Record Revenue Performance
Record full-year revenues of $41.7M, up ~12% YoY, and record Q4 revenue of $17.1M, up ~36% YoY — the highest quarterly revenue in company history.
Quarterly Profitability and Margin Expansion
Q4 2025 adjusted EBITDA of $4.9M and net income of $5.6M (vs. net loss in Q4 2024), with adjusted EBITDA margin improving to +29% from -11% year-over-year.
Substantial Gross Profit Improvement from Strategic Transaction
Related-party COGS declined materially (COGS down ~45% YoY in Q4; full-year related-party COGS down $7.7M or ~43%), driving gross profit on product sales from ~50% to 74% for full-year 2025 and Q4 gross margin improvement to ~82%.
Acquisition of U.S. Commercial and Regulatory Assets
Closed asset purchase from former parent Biofrontera AG acquiring U.S. rights, NDA/IND, manufacturing and patents; new earn-out structure of 12% (≤$65M) / 15% (>$65M) replaces prior 25–35% transfer pricing — materially improving unit economics and gross margins.
Commercial Execution and Volume Growth
Full-year Ameluz unit volume ~121,000 tubes (≈10% volume growth YoY) and Q4 unit volume ~49,840 tubes; installed RhodoLED base ~745 lamps across ~686 dermatology offices with ~85 lamp placements in 2025 (including ~70 XL models).
Clinical and Regulatory Milestones
sBCC Phase III: 76% complete histological clearance vs 19% placebo and 83% clinical clearance vs 21% placebo; FDA accepted supplemental NDA with PDUFA date 09/28/2026. AK extremities Phase III met primary endpoint and sNDA filing planned in 2026. Acne Phase II positive: 58% reduction in inflammatory lesions vs 37% with vehicle; 86% patient satisfaction.
Strengthened IP and Legal Outcomes
Approval for improved Ameluz formulation (propylene glycol removed) extends patent protection through December 2043; PTAB final written decision found challenged Sun Pharma patent claims unpatentable (Sun Pharma may seek review).
Liquidity and Financing Activity
Secured $11M gross proceeds from Series C preferred private placement and $3M initial proceeds from sale of Xepi license (up to $7M additional milestones), contributing to cash and strategic flexibility; cash and cash equivalents of $6.4M as of 12/31/2025.