Financial Data and Key Metrics Changes - Year-to-date revenues until September 30, 2025, were approximately flat compared to the same period in 2024, with Q3 revenues at $7.0 million, a 22% decline from $9.0 million in Q3 2024 [5][14] - Total operating expenses for Q3 2025 were $13.3 million, down from $14 million in Q3 2024, while net loss increased to $6.6 million from $5.7 million year-over-year [14][15] - Adjusted EBITDA for Q3 2025 was negative $6.0 million compared to negative $4.6 million in Q3 2024 [16] Business Line Data and Key Metrics Changes - The installed base of RhodoLED lamps reached approximately 750, supporting recurring high-margin sales of Ameluz gel [6][7] - Cost of revenues decreased by $2.8 million, or 58%, due to a reduced cost agreement with Biofrontera AG [14][15] - Selling, general, and administrative expenses increased to $10.4 million in Q3 2025 from $8.4 million in Q3 2024, primarily due to increased legal costs [15] Market Data and Key Metrics Changes - The company anticipates strong revenue growth in Q4 2025, driven by a normalization of sales following a transient effect in Q3 [5] - The new royalty structure for Ameluz is expected to enhance gross margins significantly, with a royalty of 12% when U.S. revenue is below $65 million and 15% above that threshold [11] Company Strategy and Development Direction - The company is focused on expanding the clinical and commercial potential of Ameluz across multiple high-value dermatologic indications, including upcoming FDA submissions for new indications [8][10] - A transformational agreement with Biofrontera AG has granted the company full control over U.S. rights, approvals, and patents for Ameluz and RhodoLED, enhancing long-term profitability [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year sales objectives despite a challenging Q3, citing a strong pipeline and upcoming catalysts for growth [5][6] - The company aims to reach cash flow breakeven by fiscal year 2026, supported by recent financing and divestments [12][19] Other Important Information - The company completed the sale of the Xepi license for $3 million, with potential additional milestones of $7 million, which will not impact current sales due to the product's inactivity [12] - As of September 30, 2025, the company had cash and cash equivalents of $3.4 million, bolstered by recent financing and divestment proceeds [18][19] Q&A Session Summary Question: Are you contemplating any price increases in the future and if so, when? - Management confirmed plans for a price increase before year-end [26] Question: When do you expect data from the trial for AK of the extremities and the plan for FDA submission? - Data is expected in January, with FDA submission planned for Q2 [27] Question: When will data be available for the acne trial and what are the next steps? - Data will be available early next year, followed by an end of phase 2 meeting with the FDA [30] Question: Should the plan for breaking even be modeled similarly to the seasonality seen in the income statement? - Management confirmed that individual quarters in 2026 might fluctuate between losses and gains, with the fourth quarter expected to be significant for achieving breakeven [33]

Revenue Performance - Revenues for the first nine months of 2025 were stable at $24.6 million, compared to $24.8 million for the same period in 2024[5] - In Q3 2025, revenues were $7.0 million, a 22% decline from $9.0 million in Q3 2024, primarily due to advanced purchases ahead of a price increase[11] - Total revenues for Q3 2025 were $6,988 million, a decrease of 22.5% compared to $9,012 million in Q3 2024[29] Operating Expenses - Operating expenses decreased by 5% year-over-year in Q3 2025, totaling $13.3 million compared to $14.0 million in Q3 2024[12] - Operating expenses for Q3 2025 totaled $13,266 million, slightly down from $13,972 million in Q3 2024[29] - Total operating expenses for the nine months ended September 30, 2025, were $40,512 million, slightly up from $40,260 million in 2024[29] Net Loss - The net loss for Q3 2025 was $6.6 million, compared to a net loss of $5.7 million in the prior-year quarter[14] - Net loss for Q3 2025 was $6,649 million, compared to a net loss of $5,669 million in Q3 2024, representing an increase in loss of 17.3%[31] - Loss from operations for the nine months ended September 30, 2025, was $(15,907) million, compared to $(15,498) million for the same period in 2024[29] Adjusted EBITDA - Adjusted EBITDA for Q3 2025 was negative $6.0 million, compared to negative $4.6 million for Q3 2024[15] - Adjusted EBITDA for Q3 2025 was $(5,987) million, with an adjusted EBITDA margin of -85.7%, compared to $(4,575) million and -50.8% in Q3 2024[31] Financing and Assets - The company closed the purchase of all Ameluz and RhodoLED US assets from Biofrontera AG, with a new earnout structure reducing payment rates to 12%-15% of U.S. net sales[5] - The company received the final $2.5 million of an $11 million financing led by existing investors in October 2025[10] - The divestiture of the Xepi antibiotic cream to Pelthos Pharmaceuticals was announced for $3 million at closing, with potential milestone payments of up to $6 million[5] Cash and Liabilities - The cash balance as of September 30, 2025, was $3.4 million, down from $5.9 million at the end of 2024[26] - Total liabilities as of September 30, 2025, were $17.996 million, compared to $17.668 million at the end of 2024[26] Research and Development - Research and development expenses increased to $854 million in Q3 2025 from $669 million in Q3 2024, reflecting a growth of 27.7%[29] Earnings Per Share - Basic and diluted loss per common share for Q3 2025 was $(0.62), compared to $(0.98) in Q3 2024[29] Interest Expense and Fair Value Changes - Interest expense, net for Q3 2025 was $(111) million, compared to $8 million in Q3 2024[31] - The company reported a change in fair value of warrants resulting in a loss of $(285) million in Q3 2025, compared to a loss of $(680) million in Q3 2024[31]

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number 001-40943 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware 47-37 ...

Core Viewpoint - Biofrontera Inc. has divested its US license for Xepi (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc., receiving a total of up to $10 million, which is expected to strengthen its balance sheet and support its path to profitability [1][2][5]. Financial Summary - The divestiture includes an initial payment of $3 million at closing, an additional $1 million upon availability of the commercial product, and up to $6 million in milestone payments tied to achieving $10 million and $15 million in annual net revenues for Xepi [1][5]. - The transaction is anticipated to bolster Biofrontera's cash position, aiding in funding its operations towards profitability [5]. Business Focus - Biofrontera specializes in photodynamic therapy (PDT) and is focused on expanding the indications for its product Ameluz® for the treatment of actinic keratosis (AK) and potentially other conditions [2][3]. - The company is also involved in clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne [3]. Product Information - Xepi (ozenoxacin) Cream, 1% is a topical non-fluorinated quinolone that is FDA-approved for treating impetigo, a common skin infection caused by Staphylococcus aureus or Streptococcus pyogenes, with no known antibiotic resistance [2].

WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces it will report financial results for the three and nine months ended September 30, 2025 after the close of the U.S. financial markets on Wednesday, November 12, 2025. The company will host a conference call on Thursday, November 13 at 10:00am Eastern Time to discuss those results, provide a bu ...

Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG.New earnout structure reduces payment rate to 12%–15% of U.S. net sales from 25%–35%.Closing releases final $2.5 million of $11 million financing led by existing investors Rosalind Advisors and AIGH Capital Management, which is expected to fund Biofrontera Inc. to profitability. WOBURN, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: ...

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 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].