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Syndax Pharmaceuticals Inc (SNDX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $37.96M, up 89% q/q and ahead of S&P Global consensus; EPS of $(0.83) beat expectations as commercial traction in Revuforj and initial collaboration revenue from Niktimvo outpaced OpEx growth . Estimates context: Revenue $26.64M*, EPS $(1.01); Actual: $37.96M, $(0.83) — both beats.
  • Revuforj net revenue rose 43% q/q to $28.6M with strong demand, earlier-line use (≈50% in 2L; ≈70% 2L/3L), and an estimated one-third of KMT2A patients proceeding to transplant; physicians plan to restart maintenance post-transplant for 1–2 years, supporting duration expansion .
  • Niktimvo’s first full quarter delivered $36.2M net revenue (Incyte), translating to $9.4M collaboration revenue to Syndax; 80–90% of patients remain on therapy and >80% of U.S. transplant centers have adopted the drug, underscoring durable uptake and cash contribution .
  • Guidance: OpEx (R&D+SG&A, ex-stock comp) maintained at $95–$100M for Q3 and $370–$390M for FY25, with management reiterating a path to profitability on relapsed/refractory indications alone and a stable expense base over 2–3 years .
  • Catalysts: Priority Review for Revuforj sNDA in R/R mNPM1 AML (PDUFA Oct 25, 2025); inclusion in treatment guidelines expected pre-approval; first real-world evidence anticipated before year-end; continued Niktimvo growth and front-line GVHD/ IPF development progress .

What Went Well and What Went Wrong

What Went Well

  • Revuforj commercial ramp: Q2 net revenue increased 43% q/q to $28.6M; patient identification robust with >500 patients treated since launch and ~25% of annual KMT2A incidence already penetrated; earlier-line use supports better outcomes and longer duration .
  • Niktimvo uptake and profitability: $36.2M net revenue (Incyte) in Q2; Syndax’s collaboration revenue of $9.4M implies 20–30% near-term margin contribution, with 80–90% of patients remaining on therapy and >80% center adoption .
  • Regulatory momentum: Revuforj sNDA for R/R mNPM1 AML granted FDA Priority Review under RTOR; PDUFA Oct 25, 2025; management expects guidelines inclusion before approval. “We are prepared for launch… regulatory front is hitting on all cylinders.” .

What Went Wrong

  • Continued net losses: Q2 net loss of $(71.8)M despite revenue beat, reflecting heavy R&D and SG&A investment to support trials and commercialization; EPS still negative at $(0.83) .
  • R&D/SG&A pressure: Q2 R&D rose to $62.2M and SG&A to $43.8M y/y, driven by trial activity, sNDA milestones, and commercial scaling; OpEx remains high even as revenue scales .
  • Q4 2024 baseline volatility: Initial five weeks of Revuforj yielded $7.68M with ~one-third inventory; S&P Global Q4 estimates were mis-calibrated vs launch timing, creating optics of an apparent miss historically* .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Total Revenue ($USD Millions)$7.68 $20.04 $37.96
Revuforj Net Product Revenue ($USD Millions)$7.68 $20.04 $28.60
Niktimvo Collaboration Revenue (Loss) ($USD Millions)$0.00 $(0.25) $9.36
R&D Expense ($USD Millions)$65.53 $61.64 $62.23
SG&A Expense ($USD Millions)$37.69 $41.03 $43.80
Net Loss ($USD Millions)$(94.17) $(84.85) $(71.85)
Basic EPS ($)$(1.10) $(0.98) $(0.83)
Cash, Equivalents & Investments ($USD Millions)$692.40 $602.14 $517.86
Actual vs S&P Global ConsensusQ4 2024Q1 2025Q2 2025
Revenue Consensus ($USD Millions)$86.51*$16.18*$26.64*
Revenue Actual ($USD Millions)$7.68 $20.04 $37.96
EPS Consensus ($)$(0.23)*$(1.27)*$(1.01)*
EPS Actual ($)$(1.10) $(0.98) $(0.83)

Values with asterisks retrieved from S&P Global.

Segment/Product detail

Product MetricQ4 2024Q1 2025Q2 2025
Revuforj Net Revenue ($USD Millions)$7.68 $20.00 $28.60
Niktimvo Net Revenue (Incyte, $USD Millions)—$13.60 $36.20
Niktimvo Collaboration Revenue to SNDX ($USD Millions)—$(0.20) $9.40

KPIs (Q2 2025)

KPIQ2 2025
Revuforj prescriptions since launch>1,300
Patients treated since launch>500
KMT2A annual incidence penetrated since launch~25%
Use concentration (2L + 3L)~70% (≈50% in 2L)
KMT2A patients proceeding to transplant (commercial est.)~33%
Niktimvo infusions administered since launch>4,000
Niktimvo patients on therapy80–90%
U.S. bone marrow transplant centers ordering Niktimvo>80%
Revuforj time from Rx to first fill<4 days
Revuforj formulary coverage>97% of lives

