Good afternoon. Welcome to Establishment Labs' Second Quarter 2022 Earnings Call. At this time, all participants will be in a listen-only mode. At the end of this call, we will open the line for a question-and-answer session and instructions will follow at that time. As a reminder, today's call is being recorded. And I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go ahead.

Thank you, operator and thank you, everyone, for joining us. With me today is Juan Jose Chacon Quiros, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q as well as other SEC filings which are available on our website at establishmentlabs.com. As a reminder, Establishment Labs received an investigational device exemption from the FDA for Motiva Implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check to the local authorities for specific product availability. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, August 8th, 2022. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statements to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

Thank you, Raj and good afternoon, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the second quarter of 2022 totaled $41.2 million, a 29% increase over the second quarter of 2021. This is a new quarterly record for a company. Excluding the negative impact of foreign currency changes, our growth in the second quarter would have been approximately 33%. Our strong market share gains continue to be driven by our singular focus on women's health and well-being. Our commitment to bring highly differentiated technology based on science and patient-centric design is wholly unique in our industry. Most importantly, with this commitment to innovation, we are expanding existing markets and creating new categories that will sustain our growth for many years to come. Raj will provide additional detail on our second quarter performance and our outlook in a moment. Before I turn the call over to him, I would like to highlight several recent events. In July, we released our annual sustainability report. We think about sustainability a little differently at Establishment Labs. Our company was founded on the understanding that the legacy of our industry cannot be our future. We are defined by our commitment to offer clinically safer and better options to women in their journey of breast health and wellness. Sustainability at its core is key to our continued growth and success. We recognize how privileged we are to lead the transformation of this industry to our commitment to women's health. We are focused on a future that is built on positive social and environmental practice. Most importantly, it is about the women who put their trust in us by choosing Motiva. By honoring this trust, we believe our business is in a strong foundation and our strong financial results are sustainable. Dr.…

Thank you, Juan Jose. Total revenue for the quarter was $41.2 million. Reported revenue growth in the second quarter was 28.7%. Foreign currency changes reduced our second quarter revenue by approximately $1.5 million. Excluding the impact of currency, revenue growth in the quarter would have been 33.3%. Direct sales were approximately 41% of this total, while distributor sales which can fluctuate based on changes in inventory levels, and the timing of reorders made up the balance. From regional perspective, sales in Europe comprised approximately 32% of global sales. Asia-Pacific and Middle East was 33% and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 16.3% of total quarterly sales. Our reported gross profit for the second quarter was $27.5 million or 66.7% of revenue compared to $21.5 million just 67.1% of revenue for the same period in 2021. The change in gross margin was primarily the result of changes in foreign currency. Overall average selling prices in the second quarter went down slightly from the first quarter of 2022. SG&A expenses for the second quarter increased approximately $11.2 million to $33 million compared to $21.8 million in the second quarter of 2021. The increase in SG&A in the second quarter resulted from continued normalization and business practices following the disruption from the global pandemic and our productization of investments in new growth initiatives like Mia, and preparations for our launch in the U.S. R&D expenses for the second quarter increased approximately $0.6 million from the same quarter a year ago to $4.9 million. R&D expenses will fluctuate quarter-to-quarter based on the timing of clinical trial and other expenses. Total operating expenses for the second quarter were $37.9 million, an increase of approximately $11.8 million from the year ago period. The increase this…

Thank you, Raj. As we invest in the significant growth ahead, we are mindful of the uncertain global environment. Our business has considerable momentum, but we are cognizant that the macro environment is unsettled. Because of this, we are taking steps to prioritize spending on our growth initiatives and to be more judicious about spending broadly. We are in a unique position given our strong sales growth, as well as a number of significant opportunities in front of us. But we are using this current environment to review and reprioritize our investments to the areas of highest return. The last few months have strengthened the foundations of Establishment Labs. We are grounded solidly in our commitment to women's health and well-being and it is well within our reach to become the leading global company in breast aesthetics and reconstruction. We will continue to transform our markets in doing so and we will create new categories for growth and more importantly, create new options for women around the world. I will now turn the call over to the operator for your questions.

