Good afternoon. And welcome to Establishment Labs' First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. At the end of this call, we'll open the line up 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, Raj.

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 mention that the 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 our other SEC filings, which are available on our website at establishmentlabs.com. I'd also like to remind you that our comments will include certain non-GAAP financial measures with respect to our performance, including but not limited to sales results, which can be stated on a constant currency basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website. Please also note that 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 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, May 8, 2023. 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 José.

Thank you, Raj, and good afternoon, everyone. Revenue in the first quarter of 2023 totaled $46.5 million, a 21% increase over the first quarter of 2022 and a new quarterly record for our company. Excluding the negative impact of foreign currency changes, our growth in the first quarter would have been approximately 22.9%. Our revenue guidance for 2023 remains unchanged at $200 million to $210 million, representing growth of 24% to 30% over 2022. Raj will provide additional details on our first quarter performance and our outlook in a moment. The last few weeks have seen a number of significant events at Establishment Labs. On March 29th, we announced that we have 3 million Motiva devices in market. This is an important event, not only because of the scale we have achieved in markets since we began commercialization over 12 years ago, but also because of the exceedingly positive outcomes we have achieved with such a large number of devices. Just like we do every year, we recently released to the scientific community our post-market surveillance report, which includes data from independent national registries, all consistently showing less than 1% device-related complications. These excellent results were corroborated and expanded upon when the three-year data from our Motiva US IDE study was presented at the Aesthetic Meeting on April 20th. Dr. Caroline Glicksman, the principal investigator of the study, provided an update following the aesthetic cohort passing the three-year endpoint in the trial. What is particularly notable about the results is that the rates of the major device-related complications of capsular contracture and rupture did not change from year two to year three. There continue to be only two patients with capsular contracture and only one patient with a suspected rupture at three years, which was the exact same number at two years. Beyond the rates themselves being quite low and much lower than has ever been seen in a major trial like this, the consistency of the results from year two to year three are very encouraging and starting to create a lot of positive buzz in our industry. US plastic surgeons are now asking the most important question: when will Motiva be available in the United States? And while we can't give them a definitive answer, we can tell them that our final module of our PMA was submitted to the FDA in the first quarter, and the full PMA has now been accepted and is under review by the agency. Of course, with so many catalysts in the near future, how we are going to fund our growth is always an important question. We answered this to a large degree on April 27th when we completed a follow-on share offering that raised gross proceeds of $90.4 million. Our team did a wonderful job in just a one-day wall cross that was many times oversubscribed and that brought significant new investors into our shareholder base. Especially in this market, conducting an offering with such demand from high-quality investors is a remarkable achievement. On April 10th, we announced the launch of Mia Femtech in Japan. The idea for Mia originated a decade ago when we recognized that breast augmentation was not meeting the needs of women in Japan. With the experience of Mia Femtech, we are providing a solution. With Mia, a plastic surgeon can shape the breast in a 15-minute minimally invasive procedure without the need for general anesthesia. The result is natural and discrete, with a one to two cup proportionate result. The procedure requires minimal downtime, with women returning to most activities the same day. By providing a solution that overcomes many of the obstacles of traditional breast augmentation, we are opening up a whole new group of women to breast aesthetics. Our launch activities are centered on creating this new category in Japan with our partner clinics. We have created marketing materials localized for the Japanese market, including a Japanese language Mia Femtech website, social media, and traditional media, all directed at creating demand and then directing interested women to our clinic partners. Mia Femtech is being launched initially at two clinic chains in Japan. Seishin Plastic and Aesthetic Surgery Clinic operates 10 premium clinics, with Mia Femtech now available at their main Tokyo clinic in Roppongi and at their newest clinic in Ginza. Joe Clinic is a high-end medical aesthetics chain in Japan that will offer Mia Femtech initially at its Tokyo and Osaka locations. It is still early in the launch of Mia, and we are focused on demonstrating that this is a new category, bringing new women into breast aesthetics and that surgeons are seeing improved efficiency and our partner clinics are benefiting from higher economics. These proof points will be important as we look to scale Mia into the multibillion-dollar opportunity that it has the potential to become. We look forward to providing updates on our progress in Japan in the coming months. We recently also announced our first European clinic partners for Mia. We have partner clinics in Spain, Switzerland, and Sweden, and I'm pleased to report that we have signed our first Mia partner in France. Clinique des Champs Elysées is a prestigious center for medical and surgical aesthetics based in Paris with a chain of 12 clinics throughout France. We continue to make good progress on finalizing European Union approval for the tools that are part of the minimally invasive system used for Mia Femtech. In our aesthetic breast recon franchise, the rollout of our Motiva Flora tissue expander continues. The market feedback continues to be very positive, with more and more surgeons making it their expander of choice in post-mastectomy breast reconstruction. What continues to resonate with clinicians globally is that Flora is a much-improved offering, with many new advances in what is unfortunately a large and often neglected category in breast reconstruction. In a recently published paper, scientists at the Medical University of Innsbruck in Austria were able to confirm in a comparative study that Flora provides much improved patient comfort and satisfaction in their breast reconstruction journeys. As a global medical device company focused on women's health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction. 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. On China, we are actively preparing for the launch of Motiva with our distribution partner. Over the last couple of months, we have conducted a significant amount of research in order to understand the opportunity in what is now the second-largest market for breast devices globally. The market in China continues to recover, with procedures in 2025 expected to exceed pre-COVID levels. There continues to be a very healthy luxury segment in China where consumers are paying procedure prices similar to the upper end of markets in places like the United States and Europe. Given the premium positioning of Motiva in other Asian markets, including South Korea and Japan, and the strong awareness of our devices in the Chinese market, we are very encouraged by what we are learning about this market and the opportunity. We continue to make progress in the regulatory process and expect to launch Motiva in this market in the second half of 2023.

