Establishment Labs Holdings Inc.

Good afternoon, and welcome to the Establishment Labs Report's second quarter 2024 financial results call. At this time, all participants will be in a listen-only mode. At the end of this call, we will open the line for question-and-answer session, and instructions will follow at that time. As a reminder, this call is being recorded. I would now like to turn the call over to Raj Danhoy, Chief Financial Officer. Please go ahead.

Thank you, operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacon Quiroz, our Chief Executive Officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements from the meeting of federal securities laws. These include statements on Establishment Lab'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. 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 authority for product availability. The content of this conference call contains time-sensitive information, accurate only as of the date of this live broadcast, August 6, 2024. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statements 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.

Thank you, Raj, and good afternoon, everyone. Revenue in the second quarter of 2024 totaled $44.1 million. Global demand for our products continues to stabilize and was reflected in the strong sequential improvement we saw in revenue this quarter. Quarter over quarter, our revenue improved by 18.7%, and this increases our confidence about our return to growth in current markets. I am sure a recent FDA pre-approval inspection is top of mind for many of you on the call. And I am pleased to tell you that during the week of July 22nd, the FDA conducted and completed their PMA pre-approval inspection of our manufacturing facility in Costa Rica. The investigator had three observations listed in a single 483 report, each of which are unrelated and not systemic in nature. This is not unexpected for a PMA pre-approval inspection and should not meaningfully impact our timeline to launch in the United States. We have already submitted our responses to the FDA to address their observations. The process towards approval should now move forward to closure. As a reminder, we have already received an approvable letter where the FDA stated that pending a satisfactory review of our facility, our PMA would be approved. We are confident that after the inspection and our timely response, we have satisfied that final step, and we believe that the final approval will be issued soon. All regions showed sequential improvement in the second quarter, with the exception of Latin America, and in particular, Brazil. As we noted in previous calls, the Brazilian market continues to suffer from softer underlying demand, and we do not expect to see improvement this year. We have a number of initiatives to strengthen our market position in Brazil while making sure that during this slowdown, we have a cost base that reflects our current demand. The rest of Latin America is stabilizing at a slower pace than other regions, and we think the current environment in the region will continue to be challenging for aesthetics in general. EMEA, on the other hand, performed well, and the second quarter was notable as there are markets that have fully recovered from the slowdown last year. We are also seeing a good recovery in demand from our distributors in the APAC region. Our second quarter results showed the tangible results of the cost reduction and efficiency improvement activities we undertook in the second half of last year. Adjusted EBITDA loss was approximately $4 million. This was similar to 1Q, despite increasing investment in our U.S. commercial organization in preparation for our launch. The loss this quarter was less than half of what we reported in the second quarter of last year. and we remain on a good trajectory to reach positive EBITDA over the coming quarters. Before Raj provides more on our financial results and outlook, it is worth highlighting several recent events. As we expect FDA approval is very near, we are moving forward with our preparations for entry into the U.S. While we are careful not to market Motiva implants in the U.S. until they are approved, the interest in our company and our technologies among U.S. surgeons is reaching an inflection point. There are a good number of US plastic surgeons in our FDA study, and they have obviously talked with many of their colleagues about their experiences. Last month, we hosted a medical advisory board of US plastic surgeons at our headquarters, and the feedback from this group has been nothing short of amazing. That there is such strong interest for a new breast implant in the US is not surprising. The US market has seen no real innovation in decades. Surgeons have had to adapt their practices to sell commodity devices developed decades ago. What we are bringing to the U.S. is not a commodity offering and is designed with the knowledge gained from years of scientific and clinical studies. The four-year data from our Motiva USID study presented earlier this year at the Aesthetic Society meeting showed less than 1% device-related complications with Motiva implants. These low complication rates are a confirmation of an entirely new standard for breast implants. It is worth noting that the FDA data from the two largest manufacturers in the U.S. showed that between 1 in 7 and 1 in 12 women developed a grade 3 or grade 4 capsular contracture at 4 years. These device-related complications are serious and in many cases require re-operation. In the Motiva study, it was only 1 in 200 women. This month, we will complete the fifth year of follow-up in the FDA study for breast augmentation and the buzz is palpable. and it is growing. Jeff Earhart, who leads our North America business, has been moving quickly to build out a team that will support our commercial effort. We are receiving inbound calls daily from some of the most experienced and highly regarded people in our industry, which is another data point to suggest that the industry recognizes what a game changer the Motiva implant is going to be in the United States. With this kind of talent eager to come to establishment labs, Jeff continues to put together an absolutely all-star team. With this tailwind, we have our back office functions ready to go, and we have a handful of reps already hired and trained, with the next group already identified. We will be ready to put our devices into surgeons' hands very quickly after approval. It is helpful as we prepare for the U.S. that Flora, our unique tissue expanders, continues to gain traction. Flora's RFID-enabled non-magnetic port is the first and only one of its kind in the industry. This, combined with our patented smooth silk surface technology, puts Flora into an entirely new class of tissue expanders. We have completed the VAC process at a number of the premier cancer centers in the U.S., and more are pending. As the benefits of this device are demonstrated and shared in the clinical community, the number of hospitals offering Flora will grow. The momentum with Mia FEMTA continues to build. Mia is creating an entirely new category within breast aesthetics where a plastic surgeon can shave 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. As the group of women who have experienced Mia grows, the level of activity on social media and in other channels is increasing. Consumers are sharing their experiences and highlighting the positive outcomes of their journey with Mia. This word of mouth, supported by our marketing activities, brings more women into the category. who then also share their positive experiences. This flywheel is picking up speed, and we are seeing it in the number of cases increasing quarter over quarter. We now offer MEA Femtech in 22 cities across the world, with 63 plastic surgeons now fully certified to provide the MEA experience. Seven MEA experience centers in the Middle East are now fully live, offering a tailored end-to-end experience for consumers in five cities across that region. We are in active negotiations with 41 clinics and will be able to increase considerably the number of cities by the end of this year. In China, we remain on track to achieve our targets this year and are building a foundation for continued growth. Medical education, training, and marketing events are taking place on a regular cadence across Tier 1 and Tier 2 cities with the support of our exclusive Chinese distribution partner and in collaboration with our global team. As a reminder, We have leading market share positions in surrounding countries across Asia, including South Korea, Taiwan, Singapore, Thailand, Vietnam, and Japan. Our early experience in China suggests that we can achieve similar market share. And given the high ASPs and the fact that China is the second largest market for breast implants globally, our success will meaningfully add to our profitability. I will now turn the call over to Raj.

