Establishment Labs Holdings - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 revenue was $51.3M (+16.3% y/y) with gross margin at 68.8% and U.S. Motiva sales of $10.3M; adjusted EBITDA loss improved to $(8.5)M from $(12.1)M in Q1.
• Guidance raised: FY25 revenue now $208–$212M (from $205–$210M), including at least $40M in U.S. Motiva sales and single‑digit OUS growth; management reiterated first EBITDA‑positive quarter in 2025 and cash flow positive in 2026.
• The company emphasized strong U.S. momentum (1,000+ accounts, sequential growth expected in seasonally soft Q3) and improving execution/efficiency; EMEA direct markets grew ~27% underlying, while China headwinds led ESTA to remove China from H2 guidance.
• Near‑term stock reaction catalyst: raised FY25 guidance and visibility into U.S. adoption and utilization ramp, plus commentary that Q3 should see sequential growth despite seasonality.

What Went Well and What Went Wrong

What Went Well

• “Our US sales momentum has continued into the third quarter, allowing us to increase our worldwide and US guidance… We remain on track to achieve positive EBITDA in 2025 and become cash flow positive in 2026.” — CEO Peter Caldini.
• U.S. Motiva revenue of $10.3M, ahead of June Investor Day range; orders increased each month April–June and momentum carried into Q3; 1,000+ U.S. accounts and expanding surgeon utilization.
• Gross margin up 320 bps y/y to 68.8% (and +160 bps q/q), driven by U.S. mix and higher ASPs; 2025 GM expected to be ~200–300 bps higher than 2024 despite <50 bps tariff impact.

What Went Wrong

• China underperformed due to market pressure in premium segment and slower‑than‑planned distributor scale‑up; China removed from H2 guidance.
• SG&A rose ~$11.4M y/y to $44.2M on U.S. ramp, shipping (air freight, last‑mile), and marketing (Meghan Trainor campaign); OpEx expected to moderate in H2.
• Adjusted EBITDA loss widened y/y to $(8.5)M (vs $(4.1)M) given higher OpEx and mix of investments, though improved sequentially vs Q1.

Transcript

Speaker 2

Good morning. Welcome to Establishment Labs Holdings Inc.'s second quarter 2025 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 a question-and-answer session, and instructions will follow at that time. 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.

Speaker 3

Thank you, Operator, and thank you, everyone, for joining us. With me today is Peter Caldini, 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 Holdings Inc.'s 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.

I'd also like to remind you that our comments may 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, or profitability of the company's business, which can be stated as EBITDA or adjusted EBITDA. Reconciliations to comparable GAAP financial measures for non-GAAP measures, if available, may be found in today's press release, which is available on our website. The content of this conference call contains time-sensitive information accurate only as of the date of this live broadcast, August 7, 2025. Except as required by law, Establishment Labs Holdings Inc. 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 Peter.

Speaker 0

Thank you, Raj. Revenue in the second quarter totaled $51.3 million, a growth of 16% over last year. Our second quarter sales included $10.3 million in the U.S., exceeding the $9.5 to $10 million range we provided at our Investor Day in early June. With Q2 behind us, we can now comfortably say that our U.S. revenue will exceed $40 million, and with this clarity, we are raising our revenue guidance to $208 to $212 million for a growth of 25% to 28%. It's also worth noting that our U.S. sales momentum has carried into Q3, and we are expecting sequential growth from Q2 to Q3 in the U.S., despite the traditional Q3 lull in plastic surgeries. We continue to make good progress on improving our operating profitability and cash flow.

Our adjusted EBITDA loss for the quarter was $8.5 million, an improvement from the $12.1 million in the first quarter. Our cash use fell to $14.5 million from $21.2 million last quarter. As discussed in our Q1 call, we expect cash use to reduce by approximately $5 million each quarter. Our U.S. business continues to do exceedingly well. We have assembled a best-in-class organization in the U.S. under the leadership of Jeff Earhardt, and we're seeing the results. Our team has successfully leveraged the superior product benefits of Motiva to drive account acquisition, and the number of procedures continues to exceed our expectations. We are executing at a high level and should achieve a leadership position in the market. Outside the U.S., our results are improving as well.

