Align Technology's (ALGN) Presents at Baird 2016 Healthcare Conference (Transcript)

| About: Align Technology, (ALGN)

Align Technology, Inc. (NASDAQ:ALGN)

Baird 2016 Healthcare Conference

September 08, 2016 10:50 AM ET

Executives

Joseph Hogan - President and Chief Executive Officer

David White - Chief Financial Officer

Shirley Stacy - Vice President of Corporate Communication

Analysts

Jeffrey Johnson - Robert W. Baird & Company, Inc.

Jeffrey Johnson

Good morning. What don’t we get started? My name is Jeff Johnson. I’m the Senior Medical Technology analyst at Baird. Our next presentation today is from Align Technology, leading manufacturer in orthodontics with its Invisalign clear aligner system.

With us today from Align we’re pleased to have Chief Executive Officer, Joe Hogan; CFO, David White; and to David’s right is VP of Investor Relations, Corporate Communications, Shirley Stacy. So, Joe, I’m going to turn it over to you, if you have any kind of opening remarks you want to make and then we’ll just go straight into Q&A.

Joseph Hogan

Jeff, we didn’t bring any slides, but I think we had a good second quarter and we announced a major deal with SmileDirectClub, in a sense I think it surprised a lot of people, and we have a lot of questions on that, but right now we collectively feel good about the Company, the momentum we have right now from a growth and margin standpoint and just happy to be here today.

Question-and-Answer Session

Q - Jeffrey Johnson

Great well, I think we’ll just jump right into the [slide] questions. But let me start somewhere else, actually. I just want to start with your long-term outlook 15% to 25% revenue growth, 25% to 30% operating margins. Those have been the stated goals for a number of years now.

If I look at the revenue side, if you can X out some of the currency stuff and all that, you guys have delivered in that range now pretty much for six straight years on the revenue side; average growth 17%-ish or so. That was easier – I was going to say easier; it was never easy – but easier when you were $300 million, $400 million revenue the clear aligner penetration rates are still low, but were lower then. Talk to me about the challenges now with revenue this year probably going to top $1 billion, what are the drivers of keeping up 25% - or 15% to 25% revenue growth?

Joseph Hogan

Yes, I think it’s – Jeff, it’s so broad and deep in the sense – so we continue to grow international in a big way, because we haven’t had strong penetration rates in the international markets and you know they’ve been outgrowing, in expenses, year-over-year our domestic markets.

And so, just going broader, this year we move into Korea, we’re making our initial forays into India, Taiwan is just coming up, some major geographies, obviously that we have to move into. We still have Brazil we’ll begin to go into next year. We’ll go into parts of Eastern Europe and the Middle East.

So that rest of the product line in the business and moving into those areas is really important. And then from an overall utilization and penetration standpoint, North America tends to be very big for us. Our growth rates in Europe I’d say are just as much breadth as they are depth, because of penetration rates in different countries.

So, just to wrap up that question, it’s just important that we continue to drive the utilization rates for me into individual geographies we can, and to broaden the Company overall globally.

Jeffrey Johnson

Yes and you talked about some of the new geographies going into – if 15% to 25% is the goal at the revenue line Companywide, how much longer – or how long do you think international can stay above the upper end of that?

David White

Look, based on what I see right now I don’t expect it to – I think it continues at those rates and when you say 25% I mean obviously you can drive a truck through that. But we’ve been in the 20% range here recently. And honestly, we have good momentum in that space and in that range.

Joseph Hogan

Okay, I think, just to add to that, I think in terms of longevity, I think one of the things that makes our business unique is the fact on that.

Jeffrey Johnson

I’m sorry. For the webcast – were you guys able to hear David also?

Joseph Hogan

Okay. Is the fact that our penetration in the overall market is still in the single-digits.

Jeffrey Johnson

Okay.

Joseph Hogan

Right and that’s measured – as measured against what we call our served available market. And there are still many geographies in the world that we’ve not even began addressing the product. And so, as we think about our long-term growth, and we feel like we’ve still got many opportunities still ahead of us to continue that.

