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Earnings Call: Q1 2018

Apr 25, 2018

Speaker 1

Greetings, and

Speaker 2

welcome to the Align Technology First Quarter 2018 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. Please go ahead.

Speaker 3

Good afternoon. Thank you for joining us. I'm Shirley Stacy, Vice President of Corporate Communications and Investor Relations. Joining me for today's call is Joe Hogan, President and CEO and John Marici, CFO. We issued Q1 2018 financial results today via GlobeNewswire, which is available on our website at investor.

Aligntech.com. Note that beginning in Q1 2018, the American region now includes the U. S, Canada and Latin America. Previously, Latin America was combined with the EMEA results for reporting purposes and included in the international total. While the Latin America region has been relatively immaterial to Align's overall results, we've adjusted our prior period regional breakouts to reflect this change, so our year over year comps are consistent.

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 May 9. To access the telephone replay, domestic callers should dial 877-660-6853 with conference number 13678,038 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 outlook and the expected financial results for the Q2 of 2018. 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 statement. We have posted historical financial statements, including the corresponding reconciliations and our Q1 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?

Speaker 4

Thanks, Shirley. Good afternoon and thanks for joining us. On our call today, I'll provide some highlights in the quarter, then briefly discuss the performance of our 2 operating segments, Clear Aligners and scanners. John will provide more detail on our financial results and discuss our outlook for the Q2. Following that, I'll come back and summarize a few key points and open up the call to questions.

I'm pleased to report better than expected Q1 results and a strong start to the year for Align with revenues volumes and EPS above guidance. Record Q1 revenues were up 41% year over year, reflecting continued strong Invisalign volume across all geographies and customer channels, as well as iTero scanner sales which were up over 84% year over year. Q1 Invisalign volume growth of 31% year over year was driven by increased utilization including strong team case growth globally and expansion of our customer base, which included over 4,200 new Invisalign trained doctors worldwide. Turning to specifics around our Q1 results, let's start with results of our Americas region. Within the Americas, Q1 was a good quarter with Invisalign volume up 7.1% sequentially and 24% year over year, reflecting growth in both our orthodontist and GP dentist channels.

In Q1, we trained 1600 new Invisalign doctors in the Americas region, of which 455 were in Brazil alone. We're also seeing a continued ramp up for Invisalign treatment. For the Americas region, year over year growth was led by ortho customers with another record quarter for North America ortho utilization of 15.3 cases per doctor. Q1 Invisalign utilization for our North American GP dentist were also up year over year, although modestly predominantly reflecting continued expansion of the GP customer base, which included 900 from new North American GPs who submitted Invisalign cases for the first time this quarter. During the quarter, we focused on key sales and marketing initiatives intended to drive growth with certain key customers.

And in Q1, we continue to see higher rates among doctors in these programs than among non participating doctors. We also saw a nice uptick in Q1 from our dental service organizations or DSO channel. DSOs remain very strategic part of our overall strategy as they look to scale operations and accelerate growth for their practices through continued investment in our end to end digital workflow, including Invisalign treatment and Itero scanners. At the Association of Dental Support Organizations, ADSO, meeting in Austin last week, 2 of our largest partners spoke to major DSOs about their success in integrating Invisalign treatment and digital scanning into their organizations, and our special markets team continues to build on these wins across the region. For international doctors, Q1 was another strong quarter with Invisalign case volume up 6.2% sequentially and 43.4% year over year, reflecting strong Invisalign volume across the board, driven by both increased adoption as well as expansion of our customer base, which included another 2,645 new Invisalign train providers with roughly half of EMEA and half in APAC.

From a customer channel perspective, while we continue to see strong growth from both the ortho and GP practices, we're beginning to see more positive traction in the GP channel from segmenting our sales and marketing resources and programs specifically around each channel. For Q1, we're continuing to help expand the market for clear aligner treatment with approximately 1600 newly trained doctors in EMEA, of which half were new Invisalign GO GPs. Year over year growth of Invisalign volume in EMEA was up 36.6% with record volume in all but one core country market. This performance reflects continued confidence in treating complex cases with Invisalign clear aligners as well as success in the GP channel, which was up over 67% year over year. The growth was led by Iberia and France, which were up over 40% year over year.

And Iberia became our 3rd largest market worldwide for the first time, following China, our 2nd largest market after the United States. We also saw strong growth across our key expansion markets led by Central and Eastern Europe and Benelux, where we continue to increase our sales and marketing resources across the board and have begun to implement consumer marketing programs. In APAC, Q1 Invisalign volumes were up 56.1% year over year, led by China, Japan and Australia, with China solidifying as our 2nd largest worldwide market. Our Q1 results reflect continued strong growth overall and especially from teen cases, which were up 73% year over year. In addition, we saw strong growth from our GP channel, which is up over 70% compared to last year.

We also continue to see positive uplift from Invisalign customers with iTero scanners. For Q1, Japan had a record quarter and showed very strong growth from doctors who have previously purchased Itero Element Scanners. Finally, Q1 was an all time high for Invisalign volume and our smaller expansion markets in Thailand, Singapore and Korea, where we are still very early in their development and adoption cycles. Now turning to the teen market. In Q1, 69,100 teenagers started treatment with Invisalign clear aligners, an increase of 8.8% sequentially and 40.9% year over year driven by continued strong adoption across all major regions and increasingly among younger teens and tweens.

Q1 was a 6th consecutive quarter that Invisalign teenage patient volumes grew faster than adults. Overall, teen case growth is outpacing adult growth on both comprehensive and non comprehensive products. For Q1 year over year Invisalign teen patient growth for North America's orthos increased 33% and internationally was up 60%. The average age among teenagers continue to get younger and younger, falling 6 months over the last 7 quarters to 14 years old. This trend in average age should continue downward as we commercialize Invisalign products that support treatment of young teens and children, including mandibular advancement and invisalign first, which we announced earlier this month.

