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Mar 31
Syndax Q1 2025 Earnings Report
Reported first quarter 2025 financial results and provided business update
Key Takeaways
Syndax Pharmaceuticals reported a combined $34 million in net sales for its products Revuforj and Niktimvo in the first quarter of 2025. Revuforj, in its first full quarter of launch, generated $20.0 million in net revenue, while Niktimvo, in its first partial quarter, generated $13.6 million in net revenue reported by Incyte. The company ended the quarter with $602.1 million in cash, cash equivalents, and investments, which is expected to fund operations to profitability.
Revuforj achieved $20.0 million in net revenue in its first full quarter of U.S. launch.
Niktimvo, reported by Incyte, achieved $13.6 million in net revenue in its first partial quarter of U.S. launch.
Syndax submitted a supplemental New Drug Application (sNDA) for revumenib in R/R mutant NPM1 (mNPM1) AML.
The company initiated a pivotal frontline trial of revumenib plus venetoclax and azacitidine in mNPM1 and KMT2Ar AML.
Syndax held $602.1 million in cash, cash equivalents, and investments as of March 31, 2025.
Syndax
Syndax
Syndax Revenue by Segment
Revenue by Segment
Revuforj Revenue
CapyFin.comNiktimvo (Incyte reported) Revenue
CapyFin.com Forward Guidance
For the second quarter of 2025, Syndax expects research and development expenses to be between $70 million and $75 million, and total research and development plus selling, general and administrative expenses to be between $110 million and $115 million. For the full year 2025, the company maintains its guidance for research and development expenses of $260 million to $280 million and total research and development plus selling, general and administrative expenses of $415 million to $435 million, which includes an estimated $45 million in non-cash stock compensation expense. Syndax anticipates that its current cash position, anticipated product revenue, and interest income will enable the company to achieve profitability.
Positive Outlook
- Expected to reach profitability with current cash and future revenue.
- Continued strong sales performance anticipated for Revuforj and Niktimvo.
- Advancement of pipeline with sNDA submission for revumenib in R/R mNPM1 AML.
- Initiation of pivotal frontline trial for revumenib in mNPM1 and KMT2Ar AML.
- Multiple ongoing trials evaluating revumenib and axatilimab across various indications.
Challenges Ahead
- Significant increase in R&D expenses expected in Q2 2025.
- Increase in total operating expenses projected for Q2 and full year 2025.
- No specific revenue guidance provided at this time.
- Collaboration with Incyte for Niktimvo resulted in a net commercial loss for Syndax in the first quarter.
- Increased expenses related to commercial launch activities for both products.
Revenue & Expenses
Visualization of income flow from segment revenue to net income