About Align Technology

Align Technology, Inc. (Align) operates as a global medical device company. The company primarily engages in the design, manufacture, and marketing of Invisalign clear aligners, iTero intraoral scanners and services for dentistry, and exocad computer-aided design and computer-aided manufacturing (CAD/CAM) software for dental laboratories and dental practitioners. The company also markets and sells consumer products that are complementary to its doctor-prescribed principal products under the Invisalign and other brands, including retainers, aligner cases (clamshells), teeth whitening products and cleaning solutions (crystals, foam and other material) (collectively ‘Consumer Products’). The company’s primary intentions are to establish clear aligners as the principal solution for the treatment of malocclusions, or the misalignment of teeth, and its Invisalign system as the treatment solution of choice by orthodontists, general dental practitioners and patients globally, its intraoral scanners as the preferred scanning technology for digital dental scans, and its exocad CAD/CAM software as the solution of choice for dental labs. The company sells the majority of its products directly through a dedicated and specialized sales force to its customers, such as orthodontists, general practitioner dentists (GPs), restorative and aesthetic dentists, including prosthodontists, periodontists, and oral surgeons, and dental laboratories. The company also sells through sales agents and distributors in certain countries. In addition, the company sells directly to Dental Support Organizations (DSOs) who contract with dental practices to provide critical business management and support, including non-clinical operations. The company sells products used by dental laboratories who manufacture or customize a variety of products used by licensed dentists to provide oral health care. The company sells its Consumer Products online through its corporate website and large e-commerce websites. The company’s clear aligners are sold under the Invisalign brand name. Its Invisalign system is intended mainly for the treatment of malocclusions and is designed to help dental professionals achieve the clinical outcomes that they expect and the results patients desire. As of December 31, 2021, over 12 million people worldwide had been treated with its Invisalign system. The company received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) to market the Invisalign system in 1998. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course. The company’s iTero intraoral scanner is used by dental professionals and/or labs and service providers for restorative and orthodontic digital procedures, as well as Invisalign case submissions. As of December 31, 2021, over 68,000 iTero scanners had been sold. The company received 510(k) clearance in the U.S. for the caries detection feature of the iTero Element 5D in 2020. Its Systems and Services products, including its iTero intraoral scanners, are primarily sold through its direct sales force and through sales agents and distributors in certain countries and directly to DSOs. The company’s exocad CAD/CAM software products provide restorative dentistry, implantology, guided surgery, and smile design to dental labs and dental practices through fully integrated workflows, paving the way for new, cross-disciplinary dentistry in labs and at chairside. There are over 200 exocad strategic distribution partners and over 47,000 software licenses installed worldwide. Segments The company operates through two operating segments, Clear Aligner; and Imaging Systems and CAD/CAM Services (Systems and Services). Clear Aligner segment Malocclusion and Traditional Orthodontic Treatment Of the 21 million cases started, the company estimates that approximately 90% or 19 million could be treated using the company’s Invisalign system. In addition, globally approximately 500 million people with malocclusion could benefit from straightening their teeth. This represents a significant opportunity for the company as it expands the market for orthodontics by training more doctors, including GPs, as well as orthodontists, educating more consumers about the benefits of straighter teeth using the Invisalign system and connecting consumers with an Invisalign-trained doctor of their choice. The Invisalign system The Invisalign system is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear polymer removable aligners. The Invisalign system offers a range of treatment options, specialized services, and access to proprietary software for treatment visualization. Products The company offers its Invisalign system in a variety of treatment packages designed to correspond with the case-by-case treatment needs of its doctors and their patients. The description below provides a general description of the categories of treatment products the company offers in various regions as they typically correspond to the severity of malocclusion and length of anticipated treatment. Comprehensive Products - Invisalign Treatment Options Invisalign Comprehensive Packages: The Invisalign Comprehensive Package is used to treat adults and teens over a wide spectrum of mild to severe malocclusion and contains a broad variety of Invisalign features to address the desired treatment goals. It also addresses 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 seven and ten years, 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. The company’s Invisalign First Comprehensive Phase 2 Package is complementary to Invisalign First Phase 1 and is generally consistent with its 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. Non-Comprehensive Products - Invisalign Treatment Options Invisalign Non-comprehensive Packages: The company offers a variety of lower priced treatment packages for less complex orthodontic cases, non-comprehensive relapse cases, or straightening prior to restorative or cosmetic treatments, such as veneers. These treatment packages include Invisalign Express, Lite, Go, Go Plus and Moderate. These packages may be offered in select countries and/or may differ from region to region. Invisalign Go Packages: The company also offers in various markets Invisalign Go and Invisalign Go Plus, streamlined Non-Comprehensive packages designed for GPs to more easily identify and treat patients with mild malocclusion. The Invisalign Go and Invisalign Go Plus packages include case assessment support, simplified ClinCheck treatment plans and a progress assessment feature for case monitoring. Feature Enhancement / New Products