Forward-Looking Statements

In addition to historical information, this quarterly report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), 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 expectations regarding the near and long-term implications of the COVID-19 pandemic on the global and regional economies, our beliefs and expectations regarding macroeconomic conditions, including inflation, customer and consumer sentiments, our expectations regarding the impact of the military conflict in Ukraine generally and specifically regarding our operations and assets in Russia, including the potential ramifications of sanctions and regarding relations with other countries, our marketing and efforts to build our brand awareness, our beliefs regarding digital dentistry and its potential to impact our business, our intentions regarding expanding our business, 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 expectation regarding customer and consumer purchasing behavior, including expectations related to consumer demand for digital solutions, 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, results of operations and financial condition, our expectations for our expenses and capital obligations and expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of our international earnings from operations, our belief regarding the sufficiency of our cash balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition and assessment of goodwill and intangible assets, our expectations regarding our tax positions and the judgments we make related to our tax obligations, our predicted level of operating expenses and gross margins and other factors beyond our control, our expectations regarding staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our business both in the United States and internationally, including sanctions and retaliatory sanctions related to the military conflict in Ukraine, as well as other statements regarding our future operations, financial condition and prospects and business strategies. These statements may contain words such as "expects," "anticipates," "intends," "plans," "believes," "estimates," or other words indicating future results. 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 I, Item 2 "Management's Discussion and Analysis of Financial Condition and Results of Operations," and in particular, the risks discussed below in Part II, Item 1A "Risk Factors." We undertake no obligation to revise or update these forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.

The following discussion and analysis of our financial condition and results of operations should be read together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the Securities and Exchange Commission (the "SEC").

Executive Overview of Results

Trends and Uncertainties

Our business strategic priorities remain focused on four principal pillars of growth: (i) international expansion; (ii) general practitioner dentists adoption; (iii) patient demand and conversion; and (iv) orthodontic utilization. Below is a discussion of the significant trends and uncertainties that could impact to our operations:

COVID-19 Pandemic Update

The COVID-19 pandemic continues to cause significant volatility and uncertainty in the global and regional economies, leading to changes in consumer and business behavior, market fluctuations, materials and product shortages and restrictions on business and individual activities, all of which are materially impacting supply and demand in broad sectors of the world markets. As the pandemic continues and new variants of the virus emerge, we are seeing a resurgence of measures to prevent its spread and, consequently, continuing fluctuations in the numbers of patients seeking treatment for dental services and the number of doctors providing services and treatments in other markets. Vaccinations and pandemic containment measures are driving the pace of economic recovery unevenly in various regions. These preventative measures and ongoing consumer concerns regarding the virus have continued to impact our results of operations, sometimes materially, and may continue to impact our results in future periods. Therefore, comparing our financial results for the reporting periods of 2022 to the same reporting periods of 2021 or earlier may not be a useful means by which to evaluate the health of our business and our results of operations.



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Our top priority remains the health and safety of our employees and their families, our customers and their staff, and we are taking prudent measures to safeguard them while remaining flexible in our operational efforts. Concerns regarding the spread and impact of the virus have lessened in many countries in which we operate, including the U.S., and consequently, we expect to substantially reopen our offices in those countries in the second quarter of 2022 and are adopting a flexible hybrid schedule that will allow many of our employees the opportunity to collaborate and connect with others in the office three days per week while having the option to work remotely other days. We believe that this added flexibility will benefit employees and Align overall.

Further discussion of the impact of the COVID-19 pandemic on our business may be found in Part II, Item 1A of this Quarterly Report on Form 10-Q under the heading "Risk Factors."

Macroeconomic Challenges and Military Conflict in Ukraine

Our revenues and costs are also susceptible to fluctuations in macroeconomic conditions, in line with changes in customer and consumer sentiment and demand, capital equipment seasonality, inflation and slowing economic growth and contractions, increasing prices for commodities and services and transportation costs, disruptions in the manufacturing, supply and distribution operations of us and our suppliers. These factors are further exacerbated by projections for slowing economic growth and contractions in the future. The nature and extent of the impact of these factors varies by region and remain uncertain and unpredictable.

