Biofrontera (NASDAQ:BFRI) reported record revenue for both the fourth quarter and full year 2025, driven by higher Ameluz photodynamic therapy (PDT) demand and a major change to its U.S. rights and supply economics following an amended arrangement with former parent Biofrontera AG.
Record revenue and a profitable fourth quarter
CEO Hermann Luebbert said fiscal 2025 was a “transformational year,” highlighted by record annual revenue of $41.7 million, up about 12% from $37.3 million in 2024. Fourth-quarter revenue climbed to $17.1 million, the highest quarterly figure in company history, representing approximately 36% year-over-year growth.
CFO Fred Leffler said Q4 operating income was $4.6 million, improving by $6.3 million versus an operating loss of $1.7 million in the prior-year quarter. Net income for the quarter was $5.6 million compared with a net loss of $1.4 million in Q4 2024. Adjusted EBITDA improved to $4.9 million from negative $1.4 million, and Adjusted EBITDA margin rose to 29% from negative 11%.
Biofrontera AG transaction reshapes economics and U.S. control
In October 2025, Biofrontera closed an asset purchase agreement with Biofrontera AG, with financial consequences active as of June 2025, according to Luebbert. The company acquired all U.S. rights, approvals, and patents for Ameluz and RhodoLED, including the NDA and IND, manufacturing rights and contracts, and related intellectual property. In December 2025, the FDA formally transferred the NDA and IND to Biofrontera, giving the company full regulatory control in the U.S.
Management also emphasized the shift away from a transfer pricing model that previously ranged from 25% to 35% of revenue. Under the new royalty/earn-out structure, Biofrontera will pay 12% when annual U.S. Ameluz net sales are at or below $65 million and 15% in years above that threshold.
Leffler said the transition drove a sharp decline in related-party cost of goods sold. In Q4, related-party COGS decreased 45% year over year, and cost of revenues per unit declined steadily to about 15% versus the prior 25%–35% range. Q4 gross profit on sales improved from about 58% to 82%.
For the full year, related-party COGS fell $7.7 million, or 43%, to $10.1 million. Biofrontera’s gross profit on product sales improved from about 50% to 74% for 2025. Leffler said the company expects the full annualized benefit in 2026 because the 12% rate applied to about 45% of Ameluz sales volume in 2025.
On the Q&A portion of the call, management reiterated expectations that gross profit margins will range between 80% and 85% in 2026, with variability driven by the mix between Ameluz and device sales. Management said it expects to be within that range from Jan. 1 and throughout 2026.
Commercial execution: unit growth, lamp placements, and lower churn
Chief Commercial Officer George Jones attributed 2025’s growth to execution improvements, including refined customer segmentation, more data-driven targeting, and increased accountability. Jones said revenue growth included approximately $4.1 million in organic volume growth.
Jones highlighted higher unit volumes for Ameluz, with Q4 unit volumes of approximately 49,840 tubes and full-year unit volume of about 121,000 tubes, representing roughly 10% growth over 2024. He also pointed to growth in RhodoLED placements, saying the company placed about 85 BF-RhodoLED lamps in 2025, including roughly 70 of the newer RhodoLED XL model.
As of Dec. 31, 2025, Biofrontera’s installed base stood at approximately 745 lamps across about 686 dermatology offices nationwide.
Jones said Biofrontera’s 2025 churn rate—defined as lost business from accounts that purchased in the prior year—was the lowest since 2021. He added that the company opened more than 150 new accounts. Biofrontera also launched an inside sales pilot in Q4 to cover vacant territories, “white space,” and smaller accounts, and Jones said the company is planning a full rollout of inside sales in 2026.
Clinical and regulatory updates: SBCC, expanded AK, and acne
Biofrontera outlined several clinical and regulatory initiatives that management believes could expand the Ameluz PDT opportunity.
- Superficial basal cell carcinoma (SBCC): Luebbert said Biofrontera submitted a supplemental NDA to the FDA in November 2025 based on a 187-patient randomized, double-blind, placebo-controlled Phase III study. Complete histological clearance was 76% with Ameluz PDT versus 19% with placebo, and complete clinical clearance was 83% versus 21%. The FDA accepted the filing and set a PDUFA target action date of Sept. 28, 2026. Luebbert said that if approved, Ameluz would be the first PDT drug approved to treat a tumor in the U.S.
- Actinic keratosis (AK) on extremities, neck, and trunk: Management said the last patient completed treatment in Q3 2025 and the database was locked in January 2026. Luebbert said Biofrontera announced positive Phase III results in February 2026, with the study meeting its primary endpoint. Combined with a completed Phase I pharmacokinetic study, the company anticipates filing a supplemental NDA in Q3 2026 to expand Ameluz’s label to treat AK beyond the face and scalp on a treatment field of up to 240 square centimeters.
- Moderate to severe acne vulgaris: The company said treatment completed in Q3 2025 and the database was locked in January 2026. Luebbert said Biofrontera announced positive Phase II results, with a three-hour incubation protocol showing a 58% reduction in inflammatory lesions with Ameluz versus 37% with vehicle gel. Patient satisfaction was cited as high, with 86% saying they would choose PDT again. Biofrontera plans to discuss the design of a future Phase III program with the FDA in Q3 2026.
Luebbert also noted planned studies in squamous cell carcinoma in situ and reduced pain PDT.
Patent updates, financing, and liquidity
Management said Biofrontera strengthened its patent portfolio in 2025, including approval for a new Ameluz formulation that removes propylene glycol and extends patent protection through December 2043. Luebbert also said the U.S. Patent Trial and Appeal Board issued a final written decision finding all claims of a Sun Pharma patent challenged by Biofrontera unpatentable, while cautioning Sun Pharma may seek further review.
To support the Biofrontera AG transaction and continued growth, Luebbert said the company raised $11 million through a private placement of Series C preferred stock led by Rosalind Advisors and AIGH Capital Management. Biofrontera also sold its Xepi antibiotic cream license to Pelthos Therapeutics for $3 million in initial proceeds, with the potential for up to $7 million in milestone payments.
Leffler said cash and cash equivalents totaled $6.4 million as of Dec. 31, 2025, compared with $5.9 million a year earlier. Cash used in operating activities was $13.4 million for the year. With the strategic transaction completed, Leffler said Biofrontera now has greater supply-chain control, shorter lead times, and improved inventory management, which management expects to help reduce cash consumption as the company works toward cash flow breakeven.
About Biofrontera (NASDAQ:BFRI)
Biofrontera AG is a specialty biopharmaceutical company focused on the research, development and commercialization of products for dermatological applications. The company’s core expertise lies in photodynamic therapy (PDT), a treatment modality that uses a photosensitizing agent activated by a specific light source to target diseased skin cells while sparing surrounding healthy tissue.
The flagship product in Biofrontera’s portfolio is Ameluz (aminolevulinic acid hydrochloride 10 % gel), which has received marketing approval in the European Union for treatment of actinic keratosis and basal cell carcinoma, and in the United States for actinic keratosis.
