Biofrontera Raises Revenue 29.8% to $9.1 Million in Third Quarter
Key Facts
Biofrontera said on November 13 that net product revenue reached $9.1 million in the third quarter of 2026, up 29.8% from $7.0 million in the same period of 2025. The company said the increase came mainly from sales of Ameluz, a photodynamic therapy used in dermatology. Ameluz unit volume sold rose 23.3%, adding $1.6 million to revenue. Price and sales mix contributed $0.3 million, while the rest of the increase reflected higher device sales. Gross profit was $6.7 million, compared with $4.9 million a year earlier, and gross margin rose to 74.4% from 70.7%.
Biofrontera said some customers moved the timing of their orders forward to early July in anticipation of potential supply restrictions. The company linked this to the limited exclusion order and cease-and-desist order issued by the U.S. International Trade Commission concerning the RhodoLED XL lamp, which took effect on July 6, 2026. It added that, in its view, this shift changed order timing but not total demand. These factors came alongside higher Ameluz unit sales, which the company described as the primary driver of revenue growth. It also reported that U.S. Customs and Border Protection concluded on September 14 that the redesigned RhodoLED XL-C was not subject to the exclusion order. The decision allowed the lamps to be imported into the U.S. market, and the company began placing them during the third quarter.
Compared with earlier periods of the year, product revenue growth slowed from the second quarter, when the company reported $12.0 million, up 32.9% year over year from $9.0 million. In the first half of 2026, revenue was $22.1 million, up 25.4% from $17.6 million in the same period. Gross margin in the second quarter was 80%, compared with 71% a year earlier, while it was 80% for the first half, compared with 67%. In the third quarter, the year-over-year margin rose to 74.4% from 70.7%, with gross profit of $6.7 million versus $4.9 million. These comparisons put third-quarter growth above the first-half rate and below the second-quarter rate. They also show that third-quarter margin remained below levels recorded in the first half and second quarter of 2026.
In a separate regulatory development, the company said the U.S. Food and Drug Administration approved Ameluz with red-light therapy on September 9 for the treatment of superficial basal cell carcinoma. Biofrontera said this makes it the first photodynamic therapy approved in the U.S. for a cancerous skin tumor. The company is preparing to begin marketing Ameluz for this use in late fourth-quarter 2026, with the launch extending into the first quarter of 2027. In October, it submitted a supplemental drug application to expand the treatment label to include the extremities, neck and trunk. The regulatory approval provides a basis for expanding the therapy's use, while the company placed the start of commercial marketing between late 2026 and early 2027. It said it is preparing for this step over the next two quarters.
Biofrontera shares, listed under the ticker BFRI, closed at $0.9259 on November 12, 2026, according to EL7 data. In the company's disclosure, third-quarter revenue growth was accompanied by higher gross profit and margin compared with the same period a year earlier. This follows revenue growth in the second quarter and first half, according to figures reported for earlier periods. At the same time, the company attributed part of the change in order timing to supply concerns related to the RhodoLED XL lamp. The next commercial step is the launch of Ameluz for superficial basal cell carcinoma starting in late fourth-quarter, with an expected extension into the first quarter of 2027. The company also submitted an application in October to expand the treatment label to additional areas of the body.