Earnings Labs

Align Technology, Inc. (ALGN)

Q3 2015 Earnings Call· Thu, Oct 22, 2015

$173.97

-2.48%

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Transcript

Operator

Operator

Greetings and welcome to the Align Technology's Third Quarter 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. I would now like to turn the conference over to your host, Shirley Stacy. Thank you. You may now begin.

Shirley Stacy - Align Technology, Inc.

Management

Good afternoon and thank you for joining us. I'm Shirley Stacy, Vice President of Corporate Communications and Investor Relations. Joining me today is Joe Hogan, President and CEO, and David White, CFO. We issued third quarter 2015 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 October 30. To access the telephone replay, domestic callers should dial 877-660-6853 with conference number 13621393 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 statements about Align's future events, product outlook and the expected financial results for the fourth quarter of 2015. 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've posted a set of GAAP and non-GAAP 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.

Management

Thanks, Shirley. Good afternoon and thanks for joining us. On our call today, I'll provide some financial highlights and then briefly discuss the performance of our two operating segments: Invisalign Clear Aligners and Scanner & Services. David will provide more detail on our financials and discuss our outlook for the fourth quarter. Q3 was another good quarter with revenue and EPS above the high end of our guidance. Our results were driven by strong Invisalign case volume, up 2% sequentially and 23% year-over-year, with growth across all customer channels and geographies. North America volumes grew 18.6% year-over-year, and our international geographies were up 35% compared to last year. This growth was driven by continued momentum in EMEA, in APAC, progress in North America, expansion in our low-stage product segment, and seasonally strong uptick in teenage patients. In North America, Invisalign volume was up both sequentially and year-over-year with the highest year-over-year growth rate for North America in three years. Sequential growth was better than expected, driven by seasonally strong teenage demand in ortho channel, where we had another record quarter for utilization at 9.9 cases per doctor. This is the third consecutive record quarter. On a year-over-year basis, growth was driven by both orthos and GPs, reflecting continued adoption of Invisalign by existing ortho customers and expansion of our GP dentist base. Our investments in sales force effectiveness are producing good results. We're pleased with the progress we see in North America. Customers are responding positively to our new sales structure, and we expect to continue to make incremental investments in go-to-market, clinical education and customer support in this important market. Invisalign volume for international doctors was up sequentially and year-over-year. Our international volume continues to be very strong across all countries in both EMEA and Asia-Pacific, which increased 31.5%…

David L. White - Align Technology, Inc.

Management

Thanks, Joe. Let's review our third quarter financial results. Revenue for the third quarter was $207.6 million, down 0.9% from the prior quarter and up 9.4% from the corresponding quarter a year ago. Third quarter revenues included a non-cash reduction of approximately $7 million related to our new Additional Aligners policy announced last quarter. Third quarter aligner revenue of $198.3 million was down 1.3% sequentially and up 11.3% year-over-year. The sequential revenue decrease was primarily related to our new Additional Aligners policy as just mentioned. Q3 ASPs were down sequentially about $45, which was almost entirely due to higher revenue deferrals from the new Additional Aligners policy. Excluding Additional Aligners, ASPs were otherwise flat quarter-over-quarter. Our year-over-year revenue growth reflected Invisalign case volume growth across all customer channels, partially offset by lower ASPs, primarily related to foreign exchange rates and the higher revenue deferrals just mentioned. For the third quarter, total Invisalign shipments of 147,500 cases were up 2.0% sequentially, reflecting growth from our North American orthodontic and international customers. Year-over-year case volume growth was 23.3%, driven by growth across all regions, with strength in international and continued progress in North America. For North American orthodontists, Q3 Invisalign case volume was up 5.4% sequentially and up 21.4% year-over-year. For North American GP dentists, case volume was down 2.6% sequentially and up 15.3% year-over-year. For international doctors, Invisalign case volume was up 2.9% sequentially and 35.1% year-over-year. Worldwide Invisalign utilization in Q3 was 4.7 cases per doctor, up slightly from 4.4 cases in Q3 last year. North America ortho utilization of 9.9 cases was a new record, increasing from 8.8 cases in the prior year. North America GP utilization was 2.9 cases, was up slightly from 2.8 cases in the prior year. And international doctor utilization of 4.6 cases was up…

Joseph M. Hogan - Align Technology, Inc.

