Greetings. Welcome to the Align Q1 2022 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.

Thank you. Good afternoon. 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 2022 financial results today via GlobeNewswire, 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. A telephone replay will be available today by approximately 5:30 PM, Eastern Time, through 5:30 PM, Eastern Time, on May 11th. To access the telephone replay domestic callers should dial 866-813-9403 with access code 335004.

International callers should dial 929-458-6194 using the same access code. 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 Form -- in our most recent periodic reports filed with the Securities and Exchange Commission available on our website and at sec.gov.

Actual results may vary significantly and Align expressly assumes no obligation to update any forward-looking statement.

We have posted historical financial statements including the corresponding reconciliations including our GAAP to non-GAAP reconciliation, if applicable, and our first quarter 2022 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?.

Thanks Shirley. Good afternoon and thanks for joining us. On our call today, I'll provide an overview of our Q1 results and discuss the performance of our two operating segments; Systems and Services and Clear Aligners. John will provide more detail on our financial performance and our view for the remainder of the year.

Following that, I'll come back and summarize a few key points and open the call to questions.

Overall, the first quarter proved to be a tougher-than-expected operating environment globally and we believe our results primarily reflect three key factors; the continued impact of COVID-19 waves in every region and especially in China, with its restrictions and lockdowns under their Zero COVID policy; a weaker economic environment and waning consumer confidence driven by increasing inflationary pressures and supply chain disruptions; and the military conflict in the Ukraine and fallout across Europe.

In addition, with approximately half our business occurring outside the United States, unfavorable foreign exchange rates negatively impacting our revenues, margins, and EPS.

Notwithstanding these headwinds, Q1 2022 total revenues of $973.2 million were up 8.8% year-over-year compared to Q1 2021 revenues of $894 million with a growth rate of 62% year-over-year. Our Q1 2022 operating income was $198 million and operating margin was 20.4%.

In Q1, Systems and Services revenues were up 15.6% year-over-year, but down 24% sequentially coming off our sixth consecutive quarter of sequential growth and record scanner and services revenue.

Sequential results primarily reflect lower volumes from our aforementioned headwinds and from seasonality as Q4 is historically a stronger capital equipment sales quarter. For Q1, Clear Aligner revenues were up 7.5% year-over-year, reflecting revenue growth across regions and products and were down slightly sequentially from Q4 at minus 0.7%.

In the teen segment, 175,000 teen started treatment with Invisalign Aligners, up 6% year-over-year. Invisalign First for kids as young as six years old grew sequentially year-over-year and was strong across all regions.

Q1 non-case revenues would include doctor-prescribed retention products, clinical training and education and other dental consumables performed well and grew both year-over-year and sequentially.

Our Doctor Subscription Plan, or DSP, pilot was launched last year in the United States and Canada, and it continues to ramp nicely, driving strong revenue growth. DSP is a monthly subscription program, designed for a segment of experienced Invisalign doctors, who are not regularly using our retainers or low-stage aligners.

We're very excited about the feedback and uptake we're seeing, and we'll expand the program into other markets this year Here are just a few things from doctors who are saying about DSP. Dr. De Ferris in Santa Barbara, California, 'we have shifted our retention model and workflow.

We really like the material, the fit and the precision of the product and having everything in Align systems versus printing in-house and having to maintain it ourselves.' Dr. Sandra Tai, in Vancouver, Canada, 'This program fits my business model very well.

I'm able to pass savings to patients.' Now let's turn to the specifics around the first quarter results, starting with the Americas. For Q1, Invisalign case volumes were down 1.5% year-over-year. On a sequential basis, Americas case volumes were down 4.3%, primarily reflecting the impact from COVID-19 waves.

First experience in North America beginning in Q4 2021 and continue into Q1 and later in Latin America, causing consumers customer staffing shortages and practice closures as well as decreased patient traffic and increased deployment cancellations.

The latest data from the gauge practice analysis tool that collect and consolidates data from about 700 ortho practices, covering more than 1,000 orthodontists across 1,600 locations in the United States and Canada, showed weakening underlying patient demand trends in the first quarter for both adult and teens and across wires and brackets and Clear Aligner products.

New patient visits were down 7.6% year-over-year ortho starts were down 7.2% year-over-year. In the DSO channel, in Q1 2022, DSO practices grew faster than non-DSO practices with utilization led by Heartland and Smile Doctors.

Earlier this month, we announced a new DSO partnership with Dental Corp, Canada's largest and fastest-growing network of dental practices. Dental Corp plans to extend its offering of Invisalign brand, Clear Aligner treatment to Canadians nationwide through its ortho acceleration program.

This strategic collaboration also provides dental course network of doctors across nearly 460 practices with access to enhanced benefits, dedicated learning opportunities, and treatment planning support for the Invisalign system.

Also this month, we launched a new Invisalign Teen subscription program in the United States and Canada to help unlock the massive opportunity from teen orthodontics, which makes up approximately 75% of the 5 million annual case starts in North America.

The teen subscription program enables orthodontists to buy Clear Aligners in case packs in advance, much like the way they buy wires and brackets today, offering simple and more predictable billing for doctors.

It also includes exclusive practice development benefits with the Invisalign brand and requires an incremental volume commitment from doctors.

The timing of the new teen program coincides with the beginning of the summer teen season, and we're excited to continue partnering with doctors to grow their practice with Invisalign treatment with less than 10% share of teen case starts, the teen subscription program has the potential to help accelerate Invisalign adoption in the largest segment of the orthodontic market teams.

For our international business, Q1 Invisalign case volumes were up 3% year-over-year. On a sequential basis, international case volumes were down 6.1%, primarily reflecting the headwinds described earlier, especially the impact of COVID-19 restrictions and lockdowns in China in the fallout across Europe from the military conflict in Ukraine.

For EMEA, Q1 Invisalign case with core growth in our core markets led by Italy and Germany and doc, along with the growth expansion markets led by Turkey and EMEA. The Q1 year-over-year Invisalign case volume in EMEA was driven by increased emissions, primarily from the orthodontist channel, especially in the teen market.

