Syndax Pharmaceuticals Inc Q4 FY2024 earnings call

• FDA approval of two first-in-class medicines in 2024, including Revuforj for relapsed/refractory acute leukemia patients with a KMT2A translocation and Niktimvo for chronic GVHD.
• Revuforj had $7.7 million net revenue in Q4 2024 from the initial five weeks of launch, with early positive trends in prescribing and payer coverage.
• Niktimvo launched in late January, with early interest shown at conferences like Tandem.
• Clinical development progress for revumenib, including plans to file a supplemental new drug application for relapsed or refractory mutant NPM1 AML in Q2 and advance frontline trials.
• Strong financial position with $692.4 million in cash, equivalents, and investments as of year-end, with expected R&D and SG&A expenses for 2025.

In the fourth quarter of 2024, Revuforj generated $7.7 million in net revenue from the initial five weeks of its launch. Revuforj is a first-in-class menin inhibitor for relapsed/refractory acute leukemia patients with a KMT2A translocation. Niktimvo, launched in partnership with Incyte in late January for chronic Graft versus Host Disease, is in early stages of its launch. The company received $350 million upfront from Royalty Pharma in exchange for a capped royalty on US net sales of Niktimvo.

• For Q1 2025, R&D expenses expected to be $65 million to $70 million, total R&D plus SG&A expenses $105 million to $110 million.
• For full year 2025, R&D expenses expected to be $260 million to $280 million, total R&D plus SG&A expenses $415 million to $435 million (includes ~$45 million non-cash stock compensation).
• No revenue guidance provided at this time.
• Recognition of revenue for Niktimvo will be 50% of net commercial profit, with upfront $350 million from Royalty Pharma classified as a liability.

Actual results may differ materially from forward-looking statements due to various factors including those discussed in the Risk Factors section of the company's most recent Form 10-K and other SEC filings.

Q: Regarding Revuforj, how to think about inventory levels throughout 2025 and penetration into accounts?

A: Inventory levels expected to be similar to other specialty launches, with limited distribution channel keeping inventory at 2-3 weeks. 33% of Tier 1 and Tier 2 accounts have ordered Revuforj, with majority of accounts using it more than once.

Q: How is Revuforj being used, off-label use, and EAP?

A: Off-label use is anecdotal with some use in NPM1 and combination treatment. EAP transitions were in single digits, with no additional patients to transfer from EAP.

Q: Confidence in NCCN guideline inclusion for NPM1 and payer discussions?

A: Confident in NCCN guideline inclusion as data is supportive, and payer coverage is growing with claims being paid across the continuum.

Q: Timing and strategy for ex-US Revuforj?

A: Ex-US plans tied to frontline trials and partnerships, with addressable market being appreciable, and looking to partner for ex-US commercialization and development.