The military conflict between Russia and Ukraine is increasing the unpredictability of the already uncertain macroeconomic conditions. We are deeply concerned about the devastating events unfolding in Ukraine and the significant humanitarian, economic and societal tragedy unfolding there. Our top priority is ensuring the safety and security of our employees and their families, particularly those most directly impacted by the hostilities and the resulting sanctions and retaliatory sanctions. We employ a significant number of research and development personnel in Russia as well as sales and marketing personnel. We do not have employees in Ukraine. We have taken extraordinary efforts to support our team members in the region, including helping them financially and working to maintain their safety and security. Our leadership continues to closely monitor the situation and evaluate ways in which we can support local leadership and employees.

Although immaterial to our consolidated financial statements, our commercial business operations in Russia have been significantly impacted by the conflict. In February 2022, after the military conflict commenced, our primary shipping vendor, UPS, ceased deliveries into Russia and shortly thereafter, we suspended all commercial activities. Our current focus is on providing continuity of care consistent with our values and ethical responsibility to patients, who are in treatment. In doing so, we are also focused on managing compliance with global sanctions applicable to our business, including significant restrictions imposed by countries on both sides of the conflict targeting business entities, persons and certain activities. The pace at which sanctions are being imposed and the expanding number and breadth of the sanctions enacted are creating significant global and regional economic challenges that bring significant uncertainty and unpredictability to our operations.

Moreover, many of our international operations are denominated in currencies other than the U.S. dollar and any weakening of the foreign currencies against the U.S. dollar could have a negative impact on our financial condition and results of operations. During the first quarter of 2022, primarily due to the military conflict between Russia and Ukraine and the significant sanctions that followed, Russia's currency, the ruble, weakened against the U.S. dollar. While the weakening did not materially impact our financial results in the first quarter of 2022, we continue to monitor the situation for future risks.

Overall, we expect the ramifications from the impacts of COVID-19, unpredictable macroeconomic conditions, and the military conflict in Ukraine to persist, creating uncertainty and unpredictability for consumers, global and regional economies as well as our business and the businesses of our customers and suppliers. We strive to manage the challenges by focusing on improving our operations, building efficiencies in our processes, and adjusting our business models to the changing circumstances. Specifically, we are managing cost impacts through pricing actions and implementing cost saving measures and averting supply chain shortages and delays by proactively communicating with our suppliers and distributors and modifying our purchase order commitments to mitigate the risks of production interruptions and maintaining inventory levels greater than historically required. We have also increased our cybersecurity measures to detect, protect and recover against potential incidents. We are actively monitoring the impact of COVID-19 cases and restrictions, macroeconomic challenges and the conflict in Ukraine and assessing various means to potentially mitigate material unfavorable impacts on our future results.

Key Financial and Operating Metrics

We measure our performance against these strategic priorities by the achievement of key financial and operating metrics.

For the three months ended March 31, 2022, we achieved the following:


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•Revenues of $973.2 million, an increase of 8.8% year-over-year;
•Clear Aligner revenues of $809.7 million, an increase of 7.5% year-over-year
reflecting the expanding opportunity for Invisalign system treatment among
adults globally, as well as the underlying orthodontic market as we continue to
build awareness of the Invisalign brand and drive utilization among teens and
younger patients through increased consumer marketing
•Americas Clear Aligner revenues of $376.2 million, an increase of 5.2%
year-over-year;
•International Clear Aligner revenues of $371.1 million, an increase of 5.0%
year-over-year;
•Clear Aligner volume increase of 0.5% year-over-year and Clear Aligner volume
increase for teenage patients of 6.0% year-over-year;
•Imaging Systems and CAD/CAM Services revenues of $163.5 million, an increase of
15.6% year-over-year primarily as a result of higher iTero service revenues
mostly due to a larger scanner install base;
•Income from operations of $198.1 million and operating margin of 20.4%;
•Effective tax rate of 28.4%;
•Net income of $134.3 million with diluted net income per share of $1.70;
•Cash, cash equivalents and marketable securities of $1,120.6 million as of
March 31, 2022;
•Operating cash flow of $30.5 million;
•Capital expenditures of $87.3 million, predominantly related to increases in
our manufacturing capacity and facilities; and
•Number of employees was 23,625 as of March 31, 2022, an increase of 24.5%
year-over-year.

