MRNA · Q4 2025 Earnings

Cautious

Moderna

Reported February 13, 2026

30-second summary

Moderna closed FY2025 at $1.944B revenue (-39.9% YoY), landing inside the $1.6–$2.0B guide but near the high end, with Q4 revenue of $678M (-29.8% YoY). FY2026 guidance frames "up to 10%" growth (~$2.09B implied ceiling) against a planned cash drawdown from $8.1B to $5.5–$6.0B — $2.1–$2.6B of burn — while R&D is cut another ~$100M to ~$3.0B and the company stakes 2026 credibility on flu refiling, INT melanoma Phase 3, and norovirus readouts. The flu RTF on mRNA-1010 is the unresolved overhang; management would not quantify 2028 break-even impact.

Headline numbers

EPS

Q4 FY2025

$-2.11

Revenue

Q4 FY2025

$0.68B

-29.8% YoY

Operating margin

Q4 FY2025

-126.4%

Key financials

Q4 FY2025

Metric	Q4 FY2025	YoY	Q3 FY2025	QoQ
Revenue	$0.68B	-29.8%	$1.02B	-33.3%
EPS	$-2.11	—	$-0.51	-313.7%
Operating margin	-126.4%	—	-25.6%	-10080bps

Guidance

Company guides FY2026 for modest recovery with up to 10% revenue growth while planning significant cash burn to $5.5-6.0B, expecting approval decisions and clinical data across multiple programs.

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

Actuals vs prior guidance

Metric	Period	Prior guide	Actual	Δ	Result
Revenue	FY2025	$1.6 - $2.0 billion	$1.944 billion	-$0.056 billion below high end of guide	Missed

New guidance

Metric	Period	Guide	YoY
Revenue Growth (YoY)	FY2026	up to 10%	—
Cost of Sales	FY2026	approximately $0.9 billion	—
Research and Development Expenses	FY2026	approximately $3.0 billion	—
Selling, General and Administrative Expenses	FY2026	approximately $1.0 billion	—
Year-end Cash and Investments	FY2026	$5.5 to $6.0 billion	—
Capital Expenditures	FY2026	$0.2 to $0.3 billion	—
Revenue Split (Geographic)	FY2026	approximately 50% U.S. and approximately 50% international	—

Other KPIs

Q4 FY2025

Segment	Q4 FY2025
R&D Expenses	$775 million (Q4 2025)
Cost of Sales	$452 million (Q4 2025)
SG&A Expenses	$308 million (Q4 2025)
Approved Products	3 (Spikevax, mNEXSPIKE, mRESVIA)
Cash and Investments	$8.1 billion (Dec 31, 2025)

Management tone

Narrative arc: Q2 — COVID franchise erosion, cost discipline real → Q3 — cost discipline accelerates, pipeline pruning intensifies → Q4 — recovery framing returns despite regulatory setback.

The headline shift is from "managing decline" to "up to 10% recovery growth," and it's happening in the same quarter as a flu Refuse-to-File from FDA. Last quarter management was narrowing the FY2025 revenue cone and explicitly pruning Phase II/III programs to defend the 2028 break-even target. This quarter the framing pivots to a positive YoY growth number for the first time since the COVID peak unwound. The flu RTF on mRNA-1010 would normally be a clear negative for 2027 revenue, but on the call CFO Jamie Mock pointed to "10 large shots on goal" and called it "too early to tell" the 2028 break-even impact given the fluid situation. The recovery narrative is being asserted while a major regulatory pathway is unresolved.

The cost-out posture has hardened into explicit operational leverage guidance. Q3 introduced cost-of-sales discipline and the $5.2–$5.4B opex framework. Q4 extends that with a more granular FY2026 cost line: R&D stepping down further to ~$3.0B, SG&A flat at ~$1.0B, CapEx at $0.2–$0.3B, total GAAP opex $4.9B and cash costs $4.2B. Management is now willing to commit numerically to a step-down in spending — a posture shift from the "we'll fund what we need to fund" language of earlier in the year. The 2026 implied burn of $2.1–$2.6B is a modest step-up from FY2025 operating cash usage of $1.873B, reflecting continued late-stage trial spend against a revenue base that has not yet inflected.

