Align Technology, Inc. (ALGN) Earnings Call Transcript & Summary

May 6, 2025

NASDAQ US Health Care investor_day 227 min

Earnings Call Speaker Segments

Unknown Executive

executive
#1

Please welcome to the stage, Shirley Stacy.

Shirley Stacy

executive
#2

Good morning. Thanks for joining. Great to see everyone here in New York. And those of you online, welcome. Real quick things I want to cover for our 2025 Investor Day. A couple of quick housekeeping items. So the meeting is being webcast, obviously, online and there's a link on our website, if anyone needs access to it. We will be posting the slides within the next day or 2. So if you're looking for those slides, those will be online. The meeting is being recorded. [Operator Instructions] We also appreciate that those of you who came during registration and went to the product cafe had an opportunity to get a face scan and an iTero Lumina scan. That will be available to you if you miss that opportunity to do that during the break or at the reception at the end of the day. Housekeeping, restrooms, all the way down the hall in the very back past the elevators. And for the Q&A session today at the very end of the day, just a reminder, there will be mics running up and down the aisles. So we want to make sure we capture your questions. So if you don't mind waiting for somebody to bring a mic to you, that would be fantastic. And I think -- oh, one last thing, and I said it earlier, in case you missed it. We are raffling off some ultrasonic Invisalign ultrasonic cleaners. So put your business card in the glass bowl at the product cafe if you get a chance. Now on to the super important things. As you all know, this is our safe harbor and forward-looking statements disclosure. This will also be posted on our website. I refer you to the company's filings and disclosures on our website and at sec.gov. Non-GAAP financial measures and any of the reconciliations also available on our website and will be posted with our presentation. We have a pack full agenda today. And we're super excited to have the Align leadership team here with you today along with other extended members of our management team, really want to spend time with you during the breaks and in the reception and Q&A afterwards. So look forward to a follow-on discussion after our presentations. And with that, I would like to turn the meeting over to our President and CEO, Joe Hogan. Thank you.

Joseph Hogan

executive
#3

Good morning, everyone. Great to have you on a sunny New York day. Doesn't ever disappoint you when I'm here for sure. It's my title slide, but honestly, if you just look at the slide, digital transformation is going to talk about a 30-year journey of Align's digital transformation. And then secondly, practice efficiency and patient experience. It's where our technology goes, it's our salespeople and conversion people knock on doors, dentists and orthodontists all around the world moving forward from a digital technology standpoint and how it changes dentistry. And these slides here will reinforce how we're getting about that and what we think the future looks like. So overall, digitizing orthodontics and the takeaway here is making tooth movement as standard of care. So it hasn't been a standard of care historically because it can only be done with wires and brackets and by a very elite group of orthodontists that do that around the world in an incredibly technical way to do that. With the digitization and aligners, you can take -- there's just a breadth that you can use as far as straightening teeth for different reasons, and we'll go over that today. And Jelco has a really great presentation on how to break that into general dentistry through labs that we'll talk about more later on. But overall, empowering doctors, in other words, giving them technology that they can face consumers with and explain not just abstractly, but with a scan and a diagnosis that you can share from a consumer standpoint exactly what you're going through. To me, dentistry has been a dark art for most of my life. You had to really trust your doctors, you had to trust your technician what's going on. Now you can be a partner like you are in the medical device industry where you can just see exactly what you're dealing with. You can see it upfront; you can have those discussions, and you can make intelligent decisions about how you want to go forward with your therapy. Enhancing patient experience, I think if you had a scan out there, you can see that right away. Increasing practice efficiency, digital does lead to efficiency and the way that we program these things and how fast we can do things now versus even 10 or 20 years ago is incredible, okay? And then expanding access to care. When you have this, when it's digital and you can spread that across the board, it's not just from a North America standpoint, from a global standpoint. It's not just an orthodontic place, it's a dental place also. So I'm going to take more time on this slide than any of the slides we have. We're on a 30-year journey, and we're 28 years into it. And this is a technical journey on digitalization. If you go back to what I'm calling digital as esoteric, 2000 to 2010, the title was scale and clinical viability. So what we had was an idea of how you could move teeth with plastic, which is ultimately digital. But there's a lot of systems that had to be in place in order to do that. And there was no company in the world that could do it because they weren't focused on it. So we had to do it ourselves. It took a lot of money and time to do it. So you can look, start with -- so we -- from 100 patients to 1 million patients during that period of time, displacement-driven systems. Srini will talk about it today. Srini's taken us from there all the way to 3D printing now. Sri will talk about how we do treatment planning, how that works. But displacement technology to me is just a simple 2D technology. The teeth are here now, I'm going to create another aligner, where those teeth should be, and it moves. What we have learned to do over the years is actually load that particular aligner with the right polymer to load it, almost 3 dimensionally in how to move teeth. You can rotate the teeth. You can extrude the teeth, right? You can spread the teeth apart those kind of things. You couldn't do that initially. We didn't know how to do it, and we had to invent that technology. Our clinical viability, fancy name for how many patients we could do in the sense of walking into the office. About 30%, we could cover in those first 10 years. They were all adults. Teens were a little bit too difficult for us to do. 3D printing SLA, there was 3D printers back then, nothing at scale. It's a prototype industry. And today, outside of sintering technology, it's still a prototype industry today. Emory Wright is going to talk to you about 3D printing and how we're going forward with it. One of the pioneers that we figured out how to do this, we use 3D systems printers. We use 3D system type of resin, but they didn't know how to get to a 1 million aligners a year. They have no way to stretch your equipment that way. We had to take the equipment. We had to modify it. We had to make sure that the resin was proper, that you could do that on that scale. It took us years and millions and millions of dollars in order to scale that business in those first 10 years. It's like no one knows how to do it even today, okay? 3D printing SLA, single layer materials. So the polymer science that encapsulates the code that Sri and her team rights that moves the teeth, it has to -- the polymer has to be a way you can express that code as well as possible. And I grew up in polymer science as my first jobs were GE Plastics or whatever. And it's hard to find one single polymer that can do everything you want to because you -- ultimately, you run in this thing with polymer science where you need ductility you need rigidity. And with those 2 things are countervailing in a sense of a molecular structure of material to make that happen, right? So we started off with a single-layer materials. I think it was a urethane-based polymer that moved teeth fairly well. But that's what we had to deal with and that's what we went forward on, right? Clinical accuracy ClinCheck was almost completely analog, right? We'd go back and forth. And it was nothing but PVS impressions down at the bottom. So if you're going to look at Invisalign case, you're going to get a bunch of goop in your mouth, wait until it hardens you're going to put it in a box as a doctor, you're going to ship it down to Mexico at that point in time. And they're going to put it on a CT scanner and actually a GTC scanner to give you an impression, right? And once you had that digital format, then we can work on it from the ClinCheck. But everything we had -- the point is we couldn't take anything from industry. There's nothing there that fit this business model, but we had to do. We had to make it ourselves. And the last is Invisalign wouldn't be here today if we didn't consume or advertise because there's no way a doctor really wanted to do Invisalign. It was hard to do. It's a different science altogether. And unless a patient came in and insisted on it, they were not going to get it. And that saved Align. I don't think Align would have ever had the investment money in time in those 10 years to do what we did, if we didn't have certain amount of adult patients that just said, "Hey, this is what I want, this's what I can do," and it got the company going. And that today, obviously, our consumer part is still a big play for us in the sense of pushing on orthodontists, pushing on GPs for patients asking for Invisalign treatment. First 10 years, a struggle to scale, I would call it, okay? And that's why it's -- digital is esoteric because we're kind of halfway there. 2011, '20, digital is hybrid. So we're almost right in between analog and digital and fully digital. And just walk down biomechanics and ML software. We started to learn the biomechanics of how do you load that aligner to really move teeth in a complex way. Clinical viability moved 80%, especially when we got to Invisalign first in 2017. And that was -- we were really deficient in the teens area. And that product, which is an arch expansion, and Srini will go over, it is a terrific product in that way, it really took us in a teen market in a way that we couldn't get there before, okay? Multilayer smart track material, combined a polyester with a polyurethane that had that span, that rigidity inductility spectrum that you needed to really move teeth the way we wanted to an incredible breakthrough for us in the sense of using -- having our algorithms properly expressed in that aligner to move the teeth, okay? 1 million aligners a day. We finally scaled to doing 1 million aligners today, and I don't think there's been any company in history that actually has made 1 million absolutely unique products. This is mass customization. I can't think of any other industry I've ever seen, read about, have been part of that got to that part of mass customization. And again, that was a long journey for us to really understand it and get it to that point, okay? ClinCheck scale and efficiency. So at some point, with ClinCheck, we move ClinCheck to the cloud from just a server-based system. And that opened up dramatically what we could do with ClinCheck and how fast that we could work back and forth with doctors all around the world. And Sri will talk about that today. And her and her team have done a great job of really bringing that to the next level overall. Consumer brand scaling, you know through that period of time, obviously, with Google in different areas and different ways to go to consumers. We've been capitalizing on that. And obviously, it helps the brand and helps us drive business. At this point in time, though, between 2011, we're still on PBS scans of only 50% roughly. Remember, every time you do a PBS scan, 7% to 8% of them are rejected. You put it in a cardboard box, you ship it somewhere, you call the doctor back say, it doesn't work or whatever. It was just a messy analog system in the front of a, I'd say, rapidly maturing digital kind of system we were doing with treatment planning. Move over to 2021 and 2030, hundreds of millions of dollars of investment, okay, in 3 key areas: Best scanner in the world. That's not a scanner anymore. It's not a PVS impression device. It's the front end of our digital ecosystem, we'll cover for you today. It's just a window on your teeth. It's a window on your oral health. It's a tool for patient communications and an incredible tool for doctors, too, okay? Biomechanics, ML and AI software, we've always been doing machine learning here. With AI, and I know every senior in the world talks about AI. With the amount of data we have, 20 million patients, and the depth and understanding of that technology, machine learning and AI just fits well. With AI really starting to scale now globally, it really helps us to even be more efficient in that area. Clinical viability is now is a 100%. We can do any case in Invisalign. And we really crossed that chasm when we got to mandibular advancement with occlusal blocks we launched recently, and then Invisalign Palatal Expander for kids in -- we'll go through those products. But now we can comfortably say, a doctor can't honestly say to anyone and Invisalign can't handle your case. Now a doctor might have a preference in the sense of what they want to do, but clinically, we can do that case, we probably can do it 6 months faster with more predictability and obviously, a lot more patient comfort than you'd have with an analog process. We're going to talk a lot today about direct 3D printing. So the dream in this business, since the time we started scaling back in early 2000 was goodness, we print the mold, we vacuum form in line over top of it. You can't change the wall thickness. You can't add different designs to it or whatever. You're frozen that 30-mill sheet of plastic did you have to pull down over that mold. Orthodontists ideally and GP's ideally will want different wall thicknesses and want different pieces for different patients in different ways. We couldn't really offer that unless it was some kind of adjunct hands-on process that add a lot of cost to each aligner in order to do it. Secondly, is 95% of the plastics we use were tossed out, thermally recycled or put in the floor tile or whatever. But 95% of them are gone because you're just using molds from an SLA printing standpoint, and then the trim that you have around the vacuum form plastic would be gone. With 3D printing, absolute design flexibility, put as much wall thickness, adjacencies or whatever you want to do on that. Secondly, a much more efficient kind of a process. No one could get us there. Srini will talk and take us through there. Srini started here. Srini's been here for almost the whole existence of the company, and took us through to the point that we have our own polymer. We have our own process. We'll walk you through what that is. And we're back to where we were 20 years ago. We got to scale a new process to get it up to millions of parts a day. ClinCheck, so ClinCheck -- remember, ClinCheck is a critical interface between a scan and us doing the diagnosis and sending it back to the doctor in some way. So what we call IPP protocols, and Sri will talk about today, probably at the end of this year, about 20% of this will be touchless. Remember, this used to take maybe 4 weeks to do back in that period between '20 and 2010. Back and forth, doctor wants to change something, we have to change it, send it back, can we manufacture it or whatever. Today, you can scan in minutes, you can have your protocols. You can get on 3D controls, which is kind of like Photoshop, change the teeth what you want. If it's within the parameters you think it makes sense, you hit a button, and it goes. Millions of lines of code in dollars and time in order to make that happen. And we're setting out a press where we think in this period to now till 2030, we'll be doing 80% of ClinCheck's will be touchless. And that's -- you scan, protocols are done, immediately the patient sees what it is, hopefully, we have aligners to them within 7 days, okay? Scaling to 2 million aligners a day, 3 million aligners a day is where we have to get, and we have to get that with our 3D printing capability. Invisalign brand, #1 for teens and adults. The teen piece is really important now because we are 100% of the product. So it's -- we're going to be heavily advertising toward teens because in the orthodontic market, it's still 75%, 80% of the marketplace. We have a portfolio that's much better for those teens. You'll see that come out today. And then 100% IOS. And the IOS is intraoral scanning. Again, not a PVS impression. This is about diagnostics now. It's a window to your oral health that we can actually provide. And again, a great conversation piece for consumers that are sitting in that chair, but also for doctors in the sense of how to develop that therapy. 30 million patients plus when you hit that. So there's been a huge amount of time, momentum and effort in those 3 areas that take us to where we'll go over the next couple of years, and you'll see this come to fruition. I thought -- this is interesting, just if you take a look at a glance. On the top, total revenues, and this -- what grabs me here is I just want to just show from a clear aligner standpoint versus iTero and a scanning standpoint. It's not a big change, but it was about 14% in 2018 and moving to 19%. But it should always be in that 15% to 20% range in the sense of the scanner revenue versus Invisalign. So as you put your models together and you think about it, I think it's just a good grounding for you. Secondly, when you look at clear liner volumes, ortho versus GP. On the left, you can see the -- in 2018, GPs were 35% of what we did and orthos were 65%. Move to the right, obviously, roughly 6 years later, it's like the same. What that tells me is that the GPs aren't stealing from the orthos. We're just growing this market. 1.3 million overall in this whole thing in cases, we're just growing this market together. So that GP market is just the biggest opportunity is ortho. It's not that the GPs are stealing the orthos business. They can peacefully coexist together and they're -- because there's 2 different ways of doing this now. Align, clear aligner volume, regional mix. And I think as you put your models together and you try to figure out or project how Align is going to grow, this is a good -- look at Americas that was back in 2018 about 59% and then 17% in APAC and 24% in EMEA. And so you lose about roughly 7 points on the Americas side over, but it's -- the business is growing, again, $1.3 million, and you just get a much better kind of around this in the sense of the geography and what we sell to. And I don't think this is going to change relatively dramatically because within the Americas, we have Brazil, Latin America that's growing well. America still has a great growth profile in both GPs and also orthos. But I think, again, when you look at 2018 to 2024, not a dramatic difference, but the Americas doesn't constitute as much of our success as it did in the past. Clear aligner shift to teens and kids. So we'd look at the teen's volume overall. And this is a big jump when you think of teens again are 80% of the marketplace from an orthodontic practice standpoint. Back in 2018, we're about 73% of adult, 27% teen. We've gained significantly 35% on the teen side and 65% of adult. You'll see that today, a lot of that came from kids. So not permanent dentition teens, but it came from Invisalign Palatal Expander, it came from Invisalign First, one of the most successful products we've ever launched, and also mandibular advancement. That those young ages where you can move bone as well as teeth and actually do facial reconstruction. We've been very successful in that area, and it really helps to round out our portfolio, not just in the U.S. but all around the world. So to me, it's great to see that teen growing in that sense because we put so much money and time from a business standpoint to address that marketplace. Just taking it all back just to ground you, 75% of the world has malocclusion. And what's that mean? It means if you don't have your teeth fixed, you're losing a enamel every day. You just losing enamel because your bite is not right, it's not -- and you're going to gradually lose enamel. And if you lose enamel, it's the most important part of the oral health. And so it's not just about aesthetics with Invisalign. It's about oral health overall in saving enamel. Digital opportunity, 2 million doctors out there. We have about 100,000 Lumina scanners Karim will give you a good talk on Lumina, Lumina is a breakthrough in technology. We've invested in it for upwards of 6 years to get to where we are today. We really wanted to move beyond confocal imaging because there's some design constraints there and capability. We want to, what I would call, almost a true medical device is what Lumina is in the sense of how it's structured and Karim will take you through it. But we couldn't be more thrilled in the sense of how this products launched, the overall acceptance in the marketplace and then a platform that we can really scale and grow from too. GPs. The GP market is a great market. It's a fascinating market for us, too. So 75% of the people I mentioned have the malocclusion. So that's a tooth movement piece, and GPs can get at it. And we've it down really well. Obviously, with Heartland, we talk about it. Our quarterly reviews, how well we've done with different DSOs that can help to multiply the effect of getting that message out there. But in a comprehensive dentistry sense, in the restorative sense, there's a lot of enamel being lost when you have an implant or when you do an aesthetic procedure on your social 6, there's a lot of times that you're going to carve off enamel of the adjacency of the implant or you're going to carve enamel off your front teeth, if it's done at a GP practice without moving them. And what Jelco is going to explain to you is how and kind in conjunction with exocad, we're going after that market to have people save enamel. So you avoid that kind of shaving off of enamel. You move the teeth first and then you apply what we call an ortho procedure -- ortho restorative procedure behind it. It's a big marketplace for us out there. And it's one we're excited about and where the exocad acquisition that we did several years ago makes sense. 22 million case starts per year. We got 10% market share. A team still -- the majority of the marketplace. Adults were kind of reversed on share, 30% adults, 10% share on teens, but we know teens is a wholly grail. That's the marketplace in ortho. That's why we are so focused on our portfolio. You get to 3D printing, when you get to 5-minute ClinCheck or ClinCheck in minutes, you have Lumina scanners in the case it is. We have technology that makes it -- and one of the big questions going to be why haven't you grown for 3 years? Like what's been going on with this business overall. A lot of it, we can point to market. My next slide, we'll deal with that, and we'll talk about it in general. But there's a lot of friction. If you're an analog doctor, whether it's on GP or if it's on the ortho side, and you look at the Invisalign system, I think it's almost unfathomable for doctors sometimes to say, "I have to change everything in my office to make this work." And so when we talk about minute ClinCheck, and we talk about Lumina how fast it is, we're trying to do is take the friction out of the system and to make it much easier for doctors to be able to adopt our system and not have to contemplate a year-long kind of a journey of moving their practice from analog to digital, especially in a time from an economic standpoint where they might have concerns on patient flow. This is how 22 million case start -- orthodontic starts a year spread out. It's pretty equal around the globe. Americas and APAC, the same and 6 million in Europe. Back to that question about why we haven't grown in [indiscernible]. A big part of it, this is unprecedented at the orthodontic market in the U.S. would be down 3 years sequentially. It's never happened before. And why is that? I think some of it could be a COVID overhang. There was such a growth rush back in 2021. There could have been some pull forward there. Obviously, the economic search and circumstances haven't been helpful in that sense. But that's the numbers on the orthodontic side. This is -- I'm not predicting the demise of the U.S. orthodontic industry. This is going to recover. It's a strong industry. Orthos are very secure from a financial standpoint. It's just that patient throughput has been down for 3 years, which is unprecedented. I'm confident that, that will come back, and that market will strengthen again in the near future. Future of teen orthodontic deal. This is -- people in this room that have been here over 25 years, been on this whole journey almost 28 years. And this is what gets us 84% of prospective teen patients prefer Invisalign clear aligners over traditional metals and brackets. When they walk into an orthodontic, orthodontists today in the United States, 30% might get it, 25% might get when they ask for it, right? Our job is to make sure we move that friction, remove any concerns that those orthodontists have technology and can look at this as well as a business opportunity as well as it is a clinical opportunity for them. Now I'm pleased when you look at Q1 '24 and Q1 '25, we're up double digits, 13.3% in teens. That's almost unprecedented for us over the years to see teens grow that way. Again, IPE, Invisalign First, MAOB are helping to lead the way. On this slide, I want to just get a few points and then I'll get off the stage here. One is we're navigating a very dynamic market right now when you look at it globally. And I think we all know what's going on globally. But I think we're navigating it well and we reported in earnings where we are in tariffs and different things. But on wires and brackets, when you think about competition, you asked about competition, our biggest competitor in the world are wires and brackets by far, it's still. That's our goal. And that ortho I'd say that ortho, parent anxiety what orthos will say that don't want to do Invisalign is this your -- 1 that used to say Invisalign can't handle your case. They really can't honestly say that anymore. Secondly is, a, your kids won't wear the aligners. We see it all the time. Many orthos though, that are over 65% Invisalign will just say, look, if they don't wear the aligners, I know they will. I look at your kid. I get their dentition. I know they take care of their teeth. They're going to wear their aligners. If they don't, I'll put them wires and bracket, no charge. Those doctors end up with 80%, 90% Invisalign or more that do that, okay? Those are the doctors who really want to do it overall and not encourage something else. But if you look that previous slide, 85% of the patients want it. That's why we're all still here. It drives us crazy, right? Patients want it. We know we can do it. We have to reduce that friction and gain doctors' confidence in order to make those critical next steps to grow the business. Our direct-to-consumer model, SDC, SmileDirectClub, it's in a rearview mirror now from whatever, but that model didn't work. It didn't work because you spend more money advertising than you actually could gain from patients, but we did learn a lot from SDC, and one, there's a severe price elasticity curve in this business as a lot of people will take digital treatment at certain price levels. They were very cognizant of, and our doctors are cognizant, too. Every conventional dental company that we compete with now have come out with a clear aligner, okay? My feeling about those clear aligners, they're all substandard, okay? The software is substandard, the plastic is substandard, their distribution force is substandard because it's not dedicated. And I'm not talking against them, it's just -- this is a tough deal to play in. Look, I've run conglomerates in my life. I had a big conglomerate at ABB that I came from. A lot of different businesses at 1 time, GE Health Care is a big one. When you run a conglomerate, you have to feed a lot of mouths. And it's very expensive. You just can't -- and it takes a lot of money to walk up that 30-year track that I talked about in that third slide, a lot of money. If you want to be good in this industry, you have to invest. I think the conglomerates are not stupid, it's just it's hard to have money to make the investments indeed to really drive this industry for you. So single players that are focused on aligners are the ones that I think will do the best. But secondly, and I'd say the one that we see the most right now of the single focused players, Angelalign out of China, we know those guys. We've known them in China for years. We're still the #1 aligner supplier in China based on revenue and growth. As they come into the marketplace and out of China, you can't scale on the average selling prices that they're moving into the marketplace. You just can't afford the scale. You can't get into 3D printing. You can't do minute ClinCheck. It just is prohibitive in that sense. So there's some kind of a piece with that where, at some point in time, you have to have a better product and not just play on price, okay, or you have to find a way to scale with this. But again, these -- all these models are tough models, and this industry is not a static industry. It's moving, technology is moving all the time, and you have to move with it. And we feel we lead that, and we'll continue to lead it. So just to end, and I can't overemphasize deep and broad technology, okay? And then again, I took a long time on that third slide, and that's one I want to get across. Distribution is so critical in this business. It's more critical than any other business I've ever run. Our salespeople are kicking doors down every day. These are individual proprietary businesses of people that aren't businesspeople, they're clinicians and you're talking to them about a whole new way of doing something. Your field -- the capability of your field force and what you arm them with is one of the most important things that we have to do in this business. Global scale with regional and local touch. So we are a very global business now. We're fully capable in China and from an Asia standpoint. We're fully capable in Europe now with Poland. And it pays to be global, and you have to have local touch. And last, brand power for doctors and consumers and patients. We have to keep emphasizing that brand. Remember, that got us as far as we are, we'll continue to drive that. So appreciate your attention with that I'll introduce Mitra, our favorite orthodontist here at Align.