Thank you, Juan Jose. Total revenue for the second quarter was $44.1 million, a decline of 9.3% from the year-ago period and 8.5% excluding the impact of foreign exchange. As Juan Jose mentioned, sequentially, this is 18.7% quarter-over-quarter growth. From a regional perspective, sales in Europe, Middle East, and Africa were approximately 48% of the global total, Asia Pacific 32%, Latin America 20%, and North America was less than 1%. We saw improving demand in Asia Pacific in the second quarter as our distributors in the region are reordering following a period of working down inventory. Europe is stable, and as Juan Jose noted earlier, several markets have fully rebounded from the softness we saw in the second half of last year. Results in Latin America in the second quarter reflected the ongoing softness in Brazil and other markets in the region. Our gross profit in the second quarter was $28.9 million, or 65.6% of revenue, compared to $30.3 million, or 62.3% of revenue from the same period in 2023. Our gross profit in the second quarter reflected an increase in average selling prices year-over-year. Foreign exchange rates between the U.S. dollar and Costa Rican cologne continue to be a headwind. As we report in U.S. dollars, the strengthening of the cologne results in higher reported costs. SG&A expenses for the second quarter declined approximately $4.2 million to $32.8 million compared to $37 million in the second quarter of 2023. R&D expenses for the second quarter declined approximately $1.4 million from the same quarter a year ago to $5.5 million. Total operating expenses for the second quarter were $38.3 million. It decreased for approximately $5.7 million from the year-ago period. The decrease in operating expenses in the second quarter were primarily the result of the cost reduction initiatives we undertook in the second half of 2023, offset by increasing investments in our U.S. commercial operation. Net loss from operations for the second quarter was $9.3 million compared to a net loss of $13.7 million in the same period of 2023. Adjusted EBITDA was a loss of $4.3 million in the quarter compared to a loss of $9.3 million in the second quarter of last year, and was flat compared to the first quarter. We are pleased with the reduction in our operating expense loss as we are increasing investments in preparation for the launch of Motiva implants in the United States. Cash used in the second quarter was $18.4 million. In the second quarter, our inventory days improved to a more normalized level and days payable also came down. Accounts receivable were higher in the second quarter versus the first as we saw improving sales results and a higher proportion of sales through our distributors. Our DSOs were flat compared to the first quarter. Our cash position on June 30th was $54.6 million. As a reminder, we have two remaining tranches on our debt facility, which total $50 million. We can access the first $25 million on US FDA approval of Motiva implants, and the second with the additional milestone of achieving $195 million in trailing 12-month sales. Our revenue guidance this year remains $174 to $184 million, representing growth of 5 to 11%. We are seeing good performance in most regions. However, as Juan Jose noted earlier, Latin America has not recovered to previous levels. Brazil remains our largest single market in terms of revenue, and revenue in 2Q was less than half of what it was a year ago, and we don't expect it will recover meaningfully this year. Following the FDA inspection, our confidence in a U.S. approval for Motiva this year has increased, where we are comfortable including U.S. revenue in our outlook. The exact timing of approval is not certain, but we remain comfortable with the guidance range we provided for 2024. For 2025, we expect revenue growth to accelerate significantly as we expand in the United States. We continue to expect gross margins in 2024 to be approximately 100 basis points higher than 2023, to a range of 65.5% to 66%. We remain very focused on managing operating expenses, which can be seen in the more than $10 million reduction in operating expenses so far this year compared to last year. However, with the FDA approval of Motiva implants in the final stages, we will see increased commercial and operating activity in the United States. As such, overall operating expenses in the second half will increase modestly from first half levels. Keeping positive adjusted EBITDA and positive cash will remain important goals for us as a company, and our targets are unchanged. With the favorable selling prices and overall economics that are generated in the U.S. market, we expect to have our first positive EBITDA quarter soon after U.S. launch, expect to be cash flow positive for the fiscal year of 2026. Importantly, the cash we currently have on hand and which is accessible to us under our credit facility can fund our business profitability without the need for additional capital. I will now turn the call back to Juan Jose.

