consider to be more appealing. We have experienced and may continue to experience
difficulties attracting and retaining personnel that meet the qualifications, experience, compliance mindset and values we expect and share our core values of
Agility, Customer and Accountability, which could impact our ability to achieve our strategic objectives and maintain compliance with obligations under our
internal controls and other requirements. We provide significant training and experience to our personnel that, for certain roles, can make key personnel, such as
our commercial and sales personnel, highly desirable to competitors and lead to increased attrition.
We have personnel represented by works councils and trade unions in certain countries and others that may be or may become eligible to be represented by
works councils, trade unions and other employee associations. Labor disputes and work stoppages involving our personnel may disrupt our operations and could
materially impact our results or operations.
We depend on our marketing activities to deepen our market penetration and raise awareness of our brands, products, and services, which may prove
unsuccessful or may become less effective or more costly to maintain in the long term.
Our marketing efforts and costs are significant and include national and regional campaigns in multiple countries involving television, film, print, social
media and alliances with professional sports teams, athletes, social media influencers and other strategic partners. Our advertising campaigns may not achieve
the desired returns on advertising spend, increase brand, product or services awareness sufficiently or generate goodwill and positive reputational goals among
the teen and adult markets, enable us to maintain commercial relationships with social media influencers and other strategic partners, or differentiate our
products from those featured in the growing number of advertising campaigns by competitors promoting similar products and messaging. Moreover, should any
entity or individual endorsing us, our products or services take actions, make or publish statements in support of, or lend support to events or causes which are
perceived by a portion of society negatively, our sponsorships or support of these entities or individuals may be questioned, our products and services boycotted
and our brand image and
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reputation harmed, any of which could materially affect our business, financial condition and results of operations. The harm of negative publicity, particularly
on social media platforms, may be immediate, without affording us an opportunity for redress or correction.
In addition, many countries prohibit certain types of marketing activities, such as direct to consumer advertising of medical devices. We have and may in
the future be alleged to violate marketing restrictions and be ordered to stop certain marketing activities or prevented from selling our products and services.
Moreover, competitors do not always follow these restrictions, which can create an unfair advantage and make it more difficult and costly to compete.
Additionally, we rely heavily on data generated from our campaigns to target specific audiences and evaluate their effectiveness, particularly data generated
from internet activities on mobile devices. To obtain this data, we are dependent on third parties and popular mobile operating systems, networks, technologies,
products and standards we do not control, such as the Android and iOS operating systems, and mobile browsers. Changes in such systems that degrade or
eliminate our ability to target or measure the results of ads or increase costs to target audiences could adversely affect our campaigns. Operating systems could
also include data privacy settings that may limit our ability to interpret, target and measure ads effectively.
Legal, Regulatory and Compliance Risks
We are subject to antitrust and competition regulations, litigation and enforcement that may result in fines, penalties, restrictions on our business
practices, and product, services or operational changes which could materially impact our business, financial condition and results of operations.
We currently are and may in the future be subject to antitrust, competition or unfair competition-related investigations, enforcement actions or claims by
governmental agencies, competitors, consumers, customers and others which, even if unfounded, could cause us to incur substantial costs (including fines),
enter into settlements or consent decrees, be subject to judgments, receive negative publicity, forego certain mergers, acquisitions, business combinations,
investments or other transactions, divert management time and attention, or change our business in ways that could have a material adverse effect on our
business practices, revenues and results of operations, such as limiting our ability to provide certain benefits to our customers and consumers, reducing the
attractiveness of our products, services and the net revenue derived from them. Governments and regulators are actively developing new competition laws,
regulations and actions aimed at the technology sector, AI and digital platforms, and global activities and expansion, including in large markets such as the
United States, the EU, and China. For more information, see Note 8 “Legal Proceedings” of the Notes to Consolidated Financial Statements in Part II, Item 8 of
this Annual Report on Form 10-K.
Antitrust considerations may also hinder our ability to settle such matters on favorable terms, as certain types of settlement agreements may be subject to
heightened scrutiny by antitrust authorities. In the E.U., for instance, antitrust regulators closely monitor settlement agreements for compliance with competition
laws, adding another layer of complexity and potential risk to these proceedings.
Failure to obtain or maintain approvals or comply with regulations and government actions regarding our products or services or those of our suppliers
could materially harm our sales, result in substantial penalties and fines, interrupt our supply chain and cause harm to our reputation.
We and many of our healthcare provider customers, suppliers and commercial intermediaries are subject to extensive and evolving regulations and
government actions under numerous federal, state, local, and foreign laws, including those regulating:
•
the access, storage, transmission, disclosure, and other processing of, and security measures with respect to, personal, financial and medical
information as well as healthcare records, including children’s personal and health data;
•
websites and application advertising, including those involving the use of cookies or involving the collection, use, disclosure, or other processing of
data relating to individuals for marketing purposes and other business purposes;
•
prohibitions against the offer, payment or receipt of remuneration to induce referrals to entities providing healthcare services or goods or to induce the
order, purchase or recommendation of our products and services; and
•
the design, manufacture, marketing and advertising of our products and services.
The healthcare and technology markets are also highly regulated and subject to evolving political, economic and regulatory influences and government
actions. Global regulators are expanding and changing regulations and guidance for products and services, which can limit their potential benefits and cause
protracted review timelines for new products and services. Our critical third-party vendors and service providers are subject to similar regulations. Our failure or
the failure of our suppliers, customers, advertisers, consultants, and influencers to strictly adhere to clearances or approvals in the labeling, marketing and sales
of our products and services could subject us to claims or litigation, including allegations of false or misleading advertising or violations of laws or regulations,
which may result in costly investigations, fines, penalties, as well as material judgments, settlements or decrees. We are also subject to complex, new and
evolving environmental, health and safety regulations. There can be no assurance we will adequately address the risks associated with the implementation and
compliance with such laws and our internal processes and procedures to comply with such laws or that we will be able to take advantage of any resulting
business opportunities.
Furthermore, we frequently must obtain regulatory clearance or approval before we can sell a new medical device or market a new use of, or claim for, an
existing product. For instance, in the United States, FDA regulations are wide-ranging and govern, among other things, product design, product materials,
development, manufacturing and testing, product labeling and product storage. It takes significant time, effort, and expense to obtain and maintain clearances
and approvals of products and
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services, and there is no guarantee we will timely succeed, if at all, in the countries in which we do business. In other countries, the requirements, time, effort
and expense to obtain and maintain clearances may differ materially. Moreover, these laws may change, resulting in additional time, expense or loss of market
access. If the requirements to market our products or services are delayed, we may be unable to offer them in markets we deem important. Additionally, failure
to comply with applicable regulatory requirements could result in enforcement actions with sanctions, including fines, civil penalties and criminal prosecution.
Delays or failures to obtain or maintain regulatory approvals or clearances, or to comply with regulatory requirements, may materially adversely affect our
domestic or international operations, and adversely impact our business. We and certain of our third-party vendors must also comply with and adhere to facility
registration and product listing requirements for Quality System regulations. The FDA enforces its Quality System regulations through periodic unannounced
inspections. Failure to satisfactorily correct an adverse inspection finding or comply with applicable regulations can result in enforcement actions, or require us
to find alternative manufacturers, which could be a long and costly process and may cause reputational harm. Enforcement actions by regulators could have a
material effect on our business, financial condition and results of operations.
We are also subject to anti-corruption and anti-bribery (“ABAC”) laws such as the Foreign Corrupt Practices Act (“FCPA”) and the U.K. Bribery Act of
2010, which generally prohibit payments to foreign officials for the purpose of obtaining or maintaining business, securing an advantage and directing business
to another. ABAC laws require us to maintain accurate books and records and a system of internal accounting controls. Under the FCPA, we may be held liable
for corruption by directors, officers, employees, agents, or other strategic or local partners, intermediaries or representatives acting on our behalf.
While we have policies and procedures requiring compliance with applicable laws and regulations and we provide training to foster compliance, our
employees, third parties acting on our behalf, and customers may not adhere to our policies and procedures or applicable laws or regulations, including the use
of certain electronic communications and maintaining accurate books and records. If our personnel or the personnel of our agents or suppliers fail to comply
with any laws, regulations, policies or procedures, or we fail to audit and enforce compliance, our reputation may be harmed, we may lose customers or
revenues or we may face regulatory investigations, actions and fines.
We are subject to various laws relating to privacy, data protection, data governance and cybersecurity, and face risks related to the data we collect,
process, and share.
We are or may become, or alleged to be or become, subject to stringent federal, state, and foreign laws and regulations, such as HIPAA, which regulates the
security and privacy of patient healthcare information applicable to healthcare providers and their business associates, and the California Consumer Protection
Act, as amended by the California Privacy Rights Act, which regulates privacy, data security, content regulation and consumer protection. Numerous other states
have enacted, or plan to enact, laws relating to privacy, data protection, data governance and cybersecurity, with such enacted laws either in operation or slated
to go into operation over the next several years. Outside of the United States, relevant legal requirements continue to evolve. For example, the collection and use
of health data and other personal information is governed in the EU by the EU GDPR, which imposes significant obligations upon companies and rights for
individuals, with substantial penalties for noncompliance. Numerous other jurisdictions maintain similar legislation or other laws or regulations addressing
privacy, data protection, data governance, or cybersecurity. Several jurisdictions, including the EU, United States, China, Australia, and Japan, have enacted data
export restrictions and international transfer laws and regulations that established legal requirements for cross-border transfers of all or certain personal
information and certain jurisdictions have also established legal requirements for data localization, which may require us to maintain separate servers located in
those countries so that all or certain personal information are maintained locally.
These laws, regulations and other obligations relating to privacy, data protection, data governance and cybersecurity are constantly evolving and may be
created, interpreted or enforced in ways that could impose new, substantially uncertain, and relatively burdensome obligations on our global operations, restrict
our activities and our ability to provide our products and services in certain jurisdictions, require us to cease operations or modify our policies and business
practices in a materially limiting manner, prevent us from resolving issues quickly or force us to resolve them in unanticipated ways, require us to engage in
additional contractual negotiations, increase our costs and obligations and limit our ability to efficiently transfer personal data across borders, cause us to incur
significant costs, expenses and damages, and present challenges in adapting our policies and practices to address their requirements. Any failure or perceived
failure by us or our vendors, customers, or service providers to comply with applicable privacy and data protection laws or to adequately safeguard personal data
or patient healthcare information, even if unfounded, may result in regulatory investigations, enforcement actions, litigation (including class actions), and
financial penalties, any of which could materially affect our operations and financial performance. Additionally, concerns over our practices with respect to
privacy, data protection, data governance, and cybersecurity could adversely affect our reputation and deter customers and consumers from using our products
and services.
We have cybersecurity and other forms of insurance coverage related to cyberattacks, breaches, and other incidents or security problems, but we cannot
guarantee applicable insurance will be available to us in the future on economically reasonable terms or at all. Damages and claims arising from incidents may
not be covered, may exceed coverage limits, and may not cover the time and effort we incur investigating and responding to any incidents, or other costs or
liabilities, which may be material. The costs to eliminate, mitigate, or recover from security problems and cybersecurity attacks and incidents could be material
and require us to implement additional or different security controls or other measures and, depending on the nature and extent of the problem and the products,
services or IT systems impacted, such security problems and cybersecurity attacks and incidents may result in network, IT system interruptions or other
disruptions, decreased product sales, data loss, damage, unavailability, or other liabilities, any of which may have a material impact on our operations, net
revenues and operating results. The costs associated with cybersecurity tools and infrastructure and competition for scarce cybersecurity and IT resources could
limit our ability to identify, eliminate or remediate cybersecurity or other security vulnerabilities or problems or enact changes to minimize the attack surface of
our network.
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Our business exposes us to potential liability for the quality and safety of our products and services, how we advertise and market those products and
services, and how and to whom we sell them, and we may incur substantial expenses or be found liable for substantial damages or penalties if we are subject
to claims or litigation.
Our products and services involve an inherent risk of claims concerning their design, materials, manufacture, safety, and performance, how we package,
bundle, or sell them to individual customers or companies, including hospitals and clinics, and how we train and support doctors, their staffs and patients who
use our products and services. Moreover, consumer products and services are routinely subject to claims of false, deceptive or misleading advertising, labeling,
consumer fraud and unfair business practices. Additionally, we may be held liable if our products or services cause injury or are otherwise found unhealthy. If
our products and services are safe but they are promoted for use or used in unintended or unexpected ways or for which we have not obtained clearance (“off-
label” usage), we may be investigated, fined or have our products or services enjoined or approvals rescinded or we may be required to defend ourselves in
litigation. Although we maintain insurance for product liability, business practices, and other types of activities we make or offer, coverage may not be available
on acceptable terms, if at all, and may be insufficient for actual liabilities. Any claim for product liability, sales, advertising and business practices, regardless of
its merit or eventual outcome, could result in material legal defense costs and damage our reputation, increase our expenses, and divert management’s attention.
Current and anticipated sustainability and social (“Sustainability”) laws and scrutiny of our Sustainability policies and practices may materially
increase our costs, expose us to liability, and adversely impact our reputation, employee retention, willingness of customers and suppliers to do business with
us and willingness of investors to invest in us.
Our operations are subject to rapidly changing and varied expectations and requirements regarding Sustainability issues from a wide range of stakeholders,
such as governmental and self-regulatory organizations, including U.S. federal and state governments, and the EU, as well as investor advocacy groups,
institutional investors, investment funds, proxy advisory services, stockholders and customers. We are also required to comply with disclosure obligations under
the SEC’s long-standing climate change disclosure guidance and other SEC regulations, as well as the European Union’s Corporate Sustainability Reporting
Directive (“CSRD”). If we fail to adopt Sustainability standards or practices as quickly as stakeholders desire, comply with or timely report on our
Sustainability efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our brand, reputation, employee retention, business,
financial performance, growth, and stock price may be adversely impacted.
Our compliance obligations span all aspects of our business and operations, including product design and development, materials sourcing and other
procurement activities, product packaging, product safety, energy and natural resources usage, facilities design and utilization, recycling and collection,
transportation, disposal activities, workers’ and human rights. U.S. and foreign regulators have or are considering enacting new or additional disclosure
requirements or limits on the emissions of greenhouse gases from power generated by fossil fuels. Additionally, customers and consumers may demand our
products, packaging and operations be more sustainable, which could affect how we manufacture and package our products, increase our costs and those of our
suppliers, and result in manufacturing, transportation and supply chain disruptions if clean energy sources are unavailable in adequate amounts when required.
Moreover, clean energy sources, coupled with reduced investments in traditional energy production and infrastructure, may not provide the predictable and
reliable energy we, our suppliers and other business partners require.
Other restrictions apply to the substances incorporated into our products, including the chemical compounds in our clear aligners, electronics in our
scanners and the packaging in which they are shipped. These laws are proliferating and new substances subject to restrictions are added regularly and may
require additional reporting or phasing out of certain chemicals and compounds such as per- and polyfluoroalkyl substances (PFAS) and microplastics. We may
be required to re-design our products or identify new suppliers to maintain compliance with these laws. Further, these laws and regulations may decrease the
number of suppliers capable of supplying our needs, thereby negatively affecting our ability to manufacture products in sufficient quantities at competitive
prices, leading customers to potentially choose competitive goods and services.
Meeting our obligations under existing Sustainability laws and regulations is costly for us and our suppliers, and we expect these regulations and costs to
increase as the regulatory frameworks in each jurisdiction in which we operate become more complex and distinct. Additionally, regulators may perform
investigations, inspections and periodically audit our compliance with these laws and regulations, and our efforts or operations may not be compliant. If we fail
to comply with any requirements, we could be subject to significant penalties or liabilities and we may be required to implement new and materially more costly
processes and procedures. Even if we successfully comply with these laws and regulations, our suppliers may not. We may also suffer financial and reputational
harm if customers require, and we cannot deliver, certification that our products are compliant. In all of these situations, customers may stop purchasing
products from us, and may take legal action against us, which could harm our reputation, business, financial condition and results of operations.
AI and machine learning technologies in our products, services and IT systems may result in legal and regulatory risks, reputational harm or have
other adverse consequences to our business.
We have and are continuing to incorporate AI and machine learning technologies into certain of our products, services and IT systems, while continuing to
explore the opportunities that AI could bring to our company. However, there can be no assurance that we or our customers will realize the expected benefits
from these investments. AI innovation presents risks and challenges that could impact our business. Our or our vendors’ AI technologies may be developed
using inaccurate, incomplete, flawed or biased algorithms, training methodologies or data, which could lead to the dissemination of false information and result
in competitive harm, regulatory penalties, legal liability, or brand or reputational harm.
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AI is subject to a dynamic and rapidly evolving legal and regulatory environment, which, without appropriate review, governance and risk management,
could expose us to unforeseen legal or regulatory scrutiny and liabilities. For example, the U.S. AI regulatory framework remains in development and has been
introduced at the federal level through executive orders and legislation has been introduced and enacted at the state level. In Europe, the EU AI Act entered into
force on August 1, 2024 which will become fully effective on August 2, 2026, with some provisions effective in February 2025. Other jurisdictions are
considering similar legislation. Although we do not engage in developing or providing AI systems for which their placement on the market, putting into service,
or use would qualify as “prohibited AI practices,” restrictions and obligations under this regulation, to the extent applicable to us, could have a negative impact
on our business, global systems, financial condition and results of operations. Additionally, other jurisdictions have proposed, and in certain cases enacted, laws
and regulations addressing aspects of the use and development of AI. The evolving AI regulatory environment may, among other impacts, result in
inconsistencies among AI regulations and frameworks across jurisdictions; onerous compliance, governance, and research and development obligations that
may require us to rework or reevaluate products or services to be compliant or result in the development of products that are unacceptable under new or revised
regulatory frameworks; increased risk of exposure to investigations, proceedings and claims related to our AI models; increased liability related to the use of AI
by our customers, consumers or suppliers beyond our control; delays in the deployment of new products and services; competitive and reputational harm; and
increased cybersecurity risks.
Additionally, as we offer more third-party AI models in our solutions, we face risks inherent in how third-party AI models used in our solutions have been
developed and deployed, including situations in which the third party may lack a proper license or consent for the training data used for their model. The use
and availability of third-party AI models in our solutions could result in scrutiny and legal liability, including intellectual property infringement claims. Such
claims or scrutiny could cause reputational harm and loss of customers, and adversely impact our business and financial results. In addition, new competition
regulations on AI development and deployment could impose new requirements on our markets that could impact our business and financial results.
The input of confidential information or trade secrets into AI systems may result in the loss of intellectual property, proprietary rights or attorney-client
privilege in such information or trade secrets. The use of AI technologies for developing products or services may adversely affect or preclude our intellectual
property rights in such products or services, or may expose us to liability related to the infringement, misappropriation or other violation of third-party
intellectual property. Further, particularly given the nascent stage of the technology, the use of AI can lead to unintended consequences, including the generation
of outputs that appear correct but are factually inaccurate, misleading, or that result in unintended biases and discriminatory outcomes, or are otherwise flawed,
which could harm our reputation and business and expose us to risks related to such inaccuracies or errors in these outputs.
Intellectual Property Risks
Our success depends in part on our proprietary technology, and if we fail to successfully obtain or enforce our IP rights, our competitive position may
be harmed.
Our success depends in part on our ability to maintain existing IP rights and obtain, maintain and enforce further IP protections for our products. Our
inability to do so could harm our competitive position.
We rely on our portfolio of issued and pending patent applications in the United States and other countries to protect a large part of our IP and competitive
position; however, these patents may not prevent third parties from producing competing products similar in design to ours if they are invalidated, held
unenforceable, circumvented or otherwise limited in scope. Furthermore, our foreign patent protections may be more limited in scope than those under U.S.
patent and IP laws.
Additionally, any of our patent applications may not result in an issued patent or the scope of the patent ultimately issued may be narrower than initially
sought. We may not be afforded the protection of a patent if our currently pending or future patent filings do not result in the issuance of patents or if we fail to
timely apply for patent protection. We may not apply for a patent if our personnel fail to timely disclose or recognize new patentable ideas or innovations. We
may choose not to file a foreign patent application if the limited protections provided by a foreign patent do not outweigh the costs to obtain it. Further, third
parties may file patents or develop IP strategies that prevent or limit the effectiveness of our patents.
We also protect our IP through copyrights, trademarks, trade secrets and confidentiality obligations. We generally enter into confidentiality agreements with
our employees, consultants and collaborative partners upon commencement of a relationship with us. However, despite the existence of these protections, our
proprietary information has been misappropriated in the past and could be misappropriated again in the future. If these agreements do not provide meaningful
protection against the unauthorized use or disclosure of our trade secrets or other confidential information, adequate remedies may not exist to prevent
unauthorized uses or disclosures. Furthermore, if these agreements are breached through the unauthorized use or disclosure of our trade secrets or other
confidential information, available remedies may be insufficient to adequately compensate for damages caused by the unauthorized use or disclosure, even with
successful enforcement of a breach of contract or trade secret claim.
Enforcement of our IP rights is time-consuming and costly, and could ultimately prove to be unsuccessful. In certain jurisdictions, enforcement of IP rights
is more difficult due to legislation and geopolitical circumstances. As we launch our products in different regions at different times, our products may be
acquired and reverse engineered by potential competitors in regions where infringement is more difficult to pursue.
Our inability to maintain the proprietary nature of our technology through patents, copyrights, or trade secrets could impair our competitive advantages and
could have a material effect on our operating results, financial condition, and future growth
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prospects. In particular, failure in protecting and enforcing our IP rights might allow competitors to copy our technology or create counterfeit or pirated versions
of our products, which could adversely affect our reputation, pricing, and market share.
Litigation regarding our IP rights, rights claimed by third parties or IP litigation by any vendors on whose products or services we rely for our products
and services may impact our ability to grow our business and adversely impact our reputation and results of operations.
Extensive litigation over IP rights is common in technologies and industries on which our products and services are based. Litigation, interferences,
oppositions, reexaminations, inter partes reviews, post-grant reviews or other proceedings have been necessary and will likely be needed in the future to
determine the validity and scope of certain of our IP rights and those claimed by third parties. These proceedings are used to determine the validity, scope or
non-infringement of certain IP rights pertinent to the manufacture, use or sale of our products and the products of competitors. We have been, and may in the
future be, sued and need to defend against lawsuits alleging infringement of third parties’ IP rights or other legal claims challenging our IP rights. In addition,
we periodically receive letters from third parties drawing our attention to their IP rights and there may be other third-party IP rights of which we are presently
unaware. As dentistry continues to become more digital, competitors may make defense of our IP more challenging. Asserting or defending these proceedings
can be unpredictable (e.g., due to differences in forums, judges, and jurisdictions; case law that continues to evolve with time; changes in administrative
policies, etc.), protracted, time-consuming, expensive, and distracting to management and technical personnel. Their outcomes may adversely affect our ability
to manufacture and market our products and services, require us to seek licenses for infringing products or technologies, or result in the assessment of
significant monetary damages. Unfavorable rulings could also include monetary damages, injunctions prohibiting us from selling our products, or exclusion
orders preventing us from importing our products in one or more countries. Moreover, independent actions by competitors, customers, or others have alleged
that our efforts to enforce our IP rights constitute unfair competition or violations of antitrust laws. Investigations and additional litigation based on the same or
similar claims may be brought in the future. The potential effects on our business operations resulting from litigation, whether or not ultimately determined in
our favor or settled by us, are costly and could materially affect our reputation, business, financial condition and results of operations.
Financial, Tax and Accounting Risks
If our goodwill, finite-lived intangible or long-lived assets become impaired, we may be required to record material charges to income.
Under U.S. GAAP, we review our goodwill annually or more frequently if we identify events or circumstances that indicate it is more likely than not the
fair value of a reporting unit has been reduced below its carrying value. We review finite-lived intangible assets and long-lived assets for impairment when
events or circumstances indicate the carrying value of the asset (asset group) may not be recoverable. The qualitative analysis performed by management to
identify indicators of impairment or the quantitative analysis used to determine fair value requires management to exercise significant judgment in determining
appropriate assumptions and estimates, including revenue growth rates, gross and operating margins, and discount rates. Consequently, we may be required to
record material charges to income during the period in which any impairment of goodwill, finite-lived intangible assets or long-lived assets is determined.
Changes in, or interpretations of, accounting rules and regulations, could result in unfavorable accounting charges.
We prepare our consolidated financial statements in conformity with U.S. GAAP. These principles are subject to interpretation by the SEC and various
bodies formed to interpret and create appropriate accounting principles. A change in these principles or in the way these principles are interpreted by us or by
our regulators could materially affect our current or previously issued financial statements.
We are required to annually assess our internal control over financial reporting and any adverse results from such assessment may result in a loss of
investor confidence in our financial reports and adversely affect our stock price.
Establishing, testing and maintaining an effective system of internal control over financial reporting requires significant resources and time commitments by
management and our finance staff, and may require additional staffing and infrastructure investments and increases our costs of doing business. If we are unable
to assert that our internal control over financial reporting is effective, if our auditors are unable to express an opinion on the effectiveness of our internal
controls, or conclude that our internal controls are ineffective, the timely filing of our financial reports could be delayed or we could be required to restate past
reports. This could cause our investors to lose confidence in the accuracy and completeness of our financial reports, which could have an adverse effect on our
stock price.
Our effective tax rate may vary significantly from period to period, which could result in volatility of our operating results and adversely affect our
financial results.
Our future effective tax rate may be impacted by various internal and external factors, such as changes in the global economic environment, our legal entity
structure or activities performed within our entities, our business operations, tax laws, regulations and/or rates, changes to existing accounting pronouncements,
changes in interpretations of existing tax laws or regulations, the relative proportions of revenues and income before taxes in the various jurisdictions in which
we operate that have differing statutory tax rates, overall levels of pretax earnings, settlements of income tax audits, non-deductible goodwill impairments, and
changes in the valuation allowance offsetting deferred tax assets. Furthermore, we may continue to experience variation in our effective tax rate related to excess
tax benefits or tax expense on stock-based compensation, particularly in the first quarter of each year when the majority of our equity awards vest.
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New tax laws and practices, changes to existing tax laws and practices, or disputes regarding the positions we take regarding tax laws, could negatively
affect our provision for income taxes as well as our ongoing operations.
Compliance with tax laws requires significant judgment concerning our worldwide provision for income taxes. Changes in tax laws, such as the Inclusive
Framework on Base Erosion and Profit Shifting (“BEPS”) established by Organization for Economic Cooperation and Development (“OECD”), the OECD/G20
Framework’s Pillar Two 15% global minimum tax, and the One Big Beautiful Bill Act, or changes to how those laws are applied to our business could affect the
amount of tax which we are subject to and the manner in which we operate. We continue to monitor the enactment of legislation to evaluate the impact of
changing global tax laws, which could adversely affect our provision for income taxes or operations.
The application of indirect taxes (such as sales and use tax (“SUT”), value-added tax (“VAT”), goods and services tax (“GST”), and other indirect taxes) to
our operations is complex and evolving. U.S. states, local and foreign taxing jurisdictions have differing rules and regulations governing differing types of taxes,
and these rules and regulations are subject to varying interpretations and exemptions that may change over time. We collect and remit SUT, VAT, GST and other
taxes in many jurisdictions and we are routinely subject to audits. The positions we take regarding taxes as well as the amounts we collect or remit have and
may continue to be challenged and we may be liable for failing to collect or remit all taxes deemed owed or the taxes could exceed our estimates. Certain
jurisdictions have applied novel or aggressive interpretations of their laws in new ways in an effort to raise additional tax revenue from U.S. based companies
such as us, and we may experience similar developments in the future. In addition, ongoing volatility due to international trade may prompt foreign governments
to expand regulatory authority or adopt new measures, increasing compliance risks, taxes, and operational complexities. We have and may continue to dispute
rulings or positions taken by tax authorities, which have and may continue to incur significant expenses, time, and effort to defend our positions.
The application of existing and new tax laws, and the results of audits could harm our business. Furthermore, there have been and will continue to be
substantial ongoing costs associated with complying with the various tax requirements and defending our positions in the numerous markets in which we
conduct or will conduct business.
Risks Related to Ownership of our Common Stock
Historically, the market price for our common stock has been volatile.
The market price of our common stock is subject to rapid and large price fluctuations attributable to various factors, many of which are beyond our control.
The factors include:
•
quarterly variations in our results of operations and liquidity, our ability to meet or exceed our forecasts and guidance or changes to or withdrawal of
our previous forecasts and guidance;
•
our ability to regain or sustain our historical growth rates;
•
changes in recommendations or valuation models for our stock by the investment community, or speculation in the press or investment community
regarding estimates of our net revenues, results of operations, or other key performance indicators;
•
negative publicity or unfavorable consumer perceptions, whether accurate or inaccurate, concerning our products or the company;
•
announcements by us, our competitors, or new market entrants, including strategic actions, management changes, and material transactions,
investments or acquisitions;
•
technical factors in the public trading markets for our stock that may produce price movements inconsistent with macroeconomic, industry, or
company-specific fundamentals, including the sentiment of retail investors (as it may be expressed on financial trading and other social media sites),
the amount and status of short interest in our securities, access to margin debt, trading in options and other derivatives on our common stock, fractional
share trading, and other technical trading factors or strategies;
•
stockholder activism or securities class action litigation;
•
announcements regarding stock repurchases, sales or purchases of our common stock by us, our officers or directors, credit agreements, and debt
issuances;
•
announcements of technological innovations or new, additional or revised programs, business models, products, or product offerings by us, our
customers, or competitors;
•
key decisions in pending litigation, new litigation, settlements, judgments, or decrees;
•
short selling or other hedging activity in our stock; and
•
general economic market conditions, including elevated interest rates, new, proposed or retaliatory tariffs, uncertainty regarding changes in trade
policies, including trade wars, inflationary pressures, recessions, consumer sentiment and demand, global geopolitical conflict, and industry factors
unrelated to our actual performance.
In addition, the stock market in general, and the market for technology and medical device companies, in particular, often experience extreme price and
volume fluctuations unrelated or disproportionate to corporate operating performance. Volatility in our stock price has increased, and may continue to increase,
our susceptibility to securities class action litigation, which could result in substantial costs and divert management’s attention and resources, which may
adversely affect our business.
We may not continue repurchasing our common stock and any repurchases may not achieve our desired objectives.
Future stock repurchase programs are contingent on a variety of factors, including our financial condition, market conditions, results of operations, business
requirements, and our continuing determination that stock repurchases are in the best interests of our stockholders and in compliance with all applicable laws
and agreements. There is no assurance we will continue repurchasing our common stock in the future at historical levels or at all, or that our stock repurchase
programs will beneficially impact our stock price. Additionally, the Inflation Reduction Act imposes a 1% excise tax on our stock repurchases, net of
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certain stock issuances, which increases our tax liabilities and the cost to repurchase stock and may impact if and how much stock we choose to repurchase in
the future.
Future sales of significant amounts of our common stock may depress our stock price.
A significant percentage of our outstanding common stock is currently owned by a small number of stockholders. These stockholders have sold in the past,
and may sell in the future, large amounts of our stock over relatively short periods of time. Sales of substantial amounts of our stock by existing stockholders
may adversely affect the market price of our stock by creating the perception of difficulties or problems with our business, which may depress our stock price.
Item 1B. Unresolved Staff Comments.
None.
Item 1C. Cybersecurity.
Overview
We have implemented a cross-functional information security program to assess, identify and manage material risks from cybersecurity risk, which includes
seeking input from our employees, management, third-party vendors, the Audit Committee of the Board of Directors (“Audit Committee”) and the Board of
Directors.
Our information security program’s ultimate goal is preventing cybersecurity incidents to the extent feasible, while simultaneously increasing our system
resilience to minimize the business impact should an incident occur. In the event of an identified cybersecurity incident, we have developed a cybersecurity
incident response process, which outlines steps to be followed from incident detection, analysis, containment, eradication, recovery and notification, including
notifying functional areas (e.g. information technology, legal, finance, operations, privacy), as well as senior leadership and the Audit Committee, as
appropriate. In certain instances, incidents are escalated to certain members of our legal team who are responsible for, among other things, the accurate and
timely disclosure of material cybersecurity incidents as required under federal securities laws, including making the materiality determination and approving
related securities disclosures.
Risk Management and Strategy
Our information security program devotes significant resources to cybersecurity and risk management processes to adapt to the changing cybersecurity
landscape and respond to emerging threats in a timely and effective manner. We regularly assess the threat landscape and take a holistic view of cybersecurity
risks, with a layered cybersecurity strategy based on prevention, detection and response. Our information security program leverages the National Institute of
Standards and Technology (NIST) and International Organization for Standardization (ISO) 27001 frameworks choosing to organize our cybersecurity risks into
five categories: identify, protect, detect, respond and recover. This does not imply that we meet any particular technical standards, specifications, or
requirements, only that we use the NIST and ISO frameworks as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
Our information security program is integrated into our overall enterprise risk management program. Our information security program includes, among
other things:
•
cybersecurity incident response;
•
vulnerability management;
•
antivirus and malware protection;
•
technology compliance and risk management;
•
encryption;
•
identity and access management;
•
application security; and
•
security monitoring.
Our information security program also includes an information security awareness program, which includes annual training regarding our acceptable use
and information classification and handling policies, regular phishing campaigns complemented by additional employee training as appropriate, and
communications and companion trainings to keep users informed on current events.
36

Our information security team engages third-party services to conduct evaluations of our security controls, including penetration testing and independent
audits. Annually, an external auditor conducts a System and Organization Controls (“SOC”) type 2 audit covering the security principle for systems supporting
our products.
Our assessment of risks associated with the use of third-party vendors is part of our overall cybersecurity risk management framework. If a third-party
vendor is unable to provide a SOC 1 or SOC 2 report, our information security team takes additional steps to assess its cybersecurity preparedness and our
initiation or continued engagement with it. Additionally, third-party vendors are required to include security and privacy addenda to our contracts where
determined applicable and are reassessed periodically as necessary depending on the risk level that has been assigned to the third-party vendor. Our legal team
also requires that our third-party vendors report cybersecurity incidents to us so the impact of the incident on us can be assessed.
As of the date of this Annual Report on Form 10-K, we have not identified any risks from known cybersecurity threats, including as a result of any previous
cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations or
financial condition. Notwithstanding the approach we take to cybersecurity, we may not successfully prevent or mitigate cybersecurity incidents that could have
a material adverse effect on us. While we maintain cybersecurity insurance, the costs related to cybersecurity threats or disruptions may not be covered or, if
covered, fully insured.
For a discussion of our cybersecurity-related risks, see Part I, Item 1A of this Annual Report on Form 10-K under the heading “Risk Factors.”
Governance
Role of Management
To more effectively assess and manage cybersecurity threats, we have a dedicated Chief Information Security Officer (“CISO”) who is responsible for
leading enterprise-wide information security strategy, policy, process, and technology. Our current CISO has 20+ years of information security and risk
management experience and holds a Certified Information Systems Security Professional (CISSP) certification. Our CISO regularly briefs our Audit Committee
on our cybersecurity and information security program and cybersecurity incidents deemed to pose a risk of a critical business impact or reputational harm.
Our information security team, comprised of employees with an expertise in cybersecurity and information technology, regularly assesses the threat
landscape and takes a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, detection and response. Our information
security team annually performs a cybersecurity enterprise risk assessment and presents the results to management and the Audit Committee. In addition, our
internal audit team conducts periodic audits of the Company’s systems and cybersecurity processes, with findings reported to the Audit Committee and senior
management.
Role of the Board of Directors and the Audit Committee
Our Audit Committee has responsibility for overseeing and reviewing our cybersecurity, data privacy, and other information technology risks, controls and
procedures, including our plans to mitigate cybersecurity risks and to respond to data breaches. Our Audit Committee also reviews with management any
specific cybersecurity issues that could affect the adequacy of our internal controls and disclosure procedures and any public disclosures about our cybersecurity
controls and procedures, the Board of Directors’ cybersecurity expertise, and its oversight of cybersecurity risk. The Audit Committee periodically reports on its
review of cybersecurity risks and our cybersecurity program to our Board of Directors. In 2025, our CISO or his team met with the Audit Committee two times
to discuss cybersecurity risks and threats.
37

Item 2. Properties.
We occupy several leased and owned facilities. As of December 31, 2025, the significant facilities occupied were as follows:
Location
Lease/Own
Primary Use
Tempe, Arizona, U.S.A.
Lease
Office for corporate headquarters
San Jose, California, U.S.A.
Own
Office for research & development and administrative personnel
Raleigh, North Carolina, U.S.A.
Own
Office for Americas regional headquarters
Belen, Heredia, Costa Rica
Own
Office for administrative personnel, treatment personnel, and customer care
La Lima, Cartago, Costa Rica
Own
Office for administrative personnel, treatment personnel, and customer care
Wroclaw, Poland
Lease and Own
Manufacturing and office for treatment and administrative personnel
Petah Tikva, Israel
Lease and Own
Manufacturing and office for research & development and administrative personnel
Rotkreuz, Switzerland
Lease
Office for EMEA regional headquarters
Juarez, Mexico
Own
Manufacturing and office for administrative personnel
Guoco Midtown, Singapore
Lease
Office for APAC regional headquarters
Ziyang, China
Own
Manufacturing and office for administrative personnel
We believe our existing facilities are in good operating condition and are suitable for the conduct of our business. The facilities noted above are used
mostly by all our reportable segments.

Item 3. Legal Proceedings.
The information set forth in Note 8 “Legal Proceedings” of the Notes to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K is
incorporated herein by reference.
Item 4. Mine Safety Disclosures.
Not applicable.
38

PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock is traded on the Nasdaq Global Select Market under the symbol “ALGN.” As of February 20, 2026, there were approximately 50
holders of record of our common stock. Because the majority of our shares of outstanding common stock are held by brokers and other institutions on behalf of
stockholders, we are unable to estimate the total number of stockholders represented by these record holders.
Dividends
We have never declared or paid any cash dividends on our common stock. We currently intend to retain earnings for use in the operations and expansion of
our business. In additional, we may use a portion of our retained earnings to repurchase shares of our common stock, if appropriate.
Securities Authorized for Issuance Under Equity Compensation Plans
Please see Part III, Item 12 of this Annual Report on Form 10-K under the heading “Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters.”
Performance Graph
Notwithstanding any statement to the contrary in any of our previous or future filings with the SEC, the following information relating to the price
performance of our common stock shall not be deemed “filed” with the SEC or “soliciting material” under the Exchange Act or subject to Regulation 14A or
14C, or to liabilities of Section 18 of the Exchange Act except to the extent we specifically request that such information be treated as soliciting material or to
the extent we specifically incorporate this information by reference.
The graph below compares the 5-year cumulative total stockholder return on Align common stock with the cumulative total returns of the NASDAQ
Composite Index, the S&P 500 Index and the S&P 1500 Composite Health Care Equipment & Supplies Industry Index. The graph tracks the performance of a
$100 investment in Align common stock and each index (assuming reinvestment of all dividends) from December 31, 2020 to December 31, 2025. Past stock
price performance is not necessarily indicative of future stock price performance.
39

Recent Sales of Unregistered Securities
None.
Issuer Purchases of Equity Securities
The following table summarizes the stock repurchase activity for the three months ended December 31, 2025:
Period
Total Number of
Shares Purchased
Average Price Paid
per Share
Total Number of Shares
Purchased as Part of Publicly
Announced Plans or
Programs
Approximate Dollar Value of
Shares that May Yet Be Purchased
Under the Plans or Programs
October 1, 2025 through October 31, 2025
319,732 
$
131.99 
319,732 
$
886,241,000 
November 1, 2025 through November 30, 2025
105,371 
$
139.31 
105,371 
$
871,563,000 
December 1, 2025 through December 31, 2025
255,577 
$
157.95 
255,577 
$
831,195,000 
Total
680,680 
680,680 
April 2025 Repurchase Program. In April 2025, our Board of Directors authorized a plan to repurchase up to $1,000,000,000 of our common stock (“April
2025 Repurchase Program”). See Note 11 “Common Stock Repurchase Programs” of the Notes to Consolidated Financial Statements for details on the April
2025 Repurchase Program.
(1)
1 
40

Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read together with 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 2025 compared to fiscal 2024 is presented under Results of Operations of
this Annual Report on Form 10-K. Discussions regarding our financial condition and results of operations for fiscal 2024 compared to 2023 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, 2024, filed with the SEC on February 28, 2025, which is available without charge
on the SEC’s website at www.sec.gov and on our investor relations website at investor.aligntech.com.
Executive Overview of Results
Our Strategic Growth Drivers
We strive to help our doctor customers move their practices forward by connecting them with new patients, providing digital solutions to help increase
practice efficiency and helping them deliver the best possible treatment outcomes and experiences to millions of people around the world. We strive to achieve
this through our continued focus on, and execution of, our strategic growth drivers:
International Expansion: Continually increasing the presence of our operations and commercial organization globally, expanding our products and service
offerings and training and educating more doctors in more markets.
General Practitioner dentists (“GP”) treatment: Making teeth straightening more relevant for GPs by enabling them to effectively scan, identify, treat,
and monitor malocclusion.
Patient Demand: Making the Invisalign  system the most recognized brand name in orthodontics by creating awareness and preference among consumers
and motivating potential patients to start treatment.
Orthodontist Utilization: Continually innovating in digital orthodontics to increase product applicability and predictability to address a range of
malocclusion, especially for teens and growing patients, enabling doctors to confidently diagnose and treat more patients.
Our growth strategy depends on our ability to facilitate the digital transformation of dentistry, our continuous focus on innovation, and expansion to meet
and exceed evolving customer expectations as the array of products and services available to them increases.
We strive to deliver on each of our strategic growth drivers through a variety of interrelated enterprise-wide efforts including:
•
Continuing penetration and adoption of Invisalign  clear aligners, iTero Element™ and Lumina™ intraoral scanners and exocad™ CAD/CAM
solutions in international markets by investing in manufacturing operations, research and development, clinical treatment planning, sales and marketing
and building our quality and regulatory capabilities in existing and emerging markets globally. Our fabrication facilities in our three key regions and
treatment planning operations in targeted regional geographies brings our operations closer to our customers and enables us to serve them more quickly
and respond to their needs more effectively. We have also diversified our research and development activities, which has created a longer term, more
stable environment for consistent hiring, retention and innovation in a variety of high technology locations.
•
Targeting growth opportunities with international orthodontists and GP customers, particularly with adopters of digital dentistry platforms by tailoring
our sales and marketing strategies, manufacturing operations and resources around the unique needs of each customer channel. As we continue
growing, we intend to opportunistically expand our research, development, manufacturing, treatment planning, and sales and marketing operations to
meet local and regional demand thoughtfully and deliberately. Over the longer-term, we expect international revenues to grow faster than Americas’
revenues as a result of growing international demand, our continued investment in international market expansion, the size of the market opportunities
and our relatively low market penetration in these regions.
®
®
41

•
Building confidence within the GP and orthodontic communities through training and education efforts to increase their adoption and utilization of
digital dental practice transformation and clear aligner treatment. We continue to expand our clear aligner customer base by educating new doctors on
the benefits of digital dentistry through the Invisalign System. We furthermore demonstrate to GPs and orthodontists how the iTero portfolio of
intraoral scanners, products like Invisalign Go™ treatment, and exocad™ CAD/CAM restorative services and workflows can increase revenues and
profitability for their dental practices by enhancing patient experiences and creating operational practice efficiencies. DSOs represent a large and
growing opportunity to help drive adoption of digital technology across the dental industry. We have well established relationships with many DSOs
globally that recognize the benefits of digital workflows enabled by our portfolio of products and services that make up the Align
 Digital Platform,
including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter cycle times to customer
proximity. We have and may continue to financially invest in or explore collaborations with key ecosystem partners, including DSOs, whose missions
and visions align with our vision, strategy, business model and goals.
•
Investing in research and development that allows us to innovate, develop and bring to market products and solutions that deliver the ever-increasing
clinical precision and predictability that doctors expect with the speed and convenience their patients require. For instance, in 2025, we announced
several new enhancements to the Align
 Digital Platform, including (i) restorative capabilities to our iTero Lumina™ intraoral scanner (without iTero
NIRI technology) and the new iTero Lumina™  Pro dental imaging system (with iTero NIRI technology), and (ii) iTero Digital Solutions, a
comprehensive ecosystem that includes intraoral scanners and integrated software tools, including enhancements to the Align™ Oral Health Suite,
Invisalign  Outcome Simulator Pro with ClinCheck
Smile Video, and the iTero™ Design Suite. Additionally, we continue to invest in AI
infrastructure, specialized talent, and strategic partnerships to further enhance the capabilities of the Align™ Digital Platform and differentiate our
product portfolio from traditional and emerging competitors. We believe our commitment to AI can unlock new and adjacent market opportunities, and
sharpen our operational focus and capital efficiency by driving automation, scalability, and productivity across our operations, while enabling doctors
and their patients to benefit from more efficient and predictable treatment experiences. We maintain governance frameworks, internal controls, and
oversight mechanisms designed to promote responsible AI development and deployment, mitigate associated risks, and ensure alignment with
applicable laws.
•
Creating demand and enabling patient conversion with targeted investments in advertising and public relations through television, film, print, social
media and alliances with professional sports teams, athletes, social media influencers and other strategic partners, to encourage treatment by Invisalign
trained doctors. We believe that well-designed, targeted sales and marketing promotions that build on our strong brand awareness allow us to
differentiate our products and solutions from traditional and emerging competitors. To increase awareness and educate young adults, parents and teens
about the benefits of Invisalign treatment, in 2025, we continued to invest in and create campaigns across markets in media platforms such as TikTok,
Instagram, YouTube, SnapChat, WeChat, and Douyin. We expect to make further investments to stimulate additional demand for Invisalign System
treatment and drive more consumers to dental professionals for those treatments.
•
Pursuing new product lines that complement our doctor-prescribed principal products currently available in certain e-commerce and retail channels in
the United States. Similarly, in 2025, we continued our focus on our doctor subscription plan and grew our underpenetrated share of the retainer
business through strategic marketing campaigns focused on driving adoption and increasing market share.
•
Increasing global orthodontic utilization rates as doctors’ clinical confidence in the efficacy and predictability of the Invisalign System increases with
advancements in products and technology and as patients and doctors demand treatments that emphasize convenience and safety through fewer visits
and less invasive and quicker treatments. In addition, the teenage and younger market makes up approximately 70% of the estimated 22 million total
annual global orthodontic case starts. We offer early interceptive treatment to this patient population with products designed to acclimate them to
wearing removable devices. Included in these treatments are the Invisalign First Phase 1 Package, designed specifically for younger patients generally
between the ages of six and ten. Also included are Invisalign Palatal Expanders, a series of removable devices that treat the most common skeletal and
dental malocclusions in growing children, and the Invisalign System with mandibular advancement featuring occlusal blocks, which addresses Class II
skeletal and dental correction for growing patients in the late mixed or early permanent dentition stages (ages 10-16). We furthermore continue to
emphasize the benefits of the Invisalign System for teenage and younger patient treatments through education, training and sales and marketing
programs. In 2025, a record number of teens and kids started treatment with Invisalign clear aligners. We expect utilization rates to continue to rise.
However, our utilization rates will fluctuate from period to period due to a variety of factors, which may include seasonal trends in our business,
consumer demand due to macroeconomic factors, and adoption rates for new products and features.
TM
TM
®
® 
42

Trends and Uncertainties
Below is a discussion of the significant trends and uncertainties that could impact our operations:
Macroeconomic Challenges, Trade Impediments and Geopolitical Tensions
Our revenues may fluctuate as a result of events and circumstances impacting customer confidence, consumer sentiment, discretionary spending and
ultimately demand for dental services and our products. These events and circumstances include, but are not limited to, macroeconomic conditions, fluctuations
in foreign currency exchange rates, tariffs or proposed tariffs, customs duties or fees, and any retaliatory tariffs or protectionist trade measures taken in response
to such tariffs or as a result of trade and international disputes, inflation, elevated interest rates, actual or potential slowdowns or recessions, wages, employment
levels and health insurance coverage, debt obligations, discretionary income, supply chain challenges, market volatility, and other factors. For more information
on events and circumstances that could impact our revenues, refer to Part II, Item 1A “Risk Factors—Macroeconomic and External Risks.”
Many of these factors may contribute to, among other things, higher raw material prices, increased transportation and labor costs, and interruptions in
supply and distribution operations, each of which can also impact the availability of certain raw materials, parts and components used in our products as well as
our costs and those of our suppliers. For example, we believe that in the beginning of the second quarter of 2025, sales of our products were adversely impacted
compared to the same period in prior years by certain macroeconomic conditions, including global tariff volatility, inflation, and higher interest rates, which we
believe may continue to impede dental patient demand. For example, patient traffic growth has been uneven for many doctors, with orthodontic starts down for
four consecutive years. We believe uncertainty not only impacts consumer purchasing decisions but also the decisions and recommendations that doctors make,
especially doctors who offer both clear aligners and wires and brackets in their practices and have the additional time to treat patients with wires and brackets
when orthodontic starts are slowing or diminishing. We believe this has resulted in an increase in orthodontic starts using wires and brackets in lieu of clear
aligners that was more pronounced in the second quarter of 2025. However, we believe these trends are continuing and will impede future sales for so long as
consumer economic uncertainty persists, particularly to the extent it impairs discretionary spending. We also anticipate the geopolitical conflicts involving
Ukraine, the Middle East, China and other regions will continue to add to market uncertainties and dampen consumer sentiment and demand.
More directly, we believe government actions relating to actual or proposed tariffs and retaliatory actions in key strategic countries or regions, particularly
in the United States, China, Europe, Brazil, Canada, Israel and Mexico may adversely impact our revenue and cost of goods sold. Additionally, the trade war
and geopolitical tensions between the United States and China may result in the limitation or prohibition of the availability of certain raw materials, components
and parts necessary for our products or the products of our suppliers. The degree of our exposure depends on, among other things, the type of goods subject to
any tariffs or trade restrictions enacted, the tariff rates or limits imposed, the timing of the tariffs or restrictions and any other retaliatory measures enacted. The
impact may vary by time and region, making operational results uncertain and difficult to predict. These events may also cause a shift in public opinion about
companies based in the United States and this may have an adverse impact on our reputation and business. We continue to closely monitor the foregoing issues,
assess their potential impact on our operations and financial results, and implement plans to seek to mitigate the impact of any adverse events.
Additionally, a material amount of our revenues are derived internationally and many of our international operations are denominated in currencies other
than the U.S. dollar. In 2025, the U.S. dollar remained weakened against major currencies, which positively impacted our financial condition and results of
operations for the year. Foreign exchange volatility and the subsequent strengthening or weakening of the U.S. dollar against other currencies remains uncertain
and unpredictable.
We continue to monitor the potential for violence and military actions that may directly or indirectly impact our personnel, manufacturing, supply chain,
and sales. For instance, the ongoing conflict in Ukraine and unstable environment in the Middle East, as well as increased geopolitical tensions involving
Taiwan and the South China Sea may further exacerbate general and regional macroeconomic instability. This is particularly true if fighting erupts, intensifies,
spreads to other locations, creates shipping and logistical challenges or cost increases, leads to sanctions or boycotts, or otherwise materially impacts our
operations or consumer spending. Our iTero business is headquartered in Israel and, although the sales, delivery times and cost of shipping have not been
materially impacted to date, the situation remains fluid. We have implemented contingency planning and business continuity measures to mitigate these risks,
but it is uncertain whether further escalation could disrupt our operations. While there have been export and import restrictions imposed against products
originating from and businesses operating in Israel, they have not materially impacted our sales or operations to date although we continue to monitor the risk.
2025 Restructuring
43

Beginning in the third quarter of 2025 and continuing into the fourth quarter, we initiated a series of restructuring actions to streamline our operations,
realign parts of our organization, and optimize our global manufacturing footprint in response to the current macro environment. These actions included
realigning certain business groups and reducing our global workforce, disposing of certain manufacturing assets prior to the end of their useful lives, and
committing to the sale of a manufacturing facility and related assets.
As part of these restructuring efforts, we incurred $41 million of expenses through December 31, 2025, primarily related to involuntary termination
benefits, including employee severance and other post‑employment costs. We also recorded $76.9 million of accelerated depreciation associated with certain
manufacturing assets we planned to dispose of other than by sale.
In addition, we undertook actions to optimize our manufacturing footprint, including the planned sale of our manufacturing facility in Juarez, Mexico,
consisting of land, building, and building improvements (the “disposal group”). During the third quarter of 2025, we determined that the disposal group met the
criteria for classification as held for sale under ASC 360‑10. Accordingly, the disposal group was measured at its fair value less estimated costs to sell, resulting
in an impairment charge of $23.1 million. As of December 31, 2025, we had $28.0 million of assets classified as held for sale.
We may incur additional costs not currently contemplated due to events related to or resulting from these restructuring actions. Refer to Note 1 “Summary
of Significant Accounting Policies,” Note 17 “Restructuring and Other Charges,” and Note 18 “Assets Held for Sale,” in the Notes to Consolidated Financial
Statements for further discussion.
Changing Product Preferences
As the markets for clear aligners and digital processes and workflows used to transform the practice of dentistry continue to mature, we anticipate
customer and patient expectations and demands will continue to evolve. We expect to meet customer demands with innovative treatment options that include
more choices to address a wider scope of treatment goals and budgets based on our existing and new products. This may result in larger and unpredictable
variations in geographic and product mix and selling prices, which could result in uncertain impacts on our financial statements and business operations. For
example, we have and may continue to experience a shift from certain products with higher ASPs to those with lower ASPs.
We strive to manage the challenges presented by the foregoing trends and uncertainties, including the macroeconomic conditions, tariffs and retaliatory
measures, military conflicts and the evolution of our target markets, by focusing on improving our operations, further increasing flexibility and efficiencies in
our processes, adjusting our business models to changing circumstances and offering products that meet market demand. Specifically, we are managing financial
impacts by implementing strategic product innovations, introductions and pricing actions, implementing cost saving measures and evaluating hiring needs.
Further discussion of the impact of these challenges on our business may be found in Part I, Item 1A of this Annual Report on Form 10-K under the
heading “Risk Factors.”
Key Financial and Operating Metrics
We measure our performance against the foregoing strategic priorities by the achievement of key financial and operating metrics. For the year ended
December 31, 2025, our business operations reflect the following:
◦
Revenues of $4,035.0 million, an increase of 0.9% year-over-year;
◦
Clear Aligner revenues of $3,245.4 million, an increase of 0.5% year-over-year;
◦
Clear Aligner case volume increase of 4.7% year-over-year and Clear Aligner volume increase for teens and growing patients from 868.1
thousand shipments to 935.8 thousand or 7.8% year-over-year;
◦
Imaging Systems and computer-aided design and computer-aided manufacturing (“CAD/CAM”) services revenues of $789.6 million, an
increase of 2.7% year-over-year;
◦
Income from operations of $545.8 million and operating margin of 13.5%;
◦
Effective tax rate of 29.9%;     
◦
Net income of $410.4 million with diluted net income per share of $5.65;
◦
Cash and cash equivalents of $1,094.9 million as of December 31, 2025;
◦
Cash provided by operating activities of $593.2 million;
◦
Capital expenditures of $102.4 million, primarily related to investments in our manufacturing capacity and facilities; and
◦
Number of employees was 20,290 as of December 31, 2025, a decrease of 3.1% year-over-year.
44

Other Statistical Data and Trends
•
As of December 31, 2025, over 22 million people worldwide have been treated with our Invisalign system.
•
For the year ended 2025, the total number of Invisalign-trained doctors cases were shipped to (doctor submitters) was 130.0 thousand compared to
130.4 thousand in 2024, a 0.3% decrease. GP and orthodontist doctor submitters decreased by approximately 2% and increased by approximately 2%,
respectively, in 2025 compared to 2024.
•
The total utilization rate in 2025 was 20.1 cases per doctor compared to 19.1 in both 2024 and 2023. Our utilization rates have been impacted by the
macroeconomic conditions and other factors as described in the “Trends and Uncertainties” section above. In general, we expect utilization rates to rise
over time although they are likely to fluctuate from period to period.
•
Clear aligner revenue per case shipment (clear aligner revenues divided by case shipments) decreased by 3.9% from $1,295 in 2024 to $1,245 in 2025.


Results of Operations
Net Revenues by Reportable Segment
We group our operations into two reportable segments: Clear Aligner segment and Systems and Services segment.
•
Our Clear Aligner segment consists of Comprehensive Products, Non-Comprehensive Products and Non-Case revenues as defined below:
•
Comprehensive Products include, but are not limited to, Invisalign Comprehensive, Invisalign First and Invisalign Comprehensive 3in3.
•
Non-Comprehensive Products include, but are not limited to, Invisalign Moderate, Lite and Express packages, Invisalign Go and Invisalign
Go Plus and Invisalign Palatal Expander.
•
In the United States, Canada, and EMEA, we also offer a Doctor Subscription Program which is our monthly subscription-based clear aligner
program. The program allows doctors the flexibility to order retainers and low-stage “touch-up” clear aligners within their subscribed tier and
is designed for a segment of experienced Invisalign trained doctors who are currently not regularly using our retainers or low-stage aligners.
The low-stage aligners, the Touch up product, are included as a Non-Comprehensive Product.
•
Non-Case revenues include, but are not limited to, retention products including retention aligners ordered through the Doctor Subscription
Program, Invisalign training, adjusting tools used by dental professionals during the course of treatment and Invisalign Accessory Products
that are complementary to our doctor-prescribed principal products such as aligner cases (clamshells), teeth whitening products, cleaning
solutions (crystals, foam and other material) and other oral health products available in certain commerce channels in select markets.
•
Our Systems and Services segment consists of sales related to our iTero intraoral scanning systems, which includes a single hardware platform and
restorative or orthodontic software options, scanner wand upgrades and non-system revenues from leases of scanner systems, sales of pre-owned
scanner systems, subscription software, disposables, pay per scan services, as well as exocad’s CAD/CAM software solutions that integrate workflows
to dental labs and dental practices.
45

Net revenues for our Clear Aligner and Systems and Services segments for the years ended December  31, 2025, 2024 and 2023 are as follows (in
millions) :
 
Year Ended December 31,
Year Ended December 31,
Net Revenues
2025
2024
Change
2024
2023
Change
Clear Aligner net revenues
$
3,245.4 
$
3,230.1 
$
15.3 
0.5 % $
3,230.1 
$
3,199.3 
$
30.8 
1.0 %
Systems and Services net
revenues
789.6 
768.9 
20.7 
2.7 %
768.9 
662.9 
106.0 
16.0 %
Total net revenues
$
4,035.0 
$
3,999.0 
$
36.0 
0.9 % $
3,999.0 
$
3,862.3 
$
136.8 
3.5 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
 Beginning with our quarterly report on Form 10-Q for the quarter ended March 31, 2025, we are no longer disclosing Clear Aligner net revenues for Americas,
International and Non-case. Rather our disclosure will align with our Clear Aligner reportable segment in total.
Clear Aligner Case Volume
Case volume data which represents Clear Aligner case shipments for the years ended December 31, 2025, 2024 and 2023 is as follows (in thousands):
 
Year Ended December 31,
Year Ended December 31,
2025
2024
Change
2024
2023
Change
Total case volume
2,611.3 
2,493.7 
117.5 
4.7 %
2,493.7 
2,408.5 
85.2 
3.5 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Total net revenues increased by $36 million in 2025 as compared to the same period in 2024, primarily due to an increase in Clear Aligner volume,
partially offset by a decrease in ASP and an increase in Systems and Services net revenues driven by strong scanner wand sales.
Clear Aligner
Clear Aligner net revenues increased by $15 million in 2025 as compared to the same period in 2024, primarily due to higher Clear Aligner volume,
resulting in an increase of net revenues of $138 million. Clear Aligner net revenues were further positively impacted by $4 million due to favorable foreign
exchange rates. These increases were partially offset by a decrease in ASP, driven by product mix shift to lower priced products and higher discounts, resulting
in a decrease of net revenue of $127 million.
Systems and Services
Systems and Services net revenues increased by $21 million in 2025 as compared to the same period in 2024 primarily due to an increase of $26 million in
sales of scanner wands, driven by strong volume partially offset by lower scanner wand ASP, a $19 million increase from non-system sales and a $1 million
positive impact from favorable foreign exchange rates. These increases were partially offset by lower scanner system sales of $25 million, driven by lower
system volume and ASP.
1
1
46

Cost of net revenues and gross profit (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Clear Aligner
Cost of net revenues
$
1,058.9 
$
952.1 
$
106.8 
$
952.1 
$
911.3 
$
40.8 
% of net segment revenues
32.6 %
29.5 %
29.5 %
28.5 %
Gross profit
$
2,186.5 
$
2,278.0 
$
(91.5)
$
2,278.0 
$
2,288.0 
$
(10.1)
Gross margin %
67.4 %
70.5 %
70.5 %
71.5 %
Systems and Services
Cost of net revenues
$
265.1 
$
247.7 
$
17.3 
$
247.7 
$
244.1 
$
3.6 
% of net segment revenues
33.6 %
32.2 %
32.2 %
36.8 %
Gross profit
$
524.5 
$
521.2 
$
3.3 
$
521.2 
$
418.8 
$
102.3 
Gross margin %
66.4 %
67.8 %
67.8 %
63.2 %
Total cost of net revenues
$
1,324.0 
$
1,199.9 
$
124.1 
$
1,199.9 
$
1,155.4 
$
44.5 
% of net revenues
32.8 %
30.0 %
30.0 %
29.9 %
Gross profit
$
2,711.0 
$
2,799.2 
$
(88.1)
$
2,799.2 
$
2,706.9 
$
92.3 
Gross margin %
67.2 %
70.0 %
70.0 %
70.1 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Cost of net revenues includes personnel-related costs including payroll and stock-based compensation for staff involved in the production process, the cost
of materials, packaging, freight and shipping, depreciation on capital equipment and facilities used in the production process, amortization of acquired intangible
assets and training costs.
For the year ended 2025, our gross margin decreased as compared to the same period in 2024 primarily due to an increase in Clear Aligner Cost of net
revenues driven by restructuring charges, impairment losses on Assets held for sale and depreciation on assets disposed of other than by sale. Our gross margin
was further impacted negatively by an impairment loss on inventory recorded in our Systems and Services segment. We also experienced a decline in ASPs in
both reportable segments. These decreases were partially offset by lower Cost of net revenues, excluding the items noted previously, from operational
efficiencies.
Clear Aligner
The gross margin percentage decreased in 2025 as compared to the same period in 2024 primarily due to accelerated depreciation on assets disposed of
other than by sale of $77 million and lower ASPs. These decreases were partially offset by operational efficiencies.
Systems and Services
The gross margin percentage decreased in 2025 as compared to the same period in 2024 primarily due to lower ASPs and an impairment loss on inventory
of $15 million. These decreases were partially offset by lower Cost of net revenues, excluding the impairment loss, from operational efficiencies.
Selling, general and administrative (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Selling, general and administrative
$
1,755.8 
$
1,763.2 
$
(7.4)
$
1,763.2 
$
1,703.4 
$
59.8 
% of net revenues
43.5 %
44.1 %
44.1 %
44.1 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Selling, general and administrative expense generally includes personnel-related costs, including payroll, stock-based compensation and commissions for
our sales force, marketing and advertising expenses including media, market research, marketing materials, clinical education, trade shows and industry events,
legal and outside service costs, equipment, software and maintenance costs, depreciation and amortization expense and allocations of corporate overhead
expenses including facilities and IT.
47

