Align Technology Q1 2024 Earnings Report

Align Technology EPS Results

• Actual EPS: $1.62
• Consensus EPS: $1.54
• Beat/Miss: Beat by +$0.08
• One Year Ago EPS: N/A

Align Technology Revenue Results

• Actual Revenue: $997.43 million
• Expected Revenue: $971.97 million
• Beat/Miss: Beat by +$25.46 million
• YoY Revenue Growth: N/A

Align Technology Announcement Details

• Quarter: Q1 2024
• Date: 4/24/2024
• Time: N/A
• Conference Call Date: Wednesday, April 24, 2024
• Conference Call Time: 4:30PM ET

Align Technology (NASDAQ:ALGN) (NASDAQ: ALGN) pioneered the use of digital technology in orthodontics through the development of the Invisalign system, a series of clear, removable aligners that provide an alternative to traditional metal braces. Since its founding in 1997 by Zia Chishti and Kelsey Wirth, the Tempe, Arizona–based company has expanded its focus to include intraoral scanners, CAD/CAM software for dental laboratories and comprehensive digital dentistry solutions.

The company’s signature Invisalign system leverages 3D imaging and computer-aided design (CAD) to create customized aligners that gradually reposition teeth, improving patient comfort and treatment predictability. Align’s iTero intraoral scanners capture high-resolution digital impressions, streamlining treatment planning and reducing the need for conventional molds. In 2019, Align further broadened its digital portfolio with the acquisition of exocad, augmenting its software capabilities for dental labs to design restorations, prosthetics and orthodontic appliances.

Today, Align Technology serves dental professionals in more than 100 countries through a combination of direct sales offices and distributor partnerships. The company maintains manufacturing facilities in the United States and other strategic locations to meet global demand and ensure product consistency. With ongoing investments in research and development, Align continues to enhance its clinical applications, expand digital workflows and introduce patient engagement tools aimed at improving outcomes and practice efficiency worldwide.

Align Technology Q1 2024 Earnings Call Transcript

Key Takeaways

• Better-than-expected Q1 results: Total worldwide revenues grew 5.8% YoY to $997.4 M, led by 3.5% Clear Aligner and 17.5% Systems & Services growth.
• Clear aligner volumes rose across all regions, with teen and younger patient starts up 5.8% YoY and DSP touch-up cases up 49%, reflecting expanded consumer and DSO demand.
• Major product milestones achieved, including acquisition of Cubicure for next-gen 3D printing, launch of the iTero Lumina intraoral scanner, and rollout of the Invisalign Palate Expander.
• 1Q24 operating margin contracted to 15.5%, down 2.5 points sequentially, as the company increased consumer marketing and incentive compensation.
• 2024 outlook upgraded: Full-year revenue now expected to grow 6–8% vs. 2023, with both segments contributing roughly equally to incremental growth.

Presentation

[Operator]

Greetings. Welcome to the Align first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note, this conference is being recorded. I will now turn the conference over to your host, Shirley Stacy, with Align Technology. You may begin.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Good afternoon, and thank you for joining us. I'm Shirley Stacy, Vice President of Corporate Communications and Investor Relations. Joining me for today's call is Joe Hogan, President and CEO, and John Morici, CFO. We issued first quarter 2024 financial results today via Business Wire, which is available on our website at investor.aligntech.com. Today's conference call is being audio webcast and will be archived on our website for approximately one month. As a reminder, the information provided and discussed today will include forward-looking statements, including statements about Align's future events and product outlook. These forward-looking statements are only predictions and involve risks and uncertainties that are described in more detail in our most recent periodic reports filed with the Securities and Exchange Commission, available on our website at sec.gov. Actual results may vary significantly, and Align expressly assumes no obligation to update any forward-looking statement.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

We have posted historical financial statements with corresponding reconciliations, including our GAAP to non-GAAP reconciliation, if applicable, and our first quarter 2024 conference call slides on our website under Quarterly Results. Please refer to these files for more detailed information. With that, I'll turn the call over to Align Technology's President and CEO, Joe Hogan. Joe?

[Joe Hogan, President and CEO at Align]

Thanks, Shirley. Good afternoon, and thanks for joining us on our call today. I'll provide an overview of our first quarter results and discuss a few highlights from our two operating segments, Systems and Services and Clear Aligners. John will provide more detail on our Q1 financial performance and comment on our views for the second quarter in 2024 in total. Following that, I'll come back and summarize a few key points and open the call to questions. I'm pleased to report better-than-expected revenue and earnings for the first quarter and a solid start to the year. For Q1, total worldwide revenues were up 5.8% year-over-year, reflecting 3.5% growth from our clear aligner segment and 17.5% growth from systems and services.

[Joe Hogan, President and CEO at Align]

On a year-over-year basis, Q1 revenue growth was up across all regions and was driven by strong clear aligner volumes, primarily in the Asia Pacific region. Year-over-year growth also reflects strength in the orthodontic channel, with total Invisalign case starts from teens and younger patients up 5.8% year-over-year, driven by continued momentum across all regions, from Invisalign First, as well as Invisalign DSP touch-up cases. On a sequential basis, Q1 total revenues were up 4.3%, reflecting a sequential increase in clear aligner revenues, especially for North American orthodontists, as well as strong systems and services revenues, primarily driven by iTero Lumina wand upgrades in North America. During the quarter, we achieved several significant milestones. We completed the acquisition of Cubicure, a leader in direct 3D printing solutions, which is the foundation for our next-generational aligner manufacturing.

[Joe Hogan, President and CEO at Align]

We successfully launched the iTero Lumina intraoral scanner, our next-generation of digital scanning technology. We launched the Invisalign Palatal Expander, or IPE system, in the U.S. and Canada, and received regulatory approval for the Invisalign Palatal Expander in Australia and New Zealand. Q1 systems and services revenue year-over-year growth reflects non-systems revenues, driven by iTero Lumina wand upgrades and higher scanner volumes and increased services revenue from a larger base of scanners sold. On a sequential basis, Q1 systems and services revenue were up 3.1%, reflecting growth from non-systems revenues and higher scanner ASPs, partially offset by lower volumes due to seasonality, a strong fourth quarter. The iTero Lumina intraoral scanner is available now with orthodontic workflows as a new stand-alone scanner or as a wand upgrade to iTero Element 5D Plus.

[Joe Hogan, President and CEO at Align]

The restorative workflow is expected to be available in the fourth quarter of 2024. In the meantime, GP practices can benefit from the iTero Lumina's new Multi-Direct Capture technology that replaces the confocal imaging technology in earlier models. The iTero Lumina intraoral scanner has a 3x wider field of capture and a 50% smaller and 45% lighter wand, delivering faster scanning speed, higher accuracy, super visualization, and more comfortable scanning experience. Overall, we're really pleased with the launch of the iTero Lumina scanner. Customer feedback has been positive, and we're really excited about the feedback from doctors, so we've included some great verbatims in our webcast slides. Q1 total clear aligner revenues were up year-over-year, reflecting revenue growth across the regions from strong year-over-year volume growth across APAC markets, as well as the EMEA region.

