Biofrontera AG Annual Report 2022
1
Biofrontera AG Annual Report 2022
Content
Biofrontera AG – Annual Report 2022
Key figures 2022
Letter to shareholders
Report of the Supervisory Board of Biofrontera AG for
the financial year 2022 (unaudited)
Corporate Governance Statement of Biofrontera AG
pursuant to Sections 289f, 315d HGB for the financial
year 2022 (unaudited)
Compensation Report
Highlights 2022
Consolidated management and group management
report for the fiscal year 2022
Consolidated balance sheet as of December 31, 2022
Consolidated statement of comprehensive income for
the fiscal year 2022
Consolidated statement of changes in equity for the
fiscal year 2022
Consolidated cash flow statement for the fiscal year
2022
Notes to the consolidated financial statements as of
December 31, 2022
Responsibility statement
Independent Auditor's Report
Page I
Page II
Page IV
Page X
Page XI
Page XXIV
Page 1
Page 35
Page 37
Page 38
Page 39
Page 40
Page 76
Page 77
Key figures 2022
Non-financial key performance indicators
Employees
Quality management
Biofrontera AG Annual Report 2022
I
In the reporting period, we made great progress towards our goal of growing the Biofrontera Group into a profitable
company. After Biofrontera had been generating losses for the past decades, we were now able to achieve positive
EBITDA and EBIT from our operating business, a significant step towards financial independence and profitability. The
restructuring of the Biofrontera Group has resulted in significant cost reductions, but also other cost-cutting measures,
such as the delisting of Biofrontera AG from the US capital market, have led to the significant savings. We will now
consistently pursue this chosen path by focusing tightly on growth-promoting measures, a decision in which the
Management and Supervisory Board are working together in a very trusting and, above all, results-oriented manner.
In addition, you, our shareholders, have given us the flexibility we need to respond quickly to market requirements
through resolutions adopted at the Shareholders' Meetings in 2022/23. We would like to sincerely thank you for this
trust.
In 2022, we achieved our sales targets and closed the reporting year with revenues of EUR 25.7 million. A direct
comparison with the 2021 figures is not possible because US revenues now came in as transfer prices within the license
agreement due to the deconsolidation of Biofrontera Inc. in December 2021. Nevertheless, our US license holder
generated with approximately 67% the largest share of the revenues. However, sales in the US market fell short of the
expectations of our US partner Biofrontera Inc., who had expected growth of 30% at the beginning of the year but only
realized market growth of 20% by the end of the year. It is therefore even more important that the Biofrontera Group
intensively analyzes the development opportunities in the US market, so that a solid planning for the coming months
and in long-term becomes possible. Currently, we are supporting US market growth through a clinical development
program with now four clinical studies running in parallel for the US label expansion of Ameluz®. We expect the first
submission of revised approval dossier to the FDA by the end of 2023.
The European market was able to record a slight single-digit increase, while the German market was slightly down in
terms of sales. This development was caused by shifts in sales resulting from reimported products from Spain. The
decree on pricing for Ameluz® in the Spanish market was removed in April 2022, but the parallel trade market was still
active until end of November. Now, this is over, and we expect solid market growth in 2023.
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Biofrontera AG Annual Report 2022
In the past few years, Biofrontera has been able to build up a business unit comprising research development, the
regulatory substructure, and a marketing and sales unit, which must now be self-financing. With the restructuring of the
Biofrontera Group that completed in the year under review, the path has now been set for organic growth. Ameluz® still
has great development potential, both through territorial expansion, but also through a fairly low-risk clinical
development profile. The task now is thus clearly focused on the growth markets that will enable us to grow organically
without moving away from the path of profitability we have already established. This is the only way to ensure that we
create the greatest possible value for all our shareholders.
The patent strategy that we have been consistently following for years to protect Ameluz® from competitors has
produced pleasing results in 2022. Ameluz® is protected in many parts of the world via the nanoemulsion formulation.
The patent has now also been granted in the USA, providing Ameluz® protection against generic products in this country.
Follow-up patents are in preparation to further extend this protection. Furthermore, in addition to a novel PDT lamp,
innovative PDT exposure protocols have also been patented. Here, too, various approvals were granted in 2022, providing
additional protection to the drug-device combination in US until 2040. Altogether, Biofrontera is not only working
intensively to protect its existing products but is also constantly modernizing the PDT market with innovative treatment
approaches .
Biofrontera is thus not only an innovation driver but is also able to hold an excellent position in the highly regulated
pharmaceutical market against the global players despite its relatively small company size.
This is feasible because of a flexible corporate structure that allows us to respond quickly to changing market conditions
and other factors beyond our control. My special thanks go to our employees, who are not afraid to take on new
challenges and grow from these tasks. And, of course, I can’t forget to thank our loyal shareholders, without their support
and trust we couldn’t have gotten where we are.
I am now delighted to be part of such a team.
Pilar de la Huerta Martínez
Chief Financial Officer Biofrontera AG
Biofrontera AG Annual Report 2022
III
Report of the Supervisory Board of Biofrontera AG for the financial
year 2022 (unaudited)
Dear Shareholders,
the 2022 financial year shows a positive operating result for Biofrontera AG. We want to further support this development with
significant cost-cutting measures and a clear focus on growth-enhancing measures. In doing so, the Supervisory Board is working
together with each other and with the new company management in a spirit of trust.
We would also like to thank our employees for their efforts in supporting the development of Biofrontera AG in the past financial
year.
Supervision and advice
The Supervisory Board performed the duties incumbent upon it by law, the Articles of Association, the German Corporate Governance
Code (the Code) and the Rules of Procedure. The Supervisory Board's activities included monitoring and advising the Executive Board
on the management of the Company and the Group. The Supervisory Board discussed forward-looking business decisions and plans
with the Executive Board.
The Executive Board provided the Supervisory Board with reports on the situation of the Company. The Supervisory Board was
informed by the Executive Board about the current development of the Company both in meetings and outside meetings. On the
basis of written and oral reports by the Executive Board, the Supervisory Board discussed the development of business and the
situation of the Company in its deliberations. In addition, there was an exchange of information and ideas between individual
Executive Board members and the Chairman of the Supervisory Board.
In the case of management measures, the Supervisory Board also reviewed their legality, regularity and expediency, as well as their
economic efficiency. The division of the operating activities of the Biofrontera Group into an independent US sales company on the
one hand and the (former) parent company Biofrontera AG on the other hand, which took place at the end of 2021, continues to be
of no sustainable value creation for the Biofrontera AG Group in the opinion of the Supervisory Board. However, in the view of the
Supervisory Board, a restructuring with the aim of re-combining the operating businesses is not readily feasible at present. The
circumstances and strategic consequences of the deconsolidation of the two companies therefore formed a focus of the Supervisory
Board's monitoring and advisory activities.
Deviations in the course of business from the plans were explained to the Supervisory Board by the Executive Board and discussed
with it. The extent to which the statutory requirements and the resolutions, suggestions and recommendations of the Supervisory
Board were subsequently taken into account or implemented by the Board of Management was also reviewed. The results led to
changes in the Executive Board.
The Supervisory Board adopted resolutions on certain measures after receiving relevant information and documents and after
consultation.
Meetings and their main areas of discussion
In the performance of its duties, the Supervisory Board held eleven meetings in the reporting year. All meetings were held as
telephone or video conferences.
At the meetings, the Executive Board reported on the current business situation. In particular, the Executive Board explained the
liquidity situation of the Company in the context of sales forecasts and cost planning.
At the meeting on February 23, 2022, the Supervisory Board discussed the 2022 budget with the Executive Board. At this meeting,
the Executive Board and Supervisory Board dealt in detail with the question of the financial situation and possible risk factors in this
respect.
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Biofrontera AG Annual Report 2020
At the meeting on April 29, 2022, the auditors reported in full to the Audit Committee and the Supervisory Board on the timing,
structure and results of the audit for fiscal 2021. After discussing the annual financial statements for 2021, the consolidated financial
statements and the combined management report, the Supervisory Board approved the auditors' reports, raised no objections
following the final results of its own review, and approved the annual and consolidated financial statements. It thus followed the
recommendation of its Audit Committee, which had previously held a meeting in the presence of the auditors and discussed the
annual financial statements 2021, the consolidated financial statements, the combined management report and the audit reports.
At the meeting on November 21, 2022, the new Executive Board reported in detail on the status of clinical trials and distribution
agreements, sales development, and market development and opportunities, particularly in Europe. In addition, the Supervisory
Board passed a resolution on the proposed resolutions for the Extraordinary General Meeting on January 9, 2023. Together with the
Management Board, the strategic orientation and development potential of the Company in the current environment were discussed.
The Supervisory Board is also constantly concerned with the efficiency of its activities. Overall, the Supervisory Board has come to
the conclusion that its cooperation adequately reflects the tasks of the Supervisory Board and the needs of the Company.
Prepared by the Personnel Committee, the possible future appointment of an additional Executive Board member was also discussed,
along with a possible requirements profile and the further procedure in this matter.
Resolutions outside meetings
Outside of meetings, the Supervisory Board adopted resolutions in 37 parallel proceedings, including on Executive Board matters,
legal issues, and in connection with the Annual General Meetings in fiscal 2022.
Committees of the Supervisory Board
In the financial year 2022, there was an Audit Committee, a Nomination and Personnel Committee, and a Litigation Committee
concerning the proceedings of Deutsche Balaton AG against Biofrontera AG. The Supervisory Board appointed one member of the
Supervisory Board to chair each committee.
According to the Rules of Procedure of the Supervisory Board, the Chairman of the Supervisory Board shall also chair the committees
that deal with Executive Board contracts and prepare the Supervisory Board meetings. Although the Supervisory Board Chairman
was not Chairman of the Nomination and Personnel Committee dealing with Executive Board contracts in fiscal year 2022, he was a
member of this committee. The Supervisory Board considers the deviation from the target provision of the Rules of Procedure in
this respect to be harmless in terms of content. The Chairman of the Supervisory Board was not supposed to chair the Audit
Committee, and this was not the case. The chairmen of the committees report to the Supervisory Board at each meeting on the work
of the committees, with the exception of the Legal Action Committee.
1. audit committee
The Audit Committee deals in particular with accounting and risk management issues, the necessary independence of the auditor
and the issuing of the audit engagement to the auditor and monitors the audit of the Company's annual financial statements. The
committee met 15 times in the reporting year, with all meetings held as video conferences.
The members of the Audit Committee in the reporting year were: Mr. Karlheinz Schmelig (Chairman since February 22, 2022), Dr.
Helge Lubenow and, since February 22, 2022, Dr. Jörgen Tielmann. Prof. Dr. Franca Ruhwedel was also a member and Chair of the
Committee until February 22, 2022, when she stepped down.
2. nomination and personnel committee
The Nomination and Personnel Committee prepares, among other things, decisions of the Supervisory Board on the appointment
and dismissal of members of the Executive Board. As the Supervisory Board as a whole is also responsible for compensation
Biofrontera AG Annual Report 2020
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decisions, the Personnel Committee also performed preparatory work in this respect. In the reporting year, it dealt in particular with
the requirements for qualifications and critical monitoring of the performance of Executive Board members. In this context, the
departure of the Chief Financial Officer Mr. Lutter and the appointment of Mr. Böckmann as interim Executive Board member as well
as the appointment of Mrs. de la Huerta Martinez to the Executive Board.
The Nomination and Personnel Committee met twice in the reporting period; both meetings were held as video conferences. In
addition to these formal meetings of the Nomination and Personnel Committee, the members of the committee held informal
exchanges at least once a month.
The members of the Personnel Committee in the reporting period were: Dr. Helge Lubenow (Chair), Mr. Wilhelm K.T. Zours and Dr.
Heikki Lanckriet.
3. other committees
In this respect, reference is made to the following section "Conflicts of interest".
Individualized disclosure of Supervisory Board members' attendance at
Supervisory Board and committee meetings in fiscal year 2022
Name
Supervisory Board
meetings / Attendance
Attendance %
Prof. Dr. Franca Ruhwedel
(Member until February 22, 2022)
1/1
Dr. Heikki Lanckriet
Dr. Helge Lubenow
Karlheinz Schmelig
Prof. Dr. Karin Lergenmüller
(Member since August 23, 2022)
Dr. Jörgen Tielmann
Wilhelm K. T. Zours
11/11
11/11
11/11
1/1
11/11
11/11
* No membership of a committee in the year under review
100%
100%
100%
100%
100%
100%
100%
Committee
meetings /
Attendance
0/0
2/2
18/18
16/16
0/0 *
16/16
2/2
Attendance %
100%
100%
100%
100%
100%
100%
100%
Annual and consolidated financial statements 2022
Baker Tilly GmbH & Co. KG Wirtschaftsprüfungsgesellschaft, Düsseldorf, was appointed auditor of the annual financial statements
and consolidated financial statements for fiscal 2022 by the Annual General Meeting on August 23, 2022, and subsequently
commissioned accordingly by the Supervisory Board. The auditor's declaration of independence was obtained. Baker Tilly GmbH &
Co. KG Wirtschaftsprüfungsgesellschaft, Düsseldorf, audited the annual and consolidated financial statements of Biofrontera AG and
the combined management report for the 2022 financial year prepared by the Executive Board and issued an unqualified audit
opinion. The auditor also found that the Executive Board has set up an appropriate information and monitoring system, the design
and operation of which are suitable for the early identification of developments that could jeopardize the continued existence of
the company.
The consolidated financial statements were prepared on the basis of International Financial Reporting Standards (IFRS). The financial
statement documents were discussed by the Audit Committee on April 24, 2023 in the presence of the auditor and the other members
of the Supervisory Board. At this meeting, the annual and consolidated financial statements were also discussed with the Executive
Board. The Audit Committee dealt in particular with the key audit matters described in the respective audit opinion, including the
audit procedures performed. The financial statement documents were discussed in the presence of the auditors. All members of the
Supervisory Board received the financial statement documents and the auditors' reports in good time before this meeting and dealt
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Biofrontera AG Annual Report 2020
with these documents. The auditors reported on the audit, commented on the main points of the audit and were available to the
Supervisory Board to answer questions and provide information. The auditors reported on the scope, focal points and main findings
of their audit, focusing in particular on the key audit matters and the audit procedures performed. The auditors were available to
the Supervisory Board to answer questions and provide further information. Questions from the Supervisory Board were answered
by the Executive Board and the auditors. The auditors also provided information on their findings regarding internal control and risk
management in relation to the financial reporting process.
At its balance sheet meeting on April 27, 2023, the Supervisory Board noted with approval the audit reports as well as the annual
and consolidated financial statements and the combined management report. After discussing the annual financial statements, the
consolidated financial statements and the combined management report, the Supervisory Board concurred with the auditor's
reports and the results of the audit, raised no objections following the final results of its own review, and approved the annual and
consolidated financial statements. The annual financial statements of Biofrontera AG were thus adopted.
This report of the Supervisory Board was adopted at the financial statements meeting on April 27, 2023, as was the corporate
governance declaration.
Auditor and responsible auditor
Baker Tilly GmbH & Co. KG Wirtschaftsprüfungsgesellschaft, Düsseldorf, is acting as auditor for Biofrontera AG and the Group for the
first time for the 2022 financial year.
Corporate Governance and Declaration of Conformity pursuant to Section 161 of
the German Stock Corporation Act (AktG)
Information on corporate governance is presented in the Annual Report and on the internet at www.biofrontera.com in the section
"Investors" / "Corporate Governance" and in the Corporate Governance Statement. There, in particular, details are also provided on
the objectives of the Supervisory Board with regard to its composition and the status of implementation.
Trainings and development measures
The Company supports the members of the Supervisory Board to an appropriate extent in their induction into office and in training
and development measures.
Conflicts of interest
Each member of the Supervisory Board is obliged to act in the interests of the Company. In making decisions, they may not pursue
personal interests or take advantage of business opportunities to which the company is entitled for their own benefit without a
resolution of the Supervisory Board. The Rules of Procedure of the Supervisory Board stipulate that each member of the Supervisory
Board shall disclose conflicts of interest to the Supervisory Board. This applies in particular to conflicts of interest that may arise
as a result of a consultancy or board position with customers, suppliers, lenders or other business partners. Material and not merely
temporary conflicts of interest in the person of a Supervisory Board member shall lead to the termination of the mandate.
On December 13, 2021, Deutsche Balaton AG, Heidelberg, filed a declaratory action against Biofrontera AG with the Cologne Regional
Court, which was decided by the Cologne Regional Court on December 9, 2022. Mr. Wilhelm K.T. Zours indirectly holds the majority of
shares in Deutsche Balaton AG via VV Beteiligungen AG and is Chairman of the Supervisory Board of Deutsche Balaton AG. There is a
de-entitlement agreement between VV Beteiligungen AG and Deutsche Balaton AG. Since December 14, 2021, Mr. Zours has also been
a member of the Company's Supervisory Board and its Chairman. In essence, the lawsuit was about Deutsche Balaton AG's opinion -
shared by the Cologne Regional Court in its judgment - that the IPO of Biofrontera Inc. together with capital measures would have
Biofrontera AG Annual Report 2020
VII
required the approval of the Annual General Meeting of Biofrontera AG. The action was directed against Biofrontera AG, represented
by the Management Board and represented by the Supervisory Board. After becoming aware of the lawsuit, the Supervisory Board
resolved that a committee be formed in this connection and appointed the following Supervisory Board members to the committee:
Mr. Jörgen Tielmann (Chairman), Mr. Karlheinz Schmelig and Dr. Helge Lubenow. The Litigation Committee met once in the reporting
period and otherwise passed resolutions in parallel proceedings.
Mr. Zours therefore did not participate in any deliberations or resolutions in connection with the lawsuit.
In the view of the Supervisory Board, the conflict of interest has thus been adequately taken into account. Even from a retrospective
perspective, it cannot be determined that there was a material and not merely temporary conflict of interest that would have
necessitated termination of the mandate.
Changes in the Supervisory Board
By resolution of the Annual General Meeting on August 23, 2022, Prof. Dr. Karin Lergenmüller was elected to the Supervisory Board
of Biofrontera AG until the end of the Annual General Meeting for the financial year ending on December 31, 2025. With the
appointment of Prof. Dr. Karin Lergenmüller, the Supervisory Board is once again composed of six members in accordance with the
Articles of Association; until August 23, 2022, it consisted of only five members following the resignation of Prof. Dr. Franca Ruhwedel
as of February 22, 2022.
Maruho Deutschland GmbH filed an action for annulment against the resolution. By further resolution of January 9, 2023, the Annual
General Meeting confirmed the election. In an extension of the action, Maruho Deutschland GmbH is also contesting this confirmation
resolution. The Company is currently conducting settlement negotiations with Maruho Deutschland GmbH to resolve the legal
dispute.
Changes in the Management Board
Effective August 14, 2022, Mr. Ludwig Lutter (Chief Financial Officer) resigned from Biofrontera AG. Legal proceedings are pending
between Mr. Lutter and the Company in which Mr. Lutter is asserting further payment claims arising from his Management Board
service contract, which was terminated by summary dismissal for cause. The interim Management Board mandate of Mr. Paul
Böckmann existed from June 9, 2022 and expired on September 30, 2022. However, he continued to support Biofrontera AG as an
external advisor during the reporting period even after his departure. In September 2022, Mrs. Pilar de la Huerta Martinez, currently
the only member of the Management Board, was appointed Chief Financial Officer. Mrs. Pilar de la Huerta has been CEO and CFO of
various technology companies in the pharmaceutical and healthcare sector for more than 25 years and thus has relevant industry
experience and a high level of professional aptitude. The Supervisory Board would like to thank Mrs. de la Huerta and Mr. Böckmann
for their strong commitment to the Company in a challenging phase of business development and for the trustful cooperation.
Future
The Supervisory Board considers discussions between Biofrontera AG and Biofrontera Inc. on further restructuring steps with the
aim of optimally combining the operating businesses to be expedient.
Even if Biofrontera AG can report a positive operating result for the 2022 financial year, we must not overlook the fact that we form
a "community of fate" with Biofrontera Inc. in which we continue to hold around 30% of the shares and which is reporting high
losses. The economic success of Biofrontera AG in the future depends to a large extent on the sales success of Biofrontera Inc. on
the US market. Only if Biofrontera Inc., equipped with the funds required until Biofrontera Inc. breaks even, can continue to
significantly increase its sales, can Biofrontera AG also continue to develop positively. The share of the US market in total sales of
the product Ameluz® is expected to continue to increase, as is the dependence of Biofrontera AG's earnings on the success of
Biofrontera Inc.
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Biofrontera AG Annual Report 2020
The development of the Biofrontera share price was also unsatisfactory in 2022. In the coming period, the Supervisory Board and
the Management Board will continue to work constructively and in a results-oriented manner to improve the economic situation of
Biofrontera AG and its valuation on the capital market.
Finally, we would again like to thank you, dear shareholders*, for your commitment and trust!
Heidelberg, April 27, 2023
Wilhelm K. T. Zours
Chairman of the Supervisory Board
Biofrontera AG Annual Report 2020
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Corporate Governance Statement of Biofrontera AG pursuant to
Sections 289f, 315d HGB for the financial year 2022 (unaudited)
The Company has made use of the option not to include the corporate governance statement pursuant to Sections 289f, 315d of the
German Commercial Code (HGB) for the financial year 2021 in the (combined) management report for the financial year 2022, but
refers to the publication of this statement as well as the statement of the Management Board and the Supervisory Board of
Biofrontera AG (the Company) on the German Corporate Governance Code pursuant to Section 161 of the German Stock Corporation
Act (AktG) (unaudited) on the Company's website at www.biofrontera.com in the section "Investors", subsection "Corporate
Governance" with the corresponding labels.
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Biofrontera AG Annual Report 2020
Compensation Report
Remuneration system for the members of the Management Board:
Principles of the system for the remuneration of the members of the Management Board of Biofrontera AG.
The remuneration system for the Management Board aims to remunerate the members of the Management Board appropriately in
accordance with their duties and responsibilities, taking into account the performance of each member of the Management Board
and the success of the company. The structure of the remuneration system for the Management Board of Biofrontera AG aims to
achieve a sustainable increase in the value of the company and success-oriented corporate governance. The remuneration system
will apply to new contracts and contract extensions from December 2021. The performance of the Management Board members is
appropriately taken into account through adequately and ambitiously set performance criteria within the variable remuneration
components (pay for performance). Current market practice is taken into account when designing the compensation system.
In principle, the Supervisory Board is guided by the following guidelines when determining compensation levels and the
compensation system:
•
•
•
•
•
The compensation system in its entirety makes a significant contribution to promoting the business strategy.
To this end, the variable compensation components in particular should also be linked to the achievement of strategic
goals.
The remuneration system and the performance criteria of its variable components incentivize the long-term and
sustainable development of the Biofrontera Group.
In this context, the strategic objectives formulated as part of the variable remuneration components are intended to
ensure long-term and sustainable growth of the company.
Furthermore, variable remuneration components with a multi-year character are intended to contribute to ensuring long-
term developments, which are based on the price development of Biofrontera AG shares and thus link remuneration to
the increase in earnings and to the interests of shareholders.
The remuneration system consists of
•
•
•
a fixed basic remuneration, payable monthly, which takes into account the tasks and performance of the members of the
Management Board ("basic remuneration"),
a short-term variable compensation dependent on the achievement of the Company's annual performance targets in the
form of an annual performance-related bonus ("Short-Term Variable Compensation"; "STI"), and
long-term compensation in the form of a stock appreciation rights program ("SAR program"), which is therefore directly
linked to the Company's performance and is intended to create an incentive for sustained commitment to the Company
("long-term variable compensation"; "LTI"),
together. The targets for short- and long-term variable remuneration are derived from Biofrontera AG's corporate strategy. In
addition, fringe benefits customary in the market are granted.
Overall, the remuneration thus contributes to the long-term development of the company.
Target total compensation
The target total compensation for the individual Management Board members is calculated on the basis of 100% target achievement
and comprises the basic compensation, the short-term variable compensation and the long-term variable compensation.
The Supervisory Board determines the level of target total compensation for each Management Board member in accordance with
the compensation system.
Biofrontera AG Annual Report 2022
XI
In doing so, it shall take into account the economic situation as well as the success and future prospects of the Company in addition
to an appropriate relationship to the duties and performance of the Management Board member. The Supervisory Board shall ensure
that the target total compensation does not exceed the customary compensation without special justification.
The assessment of customary compensation is carried out both horizontally (external comparison/peer group comparison) and
vertically (internal comparison).
Horizontal comparison
The peer group for assessing the marketability of total compensation is selected on the basis of the requirements of the Stock
Corporation Act (in particular sector and size as well as international orientation).
The composition of the peer group is based on a peer group of listed companies in terms of sales, EBIT, number of employees and
market capitalization. Furthermore, the peer group is selected as far as possible from a peer group of listed sector companies.
Vertical comparison
The compensation and employment conditions of employees are taken into account in the vertical comparison. This analysis is also
carried out over the course of the last three years.
Compensation components in detail
Fixed compensation components
The fixed compensation components granted to the members of the Management Board under the compensation system comprise
basic compensation and fringe benefits. The members of the Management Board do not receive a pension commitment.
Basic compensation
The members of the Management Board receive basic compensation, which is paid in twelve equal monthly installments.
Fringe benefits
Fringe benefits are granted on the basis of service contracts with the individual members of the Management Board and may include,
for example: Private use of company cars, special payments such as payment of tuition, housing, rent and relocation expenses,
subsidies for pension insurance (with the exception of the pension commitments presented here), subsidies for accident, life and
health insurance or other insurances. Fringe benefits may be provided on a one-time or recurring basis. Fringe benefits shall not
exceed an annual value of 10% of annual base compensation.
Short-term variable compensation (Short Term Incentives; "STI").
Members of the Management Board are entitled to short-term variable compensation which may result in an annual bonus payment.
The short-term variable compensation is linked to the achievement of performance targets, the specific target values of which are
agreed at the end of a fiscal year.
The STI payment is generally due one month after approval of the annual financial statements and the consolidated financial
statements for the relevant fiscal year by the Company's Supervisory Board. If the Company terminates the employment relationship
for good cause within the meaning of section 626 of the German Civil Code (BGB), the STI payment shall lapse for the fiscal year in
which the termination takes effect.
Target amounts
Target amounts are agreed with the Management Board members in their service contracts, which are granted to them if they
achieve 100% of their targets ("STI target amounts"). The amount of the STI target amounts is not to exceed 50% of the basic
compensation in the case of 100% target achievement. The amount of short-term variable compensation depends on the degree of
achievement of the agreed targets and can range from 0% to 200%. The exact payout is determined by multiplying the degree of
target achievement by the STI target amount for the individual Management Board member. If the target is exceeded, an increase
up to a maximum of 200% of the STI target amount (cap) takes place. If the target is achieved by up to 70%, the short-term variable
compensation is reduced on a straight-line basis; if the target is achieved by less than 70%, the STI payment is cancelled completely.
Performance targets
In determining the annual target agreement, the Supervisory Board is guided by the following performance targets:
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Biofrontera AG Annual Report 2022
The assessment factors to be determined for the STI comprise financial and non-financial performance criteria and are mutually
agreed at the end of each fiscal year for the following fiscal year in a target agreement. If no agreement is reached between the
Management Board member and the Supervisory Board, the Supervisory Board shall decide on the assessment factors at its due
discretion.
In addition to the Company's sales, earnings and profitability indicators shall be used as financial performance criteria (e.g. EBITDA
(earnings before interest, taxes, depreciation and amortization), EBITDA margin). The Supervisory Board has the option of adjusting
the earnings figure used for the valuation for extraordinary components.
In addition to criteria such as integrity, employee satisfaction and diversity as well as sustainability/environmental social
governance (ESG) aspects, which should account for at least 10% of the overall target achievement, strategic criteria should be
included in the target agreement as non-financial performance criteria. These can be, for example: the achievement of regulatory
approvals, the successful completion of studies, the conclusion of important contracts, or the execution of financing.
A non-financial, strategic component is intended to take into account the contribution of the entire Management Board as well as
the individual Management Board members to the implementation of the corporate strategy and thus also to the long-term
development of the Company.
For the non-financial, strategic targets, the target agreement should comprehensibly define the conditions under which the
respective target is fully met (100% target achievement of the individual criterion) and which parameters are used to assess the
degree of target achievement.
Calculation of target achievement
The total target achievement of the short-term variable compensation is calculated as the weighted average of the individual
performance criteria and the degree of target achievement for each criterion. In the weighting of target achievement, the financial
performance criteria should generally account for up to 55%, the non-financial criteria for up to 45%.
Short-term variable compensation in the event of exceptional developments and performance by a member of the Management
Board
In justified exceptional cases, the Supervisory Board may also grant members of the Management Board a special bonus, the amount
of which shall be at the discretion of the Supervisory Board, but which may not exceed EUR 50,000 (gross) per fiscal year and
Management Board member. The resolution on the existence of an exceptional case, which shall indicate the scope and quality of
the extraordinary performance of the Management Board member, shall also specify in more detail the concrete amount of a special
bonus and the time of payment by the Supervisory Board.
Long-term variable compensation (long-term incentive; "LTI")
Stock appreciation rights ("SARs") are granted to Management Board members as a long-term performance component. An annual
target amount of 150% of the STI target amount ("LTI target amount") is agreed with the Management Board members. The number
of SARs granted each year is equal to the LTI target amount divided by the economic value of the SARs at the grant date. The
economic value per SAR to be used corresponds to the intrinsic value determined on the basis of the non-weighted average closing
prices of the Company's shares in the closing auction in Xetra trading on the Frankfurt Stock Exchange or a corresponding successor
system on the 15 trading days prior to the grant date. Upon exercise of the SARs, the Management Board members receive a payment
based on the Company's share price performance.
Exercise requirements
SARs can only be exercised,
(i) if the reference price at the beginning of the respective exercise window exceeds the issue price by at least 20%, and
and
(ii) if, in addition, the reference price has performed as well as or better than the "MSCI World Health Care Index TR" or a
comparable successor index ("reference index") on a percentage basis compared with the issue price in the period from
the last trading day before the issue date to the 5th trading day (in each case the last calculation of the index on a day
after USA Eastern Standard Time (EST)) before the start of the respective exercise window ("reference period"). If the
Biofrontera AG Annual Report 2022
XIII
reference index is a total return index, dividends and other distributions paid by the Company to shareholders during the
reference period shall be taken into account in the calculation of the performance in the amount of their gross amount.
The "issue price" corresponds to the non-weighted average closing price of the shares of the Company between the 15th and the
last trading day preceding the issue date (inclusive).
The "Reference Price" shall correspond to the non-weighted average closing price of the shares of the Company between the 15th
and the 5th trading day (each inclusive) prior to the beginning of the respective exercise window.
"Closing prices" are the prices determined in the daily closing auction in Xetra trading on the Frankfurt Stock Exchange or in a
corresponding successor system. If a closing auction does not take place on relevant trading days or if no closing price is determined
there, the last price determined in continuous trading shall be used as the closing price, provided that such a price was determined
on the relevant trading day.
"Trading days" shall mean all days on which the Frankfurt Stock Exchange is open for securities trading.
Payout amount
The payout amount is calculated as follows:
Reference price - base amount = payout amount per SAR (gross).
The "base amount" corresponds to the lowest issue price for Biofrontera AG shares pursuant to Section 9 (1) of the German Stock
Corporation Act (AktG).
Limitation of the amount paid out (cap)
SARs for which exercise conditions otherwise exist cannot be exercised if and to the extent that the gross proceeds from all exercised
SARs granted to the Management Board member would exceed the basic compensation plus fringe benefits actually received by the
Management Board member since the first grant of SARs by more than 300% without this cap.
Restriction periods
SARs may be exercised for the first time after a vesting period.
a) The vesting period for 15% of SARs granted on an issue date is one year after the respective issue date;
b) The vesting period for a further 25% of the SARs granted on an issue date is two years after the respective issue date;
c) The vesting period for an additional 25% of the SARs granted on an issue date is three years after the respective issue date;
d) The vesting period for the remaining 35% of the SARs granted on an issue date is four years after the respective issue date.
After expiration of the respective vesting period, the SARs may be exercised until the end of six years after the respective issue
date. After this period, the right to exercise the SARs ends and the SARs not exercised by then expire without replacement.
Personal investment
Under the SARs terms and conditions, Management Board members are also required to make a personal investment in shares of
the Company in such a way that the personal investment must be made within six months of the exercise date of the SARs in the
amount of 25% of the payment amount (gross) and that the acquired shares of the Company may not be sold until at least four
years after the SARs have been granted.
Share Ownership Guidelines
In order to further increase the long-term incentive effect of the variable compensation and thus its focus on sustainable corporate
development, the Management Board members are also obligated in their Management Board contract to acquire a number of shares
in the Company to be determined by the Supervisory Board and to hold them until the end of this service contract ("Share Ownership
Guideline"). However, the total acquisition expense (including incidental acquisition costs) to be borne by the Management Board
member is limited per fiscal year to an amount equivalent to 25% of the STI payment (gross) granted to him for the previous fiscal
year.
XIV
Biofrontera AG Annual Report 2022
Blocking periods
Blocking periods relating to acquired shares in the Company imposed on Management Board members end prematurely if, after the
Management Board member has left the Company, the Company announces that the listing of the shares on the regulated market
in Germany will be terminated.
Possibilities of the Company to reclaim variable compensation components
The Supervisory Board may determine that variable compensation components of the STI and/or LTI that have not yet been paid out
are to be retained in full or in part and not paid out ("claw back") in the event of serious misconduct by the Management Board
member. The Supervisory Board decides on the claw-back at its due discretion. Serious misconduct by the Management Board
member in this sense is to be assumed in particular,
a) if he at least grossly negligently breaches his duties under § 93 AktG or
b) if he has at least grossly negligently violated internal standards of conduct or internal guidelines laid down in text form
which have or had serious consequences for the Company, or
c) in the event of at least grossly negligent conduct relevant under criminal law in the exercise of his office as a member
of the Board of Management, or
d) in the event of a deliberate violation of other statutory provisions in the exercise of the office as a member of the Board
of Management.
e) The same applies in the event of serious misconduct by employees of the Company or the Group, in particular at least
grossly negligent violations of provisions of criminal law or compliance-relevant provisions, which was recognized by the
Management Board member in his capacity as the employee's supervisor and was not immediately prevented or which
should have been recognized and immediately prevented by exercising the due care of an Management Board member.
With regard to payments from the STI, clawback is only permissible for the fiscal year in which the misconduct occurred, but not for
previous or subsequent years. With regard to payments from the LTI, a clawback is permissible if and to the extent that the serious
misconduct occurred within the four years following the granting of the entitlement from the LTI (i.e. since the SARs were granted).
A claw back of the STI is also permissible in the event of grossly negligent misconduct that was discovered after the relevant annual
financial statements were approved and audited and that led to a subsequent correction of the Company's annual financial
statements. In this case, the claw back is allowed to the extent that the STI was overstated on the uncorrected basis.
If there is a case of claw back in accordance with the above provisions, amounts of the STI and/or the LTI that have already been
paid out and could therefore have been retained may also be reclaimed. Such a claim for repayment is permissible for the year in
which the claim was made and the previous three fiscal years, calculated from the date on which the Supervisory Board became
aware of the facts triggering the claim for repayment.
Amounts withheld under the claw-back or repaid by the Management Board member shall be offset against any claim for damages
by the Company resulting from the misconduct of the Management Board member.
