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Edited Transcript of ESTA.OQ earnings conference call or presentation 9-Nov-20 10:00pm GMT

·35 min read

Q3 2020 Establishment Labs Holdings Inc Earnings Call Nov 10, 2020 (Thomson StreetEvents) -- Edited Transcript of Establishment Labs Holdings Inc earnings conference call or presentation Monday, November 9, 2020 at 10:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * David K. Erickson Establishment Labs Holdings Inc. - VP of IR * Juan José Chacón Quirós Establishment Labs Holdings Inc. - Founder, CEO & Executive Director * Renee M. Gaeta Establishment Labs Holdings Inc. - CFO ================================================================================ Conference Call Participants ================================================================================ * Christopher Cook Cooley Stephens Inc., Research Division - MD * Joshua Thomas Jennings Cowen and Company, LLC, Research Division - MD & Senior Research Analyst * Marie Yoko Thibault BTIG, LLC, Research Division - Director & Digital Health Analyst * Matthew Charles Taylor UBS Investment Bank, Research Division - Equity Research Analyst of Medical Supplies & Devices * Philip Caldwell Coover Goldman Sachs Group, Inc., Research Division - Associate * Rajbir Singh Denhoy Jefferies LLC, Research Division - MD, Equity Research & Senior Equity Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good afternoon, and welcome to Establishment Labs Third Quarter 2020 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to hand the conference over to your speaker today, David Erickson, Vice President of Investor Relations. Please go ahead. -------------------------------------------------------------------------------- David K. Erickson, Establishment Labs Holdings Inc. - VP of IR [2] -------------------------------------------------------------------------------- Thank you, operator, and thank you, everyone, for joining us. With me today are Juan José Chacón Quirós, our Chief Executive Officer; and Renee M. Gaeta, our Chief Financial Officer. Following their 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 involve material risks and uncertainties, and the company's actual results may differ materially. For a discussion of risk factors, I encourage you to review our quarterly report on Form 10-Q that we filed with the SEC today and is available on our website at establishmentlabs.com. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, November 9, 2020. 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's my pleasure to turn the call over to our CEO, Juan José. -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [3] -------------------------------------------------------------------------------- Thank you, David, and good afternoon, everyone. I hope everyone is healthy and continues to be safe. As we guided to in October preannouncement, total revenue in the third quarter was $22.8 million, which is comparable to the $22.9 million reported in the third quarter of 2019 and more than double the sales reported for the second quarter this year. With a strong recovery from the pandemic well underway, we are comfortable issuing full year 2020 revenue guidance of $80 million to $82 million. While we are now back to our 2019 revenue levels, we believe we are actually recovering faster than our global industry. Our success at returning to prepandemic levels is actually indicative of continued market share gains, which can be attributed not only to the superior aesthetic and safety profile of our implants but also in how our digital efforts have amplified how we communicate both patients and doctors. In addition to strong top line sales this quarter, our focus on lowering expenses and driving efficiencies led to a continued decrease in our operating cash burn. During the third quarter, our cash burn was $3 million, giving us a cash position at September 30 of $81.4 million. This keeps us in a strong financial position and affords us the flexibility to continue managing our business for continued growth and market share gains. Importantly, in the quarter, we continued to advance the technologies in our R&D pipeline that will contribute to our sales growth in 2021. Equally important, our submission time line to gain regulatory approval and enter the U.S. market remains on track. Like most of the world, our business and industry have not yet returned to normal, but we are on a clear path towards doing so. Of course, we are seeing country-to-country volatility as COVID-19 flares up in some places, but sales in more than 80 countries has given us some stability to manage our business throughout this period. As of today, plastic surgeons are operating even where government restrictions have limited other activities. It certainly helps that the majority of breast enhancement procedures are not performed in hospitals but in private clinics, which are generally owned or controlled by plastic surgeons. While not all countries are performing procedures at prepandemic levels, all countries in which we operate are open and performing procedures. Our Q3 sales in Europe and Asia were at or above levels reported in the third quarter last year. Latin America appears to have seen the worst of things and finished October fully reopened with continuing improvement across the region, including Brazil. Most importantly, we have seen continued month-over-month improvements since the lows of April, and this has continued into the fourth quarter. Third quarter direct sales, which continue to be the most reliable indicator