Selling, general and administrative expense decreased in 2025 compared to the same period in 2024 primarily due to lower employee costs, including
salaries, fringe benefits, and bonus, and lower marketing and outside services expense. The decrease was partially offset by higher clinical education expense.
Research and development (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Research and development
$
369.9 
$
364.2 
$
5.7 
$
364.2 
$
346.8 
$
17.4 
% of net revenues
9.2 %
9.1 %
9.1 %
9.0 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Research and development expense generally includes personnel-related costs, including payroll and stock-based compensation, outside service costs
associated with the research and development of new products and enhancements to existing products, software, equipment, material and maintenance costs,
depreciation and amortization expense and allocations of corporate overhead expenses including facilities and IT.
Research and development expense increased in 2025 compared to the same period in 2024 primarily due to higher employee costs, including salaries,
fringe benefits, stock-based compensation, offset by lower capitalized labor costs related to internal use software and lower bonus cost.
Restructuring and other charges (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Restructuring and other charges
$
35.4 
$
33.2 
$
2.2 
$
33.2 
$
13.3 
$
19.9 
% of net revenues
0.9 %
0.8 %
0.8 %
0.3 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Restructuring and other charges increased in 2025 compared to the same period in 2024 due to higher severance and other one-time post-employment
benefits, driven by a more significant restructuring plan initiated in 2025. Refer to Note 17 “Restructuring and Other Charges” of the Notes to Consolidated
Financial Statements for more information.
Legal settlement loss (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Legal settlement loss
$
4.2 
$
31.0 
$
(26.8)
$
31.0 
$
— 
$
31.0 
% of net revenues
0.1 %
0.8 %
0.8 %
— %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Legal settlement losses were incurred in 2025 and 2024 due to litigation and other settlements. For the year ended 2025, we recorded losses of $4 million
due to such legal settlements. Refer to Note 8 “Legal Proceedings” of the Notes to Consolidated Financial Statements for more information.
48

Income from operations (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Clear Aligner
Income from operations
$
1,034.8 
$
1,142.2 
$
(107.4)
$
1,142.2 
$
1,182.3 
$
(40.1)
Operating margin %
31.9 %
35.4 %
35.4 %
37.0 %
Systems and Services
Income from operations
$
306.1 
$
269.2 
$
36.9 
$
269.2 
$
191.4 
$
77.9 
Operating margin %
38.8 %
35.0 %
35.0 %
28.9 %
Total Income from operations 
$
545.8 
$
607.6 
$
(61.9)
$
607.6 
$
643.3 
$
(35.7)
Operating margin %
13.5 %
15.2 %
15.2 %
16.7 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
    Refer to Note 16 “Segments and Geographical Information” of the Notes to Consolidated Financial Statements for details on unallocated corporate expenses and the
reconciliation to consolidated Income from operations.
Total operating margin percentage decreased in 2025 compared to the same period in 2024 primarily due to lower gross margin and higher restructuring
and other charges, offset by lower legal settlement loss. Refer to Note 8 “Legal Proceedings” of the Notes to Consolidated Financial Statements for more
information.
Clear Aligner
Operating margin percentage decreased in 2025 compared to the same period in 2024 primarily due to a decrease in gross margin and an increase in
marketing and media expense and credit card transaction fees.
Systems and Services
Operating margin percentage increased in 2025 compared to the same period in 2024 primarily due to higher operating income driven by higher revenue
and lower operating expenses related to a decrease in employee costs.
Interest income (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Interest income
$
16.0 
$
20.2 
$
(4.2)
$
20.2 
$
17.3 
$
3.0 
% of net revenues
0.4 %
0.5 %
0.5 %
0.4 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Interest income generally includes interest earned on cash, cash equivalents and investment balances.
Interest income decreased in 2025 compared to the same period in 2024 primarily due to lower interest rates earned on cash and cash equivalent balances.
Other income (expense), net (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Other income (expense), net
$
23.5 
$
(18.9)
$
42.4 
$
(18.9)
$
(19.4)
$
0.5 
% of net revenues
0.6 %
(0.5)%
(0.5)%
(0.5)%
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Other income (expense), net, generally includes foreign exchange gains and losses, gains and losses on foreign currency forward contracts, interest
expense, gains and losses on equity investments and other miscellaneous charges.
Other income (expense), net increased in 2025 compared to the same period in 2024 primarily due to gains recorded on our equity investments and
changes in foreign exchange rates.
1
1
49

Provision for income taxes (in millions):
 
Year Ended December 31,
Year Ended December 31,
 
2025
2024
Change
2024
2023
Change
Provision for (benefit from) income taxes
$
174.9 
$
187.6 
$
(12.7)
$
187.6 
$
196.2 
$
(8.6)
Effective tax rates
29.9 %
30.8 %
30.8 %
30.6 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
The decrease in our effective tax rate for the year ended December 31, 2025 compared to the same period in 2024 is primarily attributable to a decrease in
U.S. taxes on foreign earnings, release of unrecognized tax benefits due to statute of limitation lapse, partially offset by the remeasurement of the deferred tax
asset due to tax rate change and change in our jurisdictional mix of income.
Liquidity and Capital Resources
Liquidity and Trends
As of December 31, 2025 and 2024, we had the following cash and cash equivalents (in thousands):
December 31,
 
2025
2024
Cash and cash equivalents
$
1,094,908 
$
1,043,887 
Our principal source of liquidity is cash provided by our operations. As of December 31, 2025 and 2024, we had cash and cash equivalents of $1,095
million and $1,044 million, respectively, of which approximately $929  million and $855 million, respectively, were held by our foreign subsidiaries. We
continue to evaluate opportunities to repatriate our foreign earnings if or when needed. We do not expect to incur significant additional costs upon repatriation of
these foreign earnings. We generate sufficient operating cash flow from our domestic operations and have access to $300 million under our revolving line of
credit. We believe that our current cash balances and the borrowing capacity under our credit facility, if necessary, will be sufficient to fund our business for at
least the next 12 months.
Our material cash requirements as of December 31, 2025 and material trends and uncertainties for the fiscal year 2026 are as follows:
•
Our purchase commitments consist primarily of open purchase orders for goods and services, including manufacturing inventory, supplies and services,
sales and marketing, research and development services and technological services, issued in the normal course of business. Our purchase
commitments totaled $1,020 million. We anticipate a majority, an estimated $935 million, will be payable within the next 12 months. These purchase
commitments exclude capital expenditures.
•
We expect our investments in capital expenditures to be between $125 million and $150 million for the next 12 months. Capital expenditures primarily
relate to technology upgrades, additional manufacturing capacity as well as ongoing maintenance.
•
We committed to a plan to dispose of, other than by sale, specifically identified manufacturing assets prior to the end of their estimated useful lives
during the third quarter of 2025. We have materially completed the disposition of these assets as of December 31, 2025. Accordingly, we have revised
the estimated useful lives of these assets to reflect our use through the disposal date. For the year ended December 31, 2025, we recorded $77 million
of accelerated depreciation expense related to these assets. The increase in depreciation expense negatively impacted Net income, net of tax, by $54
million or $0.74 per basic and diluted share.
•
We have future operating lease payments of $184 million, which includes $58 million for leases that have not yet commenced as of December 31,
2025. Refer to Note 4 “Leases” of the Notes to Consolidated Financial Statements for details on the lease payments.
•
We continually evaluate opportunities to repurchase shares of our common stock depending on various factors including our share price and current
liquidity requirements. Our stock repurchase program is subject to periodic evaluations to determine when and if repurchases are in the best interests of
our stockholders, taking into account
50

prevailing market conditions. In April 2025, our Board of Directors authorized a plan to repurchase up to $1.0 billion of our common stock, (the “April
2025 Repurchase Program”). The April 2025 Repurchase Program is expected to be completed over a period of up to three years. We repurchased $466
million during the year ended 2025, under both the April 2025 Repurchase Program and the January 2023 Repurchase Program (“January 2023
Repurchase Program”). The January 2023 Repurchase Program was completed in its entirely in the second quarter of 2025. We had approximately
$831 million available as of year end, of which approximately $31 million was repurchased in January 2026, leaving $800 million available for future
repurchase under the April 2025 Repurchase Program. Refer to Note 11 “Common Stock Repurchase Program” of the Notes to Consolidated Financial
Statements for details on our stock repurchase programs.
•
In 2025, we settled certain legal matters and issued a payment for the full settlement amount of $32 million, Settlement payments were made in
accordance with the terms and conditions as set forth in the settlement agreement. Refer to Note 8 “Legal Proceedings” of the Notes to Consolidated
Financial Statements for more information.
•
In the third quarter of 2025, we initiated a restructuring plan to realign certain business groups and reduce our global workforce. This plan represents
our continued effort to right size our labor force with the current macroeconomic environment. We incurred $41 million in total restructuring expenses,
primarily related to involuntary termination benefits, including employee severance and other post-employment benefits. We may also incur additional
costs not currently contemplated due to events related to or resulting from any such action. Refer to Note 17 “Restructuring and Other Charges” of the
Notes to Consolidated Financial Statements for more information.
•
We may be required to adjust the valuation allowance for deferred tax assets if we determine, based on available evidence at the time of the
determination, that it is more likely than not that some portion or all of the deferred tax assets will not be realized. This assessment includes deferred
tax assets associated with our Switzerland tax deductible basis created from our 2020 intra-entity transfer of intellectual property, which have a finite
utilization period and depend on our ability to generate sufficient taxable income in that jurisdiction. Any changes to the valuation allowance,
particularly those related to our Switzerland deferred tax assets, could have a material adverse effect on our results of operations. Refer to Note 13
“Income Taxes” of the Notes to Consolidated Financial Statements for more information.
•
As of December 31, 2025, we had no material off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material
impact on our liquidity or capital resources.
Sources and Uses of Cash
The following table summarizes our Consolidated Statements of Cash Flows for the years ended December 31, 2025, 2024 and 2023 (in thousands):
 
Year Ended December 31,
 
2025
2024
2023
Net cash provided by (used in):
Operating activities
$
593,223 
$
738,231 
$
785,776 
Investing activities
(112,445)
(254,912)
(195,943)
Financing activities
(464,580)
(355,722)
(598,340)
Effects of foreign exchange rate changes on cash, cash equivalents, and
restricted cash
35,025 
(21,153)
4,671 
Net (decrease) increase in cash, cash equivalents, and restricted cash
$
51,223 
$
106,444 
$
(3,836)
Operating Activities
For the year ended December 31, 2025, cash flows from operations of $593 million resulted primarily from our net income of approximately $410 million
as well as the following:
Significant adjustments to net income
•
Stock-based compensation of $186 million related to equity awards granted to employees and directors; and
•
Depreciation and amortization of $237 million related to our investments in property, plant and equipment and intangible assets.
51

Significant changes in working capital
•
Net outflow of $96 million from accrued and other long-term liabilities primarily due to timing of payments related to the payment of fiscal year 2024
bonuses in the first quarter of 2025;
•
Net outflow of $112 million from deferred revenues; and
•
Net outflow of $140 million from accounts receivable due to timing of collections and increased revenues.
For the year ended December 31, 2024, cash flows from operations of $738 million resulted primarily from our net income of approximately $421 million
as well as the following:
Significant adjustments to net income
•
Stock-based compensation of $174 million related to equity awards granted to employees and directors; and
•
Depreciation and amortization of $145 million related to our investments in property, plant and equipment and intangible assets.
Significant changes in working capital
•
Net inflow of $90 million from accrued and other long-term liabilities primarily due to timing of payments;
•
Net inflow of $68 million from prepaid expenses and other assets primarily due to settlement of tax matter. Refer to Note 8 “Legal Proceedings” of the
Notes to Consolidated Financial Statements.
•
Net outflow of $80 million from deferred revenues; and
•
Net outflow of $153 million from accounts receivable due to timing of collections and increased revenues.
Investing Activities
Net cash used in investing activities was $112 million for the year ended December 31, 2025 which was primarily related to an outflow of $102 million for
purchases of property, plant and equipment and a $10 million additional investment in SD Holding Company.
Net cash used in investing activities was $255 million for the year ended December 31, 2024 which primarily consisted of $116 million for purchases of
property, plant and equipment, $77 million for the Cubicure acquisition and $106 million for investments in privately held companies, partially offset by sales
and maturities of marketable securities of $44 million.
Financing Activities
Net cash used in financing activities was $465 million for the year ended December 31, 2025 which consisted of payments to repurchase shares of our
common stock of $466 million and payroll taxes paid for equity awards through share withholdings of $20 million, which were partially offset by proceeds from
the issuance of common stock for $22 million.
Net cash used in financing activities was $356 million for the year ended December 31, 2024 which consisted of payments to repurchase shares of our
common stock of $353 million and payroll taxes paid for equity awards through share withholdings of $28 million, which were partially offset by proceeds from
the issuance of common stock for $25 million.
Critical Accounting Estimates
Management’s discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have
been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of financial statements requires
management to make estimates and judgments that affect the reported amounts of assets and liabilities, revenues and expenses and disclosures at the date of the
financial statements. We evaluate our estimates on an on-going basis and use authoritative pronouncements, historical experience and other assumptions as the
basis for making the estimates. Actual results could differ from those estimates.
We believe the following critical accounting estimates affect our more significant judgments used in the preparation of our consolidated financial
statements. For further information on all of our significant accounting policies, see Note 1 “Summary of Significant Accounting Policies” of the Notes to
Consolidated Financial Statements.
52

Revenue Recognition
Our revenues are derived primarily from the sale of aligners, scanners, and services from our Clear Aligner and Systems and Services segments. We enter
into sales contracts that may consist of multiple distinct performance obligations. Sales contracts with multiple performance obligations require management to
exercise judgment in allocating the transaction price, based on standalone selling prices, to each performance obligation and determining the timing of revenue
recognition which directly impacts our unfulfilled performance obligations at period end.
Determining the standalone selling price (“SSP”) in order to allocate consideration from the contract to the individual performance obligations is the result
of various factors, such as historical prices, changing trends and market conditions, costs, and gross margins. While changes in the allocation of the SSP
between performance obligations will not affect the amount of total revenues recognized for a particular contract, any material changes could impact the timing
of revenue recognition, which would have a material effect on our financial position and result of operations. This is because the contract consideration is
allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.
We allocate consideration for each clear aligner treatment plan based on each unit’s SSP. Management considers a variety of factors such as same or
similar product historical sales, costs, and gross margin, which may vary over time depending upon the unique facts and circumstances related to each
performance obligation in making these estimates. In addition to historical data, we take into consideration changing trends and market conditions. For treatment
plans with multiple options, we also consider usage rates, which is the number of times a customer is expected to order more aligners after the initial shipment.
Our process for estimating usage rates requires significant judgment and evaluation of inputs, including historical usage data by region, country and channel.
We estimate the SSP of each element in a scanner system and services sale taking into consideration same or similar product historical prices as well as our
discounting strategies. For CAD/CAM services, we estimate the SSP of each element, including the initial software license and maintenance and support, using
data such as historical prices.
Unfulfilled Performance Obligations for Clear Aligners and Scanners
Our unfulfilled performance obligations, including deferred revenues and backlog, and the estimated revenues expected to be recognized in the future
related to these performance obligations are $1,353 million and $1,445 million as of December 31, 2025 and 2024, respectively. This includes performance
obligations from the Clear Aligner reportable segment, primarily the shipment of additional aligners, which are fulfilled over six months to five years. This also
includes performance obligations from our Systems and Services reportable segment, primarily services and support, which are fulfilled over one to five years,
and contracted deliveries of additional scanners. The estimate includes both product and service unfulfilled performance obligations and the time range reflects
our best estimate of when we will transfer control to the customer and may change based on customer usage patterns, timing of shipments, readiness of
customers' facilities for installation, and manufacturing availability.
Impairment of Goodwill and Finite-Lived Intangible Assets
Goodwill
We evaluate goodwill for impairment at least annually on November 30th or more frequently if indicators of impairment are identified between annual
testing dates. Goodwill is tested for impairment between annual testing dates when events or circumstances indicate that the fair value of a reporting unit has
been reduced below its carrying value. When an indicator of impairment is identified we perform a quantitative impairment assessment in which we determine
the fair value of a reporting unit and compare it to the carrying value of the respective reporting unit. We generally determine the fair value of a reporting unit
via a discounted cash flow (“DCF”) analysis and allocate our net assets to each reporting unit to determine carrying value. The use of a DCF model requires
management to exercise significant judgment related to operating assumptions and estimates including, revenue growth rates, terminal growth rates, operating
margins and discount rates, among others. Additionally, management exercises judgment when determining the methodology used to allocate net assets to each
reporting unit. We will record an impairment charge when our quantitative impairment analysis indicates that the carrying value of a reporting unit exceeds its
fair value.
Finite-Lived Intangible Assets
Finite-lived intangible assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset (asset group) may not
be recoverable. When an impairment indicator is identified, we perform a recoverability test, in
53

which the estimated, undiscounted future cash flows expected to result from the use and eventual disposition of the asset (asset group) are compared to the
carrying value of the asset (asset group). When our recoverability test results in undiscounted cash flows that are greater than carrying value, no impairment is
recorded. However, when our recoverability test results in undiscounted cash flows that are less than carrying value, we determine the fair value of the asset
(asset group) and reduce the carrying amount of the asset (asset group), through an impairment charge, to its fair value. The process of identifying impairment
indicators, preparing an undiscounted cash flow and determining the fair value of the asset (asset group) require management to exercise significant judgment
related to various assumptions and estimates.
If we were to have impairments to goodwill or finite-lived intangible assets, it could adversely affect our operating results. During the years ended 2025
and 2024, we did not have any impairment charges related to our goodwill or finite-lived intangible assets.
Accounting for Income Taxes
We are subject to income taxes in the United States and numerous foreign jurisdictions. The evaluation of our uncertain tax positions involves significant
judgment in the interpretation and application of U.S. GAAP and complex domestic and international tax laws related to the allocation of international taxation
rights between countries. We are also required to evaluate the realizability of our deferred tax assets on an ongoing basis in accordance with U.S. GAAP.
Realization of our deferred tax assets is dependent on our ability to generate future taxable income which is determined based on assumptions such as estimated
growth rates in revenues, gross margins, future cash flows and discount rates in the jurisdictions in which we operate. The accuracy of these estimates could be
affected by unforeseen events or actual results, and the sustainability of our future tax benefits is dependent upon the acceptance of these valuation estimates and
assumptions by the taxing authorities, particularly with respect to our Switzerland operation, where our deferred tax assets have a finite utilization period. While
we currently believe that it is more likely than not that these deferred tax assets will be realized and that a valuation allowance is not required, this conclusion
remains sensitive to changes in our operational performance, taxable income forecasts, and other relevant factors. We may, in the future, be required to increase
the valuation allowance to take into account deferred tax assets that we may be unable to realize, which would result in a material increase to our income tax
provision in the period the determination is made.
Accounting for Legal Proceedings
Estimates of probable losses resulting from litigation are inherently difficult to make, particularly when the matters are in early procedural stages with
incomplete facts and information. The final outcome of legal proceedings is dependent on many variables that are difficult to predict and, therefore, the ultimate
cost to resolve such matters may be materially different than our current estimates. Consequently, new information or changes in judgments and estimates could
have a material adverse effect on our business, financial condition, and results of operations or cash flows.
Recent Accounting Pronouncements
See Note 1 “Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements for a discussion of recent accounting
pronouncements, including the expected dates of adoption and estimated effects, if any, on results of operations and financial condition, which is incorporated
herein.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
In the normal course of business, we are exposed to interest rate, foreign currency exchange and inflation risks that could impact our financial position and
results of operations. In addition, we are subject to the broad market risk that is created by the global market disruptions and uncertainties resulting from
macroeconomic challenges, various military conflicts and consumer confidence. Further discussion on these risks may be found in Part I, Item 1A of this
Annual Report on Form 10-K under the heading “Risk Factors.”
Interest Rate Risk
Changes in interest rates could impact our anticipated interest income earned on our cash and cash equivalents balance. As of December 31, 2025, we are
not exposed to interest rate risk on our unsecured revolving line of credit. An immediate 10% change in interest rates would not have a material adverse impact
on our future operating results and cash flows.
We have not historically used derivative financial instruments to manage our exposure to changes in interest rates.
Foreign Currency Exchange Rate Risk
54

As a result of our international business activities, our financial results have been affected by changes in foreign currency exchange rates as well as
economic conditions in foreign markets. There is no assurance that exchange rate fluctuations will not adversely impact our results of operations or financial
condition in the future. We generally sell our products in the local currency of the respective countries. This provides some natural hedging because most of the
subsidiaries’ operating expenses are also generally denominated in their local currencies.
We enter into foreign currency forward contracts for currencies where we have exposures, primarily the Euro, British Pound, Chinese Yuan, Polish Zloty
and Canadian Dollar, to minimize the short-term impact of foreign currency exchange rate fluctuations on certain assets and liabilities. These forward contracts
are not designated as hedging instruments and are generally one month in original maturity and are marked to market through earnings every period. The gains
and losses on these forward contracts are intended to offset the gains and losses in the underlying foreign currency denominated monetary assets and liabilities
being economically hedged. We do not enter into foreign currency forward contracts for trading or speculative purposes. As our international operations grow,
we will continue to reassess our approach to managing the risks relating to fluctuations in currency rates.
Although we will continue to monitor our exposure to currency fluctuations, and, where appropriate, use forward contracts to minimize the effect of these
fluctuations, the impact of an aggregate change of 10% in foreign currency exchange rates relative to the U.S. dollar on our results of operations and financial
position could be material.
Inflation Risk
The economy has been impacted by certain macroeconomic challenges which have contributed to a rising inflationary trend that have impacted both our
revenues and costs globally. If our costs become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price
increases. There is no assurance that our results of operations and financial condition will not be adversely impacted by inflation in the future.
55

Item 8. Financial Statements and Supplementary Data.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
 
 
Page
Management's Annual Report on Internal Control over Financial Reporting
57
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)
58
Consolidated Statements of Operations for the year ended December 31, 2025, 2024 and 2023
60
Consolidated Statements of Comprehensive Income for the year ended December 31, 2025, 2024 and 2023
61
Consolidated Balance Sheets as of December 31, 2025 and 2024
62
Consolidated Statements of Stockholders’ Equity for the year ended December 31, 2025, 2024 and 2023
63
Consolidated Statements of Cash Flows for the year ended December 31, 2025, 2024 and 2023
64
Notes to Consolidated Financial Statements
65
56

MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Management of Align is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and
15d-15(f) under the Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is designed by, or under supervision of, our CEO
and CFO, and effected by the board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial
reporting includes those policies and procedures that:
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of Align;
•
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
•
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of Align’s assets that could have
a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance
with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, management
used the criteria set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission
(“COSO”).
Based on our assessment, management has concluded that, as of December 31, 2025, 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, 2025 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        
Joseph M. Hogan
President and Chief Executive Officer
February 27, 2026
/S/    JOHN F. MORICI 
John F. Morici
Chief Financial Officer and Executive Vice President, Global Finance
February 27, 2026
57

Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Align Technology, Inc.
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets of Align Technology, Inc. and its subsidiaries (the “Company”) as of December 31, 2025 and
2024, and the related consolidated statements of operations, of comprehensive income, of shareholders’ equity and of cash flows for each of the three years in
the period ended December 31, 2025, including the related notes and financial statement schedule of Valuation and Qualifying Accounts and Reserves for each
of the three years listed in the period ended in December  31, 2025 appearing under Item 15(a)(2) (collectively referred to as the “consolidated financial
statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2025, 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, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December  31, 2025 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, 2025, based on criteria established in Internal Control - Integrated Framework
(2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and
for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal
Control over Financial Reporting. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal
control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules
and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable
assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal
control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial
statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and
significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control
over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and
testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other
procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. 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 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.
58

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated
or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements
and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our
opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate
opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Revenue Recognition – Determination of Standalone Selling Price of Distinct Performance Obligations in Clear Aligner Contracts
As described in Notes 1 and 16 to the consolidated financial statements, the Company recognized net revenues of $3.2 billion from its Clear Aligner segment for
the year ended December 31, 2025. The Company enters into contracts (“treatment plans”) that involve multiple future performance obligations. 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 customer and the entity’s promise to transfer the good or service to the customer is separately
identifiable from other promises in the contract. Management allocates revenues for each treatment plan based on each unit’s standalone selling price.
Management considers a variety of factors such as same or similar product historical sales, costs, and gross margin, which may vary over time depending upon
the unique facts and circumstances related to each performance obligation in making these estimates. In addition to historical data, they take into consideration
changing trends and market conditions. Management also considers usage rates, which is the number of times a customer is expected to order additional
aligners. Management’s process for estimating usage rates requires significant judgment and evaluation of inputs, including historical usage data by region,
country and channel.
The principal considerations for our determination that performing procedures relating to revenue recognition and the determination of standalone selling price
of distinct performance obligations in Clear Aligner contracts is a critical audit matter are the significant judgment by management in determining the estimate
of standalone selling price, which includes significant assumptions related to usage rates for each distinct performance obligation. This in turn led to significant
auditor judgment, subjectivity, and effort in performing procedures to evaluate management’s determination of the estimates of standalone selling price and
usage rates for each distinct performance obligation.
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 revenue recognition, including controls over the determination of
standalone selling price for each distinct performance obligation in the Company’s Clear Aligner contracts. These procedures also included, among others, (i)
testing management’s process for determining the estimate of standalone selling price, which included testing the completeness and accuracy of inputs used and
evaluating the reasonableness of factors considered by management related to same or similar product historical sales and usage rates, and (ii) testing
management’s process for estimating usage rates, which included evaluating the reasonableness of inputs evaluated by management related to historical usage
data by region, country and channel.
/s/ PricewaterhouseCoopers LLP
San Jose, California
February 27, 2026
We have served as the Company’s auditor since 1997.
59

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
 
 
Year Ended December 31,
 
2025
2024
2023
Net revenues
$
4,034,964 
$
3,999,012 
$
3,862,260 
Cost of net revenues
1,323,951 
1,199,853 
1,155,397 
Gross profit
2,711,013 
2,799,159 
2,706,863 
Operating expenses:
Selling, general and administrative
1,755,791 
1,763,193 
1,703,379 
Research and development
369,911 
364,202 
346,830 
Restructuring and other charges
35,378 
33,168 
13,316 
Legal settlement loss
4,178 
30,968 
— 
Total operating expenses
2,165,258 
2,191,531 
2,063,525 
Income from operations
545,755 
607,628 
643,338 
Interest income and other income (expense), net:
Interest income
16,045 
20,218 
17,258 
Other income (expense), net
23,487 
(18,887)
(19,392)
Total interest income and other income (expense), net
39,532 
1,331 
(2,134)
Net income before provision for income taxes
585,287 
608,959 
641,204 
Provision for income taxes
174,936 
187,597 
196,151 
Net income
$
410,351 
$
421,362 
$
445,053 
Net income per share:
Basic
$
5.66 
$
5.63 
$
5.82 
Diluted
$
5.65 
$
5.62 
$
5.81 
Shares used in computing net income per share:
Basic
72,542 
74,877 
76,426 
Diluted
72,588 
74,993 
76,568 
The accompanying notes are an integral part of these consolidated financial statements.
60

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in thousands)
 
Year Ended December 31,
 
2025
2024
2023
Net income
$
410,351 
$
421,362 
$
445,053 
Other comprehensive income (loss):
Change in foreign currency translation adjustment, net of tax
69,410 
(15,786)
28,419 
Change in unrealized gains on investments, net of tax
— 
596 
3,033 
Other comprehensive income (loss)
69,410 
(15,190)
31,452 
Comprehensive income
$
479,761 
$
406,172 
$
476,505 
The accompanying notes are an integral part of these consolidated financial statements.
61

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
1,094,908 
$
1,043,887 
Accounts receivable, net of allowance for doubtful accounts of $34,213 and $19,131, respectively
1,101,757 
995,685 
Inventories
226,343 
254,287 
Prepaid expenses and other current assets
165,571 
198,582 
Assets held for sale
27,983 
— 
Total current assets
2,616,562 
2,492,441 
Property, plant and equipment, net
1,131,453 
1,271,134 
Operating lease right-of-use assets, net
108,322 
113,376 
Goodwill
491,833 
442,630 
Intangible assets, net
93,933 
103,488 
Deferred tax assets
1,513,542 
1,557,372 
Other assets
278,048 
234,159 
Total assets
$
6,233,693 
$
6,214,600 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
121,450 
$
108,693 
Accrued liabilities
536,749 
598,188 
Deferred revenues
1,261,816 
1,331,146 
Total current liabilities
1,920,015 
2,038,027 
Income tax payable
68,200 
96,466 
Operating lease liabilities
82,507 
88,214 
Other long-term liabilities
113,824 
139,908 
Total liabilities
2,184,546 
2,362,615 
Commitments and contingencies (Notes 8 and 9)
Stockholders’ equity:
Preferred stock, $0.0001 par value (5,000 shares authorized; none issued)
— 
— 
Common stock, $0.0001 par value (200,000 shares authorized; 71,364 and 73,849 issued and outstanding,
respectively)
7 
7 
Additional paid-in capital
1,509,595 
1,362,234 
Accumulated other comprehensive income (loss), net
75,388 
5,978 
Retained earnings
2,464,157 
2,483,766 
Total stockholders’ equity
4,049,147 
3,851,985 
Total liabilities and stockholders’ equity
$
6,233,693 
$
6,214,600 
The accompanying notes are an integral part of these consolidated financial statements.
62

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
Common Stock
Additional
Paid-In