Management

Thanks, David. I'm pleased with our Q3 results, which reflect stable patient traffic in our customers' offices and their confidence in using Invisalign on more patients and on more complex cases. Our goal is to be the best partner by providing great treatment experiences for our doctors and their patients. Overall, we continue to see good momentum across our customers' channels and believe our investments in sales, marketing and R&D are helping to drive growth. Thank you for your time today. I look forward to updating you on our progress. With that, we'll open up the call to your questions. Operator?

Operator

Operator

Thank you. At this time, we'll be conducting a question-and-answer session. Our first question comes from Robert Jones from Goldman Sachs. Nathan A. Rich - Goldman Sachs & Co.: Hi, this is Nathan Rich on for Bob this afternoon. A couple of questions on guidance. First, it looks like guidance implies that ASPs will be up sequentially in the fourth quarter versus the third, if I'm doing that math right. Just wondering if you could give us some more details on your expectations for both North America and international ASPs. I think there are a decent amount of moving pieces just with the revenue recognition change, FX and case mix.

David L. White - Align Technology, Inc.

Management

Hi, Nathan, it's David. Thanks for the question. As it relates to ASPs in the fourth quarter and the outlook as it relates there, too, we are expecting a modest increase in ASPs in Q4, not actually that substantial, primarily due to fewer promotions we run in Q4 versus what we typically do in third quarter. The other piece of it is that we implemented a price increase internationally in July and it takes a while for that price increase to work its way through work-in-process and cases that are in various stages of submission. And so ,we only got a partial benefit of that last quarter. We expect to get full benefit of that this quarter. So, those are the two things factoring from a positive standpoint. There is a little bit of FX headwind, but not very much, but a little bit positive on the ASP. Nathan A. Rich - Goldman Sachs & Co.: Okay, makes sense. And then, if I could just ask on the operating margin guidance as well. It looks like for the fourth quarter you are expecting a pretty big step up in EBIT margins. Just wanted to get your sense of how much visibility you feel like you have here? Is it just a factor of sort of leveraging higher sales volumes? And maybe could you talk about the productivity of the sales people that you've brought on and how you feel about that return on investment?

David L. White - Align Technology, Inc.

Management

So, possibly two questions there. As it relates to operating margin, our Q4 visibility, if you kind of drill down a little bit into it, you'll see that our guidance for gross margin is pretty consistent with our actual results in Q3. And where the uplift really in operating margin in Q4 comes from is the fact that our operating expenses are going down slightly quarter-over-quarter on higher revenue. And so that's the principal driver. I think it's about nine points of the operating margin increase quarter-over-quarter is that factor right there. Nathan A. Rich - Goldman Sachs & Co.: Great. Thank you.

David L. White - Align Technology, Inc.

Management

Okay.

Shirley Stacy - Align Technology, Inc.

Management

Thanks, Nathan. Next question?

Operator

Operator

Our next question comes from Steve Beuchaw from Morgan Stanley. Steve C. Beuchaw - Morgan Stanley & Co. LLC: Hi, guys. Thanks for taking the questions. So I'll ask two, one for Joe, and then, sorry, is Roger on the call as well?

Shirley Stacy - Align Technology, Inc.

Management

Yes. Steve C. Beuchaw - Morgan Stanley & Co. LLC: Okay. So first for Joe. So, Joe, could you take a step back and just talk about the volumes and maybe rank-order what the drivers are? If you take a step back and say we have growth that's materially above 20%, you listed off quite a few items that the company did well during the quarter. But if you had to look at one or two things and say, look, this is really what has sequentially come on and made the business grow faster here in 2015, what would those one or two things be and how do you see those evolving from here?

Joseph M. Hogan - Align Technology, Inc.

Management

I think versus last year is, first of all, you have to look at North America. I mean, it's the strongest comparison that we have year-over-year because they did have a poor 2014 then. And so if you look at, the growth has been there, the orthodontic sector has been terrific for us. You can see we have a penetration rate there that's a record at 9.9. And so that's very significant. We are seeing growth again in the GP area and double-digit growth that we hadn't experienced in North America prior to that in the few previous years. So I think overall that's probably one of the biggest variance I'd say year-to-year. What we had from a continuous standpoint, is you can see the terrific growth we have going on in EMEA right now in Europe and also the continued growth that we have in APAC also, which is very strong. And so, that's continued momentum and it's also on top of some pretty strong numbers from last year. So, I think those four variables I would say, Steve, overall are the big drivers. Steve C. Beuchaw - Morgan Stanley & Co. LLC: You haven't been, I'd, say wildly optimistic about GP. I mean do you think the double-digit growth in GP is sustainable in North America?

