Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the
“Company”), an international biopharmaceutical company, today
reported its consolidated results for the fiscal year ended
December 31, 2020. At the same time, the Company provided an
overview of current operational and clinical developments.
Key financial figures
FY2020
-
Revenue decreased by 3% to EUR 30.3 million compared to EUR 31.3
million in 2019;
-
Loss from operations amounted to EUR 7.6 million compared to a loss
of EUR 23.4 million in 2019;
-
Net loss before tax was EUR 12.7 million compared to a loss of EUR
4.8 million in 2019;
-
Cash and cash equivalents amounted to EUR 16.5 million as of
December 31, 2020, compared to EUR 11.1 million as of December 31,
2019.
Operational and clinical developments in
2020 and year-to-date
-
Reorganization of the US business and restructuring of
Biofrontera’s global sales organization;
-
Exclusive license and supply agreement with Maruho Co., Ltd. for
the development and commercialization of Ameluz® for all
indications in East Asia and Oceania incl. an immediate one-time
payment of EUR 6 million;
-
Approval from the European Commission for the label extension of
Ameluz® for the treatment of actinic keratosis (AK) on the entire
body;
-
Completion of the pharmacokinetics study and submission of the
application for amendment of the product information to the U.S.
Food and Drug Administration (FDA) to allow the simultaneous use of
three tubes of Ameluz® per treatment
-
Submission of the approval application to the FDA for a larger
red-light source, the BF-RhodoLED® XL, for photodynamic therapy
(PDT) in combination with Ameluz®.
“Overall, we managed to steer Biofrontera well
through a very challenging year - despite the decline in sales in
our largest sales market, the USA. Early implemented cost-saving
measures as well as cash inflows from the down payment received for
the license agreement with Maruho Co., Ltd. and from the fully
placed convertible bond in August successfully offset the negative
impact caused by the decline in product sales. In this context, the
strong fourth quarter also saw us reach operational breakeven at
Group level for the first time," explained Prof. Dr. Lübbert, CEO
of Biofrontera. "Encouragingly, sales in Germany continued to grow
even in the pandemic year, driven by the EU approval extension for
daylight PDT granted in 2018. We also recorded future-oriented
strategic successes on the regulatory and clinical side. The EU
approval extension for Ameluz® received in March, which now allows
PDT treatment of mild and moderate actinic keratoses not only on
the head but also on the entire body on label provided a further
unique selling point for Ameluz®. The completion of the
pharmacokinetics study, which tested the safety of PDT with the
simultaneous application of up to three tubes of Ameluz®.
represented another major milestone for us. The study report was
submitted to the FDA in February 2021 with the aim of removing a
restriction in the product information on the use of only one tube
per treatment. This is a prerequisite for the treatment of larger
body areas with several tubes of Ameluz® as well as for the
alignment of reimbursement modalities compared to the competitor
product in the USA and thus an increase in the competitiveness of
Ameluz® in this important market. Furthermore, to complement this
progress with an optimized light source, Biofrontera has developed
a new lamp model, the BF-RhodoLED® XL, which can be used to
illuminate larger skin areas."
in EUR thousands |
2020 |
|
2019 |
|
Q4 2020 |
Q4 2019 |
Total revenue |
30,346 |
|
31,265 |
|
9,516 |
|
12,206 |
|
Research and development costs |
(4,789 |
) |
(4,636 |
) |
(1,386 |
) |
(1,421 |
) |
General and administrative costs |
(9,150 |
) |
(16,275 |
) |
(2,268 |
) |
(4,167 |
) |
Sales costs |
(20,482 |
) |
(28,856 |
) |
(4,142 |
) |
(8,221 |
) |
Profit (loss) from operations |
(7,611 |
) |
(23,377 |
) |
753 |
|
(2,284 |
) |
Other (expenses) and income |
(2,418 |
) |
21,184 |
|
(788 |
) |
356 |
|
Net loss before tax |
(12,697 |
) |
(4,777 |
) |
(1,062 |
) |
(2,253 |
) |
Outlook and guidance 2021The
Biofrontera Group provides the following guidance for the full year
2021, which reflects the Group's assessment regarding the timing
and speed of recovery from the pandemic. We expect that due to the
vaccination programs, the pandemic will slowly subside in our key
sales markets, resulting in a growth momentum in the second half of
2021. However, our sales and thus business activities largely
depend on the further infection trend and the associated easing of
containment measures.
