Financial Position - Total current assets increased to $37,318,000 as of September 30, 2024, compared to $31,253,000 as of December 31, 2023, representing a growth of 19.7%[18] - Cash and cash equivalents rose to $25,741,000 from $19,276,000, marking an increase of 33.6%[18] - Total liabilities increased to $88,645,000 as of September 30, 2024, up from $82,028,000, reflecting a rise of 8.0%[18] - The accumulated deficit grew to $220,532,000 from $175,644,000, indicating an increase of 25.5%[18] - Total stockholders' deficit reached $40,238,000 as of September 30, 2024, compared to $38,600,000, an increase of 4.2%[18] - The accumulated deficit as of September 30, 2024, was $(220,532,000), an increase from $(166,330,000) as of September 30, 2023[22] - The total stockholders' equity (deficit) as of September 30, 2024, was $(40,238,000), compared to $(29,473,000) as of September 30, 2023[22] - As of September 30, 2024, Elutia had an accumulated deficit of $220.5 million, raising concerns about its ability to continue as a going concern[32] Revenue and Sales Performance - Net sales for the three months ended September 30, 2024, were $5,922,000, a decrease of 3.4% compared to $6,127,000 for the same period in 2023[21] - Total net sales for the three months ended September 30, 2024, were $5.922 million, a decrease of 3.4% compared to $6.127 million for the same period in 2023[137] - Device Protection segment generated $2.260 million in sales for the three months ended September 30, 2024, down from $2.575 million in the same period last year, while Women's Health sales increased to $3.100 million from $2.614 million[137] - The company generated $7.3 million in revenue from Device Protection and Cardiovascular products in the nine months ended September 30, 2024[147] - SimpliDerm, a product in Women's Health, generated $9.2 million in revenue during the nine months ended September 30, 2024[151] - Total net sales for the nine months ended September 30, 2024, were $18.9 million, a slight increase of 0.2% compared to $18.87 million in the same period of 2023[180] Expenses and Losses - Gross profit for the nine months ended September 30, 2024, was $8,383,000, down from $8,927,000 in the prior year, reflecting a decrease of 6.1%[21] - Total operating expenses increased to $12,971,000 for the three months ended September 30, 2024, compared to $10,212,000 in the same period last year, representing a rise of 27.2%[21] - The net loss attributable to common stockholders for the three months ended September 30, 2024, was $1,067,000, compared to a net loss of $9,747,000 for the same period in 2023[21] - For the nine months ended September 30, 2024, Elutia Inc. reported a net loss of $44.9 million, compared to a net loss of $28.3 million for the same period in 2023[25] - The net loss from continuing operations was $45.07 million for the nine months ended September 30, 2024, compared to a net loss of $26.03 million in 2023, reflecting a 73.2% increase in losses[178] Cash Flow and Financing Activities - The company used $10.4 million in cash for operating activities during the nine months ended September 30, 2024, an improvement from $12.7 million used in the same period in 2023[25] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $17.2 million, compared to $10.5 million for the same period in 2023, primarily due to warrant exercises yielding proceeds of $15.7 million[206] - The company expects to continue incurring cash outflows during the remainder of 2024, indicating ongoing liquidity challenges[33] - The company may seek to raise capital through the issuance of common stock or pursue asset sales to mitigate liquidity issues[33] Litigation and Legal Matters - The company has settled liabilities in 31 cases of the FiberCel Litigation for a total cash outlay of $9.6 million, with an estimated probable loss of $20.4 million for the remaining 79 cases as of September 30, 2024[122] - In the VBM Litigation, Elutia has settled nine cases for approximately $1.0 million, with an estimated probable loss of $3.9 million for the remaining 26 cases as of September 30, 2024[124] - The company incurred litigation costs of $4,683,000 for the three months ended September 30, 2024, compared to $4,096,000 in the same period last year[21] - Litigation costs increased to $8.8 million for the nine months ended September 30, 2024, compared to $7.3 million in the same period of 2023[188] Stock and Equity - The company reported a total of 30,248,692 shares issued and outstanding as of September 30, 2024, compared to 18,884,196 shares as of December 31, 2023, reflecting a growth of 60.0%[18] - The company granted 2,327,500 restricted stock units (RSUs) during the nine months ended September 30, 2024, with a total fair value of $8.3 million[86] - The company had 3,230,454 stock options outstanding as of September 30, 2024, with a weighted average exercise price of $5.23[80] - The company issued a Class A Warrant to purchase up to 187,969 shares at an exercise price of $6.65 per share, valued at approximately $0.6 million[94] Product Development and Innovation - EluPro, a new product in Device Protection, was cleared for marketing by the FDA in June 2024 and is expected to launch commercially in Q1 2025[146] - The company is focusing on expanding the EluPro offering and developing new products within the DEB product portfolio following FDA approval[164] - Research and development expenses for the nine months ended September 30, 2024, were $2,951,000, slightly down from $3,016,000 in the previous year[21] - Research and development expenses remained stable at $3.0 million for both the nine months ended September 30, 2024, and 2023[185] Market and Operational Insights - The company experienced seasonality in sales, with historically lower sales in the first and second quarters and higher sales in the fourth quarter due to hospital purchasing cycles[195] - The company evaluates the collectability of accounts receivable based on various factors, including historical experience and current business environment[45]
Elutia(ELUT) - 2024 Q3 - Quarterly Report