29th Aug 2014 11:14
LONDON (Alliance News) - Biofrontera AG Friday posted a widened pretax loss in the half year to end-June on higher, as it prepares for the US approval of its skin cancer medication Ameluz.
Biofrontera posted a pretax loss of EUR5.4 million, widened from EUR3.7 million, as revenue declined to GBP1.2 million from GBP1.4 million, on higher administration charges and research and development costs.
Weaker sales in in other European countries offset strong growth in Germany and wholesale sales to pharmacies. German sales rose 21%, and the company said it was confident of achieving 30% revenue growth in its domestic market by the end of the year.
However, it cautioned that whilst it might be able to achieve increased sales in Germany, predicted sales revenues in 2015 may fall short of its expected EUR5 million to EUR6 million overall, as a licensing agreement for further European countries will be unlikely in the current year.
Therefore, to meet its revenue expectations for the full year, it will need to successfully conclude a contract with a US-based distribution partner for which it would receive a large down-payment.
In the first half smaller quantities were delivered to its European licensing partners, which the company said indicates that the positioning of Ameluz remains challenging, but it expects to see better market penetration for the product once it is approved for the treatment of basal cell carcinoma.
The company expects to complete patient recruitment for a trial into Ameluz for the treatment of basal cell carcinoma by the fourth quarter of the year, and expects to submit an approval dossier in the US for the end of the first quarter of 2015. It expects an approval would be issued about one year later.
In the second half, it is awaiting results from its ongoing phase III trial into the therapy of actinic keratosis and the final hearing date at the US Food and Drug Administration ahead of the submission of approval documents.
Shares in Biofrontera were trading down 5.6% at 210.00 pence Friday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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