Establishment Labs (NASDAQ:ESTA) reported a “standout” fourth quarter and full-year 2025, highlighting rapid growth in its U.S. Motiva breast implant business, expanding adoption of its minimally invasive platform, and improving profitability metrics as the company scales.
Q4 and full-year results show accelerating U.S. momentum
Fourth-quarter revenue was $64.6 million, up 45.2% versus Q4 2024. Management said foreign exchange provided a benefit; excluding FX, growth would have been approximately 39.4%. For full-year 2025, revenue was $211.1 million, an increase of 27.2% over 2024.
Margins and profitability improved as operating leverage emerged
Establishment Labs posted a fourth-quarter gross margin of 70.5% (gross profit of $45.5 million), up 200 basis points year over year, and marked the second consecutive quarter at roughly 70% gross margin. Management attributed margin gains in 2025 to product and geographic mix, particularly higher-margin U.S. sales, with full-year gross margin up 330 basis points versus 2024.
Operating trends also improved. The company reported a fourth-quarter net loss from operations of $3.9 million, down 79% from Q4 2024, and adjusted EBITDA of positive $5.5 million, compared with negative $13.1 million in the year-ago quarter. CFO Raj Denhoy (who announced a transition into a strategy role) said the year-over-year adjusted EBITDA improvement of $18.6 million was driven by strong sales and higher U.S. gross profit, alongside tighter expense management.
Cash increased by $4.9 million in Q4 to $75.6 million at year-end 2025, aided by reduced operating cash use and option exercise inflows. Caldini said the company has “no need for additional capital,” and management reiterated expectations to reach a first positive cash flow quarter in 2026, with full-year cash flow positivity expected in 2027.
2026 guidance: mid-$260M revenue, rising margins, EBITDA positive each quarter
For 2026, Establishment Labs guided revenue to $264 million to $266 million, representing 25.1% to 26.0% growth. Management said there “may be some upsides” to the range and added it expects 2027 to deliver at least a similar growth rate.
Denhoy said the company expects:
- Single-digit growth outside the U.S. (OUS) in 2026
- The U.S. to exceed 30% of total sales (up from ~22% in 2025)
- Gross margin expansion of 200 to 300 basis points
- Total operating expenses of $195 million to $200 million in 2026, with quarterly variability based on timing
- Adjusted EBITDA positive every quarter in 2026
- Free cash use less than half of 2025 levels, with cash flow positivity expected in the second half of 2026
Management noted its credit facility enters the last year of its term in April and said it is evaluating refinancing options. The company also said it continues work to become eligible for index inclusion, including the Russell, and expressed increased confidence it will be included this year.
Adoption drivers: Motiva demand, account growth, and expanding sales coverage
Caldini attributed U.S. momentum to product differentiation and what he described as a “new era of transparency” driven by social media. He said surgeons report that when patients are shown multiple implant options, “9 out of 10 choose Motiva,” even at a higher price point, and that patients increasingly request Motiva by name.
Since the late-2024 launch, the company said it has onboarded more than 1,500 U.S. accounts. Management said January and early February 2026 exceeded expectations and that conference season has kept Motiva prominent in surgeon discussions. In a blinded surgeon survey cited by the company, 88% of plastic surgeons said they either use or are interested in trying Motiva; 75% reported being asked for an implant brand by name, and surgeons said 93% of those requests were for Motiva.
To support growth, management plans to expand the U.S. sales force by up to 15 representatives in 2026, noting a majority have already been hired and emphasizing a focus on experienced industry veterans.
Preserve, reconstruction, and pipeline updates
The company’s minimally invasive platform was a major focus of Q&A. Management described strong interest in Preserve, which it said offers benefits including smaller incisions, minimal anesthesia, and faster recovery, and claimed some patients are new to augmentation because of the less invasive approach. In prepared remarks, the company cited early U.S. experience suggesting about 15% of Preserve patients were not previously considering augmentation, while in Q&A management referenced a similar survey figure of 14%.
Establishment Labs said it charges about 2x more for Preserve than for traditional augmentation and argued it is expanding the category on both a dollar and procedure basis. The company said it trained more than 90 surgeons and plans a full launch in March, with a target of at least 200 trained plastic surgeons by the end of 2026. Management also stated it expects global demand for its minimally invasive platform (Preserve and Mia) to exceed $30 million in 2026.
On reconstruction, the company said it submitted Motiva implants to the FDA in December 2025 for primary and revision breast reconstruction, describing reconstruction as an opportunity that could “effectively double” its U.S. total addressable market and carry higher ASPs. Management indicated reconstruction is more likely a 2027–2028 story and noted the need to work through hospital value analysis committees and contracting, though it believes seeding with the Motiva Flora tissue expander—now in 200 facilities—could help speed ramp once approvals are obtained.
Management also said it remains in communication with the FDA regarding small sizes and expressed confidence those could be approved in the first half of 2026, while citing additional pipeline programs including Mia, Ergonomix2, and GEM for future U.S. introduction.
Finally, the company announced a management transition effective March 9, with Denhoy moving to SVP, Global Strategy and Cassandra Harris joining as Chief Financial Officer following what management described as an extensive search.
About Establishment Labs (NASDAQ:ESTA)
Establishment Labs Holdings Inc is a global medical technology company specializing in the design, development and manufacture of silicone gel breast implants for aesthetic and reconstructive surgery. The company’s proprietary portfolio is built around patient-focused safety, customization and innovation, offering solutions intended to enhance surgical outcomes and support clinical traceability.
The company’s flagship products fall under the Motiva® brand, which includes a range of ergonomic and round breast implants featuring SilkSurface® texturing and an embedded Q Inside® Safety microtransponder for unique implant identification.
