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Stifel Jaws & Paws Conference

May 30, 2024

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Guys, please grab a seat. We're gonna get going, and we're gonna open up day two from a company perspective. Align Technology, and we're pleased to have on stage their CEO, Joe Hogan, and their CFO, John Morici. Thanks, guys, for coming back p articipating again this year. No shocker, I've got a pretty long Q&A talk track, so we're gonna jump into things. If you guys have questions, throw up your hand.

But I'll start where I'm getting the most, call it incoming or questions, and it's, you know, just on the environment or the overall environment. Over the past couple of months, some of the macro data points have gotten, I'll call it a bit more mixed. Notably, U.S. consumer confidence, which you guys have said it's a relevant metric, you know for your company. How do you guys view the current environment in the U.S., and then are there any distinctions to call out between the U.S. versus what you might be seeing and experiencing in EMEA and APAC?

Joe Hogan
CEO, Align Technology

I'll start off. John we both live this every day, John. See, first of all, when we ended the quarter first quarter, we talked about stability, and stability versus 2023, and we stay with that, that feeling overall. APAC overall is holding up well for us. What we see in the United States and what we see in Europe are very similar to your question in the sense of the consumer being muted somewhat. But still, there's a stability in the sense of what we see across those dynamics. Latin America, you know, we feel good about it. We feel good about Eastern Europe and Africa and that part of our business too. So, you know, overall, again, we use the term stability.

I know the Consumer Confidence Index saw a drop from, you know, the Michigan standpoint is somewhat challenging. And look, a 10-point drop's big. It's not something that we'd look at, 'cause you understand that lag correlation that exists there. But it's also interesting that it's still 5 points above what it was in May of last year, too. So if you flip back to that end, too. So it's a big drop, but also, you know, we've seen it before.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. John, anything there or?

John Morici
CFO, Align Technology

No, I t hink that's what we see, and I think, you know, what we've taken the approach as a company under that stability, and I know we'll probably get into a lot of that, but there's a lot of new innovation that we're actually, you know, introducing, that has given our sales team a lot to be selling, that really builds off of that stability, like Invisalign Palatal Expander with Lumina that we just launched, what really gives us an opportunity to help build off of that and really, you know, create our own momentum.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

So maybe just to push a little bit, if I get the incoming of like, "Look, these guys gave guidance in 2023. Consumer confidence really crashed, and then they had to withdraw the guidance." Come on, John, what's different this time around, right? That's the incoming I'm getting. Would it be fair to sort of say, yeah, U.S. consumer confidence, one, it hasn't crashed, to your point, Joe. It, it's come in but there are other dynamics. You called out APAC, you called out LATAM, and you're more on your front foot with the product cycle that's still allowing you to operate in a overall net worldwide stable environment.

Joe Hogan
CEO, Align Technology

That's a good summary.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Okay, I'll push forward then, you know, and I'll move right to gross margin. It's funny, I, I think going into the first quarter, there were so many concerns on the top line exit rate, you know, in 1Q, and then what'd you guys do? You put up a good quarter, you beat, you raised, and then I think some of the concern moved to the margins, gross margin, and notably on the clear aligner side of things, John. So maybe just talk to us a little bit. You know, we isolate COGS per case 'cause you've taken ASP, but clear aligner gross margins have compressed, so the implied COGS per case has moved higher. Why has that happened?

You know, what could slow the increase, and is there anything to rely on, if you would, on clear aligner gross margins before maybe we get to direct fab further down the road?

John Morici
CFO, Align Technology

Yeah, I think when you look at that gross margin, very dependent on utilizing the facilities that we have. So we're still expanding out some of the Poland facility that we have. As we increase utilization drives additional productivity. As you said, we've taken price increase. We saw a price increase in the first quarter. You get part of the quarter, maybe 2/3 of the quarter, in terms of that price benefit. And then we also have offsets in labor and other changes that really kick in at the beginning of the year, that we have to make sure that we can try to offset. But we know how to play and operate in a productive way. It's a matter of continuing to do that. Volume really helps.

