Q3 2025 Establishment Labs Holdings Inc Earnings Call

November 5, 2025

One quick question and answer session and instructions will follow at that time.

Operator: At the end of this call, we will open the line for a question-and-answer session. 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, sir.

Operator: 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, Chief Financial Officer. Please go ahead, sir.

As a reminder, today's call is being recorded.

Ill now turn the call over to Raj It in Hawaii, Chief Financial Officer. Please go ahead, Sir thank.

Thank you operator, and thank you everyone for joining US with me today is Peter <unk>, our Chief Executive Officer.

Rajbir Denhoy: Thank you, Operator, 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 the 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' 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 a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q, as well as other SEC filings which are available on our website at establishmentlabs.com.

Raj Denhoy: Thank you, Operator, 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 the 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' 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 a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent annual and quarterly reports on Form 10-K and Form 10-Q, as well as other SEC filings which are available on our website at establishmentlabs.com.

Raj Denhoy: 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 the 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' 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.

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' 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 a discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements I encourage you to review our most recent annual and quarterly reports on Form 10-K, and Form 10-Q, as well as other SEC filings, which are available on our website at establishment labs Dot 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 EBITA, which we disclose on an adjusted EBITDA basis.

Raj Denhoy: 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 EBITDA, which we disclose on an adjusted EBITDA basis. 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, 5 November 2025. 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 Peter.

Rajbir Denhoy: 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 EBITDA, which we disclose on an adjusted EBITDA basis. 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, 5 November 2025. 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 Peter.

Raj Denhoy: 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 EBITDA, which we disclose on an adjusted EBITDA basis. 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, 5 November 2025. 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 Peter.

Reconciliations to comparable GAAP financial measures for non-GAAP measures is 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 November 5th 2025.

Except as required by law establish a labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances. After the date of this call.

With that is my pleasure to turn the call over to Peter.

Good morning to everyone and thank you for joining today Q3, 2025 was a standout quarter for establishment labs.

Peter Caldini: Good morning to everyone. Thank you for joining today. Q3 2025 was a standout quarter for Establishment Labs. We grew global revenue 34% with the total revenue of $53.8 million, including $11.9 million in the US. We also exceeded 70% gross profit margin for the first time, coming in at 70.1%, and we achieved the first quarter of positive EBITDA in our company's history, with $1.2 million in Q3. Getting to positive EBITDA ahead of Q4 was an important goal for our company, and we now turn our focus towards reaching cash flow positive next year. While optimizing our business, we had meaningful revenue growth in the US and our other direct markets. I'd like to thank all the employees that made this a priority and a reality, and the sense of accomplishment has all our employees eager for our next milestone of cash flow positive.

Peter Caldini: Good morning to everyone, and thank you for joining today. Q3 2025 was a standout quarter for Establishment Labs. We grew global revenue 34%, with a total revenue of $53.8 million, including $11.9 million in the US. We also exceeded 70% gross profit margin for the first time, coming in at 70.1%, and we achieved the first quarter of positive EBITDA in our company's history with $1.2 million in Q3. Getting to positive EBITDA ahead of the fourth quarter was an important goal for our company, and we now turn our focus towards reaching cash flow positive next year. While optimizing our business, we had meaningful revenue growth in the US and our other direct markets. I'd like to thank all the employees that made this a priority and a reality, and the sense of accomplishment has all our employees eager for our next milestone of cash flow positive.

We grew global revenue, 34% with the total revenue of $53 8 million, including $11 9 million in the U S.

We also exceeded 70% gross profit margin for the first time coming in at 71% and we achieved the first quarter of positive EBITDA in our company's history with $1 2 million in Q3.

Getting to positive EBITDA ahead of the fourth quarter was an important goal for our company and we now turn our focus towards reaching cash flow positive next year.

While optimizing our business, we had meaningful revenue growth in the U S and our other direct markets.

I'd like to thank all the employees that made this a priority and a reality and a sense of accomplishment has all of our employees eager for our next milestone of cash flow positive.

The U S business is our most important growth segment right now and it continues to outperform.

Peter Caldini: The US business is our most important growth segment right now, and it continues to outperform. Q3 revenue was $11.9 million, up 16% sequentially in what is a seasonally slower quarter in breast procedures. Markets can be down 20% to 30% sequentially in Q3, making our results all the more impressive. For the first three quarters, US revenue totaled $28.3 million. We are clearly going to do quite a bit better than the $40 million we committed to last quarter. We are expecting considerable acceleration of the US business in Q4, and we are already seeing a significant shift from Q3, but as it's our first full Q4, we are going to be prudent by raising our 2025 revenue guidance to exceed $210 million, where we previously had a range of $208 to 212 million.

Peter Caldini: The US business is our most important growth segment right now, and it continues to outperform. Q3 revenue was $11.9 million, up 16% sequentially in what is a seasonally slower quarter in breast procedures. Markets can be down 20% to 30% sequentially in Q3, making our results all the more impressive. For the first three quarters, US revenue totaled $28.3 million, so we are clearly going to do quite a bit better than the $40 million we committed to last quarter. We are expecting considerable acceleration of the US business in Q4, and we are already seeing a significant shift from Q3. As it's our first full Q4, we are going to be prudent by raising our 2025 revenue guidance to exceed $210 million, where we previously had a range of $208 to $212 million.

Q3 revenue was $11 $9 million up 16% sequentially in what is a seasonally slower quarter in breast procedures.

<unk> can be down 20% to 30% sequentially in Q3, making our results all the more impressive.

For the first three quarters U S revenue totaled $28 $3 million. So we are clearly going to do quite a bit better than the $40 million, we committed to last quarter.

We are expecting considerable acceleration of the U S business in Q4, and we are already seeing a significant shift from Q3, but as its our first full Q4, we're going to be prudent by raising our 2025 revenue guidance to exceed $210 million, where we previously had a raise.

<unk> of $208 million to $212 million.

Most interesting is what these results imply for 2026, because we should finish 'twenty to 'twenty, five and an approximate 20% share in U S breast augmentation market and the momentum has not slowed.

Peter Caldini: Most interesting is what these results imply for 2026, because we should finish 2025 at an approximate 20% share in the US breast augmentation market, and the momentum has not slowed. While 2026 will be a continuation of our growth in the breast augmentation segment, we are looking forward to our approval in breast reconstruction, which is similar in market size to augmentation, and we are preparing for the US launch in this segment. Outside the US, we saw good growth and remain on track for single-digit growth this year. Accelerating growth in our direct markets has been a priority, and we are seeing the benefits of the changes we have implemented. Excluding the benefit of currency and the acquisition of our Benelux distributor, our European direct market sales increased approximately 20% this quarter over Q3 2024.

Peter Caldini: Most interesting is what these results imply for 2026, because we should finish 2025 in an approximate 20% share in the US breast augmentation market, and the momentum has not slowed. While 2026 will be a continuation of our growth in the breast augmentation segment, we are looking forward to our approval in breast reconstruction, which is similar in market size to augmentation, and we are preparing for the US launch in this segment. Outside the US, we saw good growth and remain on track for single-digit growth this year. Accelerating growth in our direct markets has been a priority, and we are seeing the benefits of the changes we have implemented. Excluding the benefit of currency and the acquisition of our Benelux distributor, our European direct market sales increased approximately 20% this quarter over Q3 2024.

While 2026 will be a continuation of our growth in the breast augmentation segment. We are looking forward to our approval in breast reconstruction, which is a similar in market size to augmentation and we are preparing for the U S launch in this segment.

Outside the U S. We saw good growth and remain on track for single digit growth this year.

Accelerating growth in our direct markets has been a priority and we are seeing the benefits of the changes we have implemented.

Excluding the benefit of currency and the acquisition of our Benelux distributor our European direct market sales increased approximately 20% this quarter over Q3 2024.

In our distributor markets Asia Pac had a strong rebound from the second quarter as the orderly cadence normalized.

Peter Caldini: In our distributor markets, Asia Pacific had a strong rebound from Q2 as the ordering cadence normalized. Our US business is performing at a very high level. The number of surgeons using Motiva continues to increase. We now have over 1,300 surgeons using Motiva, including some of the highest volume and best-known practices in the country. We are attracting additional waves of adopters as the benefits of Motiva in both clinical and commercial practice resonate. We are as focused on surgeons making Motiva their primary implant of choice as we are at attracting new surgeons to our business. We continue to bring groups of surgeons down to Costa Rica for training and surgery. Over 50 surgeons attended our September and October classes. More than 250 surgeons have come to Costa Rica since launch. We are expecting a similar pace in 2026.

Peter Caldini: In our distributor markets, Asia-Pacific had a strong rebound from the second quarter as the ordering cadence normalized. Our US business is performing at a very high level. The number of surgeons using Motiva continues to increase. We now have over 1,300 surgeons using Motiva, including some of the highest volume and best-known practices in the country, and we are attracting additional waves of adopters as the benefits of Motiva in both clinical and commercial practice resonate. We are as focused on surgeons making Motiva their primary implant of choice as we are at attracting new surgeons to our business. We continue to bring groups of surgeons down to Costa Rica for training and surgery. Over 50 surgeons attended our September and October classes, and more than 250 surgeons have come to Costa Rica since launch. We are expecting a similar pace in 2026.

Our U S business is performing at a very high level. The number of surgeons using motiva continues to increase we now have over 1300 surgeons using motiva, including some of the highest volume and best known practices in the country and we are attracting additional waves of adopters.

<unk> as the benefits of Motiva in both clinical and commercial practice resonate.

We are as focused on surgeons, making motiva their primary implant of choice as we are attracting new surgeons to our business we.

We continue to bring groups of surgeons down to Costa Rica for training and surgery over 50 Surgeons attended our September and October classes and more than 250 surgeons have come to Costa Rica since launch.

We are expecting a similar pace in 2026 with seven sessions already scheduled there is no shortage of surgeons that want to make the trip.

Peter Caldini: With 7 sessions already scheduled, there is no shortage of surgeons that want to make the trip. Surgeons learn about the science behind our implant technology, see the best-in-class standards employed throughout our facilities, and experience our commitment to driving innovation in the category, including discussing and offering input to our R&D pipeline. While some surgeons come already enthused about Establishment Labs, almost every surgeon returns to their practice as a fan of our company. Social media continues to play an important role as plastic surgeons advocate Motiva to their audiences. Plastic surgeons consistently tell us that if they offer patients a choice between Motiva and legacy implants, it's almost unanimous that patients will choose Motiva. This puts us in a position of strength, and we win if we convince plastic surgeons to give patients a choice. Every legacy brand has a much more challenging proposition.

