30.04.2018
Biofrontera AG DE0006046113
DGAP-News: Biofrontera AG: Biofrontera Reports Full Year 2017 Financial Results
DGAP-News: Biofrontera AG / Key word(s): Final Results/Market Report
Biofrontera AG: Biofrontera Reports Full Year 2017 Financial Results
30.04.2018 / 08:15
The issuer is solely responsible for the content of this announcement.
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Biofrontera Reports Full Year 2017 Financial Results
Leverkusen, Germany, April 30, 2018 - Biofrontera AG (NASDAQ: BFRA;
Frankfurt Stock Exchange: B8F) ("Biofrontera" or the "Company"), an
international biopharmaceutical company, today reported its consolidated
financial results for the full year ended December 31, 2017 and provided an
update on recent operational and clinical developments.
"Over the course of 2017, we have diligently executed on our growth strategy
as we aim to establish Biofrontera as a leader in the treatment of
sun-induced skin cancers using photodynamic therapy (PDT). We reported U.S.
revenue from our first full year of sales in the U.S. of EUR6.3 million with
the support of an expanded sales and marketing infrastructure. We anticipate
continued growth in the U.S. with sales rep productivity increases resulting
from a product specific J-code and more favorable reimbursement for PDT
therapies. Furthermore, our recent Investigational New Drug (IND) filing for
basal cell carcinoma (BCC) in the U.S. represents another expansion
opportunity for Ameluz(R), our principal drug product. We expect to see
renewed growth in Europe from the recent approval from the European
Commission to expand the indication of Ameluz(R) to include the treatment of
field cancerization and actinic keratosis in combination with daylight PDT.
The daylight PDT approval makes Ameluz(R) more competitive and eligible for
reimbursement in the large self-applied topical market," commented Prof. Dr.
Hermann Lübbert, CEO of Biofrontera.
"Our recent successful initial public offering (IPO) of American Depositary
Shares (ADS) in the U.S. and concurrent rights offering in Germany, which
offerings raised in the aggregate approximately EUR21.6 million in net
proceeds, will further support the Company's future growth and expansion
initiatives for Ameluz(R).
We look forward to working to expand the reach of Ameluz(R) with new
indications and leverage more favorable reimbursement in the U.S. with a
robust sales and marketing organization. We appreciate the support of our
employees and shareholders as we treat more patients effectively and in
turn, drive shareholder value," concluded Dr. Lübbert.
Full Year 2017 Financial Highlights:
- Revenues increased 96% to EUR12.0 million for the full year 2017, compared
to EUR6.1 million in the same period 2016
- Revenues in the U.S. were EUR6.3 million for the full year 2017
- Gross profit increased 130% to EUR10.3 million for the full year 2017,
compared to EUR4.5 million in the previous year
- Research and development costs decreased 9% to EUR4.2 million in 2017,
compared to EUR4.6 million in 2016. The reduction is mainly due to a
decrease in regulatory fees in 2017
- Sales and marketing costs were EUR16.9 million for the full year 2017, an
increase of 93% from EUR8.8 million for the same period 2016. This increase
is mainly attributable to expenses related to expansion of sales structures,
and an increase in U.S. headcount
- Net loss was (EUR16.1 million) in the full year 2017, or (EUR0.42) per
share, compared to EUR10.6 million, or (EUR0.36) per share, in the same
period 2016
- Cash and cash equivalents were EUR11.1 million as of December 31, 2017,
not including proceeds from our recent rights offering and US IPO
- Completed early repayment of convertible bond 2016/2021
Recent Operational and Clinical Development Highlights:
- Successfully completed initial public offering (IPO) of American
Depositary Shares on the Nasdaq Capital Market with gross proceeds of $12.9
million in the U.S. and, in parallel, completed a preemptive rights offering
of Biofrontera's ordinary shares, with aggregate net proceeds from the U.S.
and German offerings of EUR21.6 million
- European Commission approved use of Ameluz(R) in combination with daylight
photodynamic therapy
- Received product-specific J-Code and revised CPT codes from The Centers
for Medicare and Medicaid Services (CMS) that should streamline
reimbursement for PDT prescribing physicians in the United States
- Filed Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) for Phase III trial of Ameluz(R) to treat Basal
Cell Carcinoma
- Strengthened U.S. commercial operations and internal sales support
services
Biofrontera generated total revenue of EUR12.0 million for the full year
2017, representing an increase of 96% year-over-year. Revenue in Germany
amounted to EUR2.7 million, representing a 6% increase compared with the
previous year. Revenues generated in European countries excluding Germany
grew 30% to EUR1.6 million, compared to EUR1.2 million in 2016. In the U.S.,
revenues grew significantly to EUR6.3 million for the full year 2017.
