Establishment Labs Holdings Inc. (ESTA)
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Earnings Call: Q2 2022

Aug 8, 2022

Operator

Good afternoon, and 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. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go ahead, sir.

Raj Denhoy
CFO, Establishment Labs

Thank you, operator, and thank you everyone for joining us. With me today is Juan José Chacón-Quirós, 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 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 view 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 with your local authority 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 8, 2022. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement 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 José Chacón-Quirós.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

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 our 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 through 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 on a strong foundation and our strong financial results are sustainable. Dr. Caroline Glicksman, the principal investigator in our US IDE study, presented 2-year data from the primary augmentation cohort of the study in April. The results matched the exceptional performance we have seen over the past 11 years with the over 2 million Motiva implants we have sold around the world. We continue to receive very positive feedback on the results, and the interest it has sparked in the clinical community is tangible. As we announced last week, we have completed the remaining surgeries in the reconstruction cohort of the trial. Our US IDE study is now fully enrolled, and we are moving diligently through follow-up. On the aesthetic cohort, as we've previously communicated, we are pursuing a modular PMA submission path.

I'm pleased to announce we have submitted the third module to the agency for review. This module is related to the manufacturing of our implants. We look forward to submitting the fourth and final module to the FDA in the fourth quarter. In our aesthetic breast recon franchise, the launch of our Motiva Flora tissue expander in Europe and other CE Mark countries is ongoing. Flora has many advances over other commercially available tissue expanders, including a first-of-its-kind RFID-enabled port, which allows for MRI imaging without artifacts during the time an expander is used after mastectomy. By being non-magnetic, Flora potentially opens new options for radiation oncology treatment during this stage of recovery. Flora also features our patented cell-friendly SmoothSilk surface technology, and early users have noted improved patient comfort and healthier capsule formation with this unique tissue expander. We are expanding the markets in which Flora is available.

Adoption will take time, but early efforts have been encouraging and add to our belief that we can help support women in their breast reconstruction journey. Surgeons are adopting our technology, with many making Flora their expander of choice. Flora is only the first step in our aesthetic breast recon initiative, where Establishment Labs will offer tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire and work to democratize breast reconstruction worldwide. We look forward to sharing more with you on these efforts in the future. In our consumer franchise, MIA, our minimally invasive injectable breast enhancement procedure, we continue to wait for regulatory clearance in Europe for the tools that are part of the Motiva MIA system.

The migration in Europe from the MDD to the MDR standard has created some gaps in regulation for the industry, and this is adding to the regulatory timelines. As we wait for clarity, we continue to build our direct-to-consumer capabilities centered in our women's health hub in Barcelona. We also continue to perform new MIA cases as well as track the original 100 patient cohort we completed in April of last year. We have 100% follow-up on this first group of patients, and the outcomes continue to support our belief that this approach will transform breast aesthetics and bring a new base of customers. Training of new surgeons in anticipation of our commercial launch is set to expand in the coming months.

Overall, our early experience continues to support what we found in our market research, namely that the new category created by MIA could grow to more than $5 billion globally, with approximately half of the opportunity from new patients that had not previously considered a breast enhancement. Our clinical and commercial efforts in China are ongoing and we continue to make progress in the regulatory process. Based on the updated expectations for the timing of regulatory review, given the effects of COVID-related restrictions in China, we expect approval for Motiva in this market in the first half of 2023. I will now turn the call over to Raj to cover our financial results.

Raj Denhoy
CFO, Establishment Labs

Thank you, Juan José. 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 a 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 or 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 were down slightly from the first quarter of 2022. SG&A expenses for the second quarter increased approximately $11.2 million- $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 in business practices following the disruption from the global pandemic and our prioritization of investment 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 period was again due primarily to the normalization of activity and spending relative to a year ago, as well as the investments in growth initiatives. Net loss from operations for the second quarter was $10.4 million, compared to a net loss of $4.6 million in the year ago period. Our cash position as of June thirtieth was $91.3 million.

This compared to $53.4 million at the end of the previous year. The increase in cash in the quarter was the net result of the first $150 million tranche from the new term loan we secured on April 26th. Net of fees and the repayment of our previous loan, the new facility increased our cash balance by approximately $72 million. As a reminder, the term loan has three additional tranches totaling $75 million of non-dilutive capital we can access on the achievement of revenue and regulatory milestones. Cash used in the quarter included approximately $12.4 million of investment in our new manufacturing facility that will expand our capacity more than half the world's market.

Under our current forecast, the cash we currently have on hand, as well as the additional capital available to us under our credit facility, can allow us to achieve cash flow profitability while still funding our growth initiatives. We are maintaining our sales guidance for 2022 in a range of $155 million-$165 million, representing estimated annual growth of 22%-30%. As we saw in our second quarter results, there is considerable momentum in our business and we expect that this will continue even in the current macro environment. It is important to note that we are maintaining our guidance despite a steeper headwind from foreign currency. If current rates hold, currency will impact reported revenues by approximately 3.5%. This is about a point worse than our last update in early May.