Growth in our direct markets has been a major focus for our team as we manage these markets within our own organization and have greater economics. We have restructured the O.U.S. organization, reallocated resources, and applied improved operational processes to support our direct markets. We're already seeing the benefits of these changes. Excluding the benefit of currency and the acquisition of the Benelux distributor, our European direct market sales increased by approximately 27% this quarter. This reflects a new sales record, and we believe these trends will continue. There is good early demand for PreserVay, Mia's tracking to plan, and we're seeing an increase in the number of accounts in which we sell, all very good signs for our trajectory. There are certainly continued areas for improvement. For example, China has been affected by a number of factors, and that is a particular focus for the team.

We are working with our distribution partner and their investor to ensure success in China. Motiva is the leading implant across Asia, and we expect to achieve the same position in China. On the operational side, we are focusing our resources on the areas with the most financial potential, like the U.S. and our minimally invasive portfolio, and we're reducing expenses in other areas so that we can operate as efficiently as possible. This can be seen in the improvement in the adjusted EBITDA and cash use we posted this quarter. We expect our first positive adjusted EBITDA quarter later this year and remain on track to be cash flow break-even in 2026. As noted, our progress in the U.S. is tracking well ahead of plan. At our investor meeting in June, we confirmed we had reached 1,000 accounts in the U.S., and that number continues to grow.

It is important to remember there's a difference between procedure share and surgeon share. While there are about 6,500 board-certified plastic surgeons in active practice, a much smaller percentage are responsible for the vast majority of the breast augmentation and revision procedures done each year. To put that in perspective, if the 1,000-plus accounts we currently have were to fully adopt Motiva, we would have approximately 50% of the breast augmentation market in the U.S. The most important factor in increasing surgeon utilization is time and surgeons getting comfortable with the Motiva implant. Once a surgeon gets introduced to Motiva, they follow a typical adoption curve, completing a few cases at first and then waiting to see the results. Once past that, they will start building Motiva into their consultations. A busy plastic surgeon could be booking cases out for six months.

Further, it's likely that a plastic surgeon will build Motiva into their practice over time. What starts as two initial cases could become 25% of their business after four months and then 50% after six months. This is what we're seeing. In short, while some plastic surgeons move their practice to 90% plus or minus Motiva immediately, most take several quarters to get comfortable and to work through previous consultations where a different implant was already selected. Our team is very focused on high-volume practices as well as industry leaders. Whereas industry leaders used to be defined as the key opinion leaders who spoke frequently on podiums at conferences, it means something quite a bit broader today. There's a new group of surgeons whose podium is social media through platforms like Instagram and TikTok.

Establishment Labs is attracting surgeons and patients through our digital and social media efforts, and we're seeing the results. Surgeons consistently tell us that patients regularly come in asking for Motiva Implants by name, something they have not seen before in the industry. Surgeons also tell us that patients are walking away from the competitor warranties that cover their previous surgeries, instead opting to pay for Motiva Implants rather than get replacement implants for free. This behavior is unprecedented in the aesthetics and medical device industry. Our team continues to add high-volume practices and industry leaders, making Motiva Implants more and more available across America. Early data suggests that surgeons who offer Motiva Implants are seeing an increase in their business. In other words, as patients carefully choose their surgeon, a new factor in their decision process is the availability of Motiva. Our efforts are working.

As of this call, the growth trajectory continues. Orders have increased each month from April through June, and that trend has continued into the third quarter. As such, we expect to see sequential growth in the third quarter, a period that is seasonally down for the industry. Continued growth in our core business should continue for many years, and a robust pipeline should add to that growth as well. Our ultimate goal is to have surgeons prefer our implants in all their cases, and our pipeline should help get us there. In early 2026, we should have an expanded range of sizes approved by the FDA, and this will help drive utilization as well as new surgeons to our products. This is just the start of a cycle of innovation we'll bring to the U.S.

market over the next couple of years, led by our minimally invasive portfolio as well as our efforts in reconstruction. In July, we hosted 36 U.S. plastic surgeons in Costa Rica to introduce them to PreserVay. PreserVay is an advanced, less invasive breast enhancement technique designed specifically to preserve natural breast tissue functionality, including nipple sensation and chest muscles. It also provides for a fast post-procedure recovery. The PreserVay procedure is designed to be performed with minimal anesthesia and uses the Motiva channel separator to create a tunnel without cutting any tissue, and the Motiva inflatable balloon, which gently pushes the tissue structure aside to create a precise pocket that matches the size and creates space for the breast implant. Many surgeons who attended commented for the first time in decades there is a fundamentally different way to perform breast augmentation surgery.