of real-time trends, were back to the levels of direct sales in the first quarter of 2020, which, except for the final 2 weeks of March, were mostly unaffected by COVID shutdowns. Distributor sales, which are best viewed as an indicator of future demand, showed stronger sequential gains than direct sales. The most important takeaway from our third quarter results is this: patient demand is strong. Across our many geographies, we consistently hear from surgeons that they have never been busier, as they work through their backlogs, and that new patients are interested in using this time to recover at home from aesthetic procedures. One of the interesting and unexpected outcomes of the pandemic is that with the increased time at home, patients are eager to invest in themselves. Both plastic surgeons and patients have become much more adept and comfortable with online tools for education and initial consultations. As we noted last quarter, the level of optimism and business outlook among our plastic surgeon customers remains quite positive. Turning to some recent events. I would like to recap some of the data we announced at our 10-year Motiva symposium a few weeks ago. At that event, we were pleased to report 10-year post-market surveillance data from a variety of sources, demonstrating an unmatched device-related complication rate of less than 1% for the key safety end points of capsular contracture and implant rupture. These are 2 of the most important safety metrics when evaluating the success of breast augmentation procedures. Of all the data sets that we discussed at our symposium, I would like to highlight one in particular, our warranty data from the past 5 years. With approximately 12,500 women purchasing extended warranty coverage, only 9 of them, just 0.73%, required coverage for reoperations. This data is incredibly compelling. Patients and doctors are economically incentivized to let us know about every complication, and yet the reported number remained below 1%. If continued studies support these findings, it will represent a dramatic improvement over the historical published numbers of our industry. This data speaks to something beyond a competitive advantage, however. It could change how women perceive the safety of breast augmentation procedures in general. If perception of the industry improves, along with widely reported new safety data, the total addressable market could grow substantially. While we would like to focus on the data that we are generating regarding our improved safety profile, even more important is improved patient experiences. Word-of-mouth and online forums are an important component of our growth, and the superior performance and results of our products is at the heart of our success. As firsthand experiences are the driving force behind our business, the second part of this symposium featured a panel of leading plastic surgeons who discussed the important technological differences between Motiva and other implants and shared their real-world experiences with our products. Their belief in Motiva and the growing body of evidence supporting our unmatched clinical results are why nearly 1.3 million Motiva implants have been placed worldwide over the last 10 years. If you did not get a chance to catch the symposium, we have archived it on our website, and I hope you find time to do so. Surgeons are taking time to listen to their peers. Our digital platform, MotivaEdge, offers online training programs and seminars and attracts both new and existing surgeons interested in education and the latest innovations in breast implant technology. So far this year, the total audience for online MotivaEdge scientific events has been more than 19,000 plastic surgeons and other medical professionals. Now for an update on our product pipeline. We have a number of exciting and innovative new technologies, several of which represent potential growth drivers in 2021. Beginning with our Motiva Flora tissue expander. We are continuing to collect early patient experience in advance of our broad commercial launch in Europe early next year. We believe the market will be receptive to the advancements offered by Flora, including a proprietary integrated RFID port in our SmoothSilk bioengineered service. In the 8 sites that have used Flora so far, feedback has been very encouraging with surgeons commenting on its ease of use and patients reporting overall satisfaction and comfort. Although our Motiva implants are already used in breast reconstruction procedures in Europe, the ability to pair them with one of the most advanced tissue expanders available means that we will be able to fully access this important market. As for Flora in the U.S., we now expect to submit our 510(k) in the first half of 2021. Once cleared by the FDA, we will be able to access the largest portion of the $225 million global tissue expander market. We expect receipt of CE Mark in Europe for Motiva Ergonomix2 implant in the fourth quarter. Ergonomix2 builds upon our successful Ergonomix implant, which has become our best-selling and most premium offering in many markets, including Europe and Asia Pacific. The features of this innovative new product, including enhanced mechanical properties, advanced chemistry and improved ergonomics, should result in even greater patient satisfaction. As it is so feature-rich, we expect Ergonomix2 to command a premium price over Ergonomix. Plastic surgeons familiar with Ergonomix should be able to switch easily to Ergonomix2, which will be available in a wide range of sizes throughout Europe. Turning