Joseph M. Hogan - Align Technology, Inc.

Management

Well, I think there's an aspect of GP that we don't go deep in GP right now, we go wide. So you can see we have about 2.9 or 3 cases per GP unit versus 9.9 cases on ortho. As we add sales people, we know we get more sales in GP. We have to work on and I think what you said, I haven't talked about that a lot, I'm not enthusiastic about it I think what your words were. I am, it's just we have to do better at penetration in that segment and that's what we really have to work on. Steve C. Beuchaw - Morgan Stanley & Co. LLC: Okay. And then just one for Roger, I think, first of all, welcome back to the call, Roger.

Roger E. George - Align Technology, Inc.

Analyst · Morgan Stanley

Thanks, Steve. Steve C. Beuchaw - Morgan Stanley & Co. LLC: I know this is your favorite part of the job. The SmileCareClub litigation was, I guess, a little surprising. How big are they right now? Are they even 2% or 3% of the market? And I guess while we're on the legal topic, I mean, what do you think the timelines could be as it relates to some enforcement around ClearCorrect?

Roger E. George - Align Technology, Inc.

Analyst · Morgan Stanley

Sure. So as far as the market size of SmileCareClub, it's negligible. We don't see them that much out there. As far as timing on ClearCorrect, the case at the ITC was appealed up through the federal courts, most recently at the Federal Circuit Court of Appeals, and oral arguments were held in August. And we expect a written decision from the court sometime in the first quarter of next year. Steve C. Beuchaw - Morgan Stanley & Co. LLC: Great. Thanks so much, everyone.

Shirley Stacy - Align Technology, Inc.

Management

Thanks, Steve. Next question?

Joseph M. Hogan - Align Technology, Inc.

Management

Thanks, Steve.

Operator

Operator

Our next question comes from John Kreger from William Blair. John C. Kreger - William Blair & Co. LLC: Hi. Thanks very much. Joe, just to follow up on the last question about key growth drivers. What's your assessment about the underlying market growth, particularly for orthodontists? Would you characterize it as stable or are you seeing any improvement there?

Joseph M. Hogan - Align Technology, Inc.

Management

You mean from a market overall, John, you mean outside of us or just the market itself? John C. Kreger - William Blair & Co. LLC: Yeah. So in other words, looking at that 23% case growth, how much of that if any do you think is market?

Joseph M. Hogan - Align Technology, Inc.

Management

Well, I think we have a favorable market behind us, John, is the way that I'd answer that question. I mean, we don't have a down market behind us, and that kind of market momentum is really helpful. To tell you how many points of growth that I think have to do with the market itself versus what we're driving from a penetration standpoint, I really don't have that kind of information. And so, I can't give you the specifics like that. But it's beneficial to have a market that's growing behind you.

David L. White - Align Technology, Inc.

Management

And typically, John, as you know, the industry has typically grown in low single-digits. And so nothing substantial has changed in that standpoint. John C. Kreger - William Blair & Co. LLC: Great. Okay. And Joe, as you've had a bit more time to kick the tires, so to speak, around the world can you maybe comment on what your priorities are going to be over the next year?

Joseph M. Hogan - Align Technology, Inc.

Management

Well, I mean priority is obviously growth in profitability overall for the company from a growth standpoint, John, staying on your original question. The international part is a big part of our growth and where you're going to see us continue to invest heavily in that area to drive the growth that we think we can get there. But that doesn't mean we'll negate North America. North America is a big market. There is kind of a lot of a law of large number issue in North America, we report lower percentages. But when you look at case volumes, they could be fairly close together. And so you'll see us continue to invest pretty aggressively from a distribution standpoint in all three regions. John C. Kreger - William Blair & Co. LLC: Okay. Thanks. And then one last one, now that you've had a few months to assess how clients are viewing the new policy about not charging for additional aligner refinements. How is that impacting client behavior if at all, and are there sort of key regions where that has been a bigger driver than others?

Joseph M. Hogan - Align Technology, Inc.

