Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $8.6 million, a 9% increase from the same period last year [5][12] - Net loss for Q1 2025 was $4.2 million or $0.47 per share, compared to a net loss of $10.4 million or $2.88 per share in Q1 2024 [14] - Adjusted EBITDA for Q1 2025 was $4.4 million, showing a decrease from $4.6 million in Q1 2024 [15] Business Line Data and Key Metrics Changes - Ameluz sales increased by $500,000 due to a higher unit price and the launch of the RotoLED XL lamp, which generated $200,000 in sales [12] - Total operating expenses decreased to $13.1 million in Q1 2025 from $13.4 million in Q1 2024 [12] Market Data and Key Metrics Changes - The company achieved a significant milestone with the granting of a patent for a new formulation of Ameluz, providing protection until December 2043 [6] - The final patient was enrolled in a Phase three clinical trial for Ameluz, aiming to extend its label for broader treatment applications [7][8] Company Strategy and Development Direction - The company aims to achieve record revenues in 2025 without increasing costs, supported by past investments and an effective sales force [5] - Future goals include expanding Ameluz's applications to treat superficial basal cell carcinoma and moderate to severe acne, addressing significant medical needs [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching breakeven quickly, citing improved gross profit and reduced operating costs [11] - The company is committed to exploring additional applications for Ameluz beyond actinic keratosis, indicating a proactive approach to growth [9] Other Important Information - The company has cash and cash equivalents of $1.8 million as of March 31, 2025, down from $5.9 million at the end of 2024 [15] - Inventory on hand was $6.5 million, slightly down from $6.6 million at the end of 2024 [15] Q&A Session Summary Question: How many LAMP units were sold in Q1 2025? - The company placed 18 XL lamps in the first quarter [18][19] Question: Is there any sales force attrition affecting expenses? - Management noted some turnover but is committed to reorganizing the team for efficiency [23] Question: What is the status of gross margins and transfer pricing? - The company expects to maintain a 25% transfer price for inventory moving forward, which will impact gross margins [26][27] Question: What is the status of reimbursement for the three-tube indication? - Management confirmed that there have been no reported issues with reimbursement for using more than one tube [28]

Financial Performance - Total revenues for Q1 2025 were $8.6 million, a 9% increase from the same period last year[3] - The net loss for Q1 2025 was $4.2 million, or $(0.47) per share, compared to a net loss of $10.4 million, or $(2.88) per share, for the prior-year quarter[8] - Adjusted EBITDA improved from $(4.6) million in Q1 2024 to $(4.4) million in Q1 2025[9] - The net loss for the three months ended March 31, 2025, was $4,203 million, a significant improvement from a net loss of $10,437 million in the same period of 2024[19] - Adjusted EBITDA for the period was $(4,378) million, slightly better than the $(4,577) million reported in the previous year, indicating a narrowing loss[19] - The adjusted EBITDA margin improved to -51.0% from -57.9% year-over-year, reflecting better operational efficiency[19] - Overall, the financial results indicate a trend towards improved performance and reduced losses compared to the previous year[19] Cash and Expenses - Cash and cash equivalents decreased to $1.8 million as of March 31, 2025, down from $5.9 million on December 31, 2024[3] - Total operating expenses for Q1 2025 were $13.1 million, a slight decrease from $13.4 million in Q1 2024[5] - Selling, general and administrative expenses decreased by $0.6 million, or 6.5%, compared to Q1 2024[6] - Interest expense, net decreased to $106 million from $1,407 million, showing a substantial reduction in financing costs[19] - Depreciation and amortization expenses decreased to $29 million compared to $128 million in the prior year, indicating lower asset depreciation[19] - Stock-based compensation increased slightly to $239 million from $228 million, reflecting ongoing employee incentive programs[19] - The company reported no loss on debt extinguishment in the current period, compared to a loss of $316 million in the previous year[19] Research and Development - Research and development expenses increased by $1.2 million compared to Q1 2024, attributed to the assumption of all clinical trial activities for Ameluz in the U.S.