[Joe Hogan, President and CEO at Align]

For the Americas region, Q1 clear aligner volume was consistent with prior year. For Q1, total clear aligner shipments were up 2.1% sequentially, reflecting seasonality, with increased volumes in the Americas regions offset somewhat by EMEA and APAC regions. For Q1, clear aligner shipments include over 23,000 Invisalign doctor subscription cases, or DSP touch-up cases, primarily from North America ortho channel, an increase of approximately 49% year-over-year from Q1 2023. These DSP touch-up cases are a component of the overall DSP program, which consists of retainers and touch-up cases or aligners, and it continues to be an important offering for our customers and their patients. DSP is currently available in the United States, Canada, Iberia, Nordics, the UK, and most recently in Italy, France, and Poland.

[Joe Hogan, President and CEO at Align]

We expect to continue expanding DSP into other country markets in EMEA in Q2, including a 14-stage touch-up aligner offering. For non-case revenues, Q1 was up 7.5% year-over-year, primarily due to continued growth from Vivera retainers, along with Invisalign DSP retainer revenues.... In a teen market, nearly 200,000 teens and younger patients started treatment with Invisalign clear aligners in Q1, up 5.8% year-over-year. This represents a record number of teen cases shipped as compared to prior quarters, reflecting strength in APAC and EMEA. Teen starts were up sequentially 1.2%, reflecting strength in EMEA and North America, offset by seasonally fewer teen starts in China.

[Joe Hogan, President and CEO at Align]

While the teen market tends to be less susceptible to consumer demand around discretionary spending and more resilient than adult orthodontic case starts, we're pleased that in Q1, our clear aligner volumes for both adults and teens were up sequentially and year-over-year. We believe the Invisalign Palatal Expander System is one of the most exciting innovations we've developed in our 27-year history, and is a better option for expanding a growing patient's narrow palate. Initial response from doctors and patients for Invisalign Palatal Expander System is positive. Invisalign Palatal Expander System is not a traditional Invisalign aligner. It's a series of direct 3D printed orthodontic appliances based on proprietary and patented technology that has four systems designed for skeletal expansion. Clinical data shows that Invisalign Palatal Expander System is safe, effective, and proven to deliver skeletal expansion.

[Joe Hogan, President and CEO at Align]

Specifically, our clinical data is based on 49 patients across the United States and Canada between the ages of 6.9-11, with a mean age of 8.8 years. In this group, the mean expansion of 6 mm was achieved with minimal tipping, with ranges between 3.4 mm-10.7 mm, as measured using the change in intermolar width between the initial and post-expansion scans, with a mean expansion efficacy of 97%. In addition, we found that surveyed doctors agree the Invisalign Palatal Expander is less painful than traditional expanders and facilitates better oral hygiene compared to traditional metal expanders. Phase one or early interceptive treatment includes both skeletal, orthopedic, and dental orthodontic arch expansion and makes up to 20% of the orthodontic case starts each year.

[Joe Hogan, President and CEO at Align]

Combined with Invisalign First aligner treatment, Invisalign Palatal Expanders provide doctors with a full early interceptive treatment solution that allows doctors to treat all phase one patients. We expect the Invisalign Palatal Expander to be available in other markets, pending future applicable regulatory approvals. Today, Invisalign is the most recognized orthodontic brand globally, and Invisalign clear aligner treatment is faster and more effective than traditional metal braces. Yet the underlying market opportunity remains huge and untapped. We continue to invest in consumer marketing and demand creation initiatives that raise awareness and drive potential patients to Invisalign practices globally. Below are several highlights from Q1, and more information is available in our Q1 2024 earnings webcast slides. In Q1 2024, we delivered 414.5 billion impressions and had 43 million visits to our websites globally.

[Joe Hogan, President and CEO at Align]

To increase awareness and educate young adults, parents, and teens about the benefits of the Invisalign brand, we continue to invest and create campaigns in top media platforms such as TikTok, Instagram, YouTube, Snapchat, and WeChat across markets. Reaching young adults as well as teens and their parents also requires the right engagement to Invisalign influencers and creator-centric campaigns. Our Teen Invis Drama Free campaign was recently recognized by the Association of National Advertisers with a Silver Award in the Reggie Awards for Creative and Strategic Excellence. In the U.S., in addition to our ongoing influencer campaigns, we partner with athletes such as Maxx Crosby, TikTok Gen Z influencer, Overtime Meg, and the famous fashion designer, Kristin Juszczyk, to create a compelling brand activation at the Super Bowl.

[Joe Hogan, President and CEO at Align]

Our campaigns delivered more than 6.1 billion impressions and 18.1 million unique visitors to our consumer websites across the Americas. In the EMEA region, we partner with influencers to reach consumers across social media platforms, including TikTok and Meta, and launched our global consumer campaigns for teens and parents. Our campaigns delivered more than 1.6 billion media impressions and 8.9 million visitors to our website. We continue to invest in consumer advertising across the APAC region, resulting in more than 6.6 billion impressions and 16 million visitors to our websites, a 195% increase year-over-year. We expanded our reach in Japan and India via Meta and YouTube, and partnered with key influencers to reach consumers across social media.

[Joe Hogan, President and CEO at Align]

We saw increased brand interest from consumers, as evidenced by a 285% year-over-year increase in unique visitors to our website in India and a 129% increase in Japan. Finally, digital tools such as My Invisalign Consumer and Patient app continue to increase, with 4 million downloads to date and over 381,000 monthly active users, 51.5% year-over-year growth rate. Q1 2024 clear aligner volume from DSO customers increased sequentially, reflecting growth from Americas and in major EMEA regions, and increased year-over-year, reflecting growth across international regions. Dental service organizations, or DSOs, represent a large and growing opportunity to help drive adoption of digital technology across the dental industry.

[Joe Hogan, President and CEO at Align]

We have established relationships with many DSOs globally that recognize the benefits of digital workflows, enabled by our portfolio of products and services that make up the Align Digital Platform, including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter cycle times and proximity to their customers. Smile Doctors and Heartland Dental are some of the largest DSO partners and are continuously exploring collaborations with DSOs that can further adoption of digital dentistry. Each DSO has a different strategy and business model, and our focus is on working with the and encouraging DSOs, aligned with our vision, strategy, and business model goals. Today, we announced an additional $75 million equity increase in Heartland. Following the previous $75 million equity investment a year ago, Heartland is a multidisciplinary DSO with GP and ortho practices across the United States.

[Joe Hogan, President and CEO at Align]

Their growth strategy includes Heartland's de novo dental practices, which feature modern technology, located in areas with a strong community need for dentistry, where Heartland provides practices with opportunities for mentorship, leadership training, and continuing education. In the last four years, Heartland opened 240 state-of-the-art de novo practices across the U.S. and are planning to continue investing through more de novo openings. We have a shared sense of purpose with Heartland. Their mission is to help doctors and their teams deliver the highest quality digital dental care to the communities they serve. With that, I'll now turn it over to John.