Thank you. At this time, we will be conducting a question-and-answer session. Our first question comes from the line of Chris Cooley with Stephens. Please proceed with your question.

Good afternoon, and congratulations on the record quarter. Appreciate you taking our questions here today. Good afternoon and congratulations on the record quarter. Appreciate you taking our questions here today. Juan Jose and Raj, if I may just my first question, I'd like to maybe focus on growth. And clearly the company's outpacing the global market rate of growth right now. But I would appreciate any color that you could provide, as you think about the guidance range of $155 million to $165 million, here, kind of what that implies in the back half how much of that is share gains, relative to market growth, and just kind of curious what the underlying base assumption is for the broad market. And then why you're confident in that kind of continuation of well above market growth. And then I've got a quick follow-up. Thank you.

Yes, thank you, Chris. So, again, we see Establishment Labs performing above expectations, and we feel very strongly about the way our team is able to work through any type of challenges. And if you take for instance, Brazil, as an example, we saw amazing performance coming out of Brazil, our market share, continues to increase, we're hovering somewhere around 35% market share in that very competitive price-sensitive market, even though our pricing has increased 14% in constant currency in that market. So, it shows you the strength of our technology and how medical education and being able to train surgeons around the world in the best techniques and best usage of our products is helping us move through with renewed market share gains. I think that's happening. And even though the situation of growth is, of course, a question, we think that we will continue gaining market share from our competitors. And of course, we have new markets that are coming, and that will allow us to, of course, agree on the expansion with geographic, in the U.S. and in China.

Appreciate that additional color. And then maybe just one more for me on the operating side and I'll get back in queue. Raj, you provided some incremental color there on the roughly $11 million step-up, I think versus what most of us were modeling for SG&A in the quarter, and specifically, more so sales and marketing. And knowing your prepared remarks, you stated that you expect those expenses to continue to accelerate throughout the year. But can you help us kind of think about that a little bit, especially with China looking like it's been delayed a little bit now, in the early next year, kind of, not only the gating, but maybe the kind of the underlying, implications there for the burn rate. I know, that's going to be a topic of discussion here. So, does it peak as we're exiting the year? And then you start to see a drawdown or the security over into the first half of 2023, just because of the modest push out there on China? Thank you so much.

Yes, thanks for the question, Chris. Generally speaking, if you look at all the opportunities in front of us as a company, we were clearly investing in those opportunities. Right, so not only preparing for U.S. launch, but preparing for Mia. You mentioned the push out of China China's a distributor market for us. So, our investments there while -- they will contribute it, it's less than some of the other things we're working on. And so I think when you look at the business, we're getting ready for some significant opportunities that we're about to tap into over the next couple of years and so we're spending on those. Having said that, though, we do expect our spending as a percentage of sales will trend down over time. Even this year, if you look at where we are in the first half relative to where we ended up for the full year of last year, our operating expenses as a percentage of revenue are still slightly below that and generally as we've commented in the past, the next couple of years, in particular, this year and next year, people should not expect a lot of leverage from us. But as we get into the U.S. and we start to tap into some of these opportunities, that leverage will start to flow in earnest. So, again, just appreciate that we're investing in it all the good things to come for us as a company.

Thank you and congratulations.

And our next question comes from the line of Zach Weiner with Jefferies. Please proceed with your question.

Hey, thanks for the question. And just one for me on Mia. Can you talk about how the procedure has evolved? And what you guys have learned over the last year? So in that procedure?

Yes, thank you, Zack. So, if we think about the first Mia procedures that took place in Japan in 2019, and the procedures are being performed today, I can tell you, there's just tremendous improvements in the patient experience. Since the beginning, we've had the ergonomics to diamond implant with their superior silicones, the improved chemistry and mechanical properties that allow that implant to be injected. But the procedure itself is what has been really a revelation because we are able to do this procedure without dissecting tissue the old way. So, we are preserving all the tissue. And that's what's allowing patients to have very little pain, that's what has allowed us to move decisively away from general anesthesia. And that's what's keeping, these patients with the same sensation because we are not paying touching any of the nerve endings in that breast area. So, all of that together really makes for a strong case for us being able to tap into new consumer market and that is namely women who are not interested in traditional breast augmentation that are using compensatory behaviors like a padded bra, silicon insoles, or the type of clothing that they may use. So, we feel very strongly that as soon as these products are able to go to market, they will make a substantial difference in terms of adding to real new markets. So, I was just in Japan last week, and I can tell you, the excitement there was tremendous. We're looking at chains of clinics where we can launch these products as soon as we have the necessary, go ahead and I couldn't be happier to see that progress. We're working through all the regulatory requirements in different geographies, especially in Europe, and looking forward to the launch.