Other Statistical Data and Trends

•As of March 31, 2022, approximately 12.8 million people worldwide have been treated with our Invisalign system, approximately 73,000 iTero scanners have been sold and approximately 49,000 exocad software licenses have been installed. Management measures these results by comparing to the millions of people who can benefit from straighter teeth and dental practices that could use intraoral scanners and uses this data to target opportunities to expand the market for orthodontics by educating consumers about the benefits of straighter teeth using the Invisalign system, dental professionals and/or labs and service providers to use iTero intraoral scanners, and dental labs and practitioners to install exocad CAD/CAM software.

•For the first quarter of 2022, total Invisalign cases submitted with a digital scanner in the Americas increased to 90.6%, up from 85.5% in the first quarter of 2021 and international scans increased to 82.8%, up from 75.1% in the first quarter of 2021. For the first quarter of 2022, 97.1% of Invisalign cases submitted by North American orthodontists were submitted digitally.

•Total utilization rate in the first quarter of 2022 decreased to 7.3 cases per doctor compared to 7.6 cases per doctor in the first quarter of 2021. Utilization rates in North America and our International locations were as follows:

?North America: Utilization rate among our North American orthodontist customers remained consistent at 26.8 cases per doctor in both the first quarter of 2022 and 2021 and the utilization rate among our North American GP customers increased to 5.0 cases per doctor in the first quarter of 2022 compared to 4.8 cases per doctor in the first quarter of 2021.

?International: International doctor utilization rate was 6.4 cases per doctor in the first quarter of 2022 compared to 6.8 cases per doctor in the first quarter of 2021.


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                    [[Image Removed: algn-20220331_g1.jpg]]

* Invisalign utilization rates are calculated by the number of cases shipped divided by the number of doctors to whom cases were shipped. Our International region includes Europe, Middle East and Africa ("EMEA") and Asia Pacific ("APAC"). Latin America ("LATAM") is excluded from the International region based on its immateriality to the quarter, however is included in the Total utilization.

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 and Invisalign First.

?Non-Comprehensive Products include, but are not limited to, Invisalign Moderate, Lite and Express packages and Invisalign Go and Invisalign Go Plus.

?Non-Case products include, but are not limited to, retention products, Invisalign training, adjusting tools used by dental professionals during the course of treatment and, more recently, Consumer 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 e-commerce channels in select markets. We also offer in the U.S. and Canada, 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 currently not regularly using our retainers or low-stage aligners.

•Our Systems and Services segment consists of our iTero intraoral scanning systems, which includes a single hardware platform and restorative or orthodontic software options. Our services include subscription software, disposables, rentals, pay per scan services, as well as exocad's CAD/CAM software solutions that integrate workflows to dental labs and dental practices.



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Net revenues for our Clear Aligner and Systems and Services segments by region for the three months ended March 31, 2022 and 2021 are as follows (in millions):


                                            Three Months Ended
                                                 March 31,
Net Revenues                                 2022            2021              Change
Clear Aligner net revenues:
Americas                               $    376.2          $ 357.5      $ 18.8        5.2  %
International                               371.1            353.3        17.8        5.0  %
Non-case                                     62.4             42.5        19.9       46.8  %

Total Clear Aligner net revenues $ 809.7 $ 753.3 $ 56.4 7.5 % Systems and Services net revenues

           163.5            141.5        22.0       15.6  %
Total net revenues                     $    973.2          $ 894.8      $ 78.4        8.8  %

Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.

Case volume data which represents Clear Aligner case shipments for the three months ended March 31, 2022 and 2021 is as follows (in thousands):


                             Three Months Ended
                                 March 31,
                          2022                2021             Change

Total case volume       598.8               595.8          3.0       0.5  %

Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.

For the three months ended March 31, 2022, total net revenues increased by $78.4 million as compared to the same period in 2021, primarily due to an increase in Clear Aligner ASP, an increase in Clear Aligner non-case revenues, and increased service revenues.

Clear Aligner - Americas

For the three months ended March 31, 2022, Americas net revenues increased by $18.8 million as compared to the same period in 2021, primarily due to an increase in ASP which increased net revenues by $24.3 million. Higher ASP was mainly due to processing fees charged on most clear aligner orders and price increases in certain markets which increased revenues by $11.6 million and lower net deferrals which increased net revenues by $9.8 million. Higher ASP was partially offset by 1.5% decrease in case volume, which resulted in lower net revenues of $5.5 million.

