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Establishment Labs Holdings Inc (ESTA) Q3 2021 Earnings Call Transcript

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ESTA earnings call for the period ending September 30, 2021.

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Establishment Labs Holdings Inc (ESTA -2.03%)
Q3 2021 Earnings Call
Nov 9, 2021, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Establishment Labs' Third Quarter 2021 Earnings Call. [Operator Instructions]

I will now turn the conference over to your host Raj Denhoy, Interim CFO for Establishment Labs. Thank you. You may begin.

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Raj Denhoy -- Interim Chief Financial Officer and Head of Strategy & Investor Relations

Thank you, operator and thank you, everyone for joining us. With me today is Juan Jose Chacon-Quiros, our Chief Executive Officer. Following our prepared remarks, we'll take your questions.

Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meaning of federal securities laws. These include statements on Establishment Labs' financial outlook and the Company's plan to 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 Quarterly Reports on Form 10-Q and 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, it is undergoing clinical trials for regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with the 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, November 9, 2021. 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 Jose.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Thank you, Raj and good morning, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the third quarter of 2021 totaled $29 million, a 28% increase over the third quarter of 2020. The continued momentum in our business allowed us to deliver strong sales results again, even though the third quarter is seasonally slower in the number of our major markets. Our singular focus on women's health, innovation and a track record of over 10 years of excellent clinical and aesthetic outcomes with Motiva implants continues to be the key for our market share gains and overall market growth.

We are raising our full year guidance for 2021 to a range of $124 million to $128 million. This is an upward revision from our previous guidance of $122 million to $126 million. This updated outlook represents growth of 46% to 51% over 2020 and 38% to 43% over 2019. This guidance captures our high level of confidence in our business. We continue to see healthy underlying market demand and are taking market share in geographies around the world. While the pandemic continues to create some unusual quarter-to-quarter volatility, we are confident that our market share gains and strong results will continue. Raj will provide additional detail on our third quarter performance and updated outlook in a moment.

Before I turn the call over to him, I would like to highlight several recent events. I wanted to start by updating everyone on the series of important developments that took place over the last couple of weeks. In October, we received notice from the FDA that the agency had reviewed and agreed to our modular PMA submission shell for the aesthetic cohorts of our US clinical trial. This agreement allows us to begin submitting to the FDA the four modules needed to support approval of our Motiva implants in the United States. I am delighted to report that last week we have submitted the first module of our PMA to the FDA. This first module covers the chemical characterization, toxicology and biocompatibility of Motiva implants. While there is still a lot of work ahead of us, this is an important milestone on our path to US approval.

As a reminder, in August of this year, the aesthetic cohorts passed the two-year mark and we continue to track these patients with excellent follow-up. We also closed our revision reconstruction cohort earlier this year and are still actively enrolling patients in the remaining reconstruction cohort of the trial. We will provide additional updates over the coming months on our progress toward launching our Motiva implants into the United States, which remains the largest market for breast aesthetics and reconstruction in the world.

As a company committed to women's health, we devoted the month of October, which is Breast Cancer Awareness Month to support efforts around the world to create awareness and education and to help women in their breast reconstruction journeys. We directly supported more than 40 different campaigns worldwide across five continents. The campaigns look to increase awareness and focused on education of our breast cancer, including breast health exam best practices and options for treatment and recovery.

We also directly supported three breast reconstruction initiatives in partnership with over 100 plastic surgeons. These programs helped more than 300 women receive breast reconstruction surgery. These campaigns included donations and financial support and were carried out in partnership with hospitals, clinics, doctors, federations, distribution partners and other essential stakeholders for Establishment Labs. We also conducted a breast health campaign among our employees in our different sites across the world. As an example of these efforts, on October 2, we held our first Motiva Breast Health Day at the Sant Pau Hospital in Barcelona. The day was devoted to women sharing their experiences with breast reconstruction as part of their breast cancer recovery. We plan to host similar events in other cities as part of our efforts to expand access to breast reconstruction.

Our Pink is for Power campaign was dedicated to sponsoring post-mastectomy reconstruction procedures for women that could not access them. In Brazil, 245 women took part in the program this year, that is 245 women who were able to receive a reconstruction after waiting up to a decade after their mastectomy. We expanded the program into other countries this year, including Mexico, Colombia, Poland and Korea and we'll continue to build on this important initiative.