Jeffrey Johnson

Yes and you talk about the SAM. I want to come back to some of these other drivers, but you talked about the served addressable market as opposed to the SAM. You guys have surely – this is a question I’ve asked you for years – of 50%, 50%, 50% is what you think you can address. And yet you’re coming out with all these new technologies. It seems like maybe we’re up closer to 60%, 70%, 75% now of the market you can address, of the orthodontics market. I mean is that SAM moving higher?

Shirley Stacy

[Inaudible].

Jeffrey Johnson

That’s helpful. So Joe, I think when I look at your time – it’s been what, about [18] months now as CEO? I think - correct me if I’m wrong, but it feels like one of the things you’ve come in and looked at and really tried to drive home is let’s knock down hurdles to adoption of this technology. If a dentist doesn’t like it, a patient doesn’t like it, why not? And what can we do to solve that and bring these users - again, whether it’s a doc or patient - into the fold?

So what is - the additional aligner policy, smile care club, I want to talk a little bit more about that. But we just saw a press release earlier this week that now you’re offering, at least through the next several months, a new way to tell the height of the teen season was past. It was smart timing probably on your part. But for the next several months you’re offering kind of a guaranteed in some select markets. If a patient or parents don’t feel like their child is doing - is fully complying and doing well on the clear aligners, you’ll basically pay to switch them over.

One, David, maybe what are the financial implications of that? Is there a deferred revenue component we have to think about with that? But more importantly, Joe, just strategically, why is it important to do that? What does this do to the overall growth?

Joseph Hogan

Yes, Jeff, I would say its confidence. We have a confidence that 90% of the patients faced with a choice - I’ll take wires and brackets, versus the Invisalign product, they’re going to go with Invisalign. And so just the way you summarized it, which - I’m not going to [bury] it. If someone is afraid that their child or their teen is not going to be compliant and they’re going to lose money in the sense to conversion to wires and brackets, we can’t imagine that’s going to happen at a rapid rate.

So we just - we’ll offer that option. We started that in Japan, actually in Japan, actually, in different parts of Asia. And we’ve had a certain amount of success with it, with doing that. So it is at barrier-breaker. The same way with some of the options we give patients from a price standpoint, and doctors to help them move this.

And it’s still a business where it’s really just that intuitive. Just 7% penetrated into 50, 60, 70, call it what you want. You have to say patients in general, when you focus on patients, they want clear aligners. They’d rather have clear aligners then metals and brackets. We’ll continue to find any way we can that makes business sense to approach patients and say, this is what we can offer you; or doctors through patients, to make that work.

David White

Just to answer your question on the financial side of it. We’ve ran this promotion before. We’ve ran it in North America before, so we have experience with it. And our experience has been that - has been very good, from the standpoint that we don’t - we see very, very de minimis claims on that promotion; where doctors are saying I failed, or the patient failed and I had to suit them up in wires and brackets. So from a financial standpoint, yes, we do have to defer something for that promotion, but its pretty de minimis.

Jeffrey Johnson

Okay. Something on our models we don’t really…

David White

It’s very small.

Jeffrey Johnson

Fair enough. So back on the smile care club - 17%, I think, equity stake in that business, you’ll capture then the direct sale of those aligners. Pros and cons, let me just ask just the one question I’m getting from investors is - what is the risk that you disintermediate some of the GPs or other doctors, tick them off, or they feel like now you are trying to run around them?

It’s been a month or two. You’ve had a chance, I’m sure, to go out there and talk to some of these docs. I’ve been surprised with the docs I’ve talked to don’t even know this is going on. So maybe it’s been something that’s not well known out there. Just what are you hearing in the field, the first month or two after you announced that?

Joseph Hogan

I’d just speak from a broad segregation standpoint; I’d say there’s not a whole lot of concern from a GP standpoint. The GPs as a group haven’t pushed back in a big way. From an orthodontic standpoint, I’d say it’s mixed. I would broadly categorize it just with the orthodontist is, one, is the ones who haven’t liked us in the past like us even less.

The ones who do business with us - and we’re in a substantial part of their business - they would say, we wish you wouldn’t have done this, but we understand why you did, and it doesn’t change our commitment to Invisalign. We believe in the product line. They like the idea that Invisalign stays a doctor’s office product. They like the idea that this is a commodity material.

