Executive Summary

Q4 2024 revenue rose 13% year over year to $26.5M, driven by $2.0M license revenue (Nobelpharma) and 78% ex-U.S. DANYELZA growth; U.S. DANYELZA declined 12% on unfavorable price mix. Net loss was $(6.8)M or $(0.15) per share; cost of goods sold elevated by inventory write-off and mix .
2025 guidance introduced: FY revenue $75–$90M; OpEx ex-COGS $116–$121M (incl. COGS $129–$134M); cash investment $25–$30M; Q1 2025 revenue $18–$21M; runway “into 2027.” Management emphasized realistic guidance given dispersion in Street estimates .
SADA PRIT platform advanced: 22 patients dosed in Part A GD2-SADA; 9 GD2-positive proceeded to therapeutic lutetium; no dose-limiting toxicities; full Part A readout planned in Q2 2025—a key 2025 catalyst .
Strategic realignment created two business units (DANYELZA and Radiopharmaceuticals); cash and equivalents $67.2M with 2024 cash investment $11.4M (better than guide), reinforcing liquidity ahead of pipeline milestones .

What Went Well and What Went Wrong

What Went Well
- Strong ex-U.S. momentum and licensing: ex-U.S. DANYELZA +78% YoY to $7.7M; $2.0M Nobelpharma upfront drove license revenue; patent extension through Feb 2034 supports durability .
- Platform validation without safety signals: “no dose-limiting toxicities and no treatment-related serious adverse events” in SADA Part A; full data in Q2 2025 .
- Operating discipline and liquidity: cash $67.2M; 2024 cash investment $11.4M, below $15–$20M guide; management reiterated runway “into 2027” .
- Quote: “We delivered on the strategic priorities we set out to achieve in 2024 across our business.” – Michael Rossi, CEO .
What Went Wrong
- U.S. DANYELZA softness: U.S. net product revenue fell 12% YoY to $16.8M on unfavorable price mix despite slightly higher volume; payer mix moving toward Medicaid/340B pressured margins .
- Gross profit compression and COGS spike: COGS jumped to $7.6M (incl. $0.6M inventory write-off), reducing gross profit to $18.9M vs $21.3M YoY; mix shift to regions with lower margins noted .
- Higher SG&A and lower other income: SG&A increased on personnel/severance; interest/other swung to $(1.6)M due to lower FX gains and interest; quarterly net loss widened YoY .

Financial Results

Income statement trends (USD Millions, EPS in USD)

Metric	Q2 2024	Q3 2024	Q4 2024
Total Revenues	$22.798	$18.461	$26.495
Net Product Revenue	$22.798	$18.461	$24.495
License Revenue	$0.000	$0.000	$2.000
Net Loss	$(9.249)	$(6.998)	$(6.790)
EPS (basic & diluted)	$(0.21)	$(0.16)	$(0.15)

Q4 year-over-year comparison (USD Millions, EPS in USD)

Metric	Q4 2023	Q4 2024
Total Revenues	$23.363	$26.495
Net Product Revenue	$23.363	$24.495
License Revenue	$0.000	$2.000
Cost of Goods Sold	$2.039	$7.642
Gross Profit	$21.324	$18.853
Net Loss	$(0.988)	$(6.790)
EPS (basic & diluted)	$(0.02)	$(0.15)

Revenue mix by geography/type (USD Millions)

Metric	Q2 2024	Q3 2024	Q4 2024
U.S. DANYELZA Net Product Revenue	$15.2	$15.3	$16.8
Ex-U.S. DANYELZA Net Product Revenue	$7.6	$3.1	$7.7
License Revenue	$0.0	$0.0	$2.0

Commercial KPIs

KPI	Q2 2024	Q3 2024	Q4 2024
U.S. Centers Delivered Since Launch (cumulative)	65	68	69
% U.S. Vials Sold Outside MSK	67%	65% (Q3 reference)	64%
Hospital Formularies (cumulative)	46 (as of 6/30)	40 (as of 9/30)	48 (as of 12/31)

Note: Q3 hospital formularies appear lower than Q2 (40 vs. 46) per transcripts, while Q4 totals 48; management commentary does not reconcile this discrepancy .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenues	FY 2025	N/A	$75–$90M	New
Total Operating Costs & Expenses (ex-COGS)	FY 2025	N/A	$116–$121M	New
Total Operating Costs & Expenses (incl. COGS)	FY 2025	N/A	$129–$134M	New
Total Annual Cash Investment	FY 2025	N/A	$25–$30M	New
Cash Runway	Through	Prior commentary: “into 2027” (reiterated)	Into 2027	Maintained
Total Revenues	Q1 2025	N/A	$18–$21M	New