Mitra Derakhshan

executive
#4

Thank you, Joe. Hi, everybody. I'm Dr. Mitra I've been with the Align just coming up here 25 years, and I'm super excited to be here with you all today to really talk to you about our clinical leadership and how our clinical leadership is really -- has an advantage in superiority when we look at our innovation, our products, our treatment planning, support and services. Joe talked about the global opportunity and that 75% of the population out there has malocclusion. And right? And our vision as he talked about, is about making tooth movement the standard of care. But it's about making that tooth movement through digital. It's the only way to scale. And the only way to scale is through clear aligners. But it's not only about addressing the aesthetics, in order to capture the broader market, we need to focus on helping our doctors scale and treating patients that impact as well as the function, the bite, but also the ability to do tooth movement and tooth straightening in cases that could be preventative from helping prevent something in the future for patients. Now the orthodontic opportunity, as we know, lies in with kids and teens. And our investments in the last few years have been really focused in this area around kids and teens. If you think about what we're doing with our orthodontists is we are partnering with our orthodontist to help them scale their business, their practice for efficiency and profitability, while continually deliver those exceptional clear outcomes with clear aligners. And it really boils down to 3 key bucket areas. It's about clinical and clinical superiority, continually showing that we are either on par with delivering clinical outcomes with braces or even superior in many times, having the portfolio to address the full needs clinically for kids and teens, but also bringing education, education to parents and patients around the impact of orthodontics around the impact of clear aligners for early kids and teens, and really addressing and impacting clear aligner advocacy and addressing the myths around compliance. And then it's really about helping them scale what is most critical to their business and what they do every day is treatment planning, and that ability to digitally scale that treatment plan, but what's important to orthodontists is keeping personalization and control and having that in the moment treatment planning. So there is a lot of evidence out there around the clinical efficacy of Invisalign. But what puts a line in a unique position is the power of our digital database. We have 20 million smiles like no other clear aligner company has. We have the ability to go in there and machine learn, look at that data. And in fact, we just looked at the last 2 years of data from Vivera scans, where we had braces finishes and Invisalign finishes. And you can see with the sample sizes of hundreds of thousands of cases, we can see equivalent outcomes of braces and Invisalign in the North American population in teenage population. There is no question here in the power of the Align database and the power of the efficacy of the Invisalign clear aligner system. And this further validates with hundreds of thousands of sample sizes the Invisalign system. But what the opportunity we have forward is to take this data and now help educate our doctors, but also our consumers on the efficacy of clear aligner. Now the portfolio is just as important. And Joe talked about this, and several years ago, we launched Invisalign First, very successful product for us, a product that helped us grow globally and has helped adoption for our doctor customers, orthodontic customers globally. But remember, when we talk about kids and teens, it's not only about moving teeth. We need to be able to have a portfolio that moves jaws, that moves the skeleton. Kids and teens are growing. And it's that time where we need to help not only do orthodontic tooth movement, but what we call dental facial orthopedic movement, helping them with their jaws and growth. And we need a portfolio, and we've been investing and expanding our portfolio, so that we essentially could treat any child and any teen in an orthodontic office no matter what clinical condition they have, whether they need expansion for permanent teeth, whether they need to bring their lower jaw forward because they're Class II, and Class II being one of the largest prevalences of malocclusion out there with 45%. So a product like MA and specifically mandibular advancement with occlusal blocks helps capture this market by allowing not only Class II correction, but also if there's Class II deep bite and bringing more efficiency for the doctors and treatments. So a broad portfolio is important. But we also know that as we expand into the kids and teens segment, we need to help educate the parents out there, but not only educate them about clear aligners, but focus on the clinical needs and benefits of clear aligner therapy, but for early orthodontic treatment. And what you'll start to see in market... [Presentation]

Mitra Derakhshan

executive
#5

So really helping parents understand the clinical need of why they need to see an orthodontist early. But our opportunity here as we move forward is also, we're partnering with many societies with our customer doctors in getting this message out to have children get in early to see an orthodontist and have an orthodontic exam for the future. Now what we've seen is kids are more compliant than adults with clear aligner therapy. But we also know that parents may still be skeptical and have concerns because it's a removable appliance. Despite the many advantages of a removable appliance on the quality of life, on the oral hygiene, parents may still be concerned that patients may not be wearing the aligners. And so the parents are the same. We live in a world where they're digital just like the kids are digital, and we've developed tools and Sri will continue to talk about this and how we provide digital engagement between parents, the treatment and the kids to help monitor compliance with tools like Invisalign Virtual Care. But we've expanded that not only for monitoring and support but to allow family sharing. So parents can look at multiple kids give real-time compliance feedback to parents around their child's treatment journey and also been focused on expanding that product support across our kid and teen portfolio, which is where the impact will be the most moving forward. At the core of what a doctor does and ultimately, what every patient needs is a diagnose and treatment plan. We are a medical device, and, in the end, every patient needs a treatment plan. And the only way to help an orthodontist scale is to help them scale digital treatment planning. And over the past years, we've had many building blocks around our ClinCheck software, and Joe talked about the journey, and Sir is going to talk a lot about the technology, but from a doctor perspective, it's a vision that is now realized really in 2025 with the ClinCheck signature experience. And for orthodontists, it's not only about helping them scale digitally on the treatment plan and allowing them to have that personalization and control because every orthodontist is unique, the treatment plan differently. They're distinctive and every patient is unique. And so Align really is the only one who has the technology and innovation to be able to automate multiple and hundreds of doctors' clinical preferences so that they can save time in their treatment planning. Because as we know, the -- as the Invisalign volume increases in a practice, the ClinCheck throughput reaches terminal velocity. And the investments we've made and brought together around this ClinCheck signature experience is really to help our doctors scale, the part that is most critical to their practice around digital treatment planning. We continue to provide them with tools like 3D controls, plan editor or live update, so that they can still personalize and control, but give them the time back and help them build capacity, so that they can increase more throughput in their practices and help them scale. Now in a GP practice, the opportunity is different. If you think about a GP practice, the patients and the opportunity lie in the practice and in the chair. And again, 25% of the patients in that practice have the opportunity for tooth alignment or tooth straightening. But the partnership we have for our GP customers is different. It's about how do we help them integrate tooth movement predictably and efficiently in their practice for any type of GP practice that's out there. There's many different ways, GP's practice. There are many different types of GP practice. They're not necessarily the most confident or the most proficient around tooth movements. So it's how we could help them integrate this tooth movement predictably and efficiently, but also facilitate the concept of comprehensive dentistry through multidisciplinary care. And that multidisciplinary care can be ortho-restorative. It could be ortho to -- it could be referrals to the orthodontist. It could be working in a multigroup practice. And if you think about it in a GP practice, it's different. It's about creating relevancy in the GP practice, creating relevancy for the doctor, relevancy for the patient, and they need also a relevant portfolio so that they could treat. It's about how do we provide, again, treatment planning a core part of what GPs need to be consistent and predictable as they scale and help them with their clinical confidence through the journey, and then integrating into their workflows, integrating into the workflows of the doctor, but also their staff and how their procedures are working and bring these tools so that we could help them drive profitability in their practice. So when you think about a patient population in a GP office, many can be teeth seekers -- teeth straightening seekers. They're already actively looking about for teeth straightening; they may already be educated about teeth straightening. And if you think about our focus around Invisalign Outcome Simulator, that's where we focused. Now take that and we've talked to you about that before, where you take that or maybe you've experienced it in the cafe is that you take your teeth and you put them into the patient's face into a smile, that emotional impact that comes, that patient visualization that can help lead to conversion. And we see going from a 3D model to integrating the model into the face brings that emotional connection with 2x more conversion. But there are still a lot of patients in the GP practice who may be unaware of what are the benefits of teeth straightening. They are also many patients in the practice who are unaware of their oral health or uninformed about their oral health. So bringing these other digital tools onto the iTero scanner such as Align Oral Health Suite and Align X-ray Insights allows the GP or any doctor to have those conversations with their patients by showing them the visualization, educating them and then leading to conversion. And so really broadening the type of education and conversion tools that we have to offer for doctors. As I mentioned, portfolio is so critical. So having a portfolio for GPs to address the range of case types, and the different types of practice types is critical. Whether they just want to focus on simple tooth movement cases or whether they want to get into complex ortho restorative procedures, we have the portfolio now so that they could address all these needs. And an area where Jelco is going to talk about is also the GP who may not be proficient in tooth movement or who may not even be thinking about tooth movement who's only focused on restorative for the patient and by their work and partnership with the lab, when they send the cases into the labs, then with their partnership with the lab, there could be a conversation or education about how to integrate tooth movement into their procedures. Just like I mentioned with orthodontists and really, it's for any doctor, diagnosis and treatment planning is so critical. With GPs, it's the same. And really, we're using the same signature experience because it's automated. It helps with digital scale in a practice. But really what positions us in a unique position with GPs is this concept of templates. And again, Align, we're uniquely positioned. We've developed an Align template based on our millions of patients, our ability to go in and machine learning, all the clinical protocols that we've developed over the last 25 years, our G-series, our predictability, our ability to go in and look at what are the preferences that most successful preferences or protocols and build an Align template to help with our -- help our GPs with the diagnosis and treatment planning aspect and the ability to scale. We also can take this concept of templates and expand that with DSOs. So one of the things DSOs looks for is consistency and scale. And so if you're a clinical leader in a DSO office and you have multiple clinicians, you want to be able to treatment plan in a consistent and predictable manner and this concept of templates will also help practices like DSOs further scale. So it's about bringing in the GP practice confidence and consistency around treatment planning for them. So just as we know products and services are important, they're not just the only thing that matters. It also matters that we provide, and we surround our doctors with the support and that support needs to match whatever ever doctor need or style that is. And we are in -- we understand that more than anyone else at Align in how to take our programs, our go-to-market strategies, our education pathways and journeys and really segment that for our different customer segments and look at how we could support and match the needs of the doctor where and how that they want that. And so if you think about Align and our unique position, we have the clinically proven results across our portfolio, whether it's treat simple cases, complex cases, dental, skeletal, the clinical evidence and in the hundreds of thousands that we're also seeing is there. It's about taking that and surrounding that with our aligned digital platform that helps patients to help drive conversions with patients through tools like visualization and education, helping doctors scale the treatment planning and really bringing that integration of -- into their workflow with the different tools. And with that, I'm going to call and invite Sree here to further talk to you about this aligned digital platform and the technology behind it. Thank you.