During the quarter, we launched our first ever directed teen campaign in EMEA focused on educating teens about the benefits in Invisalign treatment over traditional wires and brackets, increasing consumer demand as part of our wider teen growth plan, combined with our parent of teen campaign and to help give teens critical influence in the parent decision by driving peer word of mouth.

More recently, we launched the Invisalign Go Express system, the latest addition to the Invisalign Go portfolio for general dentists.

First launched in EMEA in 2016 as a 20-stage aligner treatment offering, the Invisalign Go portfolio system is designed for general dentists to treat mild to moderate malocclusions, to integrate tooth alignment into restorative and comprehensive dental care.

Additionally, building of our European manufacturing facility in Wroclaw, Polar remains on track to go live this quarter, increasing our flexibility and timeliness in supporting our value doctor customers across the EMEA region. Turning to APAC for Q1. APAC Invisalign case volumes were up 4.7% year-over-year.

With strengthened the GP dentist channel, primarily through increased Invisalign submissions with the Invisalign Go product and in the teen market with increased submissions from the orthodontic channel. On a sequential basis, APAC was down 2.6%, reflecting a larger impact from surges in new COVID-19 cases that led to significant lockdowns in China.

Alternatively, despite headwinds, Japan and Taiwan performed well. We had strong growth in emerging markets like Korea and India and Thailand on a year-over-year basis. Earlier this month, we expanded the Invisalign Clear Aligner product portfolio with new offerings that better serve the expanding market in China.

The two new products Invisalign Adult and Invisalign Standard Clear Aligners are designed for more specific types of malocclusion cases and private doctors and their patients with a more clinical and affordable options for moderate to complex cases.

Invisalign Adult and Invisalign Standard Clear Aligners built on our proven technology for a wider range and scope in malocclusion. During the quarter we announced new Invisalign innovations for the Align Digital platform.

Proprietary combination of software, systems and services designed to provide a seamless experience and workflow that integrates and connects all users, doctors, labs, patients and consumers.

These new Invisalign innovations include ClinCheck Live update, the Invisalign Practice App, Invisalign Personalized Plan or IPP, Invisalign Smile Architect and the cone beam computed tomography, CDCT integration feature for ClinCheck digital treatment planning software.

These innovations will revolutionize digital treatment planning for orthodontics and restorative dentistry by providing doctors with greater flexibility and real-time treatment plan access and modification capabilities.

Each of these innovations are designed to enhance Invisalign treatment planning quality, efficiency, and scale and contribute to a better doctor-patient experience. More recently, we introduced a new enhancement for the Invisalign system with mandibular advancement feature.

The Invisalign system with mandibular advancement is the only clinically proven Clear Aligner product in the world today that address a Class II correction with simultaneous alignment.

Using feedback from customers, we've enhanced the original design with new enhanced precision wins that provide increased durability and comfort as well as great overlap to help ensure that the Aligners remain seated and properly engaged to more effectively address Class II malocclusions in growing preteen and teen patients.

Our consumer marketing focus on educating consumers about the Invisalign system and driving that demand to Invisalign doctors' offices ultimately capitalizing on the massive market opportunity to transform 500 million smiles.

In Q1, we built on a successful Invis Is Multimedia campaign across the Americas, EMEA and APAC driving awareness and interest in Invisalign treatment with adult, teen, and parent consumer segments.

Globally, we delivered strong impression volume with over 23.7 million visits to our websites, 11 with a -- 113% [ph] year-over-year increase and over 7.8 billion impressions delivered, representing a 32% year-over-year increase.

In the US, we continue to amplify our campaigns across the top social platforms such as TikTok, Snapchat, Instagram, and YouTube to increased awareness of Invisalign brand with young adults and teens.

Our campaigns featured collaborations with some of the largest influencers in social media, including Charli D'Amelio, Lana Condor, Devon Key, Michael Le, and Josh Richards. Each of these creators shared their personal experience with Invisalign treatment and why they chose to transform their smiles with Invisalign Aligners.

To continue growing our young adult business across the Americas, EMEA, and APAC, we hold upon our successful Invis Is a Powerful Thing campaign, which highlights how powerful the smile transformation with Invisalign treatment can be for even young adults' self-confidence.

We leverage top influers like Leana Green and Lana Condor and integrated media campaigns. Further, we are expanding our collaboration with influencers globally and are excited to welcome Olympic Gold Medalist, Suni Lee and creators Josh Richards, [indiscernible], and Scarlett Estevez who have chosen to shape their smiles with Invisalign treatment.

In the EMEA region, we accelerated our media investments across digital media platforms, including YouTube, TikTok, Meta, and Snapchat and expanded our Invisalign Smile squad roster with new influencers.

Additionally, we launched a pilot in the UK to reach teams with special campaigns to create awareness of the unique benefits of Invisalign treatment. Our consumer campaigns delivered more 8.8 million unique visitors to our website, representing 170% increase year-over-year with over 2.5 billion media impressions.

We continue to expand our investment in consumer advertising across the APAC region, excluding -- including China, resulting in a 278% increase year-over-year in unique visitors and a 265% year-over-year increase in impressions.

We continue to strengthen our investments in Australia by expanding our reach via social media platforms such as TikTok, Meta, and YouTube. In Japan, we built upon our successful consumer campaigns by expanding into Twitter and continue to see strong response from consumers as evidenced by a 373% increase in unique visitors to our site.

For our Systems and Services business, Q1 revenues were up 15.6% year-over-year, reflecting strong scanner shipments and services and down 24.2% sequentially, primarily reflecting lower volumes from the previous mentioned headwinds and capital equipment seasonality.

During the past quarter, we saw continued adoption of the iTero Element 5D imaging system we launched last year that features innovative technology like near infrared technology that we call NIRI, which age into detection and monitoring of Interproximal Caries Lesions or cavities without -- above the gingiva without harmful radiation.

A strong indicator of the digital adoption within dental offices is a number of intraoral scans used for Invisalign case submissions. Total worldwide in oral digital scan submitted to start an Invisalign case in Q1 increased to 87.1% from 80.9% in Q1 last year.

International intraoral digital scans for Invisalign case submissions increased to 83%, up from 75% in Q1 last year. For the Americas, 91% of Invisalign cases were submitted using an intraoral digital scan compared to 85.5% in Q1 of last year.

