Final patient visit marks key milestone for Biofrontera, with top-line results expected Q1 2026Company plans FDA discussion in Q3 2026 to advance Phase 3 program and potential label expansionMore than 50 million people affected by acne in US each year, with market valued at $5.7 billion in 2024 WOBURN, Mass., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic the ...

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 Insights - Biofrontera Inc. has appointed George Jones as Chief Commercial Officer, effective August 25, 2025, to enhance its commercial functions including sales, marketing, and market access [1][2][3] Management Changes - The appointment of Mr. Jones follows the acquisition of rights and assets related to Ameluz and RhodoLED for the US market from Biofrontera AG, which includes FDA approval and patents [2] - The new royalty structure for Ameluz will range from 12% to 15%, a reduction from the previous 25% to 35% based on net sales, moving the company closer to cash break-even [2] Leadership Experience - Mr. Jones brings over 25 years of experience in commercial leadership within the specialty pharmaceutical and biotech sectors, having previously held significant roles at Currax Pharmaceuticals and Pernix Therapeutics [3][4][5] - His recent role as Chief Operating Officer at UpScriptHealth saw a threefold increase in partnership revenues, showcasing his ability to drive growth [6] Strategic Vision - The company aims to leverage Mr. Jones' expertise in building high-performing teams and driving sustainable growth to accelerate its commercial success, particularly in expanding Ameluz in the PDT space [7] - Mr. Jones expressed enthusiasm about joining Biofrontera, emphasizing the alignment of the company's focus on innovative dermatology treatments with his passion for patient outcomes [7] Company Overview - Biofrontera Inc. specializes in developing and commercializing photodynamic therapy (PDT) for dermatological conditions, particularly through its drug-device combination Ameluz and the RhodoLED lamp series [8]

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].

Core Points - Biofrontera Inc. announced the inclusion of its propylene glycol-free formulation of Ameluz nanoemulsion gel in the FDA's Orange Book, confirming its FDA-approved status and intellectual property protection [1][2][7] - The revised formulation eliminates propylene glycol, a known allergen, enhancing patient safety while maintaining treatment efficacy [3][4] - The patent for the new formulation was issued on April 22, 2025, and is valid until December 8, 2043, preventing generic competition during this period [2][3][7] Company Overview - Biofrontera Inc. specializes in biopharmaceuticals, focusing on dermatological treatments using photodynamic therapy (PDT) [5] - The company commercializes Ameluz in combination with the RhodoLED lamp series for treating actinic keratosis and is conducting clinical trials for additional applications [5]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $8,600,000, representing a 9% increase from the same period last year [5][12] - Net loss for Q1 2025 was $4,200,000 or $0.47 per share, compared to a net loss of $10,400,000 or $2.88 per share for the prior year [15] - Adjusted EBITDA decreased from $4,600,000 in Q1 2024 to $4,400,000 in Q1 2025 [15][16] Business Line Data and Key Metrics Changes - Ameluz sales increased by $500,000 due to a higher unit price and the launch of the RotoLED XL lamp, which generated $200,000 in sales [12] - Total operating expenses decreased to $13,100,000 in Q1 2025 from $13,400,000 in Q1 2024 [12][13] - Cost of revenues decreased by $900,000 or 22.1% compared to last year, attributed to a reduced cost structure under the Ameluz license [13] Market Data and Key Metrics Changes - The company achieved a significant milestone with the granting of a patent for a new formulation of Ameluz, providing protection until December 2043 [6][7] - The enrollment of the final patient in the Phase three clinical trial for Ameluz was announced, aiming to extend the label for treatment beyond the face and scalp [8] Company Strategy and Development Direction - The company aims to achieve record revenues in 2025 without increasing costs, supported by past investments and sales force effectiveness [5] - Future goals include expanding Ameluz's applications to treat superficial basal cell carcinoma and moderate to severe acne, addressing significant medical needs [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving breakeven as quickly as possible, highlighting improved gross profit and reduced operating expenses [11] - The company is committed to exploring additional applications for Ameluz beyond actinic keratosis, indicating a proactive approach to growth [9] Other Important Information - Cash and cash equivalents as of March 31, 2025, were $1,800,000, down from $5,900,000 as of December 31, 2024 [16] - Inventory on hand was $6,500,000 compared to $6,600,000 as of December 31, 2024 [16] Q&A Session Summary Question: How many LAMP units were sold in Q1 2025? - The company placed 18 XL lamps in Q1 2025 [19][20] Question: Is there any sales force attrition affecting expenses? - There has been some turnover, but the company is committed to reorganizing the team for efficiency [24] Question: What is the status of reimbursement for the three-tube indication? - The company has ensured that Medicare covers the three-tube indication, with no reported refusals from doctors [29]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $8.6 million, a 9% increase from the same period last year [5][12] - Net loss for Q1 2025 was $4.2 million or $0.47 per share, compared to a net loss of $10.4 million or $2.88 per share in Q1 2024 [14] - Adjusted EBITDA for Q1 2025 was $4.4 million, showing a decrease from $4.6 million in Q1 2024 [15] Business Line Data and Key Metrics Changes - Ameluz sales increased by $500,000 due to a higher unit price and the launch of the RotoLED XL lamp, which generated $200,000 in sales [12] - Total operating expenses decreased to $13.1 million in Q1 2025 from $13.4 million in Q1 2024 [12] Market Data and Key Metrics Changes - The company achieved a significant milestone with the granting of a patent for a new formulation of Ameluz, providing protection until December 2043 [6] - The final patient was enrolled in a Phase three clinical trial for Ameluz, aiming to extend its label for broader treatment applications [7][8] Company Strategy and Development Direction - The company aims to achieve record revenues in 2025 without increasing costs, supported by past investments and an effective sales force [5] - Future goals include expanding Ameluz's applications to treat superficial basal cell carcinoma and moderate to severe acne, addressing significant medical needs [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching breakeven quickly, citing improved gross profit and reduced operating costs [11] - The company is committed to exploring additional applications for Ameluz beyond actinic keratosis, indicating a proactive approach to growth [9] Other Important Information - The company has cash and cash equivalents of $1.8 million as of March 31, 2025, down from $5.9 million at the end of 2024 [15] - Inventory on hand was $6.5 million, slightly down from $6.6 million at the end of 2024 [15] Q&A Session Summary Question: How many LAMP units were sold in Q1 2025? - The company placed 18 XL lamps in the first quarter [18][19] Question: Is there any sales force attrition affecting expenses? - Management noted some turnover but is committed to reorganizing the team for efficiency [23] Question: What is the status of gross margins and transfer pricing? - The company expects to maintain a 25% transfer price for inventory moving forward, which will impact gross margins [26][27] Question: What is the status of reimbursement for the three-tube indication? - Management confirmed that there have been no reported issues with reimbursement for using more than one tube [28]