Invisalign teen with mandibular advancement or math as we call it continues to ramp internationally. It is currently pending FDA approval in the United States which is slotted for approval in the second half of this year. The lift analysis that we have suggest the direct halo effect from MAF users that results in a higher percentage of teenagers treated with Invisalign clear aligners. Invisalign First clear aligners is a new Invisalign treatment designed with features specifically for younger patients with early mixed dentition. Phase 1 treatment, which makes up roughly 20% of case starts each year, is early interceptive orthodontic treatment traditionally done through arch expanders or partial metal braces before all permanent teeth have erupted, typically ages 6 through 10.

To date, Invisalign First clear aligners have been used to treat over 600 patients and will be commercially available beginning July 1, 2018. Earlier this month, we announced an expanded Invisalign product portfolio that includes new options and greater flexibility to treat a broader range of patients. The revamped Invisalign product portfolio offers doctors more choices by extending desirable features across the entire portfolio and creating Invisalign treatment packages as well as a new Invisalign First option to treat young patients with early mixed dentition. The new Invisalign Clear Aligner treatment options will be effective July 1, 2018. Today, we announced a new more user friendly version of our Invisalign Go product and digital platform that offers greater flexibility and expanded treatment options for simple teeth straightening cases.

Invisalign Go offers intuitive Invisalign experience designed for GPs worldwide who are seeking to integrate clear aligner therapy into their thriving comprehensive dentistry practices. We started the year off with strong consumer interest in the Q1. Over 4,000,000 unique visitors to Invisalign websites worldwide, up 54% from the same quarter last year. More than 500,000 potential patients searched for an Invisalign provider on our doc locator webpage, up 27% from the same quarter last year. Almost 220,000 consumers opted in for follow-up and the Invisalign social media community grew over 20% year over year, adding 688,000 consumers who are following the Invisalign brand worldwide.

All metrics for tracking consumer interest are up with especially strong growth in website visitors across APAC and opt ins in the Americas region. During the quarter, we also expanded on our customer outreach through the addition of our 2nd Invisalign pilot store near our headquarters in San Jose, California. We're seeing great initial ramp up in both San Francisco and San Jose stores as we connect consumers to authorize Invisalign providers and we'll continue to monitor store activity. The Invisalign stores are a doctor based model. Consumers who visit an Invisalign store are referred to a doctor's office where a doctor performs a personal clinical examination of the patient in the treatment plan.

The doctor will follow the patient until the case is completed. In Q2, we are opening 2 additional pilot stores on the East Coast, 1 in Bethesda, Maryland and another in Philadelphia area. We look forward to continuing to learn more from these four locations and sharing our progress throughout the year. As we head into our highest investment period of the year for our consumer marketing program, which includes a very important summer season for teenage case starts, we plan to increase spend across mom and teen marketing programs to focus on raising awareness and turning more consumers into Invisalign patients through our doctors' offices. In Q1, iTero revenues were down 10% sequentially as expected following a strong Q4, which reflected year end seasonality in the capital equipment business.

Year over year Q1 scanners were up 84%, reflecting very strong growth across all regions and reflects how central digital approaches to overall customer utilization of Invisalign treatments. Use of Itero scanners for Invisalign case submissions in place of PVS impressions continues to expand and remains a positive catalyst for Invisalign utilization. For the Q1, total Invisalign cases submitted with a digital scanner in the Americas increased to a record 67.2 percent, up from 65.3% in Q4 last year. International scans increased 43.1%, up from 41.4% in Q1 last year. To date, more than 7,700,000 orthodontic scans and 2 point 7,000,000 restorative scans have been started with Itero scanners.

Today, we announced the expansion of our Itero Element portfolio with the launch of the iTero Element 2 and the iTero Element Flex scanners. These additions build on the existing high precision full color imaging and fast scan times of iTero Element portfolio while streamlining orthodontic and restorative workflows. The next generation iTero Element II is designed for greater performance with 2x faster startup and 25% faster scan processing times compared to iTero Element. The new Itero Element Flex is a wand only device that transforms compatible laptops, computers into a highly portable scanner that works anywhere. It's perfect for practices with multiple locations who need a scanner that is both convenient and easy to transport.

The new scanners will be showcased at the AAO meeting next week. Today, we also announced that we'll have received market approval for Itero Element intraoral scanner from the CFDA, that's the China Food and Drug Administration, and we've begun offering the Itera Element Scanner in China. Intra oral scanners have less than a 2% penetration rate in China today and are expected to grow 6x by 2020. The Itera Element Scanner launch in China not only supports growth of our base Invisalign clear aligner business, but also represents a major milestone for digital dentistry in China. Finally, in the doctor directed at home channel, Align is a third party supplier to SmileDirectClub with a 19% equity investment in the company.

We manufacture a portion of SDC aligners, which are non Invisalign clear aligners. For Q1, shipments to SDC were down sequentially as expected reflecting SDC's desire to produce their own clear aligners. Today we issued a separate press release commenting on SDC's allegation that the launch and operation of our Invisalign store pilot program constitutes a breach of non compete provisions. As disclosed previously, we dispute SDC's allegations and intend to continue on Invisalign store pilot program and we oppose and defend ourselves in these proceedings. While this dispute does not impact our existing supply agreement with SDC, which is in effect through 2019, we anticipate minimal volume from SDC in Q2 in the second half of twenty eighteen.

With that, I'll turn it over to John.

Speaker 1

Thanks, Joe. Now for our Q1 financial results. Total company revenue for the Q1 was a record $436,900,000 up 3.7% from the prior quarter and up 40.8% from the corresponding quarter a year ago. Year over year revenue growth includes a 5 point benefit from favorable foreign exchange. Clear aligner revenue of $385,500,000 was up 5.8% sequentially and higher than expected volume.

Year over year clear aligner revenue growth of 36.5% reflected strong Invisalign shipment growth across all customer channels and geographies and increased Invisalign ASPs. Q1 Invisalign ASPs were up sequentially approximately $5 from Q4 to $13.10 reflecting favorable foreign exchange and product mix, partially offset by sales promotions and revenue deferrals. On a year over year basis, Q1 Invisalign ASPs were up approximately $40 reflecting favorable foreign exchange, price increases and product mix partially offset by sales promotions and deferrals related to additional aligners. For the Q1, total Invisalign shipments of 272,200 cases were up 6.7% sequentially and up 30.8% year over year, driven by growth across all regions. For Americas orthodontists, Q1 Invisalign case volume was up 8.5% sequentially and up 27% year over year.

