Day One Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Progress
Day One Biopharmaceuticals (DAWN) reported its Q4 and full year 2024 financial results, highlighting strong performance of its flagship drug OJEMDA. The company achieved $29.0 million in Q4 OJEMDA net product revenues, a 44% increase from Q3, and $57.2 million for the full year 2024.
Since OJEMDA's launch in April 2024, over 1,600 prescriptions have been written. The drug received Exclusively Pediatric designation from CMS, reducing its Medicaid and 340B minimum rebate percentage to 17.1%. The company reported a net loss of $65.7 million for Q4 and $95.5 million for full year 2024.
R&D expenses increased to $227.7 million for 2024, primarily due to DAY301-related payments. The company maintains a strong financial position with $531.7 million in cash and equivalents as of December 31, 2024.
Day One Biopharmaceuticals (DAWN) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando le ottime performance del suo farmaco di punta OJEMDA. L'azienda ha raggiunto 29,0 milioni di dollari in ricavi netti da prodotto OJEMDA nel Q4, con un aumento del 44% rispetto al Q3, e 57,2 milioni di dollari per l'intero anno 2024.
Dalla sua introduzione nell'aprile 2024, sono state scritte oltre 1.600 prescrizioni. Il farmaco ha ricevuto la designazione di Esclusivamente Pediatrico da CMS, riducendo la percentuale minima di rimborso Medicaid e 340B al 17,1%. L'azienda ha riportato una perdita netta di 65,7 milioni di dollari per il Q4 e di 95,5 milioni di dollari per l'intero anno 2024.
Le spese per ricerca e sviluppo sono aumentate a 227,7 milioni di dollari per il 2024, principalmente a causa dei pagamenti legati a DAY301. L'azienda mantiene una solida posizione finanziaria con 531,7 milioni di dollari in liquidità e equivalenti al 31 dicembre 2024.
Day One Biopharmaceuticals (DAWN) informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando el sólido desempeño de su medicamento insignia OJEMDA. La compañía logró 29,0 millones de dólares en ingresos netos por productos OJEMDA en el Q4, un aumento del 44% respecto al Q3, y 57,2 millones de dólares para el año completo 2024.
Desde el lanzamiento de OJEMDA en abril de 2024, se han escrito más de 1.600 recetas. El medicamento recibió la designación de Exclusivamente Pediátrico por parte de CMS, reduciendo su porcentaje mínimo de reembolso de Medicaid y 340B al 17,1%. La compañía reportó una pérdida neta de 65,7 millones de dólares para el Q4 y de 95,5 millones de dólares para el año completo 2024.
Los gastos de I+D aumentaron a 227,7 millones de dólares para 2024, principalmente debido a los pagos relacionados con DAY301. La compañía mantiene una sólida posición financiera con 531,7 millones de dólares en efectivo y equivalentes al 31 de diciembre de 2024.
데이 원 바이오파마슈티컬스 (DAWN)은 2024년 4분기 및 전체 연도 재무 결과를 보고하며, 주력 약물 OJEMDA의 강력한 성과를 강조했습니다. 이 회사는 4분기 OJEMDA 순제품 수익 2,900만 달러를 달성했으며, 이는 3분기 대비 44% 증가한 수치입니다. 그리고 2024년 전체 연도 5,720만 달러를 기록했습니다.
OJEMDA가 2024년 4월에 출시된 이후, 1,600건 이상의 처방이 작성되었습니다. 이 약물은 CMS로부터 독점 소아 전용 지정을 받았으며, Medicaid 및 340B의 최소 리베이트 비율을 17.1%로 줄였습니다. 이 회사는 4분기에 6,570만 달러의 순손실을, 2024년 전체 연도에 9,550만 달러의 순손실을 보고했습니다.
연구개발 비용은 2024년 2억 2,770만 달러로 증가했으며, 이는 주로 DAY301 관련 지급 때문입니다. 이 회사는 2024년 12월 31일 기준으로 5억 3,170만 달러의 현금 및 현금성 자산을 보유하고 있어 강력한 재무 상태를 유지하고 있습니다.