[John Morici, CFO at Align]

Thanks, Joe. Now for our Q1 financial results. Total revenues for the first quarter were $997.4 million, up 4.3% from the prior quarter and up 5.8% from the corresponding quarter a year ago. On a constant currency basis, Q1 2024 revenues were impacted by favorable foreign exchange of approximately $10 million, or approximately 1% sequentially, and were unfavorably impacted by approximately $4.8 million year-over-year, or approximately 0.5%. For clear aligners, Q1 revenues of $817.3 million were up 4.5% sequentially, primarily from higher ASPs and higher volumes. On a year-over-year basis, Q1 clear aligner revenues were up 3.5%, primarily due to higher volumes and ASPs and increased non-case revenues.

[John Morici, CFO at Align]

For Q1, Invisalign ASPs for comprehensive treatment were up sequentially and up year-over-year. On a sequential basis, ASPs primarily reflect higher additional aligners and price increases and the variable impacts of foreign exchange, partially offset by a product-mix shift to lower ASP products. On a year-over-year basis, the increase in comprehensive ASPs primarily reflect higher additional aligners and price increases, partially offset by a product-mix shift to lower ASP products and higher discounts, and the unfavorable impact from foreign exchange. For Q1, Invisalign ASPs for non-comprehensive treatment were down sequentially and year-over-year. On a sequential basis, the decline in ASPs reflect unfavorable country-mix shift and higher discounts, partially offset by the favorable impact from foreign exchange.

[John Morici, CFO at Align]

On a year-over-year basis, the decrease in non-comprehensive ASPs reflect the product mix shifts to lower ASP products, unfavorable country mix shift, and higher discounts, partially offset by lower net revenue deferrals. As a reminder, we announced about a 5% global price increase for some Invisalign products across most markets, effective January 1st, 2024. This price increase did not include Invisalign Comprehensive 3-Year product. Invisalign Comprehensive 3-Year product is available in North America and in certain markets in EMEA and APAC, most recently launching in French territories and in the Middle East.

[John Morici, CFO at Align]

We are pleased with the continued adoption of the Invisalign Comprehensive 3-Year product and anticipate it will continue increasing, providing doctors the flexibility they want and allowing us to recognize more revenue upfront, with deferred revenue being recognized over a shorter period of time compared to our traditional Invisalign Comprehensive product. Q1 2024 clear aligner revenues were impacted by a favorable foreign exchange of approximately $8.4 million, or approximately 1% sequentially. On a year-over-year basis, clear aligner revenues were unfavorably impacted by foreign exchange of approximately $3.9 million, or approximately 0.5%. Clear aligner deferred revenues on the balance sheet decreased $26.7 million, or 2% sequentially, and increased $15.8 million, or 1.2% year-over-year, and will be recognized as the additional aligners are shipped.

[John Morici, CFO at Align]

Q1 2024 systems and services revenue of $180.2 million were up 3.1% sequentially, primarily due to increased non-systems revenues, mostly related to upgrades and higher ASPs, partially offset by lower volumes. Q1 2024 Systems and Services revenue were up 17.5% year-over-year, primarily due to increased non-systems revenues, mostly related to upgrades, higher scanner volumes, and higher services revenues from our larger base of scanners sold. CAD/CAM and Services revenue for Q1 represents approximately 51% of our Systems and Services business. Q1 2024 Systems and Services revenues were favorably impacted by foreign exchange of approximately $1.5 million, or approximately 0.9% sequentially. On a year-over-year basis, Systems and Services revenues were unfavorably impacted by foreign exchange of approximately $0.9 million, or approximately 0.5%.

[John Morici, CFO at Align]

Systems and services deferred revenues on the balance sheet was down $14.3 million, or 5.5% sequentially, and down $25.3 million, or 9.4% year-over-year, primarily due to the recognition of services revenues, which is recognized ratably over the service period. The decline in deferred revenues, both sequentially and year-over-year, reflects the shorter duration of service contracts with initial scanner purchases. As our scanner portfolio expands and we introduce new products, we increase the opportunities for customers to upgrade and make trade-ins, in addition to other scanner leasing and rental programs. Developing new capital equipment opportunities to meet the digital transformation needs of our customers and our DSO partners is a natural progression for our equipment business with a large and growing base of scanners sold. We're pleased to be able to leverage our.

[John Morici, CFO at Align]

Technological innovations and operational capabilities and efficiencies to provide different types of go-to-market models to our customers, such as rentals and leasing, selling the way our customers want to buy. Moving on to gross margin. First quarter overall gross margin was 70%, approximately flat sequentially and year-over-year. Overall gross margin was favorably impacted by foreign exchange by approximately 0.3 points sequentially, and unfavorably impacted by approximately 0.1 points on a year-over-year basis. Clear aligner gross margin for the first quarter was 70.9%, down 0.3 points sequentially, primarily due to higher manufacturing spend, partially offset by higher ASP. Clear aligner gross margin for the first quarter was down 0.8 points year-over-year, primarily due to higher manufacturing spend, partially offset by favorable ASP.

[John Morici, CFO at Align]

Systems and services gross margin for the first quarter was 65.9%, up 1.1 points sequentially due to higher ASP, partially offset by manufacturing variances. Systems and services gross margin for the first quarter was up 4.3 points year-over-year, primarily due to higher ASP, lower service and manufacturing costs. Q1 operating expenses were $543.7 million, up 9.2% sequentially and 3.1% year-over-year. On a sequential basis, operating expenses were up by $45.7 million from higher incentive compensation and consumer marketing spend, partially offset by restructuring and other charges not recurring in Q1. Year-over-year, operating expenses increased by $16.5 million, primarily due to our continued investments in sales and R&D activities and higher incentive compensation.

[John Morici, CFO at Align]

On a non-GAAP basis, excluding stock-based compensation, amortization of acquired intangibles related to certain acquisitions, and restructuring and other charges, operating expenses were $506.1 million, up 13.3% sequentially, and up 3.2% year-over-year. Our first quarter operating income of $154.1 million resulted in an operating margin of 15.5%, down 2.5 points sequentially and up 1.3 points year-over-year. The sequential decrease in operating margin is primarily attributed to investments in our go-to-market teams and higher incentive compensation. The year-over-year increase in operating margin is primarily attributed to operating leverage and proactively managing our costs, partially offset by unfavorable impact from foreign exchange of approximately 0.7 points.

[John Morici, CFO at Align]

On a non-GAAP basis, which excludes stock-based compensation, amortization of intangibles related to certain acquisitions, and restructuring and other charges, operating margin for the first quarter was 19.8%, down 4 points sequentially and up 1.3 points year-over-year. Interest and other income expense, net for the first quarter was an income of $4.3 million, compared to an income of $1.3 million in Q4 of 2023, and an income of $1.1 million in Q1 of 2023, primarily driven by a gain on our equity investments and net interest income, and offset by unfavorable foreign exchange. The GAAP effective tax rate in the first quarter was 33.7%, compared to 28.3% in the fourth quarter and 34.8% in the first quarter of the prior year.