As you said, as you get more to the direct fab, as you scale that, it takes a lot of productivity.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. And Joe, I think, you know, part of the, the positive surprise has been ongoing price realization. You know, nothing out of bounds or overstepping, but even in a more competitive environment, your ability to innovate, highlight that to your customers, and have some price realization behind it. There's been other selling strategies like three by three. Just as we look forward over the next couple of years, do you still feel like that's at your disposal in terms of your willingness to, to realize price a bit?

Joe Hogan
CEO, Align Technology

I mean, we have pricing power in the market. I think we show that every year. I, I think we're responsible in the sense with it and keeping up with inflation or pricing to value and what we have, John, and I can consider with what we offer in the marketplace and, you know, our customer base and all that, you know, we, we can continue to drive price when we need to, but it's not unlimited. You know, there's a, there is a big price inflection point in this business, but I feel like our, our accounts, though they don't like the price increases, they understand the value that we're bringing to them many times, and they accept it.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

John Morici
CFO, Align Technology

I would say the biggest change in our, the pricing philosophy that, you know, we have is, it's not typically across-the-board price increases. You price certain products that change, you know, in terms of what it costs us to serve those products. And so some products, like the three and three, haven't seen a price increase really in two years because we wanna be able to drive that type of behavior, get doctors to use that three and three, maybe supplement it with a subscription program. And from a margin standpoint, that's a good trade for us.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

I think if I got this right to that point, you know, one of your prior price increases, I believe, was more specific to the comprehensive portfolio. W hich is more differentiated from your standpoint, versus the lower acuity and so you're finding your places where you wanna leverage and lean into.

John Morici
CFO, Align Technology

That's right.

Joe Hogan
CEO, Align Technology

Not to add maybe too much to this, is we watch this through our NPS scores really closely. We know when we announce those NPS scores, are gonna take a certain drop. And we watch at how fast they do come back and those inflection points. So it's not that we're numb to the marketplace. We watch it closely, and it's a very similar pattern in the sense of you can see the doctors they accept it, but don't necessarily like it, but then it comes back pretty quickly, too, given the logic of the price increase.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Maybe one last one on, on sort of a gross margin topic, and again, we'll get into the direct fab conversation in a bit. But, but John, is it trying to stabilize clear aligner gross margins in the near term? But I think there's several tailwinds, in my opinion, to systems and services, right? The services continues to positive mix shift that's got a higher margin, and again, we'll touch on this, but Lumina, I think, is gross margin accretive versus prior system. So if I think of total corporate gross margin, is it, yeah, the tailwind might be in systems and services in the near term, and then longer term, maybe that flows back into clear aligner once direct fab starts to scale?

John Morici
CFO, Align Technology

Yeah, that's the right way to look at it. We have a lot of margin plays. Obviously, we wanna be able to grow our business, and that helps with utilization and productivity, but a lot of margin plays around it, like you said, with Lumina, where it's a new scanner. It's a lower cost, it's a higher ASP, so that helps us from a margin standpoint in terms of the overall company. But then we still have to be focused on driving that productivity and increasing the margins on clear aligner .

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. And Joe, maybe I'll turn to you for the SG&A leverage, or SG&A per case is a metric that we look at. And talk to us about, you've got a dynamic environment with the consumer, how you titrate spend, and then, you know, your level of comfort that you can still realize leverage in SG&A per case, even though the other guys, they're not really getting out there and advertising, right? They're trying to pick off the customer when they walk through the door. So even with those headwinds, are you still able to titrate the spend effectively and derive some leverage in SG&A per case?

Joe Hogan
CEO, Align Technology

John and I watch that real closely. We feel we can. A big part of what we drive is our brand through consumers, those consumers that go in to the doctors, and you know this better than us, in the sense of insisting on Invisalign as the brand that they want. Given that, you know, depending on how you wanna rate our market share, anywhere between 75% and 80%, we're still predominantly we're the recipients, you know, of, of that. But I would say, and John, you can jump in, I'd say over the last three years, we've learned much more specifically top of the funnel, where to advertise.

