Core Viewpoint - Biofrontera Inc. has divested its US license for Xepi (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc., receiving a total of up to $10 million, which is expected to strengthen its balance sheet and support its path to profitability [1][2][5]. Financial Summary - The divestiture includes an initial payment of $3 million at closing, an additional $1 million upon availability of the commercial product, and up to $6 million in milestone payments tied to achieving $10 million and $15 million in annual net revenues for Xepi [1][5]. - The transaction is anticipated to bolster Biofrontera's cash position, aiding in funding its operations towards profitability [5]. Business Focus - Biofrontera specializes in photodynamic therapy (PDT) and is focused on expanding the indications for its product Ameluz® for the treatment of actinic keratosis (AK) and potentially other conditions [2][3]. - The company is also involved in clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne [3]. Product Information - Xepi (ozenoxacin) Cream, 1% is a topical non-fluorinated quinolone that is FDA-approved for treating impetigo, a common skin infection caused by Staphylococcus aureus or Streptococcus pyogenes, with no known antibiotic resistance [2].

Core Viewpoint - Biofrontera Inc. will participate in the Lytham Partners Fall 2025 Investor Conference, engaging in a webcast presentation and one-on-one meetings with investors on September 30, 2025 [1][2][3]. Company Overview - Biofrontera Inc. is a U.S.-based biopharmaceutical company focused on dermatological conditions, particularly through photodynamic therapy (PDT) [4]. - The company commercializes Ameluz, a drug-device combination used with the RhodoLED lamp series for treating actinic keratosis (AK) and pre-cancerous skin lesions [4]. - Biofrontera is conducting clinical trials to expand the application of its products to treat non-melanoma skin cancers and moderate to severe acne [4].

Core Viewpoint - Biofrontera Inc. has completed the active treatment phase of its Phase 3 clinical trial for Ameluz PDT, targeting mild to moderate actinic keratoses, with all 172 patients now entering a 12-month follow-up phase expected to conclude in Q2 2026 [1][4]. Group 1: Clinical Trial Details - The Phase 3 study is a multicenter, randomized, double-blind trial assessing the safety and efficacy of Ameluz PDT compared to a vehicle gel for treating actinic keratoses on the extremities, neck, and trunk [3]. - Patients received one to three tubes of either Ameluz or vehicle gel applied to areas of approximately 80, 160, or 240 cm², with a single PDT treatment and a possible second treatment at 12 weeks if needed [3]. - The study enrolled a total of 172 subjects, who will be monitored for 12 months to evaluate recurrence and new lesion development [3][7]. Group 2: Market and Strategic Implications - The completion of this trial phase is seen as a significant milestone for Biofrontera, enhancing the market potential for Ameluz following recent FDA approval for using up to three tubes per treatment [4]. - The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in Q2 2026, contingent on positive trial outcomes [4][7]. - Expanding treatment options for actinic keratoses beyond the face and scalp addresses a critical unmet need in dermatology, as 58 million US adults are affected by this condition [2][5]. Group 3: Company Overview - Biofrontera Inc. specializes in the treatment of dermatological conditions, focusing on photodynamic therapy (PDT) and commercializing the drug-device combination Ameluz with the RhodoLED lamp series [6]. - The company is actively conducting clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne [6].

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $9 million, up from $7.8 million in Q2 2024, driven by a 5% increase in unit sale price and a 9.5% increase in sales volume of Ameluz [15][16] - Total operating expenses increased to $14.1 million in Q2 2025 from $12.9 million in Q2 2024, with a net loss of $5.3 million compared to a net loss of $0.3 million in the prior year quarter [18][19] - Adjusted EBITDA for Q2 2025 was negative $5.1 million, compared to negative $4.7 million in Q2 2024, reflecting higher selling, general, and administrative costs [18][19] Business Line Data and Key Metrics Changes - The company sold more than 50,000 tubes of Ameluz in the first half of 2025, with 40 ROGOLET XL lamps placed in physician offices during the year [5][6] - Cost of revenues decreased by $1.7 million or about 42% compared to Q2 2024, primarily due to a reduced transfer price for Ameluz [17][20] - Sales volume of Ameluz increased due to improvements in direct sales team efficiency [15][19] Market Data and Key Metrics Changes - The company is in the process of transferring all U.S. IP, FDA approvals, and contracts with third-party manufacturers, which is expected to enhance operational control [7][8] - CMS has officially listed Ameluz for reimbursement for up to three tubes per treatment, which is expected to significantly impact treatment options for actinic keratosis [10] Company Strategy and Development Direction - The company has restructured its relationship with Biofrontera AG, becoming completely independent, which includes a shift to a royalty model that will reduce costs and improve financial flexibility [6][9] - Future plans include expanding the label for Ameluz to treat actinic keratosis on larger body areas and superficial basal cell carcinoma, with ongoing clinical trials [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong results and the potential for Ameluz to treat acne vulgaris, with ongoing clinical trials showing promise [13][14] - The company is focused on improving operational efficiency and reducing costs through better control of manufacturing processes [22][23] Other Important Information - The company raised $11 million to support the restructuring and expansion of its operations, which is reflected in its balance sheet [23] - As of June 30, 2025, cash and cash equivalents were $7.2 million, an increase from $6 million at the end of 2024, indicating improved financial health [22] Q&A Session Summary Question: How many of each lamp were placed in Q2 2025? - 40 XL lamps were placed in 2025 [28] Question: When do you think you'll receive the $2,500,000? - Expected in Q3 2025 [31] Question: Is the data timing still as previously reported for acne and peripheral AK? - Yes, both are expected in Q4 2025 [32] Question: How do you see gross margins unfolding over the next couple of quarters? - Gross margins are expected to improve due to the new agreement with Biofrontera AG [41][43] Question: What is the timing for the FDA submission for superficial basal cell carcinoma? - The submission is being prepared and is expected in the second half of the year [49]

Core Points - Biofrontera Inc. will report its financial results for the three and six months ended June 30, 2025 on August 13, 2025, after market close [1] - A conference call to discuss the financial results and business updates will be held on August 14, 2025, at 10:00 am ET [2] Company Overview - Biofrontera Inc. is a U.S.-based biopharmaceutical company focused on developing and treating dermatological conditions, particularly through photodynamic therapy (PDT) [3] - The company commercializes the drug-device combination Ameluz with the RhodoLED lamp series for the treatment of actinic keratosis (AK) and pre-cancerous skin lesions [3] - Biofrontera is conducting clinical trials to expand the use of its products for treating non-melanoma skin cancers and moderate to severe acne [3]

Core Viewpoint - Biofrontera Inc. is in negotiations with Biofrontera AG regarding a potential combination of the two companies or adjustments to their existing license and supply agreement, which may involve the transfer of rights and obligations and a reduction in transfer prices for licensed products sold in the US [1][2]. Company Overview - Biofrontera Inc. is a U.S.-based biopharmaceutical company that specializes in photodynamic therapy (PDT) for dermatological conditions, particularly focusing on the drug-device combination Ameluz and the RhodoLED lamp series for treating actinic keratosis (AK) and pre-cancerous skin lesions [3]. - The company is also conducting clinical trials to expand the use of its products for treating non-melanoma skin cancers and moderate to severe acne [3].