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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2016 - Q3
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Executives

Shirley Stacy - Align Technology, Inc. Joseph M. Hogan - Align Technology, Inc. David L. White - Align Technology, Inc..

Analysts

Steven J. Valiquette - Merrill Lynch, Pierce, Fenner & Smith, Inc. Brandon Couillard - Jefferies LLC Jonathan Block - Stifel, Nicolaus & Co., Inc. John C. Kreger - William Blair & Co. LLC Richard Newitter - Leerink Partners LLC Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker) Robert Patrick Jones - Goldman Sachs & Co..

Operator

Greetings, and welcome to the Align Technology, Inc. Third Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms.

Shirley Stacy, VP, Corporate and Investor Communications. Thank you, Ms. Stacy. You may begin..

Shirley Stacy - Align Technology, Inc.

Good afternoon and thank you for joining us. I'm Shirley Stacy, Vice President of Corporate Communications and Investor Relations. Joining me from today's conference call is Joe Hogan, President and CEO; David White, CFO; and John Morici, incoming CFO.

We issued third quarter 2016 financial results today via Marketwired, which 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 12 months. A telephone replay will be available today by approximately 5:30 p.m. Eastern Time through 5:30 p.m.

Eastern Time on November 21. To access the telephone replay, domestic callers should dial 877-660-6853 with conference number 13646649 followed by pound. 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 statements about Align's future events, product outlooks and the expected financial results for the fourth quarter of 2016.

These forward-looking statements are only predictions and involve risks and uncertainties that are set forth in more detail in our most recent periodic reports filed with the Securities and Exchange Commission. Actual results may vary significantly and Align expressly assumes no obligation to update any forward-looking statements.

We have posted historical financial statements, including the corresponding reconciliations and our third quarter conference call slides on our website under Quarterly Results. Please refer to these files for more detailed information. With that, I'll turn the call over to Align Technology's President and CEO, Joe Hogan.

Joe?.

Joseph M. Hogan - Align Technology, Inc.

a great smile as a result of Invisalign treatment. The Invisalign brand was a primary event sponsor and created an Invisalign lounge experience to showcase the power of a confident smile through Invisalign patient testimonials, iTero scans and consults with New York City area orthodontists.

In EMEA, our consumer outreach focused primarily on our #4millionsmiles campaign and the launch of the patient experience program in the U.K. market.

This program is aimed at helping Invisalign providers create an excellent patient experience and includes learning modules aimed at practice staff to help them discuss Invisalign treatment with prospective new patients.

In Asia-Pacific, our consumer marketing campaigns are focused on demand generation in key markets including China, Australia, New Zealand, Hong Kong and Japan. In China, for example, our big bang consumer outreach program has focused on consumer engagement through Invisalign providers and social media KOLs, or key opinion leaders.

This campaign delivered a 380% year-over-year increase in consumer web traffic and is on track to deliver 150,000 lead generations behind this campaign. We'll also continue to see traction in our Australia Teen campaign.

In Q3, our Scanner business revenues were up 35% sequentially and up 274% year-over-year, reflecting a record number of units shipped in the quarter, primarily in North America. Demand for the iTero Element scanner has stabilized.

At the recent ADA meeting in Denver, we announced new software upgrades for our market-leading iTero Element Intraoral Scanner and Invisalign Outcome Simulator.

Only iTero scanners provide an optimized Invisalign scanning and treatment experience that includes the enhanced Invisalign Outcome Simulator 4.0 application, now with Invisalign 3D Progress Tracking and Patient Simulation Sharing.

The 3D Progress Tracking feature gives Invisalign providers the ability to compare a patient's new scan with a specific stage of ClinCheck treatment planned to visually assess and communicate Invisalign treatment progress with an easy-to-read color-coded tooth movement report that allows the doctors to know how each tooth is tracking.

Use of the iTero scanners for Invisalign case submissions in place of PVS impressions continues to expand. The Q3 total Invisalign cases submitted with a digital scanner worldwide increased 39.6%, which reflects a record 48.4% from North America and 22% from international doctors.

While these scans are predominantly from our own iTero scanner, we're also seeing some uptake from 3M's True Def and Sirona's Omnicam scanners.

We also completed the final validation process for 3Shape's TRIOS scanner, TRIOS Standard, TRIOS Color and TRIOS 3, in which Invisalign providers with a TRIOS scanner can now submit digital scans as part of the Invisalign case submissions.

