• Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.• Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various trademarks associated with Ameluz® and the RhodoLED® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)• In addition, 19 international patent applications and/or registered designs for Rhodo ...

Registration No. 333- As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (I.R.S. Employer Identification No.) 660 Main Street Woburn, M ...

Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of p ...

Company Performance - Biofrontera Inc. experienced a price drop to $0.05, marking a decrease of approximately 36.07%, potentially due to market dynamics or operational challenges [2][8] - IAC Inc. saw its stock decline to $0.60, a 33.31% drop, attributed to the recent spin-off of its subsidiary, Angi Inc., and subsequent market adjustments [3][8] - OmniAb, Inc. had its stock price fall to $0.08, a decrease of 44.83%, indicating investor concerns over growth prospects or market competition [4][8] - S&W Seed Company experienced a price drop to $0.11, reflecting a 48.59% decrease, possibly due to its decision to voluntarily delist from The Nasdaq Capital Market [5] - MingZhu Logistics Holdings Limited saw a significant decline to $0.17, an 83.53% drop, related to operational challenges and market competition in the logistics sector [6] Market Trends - The price movements of these companies reflect a combination of company-specific developments, sectoral challenges, and broader market trends [7]

Core Viewpoint - Biofrontera Inc. reported stable revenues for the first nine months of 2025, with expectations for substantial growth in the fourth quarter due to increased demand for its Ameluz-PDT treatment and a new royalty structure that enhances profitability [4][9][7]. Financial Highlights - Total revenues for the first nine months of 2025 were $24.6 million, slightly down from $24.8 million in the same period of 2024 [16]. - Third quarter revenues were $7.0 million, a 22% decline from $9.0 million in Q3 2024, attributed to advanced purchases ahead of a price increase [10][9]. - Operating expenses decreased by 5% year-over-year in Q3 2025, totaling $13.3 million compared to $14.0 million in Q3 2024 [11]. - The net loss for Q3 2025 was $6.6 million, compared to a net loss of $5.7 million in Q3 2024 [13]. - Adjusted EBITDA for Q3 2025 was negative $6.0 million, worsening from negative $4.6 million in Q3 2024 [14]. Recent Operational Highlights - The company is on track to meet its full-year sales objectives, supported by growing demand for Ameluz-PDT treatment [4]. - A new agreement with Biofrontera AG allows the company to acquire all U.S. rights, approvals, and patents for Ameluz and RhodoLED lamps, expected to enhance gross margins and long-term profitability [7]. - The company secured an $11 million investment from institutional investors, with $2.5 million received post-reporting period [8]. - Clinical studies for Ameluz are nearing completion, aiming for FDA approval to treat actinic keratoses on the entire body and potentially for superficial basal cell carcinoma and acne vulgaris [6]. Cash Position and Financing - Cash balance as of September 30, 2025, was $3.4 million [9]. - The company announced the divestiture of its Xepi antibiotic cream for $3 million at closing, with additional milestone payments tied to revenue thresholds [9].

Core Viewpoint - Biofrontera Inc. has successfully completed a restructuring and asset purchase agreement with its former parent company, Biofrontera AG, acquiring full U.S. rights to Ameluz and RhodoLED, which is expected to enhance its financial and operational profile [1][5][8] Group 1: Transaction Details - Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz and RhodoLED, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights, intellectual property, and personnel [1][3] - The transaction includes a new earnout structure where Biofrontera Inc. will pay 12% of U.S. net sales of Ameluz up to $65 million and 15% for sales above that threshold, replacing the previous model of 25%-35% [2][8] - The transaction was funded through an $11 million investment led by Rosalind Advisors and AIGH Capital Management, with Biofrontera AG receiving a 10% post-money equity stake in Biofrontera Inc. [4][8] Group 2: Operational Implications - Following the agreement, Biofrontera Inc. will take full responsibility for the manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz and RhodoLED in the U.S. [3] - The company anticipates completing the full transfer of assets and personnel by late Q4 2025 or early Q1 2026 [3] - The new earnout structure is expected to drive significant gross margin expansion starting in Q4 2025, positioning the company for accelerated growth of Ameluz and potential label expansion [5]

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 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 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]