Management

I think you can ask that question two ways, John. Is it a negative driver in the sense we see people trying to maybe take advantage of the policy? And then the other side of it is how comfortable does it make our customer base. We haven't seen any variant that would say that this is being abused in some way. And really I've been personally amazed that a number of comments that I get really all over the world on that change. And there is no question it is exactly the way the team represented us before I got here is that this was the number one biggest attractor that we had in the marketplace regarding our product and our policies. I'll give you an example. We talked about in our script about the Spain program that we had this year and that we just got back from. I had several doctors come up to me and just say, you know, Joe, it really increases my clinical confidence to have this policy changed. And they said because we feel like you have our back, if we run into an issue with something. It's a difficult case in some way, we don't feel like we're stranded. And I never thought that that would be one of the side effects or secondary effects of making that kind of a change. So it's been overwhelmingly received in a very positive way. And I think some of the surveys that I know you guys do and that I read, you can see a lot of the dentists that are surveyed on this will tell you that they feel happy about that and they'll be more aggressive about using Invisalign in the future, and that was the purpose of what we did. John C. Kreger - William Blair & Co. LLC: Great. Thank you.

Joseph M. Hogan - Align Technology, Inc.

Management

Okay, John. Thank you.

Operator

Operator

Thank you. Our next question comes from Richard Newitter from Leerink Partners.

Unknown Speaker

Analyst · Leerink Partners

Hi, good afternoon. This is Robbie actually in for Rich. Thank you for taking the questions. Actually, I had one follow-up on some of the doctor comments that you had made about GP adoption. Just curious in terms of, it sounds like you expect GP year-over-year growth to continue in that double-digit range. In terms of the doctors that you guys trained in the quarter, do you give any breakout in terms of how many of those are GPs versus orthodontics?

David L. White - Align Technology, Inc.

Management

Okay.

Joseph M. Hogan - Align Technology, Inc.

Management

We do have data to tell you how many. I think David will take you through that.

David L. White - Align Technology, Inc.

Management

I think if you look at the website slides, we probably break it out.

Unknown Speaker

Analyst · Leerink Partners

And is that number like new doctors?

Shirley Stacy - Align Technology, Inc.

Management

North America total?

David L. White - Align Technology, Inc.

Management

North America total.

Shirley Stacy - Align Technology, Inc.

Management

Yeah, total.

Unknown Speaker

Analyst · Leerink Partners

Yeah, but that doesn't break down...

Shirley Stacy - Align Technology, Inc.

Management

Most of the doctors we train are GPs, right?

David L. White - Align Technology, Inc.

Management

Yes. Correct.

Shirley Stacy - Align Technology, Inc.

Management

So if you guys recall historically and you can probably look at some of the historical data that we used to provide, but most of the doctors in North America are GPs.

Unknown Speaker

Analyst · Leerink Partners

And is that level increasing historically, or is it still – it's most and that's what we should expect going forward?

Shirley Stacy - Align Technology, Inc.

Management

No, you should expect that going forward most of the doctors we train will be GPs.

David L. White - Align Technology, Inc.

Management

In the North America.

Shirley Stacy - Align Technology, Inc.

Management

Yes, in North America.

Unknown Speaker

Analyst · Leerink Partners

Great, thanks. And then maybe one on litigation. Is there any read-through on this California dismissal with ITC that both you guys have now dismissed that lawsuit against one another to a potential settlement with the ITC litigation?

Joseph M. Hogan - Align Technology, Inc.

Management

Can you repeat that, I didn't hear the first part of that.

Unknown Speaker

Analyst · Leerink Partners

Should we take the dismissal of the litigation in California by both parties as any sort of indication that there could be a settlement or are you just – should we just assume that you're willing to hear the ITC case play out?

Roger E. George - Align Technology, Inc.

Analyst · Leerink Partners

You should not assume there will be a settlement.

Unknown Speaker

Analyst · Leerink Partners

Okay. Great. And then maybe one more on the Scanners business, this came in a little bit lower than we had expected. Any sort of – was that just seasonality or are you seeing any sort of capital challenges in that business there?

David L. White - Align Technology, Inc.

Management

So, (sic) Robbie, on the Scanner business it really has little to do I think with seasonality and everything to do with the cycle we're at in terms of transitioning from our historical Scanner, which we called 2.9, to our new scanner called Element. And we began shipping that product in September and up until that point in time we had been winding down the sale of the older 2.9. So it's more a function of that than anything else.