Now, I'll turn to the supply agreement we announced in July with SmileDirectClub for the emerging doctor-directed, at-home aligner market.

Our agreement with SmileDirectClub is to manufacture non-Invisalign aligners for simple cases, which include up to 20 sets of aligners with no IPR attachments and are produced with an off-the-shelf polymer material. On October 15, we began accepting cases from SDC and subsequently started manufacturing aligners.

We also recently implemented the Invisalign referral process for sending patients whose case falls outside the scope of the agreed upon SDC protocols to Invisalign providers and began scheduling Invisalign consultation appointments.

While this is still early, we are pleased with our initial progress and remain excited about the untapped opportunity to help provide access to treatment for consumers who wouldn't otherwise seek orthodontic treatment. With that, I'll now turn the call over to David..

David L. White - Align Technology, Inc.

Invisalign case volume is anticipated to be in the range of 182,500 cases to 184,500 cases, up approximately 15% over the same period a year ago, reflecting continued strong growth from international but muted by the factors just described.

We expect Q4 net revenues to be in the range of $289.2 million to $293.9 million, an increase of 27.6% year-over-year and well above our long-term target of 15% to 25%.

We expect Q4 gross margin to be in the range of 74.7% to 75.1%, essentially flat sequentially, primarily due to an increased mix of Scanner business and lower margins and slightly lower Clear Aligner ASPs.

We expect Q4 operating expenses to be in the range of $149.6 million to $150.6 million, up quarter over quarter primarily due to increased head count, offset by seasonally less advertising and lower ERP post go-live support cost. Q4 operating margin should increase sequentially and be in the range of 23.0% to 23.9%.

Our effective tax rate should be approximately 22%. We estimate the Q4 impact of the SmileDirectClub transaction will reduce diluted EPS by less than $0.01 per share. And diluted shares outstanding should be approximately 81.5 million shares exclusive of any share repurchases.

Taken together, we expect our Q4 diluted EPS to be in a range of $0.64 to $0.67. Before I turn the call back over to Joe, I want to say a few things about my decision to retire and spend more time with my family. This is something my wife, Nikki (27:20) and I have thought about and planned for some time and communicated to Joe.

This timing has afforded Joe and the board time to find a replacement for me before I step down. I want to thank many of you who I've worked with and come to know well over the past few years.

It has been a pleasure working for such a great company, and I feel honored to have been a part of history in the making as we transform and modernize the orthodontic industry. But it's not time to say good-bye just yet.

Although John will start this week and I will hand over formal CFO responsibilities immediately, I will work closely with him in the coming months, and you will see us together at upcoming financial conferences and industry meetings. Until then, let's turn the time to Joe for his closing comments and then open the call up for your questions..

Joseph M. Hogan - Align Technology, Inc.

Thanks, David. Overall, I'm pleased with our Q3 results, especially the continued strength from our EMEA and APAC region. Notwithstanding weaker-than-expected North America case receipts in Q3, our business remains solid and on track.

Based on the high end of our Q4 guidance, the implied full-year results will be significantly higher than our original outlook provided in January with 28% revenue growth, 20% Clear Aligner volume growth, and 23% operating margins. We have a huge opportunity in front of us to replace wires and brackets and transform the orthodontic market.

As we continue to execute on our strategic plans, I'm confident in our ability to outpace the market and achieve revenue growth for 2016 and beyond at the upper end of our target of 15% to 25%. Looking forward to following up with many of you in the coming weeks at various conferences and industry meeting. I'll now open the call to your questions.

Operator?.

Operator

At this time, we will be conducting a question-and-answer session. Our first question comes from the line of Steve Beuchaw of Morgan Stanley. Please proceed with your question..

Unknown Speaker

Yeah, hi. This is Jack (29:33) on for Steve. Just a question looking at the trends in the business. Clearly, the Scanner business is doing very well. The Aligner franchise not going quite as strongly as we thought into 4Q, obviously with some of the weakness in North America.

But I'm wondering if there's anything going on with the sales force and if there's a bandwidth issue at all there with Scanners drawing so much attention? Thanks..

Joseph M. Hogan - Align Technology, Inc.