Thank you, Juan José. Total revenue for the first quarter was $46.5 million. Reported revenue growth in the first quarter was 21%. Foreign currency changes reduced our first quarter revenue growth by approximately $750,000. Excluding the impact of currency, revenue growth in the quarter would have been 22.9%. Direct sales were approximately 36% of global Motiva implant sales, while distributor sales made up the balance. From a regional perspective, Motiva sales in Europe, Middle East, and Africa were approximately 44% of the global total, Asia Pacific 31%, and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 13% of total quarterly Motiva sales. Our gross profit for the first quarter was $30.1 million or 64.7% of revenue compared to $24.9 million or 64.8% of revenue for the same period in 2022. Our gross profit in the first quarter was negatively impacted by higher overhead and labor costs. Direct labor costs were higher in part from changes in foreign currency exchange rates between the US dollar and the Costa Rican colón. As we report in US dollars, a significant revaluation of the colón resulted in higher costs in the period. Average selling prices in the first quarter were up from the fourth quarter of 2022. We continue to see regular fluctuations in gross margin on mix and other factors. However, the trend in our gross margin is expected to be positive over time. SG&A expenses for the first quarter increased approximately $4.8 million to $31.7 million compared to $26.9 million in the first quarter of 2022. The increase in SG&A in the first quarter resulted in part from our investments in new growth initiatives like Mia and preparations for our launch in the United States. R&D expenses in the first quarter increased approximately $2.9 million in the same quarter a year ago to $6.5 million. Higher personnel costs and increased activity related to our US clinical trial contributed to higher spending in this period. Total operating expenses for the first quarter were $38.2 million, an increase of approximately $7.7 million in the year-ago period. Net loss from operations for the first quarter was $11.9 million compared to a net loss of $5.9 million in the same period in 2022. Our cash position as of March 31st was $42.8 million compared to $66.4 million at the end of 2022. Cash used in the first quarter included approximately $3.8 million of investments in our new manufacturing facility, as well as a planned increase in inventory of $8.5 million as we prepare for the growth we expect over the near future. On April 27th, we completed a 1.265 million share follow-on offering with net proceeds to Establishment Labs after fees and expenses of approximately $84 million. With the cash on hand at the end of the first quarter, the proceeds of the offering, as well as the two remaining tranches of our debt facility, which totaled $50 million and become available on the achievement of sales and regulatory milestones, we have access to approximately $175 million. We are reaffirming the revenue guidance we provided for 2023 of $200 million to $210 million, representing annual growth of 24% to 30%. We continue to expect gross margins in 2023 to be similar to 2022. Operating expenses as a percent of revenue in 2023 are also expected to be similar to 2022. Operating spending over the near term is reflecting our investments in development and commercialization programs. However, we expect expenses as a percentage of revenue will trend down as we move into these new initiatives and begin to leverage our spending. I will now turn the call back to Juan José.

