8-K: Day One Biopharma Reports Strong OJEMDA Revenue, Positive 2026 Outlook

Day One Biopharmaceuticals announced preliminary unaudited 2025 OJEMDA net product revenue of $155.4 million, representing 172% year-over-year growth, and projected 2026 revenue of $225-$250 million.

Summary

• Preliminary unaudited OJEMDA net product revenue for the fourth quarter of 2025 was approximately $52.8 million.
• Preliminary unaudited OJEMDA net product revenue for the full year 2025 was approximately $155.4 million, marking a 172% year-over-year growth compared to 2024.
• OJEMDA prescription volumes increased to 1,394 during Q4 2025, an 11% quarter-over-quarter growth, and 4,635 for the full year 2025, an 181% year-over-year growth.
• Cash, cash equivalents, and short-term investments stood at approximately $441.1 million as of December 31, 2025, prior to the Mersana acquisition.
• The company projects 2026 OJEMDA U.S. net product revenue to be between $225 million and $250 million, representing 53% year-over-year growth at the midpoint.
• Key milestones for 2026 include completing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial for tovorafenib in first-line pLGG in the first half of 2026, providing initial Phase 1a data for DAY301 in the second half of 2026, and delivering Phase 1 clinical data for the Emi-Le program by mid-2026.

Sentiment

Score: 9

Explanation: The filing presents exceptionally strong preliminary revenue growth for OJEMDA, robust 2026 guidance, and a solid cash position. The pipeline is advancing with clear milestones, including expansion into first-line pLGG and progress with two promising ADC programs. The overall outlook is highly positive, indicating strong commercial execution and future growth potential.

Positives

• OJEMDA net product revenue for FY 2025 reached $155.4 million, demonstrating significant 172% year-over-year growth.
• Q4 2025 OJEMDA net product revenue showed strong sequential growth of 37% compared to Q3 2025.
• The company provided robust 2026 OJEMDA U.S. net product revenue guidance of $225-$250 million, indicating continued strong growth of 53% at the midpoint.
• A solid cash position of approximately $441.1 million as of December 31, 2025, provides financial stability for ongoing operations and pipeline development.
• Advancements in the pipeline with expected completion of FIREFLY-2 enrollment in 1H 2026, initial DAY301 Phase 1a data in 2H 2026, and Emi-Le Phase 1 data by mid-2026, signal future growth drivers.
• Three-year follow-up data for OJEMDA in relapsed or refractory pLGG reinforce its durability and growing adoption as a standard of care, with a median duration of response of 19.4 months and median time to next treatment of 42.6 months.

Negatives

• The financial metrics and results presented are preliminary, unaudited, and subject to the completion of the company's financial closing procedures and potential adjustments, which could differ materially from actual results.
• Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from projections.

Risks

• Preliminary financial metrics are estimates, unaudited, and subject to adjustment; actual results may differ materially from these estimates.
• Risks and uncertainties could cause actual results to differ materially from forward-looking statements, including those identified in previous SEC filings.
• The ability to realize the anticipated benefits of the Mersana acquisition, including the possibility that expected benefits will not be realized or within the expected timeframe.
• The risk that the acquired businesses will not be integrated successfully.
• Disruption from the Mersana transaction making it more difficult to maintain business and operational relationships.
• Negative effects of the consummation of the acquisition on the market price of common stock and/or operating results.
• Significant transaction costs and unknown liabilities related to the acquisition.
• The company's ability to develop, obtain, and retain regulatory approval for or commercialize any product candidate.
• The company's ability to protect intellectual property.
• The potential impact of global business or macroeconomic conditions, including inflation, government shutdowns, rising interest rates, instability in the global banking system, and geopolitical conflicts.
• The sufficiency of the company's cash, cash equivalents, and investments to fund its operations.

Future Outlook

The company anticipates continued strong growth for OJEMDA, projecting U.S. net product revenue of $225-$250 million for 2026. Key pipeline advancements include completing enrollment in the pivotal Phase 3 FIREFLY-2 trial for tovorafenib in first-line pLGG in the first half of 2026, with topline data expected mid-2027 and potential approval in 2028. Initial Phase 1a data for DAY301 is expected in the second half of 2026, and Phase 1 clinical data for the Emi-Le program is anticipated by mid-2026, with a path toward registration.