Commitments to members of the Board of Management in the event of resignation
The Supervisory Board may determine exit regulations for each compensation component and for each case in which the
employment relationship of a member of the Management Board or the appointment as a member of the Management Board ends.
This includes cases such as retirement or full or partial reduction in earning capacity, death, ordinary termination of the service
contract or termination of the service contract for good cause, dismissal from office for good cause, transfer of a service contract
to the major shareholder of the Company or to a company affiliated with the major shareholder of the Company. For each of these
cases, the Supervisory Board may determine in advance what requirements apply in order for individual or all compensation
Biofrontera AG Annual Report 2022
XV
components to be paid either in full or in part, early or delayed, to the members of the Management Board or - in the event of death
- to the heirs of the member of the Management Board concerned, or to lapse.
In this context, any payment of variable compensation components shall be made exclusively in accordance with the agreed targets
and comparison parameters and the due dates or holding periods specified in the respective plan conditions.
Payments to a member of the Management Board on premature termination of his contract shall not exceed the value of two years'
compensation assuming 100% target achievement (severance payment cap) and shall not compensate more than the remaining
term of the employment contract.
Commitments for benefits in the event of premature termination of the employment contract by the Management Board member as
a result of a change of control should not be agreed.
The Supervisory Board may agree a post-contractual non-competition clause with members of the Management Board for a period
of up to two (2) years. If such a post-contractual non-competition clause takes effect, the members of the Management Board may
receive compensation amounting to up to half of their respective basic compensation per year of the respective period of validity
of the post-contractual non-competition clause. Payments under a post-contractual non-competition clause are to be offset against
any severance payments.
Compensation system in the event of special and exceptional circumstances
In special and exceptional circumstances (e.g. in the event of a severe financial or economic crisis), the Supervisory Board has the
right to temporarily deviate from the compensation system pursuant to Section 87a (2) sentence 2 AktG and to amend the rules
relating to the compensation structure and the individual compensation components as well as the rules on the respective
procedure, provided this is necessary in the interests of the long-term welfare of the Company. Unfavorable market developments
shall not be deemed to be special and exceptional circumstances permitting a deviation from the compensation system.
Maximum compensation
The following maximum amounts apply:
In Euro
Chairman of the Management Board
Other members of the Management Board
Basic remuneration
500.000 p.a.
350.000 p.a.
Max. 10 % of basic compensation
200% of the STI target amount p.a., which
should not exceed 50% of the basic
compensation if 100% of the target is
achieved
SARs for which exercise requirements are
otherwise met cannot be exercised if and to
the extent
the gross proceeds
generated from all exercised SARs granted to
the Management Board member would
exceed the basic compensation plus fringe
benefits
the
Management Board member since the first
grant of SARs by more than 300% without
this limit.
50.000 p.a.
received
actually
that
by
Max. 10 % of basic compensation
200% of the STI target amount p.a., which
should not exceed 50% of the basic
compensation if 100% of the target is
achieved
SARs for which exercise requirements are
otherwise met cannot be exercised if and to
the extent
the gross proceeds
generated from all exercised SARs granted to
the Management Board member would
exceed the basic compensation plus fringe
benefits
the
Management Board member since the first
grant of SARs by more than 300% without
this limit.
50.000 p.a.
received
actually
that
by
Fringe benefits
STI
LTI
Potential additional short-
term variable compensation
in the event of exceptional
developments
and
performance by a member
of the Management Board
Relative share of individual compensation components
XVI
Biofrontera AG Annual Report 2022
The Supervisory Board observes an appropriate ratio of the individual compensation components to the target total compensation.
The share of the Management Board members' compensation components in the target total compensation based on 100% target
achievement in the STI and payment of the LTI in the amount of the respective LTI target amount is as follows:
Basic compensation
STI compensation
LTI compensation
44 %
22%
33%
The share of the Management Board members' compensation components in the target total compensation based on 200% of the
STI target amount and 300% of the LTI target amount is as follows:
Basic compensation
STI compensation
LTI compensation
23,5%
23,5%
53%
The above percentages are based on the assumptions made. The actual percentages may deviate in future fiscal years and in the
event of the appointment of new members of the Management Board. The deviations may result in particular from the achievement
of STI and LTI targets and from annual expenses relating to fringe benefits.
Procedures for determining, reviewing and implementing the compensation system
The compensation of the Board of Management is determined by the Supervisory Board as a whole. To this end, the Personnel
Committee of the Supervisory Board prepares corresponding recommendations. If necessary, independent external advisors are
consulted. In accordance with the Rules of Procedure for the Supervisory Board, the members of the Supervisory Board are required
to report any conflicts of interest without delay. The Supervisory Board designs the system for the compensation of Management
Board members taking into account applicable laws and regulations, in particular the requirements of the German Stock Corporation
Act (AktG) as amended, regulatory requirements and the provisions of the German Corporate Governance Code. In doing so, it
ensures clarity and comprehensibility. The Supervisory Board determines the specific target total compensation on the basis of the
compensation system. The Management Board compensation system thus adopted by the Supervisory Board is submitted to the
Annual General Meeting for a resolution on its approval.
The Supervisory Board regularly reviews the Management Board compensation system and the appropriateness of the
compensation. The Personnel Committee of the Supervisory Board also prepares corresponding recommendations. At the end of a
fiscal year, the Supervisory Board also agrees with the Management Board on the specific target values for the short-term variable
Management Board compensation for the following fiscal year in a target agreement. In accordance with the requirements of Section
120a (1) of the German Stock Corporation Act (AktG), the Supervisory Board will submit the compensation system for the members
of the Management Board to the Annual General Meeting for approval in the event of significant changes, but at least every four
years. The present compensation system was confirmed by the Annual General Meeting on December 14, 2021.
In accordance with the statutory provision (Section 87a (2) AktG), the Supervisory Board may, at the proposal of the Personnel
Committee, temporarily deviate from the components of the compensation system described below in exceptional circumstances if
this is necessary in the interests of the long-term welfare of the Company.
Consideration of employees' remuneration and employment conditions when determining the compensation system
When determining the remuneration system and the specific amount of remuneration, the Supervisory Board also takes into account
the employment conditions of the employees in the Biofrontera Group. For this purpose, the Supervisory Board has defined the
senior management circle in the Biofrontera Group and distinguished it from the Management Board on the one hand and the total
workforce in the Biofrontera Group on the other. As part of the regular review of the appropriateness of the remuneration of the
Management Board, the Supervisory Board examines in particular whether any need for adjustment of the remuneration of the
Management Board arises from changes in the relations between the remuneration of the Management Board, the senior
Biofrontera AG Annual Report 2022
XVII
management and the total workforce. In doing so, the Supervisory Board also takes into account the development of the
compensation of the groups described over time.
Conflicts of interest
The Supervisory Board shall take appropriate measures to ensure that potential conflicts of interest of the Supervisory Board
members involved in the deliberations and decisions on the compensation system are avoided and, if necessary, resolved. In this
context, each member of the Supervisory Board is obliged to disclose conflicts of interest to the Chairman of the Supervisory Board.
The Chairman of the Supervisory Board shall disclose any conflicts of interest affecting him to his deputy. A decision on how to deal
with an existing conflict of interest shall be made on a case-by-case basis. In particular, a Supervisory Board member affected by a
conflict of interest may not attend a meeting or individual deliberations and decisions of the Supervisory Board or may abstain from
voting.
Terms of Management Board employment contracts
The agreed term of the employment contracts of the Management Board members corresponds to the term of the intended
appointment as a member of the Management Board. In the case of an initial appointment, the Supervisory Board shall determine
the duration of the appointment in a manner appropriate to the individual case and oriented to the welfare of the Company, whereby
the term of appointment shall in principle not exceed three years. The reappointment period shall be a maximum of five years, taking
into account the provision of § 84 AktG. In the event of a reappointment of the Management Board member, the employment contract
shall be extended in line with the duration of a reappointment; otherwise it shall end automatically, without the need for notice of
termination, on expiry of the scheduled regular term of appointment. Any extension of the employment contract or reappointment
shall be finally discussed with the Management Board member no later than 15 months before the expiry of the employment contract
or term of appointment and a decision taken 10 months before expiry.
Compensation system in the event of special and exceptional circumstances
In special and exceptional circumstances (e.g. in the event of a serious financial or economic crisis, restructuring of the Group under
company law such as spin-offs, acquisitions or sales of companies, or similar significant M&A transactions), the Supervisory Board
has the right to temporarily deviate from the compensation system in accordance with Section 87a (2) Sentence 2 AktG and to amend
the rules relating to the compensation structure and individual compensation components as well as the rules on the respective
procedure, provided this is necessary in the interests of the long-term well-being of the Company. A deviation from the compensation
system is only possible by a corresponding resolution of the Supervisory Board and after careful examination of the necessity. The
components of the compensation system from which deviation is possible in the above circumstances are the procedure, the
compensation structure, the individual compensation components and their performance criteria. Furthermore, in this case the
Supervisory Board may temporarily grant additional compensation components or replace individual compensation components
with other compensation components to the extent necessary to restore the appropriateness of Management Board compensation
in the specific situation.
Compensation in fiscal year 2022
The total compensation for members of the Management Board in the 2022 financial year and the total number of stock options
issued to members of the Management Board at December 31, 2022 are as follows:
XVIII
Biofrontera AG Annual Report 2022
Pilar de la Huerta Martìnez
CFO
Paul Böckmann
Ludwig Lutter
CFO
Term
in EUR thousands (unless otherwise inidcated)
September 12, 2022
0
incubent
Fixed component of compensation
Compensation in kind
Severance pay
Total fixed compensation
Short-term incentive (variable, STI)
Long-term incentive (variable, LTI), thereof from
Stock Appreciation Rights (SARs) (maturity May 3,
2030)
Fair value of SARs
Income from exercising SARs
Total LTI
Total performance-based compensation
Total compensation
Number of stock options (Dec 31)
Number of stock options granted
Fair value when granted
Number of SARs (Dec 31)
Number of SARs granted
Fair value when granted
86
4
0
90
0
0
0
0
0
0
0
90
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
June 9,2022 September 30, 2022 March 01, 2021 August 14, 2022
0
2022
2021
0
130
0
0
130
0
0
0
0
0
0
0
130
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
186
10
0
196
126
0
0
0
0
0
126
322
0
0
0
0
0
0
231
11
0
242
0
0
0
45
0
45
45
287
0
0
0
132,353
132,353
45
Paul Böckmann served the Company as interim Management Board member from June 09 to September 30, 2022. Prior to his
Management Board activity, Mr. Böckmann had already acted as a consultant for the Company since May 25, 2022, and has continued
this activity after the end of his Management Board activity, since October 01, 2022. For this advisory function, Mr. Böckmann received
a fee of EUR 66 thousand in fiscal year 2022.
Prof. Hermann Lübbert, as a former member of the Executive Board, received the bonus for 2021 in the amount of EUR 208 thousand
in June 2022, which was due in accordance with the target agreement.
Mr. Ludwig Lutter was dismissed from the Management Board for cause on August 14, 2022. A lawsuit filed by Mr. Lutter against the
termination without notice is currently still pending against the Company.
Ms. Pilar de la Huerta was appointed to the Company's Management Board as CFO on September 12, 2022 and has been conducting
business as sole member of the Management Board since October 01, 2022. She received a fee of EUR 23 thousand for her consulting
activities in the period from August 18, 2022 to September 12, 2022.
The non-performance-related compensation component amounts to 100% for Ms. de la Huerta and 61% for Mr. Lutter (previous year
84%).
Biofrontera AG Annual Report 2022
XIX
No stock options were granted to members of the Management Board in the financial year 2022. Furthermore, there are no
"promised" stock options within the meaning of Section 162 (1) sentence 2 no. 3 AktG.
The maximum compensation of the members of the Executive Board from the non-performance-related and the one-year
performance-related compensation (bonus) amounts to EUR 476 thousand for Ms. de la Huerta and EUR 540 thousand for Mr. Lutter.
The total for Mr. Lutter includes the LTIs. For Ms. de la Huerta, this has not yet been decided and contractually agreed. With regard
to the maximum compensation from the multi-year variable compensation, we refer to the following explanations on the stock
option program and SAR program.
The existing service agreements provide that - depending on the achievement of targets to be agreed - an annual bonus is to be
granted. The assessment factors are mutually agreed at the end of each fiscal year for the following fiscal year in a target agreement.
The 2021 target agreement defined the following: Sales level (30%), EBITDA (earnings before interest, taxes, depreciation and
amortization) (20%), additional financing of at least 10 million euros (30%), inclusion of a first patient in a new clinical trial (10%),
at least 40% female share in Biofrontera's management (10%).
Target definition
Weighting
Achievement
Revenue
Net loss (without
one-off effects)
Addiotonal
Funding
Research &
Development
37,425 TEUR
16,986 TEUR
10,000 TEUR
Inclusion of first
patient in new clinical
trial
30%
20%
30%
10%
28,786 TEUR
18,768 TEUR
24,000 TEUR
2
CT018 Safety
Phase 1 - 3 Tubes,
CT014 - Acne Phase
2b
Achievement
in %
77%
90%
170%
100%
Target
achievement
weighted
23%
18%
51%
10%
Sustainability
Achievement
40% females in
executive leadership
(Vice President and
above)
10%
43%
100%
10%
112%
The contractually agreed bonus for 100% target achievement amounts to EUR 185 thousand for Prof. Lübbert and EUR 113 thousand
for Ludwig Lutter. The aforementioned performance criteria set for 2021 were met 112% of the time, resulting in a bonus payment of
EUR 208 thousand for Prof. Hermann Lübbert and EUR 126 thousand for Ludwig Lutter in fiscal year 2022.
The benchmark for the achievement of the target for the amount of revenue and earnings after tax was the revenue or earnings
after tax according to the consolidated statement of comprehensive income for 2021, which was approved by the Supervisory Board.
For the additional financing, an amount of 10 million was decisive, for the clinical trial the recruitment and first treatment of a
patient. The ESG target "female leadership" was calculated as of December 31, 2021 on the basis of executives with the rank of vice
president and above.
The targets for 2022 were set at EUR 26.5 million for sales and EUR 0.3 million for EBITDA breakeven.
Compensation Report Supervisory Board
Compensation system for members of the Supervisory Board
XX
Biofrontera AG Annual Report 2022
Pursuant to Section 113 of the German Stock Corporation Act (AktG), the compensation of the members of the Supervisory Board
shall be commensurate with the tasks of the Supervisory Board members and the situation of the Company. The members of the
Supervisory Board are not involved in operational activities. Rather, the Supervisory Board contributes to the long-term
development of the Company through its monitoring activities. Recruiting outstanding members of the Supervisory Board is a
prerequisite for providing the best possible supervision and advice to the Management Board, which in turn makes a significant
contribution to a successful business strategy and the long-term success of the Company. The compensation should therefore also
make the assumption of a mandate appear sufficiently attractive from an economic point of view to be able to attract and retain
outstanding mandate holders, which also requires consideration of the compensation arrangements of other comparable listed
companies (the compensation and employment conditions of the employees, on the other hand, are not of material importance for
the compensation system of the Supervisory Board).
The Management Board and Supervisory Board are of the opinion that purely fixed compensation for the members of the Supervisory
Board is best suited to ensure independent fulfillment of the Supervisory Board's monitoring function, as variable compensation,
particularly in matters relevant to monitoring, could otherwise create a convergence of interests between the Management Board
and the Supervisory Board with regard to their own compensation. The granting of purely fixed compensation seems preferable in
this respect. Differentiated compensation for the individual functions on the Supervisory Board generally takes into account the
workload incurred by the Supervisory Board member in each case. Experience has shown that the workload is particularly high for
the Chairman of the Supervisory Board and his deputy, as well as for the chairmen and members of the committees, so that higher
compensation is envisaged in this respect. According to Recommendation C. 13 of the German Corporate Governance Code (as
amended on December 16, 2019) ("Code"), the higher time expenditure of the Chairman and Deputy Chairman of the Supervisory
Board as well as the Chairman and members of committees should be appropriately taken into account in the compensation of
Supervisory Board members. According to suggestion G. 18 of the Code, the compensation of the Supervisory Board should consist
of a fixed compensation. These aspects are appropriately reflected in the determination of Supervisory Board compensation in the
current version of Art. 18 of the Articles of Association.
The compensation is payable after the end of each quarter. There are no deferral periods for the payment of compensation
components.
Supervisory Board members who are members of the Supervisory Board or a committee for only part of the fiscal year, or who chair
or vice-chair the Supervisory Board or chair a committee, receive compensation on a pro rata basis.
There are no promises of compensation for dismissal, retirement or early retirement.
The Company reimburses the members of the Supervisory Board for expenses incurred in the performance of their duties, including
any value-added tax payable on the compensation and the reimbursement of expenses, and includes the performance of the duties
of the members of the Supervisory Board in the coverage of a pecuniary loss liability insurance policy taken out by the Company.
The compensation system for the Supervisory Board is adopted by the Annual General Meeting on the basis of a proposal by the
Management Board and the Supervisory Board, in the same way as a compensation regulation in the Articles of Association. At
regular intervals, at the latest every four years, the Management Board and Supervisory Board review whether the level and
composition of Supervisory Board compensation still appears to be in line with the market and appropriate and, if necessary, submit
proposals for adjustments to the Annual General Meeting.
As the members of the Supervisory Board are involved in the structuring of the compensation system relevant to them and must
also submit resolution proposals in this respect to the Annual General Meeting in accordance with § 124 AktG, an unavoidable conflict
of interest arises from the application of the law. However, this is effectively counteracted by the fact that the decision on the
ultimate determination of compensation is assigned to the Annual General Meeting.
Pursuant to Section 113 (3) sentences 1 and 2 of the German Stock Corporation Act (AktG), the Annual General Meeting of listed
companies must pass a resolution on the compensation of Supervisory Board members at least every four years, whereby a
resolution confirming the compensation is permissible. The compensation of Supervisory Board members is governed by § 18 of the
Company's Articles of Association. Section 18 of the Company's Articles of Association was adopted in its current version by the
Annual General Meeting on August 23, 2022 and reads:
" § 18 Compensation of the Supervisory Board
Biofrontera AG Annual Report 2022
XXI
(1) Each member of the Supervisory Board shall receive an annual fixed remuneration of EUR 22,000. The Chairperson shall receive
twice this amount, the Deputy Chairperson 1.5 times this amount.
(2) For their work on the Audit Committee of the Supervisory Board, those members of the Supervisory Board who are not
simultaneously Deputy Chairman or Chairman of the Supervisory Board shall receive additional remuneration of EUR 3,000; the
Chairman of the Audit Committee shall receive twice this amount.
(3) Supervisory Board members who are members of the Supervisory Board or the Audit Committee for only part of the fiscal year
or who chair or vice-chair the Supervisory Board or chair the Audit Committee shall receive remuneration on a pro rata basis.
(4) The remuneration shall be paid after the end of each financial year.
(5) The Company shall reimburse the members of the Supervisory Board against invoice for expenses incurred in the performance
of their duties, including any value added tax (VAT) payable on the remuneration and the reimbursement of expenses.
(6) The Company shall include the performance of the duties of the members of the Supervisory Board in the coverage of a pecuniary
damage liability insurance policy taken out by the Company."
In the immediately preceding version of the Articles of Association, applicable for the period until the resolution of the current
version by the Annual General Meeting on August 23, 2022, §18 was as follows:
"§18 Compensation of the Supervisory Board
(1) Each member of the Supervisory Board shall receive an annual fixed remuneration of EUR 20,000. The Chairman shall receive
twice this amount, the Deputy Chairman 1.5 times this amount.
(2) Members of the Supervisory Board shall additionally receive the following compensation for serving on Supervisory Board
committees:
a. Each member of the Audit Committee shall receive EUR 3,000, the Chairman of the Audit Committee shall receive twice this
amount.
b. Each member of another committee receives EUR 2,000, the chairman of another committee receives double this amount.
Membership of the Nomination Committee is not taken into account.
Committee activities are taken into account for a maximum of two committees. If this number is exceeded, the two highest-paid
memberships shall be decisive.
(3) Supervisory Board members who are members of the Supervisory Board or a committee for only part of the fiscal year or who
chair or vice-chair the Supervisory Board or chair a committee shall receive pro rata remuneration.
(4) In addition, the members of the Supervisory Board shall receive an attendance fee of EUR 1,000 for each participation in a meeting
of the Supervisory Board or its committees. Participation in telephone and video conferences or participation in a meeting by means
of connection by telephone and video conference shall be remunerated accordingly with an attendance fee. For several meetings -
whether of the Supervisory Board or of committees - held on one calendar day, an attendance fee shall be paid only once in total.
(5) Furthermore, the members of the Supervisory Board, with the exception of the Chairman and his Deputy, shall receive a
remuneration of EUR 4,000 for chairing a General Meeting.
(6) The remuneration shall be paid after the end of each quarter.
(7) The Company shall reimburse the members of the Supervisory Board for expenses incurred in the exercise of their office,
including any value-added tax (VAT) payable on the remuneration and the reimbursement of expenses.
(8) The Company shall include the performance of duties by the members of the Supervisory Board in the coverage of a pecuniary
damage liability insurance policy taken out by the Company."
XXII
Biofrontera AG Annual Report 2022
Compensation in fiscal year 2022
The total compensation of the members of the Supervisory Board in fiscal year 2022 is as follows:
in EUR thousands
Fixed compensation
Committee activity
Attendance fee
Total
in TEUR
in %
in TEUR
in %
in TEUR
in %
in TEUR
in %
Wilhelm K.T. Zours (Supervisory Board:
Chair) **
Dr. Jörgen Tielmann (Supervisory Board:
Vice Chair)
Dr. Heikki Lanckriet**
Dr. Helge Lubenow (Personnel
Committee: Chair)* **
Prof. Dr. Franca Ruhwedel (Audit
Committee: Chair until February 22,
2022)*
Prof. Dr. Karin Lergenmüller
Karlheinz Schmelig(Audit Committee:
Chair since February 23, 2022)*
Gesamt
* Member Audit Committee
** Member Personnel Committee
***Member Litigation Committee
Vertical comparison
Compensation of Management Board members
Pilar de la Huerta Martìnez*
Ludwig Lutter
Paul Böckmann*
Compensation Supervisory Board members
Wilhelm K.T. Zours*
Dr. Heikki Lanckriet*
Prof. Dr. Karin Lergenmüller**
Dr. Helge Lubenow*
Prof. Dr. Franca Ruhwedel*
Karlheinz Schmelig*
Dr. Jörgen Tielmann*
Average compensation of employees
Employees in Europe
**Previous year: time proportionate
**First payment in reporting year
43
31
21
21
3
21
147
87
77
80
66
61
64
0
1
4
1
6
1
7
20
3
11
5
18
18
20
0
12
23
12
25
1
5
78
10
12
15
16
21
16
0
56
59
34
51
5
32
245
100
100
100
100
100
100
0
Change 2022 vs. 2021
Change 2021 vs.
2020
-
12%
2700%
1033%
1600%
67%
967%
1867%
-
-
-
-
-
-
-
-
0%
8%
In the presentation of average employee compensation, all employees of the European Group companies (excluding the Executive
Board) were included. In addition to wages and salaries, average compensation also includes expenses for retirement benefits;
social security contributions were not included. The compensation of part-time employees was extrapolated to full-time
equivalents.
Biofrontera AG Annual Report 2022
XXIII
Highlights 2022
•
Positive EBITDA and EBIT from operations due to the sales increase and the restructuring of the Biofrontera Group and the
associated cost relief for Biofrontera AG
Successful capital raise with gross proceeds of approximately EUR 7.1 million
•
Appointment of Dr. Axel Drews as Vice President Global Sales & Marketing for the development of global sales strategies
•
Establishment of Biofrontera UK Ltd. subsidiary to strengthen sales activities in UK
•
Commercial launch of Ameluz® in Finland by Galenica AB
•
• Withdrawal of governmental price decree for Ameluz® in Spain
•
•
Delisting of ADS from Nasdaq
Swiss license partner Louis Widmer SA obtained Ameluz® label extension for the treatment of actinic keratosis on
extremities, trunk and neck
Granting for US patent on nanoemulsion formulation
Granting for Australian patent on innovative PDT treatment protocol
FDA added patent of novel RhodoLED® XL lamp to the FDA Orange Book
Biofrontera Pharma was approved by the FDA as a contract laboratory for batch control and stability testing for Ameluz®
Successful PDT workshop in Hamburg with more than 300 participants in livestreams and more than 50 visitors on site
•
•
•
•
•
Key figures in accordance with IFRS
01.01.-31.12.2022
01.01.-31.12.2021
Results of operations
Sales revenue
Gross profit on sales
Result on operations
EBITDA
EBIT
Profit/loss before income tax
Profit/loss for the period
in EUR thousands
Net assets
Total assets
Non-current assets
Cash and cash equivalents
Other current assets
Non-current liabilities
Current liabilities
Equity
25,738
20,981
1,591
1,869
1,124
(43,210)
(44,166)
100.00%
81.52%
6.18%
7.26%
4.37%
(167.89)%
(171.60)%
28,787
24,873
(35,341)
27,950
24,661
35,683
33,857
100.00%
86.41%
(122.77)%
97.09%
85.67%
123.96%
117.61%
December 31, 2022
December 31, 2021
32,725
17,669
6,376
8,645
8,387
4,002
20,336
76,699
62,322
6,908
7,056
17,467
1,235
57,997
XXIV
Biofrontera AG Annual Report 2022
Number of employees
Biofrontera Shares
Number of shares outstanding
Share price (Xetra closing price in EUR)
December 31, 2022
December 31, 2021
110
0
0
63,807,058
1.525
99
0
0
56,717,385
1.48
Biofrontera AG Annual Report 2022
XXV
Consolidated management and group management report for the
fiscal year 2022
Basis of the Biofrontera Group
Group structure
As of December 31, 2022, the Biofrontera Group (hereinafter also called "Biofrontera", "Biofrontera Group", “Group” or the
“Company”) consists of a parent company, Biofrontera AG and 4 (December 31, 2020: 5 (including Biofrontera Inc., USA)) wholly
owned subsidiaries in Germany. The parent company’s head office is located in Leverkusen, Germany.
Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH and Biofrontera Neuroscience GmbH are
located at the parent company's headquarters in Leverkusen, Germany.
For sales support in Spain and the United Kingdom, two additional entities were founded, firstly Biofrontera Pharma GmbH, sucursal
en España in Barcelona (03/2015) and Biofrontera UK Ltd. in Cambridge (11/2022). Biofrontera UK Ltd. is a wholly owned subsidiary of
Biofrontera Pharma GmbH. Business model
The publicly listed entity Biofrontera AG assumes the holding function within the group of companies. It is responsible for the
management, strategic planning, internal control and risk management and ensures the necessary financing needs are met.
Biofrontera Bioscience GmbH carries out research and development tasks as well as all regulatory functions for the Biofrontera
Group and holds the patents and approvals for Ameluz® as well as BF-RhodoLED® and RhodoLED® XL. According to a license
agreement with Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, which is also the holder of the CE certificate of BF-
RhodoLED®, bears the responsibility for the production, further licensing and marketing of Biofrontera Group’s approved products.
The Biofrontera Group has its own sales organizations to distribute Ameluz® and the BF-RhodoLED® lamp in Germany, Spain and
the United Kingdom. In some other European countries, sales are handled by independent license partners. Following the separation,
Biofrontera Inc. is now the licensee responsible for marketing Ameluz® and the RhodoLED® lamp series in the USA.
Asian and Oceanic markets were licensed to Maruho Co, Ltd, Osaka, Japan under the exclusive license agreement signed in April
2020. Currently, Maruho is conducting the necessary clinical studies to obtain regulatory approval in Japan.
Production of Ameluz® for all markets is carried out by a contract manufacturer in Switzerland. The PDT-lamp series is manufactured
at Biofrontera's headquarters in Leverkusen, Germany.
Ameluz® and the RhodoLED® lamp series are supplied to all the licensing partners under a license and supply agreement with
Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH, both wholly owned subsidiaries of Biofrontera AG.
Biofrontera Development GmbH and Biofrontera Neuroscience GmbH were founded in December 2012 and are additional wholly
owned subsidiaries of Biofrontera AG. These two companies are intended for the development of pipeline products that are not part
of Biofrontera's core business at this point in time and therefore currently cannot be sufficiently financed within the normal business
activities. The product BF-derm1 (without patent protection since 2009) for the treatment of severe chronic urticaria is owned by
Biofrontera Development GmbH, the product BF-1 (patent protection until 2034) for the prophylactic treatment of migraine by
Biofrontera Neuroscience GmbH. Both products are currently not being pursued any further, as the corporate strategy focuses on
the further development and marketing of Ameluz®. By outsourcing the development projects, projects, a structure has been
created which allows to separate the financing of the development of these two products from the general financing of the
Biofrontera Group.
Group strategy
The strategic goal of the Biofrontera Group is to optimize the positioning and market potential of Ameluz®, and in doing so to
develop the Company into a leading innovative specialty pharma company in dermatology. The focus of activities is on the further
territorial expansion of sales and the development of additional market potential through the expansion of the indications for
Ameluz®.
Biofrontera AG Annual Report 2022
1
Biofrontera has received a centralized approval for its own self-developed drug, which is marketed under the brand name Ameluz®.
Since the market launch in February 2012, Biofrontera has been selling Ameluz® with its own sales force to dermatologists in
Germany and since March 2015 also in Spain. In the UK, Ameluz® was initially promoted through a distribution partner, and since
May 2018 has been actively promoted by Biofrontera's own sales force. Distribution in several other countries of the European Union
and Switzerland is carried out through licensing partnerships.
The US-subsidiary, Biofrontera Inc., was set up as the commercial arm of Biofrontera in the USA and became independent with its
IPO at the end of October 2021. Under a license and supply agreement with Biofrontera Pharma GmbH and Biofrontera Bioscience
GmbH, both wholly owned subsidiaries of Biofrontera AG, and Biofrontera Inc. the responsibilities between the companies are
regulated. The agreement was entered into for a period of 15 years and will be extended for another 5 years provided that a sales
volume in the USA of more than USD 150 million has been achieved in the preceding 5 years. Under this agreement, Biofrontera Inc.
acquires Ameluz® and the PDT lamps BF-RhodoLED® and RhodoLED® XL from Biofrontera AG. Up to annual Ameluz® sales of USD
30 million, Biofrontera Inc. will pay 50% of sales as a transfer price. This share decreases in two steps to 30% with sales more than
USD 50 million, thus taking into account the associated higher distribution costs of Biofrontera Inc. Biofrontera AG has committed
to maintaining the FDA approval, manufacturing the products, providing a pharmacovigilance database and conducting previously
defined clinical trials.
Products
Ameluz® and PDT-lamps BF-RhodoLED® and RhodoLED® XL
In December 2011, Ameluz® 78 mg/g gel (Spanish for "love the light", development name BF-200 ALA) received its first centralized
European approval for the treatment of mild and moderate actinic keratoses (AK) on the face and scalp. It's significant superior
effect in combination with an LED lamp compared to the direct competitor product Metvix® for AK was proven during phase III
development. Actinic keratoses are superficial forms of skin cancer with a risk of spreading to deeper skin layers and thus developing
into potentially fatal squamous cell carcinoma. The combination of Ameluz® with light treatment is an innovative form of treatment
that is classified as photodynamic therapy (PDT). The product information authorized by the European Medicines Agency (EMA)
expressly states the significant superiority of Ameluz® in the removal of keratosis compared to the direct competitor product, both
in conventional light treatment with a special lamp and in application with ordinary daylight.
Ameluz® has a number of product advantages in terms of efficacy, handling and user-friendliness. This, together with the associated
skin rejuvenation effect and comparatively low recurrence rates, leads to the expectation that this treatment option will become
even more of a focus for dermatologists in the coming years.
In 2017, Biofrontera submitted an application for approval for daylight-PDT with Ameluz® and was granted approval by the European
Commission in March 2018. The label extension now includes the treatment of actinic keratoses and field cancerization with daylight-
PDT. Daylight-PDT is a cost-effective and painless alternative to traditional PDT treatment with a special lamp. The topically applied
drug is activated by natural or artificial daylight. As daylight-PDT does not require the treatment to be carried out in a doctor's
office, it competes directly with self-applied topical drugs, which are used much more widely in Europe. As a result, Ameluz® is also
reimbursed by the statutory health insurers in Germany for use with daylight-PDT, whereas use of the drug with conventional PDT
is generally not reimbursed.
Since March 2020 Ameluz®-PDT also covers the treatment of mild and moderate actinic keratoses not only on the head, but also on
the extremities and trunk/neck.
In May 2016, Biofrontera received the marketing approval for Ameluz® in the USA. The approved indication is "lesion and field
directed PDT in combination with the BF-RhodoLED® lamp of mild and moderate actinic keratoses on the face and scalp". As the
approval in the USA includes a combination of drug and lamp according to FDA guidelines, Biofrontera has developed its own PDT
lamp, the BF-RhodoLED®. To meet the strict requirements of the FDA for the production of a Class III medical device, production of
the lamp is carried out at the Company's headquarters in Leverkusen. This makes Biofrontera the responsible manufacturer from
the perspective of the regulatory authorities. In the EU, this lamp has already been CE-certified in 2012, which also required ISO 9001
and ISO 13485 certifications for the entire company. The ISO certification was renewed in 2019 at regular intervals. In October 2021,
the FDA approved the new, more advanced RhodoLED XL. This approval was also granted as a combination approval of lamp and the
prescription drug Ameluz®. With the new RhodoLED® XL, larger areas can be illuminated, enabling simultaneous treatment of
multiple interspersed lesions. The new lamp is protected by several patents, which also help to protect the drug Ameluz® in the
U.S. market due to the combination approval.
2
Biofrontera AG Annual Report 2022
Both RhodoLED® lamps emit light with a wavelength of approx. 635 nm via their LEDs. Light at this wavelength, which is optimal for
illumination in PDT with ALA or methyl ALA containing drugs, emits red light, but is still below the warming infrared range. The
RhodoLED® lamp series combines controlled and constant light output in the desired wavelength with simple and clear operability
and energy efficiency. Light energy and fan power can be changed during PDT treatment to respond to treatment-related pain. No
other lamp on the market offers comparable performance and flexibility. The BF-RhodoLED® can be distributed throughout the EU
as well as the USA. The use of the RhodoLED® XL is currently only planned for the US market.
Belixos®
Belixos® is a medical skin care series developed for irritated and sensitive skin. It was initially designed as a cosmetic series in
which various products precisely addressed different skin problems. Pure plant biocolloids were combined with medicinal plant
extracts to form an extraordinary combination of active ingredients with a proven deep-acting effect. Also marketed under this
brand was Belixos® Protect, a day cream with protective anti-aging properties specifically for photodamaged skin.
Since mid-2022, the Belixos® range has been undergoing restructuring. With a new type of formulation that delivers ingredients to
the skin without the use of harmful additives, Belixos® will adapt even more closely to the needs of damaged skin. This product is
so innovative that a patent application has been filed for the underlying formulation. The product launch will initially only take place
in the German market and is planned for May 2023. Further expansions in other markets are planned for the coming years.
Sales and marketing
Germany and Europe
With its Central European approval, Ameluz® can be sold and distributed in all EU countries as well as Norway, Iceland and
Liechtenstein. However, in many European countries, pricing and reimbursement status must be determined prior to launch, which
can be a lengthy process. Reference pricing and re-importation can lead to low prices in individual EU countries, which in turn can
have a negative impact on the overall EU market. For this reason, the drug is currently only available in certain EU countries.
