WOBURN, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), confirms a disclosure by the Management Board of Biofrontera AG on June 10, 2025, according to which the two companies are in negotiations regarding a possible combination of the two companies or an adjustment of the license and supply agreement between them. The latter could result in the transfer of certain rights and ...

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]

Financial Performance - Total revenues for Q1 2025 were $8.6 million, a 9% increase from the same period last year[3] - The 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, for the prior-year quarter[8] - Adjusted EBITDA improved from $(4.6) million in Q1 2024 to $(4.4) million in Q1 2025[9] - The net loss for the three months ended March 31, 2025, was $4,203 million, a significant improvement from a net loss of $10,437 million in the same period of 2024[19] - Adjusted EBITDA for the period was $(4,378) million, slightly better than the $(4,577) million reported in the previous year, indicating a narrowing loss[19] - The adjusted EBITDA margin improved to -51.0% from -57.9% year-over-year, reflecting better operational efficiency[19] - Overall, the financial results indicate a trend towards improved performance and reduced losses compared to the previous year[19] Cash and Expenses - Cash and cash equivalents decreased to $1.8 million as of March 31, 2025, down from $5.9 million on December 31, 2024[3] - Total operating expenses for Q1 2025 were $13.1 million, a slight decrease from $13.4 million in Q1 2024[5] - Selling, general and administrative expenses decreased by $0.6 million, or 6.5%, compared to Q1 2024[6] - Interest expense, net decreased to $106 million from $1,407 million, showing a substantial reduction in financing costs[19] - Depreciation and amortization expenses decreased to $29 million compared to $128 million in the prior year, indicating lower asset depreciation[19] - Stock-based compensation increased slightly to $239 million from $228 million, reflecting ongoing employee incentive programs[19] - The company reported no loss on debt extinguishment in the current period, compared to a loss of $316 million in the previous year[19] Research and Development - Research and development expenses increased by $1.2 million compared to Q1 2024, attributed to the assumption of all clinical trial activities for Ameluz in the U.S.[7] - The company achieved a key milestone in the Phase 3 study of Ameluz and RhodoLED photodynamic therapy, with the last patient completing the 1-year follow-up visit in December 2024[3] - The final patient was enrolled in the Phase 3 clinical trial evaluating Ameluz for treating mild to moderate actinic keratoses[3] - A patent approval was received for a revised formulation of Ameluz, extending protection through December 2043[3] Fair Value and Liabilities - The change in fair value of warrant liabilities resulted in a loss of $548 million, a significant decrease from a loss of $3,429 million in the previous year[19] - The change in fair value of investment related to a party was negligible, with no significant impact reported[19]

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]

Financial Performance - Net product revenue for Q1 2025 increased by $0.7 million, or 8.7%, compared to Q1 2024, driven by a $0.5 million increase in Ameluz® sales and $0.2 million from the launch of RhodoLEDXL Lamp[144]. - Total revenues for Q1 2025 were $8.588 million, compared to $7.912 million in Q1 2024, reflecting a change of $0.676 million[144]. - Research and development expenses for Q1 2025 increased by $1.2 million compared to Q1 2024, attributed to the assumption of all clinical trial activities for Ameluz in the U.S.[147]. - Selling, general and administrative expenses decreased by $0.6 million, or 6.5%, in Q1 2025 compared to Q1 2024, with a notable decrease in marketing expenses[146]. - Loss from operations improved by $0.920 million, from a loss of $5.467 million in Q1 2024 to a loss of $4.547 million in Q1 2025[144]. - Net loss for Q1 2025 was $4.203 million, significantly improved from a net loss of $10.437 million in Q1 2024[144]. - Adjusted EBITDA for Q1 2025 was $(4.378) million, an improvement from $(4.577) million in Q1 2024, driven by an increase in gross profit[161]. - The company reported a loss from operations of $4.2 million for the three months ended March 31, 2025, compared to a loss of $10.4 million for the same period in 2024[166][167]. Cash Flow and Capital Management - Cash and cash equivalents as of March 31, 2025, were $1.8 million, down from $5.9 million as of December 31, 2024[162]. - For the three months ended March 31, 2025, net cash used in operating activities was $4.1 million, compared to $3.3 million for the same period in 2024[165][167]. - The net increase in cash and restricted cash for the three months ended March 31, 2025, was a decrease of $4.1 million, compared to an increase of $2.5 million in 2024[165]. - The company had no financing activities during the three months ended March 31, 2025, while it generated $7.7 million from financing activities in the same period of 2024[169]. - The company plans to secure additional capital through equity or debt financings or asset sales to support its commercial and development activities[163]. Compliance and Regulatory Matters - Biofrontera Inc. reported stockholders' equity of $0.5 million as of March 31, 2025, below the Nasdaq requirement of $2.5 million[117]. - The company is in the process of creating a plan to regain compliance with Nasdaq listing standards[117]. - The financial statements have been prepared on a going concern basis, indicating potential adjustments may be necessary if the company cannot continue as a going concern[164]. Product and Market Strategy - The company has reduced the Transfer Price for Ameluz from 50% to 25% of the anticipated net selling price per unit for 2024 and 2025, with planned increases to 35% starting in 2026[114]. - Biofrontera plans to divest its Xepi product line, which has not generated sales since 2023 due to manufacturing delays[116]. - The company is focused on expanding sales of Ameluz and RhodoLED Lamps in the U.S. to establish Ameluz as the standard of care for actinic keratosis[127]. - The company aims to finance R&D activities through the reduced Transfer Price, supporting growth in photodynamic therapy[115]. - The company plans to expand the commercialization of Ameluz in the United States while controlling expenses and limiting capital expenditures[163]. Revenue Generation and Seasonality - Biofrontera's revenues are primarily generated from sales of licensed products, including Ameluz and RhodoLED Lamps[129]. - Biofrontera's revenue is subject to seasonality, with historically higher revenues in the first and fourth quarters[128]. Clinical Trials and Operations - The company has assumed control of all clinical trials related to Ameluz in the U.S. since June 1, 2024, for better cost management[115]. - The change in fair value of warrant liabilities was a gain of $0.548 million in Q1 2025, compared to a loss of $3.429 million in Q1 2024[149]. - The company experienced a change in fair value of warrant liabilities of $0.5 million for the three months ended March 31, 2025[166]. - The company had negligible fixed asset purchases during the three months ended March 31, 2025[168]. - There were no material changes to the company's critical accounting estimates for the three months ended March 31, 2025[172].

