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Align Technology, Inc. (NASDAQ:ALGN)

Realine Product Offering Conference

June 03, 2013 4:30 pm ET

Executives

Shirley Stacy

Thomas M. Prescott - Chief Executive Officer, President and Director

Roger E. George - Interim Chief Financial Officer, Vice President of Legal & Corporate Affairs, General Counsel and Corporate Secretary

Analysts

John Kreger - William Blair & Company L.L.C., Research Division

Steve Beuchaw - Morgan Stanley, Research Division

Robert P. Jones - Goldman Sachs Group Inc., Research Division

Spencer Nam - Janney Montgomery Scott LLC, Research Division

Matthew Dolan - Roth Capital Partners, LLC, Research Division

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

Jonathan Demchick - Morgan Stanley, Research Division

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Align Technology Realine Product Launch. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce Shirley Stacy of Align Technology. Ms. Stacy, you may begin.

Shirley Stacy

Good afternoon, and thank you for joining us today. I'm Shirley Stacy, Vice President of Corporate Communications and Investor Relations. Joining me today is Tom Prescott, President and CEO; and Roger George, Vice President Corporate and Legal Affairs, General Counsel and Interim CFO.

We issued a press release today via Marketwire announcing a new entry-level clear aligner product that will be distributed in North America exclusively through Henry Schein Dental beginning June 24. The release is available on our website at investor.aligntech.com.

Today's conference call is being audio webcast and will be archived on our website for approximately 3 months. A telephone replay will be available today by approximately 5:30 p.m. Eastern Time through 5:30 p.m. Eastern Time on June 10. To access the telephone replay, domestic callers should dial (877) 660-6853 with conference number 415887 followed by #. International callers should dial (201) 612-7415 with the same conference number.

As a reminder, the information that the presenters discuss today will include forward-looking statements, including, without limitation, statements about Align's future events and the commercial launch of Realine and expectations that it will not have a material impact on Align's financial results for fiscal 2013. These forward-looking statements are only predictions and involve risks and uncertainties such that actual results may vary significantly. These and other risks are set forth in more detail in our Form 10-K for the fiscal year ended December 31, 2012. These forward-looking statements reflect beliefs, estimates and predictions as of today, and Align expressly assumes no obligation to update any such forward-looking statements.

With that, I'd like to turn the call over to Align Technology's President and CEO, Tom Prescott. Tom?

Thomas M. Prescott

Thanks, Shirley. Good afternoon, everyone. I'm pleased to share some exciting news with you today regarding a new entry-level clear aligner product that we're launching this month through Henry Schein Dental.

Realine is a 5-stage clear aligner product for cosmetic fixes and very minor crowding and spacing issues, such as dental relapse, that's intended for non-Invisalign GP dentists. Realine offers GP dentists who are not currently using Invisalign the innovative technology and quality of Invisalign aligners as a competitively priced, easy-to-use product for patients with very simple treatment goals especially among adults.

There are approximately 100 million adult consumers in the U.S. alone who would like to improve their smile and are interested in straighter teeth, but many would never consider braces or seek out an orthodontic consultation. Over the years, Align has driven category growth in orthodontics by offering Invisalign, a clear aligner solution that especially appeals to adult patients, and by making clear aligner therapy available through Invisalign-trained orthodontists and GP practices. With Realine, we now have an opportunity to continue expanding the market for orthodontic treatment by addressing the growing number of patients with very minor crowding and spacing issues who are interested in straighter teeth and at a price point that reflects the simplicity of their case.

In 2012, Align introduced Invisalign Express 5, a full-featured 5-stage clear aligner product for minor tooth movement. And since then, we have seen strong growth in adoption of Invisalign Express 5 among existing Invisalign practices. But even with that success, we know there's a large untapped opportunity for Align to reach more patients through dentists who do not currently use Invisalign, especially for those patients who think their malocclusion is too minor to seek out a specialist or to consider comprehensive orthodontic treatment. We believe these patients are more likely to consider treatment with a simple, affordable clear aligner solution offered by their general dentists. In fact, we've seen growth in this area as offerings from dental labs providing clear aligner therapy have proliferated.