[7] - The company achieved a key milestone in the Phase 3 study of Ameluz and RhodoLED photodynamic therapy, with the last patient completing the 1-year follow-up visit in December 2024[3] - The final patient was enrolled in the Phase 3 clinical trial evaluating Ameluz for treating mild to moderate actinic keratoses[3] - A patent approval was received for a revised formulation of Ameluz, extending protection through December 2043[3] Fair Value and Liabilities - The change in fair value of warrant liabilities resulted in a loss of $548 million, a significant decrease from a loss of $3,429 million in the previous year[19] - The change in fair value of investment related to a party was negligible, with no significant impact reported[19]

Core Insights - Biofrontera Inc. reported a 9% increase in revenues for Q1 2025, driven by strong sales of Ameluz and the launch of the RhodoLEDXL Lamp [1][2] - The company is excited about the enrollment of the final patient in a Phase 3 clinical trial for Ameluz, indicating progress in its product development pipeline [1][5] - The net loss for Q1 2025 was $4.2 million, a significant improvement from a net loss of $10.4 million in the same period last year [7][19] Financial Performance - Total revenues for Q1 2025 were $8.6 million, an increase of $0.7 million or 8.7% compared to Q1 2024 [2][5] - Operating expenses decreased to $13.1 million in Q1 2025 from $13.4 million in Q1 2024, reflecting cost management efforts [3][4] - Cash and cash equivalents decreased to $1.8 million as of March 31, 2025, down from $5.9 million at the end of 2024 [5] Cost Structure - Cost of revenues related to parties decreased by $0.9 million, or 22.1%, due to a reduced cost structure under the Ameluz license agreement [3] - Selling, general, and administrative expenses decreased by $0.6 million, or 6.5%, with notable reductions in marketing and sales team expenses [4] - Research and development expenses increased by $1.2 million due to the assumption of clinical trial activities for Ameluz in the U.S. [6] Clinical Developments - The final patient was enrolled in the Phase 3 clinical trial for Ameluz targeting mild to moderate actinic keratoses [5] - The company achieved a milestone in the Phase 3 study for Ameluz and RhodoLED PDT in treating superficial basal cell carcinoma [5] - Biofrontera received patent approval for a revised formulation of Ameluz, extending protection until December 2043 [5] Adjusted Metrics - Adjusted EBITDA improved from a loss of $4.6 million in Q1 2024 to a loss of $4.4 million in Q1 2025, driven by increased gross profit [8][19] - The adjusted EBITDA margin for Q1 2025 was -51.0%, compared to -57.9% in Q1 2024 [19]

Financial Performance - Net product revenue for Q1 2025 increased by $0.7 million, or 8.7%, compared to Q1 2024, driven by a $0.5 million increase in Ameluz® sales and $0.2 million from the launch of RhodoLEDXL Lamp[144]. - Total revenues for Q1 2025 were $8.588 million, compared to $7.912 million in Q1 2024, reflecting a change of $0.676 million[144]. - Research and development expenses for Q1 2025 increased by $1.2 million compared to Q1 2024, attributed to the assumption of all clinical trial activities for Ameluz in the U.S.[147]. - Selling, general and administrative expenses decreased by $0.6 million, or 6.5%, in Q1 2025 compared to Q1 2024, with a notable decrease in marketing expenses[146]. - Loss from operations improved by $0.920 million, from a loss of $5.467 million in Q1 2024 to a loss of $4.547 million in Q1 2025[144]. - Net loss for Q1 2025 was $4.203 million, significantly improved from a net loss of $10.437 million in Q1 2024[144]. - Adjusted EBITDA for Q1 2025 was $(4.378) million, an improvement from $(4.577) million in Q1 2024, driven by an increase in gross profit[161]. - The company reported a loss from operations of $4.2 million for the three