Capital
Accumulated
Other

Comprehensive

Income (Loss), Net
Retained
Earnings
Total
Shares
Amount
Balance as of December 31, 2022
77,267 
$
8 
$
1,044,946 
$
(10,284)
$
2,566,688 
$
3,601,358 
Net income
— 
— 
— 
— 
445,053 
445,053 
Net change in unrealized gains (losses) from investments
— 
— 
— 
3,033 
— 
3,033 
Net change in foreign currency translation adjustment
— 
— 
— 
28,419 
— 
28,419 
Issuance of common stock relating to employee equity
compensation plans
335 
— 
26,595 
— 
— 
26,595 
Tax withholdings related to net share settlements of equity
awards
(70)
— 
(22,575)
— 
— 
(22,575)
Common stock repurchased and retired
(2,457)
(1)
(30,852)
— 
(564,567)
(595,420)
Equity forward contract related to accelerated stock
repurchase
— 
— 
(10,000)
— 
— 
(10,000)
Stock-based compensation
— 
— 
154,026 
— 
— 
154,026 
Balance as of December 31, 2023
75,075 
7 
1,162,140 
21,168 
2,447,174 
3,630,489 
Net income
— 
— 
— 
— 
421,362 
421,362 
Net change in unrealized gains (losses) from investments
— 
— 
— 
596 
— 
596 
Net change in foreign currency translation adjustment
— 
— 
— 
(15,786)
— 
(15,786)
Issuance of common stock relating to employee equity
compensation plans
411 
— 
25,281 
— 
— 
25,281 
Tax withholdings related to net share settlements of equity
awards
(92)
— 
(28,125)
— 
— 
(28,125)
Common stock repurchased and retired
(1,545)
— 
(20,292)
— 
(335,243)
(355,535)
Equity forward contract related to accelerated stock
repurchase
— 
— 
49,527 
— 
(49,527)
— 
Stock-based compensation
— 
— 
173,703 
— 
— 
173,703 
Balance as of December 31, 2024
73,849 
7 
1,362,234 
5,978 
2,483,766 
3,851,985 
Net income
— 
— 
— 
— 
410,351 
410,351 
Net change in foreign currency translation adjustment
— 
— 
— 
69,410 
— 
69,410 
Issuance of common stock relating to employee equity
compensation plans
494 
— 
21,749 
— 
— 
21,749 
Tax withholdings related to net share settlements of equity
awards
(104)
— 
(20,390)
— 
— 
(20,390)
Common stock repurchased and retired
(2,875)
— 
(39,868)
— 
(429,960)
(469,828)
Stock-based compensation
— 
— 
185,870 
— 
— 
185,870 
Balance as of December 31, 2025
71,364 
$
7 
$
1,509,595 
$
75,388 
$
2,464,157 
$
4,049,147 
The accompanying notes are an integral part of these consolidated financial statements.
63

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands) 
 
Year Ended December 31,
 
2025
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
$
410,351 
$
421,362 
$
445,053 
Adjustments to reconcile net income to net cash provided by operating activities:
Deferred taxes
33,085 
25,756 
(18,642)
Depreciation and amortization
237,436 
145,034 
142,401 
Stock-based compensation
185,870 
173,703 
154,026 
Non-cash operating lease cost
39,742 
38,438 
33,107 
Impairment loss on Assets held for sale
23,142 
— 
— 
Impairment and fair value adjustments for equity investments
(18,074)
(5,885)
4,990 
Other non-cash operating activities
37,686 
12,256 
32,733 
Changes in assets and liabilities, net of effects of acquisitions:
Accounts receivable
(139,909)
(153,487)
(104,614)
Inventories
808 
25,053 
30,169 
Prepaid expenses and other assets
13,431 
67,527 
(51,013)
Accounts payable
5,330 
(843)
(7,703)
Accrued and other long-term liabilities
(95,654)
89,705 
46,327 
Long-term income tax payable
(28,265)
(20,279)
(7,772)
Deferred revenues
(111,756)
(80,109)
86,714 
                   Net cash provided by operating activities
593,223 
738,231 
785,776 
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions, net of cash acquired
— 
(77,075)
— 
Purchase of property, plant and equipment
(102,445)
(115,580)
(177,716)
Purchase of marketable securities
— 
— 
(2,910)
Proceeds from maturities of marketable securities
— 
25,660 
55,170 
Proceeds from sales of marketable securities
— 
18,193 
6,234 
Purchase of equity investments
(10,000)
(106,345)
(76,999)
Other investing activities
— 
235 
278 
                   Net cash used in investing activities
(112,445)
(254,912)
(195,943)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock
21,749 
25,281 
26,595 
Common stock repurchases, net of excise tax
(465,939)
(352,878)
(592,360)
Activity for equity forward contracts related to accelerated stock repurchase agreements, net
— 
— 
(10,000)
Payroll taxes paid upon the vesting of equity awards
(20,390)
(28,125)
(22,575)
                    Net cash used in financing activities
(464,580)
(355,722)
(598,340)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash
35,025 
(21,153)
4,671 
            Net (decrease) increase in cash, cash equivalents, and restricted cash
51,223 
106,444 
(3,836)
                    Cash, cash equivalents, and restricted cash at beginning of year
1,044,963 
938,519 
942,355 
                    Cash, cash equivalents, and restricted cash at end of year
$
1,096,186 
$
1,044,963 
$
938,519 
The accompanying notes are an integral part of these consolidated financial statements.
64

ALIGN TECHNOLOGY, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
    
Note 1. Summary of Significant Accounting Policies
Business Description
Align Technology, Inc. (“we,” “us,” “our,” “Align” or the “Company”) is a global medical device company primarily engaged in the design, manufacture
and marketing of Invisalign  clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners
(“GPs”), Vivera
 retainers for retention, iTero
 intraoral scanners and services for dentistry, and exocad
 computer-aided design and computer-aided
manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners. Our vision and strategy is to revolutionize orthodontic and restorative
dentistry through digital treatment planning and implementation using the Align
Digital Platform, an integrated suite of proprietary technologies and services
designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs and lab partners. We strive to achieve our vision and strategy
through key objectives made possible with the proprietary technologies and services of the Align
 Digital Platform to establish: clear aligners as the principal
solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients globally, our iTero
intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice
for dental labs. Our corporate headquarters is located in Tempe, Arizona and we have offices worldwide. Our Americas regional headquarters is located in
Raleigh, North Carolina; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific
(“APAC”) regional headquarters is located in Singapore. We have two operating segments: (1) Clear Aligner and (2) Imaging Systems and CAD/CAM services
(“Systems and Services”).
Basis of Presentation and Preparation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and include the accounts of Align and our wholly-owned subsidiaries after elimination of intercompany transactions and balances. 
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts
reported in our consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. On an ongoing basis, we
evaluate our estimates, including those related to revenue recognition and deferred revenues, useful lives of intangible assets and property, plant and equipment,
goodwill, income taxes, contingent liabilities, the fair values of financial instruments, stock-based compensation and the valuation of investments in privately
held companies among others. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of
which form the basis for making judgments about the carrying values of assets and liabilities.
Fair Value of Financial Instruments
Fair value is an exit price, representing the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. We use the U.S. GAAP fair value hierarchy that prioritizes the inputs to valuation techniques used to
measure fair value. This hierarchy requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair
value. The three levels of inputs that may be used to measure fair value:
Level 1 - Inputs to the valuation techniques that are quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs to the valuation techniques that are other than quoted prices but are observable for the assets or liabilities, either directly or indirectly, such
as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other
inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. We obtain fair values for our
Level 2 investments. Our custody bank and asset managers independently use professional pricing services to gather pricing data which may include quoted
market prices for identical or comparable financial instruments, or inputs other than quoted prices that are observable either directly or indirectly. We are
ultimately responsible for these underlying estimates.
®
TM
TM
TM
TM 
TM
65

Level 3 - Unobservable inputs to the valuation techniques that are supported by little or no market activity and are significant to the measurement of the
fair value of the assets or liabilities. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted
cash flow methodologies or similar valuation techniques, as well as significant management judgment or estimation.
Cash and Cash Equivalents
We consider cash on hand, demand deposits, time deposits, and all highly liquid investments with an original maturity of three months or less at the date of
purchase to be cash and cash equivalents. Cash and cash equivalents are held in various financial institutions in the U.S. and internationally.
Restricted Cash
Restricted cash primarily consists of funds reserved for legal requirements. Restricted cash balances are primarily included in Other assets within our
Consolidated Balance Sheets.
Marketable Securities
Marketable securities consist of marketable debt securities which are classified as available-for-sale and are carried at fair value.  Our fixed-income
securities investment portfolio allows for investments with a maximum effective maturity of up to 40 months on any individual security. Marketable securities
classified as current assets have maturities within one year from the balance sheet date.  Unrealized gains or losses on such securities are included in
Accumulated other comprehensive income (loss), net (“AOCI”) in stockholders’ equity. Realized gains and losses from sales and maturities of marketable
securities are reported in earnings and computed using the specific identification cost method. 
Marketable securities are subject to a periodic impairment review. We evaluate if an allowance for credit loss is necessary by considering available
information relevant to the collectability of the security and information about credit rating changes, past events, current conditions, and reasonable and
supportable forecasts. Any allowance for credit loss is recorded as a charge to Other income (expense), net, in our Consolidated Statements of Operations. If we
have an intent to sell, or if it is more likely than not that we will be required to sell a security in an unrealized loss position before recovery of its amortized cost
basis, we will write down the security to its fair value and record the corresponding charge as a component of Other income (expense), net in our Consolidated
Statements of Operations.
As of December 31, 2025 and 2024, we had no marketable securities.
Variable Interest Entities
We evaluate whether an entity in which we have made an investment is considered a variable interest entity (“VIE”). If we determine we are the primary
beneficiary of a VIE, we would consolidate the assets, liabilities, income and expense of the VIE into our consolidated financial statements. In determining if we
are the primary beneficiary, we evaluate whether we have the power to direct the activities that most significantly impact the VIE’s economic performance and
the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE. Our evaluation includes identification
of activities that are significant to the VIE and an assessment of our ability to direct those activities. Our assessment of whether we are the primary beneficiary
of a VIE requires management to exercise significant judgment and utilize assumptions. We have concluded that we are not the primary beneficiary of our VIE
investments; therefore, we do not consolidate their results into our consolidated financial statements.
Investments in Privately Held Companies
Our investments in privately held companies in which we cannot exercise significant influence and do not own a majority equity interest or otherwise
control are accounted for as investments in equity securities. We have elected to account for all investments in equity securities in accordance with the
measurement alternative. Under the measurement alternative, we record the value of our investments at cost, minus impairment, if any. Additionally, we adjust
the carrying value of our investments for observable transactions for identical or similar investments of the same issuer.
On April 24, 2023 and April 22, 2024, we entered into Subscription Agreements (the “Heartland Subscription Agreements”) with Heartland Dental
Holding Corporation (“Heartland”). Pursuant to the Heartland Subscription Agreements we acquired less than a 5% equity interest in total, through the purchase
of Class A Common Stock for $150 million ($75 million in each April 2023 and April 2024).
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On December 19, 2024 and June 5, 2025, we entered into Subscription Agreements (the “Smile Doctors Subscription Agreements”) with New SD Holding
Company, L.P. (“SD Holding Company”). Pursuant to the Smile Doctors Subscription Agreements, we acquired less than a 3% equity interest through the
purchase of Class A Common Units for $40 million. SD Holding Company owns a controlling interest, through intermediary entities, in Smile Doctors, LLC.
We account for our investments in Heartland and SD Holding Company as investments in equity securities, utilizing the measurement alternative. Based
on a review of the relevant facts and circumstances, primarily observable transactions for identical investments, we recorded a $18.0 million and 6.0 million
increase to the carrying value of our Heartland investment in 2025 and 2024, respectively. This increased the total carrying value of our investment in Heartland
to $174.0 million for the year ended December 31, 2025.
Our investments in privately held companies in which we can exercise significant influence are accounted for as equity method investments. We have
elected to account for our equity method investments under the fair value option. For the years ended December 31, 2025 and 2024, we did not hold any
material investments in which we exercised significant influence.
The carrying value of our investments in equity securities and equity method investments are reported in our Consolidated Balance Sheets as Other assets
and any price adjustments or impairment, if any, are recorded in Other income (expense), net in our Consolidated Statements of Operations.
Derivatives Not Designated as Hedging Instruments
We enter into foreign currency forward contracts to minimize the short-term impact of foreign currency exchange rate fluctuations on certain assets and
liabilities. These forward contracts are classified within Level 2 of the fair value hierarchy. The gains and losses on these forward contracts are intended to offset
the gains and losses in the underlying foreign currency denominated monetary assets and liabilities being economically hedged. We do not enter into foreign
currency forward contracts for trading or speculative purposes. The net gain or loss from the settlement of these foreign currency forward contracts is recorded
in Other income (expense), net in the Consolidated Statements of Operations. As of December  31, 2025 and 2024, the fair value of outstanding foreign
exchange forward contracts was not material.
Foreign Currency
For our international subsidiaries, we analyze on an annual basis or more often, if necessary, if a significant change in facts and circumstances indicate that
the functional currency of the subsidiary has changed. For international subsidiaries where the local currency is the functional currency, adjustments from
translating financial statements from the local currency to the U.S. dollar reporting currency are recorded to change in foreign currency translation adjustment,
net of tax in our Consolidated Statements of Comprehensive Income. This foreign currency translation adjustment reflects the translation of the balance sheet at
period end exchange rates, and the income statement at the transaction date or average exchange rate in effect during the period. Foreign currency
remeasurement gains and losses that are derived from monetary assets and liabilities stated in a currency other than the international subsidiaries functional
currency are included in Other income (expense), net. For the years ended December 31, 2025, 2024 and 2023, we had foreign currency transaction gains of
$11.3 million and losses of $21.0 million and $7.0 million, respectively.
Certain Risks and Uncertainties
Our cash and investments are held primarily by five financial institutions. Financial instruments which potentially expose the Company to concentration of
credit risk consist principally of cash and cash equivalents.  These instruments have minimal credit risk exposures. Management regularly monitors their
compositions and maturities. The Company maintains its cash and cash equivalents in bank accounts that exceed federally insured FDIC limits. Through
December 31, 2025, the Company has not experienced any material credit losses on such deposits.
We invest excess cash primarily in money market funds and certificates of deposit and periodically evaluate them for credit losses. Such credit losses have
not been material to our financial statements.
We purchase certain inventory from sole suppliers. Additionally, we rely on a limited number of hardware manufacturers. The inability of any supplier or
manufacturer to fulfill our supply requirements could materially and adversely impact our future operating results.
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Accounts Receivable, net
Trade accounts receivable are recorded at the invoiced amount. Accounts receivable, net includes allowances for doubtful accounts for any potentially
uncollectible amounts. We periodically assess the adequacy of the allowance for doubtful accounts by reviewing the accounts receivable on a collective basis
and giving consideration to various factors including the aging of the receivables and a customer’s expected ability to pay. For specific customer accounts
receivable balances, we consider known disputes and collection history. In determining the amount of the allowance for doubtful accounts, we also evaluate the
creditworthiness of customers, current market conditions and forecasts of future economic conditions to make any adjustments. Actual write-offs have not
materially differed from the estimated allowances. No individual customer accounted for 10% or more of our accounts receivable, net balance at December 31,
2025 or 2024 nor net revenues for the years ended December 31, 2025, 2024 or 2023.
Accounts Receivable Factoring
We enter into factoring transactions on a non-recourse basis with financial institutions to sell certain of our non-U.S. accounts receivable. We account for
these transactions as sales of financial assets and include the cash proceeds as a part of our Cash flows from operations in the Consolidated Statements of Cash
Flows. Total accounts receivable sold under factoring arrangements was $47.9 million and $52.1 million during the years ended December 31, 2025, and 2024,
respectively. Factoring fees incurred on the sales of accounts receivable were recorded in Other income (expense), net in our Consolidated Statements of
Operations and were not material.
Inventories
Inventories are valued at the lower of cost or net realizable value, with cost computed using standard cost which approximates actual cost on a first-in-
first-out basis. Excess and obsolete inventories are determined primarily based on future demand forecasts, and write-downs of excess and obsolete inventories
are recorded as a component of Cost of net revenues.
Property, Plant and Equipment, net
Property, plant and equipment, net are stated at historical cost less accumulated depreciation. Depreciation expense is computed using the straight-line
method over the estimated useful lives of the assets. Construction in progress is related to the construction or development of property (including land) and
equipment that are not ready for their intended use and have not yet been placed in service. Upon sale or retirement, the asset’s cost and related accumulated
depreciation are removed from the balance sheet and any related gains or losses are reflected in Income from operations. Maintenance and repairs are expensed
as incurred. Refer to Note 3 “Balance Sheet Components" of the Notes of Consolidated Financial Statements for details on estimated useful lives.
Leases - Lessee
We determine if an arrangement is or contains a lease at inception. Leases with a term of 12 months or less are not recorded on the balance sheet. Right-of-
use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising
from the lease. A ROU asset and lease liability is recognized on the lease commencement date. The lease liability is determined based on the present value of
lease payments over the lease term. We use our incremental borrowing rate based on the information available at commencement date in determining the present
value of lease payments as the rate implicit in our leases is not readily determinable. The ROU asset consists of the initial lease liability adjusted for lease
incentives received and any initial direct costs incurred. The lease term represents the noncancellable period of the lease and may include options to extend the
lease when it is reasonably certain that we will exercise that option. We have lease agreements with lease and non-lease components which are accounted for as
a single lease component. Payments under our lease arrangements are primarily fixed; however, certain lease agreements contain variable payments which are
expensed as incurred and not included in the lease liability balance. The short-term portion of our lease liabilities is recorded in Accrued liabilities on our
Consolidated Balance Sheets.
Leases - Lessor
We determine if an arrangement is or contains a lease at inception. All of our leases in which we are the lessor are classified as operating leases, exclusive
of leases with a term of 12 months or less. The underlying asset in an operating lease arrangement is carried at depreciated cost within Property, plant, and
equipment, net on our Consolidated Balance Sheets.
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Business Combinations
We allocate the fair value of the purchase consideration to the assets acquired and liabilities assumed based on their estimated fair values at the acquisition
date. When determining the fair value of assets acquired and liabilities assumed, management is required to make certain estimates and assumptions, particularly
with respect to determining the fair value of intangible assets. The estimates and assumptions used in fair valuing intangible assets include, but are not limited
to, the amount and timing of projected future cash flows which are dependent on forecasted revenues and expenses, a discount rate, and the assets’ life cycle,
among others. Amounts recorded in a business combination may change during the measurement period, which is a period not to exceed one year from the date
of acquisition, as additional information about conditions existing at the acquisition date becomes available.
Goodwill
Goodwill represents the excess of the purchase price paid over the fair value of tangible and identifiable intangible net assets acquired in a business
combination and is allocated to the respective reporting units based on relative synergies generated.
Finite-Lived Intangible Assets
Our intangible assets primarily consist of intangible assets acquired as part of a business combination. These assets are amortized using the straight-line
method over their estimated useful lives. The average amortization period by intangible asset class ranges from seven to twelve years. This amortization period
reflects the period in which the economic benefits of the assets are expected to be realized.
Impairment of Goodwill and Long-Lived Assets and Finite-Lived Intangible Assets
Goodwill
We evaluate goodwill for impairment at least annually on November 30th or more frequently if indicators of impairment are identified between annual
testing dates. 
We perform an initial assessment of qualitative factors to determine whether the existence of events and circumstances leads to a determination that it is
more likely than not that the fair value of a reporting unit has been reduced below its carrying amount. In performing this qualitative assessment, we identify and
consider the significance of relevant key factors, events, and circumstances that affect the fair value of our reporting units. These factors include external factors
such as macroeconomic, industry, and market conditions, as well as entity-specific factors, such as our actual and planned financial performance. We also give
consideration to the difference between the reporting unit fair value and carrying value as of the most recent date a fair value measurement was performed. If,
after assessing the totality of relevant events and circumstances, we determine that it is not more likely than not that the fair value of the reporting unit is less
than its carrying value, no further testing is performed; however, if we conclude otherwise, then we will perform a quantitative impairment test which compares
the estimated fair value of the reporting unit to its carrying value, including goodwill. If the carrying amount of the reporting unit exceeds its fair value, an
impairment loss would be recorded in our Consolidated Statements of Operations for the amount of the excess. Management is required to exercise significant
judgment when identifying the relevant assumptions and estimates used in determining the fair value and carrying value of our reporting units.
Long-Lived Assets and Finite-Lived Intangible Assets
We evaluate long-lived assets (including ROU assets) and finite-lived intangible assets for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset (asset group) may not be recoverable. Factors we consider important which could trigger a quantitative impairment
test include, but are not limited to, significant negative industry or economic trends, significant adverse changes in our competitive environment and a
significant loss of customers. If an impairment indicator is identified, we perform a quantitative impairment analysis in which we compare the carrying value of
an asset (asset group) to the future undiscounted cash flows the asset (asset group) is expected to generate. An asset (asset group) is considered impaired if its
carrying amount exceeds the undiscounted cash flows. If an asset (asset group) is deemed to be impaired, the impairment to be recognized is calculated as the
amount by which the carrying amount of the asset (asset group) exceeds its fair value. Our estimates of future cash flows attributable to our assets (asset groups)
require significant judgment based on our historical and anticipated results and are subject to many assumptions.
In the third quarter of 2025, we committed to a plan to dispose of, other than by sale, specifically identified manufacturing assets prior to the end of their
estimated useful lives. We have materially completed the disposition of these assets as of
69

December 31, 2025. Accordingly, we have revised the estimated useful lives of these assets to reflect our use through the disposal date. In the year ended
December 31, 2025, we recorded $76.9 million of accelerated depreciation expense related to these assets. The increase in depreciation expense negatively
impacted Net income, net of tax, by $53.9 million or $0.74 per basic and diluted share.
Development Costs for Internal Use Software
Internally developed software includes enterprise-level business software that we customize to meet our specific operational needs. Such capitalized costs
include external direct costs utilized in developing or obtaining the applications and payroll and payroll-related costs for employees, who are directly associated
with the development of the applications. For the years ended December 31, 2025 and 2024, capitalized internally developed software costs were $38.5 million
and $23.1 million, respectively.
Development Costs for Software to be Marketed
The costs to develop software that is marketed externally have not been capitalized as we believe our current software development process is essentially
completed concurrent with the establishment of technological feasibility. As such, all related software development costs are expensed as incurred and included
in Research and development expense in our Consolidated Statements of Operations.
 
Product Warranty
We offer assurance warranties on our products which provide the customer assurance that the product will function as intended because it complies with
agreed-upon specifications; therefore, our warranties are not treated as a separate revenue performance obligation in accordance with the revenue standard but
rather are accounted for as guarantees.
Clear Aligner
We warrant our Invisalign products against material defects until the treatment plan is complete except in the case of retainers, which are warranted up to
three months from expected first use. We accrue for warranty costs, which are primarily based on historical product failure rates as well as current information
on replacement cost.
Systems and Services
We warrant our intraoral scanners for a period of one year, which includes materials and labor. We accrue for these warranty costs based on average
historical repair costs. An extended warranty may be purchased for an additional fee. Sales of extended warranties are accounted for as a separate performance
obligation and recorded as revenue.
We warrant our CAD/CAM software for a one year period to perform in accordance with agreed product specifications. As we have not historically
incurred any material warranty costs, we do not accrue for these software warranties.
     
Warranty costs are recorded in cost of net revenues upon shipment of products. We regularly review our warranty liability and update these balances based
on historical warranty cost trends. Actual warranty costs incurred have not materially differed from those accrued; however future actual warranty costs could
differ from the estimated amounts.
Revenue Recognition
Our revenues are derived primarily from the sale of aligners, scanners, and services from our Clear Aligner and Systems and Services reportable segments.
We identify separate performance obligations, determine the transaction price, allocate the transaction price and record revenue in accordance with ASC 606
“Revenues from Contracts with Customers.”
We identify 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 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 (“SSP”) in order to allocate the transaction price to the
individual performance obligations is the result of various factors, such as historical prices, changing trends and market conditions, costs, and gross margins.
While changes in the allocation of the SSP between performance obligations will not affect the amount of total revenues recognized for a particular contract, any
material changes could impact the timing of revenue recognition, which would have a material effect on our financial position and result of operations. This is
because the contract consideration is
70

allocated to each performance obligation, delivered or undelivered, at the inception of the contract based on the SSP of each distinct performance obligation.
Clear Aligner
We enter into contracts (“treatment plan(s)”) that involve multiple future performance obligations. Invisalign Comprehensive, Invisalign First Phase 1,
Invisalign First Comprehensive Phase 2, Invisalign Adult, Invisalign Standard, Invisalign Moderate, Invisalign Go, Invisalign Go Plus, and Lite and Express
Packages include optional additional aligners at no charge for a certain period of time ranging from six months to five years after initial shipment.
Our treatment plans comprise the following performance obligations that also represent distinct deliverables: initial aligners and the option of additional
aligners. We allocate the transaction price for each treatment plan based on each unit’s standalone selling price. Management considers a variety of factors such
as same or similar product historical sales, costs, and gross margin, which may vary over time depending upon the unique facts and circumstances related to
each performance obligation in making these estimates. In addition to historical data, we take into consideration changing trends and market conditions. For
treatment plans with multiple future options, we also consider usage rates, which is the number of times a customer is expected to order additional aligners. Our
process for estimating usage rates requires significant judgment and evaluation of inputs, including historical usage data by region, country and channel. We
recognize revenue upon shipment, as the customers obtain physical possession and we have enforceable rights to payment. We have made an accounting policy
election to account for shipping and handling costs as activities to fulfill the performance obligation. Where processing fees are charged, the consideration
received from the fees are included in the transaction price.
As we collect most consideration upfront, we consider whether a significant financing component exists; however, as the delivery of the performance
obligations are at the customer’s discretion, we conclude that no significant financing component exists.
Systems and Services
We sell intraoral scanners and CAD/CAM services through both our direct sales force and distribution partners. The intraoral scanner sales price includes
one year of warranty and unlimited scanning services. The customer may also select, for additional fees, an extended warranty and unlimited scanning services
for periods beyond the initial year. When intraoral scanners are sold with an unlimited scanning service agreement and/or extended warranty, we allocate
revenues based on the respective SSP of the scanner and the subscription services. We estimate the SSP of each element, taking into account factors such as
same or similar historical prices and discounting strategies. Revenues are then recognized over time as the monthly services are rendered and upon shipment of
the scanner, as that is when we deem the customer to have obtained control. We also have a rental program, where scanners are leased to customers. The
contracts for the program are treated as operating leases, and the revenue is recognized ratably over the lease term.
CAD/CAM services, where sold separately, include the initial software license and maintenance and support. We allocate revenues based upon the
respective SSPs of the software license and the maintenance and support. We estimate the SSP of each element using data such as historical prices. Revenues
related to the software license are recognized upfront and revenues related to the maintenance and support are recognized over time. For both scanner and
service sales, most consideration is collected upfront and in cases where there are payment plans, consideration is collected within one year and, therefore, there
are no significant financing components.
Volume Discounts
In certain situations, we offer promotions in which the discount will increase depending upon the volume purchased over time. We concluded that in these
situations, the promotions can represent either variable consideration or options, depending upon the specifics of the promotion. In the event the promotion
contains an option, the option is considered a material right and, therefore, included in the accounting for the initial arrangement. We estimate the average
anticipated discount over the lifetime of the promotion or contract, and apply that discount to each unit as it is sold. On a quarterly basis, we review our
estimates and, if needed, updates are made and changes are applied prospectively.
Accrued Sales Return Reserve
We provide a reserve for sales returns based on historical sales returns as a percentage of revenues. 
Costs to Obtain a Contract
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We offer a variety of commission plans to our sales force; each plan has multiple components. To match the costs to obtain a contract to the associated
revenues, we evaluate the individual components and capitalize the eligible components, recognizing the costs over the treatment period. The capitalized costs
to obtain contracts were $29.2 million and $25.8 million as of December 31, 2025 and 2024, respectively, and are included in Other assets in our Consolidated
Balance Sheets. We recognized amortization on our costs to obtain a contract of $15.6 million, $18.7 million, and $12.5 million during the years ended
December  31, 2025, 2024, and 2023, respectively, which is included in Selling, general and administrative expenses in our Consolidated Statements of
Operations.
Unfulfilled Performance Obligations for Clear Aligners and Scanners
Our unfulfilled performance obligations, including deferred revenues and backlog, and the estimated revenues expected to be recognized in the future
related to these performance obligations are $1,352.7 million and $1,444.9 million as of December 31, 2025 and 2024, respectively. This includes performance
obligations from the Clear Aligner reportable segment, primarily the shipment of additional aligners, which are fulfilled over six months to five years. This also
includes performance obligations from our Systems and Services reportable segment, primarily services and support, which are fulfilled over one to five years,
and contracted deliveries of additional scanners. The estimate includes both product and service unfulfilled performance obligations and the time range reflects
our best estimate of when we will transfer control to the customer and may change based on customer usage patterns, timing of shipments, readiness of
customers' facilities for installation, and manufacturing availability.
Contract Balances
The timing of revenue recognition results in deferred revenues being recognized on our Consolidated Balance Sheet. For both aligners and scanners, we
usually collect the total consideration owed prior to all performance obligations being satisfied with payment terms generally varying from net 30 to net 180
days. Contract liabilities are recorded as deferred revenue, which is generated based upon the timing of invoices and recognition patterns, not payments. If
revenue recognition exceeds the billing, the excess amount is considered an unbilled receivable or a contract asset. Conversely, if the billing occurs prior to the
revenue recognition, the amount is considered deferred revenue and a contract liability.
Shipping and Handling Costs
Shipping and handling charges to customers as well as processing fees are included in net revenues, and the associated costs incurred are recorded in cost
of net revenues.
Legal Proceedings
We are involved in legal proceedings on an ongoing basis. If we believe that a loss arising from such matters is probable and can be reasonably estimated,
we accrue the estimated loss in our consolidated financial statements. If only a range of estimated losses can be determined, we accrue an amount within the
range that, in our judgment, reflects the most likely outcome; if none of the estimates within that range is a better estimate than any other amount, we accrue the
low end of the range.
Research and Development
Research and development costs are expensed as incurred and include costs associated with the research and development of new products and
enhancements to existing products. These costs primarily include employee related costs, including payroll, benefits and stock-based compensation, equipment,
material and maintenance costs, outside consulting expenses, depreciation and amortization expense and allocations of corporate overhead expenses including
facilities and IT.
Advertising Costs
The cost of advertising and media is expensed as incurred. For the years ended December 31, 2025, 2024 and 2023, we incurred advertising costs of
$188.7 million, $185.0 million and $201.2 million, respectively.
Stock-Based Compensation
We recognize stock-based compensation cost for shares expected to vest on a straight-line basis over the requisite service period of the award, net of
estimated forfeitures. We use the Black-Scholes option pricing model to determine the fair value of employee stock purchase plan shares. We use a Monte Carlo
simulation model to estimate the fair value of awards with a market based condition which requires the input of assumptions, including expected term, stock
price volatility and the risk-free
72