With that in mind, we developed Realine, targeting the entry-level market with a clear aligner product that is very easy to use and appeals to the large number of adults with some form of minor malocclusion. It's a straightforward way for doctors to start using clear aligner therapy, including some of those that have tried some of these offerings from dental labs.

Realine is a far different product than Invisalign Express 5 as there are no doctor modifications to Realine treatment plans, no IPR, no mid-course correction and no upgrades to more comprehensive treatment options as we have with Invisalign Express 5 and other Invisalign products. Therefore, Realine does not require the same level of training as Invisalign products and yet it's based on the same effectiveness and benefits as Invisalign treatments.

We will minimize any confusion among existing customers, patients and consumers through the use of a new brand name, Realine, and totally different offering and value proposition based on simplicity, ease of use and price competitiveness while targeting the 80,000-or-so dentists currently working with Henry Schein Dental.

Getting started with Realine is designed to be easy and efficient for Henry Schein Dental's GP dentists, as you can see from the 5 steps we outlined in our press release. After setting up an account and submitting patient dental records along with a prescription form, the doctor uses a web-based 3D viewing tool that compares images of the patient's initial and final tooth positions to show what can be achieved in a maximum of 5 stages. The doctor accepts the case, and Align manufactures the custom aligners and ships them straight to the practice in a matter of days. Realine doctors with cases outside the scope of a single Realine treatment may purchase multiple treatments, refer those cases to an Invisalign provider in their area or, if interested in learning more about clear aligner therapy, may sign up for an Invisalign Clear Essentials I course offered through their Henry Schein representative.

We're very excited about this opportunity to extend the benefits of treatment to more patients and equally excited about our first distribution partnership in North America. Henry Schein Dental is the world's largest provider of health care products and services to dental practitioners. They provide the reach, scalability and existing long-term relationships with GP dentists to help us reach an untapped market of approximately 80,000 GP dentists who do not currently use Invisalign. Partnering with Henry Schein Dental will allow Align to cost effectively establish a leadership position in the entry-level clear aligner market while maintaining our primary focus on comprehensive orthodontic treatment through Invisalign providers.

Realine will be marketed solely to GP dentists in the U.S. with no direct-to-consumer marketing. Henry Schein will provide all initial sales and billing support for Realine doctors, and Align will provide customer support for Realine product inquiries, including online registration and web-based support, case status, clinical inquiries and general treatment questions.

The terms of the distribution agreement we've created are confidential and are not being disclosed. The exclusivity with Schein is based on the number of doctors who purchase Realine. Realine is not expected to have a material impact on Align's 2013 financial results, and we are not providing any specific volume assumptions. Over time, we expect Realine will contribute to continued growth in North America. And even with lower gross margins for Realine due to some distribution costs, we expect both contribution margins and operating margins to be consistent with our overall corporate range and long-term financial model.

This partnership with Henry Schein Dental and the launch of Realine is an additional way to introduce doctors and their patients to clear aligner therapy. We hope that, over time, many of these doctors will choose to become Invisalign providers. We will continue to focus our investments in research and development to accelerate product innovation, with the goal of someday having clear aligner therapy become the standard of care in orthodontics. At the same time, we will continue to invest in expanding the orthodontic category through consumer marketing, with the goal of making orthodontic treatment a more desirable and important personal objective for millions of consumers. And finally, through innovative go-to-market initiatives like this partnership with Henry Schein Dental, we will be more effective at reaching a greater number of dental practices and their patients. Ultimately, this will help extend the growth of the orthodontic market, which will be good for Align Technology and the rest of the industry.

And with that short note, let's go right to the Q&A.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of John Kreger with William Blair.

John Kreger - William Blair & Company L.L.C., Research Division

Tom, I know you said you're not going to disclose the terms. Are you willing to give us a sense about how the $575 price would be split between you and Schein?

Thomas M. Prescott

At this point, no, John. We're just not going to unpack that any more. At some point in the future where it's appropriate, we may consider that.