For Americas GP Dennis, Invisalign case volume was up 5.1% sequentially and up 19.6% year over year. For international doctors, Invisalign case volume was up 6.2% sequentially and up 43.4% year over year. Our scanner and services revenue for the Q1 was $54,400,000 down 10% sequentially due to the lower volume from the Q4 seasonality effect and up 84% year over year, primarily due to higher volume, partially offset by lower ASPs due to promotions and discounts. Moving on to gross margin. 1st quarter overall gross margin was 74.9%, down 0.6 points sequentially and down 1 point year over year.

Clear aligner gross margin for the Q1 was 77%, down 0.6 points sequentially, primarily due to increased aligners per case and higher training costs, partially offset by higher Invisalign ASPs. Clear aligner gross margin was down 0.9 points year over year, primarily due to regional expansion of our manufacturing activities, partially offset by higher worldwide ASPs. Scanner gross margin for the Q1 was 59.2 percent, down 2.8 points sequentially due to lower scanner ASPs related to promotions and discounts. Scanner gross margins were up 3.1 points year over year, primarily due to lower services costs, partially offset by lower scanner ASPs. Q1 operating expenses were $229,200,000 up sequentially 10% and up 31.8% year over year.

The increase in operating expenses reflects continued investment in our go to market activities, including higher advertising spending, geographic expansion as well as increased compensation related to expenses due to higher headcount and our planned annual increase in employee compensation programs. Our first quarter operating income was $98,200,000 down 10.4% sequentially and up 59.2% year over year. Our first quarter operating margin was 22.5 percent, down 3.5 points sequentially and up 2.6 points year over year. The sequential decrease in operating margin relates primarily to lower gross margin due to operational expansion activities, higher operating expenses as just described and lower SmileDirectClub related revenue. On a year over year basis, the increase in operating margin primarily reflects higher revenues from both clear aligner and scanner and services as well as favorable foreign exchange rates.

With regards to the Q1 tax provision, our tax rate was 2.9%, which includes $23,300,000 in excess tax benefits related to stock based compensation and is down by approximately 89.5 points compared to 92.4 percent in Q4 of 2017, primarily due to the U. S. Tax Cuts and Jobs Act enacted in December last year. 1st quarter diluted earnings per share was $1.17 up $1.04 sequentially and up $0.32 compared to the prior year. Recall that Q4 2017 diluted earnings per share of $0.13 included $86,600,000 expense or $1.06 per diluted share impact due to the U.

S. Tax Cuts and Jobs Act. Finally, Q1, we adopted ASC 606, revenues from contracts with customers using the full retrospective method. While the impact to the Q1 2017 and Q1 2018 P and Ls are immaterial, the condensed consolidated balance sheet as of December 31, 2017 has been recasted to comply with ASC 606 requirements. Moving on to the balance sheet.

As of the Q1, cash, cash equivalents and marketable securities, including both short and long term investments, were $673,000,000 This compared to $761,500,000 at the end of 2017, a decrease of approximately $88,500,000 primarily due to $100,000,000 in stock repurchase during the quarter. Of our $673,000,000 of cash, cash equivalents and marketable securities, dollars 236,000,000 was held in the U. S. And 436 $200,000 was held by our international entities. Q1 accounts receivable balance was $361,500,000 up approximately 11.5 percent sequentially.

Our overall days sales outstanding, DSOs, was 74 days, up 5 days sequentially and down 3 days from 77 days in Q1 last year. Even though our accounts receivable aging profile has improved, the Q1 DSO was up sequentially as a result of increased sales with extended payment terms that are available in certain regions. Capital expenditures for the Q1 were $57,600,000 primarily related to building purchases and improvements, equipment purchases for additional manufacturing capacity, as well as our global expansion efforts including the new manufacturing facility in Xi'an, China mentioned last quarter. Cash flow from operations for the Q1 was $77,300,000 up $29,700,000 compared to the prior year. Free cash flow from the Q1 defined as cash flow from operations less capital expenditures amounted to $19,700,000 During the Q1, we also repurchased approximately 400,000 shares of stock for $100,000,000 under the April 2016 repurchase program.

We have $100,000,000 remaining available for repurchase under this existing stock repurchase authorization. Other significant cash flow activities during the quarter included the receipt of $30,000,000 from SmileDirectClub for repayment of their existing line of credit, and we paid $47,800,000 in employee's upon vesting of restricted stock units. With that, let's turn to our Q2 outlook and the factors that inform our view, starting with the demand outlook. We expect our international business to grow significantly on a sequential basis as the European market is coming out of their winter season and most of the APAC market were observing Lunar New Year in the Q1. For the Americas region, we expect Q2 to grow as our ortho and GP customers are seasonally busier and as we continue to make progress in our Latin America expansion.

We continue to invest in our iTero go to market activities. We started selling iTero Element in Brazil in Q1 and we have started selling iTero Element in China in Q2. We expect sequential increase in iTero units sold and revenues. As Joe mentioned earlier, we are currently in litigation with SmileDirectClub regarding our Invisalign store pilot. And while this does not impact our supply agreement, the state of our relationship, we are assuming minimum volumes for SmileDirectClub in Q2 and the second half of twenty eighteen.

With this as a backdrop, we expect the 2nd quarter to shape up as follows: Invisalign case volume is expected to be in the range of 296,000 to 301,000 cases, up approximately 28% to 30% over the same period a year ago. We expect Q2 net revenues to be in the range of 460 $1,000,000 to $470,000,000 an increase of approximately 29% to 32% year over year. We expect Q2 gross margin to be in the range of 74.2% to 75%, reflecting higher expenses as we regionalize our treatment planning and manufacturing operations, partially offset by higher ASPs. We expect Q2 operating expenses to be in the range of $245,000,000 to $250,000,000 up on a sequential basis to reflect our continued investment in go to market activities. Q2 operating margin should be in the range of 21 percent to 21.8 percent.