Respecting these circumstances, the Group
expects revenue from product sales of EUR 25 to 32 million in
fiscal year 2021.
EBITDA and EBIT will be introduced as key
performance indicators in our reporting starting in 2021. Both have
become established internationally as target metrics and will
replace the previously reported key performance indicator result
from operating activities.Based on the above assumptions, the
Biofrontera Group expects EBITDA (loss) to be between EUR (11)
million and EUR (14) million and EBIT (loss) between EUR (13)
million and EUR (16) million in 2021.
From today's perspective, the Biofrontera Group
has sufficient liquidity available for the coming 12 months, taking
into account the earnings expectations for 2021, cash on hand in
the amount of EUR 16.5 million as of December 31, 2020 as well as
the capital increase carried out in February 2021.
Commercialization of Ameluz® in the USA
Revenues generated from sales in the U.S.A. were
EUR 16.6 million, compared to EUR 23.3 million in 2019,
representing a decrease of 29% year-on-year. Revenues include EUR
0.3 million from product sales of Xepi® (previous year: EUR 0.6
million).
As reported above, Biofrontera was directly
affected by the global coronavirus crisis from mid-March 2020. From
that point on, rising infection rates and the official
recommendation of the American Academy of Dermatology to provide
patients with remote diagnosis and treatment whenever possible led
to significantly declining patient numbers and extensive, albeit
temporary, practice closures. In the wake of this, our U.S. sales
in particular declined sharply. As a result, the wholly owned
US-subsidiary Biofrontera Inc. initiated extensive cost-saving
measures, including headcount reductions. After sales of our
products initially fell to almost zero in April 2020, we observed a
slow recovery of our U.S. business again in the summer and later
the first signs of stabilization in line with the usual
seasonality. In many parts of the U.S., doctors' offices reopened
during the second half of the year, at least in part, and patients
showed increasing willingness to undergo treatment for actinic
keratosis. The fourth quarter of 2020 again experienced a
seasonally strong increase in sales, but overall sales in this
quarter also remained below the level of the previous year, in part
due to the so-called second wave of coronavirus infections.
Commercialization of Ameluz® in
EuropeRevenue from product sales in Germany increased by
approximately 11% to EUR 5.1 million in fiscal 2020 compared to EUR
4.6 million in 2019, despite Corona-related restrictions. In the
rest of Europe, the pandemic led to a decline in sales, with
product sales of EUR 2.1 million compared to EUR 2.6 million in the
prior-year period.
In Germany our sales team successfully leveraged
an approval extension granted in March 2020 to include the
treatment of actinic keratoses on the body and extremities, as well
as recent study results, to promote the benefits of Ameluz® to
dermatologists even during the crisis. The advantages of
daylight-PDT, which could be performed in good weather without
immediate contact with doctors, became particularly evident during
the summer months. Spain experienced a very positive sales
development at the beginning of the year prior to the outbreak of
the pandemic, after which business declined sharply due to the
strict lockdown regulations there. In the United Kingdom, sales
remained at a low level for almost the entire year due to the
pandemic.
Regional expansion of the
commercialization of Ameluz® On March 13, 2020, the
Company announced that it had signed a non-binding term sheet for
an exclusive license and supply agreement with medac GmbH Sp. z
o.o., Warsaw, the Polish subsidiary of medac Gesellschaft für
klinische Spezialpräparate mbH, for the commercialization of
Ameluz® and BF-RhodoLED® in Poland. A final agreement is expected
to be signed in 2021.
