10th Apr 2015 07:46
LONDON (Alliance News) - Biofrontera AG Friday posted a widened pretax loss for 2014, as it ramped up investment in research and development to prepare for marketing approval of its Ameluz drug for superficial skin cancer in the US.
The biopharmaceutical firm posted a pretax loss of EUR10.7 million for 2014, widened from a pretax loss of EUR8.1 million in 2013, on flat revenue of EUR3.1 million, as research and development costs increased 42% to EUR4.5 million from EUR3.2 million.
The company said that the submission of a registration dossier with the US Food and Drug Administration is scheduled for the second quarter of 2015. Approval is expected around a year after submission of the application.
It is also working on extending the indication of Ameluz into basal cell carcinoma, initiating a phase III trial in comparison with competitor Metvix.
The company saw strong sales growth in Germany of 27%, which offset low sales in the rest of Europe. Overall sales growth outside of Germany declined as smaller quantities of products were delivered to European partners. However it expects this to pick up again "considerably" in 2015.
Biofrontera said expects to post a net loss of between EUR9 million to EUR10 million in 2015, on revenue of between EUR4 million to EUR5 million, although it cautioned that this forecast is subject to uncertainties related to the speed of market penetration. Whilst it expects to see revenue rise by around 30% in Germany, it is difficult to predict the increase in sales in other European countries. It also said it expects EUR4 million to EUR5 million in development expenses in the year.
"We will continue to strive assiduously to realise the enormous potential of Ameluz in order that Biofrontera becomes a more established independent pharmaceutical company. We achieved important milestones in 2014 and are now in a stronger position to lay the groundwork to tap into our products' full potential and make Biofrontera a highly successful company in the medium term," said Chief Executive Officer Hermann Lübbert in a statement.
Shares in Biofrontera are trading up 5.0% at 210.00 pence Friday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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