Align Technology Inc (ALGN) — Q1 2022 Earnings Call Transcript

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 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?

Thank you, Shirley. Good afternoon and thank you for joining us. Today, I will give an overview of our Q1 results and discuss the performance of our two operating segments: Systems and Services and Clear Aligners. John will provide further details on our financial performance and our outlook for the remainder of the year. After that, I'll summarize some key points and open the floor to questions. Overall, the first quarter presented a more challenging operating environment globally than we anticipated, and we believe our results mainly reflect three key factors: the ongoing effects of COVID-19 waves across all regions, particularly in China with its restrictions and lockdowns under the Zero COVID policy; a weaker economic landscape and declining consumer confidence due to rising inflationary pressures and supply chain disruptions; and the military conflict in Ukraine and its repercussions in Europe. Additionally, since about half of our business is outside the United States, unfavorable foreign exchange rates negatively affected our revenues, margins, and EPS. Despite these challenges, Q1 2022 total revenues of $973.2 million represented an 8.8% increase year-over-year compared to Q1 2021 revenues of $894 million, marking a growth rate of 62% year-over-year. Our Q1 2022 operating income was $198 million, with an operating margin of 20.4%. In Q1, Systems and Services revenues increased by 15.6% year-over-year but decreased by 24% sequentially, following our sixth consecutive quarter of sequential growth and record scanner and services revenue. The sequential results primarily reflect lower volumes due to the previously mentioned headwinds and seasonal factors, as Q4 is historically a stronger quarter for capital equipment sales. For Q1, Clear Aligner revenues grew by 7.5% year-over-year, showing revenue growth across regions and products yet slightly decreased sequentially from Q4 by 0.7%. In our teen segment, 175,000 teens began treatment with Invisalign Aligners, an increase of 6% year-over-year. Invisalign First for children aged six and older experienced sequential year-over-year growth and was robust across all regions. In Q1, non-case revenues, which include doctor-prescribed retention products, clinical training and education, and other dental consumables, performed well with both year-over-year and sequential growth. Our Doctor Subscription Plan, or DSP, pilot launched last year in the United States and Canada is progressing well, generating strong revenue growth. DSP is a monthly subscription program tailored for experienced Invisalign doctors who do not frequently use our retainers or low-stage aligners. We are enthusiastic about the positive feedback and uptake we are witnessing and plan to expand the program into other markets this year. Now, let's delve into the specifics of the first quarter results, starting with the Americas. In Q1, Invisalign case volumes dipped by 1.5% year-over-year. Sequentially, Americas case volumes fell by 4.3%, largely reflecting the impact of COVID-19 waves. We saw this first in North America starting in Q4 2021 and continuing into Q1, and later in Latin America, which caused staffing shortages and practice closures, along with diminished patient traffic and increased deployment cancellations. The latest data gathered from approximately 700 orthodontic practices, encompassing over 1,000 orthodontists across 1,600 locations in the United States and Canada, indicated a decline in underlying patient demand trends in the first quarter for both adults and teens across wires, brackets, and Clear Aligner products. New patient visits fell by 7.6% year-over-year, and ortho starts also decreased by 7.2% year-over-year. In the DSO channel during Q1 2022, DSO practices outpaced non-DSO practices in growth, with utilization led by Heartland and Smile Doctors. Earlier this month, we announced a new DSO partnership with Dental Corp, the largest and fastest-growing network of dental practices in Canada. Dental Corp intends to offer Invisalign brand Clear Aligner treatment to Canadians nationwide through its ortho acceleration program. This strategic partnership also provides Dental Corp's network of doctors across nearly 460 practices with access to enhanced benefits, dedicated learning opportunities, and treatment planning support for the Invisalign system. This month, we also introduced a new Invisalign Teen subscription program in the United States and Canada to help seize the significant opportunity in teen orthodontics, which constitutes about 75% of the 5 million annual case starts in North America. The teen subscription program allows orthodontists to purchase Clear Aligners in case packs in advance, similar to how they currently buy wires and brackets, thus providing simpler and more predictable billing for doctors. This timing aligns with the start of the summer teen season, and we are eager to continue collaborating with doctors to expand their practices utilizing Invisalign treatment. With under 10% market share of teen case starts, this teen subscription program holds the potential to enhance Invisalign adoption within the largest segment of the orthodontic market. For our international business in Q1, Invisalign case volumes increased by 3% year-over-year. However, sequentially, international case volumes decreased by 6.1%, primarily due to the