However, due to changing framework conditions, it is always necessary to monitor whether a territorial expansion might make sense.
Ameluz® is available at pharmacy retail prices ranging from EUR 150 to approximately EUR 220 per 2 g tube. In Spain, the price was
reduced by ministerial decree in 2020, against which the company successfully filed an administrative appeal. As of April 1, 2022, the
price in Spain has returned to EUR 150 per tube, and low-priced reimports to other markets are no longer causing sales to shift.
In Europe, Ameluz® and BF-RhodoLED® are marketed in Germany (since 2012), Spain (since 2015) and Great Britain (since May 2018)
by our own sales forces whereby Germany is by far the largest European market for Ameluz®. In other EU countries and in
Switzerland, the products are distributed with the help of distribution partners. In Switzerland, independent approval procedures
were required, which were carried out by our local marketing partner in collaboration with Biofrontera. The contracts with
distribution partners were concluded in such a way that Biofrontera received no or only a moderate upfront payment and the
regional partners purchase Ameluz® from Biofrontera at a price that is linked to their own sales price. Depending on the market
conditions in each country, Biofrontera's share of the sales price varies somewhat, but averages 50% of net sales.
In December 2020, the Group covered sales in Scandinavia through an exclusive licensing partnership with Galenica AB, Malmö,
Sweden. Sales of the products in the Scandinavian region started with the delivery of the first batch of Ameluz® in June 2021.
Following initial product launches in Norway, Sweden and Denmark. Since November 2022 Ameluz® is also marketed in Finland.
In July 2021, a license agreement was signed with Medac Gesellschaft für klinische Spezialpräparate mbH for the commercialization
of Ameluz® and BF-RhodoLED® in Poland. Medac started marketing Ameluz® and BF-RhodoLED® to selected customers in the fall
of 2002. To date, activities have been limited to the private healthcare sector, as Ameluz® PDT is currently not reimbursed by public
payers. Medac expects that the reimbursement of Ameluz® will be possible by the end of the year 2023.
In general, Biofrontera was able to significantly increase its presence in the European market through its own sales structures and
the territorial expansion through additional licensing partners.
USA
Biofrontera AG Annual Report 2022
3
Ameluz® was commercially launched by Biofrontera in the USA in October 2016. For marketing purposes, Biofrontera AG
established its own sales organization in the USA for this purpose in March 2015, the Biofrontera Inc. based in Woburn. With the IPO
of Biofrontera Inc. in 2021, it became a licensing holder. Since its launch, Ameluz®-PDT has gradually established itself in the US
PDT market segment, and the increased sales efforts by Biofrontera Inc. and its sales expansion efforts promise further significant
market growth. The clinical program defined in the licensing agreement also holds further market potential in the longer term
through several label extensions.
Other regions
In April 2020, an exclusive license and supply agreement was entered into with Maruho Co., Ltd., Osaka, Japan (Maruho) for the
development and marketing of Ameluz® for all indications in East Asia and Oceania. Under the agreement, the product will be
marketed for a period of 15 years from the start of sales in the countries covered by the contract. A first batch of investigational
medication was delivered to Maruho at the end of 2022. The clinical development program on which approval will be granted will
initially focus on actinic keratosis as an indication.
Market overview
Actinic keratosis
Non-melanoma skin cancer and its precursor actinic keratosis (AK) is the main market for the flagship prescription drug Ameluz®.
Actinic keratoses are superficial potentially pre-cancerous skin lesions caused by chronic sun exposure that may, if left untreated,
develop into a form of potentially life-threatening skin cancer called squamous cell carcinoma. Actinic keratoses typically appear
on sun-exposed areas, such as the face, bald scalp, arms or the back of the hands, and are often elevated, flaky, and rough in texture,
and appear on the skin as hyperpigmented spots.
These skin lesions occur not only isolated, but in many cases also over a large area. Such an area of the skin is called field
cancerization. In this case, visible and not yet visible skin damage can be in direct proximity to each other on the affected skin areas.
In about one in ten patients with AK, a malignant form of non-melanoma skin cancer (squamous cell carcinoma) can develop from a
skin lesion or in its vicinity. Even AK that are not yet visible already carry a high risk of transitioning into squamous cell carcinoma.
Lifetime dose of UV radiation plays an important role in the development of AK. Over many years, UV radiation damages the skin
cells, which then mutate and proliferate, which can lead to abnormal keratinization (hyperkeratosis). This is why AK occurs most
frequently in older people: in Germany, for example, more than 11 out of every 100 people between the ages of 60 and 70 are affected.
Men are more frequently affected than women, as, among other things, it is not uncommon for men to work outdoors and thus be
exposed to the sun, usually without protection. Particularly at risk are, for example, farmers and forestry workers, roofers,
carpenters, gardeners and lifeguards. In addition to age and gender, other factors can promote the development of AK. These include
a fair skin type, severe sunburns, or treatment with medications that weaken the immune system.
Therapy options for the treatment of actinic keratosis
Because actinic keratosis can develop into squamous cell carcinomas, actinic keratosis is classified by The European Academy of
Dermatology and Venereology and other international treatment guidelines as a tumor that requires treatment. In order to minimize
the risk of developing cancer, AK must be detected and treated early.
Actinic keratoses are treated using a wide range of methods. The traditional methods of treating actinic keratoses are cryotherapy
(or the deep freezing of skin with liquid nitrogen); simple curettage; self-administered prescription topical medications (usually
creams, gels, or solutions containing active ingredients that must be applied to the damaged areas of the skin, usually regularly
over an extended period of time); and combining a drug with photodynamic therapy (PDT). When deciding on the treatment option,
the physician takes into account the disease progression to date, the extent of the existing skin damage, and the patient's condition
(age, possible existing concomitant diseases, medications to be taken).
The international treatment guidelines list photodynamic therapy as the "gold standard" for the treatment of actinic keratoses,
especially for patients with large areas of actinic keratoses. In this process, a gel containing the active ingredient, such as
Biofrontera’s Ameluz®, is first applied to the affected areas of skin. The active ingredient is preferentially absorbed by cells with
high metabolic activity, such as cancer cells and their precursors, and converted into its light-activatable form. As a result, they
become more light-sensitive and are destroyed within a few hours by targeted illumination, while healthy skin cells remain
unharmed. The dead cells are broken down and the skin renews itself. Usually, no scarring remains and the appearance of the skin
visibly improves over the next weeks and months. There are two forms of PDT: one using an artificial light source (conventional PDT)
and one using natural/simulated daylight (daylight PDT). Compared to conventional PDT with red light or another suitable light
source, the treatment time for daylight PDT is shorter at about two and a half hours and the treatment is associated with less pain.
4
Biofrontera AG Annual Report 2022
Market overview and competitive landscape in Germany
Germany is Biofrontera's largest European sales market. In Germany, about 1.7 million people are treated by dermatologists for AK,
which corresponds to about 2 to 3% of the total population. However, the number of people suffering from the disease is probably
higher. In 2022, a total of 965,848 prescriptions were given for the treatment of AK (previous year: 851,143). Most prevalent among
these are topically applied medications such as prescription drug-containing creams and gels (topicals), which represent a market
share of 93.9%, followed by PDT (the combination of a topically applied medication with light therapy) at 6.1% (previous year: 93.3%
and 6.7%, respectively). The total 2022 market increased by 13% mainly due to the launch of another topical drug.
Although information on a frequency of use of cryotherapy or simple curettage treatments for actinic keratosis is not accessible in
Europe, we assume that a large number of patients are also treated in this way due to the simplicity of these therapies and the low
cost.
In Germany, the largest European market for Ameluz®, the market share for PDT drugs was stable at around 64% in 2022. Above all,
the further establishment of daylight PDT enabled Ameluz® to continue to prove itself as a strong leader in the PDT market compared
to its competing products. We estimate that daylight PDT will continue to capture further market share in the future that was
previously limited to self-applied topical creams. Primarily because daylight PDT is reimbursable by statutory health insurance funds,
which means that the number of patients who would in principle have access to treatment with Ameluz® has multiplied because of
this available application. Due to remaining Corona restrictions, especially in the first half of the reporting period, Ameluz® sales in
Germany only grew by around 2.3% in the year under review compared to 2021. Particularly notable in this regard was a very strong
4th quarter with growth of more than 8% compared to the same quarter of the previous year.
Since 2013, actinic keratosis has been recognized as an occupational disease in Germany by the Federal Ministry of Labor and Social
Affairs. Based on this recognition, the employers' liability insurance associations in Germany cover the treatment costs of patients
for life who have worked predominantly outdoors over an extended period and meet certain other criteria. Since March 2016,
photodynamic therapy has been included as a recognized treatment option for occupational actinic keratosis in Germany and is thus
paid for by the Berufsgenossenschaften for these patients.
Market overview and competitive situation in the other proprietary markets of Spain and the United Kingdom (UK)
In the Spanish market, Ameluz® sales in the first quarter of 2022 still benefited strongly from the price decrease mandated by the
Ministry of Health. This was one of the reasons why, after 13,397 packs of Ameluz® in 2021, 15,211 units were sold in 2022, a growth of
14%. The market share in comparison to the main competitor Metvix was slightly increased in the PDT market from 53% to 55%.
Ameluz® also showed dynamic growth of 16% in the UK market. We were able to increase sales to customers in the UK from 2,930
packs in 2021 to 3,389 units in 2022. Market figures on the competitive situation are not available.
Market overview in European countries with distribution partners
Our distribution partners Pelpharma in Austria, Louis Widmer in Switzerland, Galenica in the Scandinavian countries and Finland, as
well as our latest partner Medac in Poland can look back on a successful 2022. Overall, our partners contributed to the solid product
development with nearly 10,000 units sold. Of particular note here is 13% growth in the Austrian market, as well as the launch of
Ameluz® in Finland and Poland, in each case initially in the private sector.
Market overview and competitive situation in the USA
The USA is the most important pharmaceutical market in the world. According to the Skin Cancer Foundation, approximately 58
million people in the USA have actinic keratosis. In 2022, the market size was USD 2.3 billion for this indication, according to the
Grand View Research Report (01/2023). The US market differs from the European market in that cryotherapy dominates the market
with a market share of just over 75%. PDT has only a very small share of the overall market. Segment expansion is predicted for the
coming years, but this is based on overall market growth rather than a proportionate redistribution within therapy options.
Cryotherapy is expected to remain the dominant therapy option.
The PDT segment currently has a share of approximately 2%, with Ameluz®-PDT expanding its market share within this segment by
12% in the year under review.
It is therefore important to improve the acceptance of PDT, with its clear advantages, particularly in scar-free healing and in the
treatment of field cancers, which would be preferable to surgical intervention. To this end, our US licensing partner is continuing to
expand its US sales force and marketing expenditure is also being significantly increased. In the reporting year, the share of sales
Biofrontera AG Annual Report 2022
5
generated per sales representative was increased by almost 20% compared to 2021. For 2023 Biofrontera Inc. anticipated a further
sales improvement of about 25%.
Personnel matters
Management Board
As of December 31, 2022, the Management Board consisted of Pilar de la Huerta Martínez (CFO).
Name
Nationality
Age
Position
Date of first
appointment
Ludwig Lutter*
Paul Böckmann
Pilar de la Huerta Martínez
German
Austrian
Spanish
55
46
54
CFO
March 01, 2021
Interim Borad
Member
June 09, 2022
CFO
September 12, 2022
Term
August 13.
2022
September
30,2022
August 31,
2024
* Effective August 13, Mr. Ludwig Lutter was relieved of his position as Chief Financial Officer and his employment contract was
terminated.
Employees
As of December 31, 2022 the Biofrontera Group had EUR 110 employees (previous year: EUR 99 ) who were distributed as follows:
December 31, 2022
December 31, 2021
Total number of employees
Full-time
With academic degree
By business segments
Production
Research and development
Clinical and regulatory tasks
Marketing and sales
Quality management
Management, business development, finance, HR and administration
By countries
Germany
Spain
United Kingdom
110
81
29
110
12
9
24
33
7
25
110
98
9
3
99
76
24
99
15
5
15
29
7
28
99
88
8
3
In order to remain attractive as an employer in the competition for employees in the future, the Company must continue to be in a
position to offer attractive compensation benefits and employment conditions in line with the market. This includes, among other
things, the share- or securities-based compensation under our employee option program and the compensation from our stock
appreciation rights program. The company is working on a new program that is simpler and more attractive than the current one,
to be rolled out by the end of 2023.
Supervisory Board
6
Biofrontera AG Annual Report 2022
In 2022, the Supervisory Board comprised the following members as representatives of the shareholders:
Name
Nationality
Age
Position
Wilhelm K. T. Zours
Dr. Jörgen Tielmann
Dr. Heikki Lanckriet
Prof. Dr. Karin Lergenmüller
Dr. Helge Lubenow
German
German
Belgian
German
German
Prof. Dr. Franca Ruhwedel
German
Karlheinz Schmelig
German
61
53
45
64
54
50
57
Research and development projects
Date of first
appointment
December 14, 2021
December 14, 2021
December 14, 2021
August 23, 2022
December 14, 2021
Term
2026
2026
2026
2026
2026
Chairman
Vice Chair
Member
Member
Member
Member
December 14, 2021
Member
December 14, 2021
February 22,
2022
(resignation
from mandate)
2026
All research and development activities of the Biofrontera Group relating to nanoemulsion and Ameluz® are carried out by
Biofrontera Bioscience GmbH, which is responsible for pharmaceutical development, conducting preclinical and clinical studies, and
for granting, maintaining, and extending the drug approvals. Responsibility for project management of all development activities is
assumed internally; individual tasks such as data management and statistics for clinical studies are partially or completely
outsourced. The development of the new red-light lamp RhodoLED® XL was the responsibility of Biofrontera Pharma GmbH. All
ongoing clinical studies are carried out in the USA, this is part of the agreement entered into with Biofrontera Inc. to expand labeling
for the U.S. market. Both for the approved drug Ameluz® and for the other research and development projects, with the exception
of the further development of the new red-light lamp RhodoLED® XL, the research and development costs are recognized as
expenses in the period in which they are incurred. In the reporting period, 33 people were employed in research and development
and regulatory affairs (previous year: 20).
Update for 2022 on the ongoing clinical development program:
Phase I safety study with Ameluz®-PDT
The phase I safety study started in December 2021 is evaluating the safety and tolerability of photodynamic therapy (PDT) for the
treatment of mild to severe actinic keratosis (AK) on the face and scalp with the simultaneous application of three tubes of Ameluz®
together with the new RhodoLED® XL lamp.
This is a non-randomized, open, multicenter study in which 100 patients with mild to severe actinic keratosis are treated. Each patient
will receive the content of three tubes of Ameluz® for field-directed treatment of actinic keratosis. A total of nine clinical sites in
the USA are participating in the study.
Patient recruitment is nearing completion, so it is expected that an expanded approval dossier can be submitted to the FDA at the
end of 2023.
This study follows a pharmacokinetics (PK) study completed in October 2020, the study results of which were submitted to the FDA
in early 2021. In June 2021, the FDA had subsequently requested another safety study focusing on short-term side effects.
Phase II trial for the treatment of moderate to severe acne
In December 2021, patient recruitment started for the Phase IIb trial to evaluate the safety and efficacy of Ameluz® in combination
with the BF-RhodoLED® red light lamp in the treatment of moderate to severe acne with photodynamic therapy (Ameluz®-PDT).
During the reporting period, there were two protocol amendments to adjust the inclusion and exclusion criteria and to implement
FDA recommendations, respectively, which should now enable improved recruitment.
In the multicenter, randomized, double-blind, four-arm study, 126 adult patients suffering from moderate to severe acne are being
treated with Ameluz® PDT or placebo. The efficacy and safety of Ameluz® PDT will be tested at exposure times of one and three
hours compared to placebo. The primary endpoint of the study is the reduction in the number of inflammatory lesions in combination
Biofrontera AG Annual Report 2022
7
with an improvement in the severity of acne to "Free of acne" or "Almost free of acne". To ensure collection of highly consistent
data across all participating sites, the study will combine clinical assessments performed by the physicians conducting the study
with a cutting-edge, FDA-approved, artificial intelligence analysis platform that will provide a lesion count along with a severity
assessment. A total of seven (in 2022; nine since Feb 2023) clinical sites are participating in the study. Indication expansion is planned
for the USA, so the study is conducted there as well.
By the end of the year 2022, 23 patients had been enrolled in the study.
Phase III trial for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz®-PDT
To further increase growth potential in the US market in the medium term, the company is conducting a clinical trial for the treatment
of superficial basal cell carcinoma (sBCC) with Ameluz® together with the BF-RhodoLED® red light lamp in the USA. Intensive work
on patient recruitment has been ongoing since September 2018. By the end of the year, 87% of the planned 186 patients had been
included in the study and received treatment. However, patient recruitment, which takes a lot of time due to the demanding study
protocol and was additionally impacted by the pandemic in recent years, has picked up speed again recently. Following a successful
FDA approval, Ameluz® would be the only drug in the USA for the treatment of superficial BCC with PDT. A total of 19 clinical centers
are involved in the trial.
Phase III trial for the treatment of actinic keratosis on the extremities, neck and trunk with Ameluz®-PDT
At the end of 2022, a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial was started to evaluate the
safety and efficacy of Ameluz® in a field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. Biofrontera's
new red-light lamp RhodoLED® XL will also be used in this study. At multiple trial sites across the USA, 165 patients, each with 4-15
AK lesions on the extremities or trunk/neck, will be enrolled in the study. By introducing an optimized illumination profile, the study
design further addresses a promising approach to alleviate PDT pain, which is often a hurdle in PDT treatment for patients and
physicians. Mild to moderate actinic keratoses are treated with one or, if necessary, two PDT treatments. Patients will have their
final examination three months after their last PDT. The clinical study phase will be followed by a follow-up period of twelve months
after the last PDT. The primary endpoint of the study is efficacy in terms of the rate of complete healing of all lesions three months
after the last treatment.
At the turn of the year, the first patients were already enrolled in the study.
Patent development
The Company maintains six different company-owned patent families worldwide. The Group’s patents are held by Biofrontera
Bioscience GmbH and Biofrontera Pharma GmbH.
The patent families refer to our technologies related to our nanoemulsion, our red-light lamp for photodynamic therapy (PDT),
photodynamic therapy itself and migraine prophylaxis.
Nanoemulsion
For our nanoemulsion technology patents have been issued in Europe (validated for France, Germany, Italy, Spain,
Switzerland/Liechtenstein, and the UK), Australia, Belarus, Canada, Chile, China, Hong Kong, Israel, Japan, Mexico, New Zealand,
Russian Federation, South Africa, Singapore, and Ukraine. Patent protection in these jurisdictions will expire on December 21, 2027.
For the corresponding U.S. patent application, a patent was issued on January 03, 2023, which expires on February 07, 2028.
On November 12, 2019, the term of another patent family describing the combination of nanoemulsions with aminolevulinic acid
hydrochloride, the active ingredient in Ameluz®, expired. However, Ameluz® continues to be protected by the above listed
nanoemulsion technology patent family, which expires on December 21, 2027, and February 07, 2028, respectively. As part of the
license agreement with the strategic partner Maruho, the corresponding Japanese patent was transferred to Maruho. In addition,
the risk of potential future generic competition is further mitigated by specific challenges in the development and market launch of
generic dermatological combination products.
Red-light lamp for photodynamic therapy
8
Biofrontera AG Annual Report 2022
As part of Biofrontera's patent strategy to protect Ameluz®, further patent applications have been submitted for photodynamic
therapy itself as well as our red-light lamp.
An international patent application with the title "Illumination for photodynamic therapy" (PCT/EP2019/064642) was filed on
June 5, 2019. The national phase in the USA was initiated on November 17, 2020. In addition, a continuation-in-part application was
filed in the USA on April 19, 2021, for which a patent was issued on January 11, 2022. The patent has a maximum term until
June 5, 2039. Furthermore, the national phase of the original international application was initiated in Australia, China, Europe, Hong
Kong, Japan, New Zealand, and Singapore. Under the license agreement with the strategic partner Maruho the Japanese patent
application was assigned to Maruho.
Another patent application “Illumination device for photodynamic therapy, method for treating a skin disease and method for
operating an illumination device” was filed in the USA on October 15, 2020, also for which a continuation-in-part application was filed
in the USA on March 29, 2021. For this continuation-in-part application a patent was issued on February 01, 2022, which will expire on
October 15, 2040. Furthermore, an international patent application (PCT/EP2021/078045) was filed on October 11, 2021.
A further international patent application for protection of the lamp was filed on October 20, 2022, entitled "Illumination device for
photodynamic therapy, method for treating a skin disease and method for operating an illumination device" (PCT/EP2022/079298).
To protect the recently FDA-approved RhodoLED® XL red-light lamp against imitations, a design application for certain key design
aspects of the lamp was filed in the USA as a continuation-in-part application of the previously mentioned patent on October 19, 2021.
Additionally, two further design applications were filed on October 18, 2022 in the USA covering other innovative aspects of the lamp.
Photodynamic therapy
An international patent application "Photodynamic therapy comprising two light exposures at different wavelengths" was filed on
August 23, 2018. Entry into the regional/national phases was initiated for the EU, USA, Japan, Australia, China, Hong Kong, New
Zealand and Singapore. On June 30, 2022, a patent was granted in Australia. On December 22, 2022, the notice of allowance was sent
from the USPTO for the U.S. application. The Japanese patent application was transferred to Maruho under the license agreement.
Migraine prophylaxis BF-1
An international patent application regarding anti-migraine compounds and their use was filed. Patents were issued to the Group in
Europe (validated for Germany, Spain, France, United Kingdom, Italy) and in the USA. The Company decided in January 2022 to not
further pursue and renew, respectively, the patents in Europe.
Internal controls
Biofrontera AG is managed by its Management Board. The Management Board is responsible for and supervises the operational
business. To this end, the Management Board regularly receives and reviews internal management reports.
Key performance indicators are compiled monthly, while the budget planning for the current financial year is revised and updated
quarterly. In addition, medium-term planning is prepared once a year. In-depth cost analyses are performed on an ongoing basis.
Key financial performance indicators
With regard to the operating performance for the Group, the key figures revenue and liquidity as well as EBITDA and EBIT serve as
financial control variables. Biofrontera AG uses the key figures liquidity and net income as financial performance indicators.
In the context of internal reporting, the Group's sales revenues are the key performance indicator, which are reported by region and
by product. On a consolidated basis, revenue includes sales to wholesalers as well as to physicians and hospitals, sales to our
licensing partners, and revenue from research contracts.
In addition, liquidity trends are used as a key performance and management metric for the Group as well as for Biofrontera AG.
These are monitored daily. Liquidity is defined as the sum of cash and cash balances in bank accounts and is described as cash and
cash equivalents.
Group EBITDA includes earnings before interest, taxes, depreciation of tangible assets and amortization of intangible assets. EBIT
includes earnings before interest and taxes. These key performance indicators are suitable for describing and comparing operating
Biofrontera AG Annual Report 2022
9
performance, as they do not include non-operating fluctuation variables such as valuation adjustments and amortization of acquired
assets.
The key financial performance indicators are calculated as follows:
Result from operating activities
+ Depreciation and amortization
+ /- Other expenses and income
EBITDA
- Depreciation and amortization
EBIT
+/- Interest expense and interest income
Earnings before income taxes
Non-financial performance indicators
The maintenance and further development of our regulatory approvals is essential to secure and strengthen Biofrontera's market
positioning and is, among other things, reflected in research and development costs. Consequently, both the maintenance of our
regulatory approvals and the expansion of our labels as well as the number of external and internal audits are important nonfinancial
control parameters for the Company.
Biofrontera’s employees are an important success factor and therefore also represent a central control parameter. With respect to
personnel, particular emphasis is placed on the qualifications and the necessary know-how of the employees to achieve the set
goals in the operational and administrative areas. We therefore measure the annual number of external and internal training courses.
Personnel costs are always considered on the basis of the salary level customary in the industry.
Management report for the 2022 fiscal year
Business performance
For Biofrontera Group, the reporting period was the first year in which revenues from the USA were accounted for as licensing
income for the entire year and, at the same time, commercialization costs in the USA no longer had a negative impact on earnings.
As a result, Biofrontera has taken a major step towards long-term profitability. The projected balanced EBITDA was achieved with
EUR 1.9 million, and the company has also restructured itself in terms of costs. Research & development, general and administrative
costs and the decreased sales costs are now almost balanced at EUR 7.1 million, EUR 6.0 million and EUR 6.4 million, respectively.
During the reporting period, product sales decreased compared to the previous year, but this is due to the deconsolidation of
Biofrontera Inc. mentioned above, because of which product sales from the USA are accounted for only on a pro rata basis.
The three first quarters with a sales increase of up to 19% compared to the same period of the previous year 2021 made up for a
weak fourth quarter. License revenues from the USA are still the largest revenue contributor, accounting for considerably more than
60% of total revenues. In the fourth quarter no further product was supplied for the USA due to delays in production, with the result
that this quarter was significantly below the prior-year period.
In the German market, on the other hand, which was still noticeably behind the previous year's figures in the first three quarters, a
growth of 26% was realized in the fourth quarter. As German business was still heavily impacted by re-imports from Spain until
September, a notable recovery was visible on the sales side in the final months of 2022.
Overall, the revenues generated in 2022 were in the forecast range.
Biofrontera generated total sales of EUR 25.7 million in the period from January 1 to December 31, 2022, compared to EUR 28.8 million
in 2021, a decrease of approximately 11%. However, as already mentioned, the total revenue in the same period of the previous year
included almost entirely product sales of the USA, which, following the deconsolidation of Biofrontera Inc. is now only booked on a
10
Biofrontera AG Annual Report 2022
pro rata basis as licensing income. As a result, comparability with the previous year 2021 cannot be fully provided, but only to a
limited extent.
Marketing & Sales of Ameluz® in Europe
Sales development in Germany was more subdued year-on-year. German product sales amounted to EUR 4.8 million compared to
EUR 5.3 million in 2021, a drop of around 10%, mainly due to re-imports from Spain because of the price decree in force there until
April. By contrast, direct tube-based Ameluz® sales in the German market grew by around 2% in the reporting year compared with
2021. For the 4th quarter, growth of 8% was realized compared with the prior-year quarter. The share of Ameluz® PDT in the PDT
segment was virtually unchanged at 64% in 2022.
The In the rest of Europe, Biofrontera achieved product sales of EUR 3.5 million, compared to EUR 3.3 million in 2021, an increase of
5%. In the Spanish market, Ameluz® initially still benefited strongly in sales from the imposed price decree in the first quarter of
2022. Over the entire reporting year, significantly more tubes of Ameluz® were sold in the spanish market, with an increase of 14%,
so that the market share in the PDT segment also increased slightly from 53% to 55%.
Ameluz® also showed dynamic growth of 16% in the UK market. We were able to increase sales to customers in the UK from 2,930
packs in 2021 to 3,389 packs in 2022.
After Galenica AB started marketing Ameluz® and BF-RhodoLED® in the Scandinavian countries and now also in Finland, Medac
Gesellschaft für klinische Spezialpräparate mbH was also able to start marketing in Poland in the middle of the year, probably initially
only in the private healthcare sector with selected customers, as Ameluz is not yet reimbursed by the statutory health insurers.
Sales of Ameluz® in the USA
Sales to Biofrontera Inc. amounted to approximately EUR 16.5 million in the reporting period. A year-on-year comparison of U.S. sales
is not comparable, as U.S. market sales were presented in the previous year, whereas in the current year license revenues from
deliveries to Biofrontera Inc. are considered. The USA is also supplied with product batches, just like all European license partners,
which are then sold into the market. Therefore, it is not unlikely that certain quarters will show a significant increase in sales in the
future, while other quarterly comparisons will be significantly weaker. According to the annual report of Biofrontera Inc., it was able
to record sales growth of 19% in 2022, so its marketing offensive has already shown initial success. For 2023, the sales force is now
also being significantly increased in terms of personnel, so that a new sales momentum can be expected.
Regulatory and clinical progress
The aim of Biofrontera's commercial and clinical development strategy is to successively adapt Ameluz® to market requirements
and patient needs and to use it for additional indications. The full treatment and market potential of Ameluz® can only be leveraged
with appropriate extensions to the label.
The company is currently conducting four independent clinical trials in parallel to expand the US approval of Ameluz®. One phase I
clinical trial is evaluating FDA-required safety data on the use of three tubes of Ameluz® within a single PDT treatment. In this trial,
almost all patients were enrolled in the reporting period, so Biofrontera expects to submit an expanded approval dossier at the end
of 2023. The second trial is testing the efficacy of Ameluz®-PDT in moderate to severe forms of acne in adults. Here, two protocol
amendments were necessary to adjust the inclusion and exclusion criteria and to implement FDA recommendations. This is intended
to improve patient recruitment, so that a significantly increased recruitment rate can now be expected. To date, 28 of 126 patients
have been enrolled in the study. A phase III trial was launched before the end of December 2022 to test the efficacy of Ameluz®-PDT
on the extremities, trunk and neck. This will also involve the use of a new illumination profile that is intended to alleviate pain during
PDT.
The clinical study on Ameluz® PDT for superficial basal cell carcinoma, which has been ongoing since 2018, showed progress in
patient recruitment, with around 87% of patients now enrolled in the trial by the end of the reporting period.
Further information on the ongoing studies can be found in the Research and Development section.
Biofrontera AG Annual Report 2022
11
Execution of the capital increase resolved on April 07, 2022.
On November 11, 2022, the Company announced the completion of the capital increase resolved by the Extraordinary General Meeting
of Shareholders on April 07, 2022. In total, the Company issued 7,089,673 new ordinary shares, bringing their total number to
63,807,058 after registration in the Commercial Register. The capital measure was fully placed, with the company raising total gross
proceeds of approximately EUR 7.1 million.
Biofrontera Inc.
Biofrontera AG continues to hold its shares in Biofrontera Inc. Due to the exercise of previously issued Biofrontera Inc. warrants and
various capital measures of Biofrontera Inc. the total number of outstanding Biofrontera Inc. shares has increased significantly.
Biofrontera AG's stake in Biofrontera Inc. of 8,000,000 shares currently represents 29.9% of the current outstanding shares.
Unchanged from the ownership structure of Biofrontera Inc., Biofrontera Group benefits directly from the growing Ameluz® sales in
the USA. Under a licensing agreement, Biofrontera Group will receive up to 50% of Ameluz® sales in the form of a transfer price.
This share applies up to USD 30 million in annual sales and decreases to 40% between USD 30 million and USD 50 million in annual
sales and to 30% above that. The implementation of a clearly defined clinical trial program is also part of the licensing agreement
and is intended to significantly increase the market potential of Ameluz®-PDT in the long term.
Litigation
On December 13, 2021, Deutsche Balaton AG filed an action for a declaratory judgment with the Cologne Regional Court, the subject
of which was the legal examination and determination of a so-called unwritten competence of the Annual General Meeting for the
IPO of Biofrontera Inc. On December 9, 2022, the Regional Court of Cologne ruled in a declaratory judgment that the resolutions of
approval of the then Executive Board and the then Supervisory Board on the IPO of Biofrontera Inc. were unlawful because the prior
approval of the IPO required under the Holzmüller doctrine was unlawfully not obtained by the Annual General Meeting. The further
action was dismissed. In its reasoning, the court stated that the IPO initiated a significant loss of control in that the approval of the
IPO allowed third-party investors to acquire a majority stake in the subsidiary by waiving the exercise of the parent company's
subscription rights. In the opinion of the court, this loss of control resulted in significant asset losses for Biofrontera AG and its
shareholders. Since all of the former members of the Management Board and Supervisory Board who were involved in the resolutions
have left the company, the former members of the Management Board and Supervisory Board have been served with notices of
dispute regarding possible claims for damages. The Company has decided not to appeal against the ruling. Due to appeals by the
notices of disputes, the judgment is not yet final, but will be continued by the interveners in the second instance. The effectiveness
of the IPO of Biofrontera Inc. remains unaffected by the judgment.
Change in the composition of the Management Board
On June 09, 2022, Mr. Paul Böckmann was appointed interim Executive Board member of the Company. He was initially to support
the sole Chief Financial Officer Ludwig Lutter for a limited period until September 30, 2022. Mr. Lutter was relieved of his duties as
Chief Financial Officer with immediate effect on August 13, 2022. Ms. Pilar de la Huerta Martínez was then appointed as a member of
the Executive Board on August 19, 2022, with effect from September 12, 2022. In this context, Mr. Paul Böckmann's contract was
extended until the end of October. Since then, Ms. de la Huerta Martínez has now been the sole member of the Management Board.
Mr. Böckmann continues to support Biofrontera AG as an advisor, but without being part of the management.
Change in the composition of the Supervisory Board
Prof. Dr. Franca Ruhwedel resigned from her mandate on February 22, 2022. From that date until the Company's Annual General
Meeting, the Supervisory Board initially consisted of only five members. At the Annual General Meeting of Biofrontera AG, Prof. Dr.
Karin Lergenmüller was elected to the Supervisory Board and her election was confirmed again at the Extraordinary General Meeting
of Biofrontera on January 09, 2023. Both resolutions are still the subject of actions for annulment.
Impact of the Ukraine conflict and consequences of the pandemic
The Ukraine war has far-reaching impacts on the region and beyond. Relations between Russia and many Western countries,
including the EU and the US, have massively deteriorated. This in turn has significant economic implications. Concerns about energy
12
Biofrontera AG Annual Report 2022
security, high inflation, and the currently unpredictable end to the conflict pose significant challenges to society as well as
companies. In combination with the global post-pandemic effects, there are presently significant supply chain problems. Biofrontera
is also affected, and the extent to which this development may have an impact on business activities in the future is not yet
foreseeable. As a smaller company, Biofrontera needs to be financially flexible to face these challenges. The Extraordinary General
Meeting on 09 January 2023 approved two capital resolutions that enable such flexibility. First, Biofrontera may issue up to 7,089,673
new shares in a capital increase with subscription rights granted. The subscription price per new share shall be EUR 1.05 and the
proceeds shall be used to pre-finance the costs of the expected increased order intake in the production area. In addition, authorized
capital was created in the amount of 12.7 million shares, which the Executive Board can issue in partial amounts on one or more
occasions with the approval of the Supervisory Board.
Evaluation of the business performance of the Biofrontera Group
Comparison of actual and forecast business performance
The Biofrontera Group generated revenues of about EUR 26 million in the financial year 2022, thus meeting the revenue forecast of
24 to 27 million EUR.
For the fiscal year 2022, the Company had forecast a break-even EBITDA and exceeded this forecast with an actual EBITDA of
EUR 1.9 million, the reason being mainly lower expenses for clinical trials due to time delays and adjustments due to changed
regulatory requirements. In contrast, costs for our marketing and sales activities as well as for general and administrative expenses
developed at the planned level. Accordingly, EBIT for the fiscal year of EUR 1.1 million is also above the forecast in the low negative
single-digit million range.
Liquidity developed as expected and amounted to EUR 6,376 thousand as of December 31, 2022, slightly below the prior-year level of
EUR 6,908 thousand.