Thank you, Raj. When we founded this company almost 20 years ago, we knew that entering the U.S. market was the ultimate validation of our technology, but it was also the highest mountain we had to climb. We now find ourselves on the cusp of that achievement. The effect on our business will be transformative. The U.S. has the highest ASPs in the world, in some cases three to four times higher than we realize in other markets. As a stand-up of our commercial efforts, the profitability of sales in the U.S. will quickly move us down the path to becoming EBITDA positive, and soon thereafter, cash flow positive. U.S. approval will be a catalyst for sales globally. The FDA remains the gold standard for regulatory clearances. Many surgeons in countries outside the U.S. will only use products with the FDA stamp of approval. In some markets, this opportunity is significant. We cannot wait to introduce Motiva to women and surgeons in the U.S. As a company focused on women's health, access to the U.S. market will strengthen our foundations and further position establishment labs as a global leader in breast aesthetics and reconstruction. I will now turn the call over to the operator for your questions.

Thank you. Ladies and gentlemen, we will now begin our question and answer session. If you have dialed in and would like to ask a question, please press star followed by the number one on your touchstone phone. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. As a reminder, please limit yourself to one question and one follow-up. Thank you. Your first question comes from the line of Alan Gong from JPMorgan. Please go ahead.

Thanks for the question. Definitely great to hear that the U.S. approval, you know, looks like it's finally cleared that final hurdle. But, you know, I have a question on that. But first, I just want to touch on the guidance. You know, you talked about how your guide now includes the incremental benefit from U.S., you know, pretty marginal given the time of approval. But you've now had, you know, two quarters where you beat by a little bit and chosen to reiterate the guide. And now you're adding on U.S. revenues on top of that. So what are you seeing so far in third quarter that makes you confident that this is, you know, still the right range to be using for the full year? And, you know, I guess like how much U.S. is really in there right now?

Hi, Alan. Thanks for the question. You know, generally when we give guidance, we try to provide an outlook that reflects the current dynamics in the market. As we noted on the call, Brazil is still weak. However, we are very confident now in the U.S. approval, and so we've kind of baked those things into the guidance, and hence the range that we're still comfortable with for the year. You know, we do expect to speed back towards sort of a more normalized seasonal pattern here in the third quarter. But overall, I think the outlook in the back half of the year is sort of tracking with where we had thought. Again, with the caveat that Brazil is tracking a bit lower, but now we're extremely confident in the U.S. approval.