At Establishment Labs, supporting improved access and providing the tools needed to improve outcomes in breast reconstruction are core to our mission as a women's health company. We believe our efforts and innovations in partnership with breast reconstruction surgeons can create new standards in post-mastectomy care and further transform breast cancer into a treatable disease from which women can fully recover.

An important first step for us is our Motiva Flora tissue expander. On September 2, we held an event at the London Breast Meeting marking the official launch of Flora in Europe and other CE Mark countries. Flora has many advances of our other commercially available tissue expanders, including first of its kind RFID-enabled port which allows for MRI imaging with our 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 self-friendly SmoothSilk surface technology and several early users at the symposium in London noted improved patient comfort and healthier capsular formation with the expander.

Reconstruction surgeons understand the differentiation of the Flora tissue expander and we are already seeing regular use in the key hospitals in Europe. As the advantages of Flora become more widely known, we are seeing more and more requests for our expander including for us to participate in government tender programs. While we have high expectations for the share we can take with the Flora tissue expander in the existing reconstruction market, 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. We look forward to sharing more with you on these efforts over the next few months.

In October, we announced the launch of JOY, our new premium patient-centric breast aesthetics program. JOY includes our Motiva Ergonomix2 implants, which were designed based on the overwhelming success of our Ergonomix platform that has seen over 700,000 implants sold since being launched in 2015. The ergonomic design of these implants introduced a new dimension to breast aesthetics based on new patient comfort and natural tissue-like characteristics. Ergonomix2 continues this evolution with improved chemical and mechanical properties in our unique super silicones, making them 45% softer and 23% more adaptable. All of which we believe will result in even greater patient satisfaction.

JOY also offers the Motiva Woman's Choice Program. This first of its kind program allows women with JOY to receive financial support from Establishment Labs should they choose to have their implants removed for any reason, subject to the program terms. As part of this program participating surgeons may agree not to charge any additional fees for this procedure. JOY is the foundation for a new digital model that speaks directly with women considering breast surgery with online interactive tools and we encourage you to experience it for yourself on our motiva.health website. Early interest in JOY has exceeded our expectations, with women proactively reaching out to surgeons in countries all over the world inquiring about when and how they can get JOY.

On Motiva MIA, our minimally invasive breast enhancement procedure, we continue to perform new cases as well as tracking the original 100 patient cohort we completed last April. We have 100% follow-up on this group of patients and the outcomes continued to support our belief that this approach will transform breast aesthetics and significantly expand the market. According to our market research, this new category could grow to $5 billion, which approximately half of the opportunity from new patients that had not previously considered a breast augmentation.

Regulatory clearance in Europe for the tools that are part of the Motiva MIA system remains on track and should allow for a planned launch in 2022. Our clinical and commercial efforts in China are ongoing and we continue to make progress in this regulatory process. Our plan is to launch Motiva in this fast-growing market in the second half of 2022.

In the third quarter, we also published the latest update to our corporate sustainability review, which outlines our sustainability goals for the coming decade and the progress we are making to achieve them. The report includes a presentation of our Company's value map, stakeholders and materiality framework. We are particularly proud to have elevated women's health and well-being to a key materiality topic around which we organize our activities alongside environment, employees, social development and governance issues.

We also recently published our updated post-market surveillance data report, which now includes 11-year data on Motiva Implants as well as data from several country-level independent registries. The findings continue to show rates of capsular contracture of less than 1% with Motiva implants and importantly, the rates are statistically equivalent in the submuscular, subfascial and subglandular positions. This is something that is not seen with legacy implants and again shows that our technical innovations can have a meaningful impact on clinical outcomes and expands choices for both surgeons and patients.

Lastly, I want to highlight a recent addition to the team at Establishment Labs. Jeffrey Bettinger recently joined as Global Head of People. We are building a strong and skilled team to scale our global operations as we prepare to enter new markets as well as offer new direct-to-consumer programs. We look forward to his contributions as we build and inspire organization for continued success.

I will now turn the call over to Raj to cover our financial results.

Raj Denhoy -- Interim Chief Financial Officer and Head of Strategy & Investor Relations

Thank you, Juan Jose. The significant momentum we have seen in our business carries into the third quarter. We saw strong sales growth again in what is normally a seasonally slower quarter and our operating expenses and cash are being managed effectively even as we invest in a number of new initiatives.