months ended March 31, 2025, compared to a loss of $10.4 million for the same period in 2024[166][167]. Cash Flow and Capital Management - Cash and cash equivalents as of March 31, 2025, were $1.8 million, down from $5.9 million as of December 31, 2024[162]. - For the three months ended March 31, 2025, net cash used in operating activities was $4.1 million, compared to $3.3 million for the same period in 2024[165][167]. - The net increase in cash and restricted cash for the three months ended March 31, 2025, was a decrease of $4.1 million, compared to an increase of $2.5 million in 2024[165]. - The company had no financing activities during the three months ended March 31, 2025, while it generated $7.7 million from financing activities in the same period of 2024[169]. - The company plans to secure additional capital through equity or debt financings or asset sales to support its commercial and development activities[163]. Compliance and Regulatory Matters - Biofrontera Inc. reported stockholders' equity of $0.5 million as of March 31, 2025, below the Nasdaq requirement of $2.5 million[117]. - The company is in the process of creating a plan to regain compliance with Nasdaq listing standards[117]. - The financial statements have been prepared on a going concern basis, indicating potential adjustments may be necessary if the company cannot continue as a going concern[164]. Product and Market Strategy - The company has reduced the Transfer Price for Ameluz from 50% to 25% of the anticipated net selling price per unit for 2024 and 2025, with planned increases to 35% starting in 2026[114]. - Biofrontera plans to divest its Xepi product line, which has not generated sales since 2023 due to manufacturing delays[116]. - The company is focused on expanding sales of Ameluz and RhodoLED Lamps in the U.S. to establish Ameluz as the standard of care for actinic keratosis[127]. - The company aims to finance R&D activities through the reduced Transfer Price, supporting growth in photodynamic therapy[115]. - The company plans to expand the commercialization of Ameluz in the United States while controlling expenses and limiting capital expenditures[163]. Revenue Generation and Seasonality - Biofrontera's revenues are primarily generated from sales of licensed products, including Ameluz and RhodoLED Lamps[129]. - Biofrontera's revenue is subject to seasonality, with historically higher revenues in the first and fourth quarters[128]. Clinical Trials and Operations - The company has assumed control of all clinical trials related to Ameluz in the U.S. since June 1, 2024, for better cost management[115]. - The change in fair value of warrant liabilities was a gain of $0.548 million in Q1 2025, compared to a loss of $3.429 million in Q1 2024[149]. - The company experienced a change in fair value of warrant liabilities of $0.5 million for the three months ended March 31, 2025[166]. - The company had negligible fixed asset purchases during the three months ended March 31, 2025[168]. - There were no material changes to the company's critical accounting estimates for the three months ended March 31, 2025[172].

Core Viewpoint - Biofrontera Inc. has received patent approval for an updated formulation of Ameluz, extending protection until December 2043, and has successfully enrolled the final patient in a Phase 2b clinical trial for treating moderate to severe acne vulgaris [1][5][8]. Company Summary - Biofrontera Inc. specializes in photodynamic therapy (PDT) for dermatological conditions and commercializes Ameluz in combination with the RhodoLED lamp series [9]. - The company aims to expand the indications for Ameluz beyond its current approval for mild to moderate actinic keratosis [5]. - The successful enrollment of 120 patients in the Phase 2b trial marks a significant milestone for the company [3][5]. Industry Summary - The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3% [4][8]. - Acne vulgaris affects an estimated 50 million people annually in the U.S., with about 40% of adults experiencing the condition [6][8]. - Current treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin, which may have serious side effects, highlighting the need for effective alternatives [7][8].

