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MI

Moderna, Inc. (MRNA)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenues were $0.142B with GAAP EPS of $(2.13), beating Wall Street on both revenue and EPS; revenue came in ~26% above consensus ($112.6M*) and EPS was ~$0.87 better than consensus (−$2.998*) [Q2 2025 estimates*].
  • Guidance was recalibrated: 2025 revenue range lowered to $1.5–$2.2B (from $1.5–$2.5B) due to UK shipment timing; GAAP OpEx reduced by ~$400M to $5.9–$6.1B, R&D cut to $3.6–$3.8B, capex lowered to ~$0.3B; year-end cash reiterated at ~$6B .
  • Operational discipline showed up with double‑digit YoY declines in R&D and SG&A; cash and investments ended the quarter at $7.5B, down from $8.4B in Q1, reflecting operating losses .
  • Strategic catalysts: three recent U.S. FDA approvals (mNEXSPIKE, expanded Spikevax pediatric, mRESVIA expansion) and positive Phase 3 flu efficacy (26.6% relative vaccine efficacy vs standard dose), supporting potential filings and combo vaccine path .

What Went Well and What Went Wrong

What Went Well

  • Strong regulatory momentum with three U.S. FDA approvals (mNEXSPIKE for 65+ and 12–64 with risk, Spikevax pediatric sBLA 6 months–11 years at risk, RSV label expansion to 18–59 high risk) supporting future commercialization .
  • Positive Phase 3 flu efficacy: mRNA‑1010 demonstrated 26.6% superior relative vaccine efficacy vs licensed standard‑dose comparator in adults 50+; strong across strains and age subgroups; filing preparations underway .
  • Cost discipline intensified: 2025 GAAP OpEx cut by ~$400M; R&D down 43% YoY and SG&A down 14% YoY in Q2, driven by trial wind‑downs, manufacturing efficiencies, and broad-based reductions .
  • Management quote: “We continue to operate with financial discipline and are improving expected annual operating expenses in 2025 by approximately $400 million” – Stéphane Bancel .

What Went Wrong

  • Revenue seasonality and COVID demand normalization drove second‑quarter softness: total revenue down 41% YoY to $0.142B; net product sales $0.114B .
  • Cost of sales intensity: CoS was $119M, 105% of net product sales, up from 62% in Q2 2024, due to lower sales volume; included $38M inventory write‑downs and $52M unutilized capacity/wind-down costs .
  • Guidance high end lowered by $300M on UK delivery timing shift to Q1 2026; highlights tender timing and contracting risk amid evolving seasonal patterns .

Financial Results

MetricQ2 2024 (YoY base)Q4 2024Q1 2025Q2 2025
Revenue ($USD Billions)$0.241 $0.966 $0.108 $0.142
Net Loss ($USD Billions)$(1.279) $(1.120) $(0.971) $(0.825)
GAAP EPS ($USD)$(3.33) $(2.91) $(2.52) $(2.13)
Cost of Sales ($USD Billions)$0.115 $0.739 $0.090 $0.119
R&D ($USD Billions)$1.221 $1.122 $0.856 $0.700
SG&A ($USD Billions)$0.268 $0.351 $0.212 $0.230
Cost of Sales % of Net Product Sales62% 79% (53% ex. $238M termination) 104% 105%
Segment/Product SalesQ4 2024Q1 2025Q2 2025
COVID (Spikevax) – Total ($USD Millions)$923 $84 $114
COVID – U.S.$244 $29 $88
COVID – International$679 $55 $26
RSV (mRESVIA)$15 $2 Negligible
KPIs (Q2 2025)Value
Cash, cash equivalents and investments$7.5B
Inventory write‑downs$38M
Unutilized capacity & wind‑down costs$52M
Third‑party royalties$6M
Q2 2025 Results vs EstimatesConsensus*Actual
Revenue ($USD Millions)112.6*142
Primary EPS ($USD)−2.998*−2.13
EBITDA ($USD Millions)−912*N/A (not disclosed in PR)

Values retrieved from S&P Global for consensus metrics marked with *.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2025$1.5–$2.5B $1.5–$2.2B Lowered high end by $0.3B (timing shift to Q1’26)
Revenue split 2HFY 2025N/A40–50% in Q3; balance in Q4 New detail
Cost of SalesFY 2025~$1.2B ~$1.2B Maintained
R&DFY 2025~$4.1B $3.6–$3.8B Lowered
SG&AFY 2025~$1.1B ~$1.1B Maintained
CapexFY 2025~$0.4B ~$0.3B Lowered
Year‑end cashFY 2025~$6B ~$6B Maintained
GAAP OpExFY 2025~$6.4B (implied prior) $5.9–$6.1B Lowered by ~$400M

