Workflow
Day One Biopharmaceuticals pany(DAWN)
icon
Search documents
Day One Biopharmaceuticals pany(DAWN) - 2025 Q1 - Quarterly Results
2025-05-06 20:01
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 " ...
Day One Reports First Quarter 2025 Financial Results and Corporate Progress
GlobeNewswire News Room· 2025-05-06 20:01
Core Insights - Day One Biopharmaceuticals reported a 16% increase in OJEMDA™ (tovorafenib) prescriptions in Q1 2025 compared to Q4 2024, with net product revenue reaching $30.5 million [1][2] - The company ended Q1 2025 with $473.0 million in cash, cash equivalents, and short-term investments [1][5] - Day One is focused on executing its objectives with urgency and fiscal discipline, aiming to create value at every organizational level [2] Financial Performance - OJEMDA net product revenue for Q1 2025 was $30.5 million, an 11% increase in U.S. revenue from Q4 2024 [2][5] - Total revenues for Q1 2025 were $30.8 million, with license revenue from ex-U.S. commercial rights amounting to $0.3 million [5][15] - Research and development expenses were $39.6 million, a slight decrease from $40.2 million in Q1 2024, while selling, general, and administrative expenses rose to $29.3 million from $26.6 million [5][15] - The net loss for Q1 2025 was $36.0 million, a reduction from a net loss of $62.4 million in Q1 2024 [5][15] Product Development and Regulatory Updates - Since its launch, OJEMDA has generated $87.7 million in net product revenue, with over 2,500 prescriptions [2] - The European Medicines Agency accepted the regulatory filing for tovorafenib in April 2025, marking a significant step for its development outside the U.S. [2] - The DAY301 clinical trial has cleared its first dose cohort in the Phase 1a portion, and the pivotal Phase 3 FIREFLY-2 trial is expected to be fully enrolled in the first half of 2026 [2] Upcoming Events - Day One will host a conference call and webcast on May 6, 2025, at 4:30 p.m. ET [1][4] - The company will participate in various upcoming conferences, including the Society for Neuro-Oncology's Pediatric Neuro-Oncology Conference and the ASCO Annual Meeting [4][5]
Day One to Report First Quarter 2025 Financial Results Tuesday, May 6, 2025
Newsfilter· 2025-04-22 12:30
Company Overview - Day One Biopharmaceuticals is focused on developing and commercializing targeted therapies for life-threatening diseases, particularly in pediatric cancer [3][4] - The company aims to address the critical unmet need in pediatric cancer therapeutic development, inspired by the initial conversations between physicians and families regarding cancer diagnosis and treatment [3] Upcoming Events - Day One will host a live conference call and webcast on May 6, 2025, at 4:30 p.m. ET to report financial results and discuss corporate progress for Q1 2025 [1] - The live audio of the webcast will be accessible on the Day One Investors & Media page, with an archived version available for replay for 30 days following the event [2] Pipeline and Collaborations - The company's pipeline includes tovorafenib (OJEMDA™), DAY301, and a VRK1 inhibitor program [4] - Day One collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments [4] Communication Channels - Day One utilizes its Investor Relations website, X handle, and LinkedIn page to disseminate news, announcements, and financial performance updates [5]
UNDER ARMOUR APPOINTS DAWN N. FITZPATRICK, EUGENE D.
Prnewswire· 2025-04-15 12:30
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 ...
Day One Biopharmaceuticals Pullback Is A Potential Buying Opportunity
Seeking Alpha· 2025-04-11 03:51
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]
Day One Biopharmaceuticals pany(DAWN) - 2024 Q4 - Earnings Call Transcript
2025-02-26 12:02
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]
Day One Biopharmaceuticals, Inc. (DAWN) Reports Q4 Loss, Tops Revenue Estimates
ZACKS· 2025-02-25 23:56
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]
Day One Biopharmaceuticals pany(DAWN) - 2024 Q4 - Annual Report
2025-02-25 21:10
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].
Day One Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Progress
Globenewswire· 2025-02-25 21:05
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]
Does Day One Biopharmaceuticals (DAWN) Have the Potential to Rally 193.16% as Wall Street Analysts Expect?
ZACKS· 2025-02-13 15:56
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]