Developments in the non-financial indicators also mostly met forecasts in the fiscal year. The number of external training activities
increased slightly to 48 in the reporting year compared with 47 in the previous year. Here, the company's internal identification of
further training measures is carried out in line with requirements, so that the development of this key figure is clearly dependent
on the level of qualification of the current workforce. The number of documents describing standardized and controlled operating
procedures (SOPs) also increased slightly in the reporting period. The company currently manages 699 SOPs (previous year 683 ).
Internal training was at a similar level to the previous year. In the internal training courses, employees are trained in new and
modified SOPs. If there are product modifications or also a change in regulatory requirements, such training courses become
necessary. The regulatory environment of a pharmaceutical company sets extremely high standards in this regard, so that the
internal and external training standard at Biofrontera has already been at an extremely high level since the introduction of this
indicator. Likewise, the number of external and internal audits increased to 16 in the current year compared to 8 in the previous
year. In the past, the quality assurance system was audited in its entirety once a year. In 2022, Biofrontera switched to conducting
the internal audits on a departmental basis, so that the depth of the audit could be significantly increased. This in turn explains the
disproportionately strong increase in this key figure in the reporting period.
Regulatory progress planned for 2022, on the other hand, fell slightly short of expectations: for the phase III trial to test Ameluz®
PDT in superficial basal cell carcinoma, instead of completing patient recruitment, only 87% of patients have been included in the
trial to date. This was due to the challenging study protocol and the aftermath of the COVID-19 pandemic in 2022.
A slight delay occurred in the completion of patient recruitment in the Phase I safety trial for actinic keratosis of the face and scalp,
which was planned for 2022 and in which patients are treated with three tubes of Ameluz® each. Due to regulatory required protocol
changes and after-effects of the corona pandemic, there were delays in the initially very dynamic patient recruitment. As a result,
patient recruitment was not completed until March 2023, when the 100th patient was treated.
Fewer patients than expected were also treated in 2022 in the patient recruitment for the phase IIb trial on the efficacy of Ameluz®
in moderate to severe acne. The inclusion of suitable patients was slower than forecast due to the initially very strict inclusion
criteria and, in addition, was further delayed due to necessary protocol changes, some of which were required by regulatory
authorities. By the end of the year, just under 20% of the required patients had been enrolled in the study. With the protocol now in
place and the inclusion of two new centers, it is anticipated that patient recruitment will be significantly improved in 2023.
Biofrontera AG Annual Report 2022
13
The start of a further phase III trial on the efficacy of Ameluz® PDT in actinic keratosis with the aim of expanding the indication to
include treatment of the extremities, trunk and neck took place in the fourth quarter of 2022 with initially 2 trial centers. The first
patient was already screened in December 2022 and treated in January 2023. With the completion of the Phase I safety study in
actinic keratosis, enrollment will accelerate significantly in 2023 with the inclusion of additional trial sites.
Evaluation of the business performance by the Management Board
Business development for both the Biofrontera Group and for Biofrontera AG. was positive overall with a view to the year as a whole.
While the impact of the Covid pandemic continued to weaken as expected, the Company's business was increasingly impacted by
supply constraints during the year, which had a particular impact in the final quarter of the year.
Business development in 2022 was in line with management's expectations. Adjusting revenues for the effect of the spin-off of the
US subsidiary results in an increase compared to the previous year . Only in Germany did sales decline, due to re-import trade
triggered by the temporary decline in prices achieved in Spain. Once prices have settled back to previous levels and parallel trading
has ended, the German market will grow again. The effects resulting from deconsolidation led to a significant improvement in EBITDA,
enabling the company to report positive figures.
The Covid effect was fully compensated, although the company suffers from inflationary pressure on the cost of some materials,
mainly related to lamp production.
From a supply side perspective, there are shortages of certain raw materials on the market. For this reason, several suppliers require
advance payments in order to commit with specific delivery dates. This mainly affects lamp production and creates a peak cash
requirement, which puts a strain on our liquidity situation.
Group EBITDA reached EUR 1,869 thousand in the financial year 2022 (previous year: EUR 27,950 thousand). The year 2021 was
characterized by extraordinary effects (settlement with DUSA -EUR 19,457 thousand, deconsolidation of Biofrontera Inc. EUR 59,180
thousand). Adjusted for these effects, the development of EBITDA is as follows:
in EUR thousands
EBITDA
One-off effects
Adjusted EBITDA
Ammortizatiion and depreciation
Adjusted EBIT
2022
1,869
0
1,869
(746)
1,124
2021
27,950
(39,723)
(11,772)
(3,290)
(15,062)
Depreciation and amortization in fiscal year 2022 was lower at EUR 746 thousand than in the previous year at EUR 3,290 thousand,
resulting from the portion of Biofrontera Inc. included in the previous year's figure at EUR 2.6 million. Accordingly, EBIT in the
reporting year amounted to EUR 1,124 thousand compared to EUR 24,661 thousand in the previous year.
Despite the positive EBITDA of around EUR 2 million, earnings before income taxes amounted to EUR -43,210 thousand in fiscal year
2022 (previous year: EUR 35,683 thousand), mainly caused by the impairment of the equity investment in Biofrontera Inc. of EUR -
42,568 thousand.
In the separate financial statements of Biofrontera AG, a net loss of EUR ‑31,527 thousand is reported, compared to a loss of
EUR 4,130 thousand in the previous year.
Due to the capital measure resolved in April 2022 and implemented in December 2022, the Group was in a sufficient financial position
in the reporting year. With the successful IPO of Biofrontera Inc. in October 2021, the capital raised can be invested in further growth
to further expand the presence in the US market. Through the license and supply agreement, Biofrontera AG also benefits from a
strengthening of Biofrontera Inc. in the largest market without having to finance the largest cost block in the past, namely sales and
marketing in the USA, itself.
14
Biofrontera AG Annual Report 2022
Biofrontera Group financial position and performance
Results of operations of the Biofrontera Group
The results of operations as of December 31, 2022 are as follows; due to the fact that Biofrontera Inc. was still fully consolidated in
the previous year, comparability with the previous year is only possible to a limited extent. Please refer to our presentation of the
pro forma income statement in the notes:
in EUR thousands
Sales revenue
Gross profit on sales
Research and development costs
General administrative costs
Sales and marketing costs
Result on operations
Other expenses and income
EBITDA
EBIT
Financial result
Loss before income tax
Loss after income tax
Sales revenue
2022
25,738
20,981
(7,128)
(5,906)
(6,357)
1,591
(467)
1,869
1,124
(44,334)
(43,210)
(44,166)
2021
28,787
24,873
(7,009)
(30,781)
(22,423)
(35,341)
60,001
27,950
24,661
11,022
35,683
33,286
The Biofrontera Group generated total sales of EUR 25,738 thousand in the reporting year 2022, a decrease of 11% compared to the
previous year's figure (previous year: EUR 28,787 thousand), whereby the previous year's sales still included the US market sales of
the former subsidiary Biofrontera Inc. in the amount of EUR 20,204 thousand, which are opposed in the current year by licence
revenue from deliveries made to Biofrontera Inc. in the amount of EUR 16,487 thousand and service revenues of EUR 648 thousand.
Total revenues in Europe decreased by 4% to EUR 8,260 thousand (previous year: EUR 8,582 thousand) compared to the previous
year. Sales in Germany decreased by 10% year-on-year to EUR 4,763 thousand (previous year: EUR 5,263 thousand). In the rest of
Europe, total sales increased by 5% to EUR 3,498 thousand (previous year: EUR 3,320 thousand).
Revenues from other regions amounted to EUR 342 thousand in the fiscal year (previous year: EUR 0 thousand) and include both
license income and revenues from the sale of study materials.
Biofrontera AG Annual Report 2022
15
Gross profit on sale
Gross profit decreased by EUR 3,892 thousand in the reporting year 2022 to EUR 20,981 thousand compared to EUR 24,873 thousand
in the prior-year period. The gross margin decreased from 86% in 2021 to 82% in fiscal year 2022, mainly due to the fact that the
Company no longer consolidates U.S. sales, but only reports the license portion in the income statement.
Research and development costs
With an increase of 2% to EUR 7,128 thousand in the reporting year, research and development costs were roughly on a par with the
previous year's figure of EUR 7,009 thousand. In addition to costs for clinical trials, research and development costs also include
regulatory expenses, i.e., for the granting, maintenance, and extension of our marketing authorizations.
General and administrative costs
General and administrative expenses amounted to EUR 5,906 thousand in fiscal year 2021 (previous year: EUR 30,781 thousand) and
thus decreased by a total of EUR 24,875 thousand compared to the previous year. This was mainly due to the costs included in the
previous year's figure for the settlement payment as part of the out-of-court settlement in the legal dispute with DUSA
Pharmaceuticals Inc. amounting to EUR 19,457 thousand (USD 22.5 million) and the cost share of Biofrontera Inc. amounting to EUR
5,622 thousand in the previous year.
Sales and marketing costs
Sales and marketing expenses amounted to EUR 6,357 thousand in fiscal year 2021, an decrease of EUR 16,066 thousand compared
with the previous year (EUR 22,423 thousand), mainly due to the costs of Biofrontera Inc. of EUR 16,874 thousand included in the
previous year's figures. Selling expenses include the costs of our own sales force in Germany, Spain, the United Kingdom, and the
United States, as well as marketing expenses.
EBITDA and EBIT
The Group's EBITDA includes earnings before interest, taxes, depreciation of property, plant and equipment and amortization of
intangible assets and decreased by EUR 26,081 thousand to EUR 1,869 thousand in fiscal year 2022 compared with the prior-year
period (EUR 27,950 thousand). However, the previous year's figure includes special or non-recurring effects from the settlement
with DUSA Pharmaceuticals Inc. and from the deconsolidation of Biofrontera Inc. totaling EUR 39,723 thousand.
includes earnings before
EBIT
improved year-on-year to EUR 1,124 thousand (previous year:
EUR 24,661 thousand), whereby adjusted EBITDA in the previous year, taking into account the above-mentioned effects, amounted
to a loss of EUR 15,062 thousand accordingly.
interest and taxes and
Financial result
16
Biofrontera AG Annual Report 2022
In addition to the interest result, the financial result totaling EUR ‑44,334 thousand (previous year: loss of EUR 11,022 thousand)
includes expenses from the subsequent measurement of the carrying amount of the investment in Biofrontera Inc. amounting to
EUR 44,172 thousand (previous year: profit of EUR 14,729 thousand).
The net interest expense amounts to a loss of EUR 163 thousand (previous year: loss of EUR 3,707 thousand) and mainly includes
interest on the DUSA liability (EUR 101 thousand; previous year: EUR 0 thousand), interest expenses for a short-term bond issued in
the financial year and already repaid (EUR 34 thousand; previous year: EUR 0 thousand), and interest expense recognized in
accordance with IFRS 16 (EUR 15 thousand; previous year: EUR 23 thousand).
Other income and expenses
Other expenses and income totaled a loss of EUR 449 thousand in the reporting period (previous year: EUR 60,001 thousand), with
the previous year's figure mainly reflecting the deconsolidation gain of EUR 58,773 thousand from the departure of Biofrontera Inc.
from the Group. In addition, expenses and income from currency translation amounting to EUR 378 thousand (previous year: EUR
160 thousand) are reflected here.
Income taxes
This item includes current income taxes of EUR 156 thousand (prior-year period: EUR 47 thousand) and deferred tax expenses of EUR
800 thousand (prior-year period: EUR 1,778 thousand) from the reduction of tax-deductible loss carryforwards at Biofrontera Pharma
GmbH.
Net assets of the Biofrontera Group
The net assets position as of December 31, 2022is as follows:
in EUR thousands
Non-current assets
Current financial assets
Other current assets
Total assets
Equity
Non-current liabilities
Current financial liabilities
Other current liabilities
Total equity and liabilities
Non-current assets
December 31, 2022
December 31, 2021
17,669
9,324
5,732
32,725
20,336
4,002
5,109
3,277
32,725
61,750
8,171
6,206
76,127
57,426
1,235
10,478
6,990
76,127
Non-current assets as of December 31, 2022, totaling EUR 17,669 thousand(previous year: EUR 61,750 thousand) include recognized
deferred tax assets on tax loss carryforwards at Biofrontera Pharma GmbH in the amount of EUR 4,375 thousand (previous year: EUR
5,176 thousand), property, plant and equipment in the amount of EUR 3,012 thousand (previous year: EUR 2,281 thousand), and
intangible assets (EUR 1,198 thousand; previous year: EUR 1,139 thousand). Also included here is the investment in Biofrontera Inc.
valued at equity in the amount of EUR 8,982 thousand (previous year: EUR 53,154 thousand).
Current financial assets
Biofrontera AG Annual Report 2022
17
Current financial assets totaled EUR 9,324 thousand as of December 31, 2022 (previous year: EUR 8,171 thousand). This includes cash
and cash equivalents of EUR 6,376 thousand (previous year: EUR 6,908 thousand), trade receivables of EUR 691 thousand (previous
year: EUR 793 thousand), and other current financial assets of EUR 878 thousand (previous year: EUR 57 thousand).
Other current assets
Other current assets mainly contain inventories. This decreased slightly to EUR 4,794 thousand (previous year: EUR 4,814 thousand).
In the reporting year, impairment losses of EUR 155 thousand (previous year: EUR 42 thousand) were recognized on inventories.
Equity
In accordance with IFRS, the Group reported equity of EUR 20,336 thousand (previous year: EUR 57,997 thousand). The equity ratio
decreased from 76% to 63%.
Non-current liabilities
Non-current liabilities include financial liabilities (EUR 1,055 thousand; previous year: EUR 851 thousand), the obligations under the
SAR program in the amount of EUR 304 thousand (previous year: EUR 384 thousand) and non-current liabilities to associates
(EUR 2,642 thousand; previous year: EUR 0 thousand).
Non-current financial liabilities include liabilities from leases to be reported in accordance with IFRS 16 in the amount of
EUR 1,055 thousand (previous year: EUR 851 thousand).
Non-current liabilities to associates include the tranche of the liability from the DUSA settlement due in January 2024 in the amount
of EUR 2,642 thousand, which was included in other liabilities in the previous year in the amount of EUR 2,485 thousand.
Current financial liabilities
Current financial liabilities include in particular trade accounts payable of EUR 1,984 thousand (previous year: EUR 2,735 thousand)
and liabilities to associated companies of EUR 2,653 thousand (previous year: EUR 5,279 thousand) as well as current financial
liabilities of EUR 446 thousand (previous year: EUR 2,449 thousand).
Current financial liabilities reflect current liabilities from leases under IFRS 16 amounting to EUR 444 thousand (previous year: EUR
357 thousand).
Other current liabilities
Other current liabilities amounted to EUR 3,277 thousand (previous year: EUR 6,990 thousand) and include in particular provisions
of EUR 603 thousand
(previous year:
EUR 5,977 thousand).
(previous year: EUR 1,012 thousand) and other accruals of EUR 2,518 thousand
Financial position of the Biofrontera Group
The Company's capital management body regularly reviews the equity ratio of both the Biofrontera Group and the parent company.
The objective is to ensure an appropriate equity base, within the framework of the expectations of the capital market, and
creditworthiness with respect to national and international business partners. The Group's Management Board ensures that all Group
companies have sufficient liquidity at their disposal.
18
Biofrontera AG Annual Report 2022
in EUR thousands
Cash flow from/in operating activities
Cash flow from/in operating activities
Cash flow from/in financing activities
Cash and cash equivalents
Non-current financial liabilities
Current financial debt
Net liquidity
2022
(3,895)
(981)
4,344
6,376
1,055
446
4,874
2021
30,439
(42,259)
2,182
6,908
851
2,449
3,609
Net cash flow in operating activities of EUR ‑3,895 thousand (previous year: EUR 30,439 thousand) decreased mainly due to the
negative financial result in the amount of EUR ‑44,334 thousand(previous year: profit EUR 11,022 thousand).
Net cash flow from investing activities increased from EUR -42,259 thousand to EUR -951 thousand in fiscal year 2022 and, in addition
to investments in property, plant and equipment and intangible assets of EUR 981 thousand (previous year: EUR 629 thousand),
primarily includes the effect of the deconsolidation of Biofrontera Inc. in the amount of EUR 0 thousand (previous year: EUR -41,630
thousand).
Net cash flow from financing activities amounted to EUR 4,344 thousand (previous year: EUR 2,182 thousand) and mainly includes
the proceeds from the capital increase carried out in November.
The convertible bond 2017/2022 in the amount of EUR 2,031 thousand (previous year: EUR 2,031 thousand) was repaid on schedule in
January 2022.
Cash and cash equivalents
Cash and cash equivalents in the Group amount to EUR 6,376 thousand as of December 31, 2021 (previous year: EUR 6,908 thousand).
From today's perspective, both the Group and Biofrontera have sufficient liquidity for the next 12 months from the date of
preparation of the consolidated financial statements, taking into account the earnings expectations, the capital increase resolved
on January 9, 2023, and a level of cash and cash equivalents of EUR 6.4 million in the Group as of December 31, 2022. If, contrary to
expectations, the resolved capital increase cannot be implemented, the Company will secure interim financing through borrowing.
Although the Company expects an overall further improving earnings development in 2023, liquidity is nevertheless expected to be
below the level at the end of fiscal year 2022 due to the payment of the second and third installment of the liability from the DUSA
settlement at the end of 2023 and the beginning of 2024, respectively, without taking into account the planned capital increase.
Biofrontera AG financial position and performance
Results of operations of Biofrontera AG
Biofrontera AG Annual Report 2022
19
in EUR thousands
Sales revenue
Other operating income
Personnel costs
Depreciation and amortization
Other operating expenses
Other interest and similar income
Depreciation on financial assets
Interest and similar expenses
Other taxes
Net loss
2022
3,754
1,403
(2,751)
(22)
(6,203)
1,934
(29,492)
(146)
(2)
(31,527)
2021
3,698
12,362
(3,325)
(28)
(16,647)
1,748
0
(1,937)
(1)
(4,130)
The sales reported in the separate financial statements under commercial law include income from intercompany services. Other
operating income mainly relates to the internal recharging of litigation costs in the patent dispute in the USA.
The decrease in personnel expenses is mainly due to the reduction in Management Board compensation. For further details, please
refer to the compensation report.
Other operating expenses decreased by EUR 10,443 thousand to EUR 6,203 thousand. This is due mainly to the fact that the previous
year's figure included the costs of ending the legal dispute with DUSA Pharmaceuticals, Inc. by means of an out-of-court settlement.
Financing costs also reduced significantly by EUR 234 thousand compared to EUR 2,385 thousand in the previous year, in line with
the lower gross issue proceeds of the capital increase carried out in November 2022 compared to the capital increase carried out in
February 2021.
Interest and similar income results almost exclusively from subsidiaries. Interest expense decreased by EUR 1,791 thousand to EUR
146 thousand due to the termination of the EIB loan and the convertible bond 2017/2022.
The net loss for the year amounts to EUR ‑31,527 thousand (previous year: EUR ‑4,130 thousand), adjusted for the impairment loss
on the investment in Biofrontera Inc. in the amount of EUR 29,492 thousand, the adjusted net loss for the year was EUR -2,035
thousand. The adjusted net loss of EUR -2,035 thousand improved compared to the forecast net loss of EUR 4 million mainly due to
the previously described decrease in interest expenses and personnel expenses.
Net assets of Biofrontera AG
20
Biofrontera AG Annual Report 2022
in EUR thousands
Non-current assets
Receivables due from affiliated companies
Cash and cash balances with banks
Other assets
Total assets
Equity
Provisions
Bonds
Liabilities to banks
Other liabilities
Total equity and liabilities
December 31, 2022
December 31, 2021
41,176
72,112
5,706
609
119,603
111,493
2,417
0
0
5,694
119,603
70,689
72,126
6,516
1,052
150,383
135,879
5,866
2,031
0
6,607
150,383
Non-current assets mainly relate to shares in affiliated companies at EUR 32,224 thousand (previous year: EUR 32,224 thousand) and
associated companies at EUR 8,933 thousand (previous year: EUR 38,425 thousand).
Cash and cash equivalents decreased from EUR 6,516 thousand in the previous year to EUR 6,516 thousand in 2022. For further details
on the financial position, please refer to the presentation of the Group's financial position.
Biofrontera AG has equity under commercial
EUR 135,879 thousand). Due to the capital increase in November 2022 subscribed capital increased by EUR 7,090 thousand.
law of EUR 111,493 thousand as of December 31, 2022 (previous year:
Provisions mainly include provisions for outstanding invoices, litigation costs, SARs, bonuses for employees as well as annual audit
and tax filings.
The convertible bond 2017/22 was repaid in full on January 03, 2022 including interest.
Assessment of the financial position of Biofrontera AG and the Group
In the individual financial statements of Biofrontera AG, the liquidity of EUR 5,706 thousand is, as expected, below the previous year’s
figure of EUR 6,516 thousand. The main factors influencing this in the 2022 financial year were the repayment of the convertible
bond 2017/2022 in January and the capital increase carried out in November with gross issue proceeds of EUR 7,090 thousand. The
Group's liquidity decreased by EUR 533 thousand to EUR 6,376 thousand in fiscal year 2022.
From today's perspective, both the Group and Biofrontera AG, taking into account the expected results, the capital increase resolved
on January 9, 2023, a level of cash and cash equivalents of EUR 6.4 million in the Group as of December 31, 2022 on the date of
preparation of the consolidated financial statements, have sufficient liquidity available for the next 12 months from preparation. If,
contrary to expectations, the resolved capital increase cannot be implemented, the Company will secure interim financing through
borrowing. Although the Company expects an overall further improving earnings development in 2023, liquidity is nevertheless
expected to be below the level at the end of fiscal year 2022 due to the payment of the second and third installment of the liability
from the DUSA settlement at the end of 2023 and the beginning of 2024, respectively, without taking into account the planned capital
increase.
Outlook and forecast
General conditions
Biofrontera AG Annual Report 2022
21
We expect the global economy to grow in 2023 after overcoming the Corona crisis and despite the ongoing Ukraine war, although
the pace of recovery will be more moderate and with significant regional differences. Supply chain issues, strongly rising inflation
rates, and the energy crisis will have a significant impact on this.
The German government's (Federal Ministry for Economic Affairs and Energy) Annual Economic Report 2023, published on January
26, 2023, indicates a slight increase of 0.2% in German gross domestic product (GDP), with a more significant recovery of 1.8%
expected in 2024. At the beginning of January, the Federal Statistical Office had already announced that economic performance in
2022 had grown by 1.9%, a significantly better result than expected by the German government at the beginning of 2022. With a
strong program of measures to control inflation, manage the energy crisis and address the growing lack of skilled workers, the
German government's annual economic report predicts that inflation could be overcome as early as 2024 with a 4.9% increase in
disposable income.
According to a January 26, 2023 release by the U.S. Bureau of Economic Analysis (BEA), U.S. gross domestic product rose 2.1% in
2022, well short of the 5.9% growth in 2021. In its revised economic forecast on February 15, 2023, the Congressional Budget Office
(CBO) projects that real GDP growth will halt in 2023 and not recover until 2024 to 2027, with average growth rates of 2.4 percent.
The CBO considers persistently high inflation and faster-rising interest rates, and also assumes that unemployment will rise as a
result of slower economic growth.
For the pharmaceutical market, moderate growth of 0.1% to 0.4% is expected for Western Europe and North America in 2023 and
subsequent years. Growth of -1% to +2% is forecast for the U.S. market, representing a slight reduction from previous forecasts and
resulting from the Inflation Reduction Act. Growth in the European market is expected to be driven primarily by generics, biosimilars
and new launches, whereas pricing pressure on innovative medicines is expected to remain. The increase in the manufacturer's
discount from 7% to 12% for reimbursable medicines without a reference price decided for Germany for 2023 on the basis of the
SHI Financial Stabilization Act, which is initially limited to 2023, could remain in place beyond this period. A return to pre-pandemic
growth rates is not expected until 2024. Growth drivers in the pharmaceutical sector are likely to be oncological and immunological
therapies. The dermatology sector is expected to grow at a 5-year CAGR of 4-7% over the period 2023-27.
For the pharmaceutical market, moderate growth of 0.1% to 0.4% is expected for Western Europe and North America in 2023 and
subsequent years. Growth of -1% to +2% is forecast for the U.S. market, representing a slight reduction from previous forecasts and
resulting from the Inflation Reduction Act. Growth in the European market is expected to be driven primarily by generics, biosimilars
and new launches, whereas pricing pressure on innovative medicines is expected to remain. The increase in the manufacturer's
discount from 7% to 12% for reimbursable medicines without a reference price decided for Germany for 2023 on the basis of the
SHI Financial Stabilization Act, which is initially limited to 2023, could remain in place beyond this period. A return to pre-pandemic
growth rates is not expected until 2024. Growth drivers in the pharmaceutical sector are likely to be oncological and immunological
therapies. The dermatology sector is expected to grow at a 5-year CAGR of 4-7% over the period 2023-27.
Guidance
The Biofrontera Group provides the following guidance for full year 2023, which reflects a recovery in global economic growth. This
is based on the assumption that appropriate measures will be taken globally to limit the effects of inflation, the energy crisis and
the after-effects of the pandemic. The recovery in our key sales markets that we had already anticipated for 2022 was much more
moderate, so we expect growth to be more solid in 2023, as the restrictions imposed by the pandemic in particular no longer apply.
Forecast of key performance indicators relevant to management
The Group expects sales of EUR 27 to 33 million in fiscal year 2023. The success of our own sales teams as well as those of our
licensing partners in the U. S. and Europe, and as a result our own business activities, depend strongly on regional economic strength
and the resulting dynamics.
In the United States in particular, the main sales market for our flagship product Ameluz®, we expect to see an increasing momentum
and a rise in demand over the course of the year. Comprehensive marketing measures to support sales by our U.S. licensing partner
led us to expect a more significant market penetration.
In Germany, the most important European sales market, the Company expects for the ongoing year to expand the PDT market by
gaining market share in topical drug sector. The increasing awareness of actinic keratosis as an early form of skin cancer that
requires effective treatment and the daylight approach as a patient-friendly and reimbursable form of therapy should support a new
sales momentum in the market.
22
Biofrontera AG Annual Report 2022
As a result of the broader base of distribution partners and the resulting regional expansion of the marketing of Ameluz, particularly
in the Scandinavian region and in Poland, we expect a constant increase in sales for the European market. The higher sales price in
Spain and the expansion of sales efforts in the United Kingdom, also provided a boost to such market growth. However, as stated at
the beginning of this report, sales growth is heavily dependent on the continued recovery of the economy and the control of the
impact of the Ukraine war. As a result, there is still some uncertainty with respect to the sales revenues that can be achieved in the
current year.
Assuming a recovery in global economic strength, Biofrontera AG expects positive EBITDA of EUR 3 to 5 million and positive EBIT of
EUR 2 to 4 million in 2023. Furthermore, assuming a further recovery of the markets, the company expects further sales increases
as well as positive EBITDA and EBIT in the mid single-digit million range from 2024 onwards.
From today's perspective, both the Group and Biofrontera AG have sufficient liquidity for the next 12 months from the date of
preparation of the consolidated financial statements, taking into account the earnings expectations, the capital increase resolved
on January 9, 2023 and a level of cash and cash equivalents of EUR 6.4 million in the Group as of December 31, 2022. If, contrary to
expectations, the resolved capital increase cannot be implemented, the Company also has authorized capital in the amount of 12.7
million new shares to be created. The Company expects earnings to continue to improve in 2023, but is able to react to changing
market conditions at short notice by creating additional capital. Biofrontera expects liquidity at the end of 2023 to be between EUR
1 million and EUR 3 million due to the payment of the second of the liability from the DUSA settlement at year-end 2023, excluding
the planned capital increase.
For the separate financial statements of Biofrontera AG, we continue to expect a loss that is likely to be in the low single-digit
million range.
Forecast of further key figures
Biofrontera does not expect the number of employees to increase in 2023. Due to the slight increase in the number of employees
in 2022 and the increasing requirements for pharmaceutical companies listed on the capital market, we assume that the number of
training measures in 2023 will be at a comparable level to that in 2022.
Maintaining and extending our authorization is essential for securing and strengthening Biofrontera's market position and is
reflected, among other things, in our quality management. Thus, the number of external and internal audits are important non-
financial control parameters for the company. We expect the number of audits in 2023 to remain at a comparably high level to
2022.
Planned regulatory progress
Patient enrollment in the Phase III trial for regulatory expansion in the U.S. to include the indication of superficial BCC has already
started in September 2018. To date, close to 90% of the planned 186 patients have been enrolled in the study. The company expects
patient enrollment to be completed during 2023.
The Phase I safety study evaluating the safety and tolerability of PDT for the treatment of mild to severe actinic keratosis on the
face and scalp with the simultaneous application of three tubes of Ameluz® together with the new RhodoLED® XL lamp is nearing
completion of patient recruitment. The last patient was treated in March 2023 and the clinical part of the study was completed with
the last examination in April. The Company expects to submit the extended registration dossier in the fourth quarter of 2023.
Patient recruitment for the phase IIb trial to test the safety and efficacy of Ameluz® in combination with the BF-RhodoLED® red
light lamp in the treatment of moderate to severe acne with photodynamic therapy has been ongoing since December 2021. By the
end of 2022, just under 20% of suitable patients had been enrolled in the trial. The slow enrollment in 2022 should be overcome by
the modifications made to the study protocol and with the addition of further trial sites, Biofrontera expects to complete patient
enrollment in the first quarter of 2024.
The registration trial for Ameluz® for the treatment of AK on the extremities and trunk/neck was started in December 2022, and the
company expects the therapy phase to be completed in the third quarter of 2024.
Risk and opportunity report
Biofrontera AG Annual Report 2022
23
Each industry has its own specific characteristics that give rise to specific risks. The health industry, in particular, is in a state of
constant change, with the ensuing risks and opportunities being shaped by a wide variety of influences.
As an internationally biopharmaceutical company, the Biofrontera Group is exposed to a large number of risks arising from its
business activities, which can have a significant impact on the achievement of the targets. Deviations from the plan are to be
understood as opportunities (positive deviations) and risks (negative deviations).
Risk management system
Biofrontera's management counters the risks existing in the Group with a comprehensive risk management system. Due to its holding
function, Biofrontera AG controls all legally independent entities within the Biofrontera Group. Therefore, a uniform group-wide
assessment of risks and opportunities within the group is necessary.
The primary objective of the Biofrontera Group is to grow sustainably and thus to steadily increase the value of the company. Risk
management makes a significant contribution to achieving this goal. Risk management at Biofrontera involves the identification of
risks that could lead to a permanent or significant impairment of the Biofrontera Group's net assets, financial position and results
of operations, the responsible analysis and monitoring of these risks, and the taking of appropriate countermeasures. This requires
defined principles, organizational structures, and measurement and monitoring processes that are specifically geared to the
activities of the Biofrontera Group.
Appropriately detailed risk prevention measures are the prerequisite for fully exploiting the opportunities arising from Biofrontera's
business activities. The existing risk management structures at Biofrontera within the framework of the quality management system
required for pharmaceutical manufacturers and entrepreneurs as well as for medical device manufacturers are constantly being
further developed. The marketing and sales activities as well as the international responsibilities that a marketing authorization
holder has for the manufacture and distribution of drugs, medical devices and cosmetics are included in this system.
The Biofrontera Group's risk management is integrated into the business processes and entrepreneurial decisions, and thus into the
Group-wide planning and controlling processes. Risk management and control mechanisms are coordinated with each other. They
ensure that risks relevant to the company are identified and assessed at an early stage. At the same time, it serves to quickly seize
potential opportunities.
Risk management at Biofrontera is organized both decentrally and centrally. The Executive Board has overarching responsibility for
this. The coordinated subsystems are the responsibility of the specialist departments. Opportunities and risks are regularly identified
and evaluated across all hierarchical levels. All executives of the Group and the Audit Committee are involved in Groupwide risk
monitoring and the associated reporting. This includes both the Executive Board and the managing directors of the Group companies
as well as the process and project managers.
Risk management reports to the risk management team headed by the Management Board. The risk management team coordinates
the individual management bodies and ensures they are kept informed at an early stage and on an ongoing basis. In addition, the
team is responsible for the ongoing monitoring of the risk profile, the initiation of risk prevention measures and the corresponding
control instruments. Within the framework of regular meetings, the management of the Biofrontera Group comes together to
exchange and evaluate risk management-relevant information between the operational and central divisions across all levels.
The Group-wide contact person is the risk officer, who is also a member of the risk management team. If unforeseen risks arise, he
immediately initiates the necessary steps to counter them. On the one hand, he is responsible for the further development of the
risk management system and its documentation. In addition, the risk officer defines uniform standards and ensures that similar risk
management processes are applied within the Biofrontera Group. For example, the regular analysis of key figures relating to the
course of business serves to identify and evaluate possible deviations from expected developments in terms of potential
opportunities or risks at an early stage and to initiate necessary measures. Overall monitoring of the relevant control parameters
and business processes is carried out. Risk planning and identification are carried out in cooperation with the respective department
heads.
Accounting risk management system and internal controls
The accounting process of the Group as well as of Biofrontera AG pursues the presentation of correct and complete figures and
disclosures in the instruments of external accounting (bookkeeping, annual and consolidated financial statements, summarized
management report) as well as compliance with the relevant legal and statutory provisions. The structures and processes in place
24
Biofrontera AG Annual Report 2022
for this purpose integrate detailed internal control measures with regard to the accounting process. In connection with the
increasing business activities, the accounting-related internal control system is subject to a continuous monitoring and
improvement process.
The aim of the internal control system is to identify, assess and manage all risks that could prevent the preparation of our annual
and consolidated financial statements in accordance with the rules. Identified risks must be assessed with regard to their impact on
the annual and consolidated financial statements. It is the task of the accounting-related internal control system to ensure that the
closing process complies with the rules by implementing appropriate principles, procedures and controls. The internal control
system covers all departments that are important for the annual and consolidated financial statements and all processes relevant
to the preparation of the financial statements.
Significant aspects of risk management and control in accounting are the clear allocation of responsibilities and controls in the
preparation of the financial statements and transparent accounting policies. The dual control principle and the separation of
functions are further important control principles in the accounting process.
Risk reporting concerning financial instruments
In the ordinary course of business, the Group is exposed to risks that may have an impact on its net assets, financial position and
results of operations.
Market risk
As of the reporting date, the Biofrontera Group was exposed to foreign currency risks, in particular due to the transfer price in US-
Dollar agreed with the former 100%-owned subsidiary Biofrontera Inc. The Company does not enter into any specific currency
hedging transactions. Exchange rate fluctuations are recognized in profit or loss.
Credit risk
The Group is exposed to credit risk if transaction partners are unable to meet their obligations within the usual payment periods.
The maximum default risk is represented in the balance sheet by the carrying amount of the respective financial asset. The
development of the receivables portfolio is monitored in order to identify potential default risks at an early stage and to initiate
appropriate measures. Biofrontera's financial instruments bear a minimal risk of default.
Liquidity risk
Liquidity risk refers to the inability to meet existing or future payment obligations as they become due. To ensure the ability to pay
at all times and to avoid financial shortages, Biofrontera has established a central cash management system that monitors liquidity
requirements in the short, medium and long term. Refinancing for all Group companies is mainly provided by Biofrontera AG.
Liquidity is monitored and managed on the basis of short- and long-term corporate planning. Liquidity risks are identified at an early
stage by simulating various scenarios. Current cash and cash equivalents are recorded and monitored on a daily basis.
For further information, please refer to the section "Liquidity, profitability and capital markets access".
