Establishment Labs(US:ESTA)2024-11-12 21:33Financial Performance - Revenue for the nine months ended September 30, 2024, was $121.5 million, a decrease of $12.1 million or 9.1% compared to $133.6 million in the same period of 2023[120] - Net losses for the nine months ended September 30, 2024, were $50.1 million, compared to $58.0 million for the same period in 2023[120] - Revenue increased by $1.7 million, or 4.4%, to $40.2 million for the three months ended September 30, 2024, compared to $38.5 million for the same period in 2023[137] - Net loss for the three months ended September 30, 2024, was $16.7 million, compared to a net loss of $29.3 million for the same period in 2023[136] - Revenue decreased by $12.1 million, or 9.1%, to $121.5 million for the nine months ended September 30, 2024, compared to $133.6 million for the same period in 2023[148] - The net loss for the nine months ended September 30, 2024, was $50.1 million, influenced by changes in operating assets and liabilities[159] Cash and Liquidity - As of September 30, 2024, the accumulated deficit was $410.2 million, with a cash balance of $39.7 million[120] - The company had cash of $39.7 million as of September 30, 2024, compared to $40.0 million as of December 31, 2023[155] - The company reported a net cash used in operating activities of $37.8 million for the nine months ended September 30, 2024, compared to $80.4 million for the same period in 2023[159] - The company generated $51.4 million in net cash from financing activities for the nine months ended September 30, 2024, mainly from the issuance of common shares and pre-funded warrants[162] - The company anticipates that available cash and cash from operations will be sufficient to meet liquidity requirements for at least the next 12 months[157] - As of September 30, 2024, the company had $196.4 million in outstanding principal under its term loan[130] - As of September 30, 2024, the outstanding amount under the Credit Agreement was $196.4 million, including $21.4 million of accrued interest[164] Expenses and Cost Management - SG&A expenses decreased by $5.9 million, or 14.8%, to $34.1 million for the three months ended September 30, 2024, compared to $40.0 million for the same period in 2023[140] - R&D expenses decreased by $2.3 million, or 32.4%, to $4.8 million for the three months ended September 30, 2024, compared to $7.1 million for the same period in 2023[142] - SG&A expenses decreased by $12.9 million, or 11.9%, to $95.8 million for the nine months ended September 30, 2024, compared to $108.7 million for the same period in 2023[150] - Interest expense increased to $14.9 million for the nine months ended September 30, 2024, compared to $11.1 million for the same period in 2023[152] Product Development and Regulatory Approvals - The company received FDA approval for Motiva Implants in the United States in September 2024, and began sales in October 2024[121] - The company completed a clinical study for Mia Femtech, showing the ability to increase breast shape by 1 to 2 cups in a 15-minute procedure[121] - The construction of a new manufacturing facility in Costa Rica was completed in June 2024, increasing manufacturing capacity by approximately 730,000 units per year[121] - The company incurred approximately $56.0 million in costs for the construction of the new facility in Costa Rica[121] - The company incurred $5.9 million in costs for developing an enterprise resource planning system for the anticipated U.S. launch of Motiva Implants[161] Future Outlook - The company expects higher selling prices in the U.S. and the introduction of new products to positively impact gross margins in 2025[132] - The company expects to continue generating losses in the near term, with an accumulated deficit of $410.2 million as of September 30, 2024[155] - Future capital requirements will depend on market adoption of products, regulatory activities, and competition[157] - The company filed a Shelf Registration Statement with the SEC in April 2023, allowing for the potential raising of additional capital until April 2026[157] - The company may need to raise additional capital to execute its business plan, which could adversely affect its operations if not achieved[157]