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- **OJEMDA Dominance**: 172% YoY revenue growth ($155.4M in 2025) and 180% prescription growth highlight OJEMDA's rapid adoption in pLGG.
- **3-Year Data Strength**: 53% ORR and 19.4-month median response duration validate OJEMDA's durability and safety, positioning it for front-line trials.
- **Pipeline Expansion**: Emi-Le (ACC) shows promise for accelerated approval, while DAY301 advances in PTK7-expressing cancers.
- **Financial Fortitude**: $441M cash position and scalable model support 2026 guidance of $225-250M OJEMDA revenue.

**【CEO Summary Section】**
- Day One Biopharmaceuticals reported $155.4 million in net product revenue for 2025, up 172% year-over-year, driven by OJEMDA's launch in pediatric low-grade glioma (pLGG). Q4 revenue reached $52.8 million, a 37% sequential increase.
- OJEMDA achieved 4,600 total prescriptions in 2025, up 180% from 2024, with 1,300 prescriptions in Q4 despite seasonal impacts.
- 3-year FIREFLY-1 data showed durable responses (53% ORR, median 19.4 months) and manageable safety profile, supporting OJEMDA as a standard of care in second-line pLGG.
- 2026 OJEMDA net product revenue guidance reiterates $225 million to $250 million, reflecting confidence in growth and persistence optimization.

**【CFO Financial Commentary】**
- Full-year 2025 gross product revenue exceeded combined cost of sales and SG&A, highlighting scalability of operating model.
- Cash position of $441 million at year-end (excluding Mersana acquisition) supports pipeline advancement and commercial growth.
- Gross to net rate remained stable at 12-15%, with disciplined channel management and 2-4 weeks of days on hand.
- Operating expenses decreased 17% year-over-year to $286 million, driven by reduced one-time costs.

**【Q&A Key Highlights】**
- **OJEMDA Persistency**: Median duration of therapy trends at 19 months; focus on improving persistency through dose adjustment education, patient support programs, and targeting earlier-line relapsed/refractory patients.
- **Emi-Le (ACC Program)**: Mid-2026 data expected to support accelerated regulatory path; Phase I signals antitumor activity and manageable safety profile in aggressive ACC, a rare disease with no approved therapies.
- **DAY301 Development**: Early clinical activity observed in PTK7-expressing cancers; Phase I dose escalation ongoing with potential expansion into additional indications.
- **Pipeline Strategy**: Emphasis on high-impact, differentiated programs with clear clinical need and regulatory pathways, exemplified by Mersana acquisition.

Day One Biopharmaceuticals, Inc.(DAWN)-20260225-2025 Q4 Earnings call transcript

- **Revenue Growth Accelerates**: Q3 net product revenue up 15% QoQ to $38.5 million, with full year guidance raised to $145-150 million.
- **Clinical Data Drives Adoption**: 2-year FIREFLY-1 data boosts new patient starts, while 3-year data to highlight long-term outcomes at SNO.
- **Financial Strength**: Gross to net at 15%, cash reserves of $451.6 million, and 9% YoY expense decline reflect operational discipline.
- **Pipeline Momentum**: OJEMDA poised for European launch, FIREFLY-2 on track for frontline trial completion, and DAY301 advancing in Phase I.

**【CEO Summary Section】**
- Q3 2025 net product revenue reached $38.5 million, a 15% quarter-over-quarter increase, driven by new patient starts and treatment persistence.
- 2-year FIREFLY-1 data demonstrated reversible growth velocity delays and a median duration of response of 18 months, enhancing physician confidence.
- Full year 2025 revenue guidance updated to $145 million to $150 million, reflecting strong momentum and double-digit sequential growth expectations.
- Pipeline advancements include Ipsen's anticipated EMA approval for OJEMDA in Europe and the Phase III FIREFLY-2 trial on track for enrollment completion in H1 2026.

**【CFO Financial Commentary】**
- Q3 net product revenue of $38.5 million exceeded cost of sales and SG&A, marking a milestone in scalability.
- Total operating expenses decreased 9% YoY to $59.6 million, with disciplined cost management.
- Gross to net rate at 15% for Q3, elevated due to a July price increase impacting Medicaid rebates.
- Cash reserves of $451.6 million support ongoing commercial and pipeline investments.

**【Q&A Highlights】**
- **Treatment Duration & Persistence**: EAP patients showed a median 20-month treatment duration, with 75% continuing beyond 24 months. Commercial patients' persistence data is maturing but aligns with expectations.
- **3-Year FIREFLY-1 Data**: Focus on time to next treatment and tumor rebound post-therapy; 3-year data to be presented at SNO, highlighting long-term safety and efficacy.
- **Pipeline Updates**: DAY301 Phase Ia trial progressing with no significant safety concerns; FIREFLY-2 trial design maintains primary endpoints despite crossover flexibility.
- **Payer Access**: 90%+ first-fill approval rate supports rapid patient access, though off-label use dynamics remain physician-driven.