[John Morici, CFO at Align]

The first quarter GAAP effective tax rate was higher than the fourth quarter effective tax rate, primarily due to discrete tax benefits recognized in Q4 of 2023, partially offset by increased earnings in low tax jurisdictions in Q1 of 2024. Our non-GAAP effective tax rate in the first quarter was 20%, which reflects our long-term projected tax rate. First quarter net income per diluted share was $1.39, down sequentially $0.24, and up $0.26 compared to the prior year. Our EPS was not impacted on a sequential basis from foreign exchange. Our EPS was unfavorably impacted by $0.09 on a year-over-year basis to foreign exchange. On a non-GAAP basis, net income per diluted share was $2.14 for the first quarter, down $0.28 sequentially and up $0.32 year-over-year. Moving on to the balance sheet.

[John Morici, CFO at Align]

As of March 31st, 2024, cash, cash equivalents, and short-term and long-term marketable securities were $902.5 million, down sequentially $78.2 million, and down $18.9 million year-over-year. Of our $902.5 million balance, $217.5 million was held in the U.S., and $685 million was held by our international entities. In January 2024, we received approximately 37,000 shares of our common stock upon final settlement of the $250 million accelerated share repurchase from Q4 of 2023. In total, we repurchased approximately 1.1 million shares at an average price per share of $230.13 under the Q4 ASR contract.

[John Morici, CFO at Align]

We have $650 million available for repurchase of our common stock under our January 2023 repurchase program. During Q2 2024, we expect to repurchase up to $150 million of our common stock through either a combination of open market repurchase or an accelerated stock repurchase agreement. Q1 accounts receivable balance was $950.7 million, up sequentially. Our overall days sales outstanding was 86 days, up approximately one day sequentially, and up approximately three days as compared to Q1 last year. Cash flow from operations for the first quarter was $28.7 million. Capital expenditures for the first quarter were $9.4 million, primarily related to our continued investments to increase aligner manufacturing capacity and facilities. Free cash flow, defined as cash flow from operations less capital expenditures, amounted to $19.3 million.

[John Morici, CFO at Align]

We're continuing to use our healthy balance sheet to drive growth and profitability. During the quarter, we continued to make disciplined investments in our strategic growth drivers. We completed the acquisition of Cubicure, which will enable us to scale our 3D printing operations to eventually direct print millions of custom appliances per day, and we exited the quarter with a healthy cash flow position and no long-term debt, maintaining a strong position to support our additional $75 million investment in our DSO partner, Heartland Dental, and $150 million stock buyback. Now turning to our outlook. Assuming no circumstances occur beyond our control, we provide the following framework for Q2 and fiscal 2024. For Q2 2024, we provide the following business outlook. For Q2 2024, we expect worldwide revenues to be in the range of $1.03 billion-$1.05 billion.

[John Morici, CFO at Align]

We expect clear aligner volume to be up sequentially and clear aligner ASP to be down slightly sequentially, primarily as a result of unfavorable foreign exchange. We expect systems and services revenue to be up sequentially as we continue to ramp iTero Lumina in Q2 2024. We expect Q2 2024 GAAP operating margin and non-GAAP operating margin to be slightly above Q1 2024 GAAP and non-GAAP operating margins, respectively. For fiscal 2024, we provide the following business outlook: We expect fiscal 2024 total revenue to be up 6%-8% versus 2023, which is higher than our prior outlook of up mid-single digit growth compared to 2023. The increase in our 2024 revenue outlook reflects our Q1 results, Q2 outlook, and continued execution of our growth strategies.

[John Morici, CFO at Align]

We anticipate that the incremental revenue reflected in our 2024 outlook will be roughly split 50/50 between our two operating segments. We expect fiscal 2024 clear aligner ASPs to be slightly up year-over-year. We expect fiscal 2024 GAAP operating margin and non-GAAP operating margin to be slightly above the 2023 GAAP operating margin and non-GAAP operating margin, respectively. We expect our investments in capital expenditures for fiscal 2024 to be approximately $100 million. Capital expenditures primarily relate to building construction and improvements, as well as manufacturing capacity in support of our continued expansion. With that, I'll turn it back over to Joe for final comments. Joe?

[Joe Hogan, President and CEO at Align]

Thanks, John. In summary, Q1 was a good start for the year. While I'm pleased with our results, I'm even more excited about Align's innovation in 2024 and our next wave of growth drivers that we believe will continue to revolutionize the orthodontic and dental industry in scanning, software, and direct 3D printing. Our focused execution of our product roadmap and innovation pipeline has resulted in the largest introduction of new products and technologies in our history, further advancing our software, scanning, and 3D printing capabilities. We're excited about the potential for these strategic investments to enable a new phase of growth to transform the orthodontic industry again.

[Joe Hogan, President and CEO at Align]

The iTero Lumina intraoral scanner has the potential to set a new standard of care for dental practices by simplifying the scanning of complex oral regions while offering superior chairside visualization and a more comfortable experience for patients, especially kids. The Invisalign Palatal Expander increases the clinical applicability of the Invisalign System to nearly 100% of orthodontic case starts. It is a revolutionary, removable, 3D-printed appliance that is clinically proven to be safe and effective. It is less painful than traditional metal expanders and promotes better oral hygiene. Our recent acquisition of Cubicure, a pioneer of 3D printing solutions for polymer additive manufacturing, brings a talented team and unique cutting-edge technology into Align to help us scale our 3D printing operations, providing ultimate design freedom and highly customized outcomes from a customer and patient standpoint, as well as operational benefits to the business.

[Joe Hogan, President and CEO at Align]

We see incredible opportunities in this business and continue to make the Invisalign System the standard of care in orthodontics. By continually innovating and developing digital technologies and services that enable more doctors to easily diagnose and treat patients with crooked teeth and help them retain their healthy, beautiful smiles, we're increasing access to care for millions of people who might not otherwise receive orthodontic treatment. With that, I thank you for your time today. We look forward to sharing our continued progress in leading the digital transformation of the orthodontic and restorative dental industry. I'll now turn the call over to the operator for your questions. Operator?

[Operator]

Thank you. At this time, we'll be conducting a question-and-answer session. If you would like to ask a question, please press Star one one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star one one if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star keys. One moment, please, while we pull for questions.

[Operator]

Our first question comes from Elizabeth Anderson with Evercore ISI. You may proceed.

[Elizabeth Anderson, Senior Managing Director at Evercore ISI]

Hi, guys. Thanks so much for the question. I was wondering if you could talk about how you're seeing the overall demand environment. I guess I'm particularly curious about the U.S., sort of how you're seeing it from, like, a consumer demand perspective, especially, and any comments you could make on the SmileDirect impact on volumes in the quarter. And then secondarily, if you could comment a little bit more on the broader demand environment in China, that would be super helpful. Thank you.

[Joe Hogan, President and CEO at Align]

Hey, Elizabeth, I'll start off and have John jump in on anything. First of all, you know, we describe the business right now as stable. It's the same things that we talked about, you know, as we came out of the fourth quarter, and we see that stability, you know, broadly around the globe. You saw in our script that we just read, too, that it's good from an adult standpoint and also a teen standpoint, too, which, again, lends to that kind of stability that we talk about. If I look around the world, I mean, that stability exists, you know, whether it's in Asia, whether we've seen it in parts of Europe, and we see it in the United States and in the Americas also.