Thank you, Raj. With the launch of Mia Femtech in Japan, the presentation of the three-year data from our US study and the successful follow-on offering the last few weeks have been very meaningful for our company, but we expect the coming months to be just as eventful. We look forward to providing updates on the commercial launch of Mia in Japan and the expansion into Europe. We are also preparing for the launch of Motiva into China. As we enter the United States and China, it is a major step in our efforts to build a breast aesthetics and reconstruction industry based on technology solutions to improve women's health and well-being. This has been more than a 12-year journey for us since we first went to market with Motiva. And each year, we publish our post-market surveillance report, which in effect details how we are doing. This is the only document of its kind in our industry released every year as an exercise of transparency with our stakeholders. It catalogs the clinical data that has been collected on the performance of our devices from several different countries. The report includes our own product and warranty claims information as well as registry data from different countries and independent clinical publications on Motiva. They are all telling the same story, namely that after over 12 years in the market, Motiva implants continue to have device-related complications in the very low single digits, in many cases, well less than 1%. And this is not a surprise for us. It is a downstream effect of science and technology, as all the papers about Motiva in published peer-reviewed publications attest. We look forward to making our products and solutions available to the largest markets in the world. We continue to publish this report every year. It is available on our website at establishmentlabs.com, and we encourage everyone to download it and review it. We will also hold the opening ceremony for our new Sulàyöm Campus on July 19th. The new manufacturing capacity at Sulàyöm more than doubles the number of implants we can produce per year, and it allows us to provide over half the current world demand. This facility also brings us significant new capabilities in R&D, media, and surgeon training. We are making progress every day towards our goal of building a strong women's health foundation to create vibrant and expanding markets for breast aesthetics and reconstruction, and to make a meaningful change in the lives of women around the world. I will now turn the call over to the operator for your questions.

Our first question is coming from Anthony Petrone from Mizuho Group.

Congratulations on your strong start to the year and then, of course, on the IDE data a couple of weeks ago. I think I'm going to start on Japan. Maybe just qualitatively, how the launch of Mia in Japan is going? And then maybe more specifically, when we think about the Seishin network of clinics, there was the initial launch in Tokyo there, but there's also the Joe clinics as well, the medical aesthetic locations. When we think about those collective sites, I think Seishin has 10 sites, not sure how many Joe has in their network. But how many sites are represented in those two networks and how many of those are you in currently? And then I have a couple of follow-ups.

And we're very pleased with our launch of Mia in Japan. But I do have to remind absolutely everyone of the importance to see this as the launch of a new category and not another product into traditional breast aesthetics. If it was a traditional launch, our main target would be to get as much market share as quickly as possible while preserving our average selling prices. The objective here is really to bring in consumers that are currently not interested in traditional breast augmentation. And that's why it is so important to address the potential obstacles that these women would see in traditional breast augmentation. If you look at all the marketing efforts that we are doing in partnership with Seishin and Joe Clinic, they are focused on that. So it hasn't been yet one month, but we are already pleased with the amount of traffic we are getting in the different digital assets that we are utilizing. We are working right now with Tokyo and expect to see expansion into Osaka and furthermore later in the next year to the other locations. These are chains of clinics, so they have a presence all over Japan, and we do expect to see Mia expanding as well geographically throughout Japan.

And then the follow-up would be just on the US side and following the final clinical module submission. Not necessarily on timing, but maybe as we look at the remainder of 2023, when you think about the buildup of the infrastructure on the US side. How much of that really is ongoing now potentially accelerates ahead of a potential approval, and then how much sort of bridges after a potential approval whenever that may come over the next year or so?

Yes, we have a very detailed, carefully thought-out plan for launch in the US. It's going to be our most important launch ever for this company. We have now launched Motiva in more than 85 countries. So we have a very clear blueprint of how we do things. We've already been building up toward the launch. And as we get closer and closer, we're adding people to that team, we're making sure that we have what is necessary, while we don't bring in people too early that would increase our potential spend unnecessarily. So that's kind of like the balance that we're trying to play with our US launch strategy.

