Biofrontera progresses well in first half year 2015
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera progresses well in first half year 2015
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany, 14 August 2015 - Biofrontera (FSE/AIM:B8F), the
biopharmaceutical company focusing on sun-induced skin cancer has published its
unaudited consolidated results for the six month period ended 30 June 2015,
reporting an increase in revenues by 29% to EUR 1.57 million (2014 H1: EUR 1.22
million). The published half-yearly report is available in full on the
Company's website www.biofrontera.com.
Financial highlights
* Significant growth in sales revenue of 29% compared to the same period in
the previous year
* Improving sales performance in European countries outside German home market
* Consolidated profit/loss before tax: EUR -7.3 million, reflecting FDA
submission fee
* Cash and cash equivalents of EUR 4.1 million as at 30 June 2015
* Capital raise for FDA submission fee successfully completed
Operational highlights
* Approval application for Ameluz® and BF-RhodoLED® submitted to the FDA in
the USA
* Patient recruitment for the phase III trial on basal cell carcinoma
completed
* Successful takeover of sales and distribution in Spain from Allergan
* Preparations for marketing in the USA initiated, own US subsidiary founded,
Monica L. Tamborini appointed CEO of US Operations
The majority of revenues were again recorded in Germany with EUR 1.19 million
(2014 H1: EUR 915,000), which represents an increase of 30%. Product revenues in
other European countries also developed well with EUR 382,000 being achieved,
which represents an increase of 65% compared to the first half of the previous
year.
The Company reported a net loss before tax of EUR 7.3 million (2014 H1 loss:
EUR 5.4 million) which includes development costs of EUR 4.5 million (2014: EUR
2.1 million). The increase was primarily as a result of the application fee of
EUR 2.1 million which was paid to the FDA. This amount may be repaid by the FDA
as Biofrontera may be eligible for a waiver for small businesses.
Milestone Approaching - US filing for Ameluz(®)
One of Biofrontera's most important strategic goals is entering the US market
with its combination prescription drug Ameluz(®) and PDT-lamp BF-RhodoLED(®).
Both products are used together in photodynamic therapy for the treatment of
mild and moderate actinic keratosis. As announced during the period, the
Company's phase III actinic keratosis field therapy study with the drug/light
combination reported complete clearance in over 90% of treated patients, along
with a strong skin rejuvenation effect.
During the first half of 2015, results from all clinical studies were analysed
in the format requested by the FDA and the dossier was finalised. Submission to
the FDA was effected on 10 July 2015. This represents an outstanding milestone
in the history of Biofrontera. Management believes that globally there are very
few biotech companies that have been able to initiate an approval process with
the FDA for a drug developed in-house.
Marketing authorization will provide Biofrontera access to the largest
pharmaceutical market in the world with the associated significant and
transformational revenue potential for the Company.
European Approval Process for Ameluz(®) for the treatment of BCC
Biofrontera has also made good progress in its second project of strategic
importance, the label extension of the European approval of Ameluz(®) for the
treatment of basal cell carcinoma, one of the most frequently occurring forms of
skin cancer. Patient recruitment for this study was completed in May. The study
will therefore be finished by the end of 2015 and the extended approval is
expected to be achieved by mid-2016. This approval will, in management's view,
provide further revenue opportunities to the company far greater than with the
existing label.
Prof. Hermann Lübbert, Chief Executive Officer, commented: "We are well in line
with our targets for revenue development and can confirm our annual growth
expectation of 30% with revenue of EUR 4 to 5 million for the full year to 31
December 2015. We have also made great progress with the submission of the
application in the US as well as with completion of patient recruitment in our
Phase III study for basal cell carcinoma. Biofrontera is well underway to become
a much larger and much more prominent company in the short to medium term and we
will work very hard to secure significant value for all our shareholders".
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 / Justine James +44 (0)7872 061007
Background:
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, a cream, a gel and a scalp tonic, 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. The Belixos(®) Protect, a daily skincare for sun-
damaged skin, complements this dermo-cosmetic line. All products 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#1945419]
Unternehmensinformation / Kurzprofil:
Datum: 14.08.2015 - 08:00 Uhr
Sprache: Deutsch
News-ID 413747
Anzahl Zeichen: 8958
contact information:
Town:
Leverkusen
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 125 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Biofrontera progresses well in first half year 2015"
steht unter der journalistisch-redaktionellen Verantwortung von
Biofrontera AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
