0001104659-26-027664
SEC filingElutia Inc. reported a net income of $53.4 million for FY 2025, a significant improvement from a net loss of $53.9 million in FY 2024. This result was driven by a $69.3 million gain from discontinued operations, primarily the sale of the CIED Business. However, the company's continuing operations generated a net loss of $15.9 million, an improvement from a $45.3 million loss in the prior year. Net sales from continuing operations decreased 15.0% to $12.3 million, with Women's Health sales declining 20.9% to $9.1 million and Cardiovascular sales increasing 8.3% to $3.2 million. The company ended the year with $36.4 million in cash and cash equivalents, following the sale of its CIED Business for $80.4 million in proceeds and the full repayment of its $26.9 million SWK Loan Facility. The company's future strategy focuses on advancing its NXT-41 and NXT-41x drug-eluting biomatrix platform for reconstructive surgery.
Elutia Inc. reported a net income of $53.4 million for the fiscal year ended December 31, 2025, a significant reversal from a net loss of $53.9 million in the prior year. This result was primarily driven by a $69.3 million gain from discontinued operations related to the sale of the Cardiac Implantable Electronic Device (CIED) Business to Boston Scientific Corporation and Cardiac Pacemakers Inc. in October 2025. The company's continuing operations, however, reported a net loss of $15.9 million, an improvement from a $45.3 million loss in FY 2024. Net sales from continuing operations decreased by 15.0% to $12.3 million. The company's cash position strengthened to $36.4 million at year-end, following the $80.4 million in proceeds from the CIED Business sale and the full repayment of its $26.9 million SWK Loan Facility.
Total net sales for FY 2025 were $12.3 million, a decrease of $2.2 million (15.0%) from $14.5 million in FY 2024. This decline was concentrated in the Women's Health segment, where sales fell 20.9% to $9.1 million. The decrease was attributed to various physician users of SimpliDerm transferring to hospitals where the product is not yet available, and lower sales through the distributor Tiger Aesthetics Medical, which totaled $2.2 million in 2025 before the agreement was terminated in October 2025. Conversely, Cardiovascular segment sales increased 8.3% to $3.2 million, benefiting from the resumption of direct sales through independent sales agents in the second quarter of 2025 following the termination of the exclusive distribution agreement with LeMaitre Vascular in April 2025.
Gross profit was $6.6 million in FY 2025, a slight decrease of $0.1 million (1.8%) from $6.7 million in the prior year. Gross margin improved to 53.7% from 46.4%, driven by a higher proportion of direct sales in the Cardiovascular segment which yield better margins compared to distributor sales. Excluding intangible asset amortization expense of $1.1 million, gross margin was 62.4% compared to 53.9% in FY 2024. Total operating expenses decreased by $3.9 million (10.5%) to $33.5 million, primarily due to a $2.9 million reduction in litigation costs and a $3.0 million decrease in general and administrative expenses, partly offset by increased sales and marketing and research and development spending.
Net cash used in operating activities was $44.8 million in FY 2025, compared to $22.7 million used in the prior year, driven by higher FiberCel settlement payments and reductions in trade obligations. Net cash provided by investing activities was $78.6 million, primarily from the $80.4 million in proceeds from the sale of the CIED Business. Net cash used in financing activities was $10.6 million, reflecting the $23.1 million repayment of long-term debt, partially offset by $13.8 million in net proceeds from a February 2025 registered direct offering. The balance sheet shows total assets of $62.4 million, including $36.4 million in cash and cash equivalents and an $8.0 million divestiture proceeds receivable. Total liabilities were $34.7 million, including a $11.2 million contingent liability for legal proceedings related to the FiberCel and VBM recalls.
Following the divestiture of the CIED Business, Elutia's strategy is focused on advancing its drug-eluting biomatrix (DEB) platform, specifically the NXT-41 and NXT-41x development programs for reconstructive surgery applications. The company expects FDA clearance for NXT-41 in the second half of 2026 and for NXT-41x by mid-2027. Key risks include the company's ability to successfully develop and commercialize NXT-41x, achieve profitability from its remaining Women's Health and Cardiovascular businesses, and manage ongoing litigation related to the FiberCel and VBM recalls, for which insurance coverage is exhausted for FiberCel claims. The company may need to raise additional capital to fund its development and commercialization efforts.