Moderna (MRNA) Company Report

2025 financial results: Revenue of $1.9 billion, achieved over $1 billion in cost reductions (totaling $2 billion), ending with a $8.1 billion cash balance.
2026 guidance: Expecting up to 10% revenue growth driven by ex-U.S. partnerships in Canada, UK and Australia—international sales rising from $700 million to $1 billion—while U.S. sales are projected to decline ~20% to $1 billion.
Pipeline progress: 2025 approvals include second COVID vaccine (mNEXSPIKE), RSV indication expansion and pediatric COVID; positive phase III flu data filed in the U.S. (PDUFA Aug 5, 2026) and CHMP opinion on flu + COVID combo, with revenues anticipated from 2027.
Clinical programs: Intismeran + Keytruda in phase III adjuvant melanoma on track for an event-driven readout in 2026; norovirus vaccine phase III fully enrolled targeting ≥50% efficacy; PA rare disease study completed and partnered with Recordati.

3 days ago

Transcript

Moderna outlines 2026 growth guidance and key pipeline milestones

MRNA

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

2025 revenue of $1.9 billion at the high end of guidance, $2 billion of cost reductions achieved, and cash balance of $8.1 billion (including $600 million Ares credit draw).
2026 revenue guidance of up to 10% growth, driven by U.S. Spikevax penetration (24% market share in fall 2025) and ramp-up of UK, Canada and Australia partnerships; ex-U.S. revenue to grow from $700 million to $1 billion despite a planned U.S. sales decline to $1 billion.
Recent regulatory milestones include June 2025 approval of Spikevax 2.0, expanded RSV indication for 18–59 high-risk adults, pediatric COVID approval (6 months–5 years), and a U.S./EU flu vaccine application following positive Phase 3 data.
Key pipeline readouts expected 2026: Phase 3 adjuvant melanoma (event-driven; Phase 2 HR 0.51 at 3 years) and Norovirus Phase 3 with a target ≥50% vaccine efficacy threshold to support approval.
Path to breakeven: projected $3.5–3.7 billion cash costs in 2027 requiring 2028 revenues to match, underpinned by EU respiratory market access (~$1.8 billion), global flu roll-outs, LatAm/APAC partnerships, and 2028 launches of flu+COVID combo and Norovirus vaccines.

3 days ago

Transcript

Moderna outlines 2026 revenue guidance and pipeline milestones

MRNA

Guidance Update

2025 results: Revenue of $1.9 billion, over $2 billion of cost reductions and cash balance of $8.1 billion by year-end.
2026 guidance: Up to 10 % revenue growth driven by continued U.S. Spikevax penetration (24 % share) and ex-U.S. partnerships boosting international revenue from $700 million to $1 billion, with U.S. sales expected to decline ~20 % to $1 billion.
Key pipeline milestones: U.S. flu vaccine PDUFA date on August 5, 2026 ; CHMP positive opinion for flu + COVID combo with revenues from 2027 ; intismeran Phase 3 adjuvant melanoma readout event-driven in 2026 ; norovirus Phase 3 targeting ≥50 % efficacy.
Path to profitability: Cash operating costs projected to fall to $3.5–3.7 billion in 2027, requiring similar revenue in 2028; growth drivers include European respiratory market entry (~$1.8 billion), global flu approvals, LATAM/APAC supply deals, and 2028 launches of combo vaccine and norovirus.

3 days ago

Transcript

Moderna settles patent litigation with Arbutus/Genevant

MRNA

Legal Proceedings

On March 3, 2026, Moderna entered a settlement agreement with Arbutus Biopharma and Genevant Sciences to resolve all U.S. and international patent infringement litigation over Spikevax and related mRNA vaccines.
Under the agreement, Moderna will make a $950 million noncontingent lump‐sum payment to Arbutus/Genevant on or before July 8, 2026.
Moderna may owe up to an additional $1.3 billion contingent payment based on the Federal Circuit’s decision regarding Section 1498 infringement claims, with proration and repayment provisions if outcomes are later overturned.
The settlement grants Moderna a fully paid‐up, royalty‐free, irrevocable, non‐exclusive, worldwide license and covenant not to sue under Arbutus/Genevant patents covering SM-102 LNP formulations for its infectious disease vaccines, plus mutual releases.

Mar 5, 2026, 1:20 AM

8-K

Moderna settles LNP patent dispute

MRNA

Legal Proceedings

Moderna reached a global settlement with Genevant Sciences and Arbutus Biopharma, agreeing to pay up to $2.25 billion—$950 million upfront and up to $1.3 billion contingent on appellate rulings, while preserving a government-contractor immunity defense.
The agreement grants Moderna a global license covering existing and future vaccines (including Spikevax and mRESVIA) with no further royalties, resolving all LNP-related litigation.
Moderna will take a charge in the current quarter for the initial payment, make the lump-sum payment in Q3 2026, and, if required by appellate outcomes, promptly pay the contingent amount.
Shares jumped about 10% in extended trading after the announcement.