Risks and opportunities relating to future business development and growth
The business strategy of Biofrontera AG is based to a large extent on establishing the current products, in particular the drug
Ameluz®, on the relevant sales markets in the long term. In order to exploit market potential, it is necessary to obtain and expand
the existing approvals in the USA and Europe. In addition, the aim is to broaden the product pipeline. The protection of our intellectual
property is to be secured by a suitable patent strategy. The prerequisite for achieving these targets is ensuring sustained
profitability and sufficient liquidity.
Risks may arise from deviations from targets in the form of negative developments, the insufficient realization of targeted and
already recognized opportunities or potentials, or the failure to take advantage of new opportunities. Biofrontera's risk management
takes this into account through continuous analysis of relevant influencing factors.
Net assets
Biofrontera AG Annual Report 2022
25
Biofrontera AG has investments in subsidiaries, some of which have significant carrying amounts. If the companies do not develop
according to plan in the long term, there is a risk that the carrying amounts of the investments may have to be written down.
External influences and global risks
The increasing integration of the global economy due to globalization and digitalization can have a negative impact on Biofrontera's
target achievement in the context of macroeconomic developments. In addition, political developments in our sales markets can
have an influence on the structures relevant to Biofrontera in the respective healthcare sector.
In addition to effects on individual markets, global crises may arise in this context that could have a significant impact on the
Biofrontera Group's business operations.
As a result of potential crises, the maintenance of business processes may be jeopardized, among other things, by the ordering of
official measures that do not permit full business operations, by the fact that employees of the Biofrontera Group are affected, or
due to impairments of relevant suppliers.
However, the Executive Board assumes that it will be able to counter these possible effects by means of suitable measures.
To this end, the company had already developed a suitable set of tools after the onset of the COVID pandemic to counter these risks
and safeguard business processes through comprehensive cost reductions, contingency planning to maintain central processes,
and activities to protect employees. These could be re-executed if necessary.
The war in Ukraine, which broke out at the end of February 2022, does not currently have a direct impact on Biofrontera, as the
company is not active in Ukraine or Russia. However, there are negative indirect factors influencing the company's success, such as
price increases on the procurement markets and a further impairment of supply chains that were already impaired in the context
of the COVID 19 pandemic. There is also the possibility of further escalations and the resulting cross-regional economic risks.
For further risks in connection with the ongoing Ukraine crisis, please refer to the comments in the section on liquidity, profitability
and access to capital markets.
Since February 1, 2020, the United Kingdom is no longer a member state of the European Union. As the regulatory framework for
pharmaceutical products in the United Kingdom, which covers quality, safety and efficacy of pharmaceutical products, clinical trials,
marketing authorization, commercial distribution and sales of pharmaceutical products, is derived from European Union directives
and regulations, this could impact the future regulatory regime which applies to products and the approval of product candidates
in the United Kingdom. It remains to be determined how, if at all, withdrawal will affect the regulatory requirements for products in
the United Kingdom. Due to the immaterial volume of revenues from product sales in the United Kingdom, the Company considers
this risk to be low.
These risks cannot be influenced by Biofrontera. In the past, however, the monitoring processes and standards implemented in the
company have enabled Biofrontera to always adapt external effects or risks appropriately and successfully.
Liquidity, profitability and capital markets access
Liquidity risks can arise from possible loss situations of the company and uncertainties regarding the future further business
development, or from not being able to exploit market potentials in line with Biofrontera's business strategy due to insufficient
liquidity.
Biofrontera balances this risk with a long-term capital market strategy. In addition, potential risks are regularly identified and
assessed as part of our short-, medium- and long-term Group-wide liquidity planning in order to be able to take timely measures to
achieve targets, if necessary.
The Biofrontera Group might not be able to meet existing or future payment obligations due to insufficient availability of cash. To
date, the Group has been able to meet its payment obligations at all times. By injecting equity or debt capital, Biofrontera has so far
always succeeded in providing the financing required for its business operations.
The additional capital requirements could be covered by the capital increase resolved by the Extraordinary General Meeting on
January 09, 2023. An action for annulment against this resolution of the Annual General Meeting was filed by two shareholders with
26
Biofrontera AG Annual Report 2022
the Cologne Regional Court. The action was served on the Company on March 16, 2023. The action was withdrawn on April 13, 2023.
So-called release proceedings in accordance with section 246a of the German Stock Corporation Act (AktG) before the Cologne
Higher Regional Court are therefore no longer necessary. A prospectus, which is currently being prepared, is required for the
implementation of the capital measure.
Law and compliance
The Group may be exposed to litigation or legal proceedings in the future. These include in particular risks from the areas of product
liability, antitrust law, competition law, patent law, tax law and environmental protection. Risks may also arise in connection with
disclosure and information requirements on the capital market. Investigations and inquiries into possible infringements of statutory
provisions or regulatory requirements may result in criminal and civil sanctions, including substantial monetary penalties, as well
as other financial disadvantages, damage our reputation and ultimately have a negative impact on our business success or our
access to the capital markets.
An action for avoidance has been filed by two shareholders against all resolutions of the Company's Extraordinary General Meeting
on January 9, 2023, i.e. inter alia against the resolutions under agenda item 1 (resolution on authorized capital) and agenda item 2
(resolution on the increase in capital stock). The claim was withdrawn on April 13, 2023.
Further information on litigation is provided separately in the section "Litigation".
Regulatory approvals
Restrictions on existing approvals in Europe and the United States would jeopardize the ability to market the Company's products.
The risk also exists that strategically relevant marketing authorization extensions may not be approved, or may be approved with
delays or only to a limited extent, which could impair the Company's ability to compete with its competitors.
The Company compensates for these risks through consistent compliance with regulatory requirements and an effective quality
management system.
Research and development
The Company is also exposed to a further risk in the context of product development processes or indication expansions. No
guarantee exists that a product can be brought to market after the end of the clinical development process of a project - on average
6 to 10 years. Due to a lack of success in individual study phases, for example in study design, patient recruitment, possible quality
deficiencies or the documentation of study results, studies can prove to be more cost-intensive than planned, be delayed or even
come to a complete standstill. Invested funds may not be recovered, or only partially recovered, through the revenues generated.
The Company seeks to mitigate these risks to some extent by selecting projects with relatively appealing risk profiles and by
establishing a project control and reporting system. The project control system maps the entire development process up to approval
in detail and enables analysis of the impact that even small changes or delays, for example in clinical trials, have on the development
process and its costs. In this way, the risk of individual projects can be closely monitored and the necessary steps can be taken to
minimize development risk.
Product portfolio
With Ameluz® , the company currently has only one approved product, which is sold in some European countries and the USA with
its own sales force or by license partners. The risk exists that Ameluz® may not be sufficiently or sustainably established on the
market.
Another potential risk is that the company may be at a competitive disadvantage compared with its competitors due to advantages
in terms of the range of indications for competing products. For this reason, for example, indication extensions are initiated in order
to gain competitive advantages.
A further risk is that the company's own product pipeline cannot be broadened and that successor or supplementary products
cannot be brought to market maturity.
Biofrontera AG Annual Report 2022
27
Biofrontera counters these risks by constantly monitoring the market with regard to the activities of known competitors or the
market entry of new competitors, and carries out extensive research and development activities to broaden the indication base. In
addition, cooperation opportunities to expand the product portfolio are evaluated.
Through the acquisition of Cutanea Life Sciences, Inc. in March 2019, Biofrontera Inc. became a licensee of Xepi® and has since been
marketing the FDA-approved drug launched in the U.S. market. Prior to the deconsolidation of Biofrontera Inc. at the end of the
reporting period, Xepi was still part of Biofrontera AG's product range. For the consolidated financial statements, the risk of
impairment for the acquired Xepi® license in the event of insufficient or sustained establishment on the market thus no longer
exists.
Patent protection
The company may be subject to patent protection risks. In case of successful commercialization, the contribution margins can be
used to continue and sustainably invest in research and development. Due to the long time between the patent application and the
market launch of a product, Biofrontera usually has only a few years to generate an adequate return on its intellectual output. If a
patent expires or if a patent cannot be successfully defended, increased competition can usually be expected. Lack of patents can
jeopardize the market position of the Company's products and facilitate market entry by competitors. To avoid these risks,
Biofrontera's patent portfolio is continuously reviewed and the patent strategy is adjusted. Further information on individual patents
is presented in the section on patent and trademark development.
Lawsuits filed by third parties due to potential infringement of patents or other intellectual property rights by Biofrontera may
impede or even stop the development or manufacture of certain products and may require us to pay damages or royalties to third
parties. Our patent department regularly reviews the current patent situation in cooperation with the respective operating units
and monitors possible patent infringement attempts in order to initiate legal action if necessary.
Ameluz® is protected by a family of patents relating to nanoemulsion technology. The patent was not granted in US until January
2023 with a term until February 2028. In Europe, Australia, Canada and other countries, this patent was granted earlier, with a term
until December 2027. The risk of potential future generic competition is further mitigated by specific challenges in the development
of generic dermatological products, including regulatory hurdles. As part of Biofrontera's patent strategy to further protect
Ameluz®, additional patent applications have been filed in recent years to protect the use of the combination of Ameluz® and BF-
RhodoLED®. With the granting of these patents in December 2021, a substantial contribution has been made to limiting this risk.
Further information on patent development is provided in the section entitled "Patent development". Further information on patent
litigation is presented separately in the section "Litigation".
Products and product stewardship
As an international biopharmaceutical company, Biofrontera is subject to the highest requirements and associated risks in the
quality and safety areas. Biofrontera assesses potential environmental and health risks associated with a product along the entire
value chain. This includes every stage from research and development to disposal, including production, marketing and customer
use. Despite extensive studies, the possibility exists of previously unknown and unexpected side effects from Biofrontera products.
The Company may be exposed to a cost risk due to product safety deficiencies if, for example, our products are recalled voluntarily
or as a result of legal or regulatory action. Possible payments of damages associated with the aforementioned risks could exert a
considerable negative effect on the Company's financial results. These risks are offset by established pharmacovigilance processes
in the Company and ensure that potential side effects or other product-related problems are quickly identified. As no previously
unknown side effects of our drugs have appeared, we consider it highly improbable that risks of this kind will arise.
Both regulatory requirements and standards applied beyond them are guaranteed by a wide variety of processes integrated into
the Company. The Company's product-related risks are countered with a functioning quality management system. Biofrontera's
focus on Good Manufacturing Practice (GMP) guidelines and Standard Operation Procedures (SOPs), which are mandatory in the
pharmaceutical industry, ensures the quality and safety requirements for products and processes. Regular internal audits of
standards at suppliers and subcontractors contribute in this context. Regular checks and inspections are also carried out by
regulators.
Markets
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Biofrontera AG Annual Report 2022
Biofrontera operates in regulated competitive markets. The Company's sales and revenue targets could be jeopardized by measures
taken by competitors with an impact on sales and revenue with regard to the fields of application of their products, the pricing
strategy or the marketing strategy, but also by new products from competitors. If the sales targets are not achieved, this could also
have a negative effect on the Company's earnings and liquidity targets, as well as impairments on product inventories already
produced.
Realignments in the respective healthcare systems and changes in the reimbursement behavior of drug reimbursement
organizations, as well as market barriers in the relevant markets, may result in the risk of insufficient or unsustainable market
penetration. The competitive position of our products may also be negatively impacted by product characteristics that are not
perceived as optimal compared to competitive products in the respective market. In addition, our products compete with other
therapies such as simple curettage and, particularly in the United States, cryotherapy, which do not require the use of a drug but
have gained significant market acceptance due to their long history of use.
To avoid these risks, Biofrontera's sales and marketing organization closely monitors the market and conducts regular market
analyses. The marketing instruments used and the communication with our customers are subject to constant further development
in this context in order to be able to identify opportunities and risks and to strengthen the company's competitive position.
Procurement and production
As a pharmaceutical manufacturer, the Company is exposed to various risks in connection with the procurement and production of
its products. Biofrontera relies on individual manufacturers or suppliers for the production of its finished products as well as raw
materials, whose exchange would entail lengthy regulatory approval processes. Difficulties regarding procurement prices, quality,
delivery reliability or quantity at or with these suppliers may affect the Company's revenue and results targets. By establishing
alternative suppliers, changing production sizes and actively managing contracts and inventories, Biofrontera seeks to minimize
these dependencies and ensure the supply of the required goods and services.
Risks associated with the manufacturing, bottling, storage and transportation of products may result in personal injury or material
or environmental damage and may give rise to an obligation to pay damages. Using our own audit and monitoring system,
Biofrontera regularly ensures that the manufacturing conditions at its most important suppliers meet the required standard. This
enables us to avoid such risks and damages. We have also established our own production facilities for in-house production quality
control of the BF-RhodoLED® lamp to reduce our dependence on suppliers in this area, too.
Business strategy
Due to changing framework conditions, the strategy chosen by the Company to guarantee its sales, growth and profitability targets
may not be sufficiently effective in the future. As part of the risk management process, management uses ongoing analyses to
counteract current and potentially future influencing variables or developments in order to initiate suitable measures if necessary.
Staff
The recruitment of qualified and dedicated staff is a key prerequisite for the Company's success. A high staff turnover rate could
jeopardize the achievement of corporate goals and the safeguarding of the Company's know-how. In order to counter these risks,
motivate employees and retain key personnel, the Company offers competitive compensation, participation in option programs and
extensive training and professional development opportunities for employees. Furthermore, the Group pursues a diversity-
orientated personnel policy in order to leverage the labor market's full potential. To date, Biofrontera has always succeeded in
recruiting the qualified staff the Company requires. For this reason, the Company regards this risk as low. However, this assessment
could change significantly in the case of a change of control.
Information technology and data protection
The Group's business processes and internal and external communication are increasingly based on global IT systems. A significant
technical malfunction or total failure of IT systems could result in severe impairment of our business processes. It is of fundamental
importance to us that both internal and external data remain confidential. If the confidentiality, integrity or authenticity of data or
information were to be lost, the manipulation and/or uncontrolled outflow of data and know-how could arise. We have adopted
appropriate measures to mitigate this risk, such as an authorization concept. However, while we have IT security measures and
disaster recovery plans in place, they may prove to be inadequate or ineffective. Our IT systems may be vulnerable to cyberattacks,
unauthorized access, computer viruses, system failures, human error, natural disasters, fire, power failure, communication
Biofrontera AG Annual Report 2022
29
disruptions or acts of sabotage. The measures adopted by the Company have always proven adequate to date, so such risk is to be
regarded as low.
As a pharmaceutical company, Biofrontera is exposed to additional risks in the area of data protection. A large volume of person-
related data is generated, particularly in the area of clinical trials and drug safety reports and must be protected in particular under
the new Basic Data Protection Regulation (EU-DSGVO). Violations or violations of these regulations may result in severe penalties
against the Company. Biofrontera counteracts these risks with continuous data protection processes and the implementation of
legal guidelines.
Insurance coverage
The Company may be subject to the risk of insufficient insurance coverage for the continuation of business operations in the event
of damage, for events affecting the Company's assets or claims for damages due to product defects as well as actions by the
Company and its employees. Biofrontera mitigates these risks as part of its risk analysis with regular reviews of the adequacy of the
relevant insurance coverage.
Taxes
The future use of the tax loss carryforwards accrued to date in the consolidated group of companies may not be realized or may not
be optimized due to the organizational structure of the Company. To this end, Biofrontera carries out regular analyses to make
appropriate adjustments, if necessary.
However, the Company cannot influence the risk of limited use of the tax loss carryforwards due to changes in tax law or as a result
of a tax-relevant change in the shareholder structure.
Opportunities
In addition to the identification of risks, the Biofrontera Group's risk management system also includes opportunities, which are to
be seen as positive deviations from corporate planning.
The company considers opportunities in the expansion of the indications of its products, particularly in the extension of the approval
of Ameluz® in our important sales markets, especially in the USA to expand and exploit market potential. For example, at the time
of publication of the annual report, the company is conducting a phase III clinical trial for the treatment of superficial basal cell
carcinoma (BCC) with Ameluz® , a phase IIb trial to expand the approval of Ameluz® for moderate to severe acne in the U.S., and a
phase I safety trial to amend the product information,which currently limits use to one tube of Ameluz® per treatment, to three
tubes. In addition, a Phase III trial is in preparation for approval of the US approval extension for Ameluz® for the treatment of AK
also on the extremities and trunk/neck, which is expected to start at the end of 2022. To complement this progress with an optimized
illumination source, the Group has also achieved development and FDA approval of a larger RhodoLED® XL lamp. In addition, there
is a medium- and long-term opportunity for portfolio expansion through the development of new products based on our
nanoemulsion technology.
We also see further long-term revenue opportunities in the form of milestone and royalty payments through licensing and supply
agreements with our licensing partners in Europe, Asia, and the United States. At the same time, the company is analyzing new
markets such as Canada or Brazil with regard to cooperation with a relevant market player there. In the European market, marketing
options for countries such as France, Italy or the Netherlands are also being examined, either through a partnership or the
establishment of a dedicated sales unit. The growth and expansion of the Ameluz markets is a clear priority for Biofrontera.
Overall opportunity and risk situation at Biofrontera
The Management Board considers the overall risks not related to the current crisis to be controllable. The Management Board has
confidence in the effectiveness of the risk management system with regard to positive and negative changes in the environment
and the requirements of the current business. The assessment is based on various factors, which are summarized below:
▪
The company has developed a suitable set of tools to counteract risks and safeguard business processes if necessary
through comprehensive cost reductions, contingency planning to maintain central processes, and activities to protect
employees. These could be carried out again if necessary.
▪
To date, the Group has been able to meet its payment obligations at all times.
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Biofrontera AG Annual Report 2022
In recent years, the Company has regularly relied on external cash and cash equivalents. According to current planning
and taking into account the cash and cash equivalents available at the balance sheet date, the current liquidity position
is sufficient to meet all obligations beyond the first quarter of 2024. This analysis does not yet take into account possible
cash inflows from the capital increase resolved on January 09, 2023
The market position was further strengthened by the EU approval extensions received in recent years - the approval of
daylight PDT with Ameluz® , as well as photodynamic therapy of actinic keratoses on the extremities and the trunk and
neck in the EU. In this regard, we continue to see an increase in the market potential of Ameluz® in the EU.
To further increase growth opportunities in the US market, we are currently conducting a phase III clinical trial for the
treatment of superficial basal cell carcinoma (BCC) with Ameluz® , a phase IIb trial for the approval extension of Ameluz®
for moderate to severe acne in the US, and a phase I - safety trial to amend the product information, which currently limits
use to one tube of Ameluz® per treatment, to three tubes. In addition, a phase III trial is in preparation for approval of the
US approval extension for Ameluz® for the treatment of AK also on the extremities and trunk/neck.
To further strengthen its competitive position, Biofrontera has also achieved development and FDA approval in October
2021 of a larger RhodoLED® XL lamp, which will allow Ameluz® to be applied to larger areas. With the market launch of
this new medical product, the Group expects a further increase in sales of Ameluz® , particularly in the US market.
Also, in the medium and long term, there is an opportunity for portfolio expansion through the development of new
products based on our nanoemulsion technology.
▪
▪
▪
▪
▪ With the IPO of Biofrontera Inc., the capital raised by Biofrontera Inc. can be invested in further growth to further expand
its presence in the US market. Under a license and supply agreement, Biofrontera AG will receive up to 50% of Ameluz®
sales in the form of a transfer price. This share applies up to $30 million in annual sales and decreases to 40% between
$30 million and $50 million in annual sales and to 30% above that. With the license and supply agreement, Biofrontera AG
also benefits from a strengthening of Biofrontera Inc. in the US market without having to fund the largest cost block of
the past, sales and marketing in the US. A sufficiently financed Biofrontera Inc. is the only way for both companies to grow
and develop successfully, both together and independently of each other.
With regard to legal disputes, Biofrontera considers itself well positioned. The judgment obtained by Deutsche Balaton AG declaring
that the resolutions of the former Management Board and the former Supervisory Board approving the IPO of Biofrontera Inc. were
unlawful will not affect the IPO of Biofrontera Inc. or the company's operating business. The action for avoidance brought by two
shareholders against the capital increase resolved at the Extraordinary General Meeting on January 9, 2023 was withdrawn on April
13, 2023. the action for avoidance is thus terminated.
Litigation
Maruho Deutschland GmbH v. Biofrontera AG (actions for annulment)
In a statement of claim dated May 9, 2022, Maruho Deutschland GmbH filed an action for annulment with the Cologne Regional Court
against the capital increase resolved under agenda item 2 at the Extraordinary General Meeting on April 7, 2022. After a release
procedure requested by the Company from the Cologne Higher Regional Court was successful, Maruho Deutschland GmbH withdrew
the action for annulment.
In a further action for annulment with the Cologne Regional Court, Maruho Deutschland GmbH objected to the election of Prof. Dr.
Karin Lergenmüller to the Supervisory Board resolved under agenda item 8a at the Annual General Meeting on August 23, 2022. In
an extension of the action, Maruho Deutschland GmbH is also contesting the confirmation pursuant to Art. 244 sentence 1 AktG of
the election of Prof. Dr. Karin Lergenmüller to the Supervisory Board resolved at the Extraordinary General Meeting on January 9,
2023 under agenda item 5. The Cologne Regional Court has not yet ruled on the action and the extension of the action.
Deutsche Balaton AG v. Biofrontera AG (declaratory action)
On December 13, 2021, Deutsche Balaton AG filed an action with the Regional Court of Cologne, the subject of which was the legal
examination and determination of a so-called unwritten competence of the Annual General Meeting for the IPO of Biofrontera Inc.
The statement of claim was served to Biofrontera AG represented by the Management Board and represented by the Supervisory
Board on February 9, 2022.
Biofrontera AG Annual Report 2022
31
After service, the Supervisory Board resolved to form a Litigation Committee for further decisions in connection with the lawsuit,
consisting of Dr. Helge Lubenow, Mr. Karlheinz Schmelig and, as Committee Chairman, Dr. Jörgen Tielmann.
All members of the former Executive Board and Supervisory Board involved in the resolutions challenged by the action have since
left the Company. They have been served with notices of dispute regarding possible claims for damages.
On December 9, 2022, the Cologne Regional Court ruled in a declaratory judgment that the resolutions approving the IPO of
Biofrontera Inc. passed by the former Management Board and the former Supervisory Board were unlawful because the required
prior approval for the IPO by the Annual General Meeting was unlawfully not obtained. The further action was dismissed. In its
reasoning, the court stated that the IPO initiated a colossal loss of control by allowing third-party investors to acquire a majority
stake in the subsidiary by waiving the exercise of the parent company's subscription rights. In the opinion of the court, this loss of
control resulted in asset losses for the Company and its shareholders.
The IPO remains unaffected by the ruling. On the unanimous recommendation of the Litigation Committee, the Executive Board and
Supervisory Board have decided not to appeal the ruling. Due to the appeals of the disputants, the judgment is not yet final.
Biofrontera AG v. Biofrontera Inc.
The Company brought an action before the Court of Chancery of the U.S. State of Delaware seeking in particular to annul the
resolutions adopted at the Annual General Meeting of Biofrontera Inc. on December 12, 2022, including the elections to the Board of
Directors of Biofrontera Inc. Among other things, the Company requested a repetition of the Annual General Meeting of Biofrontera
Inc. taking into account the proposed resolutions of Biofrontera AG. After a hearing on January 22, 2023, as a preliminary decision,
the motion to expedite requested by the Company was granted. The Company has agreed in an out-of-court settlement agreement
dated April 11, 2023 ("Inc. Agreement dated April 11, 2023") with, among others, Biofrontera Inc. to file a joint statement with
Biofrontera Inc. to terminate the proceedings by mutual consent in the Court of Chancery. The Company will not file a motion for
reimbursement of its legal costs in the Court of Chancery proceeding. For the further content of the Inc. agreement of April 11,
2023, we refer to the announcement pursuant to § 248a AktG agreed therein.
Biofrontera Inc et al. v. Biofrontera AG
An action for avoidance was filed by two shareholders against all resolutions of the Company's Extraordinary General Meeting of
January 9, 2023, i.e., inter alia, against the resolutions under agenda item 1 (resolution on authorized capital) and agenda item 2
(resolution on the increase of the share capital). The action was withdrawn on April 13, 2023. The withdrawal of the action is part of
the Inc. agreement of April 11, 2023.
Ludwig Lutter v. Biofrontera AG
In two actions before the Cologne Regional Court, Mr. Ludwig Lutter is contesting his dismissal as a member of the Board of
Management and the termination of his employment contract and is claiming (partial) continuation of his remuneration. The
Cologne Regional Court has not yet ruled on the actions.
Biofrontera Inc et al. v. Biofrontera AG
In an action before the Cologne Regional Court, an injunction was obtained against Biofrontera AG prohibiting Biofrontera AG from
accessing data from certain e-mail accounts relating, among others, to a former employee and a former member of the Management
Board. The parties to the lawsuit are currently in settlement negotiations.
Takeover-relevant information
Trading platforms
Biofrontera shares are traded under the stock exchange code B8F and the ISIN DE0006046113 in the Prime Standard of the Frankfurt
Stock Exchange and on all other German stock exchanges. In the USA, Biofrontera AG share certificates were traded as American
Depository Shares (ADS) under the ticker symbol BFRA on the US Nasdaq stock exchange until 6 March 2022. One ADS certifies the
right to two ordinary shares in Biofrontera AG. With an ad hoc announcement dated 14 February, 2022 Biofrontera AG Annual Report
2022 55 announced that it will cease listing on Nasdaq and registering all classes of its registered securities with the Securities and
Exchange Commission (SEC) under the Securities Exchange Act in order to reduce reporting complexity and associated costs. On 7
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Biofrontera AG Annual Report 2022
March 2022, Biofrontera's ADSs, with the support of BNY Mellon as depositary bank, were transferred to a sponsored "Level I" ADS
programme and have since traded on the US over-the-counter (OTC) market under the ticker symbol BFAGY.
Shareholder structure
The detailed presentation of the positions held by the shareholders as of December 31, 2022 on the basis of the mandatory
disclosures by the shareholders can be found in the notes to the consolidated financial statements under 9 Equity and in the notes
to the individual financial statements of Biofrontera AG under item "III. Information on the balance sheet and income statement"
under "5 Subscribed capital, capital reserve, conditional capital".
Share capital and existing capital
The detailed presentation of share capital as of December 31, 2022 is included in the notes to the consolidated financial statements
under 9 Equity and in the notes to the single-entity financial statements of Biofrontera AG under "III. Information on the balance
sheet and income statement" under "5 Subscribed capital, capital reserves, conditional capital".
Articles of association
The Articles of Association of Biofrontera comply with the applicable statutory requirements. There are no stipulations beyond
Sections 84, 85 and Sections 133, 179 of the German Stock Corporation Act regarding the appointment and dismissal of members of
the Management Board.
Restrictions affecting voting rights or the transfer of shares
Each share grants one vote at the Annual General Meeting. The Company is not aware of any restrictions on voting rights.
Holders of special rights to shares with special rights conferring powers of control
There are no shares with special rights conferring powers of control.
Type of voting rights control if employees have an interest in the capital and do not exercise their control
rights directly.
If employees have an interest in the capital, their control rights are not subject to any restrictions.
Powers of the Board of Management to issue shares
The Board of Management is not authorized to issue shares.
Powers of the Executive Board to repurchase shares
There are no restrictions on the repurchase of shares.
Significant agreements of the Company that are subject to the condition of a change of control as a
result of a takeover bid
No agreements have been made in this respect.
Biofrontera AG Annual Report 2022
33
Compensation agreements between the Company and the Management Board or employees in the event
of a takeover bid
No agreements have been made in this respect.
Leverkusen, April 27, 2023
Biofrontera AG
Pilar de la Huerta Martínez
CFO
Corporate Governance Statement of Biofrontera AG pursuant to
Sections 289f, 315d HGB for the financial year 2022 (unaudited)
The Company has made use of the option not to include the corporate governance statement pursuant to Sections 289f, 315d of the
German Commercial Code (HGB) for the financial year 2021 in the (combined) management report for the financial year 2022, but
refers to the publication of this statement as well as the statement of the Management Board and the Supervisory Board of
Biofrontera AG (the Company) on the German Corporate Governance Code pursuant to Section 161 of the German Stock Corporation
Act (AktG) (unaudited) on the Company's website at www.biofrontera.com in the section "Investors", subsection "Corporate
Governance" with the corresponding labels.
Leverkusen, April 27, 2023
Biofrontera AG
Pilar de la Huerta Martínez
CFO
34
Biofrontera AG Annual Report 2022
Consolidated financial statements as of December 31, 2022
Consolidated balance sheet as of December 31, 2022
Assets
in EUR thousands
Non-current assets
Tangible assets
Intangible assets
Deferred tax
Investments accounted for using the
equity method
Non-current contractual assets
Total non-current assets
Current assets
Financial assets
Trade receivables
Receivables from associated companies
Other financial assets
Cash and cash equivalents
Current contractual assets
Total financial assets
Other assets
Inventories
Other assets
Total other assets
Total current assets
Total assets
* adjusted according to IAS 8 (see Notes)
(1)
(1)
(8)
(2)
(4)
(31)
(5)
(7)
(3)
(6)
December 31, 2022 December 31, 2021 December 31, 2021*
adjusted
3,012
1,198
4,375
8,982
101
17,669
691
1,344
878
6,376
35
9,324
4,794
938
5,732
2,281
1,139
5,747
53,154
0
62,322
793
413
57
6,908
0
8,171
4,814
1,392
6,206
15,056
32,725
14,377
76,699
2,281
1,139
5,176
53,154
0
61,750
793
413
57
6,908
0
8,171
4,814
1,392
6,206
14,377
76,127
Biofrontera AG Annual Report 2022
35
Equity and liabilities
in EUR thousands
Equity
Subscribed capital
Capital reserve
Loss carried forward
Loss for the period
Total equity
Non-current liabilities
Financial debt
Liabilities to associated companies
Other financial liabilities
Total non-current liabilities
Current liabilities
Financial liabilities
Trade payables
Liabilities to associated companies
Current financial debt
Other financial liabilities
Total financial liabilities
Other liabilities
Income Tax
Other provisions
Other liabilities
Total other liabilities
Total current liabilities
Total equity and liabilities
* adjusted according to IAS 8 (see Notes)
(9)
(10)
(11)
(12)
(33)
(11)
(11)
(13)
(14)
(15)
December 31 ,
2022
December 31 ,
2021
December 31 ,
2021*
63,807
137,318
(136,623)
(44,166)
20,336
1,055
2,642
0
56,717
137,332
(169,909)
33,857
57,997
851
0
384
56,717
137,332
(169,909)
33,286
57,426
851
0
384
4,002
1,235
1,235
1,984
2,653
446
26
5,109
156
603
2,518
3,277
8,387
32,725
2,735
5,279
2,449
14
10,478
0
1,012
5,977
6,990
17,467
76,699
2,735
5,279
2,449
14
10,478
0
1,012
5,977
6,990
17,467
76,127
36
Biofrontera AG Annual Report 2022
Consolidated statement of comprehensive income for the fiscal year 2022
(17)
(18)
(18)
(19)
(20)
(21)
(27)
(24)
(24)
(27)
(22)
(22)
(22)
(23)
(25)
in EUR thousands
Sales revenue
Cost of sales
Gross profit from sales
Operating expenses
Research and development costs
General administrative costs
Sales costs
Result from operations
Depreciation and amortization
Other Expenses
Other Income
EBITDA
Depriciation and amortization
EBIT
Effective interest expenses
Interest expenses
Interest Income
Income from investments accounted for using the equity
method
Profit/loss before income tax
Income tax
Profit/loss for the period
Profit attributable to non-controlling interests
Profit attributable to owners of the parent company
Other comprehensive income after income taxes
Items which may in future be regrouped into the profit and
loss statement under certain conditions.
Translation differences resulting from the conversion of
foreign business operations
01.01.-
31.12.2022
01.01.-
31.12.2021
01.01.-
31.12.2021*
25,738
(4,756)
20,981
(7,128)
(5,906)
(6,357)
1,591
746
(902)
435
1,869
(746)
1,124
0
(163)
1
28,787
(3,913)
24,873
(7,009)
(30,781)
(22,423)
(35,341)
3,290
(214)
60,215
27,950
(3,290)
24,661
(28)
(3,692)
13
(44,172)
14,729
35,683
(1,826)
33,857
(43,210)
(956)
(44,166)
0
(44,166)
28,787
(3,913)
24,873
(7,009)
(30,781)
(22,423)
(35,341)
3,290
(214)
60,215
27,950
(3,290)
24,661
(28)
(3,692)
13
14,729
35,683
(2,397)
33,286
38,318
37,747
0
-1,866
-1,866
Total profit/loss for the period
(44,166)
31,991
31,420
Basic earnings per share in EUR
Diluted earnings per share in EUR
* adjusted according to IAS 8 (see Notes)
(26)
(26)
(0.77)
(0.77)
0.69
0.68
0.68
0.67
Biofrontera AG Annual Report 2022
37
Consolidated statement of changes in equity for the fiscal year 2022 (adjusted
according to IAS 8(see Notes))
Ordinary
shares
Subscribed
capital
Capital
reserve
Number of
shares
in EUR
thousands
in EUR
thousands
Reserve from
foreign
currency
conversion
adjustment
(OCI)
in EUR
thousands
Loss carried
forward
Loss for the
period
Total
in EUR
thousands
in EUR
thousands
47,747,515
47,748
123,493
1,866
-165,732
0
0
0
0
8,969,870
0
0
0
0
0
0
0
0
8,970
0
0
0
0
0
0
0
15,697
0
-2,000
142
0
0
-1,866
-1,866
0
0
0
0
33,857
-571
0
33,286
0
0
0
0
-4,177
7,375
33,857
-571
-1,866
31,420
24,667
0
-2,000
142
-4,177
(10)
56,717,385
56,717
137,332
0
-136,623
57,427
Ordinary
shares
Subscribed
capital
Capital
reserve
Number of
shares
in EUR
thousands
in EUR
thousands
(10)
56,717,385
56,717
137,332
0
0
0
7,089,673
0
0
0
0
0
0
7,090
0
0
0
0
0
0
0
0
-64
50
(10)
63,807,058
63,807
137,318
Reserve from
foreign
currency
conversion
adjustment
(OCI)
in EUR
thousands
0
0
0
0
0
0
0
0
0
Loss carried
forward
Loss for the
period
in EUR
thousands
-136,623
-44,166
0
-44,166
0
0
0
0
Total
in EUR
thousands
57,427
-44,166
0
-44,166
7,090
0
-64
50
-180,789
20,336
Balance as of January 01,
2021
Loss for the period
Error correction (according to
IAS 8)
Foreign currency conversion
Total loss for the period
Capital increase
Conversion of stock options
from the stock option program
Cost of equity procurement
Increase in capital reserve
from the stock option program
Disposal scope of
consolidation
Balance as of December 31,
2021
Balance as of December 31,
2021
Loss for the period
Foreign currency conversion
Total loss for the period
Capital increase
Conversion of stock options
from the stock option
program
Cost of equity procurement
Increase in capital reserve
from the stock option
program
Balance as of December 31,
2022
38
Biofrontera AG Annual Report 2022
Consolidated cash flow statement for the fiscal year 2022
in EUR thousands
01.01.-
31.12.2022
01.01.-
31.12.2021
01.01.-
31.12.2021*
Cashflows from operations
Loss before income tax
Adjustments to reconcile loss before income tax to cash flow into
operations
Income tax
Financial result
Depreciation
Losses from disposal of assets
Non-cash (income) and expenses
Changes in operating assets and liabilities
Trade receivables
Other assets and income tax assets
Inventories
Trade payables
Provisions
Other liabilities
Net cash flow from/in operational activities
Cash flow from investment activities
Purchase of intangible and tangible assets
Loss of control over subsidiaries
Net cash flow from/in investment activities
Cashflows from financing activities
Proceeds from the issue of shares
Costs of equity procurement
Proceeds from draw down of EIB loan
Leasing payments
Interest paid
Net cash flows from/in financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the period
Cash and cash equivalents at the end of the period
* adjusted according to IAS 8 (see Notes)
(30)
-43,210
35,683
35,683
-956
44,334
746
11
569
-1,826
-11,022
3,290
3
259
-2,397
-11,022
3,290
3
830
-831
-788
-788
-367
20
-3,204
-309
-728
-3,895
-683
-5,938
8,250
-1,735
4,946
30,439
-683
-5,938
8,250
-1,735
4,946
30,439
-981
0
-981
-629
-41,630
-42,259
-629
-41,630
-42,259
7,090
24,667
24,667
-64
-2,031
-453
-198
4,344
-532
6,908
6,376
-2,000
-15,000
-624
-4,861
2,182
-9,638
16,546
6,908
-2,000
-15,000
-624
-4,861
2,182
-9,638
16,546
6,908
Biofrontera AG Annual Report 2022
39
Notes to the consolidated financial statements as of December 31,
2022
Information about the Company
Biofrontera AG (hereinafter also referred to as "Biofrontera" or the "Company"), registered in the Commercial Register of the Local
Court of Cologne, Department B under No. 49717, and its wholly owned subsidiaries Biofrontera Bioscience GmbH, Biofrontera Pharma
GmbH, Biofrontera Development GmbH, and Biofrontera Neuroscience GmbH, all with registered offices at Hemmelrather Weg 201,
51377 Leverkusen, Germany, and the Spanish branch Biofrontera Pharma GmbH sucursal en España with registered offices in Cornellá
de Llobregat, research, develop and distribute dermatological products.
