Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q4 2022 Earnings Call Transcript

Establishment Labs Holdings Inc. (NASDAQ:ESTA) Q4 2022 Earnings Call Transcript February 27, 2023

Operator: 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. Please note, this conference is being recorded. I will now turn the conference over to our host, Raj Denhoy, Chief Financial Officer. Thank you. You may begin.

Raj Denhoy: 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 from 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 annual and quarterly reports on Form 10-K and Form 10-Q as well as other SEC filings, which are available on our website at establishmentlabs.com.

I’d also like to remind you that our comments will include certain non-GAAP financial measures with respect to our performance, including but not limited to sales results, which can be stated on a constant currency basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today’s press release, which is available on our website. Please also note that Establishment Labs received an investigational device exemption from the FDA for Motiva Implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authorities for specific product availability. The content of this conference call contains time sensitive information, accurate only as of the date of this live broadcast 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. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.

Juan Jose Chacon-Quiros: 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. Excluding the negative impact of foreign currency changes, our growth in the fourth quarter would have been approximately 28%. For the full year of 2022, revenue totaled $161.7 million, a 28% increase over 2021. Excluding changes in currency, growth in 2022 would have been 32%. These results are at the midpoint of the pre-announced ranges we provided in early January. 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 since we first commercialize Motiva 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-centric design and this will continue into 2023 and beyond. For 2023, we are providing revenue guidance in the range of $200 million to $210 million. This outlook represents estimated growth of 24% to 30% over 2022. Raj will provide additional detail on our fourth quarter performance and our 2023 guidance in a moment. Last week was another big moment at Establishment Labs. And I’m pleased to report that we filed module four of our modular PMA with the FDA.

This is a significant step toward Motiva being approved for sale in the United States. 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. 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 to the United States. On Mia Femtech, the new category we are creating in breast aesthetics, we provided an update in early January that we have signed up our first clinic partner. Seishin Plastic and Aesthetic Surgery Clinic operates a network of 10 high-end aesthetic practices in Japan.

They will first offer Mia under 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. Our practice development and medical education teams are actively engaged with them in preparation for a launch. 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 breasts. Mia 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.

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. These proof points will be important as we look to scale Mia into the multibillion-dollar opportunity that it has the potential to become. We look forward to providing updates over the coming months. In our aesthetic breast recon franchise, the rollout of our Motiva Flora tissue expander continues. The market feedback is very positive with more and more surgeons making it their expander of choice in post-mastectomy breast reconstruction. In November, we announced regulatory approval for Flora and Motiva Implants in Japan.

As we commented at the time, launching Flora with Motiva 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 with many new advances in what has unfortunately been a neglected category in breast reconstruction. Flora is only the first step in our aesthetic breast recon initiative where Establishment Labs will offer tools and techniques that allow women to receive reconstruction surgeries that achieve the aesthetic ideals to which they aspire. As a global medical device company focused on women’s health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction.

We are not only bringing to market new technologies like Flora that can improve outcomes, but we are also engaging in advocacy efforts to promote education, awareness and access. The need and the opportunity are significant. One in eight women globally will experience breast cancer in her lifetime. But very few of them will undergo a reconstruction as part of their recovery from the disease. As we make progress in our aesthetic breast recon initiatives, the global impact will be meaningful. On China, we can 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 adoption once we launch into what is the second largest market in the world.

In January, at the J.P. Morgan Healthcare Conference, we provided an outlook for Establishment Labs to achieve $500 million in revenue in 2026. This works out to an average annual growth rate of 33% and it contemplates contributions from our existing markets. EMEA, China, the U.S., 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. However, the many layers also suggest that this target is well supported, even conservative, and that growth will continue for many years beyond 2026. 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 for us, but it provides us with a target around which to plan and organize.

It is well within our reach to become the leading global company in breast aesthetics and reconstruction. 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. I will now turn the call over to Raj.

Raj Denhoy: Thank you, Juan Jose. Total revenue for the fourth quarter was $43.8 million. Reported revenue growth in the fourth quarter was 24.1%. Foreign currency changes reduced 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%. 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. Brazil, which is our single largest market globally, accounted for approximately 14.6% of total quarterly sales. 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.

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. Our 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 mix and 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 U.S. 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 in growth initiatives. While we are investing, our operating expenses as a percentage of revenue were down slightly from the year ago period as we continue to focus on managing our costs. Net loss from operations for the fourth quarter was $13.2 million compared to a net loss of $9.4 million in the same period in 2021. 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 a 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-dilutive capital we can access on the achievement of revenue and regulatory milestones. Cash used 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 million 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 momentum in our business, and we expect this will continue into 2023.

We’re also expecting early contributions from new initiatives like Mia in China. It’s 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 from our new facility. As noted previously, we view 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.

Juan Jose Chacon-Quiros: Thank you, Raj. 2022 was 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 U.S. 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.

As 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; normalized 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 better positioned 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.

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Q&A Session

Operator: Thank you. And ladies and gentlemen, at this time, we will conduct a question-and-answer session. Our first question comes from Matt Taylor with Jefferies. Please state your question.

Zach Weiner: Hey, thanks for taking the question. This is Zach on for Matt. I was just curious if you could talk about the infrastructure you’re putting in place to support the U.S. launch and then also the Mia launch in Europe? Thanks for taking the question.

Juan Jose Chacon-Quiros: Yes. Thank you, (ph). And we couldn’t be more excited today with this news of the submission of module four, 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 logistics strategy is going to be like in the United States. And as we get obviously closer, then we will be willing to share more. When it comes to Mia, in Europe, and I would also mention in Japan, it’s very important to understand that Mia is done through 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 Mia. So, when we think about like what we can do with Mia in 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.

Zach Weiner: Thanks for taking the question.

Operator: Our next question comes from Josh Jennings with Cowen. Please state your question.

Josh Jennings: Hi, good afternoon. Congratulations on a strong finish to the year and on the submission of the fourth PMA module. 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 are all clear, that this guidance range does not assume any revenues from the United States or that does not preclude any type of approval in 2023.

Raj Denhoy: Yes, I think that’s a fair way to put it, Josh. I mean, we haven’t endorsed the timeline for U.S. approval, so we haven’t included it in our 2023 guidance. But as you mentioned, Mia and China, we do expect contribution from those to build as the year unfolds.

Josh Jennings: Great. Thanks for that. And Juan Jose, maybe to — just wanted to — just with the fourth module being submitted and the (ph) review 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 timeline or I’m assuming that you’re not. But maybe it would be helpful just to — as a refresher to remind us of the pathophysiology of capsular 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 capsular contracture, rupture, reoperation rates from year two to year three would just be helpful to review and understand. Thanks for taking the questions.