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Biofrontera AG

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Employees 51-200
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FY2023 Annual Report · Biofrontera AG
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Content 

Biofrontera AG – Annual Report 2023 

Key figures 2023 

Letter to shareholders 

Report of the Supervisory Board of Biofrontera AG for 
the financial year 2023 (unaudited) 

Corporate Governance Statement of Biofrontera AG 
pursuant to Sections 289f, 315d HGB for the financial 
year 2023 (unaudited) 

Compensation Report 

Consolidated management and group management 
report for the fiscal year 2023 

Consolidated balance sheet as of December 31, 2023 

Consolidated statement of comprehensive income for 
the fiscal year 2023 

Consolidated statement of changes in equity for the 
fiscal year 2023 

Consolidated cash flow statement for the fiscal year 
2023 

Notes to the consolidated financial statements as of 
December 31, 2023 

Responsibility statement 

Independent Auditor's Report 

III 

VI 

VIII 

XIII 

XIV 

1 

38 

40 

41 

42 

43 

77 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Our skin is a living diary that records every experience, every sunbath, and every 
environmental stress - even if they seem unnoticeable to us at the moment.  

Like a chronicle of life, the damage our skin has been exposed to is not necessarily 
obvious in the present.  

The skin never forgets; it stores the history of our dealings with it. And sometimes it 
is the inconspicuous times of yesterday that require our attention today. 

Biofrontera AG Annual Report 2023 

3 

 
 
 
 
 
 
MEMORIES FADE 
OUR SKIN FORGETS NOTHING… 

Our skin, as an extremely complex and adaptive organ, is a memory of past stresses and exposures. 
Although it may appear intact at present, it carries the memory of past sun exposure, environmental 
factors, and age-related influences. This hidden archive of past damage may later manifest as 
dermatological irregularities. 

With increasing environmental pollution and changing lifestyles, the skin is under increasing stress, 
leading to a growing prevalence of skin diseases.  

It is important to keep a close eye on your skin and react to any changes at an early stage. Early 
detection of skin abnormalities plays a crucial role in successful treatment. The earlier problems are 
detected, the better the chances of recovery and the gentler the treatment can be. 

Biofrontera has established itself as a pioneer in the field of photodynamic therapy. Many years of 
research and development have resulted in innovations that are tailored to the individual needs of 
patients.  

Our goal is to preserve the health of your skin, consolidate the role of photodynamic therapy and position 
Biofrontera as an indispensable expert in the treatment of white skin cancer. 

PDT AT A GLANCE 

CLEANING OF THE AFFECTED 
SKIN AREA AND 
APPLICATION OF THE 
AMELUZ® GEL. 

AFFECTED CELLS ABSORB THE 
ACTIVE INGREDIENT WITHIN 
THE EXPOSURE TIME AND 
CONVERT IT INTO AN LIGHT-
ACTIVATABLE MOLECULE. 

THE TREATED SKIN AREA IS 
EXPOSED TO AN ACTIVATING 
LIGHT SOURCE (DAYLIGHT, 
ARTIFICIAL DAYLIGHT, RED LIGHT 
LAMP). 

LIGHT ACTIVATES THE ACTIVE 
INGREDIENT; DISEASED CELLS 
ARE DESTROYED AND THE 
TREATED SKIN AREA HEALS 
WITHOUT SCARRING. 

4 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
OPERATIVE HIGHLIGHTS 2023

JANUARY 

Start of phase III clinical trial in the US for the treatment of 
actinic keratosis on the extremities, neck and trunk with 
Ameluz®-PDT 

MAY 

US patent granted for an innovative photodynamic treatment 
protocol 

JULY 

Launch of belixos® ACTIVE CARE, an innovative cosmetic foam 

AUGUST 

Completion of patient enrollment in pivotal study of 
Ameluz®-PDT for the treatment of basal cell carcinoma 

II 

Biofrontera AG Annual Report 2023 

 
AUGUST 

Positive results of Phase I safety study investigating 
photodynamic therapy with three tubes of Ameluz® 

OCTOBER 

U.S. Food and Drug Administration (FDA) approval of an optimized 
formulation of Ameluz® for the treatment of actinic keratosis 

NOVEMBER 

Significant increase in German revenues with growth of nearly 
50% compared to the first nine months of last year 

DECEMBER 

EMA recommendation for label extension of Ameluz® for the 
treatment of actinic keratosis with artificial daylight 

Recommendation of the EMA for a variation to the marketing 
authorization for an improved Ameluz® formulation 

II 

Biofrontera AG Annual Report 2023 

 
 
Key figures in accordance with IFRS 

01.01.-31.12.2023 

01.01.-31.12.2022 

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 

Balance sheet key figures 

Total assets 

Non-current assets 

Cash and cash equivalents 

Other current assets 

Total equity and liabilities 
Equity 

Non-current liabilities 
Current liabilities 

Number of employees 

Biofrontera Shares 

Number of shares outstanding 
Share price (Xetra closing price in EUR, Dec 29, 2023) 

32,249 

26,005 

4,782 

5,923 

5,132 

(2,127) 
(369) 

100.00% 

80.64% 

14.83% 

18.37% 

15.91% 

(6.60)% 
(1.15)% 

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)% 

December 31, 2023 

December 31, 2022 

30,732 

13,012 

3,080 

14,641 

19,980 

678 
10,073 

32,725 

17,669 

6,376 

8,680 

20,336 

4,002 
8,387 

December 31, 2023 

December 31, 2022 

95 

0 

0 

63,807,058 
0.400 

110 

0 

0 

63,807,058 
1.53 

Biofrontera AG Annual Report 2023 

III 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-financial key performance indicators 

Employees   

110

64% 

95

63% 

37% 

36% 

2023

2022

2023

2022

Quality management 

Percentage of women at management level 

56% 

73% 

2022

2023

Standard operating procedures 

Trainings and audits/inspections 

699 

803 

2022

2023

Internal inspections

94 

97 

Audits/inspections

16 

16 

External trainings

40 

48 

4 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
Sustainability as a future performance indicator 

The sustainability of our business activities has a significant impact on the environment, society, and our social interaction. We are 
aware of this responsibility and consider the impact of our actions on present and future generations. Our goal is to balance the 
economic interests of the company with the demands of sustainability through value creation. 

Improved patient care is our goal 

At Biofrontera, we are committed to skin health and want to use our products to improve the quality of life of people with  sun-
induced skin cancer. It is essential that patients have access to this effective therapy. To this end, Biofrontera, together with its 
distribution  partners,  aims  to  promote  photodynamic  therapy  worldwide  as an effective  solution for  sun-induced  forms of  skin 
cancer and to open up new indications through further research and development. 

Employees as our most important asset 

Our employees carry our company. Their high level of qualification and extraordinary commitment have made Biofrontera what it is 
today. From a very early stage, we at Biofrontera have supported our employees but also challenged them in a rapidly changing 
market  environment.  Employee  development  has  therefore  always  been  a  focus  of  the  company  and  is  now  complemented  by 
significantly more flexible working models. In addition, communication with employees is extremely important to us, which is  why 
employee feedback is given high priority as part of the annual performance appraisal. It is planned to include these results among 
the most important performance indicators so that employee commitment becomes a key performance indicator.  

Ensuring product quality 

We must ensure that our products meet all regulatory requirements and are suitable for their intended use. Biofrontera is therefore 
committed to maintaining a quality management  system  and continuously monitoring its  effectiveness. The  aim is to minimize 
manufacturing  errors  and  possible  risks  to  users  and/or  patients  regarding  safety,  quality  and  efficacy.  To  this  end,  market 
information  and  changes  in regulatory  requirements  are  continuously  evaluated  to  adapt  our  products to  customer  needs  and 
regulatory requirements. In order to do this in the best possible way, Biofrontera strives for fair, open and long-term cooperation 
with  customers,  business  partners,  suppliers  and  regulatory  authorities.  Equally  important  is  a  clearly  defined  organizational 
structure  and  process  organization  that  specifies  who,  when  and  how  quality  assurance  tasks  are  to  be  performed.  With  this 
approach, we not only fulfill the regulatory requirements of the industry, but also ensure that quality is actively practiced in our 
company. 

Biofrontera AG Annual Report 2023 

V 

 
The past year was characterized by significant developments and strategic milestones for Biofrontera. We have further consolidated 
our position as a leading biopharmaceutical company in the field of photodynamic therapy, expanded our market presence and at 
the same time strengthened the company's profitability. 

With the separation of Biofrontera Inc., Biofrontera AG has taken the opportunity to focus more strategically and with all available 
resources on the European business, to realign itself in terms of costs and thereby increase profitability.  

Our focus is clearly on expanding our sales activities in Europe and this is where we want to continue to direct our greatest efforts. 
This year's extremely positive results confirm the effectiveness of this strategic approach.  

We are proud of the new sales records in Germany, where we have grown sales by 31% compared to the previous year. The significant 
jump in sales in the German market impressively demonstrates that we dominate the photodynamic therapy market. Through the 
continuous further development of Ameluz®, we offer our patients and customers a product that we are constantly adapting to the 
changing requirements of the market and patients Biofrontera is recognized as an expert in this field and is accepted as a leading 
innovator in the market thanks to various approval extensions. In Germany, we were able to grow sales; while at the same time 
taking  an  extremely  sensitive  approach  to  costs,  so  that  the  operating  profit  achieved  in  our  home  market  in  particular  grew 
significantly. This is an indicator of future developments in Europe, where we grew by 20% across Europe as a whole.  

In view of the complex regulatory environment in the pharmaceutical industry, which influences the cost structure, it is crucial to 
carefully examine how we can both strengthen our revenue side and find more efficient solutions on the cost side. By taking this 
strategic approach, we intend to diversify our remaining dependence on the US market in the long term and thus place Biofrontera's 
business risks on a broader basis.  

Despite challenging market conditions, we are pleased that Biofrontera achieved a solid financial result in the 2023 financial year. 
We were able to increase total sales by 25% compared to the previous year. With total sales of EUR 32.2 million, we are in the upper 
third of our forecast and our targeted EBITDA of EUR 5.9 million is also well above the forecast range. 

In addition to the financial successes, we can also look back on a number of achievements in the regulatory area and in clinical 
development. We have finally been able to complete patient recruitment in the clinical trial for the extension of approval to basal 
cell carcinoma and the safety study on the use of 3 tubes of Ameluz® has now also been successfully completed. Both approval 
extensions  are  important  for  the  US  market  and  can  support  our  market  penetration  there.  The  approval  application  for  the 
extension to 3 tubes of Ameluz® was submitted to the FDA in the USA as early as December 2023. The extension of the European 

VI 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
approval to include the use of artificial daylight provides new momentum for our European market expansion. A major campaign 
was initiated at the beginning of this year to promote this even broader range of applications for Ameluz®. 

In summary, the development of Biofrontera AG was extremely positive, although this positive momentum was unfortunately not 
reflected in the share price. The uncertainty in the business development of our US licensee certainly contributed to this, causing 
considerable  uncertainty  in  the  market.  It  is  therefore  of  fundamental  importance  that  we  gradually  free  ourselves  from  this 
dependence on Biofrontera Inc. The reorganization of the license agreement between the two companies is a significant step in this 
direction. With the reorganization of clinical development, we are now significantly reduced in terms of costs and Biofrontera Inc. 
can manage clinical development independently and in line with market conditions.  

However, 2024 will be a very challenging year for Biofrontera AG, as our US licensee has built up an extensive stock of Ameluz® in 
the past year and will now monetize this stock in a liquidity-preserving manner, so that we will receive noticeably fewer orders. 
However, with Biofrontera Inc. as our most important customer, any change in their business behavior will have a significant impact 
on our business. 

We will therefore have to react to this with strict cost control in order to keep Biofrontera AG in the EBITDA break-even range. The 
expected decline in Ameluz® purchases by Biofrontera Inc. will significantly reduce our sales level in 2024 and thus burden our 
liquidity situation. For this reason, it is crucial for the company to carry out a moderate capital increase. 

Due to our share price below nominal value, it was technically not feasible for us to carry out a capital increase. With the 21:1 reverse 
split approved at the Extraordinary General Meeting in April, we can now stabilize our share price above nominal value. 

With the subsequently resolved capital measure and the signed back-stop agreement with one of our major shareholders, we now 
see ourselves in a position to raise the required capital in a timely manner. 

Over decades, Biofrontera has created structures, networks, and values that we want to develop further with commitment and care. 
Over  the  past  two  years,  far-reaching  restructuring  has  taken  place in Biofrontera's  management,  shareholders,  and  corporate 
structure. The results achieved during this time show that we are on a promising and, in particular, profitable path. 

I would like to thank all our employees, consultants and cooperation partners who have supported us throughout this time. None of 
our goals could be achieved without the  efforts and good work of our employees. And  of course I  would also like to thank our 
shareholders, who are a key element in the future success of the company. 

Together, let us continue to develop Biofrontera to realize the potential that we may not have been able to fully address in the past. 
I remain convinced that, as a small pharmaceutical company, we can compete successfully with the global players. This is because 
we drive innovation, can react flexibly to market changes and, above all, are firmly convinced of the quality and potential of our 
product. 

I would be delighted if you would accompany us on this journey. 

Pilar de la Huerta Martínez 

Chief Financial Officer Biofrontera AG

Biofrontera AG Annual Report 2023 

VII 

 
 
 
 
Report of the Supervisory Board of Biofrontera AG for the financial 
year 2023 (unaudited) 

Dear Shareholders, 

The fiscal year 2023 shows a positive operating result for Biofrontera AG. With further cost reduction measures and a clear focus on 
growth-promoting initiatives, we aim to continue supporting this development in the future. The Supervisory Board collaborates 
closely with each other and with the management team in a spirit of trust. 

We extend our thanks to the Executive Board and the employees for their contributions, which have supported the development of 
Biofrontera AG in the past fiscal year. 

Supervision and Consultation 

The Supervisory Board fulfilled its duties as stipulated by law, the Articles of Association, the German Corporate Governance Code 
(Code), and the rules of procedure. Its activities included overseeing and advising the Executive Board in the management of  the 
Company and the Group. The Supervisory Board discussed business decisions and plans with the Executive Board. 

The Executive Board provided reports to the Supervisory Board on the Company's situation. The Supervisory Board was informed by 
the Executive Board about the company's development both in meetings and outside of meetings. Based on written and oral reports 
from  the  Executive  Board,  the  Supervisory  Board  discussed  the  business  development  and  the  company's  situation  in  its 
deliberations. Additionally, there was an exchange of information and ideas between the Executive Board and the Chairman of the 
Supervisory Board. 

The Supervisory Board also reviewed the legality, regularity, appropriateness, and economic efficiency of management measures. 
The division of the operational activities of the Biofrontera  Group into an independent  US sales company  on one  hand and the 
(former) parent company Biofrontera AG on the other hand, which took place at the end of 2021, is still not optimal in the view of the 
Supervisory Board for the Biofrontera AG Group. A restructuring with the aim of reuniting the operational activities is currently not 
feasible from the Supervisory Board's perspective, at least not in the short term. 

Deviation of business performance from the plans was explained to the Supervisory Board by the Executive Board and discussed 
with them. It was also examined to what extent the legal requirements and the decisions, suggestions, and recommendations of the 
Supervisory Board were considered or implemented by the Executive Board in business management. 

The Supervisory Board made decisions on specific measures after reviewing relevant information and documents and consulting. 

Meetings and their Focus of Discussion 

In fulfilling its duties, the Supervisory Board held eight meetings during the reporting year. One meeting was held in person, while 
all other meetings were conducted via telephone or video conferences. 

During the meetings, the Executive Board reported on the current business situation. In particular, the Executive Board explained 
the liquidity position of the Company in the context of sales forecasts and cost planning. 

In the meeting on March 6, 2023, the Supervisory Board approved the budget for 2023 after intensive discussion with the Executive 
Board. 

The auditor reported to the Audit Committee and the Supervisory Board in full at the meeting on April 24, 2023, on the timing, 
structure, and results of the audit for the fiscal year 2022. 

After discussing the financial statements for 2022, the consolidated financial statements, and the consolidated management report, 
the Supervisory Board approved the auditor's reports in the meeting on April 27, 2023, without objections after the final results of 
its own review and approved the annual financial statements of the Company and the Group. It followed the recommendation of its 

VIII 

Biofrontera AG Annual Report 2023 

 
 
 
Audit Committee, which had previously held a meeting in the presence of the auditor and discussed the annual financial statements 
for 2022, the consolidated financial statements, the consolidated management report, and the audit reports. 

In the  meeting  on June 20,  2023, the Executive Board presented  a  market  analysis for  extending  the distribution of Ameluz to 
additional European countries with business cases. In addition, risks of the business planning of Biofrontera Inc. were discussed, and 
action options in the event of a decline in order intake and payments from Biofrontera Inc. were debated. 

In the meeting on September 8, 2023, the Executive Board presented liquidity plans for various scenarios of reduced product sales 
and resulting declines in payments from Biofrontera Inc. 

In the meeting on October 4, 2023, the Executive Board presented and discussed updated liquidity plans. 

In the meeting on November 2, 2023, a capital increase conducted by Biofrontera Inc. and a possible amendment to the licensing 
and  supply  agreement  with  Biofrontera  Inc.  were  discussed.  The  Supervisory  Board  noted  an  analysis  and  confirmation  of  the 
plausibility of the Company's liquidity planning conducted by an auditing firm. 

In the meeting on December 7, 2023, the Supervisory Board discussed the budget for 2024 with the Executive Board. The Executive 
Board and the Supervisory Board thoroughly examined the financial situation and potential existing risk factors. The budget was 
then approved by circular resolution. A future deviation as a whole from the German Corporate Governance Code was discussed and 
approved by subsequent circular resolution. The possibility of exempting Biofrontera Pharma GmbH from the obligation to prepare 
and audit individual financial statements for the fiscal year 2023 in accordance with § 264 paragraph 3 sentence 1 no. 1 HGB  by 
providing a parent company guarantee was discussed and approved by subsequent circular resolution. 

Decisions outside of Meetings 

Outside  of  meetings,  the  Supervisory  Board  made  decisions  in  13  parallel  proceedings,  including  decisions  on  Executive  Board 
matters, legal issues, and matters related to the Annual General Meetings in the fiscal year 2023. 

Committees of the Supervisory Board 

In the fiscal year 2023, there was an Audit Committee, a Nomination and Personnel Committee, and a Litigation Committee regarding 
the proceedings of Deutsche Balaton AG  against  Biofrontera AG.  The Supervisory Board  appointed one member to serve as the 
chairman of each committee. 

According to the rules of procedure of the Supervisory Board, the Chairman of the Supervisory Board is also the chairman of the 
committees  dealing  with  Executive  Board  contracts  and  preparing  Supervisory  Board  meetings.  Although  the  Chairman  of  the 
Supervisory Board was not the chairman of the Nomination and Personnel Committee, which deals with Executive Board contracts, 
in the fiscal year 2023,  he  was a member  of this committee. The  Supervisory Board considers this deviation from the  standard 
regulation of the rules of procedure to be inconsequential. The Chairman of the Supervisory Board should not hold the chairmanship 
of the Audit Committee, which was also not the case. The chairpersons of the committees’ report on the work of the committees in 
Supervisory Board meetings, except for the Litigation Committee. 

1. 

Audit Committee 

The Audit Committee deals in particular with questions of accounting and risk management, the necessary independence 
of the auditor, and the assignment of the audit mandate to the auditor and monitors the audit of the Company's annual 
financial  statements.  The  committee  met  eight  times  during  the  reporting  year,  with  all  meetings  held  as  video 
conferences. 

The  members  of  the  Audit  Committee  during  the  reporting  year  were:  Mr.  Karlheinz  Schmelig  (Chairman),  Dr.  Helge 
Lubenow, Dr. Jörgen Tielmann (January 1, 2023, to July 4, 2023), and Prof. Dr. Karin Lergenmüller (July 5, 2023, to December 
31, 2023). 

2.  Nomination and Personnel Committee 

The Nomination and Personnel Committee prepares, among other things, decisions of the Supervisory Board regarding 
the appointment and dismissal of Executive Board members. Since the Supervisory Board is ultimately responsible for 
compensation decisions, the Personnel Committee also acted preparatory in this regard.  

Biofrontera AG Annual Report 2023 

IX 

 
The Nomination and Personnel Committee represented the company in the legal dispute with the former Chief Financial 
Officer, Mr. Lutter.  
The  Nomination  and  Personnel  Committee  met  twice  during  the  reporting  period;  all  meetings  were  held  as  video 
conferences. In addition to these formal meetings of the Nomination and Personnel Committee, there was at least monthly 
informal exchange among committee members. 
The  members  of  the  Nomination  and  Personnel  Committee  during  the  reporting  period  were:  Dr.  Helge  Lubenow 
(Chairwoman), Mr. Wilhelm K.T. Zours, and Dr. Heikki Lanckriet. 

3.  Other Committees 

Reference is made to the section "Conflicts of Interest" below. 

Individualized Disclosure of Attendance of Supervisory Board Members at Supervisory Board and 
Committee Meetings in the Fiscal Year 2023 

Name  

Dr. Heikki Lanckriet  
Dr. Helge Lubenow  
Karlheinz Schmelig  
Prof. Dr. Karin Lergenmüller 
Dr. Jörgen Tielmann 
Wilhelm K. T. Zours 

Board Meetings 
Attendance  
8/7 
8/7 
8/8 
8/8 
8/8 
8/8 

Presence in % 

87.5% 
87.5% 
100% 
100% 
100% 
100% 

Committee Meetings 
Attendance 
2/2 
10/10 
8/8 
2/2 
6/6 
2/2 

Presence in % 

100% 
100% 
100% 
100% 
100% 
100% 

Annual and Consolidated Financial Statements 2023 

Baker Tilly GmbH & Co. KG Wirtschaftsprüfungsgesellschaft, Düsseldorf, was appointed as the auditor for the annual and consolidated 
financial  statements  for  the  fiscal  year  2023  by  the  ordinary  Annual  General  Meeting  on  June  20,  2023,  and  subsequently 
commissioned  by  the  Supervisory  Board.  The  auditor's  independence  declaration  was  obtained.  Baker  Tilly  GmbH  &  Co.  KG 
Wirtschaftsprüfungsgesellschaft, Düsseldorf, audited the annual and consolidated financial statements of Biofrontera AG prepared 
by the Management Board and the summarized management report for the 2023 fiscal year and issued unqualified audit opinions. 
The auditor also confirmed that the Management Board had established an adequate information and monitoring system that is 
suitable in its design and application for the early detection of developments endangering the continued existence of the company. 

The  consolidated  financial  statements  were  prepared  based  on  International  Financial  Reporting  Standards  (IFRS).  The  audit 
documents  were discussed in the Audit Committee on April 29, 2024, in the presence of the  auditor and  other  members of the 
Supervisory Board. During this meeting, the annual and consolidated financial statements were also discussed with the Management 
Board. In this context, the Audit Committee dealt in particular with the key audit matters described in the respective auditor's report, 
including the audit procedures performed. The audit documents were discussed in the presence of the auditor. All Supervisory Board 
members received the audit documents and the auditor's reports before this meeting and reviewed these documents. The auditor 
reported  on  the  audit,  commented  on  the  audit  focus  areas,  and  was  available  to  the  Supervisory  Board  for  questions  and 
information. The auditor also reported on the scope, focus areas, and key findings of the audit, focusing in particular on the key 
audit matters and the audit procedures performed. Questions from the Supervisory Board were answered by the Management Board 
and the auditor. The auditor also reported on his findings regarding internal control and risk management relating to the financial 
reporting process. 

