Biofrontera Inc. (NASDAQ:BFRI) Q3 2024 Earnings Conference Call November 14, 2024 10:00 AM ET Company Participants Andrew Barwicki - Investor Relations Hermann Luebbert - Chief Executive Officer, Chairman and Founder Fred Leffler - Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH Capital Bruce Jackson - The Benchmark Company Operator Welcome to the Biofrontera Inc. Third Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] Please note this e ...

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 ...

 ●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 ...

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 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 ...

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 ...

Woburn, MA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- 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 quarter of 2024 were $7.8 million, a 34% increase from the same period of the prior year Cash ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.001 per share BFRI The Nasdaq Stock Market LLC Preferred Stock Purchase Rights The Nasdaq Stock Market LLC Warrants to purchase common stock BFRIW The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ...