- **DANYELZA Growth Resilience**: Q1 revenue $20.9M (+8% YoY), Ex-U.S. surging 816%.
- **Radiopharmaceuticals Momentum**: GD2-SADA Part A complete, CD38-SADA dosing begins, May 28 R&D event to reveal pipeline updates.
- **Financial Strength**: $60.3M cash, 2027+ runway, Q2 guidance $17M-$19M.
- **Strategic Wins**: NCCN guideline inclusion, COG trial launch, and minimal tariff risk.
- **H2 Outlook**: U.S. DANYELZA rebound, Radiopharmaceuticals platform expansion, and new clinical data reads.


**【CEO Opening Remarks】**
- Q1 2025 DANYELZA net product revenues: $20.9M (8% YoY growth), driven by Ex-U.S. expansion (+816%) and U.S. market stabilization.
- Radiopharmaceuticals progress: GD2-SADA Phase I Part A completion, CD38-SADA first patient dosed, and R&D event scheduled for May 28.
- Cash position: $60.3M, runway into 2027 with disciplined spending.

**【Doug Gentilcore - DANYELZA Commercial Update】**
- U.S. revenue decline (-28% YoY) due to competitive pressures and clinical trial enrollment delays.
- Ex-U.S. growth: Western Asia named patient program (+$6.7M), Eastern Asia/Latin America expansion.
- Strategic initiatives: NCCN guideline inclusion, COG investigator-led trial, and financial messaging to drive new patient starts.

**【Peter Pfreundschuh - Financial Highlights】**
- Q1 2025 net loss: $5.2M (-$0.12/share), narrower than Q1 2024 ($6.6M loss).
- DANYELZA segment profit: $8.8M (42% margin), Radiopharmaceuticals investment: $6.1M.
- Q2 2025 revenue guidance: $17M-$19M (aligned with seasonal trends).
- Full-year 2025 guidance reaffirmed: $75M-$90M total revenue.

**【Q&A Key Takeaways】**
- DANYELZA U.S. rebound expected in H2 2025 via new starts and guideline adoption.
- Radiopharmaceuticals pipeline: GD2-SADA Part B construct optimization, CD38-SADA safety data, and new target programs to be disclosed on May 28.
- Tariff risk minimal; supply chain diversification underway.
- Naxitamab osteosarcoma development: enhanced diagnostic tools for GD2 expression targeting.


Y-mAbs Therapeutics (YMAB)-13 May 25-2025 Q1 Earnings call transcript

- **2024 Financial Performance**: Total revenue $87.7M, cash balance $67.7M, supporting operations to 2027.
- **DANYELZA Growth**: Q4 ex-U.S. sales +78%, China inventory stocking boosts Q4 revenue.
- **SADA Platform Progress**: GD2-SADA Phase 1 trial shows no toxicities; CD38-SADA sites activated.
- **2025 Outlook**: Revenue guidance $75M-$90M; focus on PRIT platform expansion and cost control.
- **Key Risks**: U.S. market competition, ex-U.S. stocking variability, clinical trial enrollment challenges.

**【CEO Opening Remarks】**
- Full year 2024 total revenue: $87.7 million (within guidance range of $87M-$95M), driven by DANYELZA net product revenues of $85.2 million.
- U.S. market share of DANYELZA remains stable at 15%-17%, despite competition from Naxitamab trials.
- Cash balance of $67.7 million at year-end, supporting operations into 2027.
- Business realignment completed, with senior leadership now based in U.S. to accelerate PRIT platform development.

**【Doug Gentilcore - DANYELZA Business Update】**
- Q4 2024 DANYELZA net product revenues: $24.5 million (+5% YoY), with 78% growth in ex-U.S. markets.
- Key metrics: 69 U.S. accounts with DANYELZA orders, 48 hospital formularies added since launch.
- China sales boosted by inventory stocking order for relabeled product.
- Global expansion efforts include named patient programs in Western Asia and Latin America.

**【Natalie Tucker - Radiopharmaceuticals Update】**
- GD2-SADA Phase 1 trial (Trial 1001): 22 patients dosed, 9 with GD2+ tumors progressing to therapeutic phase.
- No dose-limiting toxicities observed; PK data align with preclinical models.
- CD38-SADA Phase 1 trial: 5 sites activated, recruitment ongoing.
- Q2 2025 pipeline update will include new target selections (40-50 candidates narrowed from 1,200+), focusing on high-value oncology targets.

**【Peter Pfreundschuh - Financial Review】**
- Q4 2024 net loss: $6.8 million (-$0.15/share), driven by $11.4 million annual cash investment.
- 2025 guidance: Total net revenue $75M-$90M; OpEx (ex-COGS) $116M-$121M.
- R&D expenses: $49 million in 2024 (down $5.2M YoY due to milestone costs).
- SG&A increase: $54.6 million YoY (+$9.8M), including restructuring and legal costs.

**【Q&A Highlights】**
- **Revenue Seasonality**: 2025 guidance range reflects ex-U.S. stocking variability; Q1 2025 revenue $18M-$21M.
- **SADA Dose Selection**: Key tissues to monitor: kidneys, liver, bone marrow.
- **R&D Allocation**: Post-DANYELZA trial completion, shifting focus to PRIT platform optimization.
- **CD38 Enrollment Challenges**: Difficult patient population in relapsed NHL, but trials progressing.
- **WACC Impact**: 7% price increase in 2025; competitor actions not disclosed.


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