In its balance sheet meeting on April 29, 2024, the Supervisory Board duly noted the audit reports, the annual and consolidated 
financial  statements,  and  the  summarized  management  report.  After  discussing  the  annual  financial  statements,  consolidated 
financial statements, and the summarized management report, the Supervisory Board approved the auditor's reports and the results 
of  the  audit,  raised  no  objections  after  the  final  result  of  its  own  review,  and  approved  the  annual  and  consolidated  financial 
statements. The annual financial statements of Biofrontera AG were thereby adopted. 

X 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
The present report of the Supervisory Board was adopted at the balance  sheet meeting on April 29, 2024, as was the corporate 
governance statement. 

Auditor and Responsible Auditor 

Baker Tilly GmbH & Co. KG Wirtschaftsprüfungsgesellschaft, Düsseldorf, has served as the auditor for Biofrontera AG and the Group 
for the fiscal year 2023 for the second consecutive year. 

Corporate Governance and Declaration of Compliance in accordance with § 161 AktG 

Information  on  corporate  governance  is  presented  in  the  annual  report  and  on  the  Internet  at  www.biofrontera.com  under 
"Investors" / "Corporate Governance" and in the corporate governance statement. In particular, details regarding the objectives of 
the Supervisory Board regarding its composition and the status of implementation are provided there. 

Conflict of Interest 

Every member of the Supervisory Board is obligated to act in the best interest of the company. They must not pursue personal 
interests or utilize business opportunities that belong to the company without the approval of the Supervisory Board. The Rules of 
Procedure of the Supervisory Board stipulate that each member must disclose any conflicts of interest to the Supervisory Board. 
This is especially relevant in cases where conflicts of interest may arise due to consulting or organizational positions with clients, 
suppliers, lenders, or other business partners. Significant and not merely temporary conflicts of interest involving a member of the 
Supervisory Board should lead to the termination of their mandate. 

On December 13, 2021, Deutsche Balaton AG, Heidelberg, filed a declaratory action against Biofrontera AG at the Cologne District 
Court, which was decided on December 9, 2022, by the Cologne District Court. Mr. Wilhelm K.T. Zours indirectly holds the majority of 
shares in Deutsche Balaton AG through VV Beteiligungen AG and is Chairman of the Supervisory Board of Deutsche Balaton AG. There 
is a domination agreement between VV Beteiligungen AG and Deutsche Balaton AG. Since December 14, 2021, Mr. Zours has also been 
a member of the Supervisory Board of the company and its chairman. The essence of the lawsuit was that Deutsche Balaton AG 
maintains  the  view,  shared  by  the  Cologne  District  Court  in its judgment,  that  the  IPO  of  Biofrontera  Inc.  together  with capital 
measures required the approval of the Biofrontera AG General Meeting. The lawsuit was directed against Biofrontera AG, represented 
by the Management Board and represented by the Supervisory Board. Upon learning of the lawsuit, the Supervisory Board decided 
to form a committee in this context, and the following members of the Supervisory Board were appointed to the committee: Mr. 
Jörgen  Tielmann  (Chairman),  Mr.  Karlheinz  Schmelig,  and  Dr.  Helge  Lubenow.  The  lawsuit  committee  did  not  meet  during  the 
reporting period as no decisions needed to be made. 

Mr. Zours therefore did not participate in consultations and decision-making related to the lawsuit. 

From the perspective of the Supervisory Board, the conflict of interest has been appropriately addressed. Also, from a retrospective 
perspective, it cannot be determined that it was a significant and not merely temporary conflict of interest that would have required 
termination of the mandate. 

Changes in the Supervisory Board 

The  composition  of  the  Supervisory  Board  remained  unchanged  during  the  reporting  period.  The  major  shareholder  Maruho 
Deutschland GmbH withdrew its action against resolutions of the General Meeting on August 23, 2022, and the Extraordinary General 
Meeting on January 9, 2023, on July 4, 2023. Thus, the resolution-related election of Prof. Dr. Lergenmüller to the Supervisory Board 
is finally legally effective. The withdrawal of the action is part of an out-of-court settlement, which also resolved a dispute over 
potential loss of voting rights by Maruho Deutschland GmbH at past General Meetings and agreed on a procedure to avoid loss of 
voting rights at future General Meetings. 

Composition of the Management Board 

The composition of the Management Board remained unchanged during the reporting period. 

Former Chief Financial Officer Mr. Ludwig Lutter claimed further payment claims from his Executive Board service contract during 
the reporting period. The Cologne District Court awarded Mr. Lutter an amount of TEUR 250 in a decision delivered to the company 
on March 22, 2024, taking into account the income Mr. Lutter stated to have earned elsewhere. 

Biofrontera AG Annual Report 2023 

XI 

 
Since September 2022, the current sole Management Board member, Ms. Pilar de la Huerta Martinez, has been appointed as Chief 
Financial Officer. Ms. Pilar de la Huerta has been active as CEO and CFO of various technology companies in the pharmaceutical and 
healthcare sector for over 25 years, thus possessing relevant industry experience and high professional qualifications. 

The Supervisory Board thanks Ms. de la Huerta for her high commitment to the company during a challenging phase of business 
development and for the trusting cooperation. 

Future 

Even if Biofrontera AG is able to report a positive operating result for the 2023 financial year, we must not overlook the fact that we 
continue to form a "community of fate" with Biofrontera Inc. even though we only hold less than 8% of the shares in Biofrontera 
Inc. due to highly dilutive capital increases and this company is reporting high losses. The economic success of Biofrontera AG in 
the future will continue to depend to a large extent on the sales success of Biofrontera Inc. on the US market. Biofrontera AG can 
only continue to develop positively if Biofrontera Inc. can further increase its sales and reduce its costs relative to sales with the 
funds required to break even with Biofrontera Inc. The share of the US market in total sales of the product Ameluz is expected to 
remain high, as is the dependence of Biofrontera AG's earnings on the success of Biofrontera Inc. 

In February 2024, an agreement was concluded with Biofrontera Inc. to change the business relationship between the two companies. 
Biofrontera AG will focus on the utilization of its existing projects and know-how, while research and development will no longer be 
the focus of its activities. This change in strategy and the amended contract with Biofrontera Inc. as the company's largest customer 
will have a significant impact on the structure of sales and costs, both of which will be reduced. The sales of Biofrontera AG will be 
reduced in the next few years due to the reduction in the percentage of the revenue share in US sales with Ameluz; this will be offset 
by lower costs for the AG due to the assumption of the costs of Clinical Trials by Biofrontera Inc.  

The performance of the Biofrontera share was also unsatisfactory in 2023. In the coming period, the Supervisory Board and the 
Management Board will continue to work constructively and with a focus on results to improve the economic situation of Biofrontera 
AG and its valuation on the capital market.  

Finally, we would again like to thank you, our shareholders, for your patience, your trust and your willingness to support the company 
in future capital increases! 

Heidelberg, April 2024 

Wilhelm K. T. Zours  
Chairman of the Supervisory Board  

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Biofrontera AG Annual Report 2023 

 
 
 
 
 
Corporate Governance Statement of Biofrontera AG pursuant to 
Sections 289f, 315d HGB for the financial year 2023 (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 2023 in the (combined) management report for the financial year  2023, 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. 

Biofrontera AG Annual Report 2023 

XIII 

 
 
 
 
 
Compensation Report 

Remuneration system for the members of the Management Board: 

Principles of the system for the remuneration of the members of the Executive Board of Biofrontera AG 

The compensation system for the executive board aims to appropriately remunerate the executive board members in line with their 
duties and responsibilities, taking into account the performance of each board member as well as the success of the company. The 
structure of the compensation system for the executive board of Biofrontera AG aims at sustainable increase of the company's value 
and performance-oriented corporate management. The compensation system is effective from December 2021 for new contracts 
and contract extensions. The performance of the executive board members is adequately considered through appropriately and 
ambitiously  set  performance  criteria  within  the  variable  compensation components  (Pay  for  Performance). The  current  market 
practices are taken into account in designing the compensation system. 

In  determining  the  compensation  levels  and  the  compensation  system,  the  Supervisory  Board  generally  follows  the  following 
guidelines: 

▪ 
▪ 
▪ 

▪ 

▪ 

The compensation system significantly contributes to promoting the business strategy as a whole. 
In particular, the variable compensation components should be linked to the achievement of strategic objectives. 
The compensation system and the performance criteria of its variable components incentivize long-term and sustainable 
development of the Biofrontera Group. 
The strategic objectives formulated within the framework of the variable compensation components should ensure long-
term and sustainable growth of the company. 
To  ensure  long-term  developments,  variable  compensation  components  with  a  multi-year  character  should  further 
contribute, aligning with the share price performance of Biofrontera AG and thus linking compensation to profit growth 
and shareholder interests. 

The compensation system consists of: 

▪ 

▪ 

▪ 

a fixed basic remuneration, payable monthly, which takes into account the tasks and performance of the members of the 
Executive 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 goals for short- and long-term variable compensation are derived from the corporate strategy of Biofrontera AG. In 
addition, customary fringe benefits are provided.  

Overall, the remuneration thus contributes to the long-term development of the company. 

Target Total Compensation 

The target total compensation for each board member results from the base salary, the short-term variable compensation, and the 
long-term variable compensation at 100% target achievement.  

In accordance with the compensation system, the Supervisory Board determines the level of target total compensation for each 
board member.  

In doing so, it takes into account not only an appropriate relationship to the duties and performances of the board member but also 
the economic situation as well as the success and future prospects of the company. The Supervisory Board ensures that the target 
total compensation does not exceed the customary compensation without special reasons. 

The assessment of market conformity is carried out both horizontally (external comparison/peer group comparison) and vertically 
(internal comparison). 

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Biofrontera AG Annual Report 2023 

 
 
Horizontal Comparison 

The selection of the comparison group for assessing the market conformity of total compensation is based on the requirements of 
the Stock Corporation Act (especially industry and size as well as international orientation).  

The composition of the comparison group is generally determined, as far as ascertainable, on the one hand from a comparison group 
of publicly traded companies in terms of revenue, EBIT, number of employees, and market capitalization. Furthermore, the selection 
of the comparison group is made, as far as ascertainable, from a comparison group of publicly traded industry companies. 

Vertical Comparison 

The  compensation  and  employment  conditions  of  the  employees  are  taken  into  account  within  the  framework  of  the  vertical 
comparison outlined below. 

Components of Compensation in Detail 

Fixed Compensation Components 

The fixed compensation components granted to the members of the Executive Board under the compensation system include the 
base salary and fringe benefits. The members of the Executive Board do not receive any pension commitments. 

Basic remuneration 

The Executive Board members receive the base salary, which is paid out in twelve equal parts monthly. 

Fringe Benefits 

Fringe benefits are granted based on employment contracts with individual members of the Executive Board and may include, for 
example,  the  following:  private  use  of  company  cars,  special  payments  such  as  payment  of  school  fees,  housing,  rental,  and 
relocation  expenses,  contributions  to  pension  insurance  (excluding  pension  commitments  as  outlined  here),  contributions  to 
accident, life, and health insurance, or other insurances. Fringe benefits may be granted once or repeatedly. The annual value of 
fringe benefits should not exceed 10% of the annual base salary. 

Short-Term Variable Compensation (Short Term Incentives; "STI") 

Members of the Executive Board are entitled to short-term variable compensation, which can result in an annual bonus payment. 
The short-term variable compensation is linked to the achievement of performance goals, the specific target values of which are 
agreed upon at the end of a fiscal year. 

The due date for STI payment generally occurs one month after the approval of the annual financial statements and consolidated 
financial  statements  for  the  respective  fiscal  year  by  the  Supervisory  Board  of  the  Company.  If  the  Company  terminates  the 
employment relationship for good cause within the meaning of § 626 of the German Civil Code (BGB), the STI payment for the fiscal 
year in which the termination becomes effective is forfeited. 

Target Amounts 

Target amounts are agreed upon with the Executive Board in the employment contracts, which are granted to them upon 100% 
achievement of the goals ("STI target amounts"). The amount of STI target amounts should not exceed 50% of the base salary at 
100% target achievement. The amount of short-term variable compensation depends on the degree of achievement of the agreed 
goals and can range between 0% and 200%. The exact payout is determined by multiplying the degree of goal achievement by the 
STI target amount of each Executive Board member. In case of exceeding the target, an increase up to a maximum of 200% of the 
STI target amount (cap) takes place. If the target is achieved up to 70%, the short-term variable compensation is reduced linearly; 
if the target achievement is less than 70%, the STI payment is completely waived. 

Performance Goals 

In determining the annual target agreement, the Supervisory Board aligns with the following performance goals: 

The assessment criteria for STI include financial and non-financial performance criteria, which are agreed upon in a target agreement 
at the end of each fiscal year for the following fiscal year. If no agreement is reached between the Executive Board member and the 
Supervisory Board, the Supervisory Board decides on the determination of the assessment criteria at its reasonable discretion. 

Financial performance criteria should include, besides the company's revenue, financial indicators such as earnings and profitability 
ratios (e.g., EBITDA - Earnings Before Interest, Taxes, Depreciation, and Amortization, EBITDA margin). The Supervisory Board has the 
option to adjust the financial performance measure used for evaluation by excluding extraordinary components. 

Biofrontera AG Annual Report 2023 

XV 

 
Non-financial  performance  criteria  should  include  criteria  such  as  integrity,  employee  satisfaction,  diversity,  as  well  as 
sustainability/environmental-social-governance (ESG) aspects, which should account for at least 10% of the total goal achievement. 
Strategic criteria should also be included in the target agreement, such as achieving approvals, successful completion of studies, 
conclusion of significant contracts, or conducting financings. 

A non-financial, strategic component should consider the contribution of the entire Executive Board as well as individual Executive 
Board members to the implementation of the company's strategy and thus to the long-term development of the company. 

For the non-financial, strategic goals, it should be clearly defined within the target agreement under which conditions the respective 
goal  is  fully  met  (100%  achievement  of  the  individual  criterion)  and  which  parameters  are  used  to  assess  the  degree  of  goal 
achievement. 

Calculation of Target Achievement 

The total target achievement of short-term variable compensation is determined by the weighted average of individual performance 
criteria and the degree of respective goal achievement. Financial performance criteria should generally account for up to 55% of 
the goal achievement weighting, while non-financial criteria can account for up to 45%. 

Short-Term Variable Compensation for Extraordinary Developments and Performances of an Executive Board 
Member 

In justified exceptional cases, the Supervisory Board may grant the Executive Board members a special bonus at the discretion of 
the  Supervisory  Board,  not  exceeding  EUR  50,000  (gross)  per  fiscal  year  and  Executive  Board  member.  The  resolution  on  the 
existence of an exceptional case, which should specify the extent and quality of the extraordinary performance of the Executive 
Board member, also determines the specific amount of a special bonus and the timing of its payment by the Supervisory Board. 

Long-Term Variable Compensation (Long Term Incentive; "LTI") 

As a long-term success component, Executive Board members are granted Stock Appreciation Rights ("SARs"). An annual target 
amount equal to 150% of the STI target amount ("LTI target amount") is agreed upon with the Executive Board members. The number 
of SARs granted annually corresponds to the LTI target amount divided by the economic value of the SARs at the time of grant. The 
economic value per SAR to be used corresponds to the intrinsic value determined based on the unweighted average closing prices 
of  the  company's  shares  traded  in  the  closing  auction  on  the  Xetra  trading  platform  of  the  Frankfurt  Stock  Exchange  or  in  a 
corresponding successor system on the 15 trading days preceding the grant. Executive Board members receive a payout based on 
the stock price performance of the company upon exercise of the SARs. 

Exercise Conditions 

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 

(ii) if, in addition, the reference price has developed proportionally the same or better than the "MSCI World Health Care 
Index TR"  or a comparable successor index ("reference index") during the reference period from the last trading day 
before the issue date to the 5th trading day (each last index calculation day following USA Eastern Standard Time (EST)) 
before the start of the respective exercise window. If the reference index is a so-called Total Return Index, dividends and 
other  distributions  paid  out  by  the  company  to  shareholders  during  the  reference  period  are  considered  in  the 
determination of the performance. 

The "issue price" corresponds to the unweighted average closing price of the company's shares between the 15th and the last 
trading day preceding the issue date (inclusive). 

The "reference price" corresponds to the unweighted average closing price of the company's shares between the 15th and the 5th 
trading day (inclusive) before the start of the respective exercise window. 

"Closing prices" are the prices determined in the daily closing auction on the Xetra trading platform of 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 determined price in continuous trading on the respective trading day is used as the closing price, provided 
that such a price was determined on the respective trading day. 

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Biofrontera AG Annual Report 2023 

 
"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. 

Lock-Up Periods 

SARs may be exercised for the first time after the expiration of a lock-up period. 

a)   The lock-up period for 15% of the SARs granted on an issuance date is one year after the respective issuance date; 

b)   The lock-up period for an additional 25% of the SARs granted on an issuance date is two years after the respective 

issuance date; 

c)   The  lock-up  period  for  another  25%  of  the  SARs granted  on  an  issuance  date  is three  years  after  the  respective 

issuance date; 

d)   The lock-up period for the remaining 35% of the SARs granted on an issuance date is four years after the respective 

issuance date. 

After the expiration of the respective lock-up period, the SARs can be exercised until six years after the respective issuance date. 
Thereafter, the right to exercise the SARs terminates, and any SARs not exercised by then expire without compensation. 

Personal Investment 

Additionally, according to the SAR terms, Executive Board members are required to make a personal investment in the company's 
shares. This investment must be made unconditionally within six months after the SAR exercise date, in an amount equal to 25% of 
the gross payout, and the acquired company shares may not be sold earlier than four years after the SARs were granted. 

Share Ownership Guidelines 

To  further  enhance  the  long-term  incentive  effect  of  variable  compensation  and  its  alignment  with  sustainable  corporate 
development, Executive Board members are also obligated in their Executive Board contracts to acquire and hold a determined 
number  of  company  shares,  as  specified  by  the  Supervisory  Board  until  the  end  of  their  contract  term  ("Share  Ownership 
Guidelines"). The total acquisition expense to be borne by the Executive Board member (including acquisition-related costs) is limited 
to an amount equal to 25% of the STI payment (gross) granted to them for the preceding fiscal year. 

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 for the Company to Reclaim Variable Compensation Components 

The Supervisory Board may determine that unpaid variable compensation components of the STI and/or LTI are entirely or partially 
withheld and not paid out ("Clawback") in the event of serious misconduct by an Executive Board member. The Supervisory Board 
decides on the Clawback at its reasonable discretion. Serious misconduct by an Executive Board member in this regard is particularly 
assumed, 

Biofrontera AG Annual Report 2023 

XVII 

 
 
a)   if it has at least grossly negligently violated its duties under § 93 AktG or 

b)   if it has at least grossly negligently violated internally documented internal behavior standards or internal guidelines that 

have had or could have serious consequences for the company, or 

c)   in the case of at least grossly negligent behavior of a criminal nature in the exercise of office as a member of the Executive 

Board, or 

d)   in the case of an intentional violation of other legal provisions in the exercise of office as a member of the Executive 

Board. 

e)   The same applies in the case of serious misconduct by employees of the company or the group, especially in cases of at 
least grossly negligent violations of criminal or compliance-related provisions, which were recognized by the Executive 
Board  member  in  their  capacity  as  the  employee's  superior  and  were  not  immediately  stopped  or  should  have  been 
recognized and immediately stopped with the due care of an Executive Board member. 

A Clawback in relation to payments from the STI is only permissible for the fiscal year in which the misconduct occurred, but not for 
previous or subsequent years. Regarding payments from the LTI, a Clawback is permissible if and to the extent that the serious 
misconduct occurred within the four years following the grant of the entitlement from the LTI (i.e., since the grant of the SARs). 

A Clawback of the STI is also permissible in the case of grossly negligent misconduct that has been identified and audited after the 
respective financial statements have been finalized and has led to a subsequent correction of the company's financial statements. 
In this case, the Clawback is permissible to the extent that the STI was overstated based on the uncorrected basis. 

If a Clawback situation arises according to the above provisions, already paid amounts of the STI and/or LTI, which could have been 
withheld accordingly, can also be reclaimed. Such recovery is permissible, calculated from the time the Supervisory Board becomes 
aware of the triggering event, for the year of awareness and the preceding three fiscal years. 

Amounts  withheld  or  repaid  as part  of  the  Clawback  are  credited  against  any  damages claim of  the  company  arising  from the 
misconduct of the Executive Board member. 

No variable compensation components were reclaimed in the fiscal year. 

Commitments to members of the Board of Management in the event of resignation 

The Supervisory Board may establish resignation arrangements for each compensation component and for each case in which the 
employment relationship of an Executive Board member or the appointment as a member of the Executive Board ends. This includes 
cases such as retirement, full or partial incapacity for work, death, ordinary termination of the employment contract, termination 
of the employment contract for cause, removal from office for cause, transfer of an employment contract to the company's principal 
shareholder, or to an entity affiliated with the company's principal shareholder. For each of these cases, the Supervisory Board can 
predefine the requirements for individual or all compensation components to be paid, either fully or partially, prematurely or with 
a delayed timing, to the Executive Board members or - in case of death - to the heirs of the respective Executive Board member, or 
forfeited. 

Payments to an Executive Board member upon premature termination of their Executive Board activities shall not exceed the value 
of two annual compensations at 100% goal achievement (severance cap) and shall not compensate for more than the remaining 
term of the employment contract. 

Commitments for benefits in connection with the premature termination of the employment contract by the Executive Board member 
as a result of a change of control should not be agreed upon. 

The Supervisory Board may agree with Executive Board members on a post-contractual non-competition obligation for a period of 
up  to  two  (2)  years.  If  such  a  post-contractual  non-competition  obligation takes  effect,  Executive  Board  members  may  receive 
compensation  of  up  to  half  of  their  respective  base  salary  per  year  of  the  respective  duration  of  the  post-contractual  non-
competition obligation. Payments under a post-contractual non-competition obligation are offset against any severance payments. 

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Biofrontera AG Annual Report 2023 

 
Compensation System in Case 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, in accordance with § 87a para. 2 sentence 2 AktG, to temporarily deviate from the compensation system and to change the 
regulations regarding the compensation structure and the individual compensation components, as well as the regulations for the 
respective  procedure,  if  this  is  necessary  in  the  interest  of  the  long-term  well-being  of  the  company.  Unfavorable  market 
developments are not considered special and exceptional circumstances that allow deviation from the compensation system. 

Maximum Compensation 

The following maximum amounts apply: 

Chairman of the Executive Board 

Other members of the Executive Board 

Basic remuneration 

500.000 p.a. 

350.000 p.a. 

