Short answer
AVITA Medical, Inc. (RCEL) filed its fiscal 2025 10-K annual report with the SEC on Feb 12, 2026. It reported revenue of $72M (+11.5% year over year) and net income of −$49M.
- Top risk flagged: Regulatory risk: dependency on FDA PMA for RECELL, risk of modification/suspension/revocation impacting U.S. operations
FY2025 key financial metrics · XBRL
- Revenue
- $72M
- +11.5% YoY
- Net income
- −$49M
- +21.4% YoY
- Operating margin
- -59.4%
- +28.7 pp YoY
- Gross margin
- 82.1%
- −3.7 pp YoY
- EPS (diluted)
- −$1.74
- +27.2% YoY
- ROE
- 291.8%
- +1666.5 pp YoY
- Operating cash flow
- −$31M
- +36.3% YoY
Source: XBRL data from the AVITA Medical, Inc. (RCEL) FY2025 10-K on SEC EDGAR. USD.
AVITA Medical, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: Multi-product acute wound care platform focused on autologous cell harvesting technology RECELL plus complementary wound matrices
- New products: Commercial launch of Cohealyx collagen dermal matrix (Apr 2025) and FDA approval/commercial rollout of RECELL GO mini for smaller wounds (Dec 2024)
- Strategic shift: Expansion from burn centers into trauma and surgical wound markets with broadened RECELL indications for full-thickness skin defects
- Quantitative metric: Employee count approx. 226 as of Dec 31, 2025; multiple multi-year distribution and manufacturing agreements for PermeaDerm and Cohealyx
- Noteworthy fact: CMS New Technology Add-On Payment (NTAP) approval effective Oct 1, 2025 for RECELL in inpatient non-thermal full-thickness skin defects
Management Discussion & Analysis
- Revenue $71.6M in 2025, up 11% YoY from $64.3M in 2024, driven by deeper penetration and new accounts
- Gross margin 82.1% in 2025 vs 85.8% in 2024; decrease due to product mix and higher inventory reserve
- Best segment: RECELL products gross margin 84.3%; Cohealyx and PermeaDerm at 50% and 60% ASP respectively reducing overall margin
- Operating expenses $101.4M in 2025, down 9% YoY from $111.8M; sales & marketing down 9% to $53.1M, G&A down 18% to $27.3M; R&D up 2% to $20.8M
- Net loss $48.6M in 2025, improved 21% vs $61.8M loss in 2024
- Cash and equivalents $10.2M, marketable securities $7.9M at end 2025; new $60M credit facility closed Jan 2026 with $50M funded, refinancing prior debt
- Key risk: ongoing debt covenants require TTM revenue minimums ($68.5M Q1 2026, $73M full year), substantial doubt about going concern due to recurring losses and debt obligations
- Positive outlook supported by FDA NTAP reimbursement for RECELL (effective Oct 2025-Sept 2026) and CE Mark for RECELL GO in EU
Risk Factors
- Regulatory risk: dependency on FDA PMA for RECELL, risk of modification/suspension/revocation impacting U.S. operations
- Macroeconomic risk: $60M five-year senior secured credit facility with Perceptive, subject to net revenue covenants and rising interest rate exposure
- Supply chain risk: single-sourcing some critical material components since 2023, risking production delays and cost increases
- Competitive risk: rivals with greater financial resources could develop products rendering RECELL obsolete
- Financial risk: cumulative deficit $408.4M, net loss $48.6M in 2025, with continuing operating losses and cash flow insufficiency to service debt
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