Your next question is coming from Joshua Jennings from TD Cowen.

I echo Anthony’s congratulations on a strong start to the year and on the progress. I was hoping to just first ask, just two questions on Mia. First, maybe getting a little bit ahead of myself, but just thinking about the US approval track for Mia once you have Motiva approved. Is a supplemental PMA pathway a reasonable pathway to think of that could be open for establishment for Mia approval?

So right now, all of our efforts are geared towards getting approval for Motiva Round and Ergonomix. Ergonomix2 is the next-generation platform that makes Mia possible. And we do believe, and our regulatory experts have supplemented this, that once we gain approval for Motiva in the US, we would be able potentially to use that approval to build on it with an extension for these new catalogs that are necessary for Mia. So that's something that we need to explore more. And definitely, they will become more and more important as we get over the current approval process, but that's the important thing right now.

And then just second question. Again, getting ahead of myself, but just thinking about Mia, the approach, the technique, the many ways of technique your team has developed. I mean, should investors be thinking of Mia as a potential platform technology in aesthetics?

So if you think about other surgical specialties moving into minimally invasive, the creation of Mia as an experience required not only the Ergonomix2 platform but also a series of tools and techniques that go with it, so that you can have a true minimally invasive approach. So absolutely, you can use these technologies to go into other types of treatments in which minimally invasive would be required in order to get a similar experience as what you see with Mia. So it's a little bit early to go into that, but we absolutely do think that it is a platform.

Next question is coming from George Sellers from Stephens.

This is Harrison on for George. I just want to reiterate again. Congrats on the strong quarter, and thanks for taking the question. I wanted to start on Flora. I was wondering if you can give us an update on where you are as you build out that international market and specifically, what your expectations are in 2023 in terms of Flora contributing to growth? And any additional geographic areas that Flora could enter into later this year?

And Flora is the first technology that we have exclusively devoted to our aesthetic breast recon program, so it is very important to us. And what we see is quarter-to-quarter more surgeons and more hospitals taking on Flora. The build-out though of breast reconstruction demand is lower because it requires different tenders that may vary in timing from region to countries. So it is a build-out that cannot happen as accelerated as a normal breast aesthetics launch. Now we are though very pleased with the response that we get and also for the scientific backing that we are getting. This paper that I referenced in my remarks earlier is particularly important because it compares a direct competitor from the United States and their tissue expander to our Flora tissue expander in the same patient. So this is a true direct comparative evidence, and one in which most women were pleased with our expander as being their choice. So as we move along and we will continue to do so, I think this evidence will further prove the importance of this technology. And I will mention also the importance of Japan with Flora, because we received approval there at the end of last year, and we continue to add hospitals in Japan. So I think that's going to be further proof that in this type of sophisticated markets, we can do very well with Flora.

And then I wanted to ask one on Mia as well. As the launch in Japan and across Europe progresses, I wanted to ask about the partnership model and what kind of investment is required from the company as well as the clinics? And as well as this partnership model, should we expect this to be used across the company more broadly going forward, or is this specific to the launch of Mia?

So as a company, Establishment Labs has been moving closer and closer to consumers over the last decade. Mia is the first offering that is truly conceptualized and designed for the type of experience that Mia is. So when we look at this partnership model, it is also a different business proposition, one in which we are partnering with selected clinics. These clinics understand very well that they will have to invest alongside us to be able to bring in these new consumers that are not looking for traditional breast augmentation. So it is a very different type of thing. Remember, we don't have any sales reps for Mia. We invest this money in creating demand. So we will continue working with this model. In Europe, once we are able to launch there and we are very happy with the type of interactions that we are doing with these partner clinics. We'll see what happens in the future if this is a model that we want to move across the organization.

Your next question today is coming from Neil Chatergy from B. Riley Securities.

Congrats on the strong quarter. Maybe just sticking with Mia, just curious more broadly how that partner funnel is shaping up in other markets. And then just secondly, what does the French market look like with a new partner there, maybe in comparison to the Swiss market that had about, I believe, 400,000 women eligible for Mia and about 200,000 that were interested?