We're much more diligent in the sense of our doctors using our brand and trying to switch us to a competitive aligner in some way and taking actions against those doctors to make sure our brand's removed. We've really sharpened our focus on that, too. So I'd say how we advertise, how we interact with our customers in the sense of that advertising spend, who we send those accounts to, I think we've gotten better over the last couple of years.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Make sure you just don't have that leaky bucket, right? Where they go through a different door a nd it goes to someone else.

Joe Hogan
CEO, Align Technology

Ab solutely.

That's right.

John Morici
CFO, Align Technology

There's always gonna be some, but I think when you do some of that advertising in conjunction with some of the new products that we have, like Invisalign Palatal Expander, It drives different awareness, helps differentiate our products versus others, and this is a new product that no one else produces. So you do things in a way that give us a differentiation, which is great, and as Joe said, you know, the investments that you make, a lot of it you see in the US, but we also make investments outside the US, where you can see a big change in driving awareness, getting people to come to our website, Invisalign.com, then put in their zip, be able to find out a doctor close to them.

We watch that very closely and can almost titrate that on a real-time basis to make sure that we're getting the right return.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

Joe Hogan
CEO, Align Technology

You know, John, last point on that note is on IPE, we had initial ad that we ran, and we're gonna follow up with it at the end of the quarter. We had the strongest consumer response on that IPE ad than any kind of ad we've ever run.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Showing that that market is ripening and getting some-

Joe Hogan
CEO, Align Technology

Yeah, it's showing that the general population has experience with the Hyrax device, and, you know, tightening the screw at night. You know, and there's a certain amount of empathy, I think, that, that we see.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

And we'll get into IPE. I think maybe just one more on the margin side quickly. You know, taking a step back, gross margin, okay, maybe you have the tailwinds from the systems and services in the near term, direct fab long term. You seem to feel good that you're doing the right things on SG&A. R&D, right? It's funny, we had a doc up here right before you and he was making the case to the other doc to get Lumina 'cause he's like, "Hey, you have no idea how much R&D these guys spend." I said, "In my opinion, maybe a little too much." But, but what do I know, right? You almost sold an extra Lumina thirty minutes ago. I t's been 6%, it was 6% of sales from 2018 - 2021. It went to 7.5 in 2022. It's got an 8 handle.

You, you got Lumina through, which I think was a 3-year + project. You got IPE through. That clearly took some time. Direct fab's still out there, and you're working on that, but maybe walk us through, is this a high-water mark for R&D as a % of sales, and when can we expect, or can we expect the leverage to return over the next couple of years?

Joe Hogan
CEO, Align Technology

Let John hit the numbers, percents, and I'll give you the specifics on the-

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

Joe Hogan
CEO, Align Technology

The okay.

John Morici
CFO, Align Technology

I think from a, it's less about the percent, it's more about the program spend that you need to make in order to deliver these programs. And like you said, there's many programs that are delivering now, and you're gonna see the revenue on. It's really moved from the research part of it to development, and then ultimately, you don't need to spend on it because you've actually introduced the product. So I think we're getting to that point. I would expect that as a percentage, as we look forward, it would not be this high going forward. You're gonna have that revenue, but we're still gonna make investments where, especially around places that really help get us to that next level from a product standpoint, and maybe, Joe, you can you can deliver on that.

Joe Hogan
CEO, Align Technology

So, you know, you look at when we started investing heavily, probably three or four years, we really started to invest heavily into the 3D printing piece on the Cubicure side and the new resin, John, and whatever, and that's expensive. And we have a group of people in San Jose, California, that are a combination of chemists and physicists and all the other, you know, kinds of engineering capabilities you need in order to, to do this. We put in, you know, state-of-the-art labs, 'cause we had to synthesize our own materials and to make those things. And so I would say that was an inordinate spend on top of that 6% that historically hadn't been part of the company.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

It was all incremental.

