Better Health for All

Biofrontera Inc.'s core business is dedicated to health improvement, with its products delivering exceptional health benefits. Ameluz®-PDT, an FDA-approved treatment for pre-cancerous actinic keratoses (AKs), shows up to 91% clearance and can prevent progression to squamous cell carcinoma.

A Phase III trial for superficial basal cell carcinoma demonstrated 65.5% success with Ameluz®-PDT. The company has no revenue from products with negative health outcomes. However, price accessibility is a concern, as insurance coverage and reimbursement for licensed products may be limited, and the 340B drug discount program, which requires reduced prices for low-income patients, could impact sales. Similarly, vulnerable populations face access barriers due to limited insurance coverage, despite AK affecting over 58 million Americans and being the number one indication for dermatologists for those 40 and older. The company's risk transparency is good, with comprehensive risk disclosures in its Form 10-K and a Code of Conduct advising on product risks, but it also contains forward-looking statements with inherent uncertainties. Investment in health innovation is substantial, with R&D focused on label expansion for Ameluz® and improving RhodoLED® Lamps, including ongoing Phase III trials for superficial basal cell carcinoma and moderate to severe acne, and a Phase I study for AK. The company's products, particularly Ameluz®, directly address pre-cancerous conditions, demonstrating a strong focus on preventative health. For healthcare data responsibility, the company states it collects and processes data in accordance with applicable laws like GDPR and HIPAA, and protects confidential information, but no specific details on data breaches or advanced safeguards are provided. In clinical trial ethics, the company requires sponsored research to be ethical in design and implementation, conforming to international standards and FDA's good clinical practice (GCP) requirements, but no specific details on diversity, inclusion, or transparency beyond basic compliance are provided.

Fair Money & Economic Opportunity

Biofrontera Inc. is a biopharmaceutical company focused on commercializing dermatological products.

The provided articles contain no evidence that the company offers lending, deposit services, or any other financial products to consumers. Therefore, all KPIs related to 'Fair Money & Economic Opportunity' are not applicable to its business model, and no specific data points are available to score these metrics.

Fair Trade & Ethical Sourcing

No specific, concrete data points were found in the provided articles to assess BFRI.US against any of the KPIs for Fair Trade & Ethical Sourcing.

The articles did not contain information regarding fair-trade certifications, supply chain audits, incidents of forced or child labor, traceability, remediation processes, ethical clauses in contracts, high-risk materials, or supplier diversity spend.

Honest & Fair Business

The company had one financial restatement in the past five years, specifically an adjustment in 2021 correcting an error in deferred tax assets in the consolidated financial statements.

The Supervisory Board has multiple members with disclosed conflicts of interest, including Mr. Wilhelm K.T. Zours due to his indirect majority shareholding in Deutsche Balaton AG, and Mr. Link, Mr. Plaggemars, and Mr. Reich, who also have conflicts related to lawsuits. The annual and consolidated financial statements for 2022, 2023, and 2024 were audited by independent firms (Baker Tilly GmbH & Co. KG and Nexia GmbH Wirtschaftsprüfungsgesellschaft) and received unqualified audit opinions.

Kind to Animals

Belixos® products' skin-compatibility was dermatologically tested without the use of animal testing by an independent institute.

However, animal reproduction studies were not conducted for aminolevulinic acid, which is a component of Ameluz®. Belixos® products are free of animal products. The company's research and development costs increased by 37% from EUR 4,534 thousand in 2014 to EUR 6,204 thousand in 2015, but no specific percentage of this budget is allocated to animal-free technologies.

No War, No Weapons

Biofrontera Inc. operates exclusively in the pharmaceutical sector, specializing in dermatological treatments.

The company's core business is explicitly stated as pharmaceuticals, not defense or arms-related activities, resulting in zero revenue from arms or defense contracts. Its products are described as dermatological treatments, indicating no development or sale of dual-use technologies. The board's oversight focuses solely on pharmaceutical operations, with no defense business to oversee. The company's business type does not involve exports requiring end-user certificates, nor does it have any exposure to controversial or banned weapons. There is no evidence of codified ethical 'red lines' related to weapons, as this is not applicable to its business model.

Zero Waste & Sustainable Products

The company has no documented waste disposal violations in the past three years.

It participates in a product stewardship plan in Oregon, which has collected over 255,000 pounds of covered drugs since 2021 through a network of at least 200 drop-off sites and mail-back services. This plan includes an education and outreach program that has generated over 45 million impressions to state residents. The company's vendor disposal facilities are audited periodically, at a minimum every 3 to 5 years. Biofrontera states a commitment to fair, open, and long-term cooperation with suppliers, and its quality management system aims to minimize manufacturing errors and risks regarding safety, quality, and efficacy. However, the company does not have formal waste reduction targets, only general statements about optimizing market potential and finding more efficient solutions on the cost side.