Establishment Labs' Q3 2025: Contradictions Emerge in U.S. Market Growth, International Recovery, and China's Challenges

Date of Call: November 5, 2025

Financials Results

• Revenue: $53.8 million, up 33.7% YOY (approximately 31.4% ex‑FX); U.S. sales $11.9 million (22.1% of total)
• Gross Margin: 70.1%, up 620 basis points vs 63.9% in Q3 2024 and up 130 basis points sequentially from Q2 2025 (68.8%)

Guidance:

• 2025 revenue expected to exceed $210 million (raised from prior $208M–$212M).
• Gross margin ~300 bps higher in 2025 vs 2024; Q3 reached 70.1% (first time >70%).
• Company expects to remain EBITDA positive from here on and reach cash-flow positive in 2026 without further equity raises.
• U.S.: expect to exit 2025 at ~20% augmentation market share; PMA supplement for reconstruction filing by year-end; small-size approvals early 2026.
• Mia expected $8M–$10M in 2025; Mia + Preserve expected to exceed $30M in 2026.

Business Commentary:

• Revenue and Earnings Growth:
  
• Establishment Labs grew global revenue by 34% in Q3 2025, with total revenue reaching $53.8 million.
• The company achieved a gross profit margin of 70.1% for the first time and reported its first quarter of positive EBITDA at $1.2 million.

• This growth was driven by significant revenue increases in the U.S. market and strategic investments in commercial infrastructure and product development.

• U.S. Market Performance:

• U.S. revenue for Q3 2025 was $11.9 million, up 16% sequentially, contributing to a 28.3 million revenue for the year so far.

• The U.S. segment's strong performance was attributed to increased utilization of Motiva implants, new surgeon adoption, and the introduction of Preserve and small sizes.

• Minimally Invasive Platform Expansion:

• Mia and Preserve are expected to achieve $8 million to $10 million in revenue for 2025, with a target of $30 million in 2026.

• The success of these products is due to their innovative approach to breast tissue preservation and positive surgeon and patient feedback.

• International Market Stability and Growth:

• Direct markets outside the U.S. saw 15% growth in Q3 2025, with notable contributions from Latin America and Europe.
• This growth is attributed to better performance in direct markets, successful implementation of Preserve, and stabilization in regions like Brazil.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management highlighted: "grew global revenue 34% with total revenue of $53.8 million," "first quarter of positive EBITDA with $1.2 million," and an upward revision: "we are going to exceed $210 million." Management also reiterated: "expect to reach cash flow positive in 2026" and forecast continued margin and profitability improvements.

Q&A:

• Question from Anthony Petrone (Mizuho Americas LLC): Congrats to the team all around here on strong execution. 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. Just looking for some more inputs, puts and takes on the 4Q number, specifically, how should we think about O-U.S. trends? Obviously, there's 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, Preserve 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 U.S. side?
  Response: Strong momentum into Q4 led by the U.S.; expect to meaningfully exceed prior $40M U.S. estimate, with continued EBITDA expansion in 4Q and further improvement through 2026.

• Question from Joshua Jennings (TD Cowen, Research Division): 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 the 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?
  Response: Direct international markets are stabilizing and growing; China is showing improved sell‑out via partners but no firm timing for reorder cadence was committed.

• Question from K. Gong (JPMorgan Chase & Co, Research Division): I have one on the broader market. When we look to 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 -- 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 than for the broader market?
  Response: We are not observing the same weakness in U.S. breast aesthetics — Motiva adopter accounts are increasing procedures and driving growth.

• Question from Sam Eiber (BTIG, LLC, Research Division): 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 Preserve? And then what market development work needs to happen to get to those -- the at least $30 million target for next year?
  Response: Mia has doubled accounts this year; Preserve is off to a strong start in Europe and will launch in the U.S. end of Q1 with expected quick ramp — combined platforms drive the >$30M 2026 target.

• Question from Anthony (Citi) [filling in for Joanne Wuensch]: Is there any chance you could provide -- either quantify or maybe provide a little bit more granularity around your expectation to -- for U.S. sales to meaningfully exceed $40 million this year?
  Response: U.S. will materially exceed the $40M estimate, but management declined to provide a precise Q4 figure given first‑time Q4 seasonality and remaining prudence.

• Question from Mason Carrico (Stephens Inc., Research Division): So 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?
  Response: No 2026 numeric guidance yet; direct markets show strong demand and will carry momentum into 2026, while distributor visibility is more limited.