Joe Hogan
CEO, Align Technology

Yeah. But when you look at it, John, I mean, it's a phase change in the sense of, as we talked about last night, in the sense of, you know, how, how you actually make an aligner, what the cost of the aligner can be. H opefully from a clinical standpoint, what it can do in the marketplace. So it's one of those opportunities, and, and it's probably the biggest change in any. I've run some pretty big businesses. Of any business I've ever run, biggest technology change I've ever seen in my life is, is, is the opportunity through 3D printing, direct 3D printing of aligners.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay, so embedded in that R&D number, like you said, is a lot of the incremental expense associated with this massive initiative, which in your opinion, Joe, might have, sorry if I'm putting words in your mouth, but correct me, the highest return associated with it of any business that you've run when we look out over a number of years.

Joe Hogan
CEO, Align Technology

Exactly.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

John Morici
CFO, Align Technology

And it's investing in that mindset to be able to invest in business and products that we know it's difficult to follow. We know that providing products like the direct fab type of product, where doctors have the ultimate flexibility, they can create a design and a product that really is useful to their practice and give them that design flexibility and provide that, you know, the predictive type of treatment. That's where we want to invest because we know it's taken so much time and money to get to. We know that it'll give us and maintain our competitive advantage.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

So I'm gonna push on that a little bit, and I'm gonna run some annoying math by you, John. We do have it in the note that we published last night as well for investors, but direct fab will eliminate, I think you've talked about 80%-90% of the plastic needed to fabricate the aligners, right?

John Morici
CFO, Align Technology

Yeah.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

'Cause you're no longer printing, you know, the negative, you're just directly printing the aligners. So 80%-90% of the plastic goes away. Plastic is 20%-30% of your total COGS. That's a fair exercise? Okay. So you run the math on that, and just straight math is it could be a 500 basis points tailwind to your clear aligner gross margin. If I went the extreme, if I did the 30% of COGS and the 90% being eliminated, you run closer to 700 bips. Again, sound math.

And then the question that maybe we have to determine is, what percent of your business, or pardon me, what percent of your clear aligner volume moves to a direct fab process? Because you're probably not gonna entirely eliminate or move away from your SLA. And, Joe, do you wanna talk to some of those dynamics?

Joe Hogan
CEO, Align Technology

Yeah. I mean, first of all, your COGS equation, everything else lines up with just what John and I-

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

The Excel spreadsheet works.

Joe Hogan
CEO, Align Technology

Exactly.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Yeah. Okay.

Joe Hogan
CEO, Align Technology

Your math's good. Surprising, but good. But, you know, when you, when you look at overall, and you, you know, how much clarity do you have five years down the road? You're not sure, but we still have a lot of productivity we can drive in our, our normal thermoform aligner business. And there's productivity is in, in two parts of it. One is how you do treatment planning. We spent an inordinate amount of money, too, on being able to use art. This is way before artificial intelligence became the thing to talk about as a CEO. For the last three years, we've been finding out, how in the world can you do touchless cases?

How can you scan a case, have it move through, doctor makes a change on, we call 3D Controls, which is like a Photoshop, make a few tooth changes, send it right into manufacturing. So taking a two-week process, which was kind of like an analog hairball between two digital systems, and turning that into, you know, a seamless kind of a play. We're pretty, we're pretty close on marching forward on that. So we feel like in the future, we can be very efficient on vacuum form aligners, and we can be very competitive with it, too, in that kind of mode, where you want us to scan, you to be able to ship with doctor's preferences.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Low acuity case, sorry, Joe.

Joe Hogan
CEO, Align Technology

Yeah.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Low acuity case, someone comes in, low acuity case, you scan. There's almost just a quick turnaround. Your, you know, your software is able to turn around, boom, you're able to print, and you've got it off the old SLA process.

Joe Hogan
CEO, Align Technology

Five-minute turnaround

Just to take it, if you were in a doctor's chair, our vision, and we feel we'll be there within this two-year period we're talking about, you scan, it's called a 5-minute ClinCheck. Your whole system comes right, y ou'll see your smile, you'll see what it looks like, but your whole case treatment is there. 40 aligners, 50 aligners, it's done. And you in a chair can say, "I'll go with it. Here's the price." You push your button, and you go. It's a completely different dimension than how we grew this business.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

That's gonna be, you know, that, that legacy SLA and maybe that's more pertains to the lower acuity cases

How about that 3D printing, the direct fab? Maybe walk us through that, and is there rough numbers to think about in terms of conversion to that percentage by a 2026 timeline?

