DGAP-News: Biofrontera AG / Key words: 9-month numbers
Biofrontera AG: Biofrontera publishes results for the third quarter and the first nine months of 2018
16.11.2018 / 08:05
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Biofrontera publishes results for the third quarter and the first nine months of 2018
Leverkusen, 16 November 2018 – The international pharmaceutical company Biofrontera AG (ISIN: DE0006046113) today announced its results for the third quarter and nine months ending September 30, 2018. At the same time, an overview of current business developments was provided.
- An increase in revenue for the first nine months of 2018 by 98% to approximately EUR 14.6 million compared to EUR 7.3 million in the same period of the previous year.
- Increase of sales of products in the first nine months of 2018 by 131% to approximately 14.4 million EUR compared to 6.2 million in the same period of the previous year.
- Profit before tax in the first nine months of 2018 amounted to approximately -12.3 million or -0.28 EUR per share compared to approximately -14.6 million or -0.38 per share in the same period of the previous year.
- Increased sales forecast for the current year from 16 to 20 million euros to 19-22 million euros in October 2018.
- In August 2018, she completed a five-year contract with the US Veterans Ministry.
- Approval for Ameluz(R) in combination with photodynamic therapy of daylight (daylight PDT) by the European Commission in March 2018 and in Switzerland in September 2018.
- Completion of Patient Registration in Ameluz Phase III Study(R) / BF Rhodo LED(R) for the treatment of actinic keratosis in the limbs or the trunk / throat in July 2018.
- Initiation of patient registration in the Ameluz III study. Phase(R) / BF Rhodo LED(R) for the treatment of surface basal cell carcinoma in the US in September 2018.
"With the successful implementation of our corporate strategy, we have the position and market potential of our Ameluz product(R) Professor Dr. Hermann Lübbert, Managing Director of Biofrontera, said: "During the reporting period, we have achieved and even exceeded our operational objectives, especially in the United States,(R) in dermatologists. This and a significant improvement in physician compensation through code J and revised CPT code for photodynamic therapy has led to a steady increase in sales to US customers. In the third quarter, the upward price increase of 5.6% to 285 USD from 1 October also had a positive impact on sales. In Europe, the approval of PDT daylight has boosted the PDT market. Overall, in September we achieved worldwide sales of more than 22,000 Ameluz tubes sold(R) Prof. Dr. Hermann Lübbert continues.
Group data for the first nine months of 2018:
|In TEUR, unless stated otherwise||9M 2018
from the sale of products
of development projects
|R & D expenditure||-3219||-3233||0%|
|General administrative costs||-7283||-3626||-101%|
|Profit before tax||-12253||-14614||16%|
|Earnings per share (EUR)||-0.28||-0.38||26%|
Biofrontera's total revenues for the first nine months of 2018 amounted to approximately € 14.6 million, up 98% y / y. In the US, sales for the same period last year increased by 204% to EUR 10.2 million. Sales in Germany increased to EUR 2.1 million, an increase of 24% over the previous year. In other European countries, revenue grew by 73% to € 2.1 million.
Gross profit increased by EUR 5.3 million over the first nine months to EUR 11.8 million compared to EUR 6.4 million in the same period of the previous year. Gross margin decreased from 88% in the first months of 2017 to 81% in the first nine months of 2018. This is due to a significant decrease in sales from other regions or development projects that were not offset by any selling costs in the same period of the previous year.
Profit before tax for the first nine months of 2018 amounted to -12.3 mn EUR or -0.28 EUR per share compared to EUR -14.6 mn and -0.38 mn in the same period of the previous year.
Cash and cash equivalents amounted to EUR 21.1 million as at 30 September 2018, compared with EUR 11.1 million as at 31 December 2017.
Given recent business developments, the management of Biofrontera AG in October forecasts sales for the current year from 16 to 20 million euros to 19
EUR 22 million, while the forecast for the consolidation result in 2018 will not change to -15 to -16 million.
