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YT

Y-mAbs Therapeutics, Inc. (YMAB)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered $20.9M total revenues (+5% YoY) and net loss per share of ($0.12), with DANYELZA net product revenues at $20.9M (+8% YoY) driven by ex‑U.S. strength offsetting U.S. headwinds .
  • Results beat Wall Street consensus: revenue $20.90M vs $19.61M*, EPS ($0.12) vs ($0.20)*; the upside came from ex‑U.S. demand (Western Asia named‑patient program, Eastern Asia, Latin America) while U.S. volumes were pressured by clinical trial enrollment and market dynamics .
  • Gross margin of 86% (vs 89% LY) narrowed on mix shift away from higher‑margin U.S. sales; R&D fell to $11.4M (timing in GD2‑SADA) while SG&A rose to $13.1M (personnel, realignment, legal) .
  • Guidance reiterated: FY2025 total revenue $75–90M, OpEx ex‑COGS $116–121M (incl. COGS $129–134M), cash investment $25–30M, runway into 2027; Q2 2025 revenue guided to $17–19M (seasonality, fewer ex‑U.S. stock‑ins) .
  • Catalysts: NCCN Guidelines now include DANYELZA (Category 2A) in high‑risk neuroblastoma ; Radiopharmaceutical R&D update (May 28) to share GD2‑SADA Part A data and platform optimization plans .

Values for consensus estimates retrieved from S&P Global.*

What Went Well and What Went Wrong

  • What Went Well
    • Ex‑U.S. DANYELZA revenue surged to $7.5M (+$6.7M YoY) on Western Asia named‑patient program and new initiatives in Eastern Asia/Latin America .
    • Management: “We closed the first quarter of 2025 demonstrating solid DANYELZA net product revenue, advancement of our novel SADA PRIT platform and programs, and prudent operational spending.” – Michael Rossi .
    • NCCN Guidelines update to include DANYELZA (Category 2A), expected to aid U.S. adoption and remove a prior headwind .
  • What Went Wrong
    • U.S. DANYELZA revenue declined 28% YoY to $13.4M on clinical trial enrollment and competitive market dynamics; mix shift reduced gross margin .
    • SG&A increased $1.7M YoY to $13.1M from personnel/stock‑based comp, $0.5M realignment charges, and higher legal costs .
    • Gross margin fell to 86% (from 89%) amid lower U.S. contribution; management guided Q2 revenue below Q1 on seasonality and fewer ex‑U.S. stock‑ins .

Financial Results

Core P&L and Margins (chronological: Q3 2024 → Q4 2024 → Q1 2025)

MetricQ3 2024Q4 2024Q1 2025
Total Revenues ($USD Millions)$18.461 $26.495 $20.904
Net Product Revenues ($USD Millions)$18.461 $24.495 $20.904
Gross Profit ($USD Millions)$16.213 (calc: net product rev − COGS) $18.853 $17.903
Gross Margin (%)n/an/a86%
R&D ($USD Millions)$11.168 $12.214 $11.359
SG&A ($USD Millions)$13.613 $12.375 $13.087
Net Loss Per Share ($)($0.16) ($0.15) ($0.12)

Year-over-Year Comparison (Q1 2024 → Q1 2025)

MetricQ1 2024Q1 2025
Total Revenues ($USD Millions)$19.931 $20.904
DANYELZA Net Product Revenues ($USD Millions)$19.431 $20.904
Gross Profit ($USD Millions)$17.834 $17.903
Gross Margin (%)89% 86%
Net Loss Per Share ($)($0.15) ($0.12)
R&D ($USD Millions)$13.267 $11.359
SG&A ($USD Millions)$11.425 $13.087

Segment Performance (Q1 2025 vs Q1 2024)

MetricQ1 2024Q1 2025
DANYELZA Segment Profit from Operations ($USD Millions)$8.676 $8.821
Radiopharmaceuticals Segment Loss from Operations ($USD Millions)($6.041) ($6.107)
Consolidated Loss from Operations ($USD Millions)($6.908) ($6.543)

KPIs

KPIQ4 2024Q1 2025
U.S. DANYELZA Net Product Revenues ($USD Millions)$16.8 $13.4
Ex-U.S. DANYELZA Net Product Revenues ($USD Millions)$7.7 $7.5
U.S. Centers Cumulative69 70
% U.S. vials sold outside MSK64% 72%
Cash & Cash Equivalents ($USD Millions)$67.234 $60.310

Estimate Comparison (Wall Street Consensus vs Actual)

MetricConsensusActualDelta
Q1 2025 Revenue ($USD Millions)$19.61*$20.90 +$1.29M (Beat)*
Q1 2025 Primary EPS ($)($0.20)*($0.12) +$0.08 (Beat)*

