Day One Reports Preliminary 2024 OJEMDA™ Net Product Revenue and Highlights 2025 Corporate Priorities
Day One Biopharmaceuticals (Nasdaq: DAWN) reported preliminary unaudited 2024 net product revenue of approximately $57.2 million for OJEMDA™ (tovorafenib). The fourth-quarter revenue for OJEMDA reached around $29.0 million. The company ended 2024 with approximately $531.7 million in cash, cash equivalents, and short-term investments, a significant increase from $366.3 million at the end of 2023.
OJEMDA received FDA accelerated approval in April 2024, making it the first FDA-approved therapy for relapsed or refractory pediatric low-grade glioma (pLGG) with a BRAF fusion, rearrangement, or BRAF V600 mutation. Additionally, CMS approved OJEMDA exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1%.
Day One advanced its pipeline by progressing the Phase 3 FIREFLY-2 clinical trial and initiating the Phase 1a/b trial for DAY301, a PTK7-targeted ADC. The company entered into an exclusive licensing agreement with Ipsen for tovorafenib commercialization outside the U.S.
For 2025, Day One aims to grow OJEMDA revenue, advance its clinical trials, pursue business development opportunities, and maintain a self-sustaining financial position. Full financial results for Q4 and the full year 2024 will be issued in February 2025.
Day One Biopharmaceuticals (Nasdaq: DAWN) ha riportato un fatturato netto preliminare non sottoposto a revisione del prodotto per il 2024 di circa 57,2 milioni di dollari per OJEMDA™ (tovorafenib). Il fatturato del quarto trimestre per OJEMDA ha raggiunto circa 29,0 milioni di dollari. L'azienda ha chiuso il 2024 con circa 531,7 milioni di dollari in contante, equivalenti di contante e investimenti a breve termine, un incremento significativo rispetto ai 366,3 milioni di dollari alla fine del 2023.
OJEMDA ha ricevuto l'approvazione accelerata dalla FDA nel aprile 2024, diventando la prima terapia approvata dalla FDA per il glioma pediatrico a basso grado (pLGG) recidivante o refrattario con fusione BRAF, riarrangiamento o mutazione BRAF V600. Inoltre, CMS ha approvato OJEMDA esclusivamente per indicazioni pediatriche, riducendo la percentuale minima di rimborso di Medicaid e 340B dal 23,1% al 17,1%.
Day One ha fatto avanzare il suo pipeline proseguendo la sperimentazione clinica di Fase 3 FIREFLY-2 e avviando la sperimentazione di Fase 1a/b per DAY301, un ADC mirato al PTK7. L'azienda ha concluso un accordo di licenza esclusiva con Ipsen per la commercializzazione di tovorafenib al di fuori degli Stati Uniti.
Per il 2025, Day One punta a far crescere il fatturato di OJEMDA, avanzare le sue sperimentazioni cliniche, perseguire opportunità di sviluppo commerciale e mantenere una posizione finanziaria autosufficiente. I risultati finanziari completi per il quarto trimestre e l'intero anno 2024 saranno pubblicati a febbraio 2025.
Day One Biopharmaceuticals (Nasdaq: DAWN) reportó ingresos preliminares no auditados de productos netos de aproximadamente $57.2 millones para OJEMDA™ (tovorafenib) en 2024. Los ingresos del cuarto trimestre para OJEMDA alcanzaron alrededor de $29.0 millones. La compañía cerró 2024 con aproximadamente $531.7 millones en efectivo, equivalentes de efectivo e inversiones a corto plazo, un aumento significativo de $366.3 millones a finales de 2023.
OJEMDA recibió la aprobación acelerada de la FDA en abril de 2024, convirtiéndose en la primera terapia aprobada por la FDA para glioma pediátrico de bajo grado (pLGG) en recaída o refractario con fusión BRAF, reorganización o mutación BRAF V600. Además, CMS aprobó OJEMDA exclusivamente para indicaciones pediátricas, reduciendo su porcentaje mínimo de reembolso de Medicaid y 340B del 23.1% al 17.1%.