Total revenue for the quarter was $29 million. 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 38% of global sales, Asia-Pacific and Middle East were 28% and Latin America made up the balance. Brazil, which is our single largest market globally accounted for approximately 13.4% of total quarterly sales.

Our reported gross profit for the third quarter was $19.6 million or 67.6% of revenue compared to $15.1 million or 66.6% of revenue for the same period in 2020. The change in gross margin was a result of regional mix returning to more normalized levels as well as increased production volumes. Our gross profit this quarter improved from 67.1% reported in the second quarter of 2021. Average selling prices in the third quarter were down slightly from the second quarter of this year. As we've seen in the last several quarters, there will be fluctuations in gross margins. We continue to believe the best way to gauge our progress is on an aggregate basis over time and we are comfortable with the gross margin in the mid-60% range over the near-term.

SG&A expenses for the third quarter increased approximately $9.8 million to $24.8 million compared to $15 million in the third quarter of 2020. The increase in SG&A in the third quarter resulted from a normalization of business practices following the significant disruption from the global pandemic in the year-ago period. R&D expenses for the third quarter increased approximately $1.2 million in the same quarter a year ago to $3.9 million. R&D expenses also returned to more normal levels this quarter and will fluctuate quarter-to-quarter based on the timing of clinical trial and other expenses.

Total operating expenses for the third quarter were $28.7 million, an increase of approximately $10.9 million from the year-ago period. The increase this period was again due primarily to normalization of spending relative to a year ago. Net loss from operations for third quarter was $9 million compared to a net loss of $2.6 million in the year-ago period. Our cash position remains strong at $64.6 million as of September 30 compared to $84.5 million on December 31.

As Juan Jose noted earlier, we are raising our annual sales guidance for 2021 to range between $124 million to $128 million from the previous range of $122 million to $126 million. The new range represents annual growth of 46% to 51%. In refining our outlook, we took several factors into consideration, the challenges from the pandemic have not fully receded, some markets are not entirely open and we are mindful of global supply chain issues. Today, we have not experienced any disruption in our supply chain, but we are monitoring the situation closely. Overall, there is considerable momentum in our business, we are taking share globally and we expect this will continue.

As we look down the rest of the P&L, we continue to expect to see spending levels increase as we prioritize investments in a significant number of development and commercialization programs we have underway. Preparing for entry into new markets and advancing our pipeline with new technologies to drive future growth remains a top priority. However, our strong revenue growth should result in our cash use continue to trend down from pre-pandemic levels even as we increase strategic investments. Our Company remains in a very strong competitive and financial position.

And with that, I will turn the call back to Juan Jose.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Thank you, Raj. Already this quarter, Establishment Labs crossed $100 million in annual sales for the first time in our Company's history. This success is the clearest example that our strategy based on science, better safety and better aesthetic outcomes can support sustained share gains around the world. As important as this milestone is for us, we are still at the beginning of our story. Over the next few years, we will continue to redraw the map with multiple market expanding initiatives.

We will continue to innovate in our core markets by getting closer to women in their aesthetic journey, which you can see in the recent launch of JOY. We will enter the United States and China, the world's largest markets. We will work to improve awareness, access and outcomes worldwide in breast reconstruction with our Aesthetic Breast Recon program and with Flora leading those efforts. And we will launch Motiva MIA opening up a new category, a new customer base in breast aesthetics.

ESTA is on the right path to be one of the leading companies in aesthetics and we are preparing for the next chapter in this growth story grounded solidly in our commitment to women's health and well-being. We recently announced a renewed partnership with the International Chess Federation, where Establishment Labs is sponsoring professional women's chess events. Our support of women's chess highlights our commitment to supporting empowered women in all aspects of life. And you will see many more programs that promote women's health and well-being from us in the months and years ahead.

I will now turn the call over to the operator for your questions.

Questions and Answers:

Operator

Thank you. At this time, we'll be conducting a question-and-answer session. [Operator Instructions] Our first question is from Josh Jennings with Cowen.

