Establishment Labs(US:ESTA)2025-11-07 21:10Financial Performance - Revenue for the nine months ended September 30, 2025, was $146.5 million, an increase of $25.0 million or 20.6% compared to $121.5 million in the same period of 2024[226]. - Net losses for the nine months ended September 30, 2025, were $48.4 million, a slight improvement from $50.1 million in the prior year[226]. - Revenue for the three months ended September 30, 2025, increased by $13.6 million, or 33.8%, to $53.8 million compared to $40.2 million for the same period in 2024[262]. - Net loss for the three months ended September 30, 2025, was $11.1 million, compared to a net loss of $16.7 million for the same period in 2024[260]. - Gross profit for the three months ended September 30, 2025, was $37.7 million, with a gross margin of 70.1%, up from 63.9% in the same period in 2024[261][264]. - Gross margin for the nine months ended September 30, 2025, improved to 68.8% from 65.0% in the same period in 2024[275]. - SG&A expenses for the nine months ended September 30, 2025, rose by $25.2 million, or 26.3%, to $121.0 million compared to $95.8 million in 2024[277]. - Interest expense for the nine months ended September 30, 2025, was $18.0 million, an increase from $14.9 million in the same period in 2024[280]. Cash and Liquidity - As of September 30, 2025, the company had an accumulated deficit of $493.1 million and a cash balance of $70.6 million[226]. - As of September 30, 2025, the company had cash of $70.6 million, down from $90.3 million as of December 31, 2024[283]. - The company expects available cash and cash from operations to meet liquidity requirements for at least the next 12 months, covering operating expenses and interest payments[286]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $50.7 million, primarily due to a net loss of $48.4 million[290]. - The company reported a net cash increase of $(19.7) million for the nine months ended September 30, 2025, compared to $(0.3) million for the same period in 2024[289]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $37.8 million, with a net loss of $50.1 million[291]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $34.4 million, mainly from $24.5 million in borrowings under the Tranche D Term Loan[295]. - As of September 30, 2025, $246.4 million was outstanding under the Credit Agreement, with interest rates ranging from 9% to 10% per annum[299]. Product Development and Launches - The company received FDA approval for Motiva Implants in the United States in September 2024 and began sales in October 2024[225][232]. - A clinical study of Mia Femtech showed a 1% reoperation rate at 3 years, with 87% of patients reporting increased breast satisfaction[227]. - The company launched Preservé, a minimally invasive breast tissue-preserving technology, in Brazil in February 2025, with plans for further international launches[228]. - The company anticipates future capital requirements will depend on market adoption rates of its products, particularly the Motiva Implants[287]. - The company expects R&D expenses to remain elevated as it advances products under development and prepares for additional clinical studies[250]. Operational Developments - The new manufacturing facility in Costa Rica, completed in June 2024, is expected to increase production capacity by approximately 730,000 units per year[233]. - The company incurred approximately $56.0 million in costs for the construction of the new facility[233]. - The company incurred $4.2 million in property and equipment purchases as part of its investing activities for the nine months ended September 30, 2025[292]. - The company expects overall operating expenses to increase compared to 2024, while focusing on managing these expenses[258].