Biofrontera(BFRI) - 2025 Q1 - Quarterly Report

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].