• Question from Mason Carrico (Stephens Inc., Research Division): And in terms of Motiva accounts in the U.S., 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?
  Response: Adoption ramps rapidly: utilization rates are increasing, patient‑driven demand for Motiva is rising, and upcoming Preserve and small-size launches should further boost penetration.

• Question from Michael Matson (Needham & Company, LLC, Research Division): So I wanted to get some clarification on the commentary around getting to 20% share exiting the year. So we had estimated that the U.S. market -- augmentation market is 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 like as of the very last day of the quarter, you'll be ramping through the quarter, you'll be at 20% as of the very tail end of the quarter or something like that? ... 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 or I guess, sorry, two months into the quarter now. And then I know you have orders that you get. And so I don't know how much lead time there is between an order and a shipment and things like that, but.
  Response: Company says U.S. augmentation market is closer to ~$390–$400M (ASP ~ $1,300), so 20% exit implies ~ $20M; they monitor daily orders and have good visibility, expect strong Q4 but remain prudent on midpoint.

• Question from Matt (Jefferies) [on for Matt Taylor]: This is Matt on for Matt Taylor. I just wanted to ask a quick question on 2026. And 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?
  Response: Growth will be a mix: deeper penetration of existing accounts (raising utilization, adding ~15 reps) plus new-account acquisition and product launches (Preserve, small sizes).

Contradiction Point 1

U.S. Market Growth and Expectations

It involves differing expectations for U.S. market growth and sales performance, which are critical for assessing the company's growth trajectory and investment potential.

Are you seeing any broader market weakness similar to that of industry peers? - K. Gong(JPMorgan Chase & Co, Research Division)

2025Q3: There is significant momentum in the U.S. market, but it's the first fourth quarter for Establishment Labs in the U.S., so prudence is needed in setting expectations. - Filippo Caldini(CEO)

Update on Motiva's launch, including account numbers, order patterns, and whether Ergonomix2's FDA clearance is included in the $35 million guidance? - Anthony Petrone(Mizuho Group)

2024Q4: We have 650 accounts fully onboarded, with 450 placing orders and almost 90% reordering. We're signing up five accounts per day. Our $35 million guidance does not include new approvals in the US. - Juan Chacón-Quirós(CEO)

Contradiction Point 2

Market Growth and Momentum in the U.S.

It involves differing perspectives on the growth momentum in the U.S. market, which is crucial for revenue projections and investor expectations.

Can you discuss the 2025 outlook and provide insights into Q4, particularly on global trends and EBITDA? - Anthony Petrone(Mizuho Americas LLC)

2025Q3: There is significant momentum in the U.S. market, but it's the first fourth quarter for Establishment Labs in the U.S., so prudence is needed in setting expectations. - Filippo Caldini(CEO)

Will surgeon utilization acceleration lead to a hockey stick effect in U.S. growth? - Sam Eiber (BTIG, LLC, Research Division)

2025Q2: We continue to see continuous momentum in the U.S. market. - Filippo Caldini(CEO)

Contradiction Point 3

International Market Recovery and Growth

It involves differing expectations for the recovery and growth of international markets, which are crucial for the company's global expansion strategy.

Can you provide an update on your international business, especially in China? - Joshua Jennings(TD Cowen, Research Division)

2025Q3: We are seeing stabilization across international markets. Emphasis has been on direct markets with good growth outcomes, especially in Europe with a 20% increase. - Filippo Caldini(CEO)

How to model OUS revenue growth in 2025, considering seasonality and Chinese distributor order patterns? - Marie Thibault(BTIG)

2024Q4: We expect gradual recovery in EMEA and APAC. China will see reorders later this year as the market stabilizes. We start 2025 conservatively. - Juan Chacón-Quirós(CEO)

Contradiction Point 4

Market Conditions and Challenges in China

It highlights differing assessments of the market conditions and challenges faced in China, which could impact international sales and strategic decisions.

Can you provide an update on the international business, particularly in China? - Joshua Jennings(TD Cowen, Research Division)

2025Q3: In China, we are working closely with distributors and expect sales progress, but we are being cautious about timelines. - Filippo Caldini(CEO)

What are the underlying assumptions for the 2025 revenue guidance increase, specifically for $40 million in U.S. Motiva revenues and single-digit international sales growth? Also, could you detail the challenges in China? - Joshua Jennings(TD Cowen)

2025Q2: We are confident in achieving leadership in China but expect it will take longer than anticipated. - Filippo Caldini(CEO)