Core Viewpoint - Biofrontera Inc. and Almirall have launched the Hats On Challenge to raise awareness and support for actinic keratosis (AK) ahead of Global AK Awareness Day on May 24 [1][4]. Group 1: Actinic Keratosis (AK) Overview - Actinic Keratosis is a rough, scaly skin patch caused by prolonged sun exposure, commonly found on sun-exposed areas [2][8]. - AK is prevalent globally, with an estimated 14% of the population affected, and can progress to squamous cell carcinoma if untreated [3][6]. - Approximately 58 million Americans are estimated to have one or more AKs, highlighting the need for public education on prevention and treatment [6]. Group 2: Awareness Campaign - The Hats On Challenge encourages participants to wear hats and share videos on social media to promote skin protection and early detection of AK [5][7]. - The campaign aims to raise funds for The Skin Cancer Foundation, which will use the funds for public awareness and patient education [4][6]. - The initiative will run throughout May, with participants recognized through monetary donations made to The Skin Cancer Foundation by Biofrontera and Almirall [7]. Group 3: Company Profiles - Biofrontera Inc. specializes in developing and commercializing photodynamic therapy (PDT) for dermatological conditions, including AK [9][10]. - Almirall is a global pharmaceutical company focused on medical dermatology, collaborating with Biofrontera on the Hats On Challenge [1][4].

Financial Data and Key Metrics Changes - Total revenues for 2024 reached $37.3 million, representing an annual growth of approximately 9.5% compared to $34.1 million in 2023 [16] - The net loss for 2024 was $17.8 million or $3.22 per diluted share, an improvement from a net loss of $20.1 million or $13.02 per share in 2023 [19] - Adjusted EBITDA for 2024 was negative $15.3 million, an improvement from negative $19.5 million in 2023, driven by increased sales and reduced SG&A expenses [19] Business Line Data and Key Metrics Changes - The company placed 52 RotoLite XL lamps in Q4 2024, totaling 100 lamps since the launch in June 2024, contributing to the overall strategy for Ameluz PDT [3] - The cost of revenues for 2024 increased to $18.6 million from $17.4 million in 2023, influenced by sales volume but offset by lower transfer prices [17] Market Data and Key Metrics Changes - The company achieved a 5% price increase for Ameluz in Q4 2024, with the tube priced at $363, which may have influenced forward buying behavior [41] - The transfer price for Ameluz was reduced from 50% to 25% for all purchases in 2024 and 2025, expected to positively impact gross margins in 2025 [7][39] Company Strategy and Development Direction - The company aims to become cash flow positive while managing expenses without sacrificing sales, emphasizing the importance of sales growth and marketing efforts [48] - Future plans include expanding the use of Ameluz beyond actinic keratosis to treat non-melanoma skin tumors, with new data expected to be submitted to the FDA [6] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving another record year in 2025, supported by past investments and business plans [2] - The company is excited about the potential for Ameluz in treating moderate to severe acne, with ongoing phase two studies nearing completion [10] Other Important Information - Cash and cash equivalents as of December 31, 2024, were $5.9 million, a significant increase from $1.3 million at the end of 2023, attributed to strong growth and additional capital raised [20] - Inventory levels were reduced to $6.6 million from $10.9 million year-over-year, indicating improved inventory management [21] Q&A Session Summary Question: What was the Q4 2024 Ameluz unit growth year over year? - Answer: Approximately 2% [27] Question: Was there any sales force addition or attrition over 2024? - Answer: No, the number of salespeople remained approximately constant [29] Question: What is the acne enrollment number and data timing? - Answer: The enrollment number is 116, with potential for earlier trial conclusion [31] Question: How will the new transfer pricing impact gross margins in 2025? - Answer: The lower transfer price of 25% is expected to positively impact gross margins [39] Question: What was the percentage of the price increase in Q4? - Answer: There was a 5% price increase for Ameluz [41] Question: Will SG&A and R&D expenses continue to trend down in 2025? - Answer: SG&A is expected to hold steady, while R&D will remain stable compared to recent months [43][44]