PreserVay is not just a way to do an existing procedure differently, it is an entirely new procedure with real advantages for many patients. The reception from surgeons who are part of this training has been overwhelmingly positive. It's hard to overstate how meaningful it was to bring together this specific group of surgeons, which not only included some of the highest volume surgeons in the U.S., but also current and past leaders of major plastic surgeon societies. If you haven't, I would recommend following some of their social media. Their enthusiasm and content is already changing the narrative and conversation around breast implants. We expect to begin shipping in August so that the early experience group can perform their first PreserVay cases. We will collect their feedback to support the launch of PreserVay in the U.S., which we anticipate will be in the first half of 2026.

We expect PreserVay to command a premium, which will not only add to gross margins but also expand our TAM on a dollar basis as well. PreserVay highlights perhaps the most important point: all the technological advancement that has gone into Motiva Implants allows for new procedures and techniques that were previously technically inadvisable with competitor devices. For example, we've seen a rise in the use of prepectoral implant procedures, which can offer more natural outcomes and faster recovery time. This has dovetailed nicely with the increasing interest in smaller implants, a trend that was covered recently in the article of Wall Street Journal. While Motiva Implants have clear benefits across the board in breast procedures, the use of smaller implants in prepectoral positions is a segment which Motiva is uniquely able to support.

In breast reconstruction, our Motiva Floor Smooth Silk Tissue Expander is now in use at over 90 hospitals in the U.S., with more being added every month. For Motiva Implants in reconstruction, we are close to completing the three-year follow-up in this cohort. We will lock the database for a supplement in September and expect to submit for approval in reconstruction before the end of the year. Outside the U.S., we saw sequential growth in all our geographic regions in the second quarter. As I indicated previously, we have taken a number of actions to improve the performance of our direct markets. We are seeing the benefit of these activities, and as previously noted, our European direct markets grew approximately 27% versus last year. Core markets like the UK, Spain, and Germany were key drivers for that growth.

In our Latin American direct markets, we continue to see stabilization of our Brazilian affiliate and continued strong growth in Argentina. These results are being supported by our minimally invasive platforms and by the halo effect of the U.S. approval and initial success. The number of accounts we have in many markets is increasing, clearly a positive sign. Our distributor markets are generally doing well. Latin American distributors grew double digits in the second quarter. In other regions, the timing of orders to several of our partners impacted results. We believe these are short-term, and our market position overall globally continues to strengthen. For 2025, Mia remains on track to achieve $8 to $10 million in revenue. Mia is appealing to a new group of women who had not previously considered breast augmentation, and we continue to see the strong interest from clinics to offer the procedure.

PreserVay also continues to build momentum outside the U.S. and is going to be a meaningful contributor this year and next. We have clinics in Europe and Latin America already routinely performing this procedure and more being added regularly. With that, I will now turn the call over to Raj.

Speaker 3

Thank you, Peter. Total revenue for the fourth quarter was $51.3 million, an increase of 16.3% from the year-ago period. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 14.3% versus a year ago. Sales for Motiva in the U.S. were $10.3 million. On a geographic basis, sales in the U.S. were 20% of the global total. Sales in Europe, Middle East, and Africa were 40% of sales, and we saw double-digit year-over-year growth overall in the region. Latin America was 19% of sales with mid-single-digit growth, including stable results in Brazil compared to the first quarter. Asia-Pacific was 15% of sales, and while we saw sequential growth in the region, results were down year-over-year, mostly due to China and some one-off timing of orders from other distributors.

