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Syndax Pharmaceuticals Inc (SNDX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue was $45.9M, +21% q/q, driven by $32.0M Revuforj net revenue (+12% q/q) and $13.9M collaboration revenue from Niktimvo; cash and investments were $456.1M .
  • Versus S&P Global consensus, revenue slightly missed ($45.9M vs $48.0M) while EPS beat (-$0.70 vs -$0.71); mix was impacted by higher gross-to-net and a modest channel drawdown; inventory remained 2–3 weeks (unchanged) . Estimates marked with asterisks are from S&P Global.
  • FDA approved Revuforj for R/R NPM1-mutant AML on Oct 24, expanding the R/R addressable population to ~6,500 incident patients; Revuforj was added to NCCN AML Guidelines (category 2A) in late September .
  • Management reiterated a path to profitability with a stable opex base; FY25 opex (R&D+SG&A, ex-SBC) was narrowed to $380–$385M from $370–$390M; Niktimvo margin contribution expected at 25–30% near term and to increase over time .

What Went Well and What Went Wrong

  • What Went Well
    • Revuforj demand strong: TRx rose ~25% q/q; net revenue rose to $32.0M (+12% q/q) despite ~one-third of patients pausing for transplant; management sees building maintenance restarts as a growth driver .
    • Second indication secured: Revuforj won FDA approval in R/R NPM1-mutant AML (Oct 24) and was added to NCCN Guidelines in September, materially expanding the R/R opportunity .
    • Niktimvo ramp robust: Incyte reported $45.8M net revenue (+27% q/q), with Syndax booking $13.9M collaboration revenue; 90% of U.S. BMT centers have ordered, and ~80% of Q1 starters remain on therapy .
  • What Went Wrong
    • Revenue was a slight MISS vs Street as higher 340B/Medicare/Medicaid mix lifted gross-to-net; channel inventory modestly drew down; Revuforj net sales growth (+12%) lagged TRx growth (+25%) .
    • Opex still high (R&D $56.3M, SG&A $44.9M); while opex narrowed for FY, profitability depends on continued scale in Revuforj/Niktimvo and maintenance dynamics .
    • Restart rate post-transplant remains in early build phase (~35–40%), not yet fully offsetting pauses; mgmt expects this to rise over coming quarters .

Financial Results

Metric ($USD)Q3 2024Q1 2025Q2 2025Q3 2025
Product revenue, net (Revuforj)— $20.042M $28.600M $32.007M
Collaboration revenue, net (Niktimvo)— $0.000M (collab loss expensed) $9.358M $13.864M
Milestone/license revenue$12.500M — — —
Total revenues$12.500M $20.042M $37.958M $45.871M
Cost of product sales— $0.885M $1.279M $2.100M
Research & development$70.971M $61.636M $62.227M $56.280M
Selling, general & administrative$31.106M $41.031M $43.805M $44.917M
Total operating expenses$102.077M $103.799M $107.311M $103.297M
Net loss$(84.126)M $(84.846)M $(71.847)M $(60.715)M
Diluted loss per share$(0.98) $(0.98) $(0.83) $(0.70)
Cash, cash equivalents & investments (period-end)N/A$602.135M $517.860M $456.125M

Segment/KPIs

  • Revuforj: ~850 TRx in Q3; TRx and new patient starts +~25% q/q; ~33% of KMT2A patients proceeded to transplant; ~35–40% of transplant patients have restarted therapy; ~70% of use in 2L/3L; ~33% combination use; cumulative since launch ~2,200 TRx/~750 patients and ~$88M net revenue .
  • Niktimvo: $45.8M net revenue reported by Incyte (+27% q/q), translating to $13.9M collaboration revenue to SNDX; cumulative 8,500 infusions to 1,100 patients; ~90% of U.S. BMT centers have ordered; ~80% of Q1 starters remain on therapy .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D + SG&A (excl. ~$45M SBC)FY 2025$370–$390M (ex-SBC) $380–$385M (ex-SBC) Narrowed; midpoint slightly raised
Revuforj gross-to-netNear term20–25% (previously communicated) Reaffirmed 20–25% Maintained
Niktimvo margin contribution (to SNDX)Near term/longer termNot specified prior in 8-K25–30% near term; increasing over time Maintained qualitative margin outlook
Distribution inventoryOngoing2–3 weeks (typical) Remains 2–3 weeks Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025, Q2 2025)Current Period (Q3 2025)Trend
Regulatory for RevuforjsNDA submitted for R/R NPM1 AML (Apr) FDA approval (Oct 24) and NCCN addition (Sept 18) Positive inflection
Frontline strategy (menin)EVOLVE-2 initiated (1Q25) EVOLVE-2 enrollment well underway; REVEAL (7+3) starts by YE25 Execution progressing
Demand vs reported revenueNot quantifiedTRx/new starts +~25% q/q vs net +12% due to GTN and inventory drawdown Near-term headwind from mix/inventory
Post-transplant maintenanceNot quantified~35–40% restart; expected to grow over time Building tailwind
Payer/access & GTNNot highlightedCoverage strong; GTN 20–25% range; NPM1 skew may raise Part D mix modestly Stable access; mix-sensitive GTN
Safety (QT/Torsades)Not highlightedRare case addressed on label; frontline rates appear lower; no change to monitoring Manageable profile
Niktimvo uptakeLaunch in Q1; $13.6M in partial quarter $45.8M qtr revenue to Incyte; 90% center adoption; durable persistence Strong adoption/persistence

