PART I. FINANCIAL INFORMATION [Interim Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Interim%20Condensed%20Financial%20Statements%20%28Unaudited%29) Day One Biopharmaceuticals achieved its first product revenues in Q1 2025, significantly reducing its net loss while maintaining a solid financial position [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The company's total assets decreased as of March 31, 2025, primarily due to reduced cash, while total liabilities also decreased and stockholders' equity remained substantial Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,358 | $124,968 | | Short-term investments | $439,662 | $406,752 | | Total current assets | $508,651 | $562,330 | | Total assets | $534,356 | $582,788 | | **Liabilities & Equity** | | | | Total current liabilities | $47,879 | $73,451 | | Total liabilities | $54,844 | $80,037 | | Total stockholders' equity | $479,512 | $502,751 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company generated its first product revenue, significantly narrowing its net loss compared to the prior-year period Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product revenue, net | $30,503 | $0 | | Total revenues | $30,761 | $0 | | Research and development | $39,619 | $40,210 | | Selling, general and administrative | $29,325 | $26,557 | | Loss from operations | ($41,067) | ($66,767) | | Net loss | ($35,996) | ($62,412) | | Net loss per share - basic & diluted | ($0.35) | ($0.72) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased in Q1 2025, primarily due to the purchase of short-term investments, resulting in a net decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($58,997) | ($49,729) | | Net cash (used in) provided by investing activities | ($32,613) | $89,288 | | Cash provided by financing activities | $0 | $48 | | Net (decrease) increase in cash and cash equivalents | ($91,610) | $39,607 | | Cash and cash equivalents, end of period | $33,358 | $270,391 | [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's accounting policies, financial instruments, and significant agreements, including revenue concentration, milestone payments, and purchase commitments - For the three months ended March 31, 2025, two individual customers accounted for **98.4% of total net product revenue** and **96.2% of the accounts receivable balance**[39](index=39&type=chunk) - In March 2025, the company paid a **$4.0 million milestone** to XOMA following the European Medicines Agency's validation of the Marketing Authorization Application for tovorafenib[64](index=64&type=chunk) - The company has a manufacturing and supply agreement with Quotient Sciences that includes minimum purchase obligations of approximately **$12.6 million** over the next five years[94](index=94&type=chunk) - The company has an at-the-market (ATM) offering program for up to **$250.0 million**, but no shares had been sold under this agreement as of March 31, 2025[105](index=105&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a commercial-stage entity following the FDA approval of OJEMDA™, detailing its commercial launch, ongoing clinical trials, strategic collaborations, and financial performance [Overview](index=30&type=section&id=Overview) Day One is a commercial-stage company focused on developing medicines for childhood and adult diseases, with its first product OJEMDA™ approved by the FDA in April 2024 - The FDA approved OJEMDA™ (tovorafenib) on **April 23, 2024**, for patients 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion/rearrangement or BRAF V600 mutation[128](index=128&type=chunk) - The pivotal Phase 3 FIREFLY-2 trial is evaluating tovorafenib as a front-line therapy in pLGG, with enrollment expected to be complete in the **first half of 2026**[135](index=135&type=chunk) - The company licensed exclusive rights to commercialize tovorafenib outside the U.S. to Ipsen in **July 2024**[136](index=136&type=chunk) - The pipeline includes DAY301, a novel ADC targeting PTK7, which cleared its first cohort in a Phase 1a/b trial in **January 2025**, and a preclinical VRK1 inhibitor program[140](index=140&type=chunk)[141](index=141&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) The company's financial performance improved significantly in Q1 2025 due to the launch of OJEMDA, with net product revenue of **$30.5 million** and a reduced loss from operations Comparison of Results of Operations (in thousands) | Account | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $30,761 | $0 | $30,761 | N/A | | Research and development | $39,619 | $40,210 | ($591) | (1.5)% | | Selling, general and administrative | $29,325 | $26,557 | $2,768 | 10.4% | | Loss from operations | ($41,067) | ($66,767) | $25,700 | (38.5)% | | Net loss | ($35,996) | ($62,412) | $26,416 | (42.3)% | - The slight decrease in R&D expenses was mainly due to a **$4.0 million milestone payment** in Q1 2025 compared to a larger **$5.0 million amendment payment** in Q1 2024, partially offset by increased clinical trial costs for DAY301[188](index=188&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had **$473.0 million** in cash and investments, which management believes is sufficient to cover capital requirements for at least the next twelve months - As of March 31, 2025, the company had an accumulated deficit of **$590.1 million** and **$473.0 million** in cash, cash equivalents and short-term investments[195](index=195&type=chunk) - The company believes its current cash position is sufficient to fund operations for at least **twelve months** from the filing date of this report[195](index=195&type=chunk)[206](index=206&type=chunk) - Net cash used in operating activities was **$59.0 million** for the three months ended March 31, 2025[201](index=201&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there were no material changes to its market risks from those previously disclosed in its 2024 Form 10-K - There were no material changes to the company's market risks from those described in the 2024 Form 10-K[218](index=218&type=chunk) [Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective[219](index=219&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[220](index=220&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that management believes would have a material adverse effect on its business - The company is not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on its business[223](index=223&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks to its business, operations, and financial condition, including limited operating history, dependence on OJEMDA, ongoing net losses, and the need for additional capital [Risks Related to Financial Position](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) The company faces risks due to its limited operating history as a commercial entity, a history of significant net losses, and its high dependence on OJEMDA for near-term