Peter Caldini: With seven sessions already scheduled, there is no shortage of surgeons that want to make the trip. Surgeons learn about the science behind our implant technology, see the best-in-class standards employed throughout our facilities, and experience our commitment to driving innovation in the category, including discussing and offering input to our R&D pipeline. While some surgeons come already enthused about Establishment Labs, almost every surgeon returns to their practice as a fan of our company. Social media continues to play an important role as plastic surgeons advocate Motiva to their audiences. Plastic surgeons consistently tell us that if they offer patients a choice between Motiva and legacy implants, it's almost unanimous that patients will choose Motiva. This puts us in a position of strength, and we win if we convince plastic surgeons to give patients a choice. Every legacy brand has a much more challenging proposition.

Burgess learn about the science of behind our implant technology see the best in class standards employed throughout our facilities and experience our commitment to driving innovation in the category, including discussing and offering input to our R&D pipeline.

While some surgeons come already enthused about establishment labs, almost every surge and returns to their practice as a fan of our company.

Social media continues to play an important role as plastic surgeons advocate motiva to their audiences.

Plastic surgeons consistently tell us that if they offer patients a choice between Motiva and legacy implant, it's almost unanimous that patients will choose motiva.

This puts us in a position of strength and we win if we convinced plastic surgeons to give patients a choice.

Every legacy brand has a much more challenging proposition.

They have to convince plastic surgeons to offer only their products.

Peter Caldini: They have to convince plastic surgeons to offer only their products. Championing women's health and advocating for patients' choice should accelerate us to take a majority of the US market over the next several years. In Q3, we conducted a survey of surgeons that are early adopters and advocates of Motiva to understand the impact of Motiva on their practices. While industry sources point to a market that has not experienced much growth, the practices offering Motiva in our survey increased their procedures by 14.6% so far this year. Surgeons tell us that patients are coming in and asking for Motiva by name, and we hear from surgeons as well that many women are entering the category because of Motiva. We regularly hear that women are abandoning the warranty of their legacy implants and choosing to pay out of pocket for Motiva.

Peter Caldini: They have to convince plastic surgeons to offer only their products. Championing women's health and advocating for patients' choice should accelerate us to take a majority of the US market over the next several years. In Q3, we conducted a survey of surgeons that are early adopters and advocates of Motiva to understand the impact of Motiva on their practices. While industry sources point to a market that has not experienced much growth, the practices offering Motiva in our survey increased their procedures by 14.6% so far this year. Surgeons tell us that patients are coming in and asking for Motiva by name, and we hear from surgeons as well that many women are entering the category because of Motiva. We regularly hear that women are abandoning their warranty of their legacy implants and choosing to pay out of pocket for Motiva.

Championing women's health and advocating for patients choice should accelerate us to take a majority of the U S market over the next several years.

In Q3, we conducted a survey of surgeons that are early adopters and advocates of motiva to understand the impact of motiva on their practices.

While industry sources point to a market that has not experienced much growth.

The practices offering motive in our survey increase their procedures by 14.6% so far this year.

Surgeons tell us that patients were coming in and asking for Motiva by name and we hear from surgeons as well that many women are entering the category because of Motiva.

The regular here that women are abandoning the warranty of their legacy implants, and choosing to pay out of pocket for Motiva <unk>.

As many of you know this is incredibly rare in health care.

Peter Caldini: As many of you know, this is incredibly rare in healthcare, but it's happening now as our entry is changing the industry. There isn't just one single reason for this. Some women cite the improved safety profile offered by Motiva, others cite the benefits of having an above-the-muscle procedure without compromise, and yet, for others, it's the increased awareness from our marketing efforts. Whatever the reason, it's clear the conversation around breast augmentation is changing. This is a powerful combination. We are not only capturing share, but we are expanding and accelerating the market for breast augmentation. A major driver for market expansion is our minimally invasive portfolio. As we have noted, we trained a group of US plastic surgeons in July as part of our early experience group for Preservae to gain insights prior to going to market more broadly.

Peter Caldini: As many of you know, this is incredibly rare in healthcare, but it's happening now as our entry is changing the industry. There isn't just one single reason for this. Some women cite the improved safety profile offered by Motiva, and others cite the benefits of having an above-the-muscle procedure without compromise. Yet, for others, it's the increased awareness from our marketing efforts. Whatever the reason, it's clear the conversation around breast augmentation is changing. This is a powerful combination. We are not only capturing share, but we are expanding and accelerating the market for breast augmentation. A major driver for market expansion is our minimally invasive portfolio. As we have noted, we trained a group of US plastic surgeons in July as part of our early experience group for Preservé to gain insights prior to going to market more broadly.

But it's happening now as our entry is changing the industry.

There isn't just one single reason for this.

Some women site the improved safety profile offer by Motiva.

And other site the benefits of having an above the muscle procedure without compromise.

And yet for others, it's the increased awareness from our marketing efforts.

The reason, it's clear the conversation around breast augmentation is changing.

This is a powerful combination we are not only capturing share.

But we are expanding and accelerating the market for breast augmentation.

A major driver for market expansion is our minimally invasive portfolio.

As we have noted we trained a group of U S. Plastic surgeons in July as part of our early experience group for preservation to gain insights prior to going to market more broadly.

Preservation is a breast tissue preserving procedure that can be done without the need for general anesthesia.

Peter Caldini: Preservae is a breast tissue-preserving procedure that can be done without the need for general anesthesia, offering smaller scars and fast recovery. Preservae can be used in a wide cross-section of cases surgeons see in their day-to-day practices. As these surgeons have taken Preservae back to their practices and started to perform procedures, the feedback has been very positive, not only from surgeons, but also from the women who have received the procedures. I encourage you to seek out the videos and testimonials that have been posted on our social media to see the early responses. Surgeons have embraced the fundamental changes Preservae brings to breast augmentation. It is not just a new way to do an existing procedure, it is an entirely new concept in how a breast procedure can be done. Preservae has the potential to drive category growth and improve the economics for surgeons.

Peter Caldini: Preservé is a breast tissue-preserving procedure that can be done without the need for general anesthesia, offering smaller scars and fast recovery. Preservé can be used in a wide cross-section of cases surgeons see in their day-to-day practices. As these surgeons have taken Preservé back to their practices and started to perform procedures, the feedback has been very positive, not only from surgeons but also from the women who have received the procedures. I encourage you to seek out the videos and testimonials that have been posted on our social media to see the early responses. Surgeons have embraced the fundamental changes Preservé brings to breast augmentation. It is not just a new way to do an existing procedure. It is an entirely new concept in how a breast procedure can be done. Preservé has the potential to drive category growth and improve the economics for surgeons.

Offering smaller scars and fast recovery.

Preservation can be used in a wide cross section of cases surgeons see in their day to day practices.

As these surgeons have taken preservation back to their practices and starting to perform procedures.

The feedback has been very positive not only from surgeons, but also from the women who have received the procedures.

I encourage you to seek out the videos and testimonials that have been posted on our social media to see there were early responses.

Surgeons have embraced the fundamental changes present red brings to breast augmentation. It is not just a new way to do an existing procedure. It is an entirely new concept in how a breast procedure can be done.

Preservation has the potential to drive category growth and improve the economics for surgeons.

We are seeing as much as a 40% price premium to a standard breast augmentation for these early experienced surgeons.

Peter Caldini: We are seeing as much as a 40% price premium to a standard breast augmentation for these early-experienced surgeons. The group of surgeons that came for Preservae training were each supplied a small number of kits in August. A majority of the kits we provided have been used, and surgeons consistently ask us for more to alleviate the growing waitlist. From just our early experience launch, we would estimate that 300 Preservae cases have been performed in the US, and there are at least 100 women on the waitlist around the country. Not expectedly, there is a groundswell of surgeons that have asked to be trained on Preservae, and we will begin these trainings in January. We have two such trainings planned for the first quarter alone, and would expect a similar cadence throughout the year.

Peter Caldini: We are seeing as much as a 40% price premium to a standard breast augmentation for these early experienced surgeons. The group of surgeons that came for Preservé training were each supplied a small number of kits in August. A majority of the kits we provided have been used, and surgeons consistently ask us for more to alleviate the growing wait list. From just our early experience launch, we would estimate that 300 Preservé cases have been performed in the US, and there are at least 100 women on wait lists around the country. Not expectedly, there is a groundswell of surgeons that have asked to be trained on Preservé, and we will begin these trainings in January. We have two such trainings planned for the Q1 alone and would expect a similar cadence throughout the year.

The group of Surgeons that came for present right training, where each supplied a small number of kits and August eight.

A majority of the kits, we provided have been used and surgeons consistently ask us for more to alleviate growing waitlist.

From just our early experience launch we would estimate that 300 present vacations have been performed in the U S. And there are at least 100 women on waitlist around the country.

Not expectedly there is a groundswell of surgeons that have asked to be trained on preservation and we will begin. These trainings in January we have two such trainings planned for the first quarter alone and would expect a similar cadence throughout the year.

In breast reconstruction or flora tissue expander is now in use at over 150 hospitals in the United States.

Peter Caldini: In breast reconstruction, our Flora tissue expander is now in use at over 150 hospitals in the United States. This bodes well for expected launch into reconstruction, and we remain on track to file our PMA supplement by the end of the year. We also remain on track for the approval of our small sizes in the US in early 2026, and this should help accelerate growth both with new doctors, as well as increasing the usage of our current doctors. Outside the US, excluding the benefit of our Benelux acquisition in currency, direct markets globally grew 15% versus last year. We believe this performance is well above the underlying market growth rates in these regions. In our Latin American direct markets, we continue to see stabilization in Brazil, and strong growth in Argentina.

Peter Caldini: In breast reconstruction, our Flora Tissue Expander is now in use at over 150 hospitals in the US. This bodes well for expected launch in the reconstruction, and we remain on track to file our PMA supplement by the end of the year. We also remain on track for the approval of our small sizes in the US in early 2026, and this should help accelerate growth both with new doctors as well as increasing the usage of our current doctors. Outside the US, excluding the benefit of our Benelux acquisition and currency, direct markets globally grew 15% versus last year. We believe this performance is well above the underlying market growth rates in these regions. In our Latin American direct markets, we continue to see stabilization in Brazil and strong growth in Argentina.

This bodes well for expected launch in the reconstruction and we remain on track to file our PMA supplement by the end of the year.

We also remain on track for the approval of our small sizes in the U S. In early 2026, and this should help accelerate growth both with new doctors as well as increasing the usage of our current doctors.

Outside the U S. Excluding the benefit of our Benelux acquisition and currency direct markets globally grew 15% versus last year.

We believe this performance is well above the underlying market growth rates in these regions.

In our Latin American direct markets, we continue to see stabilization in Brazil, and a strong growth in Argentina.

European direct markets are being led by strong performances across the continent with standouts in the U K and Spain.

Peter Caldini: European direct markets are being led by strong performances across the continent, with standouts in the UK and Spain. The number of accounts in many of our direct countries continues to increase, a positive sign, and a reflection of the increased focus on performance in direct markets. We are taking advantage of our strong growth in direct markets to make sure that the OUS business as a whole is primed for growth. We are engaging with our distributor partners regularly. We are working to raise standards globally around payment terms, inventory forecasts, and market share expectations. In our minimally invasive portfolio, Mia remains on track to achieve $8 to $10 million in revenue in 2025, and Preservae continues to see good adoption in international markets. Surgeons globally are seeing the benefits of breast tissue preservation made possible by our minimally invasive platform.

Peter Caldini: European direct markets are being led by strong performances across the continent, with standouts in the UK and Spain. The number of accounts in many of our direct countries continues to increase, a positive sign and a reflection of the increased focus on performance in direct markets. We are taking advantage of our strong growth in direct markets to make sure that the OUS business as a whole is primed for growth. We are engaging with our distributor partners regularly. We are working to raise standards globally around payment terms, inventory forecasts, and market share expectations. In our minimally invasive portfolio, Mia remains on track to achieve $8 to $10 million in revenue in 2025, and Preservé continues to see good adoption in international markets. Surgeons globally are seeing the benefits of breast tissue preservation made possible by our minimally invasive platform.

The number of accounts and many of our direct countries continues to increase a positive sign and a reflection of the increased focus on performance indirect markets.

We are taking advantage of our strong growth in direct markets to make sure that the O U S business as a whole is prime for growth.

We are engaging with our distributor partners regularly we are working to raise standards globally around payment terms inventory forecast and market share expectations.

In our minimally invasive portfolio mere remains on track to achieve $8 million to $10 million in revenue in 2025 and preservation continues to see good adoption in international markets.

Surgeons globally are seeing the benefits of breast tissue preservation made possible by our minimally invasive platform.

The successful rollout of preservation and the continued growth of Mir has resulted in above market growth and proves its potential for market expansion.

Peter Caldini: The successful rollout of Preservae and the continued growth of Mia has resulted in above-market growth and proves its potential for market expansion. Globally, we expect the portfolio of Mia and Preservae will exceed $30 million in 2026. I will now turn the call over to Raj. Thank you, Peter. Total revenue for the third quarter was $53.8 million, an increase of 33.7% from last year. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 31.4%. Sales for Motiva in the United States were $11.9 million. On a geographic basis, sales in Europe, Middle East, and Africa were 35.6% of the global total. We saw strong sales in our direct markets in the region, while sales to distributors were lower on the timing of orders. Sales in the United States were 22.1% of the global total. Latin America was 21.7% of sales.

Peter Caldini: The successful rollout of Preservé and the continued growth of Mia Femtech has resulted in above-market growth and proves its potential for market expansion. Globally, we expect a portfolio of Mia Femtech and Preservé will exceed $30 million in 2026. I will now turn the call over to Raj Denhoy. Thank you, Peter Caldini. Total revenue for Q3 was $53.8 million, an increase of 33.7% from last year. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 31.4%. Sales for Motiva in the US were $11.9 million. On a geographic basis, sales in Europe, Middle East, and Africa were 35.6% of the global total. We saw strong sales in our direct markets in the region, while sales to distributors were lower on the timing of orders. Sales in the US were 22.1% of the global total. Latin America was 21.7% of sales.

Globally, we expect the portfolio of EMEA and preservation will exceed $30 million in 2026, I will now turn the call over to Raj.

Yeah.

Thank you Peter.

Raj Denhoy: Thank you, Peter Caldini. Total revenue for Q3 was $53.8 million, an increase of 33.7% from last year. Excluding the positive impact of foreign exchange in the quarter, growth would have been approximately 31.4%. Sales for Motiva in the US were $11.9 million. On a geographic basis, sales in Europe, Middle East, and Africa were 35.6% of the global total. We saw strong sales in our direct markets in the region, while sales to distributors were lower on the timing of orders. Sales in the US were 22.1% of the global total. Latin America was 21.7% of sales.

Revenue for the third quarter was $53 $8 million, an increase of 33, 7% from last year.

Excluding the positive impact of foreign exchange in the quarter growth would've been approximately 31, 4%.

Sales for motive in the United States were $11 $9 million.

On a geographic basis sales in Europe, Middle East Africa, where 35, 6% of the global total you saw strong sales of our direct markets in the region, while sales to distributors were lower on the timing of orders.

Sylvia United States were 22, 1% of the global total.

Latin America was 21, 7% of sales.

It will remain stable and we saw strong growth in our go direct marketing region Argentina.

Peter Caldini: Brazil remained stable. We saw strong growth in our other direct market in the region, Argentina, as well as from our distributors. Asia Pacific was 20.6% of sales. Results in the quarter rebounded sharply from last quarter as expected orders from our distributors were realized. Sequential growth in the region was 46%. Our gross profit for Q3 was $37.7 million, or 70.1% of revenue, a 620 basis point increase compared to 63.9% of revenue last year and 130 basis points higher than the 68.8% in Q2 this year. This is the first time we have crossed 70% gross margin, and the increase is primarily the result of the higher margin sales in the United States. We expect gross margins in 2025 will be approximately 300 basis points higher than in 2024.

Raj Denhoy: Brazil remained stable. We saw strong growth in our other direct market in the region, Argentina, as well as from our distributors. Asia Pacific was 20.6% of sales. Results in the quarter rebounded sharply from last quarter as expected orders from our distributors were realized. Sequential growth in the region was 46%. Our gross profit for Q3 was $37.7 million, or 70.1% of revenue, a 620 basis point increase compared to 63.9% of revenue last year and 130 basis points higher than the 68.8% in Q2 this year. This is the first time we have crossed 70% gross margin, and the increase is primarily the result of the higher margin sales in the United States. We expect gross margins in 2025 will be approximately 300 basis points higher than in 2024.

Peter Caldini: Brazil remained stable, and we saw strong growth in our other direct market in the region, Argentina, as well as from our distributors. Asia Pacific was 20.6% of sales. Results in the quarter rebounded sharply from last quarter as expected orders from our distributors were realized. Sequential growth in the region was 46%. Our gross profit for the third quarter was $37.7 million, or 70.1% of revenue, a 620 basis point increase compared to 63.9% of revenue last year, and 130 basis points higher than the 68.8% in the second quarter of this year. This is the first time we have crossed 70% gross margin, and the increase is primarily the result of the higher margin sales in the United States. We expect gross margins in 2025 will be approximately 300 basis points higher than in 2024.

As well as from our distributors.

Asia Pacific was 26% of sales results for the quarter rebounded sharply from last quarter as expected orders from our distributors were realized sequential growth in the region was 46%.

Our gross profit for the third quarter was $37 $7 million or 71% of revenue a 620 basis point increase compared to 63, 9% of revenue last year, and 130 basis points higher than the 68, 8% in the second quarter of this year.

This is the first time, we've crossed 70% gross margin in.

The increase was primarily the result of higher margin sales in the United States. We expect gross margins of 2025 will be approximately 300 basis points higher than in 2024.

As it relates to tariffs goods imported from Costa Rica to United States are subject to duties. However, as we saw in <unk>, we are managing their impact and do not meaningfully change our trajectory for gross margin improvements this year.

Peter Caldini: As it relates to tariffs, goods imported from Costa Rica to the United States are subject to duties. However, as we saw in Q3, we are managing their impact and do not meaningfully change our trajectory for gross margin improvements this year. SG&A expenses of $37.2 million were approximately $3.1 million higher than Q3 2024. R&D expenses for Q3 were $4.6 million. Total operating expenses for Q3 increased approximately $2.9 million from the year ago period to $41.7 million. Operating expenses have been approximately $45 to $46 million on average per quarter, which is what we guided to at the start of the year and what we continue to expect. As we saw in this quarter and in Q2, there can be fluctuations based on the timing of expenses. Adjusted EBITDA was positive $1.2 million in Q3.

Raj Denhoy: As it relates to tariffs, goods imported from Costa Rica to the United States are subject to duties. However, as we saw in Q3, we are managing their impact and do not meaningfully change our trajectory for gross margin improvements this year. SG&A expenses of $37.2 million were approximately $3.1 million higher than Q3 2024. R&D expenses for Q3 were $4.6 million. Total operating expenses for Q3 increased approximately $2.9 million from the year ago period to $41.7 million. Operating expenses have been approximately $45 to $46 million on average per quarter, which is what we guided to at the start of the year and what we continue to expect. As we saw in this quarter and in Q2, there can be fluctuations based on the timing of expenses. Adjusted EBITDA was positive $1.2 million in Q3.

Peter Caldini: As it relates to tariffs, goods imported from Costa Rica to the United States are subject to duties. However, as we saw in Q3, we are managing their impact and do not meaningfully change our trajectory for gross margin improvements this year. SG&A expenses of $37.2 million were approximately $3.1 million higher than the third quarter of 2024. R&D expenses for the third quarter were $4.6 million. Total operating expenses for the third quarter increased approximately $2.9 million from the year-ago period to $41.7 million. Operating expenses have been approximately $45 to $46 million on average per quarter, which is what we guided to at the start of the year, and what we continue to expect. As we saw in this quarter and in the second quarter, there can be fluctuations based on the timing of expenses. Adjusted EBITDA was positive $1.2 million in the third quarter.

SG&A expenses of $37 $2 million of approximately $3 $1 million higher than the third quarter of 2024.

R&D expenses for the third quarter were $4 $6 million.

Total operating expenses for the third quarter increased approximately $2 $9 million from the year ago period to $41 $7 million.

Operating expenses have been approximately $45 million to $46 million on average per quarter, which what we guided to at the start of the year and what we continue to expect.

As we saw in this quarter and in the second quarter, there can be fluctuations based on the timing of expenses.

Adjusted EBITDA was positive $1 $2 million in the third quarter.

This compared to a loss of $8 $5 million in the second quarter and $12 $1 million in the first quarter. This is our first EBITDA positive quarter as a company and there are a couple of things to highlight.

Peter Caldini: This compared to a loss of $8.5 million in Q2 and $12.1 million in Q1. This is our first EBITDA positive quarter as a company, and there are a couple of things to highlight. While the improvement results are being supported by the strong sales and the higher gross profit in the US, we have been very focused on managing our operating expenses. While operating expenses in Q3 increased approximately $3 million from a year ago, they were down over $5 million from Q3 2023. Over the time, we invested significantly in our US commercial operation and launched our minimally invasive portfolio. We were able to do this by finding efficiencies across all parts of the organization and making structural changes where needed.

Raj Denhoy: This compared to a loss of $8.5 million in Q2 and $12.1 million in Q1. This is our first EBITDA positive quarter as a company, and there are a couple of things to highlight. While the improvement results are being supported by the strong sales and the higher gross profit in the US, we have been very focused on managing our operating expenses. While operating expenses in Q3 increased approximately $3 million from a year ago, they were down over $5 million from Q3 2023. Over the time, we invested significantly in our US commercial operation and launched our minimally invasive portfolio. We were able to do this by finding efficiencies across all parts of the organization and making structural changes where needed.