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenuesFY 2025$75–$90M $75–$90M Maintained
Total Operating Costs & Expenses (ex‑COGS)FY 2025$116–$121M $116–$121M Maintained
Total Operating Costs & Expenses (incl. COGS)FY 2025$129–$134M $129–$134M Maintained
Total Annual Cash InvestmentFY 2025$25–$30M $25–$30M Maintained
RunwayFY 2025Into 2027 Into 2027 Maintained
Total RevenuesQ1 2025$18–$21M Actual: $20.9M Achieved near high end
Total RevenuesQ2 2025n/a$17–$19M New quarterly guidance

Earnings Call Themes & Trends

TopicPrior Mentions (Q3 2024)Prior Mentions (Q4 2024)Current Period (Q1 2025)Trend
U.S. DANYELZA dynamicsMedicaid reserve adjustment weighed on price/mix; inventory timing; reiterated confidence Competitive dynamics (maintenance therapy, trials); steady share 15–17% U.S. down 28% YoY on trial enrollments and market dynamics; advocacy and new accounts targeted to reaccelerate Near-term pressure; initiatives underway to rebuild
Ex-U.S. growth & stockingNew markets (Turkey); Japan license (upfront in Q4) China stocking order; Western Asia and LatAm strength Strong Q1 ex‑U.S.; fewer stock‑ins anticipated in Q2 Solid; normalizing quarterly stock patterns
NCCN Guidelinesn/an/aDANYELZA added (Category 2A), expected to support adoption Positive tailwind emerging
Radiopharmaceuticals (SADA PRIT)GD2‑SADA Part A progressing; no DLTs; CD38‑SADA sites initiated GD2‑SADA Part A near full data readout; platform validation; CD38 sites activated First CD38 patient dosed; May 28 R&D update to share Part A data and optimization Execution milestones achieved
Tariffs / Macron/an/aPotential tariff impact assessed as minimal; monitoring geopolitics Neutral
Cash runway & efficiencyCash into 2027; disciplined cash investment Cash into 2027; operating below cash investment guidance Cash $60.3M; runway into 2027; operating below cash investment plan Stable

Management Commentary

  • “We made excellent progress in the first quarter this year… recorded DANYELZA net product revenues of $20.9M… our financial position remains strong, with $60.3M in cash with an anticipated runway into 2027.” – Michael Rossi .
  • “With DANYELZA now included in the NCCN guidelines, we believe this will lead to even more support and interest… position DANYELZA back on a growth trajectory in the U.S.” – Doug Gentilcore .
  • “We reiterate our anticipated full year 2025 total revenue, operating expenses, and cash investment… Q2 total revenue expected $17–$19M… guidance numbers that are realistic.” – Peter Pfreundschuh .
  • “Tariff increases would have a minimal impact on Y‑mAbs; we are continuing to monitor geopolitical developments.” – Peter Pfreundschuh .

Q&A Highlights

  • Revenue mix: management expects U.S./ex‑U.S. roughly 70/30–80/20; ex‑U.S. growth steady; U.S. improving with new patient starts into Q2 .
  • Q2 guidance rationale: seasonality and absence of prior stock‑ins imply $17–$19M, still consistent with FY outlook .
  • Medicaid/340B reserves: stabilization expected in 2025 after larger adjustments in 2024 .
  • SADA platform optimization: proprietary linker/chelator planned; bridging study before Part B; platform‑wide improvements expected .
  • Commercial priorities: advocacy development, financial messaging (outpatient benefits), and global expansion to restore U.S. growth trajectory .

Estimates Context

  • Q1 2025 beats: revenue $20.90M vs $19.61M consensus*, EPS ($0.12) vs ($0.20) consensus*; drivers were ex‑U.S. demand and FX gains offsetting higher SG&A .
  • Q2 2025 setup: company guides $17–$19M; consensus ~$18.40M*, consistent with management’s seasonality commentary .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Ex‑U.S. demand is the near‑term growth lever; watch Western Asia named‑patient uptake and Eastern Asia/LatAm initiatives for sustainability into H2 .
  • U.S. headwinds from trial enrollment/maintenance therapy are transitory; NCCN inclusion should support renewed share gains over coming quarters .
  • Margins are sensitive to geographic mix; re‑acceleration in U.S. sales would be margin accretive vs ex‑U.S. contributions .
  • Radiopharmaceuticals are progressing: GD2‑SADA Part A data and platform optimization could be a strategic inflection; monitor timelines for bridging to Part B and target pipeline expansion .
  • Cash runway into 2027 and disciplined cash investment underpin optionality without near‑term financing pressure .
  • Near‑term trading: Q2 seasonal dip is guided and well telegraphed; stock likely more sensitive to May 28 R&D update and U.S. DANYELZA reacceleration signals .
  • Medium‑term thesis: DANYELZA stabilization plus radiopharmaceutical platform validation offers a balanced story of cash‑generating asset and pipeline upside .

Values retrieved from S&P Global.*