Sreelakshmi Kolli

executive
#6

Thanks, Mitra. It's great to see all of you, and I'm going to start talking about how software powers all the products and services we build out to make teeth movement, the standard of care and comprehensive dentistry. We also have a suite of solutions for orthodontists starting from teeth-straightening to retention and peer-to-peer treatment planning support that Simon will refer to and the impact it's having with diagnostics and retention solutions with iTero, we are working on very highly relevant products for GPs. Underlying all the software is very high-quality data. We have different sources. We have from x-rays, photos, scans, [indiscernible] images, CBCTs and we continue to add more. What happens is when a patient's journey starts with the iTero scan, it's that moment where raw anatomy becomes structured digital data. So every scan, every treatment, every outcome will continue to feed into the Aligned data ecosystem. And no one else has as much data in a closed-loop format that is starting with a scan to simulation, to treatments, to outcomes. And all of this high-quality data enables us to do continuous AI machine learning modeling. It gives us great insights that help develop products so that we can deliver exceptional clinical outcomes. We can deliver for practice growth and profitability to the doctors and also put tools in doctors' hands, so they can deliver great digital experiences to their patients and their practices. When we look at awareness of the product, all our marketing spend goes towards tooth straightening and the awareness around it and Invisalign as a brand, so that when patients go to the doctor's offices, they understand the treatments they're going to get. And what we do is we use science-based media planning with Meta, with YouTube, with TikTok. So we are reaching the right audience at the right time. And we're also creating compelling stories with influencers and real people telling real stories, so that for growing patients Invisalign is the brand of their choice. All of us are consumers today. And if you look at our own patterns of how we engage digitally. We are scrolling, streaming, searching, shopping seamlessly between platforms. And what we're doing is we're working with Google and their AI to ensure that we have the right message in the right format at the right time with the right audience, so that consumers can recognize what Invisalign, and tooth straightening can do. And the results show the billions of views that we are able to generate and also engagement in apps like My Invisalign that patients use where we have 5 million downloads 400,000 patients use that app monthly. So we are continuing to use this to build more and more digital doctor and patient engagement apps, and we'll continue to innovate on the platform. So now the doctors, the patient is in the doctor's office and Lumina is not just a scanner. It's an imaging platform that allows us to build out lots of different kinds of apps with high-quality scans and images. And we are starting with diagnostics. We all go to doctors' offices. We all have our hygiene appointments. Invariably the staff as well as a doctor is trying to explain to us, we have a filling here, we need a crown there. If you don't do anything about it, you're going to get a root canal. And I just like sort of roll my eyes, I'll say, I'll go home and come back and call you, which never happens. So imagine if you are in the doctor's office and we have AI-based diagnostics on X-rays, and the doctor is showing you what the implications are of not taking care of your oral health, and then also send you home with an automated patient report, you are more likely to take action. And we are integrating it with the Align Oral Health Suite, so that the combination of X-ray data and the scan data on the [indiscernible] images. We're just starting the journey, and there is a lot to come innovation that an AI is made for this type of data and diagnosis in doctor's hands. You can see the patient engagement is 100%. All of this means that the doctor is able to increase their practice revenue and also gain more patient treatment acceptances. Another conversion tool we have is the Outcome Simulator Pro that shows the before and after. We have now enhanced it with the video. And if you have not experienced it in the cafe outside, I highly encourage all of you to go see yourself and the before and the after, in real time, in real form and how that emotionally changes the patient to wanting to get the treatment right their chair side in the doctor's office. We have taken it a step further, and we are showing doctors multiple treatment plan options. So the doctor not only shows what an orthodontic treatment could look like. But if it's really applicable, they will also show what a minimally invasive or the restorative treatment looks like that protects the healthy teeth. And the patient and the doctor are able to have real-time communication that is visual chair side that is giving more tools in doctors' hands to gain patient acceptances right there. As we move into treatment planning, we know that this is a journey that we have been on for -- since the beginning of time. And where we are right now is we have the ability for every doctor to create an Invisalign personalized plan. We have introduced global templates that Mitra just talked about from the 20 million smiles and the insights that we've gotten from that. And the doctor also has several tools like the live update and the plan editor for more complicated treatments that the doctor wants to do chair side when the patient is in the chair, live in the moment, so that they can remember what the patient's clinical conditions are and how to treat them. This process used to take several days and is now down to minutes. And the doctors are telling us about how much it has improved practice efficiency, patient communication has allowed them to change their workflows to ensure that they are able to gain patient acceptances and all of the real-time visualization and the ability to engage with the patient about what the treatment plan could look like is all now available in the doctor's hands. This has been a very, very long journey. I remember similar time 20 years ago, a bunch of us engineers who are trying to write code just to do 2 things: to take ClinCheck from a one-page static view to be able to show the movie of the treatment plan, to be able to keep machines up in the data center as doctors were trying to understand what the plan could look like. And we were trying to imagine what the communication of -- between the doctors and cat technicians should look like in a very static back and forth web form. And then you'd pass forward 20 years, and we look at what we have been able to release just in the last 5. We can do ClinChecks on the Mac. We can do ClinChecks on mobile. If the doctors wanted to do it on the beach, go for it. We're able to visualize routes. We are able to set up treatment plans and also for doctors to finish all these movements live has taken hundreds of engineers 20 million Smile data, thousands of insights from our cat technicians, the convergence of cloud computing of machine learning models and very high-quality data scans that are coming out and even better with Lumina, like all of that has converged and we have able to provide just so much innovation in the last 5 years that that doctors are now able to provide ClinCheck in minutes live as a patient is in the practice. And when we combine this power of what AI can do in truly personalizing the doctor's preferences and all of the dentitions that are available in the world, the billions of them. And what Srin is going to talk about next in terms of what direct fab can provide in customizing appliance tooth by tooth, the power is so large that we are barely scratching the surface of what's possible. And I cannot even begin to imagine what the next 5 years are going to bring. In terms of the products that we're going to build out that will drive exceptional clinical outcomes, that will drive great patient experiences, that will deliver practice growth and profitability for the doctors. And as we move on from treatment planning, we've also been introducing a lot of tools around virtual care and with AI. We want to ensure that patients are taking great pictures with the lens, and we have a lot of workflow tools that we're building out so the doctors and the patients can stay in touch. And AI has helped quite a bit in ensuring that we are tracking ClinCheck to plan. What we've been able to do with growing patients is the parent's anxiety around the compliance of kids, we're now introducing AI through for monitoring across all aspects of the products that we are -- through the growing patients portfolio. And the doctors and the parents and the patients can all stay in touch through the course of the treatment, and we'll hopefully get comfortable. And we get a lot of great data in that doctors feel like they are able to provide as much engagement with their parents and the patients as they would in their own offices. And it also not only helps them stay connected, it is also improving their confidence about how the treatments are tracking, which will also improve how often patients feel about requiring less and less in office visits. So with all of that hard work in building awareness around tooth straightening, treatment planning, getting your treatments monitored, making sure they're tracking on time. We want to ensure that your smiles stay for life. So we are building out products, which are easy to use, that are in the same platform with the practice app on the My Invisalign app that doctors are able to provide subscription options for Vivera and the patients can choose what they -- what options they like. And it's very user-friendly, and we are also able to provide this opportunity for patients with braces. It's not for AI and the ability to detect braces at scale, this would not have been possible. So it's a lot of complex technology that we are using to make the product very simple for the doctors to prescribe and for the patients to use. So the end, we know that as all of the connected data and the connected workflows and all of the stakeholders, doctors, patients, consumers, labs, staff, all of them come together on the same platform that we have to earn the trust every day by ensuring that the data is safe, the data is stable. We are using the models responsibly. And what keeps me up at night is the excitement of what the convergence of technologies can do with AI, hyperscale computing, and what Srini is going to come and talk next about what direct fab can do, we're just getting started. With that, I'm going to introduce Srini to talk about direct fab.

Srini Kaza

executive
#7

Hi, there. Thank you for having me here. So the next 10 minutes or so, I'm going to talk through -- I'm hoping to convey 2 main things to you through my presentation. One is that Invisalign is still the best product in the market by quite a bit. And it's still the best product in the market; and second, innovation-wise that we're still the most innovative company in the world and innovations that matter, right, innovations that scale, that deliver the right amount of performance to our doctors and to our patients. So those -- hopefully, I can convey those 2 points as we go through these slides. Really, what I'm going to talk about is innovation at scale, kind of how we take innovations to solve key problems for our customers and how we're able to deliver it on a consistent basis at a massive scale, right? That's really what we're trying to do, to Joe's point, kind of making 2 million unique devices every day that can precisely provide the right outcomes for our doctors and our patients. That's really what we're -- what we've been doing over the years and what we'll continue to do as I talk about direct printing and so on. So if I kind of take a look back at kind of where we've come from over the years, again, Joe and others talked a little bit about it as -- previously. I would say there's probably 2 main points for you to think about. One is orthodontics is very materials. It's very kind of centric on materials, right, so having really high-performing polymers that can deliver the right outcome. You can -- otherwise, none of the other stuff matters, right, because you -- whatever you design, you need to be able to deliver it in the patient's mouth. So SmartTrack is that material that can deliver it. And we're not done with that, by the way. We keep innovating on polymer science. But polymer science is at the core of a lot of things that we do, and it took us years and hundreds of materials, hundreds of different combinations before we came up with SmartTrack. That's sort of what I'm trying to show in this time line. And it is really, by far, the best performing material out there. We know a lot of people have tried to copy it. Nobody has been able to do that. And that's because of a lot of kind of the core fundamentals that we apply to polymer science. And then once you have that, you kind of synchronize that with a lot of the other things, right, how you -- Joe talked a little bit about loading the aligners. So we call it activation. How do you activate this aligner to get -- it's not just what you see from start to finish but how do you get from start to finish, kind of being able to deliver those 4 systems, being able to activate the aligner at the right spots, again, at a massive scale, right? It's not enough if you show it on a couple of things in the lab. You got to be able to do it at massive scale and then how you move teeth. So kind of those 3 together start with the core. You got to be able to deliver that performance, and then you can layer in all these design tools on top. So that's really kind of the journey that we've come over the years. And Mitra talked about the wide portfolio, right? Kind of -- we kind of use the same principle for every phase of this. Every device that we design and deliver to the market, it's the same principle, got to solve a key problem, highly innovative but it's got to deliver consistently over a massive scale over and over again. So that's really what I believe we're really good at and how we differentiate ourselves in the market and why we're the best product out there. So Mitra talked a little bit about Invisalign First. We see great results from Invisalign First. It's one of our fastest growing products. What I would tell you is it's not by accident that doctors are seeing great results. It's not something that can be reproduced. We've taken care of a lot of things in the background. So here's a couple of examples that I'm showing here. Most common thing that doctors do with Invisalign First is dental expansion, so basically expand the teeth, so you allow your unerupted teeth to come in into the arch. So there's a lot of mechanical principles behind it, which I won't get into but taking care of that in 6 dimensions, really, right, so teeth move in 6 dimensions, taking care of all those force systems, so you can consistently get great expansion. Every time you program expansion, consistency get that great expansion, but at the same time, when you start expanding, there are some unwanted movements that can happen, right? Like the molars can start tipping and so on, so taking care of those unwanted forces and balancing those 2 in 6 dimensions and consistently delivering it aligner to aligner. And that's really why we see these great results that our doctors show all the time, the great expansions, great outcomes and so on. So it's really a great example of how the design -- if you have the right design, the right material and the right force system, you can deliver great outcomes. So the second example I'm going to talk about is Class II correction. Roughly somewhere between 30% to 40% of cases present with Class II, very common treatment in a doctor's office. We have the solutions that I'm showing on the left and the right. So we have the Precision Cuts that allow the doctors to use elastics, in some cases, to treat Class II. We have the enhanced precision ring solution that doctors use to deliver that. And I'll talk a little bit about the one in the middle that we've just introduced into the market. But I mean, this is an example from one of our doctors about how they're using these Class II solutions to create great outcomes, right? So Class II is when your lower jaw is too far back. You're trying to correct that. It is a combination of skeletal -- some people do it skeletally. Some people do it dentally. Here, you're seeing a skeletal correction, fantastic skeletal correction that's achieved using EPW right? So now we're trying to kind of take it to the next level with occlusal blocks. And that's really the solution we've introduced in the market. So there's probably 2 things I'll tell you here. One is the blocks, you'll -- if you look at the blocks, you'll notice that they're solid. And they're solid for a reason, which I'll talk about real quick. And there's a high factor of safety. These things have been tested for hundreds of thousands of cycles to deliver the right -- again, deliver the right force systems, the right design consistently over millions of devices. So the reason why these blocks are solid is if you look at the kind of the performance of a hollow block, the problem is when it's hollow, this physics -- it's just physics, right? So when you have blocks that are hollow, patients will bite on it, and they'll start deforming. This is just -- I'm just showing 3 cycles here where the blocks start deforming already, right? So imagine over the treatment of time, maybe for a small percent of cases, it might work because the patient is not biting too hard. But there's a large percent of cases where they will not work because the blocks started deforming. When they deform, you won't be able to apply the right skeletal force system. So that's really what we've solved with these occlusal blocks. They are solid, again, tested over hundreds of thousands of cycles. And again, once you design the right way, deliver it over millions of appliances, you get great results. Clinically, that's what we're seeing. We're seeing some fantastic results from our doctors already, which we'll -- hopefully we'll start publishing soon. So I'm going to switch gears a little bit to direct printing. So a lot of work going on around 3D printing, but the same core principles, right? You got to have the right polymer to start with. We work with every major chemical company out there in the world, all the large chemical companies, to try and partner and deliver these polymers. And to Joe's -- point Joe have made earlier, we weren't -- there is nothing out there in the world that can deliver these high-performance polymers with the right balance, right? So regardless of the noise you see out there in the market, that balance simply does not exist. So this is a lot of things that we have to invent not because it was fun to do it but because we had to do it to be able to get to that core. You need the right polymer, and then you can start building all these other force systems and all that stuff, and you can deliver great appliances. First example of that is Palatal Expander. So it's already out in the market, again, same principle, right? So we have 3D printing process that can deliver these designs. We have a great design, which I won't have time to talk about today, to try and balance the skeletal forces to get the palatal -- the skeletal correction and you deliver it consistently thousands and thousands of times using these appliances. And what we see is the great results you see on the right. This is not just me saying it. A lot of our doctors are showing it. There's papers being published showing very, very high efficacy. It's almost 100% in terms of efficacy. And so kind of validates that model that you design it the right way, deliver it the right way, you're going to get great results. So we're going to continue building on that platform. So last time I was here, I talked about our Cubicure acquisition. Cubicure is a very critical piece in terms of how we deliver these polymers into a printed model. And so we're working very hard. Every project that we talked about last time, we're working hard on them. But I just want to give -- show you a quick video showing some of the work that we're doing on these printers and how we're printing these devices. Play the video, please. [Presentation]

Srini Kaza

executive
#8

Okay. This is where I start dancing to the music. But this is kind of my last point on the devices. So last time we were here, Joe talked about the fact that we're going to go into a pilot with some of these devices, and we are in a pilot. We have patients wearing these devices. So the first thing -- the first product that we're scaling to introduce with the market is a retainer product, highly customized, fully -- putting the full customization and design power into the hands of our doctors and being able to deliver it consistently. So retainers is in pilot right now. We're trying to scale it. We're also working on aligners. That's also in pilot. And hopefully, we can start talking about that down the road. Again, design it the right way, deliver it the right way, we believe we're going to get great results that's going to further differentiate ourselves from anyone else out there in the market. So with that, I'm going to pass it on to Emory, who'll talk a little bit about scaling these 3D printing technologies. Thank you.

Emory Wright

executive
#9

Our direct fabrication 3D printing, especially in the clear aligner space more recently, it's been obviously around for quite a while, but a lot of that information typically has -- lacks context. Oftentimes, it can be kind of confusing, and sometimes, I think it's actually misleading. So I wanted to start by just providing a little bit of kind of context for 3D printing in the clear aligner space and then get into our direct fab platform and kind of where that's going. Okay. So there's 2 ways to make aligners using 3D printing. One is the indirect way, which is the top figure there. That's what everybody does, including us. And then the other way is the direct way, which is something that I would say is futuristic. So on the direct, it's -- you have a resin in a 3D printer. You print a model of a stage of treatment, of where the patient's teeth are for that stage. You have aligner material that you form on top of that model. You trim that off of the model. Model gets thrown away. You post process that aligner. You package it. You ship it. That's the indirect method. I've been at this -- involved with this process for, like I said, a little over 25 years, and we are the best in the world at this process. We have the largest scale by magnitude. We have the most efficient process, and we produce the highest quality aligners. Having said that, the real secret sauce in this process is the aligner material and the biomechanics that's designed into every stage of that treatment. Srini talked a lot about that. That's what makes this system work. We're also best in class in those 2 things. You don't have to take my word for it. You can talk to customers that have gone to competition and used product for a lower price. They come back to our business, and they'll tell you it's because the other guys' aligners don't finish cases. They don't move teeth predictably. So there's a lot of evidence out there. We spent a lot of time, Joe talked about this, a lot of money developing this process. It's highly efficient. It's our workhorse for the company of -- now for sure, and in the foreseeable future, it will continue to exist. So now on to direct printing. So direct printing, you have your material. Srini talked about that. We have a printer. Srini also talked about that. And you'll notice that there's no model that you have to create, and there's also no aligner material. You just directly print the appliance. There is a degree of post processing that's not insignificant and it's important. And that's that process. Technically, it's not hard to 3D print an aligner. We've been able to do it for decades. The issue is, is that the materials and the printers that are available in the market don't produce an aligner that has the mechanical properties that can actually move teeth predictably. And there's been a few announcements recently, companies that have direct printed shape memory aligners. That's what they say. They're using materials that leverage existing printers. We've tested the heck out of that. We know that those -- the resulting aligners don't move teeth predictably. So they even kind of say that in their own marketing material if you read between the lines, but it's kind of rolled into the shape memory story that's also not true. So really, when you look at the secret sauce of this process in order to print -- directly print an aligner that can move teeth predictively, you not only need the material and the biomechanics, but you also need a printer. And Align now has all of that. We own all of that. We've vertically integrated that under our umbrella. And we think that, that system will provide some substantial benefits above the indirect method, but both of those methods are still very critical to Align in the future. So I just want to make that point. Okay. So Joe talked a lot about Align's innovations over time over the past almost 30 years. I think it's important just to remind ourselves on specifically our capability on 3D printing, right? So we've been at it for almost 30 years. We pioneered it for almost 30 years. We've taken -- we're the first to take a prototyping technology, which largely today 3D printing is still a prototype technology. People don't use it in the way we use it. And we've turned it into a true mass customized manufacturing platform. We've built and maintain and continue to recruit the best talent in 3D printing, not just the printer and 3D printing but software -- related software and other engineering disciplines that are required to kind of do that end-to-end process. And we continue to push the industry beyond what the industry thinks is possible. To Srini's point, a lot of things we need to invent internally, other people can't -- they don't -- they can't do it. With our material science that Srini talked about in our recent acquisition of Cubicure, we now kind of have a force multiplier from a competitive advantage standpoint when -- with 3D printing. So with that as a background, what are we going to do with this new 3D printing platform, which is probably a question you have. So there's 3 use cases, and these are -- more or less, this is the chronological order we see them coming to market. So one is printing devices that cannot be done with the indirect method. These are things, the design freedom we have, the ability to design in very specific features, the accuracy and control we have in this allows us to make things like a multi-featured retainer. Today, you can only buy in separate devices on the market, so we could do it kind of all in one. Also things like our prefab detachment that will drive productivity in the doctors' offices, those are things that are in market right now at lower volume. We'll scale those up as our commercial and regulatory time lines predict. So that's the first use case. And like I said, we're in market. The next use case will be to be able to make existing devices work better. So that's things like occlusal blocks Srini brought up. There's a desire from our customer base to actually make a dynamic block size, right? This helps to close the bite. It's difficult to do indirectly, but direct printing, that's a perfect application for that, making that block stiffer so that it actually withstands the hardest or the people who chew on these things the most, things like that. Aligners, so there's the opportunity for us, again, using the design freedom that we have to address some difficult movements and make that aligner work better, integrate that into the Invisalign case and actually have better outcomes or more predictable outcomes from that case. And then longer term, as we scale this direct fab technology we have, it can become a manufacturing platform substitution, right? So this could be at a lower cost, less waste. You saw in the previous slides where you throw the mold away, and some of that aligner material, Joe talked about, goes away. This doesn't have that same kind of waste profile. So as we scale, this could be the next manufacturing platform. But for the foreseeable future, these things are going to coexist together and in a symbiotic way. I know cost is top of mind with you all here. It certainly is for us within the company. And so I think a lot of people are kind of wondering, "Well, what kind of cost leverage will this new direct fab platform provide?" We think that, you see on the slide here, there's kind of our top 4 cost drivers for Invisalign. We think that on the material side, there is significant room there. Again, there's less waste, and as we scale the material and are able to make that less expensive and then obviously, as we scale this process, we'll be able to take costs out there. The other thing that we believe is that this platform will allow us to, in a cost-effective way, get closer geographically to our customers, which will then allow us to reduce our freight cost, which is another one of our big drivers. For sure, as we get better at this, as we've shown with the indirect method, we'll pull cost out of all these cost drivers. But those are kind of the 2 big ones that we think we're going to have a big impact on going forward. So what's -- so what -- like where are we going to go with this thing? What's the path forward? So we're going to continue to work on solving the scalability opportunities we have around the material, around yield, throughput, things of that nature. Our experience helps tremendously here. We kind of -- we know what to look for. We have line of sight for these improvements. This is, as Joe like to say, time and distance for us. Time might not be linear, but we know what to do here, and we're confident we'll get these opportunities taken care of. How you'll see it? I mentioned it before. You're going to see it in new devices first. Then you're going to see it in better devices and then as a replacement manufacturing technology. And then kind of, I guess, the question is like, well, where are you going to put this new technology? It'll start in our San Jose campus and then our factory in Mexico, largely because that's where we have the best access to talent and control that technology as we scale it up and make sure that it's ready for prime time. And then we will move it into our other factories as that makes sense strategically or cost-wise. And longer term, I think it's possible for this technology to be able to be more local in local markets. Again, I mentioned that about freight but also responsiveness to customers and a way to kind of speed up that cycle. So that's how -- that's kind of our path forward, how you should think about how this direct fab technology, how we're going to leverage it. That is it for me. Thank you for your time, and Shirley is going to come up here and talk about the rest of the day.