Day One Biopharmaceuticals (DAWN) a annoncé ses résultats financiers du quatrième trimestre et de l'année entière 2024, mettant en avant la forte performance de son médicament phare OJEMDA. L'entreprise a réalisé 29,0 millions de dollars de revenus nets de produits OJEMDA au Q4, soit une augmentation de 44% par rapport au Q3, et 57,2 millions de dollars pour l'année entière 2024.
Depuis le lancement d'OJEMDA en avril 2024, plus de 1 600 prescriptions ont été écrites. Le médicament a reçu la désignation Exclusivement Pédiatrique de la part de CMS, réduisant son pourcentage minimum de remboursement Medicaid et 340B à 17,1%. L'entreprise a déclaré une perte nette de 65,7 millions de dollars pour le Q4 et de 95,5 millions de dollars pour l'année entière 2024.
Les dépenses de R&D ont augmenté à 227,7 millions de dollars pour 2024, principalement en raison des paiements liés à DAY301. L'entreprise maintient une solide position financière avec 531,7 millions de dollars en liquidités et équivalents au 31 décembre 2024.
Day One Biopharmaceuticals (DAWN) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei die starke Leistung seines Hauptmedikaments OJEMDA hervorgehoben. Das Unternehmen erzielte 29,0 Millionen Dollar an Netto-Produktumsätzen für OJEMDA im Q4, was einem Anstieg von 44% im Vergleich zum Q3 entspricht, und 57,2 Millionen Dollar für das gesamte Jahr 2024.
Seit der Markteinführung von OJEMDA im April 2024 wurden über 1.600 Rezepte ausgestellt. Das Medikament erhielt die Bezeichnung ausschließlich für Kinder von CMS, wodurch der Mindest-Rückerstattungsprozentsatz für Medicaid und 340B auf 17,1% gesenkt wurde. Das Unternehmen berichtete über einen Nettoverlust von 65,7 Millionen Dollar im Q4 und 95,5 Millionen Dollar für das gesamte Jahr 2024.
Die Forschung- und Entwicklungskosten stiegen auf 227,7 Millionen Dollar für 2024, hauptsächlich aufgrund von Zahlungen im Zusammenhang mit DAY301. Das Unternehmen hält eine starke Finanzlage mit 531,7 Millionen Dollar in Bargeld und Äquivalenten zum 31. Dezember 2024.
- OJEMDA Q4 revenue of $29M, up 44% from Q3
- 1,600+ prescriptions since April 2024 launch
- Strong cash position of $531.7M
- Reduced Medicaid rebate percentage to 17.1%
- Additional revenue of $73.9M from ex-U.S. rights sale
- Net loss of $65.7M in Q4 2024
- R&D expenses increased 74% YoY to $227.7M
- SG&A expenses up 53% YoY to $115.5M
Insights
Day One Biopharmaceuticals (DAWN) has delivered impressive commercial momentum in Q4 2024, with
The Exclusively Pediatric designation from CMS represents an underappreciated catalyst, reducing mandatory rebates by 6 percentage points. This translates to approximately
DAWN's financial position remains robust with
The company's pipeline diversification strategy is materializing with DAY301 (PTK7-targeted ADC) advancing through early clinical development. This represents a calculated bet on expanding beyond BRAF-mutated cancers, though meaningful revenue contribution remains years away. Meanwhile, the FIREFLY-2 trial progression could potentially expand OJEMDA's label and addressable market.
From a valuation perspective, DAWN's
The key investment consideration is whether OJEMDA can sustain its growth trajectory throughout 2025. The
The rapid adoption of OJEMDA (tovorafenib) in pediatric low-grade glioma (pLGG) represents a paradigm shift in pediatric neuro-oncology. With 1,600+ prescriptions in just eight months, OJEMDA has likely captured approximately
The clinical value proposition of OJEMDA stems from its remarkable overall response rate of
OJEMDA's mechanism as a type II RAF inhibitor specifically addresses the BRAF alterations present in
The Exclusively Pediatric designation not only provides financial benefits but recognizes OJEMDA's development specifically for children - a rarity in oncology where pediatric indications typically follow adult approvals years later. This reflects Day One's innovative pediatric-first approach that addresses the historical neglect of drug development specifically for childhood cancers.
