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 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]

[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]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a shift to a $4.7 million stockholders' deficit, a $9.5 million net loss, and a going concern warning, despite a 12% revenue increase [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $20.1 million, while liabilities rose to $24.8 million, resulting in a $4.7 million stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,239 | $5,905 | | Accounts receivable, net | $3,955 | $5,315 | | Inventories, net | $4,028 | $6,646 | | **Total Assets** | **$20,142** | **$22,101** | | **Liabilities & Equity** | | | | Total current liabilities | $19,687 | $12,021 | | Advance from Stockholders | $8,500 | $- | | 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) Q2 2025 revenue increased to $9.0 million, but net loss widened to $5.3 million, while six-month net loss improved to $9.5 million Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues, net | $9,030 | $7,839 | $17,617 | $15,750 | | Loss from operations | $(5,079) | $(5,071) | $(9,629) | $(10,538) | | Net loss | $(5,324) | $(257) | $(9,527) | $(10,694) | | Loss per common share | $(0.57) | $(0.05) | $(1.05) | $(2.45) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating activities used $7.2 million in cash, offset by $8.5 million from financing, resulting in a $1.3 million net cash increase Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Cash flows used in operating activities | $(7,162) | $(8,045) | | Cash flows used in investing activities | $(4) | $(2) | | Cash flows provided by financing activities | $8,500 | $11,083 | | **Net increase in cash** | **$1,334** | **$3,036** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the Ameluz U.S. rights acquisition, $8.5 million financing, a going concern warning, and ongoing patent litigation - The company signed a binding term sheet to acquire all U.S. rights for Ameluz and RhodoLED, replacing the transfer pricing model with a **12-15% royalty payment structure**[24](index=24&type=chunk) - Substantial doubt exists about the Company's ability to continue as a going concern, with a **$7.2 million net cash outflow** from operations and a **$126.9 million accumulated deficit**[29](index=29&type=chunk)[30](index=30&type=chunk) - The company faces multiple legal claims from DUSA Pharmaceuticals and Sun Pharmaceutical regarding breach of contract, patent infringement, and unfair trade practices[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - An **$11.0 million private placement** of Series C Preferred Stock was secured, with the first tranche of **$8.5 million received** on June 30, 2025[27](index=27&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 2025 revenue growth, reduced cost of revenues, increased SG&A from legal costs, Nasdaq non-compliance, and going concern risks [Recent Key Developments](index=33&type=section&id=Recent%20Key%20Developments) The company received Nasdaq non-compliance notices for bid price and stockholders' equity, while acquiring Ameluz U.S. rights and securing an $11.0 million private placement - Received a Nasdaq non-compliance notice for its common stock bid price falling below **$1.00**, with a deadline of November 5, 2025, to regain compliance[147](index=147&type=chunk)[148](index=148&type=chunk) - Received a second Nasdaq non-compliance notice for failing to maintain **$2.5 million** minimum stockholders' equity, with an extension until October 10, 2025[151](index=151&type=chunk)[152](index=152&type=chunk) - A binding agreement was signed to acquire all U.S. rights to Ameluz and RhodoLED, transitioning from a transfer pricing to a royalty-based model[155](index=155&type=chunk) - An **$11.0 million private placement** of Series C Preferred Stock was agreed upon to fund the strategic transaction, with **$8.5 million received** on June 30, 2025[158](index=158&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Q2 2025 revenue grew 15.3% to $9.0 million, with cost of revenues down 41.8%, but SG&A rose 33.0% due to legal costs Comparison of Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $9,030 | $7,831 | $1,199 (15.3%) | | Cost of revenues, related party | $2,380 | $4,092 | $(1,712) (-41.8%) | | Selling, general and administrative | $10,528 | $7,915 | $2,613 (33.0%) | | Net loss | $(5,324) | $(257) | $(5,067) | Comparison of Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $17,617 | $15,732 | $1,885 (12.0%) | | Cost of revenues, related party | $5,455 | $8,038 | $(2,583) (-32.1%) | | Loss from operations | $(9,629) | $(10,538) | $909 | | Net loss | $(9,527) | $(10,694) | $1,167 | - The increase in SG&A expenses in Q2 2025 was primarily driven by a **$3.4 million increase in legal costs** related to patent claims[179](index=179&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces critical liquidity issues, with a $7.2 million operating cash burn, relying on external financing and the Xepi product line sale - The company has incurred significant losses since inception, with an accumulated deficit of **$126.9 million**, raising substantial doubt about its going concern ability[202](index=202&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,162) | $(8,045) | | Net cash provided by financing activities | $8,500 | $11,083 | | Net increase in cash | $1,334 | $3,036 | - Plans to address liquidity include external financing and finalizing the sale of its Xepi product line within one to three months[203](index=203&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is exempt from providing market risk disclosures - As a "smaller reporting company," Biofrontera Inc. is not required to provide quantitative and qualitative disclosures about market risk[216](index=216&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - Management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[217](index=217&type=chunk) - No material changes were made to internal control over financial reporting during the quarter ended June 30, 2025[218](index=218&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in significant legal proceedings, including patent infringement and unfair trade practice claims from DUSA and Sun Pharmaceutical - This section refers to Note 16 for details on ongoing litigation with DUSA Pharmaceuticals and Sun Pharmaceutical regarding patent infringement and marketing practices[220](index=220&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Biofrontera Inc. is not required to provide a discussion of risk factors in its Form 10-Q - The company is not required to provide disclosure for this item as it qualifies as a smaller reporting company[221](index=221&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the reporting period - The company reported no unregistered sales of equity securities for the period[222](index=222&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including stock designations, corporate amendments, financing agreements, and officer certifications