German biotech Biofrontera (LON:B8f) is confident of hitting its target of upping domestic sales by around 30% this year.
Sales in Germany increased by 21% in the first half of the year, the company revealed, as it posted interim figures. Half-year revenues for the group were €1.22mln, versus €1.39mln the year before.
Wholesale sales to pharmacies, which the company says are indicative of market development, increased by 27% year-on-year, underpinning the company’s confidence in hitting full-year objectives.
However, though things are tickety-boo in the domestic market, Biofrontera admitted to disappointment in the performance in other European countries, with smaller quantities of its products delivered to most of its European licensing partners than the year before.
“This indicates that the positioning of Ameluz remains challenging although we expect much better market penetration once Ameluz is approved for the treatment of basal cell carcinoma in addition to the treatment of actinic keratoses as is currently the case. The clinical phase III trial started for this purpose is proceeding according to schedule,” the company said.
Ameluz is Biofrontera’s first prescription drug for the treatment of actinic keratosis (also known as solar keratosis), a skin condition typically suffered by fair-skinned people after prolonged exposure to the sun.
The National Institute for Health and Clinical Excellence (NICE) estimates that more than 23% of the UK population aged 60 and above has actinic keratoses.
Research and development costs relating to the preparation for approval in the USA and the extension of the range of indications increased to €2.06mln in the first half of 2014 from €1.16mln in the same period of the previous year.
This contributed to a widening in the half-year loss to €5.41mln from €3.70mln the year before.
Biofrontera is currently pursuing approval in the USA and the extension of the range of indications to include basal cell carcinoma as its most important strategic objectives. Basal cell carcinomas are slow-growing, locally invasive malignant epidermal skin tumours that are thought to arise from hair follicles.
The company expects the final hearing date for US approval will take place in the second half of this year, while the company also expects the results of the Phase III trial on broad area therapy of actinic keratosis before the end of the year.
The company is confident of keeping up the growth rate in Germany next year but cautioned overall sales revenues in 2015 may fall short of the expected €5-6mln.
“In addition to the slower than expected revenue increase in other European countries, this is due to the fact that a planned licensing agreement associated with a large down-payment for further European countries will be unlikely in the current year.
"Achievement of our revenue expectations for the full year will therefore be dependent on the successful conclusion of a contract with a US-based distribution partner in respect of which Biofrontera would anticipate a large down-payment. The probability that this may still be implemented this year, cannot currently yet be estimated,” the company said.