EX30 is what we offer the SmileDirectClub. It’s just a clear corrective supply to them. It’s a simple product: no attachments, no [gingival cuts], those kinds of things. And so the model I think is palatable, and has been to the doctors that are involved with Invisalign currently, from what I’ve seen…

Shirley Stacy

One thing I’d follow-up with that Joe [indiscernible].

Joseph Hogan

The only thing just to add, Jeff, is that from a doctor standpoint, one of the benefits the doctors see in this relationship – and it’s difficult to quantify at this point is the potential for referrals. Because there is a fairly meaningful percentage of the cases that go to SDC that are not going to be treatable outside of a doctor’s office type of setting.

And so we’re committed to taking that portion of what you might say the fallout, the conversion fallout there, and moving it into the Invisalign channel and giving Invisalign doctors and practices an opportunity to treat that. And so, there’s probably no one else that would have had an interest in monetizing that fallout other than Invisalign. So from that standpoint, it’s a – we hope it’s a good upside to our doctors as well.

Jeffrey Johnson

Yes. And one other question on the whole relationship is I was a little surprised, I think, it was 30,000 procedures last year. Is that the number or something like that, that I tapped into?

Shirley Stacy

Absolutely, that’s the run rate.

Jeffrey Johnson

Run rate. Okay, so we are at a 30,000 run rate. What I’m struggling to figure out, or starting to conceptually think about is, is this a Warby Parker-like model where you’re going to see more and more of those – they do the online glasses, things like that. That’s very simple to me, when you do online glasses or something like that, low-risk. But here you’re spending maybe I think it’s $799, is that right? Is it 15 all together.

Joseph Hogan

Yes.

Jeffrey Johnson

What was it? 800, is it 800 upfront or something…

Joseph Hogan

That’s right. In the end it’s [1,570]

Jeffrey Johnson

Is it? Really. Okay, so that’s even more, so that makes it even harder to think about who would necessarily want to do this? I think there’s been some early adopters. It’s kind of like LASIK. I always look at as LASIK is you get a lot of early adopters, they immediately adopt to something there. And you realize there is not infinite growth in that market. There’s only so many people that are going to choose that model or that procedure.

So, I guess my question is you made an equity investment obviously to establish some call option in there to up your equity investment. But do you think this online channel becomes a big way that clear aligners are done in the future? Or is there just always going to be kind of the small – I’d put the Millennials in there, those people who are willing to do some of that stuff, whatever – in that it will stay somewhat a small channel?

Joseph Hogan

Jeff, I think the honest question is we don’t know. But my guess is if you look at the United States today, there’s about 2.5 million to 3 million case starts in orthodontics. But we know from a quantification standpoint there’s 70 million patients out there that need to have their teeth fixed. There’s 70 million people not being addressed in the United States. You can’t address that with wires and brackets. You can only – now, there’s a certain price point on those patients, a certain amount of time lapse, in the sense of going to a doctor’s office or not going to a doctor’s office.

When you look at the SDC model, you say there’s a chance that they could really penetrate some part of that 70 million people that aren’t seeking the orthodontic treatment that they need to make. And so this could be – if you look at it from the standpoint of how much does it take away from the orthodontics and the 3 million case starts, it probably is de minimis. I don’t think it’s a big deal. But if you look at penetrating a market that hasn’t been penetrated before, it could be substantial.

And remember – I think the other part about this, too, it’s not a Parker model in the sense that this is doctor-directed. It’s just virtually doctor-directed. They are online, they look at that case, they approve that case, they move it onto manufacturing. And then you monitor that case for the patient, too. So it is doctor-directed. It’s not that it is a true direct-to-consumer model in the sense of not having an expert from a medical standpoint being involved in it.

Jeffrey Johnson

Yes. And the last question I have on the revenue side, you’ve talked about some product line extensions maybe in the mandibular extension – the palate expansion?

Joseph Hogan

I had to work on it, too.

Jeffrey Johnson

But as you move into those areas, any updates, one, on timing? I think it was the palate expansion that could come before the mandibular expansion. But any updates on time lines, and how do we think about that?