Earnings Call Themes & Trends

Topic	Q-2 (Q2’24)	Q-1 (Q3’24)	Current (Q4’24)	Trend
DANYELZA competition/market dynamics	U.S. softness from competing therapy and trial activity	Continued headwinds; modeling suggests landing low end of FY guide	DFMO entry a transient headwind; patients may cycle back; focus on high-volume centers	Competitive pressure steady; positioning clarified
Ex-U.S. growth and stocking	Ex-U.S. +55%; launches in Brazil/Mexico; approval in Hong Kong	Ex-U.S. -19% from Western Europe; China stocking revenue shifted to Q4	Ex-U.S. +78%; China stocking and Turkey program; Japan license upfront	Ex-U.S. acceleration with timing effects
SADA PRIT (GD2-SADA)	17 patients; no DLTs; proof-of-concept signs; Part A completion 4Q	20 patients; cohort 6 opened; still no DLTs	22 patients; 9 GD2+ treated; no DLTs; full Part A in Q2’25	Advancing; upcoming data catalyst
OpEx/guidance discipline	Cut FY revenue guide; maintained OpEx; runway to 2027	Reiterated FY24 guidance; runway reiterated	FY25 + Q1’25 guidance; acknowledge estimate dispersion; stick to ranges	Increasing transparency; conservative bias
Payer mix/pricing	—	$1.5M Medicaid adjustments impacted Q3; volume up QoQ	Medicaid/340B mix higher; 7% WACC increase; expect stabilization	Margin headwind stabilizing
Partnerships/regulatory	—	Japan Nobelpharma agreement signed (upfront in Q4)	$2.0M Japan upfront recognized; U.S. patent extended to 2034	Expanding ex-U.S. footprint

Management Commentary

Strategic priorities and execution: “We delivered on the strategic priorities we set out to achieve in 2024 across our business.” – Michael Rossi, CEO .
DANYELZA share and focus: “DANYELZA has kept a steady share of the anti-GD2 market in the U.S. of between 15% and 17%.” – Michael Rossi .
SADA platform: “To date, there have been no dose-limiting toxicities and no instances of any treatment-related serious adverse events…we believe we’ve achieved the validity of our SADA PRIT platform.” – Natalie Tucker .
Guidance philosophy: “There is a fair amount of variation in consensus estimates…we are committed to providing guidance numbers that are realistic.” – Peter Pfreundschuh, CFO .
Pricing and payer mix: “We took a 7% price increase this year…mix has continued to move more towards Medicaid institutions…we should see stabilization.” – Peter Pfreundschuh .

Q&A Highlights

Revenue cadence and seasonality: Management advised modeling FY25 near the midpoint of the annual range, and Q1 within $18–$21M; will provide rolling next-quarter updates to narrow ranges as the year progresses .
OpEx breakdown: FY25 OpEx ex-COGS $116–$121M; think of SG&A baseline as FY24 SG&A less ~$9M one-time items, with the remainder R&D; inclusive-of-COGS OpEx $129–$134M .
SADA dose/tissue considerations: Dose-limiting considerations will include kidney, liver, and bone marrow exposure; selection will be guided by labs and dosimetry; bridging study to Part B planned for early 2026 with relatively quick timeline .
Competitive dynamics and pricing: DFMO may temporarily divert patients but many should cycle back to GD2 therapy; WACC taken up 7%; payer mix shifts (Medicaid/340B) pressured gross margins but expected to stabilize .
COGS and inventory: Q4 COGS was elevated due to batch timing and an inventory write-off; ex-U.S. stock-ins also influenced cost profile .

Estimates Context

S&P Global consensus estimates for Q4 2024 (revenue and EPS) could not be retrieved at this time due to an API limit. As a result, explicit “vs. estimates” comparisons are unavailable in this recap. Management noted “a fair amount of variation in consensus estimates” relative to FY25 and Q1 guidance, underscoring a conservative approach to ranges .
Values would normally be sourced from S&P Global; if needed, we can supplement once access is restored.

Key Takeaways for Investors

Mix shift and timing drove the quarter: License revenue from Japan and ex-U.S. stocking (China) lifted revenue; U.S. price/mix and Medicaid/340B weighed on profitability—expect some volatility as partners manage inventory .
U.S. remains competitive short term: DFMO maintenance and trial activity remain headwinds, but management expects patient cycling back to anti-GD2; focus is on high-volume centers and outpatient differentiation .
2025 playbook is conservative and rolling: New FY25 and Q1 guidance with plans to provide next-quarter updates should reduce estimate risk; model near annual midpoint, monitor quarterly ranges and narrowing .
SADA is the medium-term catalyst: Zero DLTs so far and a Q2 2025 full Part A readout could re-rate the platform; bridging to Part B in early 2026 suggests staged path but watch execution and patient selection/dosimetry .
Ex-U.S. expansion broadening base: Turkey progress, Latin America ramp, Hong Kong approval via partner, and Japan license build durability; absolute TAM in Japan likely incremental vs U.S. .
Liquidity cushion intact: $67.2M cash and 2024 cash investment below guidance; runway into 2027 reduces near-term financing risk as OpEx steps up for SADA .

Supporting Press Releases and Documents (Q4 2024 and Relevant)

Q4 2024 earnings press release and financial tables .
Form 8-K (Item 2.02) with press release attachment .
Q4 2024 earnings call transcript (prepared remarks + Q&A) ; alt source corroboration .
Prior quarters for trend: Q3 2024 press release and call ; Q2 2024 press release and call .
Other relevant releases: Nobelpharma Japan license (Nov 4, 2024) ; Strategic realignment and preliminary FY2024 update (Jan 10, 2025) ; Nature Communications Phase 2 naxitamab interim results (Mar 3, 2025) .

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