Invisalign G8 with SmartForce Activation: Broadly released in early 2021, Invisalign G8 with SmartForce Aligner Activation is a clear aligner biomechanical innovation designed to optimize tooth movements and further improve predictability for frequently treated crowding, crossbite, and deep bite cases through the targeted application of force to teeth through surface contours on the aligners that help control the location, direction and intensity of tooth movement. New Invisalign Innovations in Treatment Planning for Align Digital Platform: Released in early 2022, the new Invisalign system innovations as a part of the Align digital platform is a combination of software, systems and services designed to provide a seamless experience and workflow that integrates and connects all users – doctors, labs, patients and consumers. These new innovations include ClinCheck Live Update for 3D controls, the Invisalign Practice App, Invisalign Personalized Plan and Invisalign Smile Architect. Non-Case Products Clear Aligner non-case products include retention products, Invisalign training, adjusting tools used by dental professionals during the course of treatment and ancillary Consumer Products and other oral health products available in certain e-commerce channels in the U.S. Retention: The company offers up to four sets of custom clear aligners called Vivera retainers 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, the company also offers single set retainers. Further, in the third quarter of 2021, the company announced a multi-year supply and distribution agreement with Ultradent Products to allow Invisalign trained doctors to exclusively offer a professional whitening system using Ultradent Products’ Opalescence PF whitening system with Vivera retainers. The company also offers in the U.S., a Doctor Subscription Program, which is a monthly subscription program based on the doctor’s monthly need for retention or limited treatment. The program allows doctors the flexibility to order both ‘touch-up’ or retention aligners within their subscribed tier and is designed for a segment of experienced Invisalign doctors who are not regularly using its retainers or low-stage aligners. SmartTrack Aligner Material SmartTrack clear aligner material is a patented, custom-engineered Invisalign clear aligner material that delivers gentle, more constant force considered ideal for orthodontic tooth movements. Conventional aligner materials relax and lose a substantial percent of the force applied in the initial days of wear. SmartTrack material maintains more constant force over time. The flexible SmartTrack material also more precisely conforms to tooth morphology, attachments and interproximal spaces to improve control of tooth movement throughout treatment. Systems and Services segment Intraoral scanning is a rapidly evolving technology that is having a substantial impact on the practice of dentistry. Beginning patient care with the early usage of the company’s iTero intraoral scanners and combining the results with digital workflows designed to assist doctors and patients visualize and evaluate various treatment options with detailed imagery and CAD/CAM solutions is helping patients decide to undergo treatment and improve treatments, outcomes and satisfaction. The accuracy of digitally scanned models substantially reduces the rate of restoration ‘remakes’, meaning patients are recalled less often and the appointment time for the restoration is shorter because of fewer adjustments, increasing overall patient satisfaction. Digital models also reduce the carbon footprint associated with the shipping of the materials used to create polyvinyl-siloxane (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 Scanner The iTero Element portfolio of intraoral scanners includes the iTero Element 2, the iTero Element Flex, iTero Element 5D Imaging System and iTero Element Plus Series, 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 the company’s Invisalign treatment such that a full arch or full mouth digital scan can be submitted as part of the Invisalign system case submission process. The company’s iTero Element 5D imaging system is the first integrated dental imaging system that simultaneously records 3D, intraoral color camera images and near imaging (NIRI) technology and enables comparison over time using the iTero TimeLapse technology. NIRI technology, included in the company’s iTero Element 5D and 5D Plus Imaging Systems, aids in detection and monitoring of interproximal caries lesions above the gingiva without using harmful radiation. The iTero Element 5D Imaging System is available in the U.S., Canada, China, and the majority of EMEA (European, the Middle East and Africa) and select APAC (the Asia Pacific) and LATAM (Latin America) countries; and is pending regulatory approval in others. The iTero Element Plus Series of intraoral scanners and imaging systems was introduced in the first quarter of 2021 and offers restorative and orthodontic digital workflows that include enhanced visualization for optimized patient experience, including a fully integrated 3D intraoral camera in certain models; seamless scanning with reduced processing time; artificial intelligence-based features; and in certain models, NIRI technology. Services and Ancillary Products The company’s services include subscription software, disposables, rentals, and pay per scan, as well as exocad’s CAD/CAM software solutions that integrate workflows to dental labs and dental practices. Restorative Software for iTero Scanners and Imaging Systems The company’s 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 its exocad Connector. iTero intraoral scans can enhance the accuracy and precision of a doctor’s downstream restorative process. Orthodontic Software for iTero Scanners and Imaging Systems The company’s iTero software is designed for orthodontists for digital records storage, orthodontic diagnosis, and for the fabrication of printed models and retainers. CAD/CAM Services The company’s 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 general dentists and dental labs in planning and delivering restorative dental treatments, adding restorative functionality to its comprehensive digital platform to deliver digital ortho-restorative workflows and interdisciplinary dentistry. The company’s exocad software is licensed and sold separately. Ancillary Products The company sells disposable sleeves for the wand and other ancillary products for the iTero scanner. iTero Models and Dies: An accurate physical model and dies are manufactured based on the digital scan