Shirley Stacy

executive
#10

Okay. Great. Thanks very much, everyone. We're going to take a very quick break, 10 minutes, please. I know we're a little bit behind on our schedule. When we come back, we want to show you, in practice, one of our doctors' practices, how this technology all comes together. Dr. David Galler, many of you know, is a local -- well, original native New Yorker, general practitioner and dentist, has trained thousands of Invisalign doctors, has done and treated thousands of Invisalign cases. And we're going to share a really great video with you when you come back. Grab a cup of coffee. Get comfortable. It's a great opportunity to see firsthand what this looks like in practice. The video was filmed prior to some of this really great innovation on the iTero Lumina scan coming to market and some of the other innovations. So just you'll keep that in mind as you watch it. But please go ahead and -- for break for 10 minutes, and we'll come back at 11:42, 11:42. Thank you, everyone. [Break]

Shirley Stacy

executive
#11

Okay. Welcome back, everyone. Grab a cup of coffee, a snack, get comfortable, take a seat. We're going to show you a really cool video of Dr. David Galler right now. It really showcases in practice how these tools come together. And without further ado, let's roll the video.

David Galler

attendee
#12

My name is David Galler. I'm going to transform the way your practice runs. And for the rest of your dental Invisalign careers, nothing will be the same. Two things we're looking for in the Invisalign game now: number one, the highest level clinical outcome; number two, maximum convenience for patients and doctors. Would you like to see what this looks like? It is 11 a.m. on a Thursday morning, and I'm in my office. Two of my millennials have already called out, and we're on to the day. Ordinarily, that would bother me, but not this time because I'm using technology today. And we're going to use technology to treat our patients. Here, I have an Invisalign consult coming at 11:00. She's already had a panorex taken, and I could see the panorex on my screen right here, and it looks good. Now she's getting an iTero scan done with the 5D Plus. After we have the scan, then my Invisalign treatment coordinator, [ Kylie ], is going to use something called the Invisalign Practice App, and she's going to take a series of 9 photos of my patient right there. She's going to input the patient information in, and it's going to go straight to the Invisalign Doctor Site. I'm going to have the patient information and all the photos right there on my site. That takes about 5 minutes to go. So we've already done 11 to 11:05. We've done a scan 11:05 to 11:10, and we have all the photos in. Now it's 11:10 and time for me to meet the patient. How are you? Welcome to my practice. I'd like to show you a little bit about your teeth. The first thing I'm going to show you is something that I call the NIRI. This is the near infrared technology. It's a way that I can look into your teeth and see whether you have Class II incipient caries or not. We don't have to take bitewings anymore, and I already took a panorex. So now I could just use this to show you what's going on in your teeth. Now I'm going to use something called the viewer. Let's take a look at your whole mouth. I know it's not as good as when I'm just leaning over you looking at it. Let's look at it together. Let's figure out what's going on in your mouth. How are these teeth doing? Let's take a look at all the different teeth, and we can move it in different directions. We're looking for abfractions, wear facets, fractures, anything that will tell us the story of your mouth. We're looking for any teeth that might malaligned, teeth that don't fit into the right spot and how that might be impacting your overall health involving your perio, your teeth, possibly even your TMD. I'm going to use this little tool. This is called the Occlusogram. And although not diagnostic, does show us a heat-seeking map of where you're biting down. And if I see spots over here like this red, that means you're biting down a little too hard here, and maybe we should move those teeth out of the traumatic spot that they're in. There are a couple of teeth here that aren't straight, and I'd like to kind of show you what it would look like if we straighten your teeth. So I'm going to use something called the outcome simulator. This is what you're going to look like if you allow me to straighten out your teeth. Look at how beautifully aligned those teeth are. See how the upper and lower teeth connect in such a healthy manner. And now my favorite part. Because we use the Invisalign Practice App and we took something called the wide smile photo, now with a few clicks on the screen here that you could see behind me, I'm going to create something called the Outcome Simulator Pro. This is a picture, a mockup showing the patient what they're going to look like at the end of treatment. This is a fake photo. She just came in 5 minutes ago. Here's how she looks now. Here's how she's going to look afterwards. How do you like the way that looks? And then I drop the key line. [ Kylie ], she looks happier here. So what do you say? Would you like to do some Invisalign treatment? Absolutely. Nobody says no to the GOAT. Well, let's mark this occasion, shall we? Starting Invisalign treatment, taking a care for your health. Here we go, everybody. Let's smile, smile, first visit. All right. Now my patient is going to go across to the front desk, and she's going to make financial payment arrangements. Meanwhile, I'm going to go to my desk over here, and I'm going to fill out the prescription for Invisalign. Now years ago -- it's 11:30 on the clock. Years ago, the prescription used to take hours. You have to do so many different things, hook up photos, hook up cameras, hook up scanners, take PVS and boxes. Now it's a few clicks. Now I'm using something called Flex Rx. It is a modified prescription where I only have to answer 3 questions, 3 clicks. I hit accept. We upload the photos automatically there, there. I attach the scan. And in 90 seconds now, I can have this prescription all the way on its way to Invisalign. I'm going to go watch my sons play some baseball. Hey, iPad, I just got a notification. Guess what? The ClinCheck is ready because I'm using something called IPP, Invisalign Personal Preference Plan, which means that I have an algorithm at Invisalign, and I could pull up the ClinCheck at any time. I don't have a tech who makes my ClinCheck. I'm using a technology algorithm. So an hour, 11:30 to 12:30 is not only possible. I do it all the time. Well, now I have the ClinCheck here, and I'm going to make a couple of changes. I'm going to be using 2 tools, 1 called 3D controls and the other 1 called Live Update because even after my own algorithm, sometimes I like to put a little nuance into some of these cases. Then I could hit Live Update, and I get the new ClinCheck back. Back in the day I used to make changes, it would go back to Costa Rica. 1 or 2 days later, I would get the ClinCheck back. I have the finished ClinCheck right here. And I'm going to go ahead. You're going to watch this in real time, and I'm going to hit accept. This ClinCheck is already being manufactured. That's how fast the game can be, 2 hours, 2 hours from the time the patient came into the office till the time I have the aligners being manufactured. This is not the future. This is not some wish list. This happens right now. I do this all the time. It's now September 14, and my patient is back. And I have aligners in 7 days. We advertise aligners in 7 days because we're utilizing all the technology tools. My patient is here, and my Invisalign treatment coordinator's putting them in, teaching them how to use them and how to take care of them. And then we do one more very cool trick that you probably don't know about. We use something called the lens. The lens is a little attachment that goes on to a cell phone, and it allows the patient to take remote photos of themselves because this is what we're going to be using for the next 17 weeks. And on this visit right here, I teach the patient how to use it. And they could do it. Everyone looking good? Good. Visit #2 is in the bag. Thanks so much. I'll see you next Thursday virtually. She -- patient leaves the office, visit #2. Now the patient goes home. Next Thursday, September 21, she's going to use that lens and she's going to use another project called the My Invisalign app, which is a patient-facing app. And from the comfort of her own home, she's going to take a series of 9 photographs with that lens, which is incredibly easy to do for anybody. She's going to push send. Those photos now go to me on my Invisalign Doctor Site. I could be anywhere in the world. I could be in my office. I could be at home, I could be anywhere. Clicks up, I look at her 9 photos. They look good to me. So I send her a text message that says, "Hey, everything is looking really good. Switch to #2." And next week, she takes another set of 9 photos and sends it to me again. And next week, September 28, I take a look at those. This time, I don't like the way lateral's tracking. So I send another note saying, "Hey, let's wear that a little bit more, get a little bit more munchy chewy action." And we do this dance for 17 weeks. The Invisalign Virtual Care lets me see the patient every week. I'm interacting with the patient every week. And if the patient knows I may be watching every week, they wear the trays. Compliance is up. Additional aligners are down and profitability is up. 17 weeks go by, and now my patient is here for the final visit. I already know everything is going to be okay. How do I know that? I've watched you every Thursday night for the last 17 weeks. By the time she comes in to get her Vivera retainers, I already know that her teeth are perfect and fitting well. And I could just come in and just be the hero. How'd it go? Amazing. You look incredible. Three visits, holy cow, let's take a selfie, Instagram this thing. Awesome. Thank you very much for being a part of Invisalign, Dr. Galler's office. That's the game I play at now. That's the level of game that some of us are playing at. And this is the first time it's all come together. If you're an Invisalign dentist in the room, there has never been a better time to be an Invisalign dentist, high-level clinical outcomes and maximum patient and doctor convenience. "Hey, let's make this easy for you. Let's make this easy for me." Two hours from the time I have the consult to the time Juarez is starting to manufacture, 17 weeks, pictures every week, no refinement, no midcourse correction, no posterior open bites, 30 pieces of the puzzle all coming together to create the most perfect digital workflow with the highest level clinical outcome and the maximum patient and doctor convenience. Thank you very much.

Shirley Stacy

executive
#13

Please welcome Karim Boussebaa.

Karim Boussebaa

executive
#14

All right. What a tough act to follow. Good afternoon. Good afternoon to all of you, and welcome to our Investor Day. It's a pleasure for me to be here and to talk about iTero. Now the theme of my slides, driving growth through continued innovation, has a double meaning. It's driving growth for our customers, and while doing that, we're driving growth for Align. Now let me put it in the context of our overall vision, Align vision. As part of the Align vision of transforming smiles and changing lives, iTero plays a crucial role in delivering innovations, delivering solutions to our customers that solve their needs and their critical challenges, especially in a time where things are getting more and more complex and where our customers in their dental practices have to deal with so many things at the same time. So our job is to make their life simpler. And as Joe mentioned earlier, we are obviously, looking at the GP segment in a more prominent way -- sorry, yes. Thank you. We're looking at the GP segment in a more prominent way because it is an untapped and growing opportunity for all of us. And the way we look at that, we put the customer at the center of everything we do. And then we make sure that every -- and we partner with them to cocreate the future of dentistry. And we do it across 4 main pillars. The first one, you've heard a lot from Mitra, is to deliver the best clinical outcome for the patients, right? It's all about evolving the digital dentistry into comprehensive dentistry. The second one is about growing the practice. If they grow, we grow. And we know that dentists like to focus on their patients. They like to deliver care to their patients. They don't necessarily know how to grow their practices. So that is also part of our job to help them adopt through the adoption of our tools to grow their practices, grow their business. The third one is about elevating the patient experience, making it simpler, faster, more comfortable so that they can come back, they will come back and send family members to the same clinic. And the last one, in a time where it's getting harder and harder to keep the staff engaged, is delivering an experience for the staff that makes them happy, engaged in what they do every day in the clinic. All of this, at the end of the day, is really to drive oral health and diagnostics. You've heard it already from multiple people today. We're not anymore about doing obscure things. We're here to make sure that we start by diagnosing the patient so that we can give them the best treatment possible -- course possible, whether it's about ortho-restorative in a comprehensive way or whether it's about delivering restorative dentistry through their labs. And we talked about iTero not being a scanner anymore. Yes, iTero does extremely well in scanning, especially with the introduction of Lumina, but the game is not anymore about scanning. There are so many tens of different scanners out there that can take a digital impression replacing a PVS. That is not where we want to play. That's hygiene, as I call it. Where we want to play is really throughout the continuum, throughout the patient journey where the iTero system, the iTero platform is really playing that key role for our customers to collect the data, which is extremely critical, then aggregate the data into insights so that they can communicate with their patients in a seamless way, agree on which chairside workflow or treatment they need to communicate with their lab or with Invisalign, make sure that they empower their staff in helping them do the critical activities so that they can focus on other things. And then lastly, we use the iTero platform for communication but also for education, education of our customers and education of their patients. And we do this with clinical backing, i.e., we are more and more doing clinical studies and independent publications that show how these innovations perform, and I'll talk about that in a few minutes. We also make sure that we integrate seamlessly with the overall ecosystem. Like I said, it's getting more and more complex. So simplifying and being sure that we integrate with all of these players out there is critical for our customers, simplifies their lives. As an example, we are now connected with more than 20,000 labs in the globe. And then lastly, it's about creating efficiencies, right? We want to -- and I'll show you that with Lumina where we integrate multiple modalities into one wand, into one swipe. Looking at our journey with iTero. This is -- we have now a very compelling portfolio that is addressing all the segments from value, performance all the way to premium. We've sold more than 100,000 scanners to date. We're doing about 5 million plus scanners, [ resto ] scanners on a yearly basis. And as I mentioned, we're connected to more than 20,000 labs. So we are catering to as well as the ortho community as we do with the GP segment. This is a snapshot. It's not comprehensive. It's a snapshot that shows the innovations that we've been working on that we've delivered over the last couple of years, and I'll take a few examples that I'm going to dive into. Oral Health Suite, this is what Sri already presented earlier. As we say that iTero is not anymore a scanner, it's a comprehensive platform. It starts by diagnosing any challenges that you have that the patient has in their mouth. We've heard from Dr. Galler how powerful that is. And as I mentioned, we obviously look at the data behind it to show how is this helping our customers. Is this moving the needle? And for this specific innovation, we've looked at about 800 customers that are using Align Oral Health, that have it on their system. And it looks like for, one, in a couple of scans and using it once, they were able to increase their top line by $15,000. And this includes everything they do in their clinic in a month, right, staggering number. So again, this is a proof point when we go and talk to our customers and help them grow their practice, we can showcase some of these innovations and how it will help them grow. Another one is the AXI that also Sri talked about earlier, which we've introduced at IDS, and it was a major hit. Now we're bringing this to chairside. We'll have it integrated into our iTero system on our Lumina in the second part of the year. Invisalign simulator, the Outcome Simulator Pro, you've heard Dr. Galler talk about it. We've also looked at the data, and it shows that people -- customers using it are getting twice the amount of acceptance from their patients. And now we're going to the next level. We're bringing Smile Video also on chairside, which has been -- Smile Video has been introduced at IDS just a couple of months ago. And now toward the second part of the year, we will bring it on our iTero platform as well. We keep moving. We keep bringing those innovations that help simplify the life, the work of our customers. And then the last one I want to talk about before switching to Lumina is iTero Design Suite. So we had a number of customers that came to us and say, "Hey, look, I would love to be able to do some level of design on my system, but I don't want to get the full exocad suite because it's just too complicated for me. I'm just a dentist." And we've been brainstorming with them. As I mentioned before, we cocreate a lot with our customers. So we came up with this idea of taking some of the capabilities of exocad, simplifying it and putting it on the chairside so that those that want to use it, GPs and ortho that want to use it for simple design can do so. We introduced this just at the end of 2024, and it's been ramping up in a very good way over the last few months. And now talking about the new kid around the corner here. Lumina Pro. As you remember, we've introduced Lumina ortho in February 2024, which was a major hit. It was -- quite helped us grow the iTero business in a significant way. And then just a couple of months ago, in March, we've introduced the Lumina Pro that brings restorative capabilities. And this is way more complete than we've ever had. We've added restorative features that are really helping our customers jump on the restorative wagon. But let's roll the video that explains this much better than me. [Presentation]

Karim Boussebaa

executive
#15

Think again. All right. This is a slide that I presented a few times already, so you should be familiar with all of your -- or most of you. It shows the difference between the previous technology, confocal/structure light, and the current technology with Lumina. And the idea is flipping the paradigm on how we acquire data. On the left side, you see that it's a complex way to back project light to the front, which introduces constraints in terms of size and weight of the wand, more components and the bigger the field of view that you see at the bottom there on the teeth, the more weight and size you're going to introduce. So we flip that paradigm and now are projecting the light right at the tip using 6 cameras, 5 projectors that allow us to increase the field of view, increase the depth, while, at the same time, we're using the size and the weight of the wand. So we are throwing away that whole limitation that exists with the old technologies. And this is just the beginning. This is just the beginning. We are obviously working in our research department on future improvements that will come on this platform. The -- what -- benefits that we get, simplicity. The scan is much faster. Compared to a 5D unit or other scanners, it's half of the time to scan it in a very quick way, including the full palate. The old the modalities, whether it's NIRI, the intraoral scanner, the photos, replacement of photogrammetry, no need for camera DSLR. They are all integrated in that one wand and in one scan. So you don't need to rescan with multiple modalities. Superior accuracy, and we did a lot of tests with other scanners out there. But thanks to this new technology, the accuracy is through the roof, which is allowing us to do work that we were not able to do before in the space, such as, for example, accurate implantology without having the need for photogrammetry device. And then patient experience, if it's shorter, smaller in the mouth, the various restorations come back and they fit properly the first time, then it's a great experience for the patient and for the customer, for the doctor. I have a few quotes here. I'm not going to go through them because we are short on time. We'll share them with you. There's nothing like listening to the feedback of our customers and hearing them telling us about it. Now the [ resto ] launch has been out there for already 2 months and the feedback we're getting is outstanding. All righty. And then closing with the slides that -- one of the slides I opened with, unlocking the full value of iTero. It's not a scanner anymore. It's really moving from a scanner to a platform, from a scanner to an ecosystem that allows our customers to do their job in a more seamless way, easy, simple and fast. And with that, their practice will grow. It will flourish, and their patient will get the best care possible. With that, I will pass it now to Zelko who will talk about comprehensive dentistry. Thank you.

