Key Highlights

  • BFRI reported Q3 net product Revenue of US$9.1 million, up 29.8% from US$7.0 million.
  • Gross Margin was 74.4% versus 70.7% in the prior-year quarter.
  • FDA approved Ameluz for superficial basal cell carcinoma on September 9, 2026.
  • Cash and cash equivalents were US$3.2 million at September 30, 2026.

BFRI reported third-quarter 2026 results on November 13, 2026, for the quarter ended September 30. Net product revenue was US$9.1 million, an increase of US$2.1 million, or 29.8%, from US$7.0 million in the third quarter of 2025. The company attributed the increase to a 23.3% rise in Ameluz unit volume, worth US$1.6 million, US$0.3 million from price and mix, and higher device sales.

Net loss was US$6.4 million, or US$(0.42) per share, versus US$6.6 million, or US$(0.62) per share, a year earlier. Adjusted EBITDA, a non-GAAP measure, was US$(5.5) million, versus US$(6.0) million. For the nine months ended September 30, net product revenue was US$31.2 million, up 26.6% from US$24.6 million, and net loss was US$11.8 million, or US$(0.89) per share, versus US$16.2 million, or US$(1.67) per share.

Margins, Operating Costs and the ITC Matter

Cost of revenues was US$2.3 million versus US$2.0 million, giving Gross Profit of US$6.7 million and a gross margin of 74.4%, compared with US$4.9 million and 70.7%. The company said the change in margin reflects a cost structure of Ameluz direct cost plus a 12% earnout on net revenue, following the strategic transaction with Biofrontera AG that closed in October 2025. Lamp and device costs rose US$0.4 million, including US$0.3 million of inventory write-downs tied to the ITC Matter.

SG&A expenses, including related party, were US$12.5 million versus US$10.4 million. The company cited US$0.9 million of higher legal fees related to the ITC Matter, US$0.7 million of lamp Manufacturing and regulatory and product affairs costs, and US$0.5 million of higher direct sales expenses. Research and Development expenses were US$0.5 million versus US$0.9 million, and the company said it has largely finished its clinical trials. Patent remediation expense was US$0.3 million, with none a year earlier. Total ITC Matter charges through September 30 were US$1.1 million: US$0.6 million of accrued remediation costs and US$0.5 million of inventory write-downs.

Regulatory Milestones and Balance Sheet

A limited exclusion order and cease and desist order from the U.S. International Trade Commission covering the RhodoLED XL lamp took effect on July 6, 2026. The company said some customers placed orders early in July ahead of potential Supply restrictions, and it believes this affected order timing rather than total demand. On September 14, 2026, U.S. Customs and Border Protection ruled that the redesigned XL-C lamp is not subject to the exclusion order, and the company began placing XL-C lamps during the quarter.

The FDA approved Ameluz on September 9, 2026, for superficial basal cell carcinoma. In October, the company submitted a supplemental New Drug Application to expand the actinic keratosis label to the extremities, neck and trunk. Cash and cash equivalents were US$3.2 million at September 30, versus US$6.4 million at December 31, 2025. Cash used in Operating Activities for the nine months was US$3.2 million versus US$11.0 million. Total liabilities were US$21.7 million, and Debt consisted of US$4.7 million of convertible notes, net, maturing in November 2027, with no bank or other term debt.

Quarter in Review: Revenue, Approvals and the Lamp Ruling

BFRI's third quarter combined revenue growth, a change in cost structure and two regulatory events. Net product revenue was US$9.1 million and net loss was US$6.4 million. The FDA approved Ameluz for superficial basal cell carcinoma, and a customs ruling allowed the XL-C lamp to be imported. The company said it is preparing to commercialize Ameluz for this indication later in the fourth quarter and into the first quarter of 2027.