Financial Performance - Total revenues for 2024 reached $37.3 million, a 9.5% increase from $34.1 million in 2023, with Q4 2024 revenues growing 18.5% year-over-year[2] - Total revenues for the year ended December 31, 2024, were $37,321 million, up 9% from $34,071 million in 2023[20] - Product revenues for Q4 2024 reached $12,560 million, a 19% increase from $10,582 million in Q4 2023[20] - The net loss for Q4 2024 was $1,396 million, compared to a net income of $3,525 million in Q4 2023[20] - Net loss for 2024 was $(17.8) million, or $(3.22) per diluted share, an improvement from a net loss of $(20.1) million, or $(13.02) per share, in 2023[11] Operating Expenses - Total operating expenses for 2024 decreased to $54.5 million from $56.7 million in 2023, reflecting a reduction of approximately 3.9%[9] - Selling, general and administrative expenses for 2024 decreased by $5.3 million, or 13.5%, compared to 2023[10] - Operating expenses for Q4 2024 were $14,272 million, slightly down from $14,462 million in Q4 2023[20] Cash and Cash Equivalents - Cash and cash equivalents increased to $5.9 million as of December 31, 2024, compared to $1.3 million at the end of 2023[2] - Cash, cash equivalents, and restricted cash at the end of 2024 were $6,105 million, up from $1,543 million at the beginning of the year[23] - Cash flows used in operating activities for the year ended December 31, 2024, were $(10,270) million, an improvement from $(24,895) million in 2023[22] Adjusted EBITDA - Adjusted EBITDA for 2024 was negative $15.3 million, an improvement from negative $19.5 million in 2023[12] - Adjusted EBITDA for the year ended December 31, 2024, was $(15,258) million, improving from $(19,456) million in 2023[25] - The adjusted EBITDA margin for Q4 2024 was -10.9%, compared to -30.5% in Q4 2023[25] Clinical and Product Development - The company placed 52 RhodoLED XL lamps in Q4 2024, totaling 100 since the launch in June 2024[2] - FDA approval was obtained to use up to three tubes of Ameluz per treatment, enhancing treatment options[2] - The company achieved significant results in the Phase 3 study of Ameluz® for treating Superficial Basal Cell Carcinoma[2] - Biofrontera Discovery GmbH was created as a wholly-owned subsidiary to manage clinical trial activities for Ameluz® in the USA[2] Legal and Settlement Gains - The company reported a gain on legal settlement of $7,385 million in Q4 2023, which significantly impacted the income statement[20] Share Information - The weighted-average common shares outstanding for Q4 2024 were 7,519,210, compared to 2,140,400 in Q4 2023[20]

Core Insights - Biofrontera Inc. reported a strong financial performance for 2024, with total revenues reaching $37.3 million, a 9.5% increase from $34.1 million in 2023, driven by higher sales volume and average selling price of Ameluz® and the successful launch of RhodoLED® XL lamps [4][8][11] - The company has refocused its strategy for 2025 to enhance customer efficiency in delivering Photodynamic Therapy (PDT) services and to support new dermatology offices in the U.S. [3] - Biofrontera has made significant advancements in its clinical development program, achieving key milestones, including FDA approval for using up to three tubes of Ameluz® per treatment [3][4] Financial Performance - Total revenues for Q4 2024 were $12.6 million, an increase of $2.0 million or 18.5% compared to Q4 2023 [4] - Total operating expenses for 2024 were $54.5 million, a decrease of about 3.9% from $56.7 million in 2023 [5][9] - The net loss for 2024 was $(17.8) million, or $(3.22) per diluted share, compared to a net loss of $(20.1) million, or $(13.02) per share in 2023 [11] Operational Highlights - The company placed 52 RhodoLED® XL lamps in Q4 2024 and a total of 100 since the launch in June 2024 [5] - Biofrontera created a wholly-owned subsidiary, Biofrontera Discovery GmbH, to manage clinical trial activities for Ameluz® in the U.S. [5] - The company has accelerated patient recruitment in its Phase 3 study for actinic keratosis and Phase 2 study for acne [5] Cost Management - Selling, general and administrative expenses for 2024 decreased by $5.3 million, or 13.5% compared to 2023, primarily due to reduced legal and financing-related expenses [10] - Cash and cash equivalents increased to $5.9 million as of December 31, 2024, compared to $1.3 million at the end of 2023 [5] Clinical Development - Biofrontera achieved statistically significant results in its Phase 3 study of Ameluz® for treating superficial basal cell carcinoma [5] - The company is close to concluding patient recruitment in its Phase 2 acne study, positioning Ameluz® strongly for future growth [3][5]