[Joe Hogan, President and CEO at Align]

So, it's hard for us to call out a particular region or whatever that is dramatically down or dramatically up. We just see them moving pretty much in unison, in the first quarter. John, would you add anything?

[John Morici, CFO at Align]

No, I agree. And that's, you know, we're driving the growth strategies. As we've said, we've seen that stability in the environment, and we're executing against that.

[Joe Hogan, President and CEO at Align]

And Elizabeth, last thing on your SmileDirectClub comment, you know, and them not being, you know, advertising like they were before, or whatever. We can't attribute, you know, any part of the demand equation up or down as part of that. And, you know, obviously that was more pronounced in the United States than it was anywhere else in the world, but I can't attribute any change in the marketplace because of them not advertising it at this point in time.

[Elizabeth Anderson, Senior Managing Director at Evercore ISI]

Great. Great to hear. Thank you so much. Appreciate the commentary.

[Joe Hogan, President and CEO at Align]

Thanks, Elizabeth.

[Operator]

Thank you. One moment for questions. Our next question comes from Brandon Vazquez with William Blair. You may proceed.

[Brandon Vazquez, Research Analyst at William Blair]

Hi, everyone. Thanks for taking the question. I wanted to focus for a second on the, on the teen side. You know, you have the palatal expander out there now, getting great reviews, and it, it seems like it closes, if I'm understanding the numbers correctly, maybe 20% of that market that you haven't been able to hit before. This is such a big opportunity. I'm curious if you can just reflect on, like, how does commercialization within teens look in the next couple of years now that you have kind of a, a broader and more full portfolio here, compared to the prior couple of years? And what does that mean for growth rates within that teen section and adoption within teen that's under-penetrated relative to teens as we look forward the next couple of years? Thanks.

[Joe Hogan, President and CEO at Align]

That's a good question, Brandon. You know, I think, you know, we, as I mentioned, it's 20%, and there's, we don't, you know, we call them tweens, really. They're young students, you know, before they really hit the teen years and have, you know, mature dentition. With Invisalign First, and now with IPE, we can handle the 20% that's out there on the phase one. And, you know, some teens just need, the tweens just need dental expansion, and some you really have to split the suture and widen the palate overall. We feel in both those cases, with IPE and Invisalign First, these are very unique products, specific to that area.

[Joe Hogan, President and CEO at Align]

And then we think it'll actually make doctors that aren't comfortable with phase one, maybe even more comfortable now because of the impact on patients is not, you know, what it was before when you tried to work these kinds of cases with wires and brackets or Hyrax expanders and those kinds of things. But like anything in the orthodontic community, it takes time. It takes time for acceptance, and the good thing about this is IPE is about a 30-35-day kind of an episode, so our feedback loop is really good. You could tell from my transcript also is, you know, right now, we're approved in the United States and Canada and recently in ANZ, and right now we're throttled by the regulatory procedures we have to go throughout the world.

[Joe Hogan, President and CEO at Align]

So we'll be able to give you more specificity on this, Brandon, as we go forward. But as I mentioned in my closing, too, we're really excited about that technology, and we didn't tie it together. The new Lumina scanner has such a broad kind of a bandwidth from a scanning standpoint. It scans that palate that you have to cover with Invisalign First extremely well. So those technologies thread together very well out there. So we're excited about it and more to come.

[Operator]

Thank you. One moment for questions. Our next question comes from Jon Block with Stifel. You may proceed.

[Joe Hogan, President and CEO at Align]

Thanks, Scott.

[Jon Block, Managing Director and Senior Analyst at Stifel]

Hey, Joe. Good afternoon. Hoping to ask 2, maybe just the first one. You know, throughout the quarter, there was sort of like an obsession or a big focus from investors on month-to-month trends. There was talk about February strength, March weakness. I don't think if anyone really knew if it was the consumer or the calendar or both. So, you know, maybe you guys can talk a little bit about how it played out for you guys, elaborate on February and March, and then as much as you can, just touch on April here for the first, you know, 2-3 weeks, and then I'll ask my follow-up. Thanks.

[John Morici, CFO at Align]

Yeah, Jon, this is John. You know, look, as we talk about the quarter and think about, we're very pleased with our results in Q1. We saw stability, as Joe mentioned, and that really continued from the end of the year into the quarter, less about month-to-month. I mean, it was the stability and then the execution that we had throughout the quarter with our products.

[Jon Block, Managing Director and Senior Analyst at Stifel]

Okay. And then I'll just shift gears. John, I might stick with you. I believe the wording of slightly above, you know, the 2023 OM, which I think is 21.4%, is unchanged, despite the higher revenues, you know, the midpoint going from roughly 5% to 7%. So can you talk about where that extra spend is going? Do we see the returns on that this year, or will that aid and give you some more tailwinds into 2025? And then just to tack on to that, you know, the new higher guidance doesn't imply sort of 6% in the back part of this year, year-over-year growth, which isn't too dissimilar from 1H. But the comps get more difficult, so the stacks need to accelerate. Why should we be comfortable with that?

[Jon Block, Managing Director and Senior Analyst at Stifel]

Is that just an accelerating contribution from some of those new products like Lumina and IPE? Thanks, guys.

[John Morici, CFO at Align]

I think that latter point is how I would look at it, John. You know, we're making investments. We make investments throughout the year. We get, you know, the shorter, longer-term investments that we make, different returns on whether they're short or long-term. But, you know, what we see is a stable environment, continued investments in go-to-market activities. We have new products coming, so that helps us accelerate with things that we'll have on the iTero side as well as IPE and others that Joe talked about, where we really get the approval later in the year. So, you know, it's about a stable environment, making investments into that environment, and then executing on our growth strategy. And that should give us the benefits that you described in the second half.

[Operator]

Thank you. One moment for questions. Our next question comes from Jeff Johnson with Baird. You may proceed.

[Joe Hogan, President and CEO at Align]

Hi, Jeff.

[Jeff Johnson, Senior Research Analyst at Baird]

Thank you. Good afternoon, guys. Hey, guys, how are you? So, John, maybe following up on, on Jon's question there, and just a little finer point on, on the guidance itself. You know, you, you've taken that guidance from mid-single digits to 6-8. Scanner and CAD/CAM services came in, obviously, you know, strongly in the double-digits, upper teens. Should we think about kind of that double-digits, maybe not the upper teens, but double-digits is kind of where the, the scanner and services continues this year, and your, your clear aligner revenue guidance kind of still in the mid-single digits? I think last quarter we were talking about both those segments being mid-single digit growers. It seems like to me now, maybe the raise here is being driven more by the scanner and CAD/CAM services.

[Jeff Johnson, Senior Research Analyst at Baird]

And as Joe calls the market stable, then maybe the clear aligner revenue is still kind of expected to be in that mid-ish single-digits. Is that a fair kind of way to look at guidance?

[John Morici, CFO at Align]

That's, that's a fair way to look at it, Jeff. I mean, you know, given the new products that we have and with Lumina and iTero, we'll see a little bit faster growth. We're very pleased with what we saw in the first quarter. Typically, in the first quarter, you don't have a sequential gain in revenue from the fourth quarter, being an equipment business, so we're very pleased with what we saw there. But then we also look at the clear aligner business, and we expect to be able to grow and continue to grow there, both in terms of the investments that we're making in a relatively stable environment and some of the new products that should help supplement that growth.

