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Align Technology Announces Record Third Quarter 2021 Financial Results

October 27, 2021 4:00 PM

Achieves 11 Millionth Invisalign Patient MilestoneiTero Scanner Installed-base Reaches 50,000 Units Worldwide

TEMPE, Ariz., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today reported financial results for the third quarter of fiscal 2021 (“Q3'21”). Q3'21 total revenues were $1.016 billion, up 0.5% sequentially and 38.4% year-over-year. Q3'21 Clear Aligner revenues were $837.6 million, down 0.4% sequentially and up 34.9% year-over-year. Q3'21 Imaging Systems and CAD/CAM Services record revenues were $178.3 million, up 5.0% sequentially and 57.3% year-over-year. Q3'21 Clear Aligner volume was 655.1 thousand cases, down 1.6% sequentially and up 32.1% year-over-year. For the Americas, Q3'21 Clear Aligner volume was up 0.7% sequentially and 36.4% year-over-year. For International regions, Q3'21 Clear Aligner volume was down 4.3% sequentially and up 27.0% year-over-year. Q3'21 Clear Aligner volume for teens was 206.0 thousand cases, up 13.8% sequentially and 26.6% year-over-year. Q3'21 operating income was $261.2 million, resulting in an operating margin of 25.7%. Q3'21 net income was $181.0 million, or $2.28 per diluted share. On a non-GAAP basis, Q3'21 net income was $228.6 million, or $2.87 per diluted share.

Commenting on Align's Q3'21 results, Align Technology President and CEO Joe Hogan said, “I’m pleased to report strong third quarter results with revenue growth of 38.4% year over year – on top of a record third quarter last year – driven by strength across all regions, customer channels, and products. For Q3 we shipped to a record 85.5 thousand doctors in the quarter and reached 11.6 million Invisalign patients cumulatively. On a sequential basis, Q3 results reflect continued adoption of iTero scanners and increased utilization of Invisalign clear aligners in the Americas and APAC regions, as well as growth in the Teen segment, especially in the North America orthodontist channel. Our third quarter revenues reflect the growing confidence of doctors and patients with Invisalign treatment, iTero scanners and exocad software, as more doctors discover the benefits of digital treatment and transform their practices with the Align digital platform.”

Financial Summary - Third Quarter Fiscal 2021

Q3'21 Q2'21 Q3'20 Q/Q Change Y/Y Change
Invisalign Case Shipments655,150 665,575 496,065 (1.6)% +32.1%
GAAP
Net Revenues$1,015.9M $1,010.8M $734.1M +0.5% +38.4%
Clear Aligner$837.6M $841.0M $620.8M (0.4)% +34.9%
Imaging Systems and CAD/CAM Services$178.3M $169.8M $113.4M +5.0% +57.3%
Net Income$181.0M $199.7M $139.4M (9.4)% +29.8%
Diluted EPS$2.28 $2.51 $1.76 ($0.23) +$0.52
Non-GAAP
Net Income$228.6M $242.1M $177.9M (5.6)% +28.5%
Diluted EPS$2.87 $3.04 $2.25 ($0.17) +$0.62

As of September 30, 2021, we had $1.2 billion in cash and cash equivalents, compared to $1.1 billion as of June 30, 2021. We also have $300.0 million available under a revolving line of credit. In Q3'21, we purchased approximately 165K shares of our common stock and have $825.0 million remaining available for repurchase under our May 2021 $1.0 Billion Repurchase Program.

Recent Announcements – October 2021:

Product

Q3'21 Announcement Highlights:

Corporate

Product

FY 2021 Business Outlook

For 2021, Align provides the following guidance:

Align Web Cast and Conference Call

Align will host a conference call today, October 27, 2021, at 4:30 p.m. ET, 1:30 p.m. PT, to review its third quarter 2021 results, discuss future operating trends and its business outlook. The conference call will also be webcast live via the Internet. To access the webcast, go to the “Events & Presentations” section under Company Information on Align's Investor Relations website at http://investor.aligntech.com. To access the conference call, please dial 201-689-8261. An archived audio webcast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately one month. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with conference number 13723267 followed by #. For international callers, please dial 201-612-7415 and use the same conference number referenced above. The telephonic replay will be available through 5:30 p.m. ET on November 10, 2021.

