Day One Reports Third Quarter 2024 Financial Results and Corporate Progress
Day One Biopharmaceuticals reported strong Q3 2024 financial results, with OJEMDA net product revenue reaching $20.1 million, a 145% increase from Q2 2024. Quarterly prescriptions grew 159% to 619. The company reported net income of $37.0 million and ended the quarter with $558.4 million in cash and equivalents. Key highlights include a licensing agreement with Ipsen for ex-U.S. commercialization of tovorafenib, bringing $111 million upfront with potential additional milestones of $350 million. Updated data from the FIREFLY-1 trial showed an 18-month median duration of response for tovorafenib in pLGG patients.
Day One Biopharmaceuticals ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con il fatturato netto da prodotto OJEMDA che ha raggiunto 20,1 milioni di dollari, un incremento del 145% rispetto al secondo trimestre del 2024. Le prescrizioni trimestrali sono aumentate del 159%, arrivando a 619. L'azienda ha riportato un reddito netto di 37,0 milioni di dollari e ha chiuso il trimestre con 558,4 milioni di dollari in liquidità e equivalenti. Tra i punti salienti c'è un accordo di licenza con Ipsen per la commercializzazione al di fuori degli Stati Uniti di tovorafenib, che porta un pagamento iniziale di 111 milioni di dollari con potenziali ulteriori traguardi di 350 milioni di dollari. I dati aggiornati dello studio FIREFLY-1 hanno mostrato una durata mediana della risposta di 18 mesi per tovorafenib nei pazienti con pLGG.
Day One Biopharmaceuticals informó sobre resultados financieros sólidos para el tercer trimestre de 2024, con los ingresos netos del producto OJEMDA alcanzando los 20,1 millones de dólares, un aumento del 145% con respecto al segundo trimestre de 2024. Las recetas trimestrales crecieron un 159%, alcanzando 619. La compañía reportó un ingreso neto de 37,0 millones de dólares y finalizó el trimestre con 558,4 millones de dólares en efectivo y equivalentes. Los aspectos destacados incluyen un acuerdo de licencia con Ipsen para la comercialización de tovorafenib fuera de EE. UU., lo que brinda 111 millones de dólares por adelantado con hitos adicionales potenciales de 350 millones de dólares. Los datos actualizados del ensayo FIREFLY-1 mostraron una duración media de respuesta de 18 meses para tovorafenib en pacientes con pLGG.
Day One Biopharmaceuticals는 2024년 3분기 강력한 재무 결과를 보고했으며, OJEMDA 순제품 수익은 2010만 달러에 도달하여 2024년 2분기 대비 145% 증가했습니다. 분기별 처방이 159% 증가하여 619건에 달했습니다. 이 회사는 3700만 달러의 순이익을 보고했으며, 5억5840만 달러의 현금 및 현금 등가물로 분기를 마감했습니다. 주요 내용으로는 Ipsen과의 계약이 포함되어 있으며, 이는 미국 외에서 tovorafenib을 상용화할 수 있게 해 주며, 1억1100만 달러의 선불금과 3억5000만 달러의 추가 마일스톤이 가능하다는 것입니다. FIREFLY-1 시험의 업데이트된 데이터는 pLGG 환자에서 tovorafenib의 반응 지속 시간이 18개월임을 보여주었습니다.
Day One Biopharmaceuticals a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec un chiffre d'affaires net du produit OJEMDA atteignant 20,1 millions de dollars, soit une augmentation de 145 % par rapport au deuxième trimestre 2024. Les prescriptions trimestrielles ont crû de 159 % pour atteindre 619. L'entreprise a déclaré un revenu net de 37,0 millions de dollars et a terminé le trimestre avec 558,4 millions de dollars en liquidités et équivalents. Parmi les faits marquants, on note un contrat de licence avec Ipsen pour la commercialisation de tovorafenib en dehors des États-Unis, apportant 111 millions de dollars initiaux avec des jalons supplémentaires potentiels de 350 millions de dollars. Les données mises à jour de l'essai FIREFLY-1 ont montré une durée médiane de réponse de 18 mois pour tovorafenib chez les patients atteints de pLGG.