Joseph Hogan

The products are progressing well in the sense of our clinical trials and then our ability to manufacture them. But I would say right now the way we look at it, there’s a 2017 launch of the mandibular product and probably an early 2018 launch of the palate expansion based on [indiscernible]. But honestly, as we look at the technology and what we can do and whatever, we’ll get this done. Clinically the feedback so far has been very strong on the mandibular product, and the palate expansion is probably pretty close to it.

Jeffrey Johnson

And is the goal to monetize selling a few more clear aligners? And I say a few – I think it would be a lot, I know – but selling more aligners in for those two indications, or to get the patient into the system; the habit of using the clear aligner in that pre-treatment phase before then; now it’s easier to get them to commit to clear aligners over brackets and bands for the full treatment?

Joseph Hogan

I go back to your comments about knocking down barriers. Right when we think one of the barriers we’ve had with the teen market that we are not – we don’t have strong utilization rates. And there’s been those early phases of – Phase I, which is palate expansion or mandibular advancement. It’s not having a product to begin that whole treatment with. It begins with wires and brackets, and it ends with wire and brackets, so it’s knocking down another barrier that we think is in on the market.

David White

And if you’ve seen the products that are in use today, [multiple speakers]. Surprisingly with a small mouth. If you really love your children [indiscernible].

Jeffrey Johnson

Fair enough. Let me pause, see if there’s any questions from the audience. So I’m going to transition. I’ll try to spend less than two minutes on this, Joe, because I’m sure you’d rather be spending even less than that, but on the IT issue.

Joseph Hogan

Yes.

Jeffrey Johnson

Can’t really talk about that 15% to 25% longer-term growth target at the topline without at least acknowledging those issues?

Joseph Hogan

Yes.

Jeffrey Johnson

How do you think that plays out over the first year or two? I will tell you, some competitors I talk to say that’s not going to be us that goes first; we’ll let somebody else develop the playbook on how to go after them. I think you guys have been very smart in that Juarez and Costa Rica used to be these super top-secret sites that none of us would ever get down to.

You kind of opened the kimono a little bit, and now all of a sudden we see how much you have invested and how much corporate know-how there really is there. And it would be a big damn investment for some of these companies to really try to compete effectively at least in not a small way, but in a real way, against you guys. So how do you think the first couple years play out? Do you see one or two big guys come after you? Do you have to adjust price? Do you have to do something else? Just what are you thinking?

Joseph Hogan

Well, I think they do come into the marketplace. I mean if you are selling wires and brackets today and you’re looking at – you’re struggling with 2% or 3% growth rates, and you look over the fence at us, it looks pretty good. So, it would be hard to explain to your Board or your management team why you wouldn’t want to do that. Right the future is [staked] just one way or another, it’s not metal.

As you said, if there are some really big entry barriers. We have a first-mover advantage of about 18 years in this business, and that’s what you are referring to down in Juarez and Costa Rica, and that has been spelled. But what I expect a company like Danaher to get into the business. So I think 3M, with their history and capability; or Unitek will get into the business. . How will it play out, I think it’s probably second half of 2017?

I really expect those companies to come out with something that is somewhat compatible with metals and brackets right. Go up front with metals and brackets; maybe you finish with a plastic aligner in some way. Because it’s not – I mean, how in the world do you tell your customers well, for the last 17 years we really haven’t been telling you the truth; plastics do work.

So I think you are going to have to contain plastics in a certain way. So, that’s as good as I can get, Jeff, in the sense of how we anticipated I think manufacturing scale-up and those kind of things, how you do the clinical work upfront to do case studies and all. There’s a lot of software and hardware associated with really ramping that up a big way. So, it’s incremental approach to lower case kind of things, something compatible with wires and brackets, would seem to be a logical approach to me.

Jeffrey Johnson

Any other questions? Maybe moving over to the margin side for a second. So, again, the stated margin goals, then, if the revenue goal has been 15% to 25%, the stated operating margin goal of kind of 25% to 30%. You do have the IP issues coming in late 2017. Maybe competition kicks up; maybe it doesn’t. In an era of potentially increasing competition, is that 25% to 30% still achievable? You knocked down some of these hurdles. Some of the knocking down of those hurdles carries some cost to you, at least initially. Is that 25% to 30% still achievable? And then I want to ask a follow-up on that.