Cumulatively, over 54.9 million orthodontic scans and over 11.4 million restorative scans have been formed with iTero scanners. During the quarter, the iTero Element 5D Plus won the best new imaging or CAD/CAM product from DrBicuspid.com and Cuspies award.

The award reflects our commitment to develop innovative solutions that help doctors transform lives by improving patients' journey to a healthy, beautiful smile.

We are pleased to share that the iTero Element scanner received in ortho town, 2021 Townie Choice Awards, which seeks to recognize the top gear recommended products and services and dentistry.

We're proud that the iTero Element 5D Plus imaging system provides dental practices with Alvadis [ph] and imaging technology, cutting-edge enhanced chair-side visualizations and applications that can drive practice growth in treatment acceptance.

Continued growth in the iTero scanner installed base is driving increased services revenues as well as exocad CAD/CAM software solutions that integrate workflows to the dental labs and dental practices.

Our Q1 exocad CAD/CAM products and services, which include restorative dentistry, implantology, guided surgery and smile design offerings are included in scanner and services revenues and are helping extend our digital dental solutions and broaden Aligned digital platform towards fully integrated interdisciplinary and workflows.

As we continue to lead the evolution of digital orthodontics and restorative dentistry, our goal is to make orthodontics a pillar of dentistry. April 2 marked our second anniversary since welcoming exocad into the Align family.

And together, we're working to ensure that every dental technician in every dentist planning restorative treatment in centers of benefits of digital orthodontics first.

We're continuing to focus on integration and road map development to strengthen the Align Digital platform by addressing restorative needs to facilitate both ortho restorative and comprehensive dentistry.

Two years after exocad joined Align, we are more excited than ever about the opportunities ahead to shape the dental industry and with technology and expertise that complement the many benefits of the Align Digital platform and bringing all key stakeholders together, doctor, customers, labs, partners and users as we continue transforming smiles and changing lives.

During the quarter, exocad participated in the 2022 Dental South China show in Guangzhou, China, showcasing its newest software release, Dental CAD 3.0 Galway plus other open software solutions like Innovative Smile Design program called Smile Creator.

The show allowed the exocad team to deepen their relationships with the dental community to discover new trends emerging in the growing dental market in China.

Attendees have both the experienced in firsthand how exocad's wizard guided workflows and easy online communication programs streamline the treatment journey from consultation to final restoration.

Finally, this quarter, exocad is opening its new headquarters in Seoul, South Korea, which provides a robust high-tech infrastructure to a key region of our business. exocad has been working with a growing number of Korean manufacturers for many years, and this location help facilitate strategic relationships in the region.

With that, I'll now turn over the call to John..

Thanks Joe. Now, for our Q1 financial results. Total revenues for the first quarter were $973.2 million, down 5.6% from the prior quarter and up 8.8% from the corresponding quarter a year ago.

For Clear Aligners, Q1 revenues of $809.7 million were down 0.7% sequentially due to lower Invisalign case volumes, partially offset by higher ASPs, reflecting higher ASPs and up 7.5% year-over-year reflecting higher ASPs in non-case revenues. In Q1, Invisalign case volume were down 5.1% sequentially and up 0.5% year-over-year.

In addition, we shipped Clear Aligners to 82,400 Invisalign doctors worldwide, of which over 5,000 were first-time customers. Q1 comprehensive volume increased 2. 4% year-over-year and decreased 5% sequentially. Q1 non-comprehensive volume decreased 4% year-over-year and decreased 5.4% sequentially.

Q1 adult patients decreased 1.6% year-over-year and decreased 5.7% sequentially. In Q1, teens or younger patients increased 6% year-over-year and decreased 3.6% sequentially. Clear Aligner revenues were unfavorably impacted by foreign exchange of approximately $6.5 million or approximately 0.8 points sequentially.

On a year-over-year basis, Clear Aligner revenues were unfavorably impacted by foreign exchange of approximately $24 million or approximately 3.2 points. For Q1, Invisalign comprehensive ASPs increased sequentially and year-over-year.

On a sequential basis, Invisalign comprehensive ASPs reflect per order processing fees charged on most Clear Aligner shipments, lower discounts, and higher additional lines, partially offset by unfavorable foreign exchange.

On a year-over-year basis, comprehensive ASPs reflect higher additional aligners and per order processing fees, partially offset by unfavorable foreign exchange. Q1 Invisalign non-comprehensive ASPs increased sequentially and year-over-year.

On a sequential basis, Invisalign non-comprehensive ASPs were favorably impacted by per order processing fees and lower discounts, partially offset by unfavorable foreign exchange. On a year-over-year basis, Invisalign non-comprehensive ASPs reflect per order processing fees, higher additional aligners, partially offset by foreign exchange.

Clear Aligner deferred revenues on the balance sheet increased $53 million or 5% sequentially and $307.1 million or 38.1% year-over-year and will be recognized as the additional lenders are shipped. Our Systems and Services revenue for the first quarter were $163.5 million, down 24.2% sequentially and up 15.6% year-over-year.

The decrease sequentially can be attributed to lower scanner volume following a strong Q4 and consistent with seasonality in the capital equipment business, coupled with the headwinds described earlier. The increase year-over-year can be attributed to increased services revenue from our larger installed base as well as slightly higher scanner volume.

Our Systems and Services deferred revenues on the balance sheet was up $16.5 million or 7.2% sequentially and up $114.9 million or 87.6% year-over-year, primarily due to the increase in scanner sales and the deferral of service revenue included with our -- with the scanner purchase, which will be recognized ratably over the service period.

Moving on to gross margin. First quarter overall gross margin was 72.9%, up 0.7 points sequentially and down 2.8 points year-over-year.

On a non-GAAP basis, excluding stock-based compensation expense and amortization of intangibles related to acquisitions, overall gross margin was 73.3% for the first quarter, up 0.7 points sequentially and down 2.8 points year-over-year.

Overall gross margin was unfavorably impacted by approximately 0.8 points on a year-over-year basis and by approximately 0.2 points sequentially due to foreign exchange.

Clear Aligner gross margin for the first quarter was 74.8%, up 0.6 point sequentially due to higher ASPs, partially offset by higher mix of additional aligner volume and higher freight costs.