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D + SG&A (ex-stock comp) ($USD Millions)Q3 2025N/A (previously reported inclusive basis)$95–$100 New format; level set
R&D + SG&A (ex-stock comp) ($USD Millions)FY 2025$415–$435 incl. ~$45 stock comp $370–$390 ex-stock comp Maintained (methodology changed)
Operating expense base outlook2025–2027Not previously framed as “stable for years”“Operating expenses to remain stable over the next few years” Maintained/clarified
Revenue guidance2025Not providedNot providing revenue guidance Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
Revuforj commercial tractionEarly launch $7.7M; high unmet need; NCCN inclusion (KMT2Ar) $28.6M; earlier-line use; one-third to transplant; duration building to 4–6 months, moving toward 6–12 months in year two Accelerating
Niktimvo uptake & contributionPartial quarter $13.6M; collab loss $(0.2)M to SNDX First full quarter $36.2M; $9.4M to SNDX; 80–90% remain on drug; >80% center adoption Strong ramp
Path to profitabilityExpected with current resources Achievable on R/R settings alone; OpEx to remain stable 2–3 years Confidence up
Regulatory/legal (Revuforj mNPM1)sNDA submission planned Priority Review; PDUFA Oct 25; guidelines inclusion expected pre-approval Imminent catalyst
R&D execution (frontline programs)EVOLVE-2 initiated; 7+3 combo planned EVOLVE-2 enrolling; REVEAL trials starting Q4; BEAT AML data encouraging; RWE before YE On track
Safety/tolerability managementQT prolongation label guidance noted earlier Real-world QT monitoring manageable; strong physician comfort Stable
Macro/supply chain/tariffsNot materialNot discussed as headwindsNeutral

Management Commentary

  • “Syndax reported another remarkable quarter… Revuforj net revenue increased 43% quarter-over-quarter… we are nearing another major inflection point with anticipated approval in R/R mNPM1 AML” — Michael Metzger, CEO .
  • “Niktimvo is already a positive cash flow contributor… margin contribution… in the 20% to 30% range in the near term” — Keith Goldan, CFO .
  • “REVUFORGE is increasingly being used earlier… ~50% second line; we estimate ~1/3 have proceeded to transplant… physicians plan maintenance 1–2 years post-transplant” — Steve Closter, CCO .
  • “EVOLVE-2… dual primary endpoints of CR and OS… REVEAL trials to initiate in 2025; first real-world evidence before year end” — Nick Botwood, CMO .

Q&A Highlights

  • Profitability drivers: Management reiterated profitability can be achieved on relapsed/refractory indications alone, aided by stable OpEx and outperformance of both launches .
  • Transplant and maintenance dynamics: ~1/3 KMT2A patients proceed to transplant; maintenance re-starts are building (≈1/3 of transplant patients already restarted), with physicians expecting a “very high proportion” ultimately to resume for 1–2 years .
  • Duration of therapy trajectory: Average duration trending 4–6 months in year one, expanding toward 6–12 months in year two as earlier-line treatment and maintenance grow .
  • NPM1 launch preparedness: Same treating centers; strong HCP relationships; expect a “decent driver” at approval given limited off-label use today and larger patient pool (2,000 → ~6,000) .
  • Niktimvo sizing: Early math implies conservative consensus; 80–90% persistence supports multi-hundred-million U.S. opportunity over coming years even pre-frontline expansion .

Estimates Context

  • Q2 2025 vs S&P Global consensus: Revenue $37.96M vs $26.64M*; EPS $(0.83) vs $(1.01)* — both significant beats driven by stronger-than-modeled Revuforj demand/earlier-line adoption and the initial collaboration revenue from Niktimvo, with inventory stable at ~2–3 weeks .
  • Q1 2025 vs S&P Global consensus: Revenue $20.04M vs $16.18M*; EPS $(0.98) vs $(1.27)* — beats as launch traction emerged and collaboration loss was minimal .
  • Q4 2024 estimates were not aligned to launch timing (actual $7.68M vs $86.51M*), a modeling gap that does not reflect current trajectory*.
    Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

  • Commercial momentum across both assets supports upward revisions to near-term revenue estimates; watch for duration expansion (maintenance) to compound Revuforj revenue beyond new patient starts .
  • The Oct 25 PDUFA for mNPM1 is a binary but high-impact catalyst; guidelines inclusion pre-approval likely to smooth payer dynamics and accelerate uptake on day one .
  • Stable OpEx guidance and collaboration economics (20–30% near-term margin from Niktimvo) strengthen the path to profitability; model improving EPS trajectory with revenue scale .
  • Near-term trading setup: Expect sentiment to track monthly demand signals and regulatory updates; any signs of acceleration in maintenance restarts or earlier-line penetrations can drive upside surprises .
  • Medium-term thesis: Frontline menin programs (EVOLVE-2, REVEAL) and Niktimvo earlier-line GVHD/IPF trials create optionality for multi-billion TAM expansion; RWE before year-end should bolster Revuforj’s real-world narrative .
  • Risk checks: Monitor QT management in real-world, inventory levels, and trial timelines; management commentary suggests safety manageable and inventories stable at 2–3 weeks .