Fringe benefits 

Max. 10 % of basic compensation 

Max. 10 % of basic compensation 

STI 

LTI 

200%  of  the  STI  target  amount  p.a.,  which 
should  not  exceed  50%  of  the  basic 
compensation  if  100%  of  the  target  is 
achieved 

200%  of  the  STI  target  amount  p.a.,  which 
should  not  exceed  50%  of  the  basic 
compensation  if  100%  of  the  target  is 
achieved 

that 

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. 

received 

actually 

by 

that 

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. 

received 

actually 

by 

50.000 p.a. 

50.000 p.a. 

Any additional short-term 
variable remuneration in the 
event of extraordinary 
developments and 
performance by a member 
of the Management Board 

Relative proportion of individual components of compensation 

The  Supervisory  Board  observes  an  appropriate  ratio  of  the  individual  components  of  compensation  to  the  target  total 
compensation. The proportion of the components of compensation for Executive Board members to the target total compensation 
based on 100% target achievement in the STI and payout of the LTI at the respective LTI target amount is as follows: 

Base salary  

STI compensation    

LTI compensation    

44% 

22% 

33% 

The proportion of the components of compensation for Executive Board members to the target total compensation based on 200% 
of the STI target amount and 300% of the LTI target amount is as follows: 

Base salary  

STI compensation    

LTI compensation    

23.5% 

23.5% 

53% 

Biofrontera AG Annual Report 2023 

XIX 

 
 
 
 
 
 
 
The above percentages are based on the assumptions made. The actual percentages may vary in future fiscal years and in the event 
of the appointment  of new  Executive Board  members. Variations  may result, in particular, from the achievement of STI and LTI 
targets and from annual expenses related to fringe benefits. 

Procedure for determining, reviewing, and implementing the compensation system 

The  compensation  of  the  Executive  Board  is  determined  by  the  Supervisory  Board  as  a  whole.  For  this  purpose,  the  Personnel 
Committee of the Supervisory Board prepares appropriate recommendations. If necessary, independent external consultants are 
consulted. According to the Rules of Procedure for the Supervisory Board, members of the Supervisory Board are obliged to disclose 
any conflicts of interest immediately. The Supervisory Board designs the system for the compensation of Executive Board members, 
taking into account applicable laws and regulations, in particular the provisions of the German Stock Corporation Act (AktG) in its 
current  version, regulatory requirements, and the provisions  of the German Corporate Governance Code. It  ensures clarity and 
comprehensibility. Based on the compensation system, the Supervisory Board determines the specific target total compensation. 
The Executive Board compensation system thus resolved by the Supervisory Board is submitted to the Annual General Meeting for 
approval. 

The Supervisory Board regularly reviews the Executive Board compensation system, compliance with the maximum compensation 
of Executive Board members, and the appropriateness of the compensation. Here, too, the Personnel Committee of the Supervisory 
Board prepares appropriate recommendations. At the end of a fiscal year, the specific target values for short-term variable Executive 
Board compensation for the following fiscal year are also determined by the Supervisory Board in a target agreement with the 
Executive Board. In accordance with the requirements of § 120a (1) AktG, the Supervisory Board will submit the Executive Board 
compensation system 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 legal regulations (§ 87a (2) AktG), the Supervisory Board, on the proposal of the Personnel Committee, may 
temporarily  deviate  from  the  components  of  the  compensation  system  described  below  in  exceptional  circumstances  if  this  is 
necessary in the interest of the long-term well-being of the company. 

Consideration of employee compensation and employment conditions when establishing the 
compensation system 

When establishing the compensation system and determining the specific level of compensation, the Supervisory Board also takes 
into account the employment conditions of employees in the Biofrontera Group. For this purpose, the Supervisory Board has defined 
the senior management level in the Biofrontera Group and demarcated it from the Executive Board on the one hand and the total 
workforce in the Biofrontera Group on the other hand. In the course of the regularly conducted review of the appropriateness  of 
Executive Board compensation, the Supervisory Board examines in particular whether changes in the relations of the compensation 
of  the  Executive  Board,  senior  management,  and  the  total  workforce  result  in  any  need  for  adjustment  in  Executive  Board 
compensation. In doing so, the Supervisory Board also takes into account the development of the compensations of the groups 
described over time. 

Conflicts of interest 

The Supervisory Board ensures, through appropriate measures, that any conflicts of interest of the Supervisory Board members 
involved in the deliberations and decisions on the compensation system are avoided and, if necessary, resolved. Each Supervisory 
Board member is obliged to disclose conflicts of interest to the Chairman of the Supervisory Board immediately. The Chairman of 
the Supervisory Board discloses any conflicts of interest concerning him to his deputy. The handling of an existing conflict of interest 
is decided on a case-by-case basis. In particular, it is possible that a Supervisory Board member affected by a conflict of interest 
does not participate in a meeting or individual deliberations and decisions of the Supervisory Board or abstains from voting. 

Duration of Executive Board employment contracts 

The agreed term of the employment contracts of Executive Board members corresponds to the duration of the intended appointment 
as  Executive  Board  member.  In  the  case  of  an  initial  appointment,  the  Supervisory  Board  will  determine  the  duration  of  the 
appointment  appropriately  and  oriented  towards  the  well-being  of  the  company  in  the  respective  individual  case,  whereby  the 
duration  of  the  appointment  should  generally  not  exceed  three  years.  The  period  for  reappointment,  in  compliance  with  the 
provisions of § 84 AktG, is a maximum of five years. In the event of reappointment of the Executive Board member, the employment 
contract is extended in accordance with the duration of a renewed appointment; otherwise, it automatically terminates without the 

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need for termination upon expiration of the intended regular term of appointment. A decision on any extension of the employment 
contract or any reappointment should be made no later than 15 months before the expiration of the employment contract or the 
term of appointment and finalized with the Executive Board member 10 months before the expiration. 

Compensation system in case of special and exceptional circumstances 

In special and exceptional circumstances (e.g., in the event of a severe financial or economic crisis, corporate restructuring of the 
group such as spin-offs, acquisitions, or sales of companies or similar significant M&A transactions), the Supervisory Board has the 
right,  in  accordance  with  §  87a  (2)  sentence  2  AktG,  to  temporarily  deviate  from  the  compensation  system  and  to  change  the 
regulations regarding the compensation structure and the individual compensation components, as well as the regulations for the 
respective  procedure,  if  this  is  necessary  in  the  interest  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 deviations can be made under the circumstances mentioned 
are  the  procedure,  the  compensation  structure,  the  individual  components  of  compensation,  and  their  performance  criteria. 
Furthermore,  in  this  case,  the  Supervisory  Board  may  temporarily  grant  additional  components  of  compensation  or  replace 
individual  components  of  compensation  with  other  components  of  compensation  to  the  extent  necessary  to  restore  the 
appropriateness of Executive Board compensation in the specific situation. 

Executive Board compensation in fiscal year 2023 

The total compensation for members of the Executive Board in fiscal year 2023 and the inventory of all shares options issued to the 
Executive Board members as of December 31, 2023, are allocated as follows: 

Biofrontera AG Annual Report 2023 

XXI 

 
Term 
in EUR thousands (unless otherwise inidcated) 

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 

Pilar de la Huerta Martìnez 
CFO 

September 12, 2022 
2023 

incubent 
2022 

280 

42 

0 

289 

47 

0 

0 

0 

0 

0 

47 

336 

0 

0 

0 

0 

0 
0 

86 

4 

0 

90 

0 

0 

0 

0 

0 

90 

0 

0 

0 

0 

0 
0 

Ms. Pilar de la Huerta was appointed as CFO to the Executive Board of the Company on September 12, 2022, and has been serving as 
sole Executive Board member since October 1, 2022. 

The non-performance-related component of compensation for Ms. de la Huerta is 84% (100% in the previous year). 

No stock options (LTI) were granted to Executive Board members in the fiscal year 2023. Furthermore, there are no promised stock 
options within the meaning of Section 162 (1) sentence 2 No. 3 of the German Stock Corporation Act (AktG). 

The maximum compensation for Executive Board members from the non-performance-related and one-year performance-related 
compensation (bonus) amounts to EUR 476 thousand for Ms. de la Huerta. This was adhered to. No LTIs have been decided and 
contractually agreed upon for Ms. de la Huerta thus far. 

The existing  service contracts provide that  - depending on the achievement of agreed-upon targets -  an annual bonus shall be 
granted. The assessment factors are determined in a target agreement each year for the following fiscal year by the end of a fiscal 
year.  The  2022  target  agreement  included  revenue  (60%)  and  EBITDA  (earnings  before  interest,  taxes,  depreciation,  and 
amortization) (40%) as goals. Revenue target for 2022 was set at EUR 26.5 million, and EBITDA Break-even was set at EUR 0.3 million. 

The contractually agreed bonus for Ms. de la Huerta at 100% target achievement is EUR 140 thousand per year. The aforementioned 
performance criteria for 2022 were weighted, evaluated, and calculated pro rata based on the length of the Executive Board's tenure. 
The  criteria  for  target  achievement  were  revenue  and  net  profit  as per  the  consolidated  income  statement  determined  by  the 

XXII 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Supervisory Board for 2022. The goals for the fiscal year 2022 were achieved, thus a bonus payment of EUR 47 thousand was granted 
to Pilar de la Huerta. 

For 2023, the performance criteria included a revenue target (EUR 33.7 million, weighting 20%) and achieving EBITDA (target EUR 5 
million, weighting 30%) as quantitative goals. As significant qualitative goals, the definition and implementation of a medium-term 
strategy  including  a  5-year  strategic  plan  for  sustainable  sales  and  profit  growth  (20%)  as  well  as  the  definition  of  a  lean 
organizational and infrastructure setup to achieve strategic goals (30%) were set. 

No benefits or grants were promised or awarded to Ms. de la Huerta by third parties regarding her activities. 

Further information on former Executive Board members of the Company: 

Mr. Prof. Hermann Lübbert, as a former corporate officer, had a severance entitlement against the Company in accordance with the 
terms  of  the  SAR  program  for  Share  Appreciation  Rights,  the  lock-up  period  of  which  had  not  yet  expired  at  the  time  of  his 
termination. The Company paid a severance payment of EUR 112 thousand to the former Executive Board member in June 2023. 

Former corporate officer Ludwig Lutter was removed from the Executive Board for good cause on August 14, 2022. In two lawsuits 
before the Cologne District Court, Mr. Ludwig Lutter contested his removal as a member of the Executive Board and the termination 
of his employment contract and claimed (partial) continuation of his compensation. We refer to the disclosures in the Group Notes 
regarding events after the reporting date. 

Following the formal end of his Executive Board mandate, Paul Böckmann served as a consultant for the Company from October 
2022 to April 2023. During this time, the Company paid EUR 61 thousand in consulting fees. 

Compensation Report Supervisory Board 

Compensation system for members of the Supervisory Board 

The compensation of the Supervisory Board members shall, in accordance with § 113 of the German Stock Corporation Act (AktG), be 
in an appropriate proportion to the duties of the Supervisory Board members and to 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  is  a  prerequisite  for  the  best 
possible supervision and advice to the Executive Board, which in turn makes a significant contribution to a successful business 
strategy and the long-term success of the company. Therefore, the compensation should make taking on a mandate economically 
attractive enough to attract and retain outstanding members, which also requires consideration of the compensation arrangements 
of  other  comparable  listed  companies.  However,  the  compensation  and  employment  conditions  of  the  employees  are  not  of 
significant importance for the compensation system of the Supervisory Board. 

The Executive Board and the Supervisory Board are of the opinion that a purely fixed compensation for Supervisory Board members 
is best  suited  to  ensure  independent  performance  of  the  control  function  of  the  Supervisory  Board,  as  variable  compensation, 
especially in matters relevant to supervision, could otherwise create a conflict of interest between the Executive Board and the 
Supervisory Board regarding their own compensation. Differentiated compensation for individual functions in the Supervisory Board 
generally  takes  into  account  the  workload  associated  with  each  Supervisory  Board  member.  In  practice,  the  chairman  of  the 
Supervisory Board and his deputy, as well as the chairman and members of the audit committee, typically have a higher workload, 
thus a higher compensation is provided. According to Recommendation G.17 of the German Corporate Governance Code in the version 
of  April  28,  2022  ("Code"),  the  compensation  of  Supervisory  Board  members  should  appropriately  reflect  the  higher  time 
commitment of the chairman and deputy chairman of the Supervisory Board, as well as the chairman and members of committees. 
According to Recommendation G.18 of the Code, the compensation of the Supervisory Board should consist of a fixed compensation. 
These  aspects  are  appropriately  reflected  in  the  current  version  of  §  18  of  the  Articles  of  Association  when  determining  the 
compensation of the Supervisory Board. 

The compensation is to be paid at the  end  of  each fiscal year. There are no deferral periods for  the payment  of compensation 
components. 

Biofrontera AG Annual Report 2023 

XXIII 

 
 
Supervisory Board members who are only members of the Supervisory Board or the audit committee or hold the chair or deputy 
chair of the Supervisory Board or the chair of the audit committee for part of the fiscal year receive a pro-rata compensation. 

There  are  no  commitments  for  severance  payments,  pension,  or  early  retirement  arrangements.  The  company  reimburses  the 
Supervisory  Board  members  for  expenses  incurred  in  the  performance  of  their  duties,  including  any  value-added  tax  (VAT) 
attributable to compensation and reimbursement of expenses, and includes the performance of the duties of the Supervisory Board 
members in the coverage of a directors' and officers' liability insurance policy taken out by the company. 

The compensation system of the Supervisory Board is resolved by the Annual General Meeting upon proposal of the Executive Board 
and  the  Supervisory  Board,  as  well  as  a  statutory  compensation  provision.  At  regular  intervals,  at  least  every  four  years,  the 
Executive Board and the Supervisory Board review whether the amount and composition of the Supervisory Board compensation 
still appear to be market-oriented and appropriate and, if necessary, submit adjustment proposals to the Annual General Meeting. 

Since the members of the Supervisory Board are involved in shaping the compensation system relevant to them and must also 
submit  proposal  resolutions  to  the  Annual  General  Meeting  in  accordance  with  §  124  of  the  German  Stock  Corporation  Act,  an 
unavoidable conflict of interest arises from the application of the law. However, this is effectively counteracted by assigning the 
decision on the final determination of the compensation to the Annual General Meeting. 

In accordance with § 113 (3) sentences 1 and 2 of the German Stock Corporation Act, the Annual General Meeting of listed companies 
must decide 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 regulated in § 18 of the Articles of Association of 
the company. The current version of § 18 of the Articles of Association of the company was resolved by the Annual General Meeting 
on June 20, 2023, and reads as follows: 

" § 18 Compensation of the Supervisory Board 

(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." 

(7) 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." 

The  Annual  General  Meeting  made  use  of  the  authorization  under  §  18 (3)  of  the  Articles of  Association and  resolved  a  special 
compensation for the Supervisory Board member Dr. Helge Lubenow as follows on June 20, 2023: 

"The member of the Supervisory Board Dr. Helge Lubenow receives an additional compensation of EUR 22,000.00 for the fiscal year 
2022 for assuming special tasks and providing special services in advising the Executive Board in the area of personnel/human 
resources. The entitlement to compensation and its due date are subject to the registration of the amendment to § 18 of the Articles 
of Association according to the provisions of agenda item 5 lit. a) in the commercial register." 

The suspensive condition occurred through registration of the authorization under § 18 (3) of the Articles of Association in  the 
commercial register on July 3, 2023. The additional compensation for the fiscal year 2022 was resolved in the fiscal year 2023 and 

XXIV 

Biofrontera AG Annual Report 2023 

 
is therefore included in the following breakdown of the total compensation of the members of the Supervisory Board in the fiscal 
year 2023. 

Compensation in fiscal year 2023 

The total compensation of the members of the Supervisory Board in fiscal year 2023 is as follows: 

in EUR thousands 

Fixed compensation 

Audit Committee activity 

Total 

Wilhelm K.T. Zours (Supervisory Board: Chair) 
Dr. Jörgen Tielmann (Supervisory Board: Vice 
Chair) 
Dr. Heikki Lanckriet 
Dr. Helge Lubenow (Audit Committee: Member) 
Prof. Dr. Karin Lergenmüller (Audit Committee: 
Member, since July 5th,2023)* 
Karlheinz Schmelig (Audit Committee: Chair) 
TOTAL 

in TEUR 

44 

33 

22 
44 

22 

22 
187 

in % 

100% 

in TEUR 

100% 

100% 
94% 

96% 

79% 

in % 

0% 

0% 

0% 
6% 

4% 

21% 

0 

0 

0 
3 

1 

6 
10 

in TEUR 

44 

33 

22 
47 

23 

28 
197 

in % 

100% 

100% 

100% 
100% 

100% 

100% 

Vertical comparison 

Compensation of Executive Board members 
Pilar de la Huerta Martìnez* 

Compensation Supervisory Board members 
Wilhelm K.T. Zours* 
Dr. Jörgen Tielmann* 
Dr. Heikki Lanckriet* 
Dr. Helge Lubenow* 
Prof. Dr. Karin Lergenmüller** 
Karlheinz Schmelig* 

Average compensation of employees 
Employees in Europe 
*2022 partial year only 

Change 2023 vs. 2022 

Change 2022 vs. 2021 

373% 

-21% 
-44% 
-35% 
-8% 

-13% 

3.8% 

- 

2700% 
1867% 
1033% 
1600% 

967% 

0.8% 

When presenting the average salary change of employees, all employees of the European group companies (excluding the Executive 
Board) were included. For comparison, the contractually agreed annual gross salary without special payments and ancillary wage 
costs was taken into account. 

The basis for comparing employee compensation has been altered. Previously, the average annual compensation including wages 
and salaries as well as expenses for bonuses, pension provisions, severance payments, and other personnel-related costs had been 
considered. It was viewed as total personnel costs per year divided by the number of employees on average per year. This approach 
results in an average change in personnel costs of 9%. This value provides a misleading impression. On the one hand, the workforce 
of the European Biofrontera companies decreased over the course of 2023, especially in the second half of the year. This trend 
continues. On the other hand, the company has strengthened itself with highly qualified personnel and has been able to fill some 
key  positions  that  were  vacant  for  a  long  time.  This  has  had  decisive  effects  on  the  increased  average  compensation  of  the 
workforce. 

The  altered  presentation  of  the  average  compensation  of  the  workforce thus  more  clearly  and  meaningfully  demonstrates  the 
development of wages and salaries in the company in vertical comparison. 

Biofrontera AG Annual Report 2023 

XXV 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated management and group management report for the 
fiscal year 2023 

Basis of the Biofrontera Group 

Group structure 

As  of  December  31,  2023,  the  Biofrontera  Group  (hereinafter  also  called  "Biofrontera",  "Biofrontera  Group",  “Group”  or  the 
“Company”) consists of a parent company, Biofrontera AG and four 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. initially based in Cambridge (11/2022), later moved to Reading. 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. Biofrontera Inc. is 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. 

Production of Ameluz® for all markets is carried out by a contract manufacturer in Switzerland. The PDT-lamp series is manufactured 
at Biofrontera's headquarter 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 AG realizes revenues through direct sales facilitated by its own sales force operating in Germany, Spain, and UK, from 
which Biofrontera retains 100% of the generated revenues.  

For Biofrontera's US licensee, a fixed transfer price is applied, structured as a tiered system. This pricing mechanism entails charging 
50% of sales for volumes up to USD 30 million, as well as 40% for all sales between USD 30 million and USD 50 million. At the 
beginning of each fiscal year, a thorough assessment of the delivered quantities is performed, followed by direct payment for the 
delivered batches. Subsequently, at the end of the year, prepaid shipments are reconciled to product sales in the US market. The 
transfer price for 2023 was 50% of the gross price per unit of Ameluz®, with a minimum of USD 110 per unit.  

The  European license  partners  also  charge  their  license  fees via  a  fixed  transfer  price.  The  transfer  price  varies,  but  currently 
averages 50% of annual net sales. Here, too, the delivery quantities are budgeted in advance, which means that there may be jumps 
in sales during the year.  

The license partner for Asia and Oceania initially made a one-time payment of EUR 6 million in the fiscal year 2020 upon acquisition. 
Until the product is ready for the market, Biofrontera charges service fees for its involvement in the clinical trials and the regulatory 
approval process. 

Due to these very different sources of income, Biofrontera may experience strong quarterly fluctuations during the year, which do 
not correlate with the actual revenue generated in the market  

Biofrontera AG Annual Report 2023 

1 

 
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,  characterized by a special degree of 
innovation. The focus of activities is on the further territorial expansion of marketing and the development of additional market 
potential, e.g. through synergistic additions to the company's own product portfolio on the basis of marketing partnerships, as well 
as the licensing of Ameluz® in other regions. 

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  (LSA)  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. For further information, please refer to the disclosures in the Notes to the Consolidated Financial 
Statements relating to events after the reporting date. 

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 actinic keratosis compared to the direct competitor product 
in conventional light treatment with a special red-light lamp.  

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.  Since  then,  the  label  extension  has  also  included  the  treatment  of  actinic  keratoses  and  field 
cancerization  with  daylight-PDT.  Daylight-PDT  is a  cost-effective  and  painless  alternative  to  conventional  PDT  treatment  with  a 
special lamp. The topically applied drug is activated by natural or artificial daylight. Since daylight-PDT does not necessarily have to 
be carried out in a physician's office, it competes directly with topical drugs, which are much more widely used in Europe, are used 
independently by patients, and are therefore reimbursed by statutory health insurers in Germany.  

2 

Biofrontera AG Annual Report 2023 

 
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  December  2023,  the  Committee  for  Medicinal  Products  for  Human  Use  (CHMP)  of  the  European  Medicines  Agency  (EMA) 
recommended  the  extension  of  the  marketing  authorization  for  Ameluz®  for  use  in  artificial  daylight.  Formal  approval  by  the 
European Commission has also been granted, meaning that marketing activities for Europe can be started. Photodynamic therapy 
with artificial daylight combines the advantages of the original daylight therapy, which significantly reduces treatment pain, with 
the  controlled  environment  of  a  doctor's  surgery,  so  that  daylight  PDT  with  Ameluz®  can  now  also  be  used  regardless  of  the 
prevailing light conditions, weather conditions and time of day. 

Also in December, the European Medicines Agency (EMA) approved an amendment to the approval of Ameluz® for an improved gel 
formulation  without  the  use  of  propylene  glycol.  By  avoiding  the  use  of  propylene  glycol,  this  improved  Ameluz®  formulation 
eliminates potential risks, particularly with regard to the formation of impurities and allergic reactions. This formulation will be 
available in Europe in the third quarter of 2024 at the earliest. 

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 13485 
certifications for the entire company. The ISO certification was renewed. 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  patent  applications,  which  also  help  to  protect  the  drug  Ameluz®  in  the  U.S.  market  due  to  the  FDA’s 
combination approval. 

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. The 
BF-RhodoLED® can be distributed throughout the EU, UK, Switzerland as well as the USA. The use of the RhodoLED® XL is currently 
only planned for the US market. 

The optimized formulation of the Ameluz® gel without propylene glycol was also submitted to the FDA as an extension of approval 
for the USA. The application was approved in October 2023. 

Belixos®  

Belixos® represents a medical skin care range specifically developed for irritated and sensitive skin.  

