Core Insights - Biofrontera Inc. reported a strategic transformation in 2025, focusing on customer segmentation and data analysis to enhance sales effectiveness, resulting in increased sales volume and revenue growth [1][4] - The company has restructured its agreement with Biofrontera AG, acquiring all rights, approvals, and patents for Ameluz® and RhodoLED® in the U.S., which is expected to improve cost management and operational efficiency [1][4] - The company secured an $11 million investment, which, along with the restructuring and improved promotional strategies, has positioned it strongly for future growth [1] Financial Performance - Total revenues for Q2 2025 were $9.0 million, a 15% increase from $7.8 million in Q2 2024, driven by a 5% increase in unit sales price and a 9.5% increase in sales volume of Ameluz® [2][4] - For the first half of 2025, total revenues reached $17.7 million, a 12% increase from $15.8 million in the same period of 2024, attributed to higher unit sales prices and increased sales volume [4][9] - Cash and cash equivalents as of June 30, 2025, were $7.2 million, up from $5.9 million at the end of 2024 [4] Operating Expenses - Total operating expenses for Q2 2025 were $14.1 million, compared to $12.9 million in Q2 2024, with a significant decrease in cost of revenues by $1.7 million, or 41.8%, due to renegotiated terms with Biofrontera AG [3][10] - Selling, general, and administrative expenses increased to $10.5 million in Q2 2025 from $7.9 million in Q2 2024, primarily due to a $3.4 million rise in legal costs [5][11] Net Loss and Adjusted EBITDA - The net loss for Q2 2025 was $5.3 million, compared to a net loss of $0.3 million in the prior-year quarter, largely due to a $5.4 million non-cash fluctuation in the fair value of warrants [6][19] - Adjusted EBITDA for Q2 2025 was negative $5.1 million, slightly worse than negative $4.7 million in Q2 2024, reflecting higher legal costs despite lower cost of goods sold [7][22] Clinical Developments - The company announced the completion of patient enrollment in a Phase 3 study for Ameluz® targeting mild to moderate actinic keratosis (AK) on the entire body and a Phase 2b study for moderate to severe acne vulgaris [4][10] - A U.S. patent for a revised formulation of Ameluz® was granted, extending patent protection until December 2043 [4]

Core Viewpoint - Biofrontera Inc. has acquired all U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, marking a strategic move to enhance its presence in the U.S. dermatology market [1][3][7] Financial Summary - The acquisition was funded by an $11 million investment led by Rosalind Advisors, Inc. and AIGH Capital Management LLC [1][7] - Biofrontera Inc. will pay a monthly royalty of 12% on Ameluz® revenue under $65 million and 15% on revenue exceeding that threshold, replacing the previous transfer pricing model of 25% to 35% [2][7] - The first tranche of funding is $8.5 million, with a second tranche of $2.5 million expected upon finalization of a detailed asset transfer agreement by September 30, 2025 [4] Operational Changes - Biofrontera Inc. will assume full responsibility for the manufacture of Ameluz® and the RhodoLED® portfolio for the U.S. market, including all regulatory, quality management, pharmacovigilance, and commercial responsibilities [3][4] - The transition to a royalty-based agreement is expected to lead to cost reductions, allowing the company to reach breakeven more quickly and improve future profitability [4] Market Potential - The acquisition is seen as a significant opportunity to unlock the untapped potential of Ameluz® in the U.S. market, with expectations for growth and alignment of interests between Biofrontera Inc. and Biofrontera AG [5][7]