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Jefferies London Healthcare Conference 2024

Nov 19, 2024

Moderator

Why don't we get started? Good morning, everyone. Thanks for joining us for our next presentation. We're excited to have Align Technology with us, representing the company. To my right is Joe Hogan, who's the CEO. To his right, John Morici, who's the CFO, and I think most of you may know Shirley Stacy, to his right, heads the investor relations function at the company.

I mean, we have 25 minutes, so we're going to try to do some rapid Q&A here with Joe, John, and Stacy, so let's just dive right into it, but thank you, guys, for taking the time. And thanks for coming to rainy London for us. We really appreciate it. All right, so maybe a good place to start, and I don't know, John or Joe, who wants to take this, but maybe a good place to start is a three-key recap.

Just give everyone sort of a refresher, any sort of highlights from the quarter that you think is sort of worth discussing, positively or negatively, and then we can just sort of dive right into our more specific questions.

John Morici
CFO, Align Technology

Yeah. I think overall, we saw a good quarter in terms of teen growth for us, year-over-year growth, really led by some of the key markets in China and some of the other places that we had: Southeast Asia, Latin America, Middle East, and so on. We saw good volume there and led to good revenue for us. Obviously, we continue to see good growth on the iTero side with Lumina, the launch that we started at the beginning of the year, and that continued into the third quarter.

We were able to deliver good gross margin and profitability as we came through. We're very pleased with the submission growth that we've had. That's a continuation of what we saw the last few quarters. It was a record number of submissions that we saw in the third quarter. So it's an overall still challenging environment.

I think when you look at Western Europe and North America in our business, we can get into more of those details if you want. But we saw some good growth in other areas. Pleased to see the iTero. And then selling to more doctors was a good surprise for us.

Moderator

All right. Well, thank you for that, John. Joe, why don't we just sort of jump right into it? I mean, I think the number one question that's always on people's minds is sort of Align's volume trends. As John just sort of mentioned, 3Q, maybe a little bit of a mixed experience by geography, sort of calling out specifically strong growth in Asia-Pac, Latin America, maybe to some extent EMEA, offsetting some weakness in the U.S.

Can you maybe just sort of unpack that a little bit for us, what you think might be driving the differences, these regional differences, how durable these recent trends are, and what you think, just your high-level perspective?

Joe Hogan
CEO, Align Technology

Yeah. I think you're starting with the areas of growth for us in Asia, whatever, Asia, Latin America, as you mentioned, Glenn. Also, Middle East has begun for us, Northern Africa. These are relatively large markets that have done well for us, too. We feel good about our product portfolio there and our teams. Their economies, I feel, are much stronger than, I think, the United States and different parts of Europe overall.

And that's the major thing when you look about what John just referenced to, is the North American business and our European business has been, it hasn't been strong. And we watched the Michigan consumer confidence indices and different things. This is a high consumer spend item. Consumers have to have a lot of confidence to spend $4,000-$7,000 for moving their teeth.

They've been pressured in the U.S. and pressured in parts of Europe overall. Hopefully, we think that if we watch those indices and the economies hopefully improve, we'll see a meaningful uptick. Another question coming, Glenn, I can imagine, is wires and brackets cases and where we stand against that.

We've seen a rebound in wire and bracket cases in the United States and different parts of Europe. I think it's simply orthodontists are below capacity right now. They pay a lot less for wires and brackets. They do aligners. When they're in that situation, they'll try to push more patients, particularly teens, into wires and brackets. We've seen that specifically in the United States, and we've seen it in some parts of Europe, too.

Moderator

All right. A lot to unpack there. So in your mind, you think it's sort of a macro uncertainty, inflation issue that's maybe creating a little bit of strain or uncertainty or anxiety amongst the consumer base?

Joe Hogan
CEO, Align Technology

That's correct.

Moderator

That's probably. All right. Now let's get back to this wires and brackets comments, because I have four kids. I had two brackets and wires kids, and I had two Invisalign kids.

Joe Hogan
CEO, Align Technology

We can give you a deal.

Moderator

What's that?

Joe Hogan
CEO, Align Technology

We can give you a deal with that many kids.

Moderator

Yeah. I should have got a deal. I should have asked for that 10 years ago. But my youngest is 18. I could see the shift between my kids' friends. There was a bigger shift towards Align, which I feel like in the 20 teens. We were just sort of talking. I did a couple of calls this week. And I think you just sort of alluded to maybe there's a little bit more of a shift back to brackets and wires being a consumer.