Hey, Jack (29:59), it's Joe. I'd say the definitive answer to your question is absolutely not. We obviously watch that closely to make sure that we primarily focus on where the focus needs to be by sales rep. And I'd also just take a difference with your initial comment as I think the overall Aligner market continues to be strong.

We had little bit of a speed bump in third quarter from an order standpoint. It's mainly GPs, low-submitting GPs that we've talked about before. But overall, in the forecast that we've given you for fourth quarter and fortunately given the timing of the call today, we get a good clear October look.

We're very confident to be on the upper-end of our 15% to 25% revenue growth that we've been indicating over the last 18 months or so..

Unknown Speaker

Okay. That's good. And just on the one-week aligner policy that you introduced about a month ago, just curious what doctor uptake has been like so far, and how quickly you might expect that to start to become the norm? And I'll hop back in the queue. Thanks..

Joseph M. Hogan - Align Technology, Inc.

Well, as we mentioned in the release, many doctors were already experimenting or were actually utilizing one-week wear, not just in North America but all over the world. So many are just continuing with what they were doing. Overall, we've had a very positive response. Again, we leave this in the doctor's hands.

There are some cases, we don't think majority of the cases at all they might have to move to two weeks at some point in time, but we feel by far the majority of our cases could go with one-week wear with a lot of confidence in the teens market also in the sense that their dentition being looser and being able to move more quickly.

So we're not predicting an immediate surge in orders based on one-week wear, but we think it's just another aspect of our go-to-market that makes Invisalign very enticing for patients versus wire and brackets.

Okay, Jack (31:53)?.

Unknown Speaker

Thank you..

Joseph M. Hogan - Align Technology, Inc.

Yeah. Thank you..

Unknown Speaker

Yes. Thanks..

Operator

Our next question comes from the line of Steven Valiquette of Bank of America Merrill Lynch. Please proceed with your question..

Steven J. Valiquette - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Yeah, thanks. Good afternoon, everybody. Congrats on these strong results..

Joseph M. Hogan - Align Technology, Inc.

Hey, Steve..

Steven J. Valiquette - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Hey, so I guess just for us, you had a comment about the Q4 shipments growth rate and you're reflecting the backlog beginning to return to normal levels.

Just curious to make sure that that should work itself through in the fourth quarter such that if the strong volume you saw in October carries over into early next year that we should mechanically then obviously see some improvement in the year-over-year growth as we go into early 2017.

Is that the right way to think about that?.

Joseph M. Hogan - Align Technology, Inc.

Steve, just to back up on it. Yeah, we expect that to stabilize in the fourth quarter. That's why we called the shipment rates that we've been calling for you too. If I interpreted the second part of your question is as we move into 2017, should we be on a stronger footing in the sense of a backlog, that's our plan..

Steven J. Valiquette - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Okay. So the backlog will not extend beyond one quarter, basically? That's what I was trying to clarify. So sorry for the poor wording the first time around, so..

Joseph M. Hogan - Align Technology, Inc.

Correct, Steve. It will naturally return to its nominal levels this quarter as our case volumes recover – case receipt volumes recover and as we're seeing early in the quarter so far..

Steven J. Valiquette - Merrill Lynch, Pierce, Fenner & Smith, Inc.

Okay, got it. Okay. All right. Great. Thanks..

Joseph M. Hogan - Align Technology, Inc.

Thanks, Steve..

Operator

Our next question comes from the line of Brandon Couillard of Jefferies. Please proceed with your question..

Brandon Couillard - Jefferies LLC

Thanks. Good afternoon. Joe or David, as we think about the economic sensitivity of the Clear Aligner business, to what extent do you think we've seen any of that bleed over into the ortho channel? And not wanting to really split hairs here, but the EMEA growth slowed a little bit sequentially.

To what extent, if at all, have you seen any I guess economic effects there in the core Western Europe market, if at all?.

Joseph M. Hogan - Align Technology, Inc.

I'll let David join in on this too. I wouldn't call these any macroeconomic effects as far as what we're seeing right now. Your comment about bleeding over into ortho, we had record utilization rates in ortho, up significantly. I think it's 9.9% to 11.1% in the quarter. So it shows terrific continued growth in ortho utilization with our product line.

So we feel broadly this is a GP blip. This has been talked about in the marketplace in the third quarter that we saw in North America across the board, not just with Invisalign but with the dental market in general.

But, again, our October order rates indicate that we're on track with the kind of growth we experienced in the second quarter of this year. And we think that will continue to – go ahead..

