Biofrontera AG

Biofrontera Reports Financial Results and Business Update for Third Quarter and First Nine Months 2016 - Seite 2

Net income loss before taxes was Eur (7.164) million for the first nine months of 2016, as compared to Eur (9.286) million for the same period in the previous year. Cash and cash equivalents were Eur 5.7 million as of September 30, 2016.
In November 2016, Biofrontera successfully placed an additional capital increase granting statutory subscription rights. The subscription price was Eur 3.00 per new share, net proceeds from the capital raise were Eur 14.8 million. In parallel, Biofrontera issued up to 49,990 convertible bonds of Eur 100.00 each. Together, these measures significantly improved the Company's liquidity by Eur 19.5 million.

U.S. Commercial Launch of Ameluz®
Biofrontera initiated its U.S. commercial launch of Ameluz® and BF-RhodoLED® for actinic keratosis at the Fall Clinical Dermatology Conference in Las Vegas, following U.S. FDA approval in May 2016. The U.S. represents the largest photodynamic therapy market in the world, with approximately 58 million patients suffering from AK, providing a significant revenue opportunity for Biofrontera. The Company is currently operating in targeted regions across the U.S. that have high concentrations of dermatology practices which will allow for the rapid adoption of Ameluz® and the development of strong support from key opinion leaders. Biofrontera's subsidiary in the U.S. is continuing to recruit experienced personnel in important functions, with the goal of developing a fully manned, highly effective sales organization by the end of 2017.

Regulatory Update
Biofrontera continues to work diligently to expand the indication opportunities for Ameluz®, and in September the Company received marketing authorization from the European Commission for the label extension of Ameluz® to include the treatment of field cancerization. Multiple actinic keratosis lesions or actinic keratosis on larger skin areas are the consequence of field cancerization, and the extended indication allows the most appropriate treatment for this very common situation.
Earlier this year, the company reported positive results from a clinical Phase III trial for the treatment of basal cell carcinoma (BCC), and filed for the label extension of Ameluz® for the treatment of non-aggressive BCC, including superficial and nodular BCC with the European Medicines Agency. The Company recently supplemented its application with the EMA with 12-month follow-up results from its Phase III trial in BCC, and expects to receive approval for the label extension of Ameluz® by the first quarter 2017.