As it relates to our supply chain, we have seen so far minimal impact on our results. We are not immune to the challenges many global companies are experiencing and we anticipate that those will remain for the rest of the year. As we look down the rest of the P&L, we continue to expect to see spending levels increase as we prioritize investment in the significant number of development and commercialization programs we have underway. The timing of expenses can make our quarterly results less linear, but overall, given our strong top line growth, operating expenses as a percentage of sales should trend down over time even as we increase strategic investments. We believe our company remains in a very strong, competitive, and financial position. With that, I will turn the call back over to Juan José.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

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.

Operator

Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing any star keys. One moment, please, while we poll for any questions. Our first question comes from the line of Chris Cooley with Stephens. Please proceed with your question.

Chris Cooley
Managing Director, Stephens

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. Clearly, you know, the company's outpacing the global market rate of growth right now. I would appreciate any color that you could provide as you think about, you know, the guidance range of $155-$165 here, kind of what that implies in the back half. How much of that is share gains relative to market growth? I'm 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. Then I've got a quick follow-up. Thank you.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

Yes. Thank you, Chris. Again, you know, we see Establishment Labs performing above expectations, and we feel very strongly about, you know, the way our team is able to work through any type of challenges. If you take, for instance, Brazil as an example, we saw amazing performance coming out of Brazil. Our market share, you know, continues to increase. You know, 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.

It shows you know, the strength of our technology and how medical education and being able to train surgeons around, you know, 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. Even though the situation, you know, of growth is, of course, a question, we think that we will continue gaining market share from our competitors. Of course, you know, we have new markets that are coming, and that will allow us to, of course, agree on the expansion with geographic, you know, in the U.S. and in China.

Chris Cooley
Managing Director, Stephens

Appreciate that additional color. Then maybe just one more from me on the operating side, and I'll get back in queue. Raj, you know, 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. I know in your prepared remarks, you stated that you expect, you know, those expenses to continue to accelerate throughout the year. Can you help us kind of think about that a little bit, especially with China looking like it's being delayed a little bit now into early next year, kind of not only the gating, but maybe kind of the underlying, you know, implications there for the burn rate? I know that's gonna be a topic of discussion here.

Does it peak as we're exiting the year, and then you start to see a drawdown, or does this carry over into the first half of 2023 just because of the modest push out there on China? Thank you so much.

Raj Denhoy
CFO, Establishment Labs

Yeah. Thanks for the question, Chris. You know, generally speaking, if you look at all the opportunities in front of us as a company, I mean, we're clearly investing in those in those opportunities, right? So not only preparing for U.S. launch, but preparing for MIA. You know, you mentioned the push out of China. You know, China's a distributor market for us, so our investments there, you know, while they will contribute, it's less than some of the other things we're working on. So I think when you look at the business, you know, 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, you know, we do expect our spending as a percentage of sales will trend down over time. You know, 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. 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. As we get into the US and we start to tap into some of these opportunities, that leverage will start to flow in earnest. Again, you know, just appreciate that we're investing in all the good things to come for us as a company.

Chris Cooley
Managing Director, Stephens

Thank you and congratulations.

Operator

Our next question comes from the line of Zachary Weiner with Jefferies. Please proceed with your question.

Zachary Weiner
Equity Research Associate, Jefferies

Hey, thanks for taking the question. 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 or so, in that procedure?

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

Yes, thank you, Zach. So if we think about the first MIA procedures that took place in Japan in 2019 and the procedures that are being performed today, I can tell you there's just tremendous improvements in the patient experience. Since the beginning, we've had, you know, the Ergonomix2 Diamond implant with their super silicones, you know, 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. 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, you know, these patients with the same sensation because we are not touching any of the nerve endings in that breast area. All of that together really makes for a strong case for us being able to tap into a new consumer market. That is namely women who, you know, are not interested in traditional breast augmentation but are using compensatory behaviors like, you know, a padded bra, silicone inserts or the type of clothing that they may use. We feel very strongly that, you know, as soon as these products are able to go to market, they will make a substantial difference in terms of adding to a real new market.

I was just in Japan last week, and I can tell you know, the excitement there is tremendous. You know, we're looking at, you know, chains of clinics where we can launch these products as soon as we have the necessary go ahead. You know, I couldn't be happier to see that progress. We're working through, you know, all the regulatory requirements in different geographies, especially in Europe, and looking forward to the launch.

Zachary Weiner
Equity Research Associate, Jefferies

All right. Thanks.