About Non-GAAP Financial Measures

To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (“GAAP”), we may provide investors with certain non-GAAP financial measures which may include gross profit, gross margin, operating expenses, income from operations, operating margin, interest income and other income (expense), net, net income before provision for (benefit from) income taxes, provision for (benefit from) income taxes, effective tax rate, net income and/or diluted net income per share, which exclude certain items that may not be indicative of our fundamental operating performance including discrete cash and non-cash charges or gains that are included in the most directly comparable GAAP measure. Unless otherwise indicated, when we refer to non-GAAP financial measures they will exclude the effects of stock-based compensation, amortization of certain acquired intangibles, non-cash deferred tax assets and associated amortization related to the intra-entity transfer of non-inventory assets, acquisition-related costs, and arbitration award gain, and, if applicable, any associated tax impacts.

We use non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. Our management believes that the use of certain non-GAAP financial measures provide meaningful supplemental information regarding our recurring core operating performance. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. These non-GAAP financial measures also facilitate management's internal evaluation of period-to-period comparisons. We believe these non-GAAP financial measures are useful to investors both because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they will be provided to and used by our institutional investors and the analyst community to help them analyze the performance of our business.

There are limitations to using non-GAAP financial measures, though, because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. The non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact upon our reported financial results. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management about which charges are excluded from the non-GAAP financial measures. We compensate for these limitations by analyzing current and future results on a GAAP as well as a non-GAAP basis and also by providing GAAP measures in our public disclosures. The presentation of non-GAAP financial information is meant to be considered in addition to, not as a substitute for or in isolation from, the directly comparable financial measures prepared in accordance with GAAP. We urge investors to review the reconciliation of our GAAP financial measures to the comparable Non-GAAP financial measures included in this presentation and not to rely on any single financial measure to evaluate our business. For more information on these non-GAAP financial measures, please see the table captioned “Unaudited GAAP to Non-GAAP Reconciliation.”

About Align Technology, Inc.

Align Technology designs and manufactures 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 210 thousand doctor customers and is key to accessing Align's 500 million consumer market opportunity worldwide. Align has helped doctors treat over 11.6 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 digital scanning system, 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.

Forward-Looking Statements

This news release, including the tables below, contains forward-looking statements, including quotations from management regarding confidence in our products and services, and statements regarding the availability of products and certain business metrics on either or both a GAAP or non-GAAP basis for 2021, including, but not limited to, anticipated net revenues and growth rate for the year and, in particular, the second half of 2021, operating margin, and in connection with the timing, means and amount of anticipated stock repurchases. 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 reflect our best judgments based on currently known facts and circumstances 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 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 and our latest Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the SEC on August 4, 2021. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

ALIGN TECHNOLOGY, INC.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share data)

Three Months Ended September 30, Nine Months Ended September 30,
2021 2020 2021 2020
Net revenues$1,015,906 $734,144 $2,921,485 $1,637,421
Cost of net revenues260,750 200,056 730,693 484,649
Gross profit755,156 534,088 2,190,792 1,152,772
Operating expenses:
Selling, general and administrative428,409 312,492 1,257,445 852,365
Research and development65,587 44,527 177,839 126,420
Total operating expenses493,996 357,019 1,435,284 978,785
Income from operations261,160 177,069 755,508 173,987
Interest income and other income (expense), net:
Interest income401 329 2,427 2,788
Other income (expense), net427 7,147 34,476 (12,368)
Total interest income and other income (expense), net828 7,476 36,903 (9,580)
Net income before provision for (benefit from) income taxes261,988 184,545 792,411 164,407
Provision for (benefit from) income taxes81,019 45,174 211,352 (1,452,493)
Net income$180,969 $139,371 $581,059 $1,616,900
Net income per share:
Basic$2.29 $1.77 $7.36 $20.54
Diluted$2.28 $1.76 $7.29 $20.45
Shares used in computing net income per share:
Basic78,904 78,824 78,971 78,729
Diluted79,516 79,163 79,677 79,078

ALIGN TECHNOLOGY, INC.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)