Business activity in the US
The US remains the largest growth market. In the first nine months, sales increased by 204% in the same period of the previous year to € 10.2 million. Significant improvements in doctor fees through Code J and revised CPTs led to a steady increase in sales to US clients. Third quarter revenues were further boosted by a 5.6% impact since 1 October due to the upcoming price increase. Another milestone in the last quarter was the completion of a five-year contract with the US Veterinary Ministry in August 2018 that will allow us to offer Ameluz (R) to all US Veterinary and Healthcare Departments.
Business activity in Europe
In the first nine months of the year, Biofrontera recorded sales growth of 73% in other European countries compared with the same period of the previous year. With the consent of Ameluz(R) for the treatment of actinic keratosis with photodynamic day therapy (daylight PDT) in Europe is Ameluz(R) now more competitive with existing PDTs and topical medications. In Germany, our largest market in the EU, the PDT Daylight Approval Status, Ameluz's payout status(R) drastically better. As a result, we recorded a significant revenue growth of 24% to EUR 2.1 million over the same period of the previous year. This increase in sales is mainly due to summer months. In addition, we observe the introduction of Ameluzu(R) combined with PDT daylight, the overall PDT market expansion.
In July 2018, Biofrontera completed the preparation of patients for an ongoing Phase III trial with Ameluz(R) for the treatment of actinic keratoses in the limbs, trunk and neck. The company expects this study to further increase Ameluz's market potential(R) and awaits results in the first quarter of 2019. After successful approval Ameluz will be(R) the only PDT drug in Europe and the US that allows surface treatment of actinic keratoses in the limbs as well as fuselage / neck and for all degrees of severity.
In order to increase growth opportunities on the US market, this is still the case in the medium term
Biofrontera is currently undergoing a study of the treatment of superficial basal cell carcinoma (BCC) with Ameluz(R) in conjunction with the red bulb BF-RhodoLED(R) which began patient recruitment in September 2018. The results of the study are expected in the first half of 2020. After successful FDA approval, Ameluz(R) the only drug in the US to treat surface BCC by photodynamic therapy. Biofrontera can offer patients and doctors a healing option with high efficiency and good cosmetic results for BCC.
Telephone conferences for shareholders and investors will take place on November 16, 2018, at the following dates:
Conference call – German
16 November 2018, 10:00 CET
Dial-in number: +49 (0) 69201744220
Confirmation number: 14005835 #
Conference Call – ENGLISH
16 November 2018, 14:00 CET
Dial-in US: +1 8774230830
Dial-in UK number: +44 2030092470
Confirmation number: 12331554 #
Enter the conference call five minutes before you start a conference call to ensure a precise start.
A quarterly statement for the first nine months of 2018 is available at https://www.biofrontera.com/en/investors/financial-reports.html
Please contact all questions:
|Contact for investors|
Thomas Schaffer, Chief Financial Officer
|Contact for journalists|
Biofrontera AG is a biopharmaceutical company specializing in the development and distribution of dermatological drugs and cosmetics.
A Leverkusen-based company with around 150 employees worldwide develops and markets innovative products for healing, protection and skin care. One of the most important products is Ameluz(R), a prescription drug for the treatment of light skin cancer and its precursors. Ameluz(R) has been marketed in the EU since 2012 and in the US since May 2016. In addition, the company sells dermocosmetics Belixos(R), special care for damaged or diseased skin. Biofrontera is the first German pharmaceutical company founded by founders to receive centralized European and American approval of their own medicines. The Biofronter Group was founded in 1997 by Prof. Chief Executive Officer. Dr. copper. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the Nasdaq Stock Exchange.
This announcement expressly or implicitly contains forward-looking statements regarding the business of Biofrontera AG. These forward-looking statements reflect Biofrontera's view as of the date of publication and include certain known and unknown risks. Actual results achieved by Biofrontera may differ materially from future results or performance outlined in the forward-looking statements. Biofrontera is not required to update forward-looking statements.
16.11.2018 Broadcasting of company reports submitted by DGAP – EQS Group AG.
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