Peter Caldini: This compared to a loss of $8.5 million in the second quarter and $12.1 million in the first quarter. This is our first EBITDA positive quarter as a company, and there are a couple of things to highlight. While the improvement results are being supported by the strong sales and the higher gross profit in the United States, we have been very focused on managing our operating expenses. While operating expenses in the third quarter increased approximately $3 million from a year ago, they were down over $5 million from the third quarter of 2023. Over the time, we have invested significantly in our US commercial operation and launched our minimally invasive portfolio. We were able to do this by finding efficiencies across all parts of the organization and making structural changes where needed.

While the equipment results are being supported by the strong sales and the higher gross profit in the United States, we've been very focused on managing our operating expenses.

While operating expenses in the third quarter increased approximately $3 million from a year ago, they were down over $5 million from the third quarter of 2023.

Over the time, we invested significantly in our U S commercial operation and launched our minimally invasive portfolio.

We were able to do this by finding efficiencies across all parts of the organization and making structural changes where needed.

We expect EBITDA will continue to improve including in the fourth quarter and expect to remain EBITDA positive from hereon.

Peter Caldini: We expect EBITDA will continue to improve, including in the fourth quarter, and expect to remain EBITDA positive from here on. For 2026, we will continue to expand our commercial infrastructure in the United States. However, the investments we make overall as a company will be at a rate well below expected top-line growth. We have been investing with the expectation of global market leadership, and have built an organization that can take full financial and commercial advantage as that occurs. Most of our spending in this regard has already happened. For example, the facilities we have today can produce more than half the world's implants. We expect revenue to grow more than 20% for at least several more years, and our business should start to show meaningful and increasing earnings in 2027 and beyond.

Peter Caldini: We expect EBITDA will continue to improve, including in the Q4, and expect to remain EBITDA positive from here on. For 2026, we will continue to expand our commercial infrastructure in the United States. However, the investments we make overall as a company will be at a rate well below expected top-line growth. We have been investing with the expectation of global market leadership and have built an organization that can take full financial and commercial advantage as that occurs. Most of our spending in this regard has already happened. For example, the facilities we have today can produce more than half the world's implants. We expect revenue to grow more than 20% for at least several more years, and our business should start to show meaningful and increasing earnings in 2027 and beyond.

Raj Denhoy: We expect EBITDA will continue to improve, including in the Q4, and expect to remain EBITDA positive from here on. For 2026, we will continue to expand our commercial infrastructure in the United States. However, the investments we make overall as a company will be at a rate well below expected top-line growth. We have been investing with the expectation of global market leadership and have built an organization that can take full financial and commercial advantage as that occurs. Most of our spending in this regard has already happened. For example, the facilities we have today can produce more than half the world's implants. We expect revenue to grow more than 20% for at least several more years, and our business should start to show meaningful and increasing earnings in 2027 and beyond.

For 2026, we will continue to expand our commercial infrastructure in the United States.

However, the investments we make overall as a company will be at a rate well below expected topline growth.

We have been investing with the expectation of global market leadership and have built an organization that can take full financial and commercial advantage as that occurs.

Most of our spending in this regard has already happened for.

For example, the facilities, we have today can produce more than half the world's implants.

We expect revenue to grow more than 20% for at least several more years.

And our business should start to show meaningful and increasing earnings in 2027 and beyond.

Cash increased $16 million in the third quarter to $70 $6 million from $54 6 million at the end of the second quarter.

Peter Caldini: Cash increased $16 million in the third quarter to $70.6 million from $54.6 million at the end of the second quarter. The increase was primarily the result of drawing the remaining $25 million tranche of our credit facility, offset by our operating cash use. Excluding the net proceeds, cash use would have been $8.5 million in the third quarter. This compares to $14.5 million in the second quarter and $21.2 million in the first quarter. We expect cash use to improve further in the fourth quarter, and expect to reach cash flow positive in 2026 without the need for any further equity raises. Our credit facility will end the last year of its term in April, and we are considering a number of refinancing options that could further reduce our cash use. We're also working to make ESTA eligible for inclusion in a number of indices, most notably the Russell.

Peter Caldini: Cash increased $16 million in Q3 to $70.6 million from $54.6 million at the end of Q2. The increase was primarily the result of drawing the remaining $25 million tranche of our credit facility offset by our operating cash sheets. Excluding the net proceeds, cash use would have been $8.5 million in Q3. This compares to $14.5 million in Q2 and $21.2 million in Q1. We expect cash use to improve further in Q4 and expect to reach cash flow positive in 2026 without the need for any further equity raises. Our credit facility opened last year of its term in April, and we are considering a number of refinancing options that could further reduce our cash use. We're also working to make ESTA eligible for inclusion in a number of indices, most notably the Russell.

Raj Denhoy: Cash increased $16 million in Q3 to $70.6 million from $54.6 million at the end of Q2. The increase was primarily the result of drawing the remaining $25 million tranche of our credit facility offset by our operating cash sheets. Excluding the net proceeds, cash use would have been $8.5 million in Q3. This compares to $14.5 million in Q2 and $21.2 million in Q1. We expect cash use to improve further in Q4 and expect to reach cash flow positive in 2026 without the need for any further equity raises. Our credit facility opened last year of its term in April, and we are considering a number of refinancing options that could further reduce our cash use. We're also working to make ESTA eligible for inclusion in a number of indices, most notably the Russell.

The increase was primarily a result of drawing the remaining 25 million tranche of our credit facility offset by our operating cashes.

Excluding the net proceeds cashiers would've been $8 $5 million in the third quarter.

This compares to $14 5 million in the second quarter and $21 $2 million in the first quarter.

We expect cash use to improve further in the fourth quarter and expect to reach cash flow positive in 2026 without the need for any further equity raises.

Our credit facility within the last year of its term in April we're considering a number of refi to financing options that could further reduce our cashews.

We're also working to make us the eligible for inclusion in a number of indices, most notably the Russell.

There are a number of things we can do to affect this and we believe it will be eligible for future rebalancing.

Peter Caldini: There are a number of things we can do to affect this, and we believe we will be eligible for future rebalancings. As Peter noted, we now expect our revenue in 2025 will exceed $210 million, an upward revision from our previous guidance of $208 to 212 million. Our updated outlook represents growth of at least 26%. The US remains a primary engine of growth this year. We have seen very strong results over the first three quarters of 2025, and this has continued into the fourth quarter. Our direct markets outside the US are also doing well, and demand globally for our products remains good. Gross margins are improving, and we are managing our operating expenses, which allowed us to achieve positive EBITDA a quarter early. We expect to see continued improvements in profitability, and remain confident we'll reach cash flow positive in 2026.

Peter Caldini: There are a number of things we can do to affect this, and we believe we will be eligible for future rebalancings. As Peter noted, we now expect our revenue in 2025 will exceed $210 million, an upward revision from our previous guidance of $208 to $212 million. Our updated outlook represents growth of at least 26%. The US remains our primary engine of growth this year. We have seen very strong results over the first three quarters of 2025, and this has continued into Q4. Our direct markets outside the US are also doing well, and demand globally for our products remains good. Gross margins are improving, and we are managing our operating expenses, which allowed us to achieve positive EBITDA a quarter early. We expect to see continued improvements in profitability and remain confident we will reach cash flow positive in 2026.

Raj Denhoy: There are a number of things we can do to affect this, and we believe we will be eligible for future rebalancings. As Peter noted, we now expect our revenue in 2025 will exceed $210 million, an upward revision from our previous guidance of $208 to $212 million. Our updated outlook represents growth of at least 26%. The US remains our primary engine of growth this year. We have seen very strong results over the first three quarters of 2025, and this has continued into Q4. Our direct markets outside the US are also doing well, and demand globally for our products remains good. Gross margins are improving, and we are managing our operating expenses, which allowed us to achieve positive EBITDA a quarter early. We expect to see continued improvements in profitability and remain confident we will reach cash flow positive in 2026.

Yeah.

As Peter noted, we now expect our revenue in 2025 will exceed $210 million, an upward revision from our previous guidance of $280 million to $212 million.

Our updated outlook represents growth of at least 26%.

The U S remains the primary engine of growth this year.

We have seen very strong results through the first three quarters of 2025 and this has continued into the fourth quarter.

Our direct markets outside the U S. We're also doing well in demand globally for our products remains good.

Gross margins are improving and we are managing our operating expenses, which allowed us to achieve positive EBITDA a quarter really.

We expect to see continued improvements in profitability and remain confident we'll reach cash flow positive in 2026.

I will now turn the call back to Peter.

Third quarter of 2025 was in many ways a turning point for our company.

Peter Caldini: I will now turn the call back to Peter. Q3 2025 was, in many ways, a turning point for our company. We achieved positive EBITDA for the first time. We achieved this in a quarter where we grew revenue 34%. These results show that we can efficiently invest in and grow our business. We will continue to do so. The next step is to achieve cash flow positive, which I am confident we will do next year. We expect our top-line growth to remain above 20% for the next several years. Our profitability should expand at a much faster pace. I am looking forward to having conversations with our shareholders about our increasing EPS and how we can keep that momentum going for the next 5 to 10 years. Operator, we're ready to take questions. Thank you.

Raj Denhoy: I will now turn the call back to Peter.

Peter Caldini: I will now turn the call back to Peter. Third quarter of 2025 was, in many ways, a turning point for our company. We achieved positive EBITDA for the first time, and we achieved this in a quarter where we grew revenue 34%. These results show that we can efficiently invest in and grow our business, and we will continue to do so. The next step is to achieve cash flow positive, which I am confident we will do next year. We expect our top-line growth to remain above 20% for the next several years, and our profitability should expand at a much faster pace. I am looking forward to having conversations with our shareholders about our increasing EPS, and how we can keep that momentum going for the next 5 to 10 years. Operator, we're ready to take questions. Thank you.

Peter Caldini: Q3 2025 was, in many ways, a turning point for our company. We achieved positive EBITDA for the first time. We achieved this in a quarter where we grew revenue 34%. These results show that we can efficiently invest in and grow our business. We will continue to do so. The next step is to achieve cash flow positive, which I am confident we will do next year. We expect our top-line growth to remain above 20% for the next several years. Our profitability should expand at a much faster pace. I am looking forward to having conversations with our shareholders about our increasing EPS and how we can keep that momentum going for the next 5 to 10 years. Operator, we're ready to take questions.

We achieved positive EBITDA for the first time and we achieved this in a quarter, where we grew revenue 34%.

These results show that we can efficiently invest in and grow our business and we will continue to do so.

The next step is to achieve cash flow positive, which I am confident we will do next year.

We expect our topline growth to remain above 20% for the next several years and our profitability should expand at a much faster pace.

I am looking forward to having conversations with our shareholders about our increasing EPS and how we can keep that momentum going for the next five to 10 years.

