MRNA · Q3 2025 Earnings

Cautious

Moderna

Reported November 6, 2025

30-second summary

Moderna posted $1.016B of Q3 revenue, down 45% YoY but landing solidly inside the implied $500M–$975M Q3 cone from last quarter's H2 split — the upper half, in fact. The real story is the cost line: management lowered FY GAAP opex by another $700M (to $5.2–$5.4B), cut R&D guidance by ~$350M at the midpoint, and disclosed a fresh cost-of-sales reduction from $1.2B to $0.8–$0.9B, while raising the year-end cash target to $6.5–$7.0B. FY revenue was narrowed with a downward bias (high-end cut $200M to $2.0B; low-end raised $100M to $1.6B), CMV failed its primary efficacy endpoint, and the 2028 cash break-even target was reiterated.

Headline numbers

EPS

Q3 FY2025

$-0.51

Revenue

Q3 FY2025

$1.02B

-45.4% YoY

Operating margin

Q3 FY2025

-25.6%

Key financials

Q3 FY2025

Metric	Q3 FY2025	YoY	Q2 FY2025	QoQ
Revenue	$1.02B	-45.4%	$0.14B	+615.5%
EPS	$-0.51	—	$-2.13	+76.1%
Operating margin	-25.6%	—	-639.4%	+61380bps

Guidance

Moderna narrowed FY2025 revenue range and substantially lowered operating expenses, R&D, and cost of sales guidance, while raising cash balance expectations—signaling tighter cost discipline and revised execution pace offset by lower revenue delivery.

Guidance is issued for the full year only, refreshed each quarter. Prior and new below are the same FY updated this quarter.

New guidance

Metric	Period	Guide	YoY
Cost of sales	FY 2025	$0.8 - $0.9 billion	—

Changes to prior guidance

Metric	Period	Prior guide	New guide	Δ	Result
Revenue	FY 2025	$1.5 - $2.2 billion	$1.6 - $2.0 billion	high-end lowered $200M (from $2.2B to $2.0B); low-end raised $100M (from $1.5B to $1.6B); midpoint lowered from $1.85B to $1.8B	Lowered
Operating expenses	FY 2025	$5.9 - $6.1 billion	$5.2 - $5.4 billion	-$700M improvement at midpoint (from $6.0B to $5.3B)	Lowered
Research and development expenses	FY 2025	$3.6 - $3.8 billion	$3.3 - $3.4 billion	-$300-500M (midpoint $3.7B → $3.35B)	Lowered
Year-end cash and investments	FY 2025	approximately $6.0 billion	$6.5 - $7.0 billion	+$500M - $1.0B (midpoint $6.0B → $6.75B)	Raised

Reaffirmed unchanged this quarter: Selling, general and administrative expenses (approximately $1.1 billion)

Segment KPIs

Q3 FY2025

Segment	Q3 FY2025
COVID vaccine U.S. sales	$781 million
COVID vaccine international sales	$190 million

Other KPIs

Q3 FY2025

Segment	Q3 FY2025
mNEXSPIKE approvals	40 countries (2025-2026 formula); FDA approved (U.S. 65+, 12-64 with risk factors); Canada approved
mRESVIA approvals	40 countries (60+); 31 countries (18-59 at-risk)
Gross margin	79.0%
R&D expenses	$801 million
SG&A expenses	$268 million
Cash, cash equivalents and investments	$6.6 billion

Management tone

Narrative arc: Q2 — COVID franchise erosion, cost discipline real → Q3 — cost discipline accelerates as revenue floor stabilizes, pipeline pruning intensifies.

The opex narrative has shifted from "$300M improvement" to "$700M improvement" in one quarter. Last quarter management framed the ~$400M opex reduction as productivity-driven and paired with continued late-stage investment. This quarter the language is sharper: cost of sales cut $400M, R&D cut $350M, and the company explicitly told analysts that R&D reductions are "mixed: clinical trial execution is more efficient, but some Phase II/III programs are being discontinued." This is no longer pure productivity — it's portfolio pruning under revenue pressure. The 50% cash-cost reduction in two years ($9B to $4.6B) is real, but the marginal cuts are now coming from program decisions, not just headcount and capacity wind-down.