I don't know if it's a consumer preference issue. You sort of made the case that you think it's maybe an economic decision being driven by dentists, that they can buy those brackets and wires cheaper. They'll tell you that there's a lot more chair time. There's a lot more expenses attached to that.

So when they break down the actual profitability of brackets and wires versus clear aligner, that it winds up being more of a push for them. So I don't know. I just wonder, is it an economic issue for the ortho or is it a consumer preference? Are the moms and dads, are they trying to drive greater compliance? They're frustrated with that. So I don't know how you untangle those pieces.

Joe Hogan
CEO, Align Technology

Yeah. I think you untangle them by saying what are the big variables in that equation, because they're all meaningful variables, but which ones are the strongest? First of all, I think you have to divide our market between general dentists and orthodontists. General dentists, by nature, just don't do wires and brackets, so they're going to push clear aligners.

And we've seen that in our marketplace and how it works, so let's just take general dentists off the table. If general dentistry isn't growing, it's more from a macro standpoint than it is a share shift. If you move to the orthodontist for a second, I think predominantly the big variable in that equation is that decision is pushed by the orthodontist, and they walk in and think, "Okay, I'm not at capacity.

I know I can make another case in the United States, another $900 a case, maybe 7%-8%, because I'm under capacity from an overall wires and brackets case." And they'll say things like they might offer a lower price for wires and brackets. They might say, "I don't think your daughter or son would qualify for Invisalign.

It's too difficult of a case," which isn't true because we do 95% of the cases today. Or it might be the comment I see often that teens don't wear aligners. And so if someone is not, if a doctor is not really set predominantly with Invisalign or with an aligner kind of case, they can push for an analog piece. And we see that a lot.

And look, I think consumers in general, when we look at it, if you ask any adult out there, 80% of adults will say they'll take, and this isn't our data. This is general data that's out there. 80% of adults say, "I want clear aligners versus wires and brackets." Teens say, 50% teens, 50%-60% say they want clear aligners. When they go to an orthodontic practice in the United States, those teens, 90% of the time, will walk out with wires and brackets. And the adults that want 80%, 50% of the time, they take wires and brackets. And that's being, again, pushed by those orthodontists.

Moderator

All right.

Joe Hogan
CEO, Align Technology

I don't want to carve out orthodontists being bad. These are just people that are looking at their wallet, and they love to do wires and brackets, and they understand it, and they think it's a good option for patients. Our data says the patients actually would favor clear aligners.

Moderator

Okay. And what about China? You talked about record teen case starts again this quarter in China. How do you sort of decipher the geographic differences in what you're seeing, for example, in that market versus the U.S. market, for example?

Joe Hogan
CEO, Align Technology

Broadly, our Asia market was double-digit growth, which is good. If you take China specifically, third quarter is our biggest. It's a big teen quarter, and so we normally see a good uptake. And the volume didn't surprise us. It was a good quarter. Remember, our biggest shift is Europe goes down in the third quarter, China goes up. And you see that.

I mean, traditionally, you have European business. You kind of understand that. So we felt good about our performance in China this year. And I can't say that China's economy is really strong. But again, in a one-child economy primarily, where parents are saving for their children, they really do lean into that teen season to push their patients.

Moderator

Could we maybe spend a minute or two on the competitive landscape? And for those who don't know, I used to cover Align for well over a decade, and then I kind of moved away from it for a few years. But I'm happy to sort of be back covering the company. In that time, SmileDirectClub kind of came and went, right?

And now, more recently, Byte is sort of no longer going to pull their product from the market. And so there's been a lot more talk about Angelalign. There's been more talk about Spark. Where are we in this competitive journey? And is that starting to become more of an issue for you relative to maybe what it might have been five or ten years ago?

Joe Hogan
CEO, Align Technology

I'll just start off by saying if you want to be successful in this business, you better bring technology. We could do 100% of the cases out there today. You better have a strong sales force that can door kickers that go out there and call on individual practices. You better have a brand because you're driving consumers through the insistence on our product line.

What we saw with direct-to-consumer, SmileDirectClub, Byte, or whatever, SmileDocs, Straumann out of Germany, their tents all folded, right? That business model doesn't work, and so it's just a matter of time with other companies that are out there trying that. It's not the right price point. It just doesn't work. So let's just take them off the table. We see what I'd say subscale conglomerates like Envista getting into the marketplace. They have a good orthodontic business.

They came in at too low of a price. Technology is somewhat questionable in finishing cases. And we've seen the results of that overall. Look, that's a good company, Envista. They have a good orthodontic. It's just difficult to do aligners and do it well. You have to have deep technology in the other variables I talked about.

