Establishment Labs - Q2 2023

Transcript

Operator (participant)

Welcome to Establishment Labs' second quarter 2023 earnings call. At this time, all participants will be in listen-only mode. At the end of this call, we will open the line for the question and answer session, and instructions will follow at that time. If anyone should require operator assistance during the conference, please press star 0 from your telephone keypad. As a reminder, today's call is being recorded. I will now turn the call over to Raj Denhoy, Chief Financial Officer. Please go ahead.

Raj Denhoy (CFO)

Thank you, operator. Thank you everyone for joining us. With me today is Juan José Chacón-Quirós, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements in the meanings of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For 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.

Please also note that Establishment Labs receives 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 regulatorily 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 day of this live broadcast, August 8, 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 José.

Juan José Chacón-Quirós (CEO)

Thank you, Raj, and good afternoon, everyone. Revenue in the second quarter of 2023 totaled $48.6 million, an 18% increase over the second quarter of 2022 and a new quarterly record for our company. We are growing well in excess of our underlying markets. There are a number of positive catalysts we expect over the coming months, all of which is providing a strong foundation on which to build for 2024 and beyond. Raj will provide additional details on our second quarter performance and our outlook in a moment. On July 19th, the 5-year anniversary of our listing as a public company, we held the grand opening of our Sulàyöm Innovation Campus, where 400 people attended the event, including representatives of the Costa Rican government, plastic surgeons, distributors from around the world, suppliers, and other business partners.

The new campus supports our strategic plans with additional capacity and capabilities in R&D, manufacturing, digital media, training, and medical education. This year, we will bring online approximately 35,000 sq ft of new manufacturing and warehouse space that more than doubles our manufacturing capacity to over 1.5 million units a year, which is about half the current global demand. We also have the ability to add an additional 45,000 sq ft of manufacturing as our growth requires. The new facilities include advanced R&D labs and a global learning center that allows us to produce content that we can stream around the world. The on-site surgical theater and procedure rooms allow for medical education and training that can scale to our global business and help us expand the market and create broad demand for our products.

State-of-the-art facility is designed to be carbon neutral and uses sustainable materials and other green design elements and standards throughout. Our goal was to build a center for creation and innovation, where our employees, healthcare professionals, and partners from all over the world can usher new standards for the future of plastic surgery. With the opening of the Sulàyöm, we are certain we have succeeded. We are better positioned than we have ever been to create and expand new markets and to make a meaningful change in the lives of women around the world. One of the most exciting near-term opportunities for us is Mia Femtech. With the recent approval in Europe of the tools needed, the global rollout of this new category, breast aesthetics, is picking up pace. Our launch activities are centered on creating this new category with a growing list of certified partner clinics.

We are strengthening our pipeline of partner clinics with new centers in Japan, Spain, Switzerland, Sweden, Germany, England, Costa Rica, and France, with more requests every week to join. We have created branding and marketing programs localized for each market that are directed at creating and capturing consumer demand. In Spain, where we launched our first campaign in July, the first week saw us generate over 175 leads, 30 of which resulted in patients seeking appointments. Most importantly, 47% of these patients were not seeking a breast augmentation prior to learning about Mia. As a reminder, as part of the Mia experience, a plastic surgeon can shape the breast in a 15-minute minimally invasive procedure without the need for general anesthesia. The result is natural and discreet, with a one to two cup proportionate result.

The procedure requires minimal downtime, with women returning to most activities the same day. By providing a solution that overcomes many of the obstacles of traditional breast augmentation, we are opening up a whole new group of women to breast aesthetics. It is still early in the launch of Mia, and we remain focused on bringing women into this new category of breast aesthetics as plastic surgeons see improved efficiency with our partner clinics benefiting from better economics. We are seeing early proof points that we can scale this new category with Mia into a multibillion-dollar opportunity. In our aesthetic breast recon franchise, the rollout of our Motiva Flora tissue expander continues. We developed Flora to provide surgeons and the women who receive these devices better options. Despite one in eight women developing breast cancer, tissue expanders before Flora have seen little meaningful innovation in decades.