Our effective tax rate, including an excess tax benefit of about $10,000,000 should be approximately 13%. We expect a $1,000,000 to $2,500,000 loss related to our share of SmileDirectClub and diluted shares outstanding should be approximately 81,600,000 exclusive of any share repurchases. Taken together, we expect our Q2 diluted earnings per share to be in the range of $1.02 to 1 $0.06 In addition, as we continue to operational our operational expansion efforts, we expect CapEx for Q2 to be approximately $65,000,000 to $70,000,000 and we expect depreciation and amortization to be $10,000,000 to $11,000,000 Now let me turn to our view of 2018. Based on the momentum in our business to date and our planned investments for the remainder of the year, we now anticipate 2018 total revenue growth rate to be above our long term model and in the low 30s. We also expect Invisalign volume and revenue and volume to be growth in that same range.

Notwithstanding continued investments in our strategic growth drivers, we expect operating margin for the full year to be flat to slightly up from 2017 operating margin of 24%. With that, I'll turn it back over to Joe for final comments. Joe?

Speaker 4

Thanks, John, and thanks to those for joining the call today. I'm pleased with our start to 2018 as well as our continued progress and execution of our strategic growth drivers. There are a lot of changes happening in dentistry and orthodontics today, but the industry remains healthy and I think customers are starting to see new opportunities for how they treat patients and reach new customers. We're looking forward to an exciting and productive AAO meeting in Washington DC where we'll get to showcase our new products on the scanner side and also with Invisalign First. We're also going to have pop up version of our Invisalign pilot store as a way to answer customer questions and to get their perspective on our program.

Then we'll be in Singapore at the end of May hosting our 3rd Asia Pacific Summit where we'll be expecting about a 1,000 delegates from across the region attending a 2 day peer to peer education event. We've got a lot going on in Q2 and I look forward to sharing more with you at our upcoming financial conference at our Investor Day in New York on Monday, May 23. I'm sorry, on May 23. I think it's on Monday for sure, on May 23. With that, I'll turn it over to the operator and we'll open up to your questions.

Thank you.

Speaker 2

Thank you. At this time, we will be conducting a question and answer session. Our first question comes from Robert Jones of Goldman Sachs. Please proceed with your question.

Speaker 5

Great. Thanks guys for the questions. Joe, just looking at the expected new revenue growth rate for the year, now above the long term model, I'm sure it's a combination of several factors, but I was hoping maybe you could just maybe in rank order attribute what really has gone better than expected so early in the year, if we think about teen off to a good start, the new product launches, obviously iTero seems to be pacing much better than certainly we were expecting. Could you maybe just give us some insight into what out of the gate this year has gone better than planned?

Speaker 4

Well, we had an aggressive plan for the year. But at the start up, Bob, I'd say, we look at the international business, continues to be very strong with APAC and EMEA. A really good performance in the Americas, particularly around North America too. When you start to segment it, you mentioned it, our team product is up pretty substantially that way. Itero sales have been terrific in that sense.

We talk about how customers more and more are recognizing that whole digital workflow and how important it is. And you can see with our scanning now in North America and being close to 67%, that's just really working out well. And we know when they purchase iTero scanner, we see more Invisalign sales. Lastly, I'd say our segmentation, I mentioned it in my script too, is the segmentation of GP and ortho very specifically, and also segmenting consumers in the sense of our concierge service and how we more and more we target consumers and lead them into the specific docs from a doc locator standpoint. That's kind of a little better than expected too.

So overall, the company has been executing well across geographies and across our segmentation and product plans.

Speaker 5

Great. And I appreciate that. And then it looks like you're seeing some early traction already from Invisalign First. I was wondering if maybe you could share with us how that launch of a product like that changes the addressable market that you can actually go after? Just getting some thoughts from you would be helpful around how much more expanded that the younger market becomes with the product like First?

Speaker 4

Yes. First of all, those 600 cases we did, that product launches in July, those were actually just cases we put in place from a clinical study standpoint to prove the whole thing. So really that 600 is and then you're going to see us do more and more clinical work like that to do a lot of cases, Bob, just to make sure that we have good evidence for our customer base as we go out there to work on. Secondly, when you look at the teen marketplace, palatal expansion or what we call Phase 1 represents about 20% of the marketplace. Now this is dental expansion.

It's not morphology or bone expansion like you have in rapid palate expansion. So in the past, we've said we've been roughly can do 60% to 65% of the cases with Invisalign. What Invisalign First Dental expansion does is expand that market served opportunity another 10%. And then we will follow that with a rapid palate expander that we're currently going through now, and that will increase it another 10% too, so we can cover that whole 20% Phase 1 part that you have with teens out there. And that also has a good entree for us because often it's Phase 1, Phase 2 treatments where teens are young children that are 7 to age or 8 age have the palate expansion play and then it goes on to dental kind of work from an orthodontic standpoint later on in their teens.

And so there's a good transition period for that too. So it's a great product. It's targeting that segment of the marketplace that we haven't had technology at before. It's specifically an orthodontic product that we've developed here.

Speaker 5

Awesome. Great. Thanks for the questions. Hi, Bob. Thanks.

Speaker 2

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

Speaker 6

Thanks. Good afternoon. Joe, to the extent you're comfortable, would love to just hear your view on kind of what the path forward is with respect to SDC, SmileDirect? And then, John, any chance you could share with us the percent of cases that you manufactured for them in the Q1?

Speaker 4

We can't really get into specifics. And obviously, we weren't going through litigation and we have to work through litigation. I'd just say, we continue to have a good relationship with David and his team. And we just have a disagreement in the sense of obviously the contract that we're in and we're going to work through this from a litigation standpoint. So as that develops, we'll be able to be more clear with you as to what's going on.

Speaker 6

Fair enough. And then one more. Joe, with respect to the Invisalign store model, would be curious to hear your views on how that's tracking relative to plans. It looks like you pulled forward, perhaps by a couple of quarters, the East Coast build outs. What are some of the things you're learning and what have you learned so far from the initial experience?

