Executive Summary

Strong first full quarter of commercialization: Revuforj net product revenue of $20.0M; Q1 total revenue $20.042M vs $7.680M in Q4 (partial launch) and $0 in Q1’24; channel inventory kept to ~2–3 weeks and largely demand-driven .
Early evidence of operating leverage in gross margin: cost of product sales $0.9M implies ~95.6% gross margin; SG&A scaled for two launches; net loss per share improved to ($0.98) vs ($1.10) in Q4 despite higher OpEx .
Niktimvo co-launch (with Incyte) tracking ahead of expectations: Incyte reported $13.6M Q1 net revenue; SNDX’s Q1 collaboration share was a modest ($0.2M) loss, with management expecting a rapid shift to profit contribution as the launch normalizes .
Guidance maintained; cash runway strong: Q2 R&D $70–$75M; Q2 R&D+SG&A $110–$115M; FY’25 R&D $260–$280M and R&D+SG&A $415–$435M unchanged; cash/investments $602.1M support path to profitability .
Catalysts: NPM1 sNDA under RTOR (Priority Review, PDUFA Oct 25, 2025), expected NCCN inclusion for NPM1 following imminent publication, and EVOLVE-2 frontline trial (dual primary endpoints CR and OS) support narrative of continued label and TAM expansion .

What Went Well and What Went Wrong

What Went Well
- Commercial traction: $20.0M Revuforj net revenue in first full quarter, with breadth and depth of prescribing improving; 44% of Tier 1/2 accounts ordered by end of March and majority repeat orders .
- Market access: ~72% managed-care lives with formal coverage by end of March; high claim approval rates; time-to-first-fill measured in days; free-drug rate low single digits .
- Pipeline momentum: sNDA submitted for R/R mNPM1 AML under RTOR; EVOLVE-2 frontline trial initiated with plan to use dual primary endpoints (CR and OS) for accelerated and full approval pathways .
What Went Wrong
- OpEx elevated vs prior year: Q1 R&D $61.6M (incl. $10M axatilimab milestone for Phase 3 start) and SG&A $41.0M, reflecting dual launches and development breadth .
- Collaboration P&L: Niktimvo posted a net commercial loss in Q1 (SNDX share: ($0.2M)) given partial-quarter dynamics and launch costs, though management expects rapid conversion to positive contribution .
- Net loss expanded YoY: Net loss ($84.8M) vs ($72.4M) in Q1’24 on higher OpEx; diluted EPS ($0.98) vs ($0.85) YoY .

Financial Results

P&L and margins vs prior periods and consensus

Metric	Q3 2024	Q4 2024	Q1 2025	vs QoQ	vs YoY	Consensus (Q1 2025)
Total Revenue ($M)	$12.500 (milestone)	$7.680 (product)	$20.042 (product)	+$12.362	+$20.042	$16.179*
Revuforj Product Rev. ($M)	N/A	$7.680	$20.000	+$12.320	+$20.000	N/A
Cost of Product Sales ($M)	N/A	$0.826	$0.885	+$0.059	+$0.885	N/A
Gross Margin (%)	N/A	~89.2% (calc)	~95.6% (calc)	+640 bps	N/M	N/A
R&D Expense ($M)	$71.0	$65.529	$61.636	-$3.893	+$5.144	N/A
SG&A Expense ($M)	$31.106	$37.690	$41.031	+$3.341	+$18.009	N/A
Net Loss ($M)	($84.126)	($94.170)	($84.846)	+$9.324	($12.446)	N/A
Diluted EPS	($0.98)	($1.10)	($0.98)	+$0.12	($0.13)	($1.273)*

Notes: Gross margin calculated as (Product revenue – Cost of product sales)/Product revenue using cited figures. Consensus estimates marked with *; Values retrieved from S&P Global.

Segment/line items of interest

Item	Q4 2024	Q1 2025
Revuforj Net Product Revenue ($M)	$7.680	$20.000
Niktimvo Net Revenue (reported by Incyte) ($M)	—	$13.6
SNDX Share of Niktimvo Commercial P/L ($M)	—	($0.247) (collab loss)
Cash, Cash Equivalents, Investments ($M)	$692.404 (12/31/24)	$602.135 (3/31/25)

KPIs and launch metrics

KPI	Detail
Revuforj breadth/depth	44% of Tier 1/2 accounts ordered by end of March; majority repeat orders .
Payer coverage	Formal coverage policies for ~72% of managed-care lives by end of March; high approval rates; time-to-first-fill often within days .
Channel inventory	~2–3 weeks at quarter-end; expected to remain at 2–3 weeks .
Free drug rate	Low single digits, focused on uninsured/underinsured; gross-to-net “tight” with no rebate need .
Niktimvo adoption	>1,250 infusions YTD as of end of March; ~95% of top accounts and >70% of BMT centers have ordered; CMS permanent J-code effective April 1 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
R&D Expense	Q1 2025	$65–$70M	—	N/A
R&D + SG&A	Q1 2025	$105–$110M	—	N/A
R&D Expense	Q2 2025	—	$70–$75M	New
R&D + SG&A	Q2 2025	—	$110–$115M	New
R&D Expense	FY 2025	$260–$280M	$260–$280M (maintained)	Maintained
R&D + SG&A	FY 2025	$415–$435M (incl. ~$45M SBC)	$415–$435M (incl. ~$45M SBC)	Maintained

