Aug 13, 2026 earnings call — Q2 results, ITC lamp restriction, sBCC PDUFA
Net product revenue grew 33% to $12 million in Q2 2026, and adjusted EBITDA was negative $0.2 million.
Revenue $0.0B (est $0.0B) · EPS $-0.05 (est $-0.10)
Key quotes
"The second quarter of 2026 was the strongest operating Q2, and the first half year was the strongest H1 in the company's history as a standalone U.S. business."
"We can no longer import or sell the current RhodoLED XL lamp in the United States. And we are restricted from selling Ameluz for use with the RhodoLED XL."
"The FDA accepted filing of our supplemental New Drug Application for Ameluz PDT for the treatment of superficial basal cell carcinoma with a PDUFA target date of September 28, 2026."
Analyst Q&A 2
Basal cell carcinoma launch steps
Q (Bruce Jackson · StoneX): He asked what steps remain before the basal cell carcinoma launch, including reimbursement and sales training. He also asked about the ITC patent situation, whether a redesign is needed and if customers will notice any performance change.
A: Management said the launch fits the current call point and the remaining tasks are to finalize marketing materials, pre-clear them with the FDA, train the sales force, and finalize reimbursement. They said they cannot use the same review to challenge the other patent, will appeal the ITC decision, and are implementing a minor hinge change as a workaround; they applied via a CBE-30 and FDA agreed, but they must wait for border control to confirm the change gets them outside the ITC ruling. They added the feature change will not change how the lamp is used or its performance.
"The actions that really need to be taken place to get ready for this launch are to finalize our marketing materials, pre-clear those with the FDA, and train our sales force, and then finalize our reimbursement strategy as well." — George Jones
Using Ameluz with existing lamps
Q (Jonathan Aschoff · ROTH Capital Partners): He asked if the count of 243 XL lamps out of 801 is correct and whether doctors who own lamps and Ameluz stock can still use it. He also asked who enforces this, whether Biofrontera will replace lamps for free or sell new ones, and how this affects revenue.
A: Management confirmed the count was about right and said they will not sell Ameluz for use with the infringing device after the order went into effect, but customers who bought Ameluz and own the lamp can use them. They said it is Biofrontera's obligation not to sell Ameluz after the order, they are developing a non-infringing device and plan to replace current lamps once it is approved by the FDA and border control. They also said they used the period between the order and its effect to sell inventory to customers, and some customers bought multiple months of inventory while other strategies are in place to care for patients.
"So it's the obligation of Biofrontera in this situation to not sell Ameluz after the order went into effect for use for the infringing device." — George Jones