September 30,2021 December 31,2020
ASSETS
Current assets:
Cash and cash equivalents$1,237,822 $960,843
Accounts receivable, net855,037 657,704
Inventories207,116 139,237
Prepaid expenses and other current assets155,332 91,754
Total current assets2,455,307 1,849,538
Property, plant and equipment, net1,002,769 734,721
Operating lease right-of-use assets, net92,727 82,553
Goodwill426,594 444,817
Intangible assets, net115,794 130,072
Deferred tax assets1,502,250 1,552,831
Other assets54,668 35,151
Total assets$5,650,109 $4,829,683
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$174,916 $142,132
Accrued liabilities545,286 405,582
Deferred revenues1,070,113 777,887
Total current liabilities1,790,315 1,325,601
Income tax payable125,986 105,748
Operating lease liabilities74,352 64,445
Other long-term liabilities142,694 100,024
Total liabilities2,133,347 1,595,818
Total stockholders’ equity3,516,762 3,233,865
Total liabilities and stockholders’ equity$5,650,109 $4,829,683

ALIGN TECHNOLOGY, INC.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands)

Nine Months EndedSeptember 30,
2021 2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net cash provided by operating activities$899,695 $280,756
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash used in investing activities(255,719) (186,840)
CASH FLOWS FROM FINANCING ACTIVITIES
Net cash used in financing activities(356,759) (28,360)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash(10,241) (568)
Net increase in cash, cash equivalents, and restricted cash276,976 64,988
Cash, cash equivalents, and restricted cash at beginning of the period961,474 551,134
Cash, cash equivalents, and restricted cash at end of the period$1,238,450 $616,122

ALIGN TECHNOLOGY, INC.INVISALIGN BUSINESS METRICS

Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3
2020 2020 2020 2020 2020 2021 2021 2021
Invisalign Average Selling Price (ASP):
Comprehensive Products ASP$1,340 $1,330 $1,245 $1,230 $1,275 $1,265 $1,250 $1,255
Non-Comprehensive Products ASP$1,050 $1,035 $1,005 $1,000 $1,020 $1,030 $1,040 $1,050
Number of Invisalign Doctors Cases Were Shipped To:
Americas32,315 22,165 34,625 38,165 49,615 38,975 40,740 41,310
International28,535 25,945 35,380 38,585 52,445 39,630 42,725 44,190
Total Doctors Cases Shipped To60,850 48,110 70,005 76,750 102,060 78,605 83,465 85,500
Invisalign Doctor Utilization Rates*:
North America6.9 4.8 8.4 8.7 19.8 9.1 9.9 9.8
North American Orthodontists18.9 11.0 24.1 25.0 67.3 26.8 29.4 29.7
North American GP Dentists3.6 2.5 4.2 4.5 9.6 4.8 5.3 5.0
International5.1 4.7 6.4 6.9 14.5 6.8 7.1 6.5
Total Utilization Rates**5.9 4.6 7.1 7.4 16.1 7.6 8.0 7.7

* # of cases shipped / # of doctors to whom cases were shipped** LATAM utilization rate is not separately disclosed but included in the total utilization rates

ALIGN TECHNOLOGY, INC.STOCK-BASED COMPENSATION (in thousands)

Q1 Q2 Q3 Q4 Fiscal Q1 Q2 Q3
2020 2020 2020 2020 2020 2021 2021 2021
Stock-based Compensation (SBC):
SBC included in Gross Profit$1,347 $891 $1,247 $1,234 $4,719 $1,306 $1,418 $1,451
SBC included in Operating Expenses21,580 24,116 23,982 24,030 93,708 25,935 27,437 26,951
Total SBC$22,927 $25,007 $25,229 $25,264 $98,427 $27,241 $28,855 $28,402

ALIGN TECHNOLOGY, INC.UNAUDITED GAAP TO NON-GAAP RECONCILIATION(in thousands, except per share data)

Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2021 2020 2021 2020
GAAP gross profit$755,156 $534,088 $2,190,792 $1,152,772
Stock-based compensation1,451 1,247 4,175 3,485
Amortization of intangibles (1)2,354 2,700 6,704 4,350
Non-GAAP gross profit$758,961 $538,035 $2,201,671 $1,160,607
GAAP gross margin74.3 % 72.7 % 75.0 % 70.4 %
Non-GAAP gross margin74.7 % 73.3 % 75.4 % 70.9 %
GAAP total operating expenses$493,996 $357,019 $1,435,284 $978,785
Stock-based compensation(26,951) (23,982) (80,323) (69,678)
Amortization of intangibles (1)(960) (580) (2,735) (2,175)
Acquisition related costs (2) (314) (104) (7,621)
Non-GAAP total operating expenses$466,085 $332,143 $1,352,122 $899,311
GAAP income from operations$261,160 $177,069 $755,508 $173,987
Stock-based compensation28,402 25,229 84,498 73,163
Amortization of intangibles (1)3,314 3,280 9,439 6,525
Acquisition related costs (2) 314 104 7,621
Non-GAAP income from operations$292,876 $205,892 $849,549 $261,296
GAAP operating margin25.7 % 24.1 % 25.9 % 10.6 %
Non-GAAP operating margin28.8 % 28.0 % 29.1 % 16.0 %
GAAP total interest income and other income (expense), net$828 $7,476 $36,903 $(9,580)
Acquisition related costs (2) 10,187
Arbitration award gain (3) (43,403)
Non-GAAP total interest income and other income (expense), net$828 $7,476 $(6,500) $607
GAAP net income before provision for income taxes$261,988 $184,545 $792,411 $164,407
Stock-based compensation28,402 25,229 84,498 73,163
Amortization of intangibles (1)3,314 3,280 9,439 6,525
Acquisition related costs (2) 314 104 17,808
Arbitration award gain (3) (43,403)
Non-GAAP net income before provision for income taxes$293,704 $213,368 $843,049 $261,903

ALIGN TECHNOLOGY, INC.UNAUDITED GAAP TO NON-GAAP RECONCILIATION CONTINUED(in thousands, except per share data)

Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
2021 2020 2021 2020
GAAP provision for (benefit from) income taxes$81,019 $45,174 $211,352 $(1,452,493)
Tax impact on non-GAAP adjustments6,605 1,093 19,978 20,931
Tax related non-GAAP items (4)(22,494) (10,763) (57,339) 1,485,286
Non-GAAP provision for income taxes$65,130 $35,504 $173,991 $53,724
GAAP effective tax rate30.9 % 24.5 % 26.7 % (883.5)%
Non-GAAP effective tax rate22.2 % 16.6 % 20.6 % 20.5 %
GAAP net income $180,969 $139,371 $581,059 $1,616,900
Stock-based compensation28,402 25,229 84,498 73,163
Amortization of intangibles (1)3,314 3,280 9,439 6,525
Acquisition related costs (2) 314 104 17,808
Arbitration award gain (3) (43,403)
Tax impact on non-GAAP adjustments(6,605) (1,093) (19,978) (20,931)
Tax related non-GAAP items (4)22,494 10,763 57,339 (1,485,286)
Non-GAAP net income$228,574 $177,864 $669,058 $208,179
GAAP diluted net income per share$2.28 $1.76 $7.29 $20.45
Non-GAAP diluted net income per share$2.87 $2.25 $8.40 $2.63
Shares used in computing diluted net income per share79,516 79,163 79,677 79,078

Notes:

(1) Amortization of intangible assets related to our exocad acquisition.(2) During 2021, acquisition related costs were for professional fees related to our exocad acquisition. During 2020, acquisition costs included third party advisory, legal, tax, accounting, banking, valuation, and other professional or consulting fees and foreign exchange losses related to a forward contract for the purchase commitment related to our exocad acquisition.(3) During Q1'21, we recorded a $43.4 million gain from the SDC arbitration award regarding the value of Align's capital account balance.(4) During Q1'20, we recorded a one-time net tax benefit for the deferred tax asset and certain costs associated with the intra-entity transfer of certain intellectual property rights and assets to our Swiss subsidiary. For the periods presented, we recorded amortization and certain adjustments to the benefit from the transferred intangible assets of our Swiss entity.

Refer to “About Non-GAAP Financial Measures” section of press release.

ALIGN TECHNOLOGY, INC. FY21 OUTLOOK - GAAP TO NON-GAAP RECONCILIATION

Range
GAAP Operating Margin24.8%to25.2%
Stock-based compensation3.0% 3.0%
Amortization of intangibles (1)0.3% 0.3%
Non-GAAP Operating Margin28.0%to28.5%

(1) Amortization of intangible assets related to our exocad acquisition in 2020

Align TechnologyZeno Group
Madelyn ValenteSarah Johnson
(408) 470-1180(828) 551-4201
[email protected][email protected]

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Source: Align Technology, Inc.

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