Biofrontera AG

Biofrontera Reports Financial Results and Business Update for Second Quarter and First Half 2016 - Seite 2

Net income loss before taxes was Eur (3.472) million for the first half of 2016, as compared to Eur (7,323) million in the previous year.

In February and April 2016, Biofrontera successfully placed capital increases. Net proceeds from the capital raises were Eur9.3 million. This represents a significant improvement in the liquidity of the Company. Cash and cash equivalents were Eur10.2 million as of June 30, 2016.

U.S. Commercial Launch of Ameluz®
Following the recent U.S. FDA approval of Ameluz® and BF-RhodoLED® for actinic keratosis on May 10, 2016, Biofrontera has been diligently preparing for its commercialization in the U.S. The Company has developed a comprehensive sales and marketing strategy for a successful launch in September 2016. The U.S. represents the largest PDT market in the world, as well as a significant revenue opportunity for Biofrontera. The Company has decided to systematically conduct targeted geographic launches in areas with the highest potential to build momentum and early success. These select regions have a high concentration of dermatologists with large practices and influential private insurers offering PDT. This approach will allow the Company to identify the early adopters and key opinion leaders who will be critical to the success of Ameluz® in the U.S. Biofrontera's subsidiary in the U.S. is continuing to recruit experienced regional sales managers and representatives, who have already begun to ensure that early adopting practices will have the BF-RhodoLED device installed prior to the launch of Ameluz®. In addition to bolstering the sales force, Biofrontera has appointed key operational and medical advisory staff to its U.S. subsidiary in order to support the sales efforts.

Regulatory Update
Biofrontera continues to make progress in strategically expanding the available indications in Europe for Ameluz®. The Company recently received a positive assessment from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the company's submission for the label extension of Ameluz® to include the treatment of field cancerization, which would significantly increase the addressable market for Ameluz®. Biofrontera anticipates that the European Commission will issue formal approval within the coming weeks.