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MI

Moderna, Inc. (MRNA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $0.97B, down 66% YoY, with diluted EPS of $(2.91); results reflect an earlier U.S. COVID vaccine launch that shifted demand into Q3 and a non-cash $238M contract termination charge driving cost of sales to 79% of net product sales .
  • Spikevax sales were $0.92B in Q4 ($0.24B U.S., $0.68B international); RSV mRESVIA contributed $15M; year-end cash and investments were $9.5B .
  • 2025 framework reiterated: revenue $1.5–$2.5B, cost of sales ~$1.2B, R&D ~$4.1B, SG&A ~$1.1B, capex ~$0.4B, ending cash ~$6B; first-half revenue ~ $0.2B given respiratory seasonality .
  • Pipeline catalysts: FDA BLAs filed for next-gen COVID (PDUFA May 31, 2025), RSV 18–59 (PDUFA June 12, 2025), and flu/COVID combo (efficacy for flu component may be required); CMV interim did not meet early efficacy, final 2025 readout expected; Norovirus Phase 3 on FDA clinical hold after single GBS case but timing impact minimal .
  • Wall Street consensus from S&P Global was unavailable due to request limits; beat/miss vs estimates cannot be assessed [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • Cost discipline: 2024 operating expenses down $2.6B ex-resizing; 2025 cash costs guided to $5.5B; management aims for breakeven on cash cost basis by 2028 .
  • Commercial execution: Strong Q3 Spikevax performance ($1.8B); U.S. retail share ~40% season to date; earlier FDA approval improved timing and logistics .
  • Strategic focus: “We remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business” — CEO Stéphane Bancel .

What Went Wrong

  • Q4 financials compressed: Revenue fell 66% YoY; cost of sales rose to 79% of net product sales, including a non-cash $238M CMO termination; net loss of $(1.12)B vs $217M income last year .
  • RSV ramp slower than planned: $15M Q4 sales; late-season contracting and competitor inventory constrained initial uptake .
  • Regulatory setbacks/uncertainty: CMV interim did not meet early efficacy (study continues); Norovirus clinical hold after a single GBS case under investigation .

Financial Results

MetricQ4 2023Q3 2024Q4 2024
Total revenue ($USD Millions)$2,811 $1,862 $966
Net product sales ($USD Millions)$2,793 $1,820 $938
Other revenue ($USD Millions)$18 $42 $28
Net income (loss) ($USD Millions)$217 $13 $(1,120)
Diluted EPS ($USD)$0.55 $0.03 $(2.91)
Cost of sales ($USD Millions)$929 $514 $739
R&D ($USD Millions)$1,406 $1,137 $1,122
SG&A ($USD Millions)$470 $281 $351
Cost of sales as % of net product sales33% 28% 79%
Cash, cash equivalents & investments ($USD Billions)$13.3 $9.2 $9.5

Segment/Product breakdown (Q4 2024):

ProductQ4 2024 ($USD Millions)
Spikevax total$923
Spikevax U.S.$244
Spikevax International$679
mRESVIA (RSV)$15
Net product sales total$938

KPIs and drivers:

KPIQ3 2024Q4 2024
Inventory write-downs ($USD Millions)$214 $193
Wind-down costs ($USD Millions)$27 $259
Contract manufacturing termination (non-cash) ($USD Millions)—$238
Cost of sales % of net product sales (reported)28% 79%
Cost of sales % of net product sales (ex termination)—53%
Cash, cash equivalents & investments ($USD Billions)$9.2 $9.5

Notes:

  • The earlier U.S. COVID approval (three weeks earlier vs prior year) shifted demand into Q3, reducing Q4 revenue and elevating cost of sales ratio due to lower volume and resizing charges .
  • Q4 cost of sales included $45M royalties, $193M inventory write-downs, and $238M non-cash termination within $259M wind-down costs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2025$1.5–$2.5B (Jan 13, 2025) $1.5–$2.5B (Feb 14, 2025) Maintained
First-half revenueFY 2025—~ $0.2B New detail
Cost of salesFY 2025—~ $1.2B New detail
R&DFY 2025—~ $4.1B New detail
SG&AFY 2025—~ $1.1B New detail
CapexFY 2025~$0.3B prior ~$0.4B Raised (timing)
Ending cashFY 2025~$6.0B ~$6.0B Maintained
TaxesFY 2025Negligible Negligible Maintained

