Establishment Labs posts first positive cash quarter

Q3 revenue hit $72.0 million, up 33.9% from $53.8 million a year earlier. U.S. revenue surged 119% to $26.0 million. The minimally invasive platform—which includes Mia Femtech and Preservé—grew 124% year-over-year to roughly $9 million. Outside the U.S., revenue rose 9.7% to $46.0 million, though the company notes this quarter included stronger-than-expected distributor sales at lower margins.

The company produced $7.7 million in operating cash flow and $5.1 million in free cash flow during the quarter. Cash on hand stood at $75.8 million at September 30.

GAAP net loss narrowed to $10.7 million, or $0.35 per share, from $11.1 million, or $0.38 per share, in Q3 2025. Adjusted EBITDA climbed to $6.4 million, representing 8.9% of revenue, compared with $1.2 million, or 2.2% of revenue, a year ago. Adjusted gross margin reached 70.8%, up 70 basis points, driven by the higher-margin U.S. business and minimally invasive growth, though the company excluded $1.3 million in inventory charges tied to restructuring.

Operating expenses (adjusted, excluding litigation and restructuring costs) totaled $49.6 million, or 68.8% of revenue, versus 77.6% a year earlier—an 880 basis-point gain. GAAP gross profit was $49.7 million, or 69.1% of revenue, compared with 70.1% in the prior-year period.

During the quarter, Establishment Labs announced FDA approval for smaller Motiva implant sizes and larger sizes for its minimally invasive platform. The company expanded its U.S. commercial footprint to over 2,100 accounts, having trained more than 400 plastic surgeons on Preservé. It also signed a new supply agreement with NuSil for long-term manufacturing capacity. The FDA review of Motiva for breast reconstruction is progressing as expected, the company said.

CEO Peter Caldini stated the results "reflect strong global revenue growth, improved operating efficiency and an important milestone in cash generation as we invest in innovation and commercial expansion. He added that the company expects 2027 revenue growth of 25% and positive cash flow.

For full-year 2026, Establishment Labs raised its revenue guidance to more than $274 million from a prior range of $269 million to $271 million. The company projects adjusted gross margin of approximately 70.7%, adjusted operating expenses of $195 million to $200 million, and positive adjusted EBITDA for the full year.

The company manufactures at two facilities in Costa Rica compliant with ISO13485:2024 and FDA 21 CFR 820. It has delivered five million Motiva devices since 2010. Its portfolio includes Motiva Flora, a tissue expander for breast reconstruction with an integrated radio-frequency port that is MRI conditional; Zensor, an RFID platform to identify implantable devices; and Zen, a biosensor measuring core breast temperature currently in an IRB-approved critical study. GEM, a next-generation minimally invasive system for gluteal ergonomic modeling, is undergoing an IRB-approved critical study.

The company's solutions are supported by over 200 patent applications spanning 20 separate patent families worldwide and more than 100 scientific and clinical studies published in peer-reviewed journals. Establishment Labs operates in over 100 countries.

The stronger U.S. performance and minimally invasive growth offset margin pressure from distributor sales outside the U.S., which carried lower margins but contributed incremental revenue and gross profit dollars. As the company scales, it has improved operational efficiency while maintaining adjusted gross margins above 70%.

Caldini's 2027 guidance projects 25% revenue growth and positive cash flow. This suggests the company expects to sustain momentum in both U.S. direct sales and the minimally invasive segment while managing the international distributor channel. The Motiva breast reconstruction indication remains under FDA review, which could open an additional market segment if approved.

Business information, not medical or legal advice. Verify regulatory status at FDA.gov.