Biofrontera Inc Stock Price, News & Analysis

Biofrontera Inc. (Nasdaq: BFRI) has appointed George Jones as Chief Commercial Officer (CCO), effective August 25, 2025. This strategic hire follows the company's recent acquisition of all US rights and assets for Ameluz® and RhodoLED® from Biofrontera AG, which includes a restructured royalty payment of 12-15% versus the previous 25-35% transfer pricing model.

Jones brings over 25 years of commercial leadership experience in specialty pharmaceuticals and biotech. His track record includes successful roles at Currax Pharmaceuticals, Pernix Therapeutics, and most recently as COO at UpScriptHealth, where he achieved a threefold increase in partnership revenues.

Biofrontera (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has scheduled its Second Quarter 2025 Financial Results announcement for August 13, 2025 after market close.

The company will host a conference call and webcast to discuss the results on Thursday, August 14, 2025, at 10:00 AM ET. Investors can access the call via U.S. toll-free number (1-877-877-1275) or international number (1-412-858-5202).

Biofrontera Inc. (NASDAQ: BFRI) has announced a major restructuring agreement with Biofrontera AG, backed by an $11 million investment from Rosalind Advisors and AIGH Capital Management LLC. The company will acquire 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 significantly reduced royalty rate of 12% of net sales (increasing to 15% for revenue above $65 million), down from the previous 25-35% transfer pricing model. Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc.

The $11 million investment will be funded in two tranches: $8.5 million with the signing of the royalty agreement and $2.5 million upon finalizing the asset transfer agreement by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share.

Biofrontera Inc. (BFRI) has confirmed ongoing negotiations with Biofrontera AG regarding potential significant changes to their business relationship. The discussions center around two possible outcomes: a merger between the companies or modifications to their existing license and supply agreement. The potential agreement modifications could involve transferring certain rights and obligations from Biofrontera AG to Biofrontera Inc., along with a reduction in transfer pricing for Biofrontera Inc.'s US-licensed products. However, no definitive terms have been established yet, and any final agreement remains subject to various conditions and the execution of definitive agreements between both parties.

Biofrontera Inc. (BFRI) announced the inclusion of its patent for a propylene glycol-free formulation of Ameluz® nanoemulsion gel in the FDA's Orange Book. The patent, approved in April 2025, extends protection until December 2043 and prevents generic competition during this period. The revised formulation eliminates propylene glycol, a known allergen, demonstrating Biofrontera's focus on patient-centric development. The formulation has been in use since 2024 after FDA acceptance. The Orange Book listing confirms FDA recognition of the drug's safety, efficacy, and quality standards. This development represents a significant improvement for patients sensitive to propylene glycol while maintaining the treatment's effectiveness in photodynamic therapy (PDT).

Biofrontera Inc. (NASDAQ:BFRI) reported its Q1 2025 financial results with total revenues of $8.6 million, marking a 9% increase from Q1 2024. The company's cash position was $1.8 million as of March 31, 2025, down from $5.9 million at year-end 2024. Notable achievements include completing enrollment in Phase 3 trials for Ameluz® for actinic keratoses treatment, receiving patent protection through 2043, and finalizing a Phase 2b study for acne vulgaris treatment. The company reported a net loss of $4.2 million ($0.47 per share), improved from a $10.4 million loss in Q1 2024. Operating expenses decreased to $13.1 million from $13.4 million year-over-year, while Adjusted EBITDA improved to ($4.4) million from ($4.6) million.

Biofrontera Inc. (BFRI) has achieved two significant milestones: patent approval for Ameluz® extending protection until December 2043, and completion of patient enrollment in a Phase 2b study for acne treatment. The study evaluates Ameluz® photodynamic therapy (PDT) for moderate to severe acne vulgaris, enrolling 120 patients with treatments involving 1-hour and 3-hour incubation periods.

The U.S. acne treatment market, valued at $5.7 billion in 2024, is growing at a 5.3% CAGR. Over 55% of market spending goes to oral antibiotics and isotretinoin, which often have systemic side effects. With approximately 50 million Americans suffering from acne vulgaris, Ameluz® PDT could provide an alternative treatment option without the side effects associated with current systemic therapies.

The Phase 2b trial's last-patient-out is expected in Q3 2025, marking a crucial step in expanding Ameluz®'s indications beyond its current approval for mild to moderate actinic keratosis.

Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has scheduled its first quarter 2025 financial results announcement for May 15, 2025, after market close. The company will hold a conference call and webcast to discuss the results and provide a business update on Friday, May 16, 2025, at 10:00 AM ET. Interested parties can access the conference call via U.S. toll-free number 1-877-877-1275 or international number 1-412-858-5202.

Biofrontera Inc. (NASDAQ:BFRI) and Almirall have launched the Hats On Challenge, a social media initiative to raise awareness about Actinic Keratosis (AK) ahead of Global AK Awareness Day on May 24, 2025. The campaign aims to support The Skin Cancer Foundation and Euromelanoma through a social media challenge where participants wear hats and post videos using specific hashtags.

AK is a common precancerous skin condition affecting an estimated 58 million Americans, with a global prevalence of 14%. The condition, characterized by rough, scaly patches on sun-exposed areas, can develop into squamous cell carcinoma if left untreated. The campaign will run throughout May 2025, with both companies making monetary donations to The Skin Cancer Foundation on behalf of participants.