Name: Moderna, Inc. Q3 2025 Earnings Call
Start: 2025-11-06T13:00:00.000Z

Executive Summary

Q3 revenue of $1.016B and GAAP EPS of $(0.51) beat S&P Global consensus materially on both the top line ($869.9M) and EPS (−$2.16), driven by stronger-than-expected COVID franchise sales and cost execution; mNEXSPIKE uptake was a key driver in the U.S. (Consensus: Values retrieved from S&P Global*)
FY25 framework tightened: revenue narrowed to $1.6–$2.0B (from $1.5–$2.2B), cost of sales cut to $0.8–$0.9B (from $1.2B), R&D to $3.3–$3.4B (from $3.6–$3.8B), and year-end cash raised to $6.5–$7.0B (from ~$6.0B) as cost-reduction programs outperformed .
U.S. vaccination season is tracking down ~30% YoY in retail through Oct. 24, but Moderna gained share (42% retail, +200 bps YoY) and mNEXSPIKE accounted for 55% of its COVID vaccination volume; international revenue visibility improved via contracted volumes and Canada ramp .
Negative: discontinuation of congenital CMV following Phase 3 miss; norovirus Phase 3 extends to a second Northern Hemisphere season due to case accrual—both shift medium-term pipeline optionality. Cost actions and prioritization continue (no new Phase 3 latent investments pre-2028 break-even target) .

What Went Well and What Went Wrong

What Went Well
- mNEXSPIKE launch traction: “mNEXSPIKE now makes up 55% of our COVID vaccination volume,” with U.S. retail share at 42% (+2 pts YoY) .
- Cost discipline: GAAP OpEx guidance lowered by another $700M; cost of sales cut by $300–$400M vs prior outlook; company targets cash break-even in 2028 .
- Manufacturing efficiency: cost of sales fell 60% YoY and improved to 21% of net product sales (vs 28% LY) on lower write-downs/unutilized capacity and productivity gains .
What Went Wrong
- CMV: congenital program discontinued after Phase 3 failed primary efficacy endpoint; refocus to bone marrow transplant Phase 2 cohort .
- Norovirus: insufficient cases in first season; trial now enrolling a second NH season, pushing timing of efficacy readout .
- Demand environment: U.S. retail vaccinations down ~30% YoY through Oct. 24; management trimmed U.S. revenue high end and narrowed FY25 revenue range .

Financial Results

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Revenue ($USD Millions)	$1,862	$108	$142	$1,016
Net (Loss)/Income ($USD Millions)	$13	$(971)	$(825)	$(200)
Diluted EPS ($)	$0.03	$(2.52)	$(2.13)	$(0.51)
Cost of Sales ($USD Millions)	$514	$90	$119	$207
R&D ($USD Millions)	$1,137	$856	$700	$801
SG&A ($USD Millions)	$281	$212	$230	$268

YoY revenue change Q3: −45% (vs $1.9B LY), driven by lower COVID sales and lack of prior-year $140M true-up; cost of sales down 60% YoY to 21% of net product sales .
U.S. vs Int’l Q3 mix (management commentary): U.S. ~$800M; Int’l ~$200M; half of Int’l from Canada as local manufacturing ramps .

Product and geography detail (Q3 2025):

Breakdown	Q3 2025
COVID-19 product sales total ($USD Millions)	$971
U.S. COVID-19 sales ($USD Millions)	$781
International COVID-19 sales ($USD Millions)	$190
RSV product sales ($USD Millions)	$2
Other revenue ($USD Millions)	$43

Key operating and market KPIs:

KPI	Q3 2024	Q2 2025	Q3 2025
Cost of sales as % of net product sales	28%	—	21%
Inventory write-downs ($USD Millions)	—	$38	$67
Third-party royalties ($USD Millions)	—	$6	$43
Cash, cash equivalents & investments ($USD Billions)	—	$7.5 (as of 6/30/25)	$6.6 (as of 9/30/25)
U.S. COVID retail vaccinations YoY	—	—	−~30% through Oct. 24
U.S. COVID retail market share	~40% prior year	—	42% (↑2 pts YoY)
mNEXSPIKE share of Moderna COVID volume	—	—	55%

Consensus vs actual (Q3 2025):

Metric	Consensus	Actual	Surprise
Revenue ($USD Millions)	$869.9M*	$1,016M	+$146.1M
Diluted EPS ($)	$(2.16)*	$(0.51)	+$1.65

Notes: *Values retrieved from S&P Global

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue	FY 2025	$1.5–$2.2B	$1.6–$2.0B	Narrowed; mid-point up, high end lowered
U.S. Revenue	FY 2025	$1.0–$1.5B	$1.0–$1.3B	Lowered high end
International Revenue	FY 2025	$0.4–$0.6B	$0.6–$0.7B	Raised range
Other Revenue	FY 2025	~$100M	—	Not updated in Q3
Cost of Sales	FY 2025	~$1.2B	$0.8–$0.9B	Lowered
R&D	FY 2025	$3.6–$3.8B	$3.3–$3.4B	Lowered
SG&A	FY 2025	~$1.1B	~$1.1B	Maintained
Capital Expenditures	FY 2025	~$0.3B	~$0.3B	Maintained
Year-end Cash & Investments	FY 2025	~ $6.0B	$6.5–$7.0B	Raised