[Jeff Johnson, Senior Research Analyst at Baird]

Yeah, that's helpful. And then one other follow-up. I think it's been asked in the past, maybe at an analyst day or something, but I don't remember if you've given a clear answer. But it's something I keep getting asked here more recently, and that's a percentage of your patient base or of maybe orthodontic cases that get financed through some sort of third-party patient financing company. You know, we have seen in areas like full arch implants, some of the aesthetic procedures outside of dental, where lending standards have gone up, FICO scores have gone from the 500s-700, something like that, to qualify for patient financing in this cost of capital and tougher capital environment.

[Jeff Johnson, Senior Research Analyst at Baird]

What percentage, do you know a percentage or roundabout of what cases get financed and if those lending standards have changed at all or put any incremental pressure on patients here more recently? Thanks.

[John Morici, CFO at Align]

Yeah. What we see, Jeff, is, and it varies country by country, I'll say U.S. is maybe the most, and I'll combine ortho and GP together. Roughly a third of the cases that we see get some type of external financing. Remember, many, many patients or, or parents will pay in advance. That's great for doctors. Many doctors, especially orthos, will do some type of kind of internal financing, where you kind of pay as you go and so on. And many doctors are, are continuing to do that, especially in the, in the tougher environment. And we're doing things to help doctors to try to give them a little bit more extension in, in payments so that they can provide and pass that on to, to their patients as well.

[John Morici, CFO at Align]

And we'll work with DSO partners to really try to help them work with these external companies to try to give better financing rates to try to get these patients to go into treatment. So we're well aware. We know we can help. We have the balance sheet and the cash to be able to help with our customers so that they can pass that on, and, and that's something that we want to keep working towards.

[Jeff Johnson, Senior Research Analyst at Baird]

John, any, any change to note over just the past few months, even in those lending standards getting tougher, or you feel like that's stable as well as just kind of the overall environment as you've, you've described that way? Thanks.

[John Morici, CFO at Align]

I look at that as more stable. I think there was a lot of things if you go back to last year, people were really getting a bit of sticker shock in terms of the higher interest rates when they came to try to go into treatment. I think people are past that. I think when I see this or what I hear from doctors or see from our customers, that it's a little bit more stable. There's not a big change.

[Jeff Johnson, Senior Research Analyst at Baird]

Thank you.

[Operator]

Thank you. One moment for questions. Our next question comes from Michael Cherny with Leerink Partners. You may proceed.

[Joe Hogan, President and CEO at Align]

Hi, Michael.

[Michael Cherny, Senior Managing Director at Leerink Partners]

Hey, can you hear me okay?

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Yeah, we can hear you fine.

[Michael Cherny, Senior Managing Director at Leerink Partners]

Okay, so just relative to the spend, I want to dive in a little bit more, if possible. You talked about the investment growth. Can you delineate, relative to that investment, how you're thinking about the growth into, call it your core markets for some of the new product launches? And especially with regards to the ramp on the printing side, how much incremental printing spend, so to speak, is coming now versus where you think it's gonna grow, what the run rate should be on ramping that over time?

[John Morici, CFO at Align]

Yeah, I think, you know, we have a core business that we're running, and obviously, there's a certain amount of investment that you have to be able to grow around sales, sales and marketing and, and, you know, the go-to-market activities that we have. There's also R&D spending that we've had throughout the time. And now as that R&D, in the case of, you know, acquiring Cubicure and now turning this into, you know, more of a platform to be able to build our 3D printing, there's a certain amount of spend that we have. You know, how that lays out, it varies over time that we'll have, but rest assured, we know how to scale products, we know how to scale 3D printing.

[John Morici, CFO at Align]

We'll make the right investments to be able to start scaling up that direct fab printing while making sure that the core business has the right investments for growth, and we'll balance that as we go forward.

[Michael Cherny, Senior Managing Director at Leerink Partners]

Got it. Thank you.

[Operator]

Thank you. One moment for questions. Our next question comes from Jason Bednar with Piper Sandler. You may proceed.

[Joe Hogan, President and CEO at Align]

Hi, Jason.

[Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler]

Hey, good afternoon. Hey, thanks for taking the questions. First, I want to build on some of the macro questions that have been asked. I don't want to belabor the point, but, you know, other consumer discretionary comp companies called out a downtick in March. It doesn't sound like you saw any of that, but just wanted to confirm that's the case with respect to Invisalign demand, and maybe speak to your confidence to drive clear aligner volumes going forward now that comps turn a little bit tougher. You know, how much do you think you might need to fund that growth with investments to drive more traffic into the office?

[Joe Hogan, President and CEO at Align]

Hey, Jason, on the first part is, you know, we talk about the stable environment, that's we've seen that stability of it. You know, we, I, we read, and I read, you know, what's going on there with consumer investment, some concerns, particularly on the luxury goods or what's going on out there. But, I think often what, what, what we see, and analysts who follow us here, just really pick up the U.S. data. And what we see is, you know, differences all around the world, and that's what's great about having an international business. You have some counter-cycling in the sense of the demand patterns and what goes on out there.

[Joe Hogan, President and CEO at Align]

But I would say there's nothing that we would highlight right now that would say that we think something's changed in what we saw in the second half of 2023 to what we saw in the first quarter of this year. John, you?

[John Morici, CFO at Align]

Yeah, and in terms of investments, you know, we make the investments that we need, go-to-market and manufacturing, other expansion as we continue to grow. We'll continue those investments. But as we've talked about, not only for now, the second quarter, when we're talking about that sequential improvement in op margin and what we've talked about in total year, where we expect the year-over-year improvement in margin, we're making sure that we're investing with that right amount of profitability. To still be able to grow into our market and expand the opportunity, expand on the opportunities that we have, but then being respectful in terms of what margin we need to be able to deliver for the company.

[Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler]

All right. Very helpful, Joe and John. And maybe one follow-up here, to maybe a multi-parter on teens, so bear with me. This might be a nuanced look. It seems like a lot of emphasis here just recently in product development and marketing that's really trying to tap into that much younger market, that phase I opportunity. You know, IPE fits in there, your new marketing branding plan has an emphasis there. There seems to be some benefits for younger patients with Lumina. So it's really, it seems intentional, but wondering if you could bifurcate for us, how your Invisalign business is performing in this younger patient population relative to teens as a whole? Where does your penetration sit in those younger patients versus the broader teen channel?

[Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler]

Maybe what kind of outsized growth you're expecting from this part of the channel as we look out over the near to intermediate term?

[Joe Hogan, President and CEO at Align]

Hey, Jason, just to back up on your question, just give you kind of a conceptual view. When you think of phase I, it's actually been controversial in the orthodontic market for years. Some orthodontists don't want to do phase I because, as I mentioned before, the kind of devices that have been used have been kind of difficult from a consumer standpoint, and so they'll just wait for all permanent dentition and move on to there. We feel confident that with Invisalign First now, for dental expansion and then for palate expansion or a morphological change, IPE will do that. And we think it will attract more orthodontists to begin phase I treatment. But this is an industry that takes a while for things to bake in and for them to gain confidence.