Speaker 4

Brandon, first of all, we didn't pull those forward. That was in our plan as we had for 2018, and we're just sequentially putting them in. And we've learned honestly, these stores, we've learned a lot in this sense and these what we learned helps our doctors an awful lot too about how you take a basic consumer and you turn them into a patient. We learned that visualization is really important. The speed of that visualization mean you scan, you can show a patient what their teeth are going to look like with certain kind of treatment options, gives them a lot of confidence then to go to a doctor and to see a doctor and to complete that treatment piece.

We've learned a lot about our software too in the sense of how it has to respond from a patient standpoint. There's also a lot that we're doing from a marketing standpoint in the sense of turning interest from a consumer over to a store and then back to a doc. In other words, turning consumers into patients also. Through all that, I'll tell you the Itero scanner again is really critical in being able to do this. It's really the key on the visualization piece, but also our treatment software planning in a sense of making it as real time as possible so patients can see how their teeth will move and what their smile will look like.

Those combinations become really important, not just in the store, but as we translate that software to our doctor partners.

Speaker 2

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

Speaker 7

Hi, thanks very much. Joe, can you give us a sense in terms of the feedback that you're hearing from your field sales force on the competitive front? Are you seeing any changes perhaps in promotional activity or pricing from competitors at least at the low end?

Speaker 4

No, we haven't seen any change at all, John. I mean, we I mean, the same cast of competitors are still out there that we had before. Obviously, we expect a 3 ms product at the AAO. We are pretty sure to see one there. We saw the debt supply announcement at the MTM expansion in the 510 that they've done, but we haven't seen that translated to any kind of strategy or implementation in the marketplace yet.

We expect to see that in the second half. Our guess, John, is pretty much what we've been telling you and the rest of the teams over the last couple of years is we expect this to be mid range products. So in the 26 aligner or less kind of an area, we expect a kind of a slow ramp up just because of the nature of how you have to scale in this business, takes some time and treatment planning and also manufacturing. So I mean you can see with our kind of bullish forecast for the second half of the year that John just called that we pretty much add this in place in the sense of what we thought we would face and we haven't really changed that analysis since we put the plan together last year.

Speaker 7

Great, thanks. And one quick follow-up on the demand tracking as well as it would appear? Do you view that as end demand tracking as well as it would appear?

Speaker 4

No stocking here, John. It's the end demand. That's a policy we have here.

Speaker 7

All right, great. Thank you.

Speaker 2

Our next question comes from Erin Wright of Credit Suisse. Please proceed with your question.

Speaker 8

Great. Thanks. Can you speak to the more recent financing pilot? I guess, any surprises with that sort of initiative and when that would be a more meaningful contributor to growth?

Speaker 1

Yes, the filing this is John. For Aaron, the pilot that we have is took place in end of Q4 and through the Q1. We saw great results and it is going wider across the U. S. Starting this quarter, where customers now customers and ultimately the patients have a lot more flexibility in terms of how they want to finance and work through different financing options that they might have.

Speaker 8

Okay. I'll follow-up later there. And then on can you speak, I guess, on China and the opportunity there, I guess, as well as the competitive landscape, not just maybe from the Clear aligner segment, but also the broader iTero opportunity with the launch announced today? Thanks.

Speaker 4

I think it's back to Joe, Aaron. We're excited about that. I mean, our growth in China, China is our 2nd largest market. Our growth over there has been tremendous. It's hard to believe that right now everything we do in China is basically PVC impressions.

So and I mentioned in my script about 2% penetration of intraoral scanners in China. So from a competitive standpoint, the market is wide open in this sense and you could see that from those kind of now we have to sell, we have to train. There's a lot of things we learned in Japan because of the iTero scanner being approved in Japan last year in the sense of how you have to ramp up and a lot of technology and people to bring our customers up to speed and all that friction we're anticipating for this year as we ramp up in China, we're putting people in place and training in place to be able to get that done.

Speaker 8

Okay, great. Thank you.

Speaker 4

Yes. Thanks, Aaron.

Speaker 2

Our next question comes from Matt O'Brien of Piper Jaffray. Please proceed with your question.

Speaker 9

Hi, guys. Thanks for taking the question. This is Kevin on for Matt today. I wanted to start with the mandibular advancement ramp abroad. Kind of what's most driving that strength?

I've heard about it being incredible for the last two quarters. And then secondly, with that, assuming approval here in the U. S, how fast exactly is the U. S. Ramp?

Is this something that ortho customers have been asking for a long time? Thank you.

Speaker 4

Hey, Kevin, it's Joe. First of all, I'd say, from a MAP standpoint, the ramp overseas, it's just a product that's unique, right? You obviously address mandibular issues and these are people or teens that are between the ages of 10 12 usually with that bone development from a jaw standpoint. And there's really nothing in the world to tell you you have twin block and things like this. This looks like a torture device basically with metal that's used to move kids forward with also composites.

This what this does is move your jaw forward with removable liners and also straightens your teeth at the same time. So it's a true breakthrough for that end of the market and I think that's why you see really good pickup. Secondly is all these products as it moves in the United States, I wouldn't model some kind of huge increase in teens because of mandibular advancement in the United States because there is always a slow take up of this because orthodontists want to try it, they want to see success with their patients, they build that kind of credibility with the product line, they continue to move on. So from a North America standpoint, this is more of a 2019 discussion with MAP in a sense of maybe significant kinds of opportunities than I would say in the second half of this year.

Speaker 9

Okay. Thanks, Joe. That's really helpful. I just had one follow-up on a previous question on the competitive front and then additionally with the DTC effort, I was just curious, are you hearing from your customers specifically becoming increasingly aware of additional offerings in your view? And secondly, are they pushing back a little bit on pricing and looking for better discounts and things like this as a result of the DTC effort increasing and then also kind of layering on new products in the next coming years?

Speaker 4

Kevin, I'd say, look, there's increasing awareness because I mean it's mainly SDC in North America has really extensive advertising. And so it's hard to watch TV and not run into an Invisalign ad or an SDC ad in that sense. But I wouldn't say our customers always want lower prices like almost any other customers in the world, anything else that you sell. So I wouldn't say that the SDC price range has created more sensitivity with our orthodontic and GP customers out there. I will say that there is a price elasticity curve and obviously that kind of lower very I'd say, minor type of tooth movement kinds of things that opens up a new segment of the marketplace that frankly hasn't been serviced in a big way before.