Day One avanzó en su pipeline al continuar con el ensayo clínico de Fase 3 FIREFLY-2 e iniciar el ensayo de Fase 1a/b para DAY301, un ADC dirigido a PTK7. La compañía firmó un acuerdo de licencia exclusivo con Ipsen para la comercialización de tovorafenib fuera de los EE. UU.
Para 2025, Day One tiene como objetivo aumentar los ingresos de OJEMDA, avanzar en sus ensayos clínicos, buscar oportunidades de desarrollo comercial y mantener una posición financiera autosostenible. Los resultados financieros completos para el cuarto trimestre y el año completo 2024 se darán a conocer en febrero de 2025.
데이 원 바이오제약 (Nasdaq: DAWN)는 OJEMDA™ (토보라페니브)에 대한 2024년 예비 미감사net 제품 수익이 약 5720만 달러라고 보고했습니다. OJEMDA의 4분기 매출은 약 2900만 달러에 이릅니다. 회사는 2024년을 약 5억 3170만 달러의 현금, 현금 등가물 및 단기 투자로 마감했으며, 이는 2023년 말의 3억 6630만 달러에서 크게 증가한 수치입니다.
OJEMDA는 2024년 4월 FDA의 신속 승인을 받아 BRAF 융합, 재배치 또는 BRAF V600 변이를 동반한 재발 또는 내성 소아 저등급 신경교종(pLGG)을 치료하기 위한 최초의 FDA 승인 요법이 되었습니다. 또한 CMS는 OJEMDA의 소아 적응증에 대해 독점적으로 승인을 내렸으며, Medicaid 및 340B의 최소 리베이트 비율을 23.1%에서 17.1%로 낮추었습니다.
데이 원은 FIREFLY-2 3상 임상 시험을 진행하고 DAY301의 PTK7을 표적한 ADC에 대한 1a/b상 시험을 시작하여 파이프라인을 발전시켰습니다. 회사는 미국 외 지역에서의 토보라페니브 상용화를 위해 Ipsen과 독점 라이선스 계약을 체결했습니다.
2025년을 위해 데이 원은 OJEMDA 수익을 성장시키고, 임상 시험을 진행하며, 비즈니스 개발 기회를 추구하고, 자립적인 재정적 위치를 유지하는 것을 목표로 하고 있습니다. 2024년 4분기 및 전체 연도에 대한 완전한 재무 결과는 2025년 2월에 발표될 예정입니다.
Day One Biopharmaceuticals (Nasdaq: DAWN) a annoncé un revenu net de produits préliminaire non audité d'environ 57,2 millions de dollars pour OJEMDA™ (tovorafenib) pour 2024. Le revenu du quatrième trimestre pour OJEMDA a atteint environ 29,0 millions de dollars. La société a terminé 2024 avec environ 531,7 millions de dollars en liquidités, équivalents de liquidités et investissements à court terme, une augmentation significative par rapport à 366,3 millions de dollars à la fin de 2023.
OJEMDA a reçu une approbation accélérée de la FDA en avril 2024, devenant ainsi la première thérapie approuvée par la FDA pour le gliome pédiatrique de bas grade (pLGG) en rechute ou réfractaire avec fusion BRAF, réarrangement ou mutation BRAF V600. De plus, le CMS a approuvé OJEMDA exclusivement pour les indications pédiatriques, réduisant le pourcentage minimum de remboursement Medicaid et 340B de 23,1 % à 17,1 %.
Day One a fait progresser son portefeuille en poursuivant l'essai clinique de phase 3 FIREFLY-2 et en lançant l'essai de phase 1a/b pour DAY301, un ADC ciblant le PTK7. L'entreprise a conclu un accord de licence exclusif avec Ipsen pour la commercialisation de tovorafenib en dehors des États-Unis.