Management Comments

• Jeremy Bender, Ph.D., chief executive officer, stated, "Following remarkable commercial and clinical progress in 2025 and the strategic acquisition of Mersana and our new pipeline program Emi-Le (emiltatug ledadotin), we're entering 2026 poised to deliver on our mission and on our growth aspirations."
• Bender also expressed, "I'm thrilled by the steady uptake of OJEMDA in relapsed or refractory pLGG, and by the opportunities for future patient impact we expect from the clinical data for OJEMDA in front line pLGG and for Emi-Le and DAY301."
• Bender further commented, "Our solid financial position will continue to enable us to invest in future programs that have strong potential to become important new medicines."

Industry Context

Day One Biopharmaceuticals operates in the specialized field of pediatric oncology and rare cancers, addressing significant unmet needs. OJEMDA's success in relapsed or refractory pediatric low-grade glioma (pLGG) positions it as a standard of care, with expansion into first-line pLGG expected to double its market opportunity. The company's strategic acquisition of Mersana Therapeutics and its Emi-Le program, along with the development of DAY301, reflects a broader industry trend towards targeted therapies and antibody-drug conjugates (ADCs) for difficult-to-treat cancers like adenoid cystic carcinoma (ACC) and various solid tumors.

Comparison to Industry Standards

• OJEMDA's 172% year-over-year revenue growth in 2025 and projected 53% growth in 2026 are indicative of strong market penetration and adoption, particularly for a therapy in a niche pediatric oncology market, often outperforming typical growth rates for established drugs.
• The median duration of response of 19.4 months and median time to next treatment of 42.6 months for OJEMDA in FIREFLY-1 are highly competitive and reinforce its role as a durable treatment option in relapsed or refractory pLGG, a disease with historically limited therapeutic options.
• The expansion of OJEMDA into first-line pLGG, which is estimated to double the addressable market from ~1,100 to ~2,200 annual treatment decisions, aligns with successful strategies seen in other oncology markets where effective therapies move earlier into the treatment paradigm.
• The development of Emi-Le (B7-H4-targeted ADC for ACC) and DAY301 (PTK7-targeted ADC for solid tumors) positions Day One in the rapidly evolving ADC space, which has seen significant investment and clinical success from companies like Seagen (now part of Pfizer) with ADCETRIS and ENHERTU, and Gilead Sciences with Trodelvy, indicating a high-value, high-potential area of oncology drug development.

Stakeholder Impact

• Shareholders: Positive impact due to strong revenue growth, optimistic future guidance, and advancing pipeline, potentially leading to increased share value.
• Patients: Positive impact through the continued availability and expanded use of OJEMDA for pLGG, and the development of new targeted therapies (Emi-Le, DAY301) for other life-threatening diseases.
• Employees: Positive impact from company growth and pipeline expansion, potentially leading to job security and new opportunities.
• Customers (Healthcare Providers): Continued confidence in OJEMDA as a standard of care, supported by durable clinical data and ongoing commercial support.
• Partners (Ipsen): Positive outlook for global expansion of OJEMDA, reinforcing the value of their licensing agreement.

Next Steps

• Deliver on 2026 OJEMDA net product revenue guidance.
• Increase OJEMDA persistency and drive new patient starts to support continued adoption as standard of care in 2L pediatric low-grade glioma (pLGG).
• Extend OJEMDA commercial opportunity beyond the U.S. with global expansions via Ipsen.
• Complete enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pLGG in the first half of 2026.
• Provide initial data from the Phase 1a clinical trial for DAY301 in the second half of 2026.
• Advance the Emi-Le program by delivering Phase 1 clinical data by mid-2026 and progressing toward registration.
• Issue full financial results for the fourth-quarter and full-year 2025 in February 2026.
• Submit 3-year follow-up data publication for BRAF-altered relapsed pLGG in Q1 2026.
• Await EMA regulatory decision for tovorafenib in 2026.
• Anticipate mid-2027 data readout for FIREFLY-2 and potential approval in 2028.

Key Dates

Recommendation

The filing demonstrates exceptional commercial momentum for OJEMDA, with preliminary 2025 revenue significantly exceeding prior year performance and robust 2026 guidance. The company's strong cash position provides ample runway for continued investment in a promising pipeline, including the expansion of OJEMDA into first-line pLGG and the advancement of two high-potential ADC programs. These factors, combined with positive clinical data reinforcing OJEMDA's efficacy and durability, suggest a strong growth trajectory and significant upside potential for investors.

Keywords

Biopharmaceuticals, Pediatric Oncology, OJEMDA, Tovorafenib, pLGG, Low-Grade Glioma, BRAF Alteration, Antibody Drug Conjugate, ADC, Emi-Le, DAY301, Adenoid Cystic Carcinoma, ACC, Clinical Trials, Financial Results, Revenue Guidance, Biotech