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

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]