John Kreger - William Blair & Company L.L.C., Research Division

Okay. A few others: If this goes well, would you consider taking a similar distribution model to Europe where I know Schein has a pretty big footprint?

Thomas M. Prescott

I think we plan -- what's it? You plan for the best, you hope for the best, you plan for the worst. And in the middle of something that we expect to have happen, we are planning for this to be successful. And we expect to learn a lot from this, both in terms of working with a big distribution partner as well as engaging these practices with a simple product. And we're just going to have to block and tackle well here to get started, and we'll have to go from there.

John Kreger - William Blair & Company L.L.C., Research Division

Okay. And then one last one. Again, if successful, would it make sense for you to consider using Schein to sell iTero as well?

Thomas M. Prescott

At this point in time, I just want to keep the comments focused on Realine. And we'll take that scanner discussion for some other day.

Operator

Our next question comes from the line of Steve Beuchaw with Morgan Stanley.

Steve Beuchaw - Morgan Stanley, Research Division

A couple of quick ones and then one strategic. First of all, I wonder if you could spend just a minute kind of giving us an outline for how you -- how do you characterize the customer, the incremental customer, here? And I say that because the backdrop is you guys have done a fantastic job on the marketing and selling front being direct and, of course, using your marketing efforts in the DTC channel to drive patient demand for the product. So when you thought about this decision, who was the prototypical customer that you weren't getting to previously?

Thomas M. Prescott

It's pretty simple. It's the iceberg that's not visible underwater. We are not, in fact, doing business with most GP dentists in the country. And our research has indicated that those everyday conversations with patients, when they're in for a hygiene visit, their normal routine cleaning and care, ask questions about very minor malocclusions. Typically, this is not a big topic for the average GP dentist office. And unless the patient has a more significant malocclusion or a more urgent need, often they won't even seek a follow-up with an orthodontic specialist. So this is an opportunity to engage that practice at the point of contact with a very simple offering for those very simple cases. And over time, we expect that to help accelerate total market growth.

Steve Beuchaw - Morgan Stanley, Research Division

Okay. And then can you give us any quantifications of the time investment or financial investment for a GP to get on board with Realine?

Thomas M. Prescott

This is very, very, very simple. Because the treatment scope is so narrow, there's no ClinCheck review. There's -- they have to review and look at the expectations, but it's not a ClinCheck file. It's a simple web-based viewer. And there's no IPR, there's no mid-course corrections. There's none of the complexities, again just being straight 5 stages. And so we expect this will be -- if they're already using some other lab-based product here, we expect this will be very simple for them to do with no hassle through their Schein representative who they have great confidence in. So from our perspectives, there's a brief tutorial there we'll provide online for them to get started. And there's the framework for Schein to bring this as a practice-building opportunity to their customers. It's not more than that. If -- we're not minimizing: If they want to learn more about doing orthodontics or learn more about Invisalign for anything other than the simplest of cases, they have lots of options to go do that, but this is not that. This is just addressing the simplest of cases that are in their office everyday.

Steve Beuchaw - Morgan Stanley, Research Division

And then last one for me is, why go exclusive? Given the simplicity and the plug-and-play nature of the offering, why not be more open to a wider range of partners?

Thomas M. Prescott

Well, I think it's a fair question. The reality is we think there's value in having a dedicated partner that's going to put real muscle and effort and their 1,300 reps behind it as they try to bring practice-building ideas and ways their GP practices can be even better taking care of their patients' needs. So I think, at this point in time, we saw the value in having a leader like Henry Schein be that partner, and we expect it to be very successful.

Shirley Stacy

Thanks, Steve.

Operator

Our next question comes from the line of Robert Jones with Goldman Sachs.

Robert P. Jones - Goldman Sachs Group Inc., Research Division

It seems like the innovation and the strategy has been targeted further downstream, and I understand the logic on expanding the market and addressing a portion that's currently not addressed. But I guess maybe if you could spend a few minutes on how we should think about or how you're thinking about cannibalization of your current lines. And in this rollout, do you anticipate any backlash you might get from your core Invisalign GP or ortho users?