Originally designed as a cosmetic series with different products, it addressed various skin irritations. A unique combination of active 
ingredients was created by combining purely plant-based biocolloids with medicinal plant extracts to achieve a proven deep skin 
effect. As  part  of  a  comprehensive  redesign,  the  Belixos®  line  has been  undergoing  transformation  since  mid-2022, which was 
successfully completed in May 2023 with the launch of Belixos® ACTIVE CARE, a novel foam formulation. With the foam formulation, 
the ingredients can now be delivered to the skin without any irritating supplements. This means that Belixos® is now even better 
adapted to the needs of damaged skin. This new product replaces the previous cosmetic line. 

In addition, a patent application has been filed for the underlying formulation due to its highly innovative character. Belixos® thus 
continues to emphasize its focus on advanced skin care to meet the individual needs of damaged skin. 

Sales and marketing 

Germany and Europe 

With  its Central  European  approval, Ameluz® can be  sold  and  distributed  in  all  EU  countries  as  well  as in  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-imports 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, Ameluz® is currently only available in certain EU countries. However, 

Biofrontera AG Annual Report 2023 

3 

 
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 140 to approximately EUR 210 per 2 g tube.  

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. 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 2022. To date, activities have been limited to the private healthcare sector, as Ameluz® PDT is currently not reimbursed by public 
payers. Medac anticipates that reimbursement of Ameluz® will be possible by the Mid of the year 2024. 

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 

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. The clinical development program 
on which approval will be granted will initially focus on actinic keratosis as an indication and will be extended to acne if appropriate.  

Market overview 

Actinic keratosis (AK) 

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. They often appear as rough or crusty patches on 
the surface of the skin that may be skin-colored, reddish, or yellowish. These skin lesions feel dry and rough to the touch. 

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, 

4 

Biofrontera AG Annual Report 2023 

 
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  therapy  options.  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  first-line  therapy  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 
with red or blue light) 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 2,5 hours and the treatment is associated with 
less pain. 

Market overview and competitive landscape in Germany 

Germany is Biofrontera's largest European sales market. In Germany, around 1.7 million people are being treated by dermatologists 
for AK, which corresponds to around 2 to 3% of the total population. However, the number of sufferers is probably higher. In 2023, 
a total of 1,089,054 prescriptions were issued for the treatment of AK (previous year: 965,848). Superficially applicable medications 
such as prescription creams and gels containing active ingredients (topicals) are primarily used, which also accounted for a constant 
market  share  of  93.9%  in the  reporting  year, followed  by  PDT  (the  combination of  a  superficially  applied  medication  with  light 
therapy) with 6.1% (previous year: 93.8% and 6.2%). The PDT market segment was therefore unable to expand further in 2023. The 
main growth in the AK market was triggered by two topical drugs, whose growth rates were just under 50%, meaning that the overall 
AK market grew by 14% in 2023. Within the PDT segment, Ameluz® grew by 17%, while our direct competitor only grew by 3%. 

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 in the PDT drugs segment increased from 62% to 65% in 
2023. Above all, the further establishment of daylight PDT enabled Ameluz® to continue to prove itself as a strong market leader in 
the PDT market compared to competing products. We estimate that daylight PDT will gain further market share in the future, which 
was previously reserved for self-applied topical creams, thanks to the expansion of the application with artificial daylight. This is 
primarily due to the reimbursement of daylight PDT by statutory health insurance companies, which means that the number of 
patients who would in principle have access to treatment with Ameluz® has multiplied as a result of this possible application. After 
the coronavirus pandemic subsided and parallel imports from Spain declined significantly, Ameluz® unit sales in Germany grew by 
around 32,8% in the reporting year compared to 2022. 

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. 

Biofrontera AG Annual Report 2023 

5 

 
 
Market overview and competitive situation in the other proprietary markets of Spain and the United Kingdom (UK) 

In the Spanish market, sales of Ameluz® recorded a significant increase in 2021 and 2022 due to the price reduction ordered by the 
Ministry of Health. After this intervention was terminated, there was a significant decline in the quantities of Ameluz® sold in 2023 
due to the loss of this considerable price advantage. A decline of  Ameluz®  units of 23,3% compared to the previous year  was 
recorded. Nevertheless, due to the consistently higher price in 2023, sales remained almost stable at around EUR 1.7 million in 2023 
(a decrease of -0.8% compared to 2022). 

Ameluz® showed a solid growth of 9,3% in the UK market. We were able to increase sales to customers in the UK from 3,389 units 
in 2022 to 3,757 units in 2023. 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 2023. Overall, our partners contributed to the solid product 
development with nearly 13,000 units sold.  

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 over 80%. 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 less than 2%, with Ameluz®-PDT expanding its market share within this segment. 

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. For 2023 Biofrontera Inc. reported a further 
sales improvement of nearlyt 20%.  

Personnel matters 

Management Board 

As of December 31, 2023, the Management Board consisted of Pilar de la Huerta Martínez (CFO). 

Name 

Nationality 

Pilar de la Huerta Martínez 

Spanish 

Age 

55 

Position 

Date of first 
appointment 

Term 

CFO 

September 12, 2022 

December 31, 
2025 

Employees 

As of December 31, 2023 the Biofrontera Group had EUR 95 employees (December 31, 2022: 110) representing 87.91 FTE (December 31, 
2022: 99 FTE) who were distributed as follows: 

6 

Biofrontera AG Annual Report 2023 

 
 
 
 
Total number of employees 

Full-time 
With PhD 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 

Supervisory Board 

December 31, 2023 

December 31, 2022 

87.91 

73.00 
20.30 

87.91 

9.75 

6.55 

18.80 

27.78 

6.85 
18.18 

87.91 

77.28 

7.63 

3.00 

99.32 

83.00 
16.32 

99.32 

11.81 

8.65 

19.67 

29.53 

5.85 
23.81 

99.32 

87.94 

8.38 

3.00 

In 2023, 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 
Karlheinz Schmelig 

German 

German 

Belgian 

German 

German 
German 

62 

54 

46 

65 

55 
58 

Chairman 

Vice Chair 

Member 

Member 

Member 
Member 

Date of first 
appointment 

December 14, 2021 

December 14, 2021 

December 14, 2021 

August 23, 2022 

December 14, 2021 
December 14, 2021 

Term 

2026 

2026 

2026 

2026 

2026 
2026 

Research and development projects 

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 U.S., as 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, except for 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, 25 full-time employees (FTEs) were employed in research and development and regulatory 
affairs (previous year: 28 FTEs). 

Update for 2022 on the ongoing pharmaceutical and clinical development program: 

Biofrontera AG Annual Report 2023 

7 

 
 
 
 
 
Optimized formulation for Ameluz® 

An improved Ameluz® formulation was approved in both the U.S. and the EU during the reporting period. The new formulation n 
longer contains contain propylene glycol, a component commonly used in semi-solid formulations. This may have a positive impact 
on the safety profile of the gel as the absence of propylene glycol eliminates potential risks, particularly in terms of the formation 
of impurities and allergic reactions. 

Extension of the marketing authorization for Ameluz® for the treatment of actinic 
keratoses with artificial daylight  

In the EU, the EMA has positively assessed the extension of approval for the photodynamic treatment of mild and moderate actinic 
keratoses (AK) with artificial daylight. Photodynamic therapy with artificial daylight combines the advantages of the original daylight 
therapy, which significantly reduces treatment pain, with the controlled environment of a doctor's office, so that daylight PDT with 
Ameluz® can now also be used regardless of the prevailing weather conditions. 

Phase I safety study with Ameluz®-PDT 

The Phase I safety study, which started in December 2021, is a non-randomized, open-label, multi-center study in which 100 patients 
with mild to severe actinic keratosis on the face and scalp will be treated. It is designed to evaluate the safety and tolerability of 
photodynamic therapy (PDT) for the field-directed treatment of actinic keratosis (AK) with the simultaneous application of three 
tubes of Ameluz® together with the new RhodoLED® XL lamp. A total of nine clinical centers in the U.S. were involved in the study.  

The study was completed with the milestone "last patient, last visit" in April 2023. The study results were submitted to the FDA in 
December 2023. 

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).  

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 
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. Currently a total of nine 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 2023, 77 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. In August, all required 186 patients were enrolled in the study, with 
the next milestone expected to be reached in February 2024, when the last patient completes the treatment phase. This is followed 
by a 5-year follow-up period for each patient. If approved by the FDA, Ameluz® would be the only drug in the U.S. for the treatment 
of superficial BCC with PDT. A total of 19 clinical centers are involved in the study.  

Since the FDA has also requested results from the first year of the follow-up phase, a submission is not expected until 2026. 

Phase III trial for the treatment of actinic keratosis on the extremities, neck and trunk 
with Ameluz®-PDT 

8 

Biofrontera AG Annual Report 2023 

 
 
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. During the reporting period, there was a protocol adjustment to implement the FDA's recommendations 
regarding the recording of local side effects and pain management during PDT.  

By the end of the year, 72 patients had been enrolled and treated in the study, although most centers were only able to start patient 
recruitment in April-May 2023 after completion of the Phase I safety study. 

Patent development 

Biofrontera's patent portfolio is constantly being expanded by filing new patent applications for new technologies and/or in other 
countries. The company currently maintains 9 different proprietary patent families worldwide. As at December 31, 2023, the patent 
portfolio consisted  of  26 granted patents and 30 pending patent  applications, including international patent applications (as  at 
December 31, 2022: 23 granted patents and 18 pending patent applications). The Group's patents are held by Biofrontera Bioscience 
GmbH and Biofrontera Pharma GmbH. The patent families relate to our innovative technologies in connection with our nanoemulsion, 
our red light lamp for photodynamic therapy, photodynamic therapy itself and migraine prophylaxis. 

Nanoemulsion 

We  have  been  granted  patents  for  our  nanoemulsion  technology 
in  Europe  (validated  for  Germany,  Spain,  UK, 
Switzerland/Liechtenstein,  France  and  Italy), Israel,  Japan, China,  Hong  Kong,  Singapore,  Australia,  New  Zealand,  Canada,  South 
Africa, Mexico, Chile, Russia, Belarus and Ukraine. The patent protection expires on December 21, 2027. A patent was granted for the 
corresponding US patent application on January 3, 2023, which expires on February 7, 2028. A divisional application has also been 
filed in the US, which is currently still pending. As part of the license agreement with our strategic partner Maruho, the corresponding 
Japanese patent was transferred to Maruho.  

The patent family serves to protect our nanoemulsion technology and thus also to protect Ameluz®. The risk of possible future 
generic competition with regard  to Ameluz® is  also mitigated by  specific challenges in the development and market launch  of 
generic dermatological combination products. Furthermore, as part of Biofrontera's patent strategy to protect Ameluz® , additional 
patent applications have been filed for photodynamic therapy itself and our red light lamp. 

Red-light lamp for photodynamic therapy 

An international patent application entitled "Illumination for photodynamic therapy" has been filed. We have already been granted 
a patent in the USA for a resulting divisional application. The patent was also granted in Australia on November 30, 2023. The patents 
have a maximum term until June 5, 2039. Further patent applications are also pending in Europe, the USA, Japan, China, Hong Kong, 
Singapore and New Zealand. The Japanese patent application was transferred to Maruho as part of the license agreement with the 
strategic partner Maruho.  

A further patent application "Illumination device for photodynamic therapy, method for treating a  skin disease  and method  for 
operating an illumination device" was initially filed in the USA; this is still pending. We have already been granted a patent in the 
USA for a resulting US divisional application. The patent has a maximum term until October 15, 2040. Furthermore, an international 
patent application was filed in this patent family, for which national/regional phases were initiated in Europe, the USA, Japan, China, 
Hong Kong, South Korea, India, Australia, Canada and Brazil in spring 2023. 

A further international patent application to protect the lamp entitled "Illumination device for photodynamic therapy, method for 
treating a skin disease and method for operating an illumination device" has been filed and is still in the international phase of the 
PCT  procedure  (PCT  =  Patent  Cooporation  Treaty).  All  contracting  states  belonging  to  the  PCT  at  the  time  of  filing  have  been 
designated.  

Biofrontera AG Annual Report 2023 

9 

 
In order to protect our new RhodoLED® XL PDT lamp from imitation, design applications have also been filed for certain key design 
aspects of the lamp. In Europe and the United Kingdom, two designs each were already entered in the register in April 2023. Further 
design applications are pending in the USA and Canada. Following a successful examination, the responsible patent office issued the 
registration decision for one of the US design applications on November 2, 2023. 

Photodynamic therapy 

In the patent family of the international patent  application "Photodynamic therapy comprising two light exposures at different 
wavelengths", Biofrontera has already been granted a patent in Australia. In addition, the corresponding US patent was granted on 
May 9, 2023. The patents protect a number of innovations relating to a new illumination method for the treatment of dermatological 
skin diseases with photodynamic therapy (PDT) and have a maximum term until August 23, 2038 (or April 23, 2039, for the USA). 
Further patent applications are pending in Europe, the USA, Japan, China, Hong Kong, Singapore and New Zealand. As part of the 
license agreement with the strategic partner Maruho, the then pending Japanese patent application was transferred to Maruho; in 
the meantime, a patent was also granted for this on 20 February 2023. 

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 performance figures, revenue and liquidity as well as EBITDA and 
EBIT serve as financial control variables. Biofrontera AG uses the key  performance figures liquidity and net income as financial 
performance indicators. 

Revenue is also considered by region. On a consolidated basis, revenues include sales to wholesalers as well as to physicians and 
clinics, sales to our licensing partners, as well as revenues from research contracts. 

In addition, the development of liquidity is used as an important key performance and management metric for the Group as well as 
for Biofrontera AG. It is monitored on daily basis. 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 
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 

10 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
Non-financial performance indicators  
The maintenance and further development of our regulatory approvals is essential to secure and strengthen Biofrontera's market 
position  and  is  reflected,  among  other  things,  in  research  and  development  costs.  Consequently,  both  the  maintenance  of  our 
regulatory approvals and the expansion of our drug labels as well as the number of external and internal audits are important non-
financial 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 2023 fiscal year 

Business performance 

Biofrontera  was  once  again  able  to  confirm  its  targeted  profitability  in  this  financial  year.  The  forecast  EBITDA  result  of 
EUR 5.9 million was clearly exceeded and the company's sales of EUR 32.2 million were also in the upper third of the issued forecast.  

In the current financial year, Biofrontera has been working intensively on its future strategic positioning after the separation of the 
cost-intensive  US  business  was  completed  and  Biofrontera  decided  to  focus  on  its  European  business.  Initially,  the  complete 
separation of the US unit was driven forward in terms of both organization and business activities. This involved reviewing existing 
corporate structures to ensure they are optimally aligned with the requirements of the newly focused business. Special  attention 
was  given  to  evaluating  the  current  European  operations  with  the  aim  of  significantly  expanding  them  in  the  future  while 
simultaneously achieving cost optimization. 

This strategic process was supported by a renowned consulting firm to ensure its efficiency and effectiveness. The long-term goal 
is to secure the profitability of Biofrontera AG independently of the business performance of the US licensing partner. To achieve 
this, a strategic expansion of Ameluz® market presence in Europe is a feasible approach. At the same time, it would be advantageous 
to expand the product portfolio through potential collaborations or licensing agreements to utilize existing complex structures more 
efficiently. Through this measures Biofrontera AG aims to reduce its revenue dependence on the US business and thus becaume less 
reliant on the business development of Biofrontera Inc. 
The management is confident that these strategic steps can contribute to the long-term stability and sustainability of the company.  
The positive growth of the European business, particularly the outstanding performance in the German market, marks significant 
milestones  in  this  long-term corporate  transformation.  In  Germany, our  consistently  good  sales  performance  in  the  first  three 
quarters of this financial year enabled us to avoid the therapy-related sales fluctuations in the summer for the first time. With the 
usual strong fourth quarter, we were then able to achieve a revenue growth of 31.4 % for the year. In total we were able to generate 
revenues in Germany amounting EUR 6.3 million, with unit sales growing significantly by roughly 33%. 

For the rest of Europe, sales development was more moderate over the past year, but we also recorded a slight growth of 5%. This 
was  mainly  due  to  a  weak  third  quarter.  Throughout  the  year,  the  Spanish  market  has  not  yet  fully  recovered  from  the  price 
adjustment.  However,  with a  satisfactory  fourth quarter,  we  see  growth  momentum that  we  expect  to  translate  into  increased 
demand this year. 

Consolidated  with  the  German  revenues,  the  overall  European  business  totalled  EUR 9,919 thousand  (previous  year: 
EUR 8,261 thousand), which corresponds to growth of slightly over 20 %. With this result, this division is now profitable.  

As part of the license agreement concluded with Maruho Ltd., income of EUR 106 thousand was generated in the reporting year from 
services and the supply of medication for clinical development (previous year: EUR 342 thousand). The decline is due to the fact that 
a one-off payment of EUR 200 thousand was made in 2022 as part of a patent transfer. 

However, in addition to these sources of income, the company's profitability is still significantly dependent on US income. In the US, 
we generated license income of EUR 22.1 million in 2023, representing growth of 34.3% compared to the previous year. Based on the 
publication of the  annual results of Biofrontera  Inc., the  sales achieved by  Biofrontera Inc. were  below the expectations set by 

Biofrontera AG Annual Report 2023 

11 

 
 
 
 
 
 
 
 
Biofrontera Inc., as the sales growth of 25 % announced for 2023 was slightly below the forecast market development with actual 
growth of 19 %. This has led to a certain level of stockpiling, which must now be reduced in 2024. It is therefore becoming increasingly 
important for Biofrontera AG to successively minimize the risk of uncontrollable uncertainties in the US business and to resolve the 
existing dependency. 

The company reorganization described above resulted in one-time expenses on the cost side, particularly in the area of consulting 
and legal costs. This was reflected in an almost constant cost level for general and administrative expenses. The increase in legal 
costs was due to legal disputes, which were, however, settled through agreements with the parties concerned. Furthermore, costs 
were also incurred in connection with the preparation of a prospectus for a capital measure planned for August 2023 but cancelled 
in July. Total G&A costs in the reporting period amounted to EUR 6,105 thousand compared to EUR 5,906 thousand in  the previous 
year. 
Research and development costs totaled EUR 7,846 thousand in the reporting year compared to EUR 7,128 thousand in the previous 
year, representing  a percentage increase of 10.1 %. This increase resulted from intensified clinical development activities in the first 
quarter to increase market potential in the USA. 
Sales and marketing costs increased to a total of EUR 7,273 thousand in the reporting year, compared to EUR 6,356 thousand in the 
previous year. This increase was primarily caused by preparations to intensify and expand our sales activities in Europe. 

Marketing & Sales of Ameluz® in Europe 

Sales  development  in  Germany  was  very  strong  compared  to  the  previous  year.  German  product  sales  totaled  EUR 6.3 million 
compared to EUR 4.8 millionin 2022, an increase of around 31.4 %, mainly due to the end of re-imports and the coronavirus pandemic. 
Direct tube-based Ameluz® sales in the German market grew by around 33% in the reporting year compared to 2022. The share of 
Ameluz® PDT in the PDT segment grew from 62% in the previous year to 65% in 2023.  

In the remaining European countries, Biofrontera generated product sales of EUR 3.7 million compared to EUR 3.5 millionin 2022, an 
increase of slightly under 5%. In the Spanish market, sales of Ameluz® fell compared to the previous year due to the lack of exports 
and the price returning to the original level. Over the reporting year as a whole, significantly fewer tubes of Ameluz® were sold in 
the Spanish market, down 23%. 

Ameluz® showed dynamic unit-based growth of 13% in the UK market. We were able to increase sales to customers in the UK from 
3,389 tubes in 2022 to 3,757 tubes in 2023. On a sales basis, revenue increased from EUR 662 thousand in 2022 to EUR 723.4 thousand 
in 2023, an increase of 9.3 %. 

Marketing by  our European licence partners  Galenica AB for the  Nordic countries, Louis Widmer for Switzerland, Pelpharma for 
Austria and Medac Gesellschaft für klinische Spezialpräparate mbH for Poland has consistently developed positively with generally 
double-digit growth rates in market sales. 

Sales of Ameluz® in the USA 

Biofrontera Inc. generated sales of EUR 22.1 million in the reporting period, an increase of 34.3 % compared to the previous year. In 
the past financial year, Biofrontera Inc. made enormous investments to expand its marketing activities and significantly increased 
both its sales force and sales support. However, with sales growth slightly under 20 %, our sales partner fell slightly short of its own 
expectations for 2023. The difference between deliveries and sales indicates a certain level of stockpiling, meaning that we will have 
to monitor market developments in the US very closely in 2024. Both companies are in close dialogue on this. 

Regulatory and clinical progress 

The aim of Biofrontera's development strategy is to successively adapt Ameluz® to market requirements and patient needs and to 
utilize  it  for  further  indications.  The  full  treatment  and  market  potential  of  Ameluz®  can  only  be  realized  with  corresponding 
extensions of the approval. 

An improved Ameluz® formulation was approved in both the USA and the EU in the reporting period. The new formulation does not 
contain propylene glycol. This may have a positive effect on the safety profile of the gel and avoid potential risks regarding the 
formation of impurities and allergic reactions. 

In the EU, the EMA has positively assessed the authorization extension for the photodynamic treatment of mild and moderate actinic 
keratoses (AK) with artificial daylight. Photodynamic therapy with artificial daylight combines the benefits of the original daylight 

12 

Biofrontera AG Annual Report 2023 

 
 
therapy, which significantly reduces treatment pain, with the controlled environment of a doctor's office, meaning that daylight PDT 
with Ameluz® can now also be used regardless of the prevailing weather conditions. 

Progress was also made in the area of clinical studies: a phase I study required by the FDA to collect more safety data on the use of 
three tubes of Ameluz® in a PDT session was completed this year. The extended approval dossier for the USA was submitted to FDA 
at the end of 2023. 

The  company  is  currently  conducting  three  independent  phase  II  and  III  clinical  trials  in  parallel  to  expand  the  US  approval  of 
Ameluz®. One of these ongoing studies is evaluating the efficacy of Ameluz® PDT in moderate to severe forms of adult acne in 
adults. So far, 77 of 126 patients have been enrolled in the study. In December 2022, another phase III trial was launched to test the 
efficacy of Ameluz® PDT on the extremities, trunk and neck. A new lighting profile will also be used to alleviate pain during PDT. So 
far, 72 patients have been included in this study. In the trial to test Ameluz® PDT for superficial basal cell carcinoma, which has been 
running since 2018, recruitment was successfully completed in August 2023. A total of 187 patients were included in the trial. We 
expect the treatment phase to be completed in the first quarter of 2024, after which all patients will be in the 5-year follow-up phase.  

Further information on the ongoing studies can be found in the Research and development section. 

Cancellation of the capital increase resolved on January 09, 2023  

Due to the significant decline in the share price, the Management Board, with the approval of the Supervisory Board, decided  in 
August 2023 not to implement the planned capital increase against cash contributions resolved by the Annual General Meeting on 
January 9, 2023, and to withdraw the proposal for approval of a corresponding securities prospectus. The share price below nominal 
value also made it impossible to restart these efforts in the course of the second half of the year, so that this capital resolution was 
no longer feasible. 