So I think it just makes doctors aware of the more of a segmentation in the market of not doing a full bite correction, but just doing maybe your Social 6 or just correcting a smile that someone's not comfortable with. That's a new segment of the market. It's priced in a different way. And I'd say that's not a pushback on us on price. It's more of a look how to service those patients and what's the best products to do that with.

Speaker 9

Okay, perfect. Thanks so much.

Speaker 2

Our next question comes from Steve Boucher of Morgan Stanley. Please proceed with your question.

Speaker 10

That's a new one. Hey, thanks for taking the questions.

Speaker 1

Hey, Steve. Hey, Steve.

Speaker 4

Steve, your friends here don't lie. Yes.

Speaker 10

Hi. Good to talk to you. The GP number in the quarter kind of sticks out in a really good way, really on a tougher comp kind of in Flex. Is there something going on in GP in the U. S?

I mean, we don't have I go out in the field. What was the magic there?

Speaker 4

I don't it's not magic and it's not a surprise, Steve. I'd say, first of all, SDO, I mean, the DSO marketplace has been big for us, right? So you know our work with Heartland, what's going on there and some other dental service organizations, team in North America has been very good at executing around those opportunities. Secondly, honestly, the increased advertising that we've been doing, okay, has an overall halo effect with driving patients to asking for Invisalign treatment. And we have noticed that since last year when we started cranking up advertising.

So that is a kind of a residual effect or a second order effect that helps the GPPs. Thirdly, Steve, is we're doing more and more segmentation on salespeople calling on GPs in a GP kind of a way. In other words, understanding GP workflows, they don't want to be orthodontists, having products like that are more simple for them to use in the sense of utilizing that within the workflow of a normal restorative kind of a dentistry type of workflow. So those three areas primarily.

Speaker 10

Super helpful. Thanks for that. And then you guys you may have set a new record for press releases in 1 afternoon. I mean, you introduced a lot of new stuff today and we could spend a lot of time on any one of them. But I wonder if there's any way to give us a sort of high level view, Joe, on what you think these products mean for the growth profile of the company over the next 2 years, the sum total of getting iTero into China and getting the GP channel a little bit more automated, getting more cameras on the market.

What does this mean for the next 2 or 3 years? Thanks so much.

Speaker 4

Hey Steve, first to be completely honest with you too, we're still learning, right? I mean, as you remember like a year ago, we weren't we wouldn't really be tied down to tell you that we sell more iTeros and we sell more aligners. Today, we'll tell you very concretely because we haven't updated today that we sell more Iteros, we sell more aligners. We're gaining a lot of confidence in APAC as we Japan is completely different in China. Now Japan is completely different in China, completely in a sense of how you do business there, but we do we know how to go in there and we can anticipate a sense of what China will need and the kind of uptake we'll have with those kind of scanners.

So the Itero that we just announced, the 2 products in Itero, remember this is equipment business. I grew up in equipment business and medical. These are platforms, right? These are new platforms that we're moving forward on that help to extend what we already know in that sense. So like the Flex product allows you to put it into a compatible computer, move it around the different offices.

It's what our customers are basically asking for. It's not a new breakthrough in scanner technology, it's an extension. You're going to see us continue to do that as we work off a successful platform that allows us not to just go wider from a geographical standpoint like China, but to go deeper in the sense of the workflow and what our orthodontists and our GPs really want out there. Now I would look at when you look at Invisalign Team First, the product we just announced, that's truly a breakthrough. When you think for years, we really couldn't do teeth that weren't completely erupted, that didn't have permanent dentition.

Now we through a lot of technology and understanding over the year, we can predict what those eruptions are going to be and that's what we've programmed into that TeamFirst product line. That's why it opens another 10% market share for us. But you've been with us long enough, Steve, to understand that the take up of those things are always cautious and it takes time. But it does establish that and when we do the rapid pilot expansion that will establish another 20% of the marketplace that we haven't had before. So I mean just look at this as the continual march of Align Technology to broaden overall our opportunities from a depth standpoint of penetrating the marketplace and from a breadth standpoint and moving into new geographies with those technologies too.

Speaker 10

Really appreciate the color. Thanks again.

Speaker 1

Yes. All right.

Speaker 2

Our next question comes from Ravi Misra of Berenberg Capital Markets. Please proceed with your question.

Speaker 11

Hi, I appreciate taking the call. A couple of questions, one on the store pilot. Just kind of trying to get a sense for what the revenue potential that you see out of that is in the long term. It sounds like you're having us moderate some of our expectations here based on what the contribution could be from SmileDirect itself as you guys work through your negotiations with them? And if you could give us some information on that, that would be great.

And then secondly, maybe just a housekeeping question just on the EPS line, the 5 points of currency, what was the flow through down to the bottom line on that? Thank you.

Speaker 4

John, take that last one.

Speaker 1

Yes. Andy, I'll take that first on, Ravi, on the EPS. We saw 5 points on revenue and the way our model works is usually we get about 3 times the benefit on revenue as it is to profitability.

Speaker 4

Ravi, on the store pilot, we're not share any data on the store pilot right now. We call them pilots for a reason, because we're learning and we're growing through that learning. And as this becomes more understandable because we have more data points, we'll be happy to share that with you. As far as the SDC and all, we haven't shared specifically what we expect from quarter to quarter. I have never wanted you to really evaluate Align stock on SDCs we sell the SDC, never wanted to do that.

And so when you say we're kind of moderating your views of volume, I would say we're talking lower 30% for this year. That's not a moderation in the sense of what we think the growth is. We just want you to not try to handicap that with SDC volume. This is our inherent volume that we're generating in this business.

Speaker 11

Yes. And I think that's pretty clear given your Case Start guidance in the low 30s now. So, I appreciate that. And then finally, just

Speaker 12

on

Speaker 11

the reapportionment of the Latin American sales, Can you just talk about whether that's going to require is that just a reporting issue? Are you going to be realigning some of the business units internally as well with that? Thanks.

