Financial Data and Key Metrics Changes - In Q3 2025, Establishment Labs reported total revenue of $53.8 million, representing a 34% increase year-over-year [4] - The company achieved a gross profit margin of 70.1%, marking the first time it exceeded 70% [4][17] - Positive EBITDA of $1.2 million was recorded for the first time in the company's history, compared to losses of $8.5 million in Q2 and $12.1 million in Q1 [19][24] - Cash increased by $16 million to $70.6 million from $54.6 million at the end of Q2 2025 [22] Business Line Data and Key Metrics Changes - U.S. revenue for Q3 was $11.9 million, up 16% sequentially, with total U.S. revenue for the first three quarters reaching $28.3 million [5][16] - European direct market sales increased approximately 20% year-over-year, excluding currency effects and the acquisition of a distributor [6][14] - The minimally invasive portfolio, including NEO and PreserVe, is expected to exceed $30 million in revenue in 2026 [16] Market Data and Key Metrics Changes - The U.S. breast augmentation market share is projected to reach approximately 20% by the end of 2025, with significant growth expected in 2026 [6][21] - Direct markets outside the U.S. grew 15% year-over-year, with strong performances in Latin America and Europe [14][15] - Asia-Pacific sales rebounded sharply with a sequential growth of 46% in Q3 [17] Company Strategy and Development Direction - The company aims to achieve cash flow positive status in 2026 without further equity raises, focusing on expanding its commercial infrastructure in the U.S. [20][22] - Establishment Labs is preparing for the U.S. launch of breast reconstruction products, which are expected to have a market size similar to breast augmentation [6][14] - The company is committed to driving innovation and expanding its market share through surgeon training and product adoption [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth exceeding 20% for several years, with expectations for meaningful earnings starting in 2027 [21][24] - The company noted strong momentum heading into Q4 2025, with a robust order book and positive trends in both U.S. and international markets [26][39] - Management highlighted the importance of surgeon adoption and patient demand for Motiva implants, which is expected to drive future growth [9][36] Other Important Information - The company is considering refinancing options for its credit facility to further reduce cash use [22] - Establishment Labs is working to make itself eligible for inclusion in various indices, including the Russell [22] Q&A Session Summary Question: Comments on 2025 outlook and Q4 expectations - Management noted strong momentum in the U.S. and expects to exceed $210 million in revenue for 2025, with a strong finish anticipated for Q4 [26] Question: Updates on international business, particularly China - Management indicated stabilization across international markets and good progress in China, with expectations for reordering to begin in Q1 2026 [28] Question: Market dynamics compared to peers - Management expressed confidence in their growth trajectory, stating they are not experiencing the same caution seen in some peers [30] Question: Contribution of minimally invasive platforms to revenue - Management reported strong progress with PreserVe and Mia, with significant demand expected to continue into 2026 [32] Question: Visibility into Q4 performance - Management confirmed strong visibility into daily orders and metrics, indicating a positive outlook for Q4 [38]