Clear Aligner - International

For the three months ended March 31, 2022, International net revenues increased by $17.8 million as compared to the same period in 2021, primarily due to a 3.0% increase in case volume, which resulted in higher net revenues of $10.7 million. Higher ASP increased net revenues by $7.1 million largely due to lower net deferrals which increased net revenues by $20.6 million, and processing fees charged on most clear aligner orders which increased net revenues by $13.9 million. The increase in ASP were partially offset by unfavorable exchange rates which decreased net revenues by $22.9 million. Clear Aligner - Non-Case

For the three months ended March 31, 2022, non-case net revenues increased by $19.9 million as compared to the same period in 2021, due to increased volume for retention products across all regions primarily driven by Vivera retainers.

Systems and Services

For the three months ended March 31, 2022, Systems and Services net revenues increased by $22.0 million as compared to the same period in 2021 primarily due to higher service revenues which increased $17.1 million mostly due to a larger install base. Net revenues also increased $4.9 million mainly due to a higher number of scanners sold.



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Cost of net revenues and gross profit (in millions):


                                    Three Months Ended
                                        March 31,
                                    2022           2021        Change
Clear Aligner
Cost of net revenues            $   204.0       $ 168.7       $ 35.3
% of net segment revenues            25.2  %       22.4  %
Gross profit                    $   605.7       $ 584.5       $ 21.2
Gross margin %                       74.8  %       77.6  %
Systems and Services
Cost of net revenues            $    59.9       $  48.9       $ 10.9
% of net segment revenues            36.6  %       34.6  %
Gross profit                    $   103.7       $  92.6       $ 11.1
Gross margin %                       63.4  %       65.4  %
Total cost of net revenues      $   263.9       $ 217.7       $ 46.2
% of net revenues                    27.1  %       24.3  %
Gross profit                    $   709.3       $ 677.1       $ 32.2
Gross margin %                       72.9  %       75.7  %

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 related costs, depreciation on capital equipment and facilities used in the production process, amortization of acquired intangible assets and training costs.

Clear Aligner

For the three months ended March 31, 2022, our gross margin percentage decreased as compared to the same period in 2021, primarily due to a higher mix of additional aligners, higher freight costs and manufacturing spend. These factors were offset in part by higher ASP.

Systems and Services

For the three months ended March 31, 2022, our gross margin percentage decreased as compared to the same period in 2021, primarily due to manufacturing inefficiencies driven by lower production volumes which was offset in part by higher service revenues and ASP.

Selling, general and administrative (in millions):


                                             Three Months Ended
                                                 March 31,
                                             2022           2021        Change

Selling, general and administrative $ 439.5 $ 397.1 $ 42.3 % of net revenues

                             45.2  %       44.4  %

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 Information Technology ("IT").

For the three months ended March 31, 2022, selling, general and administrative expense increased compared to the same period in 2021, primarily due to higher compensation related costs of $18.4 million from higher salaries and fringe benefits due to increased headcount as we continue to invest in sales and marketing to penetrate into new markets. Additionally, we also incurred higher advertising and marketing costs of $27.8 million during the three months ended March 31, 2022.


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Research and development (in millions):


                                  Three Months Ended
                                      March 31,
                                  2022           2021        Change
Research and development      $    71.8        $ 54.5       $ 17.3
% of net revenues                   7.4   %       6.1  %

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.

For the three months ended March 31, 2022, research and development expense increased compared to the same period in 2021, primarily due to higher compensation costs from higher salaries and fringe benefits driven mainly by increased headcount as we continue to focus our investments in innovation and research.

Income from operations (in millions):


                                        Three Months Ended
                                            March 31,
                                        2022           2021        Change
Clear Aligner
Income from operations              $   312.7       $ 327.5       $ (14.7)
Operating margin %                       38.6  %       43.5  %
Systems and Services
Income from operations              $    50.8       $  47.2       $   3.6
Operating margin %                       31.1  %       33.4  %

Total income from operations 1 $ 198.1 $ 225.4 $ (27.4) Operating margin %

                       20.4  %       25.2  %

Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.

1 Refer to Note 13 "Segments and Geographical Information" of the Notes to Condensed Consolidated Financial Statements for details on unallocated corporate expenses and the reconciliation to Condensed Consolidated Income from Operations.

Clear Aligner

For the three months ended March 31, 2022, our operating margin percentage decreased compared to the same period in 2021, primarily due to lower gross margins in addition to higher operating expenses as a percentage of revenues.