The pipeline confidence has moved from "near-term" hedging to specific late-stage trial differentiation. In Q&A, Stephen Hoge ranked INT histology probability with melanoma at the top citing the Phase IIb ~50% reduction in relapse/death over 5 years, walked through norovirus differentiation (trivalent composition, seropositive older adults, placebo comparator), and detailed mRNA-1010 Phase III efficacy (27% relative VE vs standard dose). Last quarter the CMV failure had cast doubt on translation from immunogenicity to efficacy; this quarter the team is leaning into clinical detail to rebuild confidence. Whether the FDA agrees on the flu pathway in the Type A meeting (standard 30-day process) is the near-term test.

Q&A highlights

Terrence Flynn · Morgan Stanley

Impact of flu RTF on 2028 cash flow break-even guidance; timing of Type A meeting with FDA; refinement of INT adjuvant melanoma data timing (H1 vs H2).

Management stated flu file is under review in Europe, Canada, Australia with goal of contributing to 2027 growth. Type A meeting timing is 30 days; U.S. pathway depends on FDA feedback. INT melanoma is event-driven but confident readout will occur in 2026; cannot provide H1 vs H2 specificity. Jamie noted situation is fluid and premature to quantify 2028 break-even impact given 10 other growth levers.

Flu vaccine under review in Europe, Canada, Australia targeting 2027 fall launchType A meeting is standard 30-day processINT melanoma Phase III has interim analyses plannedCompany has 10 large growth drivers beyond flu product

Elizabeth · Goldman Sachs

Regulatory read-through from RTF on 1010 to 1083 combo vaccine; study data supporting initial flu submission and requirements for refiling; INT histology ranking by probability of success.

Management stated combo vaccine approval expected in Europe this year; U.S. refiling gated on Type A feedback for mRNA-1010. Initial flu file included Phase III with 27% relative vaccine efficacy vs standard dose and Phase III immunogenicity study vs Fluzone High-Dose with statistical superiority. For INT, melanoma has highest probability given robust Phase IIb data showing ~50% reduction in relapse/death over 5 years; expecting read-through to Phase III study.

mRNA-1010 Phase III: 27% relative vaccine efficacy vs standard dose in 41,000-person studyComparable efficacy to licensed products (Fluzone: 24%, Flublock: 30%)Phase III immunogenicity vs Fluzone High-Dose showed statistical superiorityINT Phase IIb melanoma: ~50% reduction in relapse/death rates over 5 years

Eliana Merle · Barclays

European COVID vaccination market dynamics including vaccination rates and pricing; pathway for flu-COVID combination vaccine approval internationally; FDA discussions on strain selection for flu vaccines.

Management stated European COVID market currently ~$700 million shots-in-arms, not accounting for wastage; MNEXT Spike has higher relative vaccine efficacy (~25% higher vs. Spikevax in older adults with comorbidities) and will be competitive. Combination vaccine expected for approval in Europe this year with potential launch in 2027. Strong international regulatory appetite for delayed strain selection closer to season start, with FDA having chosen different COVID strains than rest of world in 2 of 4 past seasons. Current influenza B strain differs in U.S. vs. Northern Hemisphere.

European COVID market: ~$700 million current shots-in-arms estimateMNEXT Spike: 25% higher relative vaccine efficacy vs. Spikevax in older adults with comorbiditiesCurrent market estimated at ~20 million annual shotsFlu-COVID combination vaccine: Europe and Canada filings in review

Michael Yee · UBS

INT Phase III melanoma trial design with interim analyses; Phase II stopping for efficacy; norovirus study enrollment status, readout timing, and confidence level given prior disappointments.

Management confirmed INT Phase III melanoma has interim analysis planned this year looking at relapse-free survival (RFS) primary endpoint with additional analyses for distant metastasis-free survival if needed. Phase II hit statistical hypothesis at interim; Phase III conservatively designed to replicate. Norovirus Phase III is case-driven, expects potential readout in 2026. Differentiated from prior norovirus attempts via trivalent composition targeting 66-70% of circulating strains, focus on seropositive older adults (booster approach) rather than children, and placebo comparator (no comparator concerns like flu).

INT Phase III melanoma: interim analysis on relapse-free survival this yearPhase II demonstrated statistical hypothesis at interim with stable curvesConservative Phase III design to repeat Phase II resultsNorovirus Phase III: trivalent composition targeting 66-70% of circulating norovirus

Courtney Breen · Bernstein

Demographic composition of flu Phase III efficacy study (percentage of patients ≥65 years); FDA feedback on INT Phase III design; responsibility for INT BLA submission and CBER review.