Zelko Relic

executive
#16

Good morning. So comprehensive dentistry again. I'm going to bring again the 2 numbers that both Joe and Mitra shared. 75% of us have some kind of malocclusion. And the second number that's even more intriguing is that 45% of restorative procedures should start with tooth alignment. When we say should start, it means that they don't. And in many cases, the restorative procedures are a consequence of crowding, of malocclusion, misaligned teeth. And if they don't start with tooth alignment, you're really not addressing the underlying problem. So when you align teeth, you're not just getting better aesthetics. You're getting better function of the bite. You're getting minimally invasive restorations because you have to prep these teeth less. They're going to last longer, and they're going to be aesthetically superior. So in terms of health, function, aesthetics and longevity, half of the restorative procedures are not accomplishing that. And I think the reason is because it's hard to do that. There is no tool that makes it easy to make those comprehensive ortho-restorative treatments as opposed to restorative only. So when we talk about making tooth alignment a standard of care in dentistry, it's not about making dentists being orthodontic specialists. It's about helping dentists understand the need and the value of the tooth movement through analysis, treatment planning, visualization. And that treatment can be done by the dentist herself or refer to our orthodontic specialists based on the complexity. But the ability to understand the patient needs and deliver the highest quality of care, that is necessary. And I think we can help make that dentistry better by adding tooth alignment to the restorative procedures. And a big part of that is the fact that exocad is part of Align family. We acquired exocad 5 years ago exactly last month with a comprehensive suite of dental CAD/CAM solutions, most powerful and most advanced system in the world. It was a very healthy business 5 years ago. It's even better today. We have more than 60,000 installations, and our market share, we estimate, is more than 50%. More than half of the labs around the world use exocad. Now why is that important? There is more than 2 million doctors, dentists around the world. I would say less than 5% of them think about tooth movement, so 95-plus percent of them don't. But all of those dentists, they work with those labs who use exocad software. So how do we leverage labs to help dentists practice comprehensive dentistry? I'll show you some teeth now to explain and visualize, so bear with me. Here is a colleague of ours, was willing to be a patient for us. He's a normal guy, handsome guy. He wants a better look and smile. If the dentist sends his case to the lab to design this better smile and better hopefully means more beautiful and healthier, this is they're going to face. So now dental technician has to figure out what to do with his teeth. And you can see he has tooth wear. He has deep bite. He has crowding. He has problems. It's a very, very tough starting point. And this is what happens today. They need to figure out how to fit something, restoration that looks better. So in terms of function, they have the tool to look at occlusion David Galler talked about in a video. You look at where are the contacts. You see the purple thing. This is where centrals are hitting each other and wearing teeth. So now if the lab technician is trying to create a design and put, let's say, 4 veneers there, the underlying problem is not going away. Actually, you're likely making it worse. That's the problem. Now let me talk about the health. When they put these 4 veneers, some teeth are sticking out because they are not aligned. So everything that's sticking out to get a good aesthetic outcome, you need to take it away. You need to remove it. There is a lot of tooth mass that this patient would need to have removed to get something aesthetically looking good. So it's a very, very tough situation that dentists and dental technicians in labs face every single day. So what we have done, we have added the ability in exocad software with all of the capabilities to have a better starting point. On a click of a button, the lab technician can align these teeth using the power of Invisalign. This is all visualization now. So now you can see, on the upper, real teeth; on the lower, the real teeth after alignment. And now you can see the difference, and they can compare. So now on the right, you see restorative only situation. You see the situation after orthodontic alignment. No pink color. The function is good. No more bad contacts. Now look at the healthy part of that. You see the teeth taken out. exocad has a smile -- a facial-driven smile design, look at the situation when you're aligning teeth first. Nothing is taken out because we moved these teeth. Look at the vertical dimension. We opened up the bite. Look at the aesthetics, just by being able to put teeth in a better position. Let me just focus a little bit on preserving the healthy tooth mass. So we have the tools that a technician can use to analyze and then explain to the dentist why these teeth need to be moved. So this is the amount of healthy tooth mass that you have to take away. You've taken away enamel. Enamel is the hardest part in our body. It protects the tooth. You take it away. The tooth is weak, exposed. The life gets shorter. Another thing, if you're bonding porcelain veneers on enamel versus dentin, you have 10x longer-lasting restorations. If you bond on dentin after taking enamel off, it's not going to last long. So here is the difference between removing and moving when you bring the tooth in the right position and you have a better starting point. So when we talk about comprehensive dentistry, the plan should be you start, you align these teeth first and then you place the restorations. And this is why they say that 45% of restorations should start with tooth alignment. You're getting better function, less invasive, healthier, longer lasting, better aesthetics. This is all visualization. So part of the visualization is showing the smile to the doctor and to the patient, showing the smile based on the treatment plan, clinically confident. And when you see that, it is hard to say no. Seeing is believing, but seeing yourself like that, it's amazing. And then if this is not enough, we, of course, give the Smile Video as well. The emotional response is amazing. And that's why doctors who use Smile Video, they have a significant high rates of patient conversion. Now this is all simulation. So the lab is creating analysis and plan and visualization, creating a report, goes to the doctor. The doctor explains to the patient, sees the benefits, function, health, aesthetics. And then if the patient agrees, it becomes an Invisalign treatment. And he can be treated by the doctor or referred to a specialist, just Invisalign case. So again, 45% of the cases do not start the way they should start. And that's why I think, in the future, when a patient like this comes to a dentist asking for a better smile, more beautiful and healthier, what do you think will happen? What will the dentist do? Will the dentist remove or move? What you see on the left is what's being done today. What you see on the right should be done and will be done in the future. Now if they do it or when they do it, let's take a look at the numbers. These are just existing restorative procedures. 8 million in the U.S., you take 45% of that. You're getting incremental Invisalign opportunity of $4 billion. You go to EMEA, this number goes up to $6 billion. So between these 2 markets, not counting Brazil, APAC, you've got $10 billion of incremental revenue. And millions of people are getting better dental treatment, which is the underlying power of comprehensive dentistry. We have introduced this solution within exocad at the IDS show this year. Some of you were there. We are starting the pilot this month in a couple of countries in Europe, and I feel really good about where we are going because the interest is exciting. The labs are very engaged, and I feel very, very good about bringing this to the markets. I do know that Align has the unique ability to deliver this, transforming dentistry to something that's much, much better for patients, for doctors, for all of us because we have Invisalign, the best orthodontic system. We have iTero, the best comprehensive scanner, and we have exocad. So we're going to work very hard to bring comprehensive dentistry to reality very, very soon. Thanks a lot. Now I'm going to introduce Frank Quinn.

Frank Quinn

executive
#17

Thanks, Zelko. Good afternoon. I'm Frank Quinn. I'm representing the Americas, and I'll walk you through our go-to-market strategy. Still a tremendous market in the Americas, 8 million ortho starts annually, 5 million of those teen, 3 million as adults and a massive consumer opportunity out there as well. When you look -- take a glance at the Americas, we have a great mix between ortho and GP providers and volumes as well as a doctor community of 136,000 trained doctors and 55,000 shipped to with a utilization rate in North America of 28 cases. Obviously, the major markets in the Americas are U.S., Canada and Brazil. And what we're really looking at on a focused execution on these strategic growth drivers for the Americas is, first and foremost, orthodontic utilization, GP dentist adoption joining the franchise and getting started. Next is a DSO and clinic growth. And last but not least is consumer demand and conversion. And the main foundation amongst each of these doctor channels is clinical education. You'll hear me mention this many times throughout the talk here. Our go-to-market strategy is really designed to accelerate adoption, improve utilization and enhance the overall customer experience. And we're focused on 3 pillars to actually execute upon that. It's focused execution on growth drivers. It's commercial excellence and sales force optimization. I think Joe had mentioned this before about kicking down doors, so really making sure right customers at the right time at the right cadence. And last is the demand generation and brand differentiation as well. And I'll share a video here shortly as an example of how we're doing that. When you look at the accelerating ortho utilization, there's 3 key things that we're highly focused on. It's really repositioning the ortho brand as a partner for growth through community and partnerships. And this is really anchored on the clinical education piece. When you think of in the Americas, it is a very community-based specialty, love learning peer to peer, so setting up as many of our education events as possible to encourage not only the education and the usage of our platform but also sharing best practices peer to peer. Between all the 3 channels I had mentioned, we'll do over 500 live events, live education events this year in the Americas. Reshaping the ortho business model and growing patient innovation leader. I mean you saw the portfolio multiple times from palatal expander to first for mixed dentition and then our mandibular advancement tools; and then obviously, moving through the journey as well. So you have Invisalign for kids and teens, but you also have DSP for touch-up cases or finishing off braces cases, retention and then our comprehensive portfolio for the more complex case types. And then accelerate the ortho journey with enhanced clinical confidence goes hand in hand not only with the education but all the tools and enablers that you saw earlier today. From the GP dentist adoption perspective, attract and enable new providers, new marketing omnichannel campaigns to the broad community of GPs out there that are not only not leveraging Invisalign nor iTero are entering into the franchise with great education events and leveraging our resources to get started. Accelerate the practice growth with pathways, products and partnerships. We're deeply immersed with many of the partners around the Americas, AACA, Molis, Spear as an example, being present in everyday dentistry as the opportunity to move teeth prior to -- instead of removing them, and then build GP relevance through iTero scanning, integration and those key institutions I already mentioned. The next is the DSOs and OSOs stand for dental service organization and ortho service organizations. Strength in DSO relevance with brand preference and value prop, driving deeper engagement with new providers and programs and co-marketing. The unique thing about the DSO and the OSO channel is that they have a unique opportunity to scale and scale quickly. They're set up very similar to us. They have their clinical function, marketing, finance all the way across the board. And we get the opportunity to marry our resources and expertise with them. They can scale that, and it creates a flywheel experience. It's also a great landing place as they acquire businesses or students that are graduating, whether dental school or residency, have a nice soft landing place as they enter into these organizations. And the last piece is accelerate digital adoption and ClinCheck innovation with an iTero scanning. The reason why this is critical as well, each one of these organizations has a clinical leader. It could be a Chief Clinical Officer. Typically, they're very good Invisalign users, and they set up those templates with IPP and then broadly put that out in the organization for their doctor community so they have standardization on treatment and outcomes. Just a brief look at some of the top players in the U.S. You can see Heartland there with almost 1,600 MB2, Smile Doctors, Schulman Group, some really -- a great footprint in the U.S. Same thing holds true in Canada. So there's tremendous opportunity in this channel as well. I mentioned clinical education, and it's not just in one part of the journey. It's an always-on type thing. Capturing the dental student, a resident early. 2,000 dental students educated annually. We use AIF as an education tool for them as well. And then the last piece I'll share is this 2-day care course, which was started a couple of years ago. I had the opportunity to attend one of these in Scottsdale a few months ago. I think there was about 130 residents there, and it's fantastic. They're not only learning clinical. They're learning workflow, but they're really learning from their soon-to-be peers on the mistakes maybe they made as they entered into practice and why digital is really the answer as you enter into that -- into practice whether it's as an associate or hanging your shingle and open it yourself. Material education grant for students, 100% in the orthodontic programs and then these clinical pathways. Everything we're doing is anchored on clinical education and pathways. And equally important is being in the field and present on practice support and integration. On LatAm, slightly unique focus here. It's a different environment. We're focused on affordability, leveraging the portfolio in Invisalign Pay. Multidisciplinary, very similar to some countries in Europe. So general dentists, ortho, could be an oral surgeon, perio. This is why the iTero Lumina plays such a huge play, is so important in this space from a multidisciplinary perspective and ensuring that our go-to-market motion and approach really has multiple resources for those multidisciplinary accounts. And then once again, clinical education, I told you I'd mention it a few times. So from a demand perspective, it's really about igniting demand and shaping a culture of confidence with real people and real stories very region specific, U.S., Canada, Brazil, localized, ensuring that we're highlighting these real people every day. Adults over 45 is a growing population of those seeking to better themselves and improve their health, so ensuring that we're highlighting that. Doctor as a hero, critical. We can't do this without our doctor community. And some of the work that they do is exceptional. As a matter of fact, we were just at AAO a couple of weeks ago. We had 18 doctors come in to record and share their experiences. The thing that was amazing to me is many of them got emotional about what happened in their lives, in their practices and the way they treat patients as they went on this digital transformation with Align. So getting that out broadly with doctor as the hero, obviously, parents with kids, and Spanish in the U.S. The Spanish and Latino/Latina community has almost $3 billion in buying power in the U.S. alone. I had mentioned protecting the Invisalign brand. And this is Kat Stickler. And on TikTok alone, she's got 10.5 million followers. We had actually reached out to her to say, "Hey, you've got a great followership, right demographic. We'd love to get you started with Invisalign. I'll play the video, and you can see how it unfolded. [Presentation]

Frank Quinn

executive
#18

So a great example of us ensuring that when a consumer enters the practice, they know how to identify an Invisalign case. Our omnichannel media approach, targeting 3 core audiences: adults, parents with kids and teens. Obviously, TV and YouTube play a huge part of this. The secondary area is influencers and social media with adult, mom and teen. And then the practice marketing is critical as well. When a consumer identifies Invisalign and they see what the brand represents, they want to have that same look and feel and experience as they enter the practice, so ensuring not only in the practice, but the websites and the media that they put out at a practice level. And then the last piece is partnerships. So over time, as mentioned here, this is like ESPN for kids and high schoolers, millions and millions of hits and views every single day, highlighting kids and teens that are leveraging Invisalign on that. And then you have the NFL and Disney. And you can see a wide spectrum of influencers and women in sports as well. You see Patrick Mahomes there. We've seen him chewing on his -- what we thought was his mouth guard for years. It was actually Invisalign. So he's joined us, and you'll see new content coming out from Mahomes as well. And then the last piece, on the bottom right, is really a critical component of this. This is all great, driving demand, but you have to bring the doctor into the mix. And so in the NFL partnership, we've treated over 500 NFL players already through our Invisalign providers, and that's Dr. Zach Casagrande from Virginia treating Jayden Daniels, who is the NFL Rookie of the Year. So really highlighting that doctor as the hero, the outstanding experience and building confidence for kids and teens. From a commercial excellence and sales force optimization perspective, we're really looking to capture the demand, strengthening our commercial capabilities and really pointing the sales force and the right reach and frequency for the customers of where they are in the journey, requires significant focus and simplification, not only internally but around the customer. Everything orients around the customer. Execute and deliver outstanding results. Two key -- 2 revenue drivers in this business: Invisalign, including Vivera and retention; and iTero, leveraging all the great tools and enablers that you saw throughout the day to ensure that you have higher utilization and adoption of both of those and move into a digital dentistry and orthodontics phase. Key takeaways, obviously, an enormous opportunity in the Americas. Winning the hearts and minds of the orthos really begins with respect, right? They're entrepreneurs. They're specialists. They do incredible work. And really, this is a knee-to-knee, eye-to-eye business. That's why having our direct sales force and distribution is so critical. We actually don't kick down doors. We walk in and have those business planning meetings and identifying the objectives for the doctor and where they want to go. Relevance with GPs to drive adoption, connecting consumers into the practices and driving demand, growing the OSO footprint, and lastly, accelerating growth. Thank you. I going to welcome up David Carr.

