MASHINIi

BIOFRONTERA AG.

B8FK.XETRA | Manufacture of pharmaceuticals, medicinal chemical and botanical products

Biofrontera AG is a biopharmaceutical company specializing in the development and commercialization of dermatological drugs and medical devices. The company's primary focus is on the treatment of skin diseases, particularly skin cancer and related conditions. Their main product is Ameluz®, a prescri...Show More

Ethical Profile

Mixed.

Is Biofrontera AG ethical? The biopharmaceutical company, known for its skin cancer treatment Ameluz®, directly contributes to health outcomes. However, its ethical profile is mixed. The company paid a $22.5 million settlement in litigation with DUSA. Biofrontera also faces ongoing litigation with Deutsche Balaton AG, and critics point to alleged conflicts of interest involving the Supervisory Board Chairman. Further lawsuits allege patent infringement, breach of contract, and misleading advertising. While Biofrontera has a Code of Conduct and a whistleblower hotline, and has optimized its Ameluz formulation for waste reduction, detailed data on environmental impact, fair labor, or ethical sourcing remains largely unavailable.

Value Scores

Better Health for All-30
-100100
Fair Money & Economic Opportunity0
-100100
Fair Pay & Worker Respect0
-100100
Fair Trade & Ethical Sourcing0
-100100
Honest & Fair Business-50
-100100
Kind to Animals0
-100100
No War, No Weapons0
-100100
Planet-Friendly Business0
-100100
Respect for Cultures & Communities0
-100100
Safe & Smart Tech-20
-100100
Zero Waste & Sustainable Products-60
-100100

Better Health for All

-30

Biofrontera AG's core products, Ameluz®, Xepi®, Skinoren®, and Belixos®, are entirely focused on treating dermatological conditions, including pre-cancerous lesions, skin cancers, and bacterial infections, demonstrating an exceptional health benefit. The company's mission is to improve the quality of life for people with sun-induced skin cancer.

1
Ameluz® achieved complete elimination of basal cell carcinomas in 93.4% of cases.
2
The company actively invests in R&D, with 10.5% of 2023 sales revenue allocated to R&D, focusing on label extensions and new indications for Ameluz®. Safety is addressed through an improved Ameluz® gel formulation without propylene glycol, eliminating potential risks like impurities and allergic reactions, approved by EMA in December 2023 and FDA in October 2023.
3
However, clinical trials for Ameluz® have reported varying degrees of pain and inflammation, which can persist for up to two weeks.
4
The company discloses risks in SEC filings and through a quality management system.
5
It also addresses health equity by recognizing actinic keratosis as an occupational disease in Germany, leading to treatment cost coverage for outdoor workers.
6
During the COVID-19 pandemic, the company experienced lower product sales but implemented contingency plans and cost reductions.
7
The company conducts clinical trials in the U.S. and has adjusted protocols based on FDA recommendations for recording side effects and pain management.
8

Fair Money & Economic Opportunity

0

No evidence available to assess BIOFRONTERA AG on Fair Money & Economic Opportunity.

Fair Pay & Worker Respect

0

No evidence available to assess BIOFRONTERA AG on Fair Pay & Worker Respect.

Fair Trade & Ethical Sourcing

0

No evidence available to assess BIOFRONTERA AG on Fair Trade & Ethical Sourcing.

Honest & Fair Business

-50

Biofrontera AG has a formal whistleblower protection policy with reporting channels to supervisors, compliance representatives, and the legal department, and encourages anonymous reporting of legal violations.

1
However, there is no evidence of independent investigation processes. The company's Supervisory Board has disclosed conflicts of interest, including those related to Deutsche Balaton AG.
2
The Corporate Governance Statement notes that the Supervisory Board considers all members independent of the company and its Management Board, but this conflicts with the explicit disclosure of conflicts of interest.
3
A Code of Conduct is in place, outlining a clear policy against bribery and improper business entertainment/gifts, and emphasizing compliance with antitrust regulations and integrity in business dealings.
4
However, there is no evidence of training frequency or effectiveness metrics for this policy. External audits are conducted regularly, and unqualified audit opinions were issued by Nexia GmbH and Warth & Klein Grant Thornton AG.
5
The audit of the remuneration report for 2024 confirmed compliance with Section 162 (1) and (2) AktG, but focused on formal completeness, not content accuracy.
6
ISO certifications are also mentioned.
7

Kind to Animals

0

No evidence available to assess BIOFRONTERA AG on Kind to Animals.

No War, No Weapons

0

Biofrontera AG is a biopharmaceutical company focused on the development and commercialization of dermatological drugs and medical devices, primarily for skin diseases.

1
Its main product is Ameluz®, used in photodynamic therapy.
2
The company's core business activities, as described in the provided articles, do not involve arms manufacturing, military contracts, or dual-use technologies. There is no evidence of sales to embargoed regimes, defense-related lobbying, or procurement from conflict zones. The company's products are civilian in nature, and its operations are not described as having exposure to conflict-affected areas or requiring compliance with arms trade regulations. No information was found regarding any involvement in intelligence or surveillance contracts, or any investment in peacebuilding or disarmament initiatives.

Planet-Friendly Business

0

The provided articles, including the Corporate Governance Statement and Half-Year Report for 2024, explicitly state a lack of specific, quantitative data points related to environmental performance or planet-friendly business practices.

1
There is no information on greenhouse gas emissions (Scope 1, 2, or 3), renewable energy usage, water consumption, waste diversion rates, green building certifications, climate-related targets, or any other environmental initiatives.
2
Consequently, no KPIs can be scored based on the evidence provided.

Respect for Cultures & Communities

0

The provided articles do not contain specific, concrete data points for any of the KPIs related to Respect for Cultures & Communities. The 2022 Annual Report explicitly states that no specific details were found regarding cultural impact assessment protocols, local employment ratios, grievance mechanisms, FPIC participation rates, community governance inclusion, cultural preservation investment, local procurement share, indigenous supplier count, cultural site protection, social license to operate, charitable giving to cultural heritage organizations, community fund allocation, language inclusivity, cultural incident response, or cultural training completion.

1
Other articles also lack relevant information for these metrics.

Safe & Smart Tech

-20

Biofrontera AG states that shareholders and business partners have rights to access, rectify, restrict, object to, and delete their data, as per GDPR.

1
The company also states compliance with the German Stock Corporation Act (AktG) and GDPR.
2
For data minimization, the company processes data only as necessary, with deletion based on contractual and legal obligations, and commercial/tax retention requirements.
3
Retention periods mentioned include 180 days, 2-3 years, 3 years, 6 years, 10 years, and 30 years for various data types.
4

Zero Waste & Sustainable Products

-60

The company has implemented an optimized Ameluz formulation without propylene glycol as a waste reduction initiative.

1
No specific targets for waste reduction or recyclability are explicitly mentioned in the context of zero waste, indicating a lack of formal targets.
2

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AI-generated analysis based on publicly available data. Not financial advice. Ratings are expressions of opinion derived from automated models and may contain inaccuracies. See our Risk Disclosure for full details.