Align Technology Announces Second Quarter 2023 Financial Results

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 second quarter ("Q2'23"). Q2'23 total revenues were $1,002.2 million, up 6.3% sequentially and up 3.4% year-over-year. Q2'23 Clear Aligner revenues were $832.7 million, up 5.4% sequentially and up 4.3% year-over-year. Q2'23 Clear Aligner volume was up 5.0% sequentially and up 0.9% year-over-year. Q2'23 Imaging Systems and CAD/CAM Services revenues were $169.5 million, up 10.5% sequentially and down 1.0% year-over-year. Q2’23 Clear Aligner revenues were favorably impacted by foreign exchange of approximately $1.2 million or 0.1% sequentially and unfavorably impacted by approximately $16.3 million or 1.9% year-over-year.⁽¹⁾ Q2'23 Imaging Systems and CAD/CAM Services revenues were favorably impacted by foreign exchange of approximately $0.1 million or 0.1% sequentially and unfavorably impacted by approximately $3.1 million or 1.8% year-over-year.⁽¹⁾ Q2'23 operating income was $171.9 million resulting in an operating margin of 17.2%. Q2'23 operating margin was unfavorably impacted by foreign exchange by approximately 1.1 points year-over-year.⁽¹⁾ Q2'23 net income was $111.8 million, or $1.46 per diluted share. On a non-GAAP basis, Q2'23 net income was $170.4 million, or $2.22 per diluted share.

(1) Non-GAAP measure

Commenting on Align's Q2'23 results, Align Technology President and CEO Joe Hogan said, "Overall, I’m pleased to report another better than expected quarter with Q2 revenues and operating margins that exceeded our guidance. Q2 results reflect improving trends across regions and strength in teen and younger patient volumes, driven by momentum in both submitters and utilization as well as continued growth from Invisalign First™. In the teen segment, which represents the largest portion of the 21 million annual orthodontic case starts, 195 thousand teens and kids started treatment with Invisalign® clear aligners during the second quarter, an increase of 7% sequentially and 10% year-over-year, reflecting the highest annual growth rate in the teen segment since 2021."

Financial Summary - Second Quarter Fiscal 2023

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

As of June 30, 2023, we had over $1.0 billion in cash, cash equivalents and short-term and long-term marketable securities compared to over $921.4 million as of March 31, 2023. In Q2, we completed a $75 million equity investment in Heartland Dental, a multidisciplinary DSO with GP and Ortho practices across the US. As of June 30, 2023, we had $300.0 million available under a revolving line of credit. Currently $1.0 billion remains available for repurchases under the 2023 $1.0 Billion Stock Repurchase Program.

Q2'23 Announcement Highlights

• On June 5, 2023, we announced that Align Technology awarded eleven research grants totaling $275,000 to universities worldwide for advancing orthodontic and dental research under Align's thirteenth Annual Research Award Program. Align is committed to the advancement of the orthodontic and dental fields and we are pleased to continue to support university research around the world. All award applications received were first reviewed and prioritized in a blind evaluation by an independent academic committee. The final recipients were then determined by Align Technology.
• On April 21, 2023, we announced that Align Technology was honored as a “Technology Partner of the Year” by Junior Achievement of Northern California at the Junior Achievement of Northern California 2023 Business Hall of Fame celebration event held in San Francisco. Julie Paulsen, Align Technology vice president, Corporate Social Responsibility, was also nominated as a 2023 “Junior Achievement of Northern California Volunteer of the Year,” chosen along with 11 other volunteers from among 1,000 volunteers.

Fiscal 2023 Business Outlook

For 2023, Align provides the following business outlook:

• For Q3'23, we anticipate our WW Revenue to be in the range of $990M to $1,010M, up approximately 12% year-over-year at the midpoint.
• We expect our Q3’23 GAAP and Non-GAAP operating margin to be slightly up from Q2'23, as we continue to strategically prioritize our investments in R&D and go-to-market activities to drive growth.
• For full year 2023, assuming no circumstances occur that are beyond our control, we anticipate our 2023 WW Revenues to be in the range of $3.970B to $3.990B.
• We also expect our full year 2023 GAAP operating margin to be slightly above 17% and our 2023 Non-GAAP operating margin to be slightly above 21%, a 1-point improvement from the guidance we provided in April 2023.
• For 2023, we expect investments in capital expenditures to be approximately $200M. Capital expenditures are expected to primarily relate to building construction and improvements as well as manufacturing capacity in support of our continued international expansion.