Joe Hogan
CEO, Align Technology

Yeah. Well, yeah, on the 3D printed aligners, what we feel, and we have to prove it from a clinical standpoint, is, you know, today, when you vacuum form, we use all these terms, right? When you vacuum form, you start with 30 mils of sheet, and then you suck that down over top of a mold, right? So we're talking last night, if you get to an incisor or something, that 30 mils might be 10 mil at the bottom of your longest teeth. It's hard to move teeth with 10 mils of plastic. It just doesn't have the right type of modulus at that kind of a thickness. With 3D printing, forget about the efficiencies of 3D printing for a second and saving all the plastics. We can put the plastic where we want to put it.

So your molars are the toughest teeth in your mouth to move. If we can put 40 mils on your molars, instead of which you end up with 20 mils on a vacuum form or 15 mils, we feel we can move those molars faster and with more certainty than before. It only makes sense from a mechanical standpoint and a physical standpoint, that that would exist. Also, if, you know, if it's a Class III, it's a deep bite, and you're gonna have attachments to it, or you want to use bite ramps. And bite ramps are things that we really struggle with because it's hard to incorporate that into a vacuum-forming kind of a system.

Bite ramps are, if you have a deep bite or a Class III, which is an overbite, if you want to keep your front teeth from going down too far, you put ramps on these things to stop those teeth overall. That's a highly kind of manual process outside of our normal what I'd call automated process that we do. On 3D printing, it's simple. You can tell us how thick those bite ramps are, how many do you want, you can put them anywhere. Mandibular occlusal blocks, you know, we've worked on that. We're just finally launching that, taken three years. There's a secondary operation to put those plastic blocks in the back of your occlusal area in order to make those. 3D printing, you just print them.

So John, the freedom of design, the ability to put material where we want to put it, all those things tell us you'll gain efficiencies, but you'll also gain a certain amount of clinical capability and certainty that you can't do on a normal vacuum form.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Very helpful.

Joe Hogan
CEO, Align Technology

That's a long answer to your question.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

No, very helpful. And maybe just to put a bow on that a little bit, you know, if I look at your business, instead of the flow, but roughly 70% Comprehensive, 30% non-Comprehensive.

Joe Hogan
CEO, Align Technology

That's right.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

You know, is that maybe the right direction to think about of, "Hey, comprehensive, you want the advanced features and functionality?

Joe Hogan
CEO, Align Technology

Yeah.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Maybe that's what accompanies the direct fab process longer term, the lower acuity, turn it around SLA, might be good, a good ballpark figure to use?

John Morici
CFO, Align Technology

I think longer term, you know, we'll eventually get to direct fab being over 50% of our business, I would expect. But there's gonna be, for a long tail, we expect that some of the SLA production that we have will continue for a period of time for those low acuity cases, retainers, things like that, that maybe we just, you know, turn into something that a doctor wants and doesn't have the customization.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Can you be 50%, 2026-2027 direct fab? Just to tie back to the, you know, 500-700 basis points total math, can you be around 50% of your vols, direct fab, 2026-2027?

John Morici
CFO, Align Technology

Three years out-

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Three years out.

John Morici
CFO, Align Technology

That could be, that could be in that range.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Yeah, okay. Very helpful, thank you. Any questions, direct fab, math, or anything that we've covered so far?

Joe Hogan
CEO, Align Technology

Any kids that need treatment or anything out there?

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Otherwise, I'm gonna go to the product cycle, and we'll touch on IPE. So Invisalign Palatal Expander, you rolled out in North America. You talked about the campaign with a really good hit rate. I think you're in the midst of what? You're entering APAC as we speak, and think about EMEA being more 2025. Is that fair?

Joe Hogan
CEO, Align Technology

Yeah, well, I would look at EMEA itself as being more fourth quarter of this year.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

Joe Hogan
CEO, Align Technology

You know, certain countries in Asia, like, you know, China and some of the other countries in Asia, more first quarter of 2025.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay, and are you in areas of APAC, though? I think you launched in some areas of Asia.