Operator, we're ready to take questions.

Thank you at this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. We ask that you ask one question and one follow up for participants using speaker equipment it may be necessary.

Operator: Thank you. At this time, we will conduct a question-and-answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. We ask that you ask one question and one follow-up. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 to ask a question at this time. One moment while we pull for our first question. The first question comes from Anthony Petrone with Mizuho. Please proceed.

Peter Caldini: At this time, we will conduct a question-and-answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. We ask that you ask one question and one follow-up. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 to ask a question at this time. One moment while we pull for our first question. The first question comes from Anthony Petrone with Mizuho. Please proceed. Thanks, congrats to the team all around here on strong execution. Maybe Pete and Raj, we could start with the comments on 2025 and just the implied outlook as we head into the end of the year.

Peter Caldini: At this time, we will conduct a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. We ask that you ask one question and one follow-up. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one to ask a question at this time. One moment while we pull for our first question. The first question comes from Anthony Patron with Mizuho. Please proceed. Thanks, and congrats to the team all around here on strong execution. Maybe Pete and Raj, we could start with the comments on 2025 and just the implied outlook as we head into the end of the year. Just looking for some more inputs, puts, and takes on that Q4 number.

To pick up your handset before pressing to Sarkies once again Thats star one to ask a question at this time.

One moment, while we poll for our first question.

The first question comes from Anthony Petrone with Mizuho. Please proceed.

Thanks, and congrats to the team all around in your own strong execution.

Anthony Petrone: Thanks, congrats to the team all around here on strong execution. Maybe Pete and Raj, we could start with the comments on 2025 and just the implied outlook as we head into the end of the year. Just looking for some more inputs, puts and takes on that Q4 number, specifically how should we think about OUS trends. Obviously, there's strong momentum on the US side, but maybe a little bit more detail on what we're thinking about for new account openings from here, Preservé uptake, and then lastly, just the EBITDA positive, well ahead of expectations. How do you think about EBITDA trending from here, just given the momentum on the US side? Thanks again.

Maybe Pete and Raj you could start with the comments on 2025, and just the implied outlook as we head into the end of the year.

I was just looking for some more inputs puts and takes on that for Q numbers, specifically, how should we think about O U S trends.

Peter Caldini: Just looking for some more inputs, puts and takes on that Q4 number, specifically how should we think about OUS trends. Obviously, there's strong momentum on the US side, but maybe a little bit more detail on what we're thinking about for new account openings from here, Preservé uptake, and then lastly, just the EBITDA positive, well ahead of expectations. How do you think about EBITDA trending from here, just given the momentum on the US side? Thanks again. Yeah, thanks for the question, Anthony. Clearly, a lot of momentum in the business heading into the Q4, as we noted, we're planning to exceed $210 million now for the year. As it relates to the Q4, the US has quickly become our largest market, we have a lot of momentum in the US. For us, though, we haven't yet seen a Q4, right?

Peter Caldini: Specifically, how should we think about OUS trends? Obviously, there's strong momentum on the US side, but maybe a little bit more detail on what we're thinking about for new account openings from here, Preservae uptake, and then lastly, just the EBITDA positive, well ahead of expectations. How do you think about EBITDA trending from here, just given the momentum on the US side? Thanks again. Yeah, thanks for the question, Anthony. Clearly, a lot of momentum in the business heading into the fourth quarter, and as we noted, we're planning to exceed $210 million now for the year. As it relates to the fourth quarter, the US has quickly become our largest market, and we have a lot of momentum in the US. For us, though, we haven't yet seen a fourth quarter, right?

Obviously, there is strong momentum on the U S side, but maybe a little bit more detail on what we're thinking about for new account openings from here preservation uptake and then lastly, just the EBITDA positive you know well ahead of expectations.

How do you think about EBITDA trending from here just just given the momentum on the us side. Thanks again.

Yeah. Thanks for the question Anthony you know clearly a lot of momentum in the business heading into the fourth quarter as we noted.

Peter Caldini: Yeah, thanks for the question, Anthony. Clearly, a lot of momentum in the business heading into the Q4, as we noted, we're planning to exceed $210 million now for the year. As it relates to the Q4, the US has quickly become our largest market, we have a lot of momentum in the US. For us, though, we haven't yet seen a Q4, right?

To exceed $210 million now.

For the year as it relates to the fourth quarter in the U S has quickly become our largest market and we have a lot of momentum in the U S.

For us that we haven't yet seen a fourth quarter rate and there are some nuances in the fourth quarter around reconstruction and some of the holidays and things and so we just want to be prudent in terms of how.

Peter Caldini: There are some nuances in the fourth quarter around reconstruction and some of the holidays and things. We just want to be prudent in terms of how we set the midpoint for the fourth quarter. Clearly, we have a lot of momentum, and we expect to meaningfully exceed the $40 million we previously provided. The US is doing very well. Outside the US, we also have a lot of momentum, specifically in direct markets where we're seeing very strong growth. In Europe, we were north of 20% in direct markets this quarter. We have a really strong order book for the fourth quarter from our distributors, and we're expecting a very strong finish to the year. I think, importantly, that sets us up really well for 2026, right?

Peter Caldini: There are some nuances in Q4 around reconstruction and some of the holidays and things, and so we just want to be prudent in terms of how we set the midpoint for Q4. Clearly, we have a lot of momentum, and we expect to meaningfully exceed the $40 million we previously provided, and so the US is doing very well. Outside the US, we also have a lot of momentum, specifically in direct markets where we're seeing very strong growth. In Europe, we were north of 20% in direct markets this quarter. We have a really strong order book for Q4 from our distributors, and so we're expecting a very strong finish to the year. I think, importantly, that sets us up really well for 2026, right?

So how we set the midpoint for the fourth quarter, but clearly we have a lot of momentum and we expect to meaningfully exceed $40 million. We previously provided so so the U S is doing very well outside the U S. We also have a lot of momentum.

Specifically in direct markets, where we're seeing very strong growth in Europe, we were north of 20% indirect markets. This quarter, we havent really strong order book for the fourth quarter from our distributors and so we're expecting a very strong finish to the year.

Importantly that sets us up really well for 2026 right. The momentum we're carrying in the business that will play for the next year really is.

Peter Caldini: The momentum we're carrying in the business that will play forward in the next year really is a nice place to be as we're entering the new year. As it relates to EBITDA, again, we're all very proud of what we've achieved here a quarter early, the $1.2 million. As we also noted, it's just the beginning here, right? We have a lot of leverage we can still bring through this business as we're investing, and you'll see EBITDA continue to expand in the fourth quarter. We expect to continue to show nice improvements overall in 2026. I think the business, again, has a lot of momentum. You're starting to see the profitability and the leverage in the model, and we expect that's going to continue from here forward. Appreciate that. I'll hop back in. The next question comes from Josh Jennings with TD Cowan.

Peter Caldini: The momentum we're carrying in the business that will play forward in the next year really is a nice place to be as we're entering the new year. As it relates to EBITDA, again, we're all very proud of what we've achieved here a quarter early, the $1.2 million. As we also noted, it's just the beginning here, right? We have a lot of leverage we can still bring through this business as we're investing, and you'll see EBITDA continue to expand in the Q4, and we expect to continue to show nice improvements overall in 2026. I think the business, again, has a lot of momentum. You're starting to see the profitability, the leverage in the model, and we expect that's going to continue from here forward. Appreciate that. I'll hop back in. The next question comes from Josh Jennings with TD Cowen. Please proceed.

Peter Caldini: The momentum we're carrying in the business that will play forward in the next year really is a nice place to be as we're entering the new year. As it relates to EBITDA, again, we're all very proud of what we've achieved here a quarter early, the $1.2 million. As we also noted, it's just the beginning here, right? We have a lot of leverage we can still bring through this business as we're investing, and you'll see EBITDA continue to expand in the Q4, and we expect to continue to show nice improvements overall in 2026. I think the business, again, has a lot of momentum. You're starting to see the profitability, the leverage in the model, and we expect that's going to continue from here forward.

Nice place to be as we're entering a entering a new year.

As it relates to EBITDA.

Again, we're all very proud of what we've achieved here or early the $1 2 million.

But as we also noted it's just the beginning year right, where we have a lot of leverage we can still bring through this business as we are investing and youll see EBITDA continue to expand in the fourth quarter and.

And we expect to continue to show nice.

Nice improvement overall in 2026, and so I think the business again has a lot of momentum youre starting to see the profitability the leverage in the model and we expect that's going to continue from here forward.

Anthony Petrone: Appreciate that. I'll hop back in.

Appreciate that I'll hop back in.

The next question comes from Josh Jennings with TD Cowen. Please proceed.

Operator: The next question comes from Josh Jennings with TD Cowen. Please proceed.

Hi, good morning, and congratulation to them, arriving in the EBIT in a positive area a little bit.

Peter Caldini: Please proceed. Hi, good morning, and congrats to the Felicians on arriving in the EBITDA positive era a little bit earlier than expected. Pete and Raj, I was hoping to just start on thinking about 2026 and international business, but specifically China. Any updates just in terms of the outlook there and the distributor relationships and when reordering could start to kick in? Should we be expecting Q1 2026? Is there any chance that there could be some China orders in the fourth quarter? Yeah, thank you, Josh. In terms of the OUS markets, I think in general, we've seen stabilization for the most part across all the markets. Our focus going into this year, Josh, was really driving growth in our direct markets, and I think we've been very successful in doing that. We have better economics, and we have more upside potential in those markets.

Peter Caldini: Hi, good morning. Congratulations on arriving in the EBITDA positive era a little bit earlier than expected. Pete and Raj, I was hoping to just start on thinking about 2026 and international business, but specifically China. Any updates just in terms of the outlook there and the distributor relationships and when reordering could start to kick in? Should we be expecting Q1 2026? Is there any chance that there could be some China orders in Q4? Yeah, thank you, Josh. In terms of the OUS markets, I think, in general, we've seen stabilization for the most part across all the markets. Our focus going into this year, Josh, was really driving growth in our direct markets, and I think we've been very successful in doing that. We have better economics. We have more upside potential in those markets.

Josh Jennings: Hi, good morning. Congratulations on arriving in the EBITDA positive era a little bit earlier than expected. Pete and Raj, I was hoping to just start on thinking about 2026 and international business, but specifically China. Any updates just in terms of the outlook there and the distributor relationships and when reordering could start to kick in? Should we be expecting Q1 2026? Is there any chance that there could be some China orders in Q4?

Earlier than expected.

Ron I was hoping to just start on on thinking about 2026 and international business, specifically, China any any updates just in terms of.

The outlook, there and the distributor relationships and win when reordering could could start to kick in.

Should we be expecting Q1, 2026 is there any chance that there could be some China orders in the fourth quarter.

Yes. So thank you Josh in terms of the Oh U S markets I think in general we've seen stabilization after the most part across all the markets.

