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Align Technology Expands Global Operations to Support Growth and Adoption of the Invisalign System in EMEA With Plans for Multi-Million Dollar Manufacturing Facility in Wroclaw, Poland
Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company engaged in the design and manufacture of the Invisalign system, iTero intraoral scanners, and exocad CAD/CAM services for orthodontic and restorative dentistry, today announced plans to open a new manufacturing facility in Poland to address the large and underpenetrated market opportunity in the Europe, Middle East and Africa (EMEA) region, which represents over 5 million annual orthodontic case starts and more than 150 million EMEA consumers who can potentially benefit from a healthier, beautiful smile. The new Wroclaw plant will be Align’s first in the EMEA region and its third plant worldwide, joining Juarez, Mexico and Ziyang, China.

The new facility is expected to begin supplying customers in the EMEA region in early 2022. The investment is part of Align’s strategy to bring its operational facilities closer to its customers. Align works directly with doctors - dentists and orthodontists - to provide them with the Invisalign system of clear aligners to prescribe to their patients to straighten their teeth and transform their smiles.

“I’m excited to announce plans to open our first aligner manufacturing facility in the EMEA region, and third globally. This significant investment underscores our commitment to the more than 62,700 Invisalign trained doctors and their patients in the EMEA region and extends our local operations in the region that include treatment planning facilities (TREAT), based in Poland, Germany and Spain,” said Emory Wright, Align senior vice president, Global Operations.

Align Technology is the world’s largest 3D printing manufacturer, with as many as 700,000 unique aligner parts produced per day in its manufacturing facilities across the globe. The Invisalign system is leveraged by over 200,000 Invisalign trained dentists and orthodontists. More than 9.6 million patients have been treated with the Invisalign system worldwide, including 2 million patients in the EMEA region as of the fourth quarter of 2020.

"We are proud to open Align’s first manufacturing facility in the EMEA region. The state-of-the-art EMEA plant in Wroclaw is expected to add more than 2,500 jobs to Align by the end of 2025, making it the company’s largest investment in EMEA to date. Align has been expanding its presence in the region for the past 20 years by adding new offices, building strong regional and local teams, and expanding digital treatment planning facilities in three different markets – with plans for further expansion. This new investment will allow us to deliver on our ongoing commitment to Invisalign doctors in the region to support them with more dedicated, customized support, as well as quicker turnaround and delivery times,” added Markus Sebastian, Align senior vice president and managing director, EMEA.

“The development of Polish industry, using innovative technologies, is one of the key priorities of the Polish government, which has been highlighted in the Industrial Development Policy of Poland. We continue to create the best possible conditions to allow development of domestic companies, as well as encourage foreign capital to invest in our country. We consistently support investment in digitalization. Poland has some of the world's best specialists in digitization and support instruments, such as dedicated economic zones or the government grant program that significantly simplify the procedure for business development. We are pleased that another investor - Align Technology, has recognized these opportunities and decided to expand their presence in the EMEA region by planning to open the largest 3D printing and manufacturing plants in Poland,” said Polish Deputy Prime Minister Jaroslaw Gowin, Minister for Development, Labour and Technology.

“I am very pleased with Align Technology's decision to further develop its operations in Poland. The new project has a huge potential in terms of employment, with approximately 2,500 new jobs expected to be created. Digital transformation has changed the face of many industries and has found its place in the medical sector, which is best proved by Align, a company that uses 3D printing in production. It is worth emphasizing that the interest of the medical industry in the Polish market is still growing, as confirmed by inquiries of foreign companies coming to Polish Investment & Trade Agency (PAIH), with six medical investment projects and another five already underway. Technologies used in the medical sector are now very much needed by everyone,” added Krzysztof Drynda, Chairman of the Polish Investment and Trade Agency.

The new Align manufacturing facility will open in early 2022, with plans to support all EMEA Invisalign case shipments by 2024. The multi-million-dollar investment by Align is one of the larger projects by an international company in the greater Wroclaw area.

*total number of doctors trained in EMEA since Dec. 1998. Data on file.

About Align Technology, Inc.

Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat over 9.6 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero systems and services, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

About the Invisalign system

Invisalign clear aligners are a removable and transparent teeth-straightening solution produced using digital and 3D technologies. This type of solution differs from other orthodontic devices in that they are more comfortable and can be easily removed for eating or drinking. Used to treat minor to complex types of malocclusions, Invisalign clear aligners are replaced every one or two weeks, depending on a doctor’s recommendation, gradually moving teeth towards the projected final position.

Forward-Looking Statements

This news release contains forward-looking statements, including quotations from management regarding the expected timing and benefits of its planned manufacturing facility in Poland, including the number of new positions, manufacturing and delivery times, and customer support. Forward-looking statements contained in this news release relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

• the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, including any periodic reimplementation of preventative measures in various global locations;
• difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages, and consumer confidence, particularly in light of the pandemic and as pandemic-related restrictions are eased regionally and globally;
• unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
• increasing competition from existing and new competitors;
• rapidly evolving and groundbreaking advances that fundamentally alter the dental industry or the way new and existing customers market and provide products and services to consumers;
• the ability to protect our intellectual property rights;
• continued compliance with regulatory requirements;
• declines in, or the slowing of the growth of, sales of our intra-oral scanners domestically and/or internationally and the impact either would have on the adoption of Invisalign products;
• the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
• the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected;
• a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
• the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses; 
• the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel; 
• the compromise of customer and/or patient data for any reason;
• the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
• foreign operational, political and other risks relating to our international manufacturing operations; and
• the loss of key personnel or work stoppages.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2021. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Align TechnologyMadelyn Homick408-470-1180mhomick@aligntech.com

Zeno GroupSarah Johnson828-551-4201sarah.johnson@zenogroup.com