Day One Biopharmaceuticals, Inc. (DAWN) Q3 2025 Earnings Call Transcript

- **Revenue Milestone**: Q2 2025 net revenue of $33.6M (+10% QoQ), surpassing 1,000 scripts for the first time.
- **Guidance Confidence**: Full-year 2025 target of $140-150M reflects 150% YoY growth, driven by new patient starts and 2-year efficacy data.
- **Payer Strength**: 95% of patients covered by insurance, minimizing financial barriers.
- **Pipeline Momentum**: DAY301 ADC in Phase I, FIREFLY-2 trial on track, and $453M cash to fuel growth.
- **Strategic Focus**: Europe expansion via Ipsen, AI-driven commercial optimization, and disciplined cost management.

**【CEO Opening Remarks】**
- OJEMDA achieved $113.1M in cumulative net revenue over 12 months, surpassing expectations.
- Q2 2025 net product revenue: $33.6M (10% QoQ growth), with >1,000 scripts for the first time.
- Full-year 2025 guidance: $140-150M net revenue, driven by new patient starts and persistence.
- Strategic priorities: Expand OJEMDA in Europe via Ipsen's MAA filing, advance DAY301 ADC, and optimize portfolio.

**【CFO Financial Commentary】**
- Q2 2025: $33.6M net product revenue, $64.1M year-to-date, $113.1M trailing 12-months.
- Guidance assumptions: 150% YoY growth, 12-15% gross-to-net, stable channel stock (2-4 weeks).
- Cost control: $68.9M Q2 expenses (-5% QoQ), $453M cash balance, no debt.

**【Commercial Update】**
- 15% QoQ script growth, 95% payer coverage, <5% free drug utilization.
- 60%+ accounts prescribing >1 patient, 20%+ accounts >5 patients.
- ASCO 2025 data on 2-year growth velocity recovery and rash management drove Q2 script ramp-up.
- 3-year follow-up data expected Q4 2025 to further validate long-term efficacy.

**【Pipeline Progress】**
- DAY301 ADC: Phase Ia dose escalation ongoing, targeting PTK7 in solid tumors.
- FIREFLY-2 frontline trial: On track for 2026 enrollment completion.
- VRK1 program discontinued to refocus resources on high-priority assets.

**【Q&A Highlights】**
- Growth drivers: New patient starts (+15% QoQ) and 2-year data-driven persistence.
- ASCO 2025 rash management data reduced dropout risk, supporting 2-year treatment intent.
- DAY301: Phase I safety/tolerability data expected H2 2025, benchmarking against PTK7 competitors.
- 3-year data expected to reinforce OJEMDA as standard of care in relapsed/refractory pLGG.

Day One Biopharmaceuticals, Inc. (DAWN) Q2 2025 Earnings Call Transcript

- **Q1 Revenue Growth**: OJEMDA net revenue up 11% QoQ to $30.5M, driven by 16% script growth and 2,500+ total prescriptions.
- **Pipeline Momentum**: FIREFLY-2 on track for H1 2026 enrollment; DAY301 advancing in adult solid tumors with PTK7 targeting.
- **Financial Strength**: $473M cash balance, 4% QoQ expense decline, and stable gross-to-net rate support long-term growth.
- **Strategic Focus**: Establish OJEMDA as 2nd-line standard, deepen prescriber adoption, and evaluate high-impact portfolio additions.

**【CEO Summary Section】**
- Q1 2025 net product revenue for OJEMDA reached $30.5 million, up 11% QoQ, driven by 16% script growth to over 900 quarterly scripts.
- OJEMDA adoption continues in relapsed/refractory pLGG, with 2,500+ total prescriptions since launch and high patient retention rates.
- Pipeline progress: FIREFLY-2 trial on track for full enrollment in H1 2026; DAY301 Phase Ia dose escalation ongoing across adult solid tumors.
- 2025 priorities: Establish OJEMDA as 2nd-line standard, advance clinical pipeline, and evaluate strategic portfolio expansion.

**【CFO Financial Commentary】**
- Q1 2025 operating expenses (excluding cost of sales) were $68.9 million, down 4% QoQ (excluding one-time $20M charge), reflecting disciplined cost management.
- Gross-to-net rate remained stable at ~12-15%, with $473 million cash balance and no debt, providing financial flexibility.
- No immediate financing needs projected, with focus on strategic investments in growth and clinical development.

**【Q&A Key Takeaways】**
- **Patient Duration**: OJEMDA showing consistent retention rates similar to FIREFLY-1 data, with April 2025 marking strongest month for new patient starts.
- **Market Penetration**: 100% of priority 1 accounts have prescribed OJEMDA post-approval; focus shifting to deepening usage in current prescribers.
- **Pipeline Updates**: DAY301 targeting PTK7+ solid tumors; FIREFLY-2 expected to drive frontline pLGG expansion.
- **Business Development**: Actively evaluating high-bar opportunities to expand clinical portfolio, with no immediate asset acquisition plans.