rate of return. For restricted stock units that include a performance condition, we use the stock price on the grant date to estimate the fair value and stock-based
compensation cost is recorded based on expected attainment of performance targets. Forfeitures are estimated based on historical experience at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Income Taxes
We make certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the
calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenues and expenses for tax and financial statement
purposes.
As part of the process of preparing our consolidated financial statements, we are required to estimate our income taxes in each of the jurisdictions in which
we operate. This process involves us estimating our current tax exposure under the applicable tax laws and assessing temporary differences resulting from
differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities which are included in our
Consolidated Balance Sheets.
We account for uncertainty in income taxes pursuant to authoritative guidance based on a two-step approach to recognize and measure uncertain tax
positions taken or expected to be taken in a tax return. The first step is to determine if the weight of available evidence indicates that it is more likely than not
that the tax position will be sustained on audit based on its technical merits, including resolution of any related appeals or litigation processes. The second step is
to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. We adjust reserves for our uncertain tax
positions due to changing facts and circumstances, such as the closing of a tax audit or refinement of estimates due to new information. To the extent that the
final outcome of these matters is different than the amounts recorded, such differences will impact our tax provision in our Consolidated Statements of
Operations in the period in which such determination is made.
We assess the likelihood that we will be able to realize our deferred tax assets, including those related to our Switzerland deferred tax assets, which have a
finite utilization period. We consider all available evidence, both positive and negative, including historical levels of income, expectations and risks associated
with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If it is more
likely than not that we will not realize our deferred tax assets, we will record a valuation allowance against the deferred tax assets that we estimate will not
ultimately be realizable. The determination of whether a valuation allowance is required involves significant judgment and reflects our evaluation of changes in
our operational performance, taxable income forecasts, and other relevant factors,
Common Stock Repurchase
We repurchase our own common stock from time to time under stock repurchase programs approved by our Board of Directors. We account for these
repurchases under the accounting guidance for equity where we allocate the total repurchase value that is in excess of par value between additional paid-in
capital and retained earnings. All shares repurchased are retired.
Recent Accounting Pronouncements
(i) New Accounting Updates Recently Adopted
On December 14, 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures.” The amendments in this ASU require a public entity
to disclose in tabular format, using both percentages and reporting currency amounts, specific categories in the rate reconciliation and to provide additional
information for reconciling items that meet a quantitative threshold. The amendments in this ASU also require taxes paid (net of refunds received) to be
disaggregated by federal, state, and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative
threshold. For public business entities, the provisions of ASU 2023-09 are effective for fiscal years beginning after December 15, 2024. We adopted this
standard on a prospective basis for our annual report on Form 10-K effective for the year ended December 31, 2025. ASU 2023-09 impacts our accounting for
income tax financial statement disclosures, but did not impact our Consolidated Balance Sheets, Statements of Operations or Statements of Cash Flows.
On November 27, 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07 (“ASU 2023-07”),
“Improvements to Reportable Segment Disclosures.” The amendments in this update improve reportable segment disclosure requirements, primarily through
enhanced disclosures about significant segment expenses and other segment expenses. For public business entities, the provisions of ASU 2023-07 were
effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. We adopted this
standard for the fiscal year ended December 31, 2024 and for interim periods within the fiscal year ended December 31, 2025. See Note 14 “Segments and
Geographical Information.”
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(ii) Recent Accounting Pronouncements Not Yet Effective
On September 18, 2025, the FASB issued ASU 2025-06, “Intangibles-Goodwill and Other-Internal-Use Software.” The amendments in this ASU simplify
the accounting for internal-use software by eliminating the existing project development stages and introducing new guidance for evaluating the probable-to-
complete threshold for capitalization. The amendments in this ASU also require the application of ASC 360-10 disclosure requirements for all capitalized
internal-use software costs, regardless of how those costs are presented in the financial statements. The provisions of ASU 2025-06 are effective for all entities
for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. Early adoption is permitted. The Company is evaluating the
effect of this pronouncement on its annual consolidated financial statements.
On November 4, 2024, the FASB issued ASU 2024-03, “Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures.” The
amendments in this ASU require a public entity to disclose, in the notes to the financial statements, specified information about certain costs and expenses,
including the amounts of inventory purchases, employee compensation, depreciation and intangible asset amortization. For public business entities, the
provisions of ASU 2024-03 are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December
15, 2027. Early adoption is permitted. There will be no impact to our consolidated balance sheets or statements of operations; however, the Company is
evaluating the effect of this pronouncement on our consolidated financial statement disclosures.
Note 2. Financial Instruments
Cash, Cash Equivalents and Marketable Securities
The following tables summarize our cash and cash equivalents, and marketable securities balances recorded in our Consolidated Balance Sheets as of
December 31, 2025 and 2024 (in thousands):
Reported as:
December 31, 2025
Amortized

Cost
Gross

Unrealized

Gains
Gross

Unrealized

Losses
Fair Value
Cash and cash
equivalents
Cash
$
770,051 
$
— 
$
— 
$
770,051 
$
770,051 
Money market funds
308,940 
— 
— 
308,940 
308,940 
Certificates of deposit
15,917 
— 
— 
15,917 
15,917 
Total
$
1,094,908 
$
— 
$
— 
$
1,094,908 
$
1,094,908 
Reported as:
December 31, 2024
Amortized

Cost
Gross

Unrealized

Gains
Gross

Unrealized

Losses
Fair Value
Cash and cash
equivalents
Cash
$
752,423 
$
— 
$
— 
$
752,423 
$
752,423 
Money market funds
291,464 
— 
— 
291,464 
291,464 
Total
$
1,043,887 
$
— 
$
— 
$
1,043,887 
$
1,043,887 
We had no short-term or long-term marketable securities as of December 31, 2025 or 2024.
74

Fair Value Measurements
The following tables summarize our financial assets measured at fair value as of December 31, 2025 and 2024 (in thousands):
Description
Balance as of December 31, 2025
Level 1
Cash equivalents:
Money market funds
$
308,940 
$
308,940 
Certificate of deposits
15,917 
15,917 
$
324,857 
$
324,857 
Description
Balance as of December 31, 2024
Level 1
Cash equivalents:
Money market funds
$
291,464 
$
291,464 
$
291,464 
$
291,464 
We had no financial assets that were categorized as level 2 or level 3 in the fair value hierarchy for the years ended December 31, 2025 or 2024.
Derivatives Not Designated as Hedging Instruments
Recurring foreign currency forward contracts
We enter into foreign currency forward contracts to minimize the short-term impact of foreign currency exchange rate fluctuations on certain assets and
liabilities. These forward contracts are classified within Level 2 of the fair value hierarchy. As a result of the settlement of foreign currency forward contracts,
we recognized a net loss of $34.2 million during the year ended December 31, 2025, a net gain of $35.2 million during the year ended December 31, 2024 and a
net loss of $15.9 million during the year ended December 31, 2023. Recognized gains and losses from the settlement of foreign currency forward contracts are
recorded in Other income (expense), net in our Consolidated Statements of Operations. As of December 31, 2025 and 2024, the fair value of foreign exchange
forward contracts outstanding was not material.
75

The following tables present the gross notional value of all our foreign exchange forward contracts outstanding as of December 31, 2025 and 2024 (in
thousands):
December 31, 2025
Local Currency
Amount
Notional Contract
Amount (USD)
Euro
€183,700 $
215,895 
Canadian Dollar
C$90,000
65,802 
British Pound
£38,500
51,782 
Polish Zloty
PLN174,800
48,605 
Israeli Shekel
ILS80,500
25,283 
Japanese Yen
¥3,200,000
20,447 
Brazilian Real
R$63,500
11,440 
Chinese Yuan
¥52,000
7,461 
Swiss Franc
CHF4,200
5,316 
New Taiwan Dollar
NT$121,500
3,851 
New Zealand Dollar
NZ$6,020
3,474 
Korean Won
₩4,600,000
3,207 
Australian Dollar
A$3,500
2,337 
Czech Koruna
Kč26,000
1,262 
Total notional contract amount
$
466,162 
December 31, 2024
Local Currency
Amount
Notional Contract
Amount (USD)
Euro
€176,080 $
183,172 
Polish Zloty
PLN283,000
68,633 
Canadian Dollar
C$97,000
67,446 
British Pound
£37,600
47,090 
Israeli Shekel
ILS90,055
24,740 
Chinese Yuan
¥164,500
22,417 
Brazilian Real
R$83,100
13,327 
Japanese Yen
¥2,000,000
12,778 
Swiss Franc
CHF5,700
6,314 
New Zealand Dollar
NZ$7,000
3,924 
Czech Koruna
Kč72,800
3,004 
Australian Dollar
A$3,800
2,355 
New Taiwan Dollar
NT$58,700
1,786 
Korean Won
₩2,000,000
1,361 
Total notional contract amount
$
458,347 
Note 3. Balance Sheet Components
Inventories consist of the following (in thousands): 
December 31,
2025
2024
Raw materials
$
107,296 
$
124,377 
Work in process
65,679 
73,660 
Finished goods
53,368 
56,250 
Total inventories
$
226,343 
$
254,287 
76

During the year ended December 31, 2025, we recognized an impairment loss on inventory of $14.9 million to adjust our inventory balance to its net
realizable value. This loss was recorded in Cost of net revenues in our Consolidated Statements of Operations.
Prepaid expenses and other current assets consist of the following (in thousands): 
December 31,
2025
2024
Value added tax receivables 
$
55,819 
$
34,028 
Prepaid expenses
62,478 
82,978 
Other current assets
47,274 
81,576 
Total prepaid expenses and other current assets
$
165,571 
$
198,582 
    Refer to Note 9 “Commitments and Contingencies” of the Notes to Consolidated Financial Statements for discussion of tax matter.
Property, plant and equipment, net consist of the following (in thousands):
December 31,
Generally Used Estimated
Useful Life
2025
2024
Clinical and manufacturing equipment
Up to 13 years
$
848,473 
$
871,827 
Building
20 years
524,608 
529,716 
Leasehold improvements
Lease term 
67,402 
62,172 
Computer software and hardware
3 years
120,608 
135,756 
Land
—
57,868 
63,875 
Furniture, fixtures and other
2-5 years
151,874 
135,816 
Construction in progress
—
127,944 
133,684 
Total
1,898,777 
1,932,846 
Less: Accumulated depreciation and impairment charges
(767,324)
(661,712)
Total property, plant and equipment, net
$
1,131,453 
$
1,271,134 
    Shorter of the remaining lease term or the estimated useful lives of the assets.
Depreciation was $218.6 million, $126.2 million and $126.0 million for the years ended December 31, 2025, 2024 and 2023, respectively. Depreciation
expense in 2025 includes $76.9 million of accelerated depreciation, as discussed in Note 1 “Summary of Significant Accounting Policies."
Accrued liabilities consist of the following (in thousands):
 
December 31,
 
2025
2024
Accrued payroll and benefits
$
226,149 
$
248,003 
Accrued expenses
61,049 
66,391 
Accrued income taxes
44,049 
48,808 
Current operating lease liabilities
31,939 
31,063 
Accrued sales and marketing expenses
29,941 
37,617 
Accrued property, plant and equipment
10,469 
13,462 
Other accrued liabilities
133,153 
152,844 
Total accrued liabilities
$
536,749 
$
598,188 
1
1
1
1
77

Accrued warranty, which is included in the “Other accrued liabilities” category of the Total accrued liabilities table above, consists of the following
activity (in thousands):
Balance as of December 31, 2023
$
22,426 
Charged to cost of net revenues
21,962 
Actual warranty expenditures
(13,177)
Balance as of December 31, 2024
31,211 
Charged to cost of net revenues
5,333 
Actual warranty expenditures
(12,133)
Balance as of December 31, 2025
$
24,411 
Deferred revenues consist of the following (in thousands):
December 31,
2025
2024
Deferred revenues - current
$
1,261,816 
$
1,331,146 
Deferred revenues - long-term 
85,543 
102,164 
    Included in Other long-term liabilities within our Consolidated Balance Sheets.
During the years ended December 31, 2025 and 2024, we recognized $4,035.0 million and $3,999.0 million of net revenues, respectively, of which $840.5
million and $819.0 million was included in the deferred revenues balance at December 31, 2024 and 2023, respectively.
Note 4. Leases
Lessee Information
We have operating leases for our digital treatment planning and office facilities, retail spaces, vehicles and office equipment. The components of lease
expense consist of following (in thousands):
Year Ended December 31,
Lease Cost
2025
2024
2023
Operating lease cost 
$
43,401  $
42,299  $
44,614 
Variable lease cost 
4,054 
3,630 
16,013 
Total lease cost
$
47,455  $
45,929  $
60,627 
    Includes expense associated with short term leases, lease terms of 12 months or less, which is not material.
    Includes payments related to agreements with embedded leases that are not otherwise reflected on the balance sheet.
The following table provides a summary of our operating lease terms and discount rates:
December 31,
Remaining Lease Term and Discount Rate
2025
2024
Weighted average remaining lease term (in years)
5.1
5.4
Weighted average discount rate
4.1 %
3.8 %
1
1
1
2
1
2
78

As of December 31, 2025, the future payments related to our operating lease liabilities are as follows (in thousands):
Fiscal Year Ending December 31,
Operating Leases
2026
$
35,694 
2027
29,595 
2028
23,986 
2029
15,564 
2030
7,212 
Thereafter
13,060 
Total lease payments
125,111 
Less: Imputed interest
(10,665)
Total lease liabilities
$
114,446 
As of December 31, 2025, we had additional leases that had not commenced with future lease payments of $58.4 million. These leases will commence
during 2026 with non-cancelable lease terms of two to fourteen years.
Lessor Information
We lease iTero intraoral scanners to customers which are classified as operating leases. Our portfolio of leased iTero scanners included in Property, plant
and equipment, net are as follows:
December 31,
2025
2024
Scanners under operating leases, gross
$
55,576 
$
33,770 
Less: accumulated depreciation
(26,222)
(12,038)
Scanners under operating leases, net
$
29,354 
$
21,732 
As of December 31, 2025, the future lease payments due to us are as follows (in thousands):
Fiscal Year Ending December 31,
Operating Leases
2026
$
33,898 
2027
28,587 
2028
8,736 
2029
1,080 
Thereafter
— 
Total lease payments
$
72,301 
For the years ended December 31, 2025, 2024 and 2023, operating lease income was $28.8 million, $21.7 million and $16.6 million, respectively. Operating
lease income is recorded in Net revenues in our Consolidated Statements of Operations.
Note 5. Business Combination
On January 2, 2024 (the “Cubicure Acquisition Date”), we completed the acquisition of privately-held Cubicure GmbH (“Cubicure”) (the “Cubicure
Acquisition”). Cubicure is an Austrian company and specializes in direct 3D printing solutions for polymer additive manufacturing that develops, produces, and
distributes innovative materials, equipment, and processes for 3D printing solutions. The Cubicure Acquisition is intended to support and scale our strategic
innovation roadmap and strengthen the Align Digital Platform. In fiscal year 2021, we acquired a 9.04% equity interest in Cubicure. Subsequently, on the
Cubicure Acquisition Date, we acquired the remaining equity of Cubicure. Prior to the acquisition, we also had technology license and joint development
agreements with Cubicure.
The fair value of consideration transferred in the acquisition is shown in the table below (in thousands):
79

Cash paid to Cubicure stockholders
$
80,142 
Fair value of pre-existing equity interest ownership
7,968 
Settlement of pre-existing relationship - accounts payable
(2,316)
Total purchase consideration paid
$
85,794 
The Cubicure Acquisition was accounted for as a business combination under ASC Topic 805, Business Combinations (“ASC 805”) that was achieved in
stages. As a result of the Cubicure Acquisition, we remeasured our pre-existing equity interest in Cubicure at fair value prior to the Cubicure Acquisition. Based
on the fair value of this equity interest, derived from the purchase price, we estimated the fair value of our 9.04% pre-existing investment in Cubicure to be
approximately $8.0 million. The remeasurement resulted in the recognition of a pre-tax gain of $4.1 million, which was reflected as a component of Other
income (expense), net within our Consolidated Statements of Operations.
In 2021, we initiated Joint development (“JDA”) and Technology license agreements (“TLA”) to provide us with access to Cubicure’s technology. The
settlement of the JDA and TLA were concluded to be at market terms on the Cubicure Acquisition Date; therefore, no gain or loss was recorded related to the
settlement of these contracts. We also had accounts payable from the pre-existing arrangements with Cubicure of $2.3 million, which were effectively settled
and reduced from the purchase consideration of the Cubicure Acquisition.
The allocation of purchase price to assets acquired and liabilities assumed is as follows (in thousands):
Working capital
$
1,039 
Property & equipment
975 
Developed technology
47,000 
Other non-current asset
1,483 
Other liabilities
(12,279)
Goodwill
47,576 
Total
$
85,794 
Goodwill represents the excess of the purchase price over the fair value of the underlying net tangible and identifiable intangible assets, and represents the
value associated with future technology, future customer relationships, and the knowledge and experience of the workforce in place. None of this goodwill is
deductible for tax purposes. We allocated all goodwill to our Clear Aligner reporting unit.
As part of the Cubicure Acquisition we acquired a developed technology intangible asset. The acquired developed technology had an estimated fair value
of $47.0 million as of the Cubicure Acquisition Date and will be amortized over a useful life of thirteen years.
The fair value of developed technology was estimated under the Multi-Period Excess Earnings Method and the fair value estimates for developed
technology include significant assumptions in the prospective financial information which include, but are not limited to, the projected future cash flows
associated with the technology, the asset's life cycle and a present value factor.

Acquisition related costs are recognized separately from the business combination and are expensed as incurred. Acquisition related costs were not
material.
Our Consolidated Financial Statements include the operating results of Cubicure from the Cubicure Acquisition Date. Separate post-acquisition operating
results and pro forma results of operations for this acquisition have not been presented as the effect is not material to our consolidated financial results.
80

Note 6. Goodwill and Intangible Assets
Goodwill
The change in the carrying value of goodwill for the years ended December 31, 2025 and 2024, categorized by reportable segment, is as follows (in
thousands):
Clear Aligner
Systems and Services
Total
Balance as of December 31, 2023
$
111,086  $
308,444  $
419,530 
Additions from acquisition
47,576 
— 
47,576 
Foreign currency translation adjustments
(6,017)
(18,459)
(24,476)
Balance as of December 31, 2024
152,645 
289,985 
442,630 
Foreign currency translation adjustments
11,610 
37,593 
49,203 
Balance as of December 31, 2025
$
164,255  $
327,578  $
491,833 
We completed our annual goodwill impairment assessment in 2025 and 2024 and determined there were no impairments.
Finite-Lived Intangible Assets
Acquired finite-lived intangible assets, excluding intangibles that were fully amortized, are as follows (in thousands):
Weighted Average
Amortization Period (in
years)
Gross Carrying Amount
as of
December 31, 2025
Accumulated

Amortization
Accumulated
Impairment Loss
Net Carrying
Value as of
December 31, 2025
Existing technology
11
$
146,651 
$
(67,138)
$
— 
$
79,513 
Customer relationships
10
21,500 
(12,363)
— 
9,137 
Trademarks and tradenames
7
9,800 
(8,050)
— 
1,750 
Patents
12
480 
(320)
— 
160 
$
178,431 
$
(87,871)
$
— 
$
90,560 
Foreign currency translation adjustments
3,373 
Total intangible assets, net
$
93,933 
The Weighted Average Amortization Period decreased from 10 years to 7 years due to an intangible asset with a useful life of 15 years becoming fully amortized in 2025.
Weighted Average
Amortization Period (in
years)
Gross Carrying
Amount as of
December 31, 2024
Accumulated

Amortization
Accumulated
Impairment Loss
Net Carrying
Value as of
December 31, 2024
Existing technology
11
$
146,651 
$
(52,238)
$
— 
$
94,413 
Customer relationships
10
21,500 
(10,079)
— 
11,421 
Trademarks and tradenames
10
16,600 
(9,255)
(4,122)
3,223 
Patents
12
480 
(280)
— 
200 
$
185,231 
$
(71,852)
$
(4,122)
$
109,257 
Foreign currency translation adjustments
(5,769)
Total intangible assets, net
$
103,488 
Of the $146.7 million recorded as Existing technology intangible assets as of December 31, 2025, $47.0 million was acquired during the first quarter of
2024 as part of the Cubicure Acquisition. The existing technology acquired in the Cubicure Acquisition had an estimated useful life of 13 years, which had the
effect of increasing the weighted average amortization period from approximately 10 years as of December  31, 2023 to approximately 11 years as of
December 31, 2024. Refer to Note 5 “Business Combination”.
For the years ended December 31, 2025 and 2024, we did not identify any impairment triggering events that would indicate that the carrying value of our
finite-lived intangible assets was not recoverable.
1
1 
81

The total estimated future amortization expense for these acquired finite-lived intangible assets as of December 31, 2025 is as follows (in thousands):
Fiscal Year
Amortization
2026
$
17,922 
2027
15,607 
2028
14,505 
2029
14,505 
2030
6,328 
Thereafter
21,693 
Total
$
90,560 
Amortization expense was $18.8 million, $18.9 million and $16.4 million for the years ended December 31, 2025, 2024 and 2023, respectively.
Note 7. Credit Facility
We maintain a credit facility, as amended in December 2022, that includes a $300.0 million unsecured revolving line of credit and a $50.0 million letter of
credit sub-limit. The facility matures on December 23, 2027 and loans under the facility accrue interest, at our election, based on either the Secured Overnight
Financing Rate (“SOFR”) for the applicable period or a base rate, in each case plus an applicable margin.
The facility includes financial covenants and performance requirements. As of December 31, 2025, we had no outstanding borrowings under the facility
and were in compliance with the terms and conditions of the facility in all material respects.
Note 8. Legal Proceedings
    
Antitrust Class Actions
On June 5, 2020, a dental practice, Simon and Simon, PC (doing business as City Smiles), brought an antitrust action in the U.S. District Court for the
Northern District of California on behalf of itself and a putative class of similarly situated practices seeking treble monetary damages, interest, costs, attorneys’
fees, and injunctive relief relating to our alleged market activities in alleged clear aligner and intraoral scanner markets. Plaintiff filed an amended complaint and
added VIP Dental Spas as a plaintiff on August 14, 2020. On December 18, 2023, the court certified a class of persons or entities that purchased Invisalign
directly from us between January 1, 2019 and March 31, 2022. The court denied Plaintiffs’ motion to certify a class of purchasers of scanners. On February 21,
2024, the court granted our motion for summary judgment on all claims brought by the plaintiffs. Plaintiffs have appealed the district court’s summary judgment
ruling to the United States Court of Appeals for the Ninth Circuit. Oral argument was held on April 10, 2025.
On May 3, 2021, an individual named Misty Snow brought an antitrust action in the U.S. District Court for the Northern District of California on behalf of
herself and a putative class of similarly situated individuals seeking treble monetary damages, interest, costs, attorneys’ fees, and injunctive relief relating to our
alleged market activities in alleged clear aligner and intraoral scanner markets based on Section 2 of the Sherman Act. Plaintiffs have since filed several
amended complaints adding new plaintiffs and various state law claims. On November 29, 2023, the court certified a class of indirect purchasers of Invisalign
between July 1, 2018 and December 31, 2023 and a class of indirect purchasers of Invisalign seeking injunctive relief. On February 21, 2024, the court granted
our motion for summary judgment on the claims related to Section 2 allegations. The court entered judgment for the Section 2 and related state law claims on
March 22, 2024. Plaintiffs have appealed the district court’s summary judgment ruling to the United States Court of Appeals for the Ninth Circuit. Oral
argument was held on April 10, 2025.
We are currently unable to predict the outcome of these lawsuits and therefore we cannot determine the likelihood of loss, if any, nor estimate a range of
possible loss.
During the course of the Misty Snow lawsuit, some additional plaintiffs joined and filed allegations based on Section 1 of the Sherman Act. In June 2024,
we reached a settlement in principle with the Section 1 plaintiffs to resolve all remaining claims in the Section 1 lawsuit. In March 2025, Align and plaintiffs
agreed to a revised settlement to resolve all Section 1 claims for a
82

$31.75 million cash payment. On November 21, 2025, the court granted final approval of the settlement and dismissed the case with prejudice.
In 2025, Align issued a payment for the full settlement amount, $31.75 million, consisting of $27.5 million accrued as of December 31, 2024 and an
additional loss accrual of $4.25 million in the first quarter of 2025, to an escrow agency in accordance with the court's approval.
Straumann Litigation
On April 11, 2024, we filed a lawsuit in the U.S. District Court for the Western District of Texas against ClearCorrect Operating, LLC, ClearCorrect
Holdings, Inc. and Institut Straumann AG, (collectively the “Defendants”). The complaint asserted infringement of our patents related to aligner material,
treatment planning, and intraoral scanner technologies. Among other things, the complaint seeks relief enjoining the Defendants’ infringement of multiple Align
multilayer material patents through Defendants’ manufacture, sale and offer for sale of aligners made with Zendura FLX/ClearQuartz materials. On September
12, 2025, Defendants filed a motion to dismiss the amended complaint. That motion to dismiss remains pending. Defendants are also seeking to invalidate all of
our asserted patents at the district court.
On July 9, 2024, Defendants filed counterclaims against us alleging antitrust violations and unfair competition. Among other things, the counterclaims
seek injunctive relief and money damages. On August 29, 2025, Defendants filed amended counterclaims, which additionally allege that Align procured certain
materials patents by fraud. On September 26, 2025, Align filed a motion to dismiss the amended counterclaims. That motion is still pending. A trial in the case
is set for June 22, 2026.
On April 10, 12 and 14, 2025, Defendants filed eight inter partes review (“IPR”) petitions with the United States Patent Trial and Appeal Board
(“PTAB”), alleging that eight of the patents asserted by Align against the Defendants are unpatentable. On October 23, 2025, the PTAB issued decisions
denying institution of two of Defendants eight IPRs. On October 23, October 27, October 30, and November 6, 2025, the PTAB issued decisions instituting
proceedings on the remaining six IPRs. We believe the petitions are without merit and intend to defend ourselves vigorously.
We believe Defendants’ counterclaims are without merit and intend to vigorously defend ourselves. We are currently unable to predict the outcome of this
lawsuit and cannot determine the likelihood of loss, if any, nor estimate a range of possible loss.
Angelalign Litigation
On August 15, 2025, we initiated two actions in the European Unified Patent Court against Angelalign Technology, Inc.; Angelalign France Technology
SASU; Europe Angelalign Technology B.V.; Angelalign Technology (Germany) GmbH; Italy Angelalign Technology S.R.L. and Shanghai EA Medical
Instruments Co., Ltd. These actions allege infringement of patents related to user interfaces for treatment planning and to the “power ridge” feature of clear
aligners. Subsequently, on November 27, 2025, we initiated a third action in the Unified Patent Court against the same entities for infringement of a patent
related to treatments in complex cases. The accused entities have challenged the validity of the asserted patent in each of these actions. On January 13, 2026,
Angelalign Technology (Germany) GMBH filed an action in the European Patent Office challenging the validity of the treatment-planning patent referenced
above. These actions are currently pending.
On February 12, 2026, the Unified Patent Court issued a preliminary injunction in Align’s favor and against Angel, enjoining Angel from using its “Live
Now” feature, a user interface for treatment planning. Angel must pay €20,000 EUR per day or cease offering its infringing software feature.
On August 18, 2025, we initiated an action in the U.S. District Court for the Eastern District of Texas against Angelalign Technology Inc; Wuxi EA
Medical Instruments Technologies Ltd.; Wuxi EA Bio-Tech Co., Ltd.; and Shanghai EA Medical Instruments Co., Ltd. This action alleges infringement of
patents related to multilayer materials for clear aligners and “bite ramp” and “power ridge” features of clear aligners. On January 2, 2026, following institution
of an investigation by the U.S. International Trade Commission, referenced below, this action was stayed pending further order of the court.
On August 18, 2025, we initiated two actions in China’s Zhengzhou Intermediate People’s Court against Shanghai Angelalign Medical Devices Co., Ltd.;
Wuxi Angelalign Medical Device Technology Co., Ltd.; and Wuxi Angelalign Biotechnology Co., Ltd. These actions allege infringement of patents related to
tooth attachments and treatment planning. Separately, on September 10, 2025, we filed an action against the same entities in the Jinan Intermediate People’s
Court alleging infringement of a patent related to extraction site closure. And on January 12, 2026, we filed an action against these entities in the Fuzhou
Intermediate People’s Court alleging infringement of a patent related to extraction site closure. These actions are currently pending.
83

On January 16, 2026, Shanghai Angelalign Medical Devices Co., Ltd. filed a petition with the China National Intellectual Property Administration
(“CNIPA”) challenging the validity of our patent related to extraction site closure, which patent is the subject of an infringement action referenced above. On
January 22, 2026, Shanghai Angelalign Medical Devices Co., Ltd. filed a petition with the CNIPA challenging the validity of our patent related to tooth
attachments, which patent likewise is the subject of an infringement action referenced above. And on January 19, 2026, we filed a petition with the CNIPA
challenging the validity of a patent held by Wuxi Angelalign Medical Device Technology Co., Ltd. regarding undercut detection and filling. These invalidity
actions are currently pending.
On September 23, 2025, we filed a complaint at the U.S. International Trade Commission (“ITC”) against Angelalign Technology Inc., Wuxi EA Medical
Instruments Technologies Ltd.; Wuxi EA Bio-Tech Co., Ltd.; Shanghai EA Medical Instruments Co., Ltd.; and USA Angelalign Technology Corp. (collectively,
“the ITC Respondents”). This complaint alleges unlawful importation and sale of clear aligners that infringe patents related to multilayer materials for clear
aligners, in violation of 19 U.S.C.§ 1337. Further, the complaint requests that the ITC institute an investigation and issue an exclusion order blocking the ITC
Respondents’ importation of infringing products into the United States, and a cease-and-desist order prohibiting the ITC Respondents from selling, marketing,
or transferring infringing products within the United States. On December 19, 2025, the ITC instituted the requested investigation, which is currently pending.
On August 22, 2025, Shanghai Angelalign Medical Devices Co., Ltd. and Wuxi Angelalign Medical Devices Technology Co., Ltd. initiated an action
against us in China’s the Beijing Intellectual Property Court. The complaint alleges that we infringe a patent relating to undercut detection for mold
manufacturing. We believe that these allegations are without merit and intend to defend ourselves vigorously.
We are currently unable to predict the outcome of these lawsuits or any future litigation, and therefore we cannot determine the likelihood of loss, if any,
nor estimate a range of possible loss.
In addition to the above, in the ordinary course of our operations, we are involved in a variety of claims, suits, investigations, and proceedings, including
actions with respect to intellectual property claims, patent infringement claims, government investigations, labor and employment claims, breach of contract
claims, tax, and other matters. Regardless of the outcome, these proceedings can have an adverse impact on us because of defense costs, diversion of
management resources, and other factors. Although the results of complex legal proceedings are difficult to predict and our view of these matters may change in
the future as litigation and events related thereto unfold; we currently do not believe that these matters, individually or in the aggregate, will materially affect our
financial position, results of operations or cash flows.
Note 9. Commitments and Contingencies
Tax Matter
Beginning in the third quarter of 2023 and continuing through the first quarter of 2024, we received cumulative assessments of approximately $100 million
from His Majesty’s Revenue and Customs (“HMRC”) for unpaid value added tax (“VAT”) related to certain clear aligner sales made during the period of
October 2019 through May 2023. We were required to pay these assessments prior to contesting or litigating the matter in statutory appeal. We have historically
asserted and continue to assert that doctor prescribed clear aligners sold by dentists for the orthodontic treatment of patient malocclusions are exempt from VAT,
that we have reasonably relied upon statements and guidance by HMRC and that our interpretation of United Kingdom legislation is appropriate.
In October 2024, the Company and HMRC reached a settlement agreement regarding the unpaid VAT related to certain aligner sales made during the
period of October 2019 through mid-October 2023. As part of the settlement, HMRC agreed to vacate the judicial review (before the Administrative Court)
originally scheduled for October 9th and October 10th, 2024, refund to the Company all assessments paid for the period of October 2019 through May 2023 and
withdraw any potential assessments for the period from June 2023 through mid-October 2023. HMRC has refunded to the Company the assessed amounts,
approximately $100 million.
A statutory appeal (before the First-tier Tribunal - “Tax Tribunal”) was held on January 27th through January 30th, 2025. On April 24, 2025, the Tax
Tribunal issued a ruling in our favor indicating that clear aligners are “dental prostheses for the purposes of VAT”, which is a key condition for the VAT
exemption. On June 13, 2025, HMRC applied for permission to appeal the Tax Tribunal decision, which was granted on July 15, 2025. On August 1, 2025,
HMRC lodged their grounds for appeal to the Upper Tribunal. A hearing in front of the Upper Tribunal has been scheduled for May 2026.
84