Mar 3, 2026, 10:16 PM

Bloomberg

Moderna provides 2025 results and outlines 2026 guidance at TD Cowen Healthcare Conference

MRNA

Guidance Update

New Projects/Investments

2025 product revenue reached $1.9 billion, at the high end of the $1.6–$2.0 billion guidance, driven by over 30 million US COVID vaccinations and mNEXSPIKE’s 24% US retail share.
2026 product revenue guidance of 0.1–10% growth implies $2.0 billion at midpoint, split as $1.0 billion US (vs $1.2 billion in 2025) and $1.0 billion ex-US (vs $0.7 billion in 2025) based on strategic partnerships.
Path to cash flow break-even by 2028 assumes controlling cash operating expenses to $3.7 billion in 2027 and executing “10 shots on goal” across vaccines (flu, flu+COVID, RSV, norovirus), international expansion and new modalities.
Regulatory progress includes FDA BLA acceptance for the mRNA-1010 flu vaccine with a post-marketing real-world evidence study , CHMP positive opinion for the flu+COVID combo in Europe , and a planned norovirus interim readout in 2026.
Oncology pipeline advances with INT adjuvant melanoma trial fully enrolled in September 2024 and a potential pivotal readout in 2026, alongside Phase III trials in RCC and bladder cancer.

Mar 3, 2026, 6:50 PM

Transcript

Moderna presents 2025 results and 2026 outlook

MRNA

Guidance Update

Moderna delivered $1.9 B in product revenue for 2025, hitting the high end of guidance, with $1.2 B in U.S. sales and $700 M ex-U.S., driven by mNEXSPIKE’s strong efficacy and 24% U.S. retail share amid 30 M Americans vaccinated.
2026 revenue guidance of up to 10% growth implies roughly $2 B total product revenue, split 50/50 between U.S. (planning ~$1 B, down from $1.2 B) and ex-U.S. (up to $1 B on strategic partnerships in the UK, Canada, Australia).
Path to cash-flow break-even by 2028 relies on controlling cash costs to $3.7 B in 2027 and driving growth across a diversified portfolio—flu, flu/COVID combo, RSV, norovirus, oncology (INT), and rare disease programs.
Regulatory progress includes an unexpected RTF/BLA sequence for the standalone flu vaccine with PDUFA in August 2026 and a positive CHMP opinion for the flu/COVID combo in Europe; neither is expected to contribute revenue in 2026.
The oncology vaccine INT adjuvant melanoma Phase 3 trial, fully enrolled in Sept 2024, could read out in 2026; Phase 2 showed 49% 5-year RFS and 62% DMFS, and additional Phase 3 trials in RCC and bladder cancer are fully enrolled.

Mar 3, 2026, 6:50 PM

Transcript

Moderna updates 2025 results and 2026 guidance at TD Cowen conference

MRNA

Guidance Update

Product Launch

2025 product revenue of $1.9 billion, at the high end of guidance ($1.6–2.0 billion), driven by mNEXSPIKE capturing 24% of U.S. retail share and ~30 million U.S. COVID vaccinations.
2026 revenue guidance of 0.1%–10% growth (midpoint ~$2 billion) assumes U.S. sales slip from $1.2 billion to ~$1 billion while ex-U.S. rises from $700 million to ~$1 billion via partnerships in UK, Canada and Australia, including ~$200 million shifting into H1 2026.
To achieve cash-flow break-even by 2028, Moderna targets reducing 2027 cash costs to $3.7 billion through roll-off of development programs and disciplined capital investments.
Key growth drivers include the mRNA-1010 flu vaccine BLA (Aug 2026 PDUFA), positive CHMP for flu+COVID combo in Europe, and pivotal INT melanoma trial readout potentially in 2026.
AI-driven digital transformation lowered 2025 cash costs to $4.3 billion versus $5.5 billion guided and reduced working capital to $150 million.

Mar 3, 2026, 6:50 PM

Transcript

Moderna gets EU backing for combo COVID-flu vaccine, FDA review set

MRNA

Product Launch

Demand Weakening

The European Medicines Agency recommended marketing authorization for mCombriax, Moderna’s combined COVID-19 and influenza mRNA vaccine for people aged 50+, based on late-stage data from roughly 8,000 participants.
The FDA initially issued a refusal to file for Moderna’s standalone mRNA flu shot over comparator choices before reversing its decision; Moderna also withdrew its U.S. combo application to gather additional efficacy data.
Moderna is now pursuing full U.S. approval of its flu vaccine for adults 50–64 and accelerated approval for those 65+ contingent on a post-market study.
The EU recommendation offers a key commercial avenue as Moderna rebuilds revenue after COVID-19 vaccine demand fell and shares have dropped nearly 90% from their 2021 highs.

Feb 27, 2026, 11:17 AM

WSJ

Moderna announces Q4 2025 results

MRNA

Earnings

Guidance Update

Product Launch

Moderna reported 4Q25 total revenue of $678 M, down 30% year-over-year, with a net loss of $826 M and cash and investments of $8.1 B as of December 31, 2025.
For full-year 2025, revenue was $1.9 B, net loss $2.8 B, and Moderna realized $2.2 B in annual cost savings, ending the year with $8.1 B in cash and investments.
Moderna’s 2026 GAAP financial framework contemplates up to 10% revenue growth, cost of sales of ~$0.9 B, R&D of ~$3.0 B, SG&A of ~$1.0 B, cash cost target of $4.2 B, and year-end cash and investments of $5.5–6.0 B.
Commercially, Moderna achieved a successful mNEXSPIKE launch and secured long-term strategic partnerships (UK, Canada, Australia, Mexico), while advancing its late-stage oncology and infectious disease pipeline with positive data readouts in melanoma and norovirus programs.

Feb 13, 2026, 1:00 PM

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