Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
Patent Approval: Biofrontera received patent approval for its revised propylene glycol-free formulation of Ameluz®, extending protection until December 2043, and is now included in the FDA's Orange Book, confirming its safety and efficacy.
Patient-Centric Innovation: The new formulation aims to reduce allergic reactions for sensitive patients while maintaining treatment effectiveness, showcasing Biofrontera's commitment to innovative healthcare solutions.
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Biofrontera Inc. Announces Financial Results for Q3 2025 and Offers Business Update
Financial Performance: Biofrontera Inc. reported stable revenues of $24.6 million for the first nine months of 2025, slightly down from $24.8 million in 2024, with a notable decline in Q3 revenues to $7.0 million due to advanced purchases ahead of a price increase.
Operational Developments: The company completed the acquisition of U.S. rights for Ameluz and RhodoLED assets, which is expected to enhance gross margins and profitability, and announced the divestiture of its Xepi antibiotic cream for up to $10 million in total payments.
Clinical Trials Update: Biofrontera announced the completion of the active treatment phase for its Phase 3 clinical trial of Ameluz for actinic keratoses and the conclusion of participation in a Phase 2b trial for acne vulgaris.
Future Outlook: CEO Hermann Luebbert expressed confidence in achieving full-year sales objectives, anticipating substantial growth in Q4, supported by a revamped sales strategy and increasing demand for Ameluz-PDT treatments.
Biofrontera Inc. Completes Acquisition of All US Assets for Ameluz® and RhodoLED® from Biofrontera AG
Acquisition Details: Biofrontera Inc. has acquired full U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, including all associated patents and regulatory applications, as part of a restructuring agreement.
New Earnout Structure: The earnout payment rate has been reduced to 12%-15% of U.S. net sales, down from the previous 25%-35%, which is expected to enhance profitability and accelerate growth.
Funding and Financial Outlook: The transaction was financed through an $11 million investment from existing investors, which is anticipated to support Biofrontera Inc. in reaching profitability.
Operational Responsibilities: Biofrontera Inc. will now manage all aspects of manufacturing, regulatory compliance, and commercialization for Ameluz® and RhodoLED® in the U.S., with full asset transfer expected by early 2026.
Biofrontera Inc. Set to Attend Lytham Partners Fall 2025 Investor Conference on September 30, 2025
Company Participation: Biofrontera Inc. will participate in the Lytham Partners Fall 2025 Investor Conference with a webcast presentation on September 30, 2025, at 1:15 p.m. ET.
Investor Engagement: The company will also host virtual one-on-one meetings with investors during the event, with arrangements available through Lytham Partners.
Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update
Financial Performance: Biofrontera Inc. reported a 15% increase in second-quarter revenues to $9.0 million and a 12% increase for the first half of 2025, totaling $17.7 million, despite a net loss of $5.3 million in Q2 due to higher legal costs and non-cash fluctuations.
Business Developments: The company has restructured its agreement with Biofrontera AG, acquiring U.S. rights to Ameluz® and RhodoLED®, along with an additional $11 million in funding, which is expected to enhance operational efficiency and sales effectiveness moving forward.
Biofrontera Inc. Appoints George Jones as Chief Commercial Officer
New Appointment: Biofrontera Inc. has appointed George Jones as Chief Commercial Officer, effective August 25, 2025, to enhance its commercial functions and support growth following the acquisition of rights to Ameluz® and RhodoLED® in the US market.
Company Strategy: The appointment aims to leverage Mr. Jones' extensive experience in the pharmaceutical sector to drive sustainable growth and improve patient access to therapies, aligning with Biofrontera's focus on innovative dermatology treatments.
BIOFRONTERA INC. IS NEGOTIATING FUNDAMENTAL CHANGES TO ITS COOPERATION WITH BIOFRONTERA AG
Company Negotiations: Biofrontera Inc. is in discussions with Biofrontera AG regarding a potential merger or adjustments to their licensing agreement, which may involve transferring rights and reducing product prices for the U.S. market.