Joe Hogan
CEO, Align Technology

Yeah, we are Australia.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Yep, Australia, okay. So-

Joe Hogan
CEO, Align Technology

We don't consider them part of Asia.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Um-

Joe Hogan
CEO, Align Technology

Sorry.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Just, just for some manufacturing, this is technically your first 3D, or pardon me, direct 3D printed product. So, you know, you gotta get it right, pardon me. And so Joe, talk to us on how that process has gone, scaling up the process, fulfilling demand, any, you know, stumbling blocks or surprises, positive or negative, that you've encountered.

Joe Hogan
CEO, Align Technology

You know, honestly, on this particular 3D printing process, you know, we've been working IPE about three years on it, John. We got a great team as far as how to scale, you know, in general for 3D printing. So Srini and, and Emory and the team, you saw the move with Emory, we can talk about. In short, there's been no surprises. Frankly, I feel really good about how the manufacturing people have taken the process from R&D and actually improved upon it within the first two or three months, as far as efficiency, in other words, how much plastic you get out of a certain load, the consistency of what we're doing. And so right now, scaling has not gotten in front of demand too much as we start off here, which is, which is what we wanna do, is make sure we keep that together.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay, and, you know, maybe we'll go to the Emory topic in a little bit, but to stick with IPE for the moment, unlike some of your other products, like when you rolled out mandibular advancement, right? You've got to advance the mandible, that could take some time, feedback is on a lag. But for IPE, you're expanding the palate, some of these can be 30, 60 day cases.

Joe Hogan
CEO, Align Technology

Yeah, sure.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

So you've had people that have ordered IPE, completed IPE, we're probably gonna try to go after that in our 2Q survey, but importantly, what have you heard? You know, what has been the reaction? Are they getting the expansion that they desire? Are they seeing the compliance, the kids are wearing this all the time? But maybe talk to those variables.

Joe Hogan
CEO, Align Technology

Well, I think, you know, at the, you know, recently in New Orleans that you attended to, you could see the docs in that booth. There's a lot of excitement around IPE. That's what's great about this, is you do get the feedback so quickly versus a normal Invisalign case that we'd launch it. You know, like, mandibular advancement takes a year and a half before you really understand where it is. It's, I'd call it a huge amount of enthusiasm from doctors. Now, you know, the broad orthodontic community, when we first launched, said, "You know, you'll never split the suture you know, with a removable device."

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

And so, you know, Srini in the back room, we just kind of squint our eyes and say, "Do you really think we would do this if you can't make that work?" And so, l et me tell you one story, so, and then we'll get into the specifics. So when we were at the, you know, the ortho show down in New Orleans, I had a doctor come up to me from, from Dallas, Texas. So we do these road shows where I just take my staff out, we jump in a plane, we drop down, and all of us will go out and make calls for two days, three days with doctors and come back, and we learn together, and, and, and we agilely will make changes in the organization, whatever.

Joe Hogan
CEO, Align Technology

And I met this doctor in Texas, his name's John, and he was using mandibular advancement, but he wasn't using Invisalign First, and I was just giving a lot of grief, right? He says, "I don't, just don't wanna do young patients. It doesn't make any sense. I have a Hyrax device for suture splitting," whatever.

Long story short, he comes up to me, he says, "Hey, do you remember me in Texas?" I said, "Yeah, yeah, I remember you, John." You know, I said, "Are you using any First yet?" He says: "No, but I love IPE." And I said, "How many have you done?" He says, "I've done 15 in the last two months." And I said, "Really?" He said, "Yeah." He says, "Look, I just come in here two days before that," he says, "I was taking a Hyrax device out of one of my former accounts." I said, "And it became immediately, when I'm taking that device out, an extraction episode, 'cause that kid was gonna lose his tooth.