Got it. And then when it comes to the 483s, it's great to hear that you already have the responses in, but what gives you the confidence that you'll kind of be able to get this through the FDA in a first pass and this won't become a more drawn-out process? Are there any more specifics you can kind of provide? You know, I know Juan Jose described them as being non-systemic, but, you know, any other color you could provide there would be really helpful. Thank you very much.

Yeah, thanks, Alan. And, no, I think it's the nature of those observations which gives us confidence that, you know, our quick response already, you know, tells you, you know, how we feel about them. One of them was the timing of the submission of 10 medical device reports. from the flora tissue expander that we sell outside of the United States. That's a different tissue expander than the one we sell in the United States. And of course, it has, you know, no relevance to the safety of Motiva implants in our PMA. The second one was the tracking of the training of a production employee that was performing at the validation. And the last one was the job description and role of an internal auditor. So as you can see, those are really isolated. They're minor. And we don't believe that's going to affect, you know, our timing for approval.

Your next question comes from the line of Anthony Petroni from Mizuho Group. Please go ahead.

Thanks, and good afternoon, everyone. Maybe to stay on U.S. Motiva. You know, with the description now that FDA clearance potentially looks imminent, maybe walk us through what an early launch phase looks like. Will that happen, you know, sometime in the third quarter? Is that a reasonable expectation? And then you mentioned, Juan Jose, that, you know, there has been build out of the team in the United States. So just maybe an update there. How many sales reps are already hired? And how many will have to be hired going forward? And I'll have one quick follow-up. Thanks.

Yeah, I think most importantly is the quality of the people that Jeff is bringing on board, you know, to lead our North America business. And I think, you know, when you put people like Ann and Ben and that team and some of the sales reps that are coming in and some will come, you know, in the next few weeks, we will have, you know, really an all-star team for the U.S. You know, the back office, as we've said before, is ready. You know, we've been already shipping and invoicing the flora tissue expanders, so all of that is ready to go. In addition to that, I think it's important to say that we already began manufacturing the first batch of Motiva implants that are planned to be sent in the, you know, to the U.S. after approval.

Oh, that's helpful. Maybe to... to flip over to just Mia and looking at some of the existing centers that are out there. You mentioned 63 surgeons are active with Mia Femtech. Maybe just a little bit about the dynamics at those centers. You know, how is their surgical capacity expanded? The surgeries are being done in much less time. And when you think about those Femtech centers, I mean, How much share is establishment able to sort of command once Femtech goes live at those centers? Thanks again.

Yeah, thanks, Anthony. I think it's really, you know, important to backtrack to what we are trying to do in this first phase of the launch of MIA, which is to establish, you know, a list of clinics so that we are present with it in the most important cities around the world. So, you know, one of the important things that I think it's looking well is the fact that we are now in 22 cities, you know, across Europe, Middle East, and Japan. So, as we add more centers, you know, the capillarity will get us to be more efficient with the awareness and then that leading to more MEA treatments taking place. One of the really important things I think from Q2 is the fact that 47% of women who received MEA in Q2 were not considering a breast augmentation. And that's real market expansion. And I think in the category like breast aesthetics that has been pretty much flat over the last two decades, those are really good news for plastic surgeons. Those are really good news, I think, for aesthetics in general. because we can get this category to be vibrant again. And, you know, when you see the number of centers that we have under negotiation, you know, 41, that tells you also that, you know, there's a lot of interest. And the more they talk to their peers, you know, these 63 surgeons, you know, of course, are talking about, you know, what this is doing to their practices. So definitely, I think that as we go into 2026, we will be able to give more specifics on the number of cases, market share, and things like that related to the traditional category of REST augmentation. Thank you.

Your next question comes from the line of Josh Jennings from TD Commons. Please go ahead.

Good afternoon. Thanks for taking the questions, and congratulations on getting that inspection completed. Wanted to just ask about your comments, Juan Jose, on the medical advisory board you hosted and the buzz that I think you suggested was kind of percolating in the plastic surgeon community. Any incremental color you can add to those prepared comments and maybe just to ask from your team's checks, what do you think awareness stands within the U.S. plastic surgeon community? Do you think there's 25, 50, 75% of plastic surgeons are aware of Motiva, aware of the four-year data and the premier safety profile?