Our gross profit for the second quarter was $35.3 million, or 68.8% of revenue, a 320 basis point increase compared to the 65.6% of revenue for the same period in 2024, and 160 basis points higher than the 67.2% in the first quarter of this year. The increase reflects the higher margin sales in the U.S., and we continue to expect gross margins in 2025 will be approximately 200 to 300 basis points higher compared to 2024. As it relates to tariffs, the duties on goods imported from Costa Rica to the U.S. are expected to result in less than a 50 basis point gross margin impact on a consolidated basis and do not change our trajectory for margin improvement this year. Estimated expenses of $44.2 million were approximately $11.4 million higher than in the second quarter of 2024. R&D expenses for the second quarter were $5.2 million.

Total operating expenses for the second quarter increased approximately $11.1 million from the year-ago period to $49.4 million. The increase in operating expenses this quarter was due primarily to the ramp-up of commercial activity in the U.S., including the Meghan Trainor campaign, where the majority of the expenses fell in 2Q, as well as higher shipping costs. Shipping costs were the result of shipments sent by air in the second quarter to the U.S. and other markets to match the stronger demand. We also saw higher last-mile shipping costs in the U.S. on the higher volume of sales. We expect operating expenses will moderate in the second half of the year. For 2025, we continue to expect operating expenses will be approximately $45 to $46 million on average per quarter, which is where we are trending through the first half of the year.

Though, as we saw in the first and second quarters, there can be fluctuations based on the timing of expenses. Adjusted EBITDA was a loss of $8.5 million, an improvement from the $12.1 million in the first quarter. We expect to see further improvement into 3Q and to reach our first EBITDA positive quarter this year. Our cash in the second quarter was $14.5 million, which was down from $21.2 million in the first quarter. As we have noted previously, the first half of 2025 should be higher for us in terms of cash use, as we funded investments in the U.S. commercial platform, as well as increases in working capital to support the strong demand. Cash use is expected to come down by approximately $5 million a quarter for the next several quarters, including an expectation of approximately $10 million in the third quarter.

We expect to get to cash flow positive in 2026 without the need for any further equity raises. Our cash position on June 30th was $54.6 million. We have an additional $25 million still available under our credit facility, putting our total accessible cash balance at approximately $80 million. As a reminder, our current credit facility is approaching the last year of the term. We are exploring refinancing options that could further reduce our cash use over the coming quarters. We are increasing our revenue guidance for 2025 to a range of $208 to $212 million from the previous $205 to $210 million. Our new outlook represents growth of 25% to 28% and includes an expectation of at least $40 million in U.S. Motiva sales and single-digit growth outside the U.S. The U.S. is the primary engine of growth this year, but our direct markets outside the U.S.

are also doing well. We are making good progress in leveraging our operating expenses and improving cash flow. We continue to forecast our first EBITDA positive quarter this year and remain confident that we will reach cash flow break-even in 2026. I will now turn the call back to Peter.

Speaker 0

Thank you, Raj. Just last week, we announced that our Motiva Floor Smooth Silk Tissue Expander won both the Innovation and the Safety Awards in the 2025 Medical Device Network Excellence Awards. In its announcement, the organization noted this dual category win establishes Motiva Floor as a benchmark in breast reconstructive surgery. Our innovations are brought to market through years of hard work, and this recognition is a testament to the passion and dedication of the many people who work at Establishment Labs. Our company remains focused on four main priorities this year: driving growth in the U.S., the ongoing launch of our minimally invasive portfolio, increasing efficiency and profitability across the organization, and advancing our innovation pipeline. We are making progress on all fronts. We are advancing to profitability through growth and continued operational efficiencies.

We have a number of key growth drivers for the rest of 2025 and for many years to come. Higher surgeon utilization and adding accounts in the U.S. will drive growth for the rest of this year and into next. Approval of additional sizes will accelerate in both these areas. Having our indication for breast reconstruction in the U.S. will also be a considerable growth driver. PreserVay will create a premium offering around the world and help expand our TAM on a dollar basis, as well as contribute to gross margin expansion. Mia helps expand our TAM on a patient basis. Reaching profitability this year and cash flow break-even next year are significant milestones for us as an organization. With our differentiated technologies and market position being cash-generating and self-sustaining, it affords us a very unique opportunity to drive significant shareholder value for many years to come.

Operator, we're ready to take your questions.

Speaker 2

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the one on your touch-tone phone. You will hear a three-tone prompt acknowledging your request. If you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. First question comes from Josh Jennings at TD Cowen. Please go ahead.