David Carr

executive
#19

Thank you, Frank. Good afternoon, everybody. I thought I'd start with a brief introduction. I'm one of the newer members of the Align leadership team. I'm not a stranger to the APAC region despite the accent. I started out my career almost 30 years ago as an automotive design engineer in Japan. But in the 20-plus years that I've been in the med tech world with GE Healthcare, more recently, Medtronic, I've either been located in the APAC region or had responsibility for the APAC region. So look, delighted to be part of Align, the leadership team and excited about the opportunity and the prospects for this company. Very quickly, I'd like to kind of introduce what I believe is the opportunity for Align in the APAC region. Similar to the U.S., we have a significant addressable market. But in my years of covering the APAC market, we've always talked about growth being driven by the kind of regular demographic and economic development of the region. But in this business, it's more than that. There are enhancing beauty standards and expectations among both men and women. And there's also greater awareness of oral health. And when you think about that, in addition to the fact that APAC is probably home to the greatest prevalence of complex malocclusions, Class II, especially Class III in China, Korea, Japan, there's a significant opportunity for us. When we think about all those technologies that Srini, Sree have introduced today that help us address growing patients with alternatives to wires and brackets, I think there's a tremendous opportunity for us in APAC to continue growing at double digit for the foreseeable future, tremendous opportunity to convert the wires and brackets market. On this page, you'll see our major markets listed. For a long time, China, Japan and Australia, in particular, have contributed to more than 70% of our revenues. But what we are seeing through very deliberate investments, in what we believe can be fast-growing markets, we're going to see a reordering of our major markets even this year. When I look at India, I fully expect that by the end of the year, India will be our third highest volume market in Asia Pacific and Korea quickly catching up, too. So we do have significant progress being made in those markets where we're making very intentional investments. Our strategy since the last Investor Day remains unchanged, focus on international expansion, utilization, adoption and, of course, driving demand for our customers through consumer marketing. Over the next 4 pages, I just want to dive a little deeper into -- give you -- illustrate how we're making progress in executing the strategy by market, by product and how we drive demand in the region. I fully expected all of you to want to know how we're doing in China, right? Do we have a competitive strategy in China? And the answer is yes. Years back, we made the decision to be in China for China. We are operating as a local entity in China today. We're doing a great job. We have this formula, like we do in every market, looking to expand our submitter base. And we're doing this through stronger partnerships with DSOs, expanding beyond the Tier 1 cities where we typically grew our business years back. I'll talk in a few moments about the growing patient portfolio, but today, in China, we still have clear aligner brand leadership. We are still perceived as the best aligner system on the market. Doctors and patients are still willing to pay a premium for Invisalign. Just to give you one more proof point on this. We ran a recent Master Day forum in Shanghai. We had 69,000 people attend the event. I've never seen anything like this in my career in health care: 1,500 in the room, 67,000 people dialed in remotely. That just demonstrates to you the value that China still places on our contribution to innovation and how we educate customers in that market. It's a significant proof point for us. So we feel good about China. We remain the #1 revenue share in China. And I'm pretty confident that in quarter 1, we took share from our major local players. So I feel pretty good. Obviously, with VBP on the horizon for us, we feel pretty good about having that local presence to ensure that we maintain a leadership position in China. You've heard a lot about the growing patients portfolio from a number of the team today. If you just think back to what I said a moment ago about how China, Korea and Japan are home to the world's highest rates of complex malocclusions, there is a very significant opportunity in China for us to address. We've worked very closely. And I give -- and across APAC, I should say, this isn't just about China. But if I take China specifically, it's probably the one market even globally where the associations are working very hard to raise awareness of the benefits of early intervention with kids. And we're working very closely with them to build educational offerings to drive clinical confidence, generate clinical evidence. There's a tremendous opportunity here in how we partner with the local associations. Thirdly, we obviously have the portfolio, and we're going to be launching IPE later. We just got approval, regulatory approval, for IPE last week in China and across the region, India and Korea, in the last few weeks, too. There's a tremendous advantage we have here with our product portfolio. And then lastly, the one really important thing here, and it's a cultural thing, parents in Asia are willing to pay for anything for their kids. They will always prioritize their kids. And when I think about just the resilience of this segment for any economic headwinds that we might face, I feel very confident that the growing patients opportunity in Asia Pacific remains our greatest growth opportunity, fastest-growing market. We see it already. The percentage of our revenues across Asia Pacific, being driven by the growing patients portfolio, is growing year-over-year at the fastest rate. And then my last 2 slides are very much about demand generation. Demand within our customer base and how we expand our customer base and then obviously, the consumer demand side. But we call it the programmatic in Asia Pacific, a programmatic approach to growing our business. This is the crux of our business. This is hard work. It's all about growing submitters and growing utilization. And this is where you need discipline in the organization. Last year, we ran over 1,500 educational events, 20,000 participants attended our events. Just in quarter 1 alone, in '25, we've continued to kind of up the ante on this. We had over 9,000 participants in our new doctor onboarding and our growth programs. And we know that those participants typically grow at 2 to 3x the rate of the non-program participants simply because they're getting greater access to education, more contact, building their confidence in our products and new offerings. And that's how we take them on that journey from adoption, building confidence. We introduced more of the digital workflow, and we help them build successful practices. And this is what also drives a stickiness among our customer base. We also have treatment planning services, which support people to continue building their confidence in adopting our technologies. And then finally, we think longer term and how we're investing with universities. We have partnerships with over 124 universities across the region. And then finally, we talk about community a lot. We've built a great business for ourselves and for our customers in the region. And a lot of our customers give us a lot of credit for their success. And so in Bangkok, in a little over 4 weeks' time, we're going to have over 2,000 customers join us for what should be the biggest dental event of the year in the region, probably one of the biggest dental -- one of the biggest events for Align in its history. And that event is all about education. There's a lot of clinical education, but there's also very comprehensive workshops on practice efficiency and practice development. So we feel really good about how we're driving demand within the customer base. And then finally, it's also about driving demand and helping to generate demand among patients. This is something that our customer base depend on us for. And this is a big part of how and why they like working with Align in the region. The investments we've made in consumer marketing drive demand, which leads to direct visits and customers showing up asking for Invisalign. And so what we're doing now is making sure that the content we use is fully localized by market. We're also complementing it and making sure that it represents the superiority and differentiation we believe we offer in our product portfolio. And so I'd just like to show you a sample of how we've localized our consumer marketing across the region. So if you can play the video, please. [Presentation]

David Carr

executive
#20

All right. We all love the last one, I think. So look, just to wrap up, I think it's clear. We have a very sustainable pathway to double-digit growth in the Asia Pacific region. We've got a great portfolio. We have a very large community of loyal customers that we've worked together in developing this business and this segment within dentistry. And above all, we have a highly disciplined and tenured team in the region. So thank you all very much. And I will hand over now to Simon Beard.

Simon Beard

executive
#21

Okay. Good afternoon. Well, hopefully, I'm not going to disappoint you. I'm not going to show you any fancy videos. What I do want to do, though, is kind of excite you around the opportunity that exists within the EMEA region. Like my colleagues, the total potential market really dwarfs the actual market size that we see today. And so that's what really kind of inspires us and what really drives us every single day when you look at the potential that exists across each of our regions. I want to start by showing you kind of a quick breakdown of the EMEA region. You can see that from a volume clear aligner perspective, we're dominated by the ortho channel. So countries like Iberia, Italy, Germany, Turkey, France, we drive very strong ortho volumes. The GP side really is dominated by the U.K. and Ireland, which makes up the majority of our business there. Then if you look at [ doctors ], we've seen quite a big increase over the last few years as far as the number of customers that we serve in the region. And that's a combination of our core markets, but also our expansion markets that I'll talk about later. But if you take our top 3 markets, which is Iberia, UKI and Italy, they make up over 50% of our volume and revenue. So really strong contributors to the overall region. So like Frank and David, we focus on these key strategic growth drivers, which are pretty consistent. So it includes ortho, GP and DSO growth. One slight difference within EMEA is this real focus around geographic expansion. And like I say, I'll talk about that a little bit later. So let's start with ortho. So with ortho, a real focus around accelerating growing patients, which you'll have seen that the team are doing a really great job. Peer-to-peer is a program that was introduced 18 months ago. I'm going to show a separate slide on that. And that is really a foundational strategy for us at the moment and really driving our ortho utilization. And this year, in EMEA, we actually have finally been able to get our hands on products like the Palatal Expander. And today, actually, we are launching the Invisalign mandibular advancement with occlusal block across the EMEA region. So those 2 products, particularly IPE, which has been really well received, Europe is a very strong Phase I interceptive market. And then finally, building on North America, we recently launched the doctor subscription program, which has really been very well received by orthodontists across Europe, and we continue to add submitters there. On the GP side, one of the primary focuses has really been looking at how we increase our submitter base, not only in the U.K. but across Europe. And really, how we're kind of approaching that differently, I'll talk to in a moment. But one of the key things is, everything that Zelko and Karim have said and also Sree, is how do we bring this incredible technology platform together that really keeps it very, very relevant to our general dentist customers. So things like, obviously, the iTero Lumina, the new restorative capabilities, is really going to give us a massive opportunity there. But then other things like the Align Oral Health Suite and X-ray Insights, which is available in Europe, really talk to what a general dentist does on a day-to-day basis, which is diagnostics and then treatment planning. Reason this is so important and the very reason we're so excited about it is we truly believe that the general dentist is the gateway to the adult patient, whether that's from an orthodontic perspective or, as Zelko showed you, from an ortho kind of restorative or comprehensive dentistry angle. So let's just circle back. So on your left-hand side, I wanted to take you through the ortho peer-to-peer. This program was developed in Italy and has now been introduced across every market in EMEA. This is a 12-month program where we take our very best customers, and we pair them with 10 to 15 doctors who have got kind of low experience, low confidence. And they educate these doctors, colleague to colleague, on both the clinical side but also the digital workflow side. They give them ClinCheck mentorship. So they show them how to set up clinical cases. And then we use this network of mentors to primarily drive our new innovation. So they get access to our new innovation slightly earlier so that they can build confidence and then they teach their colleagues. So on a rolling basis, we've got about over 3,000 doctors who are involved in this program. And the really cool thing has been to see the strong growth that we are seeing, particularly in kids and teens, which is a key part of our strategy. On the right-hand side is the Invisalign digital mentoring program, which is focused on GPs. Now this is a newer program. We totally reimagined our training program for GPs in the middle of last year, particularly when we're certifying new GPs. So we flipped the model on the head based on everything that we've learned over the years. So we first train our doctors on iTero and the Align Oral Health Suite. So they then spend a month really getting that ingrained in their day-to-day workflows so that when they're doing a consult with a new patient, they're actually, rather than using a mirror and a probe, they're scanning and then talking to the patient about what's actually happening in their oral health cavity. And then after that month, we bring them in, we train them on Invisalign Go and then give them strong mentorship and support with treatment planning and ongoing education. The cool thing is in the early pilot results, we saw both a 2.5x increase in not only Invisalign cases, but just as significantly for general dental practice for their restorative cases. So they can truly see that the iTero and all the diagnostic tools that my colleagues have spoken about truly do make a difference to patient conversion and connection. So we launched in the U.K., France and DACH and Nordics, and we'll be rolling this across the rest of the region. So DSO is becoming an increasingly important part of our business. And we're learning a lot from colleagues in North America on how we build and scale our business to support those doctors. So we've made a lot of progress in really making sure that the propositions that we have, because sometimes you're looking at multi-geographic locations, mixed specialty within Europe, and how can we really build a tailored flexible solution to help them grow and scale. And we believe we're in a great position to do that, particularly with our portfolio, but also the scale that we have in that region. On to expansion markets. Expansion markets have been really incredibly important to this region. We've consistently seen fast and strong growth. And we've learned a lot over the years about what's the playbook when we enter a new market, when we go direct, what can we do to ensure that we get that kind of fast growth. So a good example of that has been Turkey, which was an expansion market 7 years ago. And then last year, we brought it into our core group because we've had great success in really scaling and growing and accelerating that business. So we currently have 34 markets that we're operating in, a mixture of direct and distribution. But within those kind of 34 markets, there are 5 that are absolutely critical, and we're really focused on, which is Saudi Arabia, Poland, Greece, Israel and South Africa, all of which have enormous opportunity to grow and are performing well at the moment. Now I wasn't going to just leave consumer out because consumer still is an important part of our overall commercial strategy. We are limited a lot by the local regulations and legal rules that exist within Europe about not being able to actually advertise to consumers. But there are some markets, like the U.K. and Germany and France, where we can go direct as far as our advertising is concerned. But the team have done a great job across both kind of search, social media and also through engagement on our platforms. So we've seen record levels of consumers going on to doc locator, looking for a doctor to treat them with Invisalign. And they've also done a great job in maintaining the strong preference and sentiment for Invisalign over all other products. So just to close, EMEA is a double-digit growth region, high growth in growing patients with iTero and also with our expansion markets. We also see a really strong adoption of and connection with our new innovation from doctors. And we've really seen the ability of using communities and peer-to-peer type relationships to really drive that growth. Like the other regions, we're really focused on keeping our business as simple as possible for our customers and focusing around execution. But the message I want to leave with all of you is there is an abundance of opportunity, whether it's looking at the different customer channels, segments or the geographies. So thanks for listening. And I'm now going to hand over to the man you've all been waiting for, and that's John Morici, our CFO.