Day One Biopharmaceuticals hat starke Finanzdaten für das dritte Quartal 2024 veröffentlicht, mit einem netto Produktumsatz von OJEMDA, der 20,1 Millionen Dollar erreicht, was einem Anstieg von 145% im Vergleich zum zweiten Quartal 2024 entspricht. Die vierteljährlichen Rezepte stiegen um 159% auf 619. Das Unternehmen meldete einen Nettogewinn von 37,0 Millionen Dollar und schloss das Quartal mit 558,4 Millionen Dollar in bar und Äquivalenten ab. Zu den wichtigsten Highlights gehört ein Lizenzvertrag mit Ipsen für die Vermarktung von tovorafenib außerhalb der USA, der 111 Millionen Dollar im Voraus bringt und potenzielle zusätzliche Meilensteine von 350 Millionen Dollar umfasst. Aktualisierte Daten aus der FIREFLY-1-Studie zeigten eine mediane Ansprechdauer von 18 Monaten für tovorafenib bei pLGG-Patienten.
- OJEMDA revenue grew 145% quarter-over-quarter to $20.1M
- Quarterly prescriptions increased 159% to 619
- Secured $111M upfront payment from Ipsen licensing deal
- Strong cash position of $558.4M
- Achieved net income of $37.0M in Q3 2024
- 18-month median duration of response in FIREFLY-1 trial
- R&D expenses increased to $33.6M from $33.2M YoY
- SG&A expenses rose to $29.0M from $18.3M YoY
Insights
Day One Biopharmaceuticals delivered a strong Q3 performance with multiple positive financial indicators.
- A
$111M upfront payment from Ipsen licensing deal - An oversubscribed
$175M private placement $73.7M in license revenue from ex-U.S. rights sale
The company's transition to profitability with
The clinical progress of OJEMDA in pediatric low-grade glioma (pLGG) shows promising durability with an 18-month median response duration in the FIREFLY-1 trial. The ongoing Phase 3 FIREFLY-2/LOGGIC trial's expansion to over 100 sites globally demonstrates strong investigator interest and potential for front-line therapy adoption. The advancement of DAY301, a first-in-class PTK7-targeted ADC, into clinical trials diversifies the pipeline beyond OJEMDA. The upcoming quality of life data presentation at SNO could further strengthen OJEMDA's clinical profile and support broader adoption.
Achieved
Ended the third quarter with
Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time
BRISBANE, Calif., Oct. 30, 2024 (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 third quarter 2024 financial results and highlighted recent corporate achievements.
“Our third quarter results demonstrate continued patient demand for OJEMDA, driven by the need for new therapies for children living with pediatric low-grade glioma,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Looking ahead to 2025, we plan to continue to drive growth by advancing our programs and pipeline, including DAY301, a potential first-in-class ADC targeting PTK7 that we expect to be in the clinic in the coming months.”
Program Highlights
- Strong growth in OJEMDA net revenue with
$20.1M in the third quarter of 2024, representing a145% increase over the second quarter of 2024. - Quarterly prescriptions (TRx) grew to 619 in the third quarter of 2024, representing a
159% increase over the second quarter of 2024. - Day One expects to dose the first patient in the Phase 1a portion of the Phase 1a/b clinical trial of DAY301 by the end of 2024 or in the first quarter of 2025.
- Day One provided updated duration of response data from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG. For the 77 patients enrolled on Arm 1, which was the dataset used to assess OJEMDA’s efficacy, the median duration of response is 18 months.
- The pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pLGG continues to enroll patients in the United States, Canada, Europe, Australia and Asia, with more than 100 sites activated.
Corporate Highlights and Upcoming Milestones
- Day One and Ipsen entered into an exclusive licensing agreement to commercialize tovorafenib outside of the U.S. in July 2024. Under the agreement, Day One received approximately
$111 million upfront in cash and equity investment at a premium with up to approximately$350 million in additional launch and sales milestone payments as well as tiered double-digit royalties starting at mid-teens percentage on net sales. - Day One entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately
$175 million in July 2024.