Day One Biopharmaceuticals (DAWN)-6 May 25-2025 Q1 Earnings call transcript

- **OJEMDA Commercial Success**: $57M annual revenue in first 8 months, Q4 2024 sales up 44% to $29M. 1,600+ prescriptions and 280 active patients highlight strong adoption. 
- **Pipeline Momentum**: DAY301 Phase Ia clearing 1st dose cohort; FIREFLY-2 trial on track for H1 2026 enrollment. 
- **Financial Strength**: $531M cash balance supports growth without external financing. CMS pediatric exclusivity reduces gross to net to ~12-15%. 
- **2025 Focus**: Expand OJEMDA prescriber depth, advance clinical trials, and pursue strategic acquisitions.

**【CEO Summary Section】**
- OJEMDA FDA approved for relapsed/refractory pediatric low-grade glioma (pLGG) in April 2024, generating $57M in net product revenue for the year (8 months of sales). Q4 2024 revenue: $29M (44% QoQ growth). 
- 1,600+ total prescriptions by end-2024, with 280 active patients on therapy. New patient starts grew double-digit QoQ. 
- 2025 priorities: 1) Expand OJEMDA prescriber base and patient access; 2) Enroll FIREFLY-2 frontline pLGG trial (targeting H1 2026 completion); 3) Acquire/diligence new pipeline assets. 
- $531M cash balance at year-end, enabling capital allocation for growth without external financing.

**【CFO Financial Commentary】**
- 2024 total revenue: $131.2M (includes $57.2M OJEMDA net sales + $73.9M Ipsen license revenue). 
- Q4 2024 net product revenue: $29M (44% QoQ growth). FY24 gross to net improved 600bps to 17.1% due to CMS pediatric exclusivity designation. 
- Operating expenses: $343.2M (2023: $206.1M), driven by OJEMDA launch costs and R&D investment (e.g., $20M DAY301 in-license fee). 
- 2025 named patient program revenue eliminated ($3M/yr), replaced by Ipsen-managed access programs.

**【Q&A Highlights】**
1. **OJEMDA Growth Outlook**: 
- 2025 focus on expanding prescriber depth (Priority 1-3 accounts) and establishing 2nd-line use. Anticipate steady, linear patient start growth (~double-digit QoQ). 
- CMS pediatric exclusivity reduces gross to net to ~12-15%, supporting margin expansion. 
- Channel inventory stable at 2-4 weeks, no material stocking impact in Q4. 

2. **Pipeline Updates**: 
- DAY301 (PTK7 ADC): Phase Ia dose escalation clearing 1st cohort, now enrolling 2nd. Differentiated by exatecan payload and 8:1 DAR ratio. Potential 1st-in-class ADC for PTK7. 
- FIREFLY-2: 110+ global sites open, targeting H1 2026 enrollment completion. 

3. **Strategic Priorities**: 
- Maintain $500M+ cash position to fund internal growth and external opportunities. 
- Focus on acquiring first/best-in-class assets in pediatric and adult oncology. 
- Leverage Ipsen partnership to expand OJEMDA ex-US access (pending regulatory approvals).

Actual	-5.04	-0.33	-0.345	-0.48	-0.6	-0.53	-0.56	-0.59	-0.61	-0.54	-0.63	-0.72	-0.05	0.38	-0.63	-0.35	-0.29	-0.19	-0.21
Forecast	-0.315	-0.2806	-0.35	-0.385	-0.4875	-0.5226	-0.5527	-0.593	-0.6143	-0.5857	-0.5744	-0.6631	-0.7508	-0.3156	-0.3625	-0.4379	-0.3565	-0.2969	-0.1489
Surprise	-1500.00%	-17.61%	+1.43%	-24.68%	-23.08%	-1.42%	-1.32%	+0.51%	+0.70%	+7.80%	-9.68%	-8.58%	+93.34%	+220.41%	-73.79%	+20.07%	+18.65%	+36.01%	-41.03%

Actual	0	0	0	0	0	0	0	0	0	0	0	0	8.19M	93.76M	29.20M	30.76M	33.91M	39.80M	53.71M
Forecast	0	0	0	0	0	0	0	0	0	0	0	0	1.03M	28.48M	27.83M	30.27M	34.93M	37.82M	49.85M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	+698.25%	+229.17%	+4.92%	+1.63%	-2.93%	+5.21%	+7.75%

DAWN

DAWN fundamentals

DAWN Q4 2025 Earnings

Earnings Call

You can ask Aime

DAWN

DAWN fundamentals

DAWN Q4 2025 Earnings

Earnings Call

DAWN Earnings Call Summary for Q4/20254:30 PM on Feb 24, 2026

DAWN Earnings Call Summary for Q3/20254:30 PM on Nov 4, 2025

DAWN Earnings Call Summary for Q2/20254:30 PM on Aug 5, 2025

DAWN Earnings Call Summary for Q1/20254:30 PM on May 6, 2025

DAWN Earnings Call Summary for Q4/20244:30 PM on Feb 25, 2025

You can ask Aime