Executive Summary

Q4 marked SNDX’s first commercial quarter: Revuforj generated $7.68M net product sales in the initial five weeks post-approval; Q4 net loss was $94.2M ($1.10/sh); cash and investments ended at $692.4M .
Early launch metrics are constructive: ~33% of Tier 1/2 accounts had ordered by end-Feb; vast majority of prescriptions reimbursed; formulary policies cover ~56% of commercial lives and 53% of all managed-care lives; channel inventory targeted at ~2–3 weeks, with ~1/3 of initial Q4 revenue from stocking .
Pipeline/expansion: sNDA for R/R mNPM1 AML expected in Q2’25 (positive pivotal Phase 2), with potential approval around YE25; frontline trials (ven/aza triplet) initiating in unfit AML via HOVON, with multiple fit-AML combo trials planned 2H25 .
2025 OpEx outlook: Q1’25 R&D $65–$70M; total R&D+SG&A $105–$110M; FY’25 R&D $260–$280M; total R&D+SG&A $415–$435M; no revenue guidance. Management expects cash plus product revenue and interest to fund to profitability .

What Went Well and What Went Wrong

What Went Well

Strong initial Revuforj uptake: $7.7M in five weeks; management “very encouraged by early patient demand, breadth of prescribing, and coverage from payers” .
Market access execution: “Vast majority” of prescriptions reimbursed; medical-exception process bridging where policies still building; 56% of commercial lives and 53% of all managed-care lives already have formal coverage policies .
Compelling clinical momentum: R/R mNPM1 pivotal Phase 2 met primary endpoint (CR/CRh 23% in protocol-defined population; 26% in expanded efficacy-evaluable set); BEAT AML triplet showed ORR 100% and CRc 95% in newly-diagnosed elderly AML (mNPM1/KMT2Ar) .

What Went Wrong

Losses widened as commercialization scaled: Q4 net loss $94.2M vs $72.5M prior-year; R&D and SG&A rose YoY as SNDX ramped for launch .
No revenue guidance provided for 2025; investors must extrapolate from early qualitative KPIs and pipeline milestones .
Early quarter revenue includes ~1/3 channel inventory; management targets ~2–3 weeks in-channel, implying some initial stocking normalization risk as sell-through patterns establish .

Financial Results

Three-month comparisons (oldest → newest):

Metric	Q4 2023	Q3 2024	Q4 2024
Total Revenue ($M)	$0.0	$12.5	$7.7
Net Product Sales ($M)	$0.0	—	$7.68
Milestone & License Revenue ($M)	—	$12.5	$0.0
Cost of Product Sales ($M)	$0.0	—	$0.83
R&D Expense ($M)	$55.13	$71.0	$65.53
SG&A Expense ($M)	$22.78	$31.11	$37.69
Net Loss ($M)	$(72.47)	$(84.13)	$(94.17)
Diluted EPS ($)	$(1.00)	$(0.98)	$(1.10)

Q4 revenue mix and product metrics:

Metric	Q4 2024
Net Product Sales – Revuforj ($M)	$7.68
Cost of Product Sales ($M)	$0.83
Implied Gross Margin % (Revuforj)	89.2% (calc. from sales and cost)
Revuforj launch window	Initial 5 weeks (late Nov–Dec)
Approx. share of stocking in Q4 sales	~1/3

KPIs and commercial readiness:

KPI	Value
Tier 1/2 account activation	33% of top accounts had ordered by end-Feb
Coverage policies	~56% of commercial lives; ~53% of all managed-care lives
Reimbursement	Vast majority of scripts reimbursed across channels
Channel inventory target	~2–3 weeks; ~1/3 of initial Q4 sales were channel stocking

