Q4 2022 Establishment Labs Holdings Inc Earnings Call
Speaker 2: Greetings and welcome to the Establishment Labs. Fourth quarter, 2022, Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press...
Speaker 2: star 0 on your telephone keypad.
Speaker 2: Please note this conference is being recorded.
Speaker 2: I will now turn the conference over to our host, Raj Denhoy, Chief Financial Officer. Thank you. You may begin.
Speaker 3: Thank you, Operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacón 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 from the meeting of Federal Securities laws. These include statements on Establishing Labs' financial outlook and the company's plan to time for product development and sales.
Speaker 3: These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q , as well as other SEC filings which are available on our website.
Speaker 3: at establishrelapse.com.
Speaker 3: 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.
Speaker 3: Reconciliations to the most directly comparable GAAP financial measures can be found in todayís press release which is available on our website.
Speaker 3: Please also note that establishment labs receive 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 the local authorities for specific product availability.
Speaker 3: The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, February 27, 2023. 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.
Speaker 3: With that, it is my pleasure to turn the call over to our CEO , Juan Jose. Thank you, Raj, and good afternoon, everyone. Record revenue in the fourth quarter of 2022 totaled $43.8 million, a 24% increase over the fourth quarter of 2021.
Speaker 4: excluding the negative impact of foreign currency changes on growth in the fourth quarter, would have been approximately 28%.
Speaker 4: For the full year of 2022, revenue totaled $161.7 million. The 28% increase over 2021, excluding changes in currency, growth in 2022 would have been 32%.
Speaker 4: These results are at the midpoint of the preannounced ranges we provided in early January .
Speaker 4: We are growing well in excess of our underlying markets and the key to these market share gains is our singular focus on building a new breast aesthetics and reconstruction industry on the fundamental pillars of women's health. This focus has allowed us to develop a 12-year track record of excellent clinical and aesthetic outcomes.
Speaker 4: since we first commercialized Mutiva implants. Over that period of time, we have elevated standards for breast aesthetics and reconstruction by bringing to market a number of meaningful innovations based on science and patient-centered design. And this will continue into 2023 and beyond.
Speaker 4: For 2023, we are providing revenue guidance in the range of $200 to $210 million.
Speaker 4: This outlook represents estimated growth of 24% to 30% over 2022.
Speaker 4: Raj will provide additional detail on our fourth quarter performance and our 2023 guidance in a moment.
Speaker 4: Last week was another big moment at Establishment Labs, and I am pleased to report that we filed Module 4 of our Modular PMA with the FDA. This is a significant step toward Mutiva being approved for sale in the United States.
Speaker 4: The submission of the final module also represents a transition in the approval process where the FDA will now begin their formal review of our full PMA.
Speaker 4: Our interactions with the FDA through the modular review period have been very collaborative and the level of interaction has been high. We look forward to the relationship continuing on a positive path as we work to bring Motiva back to the United States.
Speaker 4: January that we have signed up our first clinic partner.
Speaker 4: Seishin Plastic and Aesthetic Surgery Clinic operates a network of 10 high-end aesthetic practices in Japan.
Speaker 4: They will first offer Mia at their two locations in Tokyo, their flagship clinic in Roppongi and their newest clinic in Ginza. Seishin is one of the most prestigious aesthetic practices in the world, and we are so happy to have them as our first partner in the global rollout of Mia.
Speaker 4: Our practice development and medical education teams are actively engaged with them in preparation for a launch.
Speaker 4: With Mia, we are creating a new category in aesthetics for women that don't want a traditional augmentation, but are conscious about the shape and proportions of their breast.
Speaker 4: Nia offered these women a minimally invasive procedure that can be performed without general anesthesia in less than 15 minutes with an easy return to their daily activities. By providing a solution that is more appealing to consumers, we are opening up a whole new group of women to breast aesthetics.
Speaker 4: As we launch Mia, 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.
Speaker 4: These proof points will be important as we look to scale NIA into the multi-billion dollar opportunity that it has the potential to become. We look forward to providing updates over the coming months.
Speaker 4: In our aesthetic breast recon franchise, the whole out of our Motiva Flora tissue expander continues.
Speaker 4: The market feedback is very positive with more and more surgeons making it their expander of choice in post mastectomy breast reconstruction.
Speaker 4: In November , we announced regulatory approval for flora and motivi implants in Japan. As we commented at the time, launching flora with motivi implants in the Japanese market is a significant step in changing the global standard in breast reconstruction. What continues to resonate with clinicians globally is that flora is a much improved offering.