In August 2025, we stopped charging VAT to our United Kingdom customers. It is not possible at this stage to accurately evaluate the likelihood of an
unfavorable outcome from the Upper Tribunal statutory appeal, nor estimate a range of possible loss.
Indemnification Provisions
In the normal course of business to facilitate transactions in our services and products, we indemnify certain parties: customers, vendors, lessors, and other
parties with respect to certain matters, including, but not limited to, services to be provided by us and intellectual property infringement claims made by third
parties. In addition, we have entered into indemnification agreements with our directors and our executive officers that will require us, among other things, to
indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. Several of these agreements limit the time
within which an indemnification claim can be made and the amount of the claim.
It is not possible to make a reasonable estimate of the maximum potential amount of future payments, if any, under these indemnification agreements due
to the unique facts and circumstances involved in each particular agreement. Additionally, we have a limited history of prior indemnification claims and the
payments we have made under such agreements have not had a material adverse effect on our results of operations, cash flows or financial position. However, to
the extent that valid indemnification claims arise in the future, future payments by us could be significant and could have a material adverse effect on our results
of operations or cash flows in a particular period. As of December  31, 2025, we did not have any material indemnification claims that were probable or
reasonably possible.
Note 10. Stockholders’ Equity
Common Stock
The holders of common stock are entitled to receive dividends whenever funds are legally available and when and if declared by the Company’s Board of
Directors. We have not historically declared or paid dividends on our common stock.
Stock-Based Compensation Plans
Our Align Technology, Inc. 2005 Incentive Plan, as amended (the “2005 Incentive Plan”), provides for the granting of incentive stock options, non-
statutory stock options, restricted stock, stock appreciation rights, performance units and performance shares to employees, non-employee directors and
consultants. Shares granted on or after May 16, 2013 as an award of restricted stock, restricted stock units, performance shares or performance units (“full value
awards”) are counted against the authorized share reserve as one and nine-tenths (1 9/10) shares for every one (1) share subject to the award, and any shares
canceled that were counted as one and nine-tenths shares against the plan reserve will be returned at the same ratio. 
As of December 31, 2025, the 2005 Incentive Plan has a total reserve of 34,668,895 shares of which 4,608,476 shares are available for issuance. We issue
new shares from our pool of authorized but unissued shares to satisfy the exercise and vesting obligations of our stock-based compensation plans.
Summary of Stock-Based Compensation Expense
Stock-based compensation related to our stock-based awards and employee stock purchase plan for the years ended December 31, 2025, 2024 and 2023 is
as follows (in thousands):
 
Year Ended December 31,
 
2025
2024
2023
Cost of net revenues
$
6,177 
$
6,995 
$
7,462 
Selling, general and administrative
132,362 
123,979 
115,992 
Research and development
47,331 
42,729 
30,572 
Total stock-based compensation
$
185,870 
$
173,703 
$
154,026 
The income tax benefit related to stock-based compensation was $20.0 million, $19.0 million and $17.1 million for the years ended December 31, 2025,
2024 and 2023, respectively.
 
85

Restricted Stock Units (“RSUs”)
The fair value of RSUs is based on the closing price of our stock on the date of grant. Generally, RSUs vest over a period of four years.
The following table summarizes RSU activity for the year ended December 31, 2025:
Number of Shares
Underlying RSUs

(in thousands)
Weighted Average
Grant Date Fair Value
Weighted Average
Remaining

Contractual Term

(in years)
Aggregate
Intrinsic Value

(in thousands)
Unvested as of December 31, 2024
1,019 
$
331.10 
Granted
692 
195.43 
Vested and released
(313)
354.77 
Forfeited
(148)
274.34 
Unvested as of December 31, 2025
1,250 
$
256.80 
1.3 $
195,141 
The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (calculated by multiplying our closing stock price on the last
trading day of fiscal year 2025 by the number of unvested RSUs) that would have been received by the unit holders had all RSUs vested and been released on
the last trading day of fiscal year 2025. This amount will fluctuate based on the fair market value of our stock. During 2025, of the 312,735 shares vested and
released, 90,466 shares were withheld for employee statutory tax obligations, resulting in a net issuance of 222,269 shares.
The total fair value of RSUs vested as of their respective vesting dates during 2025, 2024 and 2023 was $61.1 million, $78.8 million and $63.0 million,
respectively. The weighted average grant date fair value of RSUs granted during 2025, 2024 and 2023 was $195.43, $307.12 and $316.16, respectively. As of
December  31, 2025, we expect to recognize $191.9 million of total unamortized compensation costs, net of estimated forfeitures, related to RSUs over a
weighted average period of 2.3 years.
Market-Performance Based Restricted Stock Units (“MSUs”)
We grant MSUs to members of senior management. Each MSU represents the right to one share of our common stock. The actual number of MSUs which
will be eligible to vest will be based on the performance of our stock price relative to the performance of a stock market index over the vesting period. MSUs
vest over a period of three years and the maximum number of shares eligible to vest is 250% of the MSUs initially granted.
The following table summarizes MSU activity for the year ended December 31, 2025:
Number of Shares

Underlying MSUs
(in thousands)
Weighted Average
Grant Date Fair Value
Weighted Average

Remaining

Contractual Term

(in years)
Aggregate

Intrinsic Value

(in thousands)
Unvested as of December 31, 2024
193 
$
679.14 
Granted
127 
362.98 
Vested and released
(30)
878.35 
Forfeited
(27)
638.92 
Unvested as of December 31, 2025
263 
$
507.88 
1.3 $
41,148 
The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (calculated by multiplying our closing stock price on the last
trading day of 2025 by the number of unvested MSUs) that would have been received by the unit holders had all MSUs been vested and released as of the last
trading day of 2025. This amount will fluctuate based on the fair market value of our stock. During 2025, of the 29,995 shares that vested and released, 11,091
shares were withheld for employee statutory tax obligations, resulting in a net issuance of 18,904 shares.
The total fair value of MSUs vested as of their respective vesting dates during 2025, 2024 and 2023 was $5.7 million, $10.1 million and $7.8 million,
respectively. As of December 31, 2025, we expect to recognize $44.9 million of total unamortized compensation costs, net of estimated forfeitures, related to
MSUs over a weighted average period of 1.3 years.
86

The fair value of MSUs is estimated at the grant date using a Monte Carlo simulation that includes factors for market conditions. The weighted average
assumptions used in the Monte Carlo simulation were as follows: 
 
Year Ended December 31,
 
2025
2024
2023
Expected term (in years)
3.0
3.0
3.0
Expected volatility
51.5 %
52.0 %
59.1 %
Risk-free interest rate
4.2 %
4.3 %
4.3 %
Expected dividends
— 
— 
— 
Weighted average fair value per share at grant date
$
362.98 
$
617.79 
$
629.53 
Restricted Stock Units with Performance Conditions (“PSUs”)
Our PSUs typically include a service and performance condition. We recognize share-based compensation expense for PSUs if it is probable that the
performance condition will be achieved.
The following table summarizes PSU activity for the year ended December 31, 2025:
Number of Shares

Underlying PSUs

(in thousands)
Weighted Average
Grant Date Fair Value
Weighted Average

Remaining

Contractual Term

(in years)
Aggregate

Intrinsic Value

(in thousands)
Unvested as of December 31, 2024
11 
$
204.33 
Granted
— 
— 
Vested and released
(5)
201.63 
Forfeited
— 
— 
Unvested as of December 31, 2025
6 
$
206.36 
1.0 $
984 
During 2025, of the 4,728 shares vested and released, 1,923 shares were withheld for employee statutory tax obligations, resulting in a net issuance of
2,805 shares. As of December 31, 2025, we expect to recognize $0.5 million of total unamortized compensation costs, net of estimated forfeitures, related to
PSUs over a weighted average period of 1.0 year.
Employee Stock Purchase Plan (“ESPP”)
In May 2010, our stockholders approved the 2010 Employee Stock Purchase Plan (as amended and restated, the “2010 Purchase Plan”) which consists of
consecutive overlapping twenty-four month offering periods with four six-month purchase periods in each offering period. Employees purchase shares at 85%
of the lower of the fair market value of the common stock at either the beginning of the offering period (grant date) or the end of the purchase period. The 2010
Purchase Plan will continue until terminated by either the Board of Directors or its administrator. The 2010 Purchase Plan also allows for purchase rights to
employees outside the U.S. and Canada with six-month offering periods and purchase periods. In May 2021, the 2010 Purchase Plan was amended and restated
to increase the maximum number of shares available for purchase to 4,400,000 shares.
The following table summarizes the ESPP shares issued:
Year Ended December 31,
2025
2024
2023
Number of shares issued (in thousands)
147 
120 
114 
Weighted average price
$
148.77 
$
213.11 
$
234.19 
As of December 31, 2025, 1,728,664 shares remain available for future issuance.
87

The fair value of the option component of the 2010 Purchase Plan shares was estimated at the grant date using the Black-Scholes option pricing model
with the following weighted average assumptions:
 
Year Ended December 31,
  
2025
2024
2023
Expected term (in years)
1.2
1.3
1.2
Expected volatility
56.2 %
49.2 %
56.4 %
Risk-free interest rate
4.0 %
4.6 %
4.9 %
Expected dividends
— 
— 
— 
Weighted average fair value at grant date
$
64.94 
$
94.75 
$
132.94 
We recognized stock-based compensation related to our employee stock purchase plan of $15.1 million, $14.0 million and $20.5 million for the years
ended December 31, 2025, 2024 and 2023, respectively. As of December 31, 2025, we expect to recognize $10.6 million of total unamortized compensation
costs related to future employee stock purchases over a weighted average period of 0.6 years.
Note 11. Common Stock Repurchase Programs
We enter into Accelerated Share Repurchase (“ASR”) agreements and Open Market Repurchase (“OMR”) programs providing for the repurchase of our
common stock based on the volume-weighted average price during the term of the agreement, less an agreed upon discount. Under the terms of each ASR, the
financial institution may be required to deliver additional shares of common stock at final settlement or, under certain circumstances, we may be required at our
election, to either deliver shares or make a cash payment to the financial institution. The ASRs limit the number of shares we would be required to deliver.
In January 2023, our Board of Directors authorized a plan to repurchase up to $1.0 billion of our common stock (“January 2023 Repurchase Program”).
The January 2023 Repurchase Program was completed in its entirety in the second quarter of 2025.
In April 2025, our Board of Directors authorized a plan to repurchase up to $1.0 billion of our common stock (the “April 2025 Repurchase Program”). The
April 2025 Repurchase Program is expected to be completed over a period of up to three years. As of December 31, 2025, we have $831.2 million remaining
available for repurchase under the April 2025 Repurchase Program.
The following tables summarize the total repurchases of our common stock pursuant to ASR agreements and OMR programs under the January 2023 and
April 2025 Repurchase Programs for the years ended December 31, 2025 and 2024:
Accelerated Share Repurchases
Agreement

 Date
Repurchase

 Program
Amount Paid 

(in millions)
Completion

Date
Total Shares

Received
Average Price per Share
Q4 2023
January 2023
$
250.0 
Q1 2024
1,086,334 
$
230.13 
Open Market Repurchases
Agreement

 Date
Repurchase

 Program
Amount Paid 

(in millions)
Completion

Date
Total Shares

Received
Average Price per Share
Q4 2023
January 2023
$
100.0 
Q4 2023
465,518 
$
214.81 
Q2 2024
January 2023
$
150.0 
Q2 2024
598,302 
$
250.73 
Q4 2024
January 2023
$
275.0 
Q1 2025
1,241,509 
$
221.50 
Q1 2025
January 2023
$
225.0 
Q2 2025
1,339,124 
$
168.02 
Q3 2025
April 2025
$
168.8 
N/A
1,203,883 
$
140.22 
On August 5, 2025, we initiated a $200 million open market repurchase program, which was completed in January 2026. The amount paid, total shares received and
average price per share per the table above are determined as of December 31, 2025.
As of December 31, 2025, we had $831.2 million available for repurchases under the April 2025 Repurchase Program. In January 2026, we repurchased
$31.2 million of our common stock initiated in the Q3 2025 open market repurchase program.
1
1        
88

Note 12. Employee Benefit Plans
We have a defined contribution retirement plan as defined in Section  401(k) of the Internal Revenue Code for our U.S. employees which covers
substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a
pre-tax basis. We match 50% of our employee’s salary deferral contributions up to 6% of the employee’s eligible compensation. We contributed approximately
$9.7 million, $10.0 million and $9.5 million to the 401(k) plan during the years ended December 31, 2025, 2024 and 2023, respectively. We also have defined
contribution retirement plans outside of the U.S. to which we contributed $59.9 million, $57.4 million and $55.1 million during the years ended December 31,
2025, 2024 and 2023, respectively.
Note 13. Income Taxes
Net income before provision for income taxes consists of the following (in thousands):
 
Year Ended December 31,
 
2025
2024
2023
Domestic
$
280,926 
$
334,485 
$
315,643 
Foreign
304,361 
274,474 
325,561 
Net income before provision for income taxes
$
585,287 
$
608,959 
$
641,204 
The provision for (benefit from) income taxes consists of the following (in thousands):
 
Year Ended December 31,
 
2025
2024
2023
Federal
Current
$
52,962 
$
95,027 
$
134,332 
Deferred
14,385 
1,578 
(16,805)
67,347 
96,605 
117,527 
State
Current
13,977 
13,702 
28,535 
Deferred
13,766 
3,384 
(3,157)
27,743 
17,086 
25,378 
Foreign
Current
74,689 
56,653 
51,306 
Deferred
5,157 
17,253 
1,940 
79,846 
73,906 
53,246 
Provision for (benefit from) income taxes
$
174,936 
$
187,597 
$
196,151 
The following table is a reconciliation of the U.S. federal statutory rate of 21% to the Company’s effective rate for the year ended December 31, 2025 in
accordance with the guidance in ASU No. 2023-09:
89

 
Year Ended December 31, 2025
 
Amount
Percent
US federal statutory income tax rate
$
122,911 
21.0 %
State income taxes, net of federal tax benefit
25,901 
4.4 
Foreign tax effects
Switzerland
Statutory tax rate difference between Switzerland and U.S.
(11,536)
(2.0)
Canton tax
3,233 
0.6 
Swiss tax rate change - Remeasurement of deferred tax assets
15,136 
2.6 
Other
4,102 
0.7 
Mexico
Impairment Loss
7,111 
1.2 
Other
1,303 
0.2 
Other Foreign Jurisdictions
14,135 
2.4 
Effect of cross-border tax laws:
Subpart F
21,622 
3.7 
Foreign-derived intangible income
(13,611)
(2.3)
Other
825 
0.2 
Tax Credits
Research and development tax credits
(7,840)
(1.3)
Nontaxable or Nondeductible Items
Share-based payment awards
17,335 
3.0 
Other
3,219 
0.5 
Changes in Unrecognized Tax Benefits
(29,673)
(5.1)
Other Adjustments
763 
0.1 
Income Tax expense
$
174,936 
29.9 %
*State and local taxes in California, New York, Minnesota and New York City made up the majority (greater than 50%) of the tax effect in this category.
The following table is a reconciliation of the U.S. federal statutory rate of 21% to the Company’s effective rate for the years ended December 31, 2024 and
2023 in accordance with the guidance prior to the adoption of ASU 2023-09: 
 
Year Ended December 31
 
2024
2023
U.S. federal statutory income tax rate
21.0 %
21.0 %
State income taxes, net of federal tax benefit
2.2 
2.9 
U.S. tax on foreign earnings
5.4 
3.7 
Impact of differences in foreign tax rates
(2.0)
1.4 
Stock-based compensation
3.4 
3.0 
Settlement on audits
— 
0.1 
Change in valuation allowance
0.9 
(1.3)
Other items not individually material
(0.1)
(0.2)
Effective tax rate
30.8 %
30.6 %
*
90

As of December 31, 2025 and 2024, the significant components of our deferred tax assets and liabilities are (in thousands):
 
December 31,
 
2025
2024
Deferred tax assets:
Net operating loss and capital loss carryforwards
$
1,683 
$
2,741 
Reserves and accruals
61,496 
67,221 
Stock-based compensation
30,975 
29,255 
Deferred revenue
140,486 
146,509 
Capitalized research & development
23,021 
32,027 
Amortizable tax basis in intangibles
1,283,968 
1,301,338 
Other
649 
12,282 
Deferred tax assets before valuation allowance
1,542,278 
1,591,373 
Valuation allowance
(11,498)
(19,390)
Total deferred tax assets
1,530,780 
1,571,983 
Deferred tax liabilities:
Depreciation and amortization
$
11,610 
$
16,485 
Acquisition-related intangibles
16,357 
28,868 
Other
14,426 
4,511 
Total deferred tax liabilities
42,393 
49,864 
Net deferred tax assets
$
1,488,387 
$
1,522,119 
As of December 31, 2025, it was considered more likely than not that our deferred tax assets would be realized with the exception of certain interest
expense carryovers, capital loss carryovers and unrealized translation losses as we are unable to forecast sufficient future profits to realize these deferred tax
assets. The total valuation allowance as of December 31, 2025 was $11.5 million. During the year ended December 31, 2025, the valuation allowance decreased
by $7.9 million primarily due to the change in deferred tax assets on certain interest expense and unrealized translation losses from our German subsidiaries. We
may be required to adjust the valuation allowance for deferred tax assets if we determine, based on available evidence at the time of the determination, that it is
more likely than not that some portion or all of the deferred tax assets will not be realized. This assessment includes deferred tax assets associated with our
Switzerland tax deductible basis created from our 2020 intra-entity transfer of intellectual property, which have a finite utilization period and depend on our
ability to generate sufficient taxable income in that jurisdiction. Any changes to the valuation allowance, particularly those related to our Switzerland deferred
tax assets, could have a material adverse effect on our results of operations.
As of December 31, 2025, we have foreign net operating loss carryforwards of approximately $4.7 million, attributed mainly to losses in Russia and
Germany. The losses in Germany can be carried forward indefinitely. The operating loss carryforwards in Russia, if not utilized, will expire beginning 2033.
The changes in the balance of gross unrecognized tax benefits, which exclude interest and penalties, for the years ended December 31, 2025, 2024 and
2023, are as follows (in thousands):
Year Ended December 31,
2025
2024
2023
Gross unrecognized tax benefits at January 1,
$
145,534 
$
149,172 
$
141,560 
Increases related to tax positions taken during the current year
8,879 
12,264 
8,616 
Increases related to tax positions taken during a prior year
1,288 
2,031 
5,647 
Decreases related to tax positions taken during a prior year
(4,286)
(3,924)
(533)
Decreases related to expiration of statute of limitations
(33,988)
(14,009)
(3,654)
Decreases related to settlement with tax authorities
— 
— 
(2,464)
Gross unrecognized tax benefits at December 31,
$
117,427 
$
145,534 
$
149,172 
The total amount of gross unrecognized tax benefits as of December 31, 2025 was $117.4 million, of which $111.9 million would impact our effective tax
rate if recognized.
91

We file U.S. federal, U.S. state, and non-U.S. income tax returns. Our major tax jurisdictions include U.S. federal, the State of California and Switzerland.
We are under IRS audit for U.S. federal tax returns from 2018 to 2020. For U.S state tax returns, we are no longer subject to tax examinations for years before
2020. With few exceptions, we are no longer subject to examination by other foreign tax authorities for years before 2017.
We have elected to recognize interest and penalties related to unrecognized tax benefits as a component of income taxes. Interest and penalties included in
tax expense for the years ended December 31, 2025, 2024 and 2023 as well as accrued as of December 31, 2025 and 2024 were not material.
Disclosed below is a summary of income taxes paid by jurisdiction pursuant to the disclosure requirement of ASU 2023-09 for the year ended
December 31, 2025:
Year Ended
December 31, 2025
United States - Federal
$
72,872 
United States - State and local
13,792 
Israel
7,291 
Other foreign jurisdictions
40,798 
Total income taxes paid
$
134,753 
Note 14. Net Income per Share
Basic net income per share is computed using the weighted average number of shares of common stock outstanding during the period. Diluted net income
per share is computed using the weighted average number of shares of common stock, adjusted for any dilutive effect of potential common stock. Potential
common stock, computed using the treasury stock method, includes RSUs, MSUs, PSUs and our ESPP.
The following table sets forth the computation of basic and diluted net income per share attributable to common stock (in thousands, except per share
amounts): 
 
Year Ended December 31,
 
2025
2024
2023
Numerator:
Net income
$
410,351 
$
421,362 
$
445,053 
Denominator:
Weighted average common shares outstanding, basic
72,542 
74,877 
76,426 
Dilutive effect of potential common stock
46 
116 
142 
Total shares, diluted
72,588 
74,993 
76,568 
Net income per share, basic
$
5.66 
$
5.63 
$
5.82 
Net income per share, diluted
$
5.65 
$
5.62 
$
5.81 
Anti-dilutive potential common shares 
1,239 
685 
293 
    Represents approximately 1,238 thousand RSU and 1 thousand ESPP weighted-average outstanding common stock equivalent shares for the year ended December 31,
2025, approximately 685 thousand RSU shares for the year ended December 31, 2024, and approximately 263 thousand RSU and 30 thousand ESPP weighted-average
outstanding common stock equivalent shares for the year ended December 31, 2023 that are excluded from the calculation of diluted net income per share as the effect
would have been anti-dilutive.
1
1
92

Note 15. Supplemental Cash Flow Information
The supplemental cash flow information consists of the following (in thousands): 
 
Year Ended December 31,
 
2025
2024
2023
Taxes paid
$
134,753 
$
177,082 
$
294,569 
Non-cash investing and financing activities:
Acquisition of property, plant and equipment in accounts payable and accrued
liabilities
$
16,592 
$
18,974 
$
32,280 
Final settlement of prior year stock repurchase forward contract
$
— 
$
50,000 
$
40,000 
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$
39,856 
$
39,526 
$
33,714 
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$
22,291 
$
32,671 
$
27,901 
Note 16. Segments and Geographical Information
Segment Information
We report segment information based on the management approach. The management approach designates the internal reporting used by our Chief
Operating Decision Maker (“CODM”), our Chief Executive Officer, for decision making and performance assessment as the basis for determining our
reportable segments. We group our operations into two reportable segments: Clear Aligner segment and Imaging Systems and CAD/CAM services (“Systems
and Services”) segment, which are based on our predominant product lines.
Our CODM uses gross profit and income from operations to assess each reportable segment’s performance, by reviewing each measure against internal
forecasts and historical performance. Our CODM may also benchmark each segment’s performance against our competitors and external expectations.
93

Summarized financial information by reportable segment is as follows (in thousands):
 
Year Ended December 31,
2025
2024
2023
Net revenues
Clear Aligner
$
3,245,404  $
3,230,122  $
3,199,329 
Systems and Services
789,560 
768,890 
662,931 
Total net revenues
$
4,034,964  $
3,999,012  $
3,862,260 
Cost of net revenues
Clear Aligner
$
1,058,893  $
952,136  $
911,291 
Systems and Services
265,058 
247,717 
244,106 
Total cost of goods sold
$
1,323,951  $
1,199,853  $
1,155,397 
Gross profit
Clear Aligner
$
2,186,511  $
2,277,986  $
2,288,038 
Systems and Services
524,502 
521,173 
418,825 
Total gross profit
$
2,711,013  $
2,799,159  $
2,706,863 
Other Segment expenses
Clear Aligner
$
1,151,720  $
1,135,782  $
1,105,781 
Systems and Services
218,412 
251,951 
227,470 
Unallocated corporate expenses
795,126 
803,798 
730,274 
Total operating expenses
$
2,165,258  $
2,191,531  $
2,063,525 
Segment income from operations
Clear Aligner
$
1,034,791  $
1,142,204  $
1,182,257 
Systems and Services
306,090 
269,222 
191,355 
Total segment income from operations
$
1,340,881  $
1,411,426  $
1,373,612 
    Management has identified Cost of net revenues as a significant expense for our Clear Aligner and Systems and Services reportable segments.
Other segment expenses typically include employee related costs, marketing and advertising costs, and depreciation and amortization expense incurred by
various functions including selling, marketing, general and administrative and research and development. Our CODM does not regularly receive these operating
expenses at the reportable segment level.
Income from operations for each segment includes all geographic revenues, related cost of net revenues and operating expenses directly attributable to the
reportable segment. Certain operating expenses are not directly attributable to a reportable segment and must be allocated. Each allocation is measured
differently based on the nature of the cost being allocated. Certain other operating expense are not specifically allocated to segment income from operations and
generally include various corporate expenses such as stock-based compensation and costs related to IT, facilities, human resources, accounting and finance,
legal and regulatory, other separately managed general and administrative costs outside the reportable segments and restructuring costs.
The following table reconciles total segment income from operations in the table above to net income before provision for (benefit from) income taxes (in
thousands):
Year Ended December 31,
2025
2024
2023
Total segment income from operations
$
1,340,881  $
1,411,426  $
1,373,612 
Unallocated corporate expenses
(795,126)
(803,798)
(730,274)
Total income from operations
545,755 
607,628 
643,338 
Interest income
16,045 
20,218 
17,258 
Other income (expense), net
23,487 
(18,887)
(19,392)
Net income before provision for income taxes
$
585,287  $
608,959  $
641,204 
The following table includes certain non-cash expenses for each reportable segment (in thousands):
1
1
94

Year Ended December 31,
2025
2024
2023
Stock-based compensation
Clear Aligner
$
23,883  $
22,888  $
13,963 
Systems and Services
1,525 
1,595 
1,293 
Unallocated corporate expenses
160,462 
149,220 
138,770 
Total stock-based compensation
$
185,870  $
173,703  $
154,026 
Depreciation and amortization
Clear Aligner
$
151,565  $
67,450  $
64,781 
Systems and Services
39,513 
30,998 
31,518 
Unallocated corporate expenses
46,358 
46,586 
46,102 
Total depreciation and amortization
$
237,436  $
145,034  $
142,401 
Our CODM does not regularly review total assets at the reportable segment level; however, we have provided geographical information related to our
long-lived assets below.
Geographical Information
Net revenues are presented below by geographic area (in thousands): 
 
Year Ended December 31,
 
2025
2024
2023
Net revenues :
U.S.
$
1,661,185  $
1,695,696  $
1,665,925 
Switzerland
920,588 
983,629 
1,168,320 
Other International
1,453,191 
1,319,687 
1,028,015 
Total net revenues
$
4,034,964  $
3,999,012  $
3,862,260 
    Net revenues are attributed to countries based on the location of where revenues are recognized by our legal entities.
Long-lived assets, which includes Property, plant and equipment, net, and Operating lease right-of-use assets, net, are presented below by geographic area
(in thousands):
 
December 31,
 
2025
2024
Long-lived assets :
Switzerland
$
493,584 
$
571,628 
U.S.
200,343 
207,689 
Other International
545,848 
605,193 
Total long-lived assets
$
1,239,775 
$
1,384,510 
    Long-lived assets are attributed to countries based on the location of our entity that owns or leases the assets.
Note 17. Restructuring and Other Charges
2023 Restructuring
During 2023, we incurred approximately $14.0 million in restructuring expenses, of which $5.3 million remained unpaid and were included in Accrued
liabilities as of December 31, 2023. As of December 31, 2024, we had no remaining restructuring liability related to the 2023 Restructuring.
2024 Restructuring
During 2024, we incurred approximately $37.0 million in restructuring expenses, of which $13.0 million remained unpaid and were included in Accrued
liabilities as of December 31, 2024. For the year ended December 31, 2025, we reduced our
 1
1
1
1
95

December 31, 2024 restructuring liability by approximately $14.6 million primarily due to cash payments, offset by approximately $2.1 million of additional
restructuring expense recorded in Cost of net revenues.
The 2023 and 2024 restructuring charges were primarily related to involuntary termination benefits, including employee severance and other post-
employment benefits.
2025 Restructuring
During the third quarter of 2025, we initiated a plan to realign certain business groups and reduce our global workforce. This plan represents our continued
effort to right size our labor force with the current macroeconomic environment. We incurred $40.9 million in total restructuring expenses, primarily related to
involuntary termination benefits, including employee severance and other post-employment benefits. We have recorded $5.5 million in Cost of net revenues and
$35.4 million in Restructuring and other charges in our Consolidated Statements of Operations as of December 31, 2025. All charges recorded to Cost of net
revenues were allocated to our Clear Aligner reportable segment and all charges recorded to Restructuring and other charges were unallocated corporate
expenses. As of December 31, 2025, $17.1 million remained unpaid and was included in Accrued liabilities in our Consolidated Balance Sheets.
Activity related to the restructuring liabilities associated with our restructuring initiatives consist of the following (in thousands):
For the twelve months ended December 31, 2024
2023 Restructuring
2024 Restructuring
Total
Balance at beginning of period
$
5,299 
$
—  $
5,2
Restructuring and other charges
(598)
36,991 
36,3
Cash payments and adjustments
(4,701)
(23,990)
(28,6
Balance at end of period
$
— 
$
13,001  $
13,0
For the twelve months ended December 31, 2025
2024 Restructuring
2025 Restructuring
Total
Balance at beginning of period
$
13,001 
$
—  $
13,0
Restructuring and other charges
2,056 
40,888 
42,9
Cash payments and adjustments
(14,569)
(23,776)
(38,3
Balance at end of period
$
488 
$
17,112  $
17,6
    Included in “Accrued liabilities” within our Consolidated Balance Sheets.
    2025 restructuring activities include an immaterial amount of charges for non post-employment benefit related restructuring expense.
Note 18. Assets Held for Sale
In connection with the 2025 Restructuring activities, refer to Note 17 “Restructuring and Other Charges”, we have undertaken additional actions to
optimize our manufacturing footprint. These actions include disposing, either by sale or other than by sale, of certain capital assets, including various
manufacturing assets and facilities. For discussion of assets disposed of other than by sale refer to Note 1 “Summary of Significant Accounting Policies."
ASC Topic 360-10, Property, Plant and Equipment - Overall, requires a long-lived asset to be classified as “held for sale” in the period in which certain
criteria are met. The Company classifies real estate assets as held for sale after the following conditions have been satisfied: (1) management, having the
appropriate authority, commits to a plan to sell the asset, (2) the asset is available for immediate sale in its present condition, (3) the Company has initiated an
active program to sell the asset, (4) it is probable the sale of the asset will be completed within one year, (5) the asset is being actively marketed for a reasonable
price, and (6) it is unlikely the plan to sell the asset will significantly change. At the time the Company classifies a property as held for sale, the Company ceases
recording depreciation. An asset classified as held for sale is measured and reported at the lower of its carrying amount or its estimated fair value less cost to
sell. Upon classification as held for sale, the Company assesses fair value less costs to sell at each reporting period until the asset is no longer classified as held
for sale.
During the third quarter of 2025, the Company committed to a plan to sell a manufacturing facility, including land, building and building improvements
(collectively the “disposal group”), located in Juarez, Mexico and determined the disposal group met the criteria for classification as held for sale. The Company
classified the disposal group as held for sale for $27.9 million, which represents the disposal group’s fair value less estimated costs to sell. Fair value of the
disposal group was
1
1
2
1
1
1
2
96

determined utilizing two equally weighted valuation techniques, the Direct Capitalization and Direct Comparison methods. The Direct Capitalization method
utilizes various inputs, including estimated market rents, vacancy rates and operating expenses, to determine an estimated net operating income, and a
capitalization rate. The Direct Comparison method utilizes sales of comparable properties, adjusted for property differences such as location, physical
characteristics and market conditions.
For the year ended December 31, 2025, we recognized an impairment loss of $23.1 million on assets held for sale, which was recorded within Cost of net
revenues in our Consolidated Statements of Operations. The entire impairment loss was attributable to our Clear Aligner reportable segment. As of December
31, 2025, we had adjusted assets held for sale of $28.0 million, which are presented separately as Assets held for sale in our Consolidated Balance Sheets. We
had no assets held for sale as of December 31, 2024.
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
Not applicable.
 
