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].

Core Insights - Biofrontera Inc. has completed the enrollment of the final patient in its Phase 3 clinical trial for Ameluz, aimed at treating mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, addressing a significant unmet need in dermatology [1][3] Company Overview - Biofrontera Inc. is a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT) for dermatological conditions, particularly through its product Ameluz, which is used in conjunction with the RhodoLED lamp series [5] Clinical Trial Details - The Phase 3 trial is a multicenter, randomized, double-blind study comparing Ameluz with a vehicle gel for treating AKs on the extremities, neck, and trunk, involving 172 patients in a 4:1 ratio [2] - Patients receive one PDT treatment and a potential second treatment at 12 weeks if lesions persist, with follow-up lasting approximately one year [2] Market Context - Actinic keratosis is the most common pre-cancerous skin lesion caused by chronic sun exposure, with around 58 million people affected in the US as of 2020, leading to 13 million treatments that year [4] Future Plans - Following the completion of the treatment phase by September 2025, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the FDA in the second half of 2026, contingent on positive trial outcomes [3]

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, which may progress to invasive skin cancers [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] Financial Results Announcement - Biofrontera Inc. will report its financial results for the three and twelve months ended December 31, 2024, on March 21, 2025 [1] - The financial results will be released before the market opens on the same day, and a conference call will be held at 10:00 AM Eastern Time [1][2] Conference Call Details - The conference call will provide an update on the fourth quarter and full year 2024 financial results [2] - Dial-in numbers for the conference call are 1-877-877-1275 for U.S. participants and 1-412-858-5202 for international participants [2]

Core Viewpoint - Biofrontera Inc. has achieved a significant milestone in its Phase 3 study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz and RhodoLED PDT, completing the one-year follow-up visit for the last patient in December 2024, which is crucial for the upcoming FDA submission in 2025 [1][4][8] Group 1: Study Details - The Phase 3 study was a double-blind, randomized, placebo-controlled trial involving 187 patients with confirmed superficial BCCs, where participants received two PDT treatments either with Ameluz or placebo [2] - Patients who did not show complete resolution of lesions after three months were retreated, and the FDA has advised Biofrontera to submit a supplemental New Drug Application (sNDA) with the one-year follow-up data [2][3] - Long-term follow-up is essential for dermatology product submissions due to the risk of local recurrence and additional skin cancer development [3] Group 2: Company Statements - Dr. Hermann Luebbert, CEO of Biofrontera, expressed satisfaction with the statistically significant results for both primary and secondary endpoints, indicating strong efficacy of the treatment [3] - The completion of the one-year follow-up is seen as a critical step towards FDA submission and potential label expansion for treating cutaneous malignancies [4] - Dr. Shane Chapman, an investigator in the study, highlighted the impressive results and expressed eagerness to offer Ameluz-PDT as a treatment option for patients with sBCC [5] Group 3: Industry Context - Basal cell carcinoma (BCC) is the most common form of skin cancer in the U.S., with approximately 3.6 million cases diagnosed annually, including a significant subset of superficial BCC [6][8] - BCCs arise from uncontrolled growth of basal cells and, if untreated, can become locally invasive, leading to severe tissue damage [6]

Core Insights - Biofrontera Inc. has achieved a significant milestone in its Phase 3 study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz and RhodoLED PDT, completing the one-year follow-up visit for the last patient in December 2024 [1][4] Study Details - The Phase 3 study was a double-blind, randomized, placebo-controlled, multi-center trial involving 187 patients with confirmed sBCCs, where participants received one cycle of two PDT treatments [2] - The FDA has advised Biofrontera to submit a supplemental New Drug Application (sNDA) with the one-year follow-up data, which will support the submission, while the lesions will be followed for a total of five years [2][3] Long-term Follow-up Importance - Long-term follow-up studies are essential for dermatology product submissions, particularly for skin cancers, due to the risk of local recurrence and additional skin cancer development [3] Company Vision and Future Plans - The completion of the one-year follow-up is crucial for Biofrontera's FDA submission in 2025 and may expand its label for treating cutaneous malignancies, reflecting the company's commitment to photodynamic therapy [4] - Biofrontera aims to partner with the dermatology community to enhance patient care through its PDT products [4] Industry Context - Basal cell carcinoma (BCC) is the most common form of skin cancer in the U.S., with approximately 3.6 million cases diagnosed annually, highlighting the significant market potential for effective treatments like Ameluz [6][8]

Core Insights - Biofrontera has successfully launched the RhodoLED XL in June 2024, which has quickly gained traction in the US market for photodynamic therapy (PDT) of actinic keratoses [1][4][9] - The RhodoLED XL is FDA-approved for use with Ameluz® and features enhanced LED technology for larger treatment areas [1][4][5] Company Performance - Over 10% of dermatology offices using Ameluz® have already installed the RhodoLED XL, indicating strong market acceptance [2] - The company has installed 100 units of the RhodoLED XL since its launch, showcasing rapid adoption [4][9] Product Features - The RhodoLED XL allows for the treatment of larger surface areas in a single session, improving efficiency for healthcare providers and convenience for patients [5][10] - The lamp's design has received positive feedback for its maneuverability and adjustability, enhancing the quality of care [10] Market Context - Actinic keratosis (AK) is a prevalent pre-cancerous skin condition affecting approximately 58 million people in the US, with 13 million treatments performed in 2020 [3] - The introduction of the RhodoLED XL is positioned to address the significant market need for effective AK treatments [3][12]

Core Viewpoint - Biofrontera Inc. has completed a private placement of a $4.2 million senior secured convertible note to support its operations and strategic investments aimed at sustainable growth [1][3]. Financing Details - The convertible note matures on November 22, 2027, carries a paid-in-kind interest of 10% per annum, and is secured by the company's assets [2]. - The principal amount of the note can be converted into common shares at a fixed price of $0.78, or automatically converted if the 10-day volume weighted average price exceeds $2.50 under certain conditions [2]. - The notes include restrictive covenants that limit the company's ability to create liens, pay dividends, incur additional debt, or engage in transactions with affiliates, with certain exceptions [2]. Use of Proceeds - Proceeds from the financing will primarily support Biofrontera's general operations and strategic investments, including commercial and clinical development initiatives [3]. - The CEO of Biofrontera stated that the financing provides a solid foundation to meet financial objectives for 2025 and beyond, as revenues are on a steady upward trajectory [3]. Company Overview - Biofrontera Inc. specializes in the treatment of dermatological conditions, focusing on photodynamic therapy (PDT) [4]. - The company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for treating Actinic Keratosis (AK) and is conducting clinical trials to expand its product applications [4].