Looking forward, the FIREFLY-2 trial could potentially expand OJEMDA's label to front-line treatment, which would approximately triple its addressable patient population. Early evidence suggests superior quality of life and neurocognitive outcomes compared to traditional chemotherapy or radiation therapy, which could drive rapid adoption in the front-line setting if approved.
The DAY301 program targeting PTK7 represents a strategic expansion beyond CNS tumors. PTK7 is overexpressed in multiple pediatric and adult solid tumors, including neuroblastoma, Ewing sarcoma, and certain gynecologic malignancies. The ADC approach could overcome traditional drug delivery challenges, particularly for notoriously difficult-to-treat pediatric solid tumors where new options are desperately needed.
From a clinical perspective, OJEMDA's success validates the precision medicine approach in pediatric oncology and likely heralds a broader shift toward targeted therapies that may offer better efficacy and reduced long-term toxicity - a critical consideration in developing brains and growing bodies.
Achieved Q4 2024 and full year 2024 OJEMDA™ (tovorafenib) net product revenues of
Ended 2024 with
Company to host conference call and webcast today, February 25, 4:30 p.m. ET
BRISBANE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its fourth quarter and full year 2024 financial results and highlighted recent corporate achievements.
“The approval of OJEMDA was the catalyst for our next stage of growth and I am proud that our team was able to offer OJEMDA to so many relapsed or refractory pediatric low-grade glioma (pLGG) patients in our first months of launch,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “With OJEMDA as our foundation and a strong balance sheet, we believe we are on a path to long-term, durable growth and to the realization of Day One’s mission.”
Program Highlights
- OJEMDA net product revenues were
$29.0 million and$57.2 million for the fourth quarter and full year ended December 31, 2024, respectively.- OJEMDA net product revenues increased
44% from the third to fourth quarter of 2024. - In approximately eight months since launch in April 2024, more than 1,600 OJEMDA prescriptions have been written.
- OJEMDA net product revenues increased
- OJEMDA received the Exclusively Pediatric designation by the Centers for Medicare & Medicaid Services in the fourth quarter ended December 31, 2024, reducing its Medicaid and 340B minimum rebate percentage from
23.1% to17.1% . - DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial.
- Day One advanced enrollment in the global, pivotal Phase 3 FIREFLY-2 clinical trial, with full enrollment expected in the first half of 2026.
Corporate Highlights
- Chief executive officer Dr. Jeremy Bender presented preliminary 2024 OJEMDA net product revenue and 2025 corporate priorities at the 43rd Annual J.P. Morgan Healthcare Conference. An archived audio webcast of the discussion is available by visiting the Events Presentations section of the Company’s website.
Fourth Quarter and Full Year 2024 Financial Highlights
- Product Revenue, Net: OJEMDA net product revenues were
$29.0 million and$57.2 million for the fourth quarter and full year ended December 31, 2024, respectively. - License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib were
$0.2 million and$73.9 million for the fourth quarter and full year ended December 31, 2024, respectively. - R&D Expenses: Research and development expenses were
$61.8 million and$227.7 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to$37.3 million and$130.5 million for the same periods in 2023. The increase was primarily due to the DAY301 upfront license payment of$55.0 million in the third quarter 2024 and initiation of the DAY301 dose escalation study milestone of$20.0 million in the fourth quarter 2024. - SG&A Expenses: Selling, general and administrative expenses were
$29.8 million and$115.5 million for the fourth quarter and full year ended December 31, 2024, respectively, as compared to$22.2 million and$75.6 million for the same periods in 2023. The increase was primarily due to employee compensation costs and professional service expenses to support the launch of OJEMDA. - Net Loss: Net loss totaled
$65.7 million and$95.5 million for the fourth quarter and full year ended December 31, 2024, respectively, with non-cash stock-based compensation expense of$11.0 million and$48.3 million for the same periods. Net loss totaled$54.5 million and$188.9 million for the fourth quarter and full year ended December 31, 2023, respectively, with non-cash stock-based compensation expense of$10.8 million and$39.3 million for the same periods. - Cash Position: The Company’s cash, cash equivalents and short-term investments totaled
$531.7 million on December 31, 2024.