Unknown Speaker

Analyst · Leerink Partners

Got it. Thank you very much.

Operator

Operator

Thank you. Our next question comes from Jeff Johnson from Robert W. Baird. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Thank you. Good afternoon, guys. Joe, I wanted to start with you maybe, strong fourth quarter guidance on the case shipments. So I think I know the answer to this already. But are you seeing any fade at all in China from a demand standpoint? In the U.S. a little concern that maybe we started to see some consumer softening kind of in the September time period in that. Are you seeing anything in your kind of month-to-month numbers that would worry you, either China or the U.S., at this point?

Joseph M. Hogan - Align Technology, Inc.

Management

The quick answer, Jeff, is no. China continues to be very strong. We had a good, strong September here in North America, too. I understand the basis of your question; I worry about it, too. What's the economic activity going on in those particular areas? But right now I'm not seeing any effect on the business in that sense. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Yeah, that's what your guidance would imply, too, so thanks. And then, David, maybe just a clarifying question for you on the Additional Aligner policy. I'm going back to my notes here, but the guidance you gave for the revenue impact in 2016, the $25 million to $30 million, that's the total revenue drag from that policy in 2016 versus what looks like it's now going to be a $13 million or $14 million drag in 2015. So the incremental drag, if you will, is only about $12 million to $15 million, is that the way to think about it?

David L. White - Align Technology, Inc.

Management

That's correct and that's primarily because it's only a six-month drag on 2015. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Yeah, yeah. Fair enough. I just wanted to make sure. And then my last question just I guess with Roger there I'll ask him, but I thought I remembered, guys, that with the ClearCorrect ITC ruling that even in appeals they could be risking some hefty day-to-day fines if they were still digitally treatment planning. So wondering, one, am I right on that? And two, does that mean anything in conjunction with what you said about them potentially treatment planning the SmileCareClub cases, and just wondering if there is any impact to potential risk there from that standpoint for them?

Roger E. George - Align Technology, Inc.

Analyst · Robert W

I don't remember specifically what the ruling is on damages in the interim, but it's continued infringement from our point of view. And it doesn't affect, I mean it's the same thing, whether they are doing it for themselves or whether they are doing it for SmileCareClub. Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker): Okay, that's helpful. Maybe I'll ask a couple more offline on that later tonight. Thanks, guys.

Joseph M. Hogan - Align Technology, Inc.

Management

Thanks, Jeff.

Shirley Stacy - Align Technology, Inc.

Management

Next question, please.

Operator

Operator

Your next question comes from Jon Block from Stifel. Jon D. Block - Stifel, Nicolaus & Co., Inc.: Great. Thanks, guys. Good afternoon. I'll focus on utilization. I guess the year-over-year GP utilization was up for the second straight quarter after being down every quarter in 2014. So, Joe, can you talk about the sustainability here with that increase, with the greater sales rep count, and maybe where you are with the sales initiative in that really long GP tail? And then part two to that would be, in the ortho channel the utilization increases have been huge. And can that continue with the current call it G portfolio or should we expect you'll need another iteration on that front?

Joseph M. Hogan - Align Technology, Inc.

Management

Hi, Jon, I think on the ortho channel side – I'll just start with that question before I back up what GP is. I think you'll see, just getting used to the statistics in this business, but I think you'll see that it normally goes down from third quarter to fourth quarter on the penetration rate. And it has to do with the teen cases that tend to come in in the third quarter versus the fourth quarter. So I think what you might you see is a little lower penetration rate on the ortho side for North America as we go into the fourth quarter. But that's just statistical and based on year-to-year. There is nothing in a sense of the demand pattern to think that we see any interest that we have in orthos on that. On the GP side, Jon, I'm just – again, my newness in this business makes me more cautious than I normally am. But what the correlation I see right now on the GP side is you have to make sure that you continue to approach this market in the GP side with sales people, because it's hard for us to have any really meaningful increase when you look at the amount of utilization that's going on in that channel. And so we've proven so far I think in 2015 is if you add sales people to this, there is a marketplace we can continue to get growth. There are some sales models that we're transferring in from – in Europe from a penetration standpoint – that we're going to employ in North America next year as a trial to see if we can help with some of that penetration. That will apply both to ortho and GP, too. Secondly is, and we talked to you before about the sales associates that we've added recently, which are basically what I would say back office support that actually make phone calls and all to customers andnot direct. We've seen some success with that model, too, and I think that might help us on the GP sector also in the sense of how do we go about that, how do we really – I've talked about this before too, Jon – how do we really segment that marketplace to see where we think we can get further penetration with doctors that are truly interested and taking Invisalign to another level, versus doctors that might just be curious on it and wanting to work with it, not necessarily in the in-depth way that we would want. Jon D. Block - Stifel, Nicolaus & Co., Inc.: Okay. Perfect. Very helpful. And then...