David L. White - Align Technology, Inc.

Yeah, Brandon, just to add a little color to that.

When we look at our GP doctors by segment in terms of the case volume that they do, the doctors that are fully engaged with Invisalign have incorporated into their practices are typically less susceptible to softness in the market because their practice have been built really around – Invisalign has become such an integral part of their practice that they typically are on the offense in terms of business development.

It's really more the lower-tier doctors that are still quite dabbling in Invisalign, haven't quite changed their practice flows and so forth. And so when we see an overall softening in the market, it tends to be those doctors that tend to be the first to pull back.

And when we look at the Q3, that's precisely where we saw it, really those doctors that are at the lower volume levels..

Brandon Couillard - Jefferies LLC

Then one more for you, David.

Through the operating cash flow and the DSO build in the period, why would it necessarily take several quarters for that to normalize?.

David L. White - Align Technology, Inc.

Well, I hope it won't. We had a very successful implementation in July. We did have some delays in invoicing a few customers, and we're working through those right now and expect to have those worked out. When we sell to 30,000-plus customers at a time, it doesn't take very many to influence that DSO.

And one of the things with most customers is when a sales tax rate or a VAT rate is incorrect, you typically wind up having to rebill the customer at the correct VAT rate or sales tax rate and then the clock starts all over again.

And so we're generally up against that issue right there and we think over the next couple quarters it will be behind us..

Brandon Couillard - Jefferies LLC

Sure, thanks..

Operator

Our next question comes from the line of Jon Block of Stifel. Please proceed with your question..

Jonathan Block - Stifel, Nicolaus & Co., Inc.

Great. Thanks, guys. Good afternoon. Two questions. The first one's got two parts, just one for Joe and David. So just to begin SDC, Joe, maybe if you can tell us what has been the Invisalign provider reaction to date? Anything surprised you on either the positive or negative side? And the second part of that question is for David.

Anything on the 4Q 2016 revenue guidance on SDC? Since I believe, as you mentioned, they'll be shipping cases for the vast majority of the quarter. And then I've just got a quick follow up. Thanks..

Joseph M. Hogan - Align Technology, Inc.

Hey, Jon, it's Joe. Look, I think honestly the provider reaction to this was anticipated. I think you picked it up in your analysis, too, with the 100 orthodontists or so that you do. Many orthodontists aren't happy with this. Many of them understand why we did it.

I think they feel good about it not being Invisalign, that it's GX30 (37:52) and it's a lip roll kind of a system and not a gingiva cut. That it's just really a complete offtake of what the product that they were using before. Jon, so I think overall I haven't been surprised with the reaction.

We haven't seen a response in the market that would be negative in some way. We're sitting here at the Ortho Summit, so we'll get on the ground feel here this week. But I would say overall good, because I think frankly there's an understanding in the marketplace of what we did and how we did this.

That doesn't mean there's not a lot of passion about a doctor-directed kind of virtual model that exists out there. But we feel the response has been in line with what we had anticipated..

David L. White - Align Technology, Inc.

one, which has to do with a renormalization of our backlog, if you call it that, coming off of Q3, a weaker case receipts; and then secondly, when you look at a year ago, Q4 of 2015, that quarter was up 25% year-over-year and up 9% quarter-over-quarter. And so it was just a rock-solid quarter for us.

And so I think when you look at the compare quarter-over-quarter, I think you're seeing a comp there that's also having some bearing on it..

Jonathan Block - Stifel, Nicolaus & Co., Inc.

Okay. I'll follow up with you offline on that one, David. I guess I'm just wondering if you're recognizing revenue from shipping out the aligners, but I'll follow up with you offline on that one. The other one – just hate to burn one on Cadent, but I do think it's important.

Just for 2017, Joe, how do we think about the scanner? And I'm just asking because it's a very different business than Invisalign, it's capital and you're coming off a big upgrade with Element. So just when we look at 2017, up, down, flat, specific to the Cadent business? Thanks, guys..

Joseph M. Hogan - Align Technology, Inc.

2017, Jon, just to be clear, up. I'm not going to give you a percentage, but it will be up. I think you can see with our announcement with our simulator product and things that we're putting together, this scanner's really important for us in the sense of how we go to market with the orthos but particularly with GPs also.

