Day One Biopharmaceuticals, Inc. (DAWN) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.46. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 23.91%. A quarter ago, it was expected that this company would post a loss of $0.35 per share when it actually produced a loss of $0.69, delivering a surprise of -97.14%.Over the last four quarters, the co ...

First Quarter 2025 Financial Results & Corporate Progress MAY 2025 Forward looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as "m ...

Day One Biopharmaceuticals (DAWN) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Hello, ladies and gentlemen, and welcome to the DayOne Biopharmaceuticals First Quarter twenty twenty five Financial and Operating Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please be advised that this conference call is being recorded. I would now like to turn the call over to Joy Peroni, Senior Vice President of Finance and ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40431 DAY ONE BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2415215 (State or oth ...

OJEMDA TM (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Exhibit 99.1 Day One Reports First Quarter 2025 Financial Results and Corporate Progress Achieved Q1 2025 OJEMDA TM (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 6, 2025 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the " ...

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Core Insights - Day One Biopharmaceuticals (NASDAQ: DAWN) received accelerated approval for Ojemda (tovorafenib) in April 2024 for treating relapsed/refractory BRAF-altered pediatric low-grade gliomas (pLGG) [1] - The product launch has been successful, with the company reporting $57.2 million in net product revenues [1] Company Performance - The approval of Ojemda marks a significant milestone for Day One Biopharmaceuticals, indicating strong potential in the pediatric oncology market [1] - The reported net product revenues of $57.2 million reflect a positive market reception and effective commercialization strategies [1]

Financial Data and Key Metrics Changes - For the full year 2024, net product revenues totaled more than $57 million, representing approximately eight months of sales following OJEMDA's April approval [10] - Fourth quarter net product revenues were $29 million, which represents a 44% growth compared to Q3 [11] - Total revenue for the fourth quarter of 2024 was $29.2 million, including $29 million in net product revenue and $200,000 from license revenue [37] - Operating expenses were $91.6 million for Q4 2024, compared to $59.5 million for Q4 2023, driven primarily by commercial investments and a one-time charge of $20 million in R&D expense [40] Business Line Data and Key Metrics Changes - OJEMDA's launch performance in 2024 showed consistent growth in quarterly net revenues, with Q4 nearly doubling the number of prescriptions in Q2 and Q3 combined [21] - The company achieved over 1,600 cumulative total prescriptions, with Q4 contributing approximately 800 new prescriptions [20][75] - 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 from 23.1% to 17.1% [39] Market Data and Key Metrics Changes - OJEMDA has broad coverage, with over 75% of covered lives having published policies and about 95% of on-label patients receiving coverage [30] - The company reported that over 80% of pLGG patients received coverage approval for OJEMDA on their initial request in Q4 [31] Company Strategy and Development Direction - The company aims to continue driving OJEMDA revenue growth, advancing its pipeline, and expanding with programs that have potential to become important new medicines [16] - The focus is on acquiring and in-licensing programs that have the potential to be first or best-in-class, supported by a strong financial position [17] - The company plans to establish OJEMDA as the standard of care in treating relapsed or refractory BRAF-altered pLGG [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of OJEMDA, emphasizing the importance of increasing the prescriber base and patient usage [32] - The company anticipates steady growth in new patient starts, with no singular inflection point expected [61] - Management highlighted the strong cash position of over $500 million, which provides the ability to operate and invest in growth opportunities [15] Other Important Information - The company ended 2024 with a cash balance of $531.7 million, allowing for continued investment in growth opportunities [41] - The company will no longer book revenue for its named patient program starting in 2025, which previously contributed approximately $3 million in 2024 [38] Q&A Session Summary Question: When might guidance for OJEMDA be provided? - Management indicated that guidance will depend on consistency in revenue growth and treatment duration, which will take time to understand [47] Question: What actions are underway to drive increased depth of prescribing? - The focus is on helping physicians gain experience with OJEMDA and understanding the full range of patients that can benefit from it [51] Question: How should the cadence of new patient starts be viewed this year? - Steady growth is expected, with no singular inflection point anticipated [61] Question: What is the breakdown of prescriptions in Q4? - Approximately 800 prescriptions were written in Q4, with a noted increase in channel stock due to growing demand [75][80] Question: What is the differentiation of DAY301 from other PTK7 targeting ADCs? - DAY301 is believed to be a first and best-in-class opportunity, utilizing a unique payload and linker that may provide a better therapeutic index [87][101]