On April 20, 2020, Biofrontera concluded an
exclusive license and supply agreement with Maruho Co., Ltd.
(Maruho) for the development and commercialization of Ameluz® for
all indications in East Asia and Oceania. As part of the licensing
agreement, Biofrontera received a one-time payment of EUR 6.0
million from Maruho. In addition, Biofrontera will receive future
payments pending on the achievement of certain regulatory and sales
milestones as well as royalties on sales.
On December 7, 2020, the Company announced that
its wholly owned subsidiary Biofrontera Pharma GmbH and Galenica
AB, Malmö, Sweden (Galenica AB), signed an exclusive license and
supply agreement for the commercialization of both Ameluz® and
BF-RhodoLED® in in Schweden, Norwegen, Dänemark, Finnland und
Island. According to the agreement, Galenica AB receives exclusive
distribution rights for these regions and a right of first refusal
for commercialization in the Baltic States. After the amicable
termination of the agreement between Biofrontera and the former
distribution partner for these regions, Galenica AB is now working
towards the reintroduction of the products in Scandinavia by
mid-2021.
Regulatory and clinical progress
Based on a positive assessment by the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) on February 3, 2020, the European Commission
granted the formal label extension for Ameluz® on March 10, 2020,
which now also covers the treatment of mild and moderate actinic
keratoses (AK) on the extremities and trunk/neck with photodynamic
therapy (PDT).
In addition, the results of the follow-up phase
of the clinical comparative study on daylight PDT with Ameluz® and
Metvix® were included in the product information (SmPC). Ameluz®
showed significantly lower recurrence rates after 12 months at
19.5% compared to competitor Metvix® at 31.2%.
In October 2020, the clinical phase of the
pharmacokinetics study (PK study) in the USA was concluded. The PK
study tested the safety of PDT for the treatment of actinic
keratoses on larger or multiple areas with the simultaneous use of
up to three tubes of Ameluz®. The study report was submitted to the
FDA in February 2021 with the objective of removing a restriction
in the prescribing information for the use of only one tube per
treatment.
In addition, the development of the new
BF-RhodoLED® XL lamp, which enables the use of Ameluz® across
larger skin areas, was completed. The application for approval was
submitted to the FDA in March 2021.
Patient recruitment for the Phase III trial for
the treatment of basal cell carcinoma (BCC) with Ameluz® in the USA
continued in 2020 despite the pandemic.
Conference callConference calls
for shareholders and interested investors will be held on Tuesday,
April 13, 2021, at the following times:
In German, April 13, 2021, 10:00 am CEST (4:00
am EST)Dial-in number: +49 69201744220 Conference code:
35968911#
In English, April 13, 2021, 2:00 pm CEST (8:00
am EST)Dial-in number USA: +1 8774230830Dial-in number UK: +44
2030092470Conference code: 21491700#
Please dial in 10 minutes ahead of time to
ensure a timely start of the conference call.-End-
Biofrontera AGPamela Keck, Head of Investor
Relationsir@biofrontera.com+49-214-87632-0
About Biofrontera:
Biofrontera AG is a biopharmaceutical company
specializing in the development and sale of dermatological drugs
and medical cosmetics.
The Germany-based company, with over 150
employees worldwide, develops and markets innovative products for
the care, protection and treatment of the skin. The company’s lead
product is the combination of Ameluz®, a topical prescription drug,
and medical device BF-RhodoLED® for the photodynamic therapy of
certain superficial skin cancers and their precursors. Ameluz® has
been marketed in the EU since 2012 and in the United States since
May 2016. In addition, the company markets the prescription
medication Xepi® for the treatment of impetigo in the United
States. In the EU, the company also sells the dermocosmetics series
Belixos®, which offers specialized care for damaged or diseased
skin.
Biofrontera is the first German founder-led
pharmaceutical company to receive a centralized European and a US
approval for a drug developed in-house. The Biofrontera Group was
founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is
listed on the Frankfurt Stock Exchange (Prime Standard) and on the
US NASDAQ. 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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