Earnings Call Themes & Trends

TopicQ2 2024 (Prev)Q3 2024 (Prev)Q4 2024 (Current)Trend
Cost disciplineSG&A down 19% YoY; revised 2024 sales to $3.0–$3.5B; focus on AI/digital SG&A down 36% YoY; narrowed cost of sales to 40–45% of sales 2024 cash costs cut $2.6B; 2025 cash costs guided to $5.5B; breakeven on cash costs by 2028 Improving
AI/technology useLeveraging AI to streamline ops Continued AI adoption to reduce purchased services Further digital/AI efficiencies cited Continuing
Supply chain/seasonalityReady supply for 2024–25 season Earlier FDA approval enabled earlier shipments; 40% retail share Earlier U.S. launch shifted Q4 demand into Q3; lower intl APA tailwinds Seasonality prominent
Spikevax performance$184M Q2 sales; seasonal shift expected $1.8B Q3 sales; retail share ~40% $0.92B Q4 sales; $0.24B U.S., $0.68B intl Strong Q3, softer Q4
RSV rampU.S. approval/launch (May/July) $10M Q3; late contracting, competitor inventory $15M Q4; filing for 18–59 high-risk Building slowly
Regulatory/legal—Filed next-gen COVID, RSV 18–59, combo CMV interim failed early efficacy; Norovirus clinical hold (GBS); combo may need flu efficacy Mixed/regulatory uncertainty
R&D executionPositive Phase 3 across respiratory portfolio New Phase 3 INT in NSCLC; norovirus and flu efficacy trials initiated Up to three 2025 approvals; INT timelines plausible 2026, event-driven Advancing late-stage

Management Commentary

  • “We remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business.” — Stéphane Bancel, CEO .
  • “Our 2025 GAAP expenses are projected at $6.4 billion… Excluding non-cash items, we project a cash cost of $5.5 billion.” — Jamey Mock, CFO .
  • “We’ve filed for approval for three respiratory vaccines… Most of the other seven prioritized programs are in pivotal studies.” — Stephen Hoge, President .
  • “Cost of sales for the quarter was $739 million… including a noncash charge of $238 million from the termination of a contract manufacturing agreement.” — Jamey Mock, CFO .
  • “GBS has not been identified as a risk factor for our RSV vaccine or our COVID vaccine to date.” — Stephen Hoge, President .

Q&A Highlights

  • R&D flexibility: Mgmt sees room to further reduce R&D beyond ~$3.6–$3.7B by 2027 if needed; ~50% of trial spend tied to respiratory programs that will roll off .
  • Norovirus clinical hold: Single GBS case prompted proactive pause and document updates; FDA review ongoing; current-season Northern Hemisphere enrollment completed, minimal timeline impact expected .
  • CMV timing: Final efficacy analysis expected in 2025; interim lacked early efficacy per DSMB; outcome could still be favorable at final analysis given wider confidence intervals at interim .
  • Combo vaccine approval: COVID component efficacy established; regulators may require flu efficacy from mRNA-1010; robust season suggests an interim efficacy analysis could occur at end of current season .
  • Inventory write-downs: $500M inventory write-downs and ~$100M unutilized capacity in 2024; targeting future write-downs <10% over time as raw materials and capacity align to demand .

Estimates Context

  • S&P Global consensus (EPS and revenue) for Q4 2024 was unavailable due to request limits; therefore, performance vs. Wall Street estimates cannot be evaluated in this recap [GetEstimates error].
  • Company-level guidance and actuals are used throughout; future estimate comparisons will be provided when S&P Global access permits.

Key Takeaways for Investors

  • Q4 compression is largely timing- and resize-driven; excluding the $238M CMO termination, cost of sales would have been 53% of net product sales, highlighting structural progress despite volume headwinds .
  • 2025 revenue guide ($1.5–$2.5B) reflects respiratory seasonality and conservative exclusion of new product revenue; first-half revenue guided to ~ $0.2B .
  • Near-term regulatory catalysts (next-gen COVID May 31, RSV 18–59 June 12) and flu efficacy readout are pivotal for FY25/26 revenue trajectory and narrative diversification beyond COVID .
  • Cash runway remains robust ($9.5B YE24; ~$6B YE25 target) while cash cost reductions continue; breakeven on cash cost basis targeted by or before 2028 .
  • RSV adoption curve is slower due to contracting dynamics and inventory; broader label and ex-U.S. launches are expected to build over 2025–2026 .
  • CMV final analysis and Norovirus efficacy will shape the latent/other virus franchise; the Norovirus clinical hold is unlikely to impact current-season efficacy timing materially .
  • INT oncology program remains a medium-term value driver; Phase 3 melanoma fully enrolled, with 2026 readout plausible and additional Phase 3s underway (NSCLC) .

Appendix: Sources

  • Q4 2024 8-K press release and financial statements .
  • Q4 2024 earnings call transcripts –; –.
  • Q3 2024 8-K and call –; –.
  • Q2 2024 8-K and call –; –.
  • JP Morgan business & pipeline update (Jan 13, 2025) –.