revenue - The company is a commercial-stage entity with a **limited operating history**, making it difficult for investors to evaluate its business and prospects[226](index=226&type=chunk) - The company has a history of **significant net losses** (**$36.0 million** for Q1 2025) and an accumulated deficit of **$590.1 million** as of March 31, 2025, with losses expected to continue[230](index=230&type=chunk) - Near-term revenues are highly dependent on the **successful commercialization of OJEMDA**, its only approved product[234](index=234&type=chunk) [Risks Related to Development and Commercialization](index=56&type=section&id=Risks%20Related%20to%20Development%20and%20Commercialization) This section details risks associated with product development and commercialization, including the high cost and uncertain outcomes of clinical trials, intense competition, and challenges in market acceptance and reimbursement - Clinical trials are **expensive, time-consuming, and have uncertain outcomes**, with a high risk of failure for product candidates[250](index=250&type=chunk)[261](index=261&type=chunk) - The company faces **intense competition** from major pharmaceutical companies like Novartis, Pfizer, and BeiGene, which have approved or developing products targeting similar pathways[281](index=281&type=chunk)[282](index=282&type=chunk)[285](index=285&type=chunk) - Market acceptance of OJEMDA and future products is not guaranteed and depends on factors like **efficacy, safety, cost-effectiveness**, and physician willingness to prescribe[305](index=305&type=chunk) - Achieving and maintaining adequate coverage and reimbursement from third-party payors, including a fragmented mix of Medicaid and private insurers for pediatric products, is a **significant challenge**[307](index=307&type=chunk)[311](index=311&type=chunk) [Risks Related to Government Regulation](index=76&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company is subject to extensive and evolving government regulation, facing risks from potential failures in marketing authorization, withdrawal of expedited approvals, and the impact of healthcare legislation like the Inflation Reduction Act - The development and commercialization of pharmaceutical products are subject to **extensive, lengthy, and uncertain regulation** by the FDA and other global authorities[320](index=320&type=chunk) - Products granted accelerated approval, like OJEMDA, require post-marketing confirmatory studies, and failure to complete these or confirm clinical benefit could lead to **withdrawal of approval**[336](index=336&type=chunk)[362](index=362&type=chunk) - Healthcare reform measures, such as the Inflation Reduction Act (IRA), could **increase pricing pressure**, introduce government price negotiation, and negatively impact revenue[375](index=375&type=chunk)[381](index=381&type=chunk) - The company's business is subject to **anti-kickback, fraud and abuse, and other healthcare laws**, violations of which can lead to significant penalties[370](index=370&type=chunk)[373](index=373&type=chunk) [Risks Related to Reliance on Third Parties](index=101&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) The company's business model relies heavily on third parties for clinical trials, manufacturing, and ex-U.S. commercialization, creating significant risks related to performance, supply chain, and geopolitical issues - The company depends on **third-party CROs** to conduct clinical trials and is responsible for ensuring their compliance with GCP regulations[409](index=409&type=chunk)[410](index=410&type=chunk) - The company relies on **third-party manufacturers**, some located in China, for the supply of OJEMDA and its product candidates, creating risks related to geopolitical issues, tariffs, and supply chain disruptions[414](index=414&type=chunk)[415](index=415&type=chunk) - The license agreement with Ipsen is crucial for ex-U.S. commercialization of tovorafenib, and **failure by Ipsen to perform its obligations** or termination of the agreement would materially harm the business[428](index=428&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk) - A substantial portion of revenue comes from a **limited number of customers**, with two customers accounting for **98.4% of net product revenue** in Q1 2025[436](index=436&type=chunk) [Risks Related to Intellectual Property](index=122&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on its ability to obtain, maintain, and defend its intellectual property, facing risks from uncertain patent issuance, potential infringement claims, and reliance on third-party licenses - The company's commercial success depends on its ability to **obtain and maintain patent protection** for its products and technology, which is an uncertain and complex process[483](index=483&type=chunk)[484](index=484&type=chunk) - The company may face claims that it **infringes on third-party patents**, which could result in costly litigation, liability for damages, or prevent commercialization[500](index=500&type=chunk) - The company relies on **licenses from third parties** (e.g., Viracta/XOMA, Takeda, MabCare) for its product candidates, and the termination or breach of these agreements would materially harm the business[508](index=508&type=chunk)[511](index=511&type=chunk) - Patent protection may not be available or enforceable in all countries, and changes in patent law in the U.S. and abroad could **diminish the value of the company's intellectual property**[534](index=534&type=chunk)[542](index=542&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=155&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales of equity securities, no use of proceeds from registered securities, and no issuer purchases of equity securities during the reporting period - There were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities in the quarter[594](index=594&type=chunk)[595](index=595&type=chunk)[596](index=596&type=chunk) [Defaults Upon Senior Securities](index=155&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[597](index=597&type=chunk) [Mine Safety Disclosures](index=155&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[598](index=598&type=chunk) [Other Information](index=155&type=section&id=Item%205.%20Other%20Information) The company disclosed that its Chief Commercial Officer entered into a pre-arranged Rule 10b5-1 stock trading plan on February 28, 2025 - On February 28, 2025, Chief Commercial Officer Lauren Merendino adopted a Rule 10b5-1 trading plan for the potential sale of approximately **120,021 shares of common stock**[601](index=601&type=chunk) [Exhibits](index=158&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including required certifications and Inline XBRL data files - The report includes required certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act, as well as XBRL financial data[604](index=604&type=chunk)

