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Establishment Labs (ESTA) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Aug 6, 2026

Source: earnings call transcript

Executive summary

Establishment Labs Q2 FY26 — Strong U.S. Growth and Raised Full-Year Revenue Guidance

Establishment Labs delivered a strong Q2 FY26, driven by exceptional U.S. market penetration and the rapidly expanding minimally invasive platform. The company raised its full-year revenue guidance and is on track to become free cash flow positive in H2 2026, demonstrating increasing operating leverage and financial discipline while continuing to invest in its innovation pipeline.

Highlights

5

  • Total revenue reached $67.5 million, representing 31.7% growth over Q2 FY25.

  • U.S. revenue grew by over 140% to $24.7 million compared to the prior year.

  • Adjusted EBITDA improved by $12.2 million to $3.7 million, compared to a loss of $8.5 million in Q2 FY25.

  • Minimally invasive platform generated $12.1 million in revenue during the quarter.

  • Cash and cash equivalents increased sequentially by $3.1 million to $71.2 million.

Concerns

3

  • OUS business grew steadily at 4.4%, significantly slower than the U.S. market.

  • Middle East revenue impacted by regional conflict, now representing less than 5% of total revenue.

  • Q3 is historically the softest quarter in the industry due to seasonal vacation periods.

Guidance & targets

CategoryTargetConfidence
Full-year revenue
$269 million to $271 million
high materiality
High
Free cash flow status
transition to free cash flow positive
high materiality
High
Free cash flow status
be free cash flow positive
high materiality
High
Minimally invasive platform revenue contribution
approaching 15% of our global business
medium materiality
High
Surgeons trained and certified on Preservé
approximately 500 surgeons
medium materiality
High
FY27 revenue growth
around the 25% growth mark
high materiality
Medium

Segment performance

SegmentRevenueYoYQoQMargin
United States
Fastest-growing region, driven by continued adoption of Motiva and increasing contribution from the minimally invasive platform. Surpassed 100,000 Motiva implants in under 21 months since launch.
Percentage of total company revenue: 36.6%Motiva implants since launch: >100,000Accounts: >2,000
$24.7 million140.9%26%—
OUS (Outside United States)
Continued to perform well, supported by strong execution in direct markets and steady demand with distributors. Exposure to volatile markets remains limited.
$42.8 million4.4%——
Europe (OUS direct markets)
Strong growth in direct markets, particularly Italy, Germany, and the U.K., reflecting increased resources and leadership changes.
—16%——
Minimally Invasive Platform (Global)
Continued to emerge as an important growth driver globally, performing ahead of original expectations and expanding the total addressable market.
$12.1 million———

Product announcements

ProductTypeDetails
Miaupdate
Preservéupdate

Risks & headwinds

Macroeconomic and geopolitical uncertainty Ongoing

Limited exposure

Mitigation:Highly diversified global business; exposure to most volatile markets remains limited.

Middle East conflict impact on orders Remainder of the year

Orders at a much lower level; less than 5% of total revenue

Mitigation:Monitoring closely and course correcting where necessary; Middle East is a small portion of overall revenue.

Seasonal slowdown in Q3 Q3 FY26

Historically the softest quarter in the industry

Mitigation:Expect U.S. business to remain strong; OUS business to reflect normal seasonal pattern; strongest quarter expected to be Q4.

What to watch in Q3 FY26

Reconstruction FDA approval timeline

Next quarter / FY27
Current BIMO audits started, routine questions being addressed
Target Further clarity on approval timeline or potential approval

Why it matters

FDA approval for reconstruction doubles the U.S. total addressable market and is a significant growth driver for the company.

So in terms of the feedback, we have heard back from the FDA. We're in the process of responding to what we consider some routine questions. What I think is very positive, they now started the BIMO audits of our clinical study sites, which I think is a normal part of the process, and I think it's a good indication that things are progressing well.

Find out whether ESTA delivers this. Inve re-checks your case every morning.

Q&A highlights

Can Mia create a new category in aesthetics, and what is the timeline for GEM's commercial launch and regulatory pathway?

Mia is a key driver for the minimally invasive platform, bringing new patients and addressing barriers to breast augmentation. GEM is a tremendous opportunity for gluteal augmentation, with a clinical study in Costa Rica and early experience in Latin America in H2 next year. U.S. contribution for GEM is not expected until 2028 and beyond, as the regulatory pathway is still being worked out.

“So where we are in that process is, we're doing a clinical study in Costa Rica. We expect next year in the back half to do an early experience in Latin America. And right now we're really working through what that regulatory pathway is going to be for the U.S. as well as OUS, primarily in Europe.”

asked by Joshua Jennings · answered by Filippo Caldini

2 min read 5 chapters

Detailed narrative

U.S. Market Penetration and Growth Drivers

The U.S. market continues to be the primary growth engine, now representing 36.6% of total company revenue, up from 20% a year ago. The company surpassed 100,000 Motiva implants in the U.S. within 21 months of launch and has expanded to over 2,000 accounts. Growth is increasingly driven by utilization within existing accounts, with surgeons converting a significant percentage of their practice to Motiva due to patient demand and product differentiation. 75% of surgeons report patients asking for a specific brand, with 93% of those requests being for Motiva.

Minimally Invasive Platform Momentum

The minimally invasive platform, including Preservé and Mia, generated $12.1 million in revenue and is approaching 15% of global business for the year. Preservé, available in the U.S., commands a premium of more than 2x traditional breast augmentation and has trained over 300 surgeons, exceeding original expectations. This platform is attracting new patients and shortening the consideration time for breast augmentation, with some surgeons reporting a significant increase in summer procedure bookings due to minimal downtime.

Innovation Pipeline and Future Growth

Establishment Labs is advancing its innovation pipeline, including a reconstruction submission with the FDA, expansion of the U.S. product matrix with smaller implant sizes, and the continued development of GEM. GEM, a potential breakthrough in gluteal augmentation, is undergoing a clinical study in Costa Rica with early experience planned for H2 next year in Latin America, though U.S. contribution is not expected until 2028 and beyond. The company expects these innovations to drive market share gains and market expansion for years to come.

OUS Performance and Strategic Focus

Outside the U.S., revenue grew 4.4% to $42.8 million, with strong execution in direct markets, particularly Europe, which saw 16% growth. The company is strengthening leadership and prioritizing resources in these markets to reduce dependency on distributors and improve economics. Demand trends remained stable despite macroeconomic uncertainties, with exposure to volatile markets remaining limited.

Financial Discipline and Outlook

The company demonstrated strong financial progress, with gross profit margin expanding to 70.6% from 68.8% in the prior year. Adjusted EBITDA improved significantly to $3.7 million from a loss of $8.5 million. Operating expenses, excluding one-time charges, showed single-digit growth, reflecting increasing operating leverage. The company expects to transition to free cash flow positive in H2 2026 and be free cash flow positive for FY27, with sufficient liquidity to execute its strategy without future equity raises.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.