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What were the key takeaways from Day One's earnings call?

- **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

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

DAWN

DAWN fundamentals

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