Core Insights - Day One Biopharmaceuticals reported a quarterly loss of $0.69 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.35, marking an earnings surprise of -97.14% [1] - The company generated revenues of $29.21 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 7.74%, compared to zero revenues a year ago [2] - The stock has underperformed the market, losing about 3.9% since the beginning of the year, while the S&P 500 gained 1.7% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.32 on revenues of $33.14 million, and for the current fiscal year, it is -$0.97 on revenues of $166.4 million [7] - The estimate revisions trend for Day One Biopharmaceuticals is favorable, resulting in a Zacks Rank 1 (Strong Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Day One Biopharmaceuticals belongs, is currently in the top 27% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - As of December 31, 2024, the company generated approximately $57.2 million in net revenue from product sales of OJEMDA[230]. - The company reported net losses of $95.5 million, $188.9 million, and $142.2 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $554.1 million as of December 31, 2024[233]. - The company anticipates needing to raise additional capital to complete the development of its product candidates, including OJEMDA, DAY301, and VRK1[248]. - The company has entered into an equity distribution agreement for an aggregate offering price of up to $250.0 million under an at-the-market offering program, with no shares sold as of December 31, 2024[249]. - As of December 31, 2024, the company had $531.7 million in cash, cash equivalents, and short-term investments, which is expected to be sufficient for at least twelve months[247]. Product Development and Regulatory Approvals - OJEMDA received FDA marketing approval in April 2024 for treating patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation[236]. - Future revenue generation will depend on the successful completion of clinical trials and obtaining marketing authorizations for its product candidates[239]. - The company must demonstrate the safety and effectiveness of its product candidates through lengthy and expensive clinical trials before obtaining marketing authorization[262]. - The company has not yet obtained FDA approval for DAY301 and VRK1, which may limit market potential[324]. - The company has received breakthrough therapy designation for tovorafenib in patients with advanced pLGG, indicating potential for substantial improvement over existing therapies[328]. Commercialization Challenges - The successful commercialization of OJEMDA is critical for the company's near-term revenues and overall financial condition[236]. - The company anticipates significant sales, marketing, and outsourced manufacturing expenses related to the commercialization of OJEMDA and its product candidates[234]. - The company is in the early stages of transitioning from a research and development focus to supporting commercial activities, which may pose challenges[231]. - Successful commercialization of OJEMDA depends on negotiations with third-party payors, which are unpredictable[308]. - Coverage and adequate reimbursement from third-party payors are critical for the acceptance of OJEMDA and product candidates[309]. Clinical Trial Risks - The company faces numerous risks and uncertainties, including the need for additional capital and the complexities of clinical trials and regulatory approvals[228]. - The company faces high risks in clinical trials, with the potential for failure at any stage, which could adversely affect its business and financial prospects[251]. - The outcome of clinical trials is uncertain, and inconclusive results may lead to additional costs, delays in marketing authorization, or restrictions on product indications[268]. - The company may need to delay, reduce, or terminate its research programs if adequate funds are not available on commercially acceptable terms[250]. - The company may face numerous challenges during clinical trials that could delay or prevent marketing authorization for OJEMDA and other product candidates, including potential FDA holds on studies[263]. Competition and Market Landscape - The company faces substantial competition in the pharmaceutical and biotechnology industries, particularly in oncology, which may affect the success of its product candidates[280]. - The BRAF V600E subset represents 10%-20% of BRAF-altered pLGG, with competitors like Novartis having received FDA approval for similar treatments[283]. - The company faces significant competition from larger pharmaceutical and biotechnology companies with greater resources and market presence[289]. - The potential addressable patient population for OJEMDA may be smaller than estimated, affecting market opportunities[303]. - The company may experience difficulties in patient enrollment for clinical trials due to competition and limited patient pools in orphan or rare diseases[274]. Regulatory and Compliance Issues - The FDA approval process is expensive and uncertain, with only a small percentage of drugs successfully completing the marketing authorization process[321]. - The company must comply with post-approval regulatory requirements, and failure to do so could result in withdrawal of marketing authorizations and limit future product marketing[364]. - The company is subject to numerous environmental, health, and safety laws, which could result in significant costs and liabilities if not complied with[389]. - The company faces substantial costs to ensure compliance with healthcare laws and regulations, which may lead to significant civil, criminal, and administrative penalties if found in violation[372]. - The Foreign Corrupt Practices Act (FCPA) requires compliance with accounting provisions and internal controls for international operations, adding to operational costs[385]. Supply Chain and Manufacturing Risks - The company relies on third-party manufacturers in China for the production of OJEMDA and product candidates, increasing risks related to supply chain disruptions and production delays[410]. - A manufacturing and supply agreement has been established with Quotient for drug manufacturing and with Sharp Corporation for packaging OJEMDA, but supply chain issues may impact delivery[412]. - The company faces risks from reliance on a limited number of suppliers for raw materials, which could result in delays in clinical trials and adversely affect operations[420]. - Any performance failure by third-party manufacturers could delay clinical development or marketing authorization of product candidates[418]. - Disruptions in logistics and transportation could adversely affect the supply chain and result in unexpected spikes in demand[411].