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 " ...

Upcoming Events OJEMDA™ (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDA™ (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 06, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to develo ...

BALTIMORE, April 15, 2025 /PRNewswire/ -- Under Armour, Inc. (NYSE: UA, UAA) announced today that, effective April 15, Dawn N. Fitzpatrick, Eugene D. Smith, and Robert J. Sweeney will join the company's Board of Directors. Dawn N. Fitzpatrick Eugene D. Smith Robert J. Sweeney "Dawn and Rob's extensive financial and operational expertise, combined with Gene's deep knowledge of intercollegiate sports management, makes them exceptional additions to our board," said Mohamed A. El-Erian, Chair of the Bo ...

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].

Core Insights - Day One Biopharmaceuticals reported Q4 2024 net product revenues of $29.0 million and full year revenues of $57.2 million for OJEMDA (tovorafenib) [1][5] - The company ended 2024 with a strong cash position of $531.7 million [1][7] - The CEO highlighted the approval of OJEMDA as a significant growth catalyst and expressed confidence in the company's long-term growth trajectory [2] Financial Highlights - OJEMDA net product revenues increased by 44% from Q3 to Q4 2024 [5] - The company wrote over 1,600 OJEMDA prescriptions within eight months of its launch in April 2024 [5] - License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.2 million for Q4 and $73.9 million for the full year [6] - Research and development expenses rose to $61.8 million for Q4 and $227.7 million for the full year, compared to $37.3 million and $130.5 million in 2023 [6] - Selling, general and administrative expenses were $29.8 million for Q4 and $115.5 million for the full year, up from $22.2 million and $75.6 million in 2023 [6] - The net loss for Q4 was $65.7 million and $95.5 million for the full year, with non-cash stock-based compensation expenses of $11.0 million and $48.3 million respectively [6][7] Corporate Developments - OJEMDA received the Exclusively Pediatric designation, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1% [5] - The DAY301 program, a PTK7-targeted ADC, successfully cleared the first dose cohort in its Phase 1a clinical trial [5] - Enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial is advancing, with full enrollment expected in the first half of 2026 [5]

Group 1 - Shares of Day One Biopharmaceuticals, Inc. (DAWN) have increased by 2.2% over the past four weeks, closing at $12.13, with a mean price target of $35.56 indicating a potential upside of 193.2% [1] - The average price target consists of nine estimates ranging from a low of $25 to a high of $43, with a standard deviation of $5.50, suggesting a potential increase of 106.1% to 254.5% from the current price [2] - Analysts show strong agreement on DAWN's ability to report better earnings than previously predicted, which supports the view of potential upside [4][9] Group 2 - The Zacks Consensus Estimate for DAWN has increased by 4.2% due to two upward revisions in earnings estimates over the last 30 days, with no negative revisions [10] - DAWN holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for near-term upside [11] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [12]