And we are as excited as everyone with Mia and the possibilities that it can have over time. We are looking at a multibillion-dollar opportunity at peak. And our job is to basically develop that market and prepare for it with these partner clinics. So if you look at Europe right now, we are looking at the first European partners in Sweden, Switzerland, Spain, and now also in France. So when you look at clinics like Nordiska in Scandinavia, Lehman and Utoquai in Switzerland, or Planas and Clinique des Champs Elysées in Spain and France, respectively, what we are looking at is like literally the best of the best in terms of the potential partners that you can use to go direct-to-consumer and compliantly be able to get them to understand that this is a different type of offering. When we look at the next few months, I think, again, it's about the qualitative part, it's about being able to get through that door, a new type of consumer. With Clinique des Champs Elysées is a particularly interesting group if they have 12 clinics throughout France. We are going to begin at their main location in Paris and nine additional other clinics throughout the country. So very excited about all these possibilities.

Maybe just switching to China. So I just wanted to check in on how things are tracking with kind of the regulatory process for Motiva there, targeting that second half launch. And then just also, I believe you're planning to leverage the distributor you have for South Korea. I’m just curious, if you could just elaborate on what they're seeing on the ground and from any market research in front of that launch?

Yes, actually, we've been doing more and more work in preparation for the launch in the second half. And one of the important things is that breast aesthetics is bouncing in China from the COVID levels into something that looks more like what we were seeing before COVID. And it is expected that by 2025, we will be back at 2019 levels. Now, the other very important thing is that you do see patients continuing to request premium brands. So that plays particularly well for us. And we are working with our partner, Human Wellness Corporation. One of the reasons we chose them as our partner for China is that the Chinese consumer does look up to what is going on in South Korea when it comes to aesthetics. Now, of course, our partner is putting together an entire team in the ground in China, locals that understand the particularities of each region and can deal with those. So as soon as we receive the approval from the NMPA, we will move on into the launch phase with our partners.

Next question is coming from Marie Thibault from BTIG.

Just wanted to follow up on Neil's question about China. I heard you say that you're expecting to launch in the second half. In the past, you've said approval planned in the first half. Is that still true, are you able to reiterate that?

We are so close to it that we think that it is time to focus on the launch. It is in the hands of the NMPA, but we have enough visibility to feel strongly that we are in the preparation last phase of the launch.

And then a question here, probably a follow-up from what Anthony asked earlier about US commercialization preparation. Your SG&A was particularly well controlled this quarter. I wanted to ask what drove that and how to think about the trend for the rest of the year, given you do have plans for the US launch here. So how to think about the sales rep build and the SG&A build from here for the rest of the year? Definitely heard the commentary on it being OpEx being similar to 2022 for the full year, but just trying to understand the cadence.

I would say that the first quarter, as we entered the year, just given some of the uncertainty that we and a lot of other companies were seeing, we took a very prudent approach to our spending, and I think you saw that in the numbers. As we've talked about, though, we do expect OpEx, as you noted, to be similar this year to last year as a percentage of revenue. And we continue to expect that. So as we move through the year, some of the investments in things like Mia will continue to pick up, and then certainly the US will start to come on. So I would really look at the first quarter as really being kind of prudent as we started the year, but the spending is still on tap as the year unfolds.

Your next question is coming from Matt Taylor from Jefferies.

So I had a couple of guidance questions for you. First thing I wanted to ask you to be clear about is, can you talk about how much China revenue, and if there's any US revenue in guidance this year?

We haven't provided specific figures for that. China is included in our guidance for this year, and we remain very confident in that. As Juan José mentioned, we are preparing for our launch in China. Regarding the US, we have not added it to our guidance for this year. We are currently waiting for the FDA's updates, so we have chosen not to include it at this time.

And then, Raj, one follow-up. Just on the guidance range for the year, Q1 needed 23% growth on kind of the second easiest comp. So I guess what I'm getting at is maybe you could talk about the big factors that would take you to the higher versus the lower end of the guidance this year. In your mind, are they more macro or more of the micro things that you're discussing here with the product launches?

I would say we are definitely monitoring the macro environment. However, the key factor is really the timing of our initiatives. For instance, when China enters the market and the pace at which Mia is introduced are critical aspects we are observing closely and managing our spending accordingly. The guidance range reflects some uncertainty regarding how these elements will play out this year. As we reaffirmed our guidance, we remain very confident in our outlook, and our perspective has not changed.

We reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

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

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.