Thanks.

And our next question comes from the line of Josh Jennings with Cowen. Please proceed with your question.

Good afternoon. Thanks for taking the questions and congratulations on the record revenue result and progress and the submission pathway wanted to ask, wanted to say just about just any challenges that your business is facing? Clearly your team is executing and navigating through a lot of headwinds, but what types of challenges is the business facing, whether it's reasonable pressures or supply chain, employee retention, any categories you can share and just in how your team is managing through?

Yes, I'll start by saying, Josh, that what Establishment Labs has done over the last few years is to be able to work through challenges and be able to pivot when necessary, find ways and make our numbers. And I think we've been doing that for the first half of this year, we've seen challenges in supply chain that we've worked through. And those challenges in supply chain, I think we don't expect them to come down, I think our team has been really good at working through it. But those supply challenges will continue. On other fronts, it's been difficult with all the difficulties in hiring and turnover rate. So, we have engaged into a culture project internally to make sure that we slow that down and we're happy to see that the turnover rate of our employees is slowing, we are at high velocity organization. And, of course, it's not for everyone, but absolutely, we feel very strongly about what we are doing to strengthen our team globally, especially when we think about everything that is coming ahead of us. Our consumer business unit in Barcelona, is being built, we have a lot of new talent that is coming on board, and that is going to help us in the launch of Mia. And of course, when it comes to Florida, we're tapping into a new type of business recipe construction requires different skills. And again, it's something that we're working through to make sure that we have what it takes. Furthermore, I think that it's a complicated year on the regulatory side, because you have all these different challenges. And they are not unique to Establishment Labs, these are things that different companies are experiencing, like what happened in China, with the lockdowns is slowing the regulatory process for many companies, what's going on with the move from the MVD to the MDR in Europe, as well as is slowing down, aesthetics in general when it comes to new products. So, working through those challenges, and hopefully we can continue doing this type of performance for the rest of the year.

Thanks for all those -- all that color. I want to follow-up is just wanted to ask about the building of physician awareness of Motiva in the United States in front of approval. The Aesthetic Meeting was a big event. We -- for the company, and especially after the data was released, the two-year data, but I was hoping to better understand how you feel U.S. plastic surgeon awareness for Motiva has built over the course of this year? And then just as we think about this three-year data, like the last patient in the augmentation -- or set of cohorts should finish their follow-up this month. But could we see three-year data presented at a Plastic Surgery Meeting in the United States this this year or any help thinking about when will that three-year data will be unlocked and made public? It would be great to understand as well. Thanks for taking the questions.

Yes, I think -- there's a growing excitement around Motiva with the U.S. plastic surgery community, but we have to balance that excitement with not promoting Motiva ahead of time, ahead of an approval. So with more surgeons traveling overseas, they are able to speak to their colleagues and of course, that always brings up the subject of Motiva. As you mentioned, the presentation of the two-year data at the Aesthetic Meeting in San Diego was a landmark event, especially when you see data that presents 0.5% capsular contracture rate, 0.3% rupture -- post-suspected rupture and that's what we've been about. For the last 11 years, we've been able to prove that less than 1% of device related complications is possible. And we continue to prove with data that it is done through science and innovation. We do think that, at some point, we will be able to show our three-year data. But our focus right now is on getting the fourth module finalized and sending it over to the FDA in the fourth quarter. So, we're not going to get ahead of ourselves, telling you about a specific date for releasing that three-year data. But as well whenever it comes to being transparent with data, we know it's always going to be in our favor. So, we're going to look for the right opportunity to do so.