Hi, good morning. Nice quarter, and it's great to see the positive 2025 revenue guidance upgrade and hear about the continued momentum in the U.S. Motiva launch. I think you guys touched on most of the points in the guidance update. Maybe if you could fine-tune or share some more details around assumptions baked into the upgrade, $40+ million, at least $40 million in U.S. Motiva revenues, and single-digit international sales. Is there anything regional you can share? Peter, you talked about some headwinds in China. I would love to hear more about that and how we should be thinking about revenue in China in the second half.

Speaker 3

Hi, Josh. Thanks for the question. Yeah, as you noted, we are seeing very strong results in the U.S. The continued momentum we're seeing in surgeon adoption and the utilization is giving us the confidence to raise the U.S. outlook to at least $40 million. That's really the basis of the comfort in raising the global outlook to $280 million to $212 million, as you mentioned. Outside the U.S., the direct markets are doing very well. As we noted in the prepared remarks, our European direct markets are up about 27% on an underlying basis, so very strong results there. Our distributor markets are performing to expectations with the exception of China. As we highlighted in prepared remarks, that market has been a little bit more challenging this year, and we have taken China out of the guidance for the second half of the year.

Speaker 0

Yeah, so Josh, thanks for the question. Just to add a little bit more context to the business in China. For us, I think the business is performing below expectations. A lot of that is driven by the market environment. You're seeing declines across a number of consumer segments, and aesthetics in particular is under pressure. Basically, also where we're positioned in the premium segment, we're seeing a lot of challenges there. We also feel that our distributors experience some challenges in terms of scaling up their commercial operations. We expect to be further along at this point in the launch. In terms of building out their commercial capabilities, in terms of the productivity in the hospitals that they're in, this is a big focus for us.

We work very closely with our partner in China, and we're still very confident that we are going to achieve the same leadership position in China that we have throughout Asia. It's just that the ramp-ups can be a little bit slower, and we're reflecting that in the guidance. As Raj mentioned, we continually do very well in the U.S. We're continuing to see that momentum in Q3. The direct markets are doing well, and that's been a priority for us. These are markets that we see significant growth opportunities, and these are areas where we have our own organizations and I think also opportunities for growth. We're very pleased with those growths, and I think that's reflected in the numbers. We're also being cautious about the current situation in China.

Speaker 2

Thank you. The next question comes from Sam Shimon Eiber at BTIG. Please go ahead.

Hi, good morning, and thanks for taking the questions this morning. Peter, really helpful commentary on the utilization trends in the U.S. as surgeons gain more experience and work through the existing consultations that they had prior. As I think about the growth trajectory going forward, is it fair to assume that we could actually see an acceleration, sort of a hockey stick type of an inflection at some point as that utilization starts to build and they work through their order book? How should we think about timing of when that could happen?

Speaker 0

Sorry, just give us one minute. We're having a bit of background noise here. Sorry about that.

Speaker 3

Yeah, thanks, Sam. As we highlighted in the prepared remarks, we continue to make great progress in the U.S. market. We continue to add additional accounts. Even going into Q3, which is a slower part of the season, we continue to build that momentum. I think as most accounts, it varies by account that I highlighted in the prepared statement. What we are seeing is we've been able to capture a number of accounts. I think we have over 40 accounts that have already done over 100 orders year to date. Some have actually reached 200. I think it's going to continue to progress in the same type of trajectory. As we add accounts, the original accounts that are moving up the adoption curve, which varies by clinic, you're going to see acceleration as well. I don't think there's necessarily going to be a hockey stick per se.

You're just going to see continued gradual growth as we add new accounts, as well as some of the accounts that we've already added are kind of moving up the adoption curve.

Speaker 2

Thank you. The next question comes from Anthony Petrone at Mizuho Group. Please go ahead.

Speaker 3

Great, thanks. Congrats on a great quarter here and a solid launch on Motiva. One on U.S., one on O.U.S. On the U.S. side, when we think about just the rate of position ads, it's been quite rapid since the FDA clearance last year. What does the trajectory look like from here when we just think about new site openings? At what point do you think this turns into more of a penetration story into those accounts rather than new site ads? I have a follow-up question, O.U.S.