Management Commentary

  • “We reported $45.9 million in total revenue for Q3, representing strong 21% growth over the prior quarter… With both medicines, a robust base of new patients are starting each quarter, and a growing number are continuing on therapy.” — CEO .
  • “In the one week since approval, we have already engaged with hundreds of physicians… They are enthusiastic to have Revuforj as the first highly efficacious targeted therapy indicated for relapsed/refractory NPM1.” — CEO .
  • “We continue to expect the Niktimvo margin contribution… to be in the 25%–30% range in the near term and increase longer term.” — CFO .
  • “We expect sales growth to meaningfully accelerate… with the approval in NPM1 and increasing average duration of therapy in KMT2A as more patients receive Revuforj as long-term maintenance post-transplant.” — CFO .

Q&A Highlights

  • Duration and restart dynamics: Management guided to KMT2A average duration of 4–6 months in 2025, expanding to 6–12 months in 2026 as maintenance builds; restart rate rose to ~35–40% and is expected to increase .
  • Rx vs revenue delta: 25% TRx growth vs 12% sales growth driven by higher 340B/Medicare/Medicaid mix within the 20–25% GTN range and a slight channel drawdown; inventory steady at 2–3 weeks .
  • Payer access: Coverage strong (KMT2A ~97% formulary coverage historically); NPM1 claims expected to adjudicate smoothly with NCCN listing and now approval; minimal friction expected .
  • Safety: With frontline patients, serious cardiac events appear lower; no change in monitoring; label includes rare torsades case .
  • NPM1 launch trajectory: Field deployed immediately; broad prescriber familiarity from KMT2A; company positions to secure dominant share on efficacy, breadth of label .

Estimates Context

MetricQ3 2025 ConsensusQ3 2025 ActualResult
Revenue$48.0M*$45.9M MISS
Primary EPS-$0.711*-$0.70 BEAT

Values with an asterisk (*) are retrieved from S&P Global.

Key Takeaways for Investors

  • Commercial momentum intact: Revuforj and Niktimvo delivered combined Q3 revenues of $45.9M with accelerating demand indicators; NPM1 approval/NCCN inclusion expands the R/R pool and should accelerate growth .
  • Near-term optics: Expect occasional disconnects between TRx and reported sales given GTN mix (340B/government) and inventory; inventory policy remains steady at 2–3 weeks .
  • Building annuity: Maintenance restarts post-transplant (~35–40% and rising) and earlier-line use support increasing duration and cohort maturation into 2026 .
  • Opex discipline: FY25 R&D+SG&A narrowed to $380–$385M (ex-SBC); mgmt highlights a stable expense base and path to profitability with current cash runway .
  • Niktimvo leverage: Near-term 25–30% margin contribution to Syndax with potential to expand as volumes scale against a largely fixed expense base .
  • Pipeline catalysts: Extensive ASH datasets (menin and CSF1R), EVOLVE-2 enrollment, and REVEAL initiation by YE25 position Revuforj for frontline paths in 2026+ .
  • Trading setup: The narrative hinges on NPM1 launch uptake, maintenance restart ramp, and GTN normalization; quarterly volatility around mix/inventory is possible, but the medium-term thesis is improving scale and operating leverage .

Appendix: Additional Detail and Source Notes

  • Third Quarter 2025 results press release and exhibits (Form 8-K): totals, segment revenue, opex, cash, and guidance .
  • Q3 2025 earnings call: demand metrics, GTN/Inventory commentary, payer access, safety, pipeline updates, and Q&A .
  • Prior quarters for trend: Q2 2025 8-K and press release; Q1 2025 8-K (first full Revuforj quarter; Niktimvo partial quarter) .