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.

Core Insights - Biofrontera Inc. has engaged Lytham Partners to enhance its investor relations and shareholder communication strategy, aiming to broaden its investor base and improve market recognition of its value proposition [1][3]. Company Overview - Biofrontera Inc. is a biopharmaceutical company focused on photodynamic therapy (PDT) for dermatological conditions, particularly through its drug-device combination Ameluz® and the RhodoLED® lamp series [4]. - The company is actively conducting clinical trials to expand the application of its products to treat non-melanoma skin cancers and moderate to severe acne [4]. Recent Developments - The company has undertaken significant actions, including restructuring its relationship with its former parent company, acquiring U.S. intellectual property, and securing $11 million in new funding, positioning itself for potential profitability in upcoming quarters [3]. - Biofrontera aims to establish itself as a leading specialty dermatology company in the U.S. by advancing innovative therapies that cater to dermatology professionals and their patients [3]. Strategic Partnership - Lytham Partners, with over 20 years of experience in investor relations, will provide a comprehensive platform for Biofrontera to enhance its visibility among institutional investors and streamline its communication practices [2]. - The partnership is expected to support Biofrontera in keeping shareholders informed about the company's developments and progress [3].

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].

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. has acquired all U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, marking a strategic move to enhance its presence in the U.S. dermatology market [1][3][7] Financial Summary - The acquisition was funded by an $11 million investment led by Rosalind Advisors, Inc. and AIGH Capital Management LLC [1][7] - Biofrontera Inc. will pay a monthly royalty of 12% on Ameluz® revenue under $65 million and 15% on revenue exceeding that threshold, replacing the previous transfer pricing model of 25% to 35% [2][7] - The first tranche of funding is $8.5 million, with a second tranche of $2.5 million expected upon finalization of a detailed asset transfer agreement by September 30, 2025 [4] Operational Changes - Biofrontera Inc. will assume full responsibility for the manufacture of Ameluz® and the RhodoLED® portfolio for the U.S. market, including all regulatory, quality management, pharmacovigilance, and commercial responsibilities [3][4] - The transition to a royalty-based agreement is expected to lead to cost reductions, allowing the company to reach breakeven more quickly and improve future profitability [4] Market Potential - The acquisition is seen as a significant opportunity to unlock the untapped potential of Ameluz® in the U.S. market, with expectations for growth and alignment of interests between Biofrontera Inc. and Biofrontera AG [5][7]

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]

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]