Pour 2025, Day One vise à accroître les revenus d'OJEMDA, à faire avancer ses essais cliniques, à rechercher des opportunités de développement commercial et à maintenir une position financière autonome. Les résultats financiers complets pour le quatrième trimestre et l'année complète 2024 seront publiés en février 2025.
Day One Biopharmaceuticals (Nasdaq: DAWN) berichtete über vorläufige, nicht geprüfte Nettoprodukterlöse von etwa 57,2 Millionen US-Dollar für OJEMDA™ (Tovorafenib) im Jahr 2024. Die Einnahmen im vierten Quartal für OJEMDA beliefen sich auf rund 29,0 Millionen US-Dollar. Das Unternehmen schloss das Jahr 2024 mit etwa 531,7 Millionen US-Dollar in Bargeld, Geldäquivalenten und kurzfristigen Investitionen, ein erheblicher Anstieg von 366,3 Millionen US-Dollar Ende 2023.
OJEMDA erhielt im April 2024 eine beschleunigte Zulassung von der FDA und wurde damit zur ersten FDA-zugelassenen Therapie für rezidivierende oder refraktäre pädiatrische niedriggradige Gliome (pLGG) mit BRAF-Fusion, -Umstrukturierung oder BRAF V600-Mutation. Darüber hinaus genehmigte CMS OJEMDA ausschließlich für pädiatrische Indikationen, wodurch der Mindestrückerstattungsprozentsatz von Medicaid und 340B von 23,1 % auf 17,1 % gesenkt wurde.
Day One hatte sein Pipeline vorangetrieben, indem es die Phase-3-Studie FIREFLY-2 vorangebracht und die Phase-1a/b-Studie für DAY301, ein auf PTK7 abzielendes ADC, gestartet hat. Das Unternehmen hat einen exklusiven Lizenzvertrag mit Ipsen über die Vermarktung von Tovorafenib außerhalb der USA abgeschlossen.
Für 2025 plant Day One, den Umsatz von OJEMDA zu steigern, seine klinischen Studien voranzutreiben, Geschäftsmöglichkeiten zu verfolgen und eine selbsttragende finanzielle Position aufrechtzuerhalten. Die vollständigen finanziellen Ergebnisse für Q4 und das gesamte Jahr 2024 werden im Februar 2025 veröffentlicht.
- Preliminary 2024 OJEMDA net product revenue of approximately $57.2 million.
- Ended 2024 with $531.7 million in cash, cash equivalents, and short-term investments, up from $366.3 million in 2023.
- OJEMDA received FDA accelerated approval in April 2024.
- CMS reduced Medicaid and 340B rebate percentage for OJEMDA from 23.1% to 17.1%.
- Progress in Phase 3 FIREFLY-2 clinical trial.
- Initiation of Phase 1a/b trial for DAY301.
- Exclusive licensing agreement with Ipsen for tovorafenib commercialization outside the U.S.
- The preliminary net product revenue results are subject to adjustment.
Insights
The preliminary financial results reveal strong commercial execution with
The reduction in Medicaid and 340B rebate percentage from
The company's focus on becoming self-sustaining while pursuing strategic business development suggests a balanced approach to growth and fiscal responsibility, critical for emerging biotech companies in the current market environment.
The clinical development strategy demonstrates thoughtful pipeline expansion beyond OJEMDA. The FIREFLY-2 Phase 3 trial's global footprint with over 100 sites accelerates enrollment potential, though completion in H1 2026 indicates a measured pace typical for rare pediatric indications.
The addition of DAY301, a first-in-class PTK7-targeted ADC, represents a strategic expansion into the high-value ADC space. Clearing the first dose cohort signals early safety, though single-patient accelerated titration requires careful interpretation. The broader development approach targeting both rare pediatric cancers (OJEMDA) and novel ADC technology (DAY301) creates multiple shots on goal with differentiated risk profiles.
Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately
First dose cohort cleared in Phase 1a/b clinical trial of DAY301 (PTK7-targeted ADC)
Ended 2024 with approximately
Company to present at 43rd Annual J.P. Morgan Healthcare Conference today at 3:45 p.m. Pacific Time (6:45 p.m. Eastern Time)
BRISBANE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (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 preliminary unaudited 2024 OJEMDA net product revenue, cash and investments at year-end and delivered business updates ahead of the company’s scheduled presentation today at the 43rd Annual J.P. Morgan Healthcare Conference at 3 :45 p.m. Pacific Time / 6:45 p.m. Eastern Time. A live webcast of the event will be available at ir.dayonebio.com.
“We started 2025 with tremendous momentum based on our 2024 achievements and are well positioned to further our mission,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Our priorities this year are to drive OJEMDA revenue, to continue investing in programs that leverage our expertise in development and commercialization, and to maintain a strong and durable financial position that allows us to operate independently from capital markets.”
Preliminary 2024 Financial Highlights
OJEMDA net product revenues were approximately
The Company’s cash, cash equivalents and short-term investments totaled approximately
2024 Highlights
- OJEMDA received U.S. Food and Drug Administration (FDA) accelerated approval in April 2024. It is the first and only FDA-approved therapy for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
- In December 2024, the Centers for Medicare & Medicaid Services agreed that OJEMDA is approved exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from
23.1% to17.1% .
- In December 2024, the Centers for Medicare & Medicaid Services agreed that OJEMDA is approved exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from
- Progressed enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pLGG with more than 100 sites activated in the United States, Canada, Europe, Australia and Asia.
- The Company expects to complete enrollment of FIREFLY-2 in the first half of 2026.
- The Company expects to complete enrollment of FIREFLY-2 in the first half of 2026.
- Expanded the pipeline with the in-licensing of DAY301 and cleared the first cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the DAY301 Phase 1a/b clinical trial. DAY301 is a potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7.
- Entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S.
2025 Upcoming Priorities and Milestones
- Continue to grow OJEMDA revenue in relapsed or refractory pLGG.
- Advance the existing pipeline, including the FIREFLY-2 Phase 3 clinical trial with tovorafenib in the front-line setting, and DAY301 in the Phase 1a/b trial.
- Pursue business development opportunities to expand the pipeline.
- Maintain a self-sustaining financial position for investing in durable growth.
The 2024 net product revenues and cash, cash equivalents and short-term investments position included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management’s initial analysis of operations for the year ended December 31, 2024. The Company expects to issue full financial results for the fourth-quarter and full-year 2024 in February 2025.
J.P. Morgan Healthcare Presentation Details
Dr. Jeremy Bender, chief executive officer, will present during the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13 at 3:45 p.m. Pacific Time / 6:45 p.m. Eastern Time. A live audio webcast of the presentation will be available by visiting the Events & Presentations section of the Company’s website at www.dayonebio.com. An archived replay of the webcast will be available for 30 days following the live presentation.
About Day One Biopharmaceuticals
Day One Biopharmaceuticals is a commercial-stage company focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, which has left children with cancer and their families waiting too long for new treatments.
At Day One, we aim to identify and develop breakthrough medicines with the goal of improving the outcomes and life trajectories of patients of any age facing serious diseases — starting from Day One. Our “search & development” strategy enables us to find, acquire, and develop potential best-or first-in-class programs with the goal of introducing new medicines that will make a real difference in the treatment of children and adults.
Day One’s pipeline includes tovorafenib (OJEMDA™), DAY301 and a VRK1 inhibitor program. The Company is based in Brisbane, California and can be found online at www.dayonebio.com, 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 ability to grow revenue from OJEMDA, plans to develop and commercialize cancer therapies and its pipeline and statements regarding its net produce revenues, cash, cash equivalents and short-term investments. 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, rising interest rates, instability in the global banking system, 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 MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
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