So think about that Scanner business as going up. Don't think of the margin being as dilutive as what we had talked about before as you put that in the model. Just think of it being almost equal to Invisalign in that sense.

I'm going to let David backtrack here on the SDC fourth quarter piece and next year so we can just clear that up now with you, Jon.

Okay?.

David L. White - Align Technology, Inc.

Yeah. So back to that question, Jon, on SDC, very minimal revenue in our outlook this quarter for SDC. We really just got off, started in the middle of October. We're taking this very slowly as we integrate into their practice. So really a minimal consideration in the revenue guidance we gave for Q4. Very small.

Going back to the Scanner, I just want to highlight one other thing about our Scanner business. There's two components to that business, one of which has to do with the sale of the hardware itself, the equipment, but then secondly the ongoing revenue that we recognize associated with maintenance and subscriptions and so forth.

That revenue grows in proportion to our installed base, and as you've seen this year, our Scanner growth rate from a unit standpoint is quite significant. So the installed base is building actually quite nicely. And so that's going to form a nice foundation I think for the Scanner business going into 2017..

Jonathan Block - Stifel, Nicolaus & Co., Inc.

Great. Thank you guys..

Joseph M. Hogan - Align Technology, Inc.

All right, Jon..

Operator

Our next question comes from the line of John Kreger of William Blair. Please proceed with your question..

John C. Kreger - William Blair & Co. LLC

Hi. Thanks very much. Joe, maybe following up on Jon's question, any other 2017 comments that you'd care to give us? You are certainly coming up against some very tough comps in terms of the Invisalign unit growth. Thanks..

Joseph M. Hogan - Align Technology, Inc.

John, I prefer not to give any more 2017 comments, but I think you can tell from my comments we're optimistic about 2017. We'll leave this year I mean obviously above guidance of what we gave you in 2016. Our international growth has been tremendous. Our ortho utilization numbers are good.

Coming up next year we have several programs with GP in North America that we think will address some of the weakness that we've experienced. Invisalign Go that we've put in place is a big one, some of our key opinion leaders and how they go about the GP market right now has really been incredibly successful.

Our TFM model that we're employing here in the United States not just in the ortho channel but the GP channel also, also gives us confidence that we can maintain that kind of momentum. But outside of that, I don't care to talk about any numbers and specifics, John..

John C. Kreger - William Blair & Co. LLC

Okay. Great. And then just one other follow-up in terms of your comments about the slower incoming case receipts. When did you start to see that? We've heard other dental providers talking about slowdowns as early as June.

Was that strictly in September? Or did you see it start earlier in the summer?.

David L. White - Align Technology, Inc.

So, John, it really began showing itself up in early July, and at the time when we were seeing it, we were thinking it just might be early seasonality. Even though we know that Q3 is a seasonally weaker quarter for GPs, a seasonally stronger quarter for ortho, particularly Teens, weaker seasonally EMEA, et cetera, that seasonality tends to move.

And so sometimes it'll show up earlier or later. So in early July, we thought it was more just simply an earlier seasonality, and what wound up happening was it wound up being more seasonally weak, you might say, across almost the entire quarter..

John C. Kreger - William Blair & Co. LLC

Great. Thanks..

Joseph M. Hogan - Align Technology, Inc.

Thanks, John..

Operator

Our next question comes from the line of Richard Newitter of Leerink Partners. Please proceed with your question..

Richard Newitter - Leerink Partners LLC

Hi. Thank you for taking the questions. Joe, just maybe one more kind of on the go-forward view, without maybe giving specific additional guidance on 2017.

Can you give us a little more color or at least some of the things we should be thinking about as we refine our models for 2017, what puts and takes should we be considering on the cost side, whether it's mix shift, just things to bear in mind as you anniversary the ERP? Can you walk us through some of the things just to think about there?.

Joseph M. Hogan - Align Technology, Inc.

No, not really. Richard, we appreciate you wanting to fill out your spreadsheet for next year. We're trying to give you as broad a guidance and positive guidance as we can. But to really start to nail those specifics wouldn't be in line with the kind of information we normally devolve..

David L. White - Align Technology, Inc.

Yeah. When we get to the January earnings call for reporting year-end results we'll be glad to throw some meat on the bones, so to speak, to kind of describe our outlook into the year. But suffice it to say at this point, I think Joe's comments earlier about revenue growth and so forth and our long-term range, et cetera should suffice..

