Establishment Labs Holdings Inc.

What they do

Establishment Labs develops, manufactures, and sells silicone gel-filled breast implants branded Motiva Implants, which it has sold since October 2010 and which are registered in over 100 countries. The product families include Round and Ergonomix Round, Ergonomix Oval, Anatomical TrueFixation, Ergonomix2 Round and Ergonomix2 Diamond, and the Flora Tissue Expander. Products are sold through exclusive distributors or a direct sales force, and the company also sells a minimally invasive platform consisting of Mia Femtech and Preserv. It received FDA approval to sell Motiva Implants in the United States in September 2024.

Revenue drivers

• Motiva Implants - international — Silicone gel-filled breast implants sold since 2010 in over 100 countries through exclusive distributors or direct sales; the company states the majority of revenue since launch has come from Motiva Implants.
• Motiva USA — U.S. sales of Motiva Implants following September 2024 FDA approval; Q2 2026 U.S. revenue was $24.7 million versus $10.3 million in the prior-year quarter.
• Minimally invasive platform (Mia Femtech, Preserv, GEM) — Mia Femtech is a minimally invasive breast harmonization offering and Preserv is a tissue-preserving technology launched in Brazil in February 2025; minimally invasive revenue was $12.1 million in Q2 2026.
• Motiva Flora Tissue Expander — Tissue expander used in breast reconstruction following breast cancer; received 510(k) clearance in October 2023.

Recent performance

Q2 2026 revenue was $67.5 million, up 31.7% from $51.3 million in Q2 2025 and up 12.8% sequentially from Q1 2026. Gross margin was 70.6% versus 68.8% a year earlier, which the company attributed to favorable geographic and channel mix including U.S. and minimally invasive growth. Loss from operations narrowed to $4.3 million from $14.1 million, and adjusted EBITDA was income of $3.7 million versus a loss of $8.5 million. Net loss was $11.7 million compared with $16.6 million, and cash was $71.2 million at June 30, 2026. For the six months ended June 30, 2026, revenue was $127.4 million versus $92.7 million, with a net loss of $25.1 million.

Strategy

Management is prioritizing U.S. market expansion following the September 2024 FDA approval and continued adoption of its minimally invasive platform, including Mia Femtech and Preserv. Preserv launched in Brazil in February 2025, with further country launches during 2025 and a full U.S. launch expected in 2026. The company refinanced its debt in April 2026, entering an amended credit agreement with lenders providing term loans of up to $300 million, of which $265 million was advanced and about $259 million used to repay prior obligations. It is also funding silicone raw material purchases, having drawn $5 million each in June and September 2025 under an inventory funding agreement at a 12% annual interest rate.

Risks

• Limited U.S. operating history — The company marketed products solely outside the United States from October 2010 until the Flora tissue expander clearance in October 2023 and Motiva approval in September 2024, so it has limited U.S. history on which to forecast results.
• History of net losses — The company has incurred net losses in each year since inception, with an accumulated deficit of $520.9 million as of June 30, 2026.
• Leverage and interest cost — Long-term debt was $261.7 million at June 30, 2026 against shareholder equity of $21.6 million, and interest expense was $14.1 million for the six months ended June 30, 2026.
• Macroeconomic and trade exposure — The company's risk factors cite unfavorable global economic and political conditions, including inflation, reduced consumer spending power, and trade wars, as factors that have affected and could affect results.

Outlook

Management raised full-year 2026 revenue guidance to $269 million to $271 million from a previous range of $266.5 million to $268.5 million. The CEO stated the company expects strong growth in the second half of 2026 and throughout 2027, with the business inflecting to be both high growth and free cash flow positive. The company also expects a full U.S. launch of Preserv in 2026.