Biofrontera(BFRI) - 2025 Q2 - Quarterly Results

Business and Operational Highlights Biofrontera Inc. achieved double-digit revenue growth in H1 2025, driven by strategic restructuring, IP acquisition, and clinical trial advancements Revenue Performance | Period | Revenue | YoY Growth | | :--- | :--- | :--- | | Q2 2025 | $9.0 million | 15% | | H1 2025 | $17.7 million | 12% | - Cash and cash equivalents increased to $7.2 million as of June 30, 2025, from $5.9 million at the end of 2024[3] - A major restructuring with Biofrontera AG was agreed upon, including the acquisition of U.S. IP and NDAs, supported by an additional $11 million in funding[3] - A new U.S. patent was granted for a revised Ameluz® formulation, extending patent protection through December 2043[3] - Significant progress was made in clinical trials, including completing patient follow-up in a Phase 3 sBCC study and completing enrollment in Phase 3 and Phase 2b studies for AK and acne, respectively[3] Strategic Restructuring with Biofrontera AG Biofrontera Inc. acquired all U.S. rights for Ameluz® and RhodoLED® from Biofrontera AG, shifting to a royalty model to enhance profitability - The company is acquiring all U.S. rights, approvals, patents, IP, NDA, and manufacturing capabilities for Ameluz® and RhodoLED® lamps from Biofrontera AG[4] Agreement Payment Structure Comparison | Agreement Term | Old Model (Transfer Pricing) | New Model (Royalty) | | :--- | :--- | :--- | | Payment Structure | 25% to 35% of net sales price per tube | 12% of revenue (if <$65M/yr) or 15% of revenue (if >$65M/yr) | - The restructuring and operational improvements are supported by a secured $11 million investment, positioning the company for future growth[4] Financial Performance Revenue increased in Q2 and H1 2025 due to Ameluz® sales, but rising legal costs impacted net loss and Adjusted EBITDA Second Quarter 2025 Financial Results Q2 2025 revenues grew 15% to $9.0 million, but increased legal costs and warrant fair value changes led to a widened net loss of $5.3 million Q2 2025 Revenue Performance | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $9.0 million | $7.8 million | +15% | | Ameluz® Sales Volume | - | - | +9.5% | Q2 2025 Operating Expenses | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $14.1 million | $12.9 million | +9.3% | | Cost of Revenues | $2.6 million | $4.3 million | -41.8% | | SG&A Expenses | $10.5 million | $7.9 million | +32.9% | Q2 2025 Net Loss and Adjusted EBITDA | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $5.3 million | $0.3 million | | Adjusted EBITDA | ($5.1 million) | ($4.7 million) | Six-Month 2025 Financial Results H1 2025 revenues rose 12% to $17.6 million, with legal expense increases largely offset by reduced cost of revenues, resulting in flat Adjusted EBITDA H1 2025 Revenue Performance | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $17.6 million | $15.8 million | +12% | H1 2025 Operating Expenses | Expense Category | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Operating Expenses | $27.2 million | $26.3 million | +3.4% | | Cost of Revenues | $5.5 million | $8.0 million | -31.3% | | SG&A Expenses | $19.2 million | $17.2 million | +11.6% | H1 2025 Adjusted EBITDA | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Adjusted EBITDA | ($9.5 million) | ($9.3 million) | Financial Statements Consolidated financial statements detail the company's financial position and performance, highlighting changes in cash, liabilities, and stockholders' deficit Condensed Consolidated Balance Sheets As of June 30, 2025, cash increased to $7.2 million, total assets decreased, and total liabilities rose to $24.8 million, leading to a $4.7 million stockholders' deficit Condensed Consolidated Balance Sheets | Balance Sheet Item | June 30, 2025 (in thousands) | Dec 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $7,239 | $5,905 | | Total current assets | $18,815 | $20,700 | | Total assets | $20,142 | $22,101 | | Total current liabilities | $19,687 | $12,021 | | Total liabilities | $24,810 | $17,668 | | Total stockholders' (deficit) equity | $(4,668) | $4,433 | Condensed Consolidated Statements of Operations For H1 2025, the company reported $17.6 million in revenue and a net loss of $9.5 million, or ($1.05) per share Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Statement of Operations (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Total revenues, net | $17,617 | $15,750 | | Total operating expenses | $27,246 | $26,288 | | Loss from operations | $(9,629) | $(10,538) | | Net loss | $(9,527) | $(10,694) | | Loss per common share (Basic and diluted) | $(1.05) | $(2.45) | GAAP to Non-GAAP Reconciliation This section reconciles GAAP net loss to Adjusted EBITDA, showing a $(9,527) thousand net loss adjusted to $(9,520) thousand Adjusted EBITDA for H1 2025 GAAP to Non-GAAP Reconciliation (Six Months Ended June 30) | Reconciliation (Six Months Ended June 30) | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Net loss | $(9,527) | $(10,694) | | Adjustments (Interest, Tax, D&A, etc.) | $2 | $1,386 | | Adjusted EBITDA | $(9,520) | $(9,308) | Company Information and Forward-Looking Statements Biofrontera Inc. is a U.S. biopharmaceutical company focused on dermatological PDT, with forward-looking statements subject to inherent risks and uncertainties - The company commercializes pharmaceutical products for dermatological conditions, with a focus on photodynamic therapy (PDT) and topical antibiotics for treating actinic keratoses[16] - The press release includes forward-looking statements concerning revenue guidance, business strategy, clinical trials, and market opportunities, which are subject to significant risks and uncertainties[17]