Moderna (MRNA) Company Report

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.

14 hours ago

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.

2 days ago

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.

2 days ago

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.

2 days ago

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.

2 days ago

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.

7 days ago

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

Presentation

Moderna announces Q4 and full-year 2025 results

MRNA

Earnings

Guidance Update

Moderna reported Q4 revenue of $700 million and full-year 2025 revenue of $1.9 billion, driven primarily by COVID vaccine sales, with a Q4 net loss of $800 million and full-year net loss of $2.8 billion.
The company ended 2025 with $8.1 billion in cash and investments, down from $9.5 billion at end-2024.
For 2026, Moderna forecasts up to 10% revenue growth, cost of sales of $900 million, R&D spend of $3 billion, SG&A of $1 billion, capital expenditures of $200–300 million, and expects to finish the year with $5.5–6 billion in cash.
Commercially, mNEXSPIKE captured 24% of the US COVID retail market in its launch season, and Moderna secured multi-year manufacturing partnerships in the UK, Canada and Australia to support vaccine supply.
Regulatory filings for its seasonal flu and flu-COVID combination vaccines are under review in Europe, Canada and Australia, with first approvals expected late 2026 or early 2027.

Feb 13, 2026, 1:00 PM

Transcript

Moderna reports Q4 2025 results

MRNA

Earnings

Guidance Update

Product Launch

Total revenue for Q4 was $700 million and full-year 2025 revenue reached $1.9 billion; Q4 net loss was $800 million, with 2025 net loss of $2.8 billion, ending the year with $8.1 billion in cash and investments.
Operating expenses declined by $2.2 billion (30%) in 2025, reflecting productivity gains and cost discipline.
2026 guidance anticipates up to 10% revenue growth, with cost of sales of ~$900 million, R&D spend of ~$3 billion, SG&A of ~$1 billion, and year-end cash projected at $5.5 – 6 billion.
mNEXSPIKE captured 24% of the US retail COVID market (34% in adults ≥ 65) in its launch year, and full-year contributions from manufacturing partnerships in the UK, Canada, and Australia will drive growth in 2026.
Pipeline progress includes flu and flu-COVID combo vaccines under review in Europe, Canada, and Australia, a US refusal-to-file letter on the flu program, positive 5-year phase II melanoma data, and a fully enrolled phase III norovirus trial.

Feb 13, 2026, 1:00 PM

Transcript

Moderna reports Q4 2025 results

MRNA

Earnings

Guidance Update

Product Launch

Moderna delivered $700 million in revenue in Q4 and $1.9 billion for full-year 2025, driven primarily by COVID-19 vaccines; operating expenses were down 31% in Q4 and 30% for the year, resulting in a Q4 net loss of $800 million (versus $1.1 billion in Q4 2024) and a full-year net loss of $2.8 billion (versus $3.6 billion in 2024).
The company ended 2025 with $8.1 billion in cash and investments, down from $9.5 billion at end-2024, and drew $600 million on its $1.5 billion credit facility.
For 2026, Moderna forecasts up to 10% revenue growth, with cost of sales of ~$900 million, R&D of ~$3 billion, SG&A of ~$1 billion, total GAAP operating expenses of $4.9 billion, cash costs of $4.2 billion, and expects to finish the year with $5.5 billion–$6 billion in cash.
Commercial momentum includes mNEXSPIKE capturing 24% of the U.S. retail COVID market (34% among adults 65+) in its launch year, new strategic partnerships in the U.K., Canada, and Australia, and ongoing regulatory reviews for its flu and flu-COVID vaccines, while the pipeline advanced with full enrollment in multiple late-stage oncology and a phase III norovirus trial.

Feb 13, 2026, 1:00 PM

Transcript

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Earnings Transcripts

Quarterly earnings call transcripts for Moderna.

Q4 2025

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Moderna (MRNA)

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Stéphane Bancel

Jacqueline Miller

James Mock

Jerh Collins

Kate Cronin

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Stephen Hoge

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Manuel Smithers

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