Biofrontera (NASDAQ:BFRI) reported a nearly 30% increase in third-quarter revenue, helped by higher Ameluz sales and orders placed ahead of restrictions on one of its photodynamic therapy lamps. The company also disclosed that substantial doubt remains about its ability to continue as a going concern.
Revenue rose to $9.1 million from $7.0 million a year earlier, while net loss narrowed to $6.4 million, or $0.42 per share, from $6.6 million, or $0.62 per share. Chief Financial Officer Fred Leffler said substantially all of the quarter’s approximately $1.6 million in volume-driven revenue growth reflected orders placed in early July before International Trade Commission orders took effect.
The results came as Biofrontera prepares to commercialize Ameluz for superficial basal cell carcinoma, a skin cancer indication approved by the U.S. Food and Drug Administration in September. The company also began distributing a redesigned lamp after a customs ruling allowed it to bypass the ITC restrictions affecting its original RhodoLED XL device.
Sales Growth and Lamp Restrictions
Chief Commercial Officer George Jones said Biofrontera sold approximately 25,120 tubes of Ameluz during the quarter, up 23% from 20,380 a year earlier. Higher prices and lamp sales contributed to the remaining revenue growth.
Jones said some customers bought Ameluz earlier than they otherwise would have ahead of the ITC orders, creating a fast start to the quarter. He said the company believes customers had largely worked through that inventory by the end of the third quarter.
The orders took effect July 6 and prevented Biofrontera from importing or selling the original RhodoLED XL and from selling Ameluz for use with that lamp, CEO, Chairman and Founder Hermann Luebbert said. Customers whose only lamp was the original XL were temporarily unable to buy Ameluz from the company.
On September 14, U.S. Customs and Border Protection ruled that the redesigned RhodoLED XL-C did not infringe the asserted claims of DUSA Pharmaceuticals’ patents and was not subject to the exclusion order, according to Luebbert. The company also sells a smaller lamp, BF-RhodoLED, that was not affected by the orders.
Jones said the restrictions initially affected approximately 200 customers and 25% of Ameluz sales volume. By placing smaller lamps and XL-C devices with customers, Biofrontera had reduced the affected share to approximately 10% at the time of the call, he said. The company expects remediation of affected lamps in the field to be substantially complete by the end of the second quarter of 2027.
New Indication and Pipeline
The FDA approved Ameluz photodynamic therapy on September 9 for superficial basal cell carcinoma in adults. Luebbert said it was the first photodynamic therapy approved in the United States to treat a skin cancer. Ameluz was previously approved for mild to moderate actinic keratosis on the face and scalp.
Biofrontera expects a full launch for the new indication in the first quarter of 2027, after receiving FDA feedback on anticipated marketing materials. Jones said the company plans to use its existing sales infrastructure and dermatology offices already equipped with its lamps.
Jones said Biofrontera believes there will be a clear path to reimbursement at launch. Ameluz tubes will be reimbursed through the existing J-code, he said, while the company is finalizing its expectations for procedure codes.
In early October, Biofrontera submitted a supplemental application to expand Ameluz’s actinic keratosis label to the extremities, neck and trunk. The FDA has set an August 5, 2027, target action date, Luebbert said.
Liquidity and Costs
Third-quarter gross margin improved to 74.4% from 70.7% a year earlier, although it was below the roughly 80% reported in the first half of 2026. Leffler cited higher lamp and device costs and inventory write-downs. He said he expects gross margin to return to around 80% in the fourth quarter.
Through September 30, Biofrontera had recognized $1.1 million in ITC-related remediation and inventory charges, excluding legal fees, Leffler said. Selling, general and administrative expenses rose to $12.5 million from $10.4 million, including higher legal costs related to the matter.
Cash and cash equivalents stood at $3.2 million at September 30, down from $6.4 million at the end of 2025. Leffler said management concluded that substantial doubt exists about Biofrontera’s ability to continue as a going concern for at least 12 months from issuance of its quarterly filing.
The company’s plans include growing revenue while controlling expenses, obtaining a working capital line of credit, receiving a potential $1 million milestone payment from its Xepi divestiture and, if necessary, raising additional capital. Leffler cautioned that some measures are outside the company’s control and have not alleviated the substantial doubt.
Biofrontera also had a $0.2 million stockholders’ deficit at quarter-end and did not meet Nasdaq’s minimum stockholders’ equity requirements, Leffler said. The company intends to submit a compliance plan as needed.
About Biofrontera (NASDAQ:BFRI)
Biofrontera Inc. (NASDAQ:BFRI) is a specialty pharmaceutical company focused on developing and commercializing prescription dermatology products, with an emphasis on treatments for precancerous and cancerous skin conditions. The company primarily serves the U.S. dermatology market through a commercial organization that supports physicians and other healthcare providers. Biofrontera’s principal product is Ameluz (aminolevulinic acid hydrochloride) topical gel, a prescription medication used with photodynamic therapy to treat actinic keratoses.
