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Biofrontera AG

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Employees 51-200
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FY2022 Annual Report · Biofrontera AG
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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.  

II 

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.  

IV 

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 

V 

 
 
 
 
 
 
 
 
 
 
 
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 

VI 

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.  

VIII 

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 

IX 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 

X 

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:  

XII 

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. 

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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 

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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 

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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 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.  

30 

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 

32 

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  

78 

Biofrontera AG Annual Report 2021 

 
 
  
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.  

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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.  

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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