Biofrontera publishes report on the third quarter of 2014 - Seite 2

Our gross margin has improved to 56% compared to 31% in the same period of the previous year. This was due both to systematic cost management and to a considerable reduction in expenditures incurred in 2013 for the qualification of new production methods and manufacturers carried out upon request by the EMA, which have not yet been completed but were reduced considerably in 2014.

Research and development costs increased from EUR 1,950 thousand in the previous year to EUR 3,146 thousand in the first nine months of 2014. The increase is due to clinical activities in connection with extending the range of indications for basal cell carcinoma and the work undertaken towards the approval of Ameluz^® in the US. As a result of savings, however, R&D costs remain below the projected amount. As planned, sales and administration costs increased from EUR 3,773 thousand to EUR 5,588 thousand compared with the same period of the previous year as a result of the approval process in the US and the setting up of an internal company infrastructure to meet the requirements of pharmaceutical companies.

The loss before tax was EUR 7,955 thousand; in the previous year it was EUR 6,022 thousand. As at 30 September 2014 cash and cash equivalents amounted to EUR 9,962 thousand.

On 30 September 2014, Biofrontera employed 41 employees, compared to 39 employees on 30 September 2013.

Study results, preparation of the approval of Ameluz® in the US

Three clinical trials have been conducted in preparation for the submission of the approval dossier to the FDA (US Food and Drug Administration). As expected, the two safety studies required by the FDA did not reveal any critical aspects in respect of drug safety. In a third, recently completed phase 3 study, in which the combination of Ameluz^® was tested with Biofrontera's PDT lamp BF-RhodoLED^®, 91% of the patients treated with Ameluz^® and 94% of the individual actinic keratoses were completely cured at the end of the study. In this study, photodynamic therapy (PDT) was tested on larger areas (fields) of skin for the first time in a phase 3 trial, although this therapy is actually recommended in the dermatological guidelines for field therapy. In field therapy, the significant effect of skin rejuvenation which occurs with PDT proves to be particularly beneficial.