Joseph Hogan

We think, as we do our long-term strategic planning – I mean we’re close to it right now, as we talked about before, in the sense you take a few exceptions in additional [ladder] policy in our ERP system. That’s a margin that is obtainable in this marketplace, too. We see it with certain competitors. So I do think, even under a competitive scenario in 2017, it is.

Now, look, the counter to that is there’s incredible investments in this business that have less than an 18 month return that David and I look at all the time, and have to prioritize. And if we do run into trouble at some point in time, we know how to play the cost game. We can [kind of modify that piece]. I think it’s a very responsible target for us, and one that’s achievable.

Jeffrey Johnson

And I think, David, you and I talked about, at the Analyst Day some of those ERP costs are coming down pretty aggressively…

David White

Yes, they’ll come down next year because the heavy investments we’ve made this year will fall off. We’ll obviously have the depreciation of the new system, but there will still be a net savings that will be meaningful year-over-year.

But to your question about the long-term model and so forth, we teeter just below 25% to 30%. And a lot of people ask questions about, well, when are you going to be in the 25% to 30%? And it really comes down to investment choices we make as a company, and how aggressively we’re investing for growth, and how quickly the returns from that growth materialize into revenue.

And so, if you look at our growth over the last couple of years, they’ve been higher in the range of that 15% to 25%. And that’s been primarily the result of investments that we’ve conscientiously made to drive that. At any point in time, we could dial those investments back and be in that range. But it would probably come at a slower vector, our growth, which we don’t think is the right trajectory for the Company.

Jeffrey Johnson

Yes, no, understood. And then, Joe, I think you referenced it. I’ve heard you say in some of those international markets, those investments are, what, like a six-month paybacks and just [indiscernible].

So one other question on the investment side, you talk to Emory and you talk to some of the guys on the manufacturing or the treatment planning side, and it sounds like - maybe going from one treatment plan facility in Costa Rica - I think your plan to maybe go to nine eventually. Is that the number? And manufacturing moving to three other manufacturing - maybe a dedicated site in Japan, and then Asia Pac and Europe. There’s going to be costs there, too.

We look at Costa Rica and Juarez, they’re huge. You invested so much. Obviously you know a lot about those, so it’s easier to port that somewhere. But how to think about the near-term or intermediate-term cost of putting up new facilities in different markets - and the benefits?

Joseph Hogan

Yes, we’re laying that out now, in a sense. What’s really important is that we move those assets that we can that make sense, Jeff, closer to customers. Because you’re translating Mandarin into English and Spanish, sometimes, back to Mandarin, and doing it eight times. It just doesn’t work in a supply chain that’s 45 days and things. You just have to do something to make up.

So, the whole focus on the Asia first is a big part of that. And we break up that supply chain in the three areas, orders, acquisitions, and then really the treat software piece, and then the fabrication of it. Within late 2017, 2018 we’ll come up with fabrication probably in Singapore, from an Asia standpoint.

And so the first two countries we’ll have the kind of clinical software we need in Japan and also China. Will it cost us? Yes, there will be some upfront investment in that sense. How much we’ll share in a sense of exactly what that is - I don’t know how discrete we’ll be about that, but they will have some costs to it. But, look, it’s resolving, we think we’ll have significant revenue increases on the other…

David White

And I said, there will also be savings associated with it. So today when we take PVS impressions from doctors, they have to be shipped all the way to Juarez, Mexico, to be scanned. We bear the cost. And then we obviously bear the cost of shipping the completed case back to the customer, wherever that is.

So to the extent we can capture those PVS impressions in-country, or in a region at least, scan them there, and then just digitally transmit that information back, that saves us on freight costs. To the extent we can get the factories closer to the region where we’re shipping, as well, that saves us on freight costs. So we don’t view this as an entirely incremental cost to the Company.