Litigation 

Biofrontera Inc. and another shareholder filed a contestation lawsuit against all resolutions of the extraordinary general meeting 
on January 9, 2023, including resolutions on Authorized Capital and the increase of the share capital. The lawsuit was withdrawn as 
part of an out-of-court settlement dated April 11, 2023 ("Inc. Agreement dated April 11, 2023"). The Inc. Agreement dated April 11, 2023, 
is reproduced in detail in Biofrontera AG's announcement in the Bundesanzeiger pursuant to Section 248a of the  German Stock 
Corporation Act (AktG) dated April 19, 2023. 

With the Biofrontera Inc. Agreement dated April 11, 2023, a lawsuit by the Company in the state of Delaware, USA, was also settled, 
seeking in particular to invalidate the resolutions adopted at the Biofrontera Inc.'s general meeting on December 12, 2022, including 
the elections to the Board of Directors. Essential components of the Inc. Agreement dated April 11, 2023, include the appointment of 
a new member nominated by the Company to the Board of Directors of Biofrontera Inc., the mutual search for a new independent 
member  for  the  Board  of  Directors,  and  the  mutual  commitment  not  to  significantly  increase  the  ownership  in  the  respective 
company and not to implement additional dilution measures that could prevent the holdings from being maintained in the event of 
capital increases. 

Deutsche  Balaton  AG  filed  a  declaratory  action  with  the  Cologne  District  Court  on  December  13,  2021,  concerning  the  legal 
examination and determination of a so-called unwritten competence of the general meeting regarding the IPO of Biofrontera Inc. On 
December 9, 2022, the Cologne District Court decided in a declaratory judgment that the approval resolutions of the then Board of 
Directors and the then Supervisory Board for the IPO of Biofrontera Inc. were unlawful because the prior approval required for the 
IPO by the general meeting, as required by the Holzmüller doctrine, was unlawfully not obtained. The further claim was dismissed. 
In its reasoning, the court stated that the IPO initiated a significant loss of control by allowing third-party investors to take over the 
majority in the subsidiary without exercising the subscription rights of the parent company. According to the court, this loss of 
control results in significant financial losses for Biofrontera AG and its shareholders. Since all former members of the management 
board  and supervisory board involved in the resolutions have left the company, former board members and  supervisory board 
members were served with statements of intervention regarding possible claims for damages. The Company has decided not to 
appeal the judgment. Appeals by the intervenors have rendered the judgment not final, and it will be continued in the second instance 
by the intervening parties. The effectiveness of the IPO of Biofrontera Inc. remains unaffected by the judgment. 

Management Board 

Biofrontera AG Annual Report 2023 

13 

 
Ms. Pilar de la Huerta Martínez was appointed as a member of the Executive Board on 19 August 2022 with effect from 12 September 
2022. Since then, Ms. de la Huerta Martínez has been the sole member of the Executive Board, and her contract was extended by the 
Supervisory Board at the end of December 2023 until December 31, 2025. 

Supervisory Board 

At the Annual General Meeting of Biofrontera AG in 2022, Prof. Dr. Karin Lergenmüller was elected to the Supervisory Board. The 
election was confirmed by the Extraordinary General Meeting on 9 January 2023. On 4 July 2023, Maruho Deutschland GmbH withdrew 
its actions for annulment brought against both decisions. This means that the election of Prof. Dr. Lergenmüller to the Supervisory 
Board is final. At the same time, with the withdrawal of the lawsuit, the last lawsuit directed against resolutions of the company's 
general meeting was also disposed of. The withdrawal of the lawsuit is part of an out-of-court agreement dated June 19, 2023, which 
simultaneously settled a dispute over possible losses of voting rights of Maruho Deutschland GmbH at past general meetings and 
agreed on a procedure to avoid loss of voting rights at future general meetings. The agreement is set out in detail in the Company's 
announcement in the Federal Gazette pursuant to Section 248a of the German Stock Corporation Act (AktG) dated July 7, 2023. 

Evaluation of the business performance of the Biofrontera Group 

Comparison of actual and forecast business performance 

The Biofrontera Group generated sales of around EUR 32.2 million in the 2023 financial year, significantly exceeding the upper third 
of the revenue forecast range of EUR 27 to 33 million. This result was achieved through a 34.3% increase in US licensing revenues 
and a remarkably positive sales performance in our home market of Germany, which also grew by 31.4%.  

For  the  fiscal  year  2023,  the  company  had  forecasted  an  EBITDA  between  EUR  3  and  5  million,  and  with  an  actual  EBITDA  of 
EUR 5.9 million, this forecast range was exceeded. Additionally, the EBIT of EUR 5.1 million, also exceeded the forecast of EUR 2 to 4 
million. Essentially, Biofrontera was able to significantly strengthen the revenue side, so that the moderate increase in costs had 
less of an impact on the result than anticipated. 

Liquidity developed as forecasted, standing at 3,080 TEUR as at 31 December 2023, was below the previous year's level of 6,376 TEUR. 
Due to a weak share price, the company decided to cancel a planned capital measure in July 2023. Over the course of the year, the 
share  price  was  unable  to  recover  from  this  low,  meaning  that  the  shares traded  below  the  nominal  value  of  EUR  1.00  for  the 
remainder of the year. This meant that the implementation of a capital measure at a later date could no longer be formally realized. 
In  the  previous  year,  liquidity  was  significantly  strengthened  by  a  successfully  implemented  capital  measure  with  gross  issue 
proceeds of around EUR 7.1 million. 

In  the  case  of  training  measures  and  internal/external  audits  as  non-financial  performance  indicators,  the  development  in  the 
financial year met the forecasts. The number of external training courses fell slightly to 40 in the year under review compared to 
48  in  the  previous  year.  The  company's  internal  identification  of  further  training  measures  is  based  on  demand,  so  that  the 
development of this key figure depends significantly on the level of qualification of the current employee base. In addition, the 
number of employees in the Biofrontera Group declined in the year under review, with the result that training courses in particular 
declined as a result of onboarding processes. The number of documents describing standardized and controlled workflows (SOPs) 
increased dramatically again during the reporting period. The company now manages 803 SOPs (previous year: 699). Internal training 
was at a similar level compared to the previous year. In the internal training courses, employees are trained in new and modified 
SOPs.  If  there  are  product  modifications  or  changes  in  official  requirements,  such  training  becomes  necessary.  The  regulatory 
environment of a pharmaceutical company sets enormously high standards here, so that the internal and external training standard 
at Biofrontera has been at an extremely high level since the introduction of this metric. The number of external and internal audits 
remained stable in 2023 compared to the previous year, with 16 audits or inspections carried out.  

The number of employees did not increase in the financial year as forecast. 

The regulatory and clinical progress planned for 2023 was largely achieved. An improved Ameluz® formulation was approved in both 
the USA and the EU in the reporting period. The new formulation does not contain propylene glycol. This may have a positive effect 
on the safety profile of the gel and avoid possible risks with regard to the formation of impurities and allergic reactions. Biofrontera 
has submitted a patent application to protect this new formulation.  

In the EU, the EMA has approved the extension of the marketing authorization for the photodynamic treatment of mild and moderate 
actinic keratoses (AK) with artificial daylight. Photodynamic therapy with artificial daylight combines the advantages of the original 

14 

Biofrontera AG Annual Report 2023 

 
daylight therapy, which significantly reduces treatment pain, with the controlled environment of a doctor's office, so that daylight 
PDT with Ameluz® can now also be used regardless of the prevailing weather conditions. 

The Phase I study required by the FDA to collect additional safety data on the use of three tubes of Ameluz® in a PDT session was 
completed this year as planned. The extended approval dossier in the USA was submitted to the FDA at the end of 2023. 

The Company is currently conducting three independent Phase II and III clinical trials to expand the U.S. approval of Ameluz®. One 
of these ongoing studies is testing the efficacy of Ameluz-PDT® in moderate to severe forms of acne in adults. So far, 77 out of 126 
patients  have been  enrolled in the study. In the  study to test Ameluz-PDT® in superficial basal cell carcinoma, which has been 
running since 2018, recruitment was successfully completed in August 2023. A total of 187 patients were included in the study. The 
treatment phase is expected to be completed in the first quarter of 2024, after which all patients will be in the 5-year follow-up 
phase. In December 2022, a Phase III study to investigate the efficacy of Ameluz-PDT® for the treatment of actinic keratoses of the 
extremities, trunk and neck started. A new lighting profile is used to alleviate pain during PDT. Recruitment progress in this study 
fell short of expectations in 2023. So far, 72 patients have been enrolled. 

Evaluation of the business performance by the Management Board 

With the exception of cancellation of the capital measure, business performance for both the Biofrontera Group and Biofrontera AG 
was positive overall for the year as a whole and thus met the management's expectations. Both total sales and the forecast EBITDA 
and EBIT were achieved or exceeded. Only in Spain did sales decline slightly, which was due to both the price increase for Ameluz® 
and personnel changes in the Spanish sales team. This delayed the expected recovery in Spanish sales, but it is expected that this 
trend will not continue in 2024 and that the extended approval of Ameluz® for artificial daylight will also provide new impetus in 
the  Spanish  market.  Over  the  course  of  the  year,  Biofrontera  continued  to  be  affected  by  supply  bottlenecks  and  inflationary 
pressure in the procurement of materials for the manufacturing of the RhodoLED® XL lamp. 

Despite the positive EBITDA of EUR 5.9 million, earnings before income taxes amounted to EUR ‑2,127 thousand in the 2023 financial 
year (previous year:EUR ‑43,210 thousand). 
The separate financial statements of Biofrontera AG show a net loss for the year of EUR -7,295  thousand after EUR -31,527 thousand 
in the previous year. 

Biofrontera Group financial position and performance 

Results of operations of the Biofrontera Group 

The results of operations as of December 31, 2023 are as follows: 

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 

Biofrontera AG Annual Report 2023 

2023 

32,249 

26,005 

(7,846) 

(6,105) 

(7,273) 

4,782 

350 

5,923 

5,132 

(7,259) 

(2,127) 

(369) 

2022 

25,738 

20,981 

(7,128) 

(5,906) 

(6,357) 

1,591 

(467) 

1,869 

1,124 

-44,334 

-43,210 

-44,166 

15 

 
 
 
Sales revenue 

The Biofrontera Group generated total sales of EUR 32,249 thousand in the reporting year 2023, an increase of 25.3% compared to 
the previous year (previous year: EUR 25,738 thousand). 

Total  revenues  in  Europe  increased  by  20%  compared  to  the  previous  year  to  EUR  9,919  thousand  (previous  year:  EUR  8,261 
thousand). In Germany, sales increased by 31.4% year-on-year to EUR 6,257 thousand (previous year: EUR 4,763 thousand) and total 
sales in the rest of Europe also increased slightly by 5% to a total of EUR 3,662 thousand (previous year: EUR 3,498 thousand). 

In the 2023 financial year, Biofrontera generated revenue of EUR 22,224 thousand with our licensee in the USA compared to EUR 
17,135 thousand in the previous year, an increase of 30%. This includes revenues from service agreements in the amount of EUR 76 
thousand (previous year: EUR 648 thousand). 

Revenue from other regions amounted to EUR 106 thousand in the financial year (previous year: EUR 342 thousand) and included 
both license income and revenue from the sale of study materials 

Gross profit on sale 

Gross profit increased by EUR 5,024 thousand and amounted to EUR 26,005 thousand in 2023 compared to EUR 20,981 thousand in 
the prior year period. The gross margin decreased from 82% in 2022 to 81% in the 2023 financial year.  

Research and development costs 

Research and development costs increased by 10% to EUR 7,846 thousand in the reporting period compared to EUR 7,128 thousand 
in the previous year due to increased activities in clinical trials. In addition to the costs for clinical trials, research and development 

16 

Biofrontera AG Annual Report 2023 

 
 
 
 
costs also include expenses for regulatory affairs, i.e. for obtaining, maintaining and expanding our approvals, expenses for patents 
and personnel costs for employees working in these departments. 

General and administrative costs 

General administrative expenses amounted to EUR 6,105 thousand in the 2023 financial year (previous year: EUR 5,906 thousand), 
an increase of EUR 199 thousand in total compared to the previous year. Expenses were incurred for one-off and extraordinary legal 
and consulting costs.  

Sales and marketing costs 

Sales and marketing expenses amounted to EUR 7,273 thousand in the 2023 financial year, an increase of EUR 917 thousand on the 
previous year (EUR 6,357 thousand), mainly due to increased marketing expenses for the expansion of approvals to include artificial 
daylight and exploratory costs for market expansion in other European countries.  

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 4,054 thousand to EUR 5,923 thousand in fiscal year  2023 compared with the prior-year 
period (EUR 1,869 thousand). The significant increase in EBIT is largely due to the increase in income, while costs remained relatively 
consistent. 

includes  earnings  before 

EBIT 
EUR 1,124 thousand). 

Financial result  

interest  and  taxes  and 

improved  year-on-year  to  EUR 5,132 thousand  (previous  year: 

In addition to  the  interest  result,  the  financial  result  totaling  EUR ‑7,259 thousand  (previous  year: loss  of  EUR 44,334 thousand) 
includes expenses from the subsequent measurement of the carrying amount of the investment in Biofrontera Inc. amounting to 
EUR 7,264 thousand (previous year: profit of EUR ‑44,172 thousand). 

Other income and expenses 

Other expenses and income amounted to a total of EUR 350 thousand in the reporting period (previous year: EUR  -467 thousand) 
and primarily include expenses and income from currency translation and the reversal of provisions. 

Income taxes 

This position includes expenses from current income taxes in the amount of EUR 685 thousand (previous year: EUR 156 thousand) 
and income from deferred taxes in the amount of EUR 2,443 thousand (previous year: EUR -800 thousand) resulting from the first-
time capitalization of deferred taxes at Biofrontera Bioscience GmbH, which is partially offset by a reduction in deferred taxes from 
tax-deductible loss carryforwards at Biofrontera Pharma GmbH. 

Net assets of the Biofrontera Group 

The net assets position as of December 31, 2023is as follows:  

Biofrontera AG Annual Report 2023 

17 

 
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, 2023 

December 31, 2022 

13,012 

11,792 

5,928 

30,732 

19,980 

678 

5,879 

4,194 
30,732 

17,669 

9,324 

5,732 

32,725 

20,336 

4,002 

5,109 

3,277 
32,725 

Non-current assets as of December 31, 2023, totaling EUR 13,012 thousand(previous year: EUR 17,669 thousand) include recognized 
deferred  tax  assets  on  tax  loss  carryforwards  at  Biofrontera  Pharma  GmbH  and  the  first  time  recognition of  deferred  taxes  at 
Biofrontera Bioscience in the amount of EUR 6,818 thousand (previous year: EUR 5,176 thousand), property, plant and equipment in 
the amount of EUR 3,290 thousand (previous year: EUR 3,012 thousand), and intangible assets (EUR 1,152 thousand; previous year: 
EUR 1,198 thousand). Also included here is the investment in Biofrontera Inc. valued at equity in the amount of EUR 1,718 thousand 
(previous year: EUR 8,982 thousand).  

Current financial assets 

Current financial assets totaled EUR 11,792 thousand as of December 31, 2023 (previous year: EUR 9,324 thousand). This includes cash 
and cash equivalents of EUR 3,080 thousand (previous year: EUR 6,376 thousand), trade receivables of EUR 774 thousand (previous 
year: EUR 691 thousand), receivables from associates of EUR 6,365 thousand (previous year: EUR 1,344 thousand), other current 
financial assets of EUR 1,556 thousand (previous year: EUR 878 thousand) and receivables from leasing contracts of EUR 54 thousand 
(previous year: EUR 35 thousand). 

Other current assets 

Other current assets mainly contain inventories. These increased slightly to EUR 5,077 thousand as of December 31, 2023 (previous 
year:  EUR  4,794  thousand).  In  the  reporting  year,  impairment  losses  were  recognized  on  inventories  in  the  amount  of  EUR  24 
thousand (previous year: EUR 155 thousand). 

Other current assets also include current receivables in the amount of EUR 207 thousand (previous year: EUR 146 thousand) and 
prepaid expenses in the total amount of EUR 643 thousand (previous year: EUR 791 thousand). 

Equity 

In accordance with IFRS, the Group reported equity of EUR 19,980 thousand (previous year: EUR 20,336 thousand). The equity ratio 
increased from 63% to 70%, mainly due to improved profit. 

Non-current liabilities 

The financial liabilities reported under non-current liabilities (EUR 678 thousand; previous year: EUR 1,055 thousand) contain the 
liabilities from leases to be recognized in accordance with IFRS 16 in the amount of EUR 678 thousand (previous year: EUR 1,055 
thousand). 

18 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
Current financial liabilities 

Current financial liabilities include, in particular, trade payables in the amount of EUR 2,594 thousand (previous year: EUR  1,984 
thousand) and current financial liabilities in the amount of EUR 468 thousand (previous year: EUR 446 thousand). Also included are 
liabilities to associated companies of EUR 2,747 thousand (previous year: EUR 2,653 thousand); the installment of the liability from 
the DUSA settlement due in January 2024 is reported here. 

Current financial liabilities include current liabilities from leases in accordance with IFRS 16 in the amount of EUR 417 thousand 
(previous year: EUR 444 thousand).  

Other current liabilities 

Other current liabilities amounted to EUR 4,194 thousand (previous year: EUR 3,277 thousand) and mainly include provisions of EUR 
895 thousand (previous year: EUR 603 thousand) as well as other accrued liabilities of EUR 2,458 thousand (previous year: EUR 2,518 
thousand) and income tax liabilities of EUR 841 thousand (previous year: EUR 156 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. 

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 

2023 

(1,905) 

(912) 

(479) 

3,080 

678 

468 
1,934 

2022 

(3,895) 

(981) 

4,344 

6,376 

1,055 

446 
4,874 

Net cash flow from operating activities improved by EUR 1,990 thousand to EUR -1,905 thousand compared to the previous year's 
figure of EUR -3,895 thousand. 

Net cash flow from investing activities amounted to EUR -912 thousand (previous year: EUR -981 thousand) and contains investments 
in property, plant and equipment and intangible assets. 

Net cash flow from financing activities amounted to EUR -479 thousand and was lower than the previous year's figure (previous 
year: EUR 4,344 thousand), which included proceeds from a capital increase carried out in the previous year.  

Cash and cash equivalents 

Cash and cash equivalents in the Group amount to EUR 3,080 thousand as of December 31, 2023 (previous year: EUR 6,376 thousand).  

Biofrontera AG Annual Report 2023 

19 

 
 
 
 
 
 
 
Biofrontera AG financial position and performance 

Results of operations of Biofrontera AG 

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 

2023 

3,311 

449 

(3,238) 

(12) 

(4,939) 

2,078 

(4,945) 

(1) 

(1) 
-7,297 

2022 

3,754 

1,403 

(2,751) 

(22) 

(6,203) 

1,934 

(29,492) 

(146) 

(2) 
-31,527 

The revenue reported in the separate financial statements under German GAAP includes income from intercompany services. Other 
operating  income  mainly  relates  to  income  from  the  reversal  of  provisions  and  income  from  costs  recharged  to  affiliated  and 
associated companies.The decrease in personnel expenses is mainly due to the reduction in Management Board compensation. For 
further details, please refer to the compensation report. 

The increase in personnel expenses is primarily due to settlements for personnel restructuring. 

Other operating expenses decreased by EUR 1,264 thousand to EUR 4,939 thousand. This is primarily due to the reduction in costs 
for legal disputes.  

Interest and other income results almost exclusively from related companies. The net loss for the year amounted to EUR  -7,297 
thousand (previous year: EUR -31,527 thousand). In the 2023 financial year, the net loss for the year was reduced by the impairment 
of the investment in Biofrontera Inc. in the amount of EUR 4,945 thousand, resulting in an adjusted net loss for the year of  EUR -
2,350 thousand.  

20 

Biofrontera AG Annual Report 2023 

 
 
 
 
Net assets of Biofrontera AG 

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, 2023 

December 31, 2022 

36,225 

69,644 

2,560 

411 

108,840 

104,208 

1,768 

0 

0 

2,864 
108,840 

41,176 

72,112 

5,706 

609 

119,603 

111,493 

2,417 

0 

0 

5,694 
119,603 

Fixed  assets  mainly  relate  to  shares  in  affiliated  companies  at  EUR  32,224  thousand  (previous  year:  EUR  32,224  thousand)  and 
investment in associates at EUR 3,988 thousand (previous year: EUR 8,933 thousand). 

Cash on hand and bank balances decreased from EUR 5,706 thousand in the previous year to EUR 2,560 thousand in 2023. For further 
details on the financial position, please refer to the presentation of the Group financial position.  

As of December 31, 2023, Biofrontera AG had equity under German commercial law of EUR 104,208 thousand (previous year: EUR 
111,493 thousand).  

The provisions mainly include provisions for outstanding invoices, litigation costs, bonuses for employees as well as the audit of the 
annual financial statements and tax returns. 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 separate financial statements of Biofrontera AG, liquidity of EUR 2,560 thousand is, as expected, below the previous year's 
figure of EUR 5,706 thousand. The Group's liquidity decreased by EUR 3,296 thousand to EUR 3,080 thousand in the 2023 financial 
year. Please refer to the section on liquidity, profitability and access to the capital market in our risk report in the management 
report for more information on the necessity of providing liquidity to ensure the continuation of business activities. 

Biofrontera AG Annual Report 2023 

21 

 
 
 
 
 
 
 
Outlook and forecast 

General conditions 

The global economic situation for 2024 remains challenging in the context of the past crises, in particular due to significant losses 
in purchasing power as a result of inflation, as well as the generally weak global economic development and geopolitically tense 
situation.  

In the current annual projection published on February 21, 2024 in the annual economic report of the Federal Ministry for Economic 
Affairs and Energy, the German government predicts an increase in price-adjusted gross domestic product of just 0.2% for 2024 and 
1.0% for the following year. According to preliminary data from the Federal Statistical Office, gross domestic product (GDP) fell by 
around 0.25% towards the end of 2023 after seasonal adjustment, resulting in an overall decline of 0.3% in 2023. The inflation rate 
had already weakened significantly at the start of the year and now stands at 2.9%, compared to an average inflation rate of just 
under 6% in 2023. Despite the economic challenges, the labor market remained robust, with employment rising to a historic high of 
just under 46 million people.  

With  stagnating  industrial  production  and  global  trade  that  has  not  yet  reached  its  full  strength  despite  slight  growth,  the 
development of the global economy will also be more subdued in 2024. International organizations are forecasting  a moderate 
recovery in the volume of global trade this year to 3.1% (2023: 0.5%). Economic growth in the western economies is expected to 
continue to converge. 

A panel of US economists expects the year to be characterized by rising growth in the US, largely due to falling inflation and job 
creation - a far cry from the widespread fears of recession that characterized 2023. The National Association for Business Economics 
(NABE) forecasts that gross domestic product will rise by 2.2 % in 2024, a much more optimistic forecast than at the end of 2023. 
According to NABE, the consumer price index is expected to fall to an annual rate of 2.4 % this year, compared to 4.1 % in 2023 and 
8  %  in  2022.  Another  indicator  closely  monitored  by  the  Federal  Reserve  to  assess  price  changes,  personal  consumption 
expenditures, is also expected to fall further.  

