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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
Segment breakdown: Not applicable (no reportable segments disclosed).
Key KPIs (Clinical Efficacy – Current Period):
Guidance Changes
Earnings Call Themes & Trends
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 .