Systems and Services

For the three months ended March 31, 2022, our operating margin percentage decreased compared to the same period in 2021, primarily due to lower gross margins.

Interest income (in millions):


                             Three Months Ended
                                 March 31,
                           2022                2021       Change
Interest income        $    0.7              $ 1.6       $ (1.0)
% of net revenues           0.1   %            0.2  %

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.


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For the three months ended March 31, 2022, interest income decreased compared to the same period in 2021 mainly due to interest earned from the SDC arbitration award in the first quarter of 2021.

Other income (expense), net (in millions):


                                     Three Months Ended
                                         March 31,
                                     2022           2021        Change
Other income (expense), net      $    (11.3)      $ 34.5       $ (45.8)
% of net revenues                      (1.2) %       3.9  %

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.

For the three months ended March 31, 2022, other income (expense), net decreased compared to the same period in 2021 primarily due to a $43.4 million gain related to the SDC arbitration award recognized in the first quarter of 2021.

Provision for income taxes (in millions):


                                    Three Months Ended
                                        March 31,
                                    2022           2021        Change
Provision for income taxes      $    53.2        $ 61.2       $ (8.1)
Effective tax rates                  28.4   %      23.4  %

Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.

Our effective tax rate differs from the statutory federal income tax rate of 21% for both the three months ended March 31, 2022 and 2021, primarily due to the recognition of additional tax expense resulting from foreign income taxed at different rates, state income taxes, and non-deductible expenses in the U.S. partially offset by the recognition of excess tax benefits related to stock-based compensation. Additionally, a change in U.S. tax laws effective January 1, 2022 which requires capitalization and amortization of research and development expenses incurred after December 31, 2021 has increased our effective tax rate for the three months ended March 31, 2022.

The increase in our effective tax rate for the three months ended March 31, 2022 compared to the same period in 2021 is primarily attributable to foreign income taxed at different rates, capitalization and amortization of research and development expenses in 2022, and lower excess tax benefits from stock-based compensation.

Liquidity and Capital Resources

Liquidity and Trends

As of March 31, 2022 and December 31, 2021, we had the following cash and cash equivalents and short-term and long term marketable securities (in thousands):



                                        March 31, 2022       December 31, 2021
Cash and cash equivalents              $       926,119      $        1,099,370
Marketable securities, short-term               86,749                  71,972
Marketable securities, long-term               107,695                 125,320
Total                                  $     1,120,563      $        1,296,662



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As of March 31, 2022 and December 31, 2021, approximately $667.6 million and $713.8 million of cash, cash equivalents and marketable securities were held by our foreign subsidiaries, respectively. Our intent is to permanently reinvest our earnings from our international operations going forward, and our current plans do not require us to repatriate them to fund our U.S. operations as we generate sufficient domestic operating cash flow and have access to external funding under our $300.0 million 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.

The geopolitical situation between Russia and Ukraine and the imposition of sanctions against Russian banks or international bank messaging systems could impact our ability to access our cash in Russia but would not materially impact our liquidity position. As of March 31, 2022, cash and cash equivalents domiciled in Russia represent approximately 5.0% of our total cash, cash equivalents and marketable securities which is required to fund their working capital.

Our material cash requirements are as follows:

•For 2022, we expect our investments in capital expenditures to exceed $300.0 million. Capital expenditures primarily relate to building construction and improvements as well as additional manufacturing capacity to support our international expansion. This includes our investment in an aligner fabrication facility in Wroclaw, Poland which is expected to begin serving doctors in the second quarter of 2022, as a part of our strategy to bring operational facilities closer to customers. As we continue growing, we intend to expand our investments in research and development, manufacturing, treatment planning, sales and marketing operations to meet actual and anticipated local and regional demands.

•As of March 31, 2022, we have $649.9 million available for repurchase under the stock repurchase program authorized by our Board of Directors in May 2021. Refer to Note 9 "Common Stock Repurchase Program" of the Notes to Condensed Consolidated Financial Statements for details on our stock repurchase programs. Subsequent to the first quarter, on April 29, 2022, we entered into an accelerated stock repurchase agreement to repurchase $200.0 million under the program.

•There have been no material changes to the purchase commitments for goods and services and future operating lease payments during the period covered by this 10-Q outside the normal course of business compared to the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2021.

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