Josh Jennings -- Cowen -- Analyst

Good morning. Thanks for taking the questions. It's exciting news that the FDA submission process is starting. I just want to have initial follow-up on that update and just thinking through the modules that you're going to be submitting. Does the FDA clearing the path for you to also include the clinical data module and will you submit that before three-year data and get a response from the FDA or have they given you anymore confirmation that your data could suffice for the submission for the aesthetics cohort?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah Josh, thank you. I think the first thing is, of course, we are super excited by the fact that the FDA approved our shell and that we have now submitted module one which is basically chemistry, toxicology and biocompatibility. Now, the most important thing is that now that we start with the modular submission, chronogram, then it is no longer about two year versus three year data, it is really by running through the modules. Module 2 is basically mechanical properties, then it goes to Module 3 with manufacturing and then the final one with clinical. So when we get to that module with clinical, we would submit with the data that we have at that time.

Josh Jennings -- Cowen -- Analyst

Understood. Thanks for those details. And then just wanted to ask a question about guidance, I think the midpoint suggests roughly $35 million in the fourth quarter or 30% revenue growth which would be an acceleration, seems like the sequential acceleration, it seems like 4Q trends are improving in October and so far into November in terms of Motiva aesthetic volumes. But any more details you can provide in terms of the assumptions baked in there, improving trends, more contribution from Flora or Ergonomix2 and Recon procedures? Any other details would be helpful? Thanks for taking the questions.

Raj Denhoy -- Interim Chief Financial Officer and Head of Strategy & Investor Relations

Hey, Josh, it's Raj. Yeah, I think you kind of outlined a lot of the things going on, right. I mean clearly, we did raise guidance, which gives you some indication of the momentum in the business and how we're feeling about things. As you noted, there are a lot of good things coming from us and on the market from us and so we remain very confident where we are heading into the last couple of months of the year here.

Josh Jennings -- Cowen -- Analyst

Thank you.

Operator

Our next question is from Chris Cooley with Stephens.

Chris Cooley -- Stephens -- Analyst

Good morning and congratulations on the stellar quarter and the continued progress with the FDA filing. Appreciate you taking the questions here this morning. From me, if we could just start off a little bit as you're thinking about raising the guidance now for the third consecutive time for this year. Clearly, you're taking share but we're all also still seeing pockets of variability in end markets, so could you help us think a little bit more, let me just kind of a follow-on to Josh's prior question. Regionally, where you're seeing strength and if this is more so driven by augmentation more so than Recon assuming at this point, but just how you're seeing those markets or what's kind of, I should say, implicit in your guidance raise to the 46% to 51% here for the full year? And then I have a quick follow-on. Thank you.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah. Thank you, Chris. I think the increase in our guidance shows our commitment to continue to gain share in all markets across the world and the fact that we feel strongly about how we are executing on that. We are seeing situations in which you still have some places around the world where the pandemic does create challenges. But I think when you look across the world, the situation is improving and it's working on our favor in many different ways. The most important thing for us is to continue to gain market share across all markets and we feel that we are doing that. Most of the revenue this year will continue to be aesthetics, although we are very happy to see the interest in the Flora tissue expander. Remember that market develops based on the tender process and that takes time to build on.

Chris Cooley -- Stephens -- Analyst

That's helpful. And then maybe just from my quick follow-on here. The Company is clearly expanding globally at a very rapid pace and you have a number of initiatives with other clinical, marketing or just women's health and support going on across the globe. And so would you help us think a little bit about timing of expenditures and planned areas of investments that we should be contemplating as we look ahead into '22. Obviously, you have the US regulatory process and the same in China before commercialization. Those launches thereafter ongoing rollout of Motiva MIA, I'm just trying to think about where we should be contemplating incremental and planned investments in '22 over '21 that help drive the sustainability of that growth that we're seeing now for the longer term? Thank you.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah, I think that's a key question because, of course, we plan to continue to invest to not only gain market share in the markets that we are in, we're also expanding into the US and China. So we're going to start preparing for those launches. And then we have these market expansion initiatives like MIA and of course going into breast reconstruction. So all of those will require investments, but we are very confident that those investments will pay off with not only increased market share but also with new patients coming into the category of minimally invasive.