Peter Caldini: Yeah, thank you, Josh. In terms of the OUS markets, I think, in general, we've seen stabilization for the most part across all the markets. Our focus going into this year, Josh, was really driving growth in our direct markets, and I think we've been very successful in doing that. We have better economics. We have more upside potential in those markets.

Our focus going into this year, Josh was really driving growth in our direct markets and I think we've been very successful in doing that we have better economics, we have more upside potential in those markets and as Raj mentioned you.

Peter Caldini: As Raj mentioned, we had 20% growth, and that's following a quarter where we had 27% growth in our European markets. We're gaining accounts. A lot of that growth is being fueled by Preservae, but very strong performance, and we're going to continue to focus on that going into 2026. We see good momentum in the fourth quarter, and that's just going to continue into next year. Yeah, as it relates to China, I think we're working very closely with our partners there. We've actually seen some good progress, especially from a sellout standpoint, and we're going to continue to work closely with them, and we're going to keep you updated, but we want to make sure we build the business there the right way. Thank you. The next question comes from Allen Gong with J.P. Morgan. Please proceed. Thanks for the question.

Peter Caldini: As Raj mentioned, we had 20% growth, and that's following a quarter where we had 27% growth in our European markets. We're gaining accounts. A lot of that growth is being fueled by Preservé, but very strong performance, and we're going to continue to focus on that going into 2026. We see good momentum in Q4, and that's just going to continue into next year. Yeah, as it relates to China, I think we're working very closely with our partners there. We've actually seen some good progress, especially from a sellout standpoint, and we're going to continue to work closely with them, and we're going to keep you updated. We want to make sure we build the business there the right way. Thank you. The next question comes from Allen Gong with JPMorgan. Please proceed. Thanks for the question.

We had 20% growth and that's following a quarter, where we had 27% growth in our European markets were gaining accounts.

Peter Caldini: As Raj mentioned, we had 20% growth, and that's following a quarter where we had 27% growth in our European markets. We're gaining accounts. A lot of that growth is being fueled by Preservé, but very strong performance, and we're going to continue to focus on that going into 2026. We see good momentum in Q4, and that's just going to continue into next year. Yeah, as it relates to China, I think we're working very closely with our partners there. We've actually seen some good progress, especially from a sellout standpoint, and we're going to continue to work closely with them, and we're going to keep you updated. We want to make sure we build the business there the right way.

A lot of that growth is being fueled by pressured day.

But very strong performance and we're going to continue to focus on that.

Going into 2026, and we see good momentum in the App.

Fourth quarter and not just going to continue into next year.

Yeah as it relates to China.

I think we're working very closely with our partners there.

We've actually seen some some good progress, especially from a sellout standpoint, and we're going to continue to work closely with them and we're going to keep you updated but we want to make sure. We build the business there are the right way.

Thank you. The next question comes from Allen Gong with J P. Morgan. Please proceed.

Operator: Thank you. The next question comes from Allen Gong with JPMorgan. Please proceed.

Thanks for the question I have one on the broader market when we looked at some of your peers in aesthetics I think some of the body language. We were getting from them was definitely a bit more cautious on market dynamics, especially heading into fourth quarter. You know looking at your results and listening to your confidence.

Allen Gong: Thanks for the question. I have one on the broader market. When we looked at some of your peers in aesthetics, I think some of the body language we were getting from them was definitely a bit more cautious on market dynamics, especially heading into Q4. Looking at your results and listening to your confidence, definitely sounds like you're not seeing that. I guess, are you not seeing that weakness? Are you just growing through it, or is there a reason why those challenges are more company-specific than for the broader market?

Peter Caldini: I have one on the broader market. When we looked at some of your peers in aesthetics, I think some of the body language we were getting from them was definitely a bit more cautious on market dynamics, especially heading into Q4. Looking at your results and listening to your confidence, definitely sounds like you're not seeing that. I guess, are you not seeing that weakness? Are you just growing through it, or is there a reason why those challenges are more company-specific than for the broader market? Yeah, thanks. First off, I mean, we can't really comment on their perspective in terms of the market. I can just tell you how we're seeing the market in the US specific to breast aesthetics.

Peter Caldini: I have one on the broader market. When we looked at some of your peers in aesthetics, I think some of the body language we were getting from them was definitely a bit more cautious on market dynamics, especially heading into fourth quarter. Looking at your results and listening to your confidence, definitely sounds like you're not seeing that. I guess, are you not seeing that weakness? Are you just growing through it, or is there a reason why those challenges are more company-specific than for the broader market? Yeah, thanks. First off, I mean, we can't really comment on their perspective in terms of the market. I can just tell you how we're seeing the market in the US specific to breast aesthetics.

Definitely it sounds like Youre not seeing that so I guess are you not seeing that weakness are you just growing through it or is there a reason why those challenges are more company specific center for the broader market.

Yeah. Thanks.

Peter Caldini: Yeah, thanks. First off, I mean, we can't really comment on their perspective in terms of the market. I can just tell you how we're seeing the market in the US specific to breast aesthetics. I think we've created a lot of momentum in the marketplace, and I think what we mentioned in the prepared remarks, in some of the accounts that have early adopters in the field, but we're seeing an increase in the number of procedures. What we are seeing as it relates to our business, we're seeing growth. We're very positive in terms of the momentum we've been able to build in the Q4, and that's just going to continue into next year.

First of all I mean, we can't really comment on their perspective in terms of the market I can just tell you how we're seeing the market in the U S specific to two breast aesthetics.

You know I think we've created a lot of momentum in the marketplace and I think we mentioned in the prepared remarks in some of the accounts that have early.

Peter Caldini: I think we've created a lot of momentum in the marketplace, and I think what we mentioned in the prepared remarks, in some of the accounts that have early adopters in the field, but we're seeing an increase in the number of procedures. What we are seeing as it relates to our business, we're seeing growth. We're very positive in terms of the momentum we've been able to build in the Q4, and that's just going to continue into next year. The next question comes from Sam Eiber with BTIG. Please proceed. Hi, good morning. Thanks for taking the questions. Maybe I can shift over to the minimally invasive platforms. You talked about the $30 million in revenue for next year.

Peter Caldini: I think we've created a lot of momentum in the marketplace, and I think what we mentioned in the prepared remarks, in some of the accounts that have early adopters in the field, we're seeing an increase in the number of procedures. What we are seeing as it relates to our business, we're seeing growth. We're very positive in terms of the momentum we've been able to build in Q4, and that's just going to continue into next year. The next question comes from Sam Eber with BTIG. Please proceed. Hi, good morning. Thanks for taking the questions. Maybe I can shift over to the minimally invasive platforms. You talked about the $30 million in revenue for next year.

Adopters move to you, but we're seeing an increase in the number of procedures. So what we're seeing and as it relates to our business, we're seeing growth with very.

Positive in terms of the momentum we've been able to build in the Q4 and that's just going to continue into next year.

Operator: The next question comes from Sam Eiber with BTIG. Please proceed.

The next question comes from Sam <unk> with B T. I G. Please proceed.

Hi, good morning, Thanks for taking the questions maybe.

Sam Eiber: Hi, good morning. Thanks for taking the questions. Maybe I can shift over to the minimally invasive platforms. You talked about the $30 million in revenue for next year. Can you just maybe help frame contribution this year, if there's any way to parse out MIA versus Preservé, what market development work needs to happen to get to the at least $30 million target for next year? Thanks for taking the questions.

Maybe I can shift over to the minimally invasive platforms, you talked about the $30 million in revenue for next year.

Can you just maybe help frame contribution this year.

Peter Caldini: Can you just maybe help frame contribution this year, if there's any way to parse out MIA versus Preservé, what market development work needs to happen to get to the at least $30 million target for next year? Thanks for taking the questions. Yeah, thanks, Sam. I mean, we're very happy with the progress we're making with Preservé and the minimally invasive platform. Speaking specifically on MIA, we've doubled the number of accounts this year. That was our goal. With Preservé, we're off to an outstanding start in Europe. We're really focusing primarily on the direct markets, we're also expanding into some of our distributor markets. That momentum is going to continue into 2026. We mentioned also that in the US, we're going to be launching early part of next year. We're looking at the end of Q1.

Peter Caldini: Can you just maybe help frame contribution this year, if there's any way to parse out Mia versus Preservae, and then what market development work needs to happen to get to the at least $30 million target for next year? Thanks for taking the questions. Yeah, thanks, Sam. I mean, we're very happy with the progress we're making with Preservae and the minimally invasive platform. Speaking specifically on Mia, we've doubled the number of accounts this year, and that was our goal. With Preservae, we're off to an outstanding start in Europe, and we're really focusing primarily in the direct markets, but we're also expanding into some of our distributor markets. That momentum is going to continue into 2026. We mentioned also that in the US, we're going to be launching early part of next year, so we're looking at the end of the first quarter.

If theres any way to parse out mi versus preservation and then.

What market development work needs to happen to get to those that at least 30 million target for next year. Thanks for taking the questions.

Yeah. Thanks, Sam.

Peter Caldini: Yeah, thanks, Sam. I mean, we're very happy with the progress we're making with Preservé and the minimally invasive platform. Speaking specifically on MIA, we've doubled the number of accounts this year. That was our goal. With Preservé, we're off to an outstanding start in Europe. We're really focusing primarily on the direct markets, we're also expanding into some of our distributor markets. That momentum is going to continue into 2026. We mentioned also that in the US, we're going to be launching early part of next year. We're looking at the end of Q1.

I mean, we're very very happy with the progress, we're making with the present value of the minimally invasive platform.

Speaking specifically on nearly doubled the number of the accounts this year and that was our goal and then with present day, we're off to an outstanding start.

In Europe, and we're really focusing primarily in the direct markets, but we're also expanding into some of our distributor markets.

And that momentum is going to continue into 2026.

We mentioned also that in the U S.

We're gonna be launching early part of next year. So we're looking at the end of the first quarter.

Already significant demand we've seen that with the early experienced surgeons, they're very excited and I think once its launch I think it is going be a pretty quick ramp up. So we're very pleased with that platform and how it's performing.

Peter Caldini: There's already significant demand. We've seen that with the early experience surgeons. They're very excited, and I think once it's launched, I think it's going to be a pretty quick ramp-up. We are very pleased with that platform and how it's performing. The next question comes from Joanne Went for Citi. Please proceed. Hi, good morning. This is Anthony filling in for Joanne. Thanks for taking the question. Is there any chance you could provide, either quantify or maybe provide a little bit more granularity around your expectation for US sales to meaningfully exceed $40 million this year? Yeah, Anthony, as I tried to answer the first question, right, the fourth quarter, again, is we're carrying a lot of momentum into the fourth quarter, right? We will do quite a bit better than the $40 million we previously talked about.