Management reiterated that newly introduced tariffs are not expected to be material .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
AI/Technology initiatives	Company-wide GPT Enterprise; 100% knowledge workers as daily users; AI to compress workflows (Q2)	Continued AI-driven productivity to reduce costs and speed planning	Improving operational leverage
U.S. COVID vaccination dynamics	Pre-season uncertainty; spring boosters only slightly down; pricing/contracting completed (Q2)	Retail vaccinations −~30% YoY through 10/24; Moderna retail share 42% (+2 pts); mNEXSPIKE majority mix	Lower volume, higher share
Tariffs/Macro	Tariffs not material; monitoring (Q2)	No material impact expected reiterated	Neutral
Product performance	FDA approvals for mNEXSPIKE, RSV label expansion; flu P3 efficacy positive (Q2)	Strong mNEXSPIKE uptake; RSV approvals in 40 countries; flu regulatory filings by Jan 2026	Execution on respiratory
Regulatory/legal	UK appeals ruling upholding Moderna patent vs PFE/BNTX (Q2)	Discontinued congenital CMV after P3 miss; continue BMT Phase 2	Mixed; reprioritization
R&D execution/prioritization	Defer new large P3s in infectious disease until 2028 break-even; focus on oncology and rare diseases within budget (Q2)	Reinforced prioritization; additional GAAP OpEx −$700M; still targeting 2028 cash break-even	Deeper cost focus
Regional trends	U.K. shipment timing shifted to Q1’26 (Q2)	Half of Q3 Int’l revenue from Canada local facility; Australia Q4 ramp, U.K. Q1’26	Canada ramping; U.K. delayed
Oncology	INT broad late-stage program; 4359 into Phase 2; 2028 potential filing prioritized (Q2)	Expect P3 melanoma data cadence; expanded metastatic settings; manufacturing cycle-time improvements	Building optionality

Management Commentary

“mNEXSPIKE now makes up 55% of our COVID vaccination volume.” — Stephen Hoge, President
“We are now on track to beat our 2025 cost plan by over $1 billion on a GAAP basis… We continue to target cash break-even in 2028.” — Jamey Mock, CFO
“We are discontinuing development of our CMV vaccine in [congenital]… We will continue to evaluate mRNA-1647 in… bone marrow transplant patients.” — Management
“We are narrowing our revenue range to $1.6–$2.0 billion… lowering cost of sales to $0.8–$0.9 billion… raising year-end cash to $6.5–$7 billion.” — Jamey Mock, CFO
“We’re seeing benefit from market share gains of mNEXSPIKE… next year will benefit from full-year contributions from Canada, the U.K., and Australia.” — Stéphane Bancel, CEO

Q&A Highlights

Cost cuts and prioritization: Savings split evenly across cost of sales and R&D; R&D focus shifts as large vaccine P3s wind down; selective advancement in oncology and rare diseases within 2028 break-even plan .
U.S. revenue visibility: Tracking shots-in-arms and channel pull-through daily; vaccination rates down 20–40% assumed; confident in $1.0–$1.3B U.S. range .
CMV read-through: Prevention of infection is a high bar; pentamer neutralizing antibodies “not sufficient”; no read-through to other latent programs pursuing disease prevention endpoints .
Norovirus: Two-season design; confidence in second season for case accrual; commercial target profile unchanged .
COVID franchise mix: Expect continued shift to mNEXSPIKE in higher-risk adults; Spikevax remains in pediatrics; split will depend on provider choice .

Estimates Context

Q3 2025 actuals vs S&P Global consensus: Revenue $1.016B vs $869.9M (beat), EPS $(0.51) vs $(2.16) (beat). 16 estimates for both revenue and EPS informed consensus (Consensus: Values retrieved from S&P Global*).
Street revisions likely: FY25 cost-of-sales and R&D cuts, higher year-end cash, and evidence of mNEXSPIKE share gains should drive upward EPS trajectory and improved cash runway expectations, while CMV discontinuation and norovirus timing temper outer-year vaccine optionality .

Key Takeaways for Investors

Beat-and-raise on profitability metrics: Strong Q3 beat on EPS and revenue, with FY25 cost and cash guidance improved—supporting a narrowing path to 2028 cash break-even .
U.S. season volume is down, but mix and share are favorable: Moderna’s share gains and mNEXSPIKE adoption offset softer retail vaccinations; international sales underpinned by contracts (Canada ramp) .
Cost discipline structural: Additional $700M GAAP OpEx cut (half in cost of sales, half in R&D) and manufacturing efficiencies signal sustainable operating improvement into 2026–27 .
Pipeline rebalanced: CMV congenital discontinued; norovirus extends into a second season; respiratory and oncology remain key catalysts (flu filings by Jan 2026; melanoma P3 events pending) .
Near-term catalysts: Analyst Day (Nov 20) for 2026–27 framework updates and 2028 break-even path detail; potential oncology and respiratory readouts through 2026; regional manufacturing scale-up (Australia Q4’25, U.K. Q1’26) .
Trading setup: Focus on durability of U.S. mNEXSPIKE share, Q4 seasonal finish vs guidance ranges, and visibility into FY26 revenue uplift from partnerships and new product approvals .

Notes:

The Q3 2025 8-K 2.02 press release and full financial statements were read in full .
The Q3 2025 earnings call transcript was read in full (multiple sources aligned) - - -.
Prior quarters (Q1 & Q2 2025) earnings press releases and Q2 call were read for trend analysis - - -.
No additional relevant company press releases in Q3 were identified beyond the earnings release.
Consensus estimates and target price from S&P Global: Revenue Consensus Mean $869.9M; EPS Consensus Mean $(2.16); # of Estimates 16 each; Target Price Consensus Mean $39.79; Consensus Recommendation (Text) unavailable (Values retrieved from S&P Global*).

Moderna, Inc. (MRNA)·Q3 2025 Earnings Summary