Third Quarter 2024 Financial Highlights
- Product Revenue, Net: OJEMDA net product revenues were
$20.1 million for the third quarter of 2024, the first full quarter of the U.S. launch. - License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was
$73.7 million for the third quarter of 2024. - R&D Expenses: Research and development expenses were
$33.6 million for the third quarter of 2024 compared to$33.2 million for the third quarter of 2023. The increase was primarily due to the clinical trial activities related to tovorafenib and additional employee compensation costs. - SG&A Expenses: Selling, general and administrative expenses were
$29.0 million for the third quarter of 2024 compared to$18.3 million for the third quarter of 2023. The increase was primarily due to employee compensation costs, commercial launch activities, and professional service expenses to support the launch of OJEMDA. - Net Income/Loss: Net income totaled
$37.0 million for the third quarter of 2024 with non-cash stock-based compensation expense of$11.6 million , compared to a net loss of$46.2 million for the third quarter of 2023, with non-cash stock-based compensation expense of$9.6 million . - Cash Position: The Company’s cash, cash equivalents and short-term investments totaled
$558.4 million as of September 30, 2024.
Upcoming Events
- Two posters on health-related quality of life and drug holiday from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG will be presented at the Society for Neuro-Oncology Annual Meeting on November 22, 2024.
- Piper Sandler 36th Annual Healthcare Conference, December 3-5, 2024.
Conference Call
Day One will host a conference call and webcast today, October 30 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 Investors & Media 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, 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 Biopharmaceuticals, Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) (unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue: | |||||||||||||||
| Product revenue, net | $ | 20,070 | $ | — | $ | 28,262 | $ | — | |||||||
| License revenue | 73,691 | — | 73,691 | — | |||||||||||
| Total revenues | 93,761 | — | 101,953 | — | |||||||||||
| Cost and operating expenses: | |||||||||||||||
| Cost of product revenue | 1,590 | — | 2,297 | — | |||||||||||
| Research and development | 33,563 | 33,163 | 165,879 | 93,173 | |||||||||||
| Selling, general and administrative | 28,972 | 18,275 | 85,715 | 53,374 | |||||||||||
| Total cost and operating expenses | 64,125 | 51,438 | 253,891 | 146,547 | |||||||||||
| Income (loss) from operations | 29,636 | (51,438 | ) | (151,938 | ) | (146,547 | ) | ||||||||
| Non-operating income: | |||||||||||||||
| Gain from sale of priority review voucher | — | — | 108,000 | — | |||||||||||
| Investment income, net | 5,322 | 5,291 | 13,649 | 12,163 | |||||||||||
| Other income (expense), net | 1,197 | (3 | ) | 1,177 | (22 | ) | |||||||||
| Total non-operating income, net | 6,519 | 5,288 | 122,826 | 12,141 | |||||||||||
| Income (loss) before income taxes | 36,155 | (46,150 | ) | (29,112 | ) | (134,406 | ) | ||||||||
| Income tax benefit (expense) | 882 | — | (670 | ) | — | ||||||||||
| Net income (loss) | 37,037 | (46,150 | ) | (29,782 | ) | (134,406 | ) | ||||||||
| Net income (loss) per share - basic | $ | 0.38 | $ | (0.54 | ) | $ | (0.33 | ) | $ | (1.73 | ) | ||||
| Net income (loss) per share - diluted | $ | 0.38 | $ | (0.54 | ) | $ | (0.33 | ) | $ | (1.73 | ) | ||||
| Weighted-average number of common shares used in net income (loss) per share - basic | 96,623,123 | 85,952,501 | 90,164,895 | 77,682,237 | |||||||||||
| Weighted-average number of common shares used in net income (loss) per share - diluted | 96,937,759 | 85,952,501 | 90,164,895 | 77,682,237 | |||||||||||
| Day One Biopharmaceuticals, Inc. Selected Condensed Balance Sheet Data (in thousands) (unaudited) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and short-term investments | $ | 558,383 | $ | 366,347 | |||
| Total assets | 600,807 | 376,048 | |||||
| Total liabilities | 45,344 | 29,508 | |||||
| Accumulated deficit | (488,367 | ) | (458,585 | ) | |||
| Total stockholders’ equity | 555,463 | 346,540 | |||||
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
FAQ
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