Management confirmed >50% of Phase III flu efficacy study was ≥65 years, with >10% above 75 years; superior efficacy consistent across age groups and higher with frailty/comorbidities/severe outcomes. Separately, Phase III immunogenicity study (P303 Part C) had 3,000 patients in head-to-head vs. Fluzone High-Dose. For INT, management reported robust engagement with FDA and global regulators; study is blinded, powered for efficacy endpoints; design discussions were productive. Merck is Phase III study sponsor and BLA sponsor; both companies participate in regulatory discussions as 50-50 joint venture partners. CBER is FDA office of review with other offices involved due to oncology import.

mRNA-1010 Phase III efficacy study: >50% age ≥65 years, >10% age >75 yearsSuperior efficacy consistent across age populationsEfficacy point estimates higher with frailty, comorbidities, or severe outcomesPhase III immunogenicity study (P303 Part C): 3,000 patients vs. Fluzone High-Dose

Answers to last quarter's watch list

Q4 FY2025 revenue vs. the implied $340M–$740M range. Q4 came in at $678M — comfortably inside the range, in the upper half. FY landed at $1.944B vs. the $1.6–$2.0B guide, near the high end. The Q3 framework held.

Resolved positively

Whether the lowered $5.2–$5.4B FY opex guide actually delivers, and whether the cuts hold into 2026. FY2025 opex came in at $5.018B, below the low end of the guided range. FY2026 cost guidance steps down further: R&D ~$3.0B (vs. $3.1B FY2025 actual), SG&A ~$1.0B (flat), COGS ~$0.9B. The cuts held and are extending into 2026.

Resolved positively

mRNA-1010 (flu) regulatory submissions by January 2026 across US, Canada, Australia, Europe. Europe, Canada, and Australia filings are under review. The US received a Refuse-to-File from FDA on mRNA-1010, with a Type A meeting (standard 30-day process) required to clarify the path forward. Three of four submissions landed; the most commercially important one did not.

Resolved negatively

Detailed CMV failure analysis publication. Not surfaced in the press release or Q&A. mRNA-1647 was not discussed as a near-term catalyst in the readout schedule.

Continue monitoring

Arbutus patent trial March 9, 2026. Not addressed in the press release; not surfaced in Q&A.

Continue monitoring

Strategic partnership revenue ramp from Canada, Australia, and UK. Q4 international product sales of $381M (59% of Q4 product revenue) suggests the partnership volumes are showing up. FY2026 guidance establishes a 50/50 US/International split target driven primarily by UK and Australia locally manufactured product launches; a $200M UK COVID order is expected to be fulfilled in 1H 2026 for the spring booster campaign.

Continue monitoring

External pharma partner for EBV or other latent vaccine programs. No announcement of an EBV or latent vaccine partnership in this print. The Merck INT partnership (where Merck sponsors Phase III and BLA) is the live external structure, but that pre-existed.

Not resolved

What to watch into next quarter

Type A meeting outcome on mRNA-1010 (flu) with FDA. Standard 30-day process from the RTF; whether the US flu refiling can target a 2026 submission cycle determines whether the 2027 launch is salvageable in the largest single market. A second adverse signal would force a reset of the "up to 10% growth" framing.

Q1 FY2026 revenue against the "up to 10%" FY growth framework. No floor was disclosed, and management guided to ~15% of revenue in 1H / ~85% in 2H. A 1H print materially below the prior-year comp would imply the FY ceiling is not the right anchor.

INT Phase III melanoma interim analysis on relapse-free survival (this year, per Hoge). This is the single most important value-driver readout on the 2026 calendar; a positive interim would reset the oncology narrative materially.

Norovirus Phase III readout pacing. Case-driven trial with potential 2026 readout — first interim event-rate disclosure will reset modeling of timing.

Cash burn cadence vs. the $5.5–$6.0B year-end target. $8.1B starting cash less $5.5–$6.0B target = $2.1–$2.6B burn. Q1 burn rate will tell whether the 2026 burn is front-loaded (concerning) or back-loaded (manageable as revenue seasonality plays in).

Arbutus patent trial verdict (March 9, 2026). Binary IP risk on the platform; resolution affects 2026 royalty exposure regardless of revenue trajectory.

Sources

Moderna Q4 FY2025 Press Release (SEC Exhibit 99.1): https://www.sec.gov/Archives/edgar/data/1682852/000168285226000015/exhibit9912025q4pressrelea.htm
Moderna Q4 FY2025 earnings call Q&A (analyst exchanges)

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