Align Web Cast and Conference Call

We will host a conference call today, July 26, 2023, at 4:30 p.m. ET, 1:30 p.m. PT, to review our second quarter 2023 results, discuss future operating trends, and our 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 833-470-1428 with access code 741941. 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 929-458-6194 with access code 342791. For international callers, please dial 44-204-525-0658 and use the same access code referenced above. The telephonic replay will be available through 5:30 p.m. ET, 2:30 p.m. PT, on August 9, 2023.

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 constant currency net revenues, constant currency gross profit, constant currency gross margin, constant currency income from operations, constant currency operating margin, gross profit, gross margin, operating expenses, income from operations, operating margin, interest income and other income (expense), net, net income before provision for income taxes, provision for income taxes, effective tax rate, net income and/or diluted net income per share, which excludes certain items that may not be indicative of our fundamental operating performance including, foreign currency exchange rate impacts and discrete cash and non-cash charges or gains that are included in the most directly comparable GAAP measure. In Q4'22, we changed to a long-term non-GAAP effective tax rate in our computation of the non-GAAP income tax provision to provide better consistency across reporting periods. Our previous methodology for calculating our non-GAAP effective tax rate included certain non-recurring and period-specific items, that produced fluctuating effective tax rates that management does not believe are reflective of the Company's long-term effective tax rate. This new methodology became effective January 1, 2022 and we recast prior periods in 2022. 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, restructuring and other charges, acquisition-related costs, and arbitration award gain, and associated tax impacts.

Our management believes that the use of certain non-GAAP financial measures provides 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. 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 are 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 as 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 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 herein 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 tables 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 approximately 247 thousand doctor customers and are key to accessing Align’s 500 million consumer market opportunity worldwide. Over the past 26 years, Align has helped doctors treat over 15.7 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.

Invisalign, iTero, exocad, Align, and Align Digital Platform are trademarks of Align Technology, Inc.

Forward-Looking Statements

This news release, including the tables below, contains forward-looking statements, including statements of beliefs and expectations regarding market opportunities, our ability to deliver products and technologies, anticipated clear aligner volumes and ASP, anticipated Systems and Services revenue, our expectations for Q3'23 revenues and GAAP and Non-GAAP operating margin, and 2023 revenues and GAAP and Non-GAAP operating margin, as well as capital expenditures. 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:

• macroeconomic conditions, including inflation, fluctuations in currency exchange rates, rising interest rates, market volatility, weakness in general economic conditions and recessions and the impact of efforts by central banks and federal, state and local governments to combat inflation and recession;
• customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing macro-economic conditions, levels of employment, salaries and wages, debt obligations, discretionary income, inflationary pressure, declining consumer confidence, and the military conflict in Ukraine;
• the economic and geopolitical ramifications of the military conflict in Ukraine, including sanctions, retaliatory sanctions, nationalism, supply chain disruptions and other consequences, any of which may or will continue to adversely impact our operations, assets, and research and development activities inside and outside of Russia;
• variations in our product mix, product adoption, and selling prices regionally and globally;
• competition from existing and new competitors;
• the timing and availability and cost of raw materials, components, products and other shipping and supply chain constraints and disruptions;
• unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
• 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 clear aligners and 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, errors or defects in software or hardware 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;
• expansion of our business and products;
• 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 our systems or networks, including any customer and/or patient data contained therein, for any reason;
• the timing of case submissions from our doctor customers within a quarter as well as an increased manufacturing costs per case;
• foreign operational, political, military and other risks relating to our 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, 2022, which was filed with the Securities and Exchange Commission ("SEC") on February 27, 2023, and our latest Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, which was filed with the SEC on May 5, 2023. 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
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