to Motiva Mia, our minimally invasive breast augmentation program. We are continuing to make good progress as we fine-tune the surgical technique. During the quarter, we received IRB approval to begin a patient series in Thailand. To broaden our experience even further, we are also planning to initiate a patient series in Latin America by the end of the year. Motiva Mia is a very promising technology, and we are excited by the opportunity to expand the addressable market for breast aesthetics by creating a new product category. We are confident of the large number of women who would be interested in a less-invasive breast procedure with safety and aesthetic outcomes similar to our current Motiva implants. If Mia is successful, it would contribute meaningfully to our growth and further differentiate us in the market. Motiva is already the implant of choice for many surgeons and patients around the world, and we are eager to introduce our innovative product portfolio to the large Chinese and U.S. markets. We are continuing to make progress with our regulatory submission in China, and we expect approval during the first half of 2022, as previously discussed. Customers in this market are active digital users for product information, breast enhancement education and scheduling of plastic surgeon consultations, and this plays very well to our strong digital capabilities. The United States represents the single largest breast implant market in the world, and we are continuing to pursue approval to offer Motiva to women and plastic surgeons in this geography. Study follow-up visits are continuing for all patients of our U.S. IDE clinical trial, and follow-up compliance is high, even during the more challenging pandemic environment. Approximately half of the patients in the aesthetic cohorts have reached their 2-year anniversary date, and all study-related activities remain on track for FDA requirements. We are very eager to demonstrate the advantages of Motiva in an FDA clinical trial. You will recall we successfully completed enrollment in the revision reconstruction subcohort during the second quarter. Enrollment in our remaining reconstruction cohorts, which was delayed by the pandemic, still continues, and we are making steady progress. With that, I'd like to turn the call over to Renee to discuss the financials in detail. Renee? -------------------------------------------------------------------------------- Renee M. Gaeta, Establishment Labs Holdings Inc. - CFO [4] -------------------------------------------------------------------------------- Thank you, Juan José. Not only did we see strong sequential growth in sales this quarter, we aggressively controlled operating expenses, and I'd like to thank the team for helping to keep Establishment Labs in a very solid financial position. You can find additional details about our third quarter financials in our earnings press release and our Form 10-Q, which we filed today. Total revenue for the quarter was $22.8 million. Direct sales were approximately 40% of this total, while distributor sales, which can fluctuate based on changes in inventory levels and the timing of reorders, made up the balance. Our direct/distributor sales mix this quarter has returned to a more typical pattern and was similar to the same period a year ago. From a regional perspective, sales in Europe comprised approximately 45% of global sales; Asia Pacific, Middle East was approximately 35%; and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 10% of total quarterly sales even though the Brazilian real has depreciated approximately 40% this year. As Juan José mentioned, both direct and distributor sales in Latin America were down year-over-year as the region continued to recover. By comparison, year-over-year growth was strongest in Asia Pacific and Europe as those regions recovered more quickly. Our reported gross profit for the third quarter was $15.1 million or 66.6% of revenues compared to $14.2 million or 62.3% of revenues for the same period in 2019. The year-over-year increase was due to the benefit of geographic mix, greater operating efficiencies and enhanced manufacturing and planning capabilities. Total operating expenses for the third quarter was $17.7 million, a decrease of $5.3 million or 23%, compared to $23 million in the same period a year ago. SG&A expenses for the third quarter declined $4.2 million or 21.9% to $15 million compared to $19.2 million in the third quarter of 2018. The majority of this decrease resulted from our commitment to preserve cash by controlling expenses, including lowering consulting fees, lower sales and marketing expenses and the reduction of other discretionary expense categories. Our research and development expenses for the third quarter decreased $1.1 million from the same quarter a year ago to $2.7 million. Most of the reduction was due to the timing of clinical trial expenses and the reprioritization of certain projects. Strengthening our product portfolio to drive future growth remains a top priority, and we will continue to invest in research and development with discipline and focus. Net loss from operations for the third quarter was $2.6 million compared to net loss of $8.8 million in the year ago period. During the third quarter, we used $3 million to fund operations compared to $6.1 million in the second quarter of 2020 and $10.9 million for the third quarter of 2019. This demonstrates our ability to restrict cash burn when circumstances require it and invest when warranted, all while driving growth. From a balance sheet perspective, our