Yeah, I think, you know, the fact that we hosted this, you know, this first group of American surgeons for an advisory board was very telling to us because what we wanted to do in this advisory board is to expose them to the technology and get their views on the potential adoption of Motiva implants. And it really went beyond our expectations, you know, the way they understand that this is going to open up, you know, new ways of doing surgery. You know, the fact that you can save the pectoralis muscle of so many active women who currently have no option because they would eventually have a capsular contracture in that anatomical placement. So while we are being super careful not to promote Motiva implants ahead of the approval, I think this type of advisory boards really gives us the confidence that we are on track with our strategy.

Thanks for that. And then just to follow up, you mentioned that FDA approval could spark increased adoption internationally. You mentioned that there's some countries that rely on the FDA approval regulatory process for their own regulatory hurdle to clear or setting the regulatory bar. But do you think in those CE mark countries, I mean, are there surgeons out there waiting for FDA approval? Anything you can share there just in terms of Is there this pent-up demand, surgeons out in CMAR countries where FDA approval will kind of get them over the hump and drive a little wave of adoption in countries where Motiva is already approved? Thanks a lot.

Yes, of course. There's a group of more traditional, more conservative surgeons outside of the United States that have always seen FDA approval as a gold standard that, you know, they should aspire to. And because of that, after Allergan pulled out of most markets around the world, all of these surgeons went to the only other option that they had. So this is going to basically give us the ability to start calling on these surgeons who before said, until you have FDA approval, please don't come in. But that's a really strong statement also to the rest of the industry because It is not only the fact that we are going to get FDA approval, it's the numbers of our clinical trial for the U.S. approval that tell a completely different story. And that combined, I think, is going to have eventually a lot of traction for our sales in many markets around the world, not just Europe. It's also true in Latin America and it's also true in several areas of Asia.

I appreciate that.

Next question comes from the line of from CP. Please go ahead.

Good afternoon and thank you for taking the question. And congratulations on the FDA inspection. Two quick questions. The first is you've put some U.S. revenue in guidance as you pulled some Brazilian revenue out or revenue from Brazil out. Is there a way to quantify how much U.S. revenue is now in your guidance? And then the second question is, gross margins really improved nicely year over year. How do we think about the trajectory of those, not just this year, but next year, as Motiva and the U.S. gains traction? Thank you.

Hi, Joanne. Thanks for the question. Yeah, you know, in terms of the U.S., there's still some uncertainty around the exact timing. You know, we're extremely confident it's coming and coming soon, but the exact timing is still not known. And so, you know, we still left the range, you know, fairly wide for the balance of the year, which reflects that. You know, we do expect there'll be revenue this year. You know, and as you noted, you know, we did take Brazil or some of Brazil out given the softness we're continuing to see there. You know, but overall, we're still very confident in the outlook in the back half of this year and in particular as we move into 2025 and the significant growth we expect to see as we start to expand in the United States. And then on your second question relative to margins, We did see a nice step up in the third quarter. Average selling prices were up, as we mentioned. We're still dealing with a little bit of headwind from the Costa Rican Cologne, but that's also starting to turn as well. As you look out over the next couple of years, really, even not just next year, really everything we're doing as a company, the launch in the U.S., MIA, our expansion to China, even Flora, the tissue expander, all of these are gross margin accretive endeavors for us. And so I think that margin will continue to go higher over time. It's not going to be linear, but, you know, we should see nice improvement over that over the next couple of years.

Thank you. Your next question comes from the line of George Southers from Stephens. Please go ahead.

Hey, good afternoon, and thanks for taking the question. Maybe going back to Mia, and apologies if I missed this, but I was just curious if you could give us some color on the growth there driven by procedure volume versus in any revenue you've received in the second quarter from licensing fees. And then also with the clinics that you're speaking with and maybe that have recently signed on to partnerships, could you give us any additional color on licensing fee revenue that you're expecting to see in the back half of this year and in early 2025?