John Morici

executive
#22

Good afternoon. I do want to talk about bringing this all together because you saw a lot of great content, great ideas, things that we're doing to affect the business, grow our business, become the standard of care. I want to go through a few slides before I tell you what it means for our model and our business going forward from a financial standpoint, but I want to take us back a couple of years here. If you look at what Joe showed, and he talked about the growth that we had in the business just going back to 2018 to 2024, growing our business $4 billion in revenue, double-digit CAGR on revenue, same way in volume, and you've seen that. To get to that, and I'll get into this in 1 second, takes a lot of new products, a lot of different ways that you need to be able to go after that market and be able to get that type of growth. Same way when you think about teens, these growing adults that we have, to be able to have products that a lot of my colleagues talked about, products to be able to help drive growth, become more relevant in this sector, to get down into not just teens, but growing adults, being able to get into the kids into new markets that we haven't been before, it takes new products to be able to get to that, to be able to see this type of growth. And we're pleased with our growth. But when you look at what it means for our financials, I want to take you through a couple of views of this. If you haven't guessed before or a lot of you have asked me in the past, I get a lot of ASP questions about what's happening with our ASPs, where they're going. When you look at our product portfolio, what we started with, just going back to 2018, we're essentially 2 products. We had a comprehensive unlimited 5 years unlimited aligners, basically trying to get orthodontists in particular, to be able to use our products to be able to treat the cases that they have. And then the rest was non-comp, 5 sets of aligners, 7 sets of aligners, 10 stages and so on. As we've evolved our portfolio and we've been able to say, "Look, what are the new products that we have." You look at Comp Three and Three, some of you talk about that. We introduced that 2.5 years ago. It's our #1 selling product that we have. We used to have comprehensive unlimited at 76%. And now it's not even our top-selling product. You look at products like First, my colleagues talked about that, being able to treat cases that are -- help doctors treat cases for 5-year-olds, 6-year-olds, 7-year-olds. IPE falls into that category. And then we talk a lot about some of the touch-up cases. These are cases where maybe there is a relapse that happens or someone just says, "Look, I don't need as much treatment," or if they're following what Zelko talked about, "Hey, move the teeth first before you do some restorative." That's a touch-up case. Well, guess what? On some of those cases that we've now introduced and products that we have, some of them have lower list prices. It's just the reality of the business. There's less cost to serve. It costs us maybe ship the aligners and there's no refinement. That's really good for us from a margin standpoint. It's not as much gross margin dollars, but it's a significant amount of margin rate. Same way with the mid-, high, some of the moderate cases that we now treat with some of the products that we have. We didn't even have Moderate back in 2018. And you introduce these products, you get higher utilization, you get doctors to come into the ecosystem. And when you look at the doctor growth that we've had from 2018 to 2024, it's tremendous. Why? Because new doctors come in and they start using our products. They might not use the most comprehensive unlimited product. It's okay. They haven't started with that. They're not maybe attuned to that, but they can use products that we have, and it gets them into the ecosystem. So there's a product mix that I talk a lot about. That's product mix here. I'm going to show you in a couple of slides what it means altogether. You also have emerging markets. My colleagues just talked about how we're growing in some of these markets, emerging APAC, Southeast Asia, where we have, we're growing in Lat Am. You grow in Turkey and Middle East and other places. Sometimes the products that serve that market, just given the market dynamics that are there, they're less ASP. They're just a lower ASP product. It might even be the same product that's sold in other markets, but it has a lower ASP, lower list price. But what you find there is you can get massive market expansion. You can grow in those areas. You can get doctors to start maybe using some of those lower list price products and they grow, they start to learn their practice and how it fits into their practice. And then guess what, they start working their way up to do more comprehensive cases. And it really becomes a part of their practice. Turkey is a great example of that. Lower list price, but the new doctors that we have and the utilization that they have is phenomenal. And we don't see that a lot. And when we have that opportunity, we're going to continue to grow. And it's what Joe talked about before about having a direct sales force to be able to sell into those markets, it's very critical. So then you say, "Okay, what does that mean for an overall ASP standpoint?" And so for us, kind of finance geeks, I can at least show you this to where things are at. If you looked at our total ASP, blue line there, going back to 2018, we started this journey through here, that total ASP includes any foreign exchange. It's just the reported numbers that we have going back to that time. If we adjust for foreign exchange, the green line that you see there, you can see prior to COVID, close to $1,290-ish or so; post-COVID, around that same number. You have a dip during COVID. It's a difference between primaries and secondaries and so on. You can see the volume growth that you had there. But there's a significant piece of FX that hits us. So what's that say? So despite the growth that we talk about with all the new products and driving utilization, new doctors and so on and the mix effects that you have, the underlying ASPs in each of these markets and each of these products are stable. And in some cases, they go up. We do list price increases. We do -- we manage our discounts and so on. And I think the headline that comes through, and I get it, ASP is the headline that you have in terms of what the market is, what we're having in terms of our growth and so on, but it's the underlying parts of this that allows us to grow our volume, grow our utilization, sell to more doctors and ultimately drive profitability. And I'll take you through what that means. So when you look at, now on a future basis, of what that global opportunity is, you talked about -- and my colleagues talked it, about 600 million potential patients, 22 million orthodontic case starts, a couple of million doctors, huge opportunity. When we think about playing offense through focused execution, I've been here 9 years now, almost 9 years now, I've never seen the opportunity that we have in each of our ways that we can try to help grow this business, whether it's brand that we've talked about, some of the videos that you see in terms of -- people know what Invisalign is. They know about us. We've been able to advertise for 28 years. It means a lot. And it means a lot, especially in this environment when there's the me-toos out there. And we have to make sure that we let our brand talk about what we are as a company instead of them talking about something that acts similar to us. All the doctors that we have, all the partnerships that we have, we talked about some of the KOLs and some of the training and things that we're doing with growing patients and so on, but giving those doctors the tools that they need to be able to treat now a wide variety of cases. They could treat -- back in 2018, we could maybe treat 60% of the cases. Now in doctors' hands, they could treat 100% of the cases, giving them the tools that they need. And then a large part of what we talked about today is how do we expand that? What are we doing from a go-to-market standpoint that's going to give new innovations, new products, new technology, being able to get at opportunities that are right in front of us. Zelko did a great job. I always cringe when I see this teeth shaved down and what it is. That's the reality of what's happening. That's going on right now today. And if we can get that message out to people, to doctors, maybe even patients, any one of you, if you go to -- and you see something like that, you might want to ask a few questions when you talk to your doctor about -- or your dentists about what they're going to do. Are they going to shave that down or not? Make this the standard of care. Educate patients so that they can then talk to their doctor about what they're doing or what they're not doing. But so much of that's education, being able to scale -- the next couple of pages, I want to talk a little bit about the scale, what it means as a growth driver to our business, to be able to drive and improve our cost and efficiency so that we can fund a lot of the new growth initiatives that Srini and Emory and others are talking about to be able to grow this business. But we need to be able to fund that to be able to get into some of these new products. And then continuing on the innovation. Sree and Mitra and others talked about what are we doing from a treatment planning standpoint? How do -- David Galler, a great presentation about taking all those tools together and turning something into an innovative digital solution to be able to solve the problems that they have. So when I take that and I say, what does it mean for us? And what does it mean for us going forward? Last week, we talked about what it meant for 2025 at earnings. And so I'll officially reiterate 3.5%, 5% to 5.5% for revenue and about 5% volume, clear aligner volume. We're talking mid-single digits, but that's what it means. There's a lot of things that are going in, a lot of the tools and products that you just saw from my colleagues, that's again what we're trying to do because what you see here -- and just to be clear on the market, I'm not assuming a market getting better. You wake up one day and there's a tweet about this or there's a tariff about this and there's a consumer sentiment about this. I can't predict that. What we are going to predict is do the things that we can do. We can grow our business in a meaningful way to build off of where we need to go in 2025 based on some of these initiatives that we have. We're going to add to that when we look at '26 to '28, again, not assuming the market gets better. The market is this. It's maybe higher inflation, maybe concerns about trade, maybe concerns about slowing economies and so on, consumer sentiment where it's at, it's what it is. We can be in the 5% to 15%, both from revenue and a clear aligner volume. Doing the things that we talked about here with direct printing and Lumina platform, scaling out all this and scaling it in a way -- and I'll show you some of the financials coming up, but doing this in a way that's respectful for driving the growth and getting the opportunity, but doing it in a way that drives the profitability in the right way as well because we need that to be able to invest back into the business. And then in 2029, I put it out there in terms of continuing new opportunities, taking those platforms to the next level, AI and other technology that we'll bring in, Lumina with Karim talking about things, direct printing that we talked about, AI improved products to be able to get to, but having new opportunities, and we're going to continue to fund those. And God willing, maybe the market gets better. But without the market, we're still going to drive to these growth numbers. I want to double-click a bit on operations and kind of how important it is because as was discussed earlier, we're going to be doing the traditional manufacturing for years to come. It's just the reality of what we have. But when I look at material, labor, overhead, logistics, that's about $1 billion of cost, roughly split across these 4 categories, split pretty equally. But we have a lot of things that we can do to be able to drive productivity, continue to take material costs out, a lot of things that we're doing to automate and improve from a labor and overhead standpoint, just to be smart about our operations. When we're scaling and making over 1 million aligners a day to 2 million aligners a day to ultimately 3 million aligners a day, every penny matters. Every penny per aligner matters, and it makes a difference whether you're growing your gross margin and op margin or not. So we've got to continue to take costs out. That includes logistics. And in the next page, I'll talk about our logistics and kind of our footprint that we have, but logistics really become an important piece. When I look at that piece, it's as meaningful as labor or materials from a cost standpoint. You're air shipping things all to different locations. There's so many packages that are going out. That cost of logistics really matters. And that influences us in terms of where our manufacturing is and how we manufacture. Because when you look at our overall footprint, back in the day, we had the Costa Rica treatment plant and manufacturing in Mexico. It's how we started out. We scaled that. We did an excellent job scaling that. And now we took that to the region, put it in China, treatment plant and so on. David talked about in China for China and so on. Thank God, we did. That limits our -- the amount of tariff or other impact that we have is minimal in China, and we made that decision years ago to be at that. And then a similar way in Poland as well to be able to have our manufacturing there and really diversify our supply chain. As we continue to scale and you take some of these new technologies, we're going to have opportunities to be even closer to our customers. And that's a good thing because if we do it the right way from a material, labor and overhead standpoint and keep those costs down and as low as possible, it might not be as cheap as it is to make something in Mexico. But if I can offset that higher cost that's made somewhere else, even in the U.S., if that's where we go, I'm going to save in freight. And net-net, it should be a benefit. At the very least, it shouldn't be worse, especially with our new technology, it's nice to have it in some of these locations as well. But our manufacturing and our operational footprint gives us a lot of opportunity to help do things in an efficient way and help scale this the right way. When I think about what it means from a margin standpoint, and we look at our margins and our gross margin means a lot. What I was just talking to you about ASPs, it doesn't matter at all if your ASPs, whatever they're at, low stage, Moderate products and whatever else, if they're not driving to gross margin, then you're just talking about it. We've got to be able to show that we can do things. So doing things like we're talking about for 2025 to be able to expand and grow and do the things that we want to do despite still having some headwinds. And I'll put tariffs out there. It's what it is. Right now, it's $1 million a month that we see this year, could be more, but we're going to operate in the right way to be able to drive as much efficiency as possible, be in the right countries that give us the best opportunity to operate better for our doctors, closer to our customers and so on. And oh, by the way, it might even help us mitigate some of the tariff concerns that we have. But we need to be able to drive that gross margin to be able to make sure that as we have new products, some of those new products on the direct fab, until we fully scale this out, when you're making 1 million aligners a day in the current manufacturing, there's a lot of efficiencies that you can drive. When you're talking about some of the products that Emory and Srini was talking about, you're not making that many a day, and therefore, they're more expensive. We need scale to be able to keep our cost out. So as we go from not making that many a day to a lot a day, we need to be able to drive productivity in other places. And we're committed to doing that. And despite the scaleup, despite the things that we need, we're going to be at those margins here and in the future, be above 73% because a good med tech company should be at that. And if we're introducing the right products and growing the market the right way and utilizing our facilities and so on, we can be back to that or above. Same way from an op margin standpoint. We talked about this year the 22.5%, and that's a 70 basis point improvement from last year. Good, great, we should be doing that. We should be doing better than that. We should -- when we think about the productivity that we can drive and what it means from a gross margin, that should fall through. We should also be getting benefit on an OpEx standpoint. We should look at things and say, "Look, we've spent a lot to R&D. And it's great new products and improvements that we have." But eventually, that has to turn from an R to a D to eventually, you don't need to necessarily spend on it. So you bear or lower some of your costs related to that. And then great. Now we have new products hitting the market. I don't -- that's revenue, MAOB, IPE, when Lumina came out. And so that's millions of dollars of investment that we've had to make to get to really great products that make a difference for our customers. But I don't have to spend that as much anymore. And then now I can enjoy the revenue benefit. And you'll see that OpEx leverage coming through in addition to the gross margin benefits that we have. So this was put out today, and this summarizes everything that I'm talking about here. So 2025, a confirmation of what I just walked through here. The numbers that I show here, this shows GAAP and non-GAAP to be able to reconcile between the 2 for '26 to '28 in this environment and 2029 and what we think we can get it back to. So that just summarizes our outlook and what we think our model represents. I wanted to go back a little bit, too, to say -- and I know Rule of 40 to me is an important metric because everything I was just talking about growth, everything I was just talking about profitability, it really -- we don't necessarily manage to Rule of 40, but I think it's a good framework to have. It's just taking revenue growth plus op margin. And how do you compare? How do you -- really, it's not so much comparing to others, you could. Rule of 40 is, okay, what companies are above 40%, what companies are below 40%. I almost look at it comparing back to ourselves. Where were we before? You have kind of that COVID macro piece of it there. And then 2022, you have no revenue growth, negative revenue growth and your op margins hit. And then we start working our way back 2023, 2024. Even in this framework here, when we talk about the margin that we're going to generate in 2025 and the revenue growth that we have, 26% to 28%. As we start to scale, as we start to do the things that we were just talking about doing on how we're going to go to market with the new products and the future that we have, we can be able to, in '26 to '28, be in the 28% to 40%, depending on what the economy does. But in the end, we should be able to drive to this range regardless of what the economy does. If the economy gets better, great. We know we're a discretionary product in the end. Even for teens, sadly, they get to a certain point where they need treatment. Do they go into treatment or not? Do they go through the doctor or not? That's what happens. But when we have a decent economy plus all the things we're doing, we can get back into that Rule of 40 framework. A lot of what we talked about is our strategic advantages and what we are. And you've seen us talk about this a lot and everything that came up today, whether it's product related or digital platform or some of the workforce that we have, the manufacturing excellence, the expansion. So companies try to pick off different pieces of it. No one has all of this. No one has all this. And the reason why I know no one has all this because no one has the profitability, the business growth, coupled with profitability that we have because we have these strategic advantages. So when you think about what we do and what we think about as we're investing for the company, we're investing for growth. We're a growth company. We are going to continue to focus on customers, expand operationally where it makes sense, come up with these new products to be able to grow submitters and grow our utilization. Basic equation. That drives volume, that drives revenue, that ultimately drives profitability. We have to continue to do that with those investments to drive that growth, but do it in a profitable way because what does that give us? That gives us free cash flow to do all that again and continue to invest that. And we're committed to, once we fund the business, once we fund some of the CapEx that we need, we've done some strategic acquisitions using our own cash to be able to get to that, the rest of the cash goes back to shareholders. And that's our commitment, to use this from a cash flow standpoint. Because we've generated in the last 25 years, $5 billion of cash flow from our operations from going back from losing money in the past, in 2001, to making more in 2024, the cash that we've generated throughout that time and the cash on the balance sheet. But more importantly, what do we do with that cash that goes back to shareholders? We'll repurchase our shares. We have authorizations. Our Board has been very comfortable with us putting money back to our shareholders. We just announced today the $1 billion buyback. You can see how much that acceleration has happened. It's interesting, you go back to that 2018 and you look at it, that's been the growth of our company, but it's growing in a profitable way that allows us to invest back into our business and be the standard of care that we all want to be, but we also want to give money back to our shareholders and buy back shares. And during my time here, I think we've netted 9 million less shares, went from 82 million-ish, 83 million to around 73 million, 74 million shares, net shares, that we've had. But it's doing this. It's being able to buy back and putting our money where our mouth is. So when you bring it all together and back, that's giving you the financial framework. It's what everybody has been talking about up here today. We have this massive opportunity with new and better technology to be able to serve our customers and give us that competitive advantage that sets us apart. And we're going to continue to reliably execute and make a difference for our customers day after day and make a difference for our shareholders so that when they invest in us, they know that they're investing in a company that's going to grow and be the key leader for the future and be able to have this unique position that we've created and do it day in and day out, and be able to grow in a profitable way. So I'll leave it at this in terms of what we believe and what we think. I'm trying to summarize in my takeaways of what my colleagues were just talking about. It's an underserved market, and it continues to be. And that competition is not other clear aligner. This is not about share shifting. This is about going after wires and brackets and making a difference and going after wires and brackets so that they're not the standard of care, we are. That is our competition in this underserved market. And we need technology. We need workflow. We need new ways to go to market so that we can make things easier for our doctors, make sure that potential patients are aware of differences of what we bring versus maybe some others. But this is not a zero-sum game from a clear aligner company. This is market expansion. We are a company that believes in the market and believes in the fact that we are going to bring digital dentistry to the world, whether you're a dentist or you're an orthodontist. So with that, I'll turn it back over to Joe Hogan.

Joseph Hogan

executive
#23

Well, that's our story. Just a quick couple of closing slides here. One, the trusted digital platform. I think you can see how that digital platform plays throughout the entire company and how it's just gained momentum over the years, especially around new technologies like 3D printing, obviously, AI, the machine learning algorithms and all that we're driving to the business. That's 20 million smiles. We're pretty proud of it. But we think that's just the foundation of where this business can grow. And I'd just like to end here with the 3D printing, touchless workflows. This is where we are right now. And that's the next phase of Align's development. It is technology-based. It's distribution-based. It's a global business. There's really not another dental company like this in the world. And look, and you've seen numbers, you've heard about stories and whatever, but what I'd encourage you to do, and I've been around it for a long time, think about the enthusiasm and commitment you see from the leadership team here. People have been here for over 1/4 of a century. I've been here 10 years now. It's the longest job I ever had in my life. I don't know if that means I'm doing well or not. Okay, but I truly believe in what the future of this company is, and the best days of Align are ahead of it based on what you've seen today, the commitment of this leadership team. And as we move the company forward, I couldn't be more excited about it. So with that, we're going to do some Q&A, and we'll take your questions. Thanks.

Shirley Stacy

executive
#24

Thanks, Joe. Thanks, everyone. Just a minute, we're going to bring some chairs up here. Can the leadership team join us? And just a reminder, we do have 2 folks on my team that will have mics. We want to make sure we capture your questions. So just 1 minute as everybody comes up, and we'll get started. All right. As we're getting settled here, why don't we go ahead. We've got some -- we'll start and go back. We'll move around, promise. Go ahead. And if you don't mind, we'll start the Q&A. Do we have enough chairs? Do we all fit? Close enough. Go ahead, let's get started.

Vikramjeet Chopra

analyst
#25

Vik Chopra, Wells Fargo. Awesome day today. A couple of questions for me. One is, can you help us out with the cadence and the pacing of the revenue growth over 2026 and 2028? And then I had a quick follow-up, please.

John Morici

executive
#26

When we look at the cadence of what we see, I think if you looked at the volume and revenue that we have as we exit this year, I think you'd see, on a year-over-year basis, you're going to get to a pace that's a little bit above mid-single digits or, as things continue to grow, we would expect that kits into next year. And if the economy doesn't change, and we don't see a dramatic change there, we will be in that 5% to 15%, and we'll continue to grow that. I wouldn't -- I'm not guiding for 2026. We're kind of laying out the framework of what we expect over the next 3 years. But look, as our products take hold and we have those additional opportunities, and there's not a -- I always kind of put the caveat out there, as long as there's not a major change in the economy, recession or other things that happen, we'll continue to be able to grow as we can and be in that range. And that will be something that, as we get closer to 2026 and into that time frame, we'll give more of an update as to what that is.

Vikramjeet Chopra

analyst
#27

Okay. A follow-up question, I didn't see anything in there about ASPs and how to think about that over the '26 to '28 and beyond time frame. And just also curious how you think about peak margins beyond the 25%.

John Morici

executive
#28

Yes. I think when you look at ASPs, just what I was describing in terms of being at some of the mix that you have and growing in certain countries that are just at a lower ASP, think of ASPs down a couple of points as a result of that when you think about it over that time period. It doesn't mean, and I put the caveat and information on from a gross margin standpoint, gross margins could go the other way. We'll see improvement there as we drive efficiency and so on. But again, list price is just what it is for certain products, and that's the difference there. And then when I look at the profitability that we have and what we're expecting to at that 25%, that's something that we want to be in. We want to be in that from a long-term standpoint of op margin, it shows a reflection of the health of the business and the revenue that you have. And ultimately, that should show up in profitability. So we're committed to getting that, maximize that revenue growth through all the different things that we've been talking about, but do it in a profitable way.

Erin Wilson Wright

analyst
#29

Erin Wright, Morgan Stanley. So can you talk a little bit more about direct fab and putting some numbers around it? I guess, one, what are some of the limiting factors near term? And are there near-term investments still that you need to make that are sizable at all? And then can you quantify what that can contribute then? And what's embedded in your longer-term guidance in terms of the contributions from direct fab?

John Morici

executive
#30

I can start with that. So in terms of the investments, we're always adding capacity for investments that we have in direct fab and previously, the existing manufacturing. So we're going to continue making those investments. We put the -- for this year, we talked about $100 million to $150 million of CapEx. That includes some of those investments that we have, and we'll continue to make that. What we will find on the direct fab, when those new products, like I was describing, when those first come out, you don't have the scale yet. You haven't scaled the manufacturing process, what's your throughput for that equipment and what's the resin, the resin cost that we have. And as you have more volume coming through, you can end up scaling both of those. So initially, 2025, it hurts our margin and into '26, it still hurts that margin on those particular products. But as you get into 2027, when you start to scale and you get through -- you're using it for retention, you've got other products that are maybe more difficult to manufacture under traditional manufacturing and now you direct fab them, you start with those. And then ultimately, as you're making aligners, now you scale that and that becomes a good business. But the other pieces of it is, from an overall margin standpoint, we're mindful of the fact that there's a scaling process that you have to go through. We know how to do it. It's just a matter of scaling that up and being able to be ahead. And not to mention, too, when you have some of those new products, we talk about ASP and so on. That, at the very least, will help us hold our ASP. And in many cases, there'll be unique products or unique applications that those doctors could do that might even be at a higher ASP as well. So that helps offset some of the additional costs, especially as you scale.

