Biofrontera(US:BFRI)2025-11-13 16:00Financial Data and Key Metrics Changes - Year-to-date revenues until September 30, 2025, were approximately flat compared to the same period in 2024, with Q3 revenues at $7.0 million, a 22% decline from $9.0 million in Q3 2024 [5][14] - Total operating expenses for Q3 2025 were $13.3 million, down from $14 million in Q3 2024, while net loss increased to $6.6 million from $5.7 million year-over-year [14][15] - Adjusted EBITDA for Q3 2025 was negative $6.0 million compared to negative $4.6 million in Q3 2024 [16] Business Line Data and Key Metrics Changes - The installed base of RhodoLED lamps reached approximately 750, supporting recurring high-margin sales of Ameluz gel [6][7] - Cost of revenues decreased by $2.8 million, or 58%, due to a reduced cost agreement with Biofrontera AG [14][15] - Selling, general, and administrative expenses increased to $10.4 million in Q3 2025 from $8.4 million in Q3 2024, primarily due to increased legal costs [15] Market Data and Key Metrics Changes - The company anticipates strong revenue growth in Q4 2025, driven by a normalization of sales following a transient effect in Q3 [5] - The new royalty structure for Ameluz is expected to enhance gross margins significantly, with a royalty of 12% when U.S. revenue is below $65 million and 15% above that threshold [11] Company Strategy and Development Direction - The company is focused on expanding the clinical and commercial potential of Ameluz across multiple high-value dermatologic indications, including upcoming FDA submissions for new indications [8][10] - A transformational agreement with Biofrontera AG has granted the company full control over U.S. rights, approvals, and patents for Ameluz and RhodoLED, enhancing long-term profitability [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year sales objectives despite a challenging Q3, citing a strong pipeline and upcoming catalysts for growth [5][6] - The company aims to reach cash flow breakeven by fiscal year 2026, supported by recent financing and divestments [12][19] Other Important Information - The company completed the sale of the Xepi license for $3 million, with potential additional milestones of $7 million, which will not impact current sales due to the product's inactivity [12] - As of September 30, 2025, the company had cash and cash equivalents of $3.4 million, bolstered by recent financing and divestment proceeds [18][19] Q&A Session Summary Question: Are you contemplating any price increases in the future and if so, when? - Management confirmed plans for a price increase before year-end [26] Question: When do you expect data from the trial for AK of the extremities and the plan for FDA submission? - Data is expected in January, with FDA submission planned for Q2 [27] Question: When will data be available for the acne trial and what are the next steps? - Data will be available early next year, followed by an end of phase 2 meeting with the FDA [30] Question: Should the plan for breaking even be modeled similarly to the seasonality seen in the income statement? - Management confirmed that individual quarters in 2026 might fluctuate between losses and gains, with the fourth quarter expected to be significant for achieving breakeven [33]