Biofrontera (NASDAQ:BFRI) reported second-quarter product revenue of $12 million, up 32.9% from $9 million a year earlier, as Ameluz unit volume increased approximately 30% and the company benefited from a price increase implemented in the fourth quarter of 2025.
Chief Executive Officer, Chairman and Founder Hermann Luebbert said the quarter represented the company’s strongest second quarter and that the first half of 2026 was its strongest first half as a standalone U.S. business. Biofrontera reported gross margin of approximately 80%, compared with roughly 71% in the prior-year quarter, while adjusted EBITDA loss narrowed to $200,000 from a $5.1 million loss.
Revenue Growth and Commercial Metrics
Jones said the company placed 21 lamps during the quarter, including 16 XL lamps and five original RhodoLED lamps. The placements brought Biofrontera’s installed base to approximately 801 lamps across about 740 physician offices.
- First-half order count increased 18.6% from the first half of 2025.
- Average tubes per order rose 10%.
- More than 81% of larger customers that purchased inventory before the fourth-quarter 2025 price increase placed additional orders in the first half of 2026.
- Among those customers that reordered, Ameluz volume increased 41%.
- The company added 66 new accounts in the first half, compared with 69 a year earlier.
Inside sales efforts generated approximately 1,070 Ameluz tubes from smaller and previously untapped accounts, as well as another 920 tubes from coverage of vacant sales territories during the first half, Jones said.
ITC Order Affects RhodoLED XL Lamp
Luebbert addressed the U.S. International Trade Commission’s May 6 final determination finding a Section 337 violation related to two Sun Pharmaceutical patents covering certain components of Biofrontera’s RhodoLED XL lamp. A limited exclusion order and cease-and-desist orders took effect July 7.
Biofrontera can no longer import or sell the current XL lamp in the United States and is restricted from selling Ameluz for use with that lamp. Luebbert said the order does not affect the original BF-RhodoLED lamp, which represents the substantial majority of the company’s installed lamp base.
The company is pursuing a remediation plan involving what Luebbert characterized as minor changes to the XL lamp’s hinge component. Biofrontera had previously recorded approximately $500,000 as its estimate of remediation costs, and management said that estimate had not changed.
During the question-and-answer session, Luebbert said the modified lamp requires a CBE-30 process with the Food and Drug Administration. He said the FDA had agreed to that process and that the company had received FDA permission to sell the modified device, but Biofrontera is awaiting a further determination from border authorities on whether the revised lamp falls outside the scope of the ITC ruling.
The company also retains the right to appeal the ITC decision to the U.S. Court of Appeals for the Federal Circuit. Luebbert said Biofrontera’s commercial plan does not depend on prevailing in an appeal, citing the remediation strategy and the predominance of unaffected original RhodoLED lamps in the installed base.
Pipeline Plans Target 2027 Growth
Biofrontera said the FDA accepted its supplemental new drug application for Ameluz photodynamic therapy in superficial basal cell carcinoma, with a PDUFA target action date of Sept. 28, 2026. If approved, the company expects to begin a full commercial launch in the first quarter of 2027, with initial customer outreach beginning in the fourth quarter of 2026.
Luebbert said approval would make Ameluz the first photodynamic therapy in the U.S. approved to treat cancerous skin tumors. Jones said prelaunch priorities include finalizing FDA-cleared marketing materials, training the sales force and completing a reimbursement strategy.
The company also plans to submit another supplemental NDA around the end of the third quarter of 2026 seeking to expand Ameluz’s actinic keratosis label to include the extremities, neck and trunk and treatment fields up to 240 square centimeters. Biofrontera said it anticipates FDA approval in the third quarter of 2027.
For acne, management cited phase IIb results showing a 58% reduction in inflammatory lesions with Ameluz, compared with 37% for vehicle. The company said it is prioritizing and designing its next clinical development steps, with acne expected to be an important part of that process.
Margins Improve, While Liquidity Remains a Focus
Chief Financial Officer Fred Leffler said first-half revenue increased 25.4% to $22.1 million. Gross margin for the first half was 80%, compared with 67% a year earlier. He attributed the improvement primarily to Biofrontera’s October 2025 transaction that replaced a transfer-pricing arrangement with Ameluz direct costs plus a 12% earn-out on net revenue.
Second-quarter net loss narrowed to $600,000, or $0.05 per share, from $5.3 million, or $0.57 per share, in the prior-year period. For the first half, net loss was $5.4 million, compared with $9.5 million a year earlier.
As of June 30, Biofrontera had $4.7 million in cash and cash equivalents, down from $6.4 million at year-end. Operating cash used during the first half declined to $1.7 million from $7.2 million a year earlier, though the period included a $3.7 million one-time paydown of related-party payables.
Leffler said the company’s financial statements include a going-concern qualification. Biofrontera plans to address its capital needs through continued Ameluz revenue growth, a $1 million milestone payment from the Xepi divestiture and, if necessary, a working-capital credit line or similar financing facility.
About Biofrontera (NASDAQ:BFRI)
Biofrontera AG is a specialty biopharmaceutical company focused on the research, development and commercialization of products for dermatological applications. The company’s core expertise lies in photodynamic therapy (PDT), a treatment modality that uses a photosensitizing agent activated by a specific light source to target diseased skin cells while sparing surrounding healthy tissue.
The flagship product in Biofrontera’s portfolio is Ameluz (aminolevulinic acid hydrochloride 10 % gel), which has received marketing approval in the European Union for treatment of actinic keratosis and basal cell carcinoma, and in the United States for actinic keratosis.
