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- **Revenue Surge**: Q3 revenue up 21% to $45.9 million, driven by Revyforge ($32M, +12%) and Nictimvo ($45.8M, +27%).
- **Market Expansion**: FDA approval triples Revyforge’s addressable population; 50% of usage in second-line KMT2A.
- **Profitability Path**: $456M cash, stable expenses, confident in reaching profitability.
- **Clinical Excellence**: 79% response rate in real-world use, 100% MRD negativity in frontline trials.
- **Growth Drivers**: Post-transplant maintenance to offset transplant pauses; NPM1 launch on track for Q4 acceleration.

**【CEO Opening Remarks】**
- Q3 2025 total revenue of $45.9 million, up 21% quarter-over-quarter, driven by Revyforge and Nictimvo launches. Revyforge net revenue $32 million (12% QoQ growth), Nictimvo collaboration revenue $13.9 million. FDA approval for Revyforge in NPM1 AML triples addressable population; 50% of Revyforge usage in second-line KMT2A. $456 million cash, confident in reaching profitability with current funds.

**【Commercial Progress】**
- **Revyforge**: 25% QoQ growth in prescriptions/new starts; 35%-40% patients restarting post-transplant. 90% of KMT2A usage in second/third-line; 50% of patients proceed to transplant. NPM1 launch: 2,200+ prescriptions in first week, 97% formulary coverage.
- **Nictimvo**: $45.8 million net sales (27% QoQ), 80% of Q1 patients remain on therapy.

**【ASH Presentations】**
- **Revyforge**: 79% overall response rate in real-world KMT2A/NPM1; 86% MRD negativity in KMT2A. Frontline trial: 88% CR in NPM1/KMT2A, 100% MRD negative. Post-transplant maintenance: 100% 1-year EFS in pediatric review.
- **Nictimvo**: Positive safety and efficacy in chronic GVHD combination trials.

**【Financial Results】**
- **Revenue Breakdown**: Revyforge: $32 million (12% QoQ), 25% gross-to-net adjustments. Nictimvo: $13.9 million (27% QoQ), 25%-30% margin contribution.
- **Cash Position**: $456 million, sufficient for commercial and clinical execution.

**【Q&A Highlights】**
- **Lines of Therapy**: Revyforge used earlier in KMT2A (70% second-line), NPM1 expected to follow.
- **Duration of Therapy**: 4-6 months in 2025, 6-12+ in 2026 as post-transplant maintenance grows.
- **Payer Access**: 97% formulary coverage for KMT2A, rapid build for NPM1.
- **Competitive Edge**: Best-in-class efficacy, 1-year first-mover advantage in NPM1.

Syndax Pharmaceuticals, Inc. (SNDX) 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

SNDX

SNDX fundamentals

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