Among the improvements in Flora are a first-of-its-kind RFID-enabled port, which allows for MRI imaging without artifacts during the time an expander is used after a mastectomy. By being non-magnetic, Flora also opens new options for radiation oncology treatment. Flora also features our patented cell-friendly SmoothSilk surface technology, which can offer improved patient comfort and healthy capsule formation. The market feedback is very positive, and we are seeing an increasing number of clinical publications confirming the benefits of Flora. A recent publication out of Switzerland was the first in human study to confirm that Flora does not affect the image quality of artifact-prone image sequences during MRI, a fundamental improvement in the standard of care for women undergoing breast reconstruction with tissue expanders.

A recent publication out of South Korea demonstrated that in radiotherapy planning, the Motiva Flora, with a non-metallic RFID-enabled port, showed superior dosimetric results to the heart and lungs versus traditional metallic ports, potentially reducing side effects to these organs. The RFID port materials also reduce artifacts on CT imaging compared to the metals used in conventional expanders. In another recently published paper, scientists at the Medical University of Innsbruck in Austria were able to confirm in a head-to-head study that Flora provides much improved patient comfort and satisfaction in their breast reconstruction journeys compared to an FDA-approved expander. As a global medical device company focused on women's health, Establishment Labs has the opportunity and the responsibility to improve breast reconstruction.

Flora is only the first step in our aesthetic breast recon initiative, where Establishment Labs will offer tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire. On China, we are actively preparing for the launch of Motiva with our distribution partner. We continue to make progress in the regulatory process and expect to launch Motiva in this market later this year. We have been in active communication with our partners in China to close the final questions remaining before regulatory approval. In the U.S., the final module of our PMA was submitted to the FDA in the first quarter, and the full PMA has now been accepted and is under review by the agency. The pace of activity and our interactions with the agency remain positive.

Clinical sites around the country have now undergone their BIMO inspections, bringing us closer in this process of approval. It is difficult to predict regulatory timelines, nothing in the process thus far has diminished our confidence that Motiva implants will be available soon to women in the United States. I will now turn the call over to Raj.

Raj Denhoy (CFO)

Thank you, Juan José. Total revenue for the second quarter was $48.6 million, which was growth of 18%. From a regional perspective, sales in Europe, Middle East, and Africa were approximately 42% of the global total. Asia Pacific, 24%, and Latin America made up the balance. Direct sales were approximately 37% of implant sales, while distributors made up the balance. Brazil, which is our single largest market globally, accounted for approximately 14% of total quarterly Motiva sales. Our gross profit for the second quarter was $30.3 million, or 62.3% of revenue, compared to $27.5 million or 66.7% of revenue for the same period in 2022. Our gross profit in the second quarter was negatively impacted by higher overhead and labor costs.

Direct labor costs were higher in part from changes in foreign exchange rates between the US dollar and the Costa Rican colón. As we report in US dollars, the significant revaluation of the colón over the last year resulted in higher costs in the period. We are also absorbing the early start-up costs for the training and certification of Mia clinics, which is reflected in cost of goods. Average selling prices in the second quarter were up from the first quarter of 2023 and year-over-year, which confirms that we are providing increased value even while we continue to take market share. SG&A expenses for the second quarter increased approximately $4 million to $37 million, compared to $33 million in the second quarter of 2022.

The increase in SG&A in the second quarter resulted in part from our investments in new growth initiatives like Mia, preparations for our launch in the United States, and the underlying growth in our business. R&D expenses for the second quarter increased approximately $2 million from the same quarter a year ago to $6.9 million. Higher personnel costs and increased activity related to the U.S. clinical trial contributed to the higher spending this period. Total operating expenses for the second quarter were $44 million, an increase of approximately $6.1 million from the year-ago period. Net loss from operations for the second quarter was $13.7 million, compared to a net loss of $10.4 million in the same period in 2022.

Our cash position as of June thirtieth was $90.2 million, compared to $66.4 million at the end of 2022. Our cash position reflects the 1.265 million share offering we completed in late April, as well as cash use in the second quarter that included approximately $9 million of investment in CapEx, including for our new manufacturing facility, as well as a planned increase in inventories, we prepare for the launches of Motiva in China and the United States and further growth we expect in the near future. As a reminder, we have two remaining tranches on our debt facility, which total $50 million and become available on the achievement of sales and regulatory milestones.