Most recently, the last thing I'll say, Glenn, too, is you have to know how to account for clear aligners, too, is when you're doing five years additional aligners or whatever, there's a certain accounting procedure that came up that you have to carry through that makes it more difficult in the sense of how you handle deferred income.

But John can hit that more. And now Angelalign is the most recent company coming in. Again, at too low of a price. We see them at prices that are sort of ridiculous, prices that are 40%-45% under what they're selling in China. We know that that's not a sustainable kind of a thing.

Moderator

But do you think it's just they're using it as a sort of a Trojan horse to gain market share?

Joe Hogan
CEO, Align Technology

They're trying to do the same thing that Ormco did or whatever, but what happens is when you go through these cases, you better be able to finish them. Because it takes sometimes 18 months. Those last three months are really minute movements that you have to do to land those cases, and it takes doctors a while to figure out.

And a lot of cases are going to have trouble with that based on the plastic and the algorithms or whatever, so then I'll just, again, summarize technology, breadth of product line. Really, you have to have a strong sales force. You better have a brand to be able to drive that, and that's what we promote.

Moderator

And so it's clear that Align is the premium player in the market. And maybe let's translate or segue the conversation into ASP, right? ASP the last several years has been flattish. You've guided ASP to be up a little bit sequentially in 4Q, John, if I'm not mistaken. But how should we think about that longer-term trend, just sort of given the conversation we were just having on the competitive landscape?

John Morici
CFO, Align Technology

Well, just given the makeup that you have, as you have more doctors that you sell to, some new doctors, they'll end up maybe doing lower-stage cases that are at lower ASPs. Or if we grow products like the doctor's subscription program where we have touch-up cases, those are at a lower ASP as well. So when we think about it longer term, you think about it being flat to slightly down.

But it's not because of different promotions or programs that we have. It's just a fundamental. As you grow, some doctors will come in at a lower-stage product, and those will be at a lower ASP. Now, what we do see on some of these lower ASPs, just based on the product itself, many of them don't have additional refinements. The cost to serve is much lower.

So we end up with a good gross margin rate from those. So that's what we try to talk about, kind of the balance. ASP is kind of a leading indicator in terms of what that product is. And sometimes it's determined by mix. But on that lower-stage products, we end up with a better ASP rate.

Moderator

We'll talk about that gross margin one second. In 1Q, you're sort of lapping the U.K. VAT issue. Anything else that we should be thinking about as it relates to 2025 that might be influencing that number?

John Morici
CFO, Align Technology

No, no. That's the one that's kind of out there that we just made a decision to do and started in the first quarter, and we'll see what the rulings come down with, but like you said, we'll lap that in the first quarter.

Moderator

The mix of products that might be moving that number, like the palate expander, for example?

John Morici
CFO, Align Technology

Yeah. You have some palate expander. And those are just from an amount of aligners and what that pricing is in the market. It's a lower ASP. But that's the mix that you have that we talk about.

Moderator

All right, so maybe let's talk about gross margins since you just brought it up. I mean, you've been in the low 70s for the last sort of several years. I mean, the company's making some investments, right? We've talked about 3D printing and other ways to maybe try to expand that gross margin. I mean, how do you do that in an environment where you're making investments? Well, maybe those investments will start to bear fruit at a time where pricing might be flattish to slightly down, but those investments hopefully outweigh the modest erosion on the ASP.

John Morici
CFO, Align Technology

You've got to manage it with productivity. We're constantly taking costs out of our ecosystem, so whether it's product costs, material costs, treatment planning, we talk about the five-minute ClinCheck and some of the touchless product that we have where we have more processes in place that drive a lot of productivity. You've got to be able to maintain that productivity.

Because if you have flattish ASPs, you've got to be able to show that productivity. 70% is a key metric that we have. Because we know we have to invest a lot of other costs in OpEx to be able to help drive conversion, whether it's new products that we have, R&D that we spend, or the marketing that we spend, or go-to-market efforts with sales and so on. There's a certain amount that we need to spend and to be able to help drive that conversion. We want to make sure that we start with a good gross margin.

Moderator

And so maybe let's just go down the P&L to sort of that operating margin, right? I mean, when you think about that margin's also been flattish for a few years in the low 20s now. On this third quarter, you announced a restructuring program, I think. The headcount reduction was about 700 people. So talk to us about how you expand that margin.

Is it really a function of, "Hey, let's pull some costs out quickly, and then over time, we'll get some modest benefits on the gross margin line," and that should flow down to the operating margin line? Or is there some other way to achieve leverage down that P&L to a higher operating margin?