Operator

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

Josh Jennings
Managing Director and Senior Equity Research Analyst, Cowen

Good afternoon. Thanks for taking the questions and congratulations on the record revenue result and the progress in the submission pathway. I wanted to ask, Juan José Chacón-Quirós, just about 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 regional pressures or supply chain, employee retention? Any categories you can share just in how you, how your team is managing through?

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

Yeah, I'll start by saying, Josh, that what Establishment Labs has done over the last few years is to be able to, you know, work through challenges and be able to pivot when necessary, find ways and make our, you know, our numbers. 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. You know, those challenges in supply chain, I think we don't expect them to come down. I think, you know, our team has been really good at working through it. You know, those supply challenges will continue. On other fronts, you know, it's been difficult with, you know, with all the difficulties in hiring and turnover rates.

You know, we have engaged into a culture project internally to make sure that we slow that down and we're happy to see that, you know, the turnover rate of our employees is slowing. You know, we are a high velocity organization and of course, you know, it's not for everyone. But absolutely, we feel very strongly about, you know, what we are doing to strengthen our team globally, you know, especially when we think about everything that is coming ahead of us. You know, 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.

Of course, you know, when it comes to Flora, we're tapping into a new type of a business. Breast reconstruction requires different skills. Again, it's something that we're working through to make sure that we have what it takes. You know, furthermore, I think that it's a complicated year on the regulatory side because you have all these different challenges and, you know, they are not unique to Establishment Labs. These are things that, you know, different companies are experiencing, like, you know, what happened in China with the lockdowns is slowing the regulatory process for many companies. What's going on with the move from the MDD to the MDR in Europe as well is slowing down, you know, aesthetics in general when it comes to new products.

you know, working through those challenges and, you know, hopefully we can continue doing this type of performance for the rest of the year.

Josh Jennings
Managing Director and Senior Equity Research Analyst, Cowen

Thanks for all that color. My 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 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. Then just as we think about the three-year data, I think 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 year? Or any help thinking about when that three-year data would be unlocked and made public would be great to understand as well. Thanks for taking the questions.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

I think there's a growing excitement around Motiva with the U.S. plastic surgery community, but we have to balance that, you know, that excitement with not promoting Motiva ahead of time, ahead of an approval. With you know, 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 2-year data at the Aesthetic Meeting in San Diego was, you know, a landmark event, especially when you see data that presents, you know, 0.5% capsule contracture rate, 0.3% rupture or suspected rupture. That's what we've been about, you know.

Over the last 11 years, we've been able to prove that less than 1% device-related complications is possible, and we continue to prove with data that you know, it is done through science and innovation. We do think that you know, 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. We're not gonna get ahead of ourselves telling you about you know, specific date for releasing that three-year data. You know as well you know, whenever it comes to being transparent with data, we know it's always gonna be in our favor, so we're gonna look for the right opportunity to do so.

Josh Jennings
Managing Director and Senior Equity Research Analyst, Cowen

Understood. Thanks again.

Operator

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

Marie Thibault
Managing Director and Senior Equity Research Analyst, BTIG

Hi, good evening, and congrats on the strong quarter. 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? Secondly, what's happening behind the scenes in China? I know you mentioned a little bit of a delay on the timing there. Would love to hear just what's happening over there.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

Yes. Thank you, Marie. When it comes to the tools, we have submitted absolutely everything that we need to submit. In the MDD to MDR transition, there's an annex called Annex XVI, and for that annex, they have to set up, you know, this, you know, new requirements. The European Commission has not given those requirements. That's why this is not only affecting us, it's affecting the entire aesthetics industry. We're waiting for those, and, you know, we hope that as soon as we get them, and those are published for the industry, then, you know, we'll be first in line to be able to, you know, 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 COVID related.

You know, so far this year, we have been making good progress, but I think over the last couple of months, as you have you know seen on the news, you know, there's been a lot of lockdowns and, you know, the ability to have conversations on the progress has you know basically diminished. That's why we updated our timeline to you know the first half of next year.

Marie Thibault
Managing Director and Senior Equity Research Analyst, BTIG

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 is anything we should be considering for the back half of the year in terms of summer seasonality or the like, as we consider Q3 and Q4 revenue cadences? Thanks for taking the questions.

Raj Denhoy
CFO, Establishment Labs

Absolutely, Marie. As you 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, you know, we're not immune to these seasonal factors. Particularly as more people are traveling and, you know, things are getting back to normal post the pandemic, the seasonality is definitely pretty pronounced here in the third quarter. 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.

Marie Thibault
Managing Director and Senior Equity Research Analyst, BTIG

Thank you.

Operator

Our next question comes from the line of Amit Hazan with Goldman Sachs. Please proceed with your question.

Philip Coover
Equity Research Associate, Goldman Sachs

Right. 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 4 submission by year-end is an indication of increased confidence or what went into the decision philosophically to give a more definitive timeline at this point?