Speaker 4: with many new advances in what has unfortunately been a neglected category in breast reconstruction.
Speaker 4: Flora is only the first step in our Static Breast Recon Initiative, where establishment labs will offer tools and techniques that allow women to receive reconstruction surgeries that achieve the aesthetic ideals to which they aspire.
Speaker 4: As a global medical device company focused on women's health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction.
Speaker 4: We are not only bringing to market new technologies like FLOR that can improve outcomes, but we are also engaging in advocacy efforts to promote education, awareness and access.
Speaker 4: The need and the opportunity are significant. One in eight women globally will experience breast cancer in her lifetime.
Speaker 4: But very few of them will undergo a reconstruction as part of the recovery from the disease. As we make progress in our aesthetic breast recon initiatives, the global impact will be meaningful.
Speaker 4: On China, we continue to make progress in the regulatory approval process, and we expect approval for Motiva in this market in the first half of 2023. The recent lifting of COVID restrictions and the return to more normal activity in China are encouraging, not only for our approval, but also for the
Speaker 4: but also for adoption once we launch into what is the second largest market in the world. In January , at the JP Morgan Healthcare Conference, we provided an outlook for establishment labs to achieve $500 million in revenue in 2026.
Speaker 4: This works out to an average annual growth rate of 33% and it contemplates contributions from our existing markets, NIA, China, the US, and from breast reconstruction globally. With the many layers of growth behind this target, we don't expect growth will be linear over the next four years.
Speaker 4: However, the many layers also suggest that this target is well supported, even conservative, and that growth will continue for many years beyond 2026.
Speaker 4: We are ready for the next chapter in our growth story and providing a long-range view not only suggests the potential we see before us, but it provides us with a target around which to plan and organize.
Speaker 4: It is well within our reach to become the leading global company in breast aesthetics and reconstruction.
Speaker 4: We will continue to transform our markets and in doing so, we will create new opportunities for growth and more importantly, create new options for women around the world.
Speaker 3: I will now turn the call over to Raj.
Speaker 3: Reported revenue growth in the fourth quarter was 24.1%. Foreign currency changes reduce our fourth quarter revenue growth by approximately $1.3 million. Excluding the impact of currency, revenue growth in the quarter would have been 27.7%.
Speaker 3: Direct sales were approximately 37% of sales this quarter, while distributor sales made up the balance. From a regional perspective, sales in Europe were approximately 28% of global sales, Asia Pacific and Middle East 40%, and Latin America made up the balance.
Speaker 3: 14.6% of total quarterly sales.
Speaker 3: Our revenue distribution this quarter reflected rebound in sales in Europe from the seasonally slower third quarter, as well as strong sales to our distribution partners across multiple geographies.
Speaker 3: Our gross profit for the fourth quarter was $28.2 million or 64.3% of revenue. This compared to $24.2 million or 68.6% of revenue for the same period in 2021.
A gross profit in the fourth quarter was negatively impacted by approximately 300 basis points from foreign currency rate fluctuations.
Average selling prices in the fourth quarter were also down from the third quarter of 2022. We see regular fluctuations in gross margin and a mix in other factors, however the overall trend in our gross margin continues to be positive over time.
SG&A expenses for the fourth quarter increased approximately $7.3 million to $34.8 million. This compared to $27.6 million in the fourth quarter of 2021. The increase in SG&A in the fourth quarter resulted from continued normalization of business practices and our investments in new growth initiatives like MIA and preparations for our launch in the US.
R&D expenses for the fourth quarter increased approximately $400,000 from the same quarter a year ago to $6.5 million.
Total operating expenses for the fourth quarter were $41.3 million, an increase of approximately $7.7 million from the year-ago period. The increase this period was again due primarily to the normalization of activity and spending relative to a year ago, as well as the investments and growth initiatives. While we are investing our operating expenses as a percentage of revenue, we are also investing
Our cash position as of December 31, 2022 was $66.4 million, compared to $53.4 million at the end of the previous year.
The increase in cash was the net result of the new term loan we secured in April .
With achievement of the required revenue milestone, we drew the second tranche of the facility in December . The term loan has two additional tranches totaling $50 million of non-delutive capital. We can access on achievement of revenue and regulatory milestones.
Cash use in the fourth quarter included approximately $9.6 million of investment in our new manufacturing facility. In total, we invested approximately $32 million in the new facility in 2022.
We are providing revenue guidance for 2023 of $200 to $210 million, representing annual reported growth of 24 to 30%. At current rates, we estimate foreign currency will have a minimal impact on 2023 sales.