Yeah, thank you, George. I think it's really important to note that, you know, as we are putting together the onboarding of these centers, you know, we provide in exchange for that license revenue, you know, the medical education, the practice development, It takes time to, you know, to get those two together. So it's one of the bottlenecks that we have right now is getting, you know, clinics onboarded quick enough. And as you saw, you know, we have 41 clinics in negotiation. And, you know, we're working to be able to onboard these clinics more quickly so they get to be doing cases more quickly. Because what we see is that, you know, some of the clinics that were launched last fall are already tracking to that aspirational goal of 24 cases per month. Because if we get to that goal and we can do that in a consecutive 12 months period, we will be basically recognizing a million dollars of revenue approximately in a center. And that's really how Mia grows. So at this point, it's about creating the capillarity, the number of clinics in each city continues to grow. And also what we see is that Every month, we are doing more cases of MIA in those different cities. I'm not going to be giving any guidance on how that revenue looks for the back half of the year. But I think for 2026, as this grows, we will be able to be a lot more precise in terms of revenue as it becomes more material.

Okay, that's helpful color. And then maybe just one clarifying point on the accounts receivable line that you touched on in the opening remarks. There was a fairly significant step up sequentially this quarter. I'm just curious if there's anything you need to read into there.

There is not. I mean, if you look at the days, it's flat on the first quarter. We did see a nice rebound, as we noted in the commentary in Asia Pacific, which is all distributors, right? So we're seeing stronger orders from that channel, which typically have longer terms. So generally, I think it's just the recovery in the business is what you're seeing.

Okay, got it. Thank you all again for the time.

Your next question comes from the line of Matthew Taylor from Jefferies. Please go ahead.

Hi, it's Michael Toomey here covering for Matt. Thanks for taking my question and congrats on the quarter. You mentioned China remains on track. I just wondered what you have baked in for China in 2024, whether anything's changed there.

Nothing has changed. You know, we've been talking about about $10 million of revenue this year. We're still tracking to that. You know, it's still over two quarters into the launch there and everything is moving as we expected.

Okay, great. And can you give us any idea how we should think about 2025? Is Is Esther's ramp in other markets in Asia a good way for us to think about the sales growth in China?

The way I would put it is that China is a much bigger market. And although in many of these markets with significant Chinese population like Singapore and Taiwan, we have become market leaders after three to four years. China is different. So our aspiration is to get there in the next few years to that market leadership. But how it grows, I think it's part of the question at this point. We are happy the way we are tracking for this year. It's been already two quarters of information that we have, but it's a little bit early to say that it's going to be the same. I think potentially it could be even quicker, but we're just beginning. At this point, I think we'll just leave it at that.

Okay, that's great. Congrats again.

Your next question comes from the line of Marie Thibault from BTIG. Please go ahead.

Hi, good evening. Thanks for taking the questions and nice quarter. My first question really just has to do with seasonality and helping us think about how to model Q3. As I look at it, maybe Latin America remains weak. We think about U.S. contribution maybe coming a little later in the year. I don't know if that's the right way to think about things, but if you can help us just think about getting a little more granular with the back half of this year.

Yeah, Marie, I think, you know, in a normal seasonal year, we could see the third quarter down about 10% from the second quarter. And I think that's not a bad way to think about it. You know, we saw a good recovery, you know, probably a little faster in the first half of the year. Now we're moving more towards sort of normal trends in the business, right? So I think, you know, down 10% in the, in the third quarter is probably the right way to think about it. And then in the fourth quarter, um, Again, it's a lot dependent on the timing of the U.S. approval, but we do expect a nice step up in the fourth quarter to finish the year.

Okay, that's perfect, Raj. Thank you. And then just to get a little bit more in the weeds on distributors reordering, glad to hear that things are coming back. Are these distributors, to your understanding, are they back to full stock? Are they still adding bit by bit? I guess I'm sort of asking, you know, did they – reorder a lot in the first half and we wouldn't expect to see as much in the second half or how to think about those trends from the reordering standpoint?

I think it's important to understand that for distributors, it's always this balance between having the right product at the right place at the right time because you don't want to lose an account because you didn't have that. On the other hand, they're careful with their cash. But I think what we've been trying to comment today is basically that we are seeing, for instance in Asia, a very healthy reordering cadence. And that tells you what is happening in those markets and how the recovery is going. I think Latin America is different. Latin America is having a lot of challenges in terms of the political cycle and what have you, Brazil especially. But I think it's good to see that our distributors feel the confidence to begin adding to those inventories again.

All right. That's very helpful. Thanks so much and good luck with things.

And that does conclude the question and answer session. I would like to turn the floor back over to Juan Jose Quiroz for closing remarks.

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.

This concludes today's conference call. Thank you for your participation. You may now disconnect.