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules  13a-15(e) and 15d-15(e) under the Exchange
Act). Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures are
effective as of December 31, 2025 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 SEC’s rules and forms.
Management’s Annual Report on Internal Control over Financial Reporting.
See “Management’s Annual Report on Internal Control over Financial Reporting” in Item 8 of this Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting.
There have been no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter
ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
During the fiscal quarter ended December 31, 2025, no director or officer (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule
10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (each as defined in Item 408 of Regulation S-K).
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K because we intend to file our definitive Proxy Statement for our
2026 Annual Meeting of Stockholders (the “Proxy Statement”) not later than 120  days after the end of the fiscal year covered by this Annual Report on
Form 10-K, and certain information to be included therein is incorporated herein by reference.
Item 10. Directors, Executive Officers and Corporate Governance.
97

The information required by Item 401 of Regulation S-K concerning our directors is incorporated by reference to the section entitled “Director Nominees”
contained in the Proxy Statement.
The information required by Item 401 of Regulation S-K concerning our executive officers is set forth in Part I, Item 1, “Business” contained in this
Annual Report on Form 10-K under the section entitled “Information about our Executive Officers.” 
If applicable, the information required by Item 405 of Regulation S-K concerning delinquent reports under Section 16(a) of the Exchange Act will be
incorporated by reference to the section entitled “Delinquent Section 16(a) Reports” contained in the Proxy Statement. 
The information required by Item 407(c)(3), 407(d)(4) and 407(d)(5) of Regulation S-K is incorporated by reference to the section entitled “Corporate
Governance” contained in the Proxy Statement.
Insider Trading Arrangements and Policies
We have adopted an Insider Trading Policy governing the purchase, sale and other dispositions of our securities by our directors, officers, employees,
consultants, contractors and our agents that we believe is reasonably designed to promote compliance with insider trading laws, rules and regulations and
Nasdaq listing standards.
The foregoing summary of our Insider Trading Policy does not purport to be complete and is qualified in its entirety by reference to the full text of the
Insider Trading Policy, which is filed as Exhibit 19.1 to this Annual Report on Form 10-K. In addition, it is our policy that any trades by us will comply with
applicable law, including laws with respect to insider trading.
Code of Ethics
We have a code of ethics (which we call our Global Code of Conduct) that applies to all of our employees, including our principal executive officer,
principal financial officer and controller. Our Global Code of Conduct is posted on the investor relations portion of our website at http://investor.aligntech.com
within the section captioned “Corporate Governance.”
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of our Global Code
of Conduct by posting such information on our website, at the address and location specified above, rather than by filing a Current Report on Form 8-K.
Item 11. Executive Compensation.
The information required by Item 402 of Regulation S-K is incorporated by reference to the sections entitled “Executive Compensation—Compensation
Discussion and Analysis,” “Compensation Tables” and “Director Compensation” contained in the Proxy Statement.
The information required by Items 407(e)(4) and (e)(5) of Regulation S-K is incorporated by reference to the sections entitled “Corporate Governance—
Committee Responsibilities and Oversight—Compensation and Human Capital Committee—Compensation Committee Interlocks and Insider Participation”
and “Compensation and Human Capital Committee Report,” respectively, contained in the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by Item 403 of Regulation S-K is incorporated by reference to the section entitled “Security Ownership of Certain Beneficial
Owners and Management” contained in the Proxy Statement.
Equity Compensation Plan Information
The following table provides information as of December 31, 2025 about our common stock that may be issued upon the awards granted to employees,
consultants or members of our Board under all existing equity compensation plans, including our 2005 Annual Incentive Plan (“2005 Plan”) and 2010 Employee
Stock Purchase Plan (“ESPP”), each as amended, and certain individual arrangements. Refer to Note 10 “Stockholders’ Equity” of the Notes to Consolidated
Financial Statements for a description of our equity compensation plans.
98

Plan category
Number of securities to be
issued upon exercise of
outstanding options, warrants
and rights
(a)
Weighted-average exercise
price of outstanding options,
warrants and rights
(b)

Number of securities remaining
available for future issuance
under equity compensation plans
(excluding securities reflected in
column (a))
(c)
Equity compensation plans approved by
security holders
1,519,520 (1)
$
7,088,161 (2),(3)
Equity compensation plans not approved
by security holders
—
—
—
Total
1,519,520
$
7,088,161
Includes 1,249,704 restricted stock units (“RSUs”), 263,516 market-performance based RSUs (“MSUs”) at 100% target and 6,300 RSUs with
performance conditions, which have an exercise price of zero.
 Includes 4,608,476 and 1,728,664 shares available for issuance under our 2005 Plan and ESPP, respectively. 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.
 Includes additional 751,021 of potentially issuable MSUs if performance targets are achieved at maximum payout.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by Item 404 and Item 407 of Regulation S-K is incorporated by reference to the sections entitled “Certain Relationships and
Related Party Transactions” and “Corporate Governance—Board Structure and Independence,” respectively, contained in the Proxy Statement.
Item 14. Principal Accountant Fees and Services.
The information required by Item 9(e) of Schedule 14A is incorporated by reference to the section entitled “Ratification of Appointment of Independent
Registered Public Accounting Firm” contained in the Proxy Statement.
(1) 
(2)
(3)
99

PART IV
 
Item 15. Exhibits and Financial Statement Schedules.
(a)
Financial Statements
1.
Consolidated financial statements
The following documents are filed as part of this Annual Report on Form 10-K:
 
Report of Independent Registered Public Accounting Firm
58
Consolidated Statements of Operations for the year ended December 31, 2025, 2024 and 2023
60
Consolidated Statements of Comprehensive Income for the year ended December 31, 2025, 2024 and 2023
61
Consolidated Balance Sheets as of December 31, 2025 and 2024
62
Consolidated Statements of Stockholders’ Equity for the year ended December 31, 2025, 2024 and 2023
63
Consolidated Statements of Cash Flows for the year ended December 31, 2025, 2024 and 2023
64
Notes to Consolidated Financial Statements
65
 
2.
The following financial statement schedule is filed as part of this Annual Report on Form 10-K:
Schedule II—Valuation and Qualifying Accounts and Reserves for the year ended December 31, 2025, 2024 and 2023
All other schedules have been omitted as they are not required, not applicable, or the required information is otherwise included.
SCHEDULE II: VALUATION AND QUALIFYING ACCOUNTS AND RESERVES
 
Balance at

Beginning

of Period
Additions

(Reductions)

to Costs and

Expenses
Write

Offs
Balance at

End of Period
 
(in thousands)
Allowance for doubtful accounts:
Year Ended December 31, 2023
$
10,343 
$
8,002 
$
(3,452)
$
14,893 
Year Ended December 31, 2024
$
14,893 
$
8,282 
$
(4,044)
$
19,131 
Year Ended December 31, 2025
$
19,131 
$
18,738 
$
(3,656)
$
34,213 
Valuation allowance for deferred tax assets:
Year Ended December 31, 2023
$
23,286 
$
(8,295)
$
— 
$
14,991 
Year Ended December 31, 2024
$
14,991 
$
4,399 
$
— 
$
19,390 
Year Ended December 31, 2025
$
19,390 
$
(7,892)
$
— 
$
11,498 
100

(b)
The following exhibits are included in this Annual Report on Form 10-K:
Exhibit
Number
Description
Form
Date
Exhibit
Number
Incorporated
by Reference
herein
Filed
herewith
3.1
Amended and Restated Certificate of Incorporation of Align Technology, Inc.
10-Q
8/6/2025
3.1
3.2
Amended and Restated Bylaws of Align Technology, Inc.
8-K
2/26/2026
3.1
4.1
Form of Specimen Common Stock Certificate
S-1/A (File No. 333-
49932)
1/17/2001
4.1
4.2
Description of the Registered Securities of Align Technology, Inc.
*
10.1†
Align Technology, Inc. 2010 Employee Stock Purchase Plan (as amended and
restated as of May 19, 2021)
8-K
5/20/2021
10.1
10.2†
Align Technology, Inc. 2005 Incentive Plan (as amended on May 21, 2025)
8-K
5/21/2025
10.1
10.3†
Form of RSU Agreement under 2005 Incentive Plan (Non-employee Director
Form)
10-K
2/28/2020
10.5
10.4†
Align 2019 Global RSU Agreement
10-K
2/28/2019
10.6
10.5†
Form of RSU Agreement under 2005 Incentive Plan (CEO Form)
10-K
2/28/2025
10.7

10.6†
Form of RSU Agreement under 2005 Incentive Plan (Executive Officer Form for
officers appointed after September 2016)
10-Q
5/5/2023
10.2
10.7†
Form of RSU Agreement under 2005 Incentive Plan (Executive Officer Form for
officers appointed prior to September 2016)
10-Q
5/5/2023
10.3
10.8†
Form of MSU Agreement under 2005 Incentive Plan (CEO Form)
10-Q
5/5/2023
10.4
10.9†
Form of MSU Agreement under 2005 Incentive Plan (Executive Officer Form for
officers appointed after September 2016)
10-Q
5/5/2023
10.5
10.10†
Form of MSU Agreement under 2005 Incentive Plan (Executive Officer Form for
officers appointed prior to September 2016)
10-Q
5/5/2023
10.6
10.11†
Form of Employment Agreement by and between Align Technology, Inc. and each
executive officer (non-CEO Form) (for executive officers appointed prior to
September 2016)
10-Q
5/8/2008
10.3
10.12†
Form of Employment Agreement by and between Align Technology, Inc. and each
executive officer (non-CEO Form) (for executive officers appointed after
September 2016)
10-K
2/28/2017
10.8
10.13†
Amended and Restated Chief Executive Officer Employment Agreement, dated
April 16, 2015, by and between Align Technology, Inc. and Joseph Hogan
10-Q
5/1/2015
10.30
10.14†
Employment Agreement, dated November 7, 2016, by and between Align
Technology, Inc. and John F. Morici
10-Q
11/8/2016
10.2
10.15†
Form of Indemnification Agreement by and between Align Technology, Inc. and
each of its directors and executive officers
*
10.16
Credit Agreement, dated July 21, 2020, by and among Align Technology, Inc. and
the lenders party thereto from time to time and Citibank, N.A., as administrative
agent
10-Q
10/30/2020
10.1
10.17
First Amendment, dated April 21, 2022, to Credit Agreement by and among Align
Technology, Inc. and the lenders party thereto from time to time and Citibank,
N.A., as administrative agent, dated July 21, 2020
10-K
2/27/2023
10.18
10.18
Second Amendment, dated December 23, 2022, to Credit Agreement by and
among Align Technology, Inc. and the lenders party thereto from time to time and
Citibank, N.A., as administrative agent, dated July 21, 2020
10-K
2/27/2023
10.19
10.19*
Share Purchase Agreement, dated September 1, 2023, by and among Align
Holdings GmbH, Align Technology Switzerland GmbH and the Sellers provided
therein
10-Q
11/3/2023
10.1
19.1
Align Technology, Inc. Insider Trading Policy
*
21.1
Subsidiaries of Align Technology, Inc.
*
101

Exhibit
Number
Description
Form
Date
Exhibit
Number
Incorporated
by Reference
herein
Filed
herewith
23.1
Consent of PricewaterhouseCoopers LLP, Independent Registered Public
Accounting Firm
*
31.1
Certifications of Chief Executive Officer pursuant to Exchange Act Rules 13a-
14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2003
*
31.2
Certifications of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a)
and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2003
*
32.1t
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2003
*
97.1
Align Technology, Inc. Clawback Policy
10-K
2/28/2024
97.1

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).
*
101.SCH
Inline XBRL Taxonomy Extension Schema Document
*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
*
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in
Exhibit 101)
*
__________________________________ 
†
Management contract or compensatory plan or arrangement.
*
Certain information contained in this exhibit has been omitted because it is not material and (i) would likely cause competitive harm to the registrant if publicly
disclosed or (ii) is the type that the registrant treats as private or confidential.
t
Furnished herewith.
Item 16. Form 10-K Summary.
None.
102

SIGNATURES
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 authorized.
 
ALIGN TECHNOLOGY, INC.
By:
/s/    JOSEPH M. HOGAN        
Joseph M. Hogan
President and Chief Executive Officer
Date:
February 27, 2026
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Joseph M. Hogan or John F. Morici, jointly and severally, his or her attorney-in-fact,
each with the full power of substitution, for such person in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the
same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all
that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.
Signature
  
Title
 
Date
/s/    JOSEPH M. HOGAN
  
President, Chief Executive Officer and Director (Principal
Executive Officer)
 
February 27, 2026
Joseph M. Hogan
/s/    JOHN F. MORICI
  
Chief Financial Officer and Executive Vice President, Global
Finance (Principal Financial Officer and Principal Accounting
Officer)
 
February 27, 2026
John F. Morici
/s/    KEVIN T. CONROY
Director
February 27, 2026
Kevin T. Conroy
/s/    KEVIN J. DALLAS
Director
February 27, 2026
Kevin J. Dallas
/s/    JOSEPH LACOB 
Director
February 27, 2026
Joseph Lacob
/s/    C. RAYMOND LARKIN, JR.     
  
Chairman of the Board
 
February 27, 2026
C. Raymond Larkin, Jr.
/s/    GEORGE J. MORROW    
  
Director
 
February 27, 2026
George J. Morrow
/s/    ANNE M. MYONG      
Director
February 27, 2026
Anne M. Myong
/s/   MOJDEH POUL
Director
February 27, 2026
Mojdeh Poul
/s/    ANDREA L. SAIA
Director
February 27, 2026
Andrea L. Saia
/s/    SUSAN E. SIEGEL 
Director
February 27, 2026
Susan E. Siegel
/s/    BRITT VITALONE 
Director
February 27, 2026
Britt Vitalone

103

Exhibit 4.2
DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED
PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
The following description of the material provisions of the capital stock and other material terms of the amended and restated certificate of incorporation
(“Certificate”) and amended and restated bylaws (“Bylaws”) of Align Technology, Inc. (the “Company”) and certain provisions of Delaware law, are
summaries only. These summaries do not purport to be complete and are qualified in their entirety by reference to the Certificate, Bylaws, and by the provisions
of applicable law.
Authorized Capital
The Company’s authorized capital stock consists of 200,000,000 shares of common stock, $0.0001 par value per share (“Common Stock”), and 5,000,000
shares of undesignated Preferred Stock, $0.0001 par value per share (“Preferred Stock”).
Common Stock
Voting. Except as otherwise required by Delaware law, as specifically set forth in the provisions of the Certificate, including any express terms of the Preferred
Stock and any series thereof or the Bylaws, at every annual or special meeting of stockholders, every holder of Common Stock is entitled to one vote per share.
When a quorum is present, the affirmative vote of the holders of the shares representing a majority of the voting power at the meeting and entitled to vote on the
subject matter shall be the act of the stockholders, unless the question is one upon which by express provisions of an applicable law or of the Certificate or
Bylaws a different vote is required, in which case such express provision shall govern and control.
Dividend Rights. Subject to the rights of holders of any then outstanding shares of Preferred Stock (discussed below), holders of Common Stock are entitled to
receive ratably any dividends that may be declared by the Company’s Board of Directors (the “Board”) out of funds legally available therefor.
Liquidation Rights. In the event of the Company’s liquidation, dissolution or winding up, holders of Common Stock are entitled to share ratably in all assets
available for distribution to stockholders after the payment of or provision for all of the Company’s debts and other liabilities and the satisfaction of any
liquidation preference granted to the holders of any then outstanding shares of Preferred Stock.
Other Rights. Holders of Common Stock do not have preemption, conversion or redemption rights. The rights, preferences and privileges of holders of Common
Stock will be subject to those of the holders of any shares of Preferred Stock the Company may issue in the future.
Listing. The Common Stock is listed on NASDAQ under the ticker symbol “ALGN.”
Transfer Agent and Registrar. The transfer agent and registrar for the Common Stock is Computershare, Inc.
Preferred Stock
There are currently no shares of Preferred Stock outstanding, and the Company has no present plans to issue any. However, under the terms of the Certificate,
the Board has the authority, without further action by the Company’s stockholders, to issue the following classes of Preferred Stock:
Undesignated Preferred Stock. The Board may issue not more than an aggregate of 5,000,000 shares of undesignated Preferred Stock in one or more series,
without stockholder approval, and to establish, from time to time, the number of shares to be included in each series of Preferred Stock, to fix the designation,
powers,

preferences, and rights of the shares of each series of Preferred Stock, and to specify any qualifications, limitations or restrictions.
Subject to the rights of holders of any outstanding shares of Preferred Stock holding prior or superior rights and except as otherwise required by Delaware law,
or as specifically set forth in the provisions of the Certificate or Bylaws, the Board may grant holders of Preferred Stock or any series thereof:
Dividend Rights. Rights to dividends as declared by the Board out of funds legally available different from and/or in addition to those of the holders of
Common Stock, including the amounts payable on, preferences in respect of any series of Preferred Stock, whether any dividends are or are not cumulative and
the dates on which dividends may be payable;
Voting Rights. Voting rights at every annual or special meeting of stockholders different from or consistent with those of the holders of Common Stock
or any other series of Preferred Stock;
Liquidation Rights. Preferential liquidation rights in the event of the Company’s liquidation, dissolution or winding up different from or consistent with
those of the holders of Common Stock or any other series of Preferred Stock;
Conversion or Exchange. Rights in regard of the conversion or exchange of Preferred Stock into shares of any other class or series or other security,
including the price(s), date(s) and other terms and condition of conversion;
Redemption. Rights of redemption different from or consistent with those of the holders of Common Stock or any series of Preferred Stock; and
Other Rights. Other rights restricting the issuance of additional shares of the same series or of any other class or series.
The purpose of authorizing the Board to issue Preferred Stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote
on specific issuances. The issuance of Preferred Stock, while providing flexibility in connection with possible acquisitions, future financings and other corporate
purposes, could make it more difficult for a third party to acquire control of the Company, or could adversely affect the rights of the holders of Common Stock.
Board of Directors
The Board is not classified and there is no cumulative voting in the election of directors. The number of directors serving on the Board may be changed by a
resolution adopted by the affirmative vote of a majority of the directors then in office.
Anti-Takeover Effects of Certain Provisions of Delaware Law, the Certificate of Incorporation and the Bylaws
The Certificate and Bylaws contain provisions that are intended to enhance the likelihood of continuity and stability in the composition of the Board and that
could make it more difficult to acquire control of the Company by means of a tender offer, open market purchases, a proxy contest or otherwise. The Company
expects that these provisions, which are summarized below, will discourage coercive takeover practices or inadequate takeover bids. These provisions are also
designed to encourage persons seeking to acquire control of the Company to first negotiate with the Board, which the Company believes may result in an
improvement of the terms of any such acquisition in favor of the Company’s stockholders. However, they also give the Board the power to discourage
acquisitions that some stockholders may favor. A description of these provisions is set forth below.

No Cumulative Voting. Under Delaware law, the right to vote cumulatively does not exist unless specifically authorized by the certificate of incorporation. The
Certificate does not grant stockholders the right to vote cumulatively; therefore stockholders holding a majority of the outstanding shares of Common Stock will
be able to elect all of the Company’s directors.
Stockholder Action by Written Consent. The Certificate and Bylaws provide that all stockholder action must be affected at a duly called meeting of stockholders
and not by written consent.
Special Meetings of Stockholders. The Bylaws provide that a special meeting of stockholders (i) may be called at any time by the Board and (ii) shall be called
by the Board upon a written request delivered by one or more stockholders of record who have continuously held at least 25% of the Company’s outstanding
Common Stock for at least one year prior to the date the request is mailed and comply with certain procedural requirements set forth in the Bylaws.
Requirements for Advance Notification of Stockholder Meetings, Nominations and Proposals. The Bylaws include an advance notice procedure for stockholder
proposals to be brought before an annual meeting of stockholders, including proposed nominations of candidates for election to the Board. Stockholders at an
annual meeting will only be able to consider proposals or nominations specified in the notice of meeting or brought before the meeting by or at the direction of
the Board, or by a stockholder of record on the record date for the meeting, who is entitled to vote at the meeting and who has delivered timely written notice in
proper form to the Company’s secretary of the stockholder’s intention to bring such business before the meeting. These provisions could have the effect of
delaying stockholder actions until the next stockholder meeting that are favored by the holders of a majority of the Company’s outstanding voting securities or
may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect its own slate of directors or otherwise attempt to obtain control of
the Company.
Blank Check Preferred Stock. The Certificate authorizes the Board to issue up to 5,000,000 shares of Preferred Stock in one or more series, without stockholder
approval, and to (i) establish from time to time the number of shares to be included in each series of Preferred Stock and (ii) fix the designation, powers,
preferences and rights of each series and any applicable qualifications, limitations or restrictions. This authority could impede the success of any attempt to
change control of the Company.
Delaware Takeover Statute
The Company is subject to the provisions of Section 203 of the General Corporation Law of the State of Delaware. Subject to certain exceptions, Section 203 of
the Delaware General Corporation Law prohibits a Delaware corporation from engaging in any “business combination” with any “interested stockholder” for a
period of three years after the date of the transaction in which the person or entity became an interested stockholder. A “business combination” includes certain
mergers, asset sales or other transactions resulting in a financial benefit to the interested stockholder. Subject to various exceptions, an “interested stockholder”
is a person who, together with his or her affiliates and associates, owns, or within the past three years has owned, 15% or more of our outstanding voting stock.
This provision could discourage mergers or other takeover or change in control attempts, including attempts that might result in the payment of a premium over
the market price for shares of the Common Stock.
Proxy Access Nominations
The Bylaws contain a “proxy access” provision that permits a stockholder, or a group of up to 20 stockholders, owning at least three percent of the outstanding
Common Stock continuously for at least three years, to nominate and include in the Company’s annual meeting proxy materials director nominees constituting
the greater of two (2) directors or twenty percent (20%) of the total number of directors on the Board, provided that such stockholder(s) and nominee(s) satisfy
the requirements specified in the Bylaws.

Exhibit 10.15
Align Technology, Inc.
Indemnification Agreement
This Indemnification Agreement (this “Agreement”) is made and entered into this ___ day of __________, by and between Align
Technology, Inc., a Delaware corporation (the “Company”), and __________________ (“Indemnitee”).
Whereas, Indemnitee, as an officer or director of the Company, performs a valuable service in such capacity for the Company;
Whereas, the stockholders of the Company have adopted the Certificate of Incorporation (the “Certificate”) providing for the
indemnification of the officers, directors, employees and agents of the Company and its subsidiaries to the maximum extent
authorized by Section 145 of the Delaware General Corporation Law, as amended (the “Code”);
Whereas, the Certificate and the Code, by their non-exclusive nature, permit contracts between the Company and its officers and
directors with respect to indemnification of such officers and directors;
Whereas, in accordance with the authorization as provided by the Code, the Company either has purchased and presently
maintains or intends to purchase and maintain a policy or policies of Directors and Officers Liability Insurance (“D&O Insurance”)
covering certain liabilities which may be incurred by its officers and directors in the performance of their duties as officers and
directors of the Company and/or a subsidiary;
Whereas, as a result of developments affecting the terms, scope and availability of D&O Insurance there exists general uncertainty
as to the extent of protection afforded officers and directors by such D&O Insurance and by statutory and bylaw indemnification
provisions; and
Whereas, in order to induce Indemnitee to serve as an officer or director of the Company and/or a subsidiary, the Company has
determined and agreed to enter into this contract with Indemnitee.
Now, Therefore, in consideration of Indemnitee’s continued service as an officer or director of the Company and/or a subsidiary
after the date hereof, and for other good and valid consideration, the receipt and adequacy of which is hereby acknowledged, the
parties hereto agree as follows:
1.
Indemnification of Indemnitee. The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest
extent authorized or permitted by the provisions of the Code, as may be amended from time to time.
2.
Additional Indemnity. Subject only to the exclusions set forth in Sections 3 and 6(c) hereof, the Company hereby further
agrees to hold harmless and indemnify Indemnitee:

(a)
against any and all expenses (including attorneys’ fees), witness fees, judgments, fines and amounts paid in settlement
actually and reasonably incurred (as demonstrated and substantiated in writing) by Indemnitee in connection with any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (including an action by or in
the right of the Company or any subsidiary of the Company) to which Indemnitee is, was or at any time becomes a party, or is
threatened to be made a party, by reason of the fact that Indemnitee is, was or at any time becomes an officer or director of the
Company or any subsidiary of the Company, or is or was serving or at any time serves at the request of the Company or any
subsidiary of the Company as an officer or director of another corporation, partnership, joint venture, trust, employee benefit plan or
other enterprise; and
(b)
otherwise to the fullest extent as may be provided to Indemnitee by the Company under the non-exclusivity provisions of the
Bylaws of the Company and the Code.
3.
Limitations on Additional Indemnity.
(a)
No indemnity pursuant to Section 2 hereof shall be paid by the Company:
(1)
in respect to remuneration paid to Indemnitee if it shall be determined by a final judgment or other final adjudication that such
remuneration was in violation of law;
(2)
on account of any suit in which judgment is rendered against Indemnitee for an accounting of profits made from the purchase
or sale by Indemnitee of securities of the Company pursuant to the provisions of Section 16(b) of the Securities Exchange Act of
1934 and amendments thereto or similar provisions of any federal, state. or local statutory law;
(3)
on account of Indemnitee's conduct which is finally adjudged to have been knowingly fraudulent or deliberately dishonest or
to constitute willful misconduct, in which event Indemnitee will then reimburse any and all expenses (including attorneys’ fees),
witness fees, judgments, fines and amounts paid in settlement actually and reasonably incurred to the Company (which
reimbursement becomes payable within 7 days of the date of the adjudgment);
(4)
on account of Indemnitee’s conduct which is the subject of an action, suit or proceeding described in Section 6(c)(ii) hereof;
(5)
on account of any action, claim or proceeding (other than a proceeding referred to in Section 7(b) hereof) initiated by
Indemnitee unless such action, claim or proceeding was authorized in the specific case by action of the Board of Directors;
(6)
if a final decision by a court having jurisdiction in the matter shall determine that such indemnification is not lawful (and, in
this respect, both the Company and Indemnitee have been advised that the Securities and Exchange Commission believes that
indemnification for liabilities arising under the federal securities laws is against public policy and is, therefore, unenforceable and that
claims for indemnification should be submitted to appropriate courts for adjudication); and
(7)
except to the extent the aggregate of losses to be indemnified thereunder exceeds the sum of (a) such losses for which
Indemnitee is indemnified pursuant to Section 1 hereof and (b)

any additional amount paid to the Indemnitee pursuant to any D&O Insurance purchased and maintained by the Company.
(b)
No indemnity pursuant to Section 1 or 2 hereof shall be paid by the Company if the action, suit or proceeding with respect to
which a claim for indemnity hereunder is made arose from or is based upon any of the following:
(1)
Any solicitation of proxies by Indemnitee, or by a group of which he was or became a member consisting of two or more
persons that had agreed (whether formally or informally and whether or not in writing) to act together for the purpose of soliciting
proxies, in opposition to any solicitation of proxies approved by the Board of Directors.
(2)
Any activities by Indemnitee that constitute a breach of or default under any agreement between Indemnitee and the
Company.
4.
Contribution. If the indemnification provided in Sections 1 and 2 hereof is unavailable by reason of a Court decision
described in Section 3(a)(vi) hereof based on grounds other than any of those set forth in paragraphs (i) through (v) of Section 3 (a)
hereof, then in respect of any threatened, pending or completed action, suit or proceeding in which the Company or any subsidiary
of the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall
contribute to the amount of expenses (including attorneys' fees), judgments, fines and amounts paid in settlement actually and
reasonably incurred and paid or payable by Indemnitee in such proportion as is appropriate to reflect (i) the relative benefits
received by the Company on the one hand and Indemnitee on the other hand from the transaction from which such action, suit or
proceeding arose, and (ii) the relative fault of the Company on the one hand and of Indemnitee on the other in connection with the
events which resulted in such expenses, judgments, fines or settlement amounts, as well as any other relevant equitable
considerations. The relative fault of the Company on the one hand and of Indemnitee on the other shall be determined by reference
to, among other things, the parties' relative intent, knowledge, access to information and opportunity to correct or prevent the
circumstances resulting in such expenses, judgments, fines or settlement amounts. The Company agrees that it would not be just
and equitable if contribution pursuant to this Section 4 were determined by pro rata allocation or any other method of allocation
which does not take account of the foregoing equitable considerations.
5.
Notification and Defense of Claim. Not later than thirty (30) days after receipt by Indemnitee of notice of the
commencement of any action, suit or proceeding, Indemnitee shall, if a claim in respect thereof is to be made against the Company
under this Agreement, notify the Company of the commencement thereof; but Indemnitee's omission so to notify the Company will
not relieve the Company from any liability which it may have to Indemnitee otherwise than under this Agreement. With respect to
any such action, suit or proceeding as to which Indemnitee notifies the Company of the commencement thereof:
(a)
The Company will be entitled to participate therein at its own expense.
(b)
Except as otherwise provided below, to the extent that it may wish, the Company shall, jointly with any other indemnifying
party similarly notified, be entitled to assume the defense thereof, with counsel reasonably satisfactory to Indemnitee. After notice
from the Company to Indemnitee of its election to assume the defense thereof, the Company will not be liable to

indemnitee under this Agreement for any legal or other expenses subsequently incurred by Indemnitee in connection with the
defense thereof, other than reasonable costs of investigation or as otherwise provided below. Indemnitee shall have the right to
employ its own counsel in such action, suit or proceeding, but the fees and expenses of such counsel incurred after notice from the
Company of the Company's assumption of the defense thereof shall be at the expense of Indemnitee unless (i) the employment of
counsel by lndemnitee has been authorized by the Company; (ii) Indemnitee shall have reasonably concluded that there may be a
conflict of interest between the Company and Indemnitee in the conduct of the defense of such action; or (iii) the Company shall not
in fact have employed counsel to assume the defense of such action; in each of which cases the fees and expenses of Indemnitee's
separate counsel shall be paid by the Company. The Company shall not be entitled to assume the defense of any action, suit or
proceeding brought by or on behalf of the Company or as to which Indemnitee shall have made the conclusion provided for in (ii)
above.
(c)
The Company shall not be liable to indemnify Indemnitee under this Agreement for any amounts paid in settlement of any
action or claim effected or in the event Indemnitee admits any personal liability towards third parties without the Company's prior
written consent. The Company shall be permitted to settle any action except that it shall not settle any action or claim in any manner
which would impose any penalty or limitation on Indemnitee without Indemnitee's written consent. Neither the Company nor
Indemnitee will unreasonably withhold its consent to any proposed settlement.
6.
Advancement and Repayment of Expenses.
(a)
In the event that Indemnitee employs his pr her own counsel pursuant to Sections 5(b)(i) through (iii) above, the Company
shall advance to Indemnitee, prior to any final disposition of any threatened or pending action, suit or proceeding, whether civil,
criminal, administrative or investigative, any and all reasonable expenses (including legal fees and expenses) incurred in
investigating or defending any such action, suit or proceeding within ten (10) days after receiving from Indemnitee copies of invoices
presented to Indemnitee for such expenses.
(b)
Indemnitee agrees that Indemnitee will reimburse the Company for all reasonable expenses paid by the Company in
investigating or defending any civil or criminal action, suit or proceeding against Indemnitee in the event and only to the extent it
shall be ultimately determined by a final judicial decision (from which there is no right of appeal) that Indemnitee is not entitled,
under the provisions of the Code, the Bylaws, this Agreement or otherwise, to be indemnified by the Company for such expenses.
(c)
Notwithstanding the foregoing, the Company shall not be required to advance such expenses to Indemnitee in respect of any
action arising from or based upon any of the matters set forth in subsection (b) of Section 3 or if Indemnitee (i) commences any
action, suit or proceeding as a plaintiff unless such advance is specifically approved by a majority of the Board of Directors or (ii) is a
party to an action, suit or proceeding brought by the Company and approved by a majority of the Board which alleges willful
misappropriation of corporate assets by Indemnitee, disclosure of confidential information in violation of Indemnitee's fiduciary or
contractual obligations to the Company, or any other willful and deliberate breach in bad faith of Indemnitee's duty to the Company
or its shareholders.
7.
Enforcement.