Richard Newitter - Leerink Partners LLC

Got it. And then maybe just – you put out there a confidence level to get to the kind of the upper part of your long-term range of 15% to 25%. Is that really just kind of the GP initiatives? Obviously some of the backlog normalizes, works itself out, but you are up against tougher comps this year.

Should we just be thinking about that as really as these initiatives around kind of the GP segment? And then kind of marketing and new direct-to-consumer and Teen that are really kind of what give you the confidence there? Or is there something else? Thanks..

Joseph M. Hogan - Align Technology, Inc.

Well, I mean, we didn't have easy comps this year when you look at – we had easy comps on 2015 versus 2014. But this year we had a, Richard, pretty difficult comp even what David just referenced in the fourth quarter last year what a tough time we had.

So look, I think when we talk about or when I talk about the GP focus that we're going to have, the international growth focus on teens next year, all those things are just to focus in areas where we develop products and systems over the course of last 18 months that go after those areas that historically have been some soft areas for us that maybe more unpredictable than they should have been.

The rest of this business, the international parts, the ortho utilization piece, those things are going really well.

Did we lose you? Richard, are you there?.

Richard Newitter - Leerink Partners LLC

Sorry, I was on mute. Yeah. No. Thanks. That's really helpful. And just maybe one last one. The difference between – what is GP Go do for you that kind of prior initiatives haven't in the past? Maybe just elaborate on that a little bit. Thank you..

Joseph M. Hogan - Align Technology, Inc.

Richard, basically GPs don't want to be orthos. They haven't been trained in tooth movements and when you look at products like we have, like ClinCheck and our full case assessments and those things, they are, as much as we want to make them, they are very sophisticated products. It's almost like using 90% of PowerPoint, which most people can't.

And so with GPs what we have to do is build their confidence in the sense that they can look at a case and quickly say, I can do this case and I can do it well for my patient or I can't, and just in a short kind of a statement that's what Invisalign Go is.

You can scan that patient or take a photo of that patient, we'll quickly assess that, we'll tell that particular GP if they can actually handle that case. If they can, we can quickly work up a case assessment and give it to the customer while they're in the chair.

It's a substantial difference than trying to in two days teach an ortho, I mean, a GP how to do ortho work, which is very difficult. We feel we can really integrate into a GP practice much more simply by making less complexity in a sense the way we do case assessments and the burden it would place on a GP to take that kind of burden.

I hope that makes sense..

Richard Newitter - Leerink Partners LLC

It does. Thank you..

Operator

Our next question comes from the line of Jeff Johnson of Robert W. Baird. Please proceed with your question..

Joseph M. Hogan - Align Technology, Inc.

Hi, Jeff..

Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker)

Good afternoon. Hey, Joe. How are you guys? Let me start just by saying, David, best of luck in retirement. It's been great working with you for the last three years or so. So best of luck going forward..

David L. White - Align Technology, Inc.

Yeah. Thank you, Jeff. Appreciate that..

Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker)

Great. So, Joe, let me ask a couple of questions here. I mean, again, kind of like John I hate to burn a question on the Scanner business but it's been so strong here. You mentioned kind of that being up next year.

If I look at your second half numbers here what's kind of implied in fourth quarter guidance and the third quarter strong result, it looks like you're up 50-some percent sequentially even first half to second half of this year.

So not to pin you in a corner but kind of up year-over-year based off the 2016 base? Or do we keep seeing growth even off these low-$30 million numbers which are just well above what I think any of us were probably thinking they would be at this point?.

David L. White - Align Technology, Inc.

I mean, growth over the 2016 base, Jeff..

Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker)

2016 base. Yes. No. That's helpful and then, David, maybe a clarifying question on the margin side. You made comments in your prepared remarks about margins. I think you said gross margin is down a little bit year-over-year, next quarter, and you said that aligner ASP is down. You kind of made reference to some bigger promotions here in this quarter.

I guess, I'm trying to figure out why aligner ASPs would be down in the fourth quarter if you've anniversaried through the additional aligner thing. Now you've got price increases.

You also have the positive mix if the backlog on North America is a little lower than the OUS backlog I would think – or the OUS growth I would think would be helping ASPs next quarter, so just trying to reconcile margins being down next quarter – gross margins..

David L. White - Align Technology, Inc.