John Morici
CFO, Align Technology

Yeah. I mean, look, we made decisions when we look at some of the. It's not like we're cutting the engineers that are actually doing the coding or the salespeople that are actually calling. You look at structure that you have. How can we simplify the organization? How can we remain an agile company? Look at span of control.

Look at what people are doing across the company, and there's ways that we can improve our structure. And that's what that focus was, to be able to give room to some of the growth platforms that we have where we need to invest in some of the direct fabrication and some of the ClinCheck improvements and so on, so we wanted to create space for that with this focus around simplification and made those changes there.

And then you look at in terms of what we want to return to our shareholders and so on, we want to be able to grow as much as we can and be focused in on our growth opportunities as a company, but do it in a way that still drives margin improvement. So this was a good way to really focus the company into the growth opportunities and the platforms that we have while still giving us margin increases.

Moderator

I'm sorry if you just said this. How quickly can you action this headcount reduction?

John Morici
CFO, Align Technology

Well, we're making changes now. I mean, and you're seeing those changes. That'll be broadly behind us in the fourth quarter. And then you'll see us, as we continue to invest and do things as we go forward, we'll have benefits into next year. And we'll be able to get that leverage that we talked about for next year.

Moderator

And then, Joe, maybe let's just talk about sort of some of the new products, right? I mean, you mentioned Lumina a couple of minutes ago. It's been sort of a big part of your growth algorithm this year. We talked about the palate expander. Maybe if you could just give us 30 seconds on each and sort of where you are in sort of the execution of that, the rollout of each, and how those two products independently can contribute to that 2025 growth algorithm at a high level.

Joe Hogan
CEO, Align Technology

Yeah. Lumina, we launched it, obviously, this year. It's been very successful, both in the orthodontic segment and the GP segment, too. It's a brand new scanner, Glenn, a completely different technology. Most of the good scanners today are based on confocal technology. It took us about six years and obviously a lot of money to get to where we are. We really like that platform.

We'll have a restorative part of that platform that will come together in the first quarter of next year. The team's doing a good job on it. So remember, that's the front end of our digital platform. It really makes doctors comfortable with running simulations and communicating with patients in the sense of how those episodes will go in the sense of patients and how they see their smile and the time it'll take to get it done.

It's a big part of our growth algorithm. And you see we've had good accretive margin on that product line, too. Secondly, when you look at IPE, it's the first 3D printed product that we've had, direct 3D printed. Everything else we do is vacuum formed. It's gone very well. It follows almost Invisalign First, which is our most successful orthodontic product when you look at it, and essentially adoption rate. We just got clearance in Europe to be able to use it, too.

And so we'll be introducing it here shortly. And IPE, as John was explaining, it's thought on patients anywhere between six and 10 years old. And it's to open up their actually moving bone to open up their space to allow teeth to come in more uniformly. And then you don't have to do as much or any adjustment after their permanent dentition.

And then we did announce our 3D printed platform we're talking about with Cubicure and new resin. We're making good progress on that. We can answer specific questions about it. But it changes everything in the sense of the efficiency of our process, but also the design flexibility that orthodontists can use to really address almost any clinical case.

Moderator

You said that Lumina will be sort of accretive to your margins. What about the palate expander, John?

John Morici
CFO, Align Technology

Short term, as you scale up, there's some gross margin impact unfavorable. But it's like anything with the direct fabrication. It comes down to volume. Get that utilization higher, things will come back. But short term, there's some impact.

Moderator

Okay. All right. Maybe another numbers question because I know it's on people's sort of mind. When you look at the growth this year, you've had your fastest quarter in 1Q, a little bit slower in 2Q, a little bit slower again in 3Q. And now, based on the guidance for the full year, the implied 4Q number is sort of a reacceleration. I mean, what do you think is the catalyst for that reacceleration in 4Q implied in the guide?

John Morici
CFO, Align Technology

I think part of it is. I mean, when we look at kind of the quarter over quarter, I mean, it's more or less a normal quarter over quarter when you look at third quarter to fourth quarter. I think the comparison then on a year-over-year basis is kind of coming back to last year. Fourth quarter last year was more of a struggle. We saw that in the second half of last year.

And so you're kind of comparing off of numbers that are a little bit lower. And I think when you look at this year, you have Lumina that's different. We didn't have that last year. You have IPE that's different. We didn't have that last year. So we have a lot of ways that we're going to market with new technology and better products. And also, you have some maybe not across the board, but in some areas, better overall markets that we can operate in.

