Biofrontera Inc. Announces Major Restructuring of Relationship With Biofrontera AG Backed By $11M Investment

Biofrontera, a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), announced that it has acquired all U.S. Rights to Ameluz® and RhodoLED® from its former parent company Biofrontera AG. An $11 million investment led by Rosalind Advisors, Inc. and AIGH Capital Management LLC funded the acquisition and transfer costs.

Biofrontera Inc. will now pay a monthly Ameluz® royalty of 12% in years where Ameluz® revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The new royalty replaces the former transfer pricing model — which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. 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.

The transaction marks a significant step in the company’s strategy to strengthen its presence in the U.S. dermatology market. As part of the agreement, the responsibility for the manufacture of Ameluz® and the RhodoLED® portfolio of lamps for the US market will be transferred to Biofrontera Inc. In addition, all regulatory, quality management, pharmacovigilance, and commercial responsibilities associated with the U.S. market now rest entirely with Biofrontera Inc.

"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. This agreement, coupled with our upcoming FDA submission for the treatment of superficial basal cell carcinoma, signals our continued commitment to realizing the potential of PDT in dermatology."

A first tranche of $8.5 million will be funded in conjunction with the signing of the new royalty agreement. The second tranche of $2.5 million will be funded upon finalization of a detailed asset transfer agreement, which is expected by September 30, 2025. The new capital will be provided in the form of preferred shares convertible to common shares at the market price of $0.6249 per share as of the close of business on June 26, 2025.

“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.”

 

Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!

Sign up now!

  • <<
  • >>

Join the Discussion