ALIGN TECHNOLOGY, INC. 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 and Section 21E of the Securities Exchange Act of 1934 (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 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 consumer demand sales and marketing activities, our expectations regarding the near and long-term implications of the COVID-19 pandemic on the global economy, the businesses of our customers and us, including our 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, the actions we will take to control spending and for investments, our intentions regarding the investment of our international earnings from operations, our belief regarding the sufficiency of our cash balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition, and assessment of goodwill and intangible assets, our expectations regarding our tax positions and the judgments we make related to our tax obligations, the level of our operating expenses and gross margins and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies. 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 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 endedDecember 31, 2020 as filed with theSecurities and Exchange Commission (the "SEC").
Executive Overview of Results
COVID-19 Update
Since the first quarter of fiscal year 2020, our sales and results of operations have been impacted first by the preventative measures implemented to slow the spread of COVID-19, including the complete closure or significantly reduced operations of dental practices and, more recently, the inconsistent pace and scale of recovery in various markets. In 2021, the pandemic continues to cause general business and societal disruptions and uncertainties worldwide, with variants of the COVID-19 virus appearing to drive regional increases in infections that has led to localized preventative measures of varying degrees to curtail further spread of the virus. Notwithstanding these setbacks, in general the scale and time during which these additional measures are implemented are less impactful on our customers and their patients than the most drastic measures imposed in 2020. For instance, globally both public and private dental practices largely remain open, although many continue to operate at less than pre-pandemic capacities. Conversely, as a result of the restrictive measures imposed to contain the spread of the virus, the demand for digital solutions has increased as society and businesses have adapted to practices such as social distancing and remote working. Our efforts to promote the digital transformation of dental practices with our clear aligners, intraoral scanners, clinical treatment planning and other offerings has allowed us to quickly respond to increased demand in the dental field. We expect the number of customers that realize the efficiencies and benefits of our digital solutions for their practices and patients to continue to grow even as the pandemic-related restrictions continue to ease generally. To address the increasing demand for digital solutions, we intend to continue targeting our investment plans in sales, marketing and innovation as well as our capital expenditures, particularly as we expand our manufacturing operations in locations such asEurope , in order to meet the anticipated demand for our solutions. 23 -------------------------------------------------------------------------------- Table of Contents Nevertheless, the continuing evolution of the pandemic, including the setbacks occurring as a result of new virus strains and the continuing business restrictions and lockdowns, the positive impacts of vaccinations, the uncertainties regarding consumer spending as demand for entertainment, dining, and travel returns and remote working diminishes, remains highly fluid and unpredictable. Consequently, the COVID-19 pandemic has caused, and is expected to continue causing for an unknown period of time, disruptions to many of the norms we have historically experienced in the cadence of our quarterly results of operations. As such, our recent operating results and levels of growth may not be indicative of our future performance. Ultimately, however, we believe the digital transition to dentistry that began before the pandemic will continue to be positive for our business, results of operations, cash flows, and financial condition and we intend to adjust spending to coincide with the pace of recovery and changes in demand.
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."
Key financial and operating metrics
Our business strategic priorities remain focused on four principal pillars of
growth: (i) international expansion; (ii) general practitioners ("GP") adoption;
(iii) patient demand & conversion; and (iv) orthodontic utilization. We measure
our performance against these strategic priorities by the achievement of key
financial and operating metrics.
For the three months ended June 30, 2021 , we achieved the following, taking into
consideration that percentage changes from prior year financial results are
unusual due to the significant impact of COVID-19 and do not necessarily reflect
our future growth rates:
•Revenues of $1.0 billion , an increase of 186.9% year-over-year;
•Clear Aligner revenues of $841.0 million , an increase of 181.9% year-over-year;
•Imaging Systems and CAD/CAM Services revenues of $169.8 million , an increase of
214.7% year-over-year;
•International Invisalign Revenues of $389.7 million , an increase of 151.0%
year-over-year;
•Clear Aligner volume increased 200.0% year-over-year and Clear Aligner volume
for teenage patients increased 156.3% year-over-year;
•Income from operations $268.9 million and operating margin 26.6%;
•Effective tax rate was 25.7%;
•Net income of $199.7 million with diluted net income per share of $2.51 ;
•Cash and cash equivalents were $1.1 billion as of June 30, 2021 ;
•Operating cash flow was $317.5 million ;
•Capital expenditures were $124.2 million and predominantly relate to increases
to our manufacturing capacity and facilities; and
•Number of employees was 20,395 as of June 30, 2021 , an increase of 31.5%
year-over-year
Other Statistical Data and Trends
•Digital Scanner Case Submissions. For the second quarter of 2021, total Invisalign cases submitted with a digital scanner in theAmericas increased to 86.6%, up from 85.7% in the second quarter of 2020 and international scans increased to 76.2%, up from 72.0% in the second quarter of 2020. For the second quarter of 2021, 95.8% of Invisalign cases submitted by North American orthodontists were submitted digitally. Our quarterly utilization rates for the last five quarters are as follows: 24
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* 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.
•Total utilization rate in the second quarter of 2021 increased to 8.0 cases per doctor compared to 4.6 cases per doctor in the second quarter of 2020.
?North America : Utilization rate among our North American orthodontist customers increased to 29.4 cases per doctor in the second quarter of 2021 compared to 11.0 cases per doctor in the second quarter of 2020 and the utilization rate among our North American GP customers increased to 5.3 cases per doctor in the second quarter of 2021 compared to 2.5 cases per doctor in the second quarter of 2020. ?International: International doctor utilization rate was 7.1 cases per doctor in the second quarter of 2021 compared to 4.7 cases in the second quarter of 2020. 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.
?Non-Case includes, but is not limited to, Vivera retainers along with our training and ancillary products for treating malocclusion.
•Our Systems and Services segment consists of our iTero intraoral scanning
systems, which includes a single hardware platform and restorative or
orthodontic software options, OrthoCAD services and ancillary products, as well
as exocad's CAD/CAM software solution that integrates 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 and six months ended June 30, 2021 and 2020 are as follows (in
millions):
Three Months Ended Six Months Ended
June 30, June 30,
Net Revenues 2021 2020 Change 2021 2020 Change
Clear Aligner net revenues:
Americas $ 400.5 $ 123.3 $ 277.2 224.9 % $ 757.9 $ 378.9 $ 379.1 100.1 %
International 389.7 155.2 234.5 151.0 % 743.0 351.1 391.9 111.6 %
Non-case 50.8 19.8 31.0 156.1 % 93.3 50.0 43.3 86.5 %
Total Clear Aligner net revenues
181.9 % $ 1,594.2 $ 780.0 $ 814.3 104.4 %
Systems and Services net revenues 169.8 54.0 115.9 214.7 % 311.4 123.3 188.0 152.5 %
Total net revenues $ 1,010.8 $ 352.3 $ 658.5 186.9 % $ 1,905.6 $ 903.3 $ 1,002.3 111.0 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
Clear Aligner Case Volume
Case volume data which represents Clear Aligner case shipments for the three and
six months ended
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Total case volume 665.6 221.9 443.7 200.0 % 1,261.4 581.3 680.1 117.0 %
Changes and percentages are based on actual values. Certain tables may not sum or recalculate due to rounding.
For the three and six months endedJune 30, 2021 , total net revenues increased by$658.5 million and$1.0 billion , respectively, as compared to the same periods in 2020 primarily as a result of increases in Clear Aligner volume of 200.0% and 117.0%, respectively, and an increase in the number of scanners recognized across all regions.
Clear Aligner -
For the three months endedJune 30, 2021 ,Americas net revenues increased by$277.2 million as compared to the same period in 2020 primarily due to a 260.7% increase in Clear Aligner volume which resulted in higher net revenues of$321.4 million , partially offset by lower Clear Aligner ASP that decreased net revenues by$44.2 million . Lower ASP was mostly due to higher net deferrals which decreased net revenues by$33.8 million and higher promotional discounts which decreased net revenues by$13.1 million . For the six months endedJune 30, 2021 ,Americas net revenues increased by$379.1 million as compared to the same period in 2020 primarily due to a 120.3% increase in Clear Aligner volume which resulted in higher net revenues of$455.7 million , partially offset by lower Clear Aligner ASP that decreased net revenues by$76.6 million . Lower ASP was mostly due to higher net deferrals which decreased revenues by$46.3 million and higher promotional discounts which decreased net revenues by$34.8 million .
Clear Aligner - International
For the three months endedJune 30, 2021 , International net revenues increased by$234.5 million as compared to the same period in 2020 primarily due to a 149.2% increase in Clear Aligner volume which resulted in higher net revenues of$231.7 million . For the six months endedJune 30, 2021 , International net revenues increased by$391.9 million as compared to the same period in 2020 primarily due to a 113.1% increase in Clear Aligner volume which resulted in higher net revenues of$397.1 million , partially offset by lower Clear Aligner ASP. Lower ASP was the result of higher net revenue deferrals partially offset by favorable foreign exchange rates. 26 -------------------------------------------------------------------------------- Table of Contents Clear Aligner - Non-Case
For the three and six months ended
Systems and Services
For the three months endedJune 30, 2021 , Systems and Services net revenues increased by$115.9 million as compared to the same period in 2020 due to a higher number of scanners recognized which increased net revenues by$63.8 million . Higher scanner ASP increased net revenues by$21.6 million mostly due to favorable product mix shift towards higher priced scanners. Additionally, net revenues increased by$30.5 million primarily as a result of higher iTero service revenues mostly due to a larger scanner install base. For the six months endedJune 30, 2021 , Systems and Services net revenues increased by$188.0 million as compared to the same period in 2020 due to a higher number of scanners recognized which increased net revenues by$113.2 million . Additionally, net revenues increased by$54.0 million as a result of higher iTero service revenues mostly due to a larger scanner install base and additional exocad CAD/CAM revenues.
