Syndax Pharmaceuticals (SNDX) Q1 2025 earnings summary

Executive summary

• Achieved $20.0 million in Revuforj net revenue and $13.6 million in Niktimvo net revenue in Q1 2025, reflecting strong commercial execution and high unmet need.

• Revuforj and Niktimvo launched as first-in-class therapies targeting significant U.S. markets in acute leukemia and chronic GVHD.

• Cash, cash equivalents, and investments totaled $602.1 million as of March 31, 2025, supporting operations and pipeline advancement.

• Net loss for Q1 2025 was $84.8 million, up from $72.4 million in Q1 2024, due to increased R&D and SG&A expenses.

• Submitted sNDA for Revuforj in R/R mNPM1 AML and initiated pivotal trials for expanded indications.

Financial highlights

• Q1 2025 total revenue was $20.0 million, all from Revuforj sales; Niktimvo collaboration revenue was $13.6 million, with Syndax recording a $0.2 million share of the collaboration loss.

• Operating expenses rose to $103.8 million in Q1 2025, driven by R&D ($61.6 million) and SG&A ($41.0 million).

• Net loss widened to $84.8 million in Q1 2025 from $72.4 million in Q1 2024.

• Interest income was $7.0 million in Q1 2025; royalty interest expense was $8.0 million.

• Gross margin on Revuforj was high, with cost of goods sold at $0.9 million on $20.0 million revenue.

Outlook and guidance

• FY25 operating expense guidance: $415M–$435M, including $45M in non-cash stock compensation; Q2 2025 R&D plus SG&A projected at $110–$115 million.

• Cash, investments, and anticipated revenue expected to fund operations to profitability.

• Anticipate continued growth in Revuforj and Niktimvo sales, with further market penetration and label expansion.

• Key milestones ahead include sNDA approval for Revuforj in R/R mNPM1 AML and multiple frontline trial initiations.