Pipeline timeline has slipped across multiple programs. Last quarter Intismeran adjuvant melanoma was "near-term"; the CMV Phase 3 final readout was framed for the fall. This quarter CMV missed its primary efficacy endpoint (pentamer neutralizing antibodies "not sufficient" to prevent infection), mRNA-1010 (flu) submissions are pushed to January 2026 across four geographies, mRNA-1647 (CMV) is being reorganized into a bone marrow transplant indication, and a "registrational study" — unspecified — was deferred to 2026. The pipeline bridge to 2028 break-even just got narrower.

On capital strategy, the language is now explicitly "we won't self-fund Phase 3s for non-core assets." Asked about M&A and partnerships, management said EBV and latent vaccine programs will look for pharma partners rather than internal Phase 3 investment. This is a meaningful change in posture from prior quarters' broad "diversified pipeline" framing — it's an acknowledgment that the cash runway can't carry every program through registrational trials.

Q&A highlights

Salveen Richter · Goldman Sachs

What is being deprioritized or changed to enable the R&D and cost of sales reductions? What is Moderna's strategy on IP dynamics and royalty/revenue with other players entering the market?

Cost of sales reductions are purely efficiency-driven (unutilized capacity, waste reduction, labor productivity) with no deprioritized investments. R&D reductions are mixed: clinical trial execution is more efficient, but some Phase II/III programs are being discontinued. Large vaccine Phase 3 trials are winding down naturally, shifting focus to oncology. On IP/Arbutus: defending vigorously against patent claims scheduled for March 9, 2026 trial, confident in technology non-infringement.

$500M to $700M recent reduction split evenly between R&D and cost of sales50% cash cost reduction over 2 years from ~$9B (2023) to $4.6B (2025)Large vaccine Phase 3 trials winding down, moving to oncology focusArbutus litigation trial scheduled March 9, 2026

Gina Wang · Barclays

How frequently does Moderna track pharmacy inventory levels for U.S. COVID revenue? What additional color on Q4 revenue estimates? Why did CMV immunogenicity data not translate to clinical benefit?

Tracks vaccinations/shots-in-arms almost daily via wholesaler data. Season-to-date through Oct 24 shows 30% decline in U.S. shots, within guidance of 20-40% decline. Originally guided flat to down 33%; now expecting down 20-40%. CMV miss: pentamer neutralizing antibodies were not the missing piece for preventing CMV infection; insufficient by itself despite earlier high hopes. Will conduct detailed data analysis and publish findings.

U.S. shots in arms down 30% season-to-date through October 24Revised U.S. revenue guidance: $1.0 to $1.3 billion (vs. prior $1.0 to $1.5 billion)CMV trial did not meet primary efficacy endpoint for prevention of infectionPentamer neutralizing antibodies were not sufficient to prevent CMV infection

Luca Issi · RBC

What gives confidence in 2028 cash break-even guidance given $4.6B cash cost and declining COVID revenue? What near-term products can drive top-line re-inflection? Can you comment on reports of large pharma deals and current thinking on D&D?

Break-even requires both revenue growth and cost reduction; still significant cost-reduction opportunities ahead with updated 2026-2027 framework to be disclosed at Analyst Day. Revenue growth expected from geographic expansion, strategic partnerships, and new product introductions. On M&A: engaging with pharma and financial sponsors on programs like EBV and latent vaccines to avoid self-funding Phase 3s. Partnerships with Blackstone on flow existing; will communicate when deals close.

2028 cash break-even remains committed target$4.6 billion 2025 cash cost (midpoint)EBV vaccine not being funded for Phase 3 self-investment; seeking pharma partnerBlackstone partnership on flow existing

Corey Kasimov · Evercore

Is slow norovirus case accrual surprising? Does it reflect commercial demand potential for the product?

Slow accrual was anticipated; study was always designed as potential two-season study, similar to flu vaccines. Management remains confident in target product profile and health economic benefits for prevention of severe-to-moderate infections in high-risk populations (long-term care, occupational risk). No change expected to commercial profile; epidemiology challenges addressable with second enrollment season.

Phase 3 norovirus study requires two seasons to accrue sufficient cases for interim analysisProceeding with second Northern Hemisphere season enrollmentCommercial target product profile unchangedExpected to accrue sufficient cases for interim analysis with second season

Jessica Fry · JPMorgan

How is U.S. COVID vaccine demand tracking vs. projections? Ex-U.S. demand outlook? What is the annual revenue potential from U.K., Canada, and Australia manufacturing partnerships?