[Joe Hogan, President and CEO at Align]

And I understand it, because you're working with kids' teeth and mouths and their dentition. But we actually think that a significant amount of growth could come from this area, but we think it'll take time. But it's been a great focus for us, and it's gonna be interesting to watch how orthodontists in the future actually focus on phase I, phase II, because these kinds of devices make it simpler for them and for patients in the future. So right now, I can't, I can only just kind of give you the ground rules on that we've changed those rules in a sense, but we, I can't project exactly where it's going.

[Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler]

Any sense, penetration-wise, or maybe where you're at relative to the broader teen market?

[Joe Hogan, President and CEO at Align]

I'd say we're just in that story. I mean, you have even Invisalign First is used sometimes on more permanent dentition, too, so it's hard. We'd have to split our cases out of Invisalign First is, what the age of patients are or whatever. But, you know, as we get more data in and we really get through with IPE and some more specificity around this, we'll, we'll share it with you and, and the rest of the people.

[Michael Cherny, Senior Managing Director at Leerink Partners]

Yeah, I mean, the only thing that. You know, I mean, if you've tracked us for a while, you know that our average age of teen patients gets younger and younger. I think we're 14 now versus 15+ before.

[Joe Hogan, President and CEO at Align]

Yes.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

So, I mean, that's a reflection of just being able to go after those younger patients with First.

[Joe Hogan, President and CEO at Align]

Yeah.

[Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler]

All right. Very helpful. Thank you.

[Operator]

Thank you... One moment for questions. Our next question comes from Nathan Rich with Goldman Sachs. You may proceed.

[Nathan Rich, Equity Research Analyst at Goldman Sachs]

Great. Good afternoon. Hi, and thanks for the questions. I wanted to go back to the guidance. I know it's kind of been touched on a few different times, but I wanted to ask on the clear aligner revenue outlook. It looks like you're raising the outlook for the full-year by about 1%. I guess, could you maybe just touch on what changed specifically with respect to that outlook? It sounds like maybe it's expectations around IPE and DSP versus, you know, market improvement. But I'd be curious, any color you could share there and, you know, maybe anything on teen versus adult within the updated guidance would be great.

[John Morici, CFO at Align]

Yeah, I'll, I'll start, Nate. So overall, we went from, you know, we had talked to a mid-single-digits, so call it 5%, to raising it to the midpoint of 7% on a year-over-year, so up two points. And really, that's a reflection of a few things. One is the continued stability that we're seeing. We're operating in an environment that's more stable. We saw that, you know, coming into the fourth quarter and now into this quarter as well, so that's good. We want that stability there.

[John Morici, CFO at Align]

And then you look at the execution that we have about on our core business to be able to grow with a lot of the innovations that we have, the promotions and other things that we have as we get into further into teen season, supplemented with the various new products that we talked about. We feel really good about Lumina and the launch that we have in iTero, and the further expansion that that can drive, as well as some of the new products like IPE and others, to really not only help those unit sales there, but then, as Joe described, we had to pull in other products around Invisalign First and others to really help drive some of that growth that we can see in the teen business.

[John Morici, CFO at Align]

It's a combination of things, Nate, but it's what we're seeing in stability, how we're executing on our core strategies, and then some of the new products really supplementing that, extended growth to help us, and that's why we adjusted our total year.

[Nathan Rich, Equity Research Analyst at Goldman Sachs]

Okay, that's helpful. Then John, maybe just sticking with you. The 2Q operating margin, I know up slightly sequentially, but down year-over-year, and I think, you know, historically it's been a little bit variable, but you've seen more of a step up in the second quarter than I think what the guidance implies. Anything to call out with respect to, you know, FX or, you know, I think you mentioned some manufacturing cost spend, but just anything there that we should keep in mind as it regards the margin cadence?

[John Morici, CFO at Align]

Well, and certainly we are seeing a stronger U.S. dollar, so that's something that we talked about when we think about our guide two, you know, we see a stronger U.S. dollar coming out of the first quarter into the second quarter. Our guide reflects that as well. But then you look at the continuing investments that we're making to be able to drive more submitters, more doctors into our ecosystem, and then ultimately drive more and more utilization. Some of it's that core business that we have to be able to drive growth, and some of it's some of the new products where there's a certain amount of OpEx spend that we have with that.

[John Morici, CFO at Align]

But we're being very mindful of what we can do to be able to drive growth, and then what it also means from an operating margin standpoint. And we're delivering that sequential improvement from 1Q-2Q in operating margin, and then talk to the total year of being up on a year-over-year basis.

[Nathan Rich, Equity Research Analyst at Goldman Sachs]

That's great. Thank you.

[Operator]

Thank you. One moment for questions. Our next question comes from Erin Wright with Morgan Stanley. You may proceed.

[Erin Wright, Research Analyst at Morgan Stanley]

Great, thanks. Hi, I'll ask my two upfront here, but I'll follow up on the guidance, and I don't want to belabor this too much, but do you think you have better visibility now just on the underlying demand trends globally, or, or would you say that there's still an element or a healthy element of macro uncertainty that's still embedded in your guidance and some conservatism there? And then second would be on Lumina and the launch, and just can you talk about where you're seeing the most success with the launch in the target markets and promotions that where you're focused in terms of expanding share and, and upgrades as well? Thanks.

[John Morici, CFO at Align]

Hi, Erin, this is John. I'll talk a little bit about visibility and guidance. I think, you know, what we enjoy now and what we want to be able to have in an operating environment is more stability, and that stability is there. Markets are open. There's a higher, overall higher inflation and interest rates, but people are operating in that environment. That stability transcends it to other things that we have. We see the Michigan Index or other indices that kind of point to that stability.

[John Morici, CFO at Align]

Based on that stability, the investments that we're making, how we're going to market some of the new products that we have, other things that we know that can, on a core basis, drive our business, as well as the new products and initiatives that we have, that's what gives us confidence to be able to have a, a guidance that we gave for Q2 and, and what it means for the total year.

[Joe Hogan, President and CEO at Align]

Yeah. And Erin, on the Lumina piece, it's Joe, obviously, you know, we're, as I mentioned in the closing of my script, we're really excited about that technology. We've been working on it for six years. It is a true new platform. It's not a derivative of the old confocal imaging platform, and there's really no other scanner in the world that's like that and how we've built it. So. And it, it'll take a while for the, I think, the market to absorb that, as you, you know, you have to do this doctor by doctor and place by place.

[Joe Hogan, President and CEO at Align]

But we've had a very enthusiastic response from the orthodontic community, but also the general dentistry community, too, even though we're not completely ready for the restorative piece, and we mentioned it'll be the fourth quarter of this year, we'll have that capability out. It's just the speed of that wand, the simplicity of being able to scan the dimension, then dimensional tolerances and all that's used in the sense of both comprehensive and orthodontic cases are really unmatched. So we're excited about that, but, you know, we just have to take this thing. We've only had it out now for, you know, roughly a couple of months, but we are expecting to have a really strong year, but more importantly, to have that really be to set the standard from a scanner standpoint for the industry going forward.