Moderate growth of 0.1% to 0.4% is expected for the pharmaceutical market in Western Europe and North America in 2023 and the 
following years. Growth of -1% to +2% is forecast for the US market, which represents a slight reduction compared to previous 
forecasts and results from the Inflation Reduction Act. Growth in the European market is likely to be driven primarily by generics, 
biosimilars and new launches, while price pressure on innovative drugs is likely to remain. In the dermatology sector, a 5-year CAGR 
of 4-7% is expected for the period 2023-27.  

A strategy paper from the German government is currently formulating stronger economic policy support for the pharmaceutical 
industry. Against the backdrop of persistent drug supply bottlenecks, geopolitical risks and regulatory changes at European and 
national level, the intention is to strengthen Germany as a pharmaceutical location. 

Guidance 

For  2024,  we  expect  both  sales  and  earnings  to  be  significantly  lower  than  in  the  previous  year.  This  largely  depends  on  the 
development of inventories at our main customer Biofrontera Inc. In the past year, Biofrontera Inc. has built up a high stock of 
Ameluz® through an aggressive stockpiling policy, which is now to be utilized in a liquidity-preserving manner. Biofrontera Inc. will 
continue to calculate with significantly reduced inventories in the future. As a result, our main customer will order significantly 
fewer merchandise from us in 2024. This change is not due to weakness in the US market or poor sales performance, but is the result 
of the change in stockpiling described above. 

22 

Biofrontera AG Annual Report 2023 

 
 
 
 
However, the solid growth in the European markets will continue.  

Forecast of key performance indicators relevant to management  

Key Figure 
Group revenue 
EBITDA 
EBIT 
Cash and cash equivalents at 31. Dezember 2024 
Nicht finanzielle Kennzahlen 
Employees 
Trainings 
External and internal audits 

*on the condition that the planned capital measure is fully placed 

Forecast 2024 
20-23 Mio. EUR 
-1 Mio.  bis +1 Mio. EUR 
-2 Mio. – 0 Mio. EUR 
3 –4 Mio. EUR* 

Decrease 
unchanged 
unchanged 

The Group anticipates revenue of EUR 20 to 23 million for the 2024 financial year, with growth of 10% expected for the European 
markets, while revenue from the US licensing business will decline significantly, as described above. This decline is due on the one 
hand to the change in stockpiling policy described above, and on the other to an adjustment to the US license agreement, which 
reduced the transfer price of Ameluz® for the second half of the year. However, this transfer price change is fully offset by the 
reduction in costs for the clinical program. 

In Germany, the most important European sales market, the company expects further expansion of the PDT market in the current 
year due to market share gains in the area of topical drugs. Increasing awareness of actinic keratosis as an early form of skin cancer 
requiring treatment and the approach of patient-friendly and reimbursable daylight therapy should support new sales momentum 
in the market. 

Furthermore, the approval of artificial daylight therapy will help us to expand the market in countries where weather conditions do 
not permit the patient-friendly daylight option. 

As a result of the expanded base of sales partners and the associated regional expansion of the marketing of Ameluz®, particularly 
in the Scandinavian countries and Poland, we expect continuous  sales growth for the European market. The expansion of sales 
efforts in Spain and the UK should also contribute to this market growth. As mentioned at the beginning, however, sales growth 
outside the USA is heavily dependent on the continued economic recovery and overcoming the effects of the global crises. There is 
therefore still a degree of uncertainty regarding the sales that can be achieved in the current year. 

Although the decrease in revenue will be approximately EUR 10 million, EBITDA will not be burdened to the same extent due to lower 
expenses  for  clinical  studies.  With  the  amendment  of  the  license  agreement  between  Biofrontera  AG  and  Biofrontera  Inc.,  all 
expenses for clinical development will be transferred to Biofrontera Inc. as of June 1. This will enable the company to maintain EBITDA 
in the break-even range of EUR -1 to +1 million until 2024. Following a normalization of the stockpiling policy of our main customer, 
EBITDA growth is expected to be in line with previous years in subsequent years. EBIT will be between EUR -2 million and break-even. 

As  of  December  31,  2023,  the  Biofrontera  Group  held  cash  and  cash  equivalents  of  EUR  3,080  thousand.  Based  on  the  current 
corporate planning for 2024 and the assumption of a successful capital measure, the Group will have sufficient liquidity to meet all 
obligations for a further 12 months from the date of preparation. In this liquidity forecast, it was assumed that a capital measure will 
result in a cash inflow of EUR 3 million in May 2024. Assuming expenses and income develop as planned and the capital measure 
described above, the Group expects to have cash and cash equivalents of between EUR 3 million and EUR 4 million as of December 
31, 2024. 

For the separate financial statements of Biofrontera AG, we continue to expect a net loss for the year, which is likely to be in the low 
single-digit million range. As the parent company, Biofrontera AG manages the liquidity of the Biofrontera Group. The planned cash 
and cash equivalents of the Group as of December 31, 2024 therefore also correspond to the planned cash and cash equivalents of 
Biofrontera AG. 

Forecast of further key figures 

Biofrontera expects the number of employees to decrease by at least 12 FTEs in 2024 due to the transfer of clinical trial activities to 
Biofrontera Inc.  

Biofrontera AG Annual Report 2023 

23 

 
 
As a result of the increasing requirements for capital market-oriented pharmaceutical companies, we assume that the number of 
training measures in 2024 will be at a comparable level to 2023.  

Maintaining and expanding our approvals is essential for securing and strengthening Biofrontera's market position and is reflected 
in our quality management, among other things. The number of external and internal audits are important non-financial performance 
indicators for the company. We assume that the number of audits in 2024 will be at a similarly high level as in 2023. 

Planned regulatory progress 

In fall 2024, we expect the FDA's response to our application to extend approval for the use of three tubes of Ameluz in a PDT session. 
The Phase I study required by the FDA to collect additional safety data on the use of 3 tubes of Ameluz® during PDT treatment was 
completed as planned in 2023. The submission of the extended approval dossier in the USA took place at the end of 2023.  

The progress of the clinical trials will no longer be reported as a key performance indicator from 2024, since clinical research and 
development will be transferred to the US licensee Biofrontera Inc. in the middle of the year (see note 35 to the consolidated financial 
statements; events after the reporting date). 

Risk and opportunity report 

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 (unaudited) 

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. 

24 

Biofrontera AG Annual Report 2023 

 
 
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-related risk management system and accounting-related 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 
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. 

Biofrontera AG Annual Report 2023 

25 

 
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 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. Corresponding adjustments to changed regulatory requirements have already been implemented. To this 
end, the specially founded Biofrontera UK Ltd. has taken over the distribution of pharmaceutical products in the United Kingdom in 
its entirety from the parent company Biofrontera Pharma GmbH on the basis of a wholesale license since September 2023. It remains 
to be seen how changed regulatory requirements will also be implemented with regard to medical devices in the United Kingdom. 

26 

Biofrontera AG Annual Report 2023 

 
Due to the implementation of the amended regulatory requirements for the distribution of pharmaceutical products, the company 
considers the risk from product sales in the United Kingdom 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.  

As  of  December  31,  2023,  the  Biofrontera  Group  held  cash  and  cash  equivalents  of  EUR  3,080  thousand.  Based  on  the  current 
corporate planning for 2024 and the assumption of a successful capital measure, the Group will have sufficient liquidity to meet all 
obligations for another 12 months from the time of preparation. The prerequisite for this is that liquidity of EUR 3,000 thousand is 
raised in the capital measure planned for May 2024. A major shareholder has already signed a backstop agreement in the amount 
of EUR 1,800,000 for this approved capital measure. These proceeds will enable the company to cover its capital requirements at a 
base level over the next 12 months. 

If the capital measure planned for May 2024 cannot be carried out to the planned extent, the continued operation of Biofrontera AG 
would be severely jeopardized (material uncertainty). 

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 

Biofrontera AG Annual Report 2023 

27 

 
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 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. 

28 

Biofrontera AG Annual Report 2023 

 
Furthermore, a patent application for an improved Ameluz® formulation without propylene glycol was filed in spring 2023. If this 
patent is granted, Ameluz® will be protected in the EU and the USA until 2043. 

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 

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 

Biofrontera AG Annual Report 2023 

29 

 
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 
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.  

30 

Biofrontera AG Annual Report 2023 

 
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  establishment  of  a  separate  sales  unit  in  France  in  particular  currently  appears 
promising in the mid to long term due to the attractive market environment and would be accompanied by an expansion of personnel 
sales structures in this country. A more comprehensive European sales structure that covers the major European markets could 
also make the company more attractive as a licensee for marketing other companies' products. 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.  
In recent years, the Company has regularly relied on external cash and cash equivalents.  As of December 31, 2023, the 
Biofrontera Group held cash and cash equivalents of EUR 3,080 thousand. Based on the current corporate planning for 
2024 and the assumption of a successful capital measure, the Group will have sufficient liquidity to meet all obligations 
for another 12 months from the time of preparation. The prerequisite for this is that liquidity of EUR 3,000 thousand is 
raised in the capital measure planned for May 2024. A major shareholder has already signed a backstop agreement in the 
amount of EUR 1,800,000 for this approved capital measure. These proceeds will enable the company to cover its capital 
requirements at a base level over the next 12 months. 

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 conducting a clinical program in the USA. This includes 
a phase III clinical trial for the treatment of superficial basal cell carcinoma (BCC) with Ameluz®, a phase IIb trial to extend 
the approval of Ameluz® for moderate to severe acne in the USA and the already completed phase I safety trial to extend 
the posology for Ameluz® to three tubes in the USA, where use is currently limited to one tube of Ameluz® per treatment.. 

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. 

Biofrontera AG Annual Report 2023 

31 

 
 
 
 
 
 
 
▪  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 the original scope of the 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. 

▪ 

An  amendment  to  the  existing  license  and  supply  agreement  between  Biofrontera  AG  and  Biofrontera  Inc.  will  be 
implemented  on  June  1,  2024.  This  contract  amendment  provides  for  Biofrontera  Inc.  to  take  over  the  entire  clinical 
development from now on, which will reduce the cost burden for Biofrontera AG. As a result, Biofrontera AG's available 
resources can now be increasingly focused on expanding its portfolio and developing the market in Europe and other 
countries. In addition, Biofrontera AG can continue to benefit significantly from the positive growth of the US business. 
Further information on changes relating to the license and supply agreement between Biofrontera AG and Biofrontera Inc 
is provided separately in the "Outlook and forecast" section. 

▪  With regard to legal disputes, Biofrontera considers itself well positioned. The judgment obtained by Deutsche Balaton AG 
in 2022 declaring that the approval resolutions of the former Management Board and the former Supervisory Board for 
the IPO of Biofrontera Inc. were unlawful does not affect the completed IPO of Biofrontera Inc. or the company's operating 
business. The proceedings are being continued by the former members of the Management Board and Supervisory Board 
in the second instance against Deutsche Balaton AG. The action for rescission brought by two shareholders against the 
capital increase resolved at the Extraordinary General Meeting on January 9, 2023 was withdrawn on April 13, 2023 on the 
basis of  a  settlement. The action for  annulment brought by  Maruho Deutschland  GmbH against the resolutions of the 
Annual General Meeting on August 23, 2022 and the Extraordinary General Meeting on January 9, 2023 was also withdrawn 
on July 4, 2023 on the basis of a settlement. This also settles the last action brought against resolutions of the company's 
Annual General Meeting. 

Litigation 

Maruho Deutschland GmbH v. Biofrontera AG (actions for annulment) 

Maruho Deutschland GmbH filed an action for annulment with the Cologne Regional Court against the election of Prof. Dr. Karin 
Lergenmüller to the Supervisory Board resolved at the Annual General Meeting on August 23, 2022 under agenda item 8a. 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. Maruho Deutschland 
GmbH withdrew the action for annulment and the extension of the action on July 4, 2023. Prof. Dr. Lergenmüller's election to  the 
Supervisory Board is therefore final. At the same time, the withdrawal of the action also settled the last action brought against 
resolutions of the company's Annual General Meeting. The withdrawal of the lawsuit is part of an out-of-court agreement dated June 
19, 2023, which also settled a dispute over possible losses of voting rights by Maruho Deutschland GmbH at past Annual General 
Meetings. At the same time, a procedure for avoiding losses of voting rights at future Annual General Meetings was agreed. The 
agreement is reproduced in detail in the company's announcement in the Federal Gazette pursuant to Section 248a AktG dated July 
7, 2023. 

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 the company on February 9, 2022.  

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. 

32 

Biofrontera AG Annual Report 2023 

 
 
 
 
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 the company. By mutual agreement, the proceedings were terminated by a 
declaration filed jointly with Biofrontera Inc. with the Court of Chancery. The amicable termination was agreed in an out-of-court 
settlement with Biofrontera Inc. dated April 11, 2023 ("Inc. Agreement dated April 11, 2023"). 

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. The Inc. agreement dated April 11, 2023 is published in detail in the announcement of 
Biofrontera AG in the Federal Gazette pursuant to Section 248a AktG dated April 19, 2023. 

Ludwig Lutter v. Biofrontera AG 

In two actions before the Regional Court of Cologne, Mr. Ludwig Lutter contested his dismissal as a member of the Management 
Board and the termination of his employment contract and claimed the (partial) continued payment of his remuneration. The 
Cologne Regional Court ruled on the two lawsuits in judgments served to the company on March 22, 2024.  

In the proceedings for a declaratory judgment, the court ruled that the employment relationship was not terminated by 
extraordinary termination, as the alleged derelictions of duty, if any, were not serious enough individually and as a whole to justify 
extraordinary termination in the opinion of the court. As a result, Mr. Lutter was awarded the continued payment of his fixed 
remuneration in the proceedings for documentary evidence. This amounts to EUR 250 thousand. This amount includes income 
earned elsewhere, which was deducted by the court. The company can claim the deduction of any other income earned elsewhere 
in subsequent proceedings relating to the documentary proceedings. 

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. 

Biofrontera Bioscience GmbH v. PCS Europe Sp. z o.o. 

In proceedings before the District Court in Warsaw (Sąd Okręgowy w Warszawie), Biofrontera Bioscience GmbH obtained an injunction 
against a competitor. The injunction of September 3, 2023 prohibited the competitor from advertising their cosmetic product by 
attributing effects that are reserved for medications. 

Biofrontera AG Annual Report 2023 

33 

 
 
 
Takeover-relevant information 

The following overview provides an explanation of the mandatory disclosures in accordance with Section 315a (1) HGB.  The 
disclosures reflect the situation as of December 31, 2023. 

Composition of the share capital 

As of December 31, 2023, the subscribed capital amounted to EUR 63,807,058 and was divided into 63,807,058 nopar value ordinary 
registered shares (no-par value shares). There were no different classes of shares. 

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.  

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. There are 
also no shares with special rights that grant powers of control. 

Disclosures on significant equity investments 

The company is aware of the following direct and indirect shareholdings in the company's share capital exceeding 10% of the 
voting rights as of December 31, 2023: 

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. In an 
accompanying voting rights notification, Mr. Takagi reported "acting in concert" over 
the entire voting rights of Maruho. 
Wilhelm Konrad Thomas Zours 
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 
Biofrontera Inc., Woburn, USA 
Free float 
Total 

December 31, 2023 

December 31, 2022 

18,850,981 

13,399,965 

18,671,057 

17,021,057 

177,465 
26,107,555 
63,807,058 

6,466,946 
26,919,090 
63,807,058 

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. 

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.  

Appointment and dismissal of members of the Management Board 

34 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
The appointment and dismissal of members of the Management Board is governed by Sections 84 and 85 AktG and Section 9 of the 
Articles of Association in the version dated June 27, 2023. In accordance with Section 9 of the Articles of Association, the 
Management Board consists of one or more persons. The number of Management Board members is determined by the 
Supervisory Board. 

Amendment of the Articles of association 

Pursuant to Section 179 AktG, amendments to the Articles of Association require a resolution by the Annual General Meeting. In 
accordance with Section 179 (2) AktG in conjunction with Section 22 (2) of the Articles of Association, the resolution of the Annual 
General Meeting requires a simple majority of the votes and the share capital represented when the resolution is passed. A 
majority of at least 75% of the share capital represented when the resolution is passed is required for changes to the purpose of 
the company. In accordance with Section 16 (6) of the Articles of Association, the Supervisory Board may resolve amendments to 
the Articles of Association that only affect the wording of the Articles of Association, i.e. do not themselves result in any material 
changes. 

Powers of the Board of Management to issue or repurchase shares  

By  resolution  of  the  Annual  General  Meeting  on  9  January  2023,  the  Executive  Board  is  authorized,  with  the  approval  of  the 
Supervisory Board, to increase the company's share capital by up to EUR 12,700,000.00 in return for cash contributions on one or 
more  occasions  until  31  December  2027  (Authorized  Capital  2022).  Shareholders  are  generally  entitled  to  subscription  rights. 
However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude subscription rights for fractional 
amounts resulting from the subscription ratio. 

The share capital was conditionally increased by up to EUR 1,359,864 by resolution of the Annual General Meeting on 28 August 2015 
(Conditional Capital I). Conditional Capital I serves to secure the granting of shares to fulfil (i) option rights and obligations or (ii) 
conversion rights and obligations that were issued, agreed or guaranteed on the basis of the authorization of the Annual General 
Meeting on 28 August 2015 until 27 August 2020. 

The share capital was conditionally increased by up to EUR 249,050.00 by resolution of the Annual General Meeting on July 2, 2010 
(Conditional Capital III). Conditional Capital III serves to secure the granting of shares for  share options in accordance with the 
conditions of the 2010 share option plan, which were issued on the basis of the authorization of the Annual General Meeting on 
02.07.2010 until 01.07.2015. 

The share capital was conditionally increased by up to EUR 1,554,984.00 by resolution of the Annual General Meeting on 28.08.2015 
(Conditional  Capital  V).  Conditional  Capital  V  serves  to  secure  the  granting  of  shares  for  share  options  in  accordance  with  the 
conditions of the 2015 share option plan, which were granted on the basis of the authorization of the Annual General Meeting on 28 
August 2015 until 27 August 2020. 

The share capital is conditionally increased by up to EUR 17,725,000.00 by resolution of the Annual General Meeting on June 20, 2023 
(Conditional Capital 2023). The contingent capital 2023 serves to grant shares to the holders of bonds with warrants or convertible 
bonds with or without warrants, profit participation rights or participating bonds (or combinations of these instruments), each with 
option or conversion rights, which are issued on the basis of the authorization of the Annual General Meeting on 20.06.2023 until 
15.06.2028. 

The Annual General Meeting has not authorized the purchase or sale of treasury 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 2023 

35 

 
 
 
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 29, 2024 

Biofrontera AG  

Pilar de la Huerta Martínez, CFO 

36 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
Corporate Governance Statement of Biofrontera AG pursuant to 
Sections 289f, 315d HGB for the financial year 2023 (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 2023 in the (combined) management report for the financial year  2023, 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 29, 2024 

Biofrontera AG  

Pilar de la Huerta Martínez 
CFO 

Biofrontera AG Annual Report 2023 

37 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
Consolidated financial statements as of December 31, 2023 

Consolidated balance sheet as of December 31, 2023 

Assets 

in EUR thousands 

Non-current assets 

Tangible assets 

Intangible assets 

Deferred tax 

Investments accounted for using the equity method 

Non-current lease receivables 

Total non-current assets 

Current assets 

Financial assets 

Trade receivables 

Receivables from associated companies 

Other financial assets 

Cash and cash equivalents 

Current lease receivables 

Total financial assets 

Other assets 

Inventories 

Other assets 

Total other assets 

Total current assets 
Total assets 

(1) 

(1) 

(9) 

(2) 

(6) 

(4) 

(33) 

(5) 

(8) 

(6) 

(3) 

(7) 

December 31, 2023 

December 31, 2022 

3,290 

1,152 

6,818 

1,718 

33 

13,012 

774 

6,365 

1,556 

3,080 

18 

11,792 

5,077 

850 

5,928 

17,720 
30,732 

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 

15,056 
32,725 

38 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Equity and liabilities 

in EUR thousands 

Equity 

Subscribed capital 

Capital reserve 

Capital reserve from foreign currency conversion adjustments 

Loss carried forward 

Loss for the period 

Total equity 

Non-current liabilities 

Financial debt 

Liabilities to associated companies 

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 

(10) 

(11) 

(13) 

(33) 

(11) 

(12) 

(14) 

(15) 

(16) 

December 31 , 2023 

December 31 , 2022 

63,807 

137,330 

1 

(180,789) 

(369) 

19,980 

678 

0 

678 

2,594 

2,747 

468 

71 

5,879 

841 

895 

2,458 

4,194 

10,073 
30,732 

63,807 

137,318 

0 

(136,623) 

(44,166) 

20,336 

1,055 

2,642 

4,002 

1,984 

2,653 

446 

26 

5,109 

156 

603 

2,518 

3,277 

8,387 
32,725 

Biofrontera AG Annual Report 2023 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated statement of comprehensive income for the fiscal year 2023 

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 

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 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 

Basic earnings per share in EUR 
Diluted earnings per share in EUR 

01.01.-31.12.2023 01.01.-31.12.2022 

32,249 
(6,243) 
26,005 

(7,846) 
(6,105) 
(7,273) 
4,782 

791 
(236) 
586 

5,923 
(791) 
5,132 

(15) 
21 
(7,264) 

(2,127) 
1,758 
(369) 
(369) 

25,738 
(4,757) 
20,981 

(7,128) 
(5,906) 
(6,356) 
1,591 

746 
(902) 
435 

1,869 
(746) 
1,124 

(163) 
1 
(44,172) 

(43,210) 
(956) 
(44,166) 
(44,166) 

1 

0 

(368) 

(44,166) 

(0.01) 
(0.01) 

(0.77) 
(0.77) 

(17) 
(18) 
(18) 

(19) 
(20) 
(21) 

(27) 
(24) 
(24) 

(27) 

(22) 
(22) 
(23) 

(25) 

(26) 
(26) 

40 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated statement of changes in equity for the fiscal year 2023  

Ordinary 
shares 

Subscribed 
capital 

Capital 
reserve 

Number of 
shares 

56,717,385 

0 
0 
0 
7,089,673 

0 

0 

0 

0 

in EUR 
thousands 

in EUR 
thousands 

56,717 

137,332 

0 
0 
0 
7,090 

0 

0 

0 

0 

0 
0 
0 
0 

0 

-64 

50 

0 

(10) 

63,807,058 

63,807 

137,318 

Ordinary 
shares 

Subscribed 
capital 

Capital 
reserve 

Number of 
shares 

in EUR 
thousands 

in EUR 
thousands 

(10) 

63,807,058 

63,807 

137,318 

0 
0 
0 
0 

0 

0 

0 

0 
0 
0 
0 

0 

0 

0 

0 
0 
0 
0 

0 

0 

12 

(10) 

63,807,058 

63,807 

137,330 

Reserve from 
foreign 
currency 
conversion 
adjustment 
(OCI) 
in EUR 
thousands 

Loss carried 
forward 
Loss for the 
period 

Total 

in EUR 
thousands 

in EUR 
thousands 

0 

0 
0 
0 
0 

0 

0 

0 

0 

0 

Reserve from 
foreign 
currency 
conversion 
adjustment 
(OCI) 
in EUR 
thousands 

0 

0 
1 
1 
0 

0 

0 

0 

1 

-136,623 

-44,166 
0 
-44,166 
0 

0 

0 

0 

0 

57,426 

-44,166 
0 
-44,166 
7,090 

0 

-64 

50 

0 

-180,789 

20,336 

Loss carried 
forward 
Loss for the 
period 

Total 

in EUR 
thousands 

in EUR 
thousands 

-180,789 

20,336 

-369 
0 
-369 
0 

0 

0 

0 

-369 
1 
-368 
0 

0 

0 

12 

-181,158 

19,980 

Balance as of January 01, 
2022 
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   
Disposal scope of 
consolidation 
Balance as of December 31, 
2022 

Balance as of December 31, 
2022 
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, 
2023 

Biofrontera AG Annual Report 2023 

41 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated cash flow statement for the fiscal year 2023 

in EUR thousands 

01.01.-31.12.2023 

01.01.-31.12.2022 

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 
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 

(8) 

-2,127 

1,758 
7,259 
791 
0 
-2,450 

-5,077 

-590 
-283 
711 
305 
-2,238 
-1,905 

-912 
-912 

0 
0 
0 
-467 
-12 
-479 

-3,296 
6,376 
3,080 

-43,210 

-956 
44,334 
746 
11 
569 

-831 

-367 
20 
-3,204 
-309 
-728 
-3,895 

-981 
-981 

0 
-64 
-2,031 
-453 
-198 
4,344 

-532 
6,908 
6,376 

42 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes to the consolidated financial statements as of December 31, 
2023 

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,  along  with  the  wholly  owned  subsidiary  Biofrontera  UK  Ltd.  based  in  Reading  (Berkshire,  United 
Kingdom) as a 100% subsidiary of Biofrontera Pharma GmbH, and the Spanish branch Biofrontera Pharma GmbH sucursal en España, 
based 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 26.4% and is reported under investments in associates 
using the at-equity method.  