The declarations on the German Corporate Governance Code required by § 161 of the German Stock Corporation Act have been
submitted and made available to the shareholders on Biofontera's website (www.biofrontera.com).
The shareholding in Biofrontera Inc. as at the reporting date amounts to 29,96% and is reported under investments in associates
using the at-equity method.
On 10 November 2022, Biofrontera Pharma GmbH founded the wholly owned subsidiary "Biofrontera UK Ltd." in Great Britain to
maintain and expand sales activities there. The company's business operations had not yet commenced as of the reporting date.
Segment reporting
Biofrontera's main business activity is the sale of pharmaceuticals and medical products and the associated research and
development activities to optimize their market potential. The Biofrontera Group is essentially a single-product company.
Accordingly, segmentation is based exclusively on geographical aspects and only with regard to sales revenues, as internal reporting
to management and corporate controlling are also based exclusively on these criteria. Internal reporting to management is a
condensed presentation of the consolidated statement of comprehensive income. The results of the companies are monitored
separately by management in order to be able to measure and assess their performance.
For further information, please refer to our comments in the notes on „Sales revenue“ (Note 17).
Summary of significant accounting policies
Basis for preparation of the consolidated financial statements
The consolidated financial statements of Biofrontera AG for the financial year from January 1, 2022 to December 31, 2022 have been
prepared in accordance with the International Financial Reporting Standards (IFRS) of the International Accounting Standards Board
(IASB) and the interpretations of the International Financial Reporting Standards Interpretations Committee (IFRS IC) valid at the
reporting date and recognized by the European Union (EU). In addition, the provisions of German commercial law applicable under
Section 315e (1) of the German Commercial Code (HGB) have been observed.
The consolidated financial statements have been prepared on a going concern basis.
Biofrontera AG is the ultimate controlling company preparing consolidated financial statements for the group of consolidated
companies.
40
Biofrontera AG Annual Report 2021
The consolidated financial statements as of December 31, 2022 are prepared in EUR or EUR thousand. Rounding differences may
occur in the tables due to commercial rounding.
The consolidated financial statements as of December 31, 2022 were authorized for issue and forwarding to the Supervisory Board
by the Executive Board on April 27, 2023.
Changes in accounting standards
The accounting policies applied are consistent with those used as of December 31, 2021, with the exception of the new and revised
standards and interpretations described below, the application of which was mandatory for the first time as of fiscal year 2022.
Standard
Description
Mandatory application Expected effects
Amendment to IFRS 3
Amendment to IAS 16
Amendment to IAS 37
“Business combinations IFRS 3” References to the
Conceptual Framework
"Property, plant and equipment IAS 16": Revenues
before the intended use
"Provisions, contingent liabilities and contingent
assets": Adverse contracts - costs of contract
fulfillment
Annual Improvements to IFRSs
Annual improvements to IFRSs
Cycle 2018-2020
January 1, 2022
No effects
January 1, 2022
No effects
January 1, 2022
No effects
January 1, 2022
No effects
Future changes in accounting standards
Biofrontera has not implemented early adoption or does not intend to implement early adoption of the following standards,
interpretations and amendments to the set of regulations approved by the IASB:
Standard
IFRS 17
Description
Insurance contracts
Amendments to IFRS 17
Insurance contracts: Initial Application of IFRS 17
Mandatory
application
January 1, 2023
January 1, 2023
Expected effects
No effects
Amendment to IAS 1
Amendment to IAS 8
Amendment to IAS 12
Amendment to IAS 1*
"Presentation of financial statements”: Disclosure of
accounting policies
January 1, 2023
No effects
"Accounting Policies, Changes in Accounting Estimates
and Errors”: Definition of accounting estimates
January 1, 2023
No effects
"Income taxes": deferred taxes relating to assets and
liabilities arising from a single transaction
January 1, 2023
Effects not reliably
estimable
"Presentation of financial statements”: Classification of
liabilities as current or non-current
January 1, 2024 *
No effects
Amendment to IFRS 16*
"Leases": Lease liability in a Sale-and-Leaseback
January 1, 2024*
No effects
* Endorsement by the EU still pending
Basis of consolidation
The consolidated financial statements as of December 31, 2022 include the financial statements of the parent company, Biofrontera
AG, and the subsidiaries in which the parent company holds a direct majority of the voting rights.
The basis for the consolidation of the companies included in the consolidated financial statements was the annual financial
statements (or HBII according to IFRS) of these companies as of December 31, 2022, prepared in accordance with uniform principles.
Biofrontera AG Annual Report 2022
41
The consolidated financial statements as of December 31, 2022 were prepared on the basis of standard accounting and valuation
principles (IFRS).
The subsidiaries are fully consolidated from the date of acquisition. The date of acquisition is the date on which the parent company
obtained control of these group companies. Subsidiaries are included in the consolidated financial statements until control of these
entities is lost.
All intercompany receivables and payables as well as income and expenses have been eliminated in the course of consolidation.
Associated companies in which the companies of the Biofrontera Group hold a share of between 20% and 50% of the voting rights,
or in which relevant indicators point to significant influence, are accounted for using the equity method. For investments accounted
for using the equity method, the carrying amounts are increased or decreased by the changes in equity corresponding to
Biofrontera's equity interest. The changes in the proportionate equity recognized in profit or loss are included in the result from
investments accounted for using the equity method.
Adjustment of errors according to IAS 8 from the consolidated financial statements 2021
The following adjustment was taken into account in the 2022 consolidated financial statements:
In the 2021 consolidated financial statements, deferred tax assets were actually recognized in the amount of EUR 5,747
thousand and not in the amount of EUR 5,176 thousand.
In accordance with IAS 8, the error was corrected through the profit and loss statement in 2021.
in EUR thousands
Profit/loss before income tax
Income tax
Profit/loss for the period
Other comprehensive income after income taxes
Items which may in future be regrouped into the profit and loss statement under
certain conditions.
Translation differences resulting from the conversion of foreign business operations
Total profit/loss for the period
Basic earnings per share in EUR
Diluted earnings per share in EUR
*adjusted according to IAS 8
Deconsolidation of Biofrontera Inc.
01.01.-31.12.2021
35,683
(1,826)
33,857
(1,866)
31,991
0.69
0.68
01.01.-31.12.2021*
adjusted
35,683
(2,397)
33,286
(1,866)
31,420
0.68
0.67
Since the Initial Public Offering (IPO) of Biofrontera Inc., headquartered in Woburn, Massachusetts, USA, in the third quarter of 2021,
Biofrontera AG’s investment in Biofrontera Inc. decreased until the control criteria of IFRS 10 were no longer met and Biofrontera
Inc. was no longer considered a subsidiary of Biofrontera AG. Accordingly, deconsolidation took place in the previous year and the
investment in Biofrontera Inc. as of the reporting date is reported under investments in associates using the equity method.
Due to the deconsolidation date of December 31, 2021, the consolidated statement of comprehensive income for the previous year
includes all remaining expenses and income of Biofrontera Inc. after consolidation of expenses and income, making direct
comparability with the consolidated statement of comprehensive income of the current financial year unfeasible.
The prior-year consolidated statement of comprehensive income that would have resulted without full consolidation of Biofrontera
Inc. is as follows:
in EUR thousands
42
01.01.-31.12.2022
01.01.-
31.12.2021
PRO-FORMA
Biofrontera AG Annual Report 2021
Sales revenue
Cost of sales
Gross profit from sales
Operating expenses
Research and development costs
General administrative costs
Sales costs
Result from operations
Depreciation and amortization
Other Expenses
Other Income
EBITDA
Depriciation and amortization
EBIT
Financial result
Profit/loss before income tax
Income tax
Profit/loss for the period
Profit attributable to non-controlling interests
Profit attributable to owners of the parent company
Other comprehensive income after income taxes
Items which may in future be regrouped into the profit and loss statement under
certain conditions.
Translation differences resulting from the conversion of foreign business operations
Total profit/loss for the period
25,738
(4,756)
20,981
(7,128)
(5,906)
(6,357)
1,591
746
(902)
435
1,869
(746)
1,124
17,185
(3,536)
13,648
(6,773)
(15,518)
(5,550)
-14,192
664
(94)
352
-13,270
(664)
-13,934
(44,334)
(2,322)
(43,210)
(956)
-44,166
0
(44,166)
(16,256)
(1,778)
-18,034
0
(18,034)
0
0
(44,166)
(18,034)
This presentation is intended solely to enhance comparability and does not represent the actual consolidated statement of
comprehensive income of the Biofrontera Group.
Translation of amounts in foreign currencies
The consolidated financial statements as of December 31, 2022 are presented in EUR (or EUR thousand), which is the functional
currency of the German entities included in the consolidated financial statements, and the presentation currency of the Group.
For subsidiaries whose functional currency, other than the Group's presentation currency, is the local currency of the country in
which the entity is domiciled, assets and liabilities denominated in foreign currencies that are reported in the balance sheets of the
foreign entities are translated into euros using the exchange rate prevailing at the balance sheet date (2022: 0.88693 GBP/EUR).
Revenue and expense items are translated at the average foreign currency exchange rates (2022: 0,96742 GBP/EUR) during the
underlying period. The difference resulting from the valuation of equity at the historical exchange rate and the closing rate is
recognized as a change in equity within other components of equity with no effect on profit or loss (2022: EUR 0 thousand).
Transactions denominated in currencies other than EUR are recognized at the current exchange rate on the date of the transaction.
Assets and liabilities are revalued at each balance sheet date using the closing rate.
Biofrontera AG Annual Report 2022
43
Application of estimates
The preparation of the consolidated financial statements as of December 31, 2022 has been made in accordance with the estimates
and assumptions by management required by IFRS, which affect the reported amounts of assets and liabilities at the balance sheet
date and the reported amounts of revenues and expenses during the reporting period.
Main areas of application for significant assumptions, estimates and the exercise of discretion arise for the following matters:
•
Assessment of the recoverability of non-current assets
Biofrontera is required to assess external and internal sources of information for non-current assets that are subject to
amortization, based on which possible indications of impairment or reversal of impairment can be identified. When
assessing whether there are indications of impairment or a reversal of impairment losses and - if such indications exist -
when determining the fair values required in this case as part of an impairment test, management must make assumptions
and estimates about the expected future cash flows from the use of the non-current assets and a determination of the
cost of capital.
•
Income taxes
Biofrontera is required to calculate the expected current income tax for each group company, as well as to assess
temporary differences arising from the different treatment of certain balance sheet items between the IFRS consolidated
financial statements and the financial statements prepared for tax purposes. Where temporary differences exist, these
generally result in the recognition of deferred tax assets and liabilities in the consolidated financial statements.
Management must make assumptions and estimates when calculating actual and deferred taxes. The recognition of
deferred tax assets of Biofrontera is subject to higher requirements due to the loss history. Deferred tax assets are only
recognized if it can be substantiated that taxable profits will be generated in the future and that it is then probable that
the deferred tax item to be capitalized can be offset against future taxable profits. In order to assess the probability of
the future utilization of deferred tax assets, various factors have to be taken into account, such as the earnings situation
in the past and operational planning. If actual results differ from these estimates, or if these estimates have to be adjusted
in future periods, this could have an adverse effect on the Group's net assets, financial position and results of operations.
If there is a change in the assessment of the recoverability of deferred tax assets, the recognized deferred tax assets -
corresponding to the original recognition - are to be written down through profit or loss or recognized in equity, or
impaired deferred tax assets are to be recognized through profit or loss or in equity.
•
Provisions for litigation risks
Provisions are recognized for pending legal proceedings on the basis of current estimates. The outcome of the legal
proceedings cannot be determined or is subject to uncertainties. In assessing the risks arising from litigation, management
must make assumptions and estimates as to whether and to what extent provisions for litigation risks should be
recognized. Actual claims arising from legal proceedings may therefore differ from the amounts accrued.
•
Estimates in connection with liabilities from the SAR program
In connection with the measurement of liabilities arising from the stock appreciation rights program, estimates are made
to determine the fair value. The determination requires management to make assumptions regarding the valuation models
used.
•
Development costs
At Biofrontera, research and development costs include expenses for clinical trials as well as for the granting, maintenance
and extension of approvals. Both for the approved drug Ameluz® and for the other research and development projects,
with the exception of the further development of the new BF-RhodoLED® XL red light lamp, research and development
costs are recognized as expenses in the period in which they are incurred. In the opinion of management, the criteria
prescribed by IAS 38.57 for the recognition of development costs as assets are not met due to the uncertainties associated
with the development of new products by the Biofrontera Group until approval in the target markets has been obtained
44
Biofrontera AG Annual Report 2021
and it is probable that future economic benefits will flow to the Company. The BF-RhodoLED® XL red light lamp is a further
development of the existing lamp, from which Biofrontera expects a future economic benefit.
Estimates are based on experience and other assumptions that are believed to be reasonable under the circumstances. They are
reviewed on an ongoing basis but may differ from actual values.
Changes in previous estimates due to the impact of the COVID 19 pandemic or the Ukraine war did not occur in fiscal year 2022.
The carrying amounts of the items affected by estimates can be found in the respective explanations of the items in the notes to
the consolidated financial statements.
Tangible assets and leases
In accordance with IAS 16, property, plant and equipment are carried at historical cost less depreciation. Depreciation of property,
plant and equipment is generally charged on a straight-line basis over the estimated useful lives of the assets (generally between
three and thirteen years). The main useful lives are unchanged:
•
•
•
•
IT equipment 3 years, linear
Other equipment, furniture and fixtures 4 years, linear
Office and laboratory equipment 10 years, linear
Laboratory equipment 13 years, linear
Since January 1, 2018, low-value assets with acquisition costs between EUR 250 and EUR 1,000 are posted in the year of acquisition
to a collective item for the respective year, which is fully depreciated over 5 years.
Biofrontera is a lessee mainly for buildings and motor vehicles used for operational and administrative purposes. The lease liability
to be recognized is calculated as the present value of the highly probable payments to be made to the lessee. It is amortized using
the effective interest method. The right-of-use asset to be recognized in return is measured at cost at the inception of the lease. In
addition to the lease payments, any initial direct costs incurred by the lessee and dismantling costs are included in the calculation.
Incentive payments granted by the lessor are to be deducted. The capitalized right-of-use asset must be depreciated on a straight-
line basis and tested for impairment if there are indications of impairment.
The main useful lives of leases are determined by the term of the lease and are as follows:
•
•
- Motor vehicles 3 years, straight-line
- Buildings 6 years, straight-line
Future lease payments are to be discounted at the lessor's imputed interest rate or, if this is not available, at the marginal borrowing
rate on the date of initial application.
For expenses from leases with a remaining term of no more than one year and from leases with a low value, Biofrontera has decided
to make use of the simplification of IFRS 16.6 and to immediately recognize the monthly lease payments in profit or loss.
Biofrontera is a sublessor with regard to the subleasing of business premises. The subleases were classified as finance leases on
the basis of the right of use from the main lease. Accordingly, rights of use from the main lease were derecognized, with
simultaneous recognition of the net investment in the lease as a contractual asset.
Intangible assets
Acquired intangible assets consist of software and licenses as well as other rights (rights of use). They are recognized at acquisition
or production cost less accumulated amortization. These intangible assets are capitalized and amortized on a straight-line basis
over their estimated useful lives of between 4 and 12 years.
The principal useful lives for intangible assets are:
•
- Software and licenses 3 years, straight-line
Biofrontera AG Annual Report 2022
45
•
- Rights of use 4 to 12 years, straight-line
Intangible assets under development relate to the further development of BF-RhodoLED®. Beyond this, no development costs are
capitalized, as the requirements for the capitalization of internally generated intangible assets are not met.
There are no intangible assets with indefinite useful lives.
Borrowing costs are not recognized as part of the cost of the acquired assets, but as an expense in the period in which they are
incurred because the Group does not have any significant qualifying assets as defined by IAS 23.5.
Associated companies
Associated companies as defined by IAS 28 are accounted for using the equity method.
An associated company is a company over which the Group can exercise influence, but not control, by participating in the financial
and operating policies. Significant influence is presumed when the parent company holds 20% or more but less than 50% of the
voting rights (Associated companies). Under the equity method, investments in associated companies are initially recognized in the
consolidated statement of financial position at cost, adjusted for changes in the Group's share of profit or loss and other
comprehensive income of the associate after the date of acquisition. At the balance sheet date, the Group's share of equity is
translated into the reporting currency using historical exchange rates. The Group's share of profit or loss for the year plus
intercompany eliminations and related deferred taxes is recognized in the income statement using the closing rate.
Impairment of assets
The Group reviews non-current tangible and intangible assets for impairment whenever there is an indication that the carrying
amount of an asset may not be recoverable. The recoverable amount of an asset is the higher of its value in use and its fair value
less costs to sell. The value in use is determined by the future cash flows expected to be generated by the asset. Biofrontera
measures any impairment to be recognized at the amount by which the carrying amount of the asset exceeds its recoverable
amount.
Financial assets
Financial assets are recognized if Biofrontera has a contractual right to receive cash or other financial assets from another party.
Customary purchases and sales of financial assets are generally recognized on the settlement date. Financial assets are assigned
to the "hold" category and measured at amortized cost. Non-interest-bearing or low-interest-bearing receivables are recognized at
present value.
Impairment of financial assets
Biofrontera determines the credit risk of trade receivables as the probability-weighted amount of the expected shortfall in
collections compared to the contractual payment claims. The basis for the estimation of expected credit losses is, in addition to
individual factors, the general experience with the collection of receivables in the past. The Company adjusts the fixed allowance
rates derived from these, which are based on the extent to which the receivables are past due, in the event of significant changes
in economic conditions.
Trade receivables
Trade receivables are recognized at their nominal value. In the case of adjustments, these are booked directly against the receivable
in question.
Cash and cash equivalents
Cash and cash equivalents comprise cash on hand and checks, bank balances and cash deposits with a maturity of up to three
months at the time of acquisition. They are measured at amortized cost.
Inventories
Raw materials and supplies as well as finished goods and work in progress are stated at the lower of cost and net realizable value.
Borrowing costs are not capitalized. Cost is determined using the first-in, first-out (FIFO) method. An allowance is made for
inventories at the balance sheet date if the net realizable value is lower than the carrying amount.
46
Biofrontera AG Annual Report 2021
Financial liabilities
Financial liabilities include original liabilities. Original liabilities are recognized if there is a contractual obligation to transfer cash
or other assets to another party. The initial recognition of a non-derivative financial liability is at fair value. In the subsequent
measurement of financial liabilities measured at amortized cost, any discount between the amount received and the repayment
amount is amortized over the term of the liability using the effective interest method.
Trade payables
Trade payables and other liabilities are recognized at their repayment amount. Due to their short-term nature, the carrying amount
reported reflects the fair value.
Provisions
Provisions are recognized if an obligation to a third party resulting from a past event exists, and it is probable that an outflow of
assets will be required to settle the obligation in the future, and a reliable estimate can be made of the amount of the obligation.
Stock options
Stock options (equity-settled share-based payment transactions) are recognized at fair value at the time of granting. The fair value
of the obligation is recognized as personnel expense over the vesting period. If Biofrontera AG has the option to settle in cash or in
shares when the option is exercised, the capital reserve is initially increased in accordance with IFRS 2.41 and IFRS 2.43. The expense
is recognized over the vesting period. The fair value of cash-settled and equity-settled share-based payment transactions is
generally determined using internationally accepted valuation techniques.
Stock Appreciation Rights
Obligations under Biofrontera's stock appreciation rights program are cash-settled share-based payments that are recognized at
fair value. Changes in the fair value during the term are recognized in profit or loss. The fair value is determined using internationally
recognized valuation techniques.
Income taxes
Biofrontera recognizes deferred taxes in accordance with IAS 12 for valuation differences between the IFRS carrying amounts and
the tax base. Deferred tax liabilities are generally recognized for all taxable temporary differences.
The recognition of deferred tax assets is subject to more stringent requirements due to the loss history. Deferred tax assets are
only recognized if there are substantial indications that taxable profits will be generated in the future and that the deferred tax item
to be capitalized can then probably be offset against future taxable profits.
The carrying amount of deferred income tax assets is reviewed at each balance sheet date and reduced to the extent that it is not
probable that sufficient taxable profit will be available against which the deferred tax asset can be at least partially utilized.
Previously unrecognized deferred income tax assets are reassessed at each balance sheet date and are recognized to the extent
that it has become probable, from a current perspective, that future taxable profit will allow the deferred tax asset to be recovered.
Deferred tax liabilities and deferred tax assets are offset if a right of set-off exists and they are levied by the same taxation authority.
Current taxes are calculated on the basis of the Company's taxable income for the period. The tax rates of the respective company
applicable on the balance sheet date are used as a basis.
Earnings per share
Earnings per share are calculated in accordance with IAS 33 ("earnings per share") by dividing net income by the weighted average
number of shares outstanding during the year.
Revenue recognition
The Company recognizes as revenue all income from product sales and the granting of licenses. The completed customer contracts
each comprise only one performance obligation. The Company is entitled to a fixed consideration for the products sold and licenses
Biofrontera AG Annual Report 2022
47
granted. To the extent that return obligations for expired products have been agreed with customers, Biofrontera recognizes
revenue only in the amount that is most likely to be recoverable, taking into account the proportion of the products that are expected
to be returned. The timing and amount of revenue to be recognized in the consolidated income statement is determined by the
extent to which Biofrontera transfers control of the products to be delivered or rights to be granted to the customers.
The majority of revenue is generated from product sales. In accordance with the respective local laws on the sale of pharmaceuticals
and medical devices, Ameluz® is sold in Germany exclusively via pharmaceutical wholesalers or directly to hospitals, and in other
European countries also directly to pharmacies or hospitals.
In the case of direct sales of BF-RhodoLED® , the deliveries and services owed are only provided after installation has taken place.
The installation service represents a purely ancillary service because, for legal reasons, the lamp may only be used after it has been
installed by the customer. This is a uniform performance obligation. In the United States, lamps are sometimes made available to
physicians for a fee for an evaluation period of up to six months, and a final purchase decision does not have to be made until the
end of this period. The Company generates revenue from monthly fees during the evaluation period and from the sale of lamps.
Belixos® is sold through Amazon and through pharmaceutical wholesalers. Revenue is recognized through Amazon upon delivery
and payment by the customer and through pharmaceutical wholesalers upon delivery. Experience has shown that customers make
only insignificant use of the rights of return granted on sales.
Sales are recognized net of sales-related taxes and sales deductions. For expected sales deductions, such as rebates and discounts,
amounts estimated at the time of revenue recognition are taken into account accordingly. The payment terms include short-term
payment terms with the possibility of cash discounts.
Cost of sales
Cost of sales includes cost of materials for products sold, payments to third parties for services directly attributable to the
generation of sales or production of the products, as well as directly attributable personnel expenses and depreciation and
amortization, and a proportion of overheads.
Research and development expenses
Pursuant to IAS 38, development costs are recognized as "intangible assets" under certain conditions. Research costs are expensed
as incurred. Development costs are capitalized if the criteria of IAS 38.57 are met, depending on the potential outcome of the
development activities.
Research and development costs for both the approved drug Ameluz® and the Company's other research and development projects
are therefore recognized as expenses in the period in which they are incurred. The intangible assets under development relate to
the further development of BF-RhodoLED® , as the recognition criteria of IAS 38.57 are fulfilled.
Notes to the consolidated balance sheet
1. Intangible and tangible assets
As in the previous year, no impairment losses were recognized on property, plant and equipment or intangible assets during the
fiscal year 2022. Biofrontera uses external and internal sources of information to determine at each reporting date whether there
are any indications of impairment or a reversal of impairment losses.
Property, plant and equipment and intangible assets break down as follows:
48
Biofrontera AG Annual Report 2021
Statement of changes in non-current assets for 2022
in EUR thousands
Purchase and production cost
Accumulated depreciation
Carrying amounts
01.01. 2022 Currency
translation Additions Disposals Transfers 31.12.2022 01.01. 2022 Currency
translation Additions Disposals 31.12.2022 31.12.2022 01.01. 2022
Tangible assets and leases
Operating and business equipment
Right-of-use leasing properties
Right-of-use leasing tangible assets
Tangible assets and leases
Intangible assets
Software and licenses
Right-of-use assets
Self-generated intangible assets
Intangible assets under development
Intangible assets
Total
3,551
2,710
949
7,210
0
0
260
887
1,073
0
2,219
0
9,429
0
0
0
0
0
0
0
0
0
0
0
0
0
767
400
165
1,332
0
0
24
12
178
0
214
0
1,546
-639
0
-159
-798
0
0
-25
-163
0
0
-188
0
-986
0
0
0
0
0
0
0
0
0
0
0
0
0
3,680
3,110
954
7,744
0
0
259
736
1,250
0
2,245
0
9,989
-2,441
-1,728
-760
-4,928
0
0
-203
-859
-18
0
-1,079
0
-6,008
0
0
0
0
0
0
0
0
0
0
0
0
0
-188
-278
-130
-595
0
0
-30
-12
-109
0
-150
0
-746
633
0
159
792
0
0
20
163
0
0
183
0
975
-1,997
-2,005
-730
-4,732
0
0
-212
-707
-127
0
-1,047
0
-5,778
1,683
1,105
225
3,012
0
0
46
28
1,124
0
1,198
0
4,210
1,110
982
189
2,281
0
0
57
28
1,055
0
1,139
0
3,421
Biofrontera AG Annual Report 2022
49
Statement of changes in non-current assets for 2021
in EUR thousands
Purchase and production cost
Accumulated depreciation
Carrying amounts
Tangible assets and leases
Operating and business equipment
Right-of-use leasing properties
Right-of-use leasing tangible assets
Tangible assets and leases
Intangible assets
Software and licenses
Right-of-use assets
Self-generated intangible assets
Intangible assets under development
Intangible assets
Financial assets
Total
01.01.2021
Currency
translatio
n
Additions
Change of
consolidat
ion group
Disposals Transfers 31.12.2021 01.01.2021
Currency
translatio
n
Additions
Change of
consolidat
ion group
Disposals 31.12.2021 31.12.2021 01.01.
2021
3,958
4,213
1,778
9,949
0
0
227
22,336
0
916
23,480
0
0
0
33,429
14
2
1
17
0
0
0
1,073
0
0
1,073
0
0
0
1,090
224
0
175
399
0
0
55
19
0
156
230
0
53,154
0
53,784
-544
-1,115
-325
-1,983
0
0
-23
-22,541
0
0
-22,564
0
0
0
-24,548
-101
-390
-681
-1,172
0
0
0
0
0
0
0
0
0
0
-1,172
0
0
0
0
0
0
0
0
1,073
-1,073
0
0
0
0
0
3,551
2,710
949
7,210
0
0
260
887
1,073
0
2,219
0
53,154
0
62,583
-2,574
-1,227
-1,098
-4,898
0
0
-201
-5,590
0
0
-5,791
0
0
0
-10,689
-4
0
0
-4
0
0
-1
-507
0
0
-508
0
0
0
-512
-281
-803
-389
-1,472
0
0
-25
-1,775
-18
0
-1,817
0
0
0
-3,290
320
-89
46
277
0
0
23
7,013
0
0
7,037
0
0
0
7,314
98
390
681
1,169
0
0
0
0
0
0
0
0
0
0
1,169
-2,441
-1,728
-760
-4,928
0
0
-203
-859
-18
0
-1,079
0
0
0
-6,008
1,110
982
189
2,281
0
0
57
28
1,055
0
1,139
0
53,154
0
56,575
1,385
2,986
681
5,051
0
0
27
16,746
916
0
17,689
0
0
0
22,740
50
Biofrontera AG Annual Report 2022
2nd
Financial assets accounted for using the equity method
Financial assets include the carrying amount of the investment in Biofrontera Inc. of EUR 8,982 thousand (previous year: EUR 53,154
thousand), which is included and measured in the consolidated financial statements using the equity method:
General information
Capital share
Share of voting rights
31.12.2022
31.12.2021
31.12.2022
31.12.2021
Fair value of the investment
when a quoted market price
exists
in TEUR
31.12.2022
31.12.2021
Biofrontera Inc., Woburn (USA)
29.96%
46.77%
29.96%
46.77%
6,854
53,154
The decrease in shares is due to dilution by further capital measures of the associated company.
Description of the type of activity of the associated company
Biofrontera Inc., based in Woburn, Massachusetts, USA, distributes Biofrontera's products in the USA as a license partner. For further
details, please refer to our related party disclosures.
Financial information
The table below summarizes the financial information of Biofrontera Inc. as presented in its own financial statements (values do not
relate to the shares attributable to Biofrontera AG, but represent the values based on a notional shareholding of 100%):
in TEUR
31.12.2022
31.12.2021
Current assets
thereof cash and cash equivalents
Noncurrent assets
Current liabilities
Noncurrent liabilities
Revenues
Operating Result
Other Income
Result after tax
40,446
16,134
7,260
19,589
5,730
0
26,884
(17,421)
16,851
(600)
Reconciliation to the carrying amount included in the consolidated balance sheet
The carrying amount of the investment in Biofrontera Inc. developed as follows:
in EUR thousands
Carrying amount as of December 31, 2021
Proportionate earnings after taxes 2022
Impairment
Carrying amount as of December 31, 2022
Biofrontera AG Annual Report 2022
43,522
23,012
6,374
12,972
26,294
0
22,595
(23,627)
11,678
(35,358)
53,154
-1,604
-42,568
8,982
51
Obligations to the associated company
The Group has obligations to Biofrontera Inc. in the amount of EUR 11 thousand resulting from services rendered under service
agreements. Furthermore, future obligations to Biofrontera Inc. in the amount of EUR 5,284 thousand in connection with the
settlement payments arising from the legal dispute with DUSA Pharamaceuticals Inc. are included in liabilities.
1. Inventories
in EUR thousands
Raw materials
Unfinished goods
Finished goods and products
Prepayment on inventories
Total
December 31, 2022
December 31, 2021
2,746
1,045
1,003
0
4,794
2,506
315
1,638
356
4,814
In the reporting year, impairment losses of EUR 218 thousand (previous year: EUR 42 thousand) were recognized on finished goods.
The advance payments on inventories included in this item in the previous year were reclassified to other financial assets in the
amount of EUR 687 thousand in the current financial year.
2. Trade receivables
Trade receivables mainly relate to the sale of Ameluz®, the PDT lamp BF- RhodoLED® and the medical cosmetic product Belixos®. It
is expected that all trade receivables will be settled within twelve months of the balance sheet date.
As in the previous year, there were no overdue, unimpaired receivables as of the balance sheet date.
3. Other financial assets
Other financial assets mainly comprise security deposits, primarily for rented premises, credit cards and leased vehicles (EUR 27
thousand; previous year: EUR 23 thousand), as well as advance payments for services (EUR 816 thousand; previous year: EUR 19
thousand). As in the previous year, there was no impairment in the year under review.
4. Other assets
Other assets mainly comprise prepaid expenses (EUR 791 thousand; previous year: EUR 1,060 thousand) and VAT receivables of EUR
147 thousand (previous year: EUR 316 thousand). As in the previous year, no impairment losses were recognized in the reporting
year.
5. Cash and cash equivalents
Cash and cash equivalents include cash on hand and checks, bank balances, and cash deposits with a maturity of up to three months
at the time of acquisition totaling EUR 6,376 thousand (previous year: EUR 6,908 thousand).
52
Biofrontera AG Annual Report 2022
6. Deferred income tax
Deferred tax assets amount to EUR 4,375 thousand (previous year: EUR 5,176 thousand) and relate exclusively to Biofrontera Pharma
GmbH.
The reduction in deferred tax assets in the amount of EUR 800 thousand (previous year: EUR 2,349 thousand) results from the
reduction in the usable tax loss carryforwards of Biofrontera Pharma GmbH, whereby the amount of the usable tax loss
carryforwards was reduced to the expected utilization during the planning period. This also includes the subsequent correction in
accordance with IAS 8 of the calculation error in the previous year in the amount of EUR 571 thousand; for further details, please
refer to our disclosures on accounting policies.
The following table explains the deferred tax assets arising from tax loss carryforwards, as they have developed within the Group:
in EUR thousands
December 31, 2022
December 31, 2021
Corporation tax including Solidarity
Surcharge
Business tax
Total
Loss carried
forward
Deferred
tax assets
Loss carried
forward
Deferred
tax assets
151,887
133,709
24,036
11,700
35,736
152,367
134,909
24,112
11,805
35,917
These loss carryforwards have an unlimited carryforward period under current German law.
in EUR thousands
December 31, 2022
December 31, 2021
Loss carried forward
Non-current assets
- Intangible assets
- Tangible assets
-Receivables and other assets
Current assets
- Receivables and other assets
Non-current and current financial liabilities
Current liabilities
- Liabilities and other
Total
Netting of deferred tax assets and liabilities
As recognized on balance sheet
Deferred tax
assets
4,651
Deferred tax
liabilities
Deferred tax
assets
5,435
0
0
0
0
0
360
5,011
(636)
4,375
(276)
(327)
(25)
(8)
0
0
(636)
636
0
0
0
0
0
288
5,723
(547)
5,176
Deferred tax
liabilities
0
(259)
(288)
0
0
0
0
(547)
547
0
Deferred taxes on loss carryforwards are capitalized to the extent that there are substantial indications that they can probably be
offset against future profits or that they are offset by deferred tax liabilities to the same extent. Due to the lack of predictability of
Biofrontera AG Annual Report 2022
53
future taxable profits, taking into account the loss history, the remaining deferred tax assets from loss carryforwards of EUR 31,085
thousand (previous year: EUR 30,428 thousand) have not been recognized in accordance with IAS 12.34.
