Biofrontera Inc. completed the transfer of its U.S. FDA approvals for the photodynamic therapy product Ameluz® and the RhodoLED® Lamp Series, including the New Drug Application (NDA) and Investigational New Drug (IND) filings, effective December 17 2025. The transaction also transferred 11 granted U.S. patents, 10 pending U.S. patent applications, and 19 international patent filings or registered designs that cover the product and lamp platform.
The deal was financed in part by an $11 million investment from strategic investors, giving Biofrontera a fresh capital base to support the transition and future growth initiatives. The investment is intended to provide runway toward cash‑flow breakeven in fiscal year 2026 and to fund ongoing clinical development and commercialization efforts.
By acquiring full U.S. control, Biofrontera eliminates the 25‑35 % transfer‑pricing costs it previously incurred through its German parent. The new royalty structure—12 % on revenue up to $65 million and 15 % on amounts above that threshold—further reduces royalty expenses. Together, these changes are expected to lift gross margins and improve profitability as the company can now directly manage manufacturing, marketing, and clinical development without the overhead of cross‑border licensing fees.
CEO Dr. Hermann Luebbert described the transaction as a “transformative milestone” that will enable the company to accelerate new indication submissions, expand its addressable market in dermatology and oncology, and refine the RhodoLED® lamp platform. He emphasized that the transfer will unlock operational efficiencies and allow Biofrontera to pursue new indications such as superficial basal cell carcinoma and acne more rapidly.
Financially, Biofrontera reported Q3 2025 revenue of $7.0 million, a 22 % decline from Q3 2024, and a net loss of $6.6 million. Cash and cash equivalents stood at $3.4 million as of September 30 2025. The IP transfer and new financing are positioned to improve the company’s financial health by reducing costs, extending liquidity, and setting the stage for a return to profitability.
The transfer also signals a strategic shift toward greater independence from its German parent, positioning Biofrontera to capture a larger share of the U.S. photodynamic therapy market and to leverage its patent portfolio for future product development.
Overall, the transaction represents a significant step in Biofrontera’s plan to transform its economics, enhance its competitive position, and secure a stronger financial footing for the coming years.
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