The company is not providing revenue guidance; management reiterates cash and expected revenue/interest can fund to profitability .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3’24 and Q4’24)	Current Period (Q1’25)	Trend
Revuforj launch ramp	Initial 5 weeks yielded $7.7M; payer groundwork; ~33% Tier 1/2 accounts ordering by end-Feb .	$20.0M first full quarter; 44% Tier 1/2 ordering; majority repeat; demand-led with 2–3 weeks inventory .	Improving breadth/depth and access.
Market access	Rapid NCCN inclusion for KMT2A; payer education underway pre-launch .	~72% managed-care coverage; high approval rates; low free-drug; tight gross-to-net .	Strengthening coverage/realization.
NPM1 regulatory path	Pivotal data readout expected; plan to file sNDA 1H’25; target guideline inclusion post-publication .	sNDA submitted under RTOR; publication accepted/publishing imminently; aim for near-term NCCN update .	Accelerating toward label/Guidelines.
Frontline strategy	Plan pivotal ven/aza combo; HOVON partnership outlined; OS primary endpoint .	EVOLVE-2 initiated; will amend to dual primaries (CR, OS) to support accelerated/full approval; ~415 pts; powered on NPM1 .	Advancing with registrational design de-risking.
Niktimvo launch	FDA approval Aug’24; U.S. launch planned early Q1’25; strong TAM premise .	$13.6M net revenue (Incyte) in first ~2 months; SNDX share (collab) was ($0.2M) but expected to turn positive quickly .	Early uptake solid; P&L inflecting.
Balance sheet/royalty	$350M Royalty Pharma deal funds to profitability .	$602.1M cash/investments; reiterate path to profitability .	Sufficient runway, disciplined spend.

Management Commentary

“Revuforj and Niktimvo generated a combined $34 million in net sales... With a solid financial position and highly skilled team, we are poised to deliver two successful product launches while aggressively advancing our development strategy.” – CEO Michael Metzger .
“We will be amending [EVOLVE-2] to include complete remission and overall survival as dual primary endpoints to support potential U.S. accelerated approval and full approval, respectively.” – CEO Michael Metzger .
“The vast majority of [Revuforj] revenue was driven by real demand with approximately just 2 to 3 weeks of inventory… We expect channel inventory levels to remain at 2 to 3 weeks.” – CFO Keith Goldan .
“Given the strong results from the first 2 months of [Niktimvo] launch, we expect that Niktimvo will quickly convert to a positive revenue contribution.” – CFO Keith Goldan .

Q&A Highlights

Prescriber expansion and refills: 44% of Tier 1/2 accounts ordering, ~80% of those ordering more than once; usage expanding beyond Tier 1/2 into community settings .
Transplant and maintenance: Early, largely anecdotal reports of patients proceeding to transplant on Revuforj, with expectation many resume post-engraftment maintenance; details to emerge as data mature .
Month-over-month trajectory and free drug: April trends described as constructive; free-drug rate low single digits as coverage builds; some patients already on 4–5 refills .
NPM1 off-label and mix: Q1 Revuforj usage primarily on-label KMT2A; some reported NPM1/off-label and combination use; SKU mix primarily 110mg/160mg .
EVOLVE-2 design/powering: Trial powered to NPM1 population with dual primary endpoints; KMT2A included but not powering driver .

Estimates Context

S&P Global consensus for Q1 2025: Revenue $16.18M* (10 ests) vs actual $20.04M; Primary EPS ($1.27)* (11 ests) vs actual ($0.98) – both beats. Estimates likely to move higher on stronger-than-expected Revuforj demand and higher realized gross margin .

Metric	Q1 2025 Consensus	Q1 2025 Actual
Revenue ($)	16,179,300*	20,042,000
Primary EPS ($)	(1.273)*	(0.98)
Revenue – # of Estimates	10*	—
EPS – # of Estimates	11*	—

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

Commercial ramp is ahead of plan: Revuforj delivered $20.0M in its first full quarter with broadening account adoption, favorable access, and tight gross-to-net; margin profile (~96% GM) is strong .
Consensus upside: Q1 revenue and EPS beat S&P consensus; momentum suggests upward estimate revisions for Q2/FY’25 as access and prescriber depth increase and Niktimvo contribution turns positive .
Regulatory catalysts: NPM1 sNDA under RTOR with Priority Review (PDUFA Oct 25, 2025), plus anticipated near-term NCCN inclusion following imminent publication, can expand TAM and accelerate adoption .
Frontline de-risking: EVOLVE-2 design change (CR and OS dual primaries) improves optionality for accelerated and full approvals; leadership position in menin inhibition intact .
Partnership economics: Niktimvo early uptake robust; SNDX’s 50% share of U.S. commercial P/L expected to swing positive quickly; synthetic royalty to Royalty Pharma excluded from collaboration P&L .
Cash runway to profitability: $602.1M cash/investments with FY’25 OpEx guidance maintained; execution priority on two launches and registrational programs .
Trading setup: Near-term stock drivers include NCCN update for NPM1, Q2 launch KPIs (payer coverage, refill cadence), and EVOLVE-2 execution; longer-term value tied to NPM1 approval and frontline data flow .

Additional Relevant Press Releases (During/around Q1 2025)

Q4/FY2024 results (context for trend): initial Revuforj $7.7M in first five weeks; FY’25 OpEx guidance introduced and reiterated .
EHA 2025 abstracts (post-Q1 but thematically relevant): updated BEAT AML frontline combo data and AUGMENT-101 expansions support clinical momentum across settings .
Priority Review for NPM1 sNDA (post-Q1 milestone): RTOR pathway; PDUFA Oct 25, 2025 .

Disclaimer on estimates: Values marked with * retrieved from S&P Global.

Syndax Pharmaceuticals Inc (SNDX)·Q1 2025 Earnings Summary