Business Focus: Biofrontera Inc. specializes in photodynamic therapy for dermatological conditions, particularly through its product Ameluz® and related devices, while also conducting clinical trials for broader applications.
Biofrontera Inc. Announces Financial Results for Q3 2025 and Offers Business Update
Financial Performance: Biofrontera Inc. reported stable revenues of $24.6 million for the first nine months of 2025, slightly down from $24.8 million in 2024, with a notable decline in Q3 revenues to $7.0 million due to advanced purchases ahead of a price increase.
Operational Developments: The company completed the acquisition of U.S. rights for Ameluz and RhodoLED assets, which is expected to enhance gross margins and profitability, and announced the divestiture of its Xepi antibiotic cream for up to $10 million in total payments.
Clinical Trials Update: Biofrontera announced the completion of the active treatment phase for its Phase 3 clinical trial of Ameluz for actinic keratoses and the conclusion of participation in a Phase 2b trial for acne vulgaris.
Future Outlook: CEO Hermann Luebbert expressed confidence in achieving full-year sales objectives, anticipating substantial growth in Q4, supported by a revamped sales strategy and increasing demand for Ameluz-PDT treatments.
Biofrontera Inc. Completes Acquisition of All US Assets for Ameluz® and RhodoLED® from Biofrontera AG
Acquisition Details: Biofrontera Inc. has acquired full U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, including all associated patents and regulatory applications, as part of a restructuring agreement.
New Earnout Structure: The earnout payment rate has been reduced to 12%-15% of U.S. net sales, down from the previous 25%-35%, which is expected to enhance profitability and accelerate growth.
Funding and Financial Outlook: The transaction was financed through an $11 million investment from existing investors, which is anticipated to support Biofrontera Inc. in reaching profitability.
Operational Responsibilities: Biofrontera Inc. will now manage all aspects of manufacturing, regulatory compliance, and commercialization for Ameluz® and RhodoLED® in the U.S., with full asset transfer expected by early 2026.
Biofrontera Inc. Set to Attend Lytham Partners Fall 2025 Investor Conference on September 30, 2025
Company Participation: Biofrontera Inc. will participate in the Lytham Partners Fall 2025 Investor Conference with a webcast presentation on September 30, 2025, at 1:15 p.m. ET.
Investor Engagement: The company will also host virtual one-on-one meetings with investors during the event, with arrangements available through Lytham Partners.
Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update
Financial Performance: Biofrontera Inc. reported a 15% increase in second-quarter revenues to $9.0 million and a 12% increase for the first half of 2025, totaling $17.7 million, despite a net loss of $5.3 million in Q2 due to higher legal costs and non-cash fluctuations.
Business Developments: The company has restructured its agreement with Biofrontera AG, acquiring U.S. rights to Ameluz® and RhodoLED®, along with an additional $11 million in funding, which is expected to enhance operational efficiency and sales effectiveness moving forward.
Biofrontera Inc. Appoints George Jones as Chief Commercial Officer
New Appointment: Biofrontera Inc. has appointed George Jones as Chief Commercial Officer, effective August 25, 2025, to enhance its commercial functions and support growth following the acquisition of rights to Ameluz® and RhodoLED® in the US market.
Company Strategy: The appointment aims to leverage Mr. Jones' extensive experience in the pharmaceutical sector to drive sustainable growth and improve patient access to therapies, aligning with Biofrontera's focus on innovative dermatology treatments.
BIOFRONTERA INC. IS NEGOTIATING FUNDAMENTAL CHANGES TO ITS COOPERATION WITH BIOFRONTERA AG
Company Negotiations: Biofrontera Inc. is in discussions with Biofrontera AG regarding a potential merger or adjustments to their licensing agreement, which may involve transferring rights and reducing product prices for the U.S. market.
Business Focus: Biofrontera Inc. specializes in photodynamic therapy for dermatological conditions, particularly through its product Ameluz® and related devices, while also conducting clinical trials for broader applications.