U.S. tracking to revised guidance of $1.0-$1.3B with vaccination rates expected down 20-40% (vs. original flat-to-down 33%). Halfway through season with good visibility. International raised to $600-$700M (vs. prior $500-$700M) due to contracted volumes; remaining variables are delivery timing and vaccination rates. Strategic partnerships (Canada, UK, Australia): Canada already contributing ~50% of Q3 international revenue; Australia expected Q4 2025, UK Q1 2026. No specific annual run-rate guidance provided, but characterized as pure growth for 2026.

U.S. revenue guidance: $1.0 to $1.3 billionInternational revenue guidance raised to $600 to $700 millionCanada contributed ~50% of Q3 international revenueAustralia manufacturing expected revenue in Q4 2025

Answers to last quarter's watch list

Q3 revenue against the implied 40–50% H2 split. Q3 came in at $1.016B — solidly in the upper half of the $500M–$975M Q3 cone, and consistent with the prior FY midpoint. The Q3 print itself is on-track; the high-end FY cut is a Q4 issue, not a Q3 miss.

Resolved positively

US fall booster volumes vs. the 1–2% 65+ decline benchmark. Management disclosed overall US shots down 30% season-to-date through Oct 24, but did not break out the 65+ cohort specifically. US revenue guidance was trimmed at the high end from $1.0–$1.5B to $1.0–$1.3B. The benchmark wasn't directly re-cited, but the high-end cut implies the 65+ cohort is not fully offsetting the broader decline.

Resolved negatively

CMV Phase 3 final analysis — VE clearing the 49.1% lower-bound threshold. CMV missed its primary efficacy endpoint. Management said pentamer neutralizing antibodies were "not sufficient" to prevent infection; mRNA-1647 is being reoriented toward a bone marrow transplant indication. This is a material loss of a 2026–27 catalyst.

Resolved negatively

Intismeran adjuvant melanoma interim efficacy readout. Not addressed in the press release; not surfaced in Q&A as a near-term event. Last quarter management said "near-term"; this quarter the catalyst calendar is silent.

Continue monitoring

Cash burn vs. the $6B YE target. Year-end cash target raised to $6.5–$7.0B (from ~$6.0B). Q3 ended at $6.6B, implying near-zero Q4 burn. Cost-out is converting to cash preservation faster than expected.

Resolved positively

Whether the $300M FY high-end cut migrates into Q1 FY2026. Not directly addressed in the press release. UK/Canada/Australia manufacturing partnerships were discussed as 2026 growth drivers, but the specific UK timing narrative from last quarter wasn't revisited.

Not resolved

Progress toward 2027 $4.2B cash cost target and 2028 break-even. 2025 cash cost midpoint $4.6B (down from $9B in 2023); 2028 break-even reiterated; updated 2026–27 framework to be disclosed at Analyst Day. On track, but increasingly dependent on R&D portfolio choices.

Continue monitoring

What to watch into next quarter

Q4 FY2025 revenue vs. the implied $584M–$984M range. FY guide of $1.6–$2.0B less Q1–Q3 reported (~$1.0B for Q3 plus prior H1 of ~$250M = ~$1.26B through Q3) implies Q4 of ~$340M–$740M. A Q4 print below ~$340M would mean the new low-end is breaking.

Whether the lowered $5.2–$5.4B FY opex guide actually delivers, and whether the cuts hold into 2026. Updated 2026–27 cash cost framework expected at Analyst Day; watch whether the $4.6B 2025 cash cost cleanly steps down toward $4.2B in 2027.

mRNA-1010 (flu) regulatory submissions by January 2026 across US, Canada, Australia, Europe. Four submissions in eight weeks is a credibility test for the regulatory team.

Detailed CMV failure analysis publication. Whether secondary endpoints showed any signal that preserves optionality on mRNA-1647 in transplant or other settings.

Arbutus patent trial March 9, 2026. Royalty exposure on mRNA platform IP is binary risk.

Strategic partnership revenue ramp from Canada (already 50% of Q3 international), Australia (Q4 2025), and UK (Q1 2026). Management called these "pure growth for 2026" without quantification — first quantified disclosure will reset 2026 modeling.

Whether Moderna announces an external pharma partner for EBV or other latent vaccine programs. Management has explicitly said it won't self-fund Phase 3 for these — a partnership deal would validate the capital strategy; the absence of one through 2026 would call it into question.

Sources

Moderna Q3 FY2025 Press Release (SEC Exhibit 99.1): https://www.sec.gov/Archives/edgar/data/1682852/000168285225000073/exhibit9912025q3pressrelea.htm
Moderna Q3 FY2025 earnings call Q&A (analyst exchanges)

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