Establishment Labs(ESTA)2025-05-09 20:01Revenue and Financial Performance - Revenue for Q1 2025 was $41.4 million, an increase of 11.3% from $37.2 million in Q1 2024[217] - Revenue increased by $4.2 million, or 11.3%, to $41.4 million for the three months ended March 31, 2025, compared to $37.2 million for the same period in 2024[249] - Gross profit rose to $27.8 million with a gross margin of 67.2%, up from 65.6% in the prior year, attributed to improved manufacturing efficiencies[251] - Net losses for Q1 2025 were $20.7 million, compared to $16.2 million in Q1 2024, with an accumulated deficit of $465.4 million as of March 31, 2025[217] - Net loss for the three months ended March 31, 2025, was $20.7 million, compared to a net loss of $16.2 million for the same period in 2024[249] - Interest expense rose to $5.9 million, an increase of $1.5 million due to higher debt principal[256] - Other income increased by $5.8 million to a gain of $2.8 million, primarily due to foreign currency fluctuations[258] - Cash used in operating activities was $20.7 million for the three months ended March 31, 2025, compared to $11.2 million in the same period in 2024[266][267] - Cash of $69.2 million was reported as of March 31, 2025, down from $90.3 million at the end of 2024[259] Operational Developments - Motiva Implants accounted for over 95% of total revenues in Q1 2025, with $6.2 million generated from U.S. sales[229][244] - The company launched Preservé, a new breast tissue-preserving technology, in Brazil in February 2025, with plans for further international launches[219] - The FDA approved Motiva Implants for U.S. sales in September 2024, and the company began selling them in October 2024[216][222] - A new manufacturing facility in Costa Rica was completed in June 2024, increasing capacity by approximately 730,000 units per year[223] Expenses and Future Outlook - Operating expenses increased by $11.5 million, or 34.6%, to $44.8 million, driven primarily by a $10.8 million increase in sales, general and administrative expenses[252][253] - The company expects overall operating expenses to increase in 2025 due to heightened commercial and operational activities following FDA approval[245] - The company may need to raise additional capital to execute its business plan, with a shelf registration statement filed in April 2023 allowing for future offerings[264] - Future capital requirements will depend on market adoption of products, regulatory activities, and commercialization costs[263] Debt and Financial Obligations - As of March 31, 2025, $221.4 million was outstanding under the Credit Agreement, including $150 million for Tranche A, $25 million for Tranche B, $25 million for Tranche C, and $21.4 million of accrued interest[274] - The interest rates for the Term Loans are 9% per annum for Tranche A and B, 10% for Tranche C and D, and can be reduced to 8.25% upon meeting a gross sale threshold of $225 million[274] Accounting and Risk Management - The financial statements are prepared in accordance with GAAP, requiring estimates and judgments that affect reported amounts of assets, liabilities, revenue, and expenses[276] - No material changes have been made to critical accounting policies as disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[277] - Market risk exposure has not materially changed from the previous disclosures in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[279]