previously discussed headwinds, especially from COVID-19 restrictions and lockdowns in China, as well as the effects of the military conflict in Ukraine in Europe. In EMEA, Q1 Invisalign cases exhibited core growth in primary markets such as Italy and Germany, alongside growth in expansion markets like Turkey. The year-over-year increase in Invisalign case volume in EMEA was driven by heightened emissions, particularly from the orthodontist channel, especially in the teen market. During the quarter, we launched our inaugural directed teen campaign in EMEA aimed at educating teens on the benefits of Invisalign treatment compared to traditional wires and brackets, fostering consumer demand as part of our broader teen growth strategy, coupled with our parent-orientated teen campaign to empower teens to influence parental decisions through peer recommendations. More recently, we introduced the Invisalign Go Express system, the latest addition to the Invisalign Go portfolio for general dentists. Originally launched in EMEA in 2016 as a 20-stage aligner treatment option, the Invisalign Go portfolio is intended for general dentists to treat mild to moderate malocclusions while integrating tooth alignment into comprehensive and restorative dental care. Additionally, the establishment of our new European manufacturing facility in Wroclaw, Poland, remains on schedule to commence operations this quarter, enhancing our flexibility and timeliness in supporting our doctor customers across the EMEA region. Moving to the APAC region for Q1, Invisalign case volumes rose by 4.7% year-over-year, driven by strengthened growth in the GP dentist channel primarily through increased submissions with the Invisalign Go product and in the teen market with more submissions from the orthodontic channel. Sequentially, APAC case volumes decreased by 2.6%, reflecting a more significant impact from surges in new COVID-19 cases that resulted in extensive lockdowns in China. However, Japan and Taiwan performed well despite challenges, and we recorded strong growth in emerging markets such as Korea, India, and Thailand on a year-over-year basis. Earlier this month, we expanded our Invisalign Clear Aligner product line with new offerings that better cater to the growing market in China. The two new products, Invisalign Adult and Invisalign Standard Clear Aligners, are designed for specific cases of malocclusion, providing greater clinical and economical options for moderate to complex cases for private doctors and their patients. During the quarter, we unveiled new Invisalign innovations for the Align Digital platform: a unique blend of software, systems, and services aimed at offering a seamless experience and workflow uniting all users: doctors, labs, patients, and consumers. These new innovations include ClinCheck Live Update, the Invisalign Practice App, Invisalign Personalized Plan, Invisalign Smile Architect, and the CBCT integration feature for ClinCheck digital treatment planning software. Together, these advancements will revolutionize digital treatment planning for orthodontics and restorative dentistry by affording doctors more flexibility and real-time access to treatment plans for adjustments. Each of these innovations is designed to improve the quality, efficiency, and scale of Invisalign treatment planning and enhance the experience for both doctors and patients. Recently, we introduced an enhancement for the Invisalign system that features mandibular advancement, making it the only clinically validated Clear Aligner solution today capable of addressing Class II corrections while simultaneously aligning teeth. Based on customer feedback, we've improved the original design with enhanced precision wins that offer increased durability and comfort, as well as effective overlap to ensure the aligners stay seated and properly engaged, addressing Class II malocclusions effectively in growing preteen and teen patients. Our consumer marketing initiatives focus on educating consumers about the Invisalign system and driving that demand to Invisalign doctors' offices, ultimately seizing the enormous opportunity to transform 500 million smiles. In Q1, we expanded on the success of the 'Invis Is' multimedia campaign across the Americas, EMEA, and APAC, increasing awareness and interest in Invisalign treatment among adults, teens, and parents. Globally, we achieved substantial engagement, with over 23.7 million visits to our websites, reflecting a 113% year-over-year increase, and we delivered over 7.8 billion impressions, which is a 32% year-over-year climb. In the US, we continued to enhance our initiatives across leading social platforms like TikTok, Snapchat, Instagram, and YouTube to raise awareness of the Invisalign brand with young adults and teens. Our campaigns featured collaborations with prominent influencers such as Charli D'Amelio, Lana Condor, Devon Key, Michael Le, and Josh Richards, who shared their personal journeys with Invisalign treatment and their motivations for transforming their smiles. To further our young adult business across the Americas, EMEA, and APAC, we are leveraging our effective campaign 'Invis Is a Powerful Thing,' emphasizing how impactful Invisalign treatment can be for enhancing the self-confidence of young adults. We are engaging top influencers like Leana Green and Lana Condor and integrating media campaigns. Additionally, we are broadening our partnerships with influencers globally and are thrilled to welcome Olympic Gold Medalist Suni Lee, alongside