Note: Dashes indicate line item not present in that period’s results disclosure.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
R&D Expense ($M)	Q1 2025	—	$65–$70	New
Total R&D + SG&A ($M)	Q1 2025	—	$105–$110	New
R&D Expense ($M)	FY 2025	—	$260–$280	New
Total R&D + SG&A ($M)	FY 2025	—	$415–$435	New
Revenue Guidance	FY 2025	—	Not provided	Maintained (none)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024 and Q3 2024)	Current Period (Q4 2024)	Trend
Product launch execution	Q2: Pre-commercial build; payer engagement; field readiness . Q3: First product (Niktimvo) approved; Revumenib PDUFA 12/26; sales infrastructure built .	Revuforj launched; $7.7M Q4 sales; 33% Tier1/2 orders; fast time to first fill; “vast majority” scripts reimbursed; Niktimvo launched late Jan .	Improving execution; building competitive “first-mover” advantage.
Market access/formulary	Q2/Q3: Early payer dialogues; plan to accelerate coverage timelines .	~56% commercial and 53% all managed-care lives with policies; approvals via exceptions where needed .	Coverage broadening; access friction low.
R&D execution (mNPM1)	Q2: pivotal readout expected 4Q24 . Q3: reiterated timing and approvability bar .	Pivotal met primary endpoint; CR/CRh 23% protocol-defined; 26% expanded; sNDA expected Q2’25 .	De-risked; regulatory path clear.
Frontline strategy (triplet)	Q2/Q3: BEAT AML data highly encouraging; planning HOVON pivotal in unfit AML; fit-AML combos to follow .	HOVON pivotal initiation Q1’25; additional fit-AML trials 2H’25; BEAT AML ORR 100%, CRc 95% update .	Advancing toward registrational footprint.
Corporate finance runway	Q3: $350M Royalty Pharma deal; funded to profitability .	YE cash/investments $692.4M; reiterates path to profitability .	Strengthened balance sheet supports launch and trials.

Management Commentary

“We are off to a strong start with the U.S. launch of Revuforj and are very encouraged by the early patient demand, breadth of prescribing, and coverage from payers.” — CEO Michael Metzger .
“Roughly 3 months into the launch… formal coverage policies [are] in place for ~56% of commercially covered lives and 53% of all managed care lives… the vast majority of prescriptions are being reimbursed.” — CCO Steven Closter .
“We expect to file the sNDA [for mNPM1 AML] in the second quarter and believe we could receive approval around year-end [2025].” — President/Head of R&D Neil Gallagher .
“We are initiating a pivotal randomized, placebo-controlled trial of revumenib with venetoclax/azacitidine in newly diagnosed… patients who are ineligible for intensive chemotherapy.” — President/Head of R&D Neil Gallagher .

Q&A Highlights

Inventory normalization: Management targets ~2–3 weeks in-channel; initial ~1/3 Q4 sales were stocking; as revenue grows absolute inventory may rise but weeks in channel should remain stable .
Prescriber depth: Majority of ordering accounts have written more than one prescription; focus on activating remaining Tier 1/2 sites over 2025 .
Off-label dynamics: Anecdotal early use in NPM1 and in combinations; EAP transitions low single digits with most eligible already transitioned .
Gross-to-net: “Very tight” gross-to-net; no rebates anticipated; low single-digit patient assistance usage .
Frontline path: HOVON unfit-AML pivotal is OS-powered primarily in NPM1; fit-AML combination trials to start 2H’25; exploring MRD as a potential surrogate with regulators (no specifics) .

Estimates Context

We attempted to retrieve Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue; data could not be pulled due to daily limit constraints. As such, comparisons versus consensus are unavailable in this report (Values retrieved from S&P Global were unavailable due to access limits).*

Key Takeaways for Investors

Early commercial read-through is positive: breadth of ordering, rapid reimbursement, and fast time-to-fill signal favorable product/market fit; watch sequential demand normalization as stocking effects dissipate .
Expansion catalysts remain robust: mNPM1 sNDA in Q2’25 (positive pivotal results) and potential YE25 approval, plus initiation of the frontline HOVON pivotal and additional fit-AML combo trials in 2H’25 .
Operating leverage hinges on execution: Q4 OpEx elevated with go-to-market build; management guides 2025 OpEx without revenue; monitor quarterly sell-through, payer policy expansion, and Niktimvo profit-share progression .
Clinical differentiation: Consistent efficacy in KMT2Ar and mNPM1 and strong combination data (BEAT AML) support potential leadership and “first-mover” stickiness among prescribers .
Balance sheet de-risks roadmap: YE cash/investments of $692.4M plus Royalty Pharma proceeds expected to fund to profitability, reducing financing risk through launch scaling and pivotal programs .
Near-term stock movers: Quarterly Revuforj demand run-rate vs Q4 stocking base; payer/formulary coverage updates; sNDA filing for mNPM1 (Q2’25); clarity on HOVON trial start and enrollment trajectory .

Footnote: *Estimates were requested from S&P Global via our tool, but access was rate-limited at the time of query; we will update comparisons to consensus upon availability.

Citations:

Q4 press release/financials:
8-K and Exhibit 99.1 (press release):
Q4 earnings call transcript:
Q3 press release and call:
ASH/clinical updates (Dec 2024):

Syndax Pharmaceuticals Inc (SNDX)·Q4 2024 Earnings Summary