These, along with the cash we have on hand at the end of 2Q, provide us with access to approximately $140 million in capital. Under our current forecast, the cash we currently have on hand, as well as the additional capital available to us under our credit facility, will allow us to achieve cash flow profitability while still funding our growth initiatives. We are maintaining our revenue guidance for 2023 in a range of $200 million-$210 million. There are a couple of things to note in the cadence of revenue for the second half of the year. We expect approval and launch of Motiva in China in the fourth quarter. Mia launch in Europe in the summer months, which is a seasonally slower period.

We expect Mia consultations to begin in earnest in the third quarter and procedures to contribute more meaningfully in the fourth quarter of the year. Overall, we continue to see good momentum in the underlying business, and we expect to have a very strong finish to the year. We expect gross margin in 2023 to be approximately 100 basis points lower than 2022, which reflects higher overhead and labor costs, the early costs of the global rollout of Mia, and the startup of manufacturing in a new Sulàyöm facility. We continue to see regular fluctuations in gross margin. However, the trend in our gross margin is expected to be positive over time.

The prices we expect to realize for our products in the US and China, which are the highest paying in the world, will provide a tailwind to our gross margins as we take share in these new markets. We continue to expect operating expenses as a % of revenue in 2023 to be similar to 2022. Operating spending over the near term is reflecting our investments in development and commercialization programs. We expect expenses as a % of revenue will trend down as we move into these initiatives and begin to leverage our spending. I will now turn the call back to Juan José.

Juan José Chacón-Quirós (CEO)

Thank you, Raj. During the opening of the Sulàyöm campus, we held a discovery session as part of the program. The session highlighted the scientific and clinical foundations that have been laid over the last two decades, which have led to the products we've introduced to the market. Motiva implants, Joy, Mia Femtech, and Flora are redefining breast aesthetics and reconstruction and are driving the strong growth we are seeing globally. Beyond fundamentally changing the current landscape, the technologies behind them have provided platforms that we are now developing into new offerings. We've taken the minimally invasive platform developed with Mia Femtech and are leveraging it into new minimally invasive aesthetic categories, the first of which is minimally invasive gluteal ergonomic modeling, which we call GEM.

The market for gluteal augmentation in 2021 was estimated by ISAPS, the International Society of Aesthetic Plastic Surgery, to be 523,000 procedures globally, which is a 41% increase from just four years ago. Despite this strong demand, the current options are lacking, with high rates of morbidity and even mortality. We have an initial IRB-approved study underway and are encouraged by what we have seen so far. We are early in the development of this new product and procedure and will provide updates as we make progress. Since 2014, our implants have been available with an RFID sensor platform we call Qid. The passive, privacy-proven sensor provides identification information about the device, such as the serial number, date of manufacturing, and others.

60% of our devices on the market now include the Qid technology, and in many markets, women are selecting devices with Qid 4 to 1 or more over non-Qid devices. We will soon introduce the next version of our sensor platform, which we are calling Zen. This new platform continues to be passive, but is non-metallic and will add additional capabilities, such as the measurement of temperature. This feature, and in particular, core temperature, is a very useful biomarker, and with Zen, we have a device which can provide measurements in real time. Temperature is only the first of what we hope will be a suite of biomarkers enabled by the Zen platform.

GEM and Zen are just two of the many exciting things we are working on. The expanded capabilities in our new Sulàyöm campus in research and development, medical education, media, and manufacturing will enable us to develop them to their full potential. We remain confident that the target we offered earlier this year of $500 million in revenue in 2026 will be proven conservative. With the continued contribution of our existing product portfolio and the growing contribution of new solutions like GEM and Zen, we believe that we will continue to grow at a healthy clip well beyond 2026. I will now turn the call over to the operator for your questions.

Operator (participant)

Thank you. We'll now be conducting a question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you. Our first question comes from the line of Matt Taylor with Jefferies. Please proceed with your questions.

Young Li (SVP)

All right, great. This is actually, Young Li in for Matt. Thanks for taking our questions. I guess to start, you know, maybe on the China launch, I think you mentioned Q4. You know, you're using the same distributor that you had been using in South Korea. And you're going to be replicating a lot of the Korean strategy for the China launch. I guess, you know, since China is a DTC market, I was wondering, you know, how you think about the adoption curve, how China might be different versus some of the other key markets?