Okay. So, for a couple of things, one, as it relates to Clear Aligner, our – well, more about ASPs, which will impact that. ASPs are affected by product mix, and our low stage products are very heavily concentrated or more so concentrated, you might say, from a mix standpoint in our EMEA region than the rest of our business.

And so since Q3 was a seasonally weaker quarter for EMEA and Q4 is seasonally stronger, that mix of low stage product is going enter into the equation and is going to influence the ASPs this next year, it will go up. That mix is going to go up by 1 plus points quarter-over-quarter and that will have some bearing on it.

And then secondly, you've got doctors – this is the end of the advantage period for many of our doctors, and so as those doctors begin to get close to or approximate the next tier of their pricing, they'll begin to see lower prices, even this year early as they're running towards that December 31 date.

So those two things right there are bringing down the ASP and bringing down very, very modestly the gross margin at the same time..

Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker)

All right. That's helpful. And Joe, last question from me, I just want to make sure I understand clearly your comment on being in the upper half of that 15% to 25% range.

I think you were talking Clear Aligners and you were saying get back to that by first quarter of 2017? Or is that just kind of a general comment getting back to that over the next few quarters?.

Joseph M. Hogan - Align Technology, Inc.

Well, from an order rate standpoint, Jeff, we feel we'll be in that range in the fourth quarter. So as we move into the first quarter of next year, we feel that way and that is why I'm quoting, as you mentioned, Clear Aligners. This is not mixing Clear Aligners with the Scanner business..

Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker)

Yeah. That's helpful. Thanks guys appreciate it..

Joseph M. Hogan - Align Technology, Inc.

All right, Jeff. See you..

Shirley Stacy - Align Technology, Inc.

Operator, we'll take one more question, please?.

Operator

Our final question comes from the line of Robert Jones of Goldman Sachs. Please proceed with your question, Mr. Jones..

Robert Patrick Jones - Goldman Sachs & Co.

Thanks for the questions, and David, yeah, congratulations on the retirement. John, look forward to working with you. I guess, Joe, just wanted to go back to something you had said about what you're seeing in case receipts quarter-to-date? Wanted to make sure I heard you correctly.

It sounded like you're saying based on what you're seeing to-date you do expect to return to the type of growth, case growth that is, that we saw in 2Q as we move into next year? Wanted to be clear that, A, I heard you correctly.

And B, are you talking specifically about North American GPs? Or was that a reference to overall North American expectation for case growth?.

Joseph M. Hogan - Align Technology, Inc.

The 20% that we're talking about is overall for the Clear Aligner business, is what we see right now in October for the entire business. We're seeing better North America performance than what we saw in the third quarter. I haven't specifically referenced if that was GP or ortho..

David L. White - Align Technology, Inc.

And better than Q2 as well..

Joseph M. Hogan - Align Technology, Inc.

Yeah. Better than Q2..

Robert Patrick Jones - Goldman Sachs & Co.

Better than Q2. Okay. Got it. And then I guess just on the international side, it does look like the 4Q guidance for international cases seems to imply a bit of a slowdown there on a year-over-year basis.

Just wanted to see if you could comment on some of the factors at play, do you feel like you're reaching any kind of capacity constraints? Anything else as far as, how quickly you can go after that big international opportunity?.

David L. White - Align Technology, Inc.

So Bob, our factory basically fabricates aligners on a first-in first-out basis and without really much respect for where those aligners come from. And so when we talk about our case receipts increasing this quarter and our backlog and factory WIP returning to a more normalized level, that cuts across all regions of our business.

And so whatever dampening effect it has, it is across all regions. So that's part of the reason..

Robert Patrick Jones - Goldman Sachs & Co.

Okay..

David L. White - Align Technology, Inc.

On the case receipt side though, international is very strong and it continues to be strong. Nothing's really changed there on the case receipt side..

Robert Patrick Jones - Goldman Sachs & Co.

Okay. That's helpful. Thanks guys..

Joseph M. Hogan - Align Technology, Inc.

Thank you Bob..

Shirley Stacy - Align Technology, Inc.

Thanks Bob..

Operator

There are no further questions over the audio portion of the conference. I would now like to turn the conference back over to management for closing remarks..

Shirley Stacy - Align Technology, Inc.

Thank you, operator, and thank you everyone for joining us today. We appreciate your time. If you have any follow-up questions, please contact Investor Relations..

Operator

This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful rest of your day..

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