Biofrontera (BFRI) investor relations material

Business overview and product highlights

• Focuses on dermatology, treating actinic keratosis with a combination drug and light therapy, generating nearly $42 million in revenue for 2025 with year-over-year growth.

• Acquired all patents, NDA, and IND for its main product, now owning manufacturing rights and paying a 12% royalty, increasing to 15% above $65 million annual revenue.

• Gross margin rose from 50% to 80% in Q1 2026, reflecting improved profitability post-acquisition.

• AMELUZ, the topical drug, is activated by red light and targets precancerous skin cells, with two lamp sizes available.

• High clinical efficacy: 94% lesion clearance in phase III trials, with 63% of patients fully cleared after one year.

Market opportunity and competitive positioning

• Actinic keratosis market is valued at $4 billion, with most U.S. patients currently treated by cryotherapy.

• AMELUZ is FDA-approved for field-directed treatment, targeting a $500 million primary market segment, with potential to expand further.

• Product is sold directly to doctors as a buy-and-bill model, with a list price of $381 and reimbursement through J and CPT codes.

• Doctors receive higher reimbursement for PDT ($267) compared to cryotherapy ($162), incentivizing adoption.

• Intellectual property protection extends to 2043, covering drug, lamp, and procedure.

Pipeline, regulatory, and growth initiatives

• U.S. label currently covers face and scalp; a phase III trial for upper extremities is complete, with FDA submission planned for September.

• Seeking FDA approval for basal cell carcinoma (PDUFA date: September 28) and preparing for phase III in moderate to severe acne.

• Growth driven by sales force productivity, new chief commercial officer, and anticipated regulatory milestones over the next two years.