Revenue from Biofrontera's development partnership with Maruho amounted to
EUR1.4 million in 2017, compared to EUR1.2 million in 2016.
Gross profit increased 130% to EUR10.3 million in 2017 from EUR4.5 million
in 2016. Gross margin increased to 86% in 2017, compared to 73% in the same
period in the previous year. The gross margin improvement reflects higher
revenue from sales in the U.S. and in those European countries which are
marketed directly by the Company.
The consolidated net loss for the full year 2017 was (EUR16.1) million, or
(EUR0.42) per share. The increase from previous year's net loss of (EUR10.6)
million, or (EUR0.36) per share, was predominantly due to higher U.S. sales
and marketing expenses and investments.
Cash and cash equivalents were EUR11.1 million as of December 31, 2017,
compared to EUR15.1 million as of December 31, 2016. This amount does not
include the EUR21.6 million net proceeds raised from Biofrontera's U.S.
public offering and preemptive rights offering in February 2018.
U.S. Commercial Update
In 2017, Biofrontera significantly strengthened its presence in the United
States as a leader in treating actinic keratosis with photodynamic therapy
using Ameluz(R) and our BF-RhodoLED(R) lamp. Biofrontera reported total U.S.
sales of EUR6.3 million for the full year 2017. The Company currently has 35
sales representatives and sales managers covering the entire continental
U.S. and intends to modestly expand the sales force in 2018.
The Company received its unique product-specific billing code, or J-code
(J7345), as of January 2, 2018. The J-code provides reimbursement coding
clarity for dermatologists in the U.S., significantly streamlining the
reimbursement process for Ameluz(R). Additionally, in 2017, CMS published
revised CPT codes that established more favorable reimbursement for
photodynamic therapy, while also reducing reimbursement for traditional
cryotherapy treatments.
Biofrontera formally met with the FDA in July 2017 to discuss the
development pathway for the approval of Ameluz(R) for the treatment of
superficial BCC. The FDA provided guidance that approval could be based on a
single Phase III trial conducted in the U.S. In December, the Company filed
an investigational new drug (IND) application with the FDA to evaluate
Ameluz(R) PDT to placebo PDT. According to FDA's response Biofrontera
anticipates enrolling approximately 180 patients into the trial, with a
potential FDA approval for superficial BCC by 2021.
EU Commercial Update
In January 2017, the Company received approval from the European Commission
for the label expansion of Ameluz(R) to include basal cell carcinoma. The
label extension includes the treatment of superficial and/or nodular basal
cell carcinoma which is deemed unsuitable for surgical options due to
possible treatment-related morbidity or poor cosmetic outcome in adults. BCC
accounts for 50-80% of all skin cancer tumors worldwide and this extension
significantly increases the market opportunity for Ameluz(R) [as it now has
an increased presence in hospitals in the EU, where most dermatologists
practice in some countries in the EU.
In March 2018, Biofrontera also received the approval for the label
extension of Ameluz(R) to include treatment with daylight PDT for actinic
keratosis and field cancerization. This approval now allows Ameluz(R) to
directly compete within the patient-applied topical market and qualifies
Ameluz(R) for full reimbursement in Germany. The Company started marketing
Ameluz(R) with daylight PDT in the EU and believes that Ameluz(R) now has
the potential to gain additional market share in the EU where dermatologists
tend to favor self-applied topical treatments.
Operational Update
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 pursuant to German law to its
existing holders of ordinary shares. The ADSs began trading on The NASDAQ
Capital Market under the symbol "BFRA" on February 14, 2018. The Company
received aggregate net proceeds from its offerings of approximately EUR21.6
million.
The annual statement including financial statements is available at
www.biofrontera.com/en/investors/financial-reports.
-End-
Enquiries, please contact: +49 (0) 214 87 63 2 0
[email protected]
Biofrontera AG
Thomas Schaffer, Chief Financial Officer
IR Germany: Brainwell Asset Solutions +49 (0) 152 08931514
Jürgen Benker
IR UK: Seton Services +44(0) 20 7729 0805
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
that we will file 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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30.04.2018 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,
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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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