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II

ImmunityBio, Inc. (IBRX)·Q1 2025 Earnings Summary

Executive Summary

  • Net product revenue jumped to $16.5M in Q1 2025, up 129% QoQ from $7.2M in Q4 2024; total revenue was $16.5M versus just $0.04M in Q1 2024 as commercialization scaled with permanent J-code billing starting January 2025 .
  • ANKTIVA unit volume rose 150% QoQ, with March volume up 69% vs February, reflecting accelerating adoption; nearly 200 urology practices began registering for the rBCG Expanded Access Program to address the national BCG shortage .
  • Despite stronger operations (loss from operations improved to $(64.4)M from $(95.2)M YoY), GAAP net loss remained high at $(129.6)M due to fair value changes and interest expense; diluted EPS improved to $(0.15) vs $(0.20) YoY .
  • Catalysts: RMAT designation for ANKTIVA + PD-L1 t‑haNK (Feb 2025), BeiGene collaboration for a Phase 3 NSCLC confirmatory trial, EMA/MHRA acceptance of ANKTIVA applications, and April $75M equity financing bolstering pro forma cash to $136.4M .

What Went Well and What Went Wrong

What Went Well

  • Commercial traction: Q1 net product revenue $16.5M (+129% QoQ), units +150% QoQ; March units +69% MoM, supported by permanent J‑code (J9028) . CEO: “We are seeing a steady growth in revenue as urologists increase their use of ANKTIVA…” .
  • Market expansion initiative: rBCG EAP scaling amid U.S. shortage—nearly 200 practices registering; 60+ sites activated and 45,000 vials anticipated for 2025 supply .
  • Strategic/regulatory momentum: RMAT designation (lymphopenia and pancreatic cancer programs), EMA/MHRA acceptance for ANKTIVA, and BeiGene PD‑1 tie‑up for Phase 3 NSCLC .

What Went Wrong

  • Persistent losses: Net loss $(129.6)M despite operational progress; non‑operating items (derivative liabilities, related‑party interest, revenue interest liability) weighed on results .
  • Cash burn: Operating cash flow was $(85.9)M in Q1, with period‑end cash of $61.1M prior to April financing; underscores dependence on external capital to bridge commercialization scale‑up .
  • No formal financial guidance: Company provided operational updates (adoption, rBCG EAP) but no specific revenue/EPS/OpEx guidance ranges, limiting visibility for estimate calibration .

Financial Results

Quarter-over-quarter comparison

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$6.106 $7.552 $16.517
Product Revenue, Net ($USD Millions)$5.954 $7.206 $16.509
Loss from Operations ($USD Millions)$(80.253) $(69.400) $(64.429)
Net Loss Attributable to Common ($USD Millions)$(85.729) $(59.162) $(129.646)
Diluted EPS ($USD)$(0.14) $(0.09) $(0.15)
Cash & Equivalents, End of Period ($USD Millions)$112.300 $143.912 $61.144

Year-over-year comparison (Q1)

MetricQ1 2024Q1 2025
Total Revenue ($USD Millions)$0.040 $16.517
Product Revenue, Net ($USD Millions)$0.000 $16.509
R&D Expense ($USD Millions)$51.322 $45.976
R&D – Related Parties ($USD Millions)$2.029 $2.258
SG&A Expense ($USD Millions)$41.454 $31.977
SG&A – Related Parties ($USD Millions)$0.431 $0.677
Loss from Operations ($USD Millions)$(95.196) $(64.429)
Net Loss Attributable to Common ($USD Millions)$(134.109) $(129.646)
Diluted EPS ($USD)$(0.20) $(0.15)

KPIs and operating metrics

KPIQ4 2024Q1 2025
ANKTIVA Unit Volume QoQ—+150% QoQ
March vs February Unit Volume—+69% MoM
rBCG EAP Sites ActivatedOver 60 (authorized Feb 2025) Scaling; nearly 200 practices registering
Pro Forma Cash & Marketable Securities ($USD Millions)$149.8 at 12/31/24 $136.4 post April financing

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2025Not providedNot providedMaintained (no guidance)
OpEx (R&D, SG&A)FY/Q1 2025Not providedQualitative: lower R&D and SG&A YoY in Q1Maintained qualitative only
EPSFY/Q1 2025Not providedNot providedMaintained (no guidance)
rBCG supply (EAP)CY 2025N/A~45,000 vials available expected in 2025New operational outlook
International regulatory2025MAA submissions planned (UK/EU)MHRA & EMA accepted for review (Feb 2025)Progressed

