The chart below shows how DAWN performed 10 days before and after its earnings report, based on data from the past quarters. Typically, DAWN sees a -3.34% change in stock price 10 days leading up to the earnings, and a -1.79% change 10 days following the report. On the earnings day itself, the stock moves by +0.95%. This data can give you a slight idea of what to expect for the next quarter's release.
Positive
FDA Approval Milestone: OJEMDA received FDA approval in 2024, marking a significant milestone for Day One and patients with relapsed/refractory pediatric low-grade glioma.
Revenue Performance Overview: Net product revenues for OJEMDA exceeded $57 million for the full year 2024, with Q4 revenues reaching $29 million, representing a 44% growth from Q3.
OJEMDA Prescription Surge: The launch of OJEMDA saw over 1,600 cumulative total prescriptions, with Q4 nearly doubling the number of prescriptions from Q2 and Q3 combined.
Exclusive Licensing Agreement: The company established an exclusive licensing agreement with Ipsen for OJEMDA's ex-U.S. rights, enhancing access for patients outside the U.S.
Clinical Trial Enrollment Progress: Enrollment in the FIREFLY-2 clinical trial is progressing well, with over 110 sites open and expected full enrollment in the first half of 2026.
Pipeline Expansion with Acquisition: The acquisition of DAY301, a clinical stage antibody drug conjugate, adds to the pipeline and is currently in the dose escalation phase of a Phase Ia/b trial.
Strong Financial Position: Day One ended 2024 with over $500 million in cash, providing a strong financial position to support operations and pipeline advancements.
Pediatric Designation Impact: The gross to net deductions improved in Q4 due to CMS granting OJEMDA an exclusively pediatric designation, reducing the Medicaid and 340B minimum rebate percentage significantly.
Negative
Rising Operating Expenses: Operating expenses increased significantly, with Q4 expenses at $91.6 million and full year expenses at $343.2 million, compared to $59.5 million and $206.1 million in the same periods of 2023, indicating a substantial rise in costs associated with the launch of OJEMDA and R&D investments.
Revenue Decline Anticipated: The company will no longer book revenue from its named patient program, which contributed approximately $3 million in 2024, suggesting a potential revenue decline in 2025.
Revenue Growth Challenges: Despite the growth in OJEMDA revenues, the company faces challenges with 30% to 40% of discontinuations occurring in patients using OJEMDA for off-label uses, which may indicate issues with the drug's effectiveness or acceptance in certain cases.
Gross to Net Deductions: The gross to net deductions are expected to stabilize at approximately 12% to 15%, which may limit revenue growth potential in the future due to the nature of the payer mix and discounts required.
Market Dependency Risks: The company has a significant reliance on the success of OJEMDA, and any setbacks in its market performance could adversely affect overall financial health and growth projections.
Day One Biopharmaceuticals, Inc. (DAWN) Q4 2024 Earnings Call Transcript
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