Raj Denhoy
CFO, Establishment Labs

Yeah, thanks for the question. I think it's really a reflection of the interaction we've had with the FDA. You know, we've now submitted, as you heard on the call, our third module. You know, the dialogue remains active. As you know, this month in August, we're passing three years on the augmentation cohort, so we have the full year, three-year data set now. 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.

Philip Coover
Equity Research Associate, Goldman Sachs

Okay, that's helpful. A comment or a question on the FX side. I believe you commented 200 basis points worse for the year than you had anticipated at 1Q. If you roll back to 4Q, can you remind us when your original guidance was set in dollar terms, how much worse is FX from a dollar standpoint than you anticipated at the start of the year? It seems to be kind of in the $3 million-$4 million range.

Raj Denhoy
CFO, Establishment Labs

It might actually be a little bit worse than that. It was probably closer to $1 million, and now we're looking at something, you know, closer to $6 million-$7 million on the year. The functional currencies, the main currencies for us are the euro, right? We do have some Northern European exposure in some of the Nordic countries, the pound, you know, all of these have weakened dramatically this year. So, it has gotten a lot worse. I think, again, it speaks to the strength of our business that we've maintained the original reported guidance of 22%-30% despite absorbing, you know, quite a bit of additional headwind this year.

Philip Coover
Equity Research Associate, Goldman Sachs

That's helpful. Thanks, Raj.

Operator

Our next question comes to the line of Anthony Petrone with Mizuho. Please proceed with your question.

Anthony Petrone
Managing Director and Senior Equity Research Analyst, Mizuho

Thanks. Congrats on the quarter. Maybe a follow-up on the IDE study and really going back to the current FDA guidance around silicone breast implants. The standard is still that, you know, the FDA wants at least three years of data for a PMA submission, but it's still, I guess, somewhat unclear that they, you know, potentially could wanna see a little bit, you know, more data beyond three years again, so it's a minimum of three years of data. Again, the follow-up here on just the confidence of getting the fourth module submitted and the PMA does suggest that three years is sufficient.

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 a couple of follow-ups.

Raj Denhoy
CFO, Establishment Labs

Yeah. Thank you, Anthony. Yeah, the guidance that says pretty clearly that it's three years of data. Of course, you know, what we have done in terms of, you know, follow-up of patients, you know, having 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, you know, our clinical outcomes with the two-year data. We are hitting our three-year data set at 100% in this month. You know, if anything, I think, you know, it has strengthened our ability to produce all the data that the FDA needs to approve Motiva implants for the U.S. market.

Anthony Petrone
Managing Director and Senior Equity Research Analyst, Mizuho

That's helpful. Just two follow-ups. One is macro-related, and then just a quick one on FX. On the macro side, just broadly across the markets you compete in and not necessarily Establishment Labs specifically, but 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? Are you noticing any price competition out there amongst competition? Just on FX, the dollar step-up in total spending this quarter, some of it sounds like it was, you know, adding headcount, but certainly there's a translational impact there as well. What was the dollar uptick related to FX overall on the sequential pickup in spending? Thanks.

Raj Denhoy
CFO, Establishment Labs

Yeah. It's a fair question, Anthony. Honestly, I don't think I can give you a terribly detailed number, right? Given the fact that we do have quite a bit of our expenses in U.S. dollars, we have quite a bit 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, you know, 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, the United States, and other things we're working on.

You know, we're standing up a lot of these operations ahead of when we're going to be realizing revenue from them. You're seeing a natural sort of lack of leverage this year and then into next year, as I mentioned earlier. That should start to pay off as we get, you know, beyond those launches and the business really starts to generate revenue in those new areas.

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

Yeah. I think, you know, when it comes to what you were mentioning with, you know, 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, you know, positioned in the premium category in that market.

You know, 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. When it comes to, you know, the way the markets have performed, I think what it shows is that over the last decade, Establishment Labs has moved what it used to be a commodity industry into an industry based on, you know, safety and aesthetic outcomes. 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.

Anthony Petrone
Managing Director and Senior Equity Research Analyst, Mizuho

Very helpful. Thank you.

Operator

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

Philip Coover
Equity Research Associate, Goldman Sachs

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 euro move against the dollar. But even then it looks like maybe performance was a little bit softer in Europe and then conversely, Lat Am strength, if I got the geographic breakdown correctly. I'm just wondering if you could give a little bit more geographic color, if there's any divergence in what's going on in end markets and what's causing it at this point. Thanks.

Raj Denhoy
CFO, Establishment Labs

Yeah. If I'm following your question correctly, you're right. We did see you know, 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. Again, I think it was mostly that we just saw much better demand out of some of these other markets. Brazil, as Juan José called out, 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.

Conversely, you know, that overwhelmed some of the demand we saw in Europe and other places.

Operator

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

Juan José Chacón-Quirós
Founder and CEO, Establishment Labs

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.

Operator

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.

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