Biofrontera Inc. (NASDAQ: BFRI) reported financial results for the three and nine months ended September 30, 2026, highlighting a 30% increase in revenue driven by the commercialization of its Ameluz product. The company filed a Current Report on Form 8-K on November 13, 2026, to disclose these results.
For the third quarter of 2026, Biofrontera recorded net product revenue of $9.1 million, representing a 29.8% increase compared to $7.0 million in the prior-year period. The growth was attributed to a 23.3% increase in Ameluz unit volume and higher device sales. The company noted that accelerated ordering by certain customers in July 2026, in anticipation of supply restrictions related to an International Trade Commission (ITC) order, also impacted the timing of revenue recognition.
Gross margin for the quarter improved to 74.4% from 70.7% in the prior year. The company cited the transition to a new cost structure following a strategic transaction with Biofrontera AG in October 2025 as a primary driver of this improvement, though this was partially offset by inventory write-downs and higher costs related to the ITC Matter.
On September 9, 2026, the FDA approved Ameluz for the treatment of superficial basal cell carcinoma (sBCC), marking the first photodynamic therapy (PDT) approved in the United States for a cancerous skin tumor. Five days later, U.S. Customs and Border Protection ruled that the redesigned RhodoLED XL-C lamp did not violate the ITC order, allowing the company to resume importing and selling the device.
For the nine months ended September 30, 2026, net product revenue totaled $31.2 million, a 26.6% increase from $24.6 million in the same period in 2025. The company reported a net loss of $11.8 million, or $(0.89) per share, for the nine-month period, compared to a net loss of $16.2 million, or $(1.67) per share, in the prior year.
As of September 30, 2026, Biofrontera held $3.2 million in cash and cash equivalents. The company has outstanding indebtedness of $4.7 million in convertible notes, maturing in November 2027, and no bank or other term debt. Biofrontera stated it is preparing to begin commercializing Ameluz for sBCC later in the fourth quarter of 2026 and into the first quarter of 2027.