Sales and Revenue - The company generated no sales from the Xepi product line in 2024 and limited revenue in 2023 due to third-party manufacturing delays[22]. - The total market size for actinic keratosis (AK) treatments is estimated to be approximately $4 billion, with cryotherapy accounting for 86% of the market, topicals for 12%, and photodynamic therapy (PDT) for 2%[30]. - The average reimbursement for Ameluz PDT treatment is $262.68 per light treatment, covered under CPT code 96574[37]. - The company has a diverse customer base with no single customer representing more than 10% of net revenues as of December 31, 2024[26]. - The Second A&R Ameluz License and Supply Agreement reduced the Transfer Price of Ameluz from 50% to 25% for 2024 and 2025, with planned increases starting in 2026[51]. - The Inflation Reduction Act introduces financial penalties for drug price increases above inflation rates, affecting future revenue projections[87]. - The 340B Drug Discount Program requires manufacturers to sell outpatient drugs at reduced prices to eligible healthcare providers, impacting pricing strategies[88]. Product Development and Clinical Trials - The company plans to divest its Xepi product line and expects to complete the sale within the next three to six months[22]. - The company assumed control of all clinical trials relating to Ameluz in the United States effective June 1, 2024, for better cost management and oversight[21]. - In a Phase III trial for superficial basal cell carcinoma, Ameluz-PDT achieved a 65.5% success rate compared to 4.8% for placebo, with complete histological clearance in 75.9% of cases[43]. - Clinical trials may face delays due to various factors, including scheduling conflicts and patient enrollment issues, which can impact the timeline for regulatory approval[70]. - Delays in clinical trials can arise from funding issues, negative results, or deficiencies in trial conduct, impacting the overall development timeline[75]. Regulatory Compliance - The FDA requires ongoing compliance with post-market surveillance programs for approved drugs, including record-keeping and reporting of adverse experiences[72]. - Quality control and manufacturing processes must adhere to Current Good Manufacturing Practices (cGMP) regulations, with potential consequences for non-compliance, including product recalls[73]. - The FDA may impose post-approval trials and surveillance to monitor the effects of approved products, which can lead to restrictions on distribution[74]. - The Safe Medical Devices Act mandates reporting of adverse events associated with medical devices, increasing regulatory scrutiny post-market[79]. - Compliance with HIPAA and HITECH regulations is essential for protecting patient information and avoiding penalties, influencing marketing activities[89]. - The company is subject to reporting requirements under the Securities Exchange Act of 1934, necessitating regular disclosures to the SEC[90]. - As a "smaller reporting company," the company is not required to provide certain market risk disclosures[361]. Product Features and Innovations - Ameluz PDT therapy has an efficacy rate of up to 91% clearance after one or two treatments with limited or no scarring[29]. - The FDA approved an increase in the maximum dosage of Ameluz from one to three tubes per treatment, enhancing treatment flexibility for healthcare professionals[41]. - The new formulation of Ameluz, approved in 2023, eliminates propylene glycol and reduces contaminant accumulation, with production changes implemented in 2024[44]. - The company launched the new RhodoLED XL lamp in June 2024, allowing simultaneous treatment of multiple actinic keratoses[40]. - The company expects to add trunk and extremities to the Ameluz label in the next couple of years, supported by the new RhodoLED XL lamp[41]. - A patent for a pain-reduced PDT procedure combining daylight and conventional PDT may extend patent protection beyond 2040 if successful[44]. - The new patent application for the Ameluz formulation filed in 2024, if granted, could extend protection to 2043[48]. Workforce and Company Structure - As of December 31, 2024, the company had 93 employees, including 92 full-time and one part-time employee[25]. - The company is qualifying a second contract manufacturer in Germany to ensure supply chain stability for Ameluz and RhodoLED lamps[45].