creators Josh Richards, [indiscernible], and Scarlett Estevez, who have chosen to improve their smiles with Invisalign treatment. In the EMEA region, we have amplified our media investments across various digital platforms, including YouTube, TikTok, Meta, and Snapchat and expanded our Invisalign Smile Squad with new influencers. Moreover, we initiated a pilot in the UK to reach teens with specialized campaigns aimed at raising awareness of the unique advantages of Invisalign treatment. Our consumer campaigns resulted in over 8.8 million unique visitors to our website, marking a 170% year-over-year rise, along with over 2.5 billion media impressions. We are also enhancing our investment in consumer advertising across the APAC region, including China, which has led to a 278% surge in unique visitors year-over-year and a 265% rise in impressions. We continue to enhance our presence in Australia by broadening our reach through social media platforms like TikTok, Meta, and YouTube. In Japan, we have built on our successful consumer campaigns by expanding into Twitter and continue to witness a robust consumer response, evidenced by a 373% increase in unique visitors to our site. For our Systems and Services segment, Q1 revenues increased by 15.6% year-over-year, driven by solid scanner shipments and services, but decreased by 24.2% sequentially, mainly due to lower volumes influenced by earlier mentioned headwinds and seasonal trends in capital equipment. Over the past quarter, we have seen ongoing adoption of the iTero Element 5D imaging system we launched last year, which incorporates innovative features like near-infrared technology (NIRI) that helps detect and monitor interproximal caries lesions or cavities while avoiding harmful radiation. A strong indicator of digital adoption in dental offices is the percentage of intraoral scans used for Invisalign case submissions. In Q1, the total worldwide intraoral digital scans for initiating an Invisalign case rose to 87.1%, up from 80.9% in the previous year. Internationally, the percentage of intraoral digital scans for Invisalign case submissions grew to 83%, increasing from 75% last year. In the Americas, 91% of Invisalign cases were submitted using intraoral digital scans compared to 85.5% in Q1 of last year. To date, over 54.9 million orthodontic scans and over 11.4 million restorative scans have been conducted using iTero scanners. During the quarter, the iTero Element 5D Plus was recognized as the best new imaging or CAD/CAM product by DrBicuspid.com and received the Cuspies award, highlighting our commitment to create innovative solutions that assist doctors in transforming lives by guiding patients on their journey to a healthy, beautiful smile. We are proud that the iTero Element scanner won the 2021 Townie Choice Awards, which honor the most recommended products and services in dentistry. The iTero Element 5D Plus imaging system delivers advanced imaging technology, sophisticated chair-side visualizations, and applications that can foster growth in treatment acceptance for dental practices. The ongoing expansion of the iTero scanner installed base is contributing to increased services revenues, along with exocad CAD/CAM software solutions that connect workflows between dental labs and practices. Our Q1 exocad CAD/CAM products and services, which encompass restorative dentistry, implantology, guided surgery, and smile design offerings, contribute to our scanner and services revenues and are vital for extending our digital dental solutions while broadening Align's digital platform to support fully integrated interdisciplinary workflows. As we continue to advance the evolution of digital orthodontics and restorative dentistry, our ambition is to establish orthodontics as a core aspect of dentistry. April 2 marked the second anniversary of exocad joining the Align family. Together, we are committed to ensuring that every dental technician and dentist planning restorative treatments benefits from digital orthodontics first. We remain focused on integration and roadmap development to enhance the Align Digital platform by addressing restorative needs for both ortho-restorative and comprehensive dentistry. Two years after exocad's integration, we are more enthusiastic than ever about the potential to shape the dental industry with innovative technology and expertise that optimize the many advantages of the Align Digital platform, thereby uniting all stakeholders: doctors, customers, labs, partners, and users, as we endeavor to transform smiles and improve lives. During the quarter, exocad participated in the 2022 Dental South China show in Guangzhou, China, where it showcased its latest software release, Dental CAD 3.0, along with other open software solutions such as an Innovative Smile Design program called Smile Creator. The event allowed the exocad team to strengthen relationships within the dental community and explore emerging trends in the growing dental market in China. Attendees experienced firsthand how exocad's guided workflows and effective online communication programs simplify the treatment journey from consultation to final restoration. Finally, this quarter, exocad is inaugurating its new headquarters in Seoul, South Korea, which offers a robust high-tech infrastructure for this critical region of our business. Exocad has been collaborating with a growing number of Korean manufacturers for many years, and this location will facilitate essential strategic partnerships in the region.

