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MI

Moderna, Inc. (MRNA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $108 million and GAAP EPS was $(2.52); EPS beat consensus while revenue missed. EPS consensus was $(3.11)* vs actual $(2.52); revenue consensus was $115.3 million* vs actual $108 million .
  • Management reiterated full‑year 2025 guidance: revenue $1.5–$2.5 billion, cost of sales ~$1.2 billion, R&D ~$4.1 billion, SG&A ~$1.1 billion, capex ~$0.4 billion, year‑end cash ~$6 billion .
  • Announced cost program extension: 2026 GAAP operating costs cut to $5.4–$5.7 billion (from prior $5.9 billion) and new 2027 target $4.7–$5.0 billion; midpoint cash cost targets ~$$4.7 billion (2026) and ~$4.2 billion (2027) .
  • Near‑term catalysts: FDA PDUFA dates for next‑gen COVID (May 31, 2025) and RSV 18–59 (June 12, 2025); flu+COVID filing timeline extended into 2026 pending standalone flu efficacy data readout this summer .

What Went Well and What Went Wrong

What Went Well

  • EPS beat consensus with disciplined OpEx execution: loss per share $(2.52) vs consensus $(3.11)*, aided by 19% YoY R&D reduction to $856 million and 23% YoY SG&A reduction to $212 million .
  • Clear cost roadmap: 2026 GAAP OpEx lowered to $5.4–$5.7B and new 2027 target $4.7–$5.0B, supporting cash breakeven objective by 2028 .
  • Pipeline/regulatory momentum: next‑gen COVID (mRNA‑1283) and RSV 18–59 PDUFA dates in Q2; norovirus Phase 3 clinical hold lifted; multiple oncology programs advancing, including intismeran Phase 3s and checkpoint mRNA‑4359 Phase 2 enrollment .

What Went Wrong

  • Top‑line softness in seasonally weak quarter: revenue $108 million vs consensus $115.3 million*, with net product sales $86 million reflecting lower vaccination rates and seasonal demand skew to H2 .
  • Gross margin pressure: cost of sales was 104% of net product sales, up from 58% in Q1 2024, driven by lower volume and cost mix (write‑downs $42M; unutilized/wind‑down $21M; firm commitments loss $10M) .
  • Flu+COVID timeline extended: FDA feedback requires flu efficacy data, pushing combo vaccine approval into 2026 and adding regulatory uncertainty to 2025 revenue optionality .

Financial Results

MetricQ1 2024Q3 2024Q4 2024Q1 2025
Total Revenue ($USD Millions)$167 $1,862 $966 $108
Net Product Sales ($USD Millions)$167 $1,820 $938 $86
Other Revenue ($USD Millions)$0 $42 $28 $22
Net (Loss) Income ($USD Millions)$(1,175) $13 $(1,120) $(971)
GAAP EPS ($USD)$(3.07) $0.03 $(2.91) $(2.52)
Cost of Sales (% of Net Product Sales)58% 28% 79% (53% ex resizing) 104%

Segment/product sales

Product SalesQ3 2024Q4 2024Q1 2025
Spikevax (COVID) ($USD Millions)$1,800 $923 $84
mRESVIA (RSV) ($USD Millions)$10 $15 $2

Cost of sales components

Cost Component ($USD Millions)Q3 2024Q4 2024Q1 2025
Inventory write‑downs$214 $193 $42
Third‑party royalties$92 $45 $5
Unutilized capacity & wind‑down$27 $259 (incl. $238 termination) $21
Losses on firm purchase commitments——$10

Results vs S&P Global consensus

MetricQ1 2025 ActualQ1 2025 Consensus
Revenue ($USD Millions)$108 $115.3*
GAAP EPS ($USD)$(2.52) $(3.11)*

