Biofrontera (NASDAQ:BFRI) executives outlined the dermatology company’s commercial progress, margin improvement and clinical expansion plans during a presentation at the Lytham Partners Spring 2026 investor conference.
Chief Executive Officer Hermann Luebbert said Biofrontera currently markets AMELUZ, a topical drug used with red light activation for the treatment of actinic keratosis, a precancerous skin disease. Luebbert said the company generated close to $42 million in revenue in 2025 from the product and is continuing to grow year over year.
Biofrontera Highlights AMELUZ Ownership and Margin Gains
Biofrontera now pays a 12% royalty to its former parent company, Luebbert said. That royalty will rise to 15% once annual revenue exceeds $65 million. He said the transaction helped increase the company’s gross margin, which Chief Financial Officer Fred Leffler later said rose from about 62% in the first quarter of 2025 to 80% in the first quarter of 2026.
Leffler said Biofrontera expects gross margins to remain in the 80% to 85% range, depending on product mix, discounts and other factors.
Actinic Keratosis Market Remains Core Focus
AMELUZ is currently approved for actinic keratosis, which Luebbert described as a sun-induced precancerous disease that can progress to squamous cell carcinoma. He said about 50% of Caucasian people over age 60 have at least one actinic keratosis lesion.
Luebbert said AMELUZ is applied to the skin and absorbed before being activated by red light from one of Biofrontera’s lamps. Upon activation, he said targeted cells are destroyed selectively because the drug is metabolized in certain cells, including tumor cells.
In Phase 3 trials, Luebbert said 94% of lesions were completely cleared, while 91% of patients were completely cleared of all actinic keratosis. One year later, 63% of patients remained completely cleared, which he described as a high clearance rate compared with other available treatments.
Luebbert said the total addressable market for actinic keratosis is about $4 billion. He said most U.S. patients are treated with cryotherapy, but argued that patients with many lesions should receive field-directed treatment of the entire area. AMELUZ has FDA approval for field-directed treatment, he said.
Reimbursement and Commercial Strategy
Luebbert emphasized that AMELUZ photodynamic therapy is administered in a physician’s office and sold by Biofrontera as a “buy and bill” product. He said the list price for AMELUZ is $381 and that doctors can bill insurers using a J code for the drug and a CPT code for the procedure.
According to Luebbert, Medicare pays an average of $267 for the largest photodynamic therapy procedural code, which includes debridement and administration by a qualified healthcare professional. He compared that with reimbursement for treating 14 lesions with cryotherapy, which he said is capped at $162.
Biofrontera is also seeking to improve sales force productivity. Luebbert said the company hired a new chief commercial officer and attributed Biofrontera’s roughly 17% first-quarter growth to improved sales force productivity.
Clinical Pipeline Includes BCC, Broader AK Label and Acne
Luebbert said Biofrontera is pursuing additional indications and label expansions for AMELUZ. The company has completed a Phase 3 trial for actinic keratosis on the upper extremities and is preparing an FDA submission planned for September.
Biofrontera is also seeking an indication for basal cell carcinoma, which Luebbert said AMELUZ has in the European Union but not in the United States. He said the application is currently under FDA review, with a PDUFA date of Sept. 28 this year.
In addition, Luebbert said the company recently finished a Phase 2 study of AMELUZ photodynamic therapy in moderate to severe acne. Biofrontera plans to prepare for an FDA meeting in the second half of the year to discuss a Phase 3 program for that indication.
First-Quarter Revenue Rises 17.4%
Leffler said Biofrontera’s first-quarter revenue increased 17.4% year over year, rising from $8.6 million to $10.1 million in 2026. He said the company expects at least double-digit growth this year.
Leffler also said adjusted EBITDA, a non-GAAP measure, has been improving over the past several years. Biofrontera expects adjusted EBITDA to be generally break-even, or at least to be cash-flow break-even, in 2026, he said. In the first quarter, adjusted EBITDA improved by $0.8 million from the prior-year period, moving from a loss of $4.4 million to a loss of $3.6 million.
As of March 31, Leffler said Biofrontera had about $6.3 million in cash and a long-term convertible note of $4.7 million. The company had approximately 11.9 million shares outstanding as of March, and Leffler said its fully converted share count was about 52 million shares. Based on the prior day’s share price, he said the fully converted market capitalization was about $42.2 million.
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.
