Summary of Biofrontera Inc. Conference Call Company Overview - **Company Name**: Biofrontera Inc. (NasdaqCM: BFRI) - **Industry**: Dermatology and Oncology - **Specialization**: Photodynamic therapy (PDT) for treating actinic keratosis (AK) and other dermatologic conditions - **Key Products**: Ameluz and BF-RhodoLED lamps - **Market Position**: Focused on expanding treatment indications and vertical integration in the U.S. pharmaceutical market [2][4] Financial Performance - **2024 Revenue**: $37.3 million - **Year-to-Date Revenue (Q2 2025)**: $17.6 million, up from $15.8 million in Q2 2024 - **Long-term Gross Margin**: Expected to be 80-85%, with current year-to-date gross margin at 71% for Q2 2025, compared to 45% in 2024 [3][17] - **Adjusted EBITDA**: Year-over-year adjusted EBITDA for 2025 is flat due to one-time legal expenses [18] Market Opportunity - **Actinic Keratosis Market**: Estimated market opportunity of $500 million - **Total Addressable Market**: Approximately $4 billion, focusing on a $520 million market suited for field therapy [3][10] - **Reimbursement**: Ameluz priced at $363, with an average reimbursement of $262 per treatment for healthcare professionals [11] Product Efficacy and Technology - **Efficacy**: 91% clearance rate after one to two treatments, significantly better than competitors [9] - **Technology**: Utilizes nanoemulsion technology for better absorption and penetration compared to traditional treatments [10][21] Competitive Landscape - **Competitors**: Main competitor is Levulan, which is limited to spot treatment; Biofrontera is the only PDT drug formulated for field treatment [21][22] - **Advantages**: Superior penetration and efficacy of Ameluz compared to cryotherapy and topical treatments [21] Growth Strategy - **Label Expansion**: Ongoing clinical trials for non-melanoma skin cancers and acne, with expected FDA submissions for basal cell carcinoma and trunk/extremities indications by mid-2027 [16][24] - **Customer Conversion**: Strategy to convert patients from other therapies to Ameluz, optimizing salesforce productivity [14][15] - **Inorganic Growth**: Actively seeking late-stage or commercial products that complement PDT [17] Leadership and Management - **CEO**: Professor Hermann Luebbert, founder of Biofrontera - **Key Executives**: Includes George Jones (Chief Commercial Officer) and Sam Whitcomb (VP of Corporate Strategy) [19] Financial Outlook - **Break-even Expectation**: Anticipated break-even in 2026, with modest growth and new indications contributing to revenue [24] - **Cash Position**: $3.5 million cash on hand, with long-term convertible debt of $4.3 million [19] Additional Insights - **Cyclical Revenue Pattern**: Revenue typically peaks in Q4 and Q1, with a decline in summer months due to patient behavior [25] - **Intellectual Property**: Strong patent protection for nanoemulsion technology until 2028, with an extension for a new formulation until 2043 [12] This summary encapsulates the key points discussed during the Biofrontera Inc. conference call, highlighting the company's market position, financial performance, growth strategies, and competitive advantages.

Woburn, MA, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc., (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced that it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025. Company Webcast The webcast presentation will take place at 1:15 p.m. ET on Tuesday, ...

Core Viewpoint - Biofrontera Inc. has reached a significant milestone in its Phase 2b clinical trial for Ameluz, aimed at treating moderate to severe acne vulgaris, with the final patient completing participation on August 22, 2025 [1][5]. Company Summary - Biofrontera Inc. is a biopharmaceutical company focused on photodynamic therapy (PDT) for dermatological conditions, including the commercialization of Ameluz for treating actinic keratosis and its potential expansion to acne vulgaris [9]. - The company plans to present top-line data from the trial in Q1 2026 and intends to discuss findings with the FDA in early Q3 2026 to advance to a Phase 3 program [5][8]. Industry Summary - Acne vulgaris affects approximately 50 million people in the U.S. annually, with about 40% of adults experiencing the condition, highlighting a significant market need for effective treatments [6]. - The U.S. acne treatment market was valued at $5.7 billion in 2024 and is projected to grow at a 5.3% CAGR, indicating a strong demand for alternative therapies due to limitations of current treatment options [6][8]. - Current treatment options for acne include topical agents, systemic antibiotics, and isotretinoin, but many have serious side effects, creating an unmet need for safer alternatives [3][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 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]