Syndax Pharmaceuticals Inc Q1 FY2025 earnings call

Commercial Front

• Launches of Revuforj and Niktimvo are off to strong starts. Revuforj had $20M net revenue in Q1 2025, and Incyte had $13.6M net revenue from Niktimvo's first two months of launch.
• Well-funded with $602.1 million in cash and equivalents as of March 31.

Development Progress

• Initiated EVOLV-2, the first pivotal frontline trial of a menin inhibitor.
• Completed submission of a Supplemental New Drug Application (sNDA) to the FDA for Revuforj seeking priority review for relapse or refractory mutant mNPM1 AML.

Pipeline

• Advancing revumenib in various clinical trials, including frontline combinations in acute leukemia.
• Axatilimab trials ongoing in chronic GVHD and IPF, with Phase 2 MAXPIRe trial in IPF proceeding well.

In the first quarter of 2025, Syndax recorded $20 million in net revenue from Revuforj. Incyte recorded $13.6 million in net revenue from the first two months of the joint launch of Niktimvo. Syndax's 50% share of the commercial Niktimvo contribution was part of the combined $34 million net sales from Revuforj and Niktimvo. Revuforj contributed $20 million, and Niktimvo (via Incyte) contributed $13.6 million, with Syndax's 50% share being a component of the combined figure.

• Cash position: $602.1 million in cash and equivalents as of March 31.
• Expect to reach profitability with cash, Revuforj gross margin contribution, collaboration revenue from Niktimvo, and interest income.
• Anticipate progress in clinical trials and regulatory milestones, such as potential approval of sNDA for Revuforj.

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 quarterly report on Form 10-Q and other reports filed with the SEC.

Q: What are you seeing in regards to the repeat prescribers for Revuforj?

A: 44% of our Tier 1 and Tier 2 accounts ordered as of the end of March, with about 80% of those having ordered more than once whether for another patient or a refill prescription.

Q: Can you share any color on the month-over-month trends for new patient adds for Revuforj in Q1?

A: Patients are too sick for a true bolus, but there's a steady stream with user base increasing, and free drug rate is low due to good formulary coverage.

Q: Do you have any color on trends in GVHD subgroups?

A: Early days, collecting real-world evidence, with patients typically in the fourth line and above.

Q: In terms of the NCCN guidelines, do you think you could realistically get in front of them with your publication by the May 19 AML panel meeting?

A: We announced acceptance of our manuscript, aiming to submit to NCCN guidelines soon, optimistic about potential inclusion, with ad hoc committee meetings possible if needed