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].

Core Viewpoint - Biofrontera Inc. and Almirall have launched the Hats On Challenge to raise awareness and support for actinic keratosis (AK) ahead of Global AK Awareness Day on May 24 [1][4]. Group 1: Actinic Keratosis (AK) Overview - Actinic Keratosis is a rough, scaly skin patch caused by prolonged sun exposure, commonly found on sun-exposed areas [2][8]. - AK is prevalent globally, with an estimated 14% of the population affected, and can progress to squamous cell carcinoma if untreated [3][6]. - Approximately 58 million Americans are estimated to have one or more AKs, highlighting the need for public education on prevention and treatment [6]. Group 2: Awareness Campaign - The Hats On Challenge encourages participants to wear hats and share videos on social media to promote skin protection and early detection of AK [5][7]. - The campaign aims to raise funds for The Skin Cancer Foundation, which will use the funds for public awareness and patient education [4][6]. - The initiative will run throughout May, with participants recognized through monetary donations made to The Skin Cancer Foundation by Biofrontera and Almirall [7]. Group 3: Company Profiles - Biofrontera Inc. specializes in developing and commercializing photodynamic therapy (PDT) for dermatological conditions, including AK [9][10]. - Almirall is a global pharmaceutical company focused on medical dermatology, collaborating with Biofrontera on the Hats On Challenge [1][4].

Financial Data and Key Metrics Changes - Total revenues for 2024 reached $37.3 million, representing an annual growth of approximately 9.5% compared to $34.1 million in 2023 [16] - The net loss for 2024 was $17.8 million or $3.22 per diluted share, an improvement from a net loss of $20.1 million or $13.02 per share in 2023 [19] - Adjusted EBITDA for 2024 was negative $15.3 million, an improvement from negative $19.5 million in 2023, driven by increased sales and reduced SG&A expenses [19] Business Line Data and Key Metrics Changes - The company placed 52 RotoLite XL lamps in Q4 2024, totaling 100 lamps since the launch in June 2024, contributing to the overall strategy for Ameluz PDT [3] - The cost of revenues for 2024 increased to $18.6 million from $17.4 million in 2023, influenced by sales volume but offset by lower transfer prices [17] Market Data and Key Metrics Changes - The company achieved a 5% price increase for Ameluz in Q4 2024, with the tube priced at $363, which may have influenced forward buying behavior [41] - The transfer price for Ameluz was reduced from 50% to 25% for all purchases in 2024 and 2025, expected to positively impact gross margins in 2025 [7][39] Company Strategy and Development Direction - The company aims to become cash flow positive while managing expenses without sacrificing sales, emphasizing the importance of sales growth and marketing efforts [48] - Future plans include expanding the use of Ameluz beyond actinic keratosis to treat non-melanoma skin tumors, with new data expected to be submitted to the FDA [6] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another record year in 2025, supported by past investments and business plans [2] - The company is excited about the potential for Ameluz in treating moderate to severe acne, with ongoing phase two studies nearing completion [10] Other Important Information - Cash and cash equivalents as of December 31, 2024, were $5.9 million, a significant increase from $1.3 million at the end of 2023, attributed to strong growth and additional capital raised [20] - Inventory levels were reduced to $6.6 million from $10.9 million year-over-year, indicating improved inventory management [21] Q&A Session Summary Question: What was the Q4 2024 Ameluz unit growth year over year? - Answer: Approximately 2% [27] Question: Was there any sales force addition or attrition over 2024? - Answer: No, the number of salespeople remained approximately constant [29] Question: What is the acne enrollment number and data timing? - Answer: The enrollment number is 116, with potential for earlier trial conclusion [31] Question: How will the new transfer pricing impact gross margins in 2025? - Answer: The lower transfer price of 25% is expected to positively impact gross margins [39] Question: What was the percentage of the price increase in Q4? - Answer: There was a 5% price increase for Ameluz [41] Question: Will SG&A and R&D expenses continue to trend down in 2025? - Answer: SG&A is expected to hold steady, while R&D will remain stable compared to recent months [43][44]