Speaker 4

No, I mean, what that does, Ravi, is we have a regional strategy here, right? So we have APAC from an Asia standpoint, we have EMEA from Europe. We've always had this North American organization. It's been kind of Latin America was reporting into another part of the organization. And so this just straightens out our organizational intention of having regions in each one of the 3 key areas.

But frankly, and then we bought up our distributorships in those areas in Latin America and also Brazil, and we're moving forward in those areas. So you saw how many doctors we trained in Brazil alone. These are good opportunities for us and allows us to focus on it in a more of a regional sense and be able to transfer best practices within the Americas throughout the organization. So it's just a move that's in line with our regional structure.

Speaker 11

Great. Thank you very much.

Speaker 4

You're welcome.

Speaker 2

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

Speaker 4

Hey, Jon.

Speaker 13

Hey, Joe. Thanks for taking the questions. So maybe 2. The first one, just on the new iGo sort of Itero offering, is there a price point on that product? I didn't see it in the release.

And clearly, you don't seem overly concerned with competition. But with that new iGo Itero offering, I believe it's up to 20 stages. Joe, is that sort of the part of the market that you do view as most susceptible?

Speaker 4

And

Speaker 13

if competition does come in the next couple of weeks, where they're going to try to crack the code a bit? And then I've got a follow-up. Thanks.

Speaker 4

John, you know this well in your analysis, right? If you take 15 up to 26, I mean, that's been kind of a vacancy in the product portfolio for years. And so, iGo wasn't derived without an understanding of that, okay? Yes, we do I wouldn't call that if you really stand back from this, trying to do a full case with all the complexity that has to do with full cases, if you were a competitor coming in here, it's a very difficult thing to do. You want to kind of gradually learn and ramp up to that.

So the logical our logical conclusion is, yes, I mean, we're probably going to see more competition in the below 30 area. The good thing about that, John, that's not new to us. We've seen competition from MTM and Angel Align and you can go down the list of competitors we've seen globally, ClearCorrect or whatever in that specific area. But when you look at Maui, when you look at iGO, Maui was the structure we put in place or whatever, It just gives us more flexibility for our customers to be able to offer these products, up and down the range than what we've had before. So, yes, could we respond better to competition?

Yes. Is that an area we think they'll come in? Yes, but we've already seen that. And this is just a continuation of how we've been working with our customers and how we structure our product portfolio.

Speaker 13

Okay, great. I appreciate you read the reports, Joe. I just need others too as well. Just to pivot for a moment, the scanners and driving utilization in the U. S, that's clearly played a big role over the past several years.

And we're seeing the scanners playing a bigger role globally. And you mentioned just starting to get into China. When you take a step back, is there any reason why the utilization step up, which you now see much more comfortable sort of verifying that utilization step up would be any different globally, especially someplace like China or Japan versus what we see in the North America? In other words, when we look out 2 or 3 years from now, could that be sort of the next leg of growth in some of these more emerging markets? Thanks, guys.

Speaker 4

To answer that question, just a flat out yes. I mean, I don't think it's going to be any different in China. It hasn't been different in Japan. We saw an uptake with the customers that took the initial iTero there, John, significantly. So we expect China to be the same way in other countries too.

In Brazil, I think we've been successful with Itero in Brazil also. So yes, that is another component of growth in the company overall. What's great is its synergistic growth, right? You have equipment growth, but it really leads to the growth of our core product line, which is Invisalign.

Speaker 2

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

Speaker 12

Hi, thanks for taking the questions. Just the first one, on the tax rate, so 13% for 2Q. Just wondering what should we be modeling for the full year?

Speaker 1

The guidance that we had given for total year was earlier on was 18 percent. So 18% of total would be what you should use, Richard.

Speaker 12

Okay. So that's unchanged. And then, Joe, just going back to the question that was asked earlier on competition and how, if at all, it's factored into your outlook. I guess just can you comment on more specifically how you contemplated the impact of any incremental competition on your prior outlook and I appreciate you've revised your outlook upward and that's a bullish signal. But compare the current factoring of competition compared to kind of how you thought about it previously and you could get as specific as possible, is it price?

Is it maybe just a little less utilization you otherwise would have felt comfortable providing to the street. Just how are you thinking about that and quantifying it?

Speaker 4

It hasn't changed for a year, honestly. I mean, you can tell what we initiated during the beginning of the year, we didn't think we'd have any really major competitive plays in that sense. We knew we'd see more competition. But we basically looked at our business and with the momentum of the business and projected that forward. And you're seeing it within our numbers.

There's no specificity that I want to share in the sense of what we think and how much in ASP and what areas. Just take a look at our bullish forecast going forward. And as competition becomes more visible to us and more in line, we'll share with you what we're seeing and how we look at the business.

Speaker 12

And it's a similar follow-up to that line of questioning. Anything baked into your outlook specifically for mandibular contributing in the back half? I know you expect approval, but is there anything baked in for actual contribution to revenue? And same on iTero, it feels like that came the approval in China came a little bit ahead of plan. I thought you had been talking about a second half kind of ramp for that and approval for that.

Was that a little earlier than expected?

Speaker 4

First of all, on math, no, I wouldn't plan on anything from a that would be material on math, as I mentioned in the other thing for North America when we finally get it approved. On China, we were happy to move that through. We've had good work with our Chinese partners over there to move it through. Right now, we're not calling any upside on that. I mean, we're as we indicated, we've had good iTero growth.

We think that will continue. As we it's not just about how fast you can sell iTero in China. There's a lot of infrastructure work you to put in place as far as training and putting things in place to be able to sell through China from an infrastructure standpoint. So what's great about that is we can kind of get a quarter up on that. If it would have been the second half of the year, then we wouldn't have as much opportunity to be able to move that product.

Speaker 12

Thank you.

Speaker 10

You're welcome.

Speaker 2

Our next question comes from Steven Valiquette of Barclays. Please proceed with your question.

Speaker 14

Okay, great. Good afternoon, Joe and John. Thanks for taking the question.