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 average selling prices reflecting higher ASPs and up 7.5% year-over-year reflecting higher ASPs in non-case revenues. In Q1, Invisalign case volume was 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 average selling prices 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 aligners 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 is 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 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 points 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 a 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 adverse 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 the 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 adversely 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 the 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's 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, and 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 increasingly 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 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. 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 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 is on our values and ethical responsibility towards patients in treatment. In the process, we are also adhering to the international sanctions that have been imposed. Our IT infrastructure, including core intellectual property, is hosted outside of Russia. Prior to the conflict, we had begun expanding our R&D teams in Downstate, Germany; Madrid, Spain; Toronto, Canada; and Austin, Texas. 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 Yerevan 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 have set up donation centers at our facilities where employees are contributing food, clothing, supplies, and humanitarian care. Many are also taking Ukrainian refugees into their homes. 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. Shortly thereafter, the launch 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 a digital platform. We've created an incredible company unlike any other. Invisalign's unique mass customization business operates in real-time without inventory or distribution at the front end of our market. Consequently, fluctuations in the macroeconomic environment are felt faster at Align than I've ever experienced anywhere in my career. We monitor these trends to make adjustments in our business when needed. Our success is a result of vision, 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 supports 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.

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, they 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. 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. Shifting over to margins, I understand you're not reducing spending given the opportunities you've discussed for a while. Are you still looking at a long-term model of over 25% operating margins? We've seen that for some periods, but is it realistic to aim for that margin while targeting 20% topline growth? Can you achieve both, or must you compromise one for the other in the long term?

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 this current situation is not going to change that.

All right. Thanks guys.

Thank you, Jason.

Hi, Jeff.

Thank you. Hi everyone, how are you? Joe, I'd like to follow up on your previous point. You mentioned that you've managed operating expenses effectively over the years. If the end markets are experiencing a cyclical slowdown, which is beyond your control, do you increase efforts to drive growth, or do you think that wouldn't have much impact? So, are you focusing on protecting margins in the short term? What’s your outlook for operating expenses in the near to intermediate term given the current macro uncertainty?

Jeff, it's more about the latter part of your question. We simply ease off the accelerator. John and I understand where adjustments can be made without negatively impacting the business. We are still committed to investing in innovation in various areas. However, there are several short-term investments that won't benefit us in this current crisis, so we will focus on preserving margins as much as possible. With those investments, we expect to achieve a trade-off, aiming for over 20 percent on a GAAP basis. We will invest where we can anticipate a return, and based on our expected volume, we aim to deliver over 20 percent operating 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? 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. Focusing on the teen market is a solid strategy. We view it as a relatively secure segment. While it can fluctuate, it won't experience the same volatility as the adult market. Comparing it to last year, especially considering the effects of Zoom, makes sense. That's why we are launching our teen products right now and preparing for the summer. We want to capitalize on that demand as much as possible, particularly during this time, since we anticipate challenges in the adult market in the US. This situation is distinct from China, which is facing its own lockdown issues. However, we plan to adopt the same approach in Europe, where our teen volume performed well 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 times 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.