Values marked with * are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$1.5–$2.5B $1.5–$2.5B Maintained
Cost of SalesFY 2025~$1.2B ~$1.2B Maintained
R&DFY 2025~$4.1B ~$4.1B Maintained
SG&AFY 2025~$1.1B ~$1.1B Maintained
CapexFY 2025~$0.4B ~$0.4B Maintained
Year‑end CashFY 2025~$6B ~$6B Maintained
GAAP Operating CostsFY 2026~$5.9B (prior) $5.4–$5.7B Lowered
GAAP Operating CostsFY 2027N/A$4.7–$5.0B New (lower trajectory)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
AI/digital efficiencyEmphasis on AI to streamline SG&A and operations; SG&A down 36% YoY in Q3 and 24% for 2024 Continued double‑digit YoY declines in combined R&D+SG&A; pursuing procurement and process efficiencies Sustained cost discipline
Supply chain/manufacturingManufacturing footprint resizing; contract termination charge in Q4 Tariffs not material; US drug substance made in MA; fill/finish overseas; localization in AU/CA/UK in 2025 Resilient, localized
RegulatoryFiled next‑gen COVID, RSV 18–59, flu+COVID; PDUFA dates set mRNA‑1283 PDUFA May 31; RSV 18–59 June 12; flu+COVID requires flu efficacy, extending to 2026 COVID/RSV near‑term; combo delayed
Product performanceQ3 COVID sales strong from earlier approval; RSV modest Q1 COVID $84M; RSV $2M; market share commentary ~38% scripts; H2 seasonal skew Seasonal demand; H2 weighted
R&D executionPrioritized 10 programs; CMV interim didn’t meet early efficacy; norovirus P3 launched Norovirus clinical hold lifted; CMV durability data; oncology portfolio expansion (checkpoint) Advancing with risk management
Macro/policyN/ABusiness‑as‑usual FDA interactions; strain selection per global regulators; dialogue on recommendations Stable regulatory engagement

Management Commentary

  • “In the first quarter, we continued to execute with financial discipline, significantly reducing our operating expenses, and further prioritized our investments in oncology…announcing a cost structure that is expected to reduce our annual operating expenses by approximately $1.5 billion by 2027.” — Stéphane Bancel, CEO .
  • “We are reducing our 2026 GAAP operating expense forecast from $5.9 billion to a range of $5.4 billion to $5.7 billion…planning to reduce 2027 GAAP expenses to between $4.7 billion and $5 billion.” — Jamey Mock, CFO .
  • “Following feedback from the FDA…flu vaccine efficacy data will now be needed to support the [flu+COVID] application…we now expect the review timeline to be extended into 2026.” — Stephen Hoge, President .
  • “Those [tariffs] in action as of today have not had a significant direct impact…materials sourced from China are not material to our total cost base.” — Jamey Mock, CFO .

Q&A Highlights

  • Flu+COVID approval path: FDA expects standalone flu efficacy; company will amend or resubmit BLA post‑readout; timeline likely extends into 2026 .
  • Next‑gen COVID (mRNA‑1283): “Business as usual” interactions; confidence in meeting PDUFA date despite broader policy noise .
  • Norovirus safety: Single GBS case; clinical hold lifted; continued monitoring with large enrollment; causality uncertain but event rare .
  • Market share and demand: Scripts indicate ~38% share; H1 is seasonally small; customers managing working capital with lower inventories .
  • Cost program drivers: Major reductions to come from R&D as Phase 3s complete; procurement and digital tools add efficiency .

Estimates Context

  • Q1 2025 EPS beat and revenue miss vs S&P Global consensus: EPS $(2.52) vs $(3.11); revenue $108M vs $115.3M .
  • With guidance unchanged and H2 seasonality emphasized, street models may hold full‑year ranges but reallocate revenue timing toward Q3/Q4; flu+COVID push to 2026 likely removes combo revenue from 2025 models .
    Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • EPS beat driven by cost discipline; OpEx trajectory reset lowers execution risk on 2028 cash breakeven target .
  • Top‑line will remain H2‑weighted; Q1 miss is consistent with seasonal respiratory demand; watch Q3/Q4 for revenue realization .
  • Regulatory catalysts near term (mRNA‑1283 and RSV 18–59 PDUFAs) vs. combo vaccine delay to 2026; risk‑reward balanced across filings .
  • Cost of sales sensitivity remains high in low‑volume quarters (104% of product sales in Q1); inventory write‑downs and capacity costs remain key levers .
  • Oncology optionality building: intismeran Phase 3 timeline (event‑driven, 2026 possible) and checkpoint program expansion may re‑rate medium‑term pipeline value .
  • International tender/approvals (EU COVID tender opportunity; RSV approvals in AU/CH/TW/UK) broaden geographic revenue opportunities for H2 .
  • Model conservatively on 2025 combo vaccine revenue (assume zero) and focus on COVID/RSV execution and cost delivery; updates on flu efficacy this summer are a pivotal swing factor .