Speaker 0

Yeah, thanks, Anthony. As we highlighted, we continue to get more accounts. We highlighted in our Investor Day we've reached 1,000 accounts. We continue to add to that. In terms of the growth moving forward, a little bit more of our focus, I would say at this point, is actually enhancing the utilization rate in the accounts that we do have. We still see opportunities to add additional accounts, especially as we expand our sales force. I think that's going to be the focus as we move forward.

Speaker 3

Just a quick follow-up there. You've had some competitors report in the aesthetics space, and there's a little bit of pressure on the consumer end. Certainly not seeing it in the Motiva numbers here. Where do you think the underlying U.S. breast augmentation is? In other words, is there another leg here to unlock once the consumer stabilizes? Quickly on the O.U.S., just wondering how much revenue was impacted by the shipping delays you referenced there in APAC specifically. Thanks again.

Speaker 0

Okay, I think what we're seeing, Anthony, as it relates to the U.S. market is we haven't seen a slowdown in the breast aesthetics augmentation market. We're continuing to see good growth, and I think some of that is driven because we are driving share and we're continuing to gain share in the marketplace. I think also, with a lot of the activities that we're doing in terms of social media, Meghan Trainor, I think we've been able to increase some of the interest in terms of patients and looking for breast augmentation procedures. I think we've been working and helping to remove some of that taboo related to it. I think in some respects, and we don't have specific data on this, we're helping to drive growth in the category. As it relates to the O.U.S. numbers, Raj.

Speaker 3

Sorry, Anthony, can you repeat the question? I think you were asking about shipping. I think we may have lost Anthony.

Speaker 0

This is phasing of the shipping.

Speaker 3

Yeah, I think the revenue attached to the shipping date comment in APAC specifically.

Speaker 0

I think what we commented on was that we did incur higher shipping costs in the quarter relative to sending product via air as opposed to via seafreight. We didn't see any impact in our results really relative to shipping days or anything related to that.

Speaker 3

Yeah, I think, Anthony, just to add, I think specific to the O.U.S., in terms of lapping versus last year, obviously we had, you know, last year we had China orders, we didn't have it this year. Some of it is just the timing of these orders. I think in a couple of cases, distributors are managing down inventory as it relates to a regulatory change that's coming. The quantification of that impact, I think, is somewhat marginal, and it's going to be really kind of something we address in the following quarters. It's more of a timing issue.

Speaker 0

Thank you very much.

Speaker 2

Thank you. The next question comes from Michael Matson at Needham & Company. Please go ahead.

Speaker 3

Yeah, thanks for taking my questions. I have two. They're sort of related, so I'll just go ahead and ask them both now. I wanted to ask one on pricing trends in the U.S. I think you had priced your implants a bit higher than some of the competitors. Are you being able to sustain that? Are you seeing any pushback? The second question would just be around competitive response. Are you seeing, what are you seeing the two bigger competitors doing, if anything, to try to fight back as they lose share to Motiva? Thanks.

Speaker 0

Yeah, thanks, Mike. In terms of pricing, as you mentioned, we do have a premium price versus our competitors because we feel we have a superior product in the marketplace. I think that's reflected by the patients' acceptance as well as the surgeons. We have not really felt any pricing pressure per se. I think as, naturally, as we gain scale with certain clinics, there's going to be volume discounts based on the number of procedures or number of the orders that they have. That's not really driven by any kind of competitive reaction. I would say from an overall competitive response, we see nothing that's a major coordinated reaction. I think much of it is really on a market-by-market basis, certain responses by individual sales reps, but nothing that I would say is a concerted, organized, and con reaction from the competitive side right now.

Speaker 3

Okay, got it. Thank you.

Speaker 2

Thank you. The next question comes from Allen Gong at JPMorgan. Please go ahead.

Thanks for the question. Sorry if this has been answered already. I joined a little bit late, but just curious on the cadence for the balance of the year. I know the $40 million target for the U.S. is a bit open-ended, but if we just think about the incremental contribution implied by that, you're saying they're going to get at least $4 million or so revenues in the back half, assuming we just straight line the second quarter. Taking into account the continued ramp and some seasonality in third quarter, how should we think about the cadence of growth for both U.S. and global in the balance of the year?