Juan José Chacón-Quirós (CEO)

Yes, thank you. I think it's, it's important to remind everyone that China is the fastest growing breast aesthetics market in the world. Of course, we are super excited about this opportunity. Already, you know, in the countries around China, we've been doing, you know, a lot of activities to create awareness about Motiva implants and make them the implant of choice. We are market leaders in Japan, in Taiwan, in South Korea, in Vietnam, and in Thailand, which tells you a lot how, you know, the Asian consumer has seen, you know, the opportunity with Motiva as the implant of choice. Before the pandemic, you know, we had around 25% of consumers in South Korea coming from China to get Motiva implants.

When you look at the data coming from China, what you see is that patients request premium brands, that brand reputation is highly valued by hospitals, and our market research shows that there's, you know, a good reception and great image to the Motiva brand. We think that, you know, given the importance of this launch and everything that we are preparing with our partner, we will be successful in, in gaining the same type of traction that we've gained in the rest of Asia.

Young Li (SVP)

All right. Excellent. My follow-up is, on Mia. You know, very early in the launch, but wanted to hear a little bit about how you think the launch is going versus your expectations. Sounds like the, the Spanish experience is very positive so far and confirms the market expanding opportunity. You know, how's the Japan launch going? You know, what are some of the positive or negative surprises that you're seeing so far?

Juan José Chacón-Quirós (CEO)

Yes, Mia is, you know, this exciting breast harmonization, new category. you know, what we are seeing is that this value preposition is opening breast aesthetics to a whole new group of women. Just to give you an example, you know, what we are seeing, for instance, in Spain, you know, where we launched our first campaign, just last month. You know, in 1 week, we had 175 leads, and that led to 30 patients seeking appointments with clinics. More importantly, 47% of those patients were not seeking a breast augmentation. That's what's exciting to us, is that we are talking about a true new category in market expansion. you know, we're strengthening the pipeline.

We now have, you know, new clinics taking, you know, the certification process in place, in Germany, in the United Kingdom, and also in, even Japan. It's early on, but it's very promising. In Japan, it will go slower for one very simple reason: compliance. We have to comply with, you know, many rules in Japan that are restrictive to us communicating directly co- to consumers. It's going to take a little longer. There's going to be more word of mouth. When we see the results, especially the outcomes for patients and the response to the experience, you know, of course, we, we feel like it's going to get there in terms of the patient acceptance and the increase in awareness and satisfaction.

Young Li (SVP)

All right. Thank you very much.

Operator (participant)

Our next question is from the line of Anthony Petrone with Mizuho Group. Please proceed with your questions.

Anthony Petrone (Managing Director of Equity Research)

Well, congrats on a strong quarter here as well as for the opening in Costa Rica, and thanks for, for hosting. It was a great event. Maybe just pivoting to Motiva U.S. clearance, obviously, the PMA is submitted here. Just wondering, sort of the behind-the-scenes mechanics here, you know, how many rounds of questioning, you know, do you expect from FDA? I, I would assume that there's no panel needed here, but I could be wrong. Is there any thoughts on the need for an advisory panel for clearance of Motiva in the U.S.? I'll, I'll have a couple of follow-ups.

Juan José Chacón-Quirós (CEO)

Yeah. Thank you, Anthony. You know, it's important to know that we submitted, you know, the full PMA and was accepted for review by the agency. You know, we are trying to be very careful to keeping to the propriety of the trial by not disclosing, you know, too many details. I can tell you some things that, you know, will, you know, will give you some comfort regarding your question. You know, about now, all of our clinical sites around the country have now undergone the BIMO inspections, which is bringing us closer to, you know, the approval. You know, we had the Investor Day, which was held in June of this year, and we're still waiting for the, you know, inspection of our manufacturing.

You know, all of our interactions with the agency have been very collaborative, and the level of interaction is great. Nothing at this point makes us think that there will be a panel.