Clear Aligner gross margin was down 2.8 points year-over-year due to higher mix of additional aligner volume and higher freight costs, partially offset by higher ASPs. Systems and Services gross margin for the first quarter was 63.4%, down 1.3 points sequentially due to lower volume and lower ASPs, partially offset by lower freight costs.

Systems and Services gross margin was down 2 points year-over-year due to higher manufacturing inefficiencies, partially offset by higher mix of service revenues and increased ASPs. Q1 operating expenses were $511.3 million, down sequentially 2.4% and up 13.2% year-over-year. On a sequential basis, operating expenses were down $12.4 million.

Year-over-year, operating expenses increased by $59.6 million, reflecting increased headcount and our continued investment in marketing sales and R&D activities and investments commensurate with business growth.

On a non-GAAP basis, excluding stock-based compensation, amortization of acquired intangibles related to certain acquisitions and acquisition costs. Operating expenses were $480.2 million, down sequentially 2.9% and up 13.1% year-over-year due to the reasons described above.

Our first quarter operating income of $198.1 million resulted in an operating margin of 20.4%, down 1.1 points sequentially and down 4.8 points year-over-year.

The year-over-year decrease in operating margin is primarily attributed to lower gross margin, investments in our go-to-market teams and technology as well as unfavorable impact from foreign exchange.

On a non-GAAP basis, which excludes stock-based compensation, amortization of intangibles related to certain acquisitions and acquisition costs, operating margin for the first quarter was 24%, down 0.7 points sequentially and down 4.6 points year-over-year.

Interest and other income and expense net for the first quarter was a loss of $10.6 million, down sequentially by $9. 7 million and down year-over-year by $46.8 million. Q1 of 2021 included the SEC arbitration award gain of $43.4 million.

The GAAP effective tax rate for the first quarter was 28.4% compared to 13.2% in the fourth quarter and 23.4% in the first quarter of the prior year. Our non-GAAP effective tax rate was 24.2% in the first quarter compared to 11.5% in the fourth quarter and 20.2% in the first quarter of the prior year.

The first quarter GAAP and non-GAAP effective tax rates were higher than fourth quarter effective tax rates, primarily due to tax benefits related to expiration of statutes of limitations for timely asserting claims and an out-of-period adjustment recorded last quarter.

First quarter net income per diluted share was $1.70, down sequentially $0.70 and down $0.81 compared to the prior year. Our EPS was unfavorably impacted by $0.13 on a sequential basis and $0.28 on a year-over-year basis due to foreign exchange.

On a non-GAAP basis, net income per diluted share was $2.13 for the first quarter, down $0.70 sequentially and down $0.36 year-over-year. Moving on to the balance sheet.

As of March 31st, 2022, cash, cash equivalents, and short-term and long-term marketable securities were $1.1 billion, down sequentially $176.1 million and down $11.1 million year-over-year. Of our $1.1 billion balance, $453 million was held in the US and $667.6 million was held by our international entities.

Q1 accounts receivable balance was $950.9 million, up approximately 6% sequentially. Our overall days sales outstanding was 87 days, up approximately nine days sequentially and up approximately 15 days as compared to Q1 last year. Cash flow from operations for the first quarter was $30.5 million.

Capital expenditures for the first quarter were $87.3 million, primarily related to our continued investment to increase aligner manufacturing capacity and facilities. Free cash flow, defined as cash flow from operations, less capital expenditures, amounted to negative $56.8 million.

In February, we repurchased $75 million of our common stock through open market repurchases of approximately 143,600 shares at an average price of $522.61 per share. We have approximately $650 million remaining available for repurchase under our May 13th, 2021, $1 billion repurchase program.

As described during our Q4 2021 earnings call, we provided our fiscal year 2022 outlook with revenue growth in line with our long-term revenue range of 20% to 30%. This revenue growth assumed no significant new COVID surges after current wave, no meaningful practice disruption nor material supply chain issues throughout the year.

At that time, we were seeing some recovery as Omicron headwinds began to ease and COVID restrictions were relaxing. However, later in the quarter, unfavorable impacts on our business occurred driven by China lockdowns, weaker consumer confidence, inflationary pressures and the Russia-Ukraine conflict.

For April, we have not seen momentum return as the headwinds previously mentioned persist. Now turning to full year 2022. We remain confident in the huge underpenetrated market, our technology and industry leadership and our ability to execute and make progress toward our long-term model of 20% to 30% revenue growth.

At the same time, the headwinds we're experiencing, which include increased COVID waves and significant China lockdowns, weaker consumer confidence, inflation pressures the Russia-Ukraine conflict have increased uncertainty across all markets.

We also anticipate capital equipment sales will be increasingly constrained throughout the year as practices adjust to these headwinds. Given less visibility and an increasing unpredictable operating environment, we are not providing revenue guidance for the year.

However, assuming no additional material disruptions or circumstances beyond our control, our goal for fiscal 2022 is to deliver GAAP operating margin above 20%, while making strategic investments in sales, marketing, R&D and operations In addition, during Q2 2022, we expect to repurchase up to $200 million of our common stock through either a combination of open market repurchases or an accelerated stock repurchase agreement.

For 2022, we expect our investments in capital expenditures to exceed $300 million. Capital expenditures primarily relate to building construction and improvements as well as a digital manufacturing capacity to support our international expansion.

This includes our investment in an aligner fabrication facility in Wroclaw, Poland, which is expected to begin serving doctors in the second quarter of 2022 as part of our strategy to bring operational facilities closer to customers.

As we continue growing, we intend to expand our investments in research and development, manufacturing, treatment planning, sales and marketing operations to meet the actual and anticipated local and regional demands. With that, I'll turn it back over to Joe for final comments.

Joe?.

Thanks, John..

Excuse me.

Joe Hogan, are you there?.

Yes, operator..

Thanks, John. I'll run by this again. Okay. That was my fault. Over our first quarter results reflect a more challenging environment than expected.

We know that COVID lockdowns, weaker consumer confidence, inflationary pressures and the Russia-Ukraine conflict have created headwinds, but we remain excited and committed to realizing the enormous opportunity in front of us to lead the evolution of digital orthodontics and comprehensive dentistry.