cash position remains strong at $81.4 million as of September 30 compared to $86.4 million on June 30. To help you with some modeling, we expect to see fourth quarter expenses similar to what was reported in the third quarter, and we plan to provide more specific 2021 guidance next year. Overall, we believe our company is in a strong competitive position. The business fundamentals are sound, and we remain very optimistic about the potential for our new products to contribute to our growth in 2021. And while the COVID pandemic still presents a degree of uncertainty, I am confident we have the flexibility to respond quickly to changes in our business and will continue to remain diligent as we progress towards cash flow breakeven and profitability. I will now turn the call back over to Juan José for some concluding remarks. -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [5] -------------------------------------------------------------------------------- Thanks, Renee. Before we open it up for questions, I'd like to express my gratitude to our plastic surgeons and business partners for their ongoing commitment to Establishment Labs. I also want to acknowledge and thank the employees of Establishment Labs for their tremendous effort and resilience, which has enabled us to successfully navigate a challenging year while meeting our operating and financial commitment. Establishment Labs has a very bright future, and we are excited about our ability to grow and create value for our shareholders. As we look to 2021, we have truly differentiated technologies coming that will expand our comprehensive portfolio. We expect continued market share gains, both from expanding our presence in breast reconstruction and also developing new product categories, like minimally invasive augmentation. These will help support our growth next year and for many years to come. We continue to plan for our entry into the U.S. and Chinese markets while staying committed to controlling expenses and increasing our efficiency to maintain the strong financial position. Finally, in honor of breast cancer and breast reconstruction awareness month in October, as part of our global campaign, Establishment Labs was privileged to partner with plastic surgeons and medical personnel in Brazil, who volunteered their time to perform more than 60 reconstruction surgeries for breast cancer survivors. Many of these women have been waiting for a long time for their surgeries, and being able to help them in their journey is an important and powerful reminder of our commitment to women's health and well-being. We thank you for your support as we continue to transform this industry while improving women's health. With that, I will turn the call over to the operator for Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Your first question comes from the line of Chris Cooley with Stephens. -------------------------------------------------------------------------------- Christopher Cook Cooley, Stephens Inc., Research Division - MD [2] -------------------------------------------------------------------------------- Can you hear me okay? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [3] -------------------------------------------------------------------------------- Yes. We can hear you. -------------------------------------------------------------------------------- Christopher Cook Cooley, Stephens Inc., Research Division - MD [4] -------------------------------------------------------------------------------- Well, congratulations on the very impressive results in light of an extremely challenging environment. Maybe just two quick ones for me. First, when we think about just what you saw in the third quarter and the exit rates here as we're going into 2021, curious what you anticipate seeing most specifically in the European theater in terms of growth here in the fourth calendar quarter. Do you think that we'll see additional spikes, and is that kind of what we need to bake in? Or is it an environment now that can manage through any flare-ups that you're seeing there? Just curious, again, a little bit more about what's built into the expectations for the fourth quarter from a top line perspective. And then similarly, if I could, maybe just as my follow-on with Renee in terms of your cash flow breakeven commentary. Could you just update us again when you expect to achieve those levels? I mean, clearly, you're getting much better leverage now, have done a great job of expense management. Just curious if you plan to spin some of those savings or that initial target on cash flow breakeven could be pulled forward somewhat. -------------------------------------------------------------------------------- Renee M. Gaeta, Establishment Labs Holdings Inc. - CFO [5] -------------------------------------------------------------------------------- Chris, thanks for the questions, and thanks for joining us today. Certainly, as we went through the third quarter, we saw strong performance in Asia Pacific and Europe as those countries responded well to the pandemic and came back online. And Latin America was certainly behind that, but we've seen improvements and well -- as well and sort of month-over-month improvements. As we think about the guidance that we gave for the fourth quarter and full year, we're factoring in a variety of things that we're juggling at the moment and the fact that we're in over 80 countries. Our guidance represents our best estimate for Q4 based on everything that we presently know, and we're obviously actively monitoring the