Establishment Labs — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $72.0 million, a 33.9% increase from $53.8 million in the prior-year period.
• U.S. revenue increased 119.0% year-over-year to $26.0 million, while Outside U.S. (OUS) revenue increased 9.7% to $46.0 million.
• Minimally invasive revenue increased 124.0% year-over-year to approximately $9 million.
• GAAP gross profit was $49.7 million (69.1% of revenue), compared to $37.7 million (70.1% of revenue) in the prior year; adjusted gross margin excluding $1.3 million in inventory charges was 70.8%.
• GAAP operating expenses were $52.3 million, compared to $41.7 million in the prior year; adjusted operating expenses excluding litigation and restructuring charges were $49.6 million (68.8% of revenue), down from 77.6% in the prior year.
• GAAP net loss was $10.7 million ($0.35 per share), compared to a net loss of $11.1 million ($0.38 per share) in the prior year.
• Adjusted EBITDA increased to $6.4 million (8.9% of revenue) from $1.2 million (2.2% of revenue) in the prior year.
• Net cash provided by operating activities was approximately $7.7 million, and free cash flow was $5.1 million, marking the first positive quarter in the company's history.
• Cash and cash equivalents totaled $75.8 million at September 30, 2026.
• Total liabilities increased to $343.3 million at September 30, 2026, from $333.6 million at December 31, 2025, driven by a note payable net balance of $267.8 million.

Guidance and Future Outlook:

• Full-year 2026 revenue guidance was raised to more than $274 million, up from the previous range of $269 million to $271 million.
• Full-year 2026 adjusted gross margin is expected to be approximately 70.7%.
• Full-year 2026 adjusted operating expenses are expected to be between $195 million and $200 million.
• The company expects positive adjusted EBITDA for the full year 2026.
• Management expects fiscal 2027 to deliver 25% growth and positive cash flow.

Business Segments and Product Lines:

• Announced a new supply agreement with NuSil to support long-term manufacturing capacity.
• Received FDA approval for additional smaller Motiva implant sizes.
• Announced larger implant sizes for the minimally invasive platform.
• Expanded the U.S. commercial footprint to more than 2,100 accounts, with over 400 plastic surgeons trained on Preservé.
• FDA review for Motiva breast reconstruction is progressing in line with expectations.
• The company's portfolio includes Mia Femtech®, Preservé™, GEM®, Motiva Flora® tissue expander, and Zensor™ RFID technology.

Market and Competitive Landscape:

• The quarterly revenue mix reflected stronger-than-anticipated OUS distributor sales, contributing incremental revenue and gross profit dollars at lower margins.
• The company operates in a competitive and rapidly changing environment with over 200 patent applications in 20 separate patent families worldwide.

Risks and Challenges:

• Forward-looking statements highlight risks including the ability to obtain regulatory clearance, product adoption rates, marketing success, and supply chain interruptions.
• Risks also include the ability to protect intellectual property, scale operations, and maintain relationships with qualified suppliers.
• Actual results may differ materially from expectations due to economic and competitive factors.

Management Commentary and Tone:

• CEO Peter Caldini stated that third-quarter results reflect strong global revenue growth, increasing operating leverage, and a milestone in cash generation.
• Management expressed confidence in entering 2027 with a strong financial foundation and significant opportunities in minimally invasive and reconstruction segments.

Other Key Points:

• The company achieved its first quarter of positive operating and free cash flow in its history.
• The company manufactures at two facilities in Costa Rica compliant with ISO13485:2024 and FDA 21 CFR 820.
• Over 5 million Motiva devices have been delivered to surgeons since 2010.
• The Motiva Flora tissue expander is the only regulatory-approved expander with an integrated port using radio-frequency technology that is MRI conditional.
• Zensor™ includes the first biosensor Zen™, currently in an IRB approved pivotal study to measure core breast temperature.