Biofrontera Inc (NASDAQ: BFRI) is a U.S.-based biopharmaceutical company that develops, manufactures, and commercializes pharmaceutical products for dermatological conditions, with a focus on photodynamic therapy (PDT). Revenue is generated by selling Ameluz gel and the RhodoLED Lamp series directly to dermatology offices and groups across the United States. In October 2025, Biofrontera finalized an Asset Purchase Agreement with Biofrontera AG to acquire all U.S. rights to Ameluz and RhodoLED, replacing a prior licensing and supply arrangement with an earnout structure set at 12% of U.S. net revenues in years when U.S. net sales of Ameluz are $65.0 million or less, and 15% in years when U.S. net sales exceed $65.0 million, continuing until patent expiration allows generic competition. The company was incorporated as a U.S. entity and operates a national commercial sales team targeting the dermatology channel.

Revenue model

Transactional product sales of Ameluz gel and RhodoLED Lamps directly to dermatology offices and groups in the United States. As of the Strategic Transaction finalized October 2025, the company holds U.S. rights to Ameluz outright and pays an earnout to Biofrontera AG of 12% of U.S. revenues when annual U.S. net sales are $65.0 million or less, and 15% when U.S. net sales exceed $65.0 million, retroactive to June 1, 2025.

Products and services

Ameluz (aminolevulinic acid hydrochloride gel) for PDT treatment of actinic keratosis (AK) on the face and scalp. In October 2024, FDA approved a Supplemental NDA allowing up to three tubes of Ameluz per treatment session, up from one tube previously. BF-RhodoLED and RhodoLED XL lamps used in combination with Ameluz for PDT. The active pharmaceutical ingredient, 5-Aminolevulinic Acid Hydrochloride, is supplied by Midas Pharma GmbH under a Supply Agreement entered December 2025 via subsidiary Biofrontera Discovery GmbH. A Phase III trial for superficial basal cell carcinoma (sBCC) reported 65.5% composite endpoint success versus 4.8% for placebo-PDT (results received October 2024).

Customers and end markets

Dermatology offices and groups in the United States. Primary end market is treatment of actinic keratosis, a pre-cancerous skin lesion condition. Secondary pipeline target is superficial basal cell carcinoma.

Value-chain role

Pharmaceutical product commercializer with a national direct sales force. Active pharmaceutical ingredient sourced from Midas Pharma GmbH. Holds U.S. rights to Ameluz following October 2025 asset acquisition from Biofrontera AG. Responsible for U.S. regulatory submissions, sales, and marketing.

Geographic exposure

United States only, based on the filing's description of U.S. commercial operations and U.S. rights acquired under the October 2025 Strategic Transaction.

Source: SEC 10-K, filed 2026-03-19

Industry: Pharmaceutical Preparations Peers: Acer Therapeutics Inc. Cocrystal Pharma Inc CalciMedica Inc Johnson & Johnson LANNETT CO INC Traws Pharma Inc Provectus Biopharmaceuticals Inc