Earnings Call Themes & Trends

TopicQ4 2024 (Q−2)Q1 2025 (Q−1)Q2 2025 (Current)Trend
Regulatory approvals (COVID/RSV)Pre‑filed programs; US approvals earlier in season, 40% retail share PDUFA dates set for mRNA‑1283 (COVID) 5/31 and RSV 6/12 FDA approvals: mNEXSPIKE; Spikevax pediatric sBLA; RSV label expansion Positive momentum
Flu vaccine & ComboInitiated Phase 3 flu efficacy study Interim efficacy readout expected summer ’25; combo review extended into ’26 26.6% superior relative efficacy; preparing FDA filing; combo filing sequencing discussed Strengthening
Cost disciplineAnnual cost reductions; resizing footprint Announced 2026–27 cost cuts; targeting ~$4.2B cash cost by 2027 2025 OpEx cut by ~$400M; workforce −~10%; path to cash breakeven 2028 reaffirmed Continued improvement
Tariffs/supply chainN/ATariffs not material; US drug substance made domestically Newly introduced tariffs not expected to materially impact CoS Neutral
Legal/regulatoryN/AN/AUK Court of Appeal upholds validity/infringement of Moderna patent vs Pfizer/BioNTech Supportive
COVID demand seasonalityStrong Q3 seasonal sales Spring booster down ~10–11%; retail scripts ~38% share Spring booster resilient; 65+ down only 1–2% YoY; fall uncertain pending ACIP Stable within seasonality

Management Commentary

  • “Today, we are updating our 2025 financial framework, reducing the high end of this year's expected revenue range by $300 million due to the timing of shipments… improving expected annual operating expenses in 2025 by approximately $400 million.” – Stéphane Bancel, CEO .
  • “Net product sales were $114 million… CoS represented 105% of net product sales… R&D expenses were $700 million, down 43%… SG&A was $230 million, down 14%.” – Jamey Mock, CFO .
  • “We rolled out GPT Enterprise in 2024… 100% of our knowledge workers are active daily users of ChatGPT… in 2025 we enhanced our AI tools to allow for deep research capabilities.” – Stéphane Bancel .
  • “The change [to revenue guidance] is primarily due to a timing shift of UK COVID shipments… the timing shift does not impact the total value of our long‑term multi‑year contract.” – Jamey Mock .

Q&A Highlights

  • CMV Phase 3 analysis: Company added powered secondary endpoints (e.g., virologic measures, shedding) while blinded; aiming for final analysis in fall 2025; success threshold aligned to ~49% VE lower bound for primary endpoint; hierarchy to pass alpha if primary met .
  • COVID fall demand: Spring booster volumes were only slightly down; 65+ down 1–2% vs prior year; fall outcomes hinge on ACIP guidance and early season uptake .
  • Pricing/contracting: U.S. COVID product sales guidance $1.0–$1.5B embeds variability for pricing/competition; contracting largely complete; within guided range .
  • Flu+COVID combo: Sequencing likely with flu monotherapy first in U.S.; parallel paths possible in Europe via file amendment with flu efficacy data .
  • Cost actions and headcount: ~10% workforce reduction; focus on R&D trial wind‑downs, manufacturing efficiencies, procurement savings; continued hiring in priority roles .

Estimates Context

  • Q2 2025 delivered a clean beat: revenue $142M vs $112.6M consensus*, driven by stronger‑than‑expected U.S. spring booster; EPS −$2.13 vs −$2.998 consensus*, aided by lower R&D and SG&A YoY .
  • Forward setup: 2H revenue mix 40–50% in Q3 with balance in Q4, contingent on regulatory approvals and shipping days; UK shift pushes ~$300M into Q1 2026 .
  • Street likely to adjust models: lower FY25 revenue high end and reduced FY25 R&D/capex imply improved cash burn trajectory; potential flu efficacy and CMV readouts are the key swing factors for 2026–2027 ramp .
    Values retrieved from S&P Global for consensus metrics.

Key Takeaways for Investors

  • Q2 beat on revenue and EPS despite seasonal headwinds; operating discipline is the near‑term support for the equity while commercialization scales beyond COVID [Q2 2025 estimates*].
  • Guidance reset is timing‑driven (UK shipments) rather than demand‑driven; watch 2H execution and U.S. share/pricing posture through retail channels .
  • Cost trajectory is improving: FY25 GAAP OpEx cut by ~$400M; R&D/SG&A declines YoY; path to ~$4.2B cash cost by 2027 and cash breakeven in 2028 underpins downside protection .
  • Regulatory catalysts: positive flu efficacy supports U.S. filing and strengthens combo case; three recent FDA approvals broaden addressable market ahead of the fall season .
  • Pipeline inflection potential: CMV final readout in fall could redefine long‑term value; norovirus efficacy timing dependent on case accrual; oncology programs (Intismeran, mRNA‑4359) gaining momentum with randomized trials .
  • Near‑term trading lens: watch ACIP guidance, early season vaccination data (late Q3), and flu filing updates; any clarity on CMV VE and combo filing approach could be stock catalysts .
  • Legal backdrop: favorable UK Court of Appeal decision on EP949 against Pfizer/BioNTech adds confidence in IP position .

Notes:

  • Consensus/estimates marked with * are values retrieved from S&P Global.
  • Source citations correspond to company documents and the Q2 2025 earnings call transcript.

References:

  • Q2 2025 8‑K 2.02 press release and exhibits .
  • Q2 2025 earnings call transcript .
  • Q1 2025 8‑K and call .
  • Q4 2024 8‑K .