And the kid's screaming, the mother's crying, and I'm saying, "I'm never gonna use this stinking device again." And he says, "What you guys did is brilliant." And I think the great thing is, when we see the enthusiasm with this, and I think you get more feedback from docs on how easy this is and patient-friendly it is. You'll start to get so right now, our utilization rates, John, we're seeing orders. It takes about 17 days from the data that I've seen so far, before they start ordering the next one, and then about 13 days, because they're, you know, they're getting confidence as they see the results, t hey continue to order.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay, so can we maybe try to, you know, quantify and go through some math behind IPE? John, maybe over to you. I think it's the list is $700, but should we think more of a realized ASP of $450-$500? Because you get your volume breaks .

John Morici
CFO, Align Technology

Yeah, $500 is a realistic ASP.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay, and then as I pull my notes going back, I got Invisalign First did 32,000 cases, 18 months post-launch. Just talk about that as an analog, good, bad, low, high, why, right? I mean, that's a phase I treatment, arguably.

John Morici
CFO, Align Technology

Well, in my opinion, that's low, because I think we have a product that we know works. There's a huge amount of demand for this type think about it, there's 16 million orthodontic case starts for teens every year, and upwards of 10% or more could be done with IPE. So you've got 1.6 million potential patients out there, and as Joe described, you have more doctors coming in. We're seeing more and more submitters start to use the product. Right now, it's North America and ANZ, and those doctors are getting confidence that they're seeing the results. They're seeing the split, they're seeing the compliance, they're seeing that it's less pain and all the other good things about it, so they're using it more and more.

So I look at that and say, well, Invisalign First, it was a good launch that we had. It just took time to actually start seeing those results, and it addressed a certain part of the portfolio. But I think this really gets at to 1.6 million potential cases, and it also addresses the shortness of the time for treatment. So I would say, you know, if it's not above that, then I, yeah, I'd be surprised.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

You're seeing the good reorder rates, Joe, that you alluded to earlier. So part of this is like, we can all do the math on the 30,000 and the 500, and we'll get there, and that's all incremental revenue, right? 'Cause you didn't play largely incremental. I know there's Invisalign First.

John Morici
CFO, Align Technology

Yeah.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

But maybe talk about the attachment rates or how that could translate into the alignment side of things, right? So at AAO, I think you were running a little bit of a bundled approach, maybe roughly $200 off if you proceed with from IPE to Invisalign First. Does it increase that attachment rate? What does IPE do for your teen business on the Invisalign side of things?

Joe Hogan
CEO, Align Technology

I think it does increase our attachment rate. We just gotta get a percentage on it, John, at some point in time, and what we're seeing is doctors kind of struggling with, "Okay, how do I, how do I wanna do this? Do I want to use the first product in conjunction with IPE to move, you know, the lower jaw and to try to bring those teeth in alignment at the same time? Do I wanna just do IPE first? Do I wanna rest it for, you know, four months “Wanna move first in again?” But in general, I think, you know, the doctors, especially the ones that are comfortable with First, see incorporating IPE in this way makes sense.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. Very helpful. Maybe I'll just move to Lumina. I wanna make sure I touch on that in the last couple of minutes. Your first quarter systems and services results were really solid. They were up Q-over-Q. That's usually not the case for Q- 1Q. John, I'm gonna go ahead and try to real-time math again. In your filing, in your 1Q, 10-Q, you had an additional disclosure where your upgrade revenue in Lumina. Sorry, your upgrade revenue, pardon me, was $9.5 million, right? Joe, you've talked about in the past, you got 100,000 iTero out there. A third are upgradable. Those are the 5D Pluses. That's where you can buy a wand, pardon me, for an extra $12,000-$15,000 and go to Lumina.

So if I just do some crude math and you've got 33,000 that are upgradable, and I say a third, I land at 10,000 of those move over the next 24 months at 15k, it's $150 million. I think we saw $10 million in the first quarter. You know, what's off about that? Or is it just like, "No, look, this upgrade opportunity might really materialize over the next 24 months?

Joe Hogan
CEO, Align Technology

Before John answers that, though, he just wants to say thanks for reading our Q, John.

John Morici
CFO, Align Technology

See, we did like it.

Joe Hogan
CEO, Align Technology

We worked so hard at it.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Very welcome.

Joe Hogan
CEO, Align Technology

Somebody actually recognized.

