Financial Performance - Net sales for the three months ended September 30, 2025, were $3,323,000, a decrease of 9.2% compared to $3,662,000 for the same period in 2024[29]. - Gross profit for the nine months ended September 30, 2025, was $4,682,000, down 13.2% from $5,393,000 in the same period of 2024[29]. - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $3,868,000, compared to a net income of $1,286,000 in the same period of 2024[29]. - For the nine months ended September 30, 2025, the net loss was $17.411 million, compared to a net loss of $44.888 million for the same period in 2024, indicating a significant improvement[34]. - The company reported a net loss of $17.4 million for the nine months ended September 30, 2025, a decrease of $27.5 million or 61.2% compared to the prior year[208]. Assets and Liabilities - Total current assets decreased from $26,172,000 as of December 31, 2024, to $18,378,000 as of September 30, 2025, representing a decline of approximately 29.7%[27]. - Cash and cash equivalents decreased significantly from $13,239,000 as of December 31, 2024, to $4,721,000 as of September 30, 2025, a decline of approximately 64.3%[27]. - The total liabilities decreased from $82,387,000 as of December 31, 2024, to $73,325,000 as of September 30, 2025, a reduction of approximately 11%[27]. - The accumulated deficit increased from $(229,593,000) as of December 31, 2024, to $(247,004,000) as of September 30, 2025, reflecting a worsening of approximately 7.5%[27]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $7,061,000, a decrease of 35.5% compared to $10,966,000 in the prior year[29]. - Research and development expenses increased to $1,088,000 for the three months ended September 30, 2025, up 55% from $702,000 in the same period of 2024[29]. - General and administrative expenses decreased by $3.0 million, or 22.0%, to $10.8 million for the nine months ended September 30, 2025, primarily due to lower non-cash equity compensation[214]. - Sales and marketing expenses increased by 29.0% to $1.6 million in Q3 2025, representing 48.2% of net sales[201]. Cash Flow and Financing - The company experienced a net cash used in operating activities of $19.996 million for the nine months ended September 30, 2025, compared to $10.400 million for the same period in 2024[34]. - The company believes its existing cash and cash equivalents, along with proceeds from the sale of its CIED Business, will be sufficient to fund operations for at least one year after the issuance of the financial statements[51]. - The company may seek to raise additional capital through equity issuance or asset sales, but such transactions may not be successful[49]. - The company raised approximately $15.0 million from the 2025 Registered Offering by selling 5,520,000 shares of Class A common stock at $2.50 per share[124]. Discontinued Operations - The company sold its cardiac implantable electronic device (CIED) business to Boston Scientific Corporation and Cardiac Pacemakers Inc. for up to $88 million in cash on October 1, 2025[167]. - The sale of the CIED Business is classified as Discontinued Operations, impacting the financial statements for the periods presented[182]. - The company completed the sale of its Orthobiologics segment for approximately $14.6 million, with potential earn-out payments of up to $20 million based on future revenues from specified products[46]. Litigation and Legal Matters - As of September 30, 2025, the Company recorded a liability of $12.7 million related to the FiberCel Litigation, which includes $12.0 million for settled cases not yet paid and $0.7 million for unsettled cases[145][146]. - The Company has settled 64 cases in the FiberCel Litigation for a total cash outlay of $22.5 million, with $9.6 million covered by insurance proceeds[144]. - The company is involved in ongoing litigation with Medtronic regarding breach of the Tissue Product Supply Agreement, with discovery still ongoing[141]. Product Development and Market Position - The company continues to market its biologic products, including SimpliDerm, which is a key component of the Women's Health segment[168]. - The company is advancing its proprietary drug-eluting biomatrix (DEB) platform, with the first commercial product, EluPro, aimed at reducing device-related complications[169]. - Research and development efforts are focusing on lead development programs NXT-41 and NXT-41x, following the FDA clearance of EluPro in June 2024[194]. Stock and Equity - The total number of shares outstanding as of September 30, 2025, was 40,198,920 for Class A and 2,351,246 for Class B[31]. - The Company has a compliance period until May 6, 2026, to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share[39]. - The Employee Stock Purchase Plan (ESPP) had 763,965 shares remaining available for future issuance as of September 30, 2025[105].
Elutia(ELUT) - 2025 Q3 - Quarterly Report