Peter Caldini: There's already significant demand. We've seen that with the early experienced surgeons. They're very excited, and I think once it's launched, I think it's going to be a pretty quick ramp-up. We're very pleased with that platform and how it's performing. The next question comes from Joanne Wuensch with Citi. Please proceed. Hi, good morning. This is Anthony filling in for Joanne. Thanks for taking the question. Is there any chance you could provide, either quantify or maybe provide a little bit more granularity around your expectation for US sales to meaningfully exceed $40 million this year? Yeah, Anthony. As I tried to answer the first question, right, the Q4, again, is we're carrying a lot of momentum into the Q4, right? We will do quite a bit better than the $40 million we previously talked about.

Operator: The next question comes from Joanne Wuensch with Citi. Please proceed.

The next question comes from Joanne Wuensch with Citi. Please proceed.

Alright, good morning, Anthony filling in for Joanne Thanks for taking the question.

[Analyst] (Citi): Hi, good morning. This is Anthony filling in for Joanne. Thanks for taking the question. Is there any chance you could provide, either quantify or maybe provide a little bit more granularity around your expectation for US sales to meaningfully exceed $40 million this year?

Very entrenched provide cheap either quantify or maybe provide a little bit more granularity around.

Your expectation too.

For yourself meaningfully exceeded $40 million this year.

Peter Caldini: Yeah, Anthony. As I tried to answer the first question, right, the Q4, again, is we're carrying a lot of momentum into the Q4, right? We will do quite a bit better than the $40 million we previously talked about.However, it is the first time we've had a Q4 in the US, right? There is some holidays, some other elements to the quarter that make it difficult to kind of tell you exactly where we're going to land. Again, it's a difficult question, but I think the reality is we're doing very well in the US, the number of accounts, the orders we're getting. All of it is really pushing in the right direction, and we simply have a lot of momentum that we're carrying right now.

Yeah Anthony.

As I tried to answer the first question right. The fourth quarter again, as we have we're carrying a lot of momentum into the fourth quarter rate and show.

Well, we will do quite a bit better than the $40 million. We had previously talked about whoever. It is the first time, we've had a fourth quarter in the United States right.

Peter Caldini: However, it is the first time we've had a fourth quarter in the United States, right? There are some holidays, some other elements to the quarter that make it difficult to kind of tell you exactly where we're going to land. Again, it's a difficult question, but I think the reality is we're doing very well in the US. The number of accounts, the orders we're getting, all of it is really pushing in the right direction, and we simply have a lot of momentum that we're carrying right now. The next question comes from Mason Carico with Stevens. Please proceed. Hey, thanks for taking the question. Reiterating the single-digit growth in international revenue, it seems like you're seeing strength across a handful of markets, stability in others.

Peter Caldini: However, it is the first time we've had a Q4 in the US, right? There is some holidays, some other elements to the quarter that make it difficult to kind of tell you exactly where we're going to land. Again, it's a difficult question, but I think the reality is we're doing very well in the US, the number of accounts, the orders we're getting. All of it is really pushing in the right direction, and we simply have a lot of momentum that we're carrying right now. The next question comes from Mason Carrico with Stephens. Please proceed. Hey, thanks for taking the question. Reiterating the single-digit growth in international revenue, it seems like you're seeing strength across a handful of markets, stability in others.

So there is some some some holiday some other elements to that quarter that make it difficult to kind of.

I'd tell you exactly where we're going to land.

And so again, it's a difficult question, but I think the reality is where we're doing very well in the U S number of accounts. The orders we're getting all of it is really pushing in the right direction and we just we think we have a lot of momentum that we're carrying right now.

Operator: The next question comes from Mason Carrico with Stephens. Please proceed.

The next question comes from Mason Curico with Stephens. Please proceed.

Hey, Thanks for taking the question.

Mason Carrico: Hey, thanks for taking the question. Reiterating the single-digit growth in international revenue, it seems like you're seeing strength across a handful of markets, stability in others. Are you willing to quantify how, at least preliminarily, you're thinking about growth in the international market next year?

So reiterating the the single digit growth in international revenue it seems like you're seeing strength across a handful of markets.

The ability and others or are you willing to quantify how at least preliminarily youre thinking about growth in the international market next year.

Peter Caldini: Are you willing to quantify how, at least preliminarily, you're thinking about growth in the international market next year? Yeah, I think, Mason, it's a good question, right? We haven't yet provided the 2026 outlook, but from a high-level standpoint, we're seeing very good demand in our direct markets. It's been an area of focus for us. We spent a lot of time making sure we have the right team there, the right structure there, and you are seeing that play out now. We don't expect that momentum will slow, and so that is going to carry us into 2026. The other part of the business is distributors. We don't have perfect visibility into how the distributed markets are doing, but generally, the tone in those markets remains very good. The end markets seem very similar to what we're seeing in our direct markets.

Peter Caldini: Are you willing to quantify how, at least preliminarily, you're thinking about growth in the international market next year? Yeah, I think, Mason, it's a good question, right? We haven't yet provided the 2026 outlook, but from a high-level standpoint, we're seeing very good demand in our direct markets. It's been an area of focus for us. We spent a lot of time making sure we have the right team there, the right structure there, and you are seeing that play out now. We don't expect that momentum will slow. That is going to carry us into 2026. The other part of the business is distributors. We don't have perfect visibility into how the distributed markets are doing, but generally, the tone in those markets remains very good. The end markets seem very similar to what we're seeing in our direct markets.

Yeah.

Peter Caldini: Yeah, I think, Mason, it's a good question, right? We haven't yet provided the 2026 outlook, but from a high-level standpoint, we're seeing very good demand in our direct markets. It's been an area of focus for us. We spent a lot of time making sure we have the right team there, the right structure there, and you are seeing that play out now. We don't expect that momentum will slow, and so that is going to carry us into 2026. The other part of the business is distributors. We don't have perfect visibility into how the distributed markets are doing, but generally, the tone in those markets remains very good. The end markets seem very similar to what we're seeing in our direct markets.

Yeah I think.

It's a good question right, we haven't yet provided the 2026 outlook, but.

You know from a high level standpoint, we're seeing very good demand in our direct markets.

<unk> been an area of focus for US we spent a lot of time, making sure. We have the right team there the REIT structure, there and you are seeing that play out now and we don't expect that momentum will slow.

That is going to carry us into 2026.

The other part of the business use distributors.

We don't have perfect visibility into how the distributor markets youre doing but generally the tone in those markets remains very good the end market seems very similar to what we're seeing in our direct markets and so overall, we're expecting in 2026 of our international markets will perform.

Peter Caldini: Overall, we're expecting in 2026, our international markets will perform well. You marry that with what we're seeing in the United States, and we commented we expect to finish it at approximately 20%, which provides a very good stepping-off point in the US for 2026. Overall, we're expecting another year of very strong growth for the company. Got it. Okay. In terms of Motiva accounts in the US, what are you guys seeing in terms of trends among customers after adoption? How quickly are you seeing them ramp up? Is there an average amount of their practice they end up converting? Just any incremental detail you can provide there. Yeah, I think, as we mentioned before, the growth in the US is really exceeding all our expectations.

Peter Caldini: Overall, we're expecting in 2026, our international markets will perform well. You marry that with what we're seeing in the United States, and we comment that we expect to finish it at approximately 20%, which provides a very good stepping-off point in the US for 2026. Overall, we're expecting another year of very strong growth for the company. Got it. Okay. In terms of Motiva accounts in the US, what are you guys seeing in terms of trends among customers after adoption? How quickly are you seeing them ramp up? Is there an average amount of their practice they end up converting? Any incremental detail you can provide there. Yeah, I think, as we mentioned before, I mean, the growth in the US is really exceeding all our expectations.

Well and then you marry that with what we're seeing in the United States and we commented we expect to finish it at approximately 20%, which provides a very good stepping off point in the U S for 2026.

We're expecting another year of very strong growth for the company.

Got it okay and in terms of Motiva accounts in the U S.

Mason Carrico: Got it. Okay. In terms of Motiva accounts in the US, what are you guys seeing in terms of trends among customers after adoption? How quickly are you seeing them ramp up? Is there an average amount of their practice they end up converting? Any incremental detail you can provide there.

What are you guys seeing in terms of trends among customers after adoption.

How quickly are you seeing them ramp up is there.

An average amount of their practice they end up converting just any incremental detail you can provide there.

Yeah, I think as we mentioned before I mean, the growth in the U S.

Peter Caldini: Yeah, I think, as we mentioned before, I mean, the growth in the US is really exceeding all our expectations. We've kind of overdelivered on most of the internal KPIs that we have, so we're very pleased with that. We continue to add additional accounts. The utilization rate continues to pick up, especially as a lot of the accounts are going through their scheduling process. What also helps quite a bit in terms of the utilization and also the penetration is the number of patients that are entering the accounts asking specifically for Motiva. We're seeing a really good growth in the Q4, and it's somewhat of an inflection point for us, and we believe that momentum will finish this year, and then it's going to continue to grow next year, especially when we start layering over some of the Preservé launch, also the small sizes as well.

Is really exceeding all our expectations, we've kind of over delivered on most of the internal kpis that we have so we're very pleased with that.

Peter Caldini: We've kind of over-delivered on most of the internal KPIs that we have, so we're very pleased with that. We continue to add additional accounts. The utilization rate continues to pick up, especially as a lot of the accounts are going through their scheduling process. What also helps quite a bit in terms of the utilization, and also the penetration, is the number of patients that are entering the accounts asking specifically for Motiva. We're seeing really good growth in Q4, and it's somewhat of an inflection point for us. We believe that momentum will finish this year, and then it's going to continue to grow next year, especially when we start layering over some of the Preservae launch, also the small sizes as well. Got it. Thank you. The next question comes from Mike Matson with Needham & Company. Please proceed. Yeah, thanks.

Peter Caldini: We've kind of overdelivered on most of the internal KPIs that we have, so we're very pleased with that. We continue to add additional accounts. The utilization rate continues to pick up, especially as a lot of the accounts are going through their scheduling process. What also helps quite a bit in terms of the utilization and also the penetration is the number of patients that are entering the accounts asking specifically for Motiva. We're seeing a really good growth in the Q4, and it's somewhat of an inflection point for us, and we believe that momentum will finish this year, and then it's going to continue to grow next year, especially when we start layering over some of the Preservé launch, also the small sizes as well. Got it. Thank you. The next question comes from Mike Matson with Needham & Company. Please proceed. Yeah, thanks.

We continue to add additional accounts utilization rate continues to pick up, especially as a lot of the accounts are going through their scheduling process would also helps quite a bit in terms of the utilization and also the penetration is the number of patients that are entering the year.

The accounts asking specifically for Motiva.

So we're seeing really good growth in the Q4, and it's somewhat of an inflection point for us and we believe that momentum will finish this year and then it's going to continue to grow next year, especially when you start learning over some of the as the present day launch also the small sizes as well.