Raj Denhoy -- Interim Chief Financial Officer and Head of Strategy & Investor Relations

Yeah, maybe Chris, I could just add to that a little bit, I think if you look at the various factors, right, to the very strong top line growth we continue to put up, strong gross margins we have. Even as we continue to invest in many opportunities in front of us, which you outlined, we do expect our cash use will continue to moderate over time. So if we are in a very nice dynamic again with that very strong top line growth allowing us to support the business. And so again we're going to keep investing, but I think we're going to be judicious and we're in a good spot.

Chris Cooley -- Stephens -- Analyst

Thank you.

Operator

Our next question is from Anthony Petrone with Jefferies.

Anthony Petrone -- Jefferies -- Analyst

Thanks. Congrats on another strong quarter here. I'm going to start maybe with Brazil, the numbers out of Brazil obviously largest market were strong. And so maybe just a little bit more detail on where you sit in Brazil as a percent of total share in that market just considering the late August suspension of J&J SILTEX brand in that market? And I'll have a couple of follow-ups.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah, we're very happy about our performance in Brazil this year. We continue to gain market share. Our view is that we have around 25% market share in Brazil and some of that has come at the expense of MENTOR. And most importantly, what we feel good about is that this year we have gained about 400 new accounts and we are continuing to invest in medical education. Remember, that's a market that has been traditionally a highly textured market and we are still the only brand offering a smooth implant. And in our case, with our proprietary surface technology, of course, this requires some level of adaptation for surgeons when they move from a highly textured implant toward SmoothSilk, but we are happy to see that all the investments that we have done in medical education are paying off and that surgeons and patients are seeing the difference with the Motiva implants.

Anthony Petrone -- Jefferies -- Analyst

Just a two quick follow-ups here. Maybe just a high level on where the discussion is among plastic surgeons now that we have an increasing level of publications nature and sheer just supporting smooth versus textured. So how are those discussions shifting between plastic surgeons in the sales force? That would be one. And just a quick one on the FDA, when we look at primary versus revision, will that be separated for the two individual clearances and is there any update on the reconstruction cohort enrollment? Thanks again.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Okay. Thanks, Anthony and I'll try to answer all of that. So first on how patients perceive the overwhelming data that is being put out. So we just published our 11-year post-market surveillance data. One of the most important things in that is that we have now independent data from several registries in Europe and in Australia. So that provides further confirmation, independent confirmation of the numbers that we have been seeing in our own registries.

On top of that, what you see there is that there is no statistically significant difference in capsular contracture rates between submuscular or subglandular replacements, and that is very important, because that's not something that you see with legacy implants and it allows for surgeons to put the implants where it's best for the patient without having to worry about capsular contracture and that's going to be fundamental when we come to the United States, because a lot of surgeons don't choose the subglandular plane, because they're afraid of capsular contracture. So this is actually very important for us that we can provide these new choices for surgeons and then get what is best for the patient.

Then when we move to new publications like the one from nature, of course, it just gives confidence to the medical community that everything that we've been seeing over the years, it is further complemented by all these publications. So we will continue to see more of those both clinical and scientific and that also is going to help with our FDA submissions because of course they do look at the science and they do look at the data, not only the data from the trial but also real-world data.

With regards to the data that will be presented in the final clinical module, of course that's going to include the primary and also the revision in the aesthetic cohorts. With regards to the Recon cohorts, of course, during the pandemic, it is the indication that was delayed because of all these hospitals using space to treat COVID patients. We continue to make progress and we are still committed to finishing that cohort before the end of the year.

Operator

Our next question is from Amit Hazan with Goldman Sachs.

Don -- Goldman Sachs -- Analyst

Hi, this is Don [Phonetic] for Amit. Thanks for the question. I thought maybe if you could opine on the recent FDA announcement about the new safety labeling requirements for US devices and how you might be positioned in the year or so when this decision comes up for your product?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah on that, those recommendation date from a year ago, now they've moved onto enforcement. And remember, we've been talking about this for years, patients need to have more information ahead of making an informed decision. And every time patients get educated, are given access to the information, we are bound to win and that is very important to us. So we are in full compliance with the international rules and when we come to the US, we will follow the rules that the FDA gives to us, but we are very happy to see that patient education is going to be a key factor, because when that happens, we will be in front of that.

