On March 19, 2026 Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported financial results for the three and twelve months ended December 31, 2025 and provided a business update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Fourth Quarter Financial Highlights
Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024.
Gross margins were 82.4%, a roughly 2,400 basis point year over year increase compared to 58.0% in 4Q24, reflecting the transition away from the transfer pricing model under the prior license and supply agreement.
Operating income was $4.6 million in 4Q25 compared to a loss of $1.7 million in 4Q24.
Cash balance was $6.4 million as of December 31, 2025.
Recent Operational Highlights
Announced positive results of its Phase 2b clinical trial evaluating Ameluz topical gel, 10% used in combination with the RhodoLED red-light lamp series for the treatment of moderate to severe acne vulgaris (AV).
Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).
Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk of up to 240 cm2.
Closed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG. New earnout structure reduces payment rate from 25%–35% to 12%–15% of U.S. net sales.
Received the final $2.5 million of $11 million financing led by existing investors in October.
In November, announced the divestiture of its Xepi antibiotic cream to Pelthos Pharmaceuticals for $3 million at closing, $1 million upon commercial availability, and up to $6 million in milestone payments tied to revenue thresholds of $10 million and $15 million.
(Press release, Biofrontera, MAR 19, 2026, View Source [SID1234669305])