Joseph M. Hogan - Align Technology, Inc.

Management

And that's a lot... Jon D. Block - Stifel, Nicolaus & Co., Inc.: It's a lot, but it's all very helpful. So I appreciate that. And then, David, just to shift gears for a second, you got the question earlier on leverage and your commentary was, well, revenues are up and OpEx is down and that doesn't happen too frequently. And I'm not asking for a 2016 guidance, but I just want to make sure, we've had situations before where your 4Q to 1Q, your leverage is usually down pretty dramatically because you've got some one-time expenses that sort of get re-upped. Can you give any color around leverage as we look out, exiting sort of 2015 into 2016, maybe near-term, long-term? Because again, the move from 3Q to 4Q is just tremendous. Is there anything that comes back into play on the OpEx front once we enter 2016? Thanks, guys.

David L. White - Align Technology, Inc.

Management

So, to the first part of that that you asked as it relates to some of the seasonality you might see in our performance, financially and so forth, you're right to call that Q1 typically is down for us. And largely, for things that are external to the company like the fact that payroll taxes start over. We have a lot of employees here in the U.S. whose payroll taxes start over and our portion of that that we have to pay. At the same time, we have internal items that influence that, such as we have focal salary reviews and increases – performance reviews and increases at that point in time. So those all put pressure, you might say, on operating expense uplift in Q1. And then, when you add to that the fact that, when we go through our annual operating plan cycle, we go through a process that looks at basically our baseline organic business in terms of what do we think our business can sustain without any additional resources, and then we look at that relative to where do we have investment opportunities and how would those investment opportunities drive both short-term as well as long-term growth of the top line and penetration into the business. And a lot of times, those investments all get made early in the beginning of the year as well, and this last year – this year that we're currently in is a case in point. We made investments in all three of our regions at the beginning of the year to begin driving further penetration within existing doctors and bringing new doctors into the family, so to speak. So there is that piece of it. I think you should anticipate that we will, as our historical pattern has shown, that we'll be making large investments, incremental investments as we move into 2016 and that that will create some downward pressure on Q1. And hopefully by the time we get to the end of the year, we begin seeing a lot of uplift to our business as we're seeing this year. Longer-term than that, Joe mentioned the fact that we see a pretty good correlation between our investments that we make in the field and investments that we make in products, one driving adoption, the other driving doctor coverage and so forth. I think that will be our business for a while. I think our challenge long-term is finding the right balance between the investments that we believe we can execute on, and at the same time, be good caretakers of being financially responsible for finding that right balance between our short-term performance and our long-term performance. So our long-term model that we've talked about historically, we still believe that's the right model for us, and that's where we'll continue to strive the business. Jon D. Block - Stifel, Nicolaus & Co., Inc.: Perfect. All right. Thanks, guys.

Shirley Stacy - Align Technology, Inc.

Management

Thanks, John. Next question?

Operator

Operator

Our next question comes from Chris Lewis from ROTH Capital Partners. Mr. Lewis, your line is live.

Shirley Stacy - Align Technology, Inc.

Management

Chris, are you there?

Chris Lewis - ROTH Capital Partners LLC

Analyst · ROTH Capital Partners. Mr. Lewis, your line is live

Hey, guys, can you hear me all right?

Shirley Stacy - Align Technology, Inc.

Management

Hey, there you are. Yeah, we can hear you fine.

Chris Lewis - ROTH Capital Partners LLC

Analyst · ROTH Capital Partners. Mr. Lewis, your line is live

Sorry about that. Good afternoon. Thanks for taking the questions. I wanted to start on the fourth quarter gross margin guidance. When I think about ASPs ticking up sequentially along with the strong implied sequential case volume growth, midpoint of the fourth quarter gross margin guidance implies a flattish level from the third quarter. So can you just walk us through the factors that are layering into that outlook, despite the sequential ASP and volume pick up?