Don -- Goldman Sachs -- Analyst

Just a quick follow-up there, given the lack of correlation ALCL from your device versus other devices, is it possible that you could have a differentiated label by the time you come to the US?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

I think it's too early to tell, but definitely the data on ALCL from Motiva implants is impressive. Now we are at 1.8 million implants and more than 11 years in the market. And when you think about the median time for ALCL, it's around eight years. So we're way past that date and if you look at publications, like the Langer publication, what we have is a low-inflammatory surface, and ALCL is a chronic inflammatory condition. So definitely that is the important part, and we will see when we get to that point, how our labeling will be.

Don -- Goldman Sachs -- Analyst

Great, thanks for that additional color. I was hoping for my second one, you could speak in a little bit more detail on the China timeline that you affirm today. How discussions and what stage we're out with the CFDA and what we should expect kind of the next steps moving forward both from a commercial and a clinical standpoint?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Yeah. Look we are committed to our Chinese market entry and we are working on our commercial strategy. This is one of the largest and most dynamic opportunities in breast aesthetics. And we think of the Chinese market as a market where we can do very well. People often speak of Korea as being a benchmark to what happens in China. And as you know, we are the number 1 brand in South Korea and continue to perform very well there. So we are hoping for a regulatory clearance in the second half of 2022 for a controlled launch shortly after. We are making progress with our regulatory filings and expect those to take place on time.

Don -- Goldman Sachs -- Analyst

Thank you.

Operator

Our next question is from Matt Taylor with UBS.

Matt Taylor -- UBS -- Analyst

Hi. Thanks for taking the question. I just wanted to follow up on two key points and questions that have already been asked. So the first one was just on the US timeline. So what I'm understanding from what you said is that you're able to move forward with the submission of these modules. Does that mean that the gating factor for the clinical module is no longer a three-year follow-up, but more or so your ability to submit the other modules in front of that?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Well, you can certainly look at it that way, but I think the way to approach it is you follow the different modules, and by the time you get to the final module, which is the clinical one, then we will have data at that time frame which will be the one that we submit. We are very confident of this strategy and we are very happy to see that the FDA approved our shell and that we then have moved on with the submission of module one.

Matt Taylor -- UBS -- Analyst

Okay. Just following that, are you able to -- have you had discussions with FDA about being able to use international data to support your submission?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

So remember, in the FDA guidance, they talk about real-world data. So definitely we will use real-world data to complement our dataset from US. We are working not only with registry data, and in that sense, the independent registry data is very strong. You can find our post-market surveillance report online in our website and look at it. But furthermore, we also have now over 1.8 million implants out there, definitely by the time we submit to the FDA the clinical module, we will be including specific datasets from different areas around the world.

Matt Taylor -- UBS -- Analyst

Okay. Okay. And then I did want to ask you a follow-up question on the recent FDA announcement about the safety requirements and the patient decision checklist that there's really two questions here. One is, do you think that those requirements could have any tampering down a negative effect on the market overall? And then the other side of that coin is another question I was asking you about a differentiated label, what is your understanding about how you would fall under this or not based on the data that you have?

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Again, I think it's too early to tell what our labeling will be, but definitely we can make claims based on the data that we submit to the FDA and based on the approval that we get from the FDA. So if you look at our international data, it is pretty impressive. So we use that all the time in international market to differentiate ourselves versus the other products.

With regards to the decision checklist, we see it as a positive evolution for patients, because now they will be fully aware of the potential side effects of breast implants, but more importantly, they will have the information necessary to make that informed decision. And when they have that, we expect them to make a choice toward Motiva implants.

Matt Taylor -- UBS -- Analyst

Great. All right. Thank you for the color.

Operator

Ladies and gentlemen, we have reached the end of the question-and-answer session. I would like to turn the call back to Juan Jose Chacon-Quiros for closing remarks.

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Thank you for joining us on today's call, and we look forward to providing our next quarterly update in early 2022, and I wish everyone happy holidays and good health.

Operator

[Operator Closing Remarks]

Duration: 40 minutes

Call participants:

Raj Denhoy -- Interim Chief Financial Officer and Head of Strategy & Investor Relations

Juan Jose Chacon-Quiros -- Chief Executive Officer and Founder

Josh Jennings -- Cowen -- Analyst

Chris Cooley -- Stephens -- Analyst

Anthony Petrone -- Jefferies -- Analyst

Don -- Goldman Sachs -- Analyst

Matt Taylor -- UBS -- Analyst

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