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].

Financial Data and Key Metrics Changes - Revenues in Q3 2024 increased by 1.5% to $9 million compared to Q3 2023, with a potential growth of 19% if not for shipping delays due to Hurricane Milton [9][23] - For the first nine months of 2024, total revenues grew by $1.3 million to $24.8 million, representing a 5.6% increase [10][29] - The net loss for Q3 2024 was $5.7 million, an improvement from a net loss of $6.3 million in Q3 2023 [27] - Adjusted EBITDA for Q3 2024 was negative $4.6 million, compared to negative $3.9 million in Q3 2023 [28] Business Line Data and Key Metrics Changes - Sales of Ameluz were impacted by a net decrease of $0.5 million in Q3 2024, primarily due to delayed shipments [23] - The RhodoLED XL lamp contributed an increase of $600,000 in device sales in Q3 2024 [23] - Total operating expenses for Q3 2024 were $14 million, up from $13.5 million in Q3 2023, driven by increased costs associated with the RhodoLED product [25] Market Data and Key Metrics Changes - The FDA approved the use of up to three tubes of Ameluz per treatment, which is expected to enhance market penetration and convenience for healthcare providers [12] - The company anticipates a significant increase in Ameluz usage following the recent FDA approval and improved reimbursement conditions [19] Company Strategy and Development Direction - The company is focusing on expanding the indications for Ameluz, including moderate-to-severe acne, which is seen as a potential blockbuster market [14] - Biofrontera has taken control of all clinical trial activities for Ameluz in the U.S., which is expected to enhance profitability and bring the breakeven point closer [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about future growth due to the increase in Ameluz tubes ordered and the positive clinical results [50] - The company expects to achieve cash flow breakeven towards the end of 2025 into 2026, with revenue growth projected in the mid- to high teens for 2024 [37] Other Important Information - The company has successfully reduced inventory levels closer to industry standards, with cash and cash equivalents increasing to $2.9 million as of September 30, 2024 [33] - The XEPI product is being evaluated for potential disposition, with the asset moved to held for sale [34] Q&A Session Summary Question: When will the cost of revenue start to better reflect the 25% that is valid through next year? - Management expects to see that impact in the fourth quarter as they needed to go through older inventory [36] Question: Do you still expect to be cash flow breakeven by the end of next year and to grow revenue this year by 20% over 2023? - Management expects revenue growth similar to prior years, in the mid- to high teens, and cash flow breakeven is anticipated towards the end of 2025 into 2026 [37] Question: Did the shipments that fell into October stick with the October 1 price hike? - Management confirmed that the older price was grandfathered in for the orders placed in Q3 [39] Question: Can you provide enrollment numbers for the acne and peripheral AK trials? - Enrollment for the peripheral AK trial is 130 of 165 patients, and for the acne study, it is 106 of 126 [39] Question: How do you see the fourth quarter developing in terms of revenue after the price increase? - Management expects a very strong Q4, traditionally the strongest quarter, despite the price increase [42][44] Question: Have you seen any customer response to the new labeling for the three-tube approval? - Management has not yet promoted the new labeling but plans to do so soon, anticipating an uptake in December [46]

Core Insights - Biofrontera Inc. reported a quarterly loss of $0.86 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.73, marking an earnings surprise of -17.81% [1] - The company's revenues for the quarter ended September 2024 were $9.01 million, missing the Zacks Consensus Estimate by 18.15%, and showing a slight increase from $8.9 million a year ago [2] - Biofrontera's shares have declined approximately 66% since the beginning of the year, contrasting with a 25.5% gain in the S&P 500 [3] Financial Performance - Over the last four quarters, Biofrontera has only surpassed consensus EPS estimates once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.03 on revenues of $14.21 million, while for the current fiscal year, it is -$3.07 on revenues of $40.97 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Biofrontera belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - The performance of Biofrontera's stock may be influenced by the overall industry outlook and trends in earnings estimate revisions [5][8]