John Morici
CFO, Align Technology

No, the math, the math works, and we're, we're very pleased with the upgrades. You know, it's doctors coming in. It's GPs and orthos. We thought maybe it'd be more ortho upgrades. We've, we've seen both, which we're happy about. The excitement is there. We're seeing that happen, and really, what we like about this is it, it keeps doctors engaged in our portfolio in terms of technology. Many times now, they're trading something else in, which gives us an opportunity at the right price point to be able to get that, that refurbished, that certified pre-owned back to doctors to be able to use in their practice and, and at the right price point.

So it really opens up a lot of opportunities for us in that product portfolio, and as we look forward, we'll see a lot of upgrades come through and as we saw in the first quarter, and then it also gives us the opportunity to sell new scanners.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay.

John Morici
CFO, Align Technology

And we're really excited about that, 'cause we know that that front edge of the digital ecosystem that we have starts with iTero, and so it's really important for us.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Got it. Very helpful. And then, and maybe I'll just sort of close in competition. You know, I'm always gonna get that question, right?

John Morici
CFO, Align Technology

Sure.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

And so I've been sort of framing Angel as the new kid on the block, and I saw them at AAO, and I have your rate of share losses versus the other main players, and that rate of share loss has abated. It's actually, you know, a sort of a three-year low in 1Q 2024. That's against, like, the legacy other lab guys. But Angel's relatively new. They're pushing outside of China. They're pushing a little bit more into the U.S. and EMEA. Any surprises, Joe? You know, how they're coming to market, the strategy, the pricing, and what that means for Align?

Joe Hogan
CEO, Align Technology

But again, we know Angel really well. We've competed with them 10 years in China. I have a lot of respect for Angel. I call them, you know, what we automate and do a lot of deep automation and things, Angel uses a lot of arms and legs. In other words, you know, the thing I talked about with treatment planning and how you make that a digital episode as much as you can, they'll throw arms and legs at it. I think they scale the same way in factories or whatever. I'm not saying that it's better or worse, I'm just saying as you grow, as you grow, that starts to compound, becomes an issue, especially at the average selling prices that they're trying to offer these products outside of China. They are a focused clear aligner company.

Which makes them good. They face a lot of competition at home, with Smartee, also us on the top end, Smartee on the other end, too. But in general, John and I take them seriously, but over time, what we've found is it's just certain cases, certain acuity, how cases finish or whatever, they're gonna have to get better at as they move into the Western world because of the expectations that are here, too. And I'm not saying they can't do that. There's just time and distance between that, and they're gonna have to spend some money to do it, too.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

And last question for you. You know, I was, we talked a little bit about this last night, but just, you know, I go back and cover you guys for a while, and ever since 2017, some of the key patents came due, but I've been answering competition questions for two years before that, right? So from 2015 to, what's today? 2024, it's been almost a decade of who's coming next, what do they have? You've taken a lot of good punches from other dental companies. You faced in-office printing on the lower acuity. Once you get behind Angel, no one's really after them.

Joe Hogan
CEO, Align Technology

Right.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

And then you're closer to direct fab, right? Which no one's gonna be there for, I don't know, 10 years. So do you feel like the narrative changes, where you go more on your front foot from a competition standpoint or innovation standpoint, versus what you've had to face over the past 5, 10 years?

Joe Hogan
CEO, Align Technology

Well, I think with Lumina and 3D printing, John, I mean, we can play the front foot in a big way, but I feel that we've always played the front foot and from a technology standpoint, if you look at Invisalign First and how we expand that mandibular advancement, and what, what we did with 5D Plus, all those things. What we do with the Oral Healthcare Suite now as part of iTero and our digital platform, I feel we play offense. I just feel like we have a much stronger offense when you look at the flexibility we'll have on 3D printing as that ramps.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Okay. We're a little bit over, guys. Thanks very much for your time.

Joe Hogan
CEO, Align Technology

Thank you.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

I appreciate it.

Joe Hogan
CEO, Align Technology

Appreciate it.

Jonathan Block
Managing Director - Medical Technology and Supplies, Stifel

Thank you.

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