Biofrontera AG: Biofrontera significantly increases its turnover in Germany in 2014
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Biofrontera AG /
Biofrontera AG: Biofrontera significantly increases its turnover in Germany in
2014
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* Increase in revenues by nearly 30% in Germany
* Major investment in R&D in order to extend product indications and to
prepare for marketing approval in the USA
* Successful completion of the Phase III study for field therapy of actinic
keratosis
* Revenues for 2015 expected to increase to EUR 4-5 million
Leverkusen, Germany, 10 April 2015 - Biofrontera AG (FSE/AIM:B8F), the
specialist in sun-induced skin cancer, increased its turnover in Germany by more
than 27% in the 2014 financial year, to EUR 2.4 million (previous year: EUR 1.9
million). Total sales were nearly constant at EUR 3.1 million. The net loss
before tax went from EUR -8.1 million to EUR -10.7 million, which is
attributable, among other things, to significantly higher expenses for the
ongoing approval process in the USA and the extension of the indications for the
main product Ameluz(®) in Europe.
Operational progress achieved
Biofrontera has achieved its objectives regarding an increase in turnover in
Germany. Sales in other European countries, however, were lower than expected.
The reason for this was that the distribution partners in Europe still had stock
inventories during 2014 that did not need to be replenished until 2015.
Biofrontera continues to pursue its two main strategic objectives: the approval
of Ameluz(®) to treat actinic keratosis in the USA and the approval of Ameluz(®)
to treat basal cell carcinoma in Europe. Biofrontera has made significant
progress with both issues. The dossier for the US approval is expected to be
submitted for approval to the Food and Drug Administration (FDA) in the second
quarter of 2015. The Phase III study to extend the indication for Ameluz(®) in
Europe to basal cell carcinoma will probably be completed by the end of 2015.
With the approval of Ameluz(®) for actinic keratosis and basal cell carcinoma,
sales are expected to increase significantly, also outside of Germany.
Key financial figures in line with forecasts
Biofrontera has remained within its revised forecast from autumn 2014, with
turnover of EUR 3.1 million. The consolidated profit/loss before tax of EUR
-10.7 million is also in line with expectations. Preparations for market entry
in the USA and market expansion in Europe required extensive preliminary work
and expense in 2014. Expenditure for research and development thus amounted to
EUR 4.5 million (previous year: EUR 3.2 million), an increase of 42% compared to
the previous year's figure. There was also a significant increase in
distribution costs, which amounted to EUR 3.9 million (previous year: EUR 3.0
million). Cost of Sales fell to EUR 1.1 million, thus now accounting for 36% of
turnover. In the previous year, the cost of sales ratio was 51%. The structural
improvement in the gross margin is attributable both to an improvement in
product costs as well as to savings compared to the previous year resulting from
the fulfilment of EMA requirements in the production area. Undiluted earnings
per share remained nearly constant at EUR -0.49 (previous year: EUR -0.47)
Following the successful capital increase in 2014, however, it is associated
with a significantly higher number of shares.
As at 31 December 2014, Biofrontera had liquid assets amounting to EUR 8.5
million, with total balance sheet assets of EUR 14.0 million. The number of
employees rose to 46 (previous year: 38).
Outlook 2015: moving forward with the approval process, increasing turnover
Biofrontera will continue to pursue its two most important objectives: the
approval of Ameluz(®) to treat actinic keratosis in the USA and the extension of
the indications to include basal cell carcinoma in Europe. We are currently
compiling the dossier with all the study results for the FDA and want to submit
this during the second quarter of 2015. About one year is then expected to be
required to be granted approval. In Europe, patient recruitment for the phase
III study for basal cell carcinoma has taken longer than originally planned, so
the number of patients required is expected to be reached only by the end of
April 2015. Hence, the clinical part of the study would end in October 2015 and
the approval extension could be submitted to the EMA by the end of the year. In
this case, approval would be expected by the first half of 2016.
Biofrontera expects a further increase in turnover in Germany and also higher
revenues in Europe in 2015. We currently expect a total turnover of EUR 4-5
million. Considerable resources are also expected to be invested in market
development in 2015. The type of business model chosen for the USA will be
crucial in determining commercial performance. So Biofrontera is faced with a
decision as to whether the distribution should be carried out in the form of a
collaboration with another company or under its own auspices. The second option
would initially require additional investment. With this, however, Biofrontera
could eventually retain all the turnover and profits itself and thus probably
lay the foundation for a much higher valuation of the company. Conversely,
cooperation with distribution partners may lead to a down payment being paid in
2015, which would improve the turnover and earnings performance in the short
term. The decision should be made in good time to allow Ameluz(®) to be launched
on the market as soon as possible after receiving approval. In the above-
mentioned target figure for turnover in 2015, neither of the scenarios have yet
been investigated in-depth, as no reliable conclusions can be drawn about this
at the moment.
Professor Hermann Lübbert, Chairman of the Executive Board: "We will continue to
strive assiduously to realise the enormous potential of Ameluz(®) so that
Biofrontera can further develop into an independent pharmaceutical company. We
have achieved important progress in this regard during 2014. We are now laying
the groundwork to tap into our products' potentials and make Biofrontera a
highly successful company in the medium term".
Ends
Enquiries, please contact:
Biofrontera AG +49 (0) 214 87 63 2 0
Prof. Hermann Lübbert, Chief Executive Officer press(at)biofrontera.com
Thomas Schaffer, Chief Financial Officer www.biofrontera.com
IR Germany: Brainwell Asset Solutions +49 (0) 152 08931514
Jürgen Benker
Nomad and Broker: Shore Capital +44(0) 20 7408 4090
Bidhi Bhoma / Toby Gibbs
IR UK: Seton Services +44(0) 20 7603 6797
Toni Vallen
Financial PR: Gable Communications +44(0) 20 7193 7463
John Bick +44 (0)7872 061007
Background:
The Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical
company specialising in the development, sale and distribution of drugs and
medical cosmetics for the care and treatment of skin diseases. Biofrontera's
most important product is Ameluz(®), a prescription drug which is approved in
Europe for the treatment of mild and moderate actinic keratosis (superficial
skin cancer) with photodynamic therapy (light therapy). Biofrontera is the first
German pharmaceutical start-up company to obtain centralised approval for a drug
it has developed itself. The company also plans for Ameluz(®) to be approved for
basal cell carcinoma and is currently preparing for approval in other countries,
especially in the largest pharmaceutical market in the world, the United States.
The company also markets the Belixos(®) dermatological range of cosmetics.
Belixos(®) products contain combinations of active substances extracted from
plants, relieve itching and redness and are used for the regenerative care of
chronic skin conditions such as atopic dermatitis or psoriasis. At the moment,
Belixos(®) cream, gel and scalp tonic are available through Amazon.
The Biofrontera Group was established in 1997 by Prof. Dr Hermann Lübbert, the
Chairman of the company's Management Board, and has its headquarters in
Leverkusen, Germany.
www.biofrontera.com
This communication expressly or implicitly contains certain forward-looking
statements concerning the business activities of Biofrontera AG. These forward-
looking statements reflect the opinion of Biofrontera at the time of this
communication and involve certain known and unknown risks. The actual results
achieved by Biofrontera may differ significantly from future results or
performances which are published in its forward-looking statements. Biofrontera
assumes no responsibility to update its forward-looking statements.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via GlobeNewswire
[HUG#1909855]
Unternehmensinformation / Kurzprofil:
Datum: 10.04.2015 - 08:00 Uhr
Sprache: Deutsch
News-ID 384817
Anzahl Zeichen: 10529
contact information:
Town:
Leverkusen
Kategorie:
Business News
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