Thomas M. Prescott

Two very different questions. Let's start with the first, and that is we've got over a full year now of Express 5. We've got multiple years of Express 10. And if there's any cannibalization in the margin, it's very small. It's Express 10 against a very, very simple full case with a very experienced orthodontist typically that can squeeze, say, a 12- or a 15-stage case out of 10 stages. And we think that's very, very minor, if any cannibalization. Secondly, in that price point, with a very experienced orthodontist, they're basically paying almost the same for Express 10 as they are for a full case given their discount. And there's no incentive for them to, in fact, cannibalize. We've seen 0 cannibalization on the low end with Express 5. And with this offering, this is -- these are -- none of these are existing customers that can order Invisalign products. So this will be truly incremental. In addition, we think there's market growth going on here. And we in fact have had a complaints, patients and others that have said, "I think I'm in Invisalign treatment," and then in fact are not. It's a -- perhaps a poorly made lab product. We think, if there's growth in this area, for the simplest of cases, we might as well do it right. And we had a -- we're world class at what we do in this area. We might as well bring that value proposition to those simplest of cases. So up and down the line, the technology we brought targeted at the orthodontic specialty also plays here to be more predictable. For whatever 5 stages we'll do, we ought to be able to do it well. Setting that aside, this is -- we branded this specifically as Realine, and it doesn't have the same -- it is has all the physical features and great materials and everything else we can do, but it doesn't have the control and flexibility and leverage of all the technology that Express 5, 10 or Full or Teen would have for our experienced Invisalign customers. It won't -- it is branded differently for that very reason. As -- part of our value proposition for our, really, valuable base of customers that are still building is to raise the water level around the Invisalign brand. So as we've had discussions with customers and other key opinion leaders, we haven't sensed there is that downside. Could someone not like this? Perhaps, but this has -- this isn't what we're thinking about. This is truly an incremental opportunity to drive a bit more market growth and to satisfy a growing need.

Robert P. Jones - Goldman Sachs Group Inc., Research Division

Got it. And I guess my follow-up, if I could, for Roger. Anything different on the IP front that we should think about here or similar legal barriers to entry that you have across the other product lines?

Roger E. George

It's the latter. There's no different contour here on the IP side.

Operator

Our next question comes from the line of Spencer Nam with Janney.

Spencer Nam - Janney Montgomery Scott LLC, Research Division

So the first question is, Tom, you mentioned in your prepared remarks that, over time, the margins from this program will be in line with the overall corporate margins. How is that possible when you're splitting some stuff with Henry Schein here?

Thomas M. Prescott

So it -- I didn't say "over time." From the very get-go, the margins on a contribution -- if we had to compare contribution margin of a full case and this, there would be -- there wouldn't be a numbers of dollars because it's a smaller sale price, but contribution margin rate is equivalent to our full cases or our teen cases for the very reason that even after sharing margin with Henry Schein, it is less than the total stack-up of customer support, sales, marketing and everything else. The second thing is it's a simpler product to produce. There isn't the detail around ClinCheck. It's a simple case. And the way we're providing it is a very -- is very web-based versus being what I may call high touch, high tech versus high touch, which we do with our Full product. And we've done this in a way that it was scalable for Schein and Align together to answer all their customers' needs. So if you look at all that, it will contribute in a favorable way, just as growth of our full cases or teen cases would be, albeit the smaller dollar per unit. So as we've said before, this is one of the things that, as the low-end market grows, our mix will shift a bit, which may trigger over time some ASP change, but that's a net, a positive effect given this is incremental growth.

Spencer Nam - Janney Montgomery Scott LLC, Research Division

Okay, that's helpful. And then, who approached whom on this?

Thomas M. Prescott

Oh, I don't want to go there. Consider this: Like minds think alike, and leave it there.

Spencer Nam - Janney Montgomery Scott LLC, Research Division

Okay. And then finally, how do you assure the cannibalization doesn't take place between Express -- Invisalign Express 5 and this -- the Realine?