As we saw in our 2022 results, there is considerable immense amount of our business, and we expect this will continue into 2023.
We are also expecting early contributions from new initiatives like Mie and China. It is important to note that contributions from these new areas will be modest in 2023 and they will build as the year unfolds and these launches take place.
As we look down the rest of the P&L, we expect gross margin in 2023 to be similar to 2022. Gross margin in 2023 will see the impact of new product and geographic launches as well as the start of production for our new facility. Please note that previously we viewed the overall trend in our gross margin to be positive over time.
Operating expenses as a percent of revenue in 2023 are also expected to be similar to 2022. While operating spending over the near term is reflecting our investment in the significant number of development and commercialization programs we have underway, we expect expenses as a percentage of revenue will trend down as we get further into these growth initiatives. I will now turn the call back to Juan Jose. Thank you, Raj.
2022 is a year of tremendous progress for our company, and we are preparing for a busy 2023.
Among the events we have coming are the commercial launch of MIA, our Motiva launch into China, and the approval process for Motiva in the United States. In 2023, we will also finish the initial phases of construction of our new Sulayom Campus, and begin producing commercially sellable units out of the facility.
As a reminder, the new manufacturing capacity at Sulayom more than doubles the number of implants we can produce per year, and it allows us to provide over half the current world demand. We are also planning for the presentation of the three-year data from our US PMA study. With the PMA now submitted to the FDA.
We will look for an appropriate forum to share this data with the scientific community. It's impactful as each of these initiatives will be. They are all part of a broader strategy we have to continue to heal the relationship that women have with the legacy breast implant industry.
by offering innovative and safer options backed by science and supported by clinical data, which could expand the existing market.
normalize breast aesthetics with valuable new categories so that new groups of women will be open to our technologies, and finally and perhaps most importantly, democratize access to breast reconstruction.
so that the restorative benefits of reconstruction after breast cancer can be available to women globally to at least the level of access that is available in the United States. If we are successful in these initiatives, we will be able to achieve and even exceed the recent long-term revenue goal we provided of $500 million in revenue in 2026.
and much more beyond. We are a better position than we have ever been to transform our markets 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. Thank you. And ladies and gentlemen, at this time we will conduct our question and answer session. If you would like to ask a question please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press.
star followed by the number 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, to ask a question, press star 1. We'll pause for a moment while we pull for questions. Thank you.
Our first question comes from Matt Taylor with Jefferies. Please state your question. Hey, thanks for taking the question. This is Zach. I'm from Matt. I'm just curious if you could talk about the infrastructure you're putting in place to support the US launch and then also the MEO launch in Europe . Thanks for taking the question. Hi.
Yes, thank you, Matt. And we couldn't be more excited today with these news of the submission of Module 4, which basically means that we are now in the full PMA approval phase. For competitive reasons, and because we are getting closer to...
the timing of approval, we are not going to give details on exactly what we are going to do, but make no mistake, we will be prepared. And this year, we are continuing, just like we did last year, to put in place systems. We continue to work through what our logistic strategy is going to be like in the United States.
a business model without sales reps. It is done in a completely different way. It's a partnership that we create with selected clinics that can be good partners, that they have already good marketing assets that can be mixed with our amazing technologies that are embedded in Nia.
So when we think about what we can do with me and the first half of this year, with launches in Japan and Europe , it's super exciting because it is really a different type of business model. So we are looking to this year as one of the most exciting ones in the history of our company.
Thanks for seeing the question. Thank you. Our next question comes from Josh Jennings with Cowan. Please state your question. Hi, good afternoon. Congratulations on the strong finish of the year and on the submission of the fourth PMA module. Thank you.
I wanted to ask about 2023 guidance. And I think, Raj, you mentioned that there were some modest contributions baked in from MIA and China. Just wanted to make sure I was clear, that we were all clear that this kind of change does not assume any revenues from the United States, or that does not mean they are going to be
preclude any type of approval in 2023.
Yeah, I think that's that's a fair way to put it, Josh. I mean, we know we haven't endorsed the timeline for U.S. approval, so we haven't included it in our 2023 guidance. But, you know, as you mentioned, me and China, we do expect contributions from those to build as the year unfolds.
Great, thanks for that. And Juan Jose, maybe to just wanted to, with the fourth monitor being submitted and the four of you going on, you mentioned that three-year data may be presented in the appropriate form at some point. I know you're not giving that time, but I'm assuming that you're not.
