Align Technology Announces Record Third Quarter 2021 Financial Results

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

• Q3 total revenues up 38.4% year-over-year to record $1.016 billion and up 0.5% sequentially
• Q3 diluted net income per share of $2.28; Q3 non-GAAP diluted net income per share of $2.87
• Q3 operating margin of 25.7%, down 0.9 points sequentially and up 1.6 points year-over-year
• Q3 Clear Aligner volume for teens up 26.6% year-over-year to a record 206.0 thousand cases and up 13.8% sequentially
• Q3 Imaging Systems and CAD/CAM Services record revenues of $178.3 million, up 57.3% year-over-year and up 5.0% sequentially

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

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

• On October 27, 2021, we announced the findings of a multi-center clinical study, “Reflected near-infrared light versus bite-wing radiography for the detection of proximal caries: a multicenter prospective clinical study conducted in private practices,” published in the Journal of Dentistry (Oct. 24, 2021) which validates and further demonstrates the significant benefits of the iTero Element 5D imaging system as an aid in detection and monitoring of interproximal caries lesions above the gingiva without harmful radiation.

Q3'21 Announcement Highlights:

Corporate

• On July 21, 2021, we announced our new offices in Israel to support long term growth for the iTero scanner and services business which are atop one of the three high-rise buildings that make up the “Global Towers” in Petach Tikva, Israel.
• On July 20, 2021, we announced our plans to showcase our digital portfolio at the International Dental Show 2021 (IDS) in Cologne, Germany on September 22-25, 2021. Together, the Align and exocad booths represented our biggest IDS exhibition space to date, showcasing our many innovative products and services.

Product

• On August 2, 2021, we announced an exclusive supply and distribution agreement with Ultradent Products Inc., a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. As part of the multi-year agreement, Align will begin offering Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula from Ultradent, optimized for use with Invisalign clear aligners and Vivera retainers.

FY 2021 Business Outlook

For 2021, Align provides the following guidance:

• Net revenues are expected to be in the range $3.90 billion to $3.95 billion, up approximately 58% to 60% over full-year 2020. We also expect revenue growth for the second half of 2021 to be at the high end of our long-term operating model target of 20% to 30%
• On a GAAP basis, we anticipate our 2021 operating margin to be around 25.0%
  • Non-GAAP operating margin is expected to be approximately 3 points higher than GAAP operating margin for 2021
• In addition, during Q4'21 we expect to repurchase up to $100 million of our common stock through either or a combination of open market repurchases or an accelerated stock repurchase agreement

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 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, inflation 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 intraoral 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 primary 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, labor shortages or work stoppages for us or our suppliers.

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)

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

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

ALIGN TECHNOLOGY, INC.
INVISALIGN BUSINESS METRICS

* # 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)

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

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

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

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