Hey, Jon.

Thank you for the introduction. I'll begin with the teen case packs. We initiated that program just after April. Honestly, I remember the international teen pack programs from about ten years ago, and if I recall correctly, Joe, it was challenging to collect when someone fell short of their threshold. Hopefully, that makes sense. So, could you explain how this time around, as you target teens specifically, what will be different when someone commits to either a 50-case pack or a 100-case pack? Let’s consider the 100-case pack. If they only manage 88 cases, you have to go back to them and explain the importance of collection and maintaining the goodwill of the relationship, especially since they have more options now than they did a decade ago. Could you elaborate on that and the timing for launching the program? That would be a great starting point.

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 they 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 are 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 at 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 this is John. As we discussed during the last earnings call, there have been many changes in the marketplace and the world. Consequently, we have retracted our top line guidance until we gain more clarity on how the situation will unfold. We are committed to achieving profitable growth in a responsible manner, aiming for over 20 percent, but we have withdrawn that guidance due to 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.

Hi Erin.

Great to hear from you. In the Americas, can you elaborate on what you're observing regarding macroeconomic challenges compared to any lingering effects from COVID? It seems that some cases are not resurging following the delays caused by Omicron. What are the dynamics in that area? Last quarter, you provided details on the COVID impact; can you do the same this quarter?

It's challenging to clearly identify the exact impact, Erin. We encountered staffing shortages with various doctors during the early part of the first quarter, which had an effect on us. This situation persisted until about late February or early March. Following that, consumer confidence statistics in the United States took a significant downturn. We began receiving numerous reports from our doctors indicating that patients were hesitant; they were not as quick to agree to treatment. This trend was observed in both the GP and orthodontic segments. While you can interpret the situation in different ways, we do notice some reluctance in the market regarding moving forward with treatment. However, it’s not an all-or-nothing scenario; not everyone is declining treatment as was seen during the severe recession of 2007 or 2008. Instead, there is a general increase in caution among individuals regarding 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 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.

Hi, thanks for taking my call.

Hi. My first question is why have doctor ads been so slow? Is it due to demand, competitive factors, or something else? I would like to understand why, particularly in the US, doctor ads have remained flat over the last few quarters. Is it related to macroeconomic, microeconomic, or competitive issues?

I believe I understood your question regarding competition. We have a clear view of what we've observed globally and in the United States from a macro perspective. From a competitive angle, we do not perceive any significant issues that would impact the current demand cycle we are discussing.

When considering the factors influencing the current situation, how much of this can be attributed to economic conditions? You mentioned longer decision-making times, increased hesitancy, and reduced volumes. Have you been able to determine the percentage breakdown of these influences, specifically the roles of the economy, COVID, and other factors? Is the primary issue that we are in an inflationary environment where consumers have less disposable income and are not spending as much, or is it more related to an overall demand for your products and/or the effects of COVID? How would you categorize these three influences?

Kevin, in our announcements and communication with the market, we emphasize the vast opportunity ahead of us, especially in the orthodontic segment where we are significantly underrepresented, capturing less than 10% of the 21 million case starts each year. Given the 500 million patients out there, there is no shortage of demand or opportunity. We don't believe that any competitive factors are hindering our growth or profitability. COVID has certainly affected the situation, and in Europe, the ongoing Ukraine conflict has also had an impact. Additionally, we see shifts in consumer behavior in the marketplace. It's challenging to assign specific weights to these influencing factors, but compared to our discussions earlier in February, the variables affecting us have changed considerably. Thus, predicting future trends is quite difficult.