situation in Europe. But it's nice to see that most of the governments that are providing restrictions, they aren't doing full lockdowns. And so we've continued, as of today, to continue to see procedures continue to operate. But as your question implies, we're watching it closely, and we'll have to see how the rest of the quarter plays out. As you, in your second question, asked about cash burn, I'm very happy with the team's response to this year and everything that we've been juggling. And it's great to see that we can restrict cash burn when needed, but we also fully appreciate that we will want to continue to invest in research and development and new product innovation so that we can continue to bring amazing products to this industry. So I'm not going to specifically comment on when I think the cash burn is going to turn profitable or turn positive, but I'm extremely excited with what we've done this year and look forward to getting there. -------------------------------------------------------------------------------- Operator [6] -------------------------------------------------------------------------------- And our next question comes from the line of Matt Taylor with UBS. -------------------------------------------------------------------------------- Matthew Charles Taylor, UBS Investment Bank, Research Division - Equity Research Analyst of Medical Supplies & Devices [7] -------------------------------------------------------------------------------- So Renee, maybe one for you. I was wondering on the Q4 guidance, if you could help us understand between Q3 and Q4, how much stocking do you think there was for some of your distributors? Did that help you in Q3? And are you expecting a similar, more or less, benefit in Q4? -------------------------------------------------------------------------------- Renee M. Gaeta, Establishment Labs Holdings Inc. - CFO [8] -------------------------------------------------------------------------------- We -- our Q3 results, most of our distributors are ordering based on sales forecast for future quarters. I would not indicate that there was restocking or replenishments there. I think we're very happy to see the activity that's coming from our distributors, and we're talking with them on a monthly basis. So when I look back at Q3 and look back at it in comparison to the prior year Q3, sort of gave some commentary where we're really seeing it sort of return to normal, both not only the balance of direct versus distributor but then also some of the geographic stuff. So we're happy to see business returning that way. -------------------------------------------------------------------------------- Matthew Charles Taylor, UBS Investment Bank, Research Division - Equity Research Analyst of Medical Supplies & Devices [9] -------------------------------------------------------------------------------- Okay. And can you speak a little bit to the outlook for surgical schedules? Have you talked to your customers? Do you have any beat on how things are looking early into next year relative to the pre-COVID baseline? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [10] -------------------------------------------------------------------------------- Yes. Matt, what we are seeing is that the business continues to progress well. And while we continuously have seen as well these flare-ups in different areas of the world, what we have found is that surgeons have gotten really good at adapting to the situation. So the way they are conducting online consultations, the way they are providing very safe protocols for patients to come in when they need to, everything they're doing around providing safe protocols for the surgery procedures to take place, so all of that is going on. So the situation is very different from last spring. And what we are seeing now in Europe, we have seen in other places at different times. So I think by now, the plastic surgery community is well adapted to the situation. So of course, we're monitoring things literally week-to-week over those 80 countries, but we feel confident of where we are in terms of patient demand, and the online search activity supports that confidence. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- And our next question comes from the line of Raj Denhoy with Jefferies. -------------------------------------------------------------------------------- Rajbir Singh Denhoy, Jefferies LLC, Research Division - MD, Equity Research & Senior Equity Research Analyst [12] -------------------------------------------------------------------------------- I wonder if maybe, Juan José, I could start with you on Flora rolling out, I guess, CE Mark later this year -- by the end of this year and then the U.S. at some point next year. Maybe you could give us some -- your thoughts around how quickly this could start to take share. And that $225 million market opportunity you described, what would be a reasonable expectation for you over the next, say, call it, 12 to 18 months? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [13] -------------------------------------------------------------------------------- Yes. Thank you, Raj. Well, look, we are, of course, super happy that we got the CE Mark for Motiva Flora earlier this year. We are conducting premarketing activities, and we're doing that in preparation of a broader commercial launch in 2021. What we have seen so far in the different centers where they are using Motiva Flora is that they are commenting on its ease of use and patients reporting overall satisfaction and comfort with the device. Now we need to educate surgeons about the unique features of Flora, including what this bioengineered surface means if you pair that surface in the tissue expander ahead of the use of our Motiva implants. And then also, there's that integrated RFID port that is MRI compatible. So we're doing a lot of good work to measure the benefits because, of course, what we want to be able is to bring to market, once we fully launch this, at the right price point. So I think that we're not in a hurry to do this. I think when we see the sales of -- in the past that we've had of breast implants in reconstruction, it's been very low for us because we've been focused mostly on aesthetics. But the plan is next year that as we start bringing to market this Motiva Flora, we're also going to be bringing to market the Ergonomix implants, for instance, for breast reconstruction. Now remember, most of the countries in Europe for reconstruction, you're talking about government contracts, hospital contracts, and that takes time. So although we may do a broad launch in the first half of next year, do remember that we have to go through the process of how contracting takes place. -------------------------------------------------------------------------------- Rajbir Singh Denhoy, Jefferies LLC, Research Division - MD, Equity Research & Senior Equity Research Analyst [14] -------------------------------------------------------------------------------- That's helpful. And maybe just also on Europe, maybe as a follow-up there, there was a report, which I'm sure, I think you guys actually sent around, out of European Commission recently on -- again, on textured implants and their association with ALCL. It's not something that seems to be getting a lot of focus, at least not as much as it used to get, but maybe you could describe a bit about what you're hearing on the ground in terms of how much are these issues with textured implants still pushing surgeons to move towards Motiva? Is that still a very active process, you think? Or it's sort of through the worst of that in the sense that people have sort of already voted where they want to be in terms of their implant choice, and these reports are really just sort of nothing new in maybe physician's minds? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [15] -------------------------------------------------------------------------------- Yes. As you well know, we were the company that saw this coming a decade ago, and that's why we created that proprietary bioengineered surface. What I would say is that what we have seen last month is more of the same. What we are talking is about regulators placing another set of restrictions. So first, we saw earlier last month, the TGA in Australia taking out of the market 2 microtextured devices and polyurethane implants completely out of the market in Australia. And then this committee report, the SCHEER Committee, which is basically a committee of the European Commission that looks at safety issues, what they are highlighting and what's particularly interesting there is that they are calling out on the association between textured implants and ALCL. And as you know, according to ISO 14607, we are a smooth surface. So we do think that this purge of unsafe devices is good for the industry. It's going to bring us closer to the patients and closer to women who were worried about these devices. And just like we've done over the last few years, we will continue to push the message of safety and trying to gain as much market share that we can because of that superiority. -------------------------------------------------------------------------------- Operator [16] -------------------------------------------------------------------------------- And our next question comes from the line of Josh Jennings with Cowen. -------------------------------------------------------------------------------- Joshua Thomas Jennings, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [17] -------------------------------------------------------------------------------- I want just two questions. First, on the FDA trial, I think with your symposium and the stellar data that was presented there, it's catalyzed some questions from investors around when we could see data from the augmentation cohort. The aesthetics cohort, to your follow-up, should be completed by next August. Should we be expecting the initial look at that augmentation cohort data before the end of 2021? Or could it come sooner? Just wondering if you could help investors think about timing of when we could see the initial data from the FDA trial? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [18] -------------------------------------------------------------------------------- Yes. Thank you, Josh. One of the really good things in terms of the progress is the fact that half of the patients in the aesthetic cohorts have now reached their 2-year anniversary of their surgery, so that shows the progress that we are making. Now we are -- of course, we're looking very much forward to showing our data because we believe that data will be consistent with what we have seen outside of the United States. However, all of these things are ongoing. The conversations with the FDA are a part of that. And we do plan to show our progress as soon as it is possible. But those conversations keep on going with the FDA. We'll let you know as soon as we know some of the, I would say, clear images regarding this. -------------------------------------------------------------------------------- Joshua Thomas Jennings, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [19] -------------------------------------------------------------------------------- Understood. And then just thinking about China, I mean, huge market opportunity you're going to unlock. I was hoping you could just share this. What's left in the regulatory process for China FDA approval, if that's the pathway you guys are taking? And should we be expecting approvals in China, when they happen, for Ergonomix2, Mia and Flora? Or what will be the initial implants or devices that will be approved with that initial opening up of the China gate? