Biofrontera Inc. Reports Strong Third Quarter 2026 Financial Results Driven by 30% Year-Over-Year Revenue Growth

WOBURN, Mass., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended September 30, 2026.

Third Quarter 2026 Highlights * Net product revenue of $9.1 million, an increase of 29.8% compared to $7.0 million in the prior-year period. * Gross margin of 74.4%, compared to 70.7% in the prior-year period, an improvement of approximately 370 basis points, reflecting the lower Ameluz(®) cost structure established following the closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic Transaction”), partially offset by ITC Matter-related inventory write-downs and higher lamp and device costs. * Net loss of $6.4 million, or $(0.42) per share, compared to a net loss of $6.6 million, or $(0.62) per share, in the prior-year period. * Adjusted EBITDA of $(5.5) million, compared to $(6.0) million in the prior-year period. * On September 9, 2026 FDA Approval of Ameluz on September for the treatment of Superficial Basal Cell Carcinoma (sBCC), making Ameluz plus Red-Light the first and only PDT approved for the treatment of cancerous skin tumors. * US Customs and Border Protection ruled that the re-designed XL-C lamp did not violate the ITC order and could be imported for use in the US market. Nine Months Ended September 30, 2026 Highlights * Net product revenue of $31.2 million, an increase of 26.6% from $24.6 million in the prior-year period. * Gross margin of 78.0%, compared to 67.7% in the prior-year period. * Net loss of $11.8 million, or $(0.89) per share, compared to a net loss of $16.2 million, or $(1.67) per share, in the prior-year period. * Adjusted EBITDA of $(9.3) million, compared to $(15.5) million in the prior-year period. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "The third quarter was a pivotal one for Biofrontera. On September 9, the FDA approved Ameluz(®) PDT for the treatment of superficial basal cell carcinoma (sBCC), making it the first PDT approved in the United States for a cancerous skin tumor. Five days later, U.S. Customs and Border Protection ruled that our redesigned RhodoLED(®) XL-C is not subject to the ITC exclusion order, which allows us to again serve the customers who rely on our large-field lamp. Revenue grew 30% in the quarter and 27% for the first nine months, and our gross margin continues to reflect the lower cost structure we put in place with the Strategic Transaction. The quarter also carried the legal and remediation costs of the ITC Matter, and with the XL-C now cleared our attention is on execution. We are preparing to begin commercializing Ameluz(®) for sBCC later in the fourth quarter and into the first quarter of 2027, and in October we submitted a supplemental New Drug Application to expand the Ameluz(®) label for actinic keratosis to the extremities, neck and trunk. Each of these indications is served by the lamps and the sales force we already have in place.”