Elutia (ELUT) Q4 2025 earnings summary

Executive summary

• Q4 2025 revenue rose 16% year-over-year to $3.3 million, driven by cardiovascular segment performance and a return to direct distribution for key product lines.

• Completed $88 million sale of BioEnvelope business, enabling full debt repayment and strengthening the balance sheet.

• Focused on advancing NXT-41 and NXT-41x, targeting the $1.5 billion breast reconstruction market, with FDA submission and anticipated clearances in 2H26 (NXT-41) and 1H27 (NXT-41x).

• Strengthened leadership team and initiated strategic review of SimpliDerm product line.

• Achieved compliance with all Nasdaq continued listing requirements and certified as a Great Place to Work.

Financial highlights

• Q4 2025 net sales from continuing operations were $3.3M, up from $2.8M in Q4 2024; full year net sales were $12.3M.

• Q4 gross margin was 58.5% (GAAP) and 66.8% (adjusted), up from 46.9% and 56.5% respectively; full year gross margin was 53.7% (GAAP) and 62.4% (adjusted).

• Q4 net loss from continuing operations was $6.5M, improved from $7.2M; Q4 net income was $70.8M including $77.3M gain from discontinued operations.

• Adjusted EBITDA loss was $4.2M in Q4 and $12.8M for the year.

• Cash and escrowed proceeds at year-end totaled $44.4M.

Outlook and guidance

• Anticipates FDA clearance for NXT-41 in 2H26 and for NXT-41x in 1H27, with launch in 2H27.

• Strategic focus on NXT-41x as a transformational solution for breast reconstruction infection.

• SimpliDerm strategic options being explored to concentrate resources on NXT-41x.

• Company is fully resourced to fund operations through product approval and commercialization of NXT-41x.