Jeffrey Johnson

Can’t you just give iTeros away and make sure - then you don’t have to ship it…

David White

That, too. Everybody wants to give iTero away.

Jeffrey Johnson

Not even going to touch that comment. So, it sounds like fabrication - if it’s in the hierarchy of those three things, fabrication - in my mind, it was going to be the treat side, which is local dialect. Now you have to doctor in Japan calling a Japanese treatment planner that they can talk about the local [fort] teams, whatever that would be. Even when you put it all in local as opposed to calling somebody in Costa Rica, that to me was the more important. It sounds like to you guys, more fabrication would be in the hierarchy of importance.

Joseph Hogan

A critical part – just like you said, a critical part. But having another fab area is important to us. Look, these are incremental pieces. Those are stereolithography machines and CNC machines, or laser machines that cut this thing at the end. So a very discrete manufacturing kind of capability. We can parcel those, move them out, put them in different geographies. Having those close to the customers, too, gives us a certain insurance policy to – from the standpoint of continuing supply to customers, also.

Jeffrey Johnson

Okay. And we’re down to the last four minutes. I just wanted to ask – it’s a short-run question and I hate to even ask it, but given that we’re down to a few minutes. The dental data points have been mixed. I mean we’re hearing things from Schein, from Patterson; the last couple of months may be questionable. As you guys know, we do a lot of survey work. And really June, July, and even August survey work has been somewhat softer than we would have expected.

So just kind of from a specialty dental perspective, and kind of trying to put your strong Q2 numbers into context in that – what are you hearing in the channel the last few months? Is there anything you can talk about over the last couple-few months, as you’ve heard some of these comments from the Scheins and Pattersons relative to your business?

Joseph Hogan

Yes. Jeff, we won’t make any comments from an in-quarter standpoint. But I mean we read the Schein’s comments at the end of the second quarter and what they had. We had some data specifically that we contract with an outside agency on orthodontic procedures. There’s some indications that were harder to close cases, a little bit more difficult than it was this time last year. But we certainly didn’t see that in the second quarter results. So I think at any point in time, taking a look at August is probably not the right time to take good, thick look at something.

Jeffrey Johnson

Yes.

Joseph Hogan

So we’ll work through this.

Jeffrey Johnson

That’s right.

Joseph Hogan

So we’ll work through this quarter. We’ll give you a strong assessment at the end of it.

David White

And it’s true that our third quarter in North America is seasonally weaker for GPs. And it’s been that way historically for a long time. So not that unusual.

Jeffrey Johnson

And you do come up against tougher comps, too, [second to] third quarter. I know you are not a huge believer in comp. But David, you’ve counseled me many times on sequentially looking at things, not year-over-year looking at things in that. But those comps do get tougher. But I guess one last question on that North American side, the orthodontic side, as you expand indications, you bring more and more technology, the orthodontists respond more and more. But there’s no doubt that’s been a clear inflection point over the last five years or so in your business, four or five years.

On the GP side, I almost view that as it’s almost more brute force. The extra technology is nice, but you have to get the sales rep in there, you got to be pushing these guys and convincing them to do these cases, and taking on kind of orthodontics in their office. You put in some really nice investments late in 2014. That’s helped 2015 and early 2016. Is it just a continuous cycle you have to keep up investing in that U.S. GP to really keep that number going? Or what else kind of keep the [indiscernible]?

David White

There is another dimension to it, Jeff, than just salespeople. I think what we’ve really learned over the last couple years is you can’t turn GPs into orthodontists. They don’t want to be. And so taking the sophisticated program we have with ClinCheck, and how we go about things and asking GPs to do that, doesn’t make sense.

So, you’ll see us come out with very simple products and simple ways of doing cases that will fit much better into a GP’s workflow. So that’s just a combination of product. It’s also our clinical systems. And then having feet on the street to take that product line into a customer so I think it’s more of a balanced approach as we go forward.

End of Q&A

Jeffrey Johnson

Any last question from the audience? Going once? All right. Well, I think with that our time is up. And we’re actually a minute and a half, so that is a good thing. Still an extra minute if you want, but I think we’ll just call it with that. So please join me in thanking Joe and the team for a great overview here of Align Technology.

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