Speaker 3

Yeah, thanks, Allen. Thanks for the question. We do expect the U.S. will see some sequential growth into the third quarter. It's usually a seasonally slow period, but given the momentum of the business, we do expect it will be up in the third quarter. We'll, of course, see a nice presumption into the fourth quarter. The guidance is for at least $40 million, right? We continue to look at it in terms of trying to offer a conservative view on it. Clearly, the momentum in the business is quite strong. $40 million is really the low end of where we expect to be for the year. As it relates to outside the United States, as you know, the third quarter is seasonally slower, as I mentioned. We shouldn't see that in the O.U.S. business. That will give you the timing of certain orders.

We do expect that the third quarter might not be down as much as it is in historic periods. We should see a nice step up into the fourth quarter.

Thank you. Just a quick follow-up on spend. SG&A came in, I think, a little bit higher than we were thinking. Is that just additional investment to support the U.S. launch? How should we think about the leverage you can maybe get in the back half now that we're moving past the initial phases of the domestic launch? Thank you.

Yeah, as noted in the prepared remarks, there were primarily two major factors in the quarter. As I mentioned, the shipping costs were higher. That was a combination of sending more product via air versus seafreight in order to meet the demand that we're seeing both in the U.S. and outside. In the U.S., given the higher volumes that were moving, we did have higher last-mile shipping costs, actually getting the product from the warehouse to the customers. The second piece of that is the timing of certain expenses. We did have some higher marketing spending in the U.S. relative to some of the activities, the Meghan Trainor campaign and the like. That was really more of a timing question. As we think about the back half of the year, we do expect that operating expenses will trend down from where they were here in the second quarter.

We'll see a nice improvement into the third quarter. As we've spoken about previously, it is the increase in revenue primarily driven by the U.S. that is providing the leverage. As we keep operating expenses on a quarterly basis relatively consistent, as those revenues come in, and particularly the higher gross margin U.S. revenues, that's where the leverage starts to flow from. We remain confident that we'll achieve EBITDA positive in the back half of the year and then ultimately cash flow positive next year.

Speaker 2

Thank you. The next question comes from Matthew Taylor at Jefferies. Please go ahead.

Hi, thanks for taking the question. I had a follow-up on China. I know last year that on the Q3 call you announced this partner in principle had committed to invest up to $50 million in the distributor. I was wondering if you could just give an update on how that investment is tracking, how much have they invested so far?

Speaker 3

We don't have perfect visibility into the investments from that distributor, from the investor into our distribution partner. They have been building the activity in China. The issue so far has been that they're experiencing some challenges in scaling the commercial operations there, and they're a little bit behind where we would have expected at this point in the launch. We are doing what we can to support that distributor to help them achieve what we all expect we can in the region. As we've mentioned in our prepared remarks, we're the leading implant in all of the surrounding countries in Europe, and our expectations are we'll achieve a similar position in China. It is clearly going a bit slower than we had hoped at this point.

Okay. The second question was, I wanted to ask about the difference between Mia and PreserVay. I mean, you've talked a lot about Mia in the past and the excitement around that, and it seems just maybe it's recency bias, but now you're talking a lot more about PreserVay. I know there's some similarities and some differences. Maybe I'll just ask, you know, if you look five years out, do you think Mia is going to be bigger than PreserVay in terms of dollars or the other way around? Just help us think about the two approaches into the future.

Speaker 0

Yeah, thanks, thanks, Matt. You know, both Mia and PreserVay are part of our minimally invasive platform, and they work very complementary. Mia is for, you know, procedures two cup sizes. It's transaxillary. It's not for every patient or every surgeon. I think when you look at PreserVay, it's much broader. What we call for everyday uses, you can have different or more types of procedures. You can go with more cup sizes. I think in general, you know, I think you're going to see both of them playing quite well together because you could have a Mia patient that, or somebody that's interested in Mia that's just not going to be the right patient, and they usually shift to PreserVay. I think over time, I would suspect that PreserVay would be larger than Mia because it attracts to more patients and also more surgeons.