Thomas M. Prescott

In -- Schein won't be calling on any Invisalign doctors. And any Invisalign doctors would -- why would they want to order this product when they can get Express 5 with more features at the same price? So I think the -- as we've tested this a bit, there's no cannibalization between Express 5 structurally possible because the Invisalign-trained doctors are off the list for Schein. We wouldn't accept a Realine or register a Realine order from that practice. But it's truly incremental.

Operator

Our next question comes from the line of Matt Dolan with Roth Capital Partners.

Matthew Dolan - Roth Capital Partners, LLC, Research Division

So I wanted to just go into the genesis of the agreement. You've trained now, Tom, I think, probably close to 45,000 GPs life to date, so to speak, in the U.S. And I think you mentioned there's 80,000 that you still want to touch. So maybe first, what percent of the market do you feel like you can target directly? Or do you feel there was maybe some type of ceiling you were bumping up against that led to this deal? And then the second part is, if an account starts to really use this Realine, what's the process for an Invisalign rep to then approach that account and try to take that customer to the next level?

Thomas M. Prescott

I'll take -- those are 2 different but somewhat related questions. Starting with the first one, we don't have any lack of headroom here. This -- we've trained 40. I'd say we lost 15 over the last 10 years for a variety of reasons, including lack of our ability to be ready for prime time, if I go back to the early years. We, in a given year, do business with over 20,000 GPs today. And we have, I'll call, moderate volume of new doctor training going forward. There are 140,000 GPs. There's 100,000 left just in North America, active GPs, and we think there continues to be a great opportunity to get at half or more of those over the next 5 to 7 to 10 years. So there's no kind of lack of headroom that's driving this. On the contrary, it's -- really, it's strategically valuable for us to build here. We see growth coming from maybe a "less than superb quality" dental lab-based products. As I said in my notes, there is a bit of a proliferation. If you go to all the trade shows, you'll see more and more dental labs offering clear aligner products that are not informed by the kind of science and precision and control that we bring. And so kind of at the same price point, we'll have a good solution there. And then the rest of it kind of relates to your second question, that is, if a customer gets going and they're doing a dozen or 2 dozen a year of these just through a local lab, and it's been so-so for a patient experience, they can do dramatically better. And if they want to learn a bit more about clear aligner therapy and do something more than just the simplest of cases, the Schein -- through the Schein representative, not an Align person making the call, here you have someone who's got some experience now doing clear aligner therapy that's kind of opted-in, through the Schein team, they can actually sign up for Clear Essentials I, which is our first-step course for GPs. And from that point on, after they get trained, then they become an Invisalign account, they're no longer a Schein account, and they would -- an Align rep would service them. And we spend a lot of time in that with Schein to make sure the right incentives were in place for everybody to where those customers wanted to evolve and grow and opted in. It's a great way for us to understand that you have a motivated customer that wants to learn more about clear aligner treatment. So we think this system works. We got a lot of work to do to make it happen. We're just step one. But the Schein team is going to get it in their hands, and we're formally going to launch this over the next month. And then we're going to learn and grow and see where we are.

Matthew Dolan - Roth Capital Partners, LLC, Research Division

Okay. And then secondly, I know you don't want to get into the details of the agreement, but you did give up exclusivity. You said there's no material impact this year. So I guess what I'd like to know is, why is there no impact? And in conjunction with that, are there any minimum requirements that are layered into the deal over time?

Thomas M. Prescott

Matt, the good news, bad news is we're big enough now that, while this is going to be a nice contributor over time, my lawyers tell me it's not material. So I think this is, we think, good strategically, good tactically. It will be a contributor over time. It's not material because there's no big upfront investment by us. All the development and investments have been made in the -- certainly in all the periods we've gone through. This is part of our upstream product development and offerings development cycle. And so going forward, now we'll just go execute on it. And if it's really successful, then maybe we'll have to talk about it as material. That would be a good problem to have.

Matthew Dolan - Roth Capital Partners, LLC, Research Division

And minimums?

Thomas M. Prescott

We don't intend to talk about that at this point.

Operator

Our next question comes from the line of Jon Block with Stifel, Nicolaus.

