31.08.2018
Biofrontera AG DE0006046113
DGAP-News: Biofrontera AG: Biofrontera reports significant revenue growth for the first 6 months of 2018
DGAP-News: Biofrontera AG / Key word(s): Half Year Results
Biofrontera AG: Biofrontera reports significant revenue growth for the first
6 months of 2018
31.08.2018 / 07:56
The issuer is solely responsible for the content of this announcement.
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Biofrontera reports significant revenue growth for the first 6 months of
2018
Leverkusen, Germany, August 31, 2018 - Biofrontera AG (NASDAQ: BFRA;
Frankfurt Stock Exchange: B8F) (the "Company"), an international
biopharmaceutical company, today reported its financial results for the six
months ended June 30, 2018 and provided an update on recent operational and
clinical developments.
- Total revenue increased 79% to approximately EUR 9.0 million for the first
six months of 2018, compared to approximately EUR 5.0 million in the same
period 2017.
- Product revenue increased 109% to approximately EUR 8.8 million for the
first six months of 2018, compared to approximately EUR 4.2 million in the
same period 2017.
- Net loss was approximately EUR 7.7 million or 0.18 per share in the first
half of 2018, compared to approximately EUR 8.7 million or 0.23 per share,
in the same period 2017.
- Grant of U.S. product-specific J-Code and revised CPT codes for more
favorable reimbursement for daylight photodynamic therapy (PDT) -prescribing
physicians in January 2018.
- Successfully completed capital increase and dual listing on the U.S.
NASDAQ Stock Market in February 2018.
- European Commission approved use of Ameluz(R) in combination with PDT in
March 2018.
"Throughout the first half of 2018, we continued to make significant
commercial and clinical advancements to optimize our product positioning and
market potential of Ameluz(R). In accordance with our strategy, we extended
the approvals of Ameluz(R) to include further uses and expanded our product
sales," says Prof. Dr. Hermann Lübbert, CEO of Biofrontera. "We successfully
doubled our revenue from product sales in the first six months of 2018
compared to the first 6 months last year, primarily driven by sales in the
U.S. as our sales force leverages improved reimbursement and coding clarity.
In the EU, the label extensions of Ameluz(R) for daylight photodynamic
therapy and the the treatment for basal cell carcinoma (BCC) have begun to
have a positive impact on our sales. Furthermore, the initiation of a U.S.
Phase III trial for the treatment of BCC this September and results of our
EU Phase III trial for the treatment of actinic keratoses on the
extremities, trunk and neck expected in 2019, both represent future growth
opportunities. We remain committed to the successful execution of our
strategy for Ameluz(R) as we position ourselves as a global leader in
photodynamic therapy and drive long-term shareholder value," commented Prof.
Dr. Hermann Lübbert, CEO of Biofrontera.
First Half 2018 Financial Highlights:
Thousands of EUR, except where noted 6M 2018 6M 2017 Change in %
Revenue 8,969.2 5,006.4 79%
from product sales 8,837.9 4,221.5 109%
from development projects 91.3 784.9 (88%)
other 40.0 0.0 n/a
Research and development costs (2,187.7) (2,185.4) 0%
Sales costs (8,310.9) (8,275.3) 0%
General administrative costs (4,078.9) (1,695.5) (141%)
Net loss (7,684.9) (8,736.6) 12%
Earnings per share (in EUR) (0.18) (0.23) 28%
Biofrontera generated total revenue of approximately EUR 9.0 million in the
first six months of 2018, representing 79% year-over-year growth. In the
U.S., revenues increased 170% during the first half of 2018 to EUR 6.4
million, compared to the same period 2017. Sales in Germany improved
slightly to EUR 1.2 million, representing a 7% increase compared to the
previous year. Revenue in the remainder of Europe amounted to EUR 1.2
million, an increase of 65% compared to the same period last year.
Gross profit increased 67% to EUR 7.3 million in the first half of 2018 from
EUR 4.4 million in the same period 2017. Gross margin decreased slightly to
81% in the first six months of 2018, compared to 87% for the same period in
the previous year. One-time costs for the introduction of larger production
batch sizes negatively affected gross margins.
The consolidated net loss for the first half of 2018 was EUR -7.7 million,
or EUR -0.18 per share, compared to the net loss of EUR -8.7 million, or EUR
-0.23 in the same period last year.
Cash and cash equivalents were EUR 26.3 million as of June 30, 2018,
compared to EUR 11.1 million as of December 31, 2017.
Management reaffirms the current guidance, including revenues of EUR 16 to
EUR 20 million for the full year 2018 and continues to expect a significant
increase in revenue for the second half of 2018.
U.S. Commercial and Operational Update
Biofrontera continued to generate strong sales in the U.S., increasing 170%
year-over-year to EUR 6.4 million for the first half of 2018. The Company's
53 U.S. employees, including 32 sales representatives and 5 regional
managers, continue to ramp up sales as dermatologists become more familiar
with Ameluz(R) and leverage the Company's unique product-specific J-code
(J7345) and revised CPT codes that significantly improved physician
reimbursement.
In August 2018, Biofrontera was awarded a 5-year contract with the U.S.