Anthony Petrone (Managing Director of Equity Research)

Okay. Okay, then just a follow-up here. One would be on GEM, unveiled at the Sulàyöm campus opening. You mentioned Juan José, 523,000 procedures globally. I'm just wondering if there's any pricing data you can share on gluteal implants relative to breast augmentation? Then one in there, I'll just sneak in for Raj. When we think of the new campus manufacturing, as that expands, but also as we layer in price from China, for instance, and possibly the U.S., you know, how should we think about gross margin, let's say, over the next 2 years from the 2Q level? Thanks again, and congrats on a good quarter.

Juan José Chacón-Quirós (CEO)

Well, first, the interest from consumers on contour aesthetics, and in particular, gluteal aesthetics, has been increasing over the last few years. When you look at that number, you know, more than 500,000 procedures per year, of course, you know, as a women's health company, we are looking to solve for the problems that we see in terms of safety and the quality of the outcomes. You know, what is the correct pricing for that procedure? I think we will know as we, you know, we gather more data and, you know, we do more market research. I think, you know, you know, when you, when you look at Mia as improving procedure compared to traditional breast aesthetics, I think you can use a similar mindset to think about, you know, what GEM could be compared to traditional gluteal options.

Raj Denhoy (CFO)

Hey, Anthony. On, on the gross margin, you know, we are absorbing several things right now. As we noted in the prepared remarks, you know, the, the cost in Colón, in particular, has revalued about 25% in the second quarter alone. We're, we're up against that headwind right now, but as we move out of this and into next year, and we launch into China and then hopefully in the U.S. very soon, the tailwind in our gross margins is going to be pretty meaningful. You know, the pricing in those markets are, are the best in the world. We expect you're going to see a very, a nice improvement in our gross margin over the next couple of years.

Anthony Petrone (Managing Director of Equity Research)

Thanks again.

Operator (participant)

Our next question is from the line of Joanne Wuensch with Citi. Please proceed with your question.

Speaker 9

Hey, good afternoon, guys. This is actually Anthony on for Joanne. Thank you for taking our question. My first just on guidance, since there's some moving pieces with the US, China launches, can you just talk about what your assumptions are at the low end of the guidance versus the high end of guidance? I just had a quick follow-up. Thank you.

Raj Denhoy (CFO)

Yeah, thanks for the question. You know, it, it is, there are a lot of swing factors for us over the balance of the year. You know, we're thinking about the contribution from Mia, of course, the China approval, which we talked about, we're expecting in the fourth quarter, and there's a lot of different ways that the year could unfold. You know, generally, we're comfortable with the entire range we've provided, but it's just very difficult to pinpoint exactly where we'll fall, given all these various dynamics at play.

Speaker 9

Got it. That's helpful. I thought the sort of information on Spain, on the, the leads to a consultation conversion was interesting. Do you know how many of those, I think it was 30 patients that sought out the Mia appointments. Do you know how many actually moved on to get the procedure?

Juan José Chacón-Quirós (CEO)

Yes, thank you. What I can tell you is that because it is summer, you know, many of these potential patients are scheduling either the appointments or the procedure for after the summer break. In Europe and in particular in Spain, you know, they take off the entire month of August. You know, part of what Raj was referring to, you know, is indicative of the way we are looking at Mia. You know, when we think about Mia, we see this amazing initial response that could transform itself into many appointments and potentially procedures. As that ramps up, you know, we expect to see more and more clinics coming in, and that's, you know, what we want to see with the Mia launch.

Speaker 9

Great. Thank you.

Operator (participant)

Thank you. Our next question is from the line of Josh Jennings with Cowen and Company. Please proceed with your question.

Josh Jennings (Managing Director)

Good afternoon. Thanks for taking the questions, Juan José and, and Raj. I wanted to start just on, on Joy Plus and, you know, the Ergonomix2 implant the premium pricing associated with, with that program, and, and just to, to get a better understanding of the momentum, this year in 2023 as the new countries are getting approval and, and launching Joy Plus, and, and the pricing premium associated with that, and, and how you see that ramping over the course of the next 6, 12, 24 months.

Juan José Chacón-Quirós (CEO)

As we launch new, exciting experiences like the one we have with Joy, which is, you know, a program to promote the Ergonomix2 platform, what we see is that once consumers understand the value proposition, they understand that upgrading to these type of offerings is worth the price premium. You know, more than 10% of the market in certain countries has been, you know, moving to Joy for us. And that's very important because it tells you that, you know, what we came into more than a decade ago, which was a commodity market, no longer is, and we've been able to shape that through technology and through, you know, the type of value propositions that, you know, Joy embodies.