and sent to the laboratory of the dentist’s choice for the completion of the needed restoration. The laboratory also has the option to export the digital file for immediate production of coping and full-contour restorations on their laboratory CAD/CAM systems. The laboratory then completes the ceramic buildup or staining and glazing and delivers the end result - a precisely fitting restoration. Third-Party Scanners and Digital scans: The company accepts case submissions for its clear aligner products in two ways, such as PVS impressions of patients’ teeth or intraoral scans of their teeth. With respect to intraoral scans, the company accepts scans from iTero scanners and certain third-party scanners that have an interoperability relationship with its systems and processes. iTero Applications and Tools Invisalign Outcome Simulator: The Invisalign Outcome Simulator is an exclusive chair-side and cloud-based application for the iTero scanner that allows doctors to help patients visualize how their teeth may look at the end of Invisalign treatment. This is achieved through a dual view layout that shows a prospective patient an image of their own current dentition next to a simulated final position after Invisalign treatment. 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. TimeLapse Technology: The company’s TimeLapse technology allows doctors or practitioners to compare a patient’s historic 3D scans to a 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. The company’s 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. The company also introduced its 5D Photo uploader enhanced workflow that simplifies the process for submitting images needed for treatment planning. Other proprietary software, such as software embedded in the company’s iTero scanners, ClinCheck and ClinCheck Pro software, the Invisalign Doctor Site, 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 The company’s strategic growth drivers include international expansion, GP adoption, patient demand and conversion, and orthodontist utilization. Sales and Marketing The company’s sales and marketing efforts focus on increasing adoption and utilization of the Invisalign system and Vivera retainers by orthodontists and GPs worldwide; and integrating the iTero scanner and exocad CAD/CAM products into dental labs and practices. In each region, the company has direct sales, marketing and support organizations, which include quota carrying sales representatives, sales management and sales administration. The company also has distribution partners in certain markets. The company’s sales and marketing personnel are organized to support orthodontists and GPs separately, allowing highly trained and specialized personnel to serve each customer category, thereby increasing its focus and effectiveness on both. The company continues to expand in existing markets through targeted investments in sales resources, professional marketing and education programs. Additionally, its consumer marketing programs are designed to create awareness and educate consumers on the benefits of Invisalign treatment and Vivera retainers, including where they can find a trained doctor to provide treatment. The company provides training, marketing and clinical support to orthodontists and GPs. As of December 31, 2021, it had approximately 122,500 active Invisalign trained doctors. Intellectual Property As of December 31, 2021, the company had 642 active U.S. patents, 724 active foreign patents, and 736 pending global patent applications. Its active U.S. patents expire between 2022 and 2040. Invisalign, Align, the Invisalign logo, ClinCheck, Made to Move, Invisalign Assist, Invisalign Teen, Invisalign Go, Vivera, SmartForce, SmartTrack, SmartStage, SmileView, iTero, iTero Element, Orthocad, iCast, iRecord and exocad, among others, are trademarks and/or service marks of the company or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries. Seasonality General economic conditions impact the company’s business and financial results, and it has historically experienced seasonal trends within the company’s two operating segments, customer channels and the geographic locations that it serves. The sale of the Invisalign system is often weaker in Europe, especially southern European countries during the summer months due to the company’s customers and their patients being on holiday and seasonally higher in China during the third quarter (year ended December 2021). Similarly, other international holidays like Lunar New Year can impact the company’s sales in APAC. In North America, summer is typically the busiest season for orthodontists with practices that have a high percentage of adolescent and teenage patients as many parents want to get their teenagers started in treatment before the start of the school year, however, many GPs are on vacation during this time and therefore tend to start fewer cases. For the company’s Systems and Services segment, capital equipment sales are often stronger in the fourth calendar quarter. Government Regulation With regards to premarket authorization in the U.S., many of the company’s products are classified as medical devices under the U.S. Food, Drug, and Cosmetic Act (FD&C Act). Within the European Union (EU), the company’s 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. The company’s QMS (Quality Management System) is routinely audited by certification bodies, as well as country regulators for compliance with applicable regulations. The company is in compliance with all state, federal, and international regulatory requirements applicable to its products. In the U.S., the company must comply with final regulations implementing amendments to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the associated HIPAA Security Rule. The company is also required to comply with the California Consumer Privacy Act and is preparing for a number of state-level laws and bills in the U.S., including the California Privacy Rights Act of 2020. In the EU, the company must comply with the General Data Protection Regulation, which serves as a harmonization of European data-privacy law and the Swiss Federal Act on Data Protection, where Align has its EMEA headquarters. In LATAM markets, the company must comply with Brazil's Lei Geral de Proteção de Dados. Meanwhile, the APAC and EMEA regions have also seen rapid development of privacy laws, including Turkey, Morocco, Ghana, India, Russia, China, South Korea, Singapore, Hong Kong, Israel, and Australia. History Align Technology, Inc. was founded in 1997. The company was incorporated in Delaware in 1997.