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.