Maybe it would be helpful just as a refresher to remind us of the pathophysiology of capture, contracture, rupture, and maybe just reoperation rates as a whole. And in terms of precedent data sets in the breast implant sector, just the increase of capture, the contracture, rupture, reoperation rates from year two to year three..
you know, the Mutivai implants. You know, when we published in Nature Biomedical Engineering about the mechanism by which our surface design creates higher biocompatibility, what we wanted to highlight is that when you see the numbers, whether in our 10 year, you know, post-market surveillance data with more than 2.5 million implants,
when you look at the different data sets, when you look at our two-year data, what you are looking at is at the downstream effect of that design. And of course, we do track numbers year to year. We've been in the market now for 12 years internationally. And what we see is that, of course, complications get aggregated over time.
But capsule contracture is a phenomenon that takes place mostly in year one and two. Of course, you can continue capturing some of those numbers as patients come back for their checkup. But overall, these additions tend to be modest.
Same thing with rupture over time, you know, for the first few years, you will see, you know, things that may have happened inadvertently during the procedure or things that may happen, you know, towards the tail end of the life of those implants, but that would be many, many years later. So overall, I think, you know, based on all the data sets that we have.
And our next question comes from George Sellers with Stevens. Please state your question.
Good afternoon and congrats on a great quarter. Maybe sticking with Mia in Japan, could you just give us some additional color on how that launch is progressing and maybe some early feedback from surgeons and patients and also maybe timing for expanding that launch to the additional clinics that this group is working on?
you know, selves through. Yeah, thanks George. And to be clear, we have signed up our first group of clinics, which is the Seishin Plastic and Aesthetic Surgery Clinic, which manage 10 high-end clinics overall in Japan. We are planning to launch soon.
You know, our medical education and practice development teams are working hard with them to put everything in place. So as soon as we start doing commercial cases with Sation, we will let you know. And of course, you know, we are very happy to do this in Japan. Japan is at the genesis of Mia.
that's where we had the original idea of the need for this type of procedure. And eventually we realized that there were these type of customers all over the world. So, you know, what we plan to do with me at this year is to prove that we have new consumers that we're not seeking for a traditional breast augmentation. We want to be able to show how these plan X, you know, basically scale up.
Because as we bring me up to different geographies, this is the type of information that I think is going to get everyone excited about the market expansion that it can create.
Okay, got it. That's really helpful. Maybe switching gears a little bit to margins. There's obviously a lot of moving pieces this year with the launch of Mie in Japan and in Europe as well, hopefully.
and China and then potentially the US at the end of the year. So could you just maybe help us with how we should think about the quarterly cadence for gross margins? It sounded like there were some maybe some ASP headwinds here in the fourth quarter, but how should we think about that as the year progresses and these additional markets start to contribute more significantly? Yeah, good question, George. So you notice in the quarter that
and everything we're doing in terms of launching into these new geographies, the MIA system, these are all positive to gross margin over time. And so the trend there is definitely to the upside. You know, as you think about 2023, there are some puts and takes. The early launch of MIA, as well as standing up the new facility, you know, and the lower yields out of the new facility.
Okay, great. Thank you all for the time.
Our next question comes from Anthony Petron with Mizzouho Group. Great. Good afternoon. Congratulations on the submission of the clinical module. Maybe just a little bit on guidance 200 to 210. How should we be thinking about contribution from Japan for... ...but...
from the MIA launch in January , how does that flow through in the 200 to 210? And then when we think about MIA in China in the second half potentially being launched upon receipt of regulatory clearances, how should we be thinking about that contribution in the top line guidance and all the couple of follow-ups?
Sure. Hey Anthony. You know, when we think about guidance, right, there are a lot of moving parts, as you suggested here in 2023. You know, when we think about providing numbers, though, we're looking at, you know, different scenarios around when we could see the timing of these, the contribution of them. And we started looking at kind of risk adjusting the various pieces of that.
That's how we kind of come up with that, you know, 200 to 210 million number. You know, certainly, you know, the different analysts, yourself included, will have different expectations for that, and it's typical for us to provide exact numbers, but I think you will see the contribution from those new things build as the year unfolds, you know, with the underlying business still posting really strong growth as we saw in 2022.
And then maybe a couple of follow-ups here. One would be on the sort of medium-term sort of outlook on manufacturing, if you will. If I'm not mistaken, the new manufacturing site brings you from about 700,000 implants to...
