Biofrontera books $9.1m quarterly sales as new skin-cancer label and lamp clearance reshape Ameluz outlook

Biofrontera Inc. reported net product revenue of $9.1m for the three months to 30 September, a gross margin of 74.4% and a net loss of $6.4m. The company describes the revenue figure as growth of 30%, though the material available does not specify the comparison period or give a full-year outlook.

The commercial story for coming quarters rests on a regulatory decision taken within the period. On 9 September the US Food and Drug Administration approved Ameluz, used with photodynamic therapy, for superficial basal cell carcinoma, a form of skin cancer. Biofrontera plans to bring the indication to market from late in the fourth quarter of 2026 into the first quarter of 2027. No sales targets or pricing for the new use were provided.

Five days later, US Customs and Border Protection determined that the redesigned RhodoLED XL-C lamp falls outside the exclusion order issued by the US International Trade Commission. The company's summary offers no detail on what changed in the device or how the ruling affects import volumes or timing.

In October, the company also filed a supplemental new drug application asking the FDA to extend Ameluz's actinic keratosis labelling to the extremities, neck and trunk. Such filings are how a sponsor seeks approval for a new use or treatment area on an already-authorised product. The material gives no review timetable, so the outcome and timing remain open.