Product Performance and Development - The principal licensed product, Ameluz, achieved a 65.5% success rate in a Phase III trial for superficial basal cell carcinoma, compared to 4.8% for placebo [126]. - Effective June 1, 2024, the company assumed control of all clinical trials related to Ameluz in the U.S., enhancing cost management and trial efficiency [124]. - The FDA approved an increase in the maximum dosage of Ameluz from one to three tubes per treatment, improving treatment flexibility for healthcare professionals [125]. - The Transfer Price for Ameluz was reduced from 50% to 25% through 2025, allowing the company to finance R&D activities and support commercial growth [127]. - The company focuses on expanding sales of Ameluz in the U.S. and aims to position it as the standard of care for actinic keratoses [132]. Financial Performance - Revenue from product sales is primarily generated from Ameluz, with Xepi and RhodoLED Lamps contributing relatively insignificant amounts [139]. - For the three months ended September 30, 2024, net product revenue increased by $0.1 million, or 1.5%, to $9.012 million compared to $8.896 million in the same period of 2023 [152]. - The net loss for the three months ended September 30, 2024, was $5.669 million, an improvement of $0.673 million compared to a net loss of $6.342 million in the same period of 2023 [152]. - Net product revenue for the nine months ended September 30, 2024 increased by $1.3 million, or 5.6%, compared to the same period in 2023, driven by a $1.1 million increase in the average sale price of Ameluz and a $0.6 million increase in device sales from the launch of the RhodoLEDXL Lamp [163]. - The net loss for the nine months ended September 30, 2024 was $16.4 million, a decrease of $7.3 million compared to a net loss of $23.7 million in the same period of 2023 [162]. Expenses and Cost Management - Selling, general and administrative expenses decreased by $0.2 million, or 2.3%, primarily due to a reduction in general business administration expenses and non-personnel sales and marketing expenses [156]. - Research and development expenses increased by $0.6 million, attributed to the assumption of all clinical trial activities for Ameluz in the United States effective June 1, 2024 [157]. - Total operating expenses for the nine months ended September 30, 2024 decreased by $2.0 million, or 4.8%, to $40.3 million compared to $42.3 million in 2023 [162]. - Selling, general and administrative expenses decreased by $4.3 million, or 14.3%, primarily due to a $1.7 million decrease in legal costs and a $1.3 million decrease in non-personnel sales and marketing expenses [166]. Cash Flow and Liquidity - The company incurred net cash outflows from operations of $9.3 million for the nine months ended September 30, 2024, compared to $16.0 million for the same period in 2023, indicating a 42% improvement in cash flow management [185][190][191]. - As of September 30, 2024, the company had cash and cash equivalents of $2.9 million, an increase from $1.3 million as of December 31, 2023, reflecting improved liquidity [185]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $10.8 million, significantly higher than $1.7 million for the same period in 2023 [189][194][195]. - The company is actively pursuing additional capital through equity securities, debt issuance, or asset sales to address liquidity concerns [186]. Financial Challenges and Future Outlook - The company reported an accumulated deficit of $116.0 million as of September 30, 2024, highlighting ongoing financial challenges [185]. - Management has determined that substantial doubt exists about the company's ability to continue as a going concern for at least twelve months from the issuance date of the financial statements [186]. - The financial statements have been prepared on a going concern basis, indicating the need for successful execution of management's plans to mitigate financial uncertainties [188]. - The company plans to expand the commercialization of Ameluz in the United States while decreasing discretionary expenses to improve liquidity and profitability [186].

Exhibit 99.1 Biofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results and Provides Business Update ● Total revenues for the third quarter 2024 were $9.0 million, an increase of 1.5% from Q3 2023. Revenue increase would have been 19% if shipments were not delayed due to Hurricane Milton. ● Total revenues for the first 9 months were $24.8 million, an increase of $1.3 million, or 5.6% as compared to the same period last year. Without the impact of Hurricane Milton delaying shipments, the in ...