The following is a reconciliation of the expected income tax expense to the income tax expense actually recognized, using the
applicable income tax rate of 24.575% (previous year: 24.575%) of the parent company as the starting point.
December 31, 2022
December 31, 2021*
adjusted
(43,210)
10,619
0
(394)
(10,461)
(117)
0
0
(617)
0
13
(957)
35,685
(8,770)
260
0
0
468
0
124
(6,541)
12,074
(12)
(2,396)
in EUR thousands
Consolidated loss before tax
Expected income tax reimbursement
Differences arising from different tax rates
Share of result of associated companies
Tax increases due to non-deductible expenses
- from impairment of at-equity investments
- other non-deductible expenses
Changes in unrecognized deferred tax assets
- from active temporary differences
- from loss carryforwards
Tax-free income (deconsolidation result)
Other effects
Income taxes per statement of comprehensive income
* adjusted according to IAS 8
7. Equity
Share capital
The fully paid-in share capital of the parent company, Biofrontera AG, amounted to EUR 63,807,058.00 as of December 31, 2022. It
consisted of 63,807,058 registered shares with a nominal value of EUR 1.00 each. On December 31, 2021, the share capital had
amounted to EUR 56,717,385.00.
The shares of Biofrontera AG were listed on the Regulated Market of the Düsseldorf Stock Exchange in 2006. In August 2012, at the
request of the Company, admission to trading on the Regulated Market of the Frankfurt Stock Exchange was also granted. The shares
are also traded on the Xetra computer trading system and on all other German stock exchanges. On June 03, 2014, the shares were
admitted to the Prime Standard of the Frankfurt Stock Exchange.
The listing on the NASDAQ Capital Market in the USA took place on February 14, 2018, where Biofrontera AG share certificates are
traded as American Depositary Shares (ADS) under the ticker symbol BFRA. One ADS certifies the right to two ordinary shares of
Biofrontera AG. Biofrontera delisted its ADSs from the Nasdaq Capital Market ("Nasdaq") effective at the beginning of March 2022,
since when ADSs can be traded through a Level I program on the U.S. over-the-counter (OTC) market under the symbol BFAGY. One
ADS represents the right to two ordinary shares of Biofrontera AG.
The share capital was held as follows on December 31, 2022:
Maruho Co., Ltd., Osaka Japan
The total share of voting rights is assigned to Maruho Co., Ltd, Osaka, through the company Maruho
Deutschland GmbH, Düsseldorf, which is controlled by the former.
Wilhelm Konrad Thomas Zours
December 31,
2022
December 31,
2021
13,399,965
13,399,965
54
Biofrontera AG Annual Report 2022
The voting rights through the chain of subsidiaries listed below are attributed to Mr. Zours:
• DELPHI Unternehmensberatung Aktiengesellschaft;
• VV Beteiligungen Aktiengesellschaft
• Deutsche Balaton Aktiengesellschaft;
• Heidelberger Beteiligungsholding AG;
• SPARTA AG;
• Deutsche Balaton Biotech AG (*no longer included in the group of companies listed in 2021 - AEE Ahaus-
Enscheder AG; MARNA Beteiligungen AG; Youbisheng Green Paper AG; Strawtec Group AG)
Biofrontera Inc., Woburn, USA
Free float
Total
17,021,057
14,218,773
6,466,946
26,919,090
63,807,058
n.a.
26,327,221
56,717,385
Only those shareholders are listed who are subject to reporting requirements under the German Securities Trading Act (WpHG) and
the Securities and Exchange Commission (SEC) and have made a corresponding notification. This includes all shareholders who hold
at least 3% of the outstanding shares or voting rights. The number of shares listed here refers to the last notification of the
respective shareholders, since then they may have changed their holdings within the respective notification thresholds without
informing the Company.
In the event of the Company achieving an annual surplus, the Management and Supervisory boards are authorized to transfer all or
part of the annual surplus that remains, after deduction of the sums to be placed in the legal reserves and of a loss carried forward,
to retained earnings. It is not permissible to transfer more than half of the annual surplus to retained earnings if, after such a
transfer, the other retained earnings would exceed half of the share capital. The shareholders' share of profits is calculated based
on the size of their holding of the share capital.
Authorized/conditional capital
The Company had no authorized capital as of the reporting date.
The conditional capital consisted of three share capital amounts.
The conditional increase in the share capital (Conditional Capital I) of EUR 6,434,646 was approved on August 28, 2015, of which is
EUR 1,359,864 available as at December 31, 2022. Conditional Capital I serves to secure the granting of option rights and the
agreement of option obligations in accordance with the bond terms and conditions.
The conditional increase in the share capital (Conditional Capital III) of EUR 542,400 was approved on February 28, 2015, of which is
EUR 249,050 available as of December 31, 2022, and serves exclusively to fulfill option rights (2010 share option program) granted
on July 1, 2015 on the basis of the annual general meeting (“AGM”) of July 2, 2010.
The conditional increase in the share capital (Conditional Capital V) of EUR 1,814,984 approved on February 28, 2015. of which is EUR
1,554,984 available as at December 31, 2022 and serves exclusively to fulfill option rights (2015 share option program) granted until
August 27, 2020 on the basis of the AGM on August 28, 2015.
Convertible bond 2017/2022
On December 23, 2016, the Executive Board of the Company resolved to issue a convertible bond, which was fully placed in the
amount of EUR 5.0 million in January 2017. The individual bonds bear interest of 6% per annum on their nominal amount from
February 1, 2017. Interest is payable semi-annually in arrears on January 1 of each year, for the first time on July 1, 2017. The fair
value of the convertible bond was calculated in the initial valuation using an interest rate of 7.6%. The term of the convertible bond
2017/2022 starts on the date of its initial issue ("issue date") and ends on December 31, 2021 and is due for repayment on January
01, 2022.
As in the previous year, no bonds were converted into no-par shares in 2022. The convertible bond 2017/2022 was repaid on time
and in full on January 03, 2022.
2015 stock option program
Biofrontera AG Annual Report 2022
55
At the AGM on August 28, 2015, the Management Board and Supervisory Board proposed a new share option program for employees
to the AGM, which approved the initiative. Accordingly, the Management Board or, to the extent that the beneficiaries are
Management Board members, the Supervisory Board, are entitled until August 27, 2020 to issue up to 1,814,984 subscription rights
to up to EUR 1,814,984 of the Company's ordinary registered shares, whose exercise is tied to certain targets.
The program has a total nominal value of EUR 1,814,984 and a term of five years from the issue date, in other words, until August 27,
2020. Eligibility for the 2015 share option program was granted to members of the Management Board and employees of the Company
as well as to members of management bodies and employees of affiliates of Biofrontera AG. The granting of options is made without
any payment being provided in return.
In accordance with the associated conditions, each subscription right that is granted entitles the beneficiary to acquire one new
registered no par value unit share in the Company. The exercise price is equal to the arithmetical average (unweighted) of the
closing prices on the Frankfurt Stock Exchange in floor trading and in Xetra trading for the Company's shares on the ten trading
days prior to the issuing of the share. However, the minimum exercise price shall amount to the proportionate share of the
Company's share capital allocated to each individual no par value unit share, pursuant to Section 9 (1) of the German Stock
Corporation Act (AktG).
The options granted can only be exercised after expiry of a vesting period. The vesting period is four years from the respective date
of issue. A prerequisite for the whole or partial exercising of the options is that the following performance target is achieved:
Exercising the options from a tranche is possible, if at the beginning of the respective exercise period, the price (hereinafter referred
to as the "reference price") of a share in Biofrontera Aktiengesellschaft exceeds the exercise price by at least 20%, and a minimum
reference price of EUR 5.00 is reached (hereinafter referred to as the "minimum reference price"). The reference price is equal to
the arithmetical average (unweighted) of the closing prices on the Frankfurt Stock Exchange in floor trading and Xetra trading for
the Company's shares between the 15th and the 5th stock market day (in each case inclusive) before the start of the respective
exercise window. The minimum reference price is adjusted in the following cases to align the specified performance target with
changed circumstances:
•
•
In the event of a capital increase from company funds being implemented by issuing shares, the minimum reference price
is reduced by the same ratio as new shares issued compared to existing shares. If the capital increase is implemented
from company funds without issuing new shares (Section 207 (2) Clause 2 of the German Stock Corporation Act [AktG]),
the minimum reference price is not changed.
In the case of a capital reduction, no adjustment of the minimum reference price is implemented, provided that the total
number of shares is not changed by the capital reduction, or if the capital reduction is connected to a capital repayment
or purchase of treasury shares. In the case of a capital reduction performed by consolidating shares without capital
repayment and in the case of increasing the number of shares with no associated change in capital (share split), the
minimum reference rate increases in line with the capital reduction or share split.
Other adjustments to the minimum reference price are not implemented.
The exercising of options is limited to the following time periods (hereinafter "exercise windows"), in other words, only declarations
of exercising of rights submitted to the Company within an exercise window will be considered:
a) on the 6th and subsequent 20 banking days after the date of the AGM (exclusive),
b) on the 6th and subsequent 20 banking days after the date of submission of the semi-annual or quarterly report or an
c)
interim statement by Biofrontera AG (exclusive)
in the period between the 15th and 5th banking day prior to the expiration of the option rights of the respective
expiration day (exclusively).
After the vesting period, the options can be exercised up until the expiry of six years from the date of issue (exclusive). For the
valuation of the employee share options, we have assumed an average holding period of 5 years.
Any claim by the beneficiaries to receive a cash settlement in the event of non-exercise of the options is invalid even in the event
of the existence of the above exercise prerequisites. An option may only be exercised if the holder has a current service or
56
Biofrontera AG Annual Report 2022
employment contract with the Company or another Company affiliated with the Company or if the holder is a member of the
Management Board or the management team of another company affiliated with the Company.
In the event of the exercising of a subscription right, the Company is generally and in specific cases permitted to choose between
granting the registered share in exchange for payment of the exercise price, or fulfilling its debt by paying a cash settlement to the
holder of the subscription right. The cash settlement per subscription right is equal to the difference between the exercise price per
share and the share price on the exercise date, minus due taxes and fees.
As this stock option scheme entails share-based payment transactions in which the terms of the arrangement provide the Company
with a choice of settlement, the Company has decided, in accordance with IFRS 2.41 and IFRS 2.43, to recognize the transactions
pursuant to the provisions for equity-settled share-based payments (IFRS 2.10-29).
Number of options issued
End of vesting period
Exercise price
Adjusted exercise price March 2018
End of vesting period
End of exercise window
Fair value per option
Share price volatility
Dividend yield
Share price yield
Risk-based interest rate
Fluctuation rate
Tranche 1
Tranche 2
Tranche 3
Tranche 4
Tranche 5
Tranche 6
425,000
18.04.2016
2.49 EUR
2.25 EUR
18.04.2020
18.04.2022
1.00 EUR
50.59%
0%
2.31%
5.92%
12%
130,500
01.12.2016
3.28 EUR
3.04 EUR
01.12.2020
01.12.2022
1.30 EUR
49.00%
0%
7.00%
13.26%
12%
329,000
28.04.2017
4.02 EUR
3.78 EUR
28.04.2021
28.04.2023
1.56 EUR
47.00%
0%
7.50%
13.94%
12%
300,500
28.11.2017
3.33 EUR
3.09 EUR
28.11.2021
28.11.2023
1.48 EUR
46.00%
0%
7.60%
14.05%
12%
180,000
07.05.2022
5.73 EUR
0
07.05.2022
07.05.2024
2.35 EUR
47.00%
0%
7.60%
14.03%
9%
333,485
14.05.2019
6.710 EUR
0
14.05.2023
14.05.2025
2.55 EUR
47.30%
0%
7.60%
13.35%
9%
The fair value of a stock option under this option program is determined on the basis of a Monte Carlo risk simulation. The pro rata
amounts are recognized ratably over the vesting period as personnel expenses and an increase in the capital reserves.
2015 stock option program
December 31, 2022
December 31, 2021
Outstanding at the beginning of the period
Granted during the period
Forfeited during the period
Exercised during the period
Expired during the period
Outstanding at the end of the period
Exercisable at the end of the period
Range of exercise prices for outstanding options
Weighted average of remaining contractual life
Cost during the period
693,990
0
231,000
0
124,500
338,490
0
1,021,485
0
327,495
0
0
693,990
0
2,25-6,710 EUR
2,25-6,710 EUR
35 months
50 TEUR
44 months
142 TEUR
Due to the non-fulfillment of the exercise conditions, no options were exercisable as of December 31, 2022.
Capital reserves
Biofrontera AG Annual Report 2022
57
The capital reserves shown on the balance sheet comprise the capital reserve, the reserves from currency translation, the loss
carried forward and the result of the period. The consolidated statement of changes in equity provides further information about
the development of equity.
In accordance with IAS 32.37, equity procurement costs in connection with capital increases are deducted from the capital reserve
in an amount of EUR 64 thousand (previous year: EUR 2,000 thousand) for the year ended December 31, 2022.
Capital management
The Group's equity calculated in accordance with IFRS is managed as capital. The Company's capital management regularly reviews
the Group's equity and liquidity position. The objective is to provide adequate financing in line with capital market expectations and
to ensure creditworthiness in relation to national and international business partners in order to secure the Group's business
operations for at least 12 months. The Company's Management Board ensures that sufficient capital is available to all Group
companies in the form of equity and debt, with the aim of achieving Group equity of at least 20% of total assets.
The development of the liquidity of the Group and of Biofrontera AG is used as an important key figure and control parameter. This
is monitored on a daily basis and reported to the company's Management Board. In addition, the liquidity status is reviewed in
regular target/actual variance analyses and communicated to the Management Board.
The Group's equity calculated in accordance with IFRS is managed as capital. The Company's capital management regularly reviews
the Group's equity and liquidity position. The objective is to provide adequate financing in line with capital market expectations and
to ensure creditworthiness in relation to national and international business partners in order to secure the Group's business
operations for at least 12 months. The Company's Management Board ensures that sufficient capital is available to all Group
companies in the form of equity and debt, with the aim of achieving Group equity of at least 20% of total assets.
The development of the liquidity of the Group and of Biofrontera AG is used as an important key figure and control parameter. This
is monitored on a daily basis and reported to the company's Management Board. In addition, the liquidity status is reviewed in
regular target/actual variance analyses and communicated to the Management Board.
8. Financial liabilities
The repayment of the convertible bond 2017/2022 in the amount of EUR 2,031 thousand was made on schedule by January 03, 2022;
the repayment amount was included in current financial debt in the previous year.
in EUR thousands
December 31, 2022
December 31, 2021
Non-current financial liabilities
Leasing liabilities
Total non-current financial liabilities
Current financial liabilities
Leasing liabilities
Other current liabilities
Total current financial liabilities
1,055
1,055
446
0
446
851
851
357
2,092
2,449
58
Biofrontera AG Annual Report 2022
in EUR thousands
Leasing liabilities
Principal repayment
Interest payment
December 31, 2022
2023
2024
2025
2026
2027
Total
446
10
408
374
273
6
3
1
0
0
1,501
20
in EUR thousands
December 31, 2021
Convertible bon 2017/2022:
Principal repayment
Interest payment
Leasing liabilities
Principal repayment
Interest payment
Leasing liabilities
2022
2023
2024
2025
2026
Total
2,031
61
0
0
0
0
0
0
358
324
296
221
17
11
6
1
0
0
9
0
2,031
61
1,208
35
The carrying amount of current and non-current lease liabilities is EUR 1,501 thousand (previous year: EUR 1,208 thousand). Future
lease payments are discounted at the lessor's imputed interest rate or, if this is not available, at the marginal borrowing rate.
For further details, please refer to the section on significant accounting policies.
Development of lease liabilities:
Lease liabilities
in EUR thousands
Buildings
Cars
Others
Total
as of
01.01.2022
1016
130
62
1208
9. Other financial liabilities
Additions
Additions
Revaluation
291
0
0
291
274
165
0
439
Disposals
0
0
0
0
Principal
paymnets
-307
-117
-13
-437
as of
31.12.2022
1
0
0
2
Leasing
payments
308
4
14
325
Interest
expense
11
121
1
132
Biofrontera AG Annual Report 2022
59
in EUR thousands
December 31, 2022
December 31, 2021
Non-current other financial liabilities
Liability
from SAR program
Current financial liabilities
0
0
26
384
384
14
Trade accounts payable amount to EUR 1,984 thousand as of December 31, 2022 (previous year: EUR 2,735 thousand).
10.
Trade payables
As of December 31, 2022, trade payables amount to EUR 1,984 thousand (previous year: EUR 2,735 thousand).
11.
Income taxes
Income tax liabilities of EUR 156 thousand (previous year: EUR 0 thousand) relate to corporate income tax liabilities (EUR 83 thousand)
and business tax liabilities (EUR 73 thousand) at Biofrontera Pharma GmbH.
12. Other provisions
The development of other provisions of the Biofrontera Group is as follows:
in EUR thousands
December 31,
2021
Utilized
Released
Added
Reclassified
December 31,
2022
Outstanding invoices
Auditing costs
Provisions for litigation
costs
Other provisions
Total
510
384
0
119
(868)
(378)
0
(58)
1,012
(1,304)
(21)
(6)
0
(35)
(61)
1,566
215
518
59
2,358
(1,187)
(215)
0
0
(1,402)
0
0
518
85
603
Other provisions relate to various identifiable individual risks and uncertain obligations. The provisions classified as current are
expected to result in an outflow of economic benefits within the subsequent financial year.
The obligations for outstanding invoices (EUR 1,187 thousand) and for closing and audit costs (EUR 215 thousand) were reclassified
to other liabilities in the financial year 2022.
The companies included in the consolidated financial statements of Biofrontera AG face pending legal proceedings at the time of
reporting, the outcome of which either cannot be determined or cannot be predicted due to the uncertainty associated with such
legal proceedings. For passive lawsuits, provisions for litigation costs have been recognized in the amount of the expected
payments; for active lawsuits, provisions have solely been recognized in the amount of the legal services rendered to date. For
further details, please refer to our disclosures on litigation in the Group management report.
13. Other current liabilities
60
Biofrontera AG Annual Report 2022
in EUR thousands
Liabilities from SAR program
Total other non-current liabilities
Accrual for employee bonuses
Accrual for outstanding vacation
Accrual for settlement payment
Payroll tax
Accruals for outstanding invoices
Accruals for financial statement and audit costs
Other accruals
Total other current liabilities
December 31, 2022
December 31, 2021
304
304
563
117
0
101
1,187
215
335
2,518
0
0
706
112
4,970
98
0
0
91
5,977
Employees entitled to receive stock options whose vesting period has not yet expired are entitled to a severance payment in the
event that an affiliated company leaves the Group in accordance with §10 of the option conditions for employee stock options. A
liability of EUR 15 thousand (previous year: EUR 33 thousand) is therefore included under other accruals for the settlement of
employees of Biofrontera Inc. entitled to receive stock options.
The obligations under the DUSA settlement were reclassified to liabilities to associated companies in the financial year 2022.
Stock Appreciation Rights Program 2019
In April 2019, the Executive Board, with the approval of the Supervisory Board, established a stock appreciation rights plan under
which the Company grants virtual options ("stock appreciation rights" or "SARs") entitling the "beneficiary" to receive cash
payments in accordance with the specific terms of the SAR plan. However, SARs do not confer any right to subscribe to shares of
the Company. SARs may be issued to members of the Management Board of the Company, to members of the management of
affiliated companies as well as to employees of the Company and affiliated companies (hereinafter collectively referred to as
"beneficiaries"). The exact number of beneficiaries and the number of SARs to be granted to them are determined by the Company's
Management Board. To the extent that members of the Management Board are to receive SARs, the Supervisory Board alone is
responsible for determining and deciding on the issue of the SARs. In accordance with the SAR Plan, a maximum of 4,000,000 SARs
may be issued until March 31, 2024, of which a maximum of 1,600,000 SARs may be granted to members of the Management Board
and a maximum of 2,400,000 SARs to other beneficiaries. The SAR Plan sets the dates for the payment of cash in connection with
the SARs, unless there are legally binding regulations that conflict with the payout for the beneficiary. In addition, the eligible party
must meet certain conditions for the grant of SARs and must enter into a written contract ("SAR Agreement") with the Company
prior to exercise and delivery. Finally, SARs are subject to regulations on vesting periods, expiry and forfeiture. In particular, the
SARs may be exercised for the first time after a "vesting period" has expired:
d) The vesting period for 15 % of the SARs granted on an issue date is one year after the issue date;
e) The vesting period for an additional 25% of the SARs granted on an issue date is two years after the issue date;
The vesting period for an additional 25% of the SARs granted on an issue date is three years after the issue date;
f)
g) The vesting period for the remaining 35% of the SARs granted at an issue date is four years after the issue date.
After expiry of the respective vesting period, SARs may be exercised until six years after the respective issue date, unless mandatory
legal provisions stipulate otherwise in individual cases. If the SARs have not been exercised by that date, they expire without
replacement. The beneficiary has no claim to payment if the SARs are not exercised on time and no further compensation will be
granted.
SARs may only be exercised as long as their holder is in an ongoing employment or service relationship with the Company or with
an affiliated company or as a member of the Company's Management Board.
Biofrontera AG Annual Report 2022
61
SARs may only be exercised if the reference price at the beginning of the respective exercise window exceeds the issue price by at
least 20%. Furthermore, the reference price must be at least as high as the MSCI World Health Care Index TR or a comparable
successor index in the time between the last trading day before the issue date and the 5th trading day before the beginning of the
respective exercise window.
Upon effective exercise of the SARs, the Company is obligated, subject to certain adjustments, to make a payment (gross) for each
SAR exercised as follows: reference rate - base amount = payout amount per SAR (gross).
SAR program 2019
December 31, 2022
December 31, 2021
Outstanding at the beginning of the period
Granted during the period
Forfeited during the period
Exercised during the period
Outstanding at the end of the period
Exercisable at the end of the period
Fair value at the end of the period
Cost during the period
569,205
0
227,701
0
341,504
0
80 TEUR
-22 TEUR
727,750
429,529
588,074
0
569,205
0
102 TEUR
-81 TEUR
The fair value of a stock option under this option program is determined on the basis of a Monte Carlo risk simulation. The pro rata
temporis amounts are recognized ratably as personnel expense over the vesting period until the end of the blocking period and are
reported under other liabilities (previous year: other financial liabilities).
In the event of an affiliated company leaving the Group, the SAR beneficiaries are entitled to a compensation payment in accordance
with §10 of the SAR terms and conditions for the SARs whose vesting period has not yet expired. A liability from SARs of EUR 224
thousand (previous year: EUR 282 thousand) exists for the settlement of employees of Biofrontera Inc. who are eligible for
compensation.
14. Reporting on financial instruments
The following tables present the carrying amounts and fair values of the individual financial assets and liabilities for each category
of financial instrument in accordance with IFRS 9:
Financial assets
in EUR thousands
Valuation
category
Fair value
as of
Carrying
amount
as of
Fair value
as of
Carrying
amount
as of
Hierarchy level
according to IFRS 9
December 31,
2022
December 31,
2022
December 31,
2021
December 31,
2021
Cash and cash equivalents
Trade receivables
Other financial asstes
Total
AC
AC
AC
6,376
2,035
878
9,289
6,376
2,035
878
9,289
6,908
1,206
57
8,171
6,908
1,206
57
8,171
1
2
2
62
Biofrontera AG Annual Report 2022
Valuation
category
Fair value
as of
Carrying
amount
as of
Fair value
as of
Carrying
amount
as of
Hierarchy level
according to
IFRS 9
December 31,
2022
December 31,
2022
December 31,
2021
December 31,
2021
December 31,
2022
Financial liabilities, current
Trade payables
Liabilities to associated companies
current
Other financial liabilities
Financial liabilities, non-current
Liabilities to associated companies
non-current
Total
AC
AC
AC
AC
AC
AC
446
1,984
26
1,055
446
1,984
26
1,055
2,449
2,735
14
851
2,449
2,735
14
851
8,807
8,807
11,328
11,328
2
2
2
2
2
Based on the input factors used at the valuation methods fair values are divided into different steps of the fair value hierarchy:
Level 1: Fair value valuations using prices listed on active markets (not adjusted) for identical assets or liabilities.
Level 2: Fair value valuations using inputs for the asset or liability that are either directly observable (as prices) or indirectly
observable (derived from prices), but which do not constitute listed prices pursuant to Level 1.
Level 3: Fair value valuations using inputs for the asset or liability that are not based on observable market data (unobservable input
data).
No reclassifications were made between the individual levels of the fair value hierarchy during the 2021 financial year. For further
details, please refer to the disclosures in the general accounting policies and the notes to the statement of financial position and
statement of comprehensive income (Notes 10 and 11).
Expenses, income, losses and gains/losses from financial instruments:
in EUR thousands
Assets AC
Liabilities AC
Total
Income from currency translation
Expenses from currency translation
Total
22
-186
-164
187
-397
-209
209
-582
-373
Net gains and losses generally include currency translation effects as well as impairment losses and reversals. Fair value changes
of liabilities measured at fair value are included in interest expense. Interest income and other interest expense are not included in
net income.
Principles of risk management
In the ordinary course of business, the Group is exposed to risks that may have an impact on its net assets, financial position and
results of operations. The company's risks from financial instruments result primarily from foreign currency-related market price
risks. In contrast, credit and default risk is of minor importance.
In general, Biofrontera's market risk consists primarily of foreign currency risk.
•
Foreign currency risk: The Biofrontera Group was exposed to foreign currency risks as of the balance sheet date. Risks
with regard to the valuation of trade receivables are of minor importance, as the company mainly invoices in Euro.
Biofrontera AG Annual Report 2022
63
However, due to the fact that sales with license partners are tied to the prices achievable in the respective market, there
is a foreign currency-related market price risk with regard to the Company's sales valued in Euro, primarily for the U.S.
market due to the expansion of business in the United States. Trade payables denominated in foreign currencies in these
markets have a corresponding offsetting effect. There is also a foreign currency risk in Switzerland, particularly with
regard to the production of wages and salaries and due to the fact that the sales of the license partner are tied to the
local currency. In addition, there is a foreign currency risk in the United Kingdom for the sales organization based there.
Exchange rate related change in profit 2022
in EUR
thousands
Profit
in EUR
thousands
Profit
USD
EUR +10%
-2,264
CHF
EUR +10%
187
GBP
EUR +10%
-4
USD
EUR -10%
2,767
CHF
EUR -10%
-228
GBP
EUR -10%
5
•
The Company does not enter into any specific currency hedging transactions. Exchange rate fluctuations are recognized
in profit or loss.
Credit risk: The Group is exposed to credit risk if counterparties are unable to meet their obligations within the customary payment
periods. The maximum default risk is represented in the balance sheet by the carrying amount of the respective financial asset. The
development of the receivables portfolio is monitored in order to identify potential default risks at an early stage and to initiate
appropriate measures. Biofrontera's financial instruments have a low default risk.
Individual valuation allowances on trade receivables were not recognized in fiscal year 2021 (previous year: EUR 0 thousand).
Similarly, due to the very low default rate in the past and the lack of overdue receivables, it was not necessary to recognize portfolio-
based allowances. Cash and cash equivalents are invested with banks and insurance companies with adequate deposit protection.
All financial assets are due in the short term. As in the previous year, there are no material overdue financial assets.
Liquidity risk refers to the inability to meet existing or future payment obligations as they become due. To ensure the ability to pay
at all times and to avoid financial shortages, Biofrontera has established a central cash management system that monitors liquidity
requirements in the short, medium and long term. Refinancing for all Group companies is mainly provided by Biofrontera AG.
Liquidity is monitored and managed on the basis of short- and long-term corporate planning. Liquidity risks are identified at an early
stage by simulating various scenarios. Current cash and cash equivalents are recorded and monitored on a daily basis.
For information on the (undiscounted) payments from financial debt due in the next few years and other financial liabilities, please
refer to the corresponding notes on this balance sheet item. All other financial liabilities are current and are expected to be settled
within one year.
Maturity analysis of financial instruments
in EUR thousand
Financial liabilities current
Trade payables
Liabilities to associated companies current
Other financial liabilities current
Financial liabilities non-current
Liabilities to associated companies non-current
Total
Carrying
amount
31.12.2022
446
1,984
2,653
26
1,055
2,642
8,807
Maturity
2025
0
0
0
0
374
0
374
2024
0
0
0
0
408
2,642
3,050
2023
446
1,984
2,653
26
0
0
5,109
2026
0
0
0
0
273
0
273
2027
0
0
0
0
0
0
0
Notes to the consolidated statement of comprehensive income
64
Biofrontera AG Annual Report 2022
15.
Sales revenue
01.01.-31.12.2022
01.01.-31.12.2021
in EUR
thousands
Product
revenues
Service
revenues
Licensing
revenues
Product
revenue
Development
revenues
Licensing
revenues
Germany
Europe
U.S.
Other regions
Total
4,763
2,418
-
-
7,181
-
-
648
-
648
-
1,079
16,487
342
17,908
5,263
1,954
20,204
-
27,421
-
-
-
-
-
-
1,365
-
-
1,365
In the 2022 financial year, license revenues of EUR 16,487 thousand with the former subsidiary Biofrontera Inc., USA, were recognized
for the first time; in the previous year, however, the US market sales of Biofrontera Inc. in the amount of EUR 20,204 thousand were
still included in product sales. Sales with Biofrontera Inc. account for 67% of the Group's total sales.
In the current fiscal year, no license revenues were received from down payments of license agreements (previous year: EUR 50
thousand).
Provisions for manufacturer rebates amount to 0.17% of total sales in fiscal 2022 (previous year: 0.09%), while provisions for return
obligations amount to 0.21% of total sales (previous year: 0.30%).
16.
Cost of sales, gross profit
The cost of materials included in the cost of sales amounted to EUR 3,069 thousand in fiscal year (previous year: EUR 2,942 thousand).
The gross profit decreased by EUR 3,892 thousand in the reporting year 2022 to EUR 20,981 thousand compared to
EUR 24,873 thousand in the prior-year period.
17. Research and development costs
Research and development costs amounted to EUR 7,128 thousand (previous year: EUR 7,009 thousand). They include costs for
clinical trials, but also regulatory expenses, i.e., for the granting, maintenance, and extension of our marketing authorizations. The
increase in research and development costs is mainly due to increasing activities in our clinical trials.
18. General administrative costs
General and administrative expenses amounted to EUR 5,906 thousand (previous year: EUR 30,781 thousand) in fiscal year 2022 and
thus decreased by a total of EUR 24,875 thousand compared to the previous year. The main reason for this was the cost of the
settlement payment to DUSA Pharmaceuticals Inc. that was included in the previous year in the amount of EUR 19,457 thousand (USD
22.5 million) as well as the cost share attributable to the former subsidiary Biofrontera Inc. which left the scope of consolidation
19.
Sales and marketing costs
Sales and marketing costs amounted to EUR 6,357 thousand(previous year: EUR 22,423 thousand) in fiscal year 2022. Sales costs
include the costs of our own sales force in Germany, Spain, and the United Kingdom, as well as marketing expenses.
Biofrontera AG Annual Report 2022
65
20.
Interest expenses and income
Interest expense of EUR 163 thousand (previous year: EUR 3,720 thousand) mainly results from interest on arrears in connection with
the DUSA settlement payments of EUR 101 thousand (previous year: EUR 0 thousand), interest to be recognized for leases in
accordance with IFRS 16 of EUR 15 thousand (previous year: EUR 23 thousand), and interest on a short-term bond issued and repaid
in fiscal year 2022 of EUR 34 thousand (previous year: EUR 0 thousand).
Interest income amounts to EUR 1 thousand (previous year: EUR 13 thousand) and results mainly interest income under finance lease
agreements amounting to EUR 1 thousand (previous year: EUR 13 thousand).
21. Result from investments
In addition to the update of the carrying amount of the investment in Biofrontera Inc. in the amount of EUR -1,604 thousand, income
from investments also includes an impairment loss of EUR 42,568 thousand on the carrying amount of the investment.
22. Other expenses and income
Other expenses and income totaled to a loss of EUR 467 thousand in the reporting period (previous year: profit of
EUR 60,001 thousand) and mainly include expenses and income from currency translation amounting to a loss of EUR 677 thousand
(previous year: profit of EUR 155 thousand) as well as other income from the recognition of non-cash benefits and the recharging of
costs in the amount of 204 TEUR (previous year: 168 TEUR). In the previous year the deconsolidation gain of EUR 59,180 thousand
from the withdrawal of Biofrontera Inc. from the Biofrontera Group was reflected here.
23.
Income tax
in EUR thousands
Deferred taxes
Actual income taxes
Total income taxes
* adjusted according to IAS 8 (see Notes)
December 31, 2022
December 31, 2021*
(800)
(156)
(956)
(2,349)
(47)
(2,397)
The deferred tax expense of EUR 800 thousand (previous year: EUR 2,349 thousand) results from the reduction of the tax loss
carryforwards of Biofrontera Pharma GmbH; the amount of the tax loss carryforwards was reduced to the expected utilization during
the planning period. As in the previous year, there were no tax effects from entries in other comprehensive income after taxes (OCI).
24.
Earnings per share (EPS)
Earnings per share are calculated on the basis of the net loss for the year of the Biofrontera Group and the average ordinary shares
in circulation in the financial year, in accordance with IAS 33.
66
Biofrontera AG Annual Report 2022
Number of weighted ordinary shares in circulation (on average)
Result attributable to owners of the parent in EUR
Basic earnings per share in EUR
Number of weighted ordinary shares in circulation (on average)
Result attributable to owners of the parent in EUR
Diluted earnings per share in EUR
December 31, 2022
December 31, 2021*
57,474,912
(44,166,205)
(0.77)
57,474,912
(44,166,205)
(0.77)
55,390,336
37,746,813
0.68
56,717,385
37,746,813
0.67
25. Additional information to the consolidated statement of comprehensive income
Other comprehensive income after tax only includes exchange differences from the conversion of foreign currency from our foreign
operations into the Group currency.
Depreciation and amortization expense
The amortization of intangible assets and depreciation of tangible assets are included in the following items of the statement of
comprehensive income:
in EUR thousands
Research and development costs
General administrative costs
Cost of sales
Sales and marketing
Depreciation and amortization expense
Personnel costs
in EUR thousands
Wages and salaries
Social security charges
Cost for pension schemes
Total
26.
Staff
December 31, 2022
December 31, 2021
158
433
129
25
745
56
1,298
133
1,803
3,290
December 31, 2022
December 31, 2021
6,904
1,123
94
8,121
16,925
2,527
263
19,715
In 2022 the Biofrontera Group had an average of 100 salaried employees (previous year: 163).
As of December 31, 2022, 110 (previous year: 99 ) employees were working in the Biofrontera Group and were distributed as follows:
Total number of employees
Biofrontera AG Annual Report 2022
December 31, 2022
December 31, 2021
110
99
67
Full-time
With academic degree
By business segments
Production
Research and development
Clinical and regulatory tasks
Marketing and sales
Quality management
Management, business development, finance, HR and administration
By countries
Germany
Spain
United Kingdom
Notes to the consolidated cash flow statement
81
29
110
12
9
24
33
7
25
110
98
9
3
76
24
99
15
5
15
29
7
28
99
88
8
3
27.
