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Celldex Therapeutics, Inc. (CLDX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $1.18M, down 63% sequentially versus Q3 ($3.19M) and down 72% year over year versus Q4 2023 ($4.13M), driven by lower services under Rockefeller agreements .
  • EPS was ($0.71), widening from ($0.64) in Q3 and improving versus ($0.83) a year ago as investment and other income partially offset elevated R&D .
  • Cash, cash equivalents and marketable securities ended the quarter at $725.3M, down from $756.0M in Q3, supporting operations through 2027 (guidance unchanged) .
  • Pipeline execution continued: Phase 3 CSU enrollment ongoing; Phase 2 AD initiated; EoE fully accrued; PN enrolling; CDX-622 Phase 1 in healthy volunteers underway—key 2025 data readouts expected (CSU 76-week, CIndU through week 44, EoE; CDX-622 biomarker readouts) .
  • Street consensus for Q4 2024 (EPS and revenue) was unavailable due to S&P Global access limits; we cannot assess beat/miss this quarter.

What Went Well and What Went Wrong

What Went Well

  • Management highlighted “best-in-disease” Phase 2 efficacy across CSU and CIndU; CSU Week 52 showed 71% complete response at 150 mg Q4W with deepening of response, and favorable tolerability .
  • CDX-622 (bispecific SCF & TSLP) advanced into the clinic (Phase 1, healthy volunteers), strengthening the inflammatory pipeline and mast cell leadership .
  • Cash runway remains robust with guidance to fund operations through 2027, enabling continued Phase 3/program execution without near-term financing pressure .

What Went Wrong

  • Revenue fell sharply QoQ and YoY; Q4 decline was primarily due to reduced services under Rockefeller manufacturing/R&D agreements .
  • R&D expense rose to $46.9M vs. $45.3M in Q3 and $30.4M in Q4 2023, reflecting higher clinical trial and personnel costs tied to the expanded pipeline .
  • Net loss widened sequentially to ($47.1M) from ($42.1M) in Q3, reflecting operating expense growth outpacing investment income .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total Revenues ($USD Thousands)2,498 3,191 1,175
Operating Loss ($USD Thousands)(46,317) (52,126) (56,027)
Net Loss ($USD Thousands)(35,842) (42,121) (47,092)
Basic & Diluted EPS ($USD)(0.54) (0.64) (0.71)
R&D Expense ($USD Thousands)39,687 45,263 46,939
G&A Expense ($USD Thousands)9,128 10,054 10,263
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)802,317 755,999 725,281
Shares Outstanding (Millions)66.3 66.3 66.4

Segment breakdown: Not applicable (no reportable segments disclosed).

Key KPIs (Clinical Efficacy – Current Period):

KPIResultContext
CSU Week 52 Complete Response (150 mg Q4W)71% Deepening of response over 52 weeks; well tolerated
CIndU Week 12 Complete Response – ColdU46.9% (150 mg Q4W) / 53.1% (300 mg Q8W) vs 12.5% placebo Highly significant primary endpoint; rapid, durable responses
CIndU Week 12 Complete Response – Symptomatic Dermographism57.6% (150 mg Q4W) / 42.4% (300 mg Q8W) vs 3.2% placebo Secondary endpoints supportive; favorable safety

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity RunwayThrough 2027“Sufficient to fund operations through 2027” (Q2 2024) ; (Q3 2024) “Sufficient to fund operations through 2027” (Q4 2024) Maintained
Phase 3 Program – CIndU2025 initiation“Global Phase 3 program in CIndU expected to initiate in 2025” (Q3 2024) “Global Phase 3 program in CIndU expected to initiate in 2025” (Q4 2024) Maintained
Key 2025 Data Readouts2025CSU 52-week data presented Q3 2024 CSU 76-week data (2025); CIndU data through Week 44 (2025); EoE Phase 2 data (2025); CDX-622 Phase 1 biomarkers (2025) Added specificity (timing)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D ExecutionPhase 3 CSU initiated; topline CIndU achieved primary; 52-week CSU data to be reported 2H 2024 Phase 3 CSU enrolling; all endpoints met; CSU Week 52 shows 71% CR; CIndU 12-week strongly positive AD Phase 2 initiated; EoE fully accrued; PN ongoing; CDX-622 Phase 1 enrolling; 2025 readouts detailed Strengthening execution across multiple indications
Product Performance (Clinical)CIndU topline Week 12 met primary endpoints CSU Week 52 deepening response; highest CR observed in controlled CSU study (71%) CIndU secondary endpoints detailed; SD/ColdU robust response rates; favorable safety Continued strong efficacy signals
Cash Runway/CapitalCash $802.3M; runway through 2027 Cash $756.0M; runway through 2027 Cash $725.3M; runway through 2027 Runway maintained while investing
Bispecific Platform (CDX-622)Plan to enter clinic by YE 2024 Phase 1 initiation by YE 2024 Phase 1 initiated; enrollment ongoing; plan initial asthma pipeline after HV study Advancing per plan

Management Commentary

  • “In 2024, Celldex set a new bar for efficacy in chronic urticarias—presenting best-in-disease data across both our Phase 2 studies in CSU and CIndU. Our Phase 3 studies in CSU have been met with great enthusiasm… We look forward to… Phase 3 in CIndU.” — Anthony Marucci, Co-founder, President & CEO .
  • “We closed 2024 with the initiation of two new programs—advancing barzolvolimab into its fifth indication, atopic dermatitis, and… CDX-622… We expect 2025 will be a year of continued execution… supported by important data.” — Anthony Marucci .
  • “Two-thirds of patients treated with first line systemic therapy do not achieve complete control of their atopic dermatitis… utilizing our mast cell depleting agent, barzolvolimab, could yield meaningful benefit…” — Diane C. Young, M.D., SVP & CMO .

Q&A Highlights

  • A Q4 2024 earnings call transcript was not available in our source set; no Q&A highlights can be provided this quarter.

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable due to SPGI access limits this session; we cannot assess beat/miss versus estimates for this quarter. If access is restored, we will add comparisons to “Primary EPS Consensus Mean” and “Revenue Consensus Mean” with S&P Global attribution.

Key Takeaways for Investors

  • Cash runway through 2027 remains intact while R&D scales—supports multi-indication development and Phase 3 programs without near-term raise .
  • Clinical momentum is strong: CSU Week 52 71% complete response; CIndU Week 12 robust complete responses vs. placebo; AD Phase 2 launched; EoE fully accrued .
  • Near-term catalysts in 2025: CSU 76-week data, CIndU Week 44, EoE Phase 2 readout, and CDX-622 biomarker data—each can be stock-moving given prior “best-in-disease” efficacy signals .
  • Operating loss and R&D trend higher as Phase 3 and multi-study execution ramp; investment income softens the blow but EPS is likely to remain negative near term .
  • Revenue volatility is non-core (services/grants) and not a driver of valuation; investor focus should remain on registrational path (CSU, CIndU) and breadth of barzolvolimab opportunity .
  • Watch for Phase 3 CIndU initiation timing and regulatory interactions; smooth execution across global sites and manufacturing scale-up are critical de-risking steps .
  • CDX-622 represents strategic expansion beyond urticaria; early HV biomarker readouts in 2025 and subsequent asthma plans broaden the long-term thesis .