What we are very pleased about so far in the launch in Europe is, you know, not only have we gotten a very strong interest, but we're also finding that it has not cannibalized our Mia business. In fact, a number of clinics that are signed up for Mia are also taking on PreserVay. They're seeing the value of, you know, leveraging both types of procedures.

Great, thanks so much.

Speaker 2

Thank you. Next question comes from Mason Carrico at Stephens Inc. Please go ahead.

Hey, thanks for the questions. At your Investor Day, you called out an initiative to place permanent consignment inventory at some of your largest customers. I was just curious, how is that initiative going? Have you seen any impact on utilization at accounts where you have placed that inventory?

Speaker 0

Yeah, so that's, I think that's going very well. We've reached over 100 accounts where we have permanent consignment, and I think that's really been a process for us to get the inventory into the U.S., and I think that's one of the reasons why, you know, Raj highlighted earlier, you know, there's a lot more air shipments just to get the inventory into the U.S. We've been able to get that in the markets, and it certainly helps in terms of enhancing the utilization rate, and it also improves our ability to kind of get products out to the clinics in a timely manner. It has been, you know, it's been a process kind of getting it to that level, and we continue to expand the number of accounts as we get more products into the market and also as we sign up more clinics.

Got it. Could you just update us on the U.S. sales force expansion? Where does that team stand today? Have your expectations around pacing of hires changed at all?

Yeah, so right now, as I mentioned in the last call, we are up to 43 reps in the U.S. As we are looking to go into next year, we're probably going to be adding 10 to 15 reps. On top of that, management roles or leadership roles in the sales organization. From a rep standpoint, 10 to 15, and a lot of that is to cover some of the areas as we enhance penetration in some of the geographies. We're going to need a little bit more coverage there, also in preparation for the PreserVay launch. Some of that's going to be starting in the back half of Q4. The majority of that's going to be in the first quarter as we continue to ramp up our sales and in preparation for PreserVay, we're going to be enhancing our sales force.

Understood. Thank you.

Speaker 2

Thank you. The next question is a follow-up from Joshua Jennings at TD Cowen. Please go ahead.

Hi, thanks for taking me back in. I wanted to build on Matthew Taylor's question. I can ask it already, but you talked about the potential for Mia accounts without PreserVay. I was just thinking about the U.S. strategy in terms of launching PreserVay first here, and then Mia kind of setting the stage and then introducing Mia. Internationally, you've had Mia commercialized now with the PreserVay launch. Do you think PreserVay ultimately can drive increased adoption and utilization of Mia? I think you talked about Mia accounts adopting PreserVay, and do you think it can go the other way as well? We think it can. The last follow-up is just on the limited launch dynamics in the U.S. You had that training session down in Costa Rica with the U.S. Motiva revenue guidance update.

We're assuming minimal contributions from PreserVay in the second half of 2025 and then more meaningful in 2026. Maybe just refresh on whether PreserVay is included in that update for the U.S. Motiva revenue. Thank you for taking all the questions.

Speaker 0

Yeah, thanks, Josh. In terms of the U.S. launch, we're going to be launching PreserVay first. As I mentioned, it's in the first half of 2026. I think it's going to be a great introduction into our minimally invasive platform. I think it's very consistent to the type of procedures that surgeons currently do in the U.S. Once we have that established, I think the Mia business, the Mia opportunity, once we get the regulatory approval for Ergo2, which we plan on submitting in the early part of 2026, depending on that approval timing, will really dictate our launch timing with Mia. I think it's going to be a great add-on to PreserVay. I think your second question was the early experience for PreserVay. We're not expecting really a significant or even really an impact in terms of our revenue guidance from Motiva in 2025.

This is really, as we said, intended to be an opportunity for us to learn and really hone our strategy in terms of launching it in the U.S. I think the revenue potential for PreserVay in the U.S. is very small, and that's not how we're really kind of looking at that. We don't really have that as currently part of the guidance.

Thanks again.

Speaker 2

Thank you. We have no further questions. I will turn the call back over to Peter Caldini for closing comments.

Speaker 0

Thank you, Operator. Thanks for everybody joining the call today. I look forward to seeing everybody in the next call, and hopefully you get a chance to enjoy what little bit is left of the summer. I look forward to getting together again in the near future. Thank you.

Speaker 2

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your line.