Got it thank you.

Peter Caldini: Got it. Thank you.

The next question comes from Mike Matson with Needham and company. Please proceed.

Peter Caldini: The next question comes from Mike Matson with Needham & Company. Please proceed. Yeah, thanks.

Yeah. Thanks so.

I wanted to get some clarification on the commentary around getting to 20% share exiting the year.

Peter Caldini: I wanted to get some clarification on the commentary around getting to 20% share exiting the year. We had estimated that the US augmentation market's around $600 million, so about $150 million a quarter if you flatline it, and 20% of that would sort of imply about $30 million. I mean, is that math reasonable, or am I missing something? Maybe you mean as of the very last day of the quarter you'll be at it, and it's ramping through the quarter, and you'll be at 20% as of the very tail end of the quarter or something like that? Yeah, I think just to level set, I think your expectation for the size of the market may be a little bit off.

Peter Caldini: I wanted to get some clarification on the commentary around getting to 20% share X in the year. We had estimated that the US augmentation market is around $600 million, so about $150 million a quarter if you flatline it. Twenty percent of that would sort of imply about $30 million. I mean, is that math reasonable, or am I missing something? Maybe you mean as of the very last day of the quarter, you'll be at, it's ramping through the quarter, and you'll be at 20% as of the very tail end of the quarter or something like that? Yeah, Mike, I think just to level set, I think your expectation for the size of the market may be a little bit off.

No.

We had estimated that the U S market augmentation markets around 600 million.

So about $150 million a quarter, if you fly lineup.

And 20% of that would sort of imply about $30 million.

I mean is that math, a reasonable or am I missing something maybe you mean like as of the very last day of the quarter, you'll be ramping through the quarter and it'll be at 20%.

Very tail end of the quarter or something like that.

Yeah, Mike I think just to level set I think your expectation for the size of the market may be a little bit off.

If you look at it.

From the clinical societies the market in the United States is estimated at approximately 300000 procedures a year.

Peter Caldini: If you look at some of the data from the clinical societies, the market in the United States is estimated at approximately 300,000 procedures a year. Our ASPs, we've talked about, are around 1,300, a little under 1,300 per case. That puts you at a little bit below $400 million for the augmentation market. The reconstruction market is a market about that same size, right? If you just think about the augmentation market, you're looking at a market closer to $390, $400 million in that range. That is the market against which we expect to exit at about 20%. Okay, more like a $20 million number then. Again, that's also an exit rate, right, as we're leaving 2025 and 2026. Okay. All right, understand. Just as far as the fourth quarter goes, how much visibility do you feel you have?

Peter Caldini: If you look at some of the data from the clinical societies, the market in the United States is estimated at approximately 300,000 procedures a year. RASPs, as we've talked about, are around 1,300, a little north of 1,300 per case. That puts you at a little bit below $400 million for the augmentation market. The reconstruction market is a market about that same size, right? If you just think about the augmentation market, you're looking at a market close to $390, 400 million in that range, and that is the market against which we expect to exit at about 20%. More like a $20 million number then. Again, that's also an exit rate, right, as we're leaving 2025 and 2026. Yeah. Okay. All right, understand. Just as far as the Q4 goes, how much visibility do you feel you have?

So again as we've talked about around 300, a little north of <unk> 800 per case that puts you at a little bit below $400 million for the augmentation market. The reconstruction market is a market.

About that same size right. So if you just think about the augmentation market youre looking at a market closer to 390 $400 million in that range and that is the market against which we expect to exited about 20%.

Okay, so more like a $20 million number then.

But again, that's also an exit rate right as we're leaving yeah.

Okay Alright.

Alright I understand.

And then just as far as the fourth quarter goes.

How much visibility do you feel you have I mean, we're over a month into the quarter now.

Peter Caldini: I mean, we're over a month into the quarter now, or I guess, sorry, two months into the quarter now. I know you have orders that you get, and I don't know how much lead time there is between an order and a shipment and things like that, but we do. I mean, we do see the daily orders, right? We know the number of customers we have, and we have quite a bit of visibility in how the business is tracking. As we've noted, there's a lot of momentum right now. Those metrics all continue to go higher. As we're leaving the third quarter and we've entered the fourth quarter here, moving out of that seasonally slow period, there's a lot of acceleration in this business.

Peter Caldini: I mean, we're over a month into the quarter now or I guess, sorry, 2 months into the quarter now. I know you have orders that you get. I don't know how much lead time there is between an order and a shipment and things like that. We do. I mean, we do see the daily orders, right? We know the number of customers we have, we have quite a bit of visibility in how the business is tracking. As we've noted, there's a lot of momentum right now. Those metrics all continue to go higher. As we're leaving Q3 and we've entered Q4 here, moving out of that seasonally slow period, there's a lot of acceleration in this business.

Sorry, two months into the quarter now and you know.

And then I know you have orders that you get and so I don't know how much lead time, there is between the order and shipment and things like that but.

We do I mean, we do see the daily orders right. We know the number of customers, we have and so we have very.

We have quite a bit of visibility in how the business is tracking as we go through there's a lot of momentum right now those metrics all continues to go higher.

And as we're leaving the third quarter and we've entered the fourth quarter here.

Moving out of that seasonally slow period, there is a lot of acceleration in this business.

Again, it's our first fourth quarter as a company in the United States and so we just want to be prudent in terms of where we set the midpoint of where we think we end up.

Peter Caldini: Again, it's our first fourth quarter as a company in the United States, and we just want to be prudent in terms of where we set the midpoint of where we think we end up. You shouldn't think that there's anything behind that, right? The business is doing extremely well, and we're going to have a very strong finish to the year. Okay, understand. Thanks. The next question comes from Matthew Taylor with Jefferies. Please proceed. Hi, good morning. This is Matt on for Matt Taylor. I just wanted to ask a quick question on 2026. Assuming you're exiting 2025 with around 20% market share, looking at your kind of strategy into next year, do you anticipate driving your expansion primarily through penetration with these existing accounts, or is it mainly blocking and tackling, going after new accounts?

Peter Caldini: It's our first Q4 as a company in the United States, we just want to be prudent in terms of where we set the midpoint of where we think we end up. You shouldn't think that there's anything behind that, right? The business is doing extremely well, we're going to have a very strong finish to the year. Okay, understand. Thanks. The next question comes from Matthew Taylor with Jefferies. Please proceed. Hi, good morning. This is Matt on for Matthew Taylor. I just wanted to ask a quick question on 2026. Assuming you're exiting 2025 with around 20% market share, looking at your kind of strategy into next year, do you anticipate driving your expansion primarily through penetration with these existing accounts, or is it mainly blocking and tackling going after new accounts?

But you shouldn't you shouldn't think that there is anything behind that right. The business is doing extremely well and we're going to have a very strong finish to the year.

Okay understand thanks.

The next question comes from Matthew Taylor with Jefferies. Please proceed.

Okay.

Hi, Good morning, this is Matt on for Matt Taylor.

I just wanted to ask a quick question on 2026 and <unk>.

Assuming you're exiting 2025 with around 20% market share.

Looking at your kind of strategy into next year do you anticipate driving your expansion primarily through penetration with these existing accounts or is it mainly blocking and tackling going after new accounts.

Yeah. So I mean, as we mentioned before them and where we're exiting 2025 with tremendous momentum we keep on adding existing accounts, adding accounts the utilization rate continues to pick up.

Peter Caldini: Yeah, so I mean, as we mentioned before, we're exiting 2025 with tremendous momentum. We keep on adding existing accounts or adding accounts. The utilization rate continues to pick up, and that momentum is going to continue into next year. Now, what we're also doing is, and we mentioned this on the previous call, we're going to be adding additional reps, up to about 15 reps for next year. That will help increase the utilization, also the reach in some of those accounts that we can add into next year. We're also going to be launching Preservae at the end of the first quarter, and we also have the launch of the small size, which we anticipate at the beginning of next year.

Peter Caldini: I mean, as we mentioned before, I mean, we're exiting 2025 with tremendous momentum. We keep on adding existing accounts or adding accounts. The utilization rate continues to pick up. That momentum is going to continue into next year. What we're also doing is we mentioned this on the previous call. We're going to be adding additional reps, up to about 15 reps, for next year. That will help increase the utilization, also the reach, in some of those accounts that we can add into next year. We're also going to be launching Preservé at the end of Q1. We also have the launch of the small sizes, which we anticipate the beginning of next year.

And that momentum is going to continue into next year now what we're also doing as we and we mentioned this on the previous call, we're going to be adding additional reps up to about 15 reps.

For next year.

And that will help increase the utilization also the reach.

And some of those accounts that we have.

That we can add into the next year.

We're also going to be launching a president's day at the end of the first quarter and then we also have the launch of the small sizes, which we anticipate on the beginning of next year. So I think you're going to see a combination of continued growth in the accounts that we are in and as we continue to increase the utilization rate.

Peter Caldini: I think you're going to see a combination, continued growth in the accounts that we are in, and as we continue to increase the utilization rate, we're going to be adding additional accounts. You also have with the expansion in terms of filling out our matrix as well as with the Preservae launch. I think you're going to see a combination of both. Okay, that's helpful. I'd say looking at your five-year plan, you're still fairly confident in kind of reaching that goal of, I don't know, 40% to 70% that you've seen in other markets. Is that fair to assume? Yes. Yes. Okay. Thank you. Thank you. This is all the time we have for questions today. I will now turn the call back over to Peter Caldini for closing remarks. Okay, thank you, everybody, for joining.

Peter Caldini: I think you're going to see a combination, continued growth in the accounts that we are in, and as we continue to increase the utilization rate, we're going to be adding additional accounts. You also have with the expansion in terms of filling out our matrix as well as with the Preservé launch. I think you're going to see a combination of both. Okay, that's helpful. I'd say looking at your five-year plan, you're still fairly confident in kind of reaching that goal of, I don't know, 40% to 70% that you've seen in other markets. Is that fair to assume? Yes. Yes. Okay. Thank you. Thank you. This is all the time we have for questions today. I will now turn the call back over to Peter Caldini for closing remarks. Okay, thank you, everybody, for joining.

Going to be adding additional accounts and then you also have with the expansion in terms of.

Filling out our matrix as well as with impressive they launched I think youre going to see a combination of both.

Okay. That's helpful. So I would say like looking at your five year plan, you still fairly confident in kind of reaching.

We're reaching that.

Goal of I don't know.

40% to 70% that you've seen in other markets.

Is that fair to assume yes, yes.

Yes, okay.

Thank you.

Thank you. This is all the time, we have for questions today I will now turn the call back over to Peter counting any for closing remarks.

Okay. Thank you everybody for joining us look forward to the next call.

Peter Caldini: Look forward to the next call, and thank you very much for attending. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.

Thank you very much for attending.

This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a great day.

Q3 2025 Establishment Labs Holdings Inc Earnings Call

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