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].

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 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].

Core Viewpoint - Biofrontera Inc. is conducting its Second Quarter 2025 Financial Results and Business Update Conference Call, indicating a focus on financial performance and business developments [1]. Company Overview - The conference call is led by key executives including the Chief Financial Officer and the CEO, highlighting the importance of leadership in communicating financial results [1]. - The call is part of a structured financial update, suggesting a commitment to transparency and investor relations [2]. Financial Information - The company will discuss non-GAAP financial measures, which are intended to provide additional insights for investors, although they should not replace GAAP measures [5].

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]

As filed with the Securities and Exchange Commission on August 13, 2025. Registration No. 333-288717 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) 120 Presidential Way, Suite 330 Woburn, MA 01801 Telephone: 781-245-1325 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) BI ...

[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) Biofrontera Inc. achieved double-digit revenue growth in H1 2025, driven by strategic restructuring, IP acquisition, and clinical trial advancements Revenue Performance | Period | Revenue | YoY Growth | | :--- | :--- | :--- | | Q2 2025 | $9.0 million | 15% | | H1 2025 | $17.7 million | 12% | - Cash and cash equivalents increased to **$7.2 million** as of June 30, 2025, from **$5.9 million** at the end of 2024[3](index=3&type=chunk) - A major restructuring with Biofrontera AG was agreed upon, including the acquisition of U.S. IP and NDAs, supported by an additional **$11 million** in funding[3](index=3&type=chunk) - A new U.S. patent was granted for a revised Ameluz® formulation, extending patent protection through **December 2043**[3](index=3&type=chunk) - Significant progress was made in clinical trials, including completing patient follow-up in a Phase 3 sBCC study and completing enrollment in Phase 3 and Phase 2b studies for AK and acne, respectively[3](index=3&type=chunk) [Strategic Restructuring with Biofrontera AG](index=2&type=section&id=Strategic%20Restructuring%20with%20Biofrontera%20AG) Biofrontera Inc. acquired all U.S. rights for Ameluz® and RhodoLED® from Biofrontera AG, shifting to a royalty model to enhance profitability - The company is acquiring all U.S. rights, approvals, patents, IP, NDA, and manufacturing capabilities for Ameluz® and RhodoLED® lamps from Biofrontera AG[4](index=4&type=chunk) Agreement Payment Structure Comparison | Agreement Term | Old Model (Transfer Pricing) | New Model (Royalty) | | :--- | :--- | :--- | | **Payment Structure** | 25% to 35% of net sales price per tube | 12% of revenue (if <$65M/yr) or 15% of revenue (if >$65M/yr) | - The restructuring and operational improvements are supported by a secured **$11 million** investment, positioning the company for future growth[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Revenue increased in Q2 and H1 2025 due to Ameluz® sales, but rising legal costs impacted net loss and Adjusted EBITDA [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Q2 2025 revenues grew 15% to $9.0 million, but increased legal costs and warrant fair value changes led to a widened net loss of $5.3 million Q2 2025 Revenue Performance | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $9.0 million | $7.8 million | +15% | | **Ameluz® Sales Volume** | - | - | +9.5% | Q2 2025 Operating Expenses | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Operating Expenses** | $14.1 million | $12.9 million | +9.3% | | **Cost of Revenues** | $2.6 million | $4.3 million | -41.8% | | **SG&A Expenses** | $10.5 million | $7.9 million | +32.9% | Q2 2025 Net Loss and Adjusted EBITDA | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Net Loss** | $5.3 million | $0.3 million | | **Adjusted EBITDA** | ($5.1 million) | ($4.7 million) | [Six-Month 2025 Financial Results](index=3&type=section&id=Six-Month%202025%20Financial%20Results) H1 2025 revenues rose 12% to $17.6 million, with legal expense increases largely offset by reduced cost of revenues, resulting in flat Adjusted EBITDA H1 2025 Revenue Performance | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | $17.6 million | $15.8 million | +12% | H1 2025 Operating Expenses | Expense Category | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Operating Expenses** | $27.2 million | $26.3 million | +3.4% | | **Cost of Revenues** | $5.5 million | $8.0 million | -31.3% | | **SG&A Expenses** | $19.2 million | $17.2 million | +11.6% | H1 2025 Adjusted EBITDA | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | **Adjusted EBITDA** | ($9.5 million) | ($9.3 million) | [Financial Statements](index=5&type=section&id=Financial%20Statements) Consolidated financial statements detail the company's financial position and performance, highlighting changes in cash, liabilities, and stockholders' deficit [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, cash increased to $7.2 million, total assets decreased, and total liabilities rose to $24.8 million, leading to a $4.7 million stockholders' deficit Condensed Consolidated Balance Sheets | Balance Sheet Item | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $7,239 | $5,905 | | **Total current assets** | $18,815 | $20,700 | | **Total assets** | $20,142 | $22,101 | | **Total current liabilities** | $19,687 | $12,021 | | **Total liabilities** | $24,810 | $17,668 | | **Total stockholders' (deficit) equity** | $(4,668) | $4,433 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For H1 2025, the company reported $17.6 million in revenue and a net loss of $9.5 million, or ($1.05) per share Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Statement of Operations (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | **Total revenues, net** | $17,617 | $15,750 | | **Total operating expenses** | $27,246 | $26,288 | | **Loss from operations** | $(9,629) | $(10,538) | | **Net loss** | $(9,527) | $(10,694) | | **Loss per common share (Basic and diluted)** | $(1.05) | $(2.45) | [GAAP to Non-GAAP Reconciliation](index=7&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliation) This section reconciles GAAP net loss to Adjusted EBITDA, showing a $(9,527) thousand net loss adjusted to $(9,520) thousand Adjusted EBITDA for H1 2025 GAAP to Non-GAAP Reconciliation (Six Months Ended June 30) | Reconciliation (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | **Net loss** | $(9,527) | $(10,694) | | **Adjustments (Interest, Tax, D&A, etc.)** | $2 | $1,386 | | **Adjusted EBITDA** | $(9,520) | $(9,308) | [Company Information and Forward-Looking Statements](index=4&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) Biofrontera Inc. is a U.S. biopharmaceutical company focused on dermatological PDT, with forward-looking statements subject to inherent risks and uncertainties - The company commercializes pharmaceutical products for dermatological conditions, with a focus on photodynamic therapy (PDT) and topical antibiotics for treating actinic keratoses[16](index=16&type=chunk) - The press release includes forward-looking statements concerning revenue guidance, business strategy, clinical trials, and market opportunities, which are subject to significant risks and uncertainties[17](index=17&type=chunk)