[Operator]

Thank you. As a reminder, to ask a question, please press Star one one on your telephone keypad. Our next question comes from Michael Ryskin with Bank of America. You may proceed.

[Michael Ryskin, Managing Director at Bank of America]

Hey, hey, Joe, John, thanks for taking the question, and congrats on

[John Morici, CFO at Align]

Hey, Michael

[Michael Ryskin, Managing Director at Bank of America]

on the quarter.

[John Morici, CFO at Align]

Hey, Michael.

[Michael Ryskin, Managing Director at Bank of America]

Hey, I want to follow up on something I think, Joe, you touched on in the prepared remarks. If I caught it correctly, you kind of pointed to a little bit of strength in US ortho or Americas ortho in the quarter. It stood out for us. It seems like it's one of the stronger results in a number of quarters. Just wondering if you could expand on that a little bit. You know, is it the Lumina launch? Is it the fact that, you know, you're moving into younger teens and younger kids, which obviously is gonna be a little more ortho-focused? Just any structural change you're seeing there with that group of dentists, or am I just reading it too much?

[Joe Hogan, President and CEO at Align]

Yeah, no, Michael, I understand your question. I'd say, you know, it's we feel it's... You know, we've seen more stability in that market, you know, this year than we have last year. You know, we've always known that the teen segment of that, you know, much more solid than the adult segment, but the adult segment held up for us in the quarter, too, and so that aspect of the adults was good for us also. But I'm very cautious about projecting this market going forward, because, as you can see with a lot of the surveys that are done, this moves pretty dramatically from month to month. But, you know, again, it's not just the United States market we're focused on. The global market has been, you know, good for us, too, in that sense.

[Joe Hogan, President and CEO at Align]

So we're gonna take this thing a month at a time, but we're confident enough to say this is stable, that we have products in here that are very, helpful from an orthodontic standpoint and new, like you mentioned, Lumina and also IPE. That gives us more ground to stand on in the sense of those orthos, and so we're excited about that. But in, in no way do I think there's a, a phase change between what we saw last year and this year in ortho. It's just more stable and, and with more continuity, is another word that I'd use to describe it.

[Michael Ryskin, Managing Director at Bank of America]

Okay. And if I could squeeze in a follow-up, if there's time. You know, again, also impressed by the the DSP touch-up progress. You called it out in the deck. You got some additional launches later this year. You got the 14-stage touch-up aligner offering you're talking about. Any way you can start framing in terms of, you know, would you incorporate that into guidance at some point, in terms of where you think that can go, in terms of volumes and revenues or any update longer-term, how you see DSP and touch-up evolving over time? Thanks.

[John Morici, CFO at Align]

Yeah, Michael, I'll take that one. Look, DSP is very popular because it really serves the needs that doctors have. They wanna be able to buy things kind of the way they wanna buy. They wanna be able to, instead of making things or doing things themselves, they can use our aligners as part of that DSP and be able to treat those touch-up cases, and we like that. That's incremental for us in terms of what we see there. And they can also then use a lot of that aligners that they have for retention, and that's great, too, because that's typically incremental volume that we have.

[John Morici, CFO at Align]

So I think when we see us rolling this out, like we said, a few years ago, it was U.S. and North America, and now it's into Europe. It continues to do what we expect it to do. Doctors, they adopt it more and more because part of their workflow, and we see positive volume from that. And in success for projects, programs like that, we'll continue to expand those out.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Okay.

[Michael Ryskin, Managing Director at Bank of America]

All right.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Thanks, Michael.

[Michael Ryskin, Managing Director at Bank of America]

Thanks.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Operator, we can take one more question.

[Operator]

Thank you. One moment for a question. Our last question comes from Kevin Caliendo with UBS. You may proceed.

[Kevin Caliendo, Managing Director at UBS]

Hi. Thanks for getting me in. I appreciate it. I have 2 questions. So the first one is on Heartland. Can you talk a little bit about the benefits of the Heartland investment, operationally? And also, Heartland is, my understanding, is a pretty profitable business, and now with 2, 2 separate investments there, how does, how does their profits, or how does the accounting work for that from your perspective at this point? And then secondly, if you can provide... I guess, you know, with regards to the guidance, I think we understand it, but was that in any way based on the trends that you've seen so far in April? Or if you can elaborate on those, in any way, that would be great. Thanks.

[John Morici, CFO at Align]

I can start with the guidance, part of that, Kevin. Look, we use a lot of factors to look at where our guidance is. So we're using data from, you know, Q1 and, you know, the most recent information. But, you know, it goes back to the stability that we've seen. You can see it in a lot of the surveys and other things that a lot of people do. But what we see is that stability coupled with what we're trying to do to go to market, to drive the initiatives we have and the new products that we have. So that's, you know, a key part of what we factor in into our guidance. No change from what we normally do.

[John Morici, CFO at Align]

This is how we have, you know, come together in terms of a guidance standpoint. In terms of Heartland, we look at Heartland as this is a great investment from investing in a company that shares a digital orthodontic mindset that we have, to be able to do things in a similar mindset, to be able to expand like they're expanding, to be able to get into markets that in some cases we don't have much market share with or a big presence there. And they share that same mindset, that expansion. They've been around for a lot of years as well. You know, with this investment, it's less than 5%. There's no consolidation or anything else that's required.

[John Morici, CFO at Align]

You know, we'll evaluate going forward on whether there's any mark-to-market that we have to do going forward. But it's a continuation of that investment, the expansion that they're doing, and we're pleased with the results that we've seen over the last year.

[Kevin Caliendo, Managing Director at UBS]

Good. Super helpful. Thank you.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Thanks, Kevin.

[Kevin Caliendo, Managing Director at UBS]

Thank you.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Will that actually conclude. Sorry, go ahead, operator.

[Operator]

And we have reached the end of our question and answer session. I will now turn the call back over to Shirley Stacy for closing remarks.

[Shirley Stacy, VP of Corporate Communications and Investor Relations at Align]

Thank you so much, and thank you everyone for joining us today. We look forward to speaking to you at upcoming financial conferences and industry meetings, including the American Association of Orthodontists meeting in New Orleans, May 4th and 5th. If you have any questions, please give us a call. Thank you.

[Operator]

Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• John Morici, CFO

Analysts

• Brandon Vazquez, Research Analyst at William Blair
• Elizabeth Anderson, Senior Managing Director at Evercore ISI
• Erin Wright, Research Analyst at Morgan Stanley
• Jason Bednar, Managing Director and Senior Research Analyst at Piper Sandler
• Jeff Johnson, Senior Research Analyst at Baird
• Joe Hogan, President and CEO at Align
• Jon Block, Managing Director and Senior Analyst at Stifel
• Kevin Caliendo, Managing Director at UBS
• Michael Cherny, Senior Managing Director at Leerink Partners
• Michael Ryskin, Managing Director at Bank of America
• Nathan Rich, Equity Research Analyst at Goldman Sachs
• Shirley Stacy, VP of Corporate Communications and Investor Relations at Align