With less than 10% share of the 21 million starts each year with over 500 million people globally who can benefit from a healthy beautiful smile, our market is as large as ever. No other company is as well positioned as us to take advantage of that potential as the environment improves and growth trends return.

We will continue to focus on the execution of our strategic growth drivers, while managing investments in the near-term to account for the headwinds and uncertainty, and we will remain confident in our long-term revenue growth model of 20% to 30%.

Before we open the call to questions, I want to address the military conflict in the Ukraine and our operations in Russia. It's a human tragedy for all people involved and our thoughts go out to everyone impacted and especially to those with personal connections who are undoubtedly concerned with their families and loved ones.

Our primary concern remains the safety and security of our employees and their families, our doctors, their staff and patients. We have nothing to do with this conflict. As a global medical device provider of doctor-prescribed products, continuity of care is critical to the doctors and their patients in orthodontic treatment.

We discontinued commercial activities in Russia that are not essential to providing continuity of care to patients. Our focus on only our values and ethical responsibility of patients in treatment. In the process, we are also adhering to the international sanctions that have been imposed.

Our IT infrastructure, including covet intellectual property is hosted outside of Russia. Prior to the conflict, we have begun expanding our R&D teams in Downstate, Germany; Madrid, Spain; Toronto, Canada; and Austin, Texas. And we're prudently working with the team on the ground in Russia on work pieces.

A number of our Russian employees have already transitioned and are in various stages of transitioning their families to Armenia, where we've set up an R&D center in urban to support those who choose to relocate.

At the same time, it's humbling to see the tremendous outpouring of kindness and support throughout the company as our employees respond to the humanitarian needs of the crisis. Our Polish team members has set up donation centers at our facilities where employees are contributing food, clothing, supplies, and human care.

Many are also taking Ukrainian refugees into their homes. And we're proud of the tremendous initiative by our colleagues and are grateful for their actions. In addition to our employees' efforts, Align is donating $300,000 to support humanitarian relief efforts through organizations providing shelter food, medicines and vital supplies.

We can only hope that the conflict in Ukraine will end soon, that the ongoing impact of the pandemic will lessen for good, and that economic factors facing many customers and consumers will abate.

But these things are beyond our control, so we will continue to prioritize the health and safety of employees, customers, and patients and will stay focused on strategic initiatives. In closing, April 3rd marked the 25th anniversary of the founding of Align Technology. And shortly thereafter, the long of the Invisalign system.

Over the past 25 years, we've transformed the orthodontic industry with a passion for innovation as we've evolved from leading the evolution from digital appliances to digital platform. We've created an incredible company unlike any other.

Invisalign's unique mass customization business operating in real time with no inventory or distribution at the front end of our market. Consequence of fluctuations in the macroeconomic environment are felt faster at Align than I've ever experienced anywhere in my career. And we monitored these trends to make adjustments in our business when needed.

Our success is a result of a vision and purpose and results. Thanks to our employees and our doctor customers around the world, who took a chance on a Silicon Valley start-up and risked everything.

Today, Align is the largest 3D printing operation in the world, producing 1 million customized aligners each day based on the learnings gained from nearly 13 million Invisalign patients and 60 million iTero digital scans Our global team of over 25,000 employees support more than 250,000 doctors and labs in more than 150 countries.

There are more than 500 million people in the world that can benefit from orthodontic procedures. It's huge. And you can only address opportunities of that size with digital orthodontics. It could never happen using old analog methods. As we have digitized that capability, it has opened up a market broadly for orthodontic treatment to the masses.

It's hard to believe that after 25 years, we're still in the early phases of transforming the orthodontic market.

We look forward to sharing more milestones over the next 25 years as we continue to lead the digital evolution of orthodontics and dentistry, deliver great treatment outcomes and treatment experiences to doctors and patients around the world. Thank you for your time today. I'll now turn it over to the operator for questions.

Operator?.

Thank you. At this time we will be conducting a question-and-answer session. [Operator Instructions] The first question is from the line of Jason Bednar with Piper Sandler. You may proceed..

Hi, Jason..

Hey, good afternoon, everyone. Hey, there. Thanks for taking the questions. So Joe, I guess just to start with you. I mean, you and John called out the consumer confidence items and the inflationary pressures impacting the business. The wind shifting pretty abruptly on you.

I guess, are there tools you have at your disposal to manage through these pressures, or is this a matter of just keeping your head down, waiting for the macro environment to settle down, I guess, really just trying to get a sense of how we should be moderating expectations from what's typical sequential growth we would see in the business?.

Yes, Jason, good question. I'd say being a global business, we talked about having 50% of our revenues outside. It just gives us good scope in the sense to take advantage where opportunities are. And so I feel really good about the company in that sense. And we've made great development over the last three years from an international standpoint.

We also have a great portfolio. We have iTero scanners. We talked about some reluctance in the sense that we saw at the end of the first quarter as some doctors to really commit to it. But I mean that demand is still out there.

When you look at iTero scanners are so underpenetrated still when you look at digital dentistry and what the future really brings. And so pushing that and pushing it in the right places and also you see the expansion of our Invisalign technology and what we're doing in different areas, too.

So I feel like we have a lot of levers that we can pull, but we are constrained by these headwinds that we've seen. And obviously, we'll respect those and make the kind of adjustments needed to make sure this business stays on track with. Look, I love our portfolio. I love our position. I see a great future. We'll manage our way through this, Jason..

Okay. That’s helpful. And then maybe shifting over to the – the margin side, you're not stepping off the gas with spending. I wouldn't expect it to given the opportunity that you're talking about here today and you've talked about for quite some time.

But I guess are you still comfortable with that long-term model of 25% plus operating margins? I know we've seen that for some select periods for the business.

But is that the right margin level to think about for the business when you're driving towards that 20% topline growth? Just -- can you truly balance that, or do you have to sacrifice one for the other, again, thinking longer term here?.

I think, Jason, honestly, I think we've managed that well over the years. I mean you can see how well we did last year in the sense of that operating profit has been squarely on top of that piece. And I think we've managed it within that bandwidth very well, and that's -- this current situation is not going to change that..

All right. Thanks guys..

Thank you, Jason..

Thank you. The next question is from the line of Jeff Johnson with Baird. You may proceed..

Hi Jeff..