Core Insights - Biofrontera Inc. reported a strategic transformation in 2025, focusing on customer segmentation and data analysis to enhance sales effectiveness, resulting in increased sales volume and revenue growth [1][4] - The company has restructured its agreement with Biofrontera AG, acquiring all rights, approvals, and patents for Ameluz® and RhodoLED® in the U.S., which is expected to improve cost management and operational efficiency [1][4] - The company secured an $11 million investment, which, along with the restructuring and improved promotional strategies, has positioned it strongly for future growth [1] Financial Performance - Total revenues for Q2 2025 were $9.0 million, a 15% increase from $7.8 million in Q2 2024, driven by a 5% increase in unit sales price and a 9.5% increase in sales volume of Ameluz® [2][4] - For the first half of 2025, total revenues reached $17.7 million, a 12% increase from $15.8 million in the same period of 2024, attributed to higher unit sales prices and increased sales volume [4][9] - Cash and cash equivalents as of June 30, 2025, were $7.2 million, up from $5.9 million at the end of 2024 [4] Operating Expenses - Total operating expenses for Q2 2025 were $14.1 million, compared to $12.9 million in Q2 2024, with a significant decrease in cost of revenues by $1.7 million, or 41.8%, due to renegotiated terms with Biofrontera AG [3][10] - Selling, general, and administrative expenses increased to $10.5 million in Q2 2025 from $7.9 million in Q2 2024, primarily due to a $3.4 million rise in legal costs [5][11] Net Loss and Adjusted EBITDA - The net loss for Q2 2025 was $5.3 million, compared to a net loss of $0.3 million in the prior-year quarter, largely due to a $5.4 million non-cash fluctuation in the fair value of warrants [6][19] - Adjusted EBITDA for Q2 2025 was negative $5.1 million, slightly worse than negative $4.7 million in Q2 2024, reflecting higher legal costs despite lower cost of goods sold [7][22] Clinical Developments - The company announced the completion of patient enrollment in a Phase 3 study for Ameluz® targeting mild to moderate actinic keratosis (AK) on the entire body and a Phase 2b study for moderate to severe acne vulgaris [4][10] - A U.S. patent for a revised formulation of Ameluz® was granted, extending patent protection until December 2043 [4]