I think nearly 2 million per year in terms of production capacity. And fully understand, you know, in the early days maybe it's margin dilutive, but as you get out into
your two, three, and four, how does the new facility play into gross margins specifically of the MEA implants? And then I'll have one last follow-up. Thanks. You know, overall, the new facility, as you mentioned, the volumes that that facility is capable of producing, you know, and the efficiencies that we can get out of that.
facility is definitely a positive to our margin over time. You know, you couple that with things like the United States, China, which are ASP-Ipridive, Mia, which is ASP-Ipridive. You know, the margin profile of our company on the gross margin line is going higher over time. You know, as we mentioned, 2023, there's some moving parts here, but overall that margin...
directional point as you can give us would be helpful. Thanks.
Yeah, you know, it's an interesting or a good question, right? Because there's a lot of layers to how you get to $500 million for us over time. And you know, the number of permutations that can get you there is infinite, right? When we look at a number like that, though, in all the different supports we have underneath it, those one as I mentioned, it's not only well supported, it could even be proven conservative over time.
But in terms of breaking out individual contributions to that number, I think it's a little bit early for us to do that. As we get further into it, we'll certainly provide more visibility into what contributes to it, and then ultimately also kind of how we look at the margin profile over time as we move through that. So we'll be providing more over time on that number.
Thank you. Our next question comes from Neil Chatterjee with B. Riley Securities. Please do your question. Thanks for taking the questions.
Maybe since we haven't touched on it yet in the Q&A, just curious if you could provide maybe some additional color just on the kind of traction you're seeing with Flora for the breast recon market and maybe the pipeline that you're planning for that market.
Yeah, of course, I'm glad you asked about breast reconstruction because it is to us one of the most important things. This is such an underpenetrated market globally and FLORA is the first of a series of technologies that we will bring to market to make sure that we democratize access to breast recon. What we mean by that is that, you know, the current market.
may be considered of appropriate size in the United States, but when you look at outside of the United States, if you were to take those same axis numbers and moved it to the rest of the world, that market would be substantially, substantially higher. Now, when we look at FLORA, we continue to make gains quarter to quarter.
However, this is a market that is based on tenders, takes times. There are regions around the world that do this on an annual and even biannual basis. So we have to wait for them as they happen. However, we do plan to make sure over the next few years that we become the market leaders in breast reconstruction as we see it today. But more than that, and
that we are able to create the kind of market that we see in the United States for breast reconstruction. Great, thanks for that. Maybe just one quick follow-up. You've already talked about the launch partner for me, but just curious, how might that launch partner in Japan kind of serve as a model for future clinics that you're either prospecting or targeting?
I think, say, Session is a great model for what you will see in the future because you're talking about the chain of 10 clinics with marketing assets, with a professional staff on the business side that can scale this to the right level.
So, we will be looking for partners like Sation around the world. And again, it's not a buy-sell relationship. This is a true partnership. Great, thanks. I'll just hop back into the queue.
Thank you, and a reminder to the audience to ask a question, press star one on your telephone keypad. To remove yourself from the queue, press star two on your telephone keypad. Our next question comes from Marie Tibault with BTIG. Please state your question. Hey, good afternoon Juan Jose and Raj. This is Sam Igeron from Marie Tibault. This is Sam Igeron from Marie Tibault.
investments here and then as you get the contribution in the top line, that's when we might start to see leverage towards the back half and then more so in 2024. I think that's the right way to think about it. As we've described here in 2023, there's just so many opportunities for us to support between the launch of MIA, preparations for the United States, the standing up of the new facility, moving into operational capacity there.
the early days in China, which again we're using a distributor there, but there's some efforts we'll be supporting. And as we move into those initiatives, you'll start to see the leverage flow out of them. But this year is the year where we're investing, and as you get into 24 and beyond, you should start to see that leverage materializing our model. Okay, really helpful. And then maybe I can ask a follow up here on the regulatory environment in the U.S. I guess any updates on if you're expecting an ad come, how soon might you be able to figure that out? And is there even potential for...
a faster approval process considering you've had this modular submission process for a number of months now. Yeah, I think it's a little bit early for that and you know, the most important thing is that we focus on the final stage of the regulatory process. I think as you know, as this unfolds there may be opportunities, but I think we just have to keep ourselves to the propriety of the trial in making sure that we answer every single question that comes away from the FDA. Okay, really helpful. Thanks, taken questions.
Thank you. There are no further questions at this time. I will hand the floor back over to Juan Jose Chaco Enquitos for closing remarks. Thank you for joining us on today's call. We look forward to providing our next quarterly update in mid-May. And we wish everyone continued good health and happiness. Thank you. This concludes today's conference. I'll partage me disconnect. Have a great day.