Understood. Thanks again.

Thank you. And our next question comes from the line of Marie Thibault with BTIG. Please proceed with your question.

Hi, good evening and congrats on the strong quarter. I wanted to ask here first, a little bit about the regulatory timelines with the Mia tools, the timing in Europe, is that specifically just with the MDR transition or is there anything in particular that the agency is looking at around the tools themselves? And then secondly, what's happening behind the scenes in China? I know you mentioned a little bit of a delay on the timing there. We'd love to hear just what's happening over there.

Yes, thank you, Marie. When it comes to the tools, we have submitted absolutely everything that we need to submit in the MVD to MDR transition, there's an annex called Annex 16. And for that Annex, they have to set up this new requirements, and European Commission has not given those requirements. So, that's why this is not only affecting us, it's affecting the entire aesthetics industry. So, we're waiting for those and we hope that as soon as we get them and those are published for the industry, then we'll be first in line to be able to respond to them. We have done again, everything that we needed to do up to now. When it comes to China, it is definitely could be related. So far this year, we have been making good progress. But I think over the last couple of months as you have seen on the news, there's been a lot of lockdowns and the ability to have conversations on the progress has basically diminished. So that's why we updated our timeline to the first half of next year.

Okay. That's very helpful. Thank you for that. And then maybe a question for Raj, I apologize if I missed this, but I wanted to hear if there's anything we should be considering for the back half the year in terms of summer seasonality, or the like, as we consider Q3 and Q4 revenue cadences? Thanks for taking the questions.

Absolutely, Marie. As we saw last year, in our third quarter, we saw a meaningful step down from the revenue reported in the second quarter. And we expect that same trend will continue this year. As our business matures, we're not immune to these new seasonal factors. And particularly as more people are traveling and things are getting back to normal post pandemic. The seasonality is definitely pretty pronounced here in the third quarter, so we would, again, endorse the idea that we'll see some seasonality here in the third quarter, and then we should see a nice step up in the fourth quarter, as we saw again last year. Thank you.

Thank you.

And our next question comes from the line of Amit Hazan with Goldman. Please proceed with your question.

Thanks, it's Phil on for Amit. And thank you for taking our questions as well. On the US IDE, historically, you guys have been a little bit reticent to provide specific timelines when the FDA is involved and interested if your willingness to now provide a timeline for Module for submission by year end is an indication of increased competence, or what went into the decision philosophically to give a more definitive timeline at this point?

Yes. Thanks for the question. I think it's really a reflection of the interaction we've had with the FDA. We've now submitted as you heard on the call our third module, the dialogue remains active. As you know, this month in August, we're passing three years on the on the, on the augmentation cohorts. So we have the full year, three year data set now. And so our expectation, again, based upon everything we're seeing in our interaction with the FDA and how things are progressing has given us the confidence to again endorse the idea that by year end, we should have everything in for approval.

Okay, that's helpful. Comment or a question on the on the FX side, I believe you commented, a couple of 100 basis points worse for the year than you had anticipated in 1Q. If you rolled back to 4Q, can you remind us when your original guidance was set in dollar terms, how much worse is FX from $1 standpoint than you anticipated at the start of the year, it seems to be kind of in the $3 million to $4 million range?

It might actually be a little bit worse than that it was probably closer to a million dollars. And now we're looking at something closer to 67 million on the year. That the functional currency, that's the main currencies for us or the euro, right, and we do have some northern European exposure in some of the Nordic countries, the pound, all these we can dramatically this year and, and so it has gotten a lot worse. And I think again, it speaks to the, to the strength of our business that we've maintained the original reported guidance of 22 to 30%, despite absorbing quite a bit of additional headwind this year.

That's helpful. Thanks, Raj.

And our next question comes from the line of Anthony Petrone with Mizuho Group. Please proceed with your question.