You know, still many countries that we we need to go to with Joy, but definitely super pleased about it. Further to that, I think it's important to recognize that, you know, although we are creating a lot of, of, you know, potential awareness and interest with Mia, some of those patients are not suitable for Mia. You know, Joy becomes like the alternative for them that is high quality and, you know, close in the type of experience.

Josh Jennings (Managing Director)

Thanks for that, and I apologize for referencing that as Joy Plus and not just Joy. Wanted to follow up on this topic, and you did unveil a development program for Mia Plus down in Costa Rica at the Sulàyöm grand opening. Wanted to just, I think you've commented multiple times on the Mia launch so far, but just any signals that Mia or Mia Plus has the potential to cannibalize traditional breast augmentation procedures as well, as you move forward with that Mia Plus development program? Thanks for taking the questions.

Juan José Chacón-Quirós (CEO)

In all the market research that we have done over the last few years, you know, what we have seen is that, you know, the market expansion comes from around half of the consumers interested in Mia were not considering a breast augmentation before. The other half, you know, were considering it, but when they see, you know, Mia, it's appealing to them. Now, given the you know, significant difference in the price points for Establishment Labs with Mia, I think it is a quite positive development for the company. Either, you know, the expansion that we see in terms of new entrants to the category with Mia alone, or the ones that are, you know, moving through the consideration phase and end up in Mia, both very positive for us.

Josh Jennings (Managing Director)

Thanks for that. If I could just sneak one more in for Raj, just on the FX impact in the quarter on the top line, any, any quantification you provide would be great. Sorry about that. Thank you.

Raj Denhoy (CFO)

Yeah, no, no problem, Josh. It was minimal in the quarter, you know, not really worth calling out.

Josh Jennings (Managing Director)

Excellent. Appreciate it.

Operator (participant)

Our next question is from the line of Marie Thibault with BTIG. Please proceed with your questions.

Sam Eiber (Vice President and Medical Technology Analyst)

Hey, good afternoon, Juano and Raj. This is Sam Eiber for Marie. Thanks for taking the questions. Maybe I can ask my first question here on the cadence of the back half of the year. Raj, I appreciate your comments in the prepared remarks. In terms of seasonality here in Q3, you know, is that something we should expect relatively in line with, you know, 2021 and 2022?

Raj Denhoy (CFO)

We, we do expect seasonality, right? I think one thing you're seeing probably in our numbers is that the, the amount of revenue going through distributors is also increasing, right? As our distributors start to experience that seasonality as well, it becomes even more pronounced in our numbers. So we are expecting it's going to show up here in the third quarter as we've seen. Also, we expect, you know, the dip in the third quarter to probably be a bit more pronounced than we've seen, you know, relative to the overall cadence of revenue for the year than we've seen in years past.

Sam Eiber (Vice President and Medical Technology Analyst)

Okay, that's helpful. I appreciate the comments. Maybe just to follow up here on some of the questions out of the, the initial Spain experience for Mia. You know, in the past, for typical breast augmentations, we've heard that it takes anywhere from months to a few years to, you know, for a patient to decide to go through the procedure. But it sounds like with Mia, that's potentially accelerating some of that conversion. Just wondering if that was something you think is a phenomenon that's maybe translatable to the broader market for Mia?

Juan José Chacón-Quirós (CEO)

I think it's one of the most interesting things, because, you know, the consideration phase in traditional breast augmentation tends to be around 4 to 8 years. You know, when you look at the group that was not interested in a traditional breast augmentation, you know, that would signal that their cycle of decision making is made a lot easier by the fact that you are removing all these obstacles, you know, from the decision. I think that's, that's absolutely logical. Then when you look at the group that was considering a breast augmentation, what you see is that, you know, Mia, again, is getting them through the finish line by, you know, removing the obstacles that they were looking at.

Sam Eiber (Vice President and Medical Technology Analyst)

Thanks. Second questions.

Juan José Chacón-Quirós (CEO)

Thank you.

Operator (participant)

Our next question is from the line of Neil Chatterji with B. Riley. Please just proceed with your questions.