Thank you. Hey guys, how are you? So, Joe, let me just pick up on that last point. I mean, you said you've managed OpEx well over the years in that. I guess, let me just be direct on it.

I mean, if end markets are cyclically slowing that's kind of out of your control, do you put the gas pedal down to the accelerator? Do you say there's not a whole lot that that's going to accomplish? So I kind of protect margins here in the short run.

Just what's your OpEx outlook kind of in the near term -- near to intermediate term, I guess, given some of this macro uncertainty?.

But with those investments, yes, it will be -- when we talked about the 20-plus percent on a GAAP basis, that's the trade-off that we'll have. We'll invest where we can see a return. And based on the volume that we expect, but deliver 20-plus percent op margin..

Yes, got it. Thanks John. And then a follow-up question, I guess, just on the gauge data, you talked about down 7% case starts ortho year-to-date. I'm hearing that through April, not just through March. But I don't get the whole gauge data set, but what I've seen is that the adult data is worse than the teen data, which would make sense to me.

Everybody sitting at home, all the adults sitting home last year with the Zoom effect going on at this point in stimulus checks, sitting in pockets and all that. So, that all makes sense.

But just what's the tenor in North America or in those markets that aren't impacted by China and Russia, Ukraine in that? What's the tenor of the teen business? And is the core that part of the business still doing better than you've just got real tough comps because all those adults were coming in last year as they were sitting at home and had nothing better to do than get Clear Aligners?.

Hey Jeff, it's Joe. Look, the teen market, you're good to focus on that. I mean that's -- we look at that as a fairly secure market.

Obviously, it can move up and down, but it won't have the volatility and you've seen in the adult market and you're comparing a against last year is a good way to look at it, given the Zoom effect and things we talked about before.

So -- and Jeff, that's why you see us launching these teen products right now and getting ready from a summer time standpoint. We want to take advantage of that demand as much as we possibly can, especially in times like this. We know the adult market is going to be pressured.

I'm talking about the US right now, but this sets leave China now because China is a unique position in the sense of a lockdown that they're going through. But we're -- you're going to see us take the same tact in Europe also. And you saw our teen volume in Europe was actually pretty good in the first quarter..

What about that teen volume in the US, Joe?.

We expect that teen volume to be good. Summer seasonality is there. And it's funny. There's a window for to really have their teeth treated. And we've known that here for years, and that's why we prepared for teen season. And this year, honestly, Jeff, I feel better about our positioning for teens in the United States and also in Europe.

I have many time since I've been here with these teen packs that we just talked about and how we'll go about it, I think we're well positioned to make further penetration in the teen market versus wires and brackets..

Yes, got it. Thanks, guys..

Thank you..

Thank you. Your next question is from the line of Jonathan Block with Stifel. You may proceed..

Hey, Jon..

Hey, guys. Thanks. Hey, guys. Good segue. I'll start with the teen case packs. We picked up on that program right after April. Quite honestly, unfortunately, I'm old enough to remember your teens pack programs internationally from like a decade ago.

And if I remember this correctly, Joe, it is just hard to collect, if you would, if someone did below their threshold and hopefully, I'm making some sense. So maybe just talk to us -- here you are going after it, you're going after for teens, not overall, you're launching it.

What's going to be different this go round when someone commits to a 50-case pack or a 100-case pack, let's go with 100, they do 88 and you've got to go out there and say, 'Hey, look, it's a user or lose it, we got to collect for you and then also just keep the tenor of the relationship or the goodwill of the relationship intact because now argue even have more options to go somewhere else versus what they were staring down a decade ago.

So maybe if you could talk to that and just the timing behind kicking off the program, that will be a great place to start..

Jon, you're like an Align history, and that's a good question, right? Because I can tell you, I doesn't hear where that happened in Europe, but it's legendary here. But if you go back in time, I think our business in Europe was less than $10 million back then. Okay, now it’s over $1 billion.

And I think the whole world is much more coined with Clear Aligners than when it was back then, we were really pioneers at that point in time. If you look at our DSP program, it's basically the same thing. They make commitments to how many aligners are going to buy over a certain period of time.

We haven't had any issues in DSP with having customers regress or not making those benchmarks. So we feel pretty good about where we are. I mean will we run into a few situations, I think we will. I think they'll be outliers, and we'll deal with them in time..

Okay. Fair enough. And I just might go back to sort of where Jason started a little bit. There's going to be a lot of questions on 2022 and pulling the top line guidance. So let me just throw out a couple of things, and we could sort of work through it. If I look back the past five to six years, the first quarter was about 22% of total revenue.

And if you run that exercise for this year, you get about 11% or 12% year-over-year revenue growth and you've got an incremental FX headwind. So should we throw a dart at 10%? And what's wrong with that thought process in getting to, call it, low double-digit 10%, 12% top line growth for 2022? Thanks, guys..

I think -- Jon, this is John. As we talked about that last earnings, there's a lot of changes that have happened in the marketplace and in the world. And as a result of that, we pulled the top line guidance until we get further clarity as how things are going to shake out.

What we have committed to is being able to grow in a profitable way in a way that you would expect us to be responsible being at 20-plus percent, but we pulled that guidance because of the uncertainty..

Jon, just to add to John's comments, too, is that as we look at April versus March, we haven't seen any momentum from an April standpoint too. And we start from that standpoint also..

Okay. That’s helpful color. Thanks, guys..

Thank you. The next question is from the line of Erin Wright with Morgan Stanley. You may proceed..

Great. Thanks..

Hi Erin..

In the Americas -- hi, good to hear from you. So, in the Americas, can you parse out a little bit about what you're seeing in terms of macro headwinds compared to maybe some of the lingering COVID impact? And does it seem like some -- I mean it doesn't seem like some of these cases are coming back from maybe Omicron delays.

But what are in terms of the dynamics there? Just trying to kind of parse out.

Last quarter, you did break out kind of a COVID impact, but could you do that this quarter?.

It's hard to be very discrete in the sense of what that impact is, Erin. But I'd say we -- obviously faced staffing shortages and things at different doctors in the first part of the first quarter that affected us. I'd say that drifted through to basically late February, early March.

