Biofrontera Inc. has completed a transformational acquisition of all US rights to its photodynamic therapy products Ameluz® and RhodoLED® from its former parent company Biofrontera AG, backed by an $11 million investment that positions the company for profitability. The transaction fundamentally restructures the relationship between the US and German entities while providing Biofrontera Inc. with complete operational control in the American dermatology market.
Strategic Asset Acquisition
The acquisition encompasses all US assets related to Ameluz® and RhodoLED®, including the New Drug Application (NDA) and associated patents. Under the new agreement, Biofrontera Inc. will pay a monthly royalty of 12% on Ameluz® revenue when US sales are below $65 million annually, and 15% when revenue exceeds that threshold. This represents a dramatic reduction from the previous transfer pricing model, which required payments of 25% to 35% of net sales per tube depending on timing and indication.
"This acquisition gives us full control and accountability for the success of Ameluz and RhodoLED in the U.S.," said Dr Hermann Luebbert, President and CEO of Biofrontera Inc. "It allows us to drive commercial and operational decisions with greater agility. The move from transfer pricing to a royalty-based agreement and the resulting cost reductions will allow us to reach breakeven more quickly and be more profitable in the future."
Financing Structure and Timeline
The $11 million investment was led by existing investors Rosalind Advisors, Inc. and AIGH Capital Management LLC. The funding will be provided in two tranches: $8.5 million upon signing of the new royalty agreement, and $2.5 million upon finalization of a detailed asset transfer agreement expected by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share, based on the market price as of June 26, 2025.
As part of the agreement, Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the entities while maintaining the German company's involvement in the US operations' success.
Operational Control and Market Expansion
The transaction transfers complete responsibility for manufacturing Ameluz® and the RhodoLED® portfolio of lamps to Biofrontera Inc. for the US market. All regulatory, quality management, pharmacovigilance, and commercial responsibilities associated with the US market now rest entirely with the American entity.
Biofrontera Inc. currently commercializes the drug-device combination of Ameluz® with the RhodoLED® lamp series for photodynamic therapy of actinic keratosis, pre-cancerous skin lesions that may progress to invasive skin cancers. The company is conducting clinical trials to extend product use to treat non-melanoma skin cancers and moderate to severe acne, with an upcoming FDA submission planned for the treatment of superficial basal cell carcinoma.
Market Potential and Investment Rationale
"Ameluz has significant untapped potential in the U.S. market," said Dr Gil Aharon of Rosalind Advisors Inc. "This transformational announcement creates the clarity and alignment needed to unlock that value. We are excited to support Biofrontera Inc. through its next phase of growth."
The restructuring is expected to provide Biofrontera Inc. with the financial flexibility and operational independence needed to accelerate its growth in the US dermatology market while expanding the therapeutic applications of its photodynamic therapy platform.