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,  along  with  the  wholly  owned  subsidiary  Biofrontera  UK  Ltd.  based  in  Reading  (Berkshire,  United 
Kingdom) as a 100% subsidiary of Biofrontera Pharma GmbH, and the Spanish branch Biofrontera Pharma GmbH sucursal en España, 
based in Cornellá de Llobregat, research, develop and distribute dermatological products. 

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 18). 

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, 2023 to December 31, 2023 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 are prepared on a going concern basis. This assumes that a capital increase of around EUR 
3,000 thousand planned for May 2024 will be successfully implemented (material uncertainty). To this end, the company has entered 
into a backstop agreement with a major shareholder in the amount of EUR 1,800 thousand to ensure that the company has sufficient 
cash to cover its liquidity requirements over the next 12 months, regardless of the final subscription ratio of the capital increase. 
Without the planned capital increase, the company's continued existence as a going concern is seriously jeopardized. 

Biofrontera AG Annual Report 2023 

43 

 
 
Biofrontera  AG  is  the  ultimate  controlling  company  preparing  consolidated  financial  statements  for  the  group  of  consolidated 
companies. For Biofrontera Pharma GmbH, Leverkusen, which is included in the consolidated financial statements, the exemption 
provisions pursuant to Section 264 (3) of the German Commercial Code (HGB) are utilized. 

The consolidated financial statements as of December 31, 2023 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, 2023 were authorized for issue and forwarding to the Supervisory Board 
by the Executive Board on April 29, 2024. 

Changes in accounting standards 

The accounting policies applied are consistent with those used as of December 31, 2022, 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 2023. 

Standard 

Description 

Mandatory application  Effects 

Initial Application of IFRS 17 

Insurance contracts 

Amendments to IFRS 17 

Insurance contracts: Initial Application of IFRS 17 

"Presentation of financial statements”: Disclosure of 
accounting policies 

January 1, 2023 

January 1, 2023 

No effects 

No effects 

January 1, 2023 

No effects 

Amendment to IAS 1 

Amendment to IAS 8 

Amendment to IAS 12 

Amendment to IAS 12 

"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 

No effects 

"Income taxes": Deferred taxes resulting from the 
introduction of global minimum taxation 

January 1, 2023 

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 

Description 

Mandatory 
application 

Expected effects 

Amendment to IAS 1 

"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 

Amendments to IAS 21 * 

"The Effects of Changes in Foreign Exchange Rates": 
Lack of Exchangeability 

January 1, 2025 

No effects 

Amendments to IAS 7 and IFRS 7 
* 

" Statement of Cash Flows" and "Financial Instruments": 
Disclosures: Supplier Finance Arrangements 

January 1, 2024 

No effects 

* Endorsement by the EU still pending 

Basis of consolidation 

The consolidated financial statements as of December 31, 2023 include the financial statements of the parent company, Biofrontera 
AG, and the subsidiaries that the parent company controls. Control exists when Biofrontera is subject to, or has rights to, variable 
returns from its involvement with the subsidiary and has the ability to affect those returns through its power over the subsidiary. 

44 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
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, 2023, prepared in accordance with uniform principles. 
The consolidated financial statements as of December 31, 2023 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. 

Translation of amounts in foreign currencies 

The consolidated financial statements as of December 31,  2023 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 (2023: 0.86905 GBP/EUR). 
Revenue and expense items are translated at the average foreign currency exchange rates (2023: 0,86979 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 (2023: EUR 1 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.  

Application of estimates 

The preparation of the consolidated financial statements as of December 31, 2023 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. 

Biofrontera AG Annual Report 2023 

45 

 
 
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 
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.  

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  the  lessee  mainly  for  buildings  and  motor  vehicles  used  for  operational  and  administrative  purposes.  The 
corresponding lease liability is calculated  as the present value of the  highly probable payments to be made to the lessee. It is 

46 

Biofrontera AG Annual Report 2023 

 
amortized  using  the  effective  interest  method.  The  right-of-use  asset  to  be  recognized  in  return  for  the  underlying  asset  is 
recognized  at  cost  at  the  inception  of  the  lease.  In  addition  to  the  lease  payments,  any  initial  direct  costs  of  the  lessee  and 
dismantling costs are included in the calculation. Incentive payments granted by the lessor must 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 such 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 an 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 
- Self-generated assets 10 years, straight-line 
- 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.  

Biofrontera AG Annual Report 2023 

47 

 
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  carrying  amount.  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.  

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. 

48 

Biofrontera AG Annual Report 2023 

 
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 
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. Revenue from 
product sales to third parties and licensees is recognized at the time of delivery. 

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.  

Biofrontera AG Annual Report 2023 

49 

 
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 2023. 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:  

50 

Biofrontera AG Annual Report 2023 

 
 
 
Statement of changes in non-current assets for 2023 

in EUR thousands 

Purchase and production cost 

Accumulated depreciation 

Carrying amounts 

01.01. 2023  Currency 

translation  Additions  Disposals  Transfers  31.12.2023  01.01. 2023  Currency 

translation  Additions  Disposals  31.12.2023  31.12.2023  01.01. 2023 

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 

Total 

3,680 
3,110 
954 
7,744 
0 
0 
259 
736 
1,250 
2,245 
0 
9,989 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

799 
0 
62 
861 
0 
0 
40 
0 
73 
113 
0 
974 

-16 
86 
-110 
-40 
0 
0 
-26 
0 
0 
-26 
0 
-66 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

4,462 
3,196 
906 
8,564 
0 
0 
273 
736 
1,323 
2,332 
0 
10,896 

-1,997 
-2,005 
-730 
-4,732 
0 
0 
-212 
-707 
-127 
-1,047 
0 
-5,778 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

-214 
-295 
-124 
-633 
0 
0 
-43 
-9 
-107 
-159 
0 
-791 

16 
-36 
110 
90 
0 
0 
26 
0 
0 
26 
0 
116 

-2,194 
-2,336 
-743 
-5,274 
0 
0 
-230 
-716 
-234 
-1,180 
0 
-6,454 

2,268 
859 
163 
3,290 
0 
0 
43 
20 
1,089 
1,152 
0 
4,442 

1,683 
1,105 
225 
3,012 
0 
0 
46 
28 
1,124 
1,198 
0 
4,210 

Biofrontera AG Annual Report 2023 

51 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Statement of changes in non-current assets for 2022 

in EUR thousands 

Purchase and production cost 

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 
Intangible asset under development 
Intangible assets 

Total 

01.01. 2022  Currency 

translation  Additions 

Disposals  31.12.2022  01.01. 2022  Currency 

translation  Additions 

Disposals  31.12.2022  31.12.2022  01.01. 2022 

3,551 
2,710 
949 
7,210 

260 
887 
1,073 
2,219 

9,429 

0 
0 
0 
0 

0 
0 
0 
0 

0 

767 
400 
165 
1,332 

24 
12 
178 
214 

-639 
0 
-159 
-798 

-25 
-163 
0 
-188 

3,680 
3,110 
954 
7,744 

259 
736 
1,250 
2,245 

-2,441 
-1,728 
-760 
-4,928 

-203 
-859 
-18 
-1,079 

1,546 

-986 

9,989 

-6,008 

0 
0 
0 
0 

0 
0 
0 
0 

0 

-188 
-278 
-130 
-595 

-30 
-12 
-109 
-150 

-746 

633 
0 
159 
792 

20 
163 
0 
183 

-1,997 
-2,005 
-730 
-4,732 

-212 
-707 
-127 
-1,047 

1,683 
1,105 
225 
3,012 

46 
28 
1,124 
1,198 

1,110 
982 
189 
2,281 

57 
28 
1,055 
1,139 

975 

-5,778 

4,210 

3,421 

52 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.  Financial assets accounted for using the equity method 

Financial  assets  include  the  carrying  amount  of  the  investment  in  Biofrontera  Inc.  of  EUR 1,718 thousand  (previous  year: 
EUR 8,982 thousand), which is included and measured in the consolidated financial statements using the equity method: 

General information 

Capital share 

Share of voting rights 

31.12.2023 

31.12.2022 

31.12.2023 

31.12.2022 

Fair value of the investment 
when a quoted market price 
exists 
in TEUR 

31.12.2023 

31.12.2022 

Biofrontera Inc., Woburn (USA) 

26.40% 

29.96% 

26.40% 

29.96% 

1,108 

6,854 

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 

31.12.2023 

31.12.2022 

Current assets 

thereof cash and cash equivalents 

Noncurrent assets 
Current liabilities 
Noncurrent liabilities 

Revenues 
Operating Result 
Other Income 
Result after tax 

20,882 
1,215 
4,395 
16,369 
4,571 
0 
30,833 
(20,522) 
2,317 
(18,218) 

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, 2022 
Proportionate earnings after taxes 2023 
Impairment 
Carrying amount as of December 31, 2022 

Biofrontera AG Annual Report 2023 

40,446 
16,134 
7,260 
19,589 
5,730 
0 
26,884 
(17,421) 
16,851 
(600) 

8,982 
-7,264 
0 
1,718 

53 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obligations to the associated company 

The Group has obligations to Biofrontera Inc. in the amount of EUR 201 thousand resulting from services rendered under service 
agreements.  Furthermore,  future  obligations  to  Biofrontera  Inc.  in  the  amount  of  EUR  2,545  thousand  in  connection  with  the 
settlement payments arising from the legal dispute with DUSA Pharamaceuticals Inc. are included in liabilities. 

3.  Inventories 

in EUR thousands 

Raw materials 

Unfinished goods 

Finished goods and products 
Total 

December 31, 2023 

December 31, 2022 

2,749 

921 

1,407 
5,077 

2,746 

1,045 

1,003 
4,794 

In the reporting year, impairment losses of EUR 24 thousand (previous year: EUR 218 thousand) were recognized on finished goods.  

4.  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. 

5.  Other financial assets 

Other financial assets mainly comprise security deposits, primarily for rented premises, credit cards and leased vehicles (EUR 30 
thousand; previous year: EUR 27 thousand), as well as advance payments for services (EUR 1,508 thousand; previous year: EUR 816 
thousand). As in the previous year, there was no impairment in the year under review. 

6.  Receivables from leases 

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.  As  of  December  31,  2023,  there  were  non-current  receivables  of 
EUR 33 thousand(previous  year:  EUR 101 thousand)  and  current  receivables  of  EUR 18 thousand  (previous  year:  EUR 35 thousand) 
under the subleases. 

7.  Other assets 

Other assets mainly comprise prepaid expenses (EUR 643 thousand; previous year: EUR 791 thousand) and VAT receivables of EUR 
207 thousand (previous year: EUR 147 thousand). As in the previous year, no impairment losses were recognized in the reporting 
year. 

8.  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 3,080 thousand (previous year: EUR 6,376 thousand).  

9.  Deferred income tax 

Deferred tax assets amount to EUR 6,818 thousand (previous year: EUR 4,375 thousand) concern both Biofrontera Pharma GmbH and 
Biofrontera Bioscience GmbH.  

The increase in deferred tax assets of EUR 2,443 thousand (previous year: EUR -800 thousand) results from the first-time recognition 
of  deferred  tax  assets  at  Biofrontera  Bioscience  GmbH,  which  is  offset  by  a  reduction  in  the  usable  tax  loss  carryforwards  of 

54 

Biofrontera AG Annual Report 2023 

 
 
Biofrontera Pharma GmbH, with the amount of the usable tax loss carryforwards being reduced to the probable utilization during 
the planning period. 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, 2023 

December 31, 2022 

Corporation tax including Solidarity 
Surcharge 

Business tax 
Total 

Loss carried 
forward 

Deferred 
tax assets 

Loss carried 
forward 

148,164 

129,303 

23,447 

11,314 
34,761 

151,887 

133,709 

Deferred 
tax assets 

24,036 

11,700 
35,736 

These loss carryforwards have an unlimited carryforward period under current German law.  

in EUR thousands 

December 31, 2023 

December 31, 2022 

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 

7,086 

Deferred tax 
liabilities 

Deferred tax 
assets 

4,651 

0 

0 
0 

0 

0 

264 

7,350 

(532) 

6,818 

(268) 

(251) 
(13) 

0 

0 

0 

(532) 

532 

0 

0 
0 

0 

0 

360 

5,011 

(636) 

4,375 

Deferred tax 
liabilities 

0 

(276) 

(327) 
(25) 

(8) 

0 

0 

(636) 

636 

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 
future taxable profits, taking into account the loss history, the remaining deferred tax assets from loss carryforwards of EUR 27,675 
thousand (previous year: EUR 31,085 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. 

Biofrontera AG Annual Report 2023 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
in EUR thousands 

December 31, 2023 

December 31, 2022 

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 

Other effects 

Income taxes per statement of comprehensive income 

10. Equity 

Share capital 

(2,127) 

523 

(57) 

(1,785) 

0 
(147) 
0 
(85) 

3,309 

0 

1,758 

(43,210) 

10,619 

0 

(394) 

(10,461) 
(117) 
0 
0 

(617) 

13 

(957) 

The fully paid-in share capital of the parent company, Biofrontera AG, amounted to EUR 63,807,058.00 as of December 31, 2023. It 
consisted of   63,807,058 registered  shares with a nominal value  of EUR 1.00  each. On December 31,  2022, the  share capital  had 
amounted to EUR 63,807,058.00.   

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 share capital was held as follows on December 31, 2023: 

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. In an accompanying voting rights 
notification, Mr. Takagi reported "acting in concert" over the entire voting rights of Maruho. 
Wilhelm Konrad Thomas Zours 
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 
Biofrontera Inc., Woburn, USA 
Free float 
Total 

December 31, 
2023 

December 31, 
2022 

18,850,981 

13,399,965 

18,671,057 

17,021,057 

177,465 
26,107,555 
63,807,058 

6,466,946 
26,919,090 
63,807,058 

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 

56 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
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 

By resolution of the Annual General Meeting on 9 January 2023, the Management Board is authorized, with the approval of the 
Supervisory Board, to increase the company's share capital once or several times by up to EUR 12,700,000.00 until 31 December 2027 
in return for cash contributions (Authorized Capital 2022). 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,  2023.  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, 2023, 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, 2023 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. 

The share capital has been conditionally increased by up to EUR 17,725,000.00 by resolution of the Annual General Meeting on June 
20, 2023 for the issue of bonds with warrants and convertible bonds (Conditional Capital 2023). 

2015 stock option program 

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 

Biofrontera AG Annual Report 2023 

57 

 
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 
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). 

58 

Biofrontera AG Annual Report 2023 

 
 
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 
07.05.2018 
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, 2023 

December 31, 2022 

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 

338,490 

0 

96,500 

0 

157,000 

84,990 

0 

693,990 

0 

231,000 

0 

124,500 

338,490 

0 

5,73-6,71 EUR 

2,25-6,710 EUR 

16 months 
12 TEUR 

14 months 
50 TEUR 

Due to the non-fulfillment of the exercise conditions, no options were exercisable as of December 31, 2023. 

Capital reserves 

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 0 thousand (previous year: EUR 64 thousand) for the year ended December 31, 2023. 

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. 

Biofrontera AG Annual Report 2023 

59 

 
 
 
 
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. 

11.  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, 2023 

December 31, 2022 

Non-current financial liabilities 

Leasing liabilities 

Total non-current financial liabilities 

Current financial liabilities 

Leasing liabilities 

Other current liabilities 
Total current financial liabilities 

678 

678 

429 

39 
468 

1,055 

1,055 

446 

0 
446 

The contractual interest and principal payment obligations from financial liabilities at the balance sheet date break down as 
follows: 

in EUR thousands 

Leasing liabilities 
Principal repayment 
Interest payment 

December 31, 2023 

2023 

2024 

2025 

2026 

2027 

Total 

428 
8 

395 
4 

284 
1 

0 
0 

0 
0 

1,107 
13 

in EUR thousands 

December 31, 2022 

Leasing liabilities 
Principal repayment 
Interest payment 

60 

2023 

2024 

2025 

2026 

2027 

Total 

446 
10 

408 
6 

374 
3 

273 
1 

0 
0 

1,501 
20 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Leasing liabilities 

The carrying amount of current and non-current lease liabilities is EUR 1,107 thousand (previous year: EUR 1,501 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 
01.01.2023 
1,274 
178 
49 
1,501 

Additions 

Disposals 

0 
62 
0 
62 

0 
0 
0 
0 

Principal 
paymnets 
(332) 
(111) 
(13) 
(456) 

as of  
31.12.2023  
942 
129 
36 
1,107 

Leasing 
payments 
308 
4 
14 
325 

Interest 
expense 
11 
121 
1 
132 

For further details, please refer to the presentation of the significant accounting policies.  

12. Other financial liabilities 

in EUR thousands 

December 31, 2023 

December 31, 2022 

Non-current other financial liabilities 

Liability 
from SAR program 

Current financial liabilities 

0 
0 

71 

0 
0 

26 

Trade accounts payable amount to EUR 1,984 thousand as of December 31, 2022 (previous year: EUR 2,735 thousand). 

13. Trade payables 

As of December 31, 2023, trade payables amount to EUR 2,594 thousand (previous year: EUR 1,984 thousand). 

14. Income taxes 

Income tax liabilities amounting to EUR 841 thousand (previous year: EUR 156 thousand) relate to liabilities from  corporation tax 
(EUR 499 thousand, previous year: EUR 83 thousand) and commercial tax (EUR 342 thousand, previous year: EUR 73 thousand) at 
Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH. 

15. Other provisions 

The development of other provisions of the Biofrontera Group is as follows: 

in EUR thousands 

December 31, 
2022 

Utilized 

Released 

Added 

Reclassified 

December 31, 
2023 

Provisions for litigation 
costs 

Other provisions 

Total 

518 

85 

603 

(23) 

(3) 

(26) 

(15) 

0 

(15) 

325 

7 

332 

0 

0 

0 

Biofrontera AG Annual Report 2023 

805 

89 

895 

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 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. 

16. Other current liabilities 

in EUR thousands 

Liabilities from SAR program 

Total other non-current liabilities 

Accrual for employee bonuses 

Accrual for outstanding vacation 

Payroll tax 

Accruals for outstanding invoices 

Accruals for financial statement and audit costs 

Other accruals 
Total other current liabilities 

December 31, 2023 

December 31, 2022 

0 

0 

738 

139 

87 

1,049 

215 

230 
2,458 

304 

304 

563 

117 

101 

1,187 

215 

335 
2,518 

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  15  thousand)  is  therefore  included  under  other  accruals  for  the  settlement  of 
employees of Biofrontera Inc. entitled to receive stock options. 

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. 

62 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
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.  

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, 2023 

December 31, 2022 

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 

341,504 

0 

250,791 

0 

90,713 

0 

0 TEUR 
-304 TEUR 

569,205 

0 

227,701 

0 

341,504 

0 

80 TEUR 
-22 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. 

17. 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 

Biofrontera AG Annual Report 2023 

63 

 
 
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, 
2023 

December 31, 
2023 

December 31, 
2022 

December 31, 
2022 

Cash and cash equivalents 

Trade receivables 

Receivables from associated 
companies 

Receivables from leases 

Other financial asstes 

Total 

AC 

AC 

AC 

AC 

AC 

3,080 

774 

6,365 

18 

1,556 

11,792 

3,080 

774 

6,365 

18 

1,556 

11,792 

6,376 

691 

1,344 

35 

878 

9,324 

6,376 

691 

1,344 

35 

878 

9,324 

1 

2 

2 

2 

2 

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, 
2023 

December 31, 
2023 

December 31, 
2022 

December 31, 
2022 

December 31, 
2023 

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 

468 

2,594 

2,747 

71 

678 

0 

468 

2,594 

2,747 

71 

678 

0 

446 

1,984 

2,653 

26 

1,055 

2,642 

446 

1,984 

2,653 

26 

1,055 

2,642 

6,558 

6,558 

8,807 

8,807 

2 

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 2023 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 11 and 12).  

Due to the generally short maturity of trade receivables and trade payables as well as receivables from associates, other financial 
receivables and liabilities and cash and cash equivalents, the carrying amounts on the balance sheet date do not differ 
significantly from the fair values.  

64 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
Expenses, income, losses and gains/losses from financial instruments: 

in EUR thousands 

Assets AC 

Liabilities AC 

Income from currency translation 
Expenses from currency translation 
Total 

34 
(25) 
10 

245 
(223) 
22 

Total 

279 
(248) 
32 

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. 
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% 

(1,898) 

CHF 
EUR +10% 

193 

GBP 
EUR +10% 

(1) 

USD 
EUR -10% 

2,320 

CHF 
EUR -10% 

(236) 

GBP 
EUR -10% 

2 

▪ 

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.  

No individual valuation allowances were recognized on trade receivables in the 2023 financial year (previous year: EUR 0 thousand). 
The very low default rate in the past and the lack of overdue receivables also meant that no portfolio valuation allowances  were 
recognized; the company expects the default rate to remain very low in the future due to the existing customer structure. 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. 

Biofrontera AG Annual Report 2023 

65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 
31.12.2023 
468 
2,594 
2,747 
71 
678 
0 
6,558 

2023 
468 
2,594 
2,747 
71 
0 
0 
5,879 

Maturity 

2025 
0 
0 
0 
0 
284 
0 
284 

2024 
0 
0 
0 
0 
395 
0 
395 

2026 
0 
0 
0 
0 
0 
0 
0 

2027 
0 
0 
0 
0 
0 
0 
0 

66 

Biofrontera AG Annual Report 2023 

 
 
 
 
Notes to the consolidated statement of comprehensive income 

18. Sales revenue 

01.01.-31.12.2023 

01.01.-31.12.2022 

in EUR thousands 

Product 
revenues 

Service 
revenues 

Licensing 
revenues 

Germany 

Spain 

U.K. 