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available; we used the April 15, 2025 Investor Day transcript for management commentary and Q&A insights.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Billing/J-code adoptionJ-code issued (effective Jan 1, 2025); coverage >200M lives; net product revenue ~$6.0M Permanent J-code in place; Q4 net product revenue $7.2M; early 2025 units up sharply Q1 net product revenue $16.5M; units +150% QoQ; March +69% MoM Accelerating adoption
rBCG supply/EAP—FDA rBCG EAP authorized; 60+ sites; 45k vials anticipated for 2025 Nearly 200 practices registering; initial dosing underway Scaling supply and access
Regulatory (UK/EU)UK MAA submission planned MHRA and EMA accepted ANKTIVA MAAs (Feb 2025) Continued emphasis on global expansion Progressing reviews
R&D executionPipeline expansion; prostate/BCG-naive design; lung cancer plans BeiGene tislelizumab collaboration; Phase 3 NSCLC confirmatory trial setup Investor Day detailed lymphopenia strategy; RMAT designation for ANKTIVA + PD-L1 t‑haNK Broadening indications
Supply chain resilience—J-code plus rBCG authorization; episodes of saline shortages addressed via control of supply chain Full control over ANKTIVA, rBCG, diluent highlighted Strengthening logistics

Management Commentary

  • CEO on commercial momentum: “We are seeing a steady growth in revenue as urologists increase their use of ANKTIVA to treat NMIBC CIS patients… [rBCG] opens a new marketplace for ImmunityBio’s therapies” .
  • Executive Chairman on platform strategy: “ANKTIVA’s increasing use… shows the real-world benefits of our unique approach to immunotherapy… multiple sites open for our second-line lung cancer study” .
  • Investor Day framing: management emphasized lymphopenia as a critical, cross-tumor immunologic deficit and positioned ANKTIVA as a “lymphocyte-stimulating agent” to restore NK/T cells and enhance checkpoint efficacy across tumor types .

Q&A Highlights

  • Radiation + immunotherapy synergy: Discussion on lowering radiation doses to expose tumors (abscopal effect) while preserving NK/T cells; described protocol integration to minimize lymphopenia and maximize immune “heavy lifting” .
  • Neutrophil/lymphocyte ratio: High ANC/low ALC associated with poorer survival; caution against upregulating suppressor cells (e.g., GM‑CSF) in oncology regimens .
  • Papillary sBLA timeline and regulatory consistency: Management reiterated submission and urged common-sense acceptance given similar efficacy/safety to CIS, noting ongoing engagement with FDA .
  • rBCG EAP ramp: Nearly 90 centers in process and many more signing up; emphasis on removing care rationing constraints and ensuring supply of BCG and diluent .
  • Preventative/host targeting: Dialogue on training T-cell memory with adenoviral vaccines in Lynch syndrome and exploring preventative use cases contingent on ALC status .

Estimates Context

  • Q1 2025 Wall Street consensus estimates were unavailable via S&P Global at the time of this analysis; as such, beat/miss assessment cannot be quantified for revenue or EPS at the quarterly level (Values retrieved from S&P Global).*
  • For context, IBRX noted that Q3 2024 net product revenue “surpassed analyst estimates,” reflecting early commercialization traction post-approval .

Key Takeaways for Investors

  • Commercial inflection confirmed: Q1 net product revenue of $16.5M with triple-digit unit growth suggests sustainable acceleration post permanent J-code; watch for continued sequential growth in Q2/Q3 .
  • rBCG EAP is a meaningful market enabler: Addressing supply shortages broadens ANKTIVA’s reach; execution on enrolling practices and site activation should underpin utilization .
  • Operating discipline improving, but capital needs persist: Op loss narrowed YoY; however, high non‑operating charges and cash burn necessitated April $75M raise—monitor cash runway versus commercialization ramp .
  • Multi-pronged pipeline/regulatory catalysts: RMAT designation (lymphopenia/pancreatic), BeiGene PD‑1 partnership (Phase 3 NSCLC), EU/UK reviews—all provide optionality beyond NMIBC CIS .
  • No formal financial guidance: Limited visibility for consensus modeling—investors should track disclosed operating KPIs (units, practice onboarding, EAP expansion) for near-term estimate revisions .
  • Narrative shift to “host immunity”: Management’s lymphopenia-centric thesis posits ANKTIVA as backbone therapy to restore NK/T cells—trial readouts and regulatory feedback will be critical to broader oncology adoption .
  • Near-term trading lens: Stock likely reacts to monthly/quarterly demand data (units, rBCG EAP scaling), regulatory milestones (EMA/MHRA), and any clarity on U.S. papillary sBLA pathway; watch non‑operating items’ volatility on GAAP results .

Appendix: Other Relevant Q1 2025 Press Releases

  • Permanent J‑code (J9028) announcement (Jan 2025) and subsequent sales momentum update (Mar 3, 2025) .
  • FDA authorization for rBCG Expanded Access (Feb 2025); 60+ sites activated and 45k vials expected .
  • MHRA and EMA acceptance of ANKTIVA MAAs (Feb 2025) .
  • RMAT designation for ANKTIVA + PD‑L1 t‑haNK (Feb 2025) .
  • April 2025 $75M equity financing (pro forma cash to $136.4M) .