Cost of net revenues and gross profit (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Clear Aligner
Cost of net revenues $ 194.3 $ 106.0 $ 88.3 $ 363.0 $ 236.1 $ 126.9
% of net segment revenues 23.1 % 35.5 % 22.8 % 30.3 %
Gross profit $ 646.7 $ 192.4 $ 454.3 $ 1,231.2 $ 543.9 $ 687.3
Gross margin % 76.9 % 64.5 % 77.2 % 69.7 %
Systems and Services
Cost of net revenues $ 58.0 $ 22.0 $ 36.0 $ 106.9 $ 48.5 $ 58.4
% of net segment revenues 34.1 % 40.8 % 34.3 % 39.3 %
Gross profit $ 111.9 $ 32.0 $ 79.9 $ 204.4 $ 74.8 $ 129.6
Gross margin % 65.9 % 59.2 % 65.7 % 60.7 %
Total cost of net revenues $ 252.3 $ 128.0 $ 124.3 $ 469.9 $ 284.6 $ 185.4
% of net revenues 25.0 % 36.3 % 24.7 % 31.5 %
Gross profit $ 758.5 $ 224.3 $ 534.2 $ 1,435.6 $ 618.7 $ 817.0
Gross margin % 75.0 % 63.7 % 75.3 % 68.5 %
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, shipping 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 and six months endedJune 30, 2021 , our gross margin percentage increased as compared to the same periods in 2020 primarily due to manufacturing efficiencies driven by higher production volumes, which was partially offset by lower ASP. Systems and Services For the three months endedJune 30, 2021 , our gross margin percentage increased as compared to the same period in 2020 as a result of higher ASP from a product mix shift, an increase in iTero service revenues and manufacturing efficiencies driven by higher production volumes which was partially offset by higher freight costs. 27 -------------------------------------------------------------------------------- Table of Contents For the six months endedJune 30, 2021 , our gross margin percentage increased as compared to the same period in 2020 primarily driven by higher ASP from a product mix shift and manufacturing efficiencies driven by higher production volumes.
Selling, general and administrative (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Selling, general and administrative
$ 175.0 $ 829.0 $ 539.9 $ 289.2 % of net revenues 42.7 % 72.9 % 43.5 % 59.8 %
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, public relations,
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 June 30, 2021 , selling, general and administrative
expense increased compared to the same period in 2020 primarily due to higher
compensation related costs of $86.9 million mainly from higher salaries, fringe
benefits, commissions, incentive bonuses and stock-based compensation. Higher
salaries were driven by an increase in 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 $64.2 million during the
three months ended June 30, 2021 .
For the six months ended June 30, 2021 , selling, general and administrative
expense increased compared to the same period in 2020 primarily due to higher
compensation related costs of $150.2 million mainly from higher salaries, fringe
benefits, commissions, incentive bonuses and stock-based compensation driven by
an increase in headcount. We also incurred higher advertising and marketing
costs of $93.8 million during the six months ended June 30, 2021 .
Research and development (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Research and development $ 57.7 $ 40.4 $ 17.4 $ 112.3 $ 81.9 $ 30.4
% of net revenues 5.7 % 11.5 % 5.9 % 9.1 %
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 and six months endedJune 30, 2021 , research and development expense increased compared to the same periods in 2020 primarily due to higher compensation costs including higher salaries, fringe benefits, and incentive bonuses mainly from an increased headcount as we continue to focus our investments in innovation and research. 28 -------------------------------------------------------------------------------- Table of Contents Income (loss) from operations (in millions): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 Change 2021 2020 Change Clear Aligner Income from operations$ 347.6 $ 38.9 $ 308.7 $ 675.1 $ 205.3 $ 469.8 Operating margin % 41.3 % 13.0 % 42.3 % 26.3 % Systems and Services Income from operations$ 64.7 $ 2.9 $ 61.8 $ 111.9 $ 17.3 $ 94.6 Operating margin % 38.1 % 5.4 % 35.9 % 14.0 % Total income (loss) from operations 1$ 268.9 $ (73.0) $ 341.9 $ 494.3 $ (3.1) $ 497.4 Operating margin % 26.6 % (20.7) % 25.9 % (0.3) %
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 and six months ended
Systems and Services
For the three and six months ended
Interest income (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Interest income $ 0.4 $ 0.5 $ (0.1) $ 2.0 $ 2.5 $ (0.4)
% of net revenues - % 0.1 % 0.1 % 0.3 %
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.
