Establishment Labs' Q1 2025: Unpacking Contradictions in U.S. Revenue, OUS Growth, and FDA Approval

U.S. Revenue Guidance and Performance, OUS Revenue Growth Expectations, U.S. Sales Force Expansion and Strategy, FDA Approval Process and Impact, and Market Performance and Revenue Guidance are the key contradictions discussed in Establishment Labs' latest 2025Q1 earnings call.



Revenue and U.S. Launch Success:
- Establishment Labs reported revenue of $41.4 million for Q1 2025, representing an 11% increase from the previous year.
- The U.S. sales component showed particular strength, with $6.2 million in Q1, exceeding the $5.5 million forecast.
- The success in the U.S. market is attributed to the superior product, safety profile, and effective marketing campaigns.

Gross Margin Improvement:
- Establishment Labs' gross margin improved to 67.2% in Q1 2025, up from 65.6% in the same period last year.
- The increase is primarily due to the higher realized prices in the U.S. market, which account for a growing share of overall revenue.

Operating Expenses and Cash Flow:
- SG&A expenses for the first quarter were $39.7 million, approximately $10.8 million higher than the previous year.
- Higher cash use in the first quarter was due to investments in the U.S. launch, with a focus on leveraging these investments for future sales growth and anticipated cash flow breakeven in 2026.

Minimally Invasive Platform Expansion:
- The company's minimally invasive product platforms, Mia and Preserve, are expanding their market reach, with Mia on track for $8 million to $10 million in revenue this year.
- This expansion is driven by the appeal of natural and safer breast procedures, attracting more consumers and potentially increasing market share.