Neil Chatterji (Senior Analyst)

Yeah, good afternoon, and, and thanks for taking our questions. Maybe just sticking with Mia, you know, you, you've touched on Spain. Just curious how that, that kind of initial experience is maybe similar across the other European countries or centers. And, and if, if not, if there's any other anecdotal feedback you, you've gotten from those centers.

Juan José Chacón-Quirós (CEO)

Yeah, I think what we are seeing is that, you know, these clinics that have moved from certification to actually launching, you know, are getting a lot of interest from potential consumers. Now, the, the summer months did get in the middle of, you know, of this, but I think what we expect is that many of these potential consumers, once they go and get their consultations, will make a decision to go ahead with Mia. You know, just to, to let you know, you know, we have also added another chain of clinics in Japan. You know, we've added two, you know, high, you know, premium clinics in Germany and, you know, we're adding more, you know, as the, as the, as the summer progresses. I think that's really good for us because not-...

potentially fill that interest.

Neil Chatterji (Senior Analyst)

Great. Then just, just one follow-up here for me. I think you talked about kind of the ASP, you know, being up, I think, sequentially year-over-year. Just curious, you know, if there's any, any nuances or dynamics to think about, you know, for the various, you know, international regions?

Raj Denhoy (CFO)

Oh, hey, Neil. No, I think it's, you know, it's kind of a reflection of a number of things, right? I mean, we are, as, as the earlier question noted, we're seeing Joy, you know, start to, to get, more utilization. That's a higher priced product for us. We've taken a little bit of price in a number of our markets. It really reflects, you know, the value that we're bringing with the products that we're taking to market. So I'd say it's, you know, really a combination of, again, that mix and then the pure price we're seeing. Overall, we're pretty pleased at how things are progressing there.

Neil Chatterji (Senior Analyst)

Great. That's it for me. Thanks.

Operator (participant)

Thank you. As a reminder, to ask a question today, you may press star 1. The next question is from the line of George Sellers, Stephens. Please proceed with your questions.

George Sellers (Equity Research Analyst)

Hey, good afternoon, and thanks for taking my question. I apologize if I missed this. I'm hopping from a few calls, but I was just curious if you could give some color on maybe what you're expecting in terms of contribution within the guidance from China. I'm not sure if you've specifically quantified that, but obviously, that approval has been a little bit slower than we'd expected. Just curious if that's a potential headwind or risk to the guidance at this point.

Raj Denhoy (CFO)

Oh, hey, George. You know, we're not going to provide specifics around the, the number, right? The, the amount of revenue we expect from China for competitive and other reasons. You know, our level of confidence and approval this year is very high. We continue to work with our partner in, in China and answer the last few questions that we've received. You know, as I noted on an earlier question, there's just a number of different ways that the year can play out with the contribution from Mia, with China approval. So again, we're comfortable with the entire range we've given, and it's just really difficult to pinpoint where exactly we're going to fall within that.

George Sellers (Equity Research Analyst)

Okay. That, that's totally understandable. Maybe switching to Mia. You've announced 14 partnerships so far. I'm just curious how you're thinking about that, playing out the rest of this year, what your expectations are, and, if you're trying to sort of accelerate, those partnerships, maybe what gets that, or gets doctors to sign up faster, or if this is maybe, a purposeful, slower rollout and, and sort of picking and choosing the, the best partners at this stage.

Juan José Chacón-Quirós (CEO)

No, absolutely. I think what we're trying to do is, you know, accelerate the number of premium partner clinics that we bring on board in Europe. I think, you know, there's still a lot of space for us to, you know, to acquire some of those premium partners. Also, more importantly, you know, we need to train them, certify them, and get them to launch. I think the importance is that as we move, you know, through this and month by month, we've been seeing it, we learn more and more, you know, what works in terms of creating awareness and what is most efficient. You know, clinics that come later on will benefit from those learnings.

George Sellers (Equity Research Analyst)

Okay, great. Thanks for the time again. I appreciate it.

Operator (participant)

Thank you. This is all the time we have for questions today. I'll turn the call back over to Juan José, Juan José Chacón-Quirós. Please just proceed with your comment, closing comments.

Juan José Chacón-Quirós (CEO)

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

Operator (participant)

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.