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Biofrontera Inc. Announces 100 RhodoLED® XL Machines Now Placed in US Market
Newsfilter· 2024-12-23 14:30
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]
Biofrontera Inc. Closes a $4.2 Million Senior Secured Convertible Note
GlobeNewswire News Room· 2024-11-22 14:10
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].
Biofrontera(BFRI) - 2024 Q3 - Earnings Call Transcript
2024-11-14 20:02
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]
Biofrontera Inc. (BFRI) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2024-11-14 01:11
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]
Biofrontera(BFRI) - 2024 Q3 - Quarterly Report
2024-11-13 23:00
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].
Biofrontera(BFRI) - 2024 Q3 - Quarterly Results
2024-11-13 22:20
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 ...
Biofrontera Inc. Reports Third Quarter and Nine-Month 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-11-13 22:15
 ●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 increase would have been 12%.    ●Ameluz® achieved record volume in September 2024.      ●Organization continues to pru ...
FDA Approves Use of Up To Three Tubes of Biofrontera Inc.'s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment
GlobeNewswire News Room· 2024-10-07 12:45
Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies AK is the second most common diagnosis made by dermatologists in the United States1 An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) ("Biofrontera" or the "Company"), a biopharmace ...
Biofrontera(BFRI) - 2024 Q2 - Earnings Call Transcript
2024-08-15 17:34
Biofrontera Inc. (NASDAQ:BFRI) Q2 2024 Earnings Conference Call August 15, 2024 10:00 AM ET Company Participants Andrew Barwicki - Barwicki Investor Relations Hermann Luebbert - CEO, Chairman and Founder Fred Leffler - CFO Conference Call Participants Jonathan Aschoff - ROTH MKM Bruce Jackson - The Benchmark Company Operator Good day, and welcome to the Biofrontera Inc. Second Quarter 2024 Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instru ...
Biofrontera(BFRI) - 2024 Q2 - Quarterly Results
2024-08-14 20:49
Exhibit 99.1 Biofrontera Inc. Reports Second Quarter 2024 Financial Results and Provides a Business Update Woburn, MA / August 14, 2024 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three and six months ended June 30, 2024 and provided a business update. Highlights from the second quarter of 2024 and subsequent weeks included the following: ● Total revenues for the second ...