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [20] -------------------------------------------------------------------------------- Yes. Thank you. And of course, for us, the opportunity in China is super exciting. Already, many patients fly from China to places like South Korea, Japan or Vietnam to get Motiva implants, at least they were doing so before the pandemic. And out of those, in countries like South Korea, 25% of patients used to come from China. So we know that our technology is going to fit very well into that market, which is said to be the fastest-growing breast aesthetic market in the world and the one with the highest average selling prices. So we just passed our latest round of testing earlier in last quarter, and we continue to make progress. We are going to continue working on that product testing that is coming and then complete the remaining regulatory steps. We are expecting approval in the first half of 2022. Those are for Ergonomix and round SmoothSilk implants. But we are planning all of the work that we are doing now with the Chinese regulators to allow us to build on that so that we can bring, of course, Ergonomix2 and especially Motiva Mia because we do believe that Motiva Mia is particularly well-suited for the Chinese market. And some of the early experience work that we are doing with Ergonomix2 and some of the patient series that we are planning with Mia, they all will be in that same line to eventually use that information for the Chinese market. -------------------------------------------------------------------------------- Operator [21] -------------------------------------------------------------------------------- And our next question comes from the line of Marie Thibault with BTIG. -------------------------------------------------------------------------------- Marie Yoko Thibault, BTIG, LLC, Research Division - Director & Digital Health Analyst [22] -------------------------------------------------------------------------------- I wanted to ask one here, recalling the symposium you hosted last month and that excellent 10-year data. In line of that, I wanted to hear sort of the feedback you've been hearing from industry. And on a related note, any details you can tell us about Establishment Labs' ability to pick up new surgeons during the COVID? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [23] -------------------------------------------------------------------------------- Yes, of course. So I think we've talked about this before, is that for many years, our competitors spoke about Motiva implants not having been in the market for long enough to really measure the safety profile of our devices. And because the FDA establishes the studies as a 10-year study, then surgeons tend to look at that 10-year mark very carefully. So of course, we have received very good feedback from the plastic surgery community, but also from patients that have these devices now for 10 years. So we were very happy to show in that symposium, for instance, the results of patients who've had the devices for that long. So that's definitely very helpful for us. And it also allows us to really go into our medical education platform and to MotivaEdge with that message of 10 years in the market with that amazing safety data. And just to remind everyone, so far this year, we've had over 19,000 plastic surgeons trained using MotivaEdge, and out of those, thousands of new accounts. So I think that, of course, we want to get those new accounts to start using Motiva as quickly as possible. We are working towards that. But it does show that there is a strong connection between the safety data, our ability to conduct online education and eventually turning that into new accounts. -------------------------------------------------------------------------------- Marie Yoko Thibault, BTIG, LLC, Research Division - Director & Digital Health Analyst [24] -------------------------------------------------------------------------------- That's great. I wanted to ask a follow-up on Motiva Mia. Good to hear that you'll be expanding into a patient series in Latin America. But I wondered where is this taking us in terms of sort of the time line for Motiva Mia? When might we see kind of data from that patient series? And then what is the plan for, I guess, formal trials and the regulatory process? -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [25] -------------------------------------------------------------------------------- Yes. Thank you. And what we want to be able to do with these patient series is to not only expand the number of patients who have received Motiva Mia but also look at different geographies. So we started the series in Asia with some patients being -- getting Motiva Mia in Japan. And the plan now is to turn those series also to Latin America so that we can learn how fast can plastic surgeons begin doing this procedure because, in a way, it's a simpler procedure but it's different. So we want to learn