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

Sorry if you addressed any of this stuff, I was jumping a little bit on and off the call. But the first one, you mentioned not a material impact to your '13 guidance -- or your '13 numbers, but we don't know your '13 numbers and you don't give '13 guidance. So I guess the first one is, start-up costs associated with the deal, Tom, are any of those start-up costs that could impact your ability to reach that 25% op margin goal that you did put out there by the fourth quarter of 2013?

Thomas M. Prescott

We don't give full year guidance. We gave a framework early in the year to think about it with. As we've said, our goal was, on a non-GAAP operating basis, to be approaching that -- the low end of our long-term model. With that said, the reason why there's no material kind of upfront cost is the development and the activity and putting all this in place has been going on for quarters and quarters and we've now got it ready to go, and it's the right time. And Schein is in the middle of having their annual kickoff meeting, and we're in the middle of that shortly. So there's really no kind of OpEx hit to get this started. And so it's just -- it's one more kind of combination of product and offerings and go-to-market innovation that we've had in the pipe that we're now ready to talk about and, we believe, over time will be a nice contributor.

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

Okay. So you're standing by -- any previous comments around your op margin exiting 4Q, you're standing by, correct?

Thomas M. Prescott

I won't change or confirm any of those, but it's a comment we've made multiple times about our intentions by yearend to approach that low end of that number on a non-GAAP operating basis.

Jonathan Demchick - Morgan Stanley, Research Division

Okay, okay. And then let's just shift gears a little bit. I guess, sort of a "why now" question. And I ask that because, going into this year, you expanded the North American sales force, you beefed up the rep count a little bit. You've been doing what seemed like, on the surface, an effective job picking up Express 5. I mean, just look at the growth rates. So that's seem pretty impressive. So why now, Tom, especially in light of, again, the increased rep count going into '13?

Thomas M. Prescott

The two are very much related in some ways, Jon. If we're really successful at this -- and I think Schein used the term "graduate." If doctors graduate and want to be that interested and committed and sign up, it won't happen overnight, but we wanted to make sure we had some more reps able to service that -- those interested new doctors coming in, along with others that we trained for CE1. In addition, these are fundamentally different channels, and these are not Invisalign doctors that will be taking any time or effort from our sales team. This is -- there -- we're out there chasing a whole bunch of interested customers, helping them elevate their practice. So totally different effort. And I -- our view is that those investments in coverage, the evolution in product and the improvements in consumer will all start to pay off in our primary demand. That -- part of that comes together also on this side with a dramatically better product offering than what the labs can put up there in a very simple way with customers that haven't wanted the hassle of doing more than those simplest cases. So they're related in some way, but they're very different channels. And the final part of your question was, why now? The answer is it's the kickoff meeting for Schein when they put a big focus on their product push for the next year forward, and we've slided into that cycle. It was time to roll it out for them and to talk about it publicly, knowing that's been there.

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

Okay. And last one is just a housekeeping, and I'll follow up with you guys offline. But we all saw the sensitivity around numbers when you purchased Cadent in how you reported the numbers. Can you tell us how you're going to break out these numbers in your Q going forward or in your press releases going forward?

Thomas M. Prescott

We'll figure that out as we go. I'd love to have it become a big standalone problem quickly, but I think what we've said multiple times is we expect a mix shift towards value-based offerings to do a couple of things: one, provide incremental growth and operating margins, contribution margins, equivalent to, in some cases better than, our current core business; and secondly -- and without cannibalizing. And then secondly, in this case, there's really no outlay upfront, so we don't expect any catches [ph]. There's no integration cost. There's nothing else going on. It's simply initiating a go-to-market strategy which we expect to start slowly but build. And we're both invested, Schein and Align Technology, to ensure this works very well for their customers and the patients they represent. So -- and over time, if we wind up having these 5-stage, 10-stage offerings be a much bigger part, well, we're going to be happy to talk about that.

Operator

There are no further questions at this time. I would like to turn the floor back over to management for closing comments.

Shirley Stacy

Thank you, everyone, for joining us today. This concludes our conference call. We look forward to seeing you at upcoming financial conferences and industry meetings. If you have any follow-up questions, please contact investor relations. Have a great day.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.

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