Day One Biopharmaceuticals pany(DAWN) - 2025 Q2 - Quarterly Results

Day One Second Quarter 2025 Financial Results and Corporate Progress Financial & Commercial Highlights The company reports strong OJEMDA revenue growth, raises full-year guidance, and maintains a robust cash position Q2 2025 Performance Metrics | Metric | Q2 2025 | Change vs. Q1 2025 | Change vs. Q2 2024 | | :--- | :--- | :--- | :--- | | OJEMDA Net Product Revenue | $33.6 million | +10% | +310% | | OJEMDA Prescriptions | >1,000 | +15% | +346% | - The company provides full-year 2025 net product revenue guidance of $140 to $150 million[1][3] - The company ended the second quarter with $453.1 million in cash, cash equivalents, and short-term investments[1][15] - Achieved $113.1 million in OJEMDA net product revenue for the trailing twelve-month period ending June 30, 2025[3] Pipeline and Corporate Updates The company advances its clinical pipeline, provides trial updates, and announces key leadership and collaboration changes - Key pipeline progress includes the DAY301 trial actively enrolling patients, with 3-year FIREFLY-1 data expected in Q4 2025[7] - The research collaboration and license agreement with Sprint Bioscience AB for the VRK1 program was terminated based on strategic objectives[7] - Dr. Michael Vasconcelles, an industry leader with over 25 years of oncology R&D experience, was appointed as Head of Research and Development in June 2025[5] Second Quarter 2025 Financial Results The company reports total revenues of $33.9 million and a net loss of $30.3 million, with a notable decrease in R&D expenses year-over-year Financial Performance Summary Net product revenue grew significantly while R&D expenses decreased due to a one-time license payment in the prior year Key Financial Metrics | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Product Revenue | $33.6 million | $8.2 million | | R&D Expenses | $36.1 million | $92.1 million | | SG&A Expenses | $29.0 million | $30.2 million | - The decrease in R&D expenses was primarily due to the upfront payment of $55.0 million for the MabCare Therapeutics license agreement in the second quarter of 2024[8] Net Loss and Cash Position | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $30.3 million | $4.4 million | | Cash Position (end of period) | $453.1 million | N/A | Condensed Statements of Operations The unaudited income statement details revenues, expenses, and net loss for the three and six months ended June 30, 2025 Unaudited Condensed Consolidated Statements of Operations | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $33,908 | $8,192 | | Total cost and operating expenses | $68,882 | $122,999 | | Loss from operations | $(34,974) | $(114,807) | | Total non-operating income, net | $4,652 | $111,952 | | Net loss | $(30,322) | $(4,407) | | Net loss per share - basic & diluted | $(0.29) | $(0.05) | Selected Condensed Balance Sheets The balance sheet shows the company's financial position, comparing key assets and liabilities at June 30, 2025, and December 31, 2024 Unaudited Selected Condensed Consolidated Balance Sheets | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $453,103 | $531,720 | | Total assets | $519,037 | $582,788 | | Total liabilities | $58,203 | $80,037 | | Total stockholders' equity | $460,834 | $502,751 | Company and Product Overview Day One Biopharmaceuticals focuses on targeted cancer therapies, with its lead product OJEMDA™ approved for pediatric low-grade glioma - OJEMDA (tovorafenib) is indicated for patients 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion, rearrangement, or V600 mutation[11] - The indication for OJEMDA was granted under accelerated approval by the FDA, with continued approval contingent on confirmatory trials[11][12] - Day One's mission is to address the critical unmet need for therapeutic development in pediatric cancer[13] Legal Disclaimers This section contains forward-looking statements and cautions that actual results may differ due to various risks and uncertainties - The press release includes forward-looking statements concerning plans to develop and commercialize cancer therapies and expectations from clinical trials[18] - These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially[20]