Other European countries 

Total Europe (excluding 
Germany) 

Total Europe 

U.S.A. 

Other regions 

Total 

6,257 

1,743 

723 

- 

2,466 

8,723 

- 

- 

8,723 

- 

- 

- 

- 

- 

- 

76 

- 

76 

Total 

2023 

6,257 

1,743 

723 

1,195 

3,662 

- 

- 

- 

1,195 

1,195 

1,195 

9,919 

22,148 

106 

22,224 

106 

Product 
revenue 

Developme
nt 
revenues 

Licensing 
revenues 

Total 

2022 

4,763 

1,757 

662 

- 

2,419 

7,182 

- 

- 

- 

- 

- 

- 

- 

- 

648 

- 

648 

- 

4,763 

- 

- 

1,757 

662 

1,079 

1,079 

1,079 

3,498 

1,079 

8,261 

16,487 

17,135 

342 
342 
17,908  25,73
8 

23,449 

32,249 

7,182 

All sales revenues result from contracts with customers. Sales with Biofrontera Inc. account for 69% of the Group's total sales. 

As in the previous year, no license income from downpayments of license agreements was received in the current financial year. 

Provisions for manufacturer rebates amount to 0.17% of total sales in fiscal 2023 (previous year: 0.17%), while provisions for return 
obligations amount to 0.19 % of total sales (previous year: 0. 21%). 

19. Cost of sales, gross profit 

The cost of materials included in the cost of sales amounted to EUR 4,117 thousand in fiscal year (previous year: EUR 3,069thousand).  

The  gross  profit 
EUR 20,981 thousand in the prior-year period. 

increased  by  EUR 5,024 thousand 

20. Research and development costs 

in  the  reporting  year  2023  to  EUR 26,005 thousand  compared  to 

Research  and  development  costs  amounted  to  EUR 7,846 thousand  (previous  year:  EUR 7,128 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. 

21. General administrative costs 

General and administrative expenses amounted to EUR 6,105 thousand (previous year: EUR 5,906 thousand) in fiscal year 2023  a 
slight increase of 3% compared to the previous year.  

Biofrontera AG Annual Report 2023 

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
22. Sales and marketing costs 

Sales and marketing costs  amounted to EUR 7,273 thousand (previous year: EUR 6,356 thousand) in fiscal year 2023. Sales costs 
include the costs of our own sales force in Germany, Spain, and the United Kingdom, as well as marketing expenses. 

23. Other expenses and income 

Other expenses and income totaled to a profit of EUR 350 thousand in the reporting period (previous year: loss of EUR 467 thousand) 
and mainly include expenses and income from currency translation amounting to a profit of EUR 42 thousand (previous year: loss of 
EUR 677 thousand) as well as other income from the recognition of non-cash benefits and the recharging of costs in the amount of 
308 TEUR (previous year: 204 TEUR).  

24. Interest expenses and income 

The interest expenses of EUR 15 thousand (previous year: EUR 163 thousand) mainly result from interest of EUR 11 thousand (previous 
year: EUR 15 thousand) to be recognized for leases in accordance with IFRS 16. 

Interest income amounts to EUR 21 thousand (previous year: EUR 1 thousand) and increased by EUR 20 thousand compared to the 
previous year. 

25. Result from investments 

The investment result reflects the adjustment of the carrying amount of the investment in Biofrontera Inc. by the share of earnings 
in the amount of EUR -7,264 thousand (previous year: EUR -1,604 thousand). In the previous year, the investment result also included 
impairment losses of EUR 42,568 thousand. 

26. Income tax 

in EUR thousands 

Deferred taxes 

Actual income taxes 
Total income taxes 

December 31, 2023 

December 31, 2022 

2,443 

(685) 
1,758 

(800) 

(156) 
(956) 

The income from the capitalization of deferred taxes in the amount of EUR 2,443 thousand(previous year: EUR ‑800 thousand) results 
from the first-time recognition of deferred tax assets at Biofrontera Bioscience GmbH, which is partially offset by a reduction in the 
tax loss carryforwards of Biofrontera Pharma GmbH, with the amount of the recognizable tax loss carryforwards being reduced to 
the expected utilization during the planning period.  

27. 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. 

68 

Biofrontera AG Annual Report 2023 

 
 
 
 
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, 2023 

December 31, 2022* 

63,807,058 

(369,347) 

(0.01) 

63,807,058 

(369,347) 

(0.01) 

57,474,912 

(44,166,205) 

(0.77) 

57,474,912 

(44,166,205) 

(0.77) 

28. 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 

December 31, 2023 

December 31, 2022 

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 

29. Staff 

166 

433 

154 

38 

791 

158 

433 

129 

25 

745 

December 31, 2023 

December 31, 2022 

7,652 

1,539 

106 
9,297 

6,904 

1,123 

94 
8,121 

In 2023 the Biofrontera Group had an average of 103 salaried employees (previous year: 100). 

Biofrontera AG Annual Report 2023 

69 

 
 
 
 
 
 
 
 
 
 
 
Notes to the consolidated cash flow statement 

30. 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 ‑3,296 thousand (previous year: EUR ‑532 thousand).  

Interest  paid  amounted  to  EUR  12  thousand  (previous  year:  EUR 198 thousand).  Interest  payments  received  amounted  to  EUR  21 
thousand (previous year: EUR 13 thousand). 

Expenses for short-term leases and leases of low value amounted to EUR 11 thousand (previous year: EUR 19 thousand). Income from 
subleases amounted to EUR 36 thousand (previous year: EUR 30 thousand). 

in EUR thousands 

January 1, 2023 

Cash 
effective 

Addition/ 
retirement 

Fair value 
change 

December 31, 
2023 

Leasing liabilities 
Total financial liabilities 

1,501 
1,501 

(456) 
(456) 

62 
62 

- 
- 

1,107 
1,107 

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 

Other explanatory notes 

31. Members of the Management Board 

The Executive Board in 2023 consisted of Ms. Pilar de la Huerta Martínez (Chief Financial Officer).  

70 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Management Board compensation 

in EUR thousands 

December 31, 2023 

December 31, 2022 

Short-term benefits 

Performance-based compensation 

Total compensation 

336 

- 
336 

542 

- 
542 

The previous year's figure included the remuneration of former Management Board members Ludwig Lutter and Paul Böckmann 
totaling EUR 452 thousand.  

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 

CELAX Innovation S.L., Spain 

Sarcorem S.L., Spain 

Board 

Board of Directors 

Board of Directors 

Board of directors 

Board of Directors 

Position 

Member 

Member 

Member 

Member 

Board of Directors 

Sole adminstrator 

Board of Directors 

Sole adminstrator 

32. Members of the Supervisory Board 

Name 

Wilhelm K.T. Zours 

Nationality 

German 

Age 

62 

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 

54 

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 

46 

Member 

December 14, 2021 

2026 

CV 

Dr. Lanckriet is Chief Executive Officer and Chief Scientific Officer at 4basebio Plc. Earlier in his career, Dr. Lanckriet was 
Chief Executive Officer & Chief Scientific Officer at Expedeon AG and Principal at Puratos NV. Dr. Lanckriet holds a 
Bachelor and Master degree in Biochemical Engineering from the University of Ghent, Belgium and a PhD in Biochemical 
Engineering from the University of Cambridge, UK. 

Biofrontera AG Annual Report 2023 

71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prof. Dr. Karin 
Lergenmüller 

CV 

German 

65 

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 

55 

Member 

December 14, 2021 

2026 

CV 

Dr. Helge Lubenow studied biology and obtained her doctorate in the field of genetics at the University of Cologne and 
the Max Planck Institute. After completing 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 and from 
January 2020 to 2023 she was Managing Director of Proteomedix AG, Zurich, Switzerland. 

Karlheinz Schmelig 

German 

58 

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 

in EUR thousands 

Wilhelm K.T. Zours 

Dr. Jörgen Tielmann 

Dr. Heikki Lanckriet 

Dr. Helge Lubenow 

Prof. Dr. Karin Lergenmüller 

Karlheinz Schmelig 

Prof. Dr. Franca Ruhwedel 

Gesamt 

2023 

2022 

44 

33 

22 

47 

23 

28 

0 

197 

49 

41 

26 

31 

n.a. 

31 

5 

191 

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: 

72 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 

Biofrontera Inc. 

Dr. Helge Lubenow 

Epigenomics AG 

Human Gesellschaft für Biochemika und Diagnostika 
mbH 

Neracare GmbH 

Avelo AG 

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 

Chair 

Advisory Board 

Member 

Supervisory Board 

Member 

Board of Directors 

Chair 

Karlheinz Schmelig 

Prostatype Genomics AB, Stockholm, Schweden 

Supervisory Board 

Member (until June 30, 
2023) 

CryoTherapeutics S.A., Awans, Belgien 

Tacalyx GmbH, Berlin 

Supervisory Board 

Advisory Board 

Member 

Member 

33. Related party disclosures 

The group of related parties is limited to the group of persons listed in Notes 31 and 32 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. 

Biofrontera AG Annual Report 2023 

73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  The following relationships exist with Biofrontera Inc.: 

in EUR thousands 

Sales revenues 

Other income 

Clinical trial expenses 

Other expenses 

Trade receivables 

Trade payables 

Payables from DUSA settlement 

December 31, 2023 

December 31, 2022 

22,224 

775 

61 

6,365 

201 

2,545 

17,135 

436 

64 

1,344 

11 

2,642 

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, 2023 

December 31, 2022 

0 

106 

34 

0 

200 

141 

32 

34 

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. 

74 

Biofrontera AG Annual Report 2023 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Under the license agreement, Maruho has made a one-time payment of EUR 6 million to Biofrontera AG in the previous year. Further 
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 the financial year  2023, there  were no further reportable transactions  or relationships with related parties other than those 
mentioned above and in Note 31 and Note 32. 

34. Auditor's fees and services 

The total fee invoiced by the auditor for the 2023 financial years consist of: 

in EUR thousands 
Auditing services 

of which for the previous year 

Other consulting services 

December 31, 2023 
198 
0 

48 

December 31, 2022 
197 
2 

0 

The auditing services relate to the mandatory audits of the annual and consolidated financial statements of Biofrontera AG.  

35. Subsequent events 

Extraordinary shareholders‘ meeting / Resolution on capital reduction 

At the Extraordinary  General  Meeting on April 4, 2024, a capital reduction at a ratio of  21:1 was resolved  at the proposal of the 
Executive Board and Supervisory Board. To enable this ratio, a resolution was previously passed to cancel seven shares. Following 
the implementation of the capital reduction, the new share capital amounts to EUR 3,038,431.00. The Biofrontera AG share will be 
listed  on  the  stock  exchange  under  a  new  ISIN.  The  capital  reduction  will  ensure  that  the  price  of  the  Biofrontera  share  rises 
significantly above EUR 1.00 again and that necessary capital measures can be implemented in the future, which was previously not 
possible  due  to  the  prohibition  of  the  sub-par  issue,  i.e.  the  prohibition to  issue  shares  for  less  than  EUR  1.00  per  share.  Both 
resolutions were adopted with the required majority. 

Capital increase 

On April 4, 2024, the administration of Biofrontera AG decided to carry out a capital increase from authorized capital. This is based 
on the resolutions of the Extraordinary General Meeting to reduce the company's share capital to EUR 3,038,431.00. The reduced 
share  capital  is  to  be  increased  at  a  ratio  of  1:1  by  issuing  up  to  3,038,431  new  shares.  Shareholders  will  be  granted  statutory 
subscription rights, with one existing share (after the capital reduction) entitling them to subscribe to one new share. In addition, 
the shareholders are to be granted a multiple subscription right; the subscription rights are to be traded on the stock exchange. The 
subscription price is to be EUR 1.10 per share. The company has entered into a backstop agreement with a major shareholder in the 
amount of EUR 1,800 thousand to ensure that the company has sufficient cash to cover its liquidity requirements over the next 12 
months, irrespective of the final subscription ratio of the capital increase. The funds from the capital increase will be used to finance 
the operating business. 

Amendment of license agreement with Biofrontera Inc. 

In February 2024, Biofrontera  Inc. and Biofrontera agreed on an amendment to the  existing license and supply  agreement. The 
amendment provides for Biofrontera Inc. to take over the entire clinical development program effective on or before June 1, 2024. 

Legal issues 

In two lawsuits before the Regional Court of Cologne, Mr. Ludwig Lutter challenged his dismissal as a member of the Management 
Board  and  the  termination  of  his  employment  contract  and  asserted  the  (partial)  continued  payment  of  his  remuneration. The 
Regional Court of Cologne ruled on the two actions in judgments served on the company on March 22, 2024.  

Biofrontera AG Annual Report 2023 

75 

 
 
In the declaratory proceedings, the court ruled that the employment relationship was not dissolved by extraordinary termination, 
as the alleged derelictions of duty, if any, were not serious enough individually and collectively to justify extraordinary termination 
in the opinion of the court. As a result, Mr. Lutter was awarded the asserted continued payment of his fixed remuneration in  the 
documentary proceedings. This amounts to EUR 250 thousand. This amount includes income earned elsewhere, which was deducted 
by the court. The company can claim the deduction of any other income earned elsewhere in subsequent proceedings relating to 
the documentary proceedings. 

Regulatory progress 

The Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory authority for medicinal products in the UK, has 
approved the extension of the marketing authorization for Ameluz® to include use with artificial daylight. 

No other events occurred after the balance sheet date. 

Leverkusen, April 29, 2024 

Pilar de la Huerta Martinéz 

Chief Financial Officer

76 

Biofrontera AG Annual Report 2023 

 
 
 
 
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 29, 2024 

Biofrontera AG  

Pilar de la Huerta Martínez 
CFO 

Biofrontera AG Annual Report 2023 

77 

 
 
 
 
 
 
 
 
- 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, 2023, 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, 2023 to December 31, 
2023, 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, 2023 to December 31, 2023. In accordance with German legal 
requirements, we have not audited the content of the "Risk management system (unaudited)" section 
of the risk and opportunity report or the declaration on corporate governance pursuant to Sections 289f 
and 315d HGB, which also contains the declaration on the German Corporate Governance Code. 

In our opinion, based on the findings of our audit:  

• 

• 

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, 2023 and of its financial performance for 
the fiscal year from January 1, 2023 to December 31, 2023 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 opinion on the combined management  report  does not  cover the 
content  of  the  statement  referred  to  above  or  the  non-management  report  information  marked  as 
unaudited. 

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 

78 

Biofrontera AG Annual Report 2023 

 
 
 
 
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.  

Material uncertainty in connection with the company's ability to continue as a going concern  

We first refer to the disclosures in the "Risk and opportunity report" of the combined management 
report and the disclosures in the section "Summary of significant accounting policies, basis of 
preparation of the consolidated financial statements" in the notes to the consolidated financial 
statements, in which the legal representatives describe that if the capital measure of EUR 3,000 
thousand planned for May 2024 cannot be carried out to the planned extent, the continued existence of 
Biofrontera AG would be severely jeopardized. It is also stated that an investor has already signed a 
backstop agreement for this capital increase in the amount of EUR 1,800 thousand. As explained in the 
"Risk and opportunities report" in the combined management report and in the section "Summary of 
significant accounting policies" in the notes to the consolidated financial statements, these events and 
circumstances indicate that a material uncertainty exists that may cast significant doubt on the 
company's ability to continue as a going concern and that constitutes a going concern risk within the 
meaning of Section 322 (2) sentence 3 HGB.  

In accordance with Article 10 (2) (c)ii) of the EU Audit Regulation, we summarize our audit response to 
this risk as follows:  

On the basis of the corporate planning presented, we have assessed whether the assessment made by 
the Management Board of the Biofrontera Group's ability to continue as a going concern is appropriate. 
For this purpose, we first reviewed the planning for formal consistency (mathematical accuracy, correct 
implementation of the underlying assumptions) and checked its plausibility. In addition, we obtained 
and assessed evidence on the planned financing measures of the management (including: capital 
measure and backstop agreement). Based on the results of our audit, we consider the going concern 
assumption used by the executive directors to be appropriate. 

Our audit opinions on the consolidated financial statements and on the combined management report 
are not modified with respect to this matter. 

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 financial year from January 1, 2023 to December 
31, 2023. These matters were addressed in the context of our audit of the consolidated financial 
statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion 
on these matters. In addition to the matter described in the "Material uncertainty related to going 
concern" section, we have determined the matters described below to be the key audit matters to be 
communicated in our auditor's report. 

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. Facts and problem  

Biofrontera AG Annual Report 2023 

79 

 
 
2. Audit approach and findings  

3. 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 1.718 thousand, which thus represent 5.5% 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 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, the valuation parameters and assumptions applied by the legal representatives, 
taking into account the available information, are suitable overall for testing the determination 
of the recoverable amount.  

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 "25. Income 
from Investments.  

Biofrontera AG Annual Report 2023 

3.  

80 

 
 
 
 
 
Other information  

The legal representatives and the Supervisory Board are responsible for the other information. The 
other information includes:  

• 

the responsibility statement of the legal representatives attached to the notes to the consolidated 
financial statements  

pursuant to Section 297 (2) sentence 4 HGB and Section 315 (1) sentence 5 HGB on the combined 
management report (unaudited balance sheet) 

• 

• 

the declaration on corporate governance published on the company's website, to which reference is 
made in the section "Declaration by Biofrontera AG on corporate governance pursuant to Sections 289f, 
315d HGB for the 2023 financial year (unaudited)" of the combined management report  
the remaining parts of the annual report the subsection "Risk management system (unaudited)" of the 
combined management report but not the consolidated financial statements, not the information of the 
combined management report included in the content of the audit and our auditor's report thereon. 

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  

• 

• 

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 

Biofrontera AG Annual Report 2023 

81 

 
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.  

▪ 

▪ 

▪  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.  
Evaluate the appropriateness of accounting policies used and the reasonableness 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.  

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▪  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 forwardlooking 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 

We have performed an assurance engagement in accordance with § 317 Abs. 3a HGB to obtain 
reasonable assurance about whether the reproduction of the consolidated financial statements and the 
combined management report (hereinafter also referred to as "ESEF documents") contained in the 
provided file "biofronteraag-2023-12-31-en.zip" and prepared for publication purposes complies in all 
material respects with the requirements of § 328 Abs. 1 HGB for the electronic reporting format ("ESEF 
format"). In accordance with German legal requirements, this audit only extends to the conversion of 
the information contained in the consolidated financial statements and the combined management 
report into the ESEF format and therefore does not extend to the information contained in these 
reproductions or any other information contained in the above-mentioned file. 

Biofrontera AG Annual Report 2023 

83 

 
 
 
In our opinion, the reproduction of the consolidated financial statements and the combined 
management report contained in the above-mentioned file and prepared for publication purposes 
complies in all material respects with the requirements of Section 328 (1) HGB for the electronic 
reporting format. We report on this audit opinion and on our audit opinions on the accompanying 
consolidated financial statements and on the accompanying combined management report for the 
financial year from January 1, 2023 to January 31, 2023 contained in the "Report on the Audit of the 
Consolidated Financial Statements and of the Combined Management Report" above.  

January 1, 2023 to December 31, 2023, we do not express any opinion on the information contained in 
these disclosures or on the other information contained in the above-mentioned file. 

Basis for the audit opinion 

We conducted our audit of the reproduction of the consolidated financial statements and of the 
combined management report contained in the above-mentioned file provided in accordance with 
Section 317 (3a) HGB and in compliance with IDW Auditing Standard: Audit of the Electronic 
Reproduction of Financial Statements and Management Reports Prepared for Publication Purposes in 
Accordance with Section 317 (3a) HGB (IDW PS 410 (06.2022)). Our responsibilities under those 
requirements are further described in the "Auditor's responsibilities for the audit of the ESEF 
documents" section. Our auditing practice has complied with the requirements of the IDW Quality 
Management Standard: Requirements for Quality Management in the Auditing Practice (IDW QMS 1). 

Responsibilities of the executive directors and the supervisory board for the ESEF documents 

The executive directors of the company are responsible for the preparation of the ESEF documents 
including the electronic reproduction of the consolidated financial statements and the combined 
management report in accordance with § 328 Abs. 1 Satz 4 Nr. 1 HGB and for the tagging of the 
consolidated financial statements in accordance with § 328 Abs. 1 Satz 4 Nr. 2 HGB.  

Furthermore, the company's management is responsible for such internal control as they have 
determined necessary to enable the preparation of ESEF documents that are free from material non-
compliance with the requirements of Section 328 (1) HGB for the electronic reporting format, whether 
due to fraud or error.  

The Supervisory Board is responsible for overseeing the process of preparing the ESEF documents as 
part of the financial reporting process. 

Auditor's responsibilities for the audit of the ESEF documents 

Our objective is to obtain reasonable assurance about whether the ESEF documents are free from 
material - intentional or unintentional - non-compliance with the requirements of Section 328 (1) HGB. 
We exercise professional judgment and maintain professional skepticism throughout the audit. In 
addition 

• 

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 opinion. 

•  Obtain an understanding of internal control relevant to the audit of the 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 these controls. 

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Biofrontera AG Annual Report 2023 

 
• 

• 

• 

Evaluate the technical validity of the ESEF documents, i.e. whether the file containing the ESEF documents 
complies with the requirements of the Delegated Regulation (EU) 2019/815 in the version applicable at 
the reporting date regarding the technical specification for this file. 

Evaluate whether the ESEF documents enable an XHTML reproduction with content equivalent to the 
audited consolidated financial statements and the audited combined management report. 

Evaluate whether the tagging of the ESEF documents with Inline XBRL technology (iXBRL) according to 
Articles 4 and 6 of the Delegated Regulation (EU) 2019/815 in the version applicable at the reporting date 
provides an adequate and complete machine-readable XBRL copy of the XHTML reproduction. 

Other information pursuant to Article 10 EU-APrVO 

We were elected as auditor and group auditor by the annual general meeting on June 20, 2023. We 
were engaged by the supervisory board on November 2, 2023. We have been the auditor of Biofrontera 
AG, Leverkusen, without interruption since the financial year 2022. 

We declare that the audit opinions expressed in this auditor's report are consistent with the additional 
report to the audit committee pursuant to Article 11 EU Audit Regulation (audit report). 

OTHER MATTERS - USE OF THE AUDITOR'S REPORT 

Our audit opinion should always be read in conjunction with the audited consolidated financial 
statements and the audited combined management report as well as the audited ESEF documents. The 
consolidated financial statements and the combined management report converted into the ESEF 
format - including the versions to be filed in the company 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 report and our audit opinion contained therein can only be 
used in conjunction with the audited ESEF documents provided in electronic form.  

AUDITOR RESPONSIBLE FOR THE AUDIT 

The German Public Auditor responsible for the engagement is Andreas Weissinger."  

Munich, April 29, 2024 

Baker Tilly GmbH & Co. KG 

Wirtschaftsprüfungsgesellschaft 

(Düsseldorf) 

Weissinger 

Nitsche 

Wirtschaftsprüfer 

Wirtschaftsprüfer 

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