about that, how can we make this procedure replicable because we're setting a new standard for minimally invasive breast augmentation? And of course, we do plan to expand our series in Asia to Thailand so that we can also see in another market in Asia how does that relationship between the education, the standard can take place in a way that we can capture as much value with Mia. Now because this technology is so promising, we are being patient, and we are being patient because we want to get it right. There's also a strong direct-to-consumer part of this that we are also working very hard on. And this is going to be perhaps the other building block that we're going to begin talking about more and more, which is how can we get women who are currently using padded bras but not thinking about a breast augmentation because that's not what they want to eventually see this as an option. And I think that's one of the key things in this whole equation and one that we are working on very hard. So I would say, Marie, is we will show data as soon as we can. But most importantly, we already have the safety data of the surface. We are talking about implants manufacture under the same conditions as the rest of our products. So we are fairly confident on that side. It is mostly about getting to the final details of the surgical procedure and then how do we teach this to surgeons all over the world. -------------------------------------------------------------------------------- Operator [26] -------------------------------------------------------------------------------- And our last question comes from the line of Amit Hazan with Goldman Sachs. -------------------------------------------------------------------------------- Philip Caldwell Coover, Goldman Sachs Group, Inc., Research Division - Associate [27] -------------------------------------------------------------------------------- This is Phil on for Amit. I thought I should start maybe for Renee. It's a question around cost controls and the great job you guys have done with OpEx so far this year. I'm wondering how durable some of those cost savings might be as we look out to 2021 and maybe how those are going to be related to a resumption in procedures and a ramping back up of sales next year. -------------------------------------------------------------------------------- Renee M. Gaeta, Establishment Labs Holdings Inc. - CFO [28] -------------------------------------------------------------------------------- Yes. Thanks, Phil. Yes, I mean, we've been very pleased with this year and how the team has worked diligently across all departments of the organization, thinking about different ways to do things differently. I think not unlike many other companies, sort of reevaluating how we do business in the most efficient manner and yet -- while still delivering on our growth targets and our innovation product pipeline. So we will -- obviously, costs will come back in as growth continues to ramp, but I think we've learned a big lesson this year, and I'm hopeful that some of those are going to stick. Some of the cost controls that came in, you have to keep in perspective that they are volume based, so they will just automatically come back when revenue continues to grow. But again, I think things like travel or events or, again, just different ways of working with our vendors or consultants, I'm really pleased to see the sort of new culture that we've adopted. -------------------------------------------------------------------------------- Philip Caldwell Coover, Goldman Sachs Group, Inc., Research Division - Associate [29] -------------------------------------------------------------------------------- That's great color. I appreciate it. I think the second one, looking to 4Q, certainly appreciate the conservatism you guys are taking given all the question marks ahead. I'm wondering if a 30% growth number on '21 right now from The Street is an appropriate place to start as you guys think about the recovery and the visibility that you have maybe in light of some of the developments today. -------------------------------------------------------------------------------- Renee M. Gaeta, Establishment Labs Holdings Inc. - CFO [30] -------------------------------------------------------------------------------- Yes. It's a good question, and I totally appreciate it. I think we're still finalizing our 2021 annual operating plan, which includes real-time assessment of business conditions in all of the countries that we operate and how the pandemic is happening and flowing through. So at this stage, I'm not going to be able to give too much more color to that, but we're trying to be really thoughtful in this process, and we're just excited with the results that we've seen today. -------------------------------------------------------------------------------- Operator [31] -------------------------------------------------------------------------------- Thank you. And this does conclude today's question-and-answer session. I would now like to turn the call back to management for any further remarks. -------------------------------------------------------------------------------- Juan José Chacón Quirós, Establishment Labs Holdings Inc. - Founder, CEO & Executive Director [32] -------------------------------------------------------------------------------- Thank you for joining us on today's call. We look forward to providing our next quarterly update early next year. Have a very good rest of the day, and please stay healthy. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.