Thanks, congrats on the quarter, maybe a follow up on the IDE study. And, and really going back to the current FDA guidance around silicone breast implants. And so the standard is still that, the FDA wants at least three years of data for a PMA submission, but it's still, I guess, somewhat unclear that they potentially could want to see a little bit, more data beyond three years again, so it's a minimum of three years of data. But again, the follow-up here on just the competence of getting the fourth module submitted, and the PMA does suggest that three years is sufficient. So just want to sort of take a temperature check on that, the guidance, specifically around at least three years of data, and potentially if they're looking for more data? And then I'll have couple of follow ups.

Yes, thank you, Anthony. And yes, the guidance that says pretty clearly that is three years of data. Of course, what we have done in terms of, follow up of patients, having that, that amazing number above 90%. Patient compliance is very helpful. Also, when you look at the complication numbers, that's also very helpful, because it shows the strength of our clinical outcomes with the two year data. So we are hitting our three year data set at 100% in this month, so, if anything, I think, it has strengthened our ability to produce all the data that the FDA needs to approve Motiva implants for the U.S. market.

That's helpful. And just two follow-ups, one is macro related, and then just a quick one on FX. So a macro saw just broadly across the market you compete in and not necessarily establishment left, specifically, what are you seeing some price competition from your competitors? Perhaps maybe as spending gets tested a little bit either by the patient or physician practices? So are you noticing any price competition out there amongst competition? And then just on FX, the dollar step up in total spending this quarter? Some of it sounds like it was, adding headcount. But certainly there's a translational impact there as well. So what was the dollar uptick related to FX overall on the sequential pickup in spending? Thanks.

Yes. It's a fair question, Anthony. And honestly, I don't think I can give you a terribly detailed number, right? So given the fact that we do have quite a bit of our expenses in US dollars, we have quite a bit of expense in Costa Rica, we have expenses in Europe, there is a natural offset to a lot of currency exposure for us. But in terms of an exact number as it relates to our spending, I don't have that in front of me here. But I think as you mentioned, for us, when we look at spending, we are investing in the business, right? You look at the number of opportunities in front of us with Mia in the United States and other things we're working on, we're standing up a lot of these operations ahead of when we're going to be realizing revenue from them. And so you're seeing a natural sort of lack of leverage this year and then into next year, as I mentioned earlier, but that should start to pay off as we get beyond those launches and the business really starts to generate revenue in those new areas.

Yes. And I think when it comes to what you were mentioning with price competition, as I said before for instance, we have made significant share gains in Brazil this year. Although in local currency, we are 14% higher than last year, and we are positioned in the premium category in that market. I was in Asia last week, and both in Japan and in South Korea, we have over 50% market share in breast aesthetics, and we continue to be solidly positioned as a premium brand in both markets. So when it comes to the way the markets have performed, I think what it shows is that over the last decade, Establishment Labs has moved a -- what it used to be a commodity industry into an industry based on safety and aesthetic outcomes. And when it comes to that, I think we continue to prove that we can continue to gain market share even though our pricing is on the higher end.

Very helpful. Thank you.

And our next question comes as a follow-up from Amit Hazan with Goldman Sachs. Please proceed.

Hi. Thanks for taking the follow up. It's Phil again. Just running the math, I assume most of the currency headwind was in Europe given the move against the euro. But even then, it looks like maybe performance was a little bit softer in Europe and then conversely LatAm strength, if I got the geographic breakdown correctly. So I was just wondering if you could give a little bit more geographic color if there's any divergence and what's going on in the end markets and what's causing it at this point? Thanks.

Yes. If I'm following your question correctly, you're right, we did see stronger performance in our distributor markets in the quarter, which is both Latin America and some Asia Pacific markets. We did see a little bit of a softer demand side out of Europe. But again, I think it was mostly that we just saw much better demand out of some of these other markets. Brazil is one of the vehicle that was a very strong market for us. I didn't mention earlier, but the real is another currency which we're exposed to from Brazil. So if I'm hearing your question, I think your observation is correct. We saw very strong demand in Latin America and some of our other distributor markets. And conversely, that overwhelmed some of the demand we saw in Europe and other places.

Thank you. At this time, we have reached the end of the question-and-answer session. And I will now turn the call back over to Juan Jose for any closing remarks.

Thank you for joining us on today's call. We look forward to providing our next quarterly update in November. And we wish everyone continued good health.

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