Company overview

Dermatologists use Biofrontera Inc.’s prescription drug Ameluz together with its RhodoLED lamps to treat mild-to-moderate actinic keratoses on the face and scalp in their offices. This drug-and-light treatment is called photodynamic therapy. Ameluz supplies most of the company’s revenue, with lamp sales making up the rest. Its own sales force sells directly to U.S. dermatology offices and groups, rather than to patients.

Sales depend on physicians using the treatment and on government and private insurers covering enough of its cost. The customer base is broad, but purchasing groups increasingly influence buying and press for lower prices. The company is developing additional uses for Ameluz, but it cannot market a new indication without FDA approval.

Biofrontera has taken control of Ameluz’s U.S. regulatory application and manufacturing responsibility, but temporarily still relies on former licensor Biofrontera Pharma to manufacture the drug through European contractors. Maintaining compliant supply is essential to sales. The company also needs additional financing to support operations while it works toward sufficient operating cash flow.