After that, you can -- if you watch the consumer confidence statistics in the United States, they've gone down pretty dramatically. And we started getting a lot of reports from our doctors is patients thought saying no, but patients not as quick to say, yes, that they wanted treatment.

And we hear that both in the GP segment in the orthodontic segment. So, you can call out what you want to, okay? But do we see some reticence in the marketplace to move forward with treatment and again, it's not binary. It's not everybody is saying, no, like in the heart of a deep recession or something we saw back in 2007 or 2008.

It's just more cautiousness from people about their personal finances..

Okay, great. Thanks. And then on ASPs for the balance of the year, I guess, how should we be thinking about that and the levers, I guess, you can pull on that front? Thanks..

Hey Erin, this is John. From an overall ASP standpoint, we don't have any anything unusual from a promotion standpoint or anything else that would affect us. Obviously, notwithstanding FX, we've seen unfavorable FX as we've gone through this year so far. But notwithstanding FX, we wouldn't expect anything dramatically different from an ASP standpoint..

Okay, great. Thank you..

Thanks Erin..

Thank you. The next question is from the line of Kevin Caliendo with UBS. You may proceed..

Hi, thanks for taking my call..

Hey Kevin..

Hi.

So, I guess the question I have is, the first one is really why have the doc adds -- doc starts been so sluggish? Is it demand driven? Is it competitive positioning? Is it -- I would just love to hear sort of why in the US, especially the sort of doc ads have been flattish for the last couple of quarters? If there's anything, if it's macro or micro or competitive?.

Well, I think I read your question, I think you're asking if it's competitive because I mean we're pretty clear on what we've been seeing around the globe in the United States from a macro standpoint, Kevin.

So, I just -- look, from a competition standpoint, we don't see any major issue with competition in the sense of being a factor in this demand cycle that we're talking about..

And when we try to think about the impacts here that are driving all of this, how much do you -- have you guys been able to ascertain how much of this is economic-driven? You're talking about decisions taking longer and people being more hesitant and volumes being down, how much of that is economic versus COVID versus other -- like have you been able to just parse out what's really driving it as a percentage? Is it mostly simply listen, we're in an inflationary environment.

People don't have as much to spend, consumers aren't spending as much broadly versus just an overall demand for your products and/or COVID, like those three things, if you were to group them?.

Kevin, our announcement and the way we communicate to the marketplace, we talk about this huge market, right? We're totally underpenetrated in the orthodontic segment, less than 10% of 21 million case starts a year. Talking about what we see through the 500 million patients. So there's not a lack of demand out there and the lack of opportunity.

There's not a competitive issue that we think is affecting our growth or our earnings. And so obviously, COVID is part of this thing. Part of it we see in Europe was the Ukraine conflict that's going on today. And I think significant amount of it is too is what we're seeing in the marketplace, too, from a consumer standpoint.

I can't put any weighted averages on these things to give you an example. And I think -- if I compare to when we last talked to you at the first couple of days of February, the way things have changed, those variables in that equation, I think, have changed pretty dramatically. So it's really hard to say going forward what that might be..

Are there any goals that you have -- one last one for me. Are there any goals that you have for this year in terms of quantifiable goals in terms of whether it be doc ads or utilization uptick or -- I mean, I know those are the things you were focused on when you talked about increasing your spend.

Like what are you targeting at this point? Is there anything that we can sort of put a stick in the ground and say, 'okay, here's something that the company is hoping to achieve in 2022 in terms of a quantifiable number..

Kevin, this is a growth company. And it never leaves our thought process. So what are we trying to do? We're trying to run the way we always do. We're running at these plays in a much more difficult market with more headwinds. That's all. And so we'll move these place around. We'll look at them by country. We'll see what makes the most sense.

We still keep a good strong focus on how we can grow and where we can grow and we'll find those ways..

Appreciate it. Thanks, guys..

Thanks, Kevin..

Thank you. The next question is from the line of Michael Ryskin of Bank of America. You may proceed..

Great. Thanks for taking the questions, guys. I got two, a few I want to touch on.

Can you hear me?.

Yes..

Okay. Great. Thanks. One is just sort of talking through some of the dynamics we're talking to. You talked for the quarter.

I think we can all kind of see that a lot of it or a lot of it is macro driven, a lot of it's global driven and each of these events that we're following, whether it's the China lockdowns or the conflict in Europe or even things like FX are going to be more temporary than others.

I know your long-term outlook is still there for the 20% to 30% volume growth and revenue growth.

But what about sort of catch-up spend on these things? Is there an expectation somewhere and you kind of touched on this when you talked about your spend and your expectations on investment this year? As we go through the next couple of months, next couple of quarters as some of these things start to fade, are you expecting another bolus of catch-up as these cases come back like we saw in 2020 and 2021? Anything you can sort of comment on that? And then I've got a follow-up..

I think a bolus, you talked about -- I mean, that was interesting is what we saw after the last downturn, it was first like COVID. I mean I look at that, Mike, overall, is it just shows you the demand out there for our kind of procedures. So it's there.

And so John and I are in setting here are predicting another bolus or a wave or whatever, but I think it just shows you the demand that exists in this business and it can be pent up at times. We'll just have to see how the headwinds that we see filter through the marketplace and how it affects consumers and doctors..

Okay. I appreciate that. And then the follow-up, you touched on this in an answer earlier when you sort of referenced the 2007, 2008 downturn. Obviously, hopefully, we're not going to something quite like that in the coming year, too.

But there's still a lot of talk about recession and sort of what the impact of prolong inflation is going to be on the consumer.

Could you talk us through your plans if things do continue to deteriorate on that front, we're not there yet, but six months from now, a year from now, things are still heading in that direction sort of what are your internal plans for adjusting both on operations growth in that kind of environment? Because if you look back at 2007, 2008, 2009, there was a protracted period of essentially flat growth.

So could you compare--.

Yes, it's Joe again. I just -- we have a really strong balance sheet to start with. It's great to have a strong balance sheet and really no net debt from a company standpoint.

So, look, it's -- I'm not an economist, but I'm not predicting a meltdown of our financial system, like we saw in 2007, 2008 depending on what Federal Reserve does or whatever, we're probably going to see an adjustment as they try to attack inflation. So, look, we -- this business is incredibly healthy. It generates a lot of cash.