Department of Veterans Affairs (VA) for the sale of Ameluz(R) in combination
with the medical device BF-RhodoLED(R). This contract allows Biofrontera to
offer Ameluz(R) to all VA as well as U.S. Department of Defense medical
facilities. It further validates the efficacy of Ameluz(R) and allows more
patients to receive effective treatment.
EU Commercial Update
Biofrontera reported a 65% increase in revenues in all our European markets
in the first half of 2018 as compared to the same period in 2017. With the
initiation of sales of Ameluz(R) for BCC and the European Commissions'
approval for treatment with daylight PDT for actinic keratosis, Ameluz(R)
has become more competitive against existing PDT drugs, as well as
patient-applied topical treatments. The Company further strengthens its
market position with the launch of a dedicated UK sales team. In addition,
Ameluz(R) now qualifies for full reimbursement by public healthcare funds in
Germany.
Recently, Biofrontera announced that it had completed patient recruitment
for its Phase III trial of Ameluz(R) and BF-RhodoLED(R) for the treatment of
actinic keratoses on the extremities, trunk and neck. The multi-center,
randomized, double-blind, intra-individual study includes 50 patients at six
study sites in Germany. Results of the trial are expected in the first
quarter of 2019 with applications for marketing authorization extensions to
be submitted to the European Medicines Agency and the FDA by the third
quarter of 2019.
In February 2018, the Scottish Medicines Consortium recommended the
prescription of Ameluz(R) for the treatment of superficial or nodular basal
cell carcinoma within the National Health Service.
Operational Update
In July 2018, Biofrontera announced the completion of phase 1 of its
collaboration with Maruho Co., Ltd. Both companies are currently considering
a continuation of the collaboration under a new agreement. However, no
decision has yet been made concerning the details and timing of such a new
agreement.
In February 2018, Biofrontera successfully completed its initial public
offering in the U.S. of American Depositary Shares and concurrent preemptive
rights offering of its ordinary shares to its existing holders of ordinary
shares. The Company received aggregate net proceeds from its offerings of
approximately EUR 21.6 million.
Conference Call
Conference calls for shareholders and interested investors will be held on
August 31, 2018 at the following times:
In German, at 10:00 am CEST (4:00 am EDT)
Dial-in number Germany: +49 (0)69 2222 25204
Conference code: 3448423
In English, at 2:30 pm CEST (8:30 am EDT)
Dial-in number USA: +1 929 477 0402
Dial-in number UK: +44 (0)330 336 9411
Conference code: 5675352
Please dial in 5 minutes ahead of time to ensure a timely start of the
conference call.
The Company's half-year report including financial statements is available
at
www.biofrontera.com/en/investors/financial-reports.
-End-
For enquiries, please contact: +49 (0) 214 87 63 2 0
Biofrontera AG [email protected]
Thomas Schaffer, Chief Financial Officer
IR UK: Seton Services +44 (0) 207 224 8468
Toni Vallen
IR and PR US: The Ruth Group +1 646-536-7035
IR: Tram Bui +1 508-280-6592
PR: Kirsten Thomas
About Biofrontera:
Biofrontera AG is an international biopharmaceutical company specializing in
the development and commercialization of a platform of pharmaceutical
products for the treatment of dermatological conditions and diseases caused
primarily by exposure to sunlight that results in sun damage to the skin.
Biofrontera's approved products focus on the treatment in the U.S. and
Europe of actinic keratoses, which are skin lesions that can sometimes lead
to skin cancer, as well as the treatment of certain forms of basal cell
carcinoma in the European Union. American Depositary Shares representing
Biofrontera's ordinary shares are listed on the NASDAQ Capital Market under
the symbol "BFRA", and Biofrontera's ordinary shares are listed in the
Frankfurt Stock Exchange (B8F, ISIN: DE0006046113). Information is also
available at www.biofrontera.com.
Forward Looking Statements:
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995 regarding
the public offering and the intended use of proceeds from the offering.
These statements may be identified by the use of forward-looking words such
as "anticipate," "believe," "forecast," "estimate" and "intend," among
others. Such forward-looking statements are based on the currently held
beliefs and assumptions of the management of Biofrontera AG, which are
expressed in good faith and, in their opinion, reasonable. Forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause the actual results, financial condition, performance, or
achievements of the Company, or industry results, to differ materially from
the results, financial condition, performance or achievements expressed or
implied by such forward-looking statements. These risks, uncertainties and
other factors are set forth in the Registration Statement on Form F-1 filed
with the SEC, including in the section "Risk Factors," and in future reports
filed with the SEC. Given these risks, uncertainties and other factors,
prospective investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake an obligation to
update or revise any forward-looking statement.
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31.08.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: Biofrontera AG
Hemmelrather Weg 201
51377 Leverkusen
Germany
Phone: +49 (0)214 87632 0
Fax: +49 (0)214 87632 90
E-mail: [email protected]
Internet: www.biofrontera.com
ISIN: DE0006046113, NASDAQ: BFRA
WKN: 604611
Listed: Regulated Market in Dusseldorf, Frankfurt (Prime
Standard); Regulated Unofficial Market in Berlin, Hamburg,
Munich, Stuttgart, Tradegate Exchange; Nasdaq
End of News DGAP News Service
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