Speaker 4

I guess for us, just

Speaker 14

one or two quick follow ups here on the addressable market. First, probably an easy one, but just to make sure to clarify here, when we're talking about this 20% of untapped orthodontic case starts, you can now treat with Invisalign first. That 20% that is within the prior industry view of roughly 10,000,000 worldwide annuals orthodontic case starts. Is that correct?

Speaker 4

Steve, first of all, it's not 20%, okay. Invisalign First is about 10%, because that's dental expansion, which means you're just really taking the teeth and rounding the arch, right? Rapid palate expansion moves the bone, moves the palate now. So it's 10% that more of the market would be Invisalign First, another 10% would be for rapid palate expansion.

Speaker 3

Steve, you're talking 20% of cases are related to Phase 1 and that's correct. That's right. What Joe is explaining is you're talking about TAM, right?

Speaker 14

Yes, more on the TAM, that's correct. And really, I mean, the more important question I wanted to get to at the end of the day really was that when we think about the $10,000,000 worldwide orthodontic case start TAM, I guess my real more critical question here is once Invisalign First is generally available and also once you do have U. S. Approval for mandibular advancement, I'm just curious where we would stand after those events just on the approximate percent of that $10,000,000 worldwide orthodontic K Stars, do you think you could treat right now overall with the overall Invisalign product portfolio and approval? That's really the more important question I wanted

Speaker 4

to ask. I think the simple one on that, Steve, is that before Invisalign First, we said 60%. Invisalign First takes us to 70%. Once we get rapid pilot expansion, it takes us to 80. And that's of the 10,000,000 case starts that are out there, that's based on 25% adult and 75% being teens.

So you really want to nail that number, you're going to have to take 75% of 10x0.8, okay?

Speaker 5

Okay. All right.

Speaker 1

I think

Speaker 4

I got it.

Speaker 5

Yes. Okay. Thanks.

Speaker 4

Yes.

Speaker 2

Our final question comes from Jeff Johnson of Robert W. Baird. Please proceed with your question.

Speaker 15

Thank you. Good evening, guys. Hey, Joe. Let me go after the competition question, maybe one other way here. I think we're all trying to circle around different things.

But you guys are launching obviously a ton of stuff right now with the iGo and the Phase 1 and iTero expansion, all that stuff. What's your view in the second half here? You guys expand the market quite a bit and so competition gets some share, but you guys are expanding market so fast that you can put up that solid or that very strong second half guidance that seems to be implied there now? Or do you just really think competition doesn't get much traction? Your comps get tougher in that, so it's getting a little messy to try to figure out kind of how much of this is market expansion, how much maybe competition is or isn't having an impact, but just conceptually, how do you think it plays out that way?

Competition comes

Speaker 4

in and just takes our share. We actually think that Competition comes in and just takes our share. We actually think that competition to a certain extent will lift share because it will give more legitimacy to clear aligners. And so possibly in that lower segment of the marketplace, could we lose some share? Sure, we could.

At the same time, we're expanding on the upper end with our product lines that you just saw with the obviously mandibular advancement in teen and iGo in those areas. Jeff, the other side of this too is it's we've been saying this for a long time, it's hard to do this. I mean treatment planning facilities, making sure that you can ship aligners and actually ship them in sequence, So first, second, third are really first, second and third aligners. Putting a sales team out there that really can walk through customers and hold their hand in a sense of it takes time to do this. It's not this is not like a patent clip we've been saying all along that something is a biosimilar and you can put it in your portfolio and sell it the next day.

It's not like that. It'll take time to ramp for our competition.

Speaker 15

Yes. No, that makes sense. And then one last question for me. Just iTero, anything qualitatively you can talk about maybe scanner sales in the U. S?

And are you seeing any traction outside of Invisalign cases with iTero on any kind of restorative procedures, anything like that? Just kind of trying to get to what is the mindset of the U. S. Dentists right now? Are they willing, are they at the point where they're wanting to use scanners for things, obviously, for Invisalign, but for other things as well?

Just what's your view there would be helpful?

Speaker 4

Yes. I mean, if you look at 3Shape and us, right? I mean, 3Shape has a good position with GPs in a sense of restorative workflow and with labs and whatever. And they've helped from a GP standpoint to grow the marketplace. We're the same way.

We have a good restorative scanner. We have a great scanner from overall Invisalign standpoint and both of us kind of raise the awareness and capability out in the marketplace. So honestly, when you look at this thing, Jeff, long term, this is you're going to have a scanner. One way or another, your workflow is going to be digital going forward in dentistry. It starts around these kind of application restorative versus aligners and those kind of things.

It will flow through for the rest. So I don't know what you're thinking of in the sense of how to model that, Jeff, or what it means, but it just shows you more and more that this isn't just for orthodontics. This is we're developing a scanner that's broad across the marketplace too. We wanted to function well for GP and restorative. You go back to Itero's beginning, right, it was a restorative scanner.

When we bought that business, it primarily was in the general dentistry segment. That's what was developed around. And so I think I reported that we had 2,500,000 restorative scans done on iTero. So when our teams out there calling on a GP, we're talking about not just that you can do our aligners with this, we've got them confident you can this is a great, very accurate restorative scanner that can communicate very well with your dental lab. That's really important in that workflow.

Speaker 15

Yes. And scanner sales growing in the U. S. Still? There's still a good market there for you guys on the scanner side?

Speaker 4

No question. Yes.

Speaker 15

Yes. All right. Thanks guys.

Speaker 3

You saw the results of the iTero scanner business. The vast majority of the business is still in North America.

Speaker 15

Yes. Just with the Japan approval and moving Brazil, where you did into the Americas and that, just wanted to check on that. So thanks.

Speaker 4

Yes. Okay.

Speaker 3

Well, thank you, everyone. This concludes our conference call for today. I want to remind everyone that we will be hosting our Investor Day at the Park Central Hotel in New York City on May 23. You can find more information and register directly on our Investor Relations webpage. Hotel rooms that are our group walk are limited and the cutoff to make your reservation is April 30.

We hope to see you all there. If you have any questions, please let us know.

Speaker 2

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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