David L. White - Align Technology, Inc.

Management

Well, we do have some ASP uplift. But we also have a higher training volume during this quarter, which typically is with lower gross margin. So that tends to hold some of that uplift back as a result. The other piece of it is that we are shipping our Element product this quarter, and Element, although it is a much better business model, you might say, for our company in many respects and I think also for the doctor and it does have a higher gross margin than the older version, it is still below our clear aligner overall gross margin. And so as that Element business picks up, that also puts some downward pressure, you might say, on the gross margin, just from a mix standpoint.

Chris Lewis - ROTH Capital Partners LLC

Analyst · ROTH Capital Partners. Mr. Lewis, your line is live

Then on the OSA market opportunity, can you talk about that decision and potentially quantify the impact that will have on R&D spend going forward? Thanks.

Joseph M. Hogan - Align Technology, Inc.

Management

I'll let David do the quantification, Chris. I'd say that when you look at that, it's not that we didn't that OSA was a good market. In fact, it might be a good market for some company at some point in time in the sense of how that can compete against other kinds of opportunities out there. But from us, we have I feel much better places in our core market to invest that money right now and that's what we're going to do in the future is just stay focused.

David L. White - Align Technology, Inc.

Management

And back to your question about impact, we gave some guidance at the beginning of the year that we thought OSA would be somewhere around a 1 point cost on revenue. And you'll see in the slides that we've provided on the webcast in the quarter the wind-down cost on that was about $0.02 a share.

Chris Lewis - ROTH Capital Partners LLC

Analyst · ROTH Capital Partners. Mr. Lewis, your line is live

Okay. Thanks for the time.

Joseph M. Hogan - Align Technology, Inc.

Management

Yeah. Thanks, Chris. See you.

Shirley Stacy - Align Technology, Inc.

Management

Thanks, Chris.

Operator

Operator

Thank you. Our next question is a follow-up coming from Richard Newitter from Leerink Partners.

Shirley Stacy - Align Technology, Inc.

Management

Hey, Rich?

Unknown Speaker

Analyst · Leerink Partners

Hi, thanks. It's actually Robbie. Thanks for taking the follow-up again.

Shirley Stacy - Align Technology, Inc.

Management

Oh, sorry. Hi, Robbie.

Unknown Speaker

Analyst · Leerink Partners

No problem. I have a question maybe on ASPs for sort of by product segment, the Express and Light segment. It looks like it's stepped down a little bit again sequentially. How should we think about that going forward in terms of is this the new normal or should we continue to expect price declines from this area?

David L. White - Align Technology, Inc.

Management

So, Robbie, as we've talked about in the past, there's a lot of variables that make up our ASP. And they come down – if I summarize them at the highest level, they come down to product mix, doctor mix, and – let me focus on those two for a second. So when you look at product mix, certainly lower-stage products and so forth are going to drive down – all other things being equal, a richer mix of lower-stage products will obviously bring ASPs down. And from time to time you're going to see us running promotions and so forth to incent doctors to give those low-stage cases, prize and so forth. But ultimately an objective for many doctors is to treat those and to get them to not only treat the simple cases but get them to build their clinical confidence on those simple cases and begin adopting full cases, where they feel they're capable and confident that they can do so. So you're going to see some ups and downs on product mix. And as we introduce new products in the future and so forth, I think you can anticipate that most of our R&D effort is focused on improving the clinical efficacy in those more complex cases. I think you'll see pressure from a product mix standpoint going in the other direction. So I wouldn't be too fixated I think on the last quarter or so as we ran some promotions on that case. We've said over time that over the long period we think ASPs can be relatively stable, plus or minus. And the other piece that kind of enters into it, the second piece I forgot to mention is when you look at the types of doctors we're bringing in. So as we dabble…

Unknown Speaker

Analyst · Leerink Partners

Great. Thank you for the very detailed response. Appreciate it.

Shirley Stacy - Align Technology, Inc.

Management

Thanks, (sic) Robbie. Well, everyone, I think this concludes our call today. We appreciate your time and look forward to seeing you at upcoming conferences and industry meetings. If you have any follow-up questions, please contact Investor Relations. Have a great day.