Moderator

Can we talk about sort of the investments you made in Heartland? I mean, what's sort of the rationale for that? What have you learned? I mean, do you feel like you'll get some sort of outsized return? Is there a bigger game here? I think people, when they look at sort of your capital allocation, you have the benefit of generating all this cash and a great balance sheet. And so maybe talk about Heartland and kind of is there room for more investment? Could you invest in another DSO? Just how do you think about that?

Joe Hogan
CEO, Align Technology

I'll start off, and John can give the specifics of it. First of all, when you look at it, Heartland is arguably the most successful DSO in the world. And they're certainly the biggest one in the U.S. And we find that Heartland has a real growth mentality, Glenn. We work together with them so well in translating our technology through their doctors. And it's just a great way to amplify our because to ramp up an Invisalign, it takes a lot of focus for a dentist to be able to do that. And so we just find that we think alike, they're a good partner to invest in. At the same time, we think we'll get a good return.

Moderator

And John?

John Morici
CFO, Align Technology

But I look at that, and I've been asked this a number of times. I don't look at Heartland as an or. I look at it as an and. I mean, we generate cash as a business. It's great. We're able to invest back into the business with CapEx and other investments that we have. We're able to buy Cubicure and fund that with our cash that we have, no debt. And we want to keep it that way.

But then, as Joe said, when we have opportunities like a Heartland that they share the digital orthodontic mindset similar that we have, and they're using that capital to put up new locations that are digital. And we know that they're going to stay with Invisalign and not switch to something else because they don't have a wires and brackets or anything else that they do that way.

So they share that digital orthodontic mindset. That's a good combination. And so I think of when we think about our capital allocation, think of it as an and. Because we're able to do all that and still do the biggest buyback in our history at one shot, just as fast as we can.

Moderator

Yeah. Maybe just quickly remind for people, John, the sort of capital deployment priorities, right? Because, I mean, the company has over $1 billion in cash on hand. You're generating over the next few years another couple $1 billion. I think as of the end of the third quarter, did you have $500 million remaining on the authorization? And so it's kind of a high-class problem to have, right? A lot of cash. How do you think about putting that money to work? And maybe is there an opportunity to get more aggressive in terms of repo if the market cooperates or fails to cooperate?

John Morici
CFO, Align Technology

First and foremost, we want to fund our business growth. All the things that we're talking about with direct fabrication and investments that we make in the business, we want to be able to do that. Sometimes you have to do it with capital expenditures, and we'll do that where it's needed. We bought a company, like I said, be able to fund that with cash, be able to invest in DSOs or other like-minded customers that we have to be able to expand their growth, which also helps us as well. You mentioned the $500 million left on our authorization. Just this quarter, we announced the $275 million against that.

So we're able to fund everything we need to really drive growth in our business and really take us to that next level and some of these growth platforms and so on, but then do it in a way that we're returning excess cash to our shareholders. And we think that's a good balance.

Joe Hogan
CEO, Align Technology

One thing I'd add to it, too, is we move teeth. We straighten teeth. Don't look for us to do some kind of crazy acquisition that's parallel or whatever. We move teeth. We won't surprise you in any way.

Moderator

Okay. Maybe we're out of time, but I do have one last question I wanted to sneak in. I know we're not in any way giving guidance here. We're not talking about next year. One of the things that questions I get that's on investors' minds, so I'll bring it up, is when you look at the way consensus models next year accelerating revenue growth, when you look at the way consensus models 2026 accelerating further from there, right?

Amidst this period of uncertainty, the company has had this long-term guidance out there, which I guess is aspirational maybe, but I'm not sure that people put a lot of stock in it at this point. Is there anything that you think about looking out over the next couple of years that can be a tailwind for you or conversely maybe a headwind for you? I'm just trying to think if there's anything at a high level I should be thinking about as we look out over the next kind of couple of years.

Joe Hogan
CEO, Align Technology

I just start off, Glenn, to say we're only 20% penetrated in just the orthodontic marketplace. We can do 100% of the cases. Who in the world wants to put metal on their teeth rather than use Invisalign? Eat what you want to, take it out or whatever. And so for us to drop it and say we don't think we can actually penetrate that market in a meaningful way going forward would be just denying in a sense of how the company's been founded and what we look at. And John, you.

John Morici
CFO, Align Technology

Look, we're not expecting. We're kind of saying that the economy stay where they're at. If they get better in places, we'll see a tailwind. We know that as consumer confidence improves, that discretionary purchase becomes more real, and we see added volume from that.

Moderator

Okay. Joe, John, Shirley, we'll leave it there. Thank you all very much. Appreciate your attendance. Thank you guys very much.

Joe Hogan
CEO, Align Technology

Thank you.

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