Core Insights - Biofrontera Inc. reported a 9% increase in revenues for Q1 2025, driven by strong sales of Ameluz and the launch of the RhodoLEDXL Lamp [1][2] - The company is excited about the enrollment of the final patient in a Phase 3 clinical trial for Ameluz, indicating progress in its product development pipeline [1][5] - The net loss for Q1 2025 was $4.2 million, a significant improvement from a net loss of $10.4 million in the same period last year [7][19] Financial Performance - Total revenues for Q1 2025 were $8.6 million, an increase of $0.7 million or 8.7% compared to Q1 2024 [2][5] - Operating expenses decreased to $13.1 million in Q1 2025 from $13.4 million in Q1 2024, reflecting cost management efforts [3][4] - Cash and cash equivalents decreased to $1.8 million as of March 31, 2025, down from $5.9 million at the end of 2024 [5] Cost Structure - Cost of revenues related to parties decreased by $0.9 million, or 22.1%, due to a reduced cost structure under the Ameluz license agreement [3] - Selling, general, and administrative expenses decreased by $0.6 million, or 6.5%, with notable reductions in marketing and sales team expenses [4] - Research and development expenses increased by $1.2 million due to the assumption of clinical trial activities for Ameluz in the U.S. [6] Clinical Developments - The final patient was enrolled in the Phase 3 clinical trial for Ameluz targeting mild to moderate actinic keratoses [5] - The company achieved a milestone in the Phase 3 study for Ameluz and RhodoLED PDT in treating superficial basal cell carcinoma [5] - Biofrontera received patent approval for a revised formulation of Ameluz, extending protection until December 2043 [5] Adjusted Metrics - Adjusted EBITDA improved from a loss of $4.6 million in Q1 2024 to a loss of $4.4 million in Q1 2025, driven by increased gross profit [8][19] - The adjusted EBITDA margin for Q1 2025 was -51.0%, compared to -57.9% in Q1 2024 [19]

Core Viewpoint - Biofrontera Inc. has received patent approval for an updated formulation of Ameluz, extending protection until December 2043, and has successfully enrolled the final patient in a Phase 2b clinical trial for treating moderate to severe acne vulgaris [1][5][8]. Company Summary - Biofrontera Inc. specializes in photodynamic therapy (PDT) for dermatological conditions and commercializes Ameluz in combination with the RhodoLED lamp series [9]. - The company aims to expand the indications for Ameluz beyond its current approval for mild to moderate actinic keratosis [5]. - The successful enrollment of 120 patients in the Phase 2b trial marks a significant milestone for the company [3][5]. Industry Summary - The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3% [4][8]. - Acne vulgaris affects an estimated 50 million people annually in the U.S., with about 40% of adults experiencing the condition [6][8]. - Current treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin, which may have serious side effects, highlighting the need for effective alternatives [7][8].