For the three months ended
For the six months endedJune 30, 2021 , interest income decreased compared to the same period in 2020 mainly due to the divestiture of our marketable securities portfolio during the first quarter of 2020 offset by interest income recognized during the six months endedJune 30, 2021 from the SDC arbitration award regarding the value of Align's capital account balance.
Other income (expense), net (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Other income (expense), net $ (0.5) $ (1.0) $ 0.5 $ 34.0 $ (19.5) $ 53.6
% of net revenues - % (0.3) % 1.8 % (2.2) %
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.
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For the three months ended
For the six months endedJune 30, 2021 , other income (expense), net increased compared to the same period in 2020 primarily due to a$43.4 million gain related to the SDC arbitration award recognized in the first quarter of 2021 in addition to a$10.2 million loss on a foreign currency forward contract related to the exocad acquisition recognized in 2020.
Provision for (benefit from) income taxes (in millions):
Three Months Ended Six Months Ended
June 30, June 30,
2021 2020 Change 2021 2020 Change
Provision for (benefit from)
income taxes $ 69.1 $ (32.9) $ 102.0 $ 130.3 $ (1,497.7) $ 1,628.0
Effective tax rates 25.7 % 44.8 % 24.6 % 7,437.0 %
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 the three and six months endedJune 30, 2021 primarily due to state income taxes, non-deductible expenses in theU.S. and foreign income taxed at different rates, partially offset by the recognition of excess tax benefits related to stock-based compensation. Our effective tax rate differs from the statutory federal income tax rate of 21% for the three months endedJune 30, 2020 primarily due to foreign income taxed at different rates. Our effective tax rate differs from the statutory federal income tax rate of 21% for the six months endedJune 30, 2020 mainly as a result of the recognition of a deferred tax asset and related one-time tax benefit associated with the intra-entity transfer of certain intellectual property rights completed last year and the recognition of excess tax benefits related to stock-based compensation, partially offset by foreign income taxed at different rates. The decrease in our effective tax rate for the three months endedJune 30, 2021 compared to the same period in 2020 is primarily attributable to foreign income taxed at lower rates. The decrease in our effective tax rate for the six months endedJune 30, 2021 compared to the same period in 2020 is primarily attributable to the recognition of a deferred tax asset and related one-time tax benefit associated with the intra-entity transfer of certain intellectual property rights during the six months endedJune 30, 2020 . During the six months endedJune 30, 2020 , we completed an intra-entity transfer of certain intellectual property rights and fixed assets to our Swiss entity. The transfer of intellectual property rights did not result in a taxable gain; however, it did result in a step-up of the Swiss tax deductible basis in the transferred assets, and accordingly, created a temporary difference between the book basis and the tax basis of such intellectual property rights. Consequently, this transaction resulted in the recognition of a deferred tax asset and related one-time tax benefit of approximately$1,493.5 million during the six months endedJune 30, 2020 , which is the net impact of the deferred tax asset recognized as a result of the additional Swiss tax deductible basis in the transferred assets and certain costs related to the transfer of fixed assets and inventory. The amortization of this deferred tax asset depends on the profitability of our Swiss headquarters and the recognition of this tax benefit is allowed for a maximum recovery period of 15 years.
Liquidity and Capital Resources
Liquidity and Trends
We fund our operations from product sales. As of
As ofJune 30, 2021 andDecember 31, 2020 , approximately$535.3 million and$412.5 million of cash and cash equivalents was 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 ourU.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. For 2021, we expect our investments in capital expenditures to be approximately$500.0 million . Capital expenditures primarily relate to building construction and improvements as well as additional manufacturing capacity to support our international expansion. This includes our planned investment in a new manufacturing facility in Wroclaw,Poland , our first one 30
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Table of Contents in the EMEA region. As we expand our manufacturing operations and penetrate into newer markets, we also expect to invest significantly in sales, marketing and innovation to meet the growing demand for our solutions. As ofJune 30, 2021 , we have$900.0 million available for repurchase under the stock repurchase program authorized by our Board of Directors inMay 2021 . Subsequent to the second quarter, onJuly 30, 2021 , we entered into an accelerated stock repurchase agreement to repurchase$75.0 million under the program. Additional information regarding the impact of COVID-19 on our liquidity and capital resources may be found in Part II, Item 1A of this Quarterly Report on Form 10-Q under the heading "Risk Factors".
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