(a)
The Company expressly confirms and agrees that it has entered into this Agreement and assumed the obligations imposed
on the Company hereby in order to induce Indemnitee to continue as an officer or director of the Company or any subsidiary of the
Company, and acknowledges that Indemnitee is relying upon this Agreement in continuing in such capacity.
(b)
In the event Indemnitee is required to bring any action to enforce rights or to collect moneys due under this Agreement and is
successful in such action, the Company shall reimburse Indemnitee for all Indemnitee's reasonable fees and expenses, including
attorney's fees, in bringing and pursuing such action.
8.
Subrogation. In the event of payment under this agreement, the Company shall be subrogated to the extent of such
payment to all of the rights of recovery of Indemnitee, who shall execute all documents required and shall do all acts that may be
necessary to secure such rights and to enable the Company effectively to bring suit to enforce such rights.
9.
Continuation of Obligations. All agreements and obligations of the Company contained herein shall commence upon the
date that Indemnitee first became an officer or director of the Company or any subsidiary of the Company, as the case may be, and
shall continue during the period Indemnitee is an officer or director of the Company (or is or was servicing at the request of the
Company or any subsidiary of the Company as an officer or director of another corporation, partnership, joint venture, trust,
employee benefit plan or other enterprise) and shall continue thereafter so long as Indemnitee shall be subject to any possible claim
or threatened, pending or completed action, suit or proceeding, whether civil, criminal or investigative, by reason of the fact that
Indemnitee was an officer or director of the Company or any subsidiary of the Company or serving in any other capacity referred to
herein.
10.
Survival of Rights. The rights conferred on Indemnitee by this Agreement shall continue after Indemnitee has ceased to be
an officer or director of the Company or any subsidiary of the Company and shall inure to the benefit of lndemnitee’s heirs,
executors and administrators.
11.
Non-Exclusivity of Rights. The rights conferred on Indemnitee by this Agreement shall not be exclusive of any other right
which Indemnitee may have or hereafter acquire under any statute, provision of the Company's Certificate of Incorporation or
Bylaws, agreement, vote of stockholders or directors, or otherwise, both as to action in her official capacity and as to action in
another capacity while holding office; provided, however, that this Agreement shall supersede and replace any prior indemnification
agreements entered into by and between the Company or any subsidiary of the Company and Indemnitee and that any such prior
indemnification agreement shall be terminated upon the execution of this Agreement.
12.
Separability. Each of the provisions of this Agreement is a separate and distinct agreement and independent of the others,
so that if any or all of the provisions hereof shall be held to be invalid or unenforceable for any reason, such invalidity or
unenforceability shall not affect the validity or enforceability of the other provisions hereof or the obligation of the Company to
indemnify the Indemnitee to the full extent provided by the Bylaws or the Code.
13.
Governing Law. This Agreement shall be interpreted and enforced in accordance with the laws of the State of Delaware.

14.
Binding Effect. This Agreement shall be binding upon Indemnitee and upon the Company, its successors and assigns, and
shall inure to the benefit of Indemnitee, his or her heirs, personal representatives and assigns and to the benefit of the Company, its
successors and assigns.
15.
Amendment and Termination. No amendment, modification, termination or cancellation of this Agreement shall be effective
unless it is in writing and is signed by both parties hereto.

In Witness Whereof, the parties hereto have executed this Agreement on and as of the day and year first above written, with effect
as of ________, Indemnitee’s date of appointment as an officer or director of the Company.
Align Technology, Inc.
a Delaware corporation
___________________________________
Name: Joseph M. Hogan
Title: President and Chief Executive Officer
Indemnitee
___________________________________
Name:


Exhibit 19.1
        ALIGN TECHNOLOGY, INC.
INSIDER TRADING POLICY
(Amended and Restated as of December 10, 2025)
The Board of Directors (the “Board”) of Align Technology, Inc. (“we,” “our,” the “Company” or “Align”) has adopted this
Insider Trading Policy (the “Policy”) in order to take an active role in the prevention of insider trading violations by our Board
members, officers, employees, consultants, contractors and other agents.
A.
Why do we have this Policy?
We regularly provide our Board members, officers, employees, consultants, contractors and other agents with confidential
information regarding many aspects of our business. Under federal and state securities laws, it is illegal to trade in the securities of a
company while in possession of material nonpublic information about that company or to “tip” (disclosing material nonpublic
information to) others who then trade on the basis of that information. Thus, because these individuals may have knowledge of
specific confidential information that could constitute material nonpublic information, trading in the securities of Align, including our
common stock, any securities that are exercisable for, or convertible or exchangeable into, shares of common stock, and any other
type of securities that we may issue from time to time, including (but not limited to) options, preferred stock, debt securities,
convertible debt and warrants, as well as derivative securities that are not issued by the Company, such as exchange-traded put or
call options or swaps relating to the Company Securities (collectively referred to in this Policy as “Company Securities”), by these
individuals could constitute “insider trading” and violate the law, as could tipping or disclosing material nonpublic information to
others. The consequences of insider trading or tipping of material nonpublic information can be severe. In fact, the person violating
the laws, as well as Align and our individual Board members, officers and other supervisory personnel, may be subject to criminal
and civil lawsuits and financial penalties in connection with a violation of the insider trading laws.
We have adopted this Policy to comply with the laws governing (i) trading in Company Securities while in possession of
material nonpublic information concerning Align and (ii) tipping or disclosing material nonpublic information to others, and to prevent
the appearance of improper trading or tipping. We reserve the right to prohibit any transaction to enforce compliance with this Policy.
B.
What is Align’s policy on Insider Trading?
1.
You are prohibited from trading while aware of material nonpublic information
Whether or not the trading window (as described below) is open and except as discussed in the section below entitled “Are
there any exceptions to this Policy?”, you may not, directly or indirectly through family members or other persons or entities, engage
in any transaction involving Company Securities while aware of material nonpublic information about Align. It is not an excuse that
you did not “use” the information in deciding whether to engage in the transaction.

Similarly, you may not engage in transactions involving the securities of any other company if you learn of material nonpublic
information of, regarding or relating to another company while performing your duties for Align. For example, you may be involved in
a proposed transaction or project involving a prospective business relationship or transaction with another company. If information
about that transaction or project or any company involved in that transaction or project constitutes material nonpublic information,
you are prohibited from directly or indirectly engaging in transactions involving the securities of any such company, including Align,
any company directly involved in such transaction or project, and any other company that may be impacted by the transaction or
project. It is important to note that “materiality” is different for different companies. Information that is immaterial to Align may be
material to another company.
2.
Do not disclose material nonpublic information
You may not disclose material nonpublic information concerning Align or any other company to other persons within Align
whose jobs do not require them to have such information, friends, family members, business associates, investors, or any other
person or entity not authorized to receive such information. Nonpublic information about Align is subject to the Employee Proprietary
Information and Invention Agreement, Consulting Agreement and/or any other contractual or fiduciary confidentiality obligations you
may have to Align. Any nonpublic information you acquire in the course of your service with or to Align may only be used for Align’s
legitimate business purposes. In addition, you are required to handle the nonpublic information of others in accordance with the
terms of any relevant nondisclosure agreements and limit your use of the nonpublic information to the purpose for which it was
disclosed.
Even if you are not directly disclosing material nonpublic information, you may not make recommendations or express
opinions about securities of any company, Align or otherwise, based on material nonpublic information concerning Align or that
company. In particular, you may not participate, in any manner other than passive observation, in any Internet “chat” room or
message board that is related to trading in Company Securities. You are prohibited from engaging in these actions whether or not
you derive any profit or personal benefit from doing so.
3.
Do not respond to outside inquiries for information
In the event you receive an inquiry for information from someone outside of Align, such as a stock analyst, survey group,
industry marketing association or others, you should refer the inquiry to our Chief Legal and Regulatory Officer or their delegate(s)
(each, the “Compliance Officer”) or to our investor relations team. Responding to a request yourself is a violation of this Policy and,
in some circumstances, may be a violation of the law.
4.
Take personal responsibility
It is your responsibility to comply with this Policy and applicable laws. Ultimately, this Policy is intended to reduce risk of violating the
law, but you should understand that compliance with this Policy is not an assurance that you will not be found to have violated it or
applicable insider trading laws, particularly when your actions or those of others with whom you communicate will be viewed after-
the-fact with the benefit of hindsight. As we request you do in all aspects of your work with Align, please consider how your actions
may be viewed by others, including legal authorities, by always using your best judgment and consult with the Compliance Officer if
you have questions.
2

C.
Who does this Policy apply to?
This Policy applies to all (i) members of the Board, (ii) officers and employees of Align and its subsidiaries, (iii) consultants,
contractors and other agents of Align and you (“you”) upon the commencement of their or your relationship with Align. We may also
determine that other persons should be subject to this Policy, such as persons who have access to material nonpublic information.
References in this Policy to “you” also include (i) persons with whom you share a household (including a spouse, a child, a
child away at college, stepchildren, grandchildren, parents, stepparents, grandparents, siblings and in-laws (each, a “Family
Member”)), and (ii) any other individuals or entities whose transactions in Company Securities you influence, direct or control (each,
a “Controlled Entity”). You are responsible for the transactions of these and other persons and therefore should make sure that
these individuals and entities understand and comply with this Policy and of the need to confer with you before they trade in
Company Securities, and you should treat all such transactions for the purposes of this Policy and applicable securities laws as if
the transactions were for your own account. This Policy does not, however, apply to personal securities transactions of Family
Members where the purchase or sale decision is made by a third party not controlled by, influenced by, or related to you or your
Family Members.
You are expected to comply with this Policy as long as you possess any material nonpublic information regarding Align or
another company. This means that, even after you cease to be affiliated with Align, you must continue to abide by the applicable
trading restrictions until you no longer have material nonpublic information. In addition, if you are subject to a blackout period under
this Policy at the time you cease to be affiliated with Align, you are expected to abide by the applicable trading restrictions until at
least the end of the relevant blackout period.
D.
What types of transactions are covered by this Policy?
This Policy applies to all transactions involving Company Securities. This Policy also applies to any arrangements that affect
economic exposure to changes in the prices of Company Securities. These arrangements may include, among other things, hedging
transactions, short sales and certain decisions with respect to participation in benefit plans. This Policy also applies to any offers
with respect to such transactions. Although there are limited exceptions to this Policy (described in “Are there any exceptions to this
Policy?” below), please note that there are no exceptions from insider trading laws or this Policy based on the size of the transaction
(e.g., this policy applies whether a transaction involves one share or 10,000 shares of Align’s common stock).
E.
Transactions that are Strictly Prohibited or Require Special Consideration
1.
You may NOT:
a.
Short sales – Engage in short sales (i.e., the sale of a security that must be borrowed to make delivery) or
“sell short against the box” (i.e., sell with a delayed delivery) if such sales involve Company Securities. Short sales may signal to the
market possible bad news about Align or a general lack of confidence in Align’s prospects, and an expectation that the value of
Company Securities will decline.
3

b.
Engage in derivative securities or hedging transactions – Trade in publicly-traded options, such as puts and
calls, and other derivative securities with respect to Company Securities. This includes any hedging or similar transaction designed
to decrease the risks associated with holding Company Securities. Stock options, restricted stock units (“RSUs”) and other
securities issued pursuant to Align equity plans or other compensatory arrangements are not subject to this prohibition.
c.
Use Company Securities as collateral for loans – Pledge Company Securities as collateral for loans. If you
default on the loan, the lender may sell the pledged securities as collateral in a foreclosure sale. The sale, even though not initiated
at your request, is still considered a sale for your benefit and, if made at a time when you are aware of material nonpublic
information or otherwise are not permitted to trade in Company Securities, may result in inadvertent insider trading violations.
d.
Hold Company Securities in margin accounts - Hold Company Securities in margin accounts because your
broker may sell securities held in the margin account during a blackout period.
2.
Open orders – Align discourages open orders, such as limit orders or stop orders, with brokers (except limit orders
and stop orders under approved 10b5-1 trading plans, as described below), particularly where the order is likely to remain
outstanding for an extended period of time. Open orders may result in the execution of a trade during a blackout period, which may
result in inadvertent insider trading. If you determine that a limit order or stop order must be used, the order should be limited to a
short duration.
F.
What does “Material Nonpublic Information” mean?
Information is “material” if a reasonable investor would consider it important when deciding to buy, sell or hold Company
Securities. Both positive and negative information may be material. Information is “nonpublic” until it has been widely disseminated
to the public (through, for example, a press conference or release) and the public has had a chance to absorb and evaluate it.
Examples of information that may be regarded as “material” include the following, although the list is not exclusive:
•
Financial results, earnings pre-announcements, guidance, projections or forecasts or any changes to, or suspensions of,
the foregoing;
•
Significant developments involving business relationships, including execution, modification or termination of significant
agreements or the gain or loss of a significant customer or supplier;
•
Product certifications or approvals, introductions, modifications, defects or recalls or other product announcements of a
significant nature;
•
Significant pricing or cost structure changes;
•
Significant marketing changes;
•
Significant developments in research and development or relating to intellectual property;
•
Significant litigation or regulatory developments;
4

•
Major events involving Company Securities, including adoption of stock repurchase programs, stock splits, changes in
dividend policies, and public or private securities offerings;
•
The establishment of, or any significant developments or changes regarding, a repurchase program for Company
Securities (such as planned repurchases, increases or decreases in the program’s authorization, suspensions and similar
changes);
•
Significant corporate events, such as a pending or proposed merger, joint venture or tender offer, a significant
investment, the acquisition or disposition of a significant business or assets or a change in control of the Company;
•
Major personnel changes, such as changes in senior management, the Board, lay-offs or internal restructuring;
•
Significant related party transactions;
•
Restatements of financial results, or material impairments, write-offs or write-downs of assets or material changes in
accounting methods;
•
Bank borrowings or other financing transactions not in the ordinary course of business;
•
Impending bankruptcy or the existence of severe liquidity problems;
•
The imposition of a restriction on trading in Company Securities or the extension or termination of such restriction;
•
Significant actual or potential cybersecurity incidents (e.g., a data breach or any other significant disruption in the
Company’s operations, or loss, potential loss, breach or unauthorized access of its property or assets, whether at its
facilities or through its information technology infrastructure); and
•
Changes in independent auditors.

Evaluating information to determine whether it is “nonpublic” requires two steps. First, the information must be widely
disseminated to the public. Second, after being disseminated, the public must have a chance to absorb and evaluate it. As a
general rule, information is generally considered widely disseminated if it has been disclosed through newswire services, a
broadcast on widely available radio or television programs, publication in a widely available newspaper, magazine or news website,
or public disclosure documents filed with the Securities and Exchange Commission (“SEC”) on the SEC’s website. By contrast,
information would likely not be considered widely disseminated if it is available only to the Company’s employees, or if it is only
available to a select group of analysts, brokers and institutional investors. Unless you have seen material information publicly
disseminated, you should assume the information is nonpublic.
Once information is widely disseminated, the investing public still requires sufficient time to absorb the information. As a
general rule, information is considered fully absorbed by the marketplace after one full trading day has elapsed after the information
is widely disseminated. Depending on the particular circumstances, Align may determine that a longer or shorter period should apply
to the release of specific material nonpublic information.
When in doubt, assume information is material and nonpublic. If you are uncertain whether information is “material” or
“nonpublic,” please consult with the Compliance Officer.
5

G.
When may I trade in Company Securities?
Even when not in possession of any material nonpublic information, you may only trade in Company Securities if all the
following conditions have been met:
1.
Open trading window: You may only trade in Company Securities during an open trading window. See “When is our
Blackout Period?” below.
2.
Pre-clearance: If you are a Board member, a member of the executive management team, or have been designated
by the Compliance Officer as an individual or a member of a department or group likely to have access to material information of
Align (e.g., Finance, Legal, FP&A) you and your Family Members and Controlled Entities (all of the foregoing are referred to as
“Restricted Persons”), must receive pre-clearance from the Compliance Officer of your proposed trade in accordance with
processes and procedures periodically established or revised by the Compliance Officer. A request for pre-clearance should be
submitted to the Compliance Officer at least two business days before the proposed transaction. The Compliance Officer must
obtain pre-clearance to trade from the CEO or CFO. The Compliance Officer is under no obligation to approve a trade submitted for
pre-clearance and may determine not to permit the trade.
    If a Restricted Person seeks pre-clearance and the request is denied, then they should refrain from engaging in any transaction in
Company Securities, and should not inform any other person of the restriction. Moreover, pre-clearance does not, in any
circumstance, relieve anyone of their legal obligation to refrain from trading while in possession of material nonpublic information. In
other words, even if pre-clearance is received, if the requesting person becomes aware of material nonpublic information or
becomes subject to a blackout period (as discussed below), the transaction may not be completed. Pre-clearance of a transaction is
valid only for the 5-business day period immediately following receipt by the Restricted Person of such pre-clearance.
3.
10b5-1 Trading Plans: The SEC has enacted rules that provide an affirmative defense against alleged violations of
U.S. federal insider trading laws for transactions made pursuant to trading plans that meet certain requirements, commonly referred
to as “10b5-1 trading plans.” These 10b5-1 trading plans must meet the requirements set forth in Align’s “Requirements for Trading
Plans” and must otherwise meet the requirements set forth in Rule 10b5-1 of the Securities Exchange Act of 1934, as amended
(“Rule 10b5-1”). Any adoption of a new 10b5-1 trading plan, or termination of or amendment to any existing 10b5-1 trading plan, by
a Restricted Person is subject to the pre-clearance procedures described above and must be filed with the Compliance Officer. In
general, a 10b5-1 trading plan must be entered into at a time when the person entering into the plan is not aware of material
nonpublic information. Once the 10b5-1 trading plan is adopted, the person must not exercise any influence over the number of
securities to be traded, the price at which they are to be traded or the date(s) of any trade(s).
Trades in Company Securities made pursuant to an approved 10b5-1 trading plan that complies with Rule 10b5-1 are not
thereafter subject to the restrictions in this Policy, even if you later are or become aware of material nonpublic information at the time
of the trade or a blackout period is in effect.
6

4.
Post-Transaction Notice: Restricted Persons who have reporting obligations under Section 16 of the Exchange Act
shall also notify the Compliance Officer (or their designees) of the occurrence of any purchase, sale or other acquisition or
disposition of Company Securities (including any gifts or donations) as soon as possible following the transaction, but in any event
within one business day after any transaction. Such notification should be in writing (including by e-mail) and should include the
identity of the Restricted Persons, the type of transaction, the date of the transaction, the number of shares involved and the
purchase or sale price, if applicable. For both the “Pre-Clearance” section above and this “Post-Transaction Notice” section, a
purchase, sale or other acquisition or disposition shall be deemed to occur at the time the person or entity becomes irrevocably
committed to it (for example, in the case of an open market purchase or sale, this occurs when the trade is executed, not when it
settles).
H.
When is our Blackout Period?
To limit the likelihood of trading at times when there is a significant risk of insider trading exposure, Align has instituted
quarterly trading blackout periods and may institute special blackout periods from time to time (each as described below). Please
note that quarterly blackout periods and special blackout periods are compliance requirements of Align and do not create or
constitute a legal right to trade when they are not in effect. Whether or not a quarterly blackout period or special blackout period is in
effect, you must comply with this Policy and may not engage in any transaction involving Company Securities when in the
possession of material nonpublic information.
1.
Quarterly blackout periods
Except as discussed in the section titled “Are there any exceptions to this Policy?”, you may not engage in transactions
involving Company Securities during quarterly blackout periods. Again, transactions covered by this Policy include purchases, sales,
transfers, distributions, and any other dispositions of Company Securities regardless of how you come to possess Company
Securities, e.g., Align’s 2005 Stock Incentive Plan or 2010 Employee Stock Purchase Plan.
Quarterly blackout periods begin at the close of business on the last day of February, May, August, and November and end
after one full trading day has elapsed following the public disclosure of Align’s financial results for the prior quarter (“quarterly
blackout periods”). Quarterly blackout periods are a particularly sensitive time for transactions involving Company Securities from
the perspective of compliance with applicable securities laws due to the fact that, during these periods, individuals may often
possess or have access to material nonpublic information relevant to Align’s expected financial results for the quarter. The term
“trading day” means a day on which national stock exchanges and the National Association of Securities Dealers, Inc. Automated
Quotation System are open for trading. A “full” trading day has elapsed when, after the public disclosure, trading in the relevant
security has opened and then closed.
2.
Special blackout periods
From time to time, we may also implement additional blackout periods when, in the judgment of the Compliance Officer, a
trading blackout is warranted (“special blackout periods”). We will generally impose special blackout periods when there are
material
7

developments known to us that have not yet been disclosed to the public. For example, we may impose a special blackout period in
anticipation of announcing interim earnings guidance or a significant transaction or business development. However, special
blackout periods may be declared for any reason.
The Compliance Officer will notify you if you are subject to a special blackout period. If you receive a notice that you are
subject to a special blackout period, you may not disclose to others the fact that you are subject to the special blackout period and
except as discussed in the section titled “Are there any exceptions to this Policy?”, you may not engage in transactions involving
Company Securities during special blackout periods until approved by the Compliance Officer.
I.
Are there any exceptions to this Policy?
There are limited exceptions to this Policy, which are described below. Please note that there may be instances where you
suffer financial harm or other hardship or are otherwise required to forgo a planned transaction because of the restrictions imposed
by this Policy. Transactions that may be necessary or justifiable for independent reasons (such as the need to raise money for an
emergency expenditure, house purchase, tuition, etc.), and small transactions are not exempt from this Policy (e.g., this Policy
applies whether a transaction involves one share or 10,000 shares of Company Securities). Federal securities laws do not recognize
any mitigating circumstances including personal financial emergency or other personal circumstances, and, in any event, even the
appearance of an improper transaction must be avoided to preserve Align’s reputation for adhering to the highest standards of
conduct.
1.
Receipt, vesting and exercise of stock options and RSUs
The trading restrictions under this Policy do not apply to the acceptance or purchase of Company Securities through stock
options, RSUs or the like issued or offered by Align. The trading restrictions under this Policy also do not apply to the vesting,
cancellation or forfeiture of stock options, RSUs or the like under our equity plans.
The trading restrictions under this Policy do not apply to the exercise of stock options for cash under our equity plans or to
our withholding of Company Securities to cover tax obligations in connection with an option exercise or an RSU vesting event.
However, the trading restrictions under this Policy do apply to (i)  the sale of any Company Securities issued upon the
vesting of an RSU or exercise of a stock option, (ii) a cashless exercise of a stock option through a broker, since this involves selling
a portion of the underlying shares to cover the costs of exercise, and (iii) any other market sale for the purpose of generating the
cash needed to pay the exercise price of an option or related taxes.
2.
Purchases pursuant to the Align Employee Stock Purchase Plan
The trading restrictions in this Policy do not apply to elections with respect to participation in Align’s 2010 Employee Stock
Purchase Plan or to purchases of Company Securities under such plan. However, the trading restrictions do apply to subsequent
sales of Company Securities that were purchased pursuant to Align’s 2010 Employee Stock Purchase Plan.
8

3.
Stock splits, stock dividends and similar transactions
The trading restrictions under this Policy do not apply to a change in the number of securities held as a result of a stock
split or stock dividend applying equally to all Company Securities of a class, or similar transactions.
4.
Bona fide gifts, inheritance or change in form of ownership
The trading restrictions under this Policy do not apply to bona fide gifts of Company Securities made (1) during an open
trading window when the person making the gift is not in possession of any material nonpublic information or (2) pursuant to a 10b5-
1 trading plan adopted in accordance with this Policy. Restricted Persons must pre-clear any such gift transaction and report any
such gift transaction, in each case, in the manner described in “When may I trade in Company Securities” above. The trading
restrictions under this Policy do not apply to transfers by will or the laws of descent and distribution or transfers for tax planning
purposes in which your beneficial ownership and pecuniary interest in the transferred Company Securities does not change. Some
transactions that involve merely a change in the form in which you own securities may be permitted.
5.
Other exceptions
Any other exception from this Policy must be approved by the Compliance Officer in consultation with the Nominating and
Governance Committee of the Board.
Please be aware that even if a transaction falls within one of the exceptions described above, you will need to separately
assess whether the transaction complies with applicable law. If you have any questions, please consult with the Compliance Officer.
J.
What are the consequences of Insider Trading and How May This Policy Be Enforced?
Penalties for violating insider trading laws can include disgorging profit made or loss avoided by trading, paying the loss
suffered by the persons who purchased Company Securities from, or sold Company Securities to, the insider tippee, paying civil
and/or criminal penalties, and/or serving a jail term. Align and/or supervisors of the person violating the rules may also be required to
pay civil or criminal penalties and could be subject to private lawsuits.
A violation of this Policy is not necessarily a violation of law. In fact, for reasons explained in this Policy, it is not necessary for
us to wait for the filing or conclusion of any civil or criminal action against an alleged violator before taking disciplinary action as your
employer. In addition, please remember that we may prohibit a transaction from being completed to enforce compliance with this
Policy.
If you fail to conduct yourself consistently with the requirements of this Policy, you may be subject to disciplinary action, up to
and including termination of your relationship with Align, as well as civil and criminal penalties.
9

K.
What should I do if I suspect that this Policy has been violated?
Please promptly report violations or suspected violations of this Policy to the Compliance Officer. You may also report via our
confidential reporting hotline at www.ethicspoint.com.
L.
Priority of Statutory or Regulatory Trading Restrictions
The trading prohibitions and restrictions set forth in this Policy will be superseded by any greater prohibitions or restrictions
prescribed by federal or state securities laws and regulations, or contractual restrictions on the sale of securities.
M.
Amendments
Align is committed to continuously reviewing and updating its policies and therefore reserves the right to amend this Policy at
any time, for any reason, subject to applicable law.
10

Exhibit 21.1
Subsidiaries of Align Technology, Inc.
The registrant’s principal subsidiary as of December 31, 2025, are as follows:
Entity
Align Technology Switzerland GmbH, Switzerland

Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statement on Form S-8 (Nos. 333-55020, 333-82874, 333-116912, 333-125586, 333-
134477, 333-143319, 333-161054, 333-168548, 333-176134, 333-190351, 333-214493, 333-258449 and 333-289304) of Align Technology, Inc. of our report
dated February 27, 2026 relating to the financial statements, financial statement schedule and the effectiveness of internal control over financial reporting, which
appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP
San Jose, California
February 27, 2026

Exhibit 31.1
CERTIFICATION
I, Joseph M. Hogan, certify that:
1.
I have reviewed this annual report on Form 10-K of Align Technology, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: February 27, 2026
 
/S/    JOSEPH M. HOGAN
Joseph M. Hogan
President and Chief Executive Officer

Exhibit 31.2
CERTIFICATION
I, John F. Morici, certify that:
1.
I have reviewed this annual report on Form 10-K of Align Technology, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
a.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
b.
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c.
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: February 27, 2026
 
/S/    JOHN F. MORICI     
John F. Morici
Chief Financial Officer and Executive Vice President, Global Finance

Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Align Technology, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2025 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-
Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
By:
/S/    JOSEPH M. HOGAN
Date:
February 27, 2026
Name:
Joseph M. Hogan
Title:
President and Chief Executive Officer
In connection with the Annual Report of Align Technology, Inc. (the “Company”) on Form 10-K for the period ending December 31, 2025 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-
Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
 
By:
/S/    JOHN F. MORICI   
Date:
February 27, 2026
Name:
John F. Morici
Title:
Chief Financial Officer and Executive Vice President, Global Finance