Jonathan Block

analyst
#31

Great. Jon Block from Stifel, maybe two. Joe, the first one for you, a ton of new products, right, Simulator, Sim Pro, Sim video, oral health and a lot of R&D dollars that go into that, and you're showing conversion that occurs. Any changes sort of the marching orders to the reps or from a commercial strategy to help incentivize and make sure that all these features and functionality, IPP, I can go on and on, is being utilized, utilized to its fullest extent, to help sort of drive ultimately that top line result?

Joseph Hogan

executive
#32

Jon, it's a good question. I started in commercial in my life, too, and what you're asking is really important, is how are they incentivized to really go forward. The great thing, and Frank and Simon and David can join in here, too, is we have to train our sales force really well because what you could see is very sophisticated tools that we have to bring forward. And there's a number of constituencies that they're talking to, right? You're going to be talking to lab techs, you're talking to doctors themselves, you're talking to hygienists or whatever. And there's a different tool in different area that all comes together with that digital platform and what we want to make. And so the main thing, we reward salespeople on being able to sell product and revenue and product. The thing is to make sure they have the proper training in place. We start incentivizing them on, hey, how you're trained or what you know, whatever, but we'll watch very closely in the sense of what tools they use, test them and how they're cognizant in the different product lines or whatever. But that's what I want to end my talk to is, honestly, that distribution force is so critical. And what we sell is a very sophisticated product targeted at a sophisticated audience from a clinical standpoint, we have to have top-of-the-line training and people to be able to bring that home.

Jonathan Block

analyst
#33

Very helpful. And maybe to shift gears, John, I do want to go back to ASP. It's probably the #1 inbound I get. So you had this slide, I think it was 2018 to 2024, FX adjusted ASP was flat. I think it was $1,295. And you're talking about maybe a 1% to 2% disconnect on ASPs going forward. But should we be cognizant that it's a little bit more pronounced in the near term? You've got IPE, $500. You've got DSP, Simon said coming to EMEA, right? So like the incrementality of those lower ASP products are more pronounced in the near term. When you get to '27, '28, you'll be commercializing direct fab. I'm guessing some of those offerings might have more of a premium feel to it. So if it's 1% to 2% over that 4-year period, is it a little bit more acute in the near term and then it sort of unwinds as we get to some of the premium offerings?

John Morici

executive
#34

That's a fair comment. And I would look at that and say, look, some of that DSP and other products will be -- they're at a lower list price. That's what it is. So you're right about that. Then as we have more premium products coming in with some of the direct fab, those are mostly going to start with some of the comprehensive cases. So you will see it show up in the comprehensive cases at a higher list price. So I think that's a fair statement. I think you would also then see some of the offset in volume because if we're growing like that in DSP and some of the others -- because that revenue number that I gave for this year and kind of how we're looking at stuff, revenue for this year, 3.5% to 5.5%, look, you can model how you want with ASP and so on, but if you take that approach and you have some of the newer offerings that are a lower ASP, we'll get more volume, and we'll be able to generate that revenue and ultimately, be able to generate the profitability. So when we talk about holding the 22.5% for this year and so on, that's taking all that into account. But it might be at initially at lower ASP just because that's the mix that you're facing in the short term.

Michael Cherny

analyst
#35

Mike Cherny from Leerink Partners over here. I guess I'll just ask one kind of big picture question. Obviously, both medium-term guidance as well as long-term guidance assumes an acceleration of case starts. You said at the beginning, early on, your biggest competition still are against brackets and wires, not a big surprise. As you think about what's embedded in your build on case starts, knowing it's a very wide range, how are you thinking about the clinical education, clinical advancement of clear aligners relative to kind of market awareness across various different markets. Do you need a sea change from kind of the scientific community, from the user community in terms of getting back to those more elevated case start levels? Curious how you're thinking about the awareness side of where clear aligners go?

Joseph Hogan

executive
#36

Yes. Michael, it's a good question. I'd just say there's many touch points to make this happen. One, you have to start with the portfolio and capability we talked about with the uniqueness of our product line and the efficiency, so you don't knock down as much, many of what I call the frictional barriers of those accounts, that they would want to take that step and go to digital, which is a dramatic change from doing analog together. You could think you could run into the academic community and how do you train orthodontists or whatever. We've made good progress in that area over the last 5 years in the sense that we have several universities we work with today that will offer -- maybe do 20, 40 Invisalign cases as part of an orthodontist training going forward, which is kind of a ground. So one of the critical things we run into, though, is doctors graduate with about $0.5 million of debt. If they go into the marketplace, more likely they're going to do wires and brackets for 5 years. That's the workflow that they have. And they come out, they buy a practice, they start a practice, they want to move into that. We're going to try to find ways, and we've worked that with DSOs or work in different ways, of being able to have digital practices that will be set up, that doctors could go into and help to fund those. And first of all, starting with DSOs is a good way to go about that. But somehow of getting those digital practices in front, if we wait for academia, we'll all be dead in this room. It's just those -- many of those facilities are run by people that are around -- they're 75 years old. They've been doing wires and brackets for 50 years. They don't really want to move from it. We're going to have to move from a market standpoint. So ease of use of technology, make it line of sight for doctors to say, "Look, I think I can do the digital thing," also be able to work with organizations that have mass to them to be able to set up digital practices that orthodontists can eventually evolve to. I hope that helps.

David Saxon

analyst
#37

David Saxon from Needham. I just had a follow-up on direct fab. So I'm not sure if this is for Emory or John. But I think in the past, you've talked about the actual mold being 70%, 75% of the actual clear aligner COGS. Today, there's obviously other benefits, freight, labor, et cetera. So once direct fab is scaled, what percent of today's COGS, clear aligner COGS, are ultimately taken out? And then I'll just have one follow-up.

Joseph Hogan

executive
#38

Where's Srini? Oh, Emory?

Emory Wright

executive
#39

Okay. So I think -- I mean, one of the -- I think you mentioned a high percentage of total COGS. Really, the mold being eliminated goes into the material COGS. So it's not the whole bucket. It's just that one bucket, right? And I think if you -- it's hard to speculate, but you're probably talking in that bucket, low single digit to -- high single-digit to low double-digit reduction on the material side.

David Saxon

analyst
#40

Okay. And then I guess, anything on like freight, labor, overhead?

Emory Wright

executive
#41

I think we'll see, I'm not -- at this point in time, it's hard to nail that down.

David Saxon

analyst
#42

Yes, sure. Okay. And then my second is just for David. So I think if I saw the slides right, it was 51% of volumes are in the GP channel. So is there anything specific to the APAC region that's allowing you to kind of engage the GP channel in that way? Or can you kind of replicate that in the Americas and EMEA?

David Carr

executive
#43

Yes. I just think a point of caution just with those statistics because in APAC, we have a much smaller percentage of our customer base that are specialized orthos. We have a lot of GP orthos. So just when we make that breakdown, a lot is represented by GP orthos. So it's kind of hard to make that direct comparison. As I said in my presentation, we just run -- if you look at our growth programs between new doctor onboarding and then the growth programs for existing customers, that's really how we're driving that increase in submitter base and utilization.

Brandon Vazquez

analyst
#44

Brandon Vazquez from William Blair. Maybe first, I'll start for the commercial heads in the regions. A lot of you had made comments that this is a similar playbook we've used before, and you're kind of executing on the same thing. But as Joe had showed out to us, you guys are kind of entering a new era where you have the broadest portfolio you've ever had, most clinical applications, most price points. So the question is, does anything change from here? Are there any incremental new strategies given that you have -- you're kind of entering a new era of Align from a commercial perspective?

Frank Quinn

executive
#45

Yes. I think it's -- a lot of it is around the sales and doctor training. So you have your core product portfolio in Invisalign as we talked at length about today. Obviously, the iTero Lumina is a huge part of the platform as well. But it really is getting the enablers that help with conversion and drive practice efficiency so that the practice can really take the benefit because they're still under staffing pressure and whatnot. So you really gain some benefit with all the enablers. And then the ClinCheck component, which is arguably, I think, the most impressive, moving from weeks to minutes and live updates, having the doctors' personal preferences, having their own signature on every case essentially is really where the critical path is from a commercial perspective and ensuring that doctors are engaged, leveraging that ClinCheck, all the pieces of the platform that drive efficiency and those enablers that are in there. So that's where the focus is: training, sales force, doctors and ensuring that we're partnering with our customers.

Steven Valiquette

analyst
#46

It's Steven Valiquette from Mizuho. So I still think about some of the cost of manufacturing maybe on a per unit basis, if we think about just Invisalign case cost of manufacturing, maybe $350, $400. I guess the question I really have is, if that does come down a little bit, what's the mindset philosophically on whether that just falls right to your pretax profit line? Or do you use that maybe to bring down Invisalign pricing and ASPs to drive more volume growth? Just curious how you think about that longer term. And to get to that 15%-plus volume growth, do you have to -- I guess, what's your mindset on the pricing versus just the macro driving most of that?

Joseph Hogan

executive
#47

I think you saw in John's chart, and I can let John pick that up, too, is how we've -- Steven, how we've modified additional aligners. Now we have -- 3x3 is our biggest product. Our moderate product is in there, too. That's the way we've addressed this with. Customers ask and doctors and patients ask for different things, and we will modify our portfolio in order to do that. How we use average selling price, at times, I think in the future, it might be pressured somewhere on average selling price or whatever. We saw a lot of value with our product line. Our competition just comes in on price. And if a doctor is doing 20 cases a year and someone comes in with a couple of hundred dollars different, they'll probably make a change, but that's nothing that's going to be material to us. I don't think we can chase those kind of little things and have them force our price down. I want our people to sell value. You can see with 3D printing, we have a lot of value to sell. Underneath that, though, we'll have an incredible vacuum-formed aligner that's almost zero touch on ClinCheck. It's probably the most efficient thermoformed aligner and the highest quality in the world. And I'd rather play the game with that end, in the upper end of our portfolio. And so as this works its way through, I see that being a specific way for us to go about that, right? We'll sell high end and we'll sell an efficiency product, too. So we don't have to match a higher-quality product with a lower-quality product because of price. It would be the worst thing to do. I hope that makes sense.

Jeffrey Johnson

analyst
#48

Jeff Johnson, Baird. John, just starting with you, I guess. On the 5% to 15%, I just want to make sure we're clear on this. So I think you said it's kind of independent of macro, of current inflationary rates, other kind of issues. What would it take then to get to the top end of that versus the bottom end of that? If macro isn't the driver of going from 5% to 15%, what goes right to get you to 15%? What maybe makes you perform at the lower end of that 26% to 28% range? And then I have one follow-up.

John Morici

executive
#49

Yes. And to be clear on the macro, I'm just assuming it doesn't change from where it's at. We can think whatever you think of the macro now, I'm just saying it doesn't change. And so when you think about as we operate in this environment, looking at what we can control as we have new products that come out, so you have mandibular advancement with occlusal blocks, you have IPE, you have new ways to go to market with some of the stuff we're talking about, the ortho restorative and so on, those help us grow, be able to grow our business and be able to drive more volume and so on. So it's continuing to do the things that we're doing to be able to operate within that environment. If the macro -- and we're seeing in some countries where the macro, it's better. I mean you're seeing double-digit growth in various countries we have. We talked about kind of Mainland Europe being better than what we've seen in the past. And just most recently at earnings, we talked about the Americas, and specifically in North America, starting to get a little bit better. We want to continue to drive that with some of the products and things that we're doing, go-to-market and so on, partnering with DSOs and so on. If some of that hits and macro stays the same, we'll operate within that model. If some of these take off themselves, we can operate further into that model. And if you get macro to at least not be as negative as it is now and give us some more stability, meaning interest rates a little bit lower, a little bit better consumer sentiment, we'll be further up into that 5% to 15% model.

Jeffrey Johnson

analyst
#50

All right. Fair enough. And David, maybe for you just on China. I feel like I'm feeling maybe a little better on China after today. So maybe that's kudos to you on that. But I guess one thing I still want to understand is, in a VBP world in China, you talk about consumers and doctors still willing to pay a premium for Invisalign. I understand that would be in the private market and VBP is in the public market, but we often see public market pricing kind of bleed its way into the private market over time. Can you continue to get that price premium even in Tier 1 cities in the private market over the longer term if VBP is going to bring all these prices down to one kind of competitive bid level, if you want to think about it that way?

David Carr

executive
#51

Yes. Look, I've had a chance to watch VBP unfold in a prior life and seen how really the secret to VBP is playing the portfolio and understanding that there will be one product that you probably have to bid competitively on, but then understanding how you leverage other products in your portfolio. And there are a lot of different scenarios that we're kind of looking at with how VBP may unfold. There are some examples, as I said from that I've seen in my prior days in Medtronic and I've seen in the dental space, how it's playing out for certain suppliers in other areas of dental. So we're just modeling different scenarios and kind of thinking through how we would strategize the portfolio. But it's a portfolio. To those who are successful, it's a portfolio play.

Shirley Stacy

executive
#52

I think we have time for maybe one more question.

Jason Bednar

analyst
#53

Jason Bednar, Piper Sandler. I'll start first with Joe and then I got a follow-up for John. So Joe, you mentioned you've been here 10 years. You've kind of guided, it seems like Align from Align 2.0 to Align 3.0 just based on the slides you had up there, digital is prolific. That's kind of in the realm we're in the midst of right now. I guess as you think about your own LRP with yourself personally, how are you thinking, you and the Board are thinking, about succession planning? Just because we are at the point now and sort of getting the question of what's next for Align. We've laid out a lot of what's next for the company. I'd love to hear what's next for you and again, what's beyond you as well.

Joseph Hogan

executive
#54

Jason, I mean, obviously, I'm not a young character anymore. I've been around for a while. The Board and all of us, we have an active CEO succession planning system. We revisit it almost every quarter. I feel good about the process and the opinions and the people that are onboard with that. From my standpoint, look, there's -- obviously, this Align 3.0, as we referred to, I really feel we're on the crux of the next phase of Align. I want to make sure that's solidly in place. And you can see we have a good team here, a very good team. I couldn't ask for a better group of people to work with and from a commitment standpoint. And also, from the Board to me and I think realistic expectations of where my career is at this point in time, the team and the momentum we have, that's really what we all look for. And there'll be a point where I say that's enough. It's not right now. But obviously, that's coming, but there's a good process behind it, I can assure you.

Jason Bednar

analyst
#55

Okay. Very helpful. And John, on capital allocation, I know we all saw the share repo. That was a big focal point on the slides. You've also done other -- you've done M&A in the past. We've seen other things like investments in DSOs, OSOs. So I guess we can't predict M&A. I guess, is the investment in the DSO, OSO side still something that you're committed to being a part of the overall capital allocation plan? Should we expect more of that or an acceleration in that? And then the secondary part of this, as we look at dfab scaling, is that going to be something that requires greater CapEx investment from the company?

John Morici

executive
#56

No, it's good. Look, first and foremost, when we're investing, we're investing for a return that's right for the business. So whether we're -- I always look at it as this is not an or discussion, I don't think of it as this or that. I think of it as an and discussion. So when we talk about the capital allocation and the free cash flow that we generate and so on, one, I want to be able to use that cash and what we're doing to be able to drive the business, grow the business, drive top line, drive efficiency and productivity and so on, new products and other things that we invest in the business. There have been some acquisitions that make sense. We use our cash for it, exocad being the biggest, but back in the day, even Cadent before that and then most recently, with Cubicure. And we use our cash for that. But we're doing all the other things to be able to grow the business as well as that. CapEx from the standpoint that I don't see like an extraordinary amount in the short term. I think it as kind of a level amount of CapEx that we need to spend for expansion. In this case, instead of doing the vacuum formed expansion and other things we're doing, a lot of that's going to be supplemented and put into the Cubicure and the machines that we're going to need to do the direct fab. It's not like it's more. It's just different type of spending to be able to add that capacity because, in the end, we're committed to growing this business, utilize the cash that we have to be able to grow and do things in a mindful way and then return the cash back to shareholders with our buyback. So I hope you saw that come out. I mean we think about the growth and the productivity and the margin opportunity because it's so important to us to generate the cash that we do because that gives us a lot of flexibility, flexibility for new products and development, flexibility to be able to give back to our shareholders based on where we think a good investment would be, and that's do buybacks.

Joseph Hogan

executive
#57

Maybe just behalf of the entire company, thanks for coming. We were looking forward to this. We hope you found it valuable. I think if you can step back and maybe just take off your business mask for a second and think about just -- you probably walk in here and you see things personally from a health care standpoint. It might be appealing to you in the sense of moving your teeth or Zelko's slide. You can't get that out of your head about how you grind down enamel or whatever. And so I think as you think about Align as a business opportunity or whatever, think about it also from a consumer standpoint. We really feel we're on the right side of this. We have a lot of technology to offer. And it's both from a consumer standpoint, convincing consumers, but also lowering that frictional point with doctors and moving our product through. And again, I feel we're on really a good plane to really change the industry. So thanks. Thanks for your questions. Thanks for your time.

Shirley Stacy

executive
#58

Thanks, everyone. please join us in the reception area for some beverages and snacks, and if you have time to also do a scan.

This call discussed

For developers and AI pipelines

Programmatic access to Align Technology, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.