Are there any goals that you have for this year in terms of quantifiable targets, such as doctor ads or an increase in utilization? I know those were the areas you focused on when discussing increased spending. What are you currently targeting? Is there anything specific we can identify as something the company aims to achieve in 2022 in terms of a measurable 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 plays 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.

Great. Thanks for taking the questions, guys. I got two, a few I want to touch on. Can you hear me?

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 found it interesting to see what happened after the last downturn, especially during COVID. Overall, it demonstrates the demand for our procedures. John and I are considering the possibility of another surge, but it highlights the existing demand in our industry, which can sometimes be pent up. We will need to see how the current challenges in the market impact consumers and doctors.

I appreciate that. As a follow-up, you mentioned earlier the downturn of 2007 and 2008. Hopefully, we won't experience anything quite like that in the upcoming year. However, there is still significant discussion about a potential recession and the effects of prolonged inflation on consumers. Could you elaborate on your plans in case conditions continue to worsen? We aren't there yet, but looking six months to a year ahead, if the situation is still trending negatively, what are your internal strategies for adjusting operations and growth in such an environment? Historically, during the downturn from 2007 to 2009, we experienced an extended period of flat growth. Could you compare that to our current situation?

Yes, it's Joe again. We have a really strong balance sheet to start with, and it's great to have no net debt from a company standpoint. I'm not an economist, but I don't foresee a meltdown of our financial system like we experienced in 2007 and 2008, depending on what the Federal Reserve does. We are likely to see some adjustments as they work to combat inflation. Our business is incredibly healthy; it generates a lot of cash and is now very international. We have many strategies to keep this business thriving. If something serious were to occur, I believe our balance sheet would allow us to handle it, and we will manage the business responsibly. So, I encourage you not to lose faith in us. We are passionate about this business and confident about its position and future. We will monitor how these challenges impact us and be prepared to adapt accordingly.

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 product, 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.

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 provide a brief overview, and John can offer more details too. This situation appears to be relatively flat. When comparing March and April, it's more stable than anything else. However, keep in mind that China remains our second largest market, and it is currently under lockdown. Shanghai has been affected, and Beijing is also entering lockdown. This isn't the first lockdown we've encountered in China, as several provinces have previously experienced similar conditions. Consequently, this aspect of our business has been significantly impacted, contributing to the flatness we mention. We're noticing effects in every global region in various ways, and in the APAC region, particularly with China, the impact is quite severe.

I don't have much to add. A lot has changed 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 differences that you've seen among maybe the different segments of the population that could be considering treatment?

I mentioned earlier that the question about teens is important. The teen segment in orthodontics remains strong, as there is always a demographic of parents who can afford treatment for their children. The adult segment varies widely; sometimes it's just about straightening teeth, while other times it involves more extensive corrections. We don't have specific data on how external factors like FIFA scores or match events may influence treatment uptake in adults. It's difficult to ascertain if the economic situation affects interest, but it seems logical that people would be less inclined to invest in a treatment that costs between $3,500 to $7,000 during times of financial uncertainty.

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

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 want to start by noting that the market is largely untapped when it comes to scanners. On the general practitioner side, particularly for orthodontists who frequently use Invisalign, it's common for them to have multiple scanners, sometimes up to six. Having worked with GE Healthcare for years and ABB, I'm familiar with the cycles in capital equipment. These cycles can lead to delays in purchases when there's uncertainty. Currently, among the 250,000 doctors we serve, some may be concerned about their cash flow, making them hesitant to commit to purchasing scanners that range from $15,000 to $35,000. While I can't provide specifics by country or region, we didn't notice a complete halt in demand. However, as the quarter progressed, we saw that the demand for iTero was not as robust as we had anticipated. We will need to see how this develops moving forward. There will likely be increased caution regarding capital investments if doctors experience reduced patient traffic.

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 scales? 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. We are planning to go live in the second quarter, which will have an impact on our gross margin. The key is to maximize utilization at the plant by efficiently processing the countries and doctors. As utilization increases, we will see a boost in productivity. This impact will last for about a quarter, possibly slightly longer, before it levels off and we start to operate on a more regular 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.