Upcoming Events
- 44th Annual TD Cowen Health Care Conference
- Management will participate in a fireside chat on Tuesday, March 4 at 1:10 p.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events Presentations section of the Company’s website.
Conference Call
Day One will host a conference call and webcast today, February 25 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.
About OJEMDA™
OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.
OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.
For more information, please visit www.ojemda.com.
About Day One Biopharmaceuticals
Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.
Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™), DAY301 and a VRK1 inhibitor program.
Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.
Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies, expectations from current and planned clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, expectations with respect to the timing of Day One’s Phase 1a/b clinical trial of DAY301, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications.
Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, interest rate volatility, significant political, trade or regulatory developments, geopolitical conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
| Day One Biopharmaceuticals, Inc. Statements of Operations (in thousands, except share and per share amounts) (unaudited) | |||||||||||
| Year Ended December 31, | |||||||||||
| 2024 | 2023 | 2022 | |||||||||
| Revenue: | |||||||||||
| Product revenue, net | $ | 57,217 | $ | — | $ | — | |||||
| License revenue | 73,944 | — | — | ||||||||
| Total revenues | 131,161 | — | — | ||||||||
| Cost and operating expenses: | |||||||||||
| Cost of product revenue | 5,279 | — | — | ||||||||
| Research and development | 227,702 | 130,521 | 85,618 | ||||||||
| Selling, general and administrative | 115,450 | 75,543 | 61,291 | ||||||||
| Total cost and operating expenses | 348,431 | 206,064 | 146,909 | ||||||||
| Loss from operations | (217,270 | ) | (206,064 | ) | (146,909 | ) | |||||
| Non-operating income: | |||||||||||
| Gain from sale of priority review voucher | 108,000 | — | — | ||||||||
| Investment income, net | 19,701 | 17,187 | 4,746 | ||||||||
| Other income (expense), net | 1,217 | (40 | ) | (18 | ) | ||||||
| Total non-operating income, net | 128,918 | 17,147 | 4,728 | ||||||||
| Loss before income taxes | (88,352 | ) | (188,917 | ) | (142,181 | ) | |||||
| Income tax expense | (7,144 | ) | — | — | |||||||
| Net loss | (95,496 | ) | (188,917 | ) | (142,181 | ) | |||||
| Net loss per share - basic | $ | (1.02 | ) | $ | (2.37 | ) | $ | (2.17 | ) | ||
| Net loss per share - diluted | $ | (1.02 | ) | $ | (2.37 | ) | $ | (2.17 | ) | ||
| Weighted-average number of common shares used in net loss per share - basic | 93,234,195 | 79,773,004 | 65,466,773 | ||||||||
| Weighted-average number of common shares used in net loss per share - diluted | 93,234,195 | 79,773,004 | 65,466,773 | ||||||||
| Day One Biopharmaceuticals, Inc. Selected Condensed Balance Sheet Data (in thousands) (unaudited) | |||||||
| December 31, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and short-term investments | $ | 531,720 | $ | 366,347 | |||
| Total assets | 582,788 | 376,048 | |||||
| Total liabilities | 80,037 | 29,508 | |||||
| Accumulated deficit | (554,081 | ) | (458,585 | ) | |||
| Total stockholders’ equity | 502,751 | 346,540 | |||||
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
FAQ
What were DAWN's OJEMDA revenue numbers for Q4 2024?
How many OJEMDA prescriptions has DAWN recorded since launch?
What is DAWN's cash position as of December 31, 2024?
How did DAWN's R&D expenses change in 2024 compared to 2023?
What impact does the Exclusively Pediatric designation have on DAWN's OJEMDA?