Composition and change
The cash flow statement is presented in accordance with IAS 7. The net result is adjusted for the effects of non-cash transactions,
accruals or deferrals of past or future operating cash receipts or payments, and items of income and expense attributable to
investing or financing activities.
In the consolidated statement of cash flows, cash and cash equivalents include cash on hand and checks as well as bank balances
and cash deposits with a maturity of up to three months. Current account liabilities are included in cash and cash equivalents where
appropriate.
The change in cash and cash equivalents in the fiscal year amounted to EUR ‑532 thousand (previous year: EUR ‑9,638 thousand).
Interest paid amounted to EUR 198 thousand (previous year: EUR 4,861 thousand). Interest payments received amounted to EUR 13
thousand (previous year: EUR 26 thousand).
in EUR thousands
January 1, 2022
Cash
effective
Addition/
retirement
Fair value
change
December 31,
2022
Convertible bond 2017/2022
Interest convertible Bond
2017/2022,
Convertible Bond 2017/22
Leasing liabilities
Total financial liabilities
2,031
61
1,208
3,300
(2,031)
(61)
(437)
(2,529)
-
-
730
730
-
-
-
-
-
-
1,501
1,501
68
Biofrontera AG Annual Report 2022
in EUR thousands
January 1, 2021
Cash
effective
Addition/
retirement
Fair value
change
December 31,
2021
Convertible bond 2017/2022
EIB loan 2017
EIB loan 2019
Interest convertible Bond
2017/2022,
Convertible Bond 2017/22
Interest EIB loan 2017
Interest EIB loan 2019
Leasing liabilities
Total financial liabilities
2,003
12,484
5,591
61
(8)
28
3,715
23,874
-
(13,596)
(6,143)
(122)
(315)
(190)
(624)
(20,990)
28
1,107
536
122
323
162
(1,883)
395
-
5
16
-
-
-
-
21
2,031
-
-
61
0
-
1,208
3,300
Other explanatory notes
28. Members of the Management Board
The Executive Board in 2022 consisted of Ms. Pilar de la Huerta Martínez (Chief Financial Officer, since September 12, 2022), Mr. Paul
Böckmann (from June 09, 2022 to September 30, 2022) and Mr. Ludwig Lutter (Chief Financial Officer, until August 13, 2022).
Management Board compensation
in EUR thousands
December 31, 2022
December 31, 2021
Short-term benefits
Performance-based compensation
Total compensation
542
-
542
1,179
110
1,289
Further information on individualized compensation of the Management Board can be found in the "Compensation Report" in the
Management Report.
The Management Board members held the following supervisory board positions and positions on comparable domestic and foreign
boards during the reporting period:
Name
Company
Pilar de la Huerta Martínez
4BaseBio Ltd, UK
Vaxdyn, S.L., Spain
Epidisease S.L., Spain
Atlas S.L:, Spain
29. Members of the Supervisory Board
Board
Supervisory Board
Supervisory Board
Supervisory Board
Supervisory Board
Position
Member
Member
Member
Member
Biofrontera AG Annual Report 2022
69
Name
Wilhelm K.T. Zours
Nationality
German
Age
61
Position
Chair
Date of first
appointment
December 14, 2021
Term until
2026
CV
Mr. Zours is shareholder and managing director of DELPHI Unternehmensberatung AG as well as chairman of the
supervisory boards of Deutsche Balaton AG, Beta Systems Software AG, Strawtec Group AG and SPARTA AG. Since 1985,
Mr. Zours has held various management and supervisory board mandates and founding participations in various
companies, including Balaton Ungarn Beteiligungen AG, Sparta Beteiligungen AG and Elsö Nemet Ertekpapirkereskedelmi
Kft (co-founder of the Budapest Stock Exchange in 1990).
Dr. Jörgen Tielmann
German
53
Vice Chair
December 14, 2021
2026
CV
Dr. Jörgen Tielmann studied law at the Universities of Tübingen and Göttingen and received a Master of Laws from the
University of Manchester. He has been advising companies and entrepreneurs on corporate law since his admission to
the bar in Hamburg in 1998 and has been practicing this activity as a partner at Luther since 2006. Dr. Jörgen Tielmann
was head of Luther's Stock Corporation, Banking and Capital Markets Law department from 2008 - 2018.
Dr. Heikki Lanckriet
Belgian
45
Member
December 14, 2021
2026
CV
Prof. Dr. Karin
Lergenmüller
CV
Dr. Lanckriet is Chairman of the Board and Chief Scientific Officer at 4basebio Plc and CEO & CSO of Expedeon Ltd. Earlier
in his career, Dr. Lanckriet was Chief Executive Officer & Chief Scientific Officer at 2invest AG, Principal at Puratos NV
and Principal at the University of Cambridge.Dr. Lanckriet holds a Bachelor's and Master's degree in Biochemical
Engineering from Ghent University, Belgium and a PhD in Biochemical Engineering from Cambridge University, UK.
German
64
Member
August 25, 2022
2026
Prof. Dr. Karin Lergenmüller is Professor of Marketing and General Business Administration at the Rhine-Main University
of Applied Sciences, Wiesbaden since 1999. She worked for Deutsche Bank AG after holding positions in the management
consulting industry, including at Andersen Consulting and Gemini Consulting. From 1996 to 1998 she was a member of
the management of Joas & Comp., Bad Homburg. Since 2000 Prof. Dr. Karin Lergenmüller is Global Equity Investor,
specialized in Digital World, Technology companies, NFT's and Crypto.
Dr. Helge Lubenow
German
54
Member
December 14, 2021
2026
CV
Prof. Dr. Franca
Ruhwedel
CV
Dr. Helge Lubenow studied biology and received her doctorate in genetics from the University of Cologne and the Max
Planck Institute. Following her doctorate, Dr. Lubenow joined the diagnostics company Qiagen in 1997. In the course of
her professional career at Qiagen, Dr. Lubenow held various management positions. From 2011 to 2015, Dr. Lubenow led
the molecular diagnostics business as Senior Vice President. In 2016, Dr. Lubenow founded her own consulting company,
AGOS Consulting. From 2018 to 2019, she was managing director of tesa Labtec GmbH. Since January 2020, Dr. Lubenow
has been appointed Managing Director of Proteomedix AG, Zurich, Switzerland.
German
50
Member
July 10, 2019
February 22, 2022
Franca Ruhwedel is Professor of Finance & Accounting at the Rhein-Waal University of Applied Sciences in Kamp-Lintfort.
At the same time, she has many years of experience as a supervisory board member and member of audit committees.
After a banking apprenticeship and studies in Münster, she completed her doctorate in Bochum and then worked in the
Mergers & Acquisitions department of the thyssenkrupp Group. She has been a university professor since 2007; her
research focuses on the capital market and corporate governance.
Karlheinz Schmelig
German
57
Member
December 14, 2021
2026
CV
Karlheinz Schmelig is managing partner of Creathor Venture Management GmbH, where he has been responsible for
investments in the life sciences sector since 2004. At the beginning of his career, Mr. Schmelig worked for Boehringer
Mannheim and later for Roche Diagnostics in Germany and the USA. His responsibilities there included supply chain
management, global marketing and business development. Mr. Schmelig holds a Bachelor's degree from the Baden-
Wuerttemberg Cooperative State University Mannheim and an MBA from the Kelley School of Business, USA.
Supervisory Board compensation
70
Biofrontera AG Annual Report 2022
in EUR thousands
Wilhelm K.T. Zours
Dr. Heikki Lanckriet
Prof. Dr. Karin Lergenmüller
Dr. Helge Lubenow
Prof. Dr. Franca Ruhwedel
Karlheinz Schmelig
Dr. Jörgen Tielmann
Gesamt
2022
49
26
8
31
5
31
41
191
2021
2
3
n.a.
3
3
3
3
15
The payments are short-term payments within the meaning of IAS 24.17 (a).
The Supervisory Board members held the following other supervisory board positions and positions on comparable domestic and
foreign boards during the reporting period:
Biofrontera AG Annual Report 2022
71
Name
Company
Board
Position
Wilhelm K.T. Zours
Deutsche Balaton AG
Beta Systems Software AG
SPARTA AG
YVAL Idiosynkratische Investments SE
Dr. Heikki Lanckriet
4basebio UK limited, Cambridge, UK
4basebio Discovery Ltd., Cambridge, UK
4basebio SLU, Madrid, ES
Neophore Ltd., Cambridge, UK
I2i capital Ltd., Cambridge, UK
Kither Biotech s.r.I., Italy
Heqet Therapeutics s.r.l., Italy
Dr. Helge Lubenow
Epigenomics AG
Human Gesellschaft für Biochemika und Diagnostika
mbH
Neracare GmbH
Prof. Dr. Franca Ruhwedel
NATIONAL-BANK AG, Essen
VTG AG, Hamburg
Karlheinz Schmelig
Prostatype Genomics AB, Stockholm, Schweden
CryoTherapeutics S.A., Awans, Belgien
Tacalyx GmbH, Berlin
Supervisory Board
Supervisory Board
Supervisory Board
Board of Directors
Chair
Chair
Chair
Chair
Board of Directors
Board of Directors
Board of Directors
Board of Directors
Board of Directors
Board of Directors
Board of Directors
Member
Member
Member
Member
Member
Member
Member
Supervisory Board
Member
Advisory Board
Member
Supervisory Board
Member
Supervisory Board
Supervisory Board
Member
Member
Supervisory Board
Supervisory Board
Advisory Board
Member
Member
Member
30. Related party disclosures
The group of related parties is limited to the group of persons listed in Notes 30 and 31 as well as to the persons and companies
listed in Note 10. The group of key management personnel is limited to the Management Board and the Supervisory Board.
Within the framework of the underlying holding structure, Biofrontera AG assumes the administrative and control tasks. Biofrontera
AG is also responsible for the financing of the currently still in the loss-making business areas, since as a listed company it has the
best access to the capital market. Against the background of the close cooperation between the Group companies, an internal
settlement is carried out which is adjusted annually to meet current requirements.
The following relationships exist with Biofrontera Inc.:
72
Biofrontera AG Annual Report 2022
in EUR thousands
Sales revenues*
Other income
Clinical trial expenses*
Other expenses*
Trade receivables
Trade payables
December 31, 2022
December 31, 2021*
17,135
436
64
1,344
11
8,602
263
86
413
302
4,977
Payables from DUSA settlement
* The income statement items mentioned here have been eliminated in the previous year in the course of consolidation.
5,295
Biofrontera Inc. was established to market our products in the USA. Under a license and supply agreement between Biofrontera
Pharma GmbH and Biofrontera Bioscience GmbH, both wholly owned subsidiaries of Biofrontera AG, and Biofrontera Inc. the
responsibilities between the companies are regulated. The agreement was concluded for a period of 15 years and will be renewed
for another 5 years, provided that a sales volume in the USA of more than USD 150 million has been achieved in the preceding 5
years. Under this agreement, Biofrontera Inc. acquires Ameluz® and the PDT lamps BF-RhodoLED® and RhodoLED® XL from
Biofrontera AG. Up to annual Ameluz® sales of USD 30 million, Biofrontera Inc. pays 50% of sales as a transfer price. This share
decreases in two steps for higher sales, down to 30% for sales in excess of USD 50 million. Biofrontera AG has agreed to maintain
FDA approval, to manufacture the products, to provide a pharmacovigilance database and to conduct predefined clinical trials.
Additionally, services that were previously invoiced as part of intercompany billing are now performed and invoiced on the basis of
corresponding service agreements with Biofrontera Inc. This relates primarily to services in the areas of pharmacovigilance, quality
management, IT and investor relations. In the financial year 2022, Biofrontera entered into a sublease agreement for business
premises and a service agreement for accounting services with Bio-FRI GmbH, the German subsidiary of Biofrontera Inc.
The following relationships exist with the Maruho Group:
in EUR thousands
Revenue from patent transfer
Revenue from license agreements
Income from subleases
Trade receivables
December 31, 2022
December 31, 2021
200
141
32
34
0
0
33
0
In April 2020, Biofrontera entered into an exclusive license agreement with Maruho Co, Ltd, Osaka, Japan (Maruho) for the
development and commercialization of Ameluz® for all indications in East Asia and Oceania. The agreement has a term of 15 years
from the start of sales in the countries covered by the agreement. Under the agreement, Maruho receives exclusive development
and marketing rights, including permission to sublicense Ameluz® in Japan, China, Korea, India, Pakistan, Vietnam, the Philippines,
Australia, New Zealand, and surrounding countries and islands (territory of applicability). Maruho is entitled, with Biofrontera's
consent, to conduct its own research and development under the license agreement. Maruho will grant to Biofrontera a royalty-free
and perpetual license to any results of such research and development conducted by Maruho for commercialization outside the
Territory. Under the License Agreement, Biofrontera will supply Ameluz® to Maruho at cost plus 25%, while Maruho has an obligation
to use commercially reasonable efforts to develop, register and commercialize Ameluz® in all countries in the Applicable Territory.
Under the license agreement, Maruho has made a one-time payment of EUR 6 million to Biofrontera AG in the previous year. Further
Biofrontera AG Annual Report 2022
73
future payments will be due upon the achievement of certain regulatory and sales milestones. Maruho will also pay royalties of
initially 6% of net sales in the countries of the scope, which may increase to 12% depending on sales volumes and will decrease in
the event of generic launches in these countries. In the reporting year, revenue from this licensing agreement was recognized for
the supply of materials for clinical trials and the recharging of associated costs.
In December 2021, Biofrontera Pharma GmbH and Maruho Ltd. agreed in a license agreement that the patent "Illumination for
photodynamic therapy" in Japan will be transferred to Maruho Ltd. The patent transfer and the resulting revenue recognition are
expected to take place in 2022. The patent transfer and the resulting revenue recognition in the amount of EUR 200 thousand took
place in 2022.
In the financial year 2022, there were no further reportable transactions or relationships with related parties other than those
mentioned above and in Note 30 and Note 31.
31. Auditor's fees and services
The total fee invoiced by the auditor for the 2022 financial years consist of:
in EUR thousands
Auditing services
[of which for the previous year]
December 31, 2022
December 31, 2021
197
[2]
426
[24]
The auditing services relate to the mandatory audits of the annual and consolidated financial statements of Biofrontera AG and
Biofrontera Pharma GmbH.
32.
Subsequent events
Extraordinary shareholders‘ meeting
At the Extraordinary General Meeting on January 09, 2023, a resolution was passed, on the one hand, on the proposal of the
Executive Board and the Supervisory Board, to increase the Company's capital stock by up to EUR 7,089,673.00 million by issuing
new shares. This ordinary capital increase is to be carried out by granting subscription rights at a subscription price of EUR 1.05.
Secondly, a proposed resolution was submitted to the Annual General Meeting for the creation of authorized capital in the amount
of EUR 12.7 million, which is intended to authorize the Board of Management to issue shares either in full or in partial amounts as
required until December 2027. Such a contingency resolution provides Biofrontera with some flexibility in raising liquidity in order
to be able to react quickly to changing market conditions or market opportunities. Both resolutions, as well as all other resolutions
presented by the management, were passed with the required majority. The capital measure is already in the planning phase, but
will not be implemented until the second quarter of 2023 due to the prospectus requirement. The proceeds from the capital
increase are to be used to pre-finance the costs of the expected increase in orders in the manufacturing area.
Legal issues
Biofrontera has decided not to appeal against the judgment of the Cologne Regional Court on the resolution on the competence of
the Annual General Meeting on the IPO of Biofrontera Inc. All former members of the Management Board and Supervisory Board
involved in the resolutions have since left the company. These persons have been notified of the dispute in this legal action. As
interveners, they are continuing the litigation in the 2nd instance on their own initiative.
Maruho Deutschland GmbH and Biofrontera Inc. have filed actions for avoidance against the resolutions of the extraordinary general
meeting, thereof Maruho Deutschland GmbH against the confirmation of the appointment of Prof. Lergenmüller to the Supervisory
Board of Biofrontera AG and Biofrontera Inc. against all resolutions of the general meeting. The action for rescission filed by
Biofrontera Inc. was withdrawn on April 13, 2023. The withdrawal of the action is part of an out-of-court settlement reached by the
Company with, among others, Biofrontera Inc. with effect from April 11, 2023 ("Inc. Agreement April 11, 2023").
74
Biofrontera AG Annual Report 2022
The Inc. Agreement April 11, 2023 further provides for the filing of a joint statement with Biofrontera Inc. for the amicable termination
of the proceedings filed by the Company in the Court of Chancery. The proceedings were directed against resolutions adopted at
the Annual General Meeting of Biofrontera Inc. on December 12, 2022.
For the further content of the Inc. agreement April 11, 2023, we refer to the announcement agreed therein pursuant to § 248a AktG.
No other events occurred after the balance sheet date.
Leverkusen, April 27, 2023
Pilar de la Huerta Martinéz
Chief Financial Officer
Biofrontera AG Annual Report 2022
75
Responsibility statement
Responsibility statement pursuant to section 297 (2) sentence 4 HGB and
section 315 (1) sentence 5 HGB
We affirm that, to the best of our knowledge and in accordance with the applicable accounting principles, the consolidated financial
statements give a true and fair view of the Group assets, financial position and results of operations of the Group and that the
combined management and group management report presents the course of business, including the business results and the
position of the Biofrontera Group and Biofrontera AG, in such a way that a true and fair view is given and that the main opportunities
and risks of the expected future development of the Biofrontera Group and Biofrontera AG are described.
Leverkusen, April 27, 2023
Biofrontera AG
Pilar de la Huerta Martínez
CFO
76
Biofrontera AG Annual Report 2021
- convenience translation –
AUDITOR'S REPORT OF THE INDEPENDENT AUDITOR
To Biofrontera AG, Leverkusen, Germany
NOTES ON THE AUDIT OF THE CONSOLIDATED FINANCIAL STATEMENTS AND THE
COMBINED MANAGEMENT REPORT
Audit Opinions
We have audited the consolidated financial statements of Biofrontera AG and its subsidiaries (the
Group), which comprise the consolidated statement of financial position as of December 31, 2022,
the consolidated statement of comprehensive income, the consolidated statement of changes in
equity and the consolidated statement of cash flows for the financial year from January 1, 2022
to December 31, 2022, and the notes to the consolidated financial statements, including a
summary of significant accounting policies. We have also audited the combined management
report of Biofrontera AG for the financial year from January 1, 2022 to December 31, 2022. The
audit procedures described in the section "Corporate Governance Statement of Biofrontera AG
pursuant
§§ Sections 289f, 315d of the German Commercial Code (HGB) for the financial year 2022" of
the annual report, we have not audited the content of the (Group) corporate governance statement
in accordance with German commercial law.
In our opinion, based on the findings of our audit:
sec.
to
the accompanying consolidated financial statements comply in all material
•
respects with IFRSs as adopted by the EU and the additional requirements of German law
pursuant to § 315e (1) HGB and give a true and fair view of the financial position of the
Group as of December 31, 2022 and of its financial performance for the fiscal year from
January 1, 2022 to December 31, 2022 in accordance with these requirements and
the accompanying combined management report as a whole provides a suitable
•
view of the Group's position. In all material respects, this combined management report is
consistent with the consolidated financial statements, complies with German legal
requirements, and suitably presents the opportunities and risks of future development .
Our audit opinion on the combined management report does not cover the content of the
aforementioned corporate governance statement pursuant to Arts. 289f, 315d HGB.
In accordance with § 322 (3) sentence 1 HGB, we declare that our audit has not led to any
reservations concerning the propriety of the consolidated financial statements and the combined
management report.
Basis for the audit judgments
We conducted our audit of the consolidated financial statements and the combined management
report in accordance with Section 317 HGB and the EU Regulation on Auditors (No. 537/2014;
hereinafter "EU-APrVO") and German generally accepted standards for the audit of financial
statements promulgated by the Institut der Wirtschaftsprüfer (IDW). Our responsibility under those
regulations and standards is further described in the section "Auditor's Responsibility for the Audit
of the Consolidated Financial Statements and the Combined Management Report" of our auditor's
report. We are independent of the Group companies in accordance with European law and
German commercial and professional regulations and have fulfilled our other German
professional obligations in accordance with these requirements. Furthermore, in accordance with
Article 10 (2) (f) EU-APrVO, we declare that we have not performed any prohibited non-audit
services as defined in Article 5 (1) EU-APrVO. We believe that the audit evidence we have
obtained is sufficient and appropriate to provide a basis for our audit opinions on the consolidated
financial statements and the combined management report.
Particularly important audit matters in the audit of the consolidated financial statements
Key audit matters are those matters that, in our professional judgment, were of most significance
in our audit of the consolidated financial statements for the fiscal year from January 1, 2022 to
December 31, 2022. These matters were considered in the context of our audit of the consolidated
financial statements as a whole, and in forming our opinion thereon; we do not provide a separate
opinion on these matters.
Biofrontera AG Annual Report 2022
77
In our view, the following matter was most significant in our audit:
•
Valuation of shares in Biofrontera Inc., Woburn, USA
We have structured our presentation of this particular key audit matter as follows:
1.
2.
3.
Facts and problem
Audit approach and findings
Reference to further information
We present this particularly important audit matter below:
Valuation of shares in Biofrontera Inc., Woburn, USA
1. In the consolidated financial statements of BIOFRONTERA AG, the shares in Biofrontera Inc.
Woburn, USA, amounting to EUR 8,982 thousand, which thus represent 27.45% of total assets,
are reported under the balance sheet item "Financial assets accounted for using the equity
method". After application of the equity method, the Company assesses whether there is
objective evidence that the net investment in the associate is impaired. In determining whether
an impairment exists, management makes assumptions about the future development of
Biofrontera Inc. and the present values of future cash flows resulting from this investment. The
result of this assessment is highly dependent on management's estimate of future cash flows
and the discount rate used, and is therefore subject to considerable uncertainty, which is why
this matter is of particular importance in the context of our audit.
2. In order to test this risk appropriately, we critically reviewed management's assumptions and
estimates and performed the following audit procedures, among others:
We have traced the methodical procedure for determining the present value of future cash
flows and assessed the determination of the discount rate used.
We have satisfied ourselves that the assumptions underlying the future cash flows and the
discount rates used, taken as a whole, provide an appropriate basis for determining the
recoverable amount of this investment.
Our assessment of the planned future cash flows was based, among other things, on a
comparison with general market expectations and management's explanations of the main
value drivers of the plans, as well as a comparison of this information with the current budgets
from the planning approved by the Supervisory Board.
Knowing that even relatively small changes in the discount rate can have a material impact
on the recoverable amount determined in this way, we considered the parameters used in
determining the discount rate and understood the Company's calculation scheme.
In our opinion,
legal
representatives, taking into account the available information, are suitable overall for testing
the determination of the recoverable amount.
the valuation parameters and assumptions applied by
the
3. The Company's disclosures on the shares in Biofrontera Inc., Woburn, USA, are included in
the notes to the consolidated financial statements in the sections "Information on the
Company," "Summary of Significant Accounting Policies" in the subsection "Principles of
Consolidation" and in the subsection "Associated Companies," in the section "Notes to the
Consolidated Balance Sheet" under "2. Investments Accounted for Using the Equity Method,"
and in the section "Notes to the Consolidated Statement of Comprehensive Income" in
subsection "23. Income from Investments.
Other information
The legal representatives and the Supervisory Board are responsible for the other information.
The other information includes:
Compensation Report in accordance with § 162 AktG,
•
all other parts of the annual report, without extensive cross-references to external
•
information, with the exception of the audited consolidated financial statements, the
audited combined management report and the auditor's report.
Our audit opinions on the consolidated financial statements and the combined management
report do not cover the other information and, accordingly, we do not express an audit opinion or
any other form of assurance conclusion thereon.
In connection with our audit, we have a responsibility to read the other information and, in doing
so, evaluate whether the other information is
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are materially inconsistent with the consolidated financial statements, the
•
combined management report or our knowledge obtained in the audit, or
•
otherwise appear to be materially misrepresented.
If, based on our work performed on the other information obtained before the date of this auditor's
report, we conclude that there has been a material misstatement of such other information, we
are required to report that fact. We have nothing to report in this regard.
Responsibility of the legal representatives and the Supervisory Board for the consolidated
financial statements and the combined management report
Management is responsible for the preparation and fair presentation of these consolidated
financial statements in accordance with IFRSs as adopted by the EU and the additional
requirements of German law pursuant to Section 315e (1) HGB and for such internal control as
management determines is necessary to enable the preparation of consolidated financial
statements that are free from material misstatement, whether due to fraud or error. Furthermore,
management is responsible for such internal control as management determines is necessary to
enable the preparation of consolidated financial statements that are free from material
misstatement, whether due to fraud or error (i.e. manipulation of the accounting system or
misstatement of assets).
In preparing the consolidated financial statements, management is responsible for assessing the
Group's ability to continue as a going concern. They are also responsible for disclosing, as
applicable, matters related to going concern. Furthermore, they are responsible for preparing the
financial statements on a going concern basis unless there is an intention to liquidate the Group
or to cease operations, or there is no realistic alternative but to do so.
In addition, management is responsible for the preparation of the combined management report
that as a whole provides a suitable view of the Group's position and is consistent in all material
respects with the consolidated financial statements, complies with German legal requirements,
and suitably presents the opportunities and risks of future development. Furthermore,
management is responsible for the arrangements and measures (systems) that it determines are
necessary to enable the preparation of the combined management report in accordance with the
applicable German legal requirements and to provide sufficient appropriate evidence for the
statements made in the combined management report.
The Supervisory Board is responsible for overseeing the Group's financial reporting process for
the preparation of the consolidated financial statements and the combined management report.
Auditor's Responsibility for the Audit of the Consolidated Financial Statements and the
Combined Management Report
Our objective is to obtain reasonable assurance about whether the consolidated financial
statements as a whole are free from material misstatement, whether due to fraud or error, and
whether the combined management report as a whole provides a suitable view of the Group's
position and is consistent, in all material respects, with the consolidated financial statements and
the audit findings, complies with German legal requirements, and suitably presents the
opportunities and risks of future development, and to issue an auditor's report that includes our
audit opinions on the consolidated financial statements and the combined management report.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted
in accordance with § 317 HGB and the EU-APrVO and in compliance with German generally
accepted standards for the audit of financial statements promulgated by the Institut der
Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from
fraud or error and are considered material if, individually or in the aggregate, they could
reasonably be expected to influence the economic decisions of users taken on the basis of these
consolidated financial statements and combined management report.
During the audit, we exercise dutiful judgment and maintain a critical mindset. In addition:
Identify and assess the risks of material misstatement of the consolidated financial
•
statements and the combined management report due to fraud or error, design and
perform audit procedures responsive to those risks, and obtain audit evidence that is
sufficient and appropriate to provide a basis for our audit opinion. The risk of not detecting
a material misstatement resulting from fraud is higher than the risk of not detecting a
material misstatement resulting from error because fraud may involve collusion, forgery,
intentional omissions, misleading representations, or the override of internal control.
Biofrontera AG Annual Report 2022
79
Evaluate the appropriateness of accounting policies used and the reasonableness
Obtain an understanding of internal control relevant to the audit of the consolidated
•
financial statements and of the arrangements and actions relevant to the audit of the
combined management report in order to design audit procedures that are appropriate in
the circumstances, but not for the purpose of expressing an opinion on the effectiveness
of those systems.
•
of accounting estimates and related disclosures made by management.
Conclude on the appropriateness of the going concern basis of accounting used
•
by management and, based on the audit evidence obtained, whether a material
uncertainty exists related to events or conditions that may cast significant doubt on the
Group's ability to continue as a going concern. If we conclude that a material uncertainty
exists, we are required to draw attention in our auditor's report to the related disclosures
in the consolidated financial statements and the combined management report or, if such
disclosures are inadequate, to modify our respective audit opinions. We draw our
conclusions based on the audit evidence obtained up to the date of our audit opinion.
However, future events or conditions may result in the Group being unable to continue as
a going concern.
we assess the overall presentation, structure and content of the consolidated
•
financial statements, including the disclosures, and whether the consolidated financial
statements represent the underlying transactions and events in such a way that the
consolidated financial statements give a true and fair view of the net assets, financial
position and results of operations of the Group in accordance with IFRSs as adopted by
the EU, and the additional requirements of German law pursuant to § 315e Abs. 1 HGB.
obtain sufficient appropriate audit evidence regarding the accounting information
•
of the entities or business activities within the Group to express opinions on the
consolidated financial statements and the combined management report. We are
responsible for directing, supervising and performing the audit of the consolidated financial
statements. We are solely responsible for our audit opinions.
we assess the consistency of the combined management report with the
•
consolidated financial statements, its legality and the overall presentation of the Group's
position in the consolidated financial statements.
We perform audit procedures on the forward-looking statements made by
•
management in the combined management report. In particular, based on sufficient
appropriate audit evidence, we reproduce the significant assumptions made by
management regarding the forward-looking statements and evaluate the appropriateness
of the information derived from these assumptions. We do not express an independent
opinion on the forward-looking statements or on the underlying assumptions. There is a
significant unavoidable risk that future events may differ materially from the forward-
looking statements.
We discuss with those charged with governance, among other matters, the planned scope and
timing of the audit and significant audit findings, including any significant deficiencies in internal
control that we identify during our audit.
We make a declaration to those charged with governance that we have complied with the relevant
independence requirements and discuss with them all relationships and other matters that may
reasonably be thought to bear on our independence and, where relevant, the actions taken or
safeguards implemented to address independence threats.
From the matters we discussed with those charged with governance, we determine those matters
that were of most significance in the audit of the consolidated financial statements of the current
period and are therefore the key audit matters. We describe these matters in our auditor's report
unless law or regulation precludes public disclosure of the matter.
OTHER STATUTORY AND OTHER LEGAL REQUIREMENTS
Report on the Audit of the Electronic Reproductions of the Consolidated Financial
Statements and the Combined Management Report Prepared for the Purposes of
Disclosure Pursuant to Section 317 (3a) of the German Commercial Code (HGB)
Audit opinion
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Biofrontera AG Annual Report 2021
above.
In accordance with Section 317 (3a) of the German Commercial Code (HGB), we have performed
a reasonable assurance audit to determine whether the reproductions of the consolidated
financial statements and the combined management report (hereinafter also referred to as "ESEF
documents") contained in the file "biofronteraag-2022-12-31-en.zip" provided and prepared for
disclosure purposes comply in all material respects with the requirements of Section 328 (1) of
the German Commercial Code regarding the electronic reporting format ("ESEF format"). In
accordance with German legal requirements, this audit extends only to the conversion of the
information in the consolidated financial statements and the combined management report into
the ESEF-format and therefore neither to the information contained in these reproductions nor to
any other information contained in the aforementioned file.
In our opinion, the reproductions of the consolidated financial statements and the combined
management report contained in the above-mentioned file and prepared for disclosure purposes
comply, in all material respects, with the electronic reporting format requirements of Section 328
(1) HGB. We have audited the accompanying consolidated financial statements and the
accompanying combined management report for the fiscal year from January 1, 2022 to January
31, 2022 in accordance with German generally accepted standards for the audit of financial
statements promulgated by the Institut der Wirtschaftsprüfer (IDW) and in our opinion set out in
the "Report on the audit of the consolidated financial statements and the combined management
report"
January 1, 2022 to December 31, 2022, we do not express any opinion on the information
included in these reproductions or on the other information included in the aforementioned file.
Basis for the audit opinion
We conducted our audit of the reproductions of the consolidated financial statements and the
combined management report contained in the above-mentioned provided file in accordance with
Section 317 (3a) HGB and IDW Auditing Standard: Audit of Electronic Reproductions of Financial
Statements and Management Reports Prepared for Disclosure Purposes in Accordance with
Section 317 (3a) HGB (IDW PS 410 (06.2022)). Our responsibility thereafter is further described
in the section "Auditor's Responsibility for the Audit of the ESEF Documents". Our auditing
practice has complied with the quality assurance system requirements of the IDW Quality
Assurance Standard: Requirements for Quality Assurance in the Auditing Practice (IDW QS 1)
applied.
Responsibility of the legal representatives and the supervisory board for the ESEF
documents
The Company's management is responsible for the preparation of the ESEF documents
containing the electronic reproductions of the consolidated financial statements and the combined
management report in accordance with section 328 (1) sentence 4 no. 1 HGB and for the award
of the consolidated financial statements in accordance with section 328 (1) sentence 4 no. 2
HGB.
Furthermore, management is responsible for such internal control as management determines is
necessary to enable the preparation of ESEF documents that are free from material non-
compliance, whether due to fraud or error, with the requirements of Section 328 (1) HGB
regarding the electronic reporting format.
The Supervisory Board is responsible for overseeing the process of preparing the ESEF
documents as part of the financial reporting process.
Auditor's Responsibility for the Audit of the ESEF Documents
Our objective is to obtain reasonable assurance about whether the ESEF documents are free
from material non-compliance, whether due to fraud or error, with the requirements of Section
328 (1) HGB. During the audit we exercise professional judgment and maintain a critical attitude.
Furthermore
identify and assess the risks of material non-compliance with the requirements of
•
Section 328 (1) HGB, whether due to fraud or error, design and perform audit procedures
responsive to those risks, and obtain audit evidence that is sufficient and appropriate to
provide a basis for our audit opinion.
Obtain an understanding of internal control relevant to the audit of ESEF
•
documents in order to design audit procedures that are appropriate in the circumstances,
but not for the purpose of expressing an opinion on the effectiveness of those controls.
Biofrontera AG Annual Report 2022
81
we assess the technical validity of the ESEF documentation, i.e. whether the file
•
provided containing the ESEF documentation complies with the requirements of
Delegated Regulation (EU) 2019/815 as amended on the reporting date regarding the
technical specification for this file.
we assess whether the ESEF documentation provides a consistent XHTML
•
representation of the audited consolidated financial statements and the audited combined
management report.
we assess whether the markup of the ESEF documents with inline XBRL
•
technology (iXBRL) in accordance with Articles 4 and 6 of Delegated Regulation (EU)
2019/815, as applicable on the reporting date, provides an adequate and complete
machine-readable XBRL copy of the XHTML rendering.
Other information according to Article 10 EU-APrVO
We were elected as auditors of the consolidated financial statements by the Annual General
Meeting on August 23, 2022. We were engaged by the Supervisory Board on October 4, 2022.
We have served as the auditors of Biofrontera AG, Leverkusen, since fiscal year 2022.
We declare that the audit opinions contained in this audit opinion are consistent with the additional
report to the Audit Committee pursuant to Article 11 EU-APrVO (Audit Report).
OTHER MATTERS - USE OF THE AUDIT OPINION
Our audit opinion should always be read in conjunction with the audited consolidated financial
statements and the audited combined management report and the audited ESEF documents. The
consolidated financial statements and combined management report converted to the ESEF
format - including the versions to be entered in the companies register - are merely electronic
reproductions of the audited consolidated financial statements and the audited combined
management report and do not replace them. In particular, the ESEF opinion and our audit opinion
contained therein can only be used in conjunction with the audited ESEF documents provided in
electronic form.
AUDITOR IN CHARGE
The auditor responsible for the audit is Dominik Nitsche."
Munich, April 27, 2023
Baker Tilly GmbH & Co KG
Auditing firm
(Düsseldorf)
Weissinger Nitsche
WirtschaftsprüferAccountant
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Biofrontera AG Annual Report 2021