It's extremely international now. And we have a lot of levers to pull and a lot of things to do to keep this business going. So -- but if something dire did happen, I feel we got a balance sheet to be able to cover it, too, and we'll manage the business responsibly that way. So, I'd just tell you don't give up on us, okay? We love this business.

We love the position that it's in. We're confident about the future. We're just going to see how these headwinds hit and how they subside, and we'll be ready on either end of that to be able to position this company to do well..

And I might add, just we are a different business than we were back in 2007, 2008. We didn't have iTero.

We have iTero, much more of a global products, much further along in the teen market, more consumer awareness, all the things that we've done over this time period now being 25 years, we've evolved over time and created a business where we're very mindful of what is happening from a demand standpoint, and we can do a lot of things from a leverage standpoint in order to drive that right amount of profitability..

Thank you..

Thanks Mike..

Thank you. The next question is from the line of Nathan Rich with Goldman Sachs. you may proceed..

Hi, thanks for the questions. I wanted to follow-up on your commentary on April and not seeing momentum return.

I was just wondering if there's any parameters you could put around that relative to maybe what you've seen in the first quarter? I guess like would that sort of mean volumes more flattish, anything that you could do to kind of help us think about how the business kind of exited the first quarter and where the current run rate is would be helpful?.

Yes. Nate, I'll give you a quick rundown, and John can give you specifics to is. Look, we -- this is flattish to use your term. When you look at between March and April is more flattish than anything. But just remember, we have -- China is still our second biggest country in the world. It's locked down. Shanghai -- Beijing is going into lockdown.

That's not the first lockdown we've seen in China. Remember, there are several provinces that were locked down before that, too. So, that part of our business has really been impacted in a big way, and that's part of that flattishness that we're talking about, too. So we're seeing impact in every region of the world in different ways.

And on the APAC side, particularly with China, it's dramatic..

I don't have much -- anything to add to it. I just -- a lot has changed as we've seen over the last couple of months, and we're responding to that change..

Makes sense. And I guess, I'd be curious just to get your thoughts on sort of the consumer environment. I know it's been touched on in other questions. But Invisalign treatment is a higher ticket purchase, and we've kind of always thought of it as catering to a more affluent consumer.

I guess, is there anything that you've seen kind of between higher-end consumer versus lower-end consumer? And they're going back to, I think, the way you framed it, kind of the reticence to start treatment, any difference that you've seen among maybe the different segments of the population that could be considering treatment? ..

I commented that back to the other question was asked about teens, right? The teen aspect in the orthodontic segment is pretty resilient, and that is a certain demographic that it's always existed in the sense of the parents that they can afford that kind of treatment of young children.

The adult segment, it's all over the place depending on -- sometimes, it's just teeth straightening. Some of times, it's a broad worth correction on what's going on. We don't have any data in that adult segment to say that a certain FIFA score certain match, certain amount would be fewer people taking treatment or whatever. I don't have that data.

I don't know if John has seen it either. But you'd have to guess that the more your finances are impacted, you're actually going to sign up for a $3,500 to $7,000 treatment depending on what you want or how you're in a contract for it. So it's logical that certain demographics would be less willing at this point in time..

Thanks. Operator, we'll take one more question, please..

Absolutely. The next question is from the line of Elizabeth Anderson with Evercore ISI. You may proceed..

Hi, guys. Thanks so much for the question..

Hi, Elizabeth..

So maybe one question on the iTero scanner growth. Obviously, we saw a deceleration quarter-over-quarter, but still year-over-year growth there. When you sort of talk about how providers are looking at demand, and I realize that not all of that is like pure like iTero sales.

How do we think about sort of what's driving the purchases in the first quarter? Obviously, there is some seasonality. But if you like, overall visits, maybe ex-Clear Aligners are not has maybe haven't been quite as impacted.

Are we seeing sort of a reticence to spend? Is it sort of interest rates going up and people worried about sort of equipment financing? Could you walk us through some of the puts and takes of the demand drivers there?.

Elizabeth, it's Joe. I'd start with the still market is broadly unpenetrated from a scanner standpoint. GP side, the ortho side, an ortho that does a lot of Invisalign, they can have four, five, six scanners overall. So look, with the GE Healthcare for years, ABB, I understand the capital equipment cycle. There is a true cycle in capital equipment.

When people get concerned, they'll delay those kinds of purchases. And I think, obviously, you have -- when I talk about 250,000 doctors that we service today, some of them are going to be worried about what their cash flow is going to look like.

They're going to be reticent in the sense of saying they want to sign up for a scanner that can cost anywhere between $15,000 to $35,000 right now and what we sell. So, I can't tell you by country or by region or whatever, but we didn't see things shut off.

We just saw things as the quarter got through, they just didn't have as strong as demand for iTero than we anticipated. So, we'll have to -- obviously, we get into this way it goes. But there's going to be some more scrutiny, I think, around capital investment, if doctors are seeing less traffic through their practices..

Yes. It's just the delays that they put to not close and necessarily within the quarter. It's not going away, but it's just a delay. And we have to work to try to get them to say..

And you're not having any like supply chain issues on that side in terms of like being able to manufacture the equipment?.

We didn't have any in the first quarter. We won't have any in the second quarter either..

Okay. And one more quick follow-up. In terms of the gross margin impact of the new Poland facility, can you remind us about the cadence of the gross margin pressure when you open a new facility as it scale? So, I'm just trying to be able to parse that out versus maybe some of the deleveraging impact of some of the volume shifts versus that..

Yes, Elizabeth. What we'll see is we'll go live in the second quarter here and that does have a gross margin impact. It really comes down to trying to get as much utilization through the plant as possible converting -- moving those countries and doctors through the plant.

And then once that utilization increases, then you start to see some of that productivity. So, it hits about a quarter, maybe a little bit more than a quarter and then it subsides and then it gets more on a regular operating basis..

Got it. Thank you very much..

Thanks, Elizabeth. Well, thank you, everyone, for joining us today. This concludes our conference call. We look forward to speaking to you at upcoming conferences and industry meetings. And if you have any questions, please contact Investor Relations, and have a great day..

This concludes today's conference. You may now disconnect your line at this time. Thank you for your participation..