Moderna, Inc. (MRNA) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call presented a mixed outlook. Financial performance showed cost reductions and a higher cash balance, but revenue guidance was narrowed. Product development updates were promising, with potential approvals and partnerships, but guidance was cautious. The Q&A highlighted optimism in certain areas but also noted management's avoidance of direct answers on key timelines and data. The combination of strong financial metrics and cautious guidance, along with strategic partnerships, suggests a neutral impact on the stock price over the next two weeks.
Key Financial Performance
Revenue Total revenue for 2025 was $1.9 billion, a decrease from the previous year. The decline was primarily due to reduced COVID vaccine sales, although operational performance and vaccination rates in international markets were above or in line with expectations.
Operating Expenses Operating expenses for 2025 were down $2.2 billion or 30% year-over-year. This reduction was attributed to cost discipline, productivity improvements, and efficiency gains in clinical trial execution.
Net Loss Net loss for 2025 was $2.8 billion, an improvement from the $3.6 billion net loss in 2024. The improvement was driven by cost reductions and operational efficiencies.
Cash and Investments Cash and investments at the end of 2025 were $8.1 billion, down from $9.5 billion at the end of 2024. The decrease was primarily due to operating losses, partially offset by a $600 million initial draw from a $1.5 billion credit facility.
Cost of Sales Cost of sales for 2025 was $868 million, representing a 41% decrease compared to 2024. This was driven by productivity improvements, lower inventory write-downs, and reduced contract manufacturing wind-down costs.
R&D Expenses R&D expenses for 2025 were $3.1 billion, a 31% decrease compared to 2024. The reduction was due to investment prioritization and efficiency gains, partially offset by increased investment in norovirus vaccine and oncology programs.
SG&A Expenses SG&A expenses for 2025 were $1 billion, a 13% decrease compared to 2024. The decline was driven by cost-saving measures across all functions while maintaining support for the business.
Fourth Quarter Revenue Revenue for the fourth quarter of 2025 was $700 million, with $300 million from the U.S. and $400 million from international markets. This was at the higher end of guidance, supported by strong market share in the U.S. retail channel and operational performance internationally.
Fourth Quarter Net Loss Net loss for the fourth quarter of 2025 was $800 million, an improvement from the $1.1 billion net loss in the fourth quarter of 2024. This was due to reduced operating expenses and improved cost discipline.
You have reached the limit. Sign up to access full content
Get started
Operating Highlights
mNEXSPIKE: Approved in the U.S. in 2025, had an excellent launch, quickly became the leading product in the U.S. capturing 24% of the total U.S. retail market and 34% of the retail market among adults aged 65 and older.
mRESVIA: Approved for adults aged 60 and older in 40 countries and for high-risk adults aged 18 to 59 in 31 countries.
mRNA-1010 (Flu vaccine): Filed and under review in Europe, Canada, and Australia. FDA issued a refusal-to-file letter in the U.S.
mRNA-1083 (Flu + COVID combination vaccine): Filed and under review in Europe and Canada.
Norovirus vaccine: Phase III trial fully enrolled, with data expected in 2026.
Strategic agreements: Signed a 5-year agreement with the government of Mexico for respiratory vaccine supply. Also announced agreements with Taiwan and Brazil.
Geographic expansion: Plans to sell locally manufactured products in the U.K. and Australia in 2026, contributing to international revenue growth.
European respiratory vaccine market: Expected to open in 2027, with plans to launch multiple vaccines including mNEXSPIKE, mRNA-1010, and mRNA-1083.
Cost reductions: Operating expenses reduced by $2.2 billion (30%) in 2025. R&D expenses decreased by 31%, and SG&A expenses decreased by 13%.
AI adoption: AI tools implemented across the business to improve productivity.
Oncology pipeline expansion: Intismeran program advanced with multiple Phase II and III trials fully enrolled. Positive 5-year Phase II data in adjuvant melanoma reported.
Rare disease focus: Propionic acidemia program fully enrolled in a registrational study. Strategic collaboration with Recordati for global commercialization.
You have reached the limit. Sign up to access full content
Get started
Risk or Challenges
Regulatory Uncertainty: The FDA's refusal-to-file letter for the flu program (mRNA-1010) highlights challenges in the U.S. regulatory environment. Unpredictable expectations and review timelines create risks for businesses, potentially delaying investments and patient access to breakthrough medicines. This could also lead to U.S. companies losing leadership in innovative medicines.
Financial Losses: The company reported a net loss of $2.8 billion for 2025, following a $3.6 billion loss in 2024. This ongoing financial strain could impact its ability to invest in R&D and other strategic initiatives.
Declining COVID Vaccine Demand: COVID market demand declined year-over-year in the U.S., which could affect revenue growth. Future revenue projections also assume no revenue from the flu vaccine or flu/COVID combination vaccine in 2026.
Pipeline Risks: Several pipeline programs, including the flu vaccine and flu/COVID combination vaccine, are under regulatory review in multiple countries. Delays or rejections in approvals could hinder revenue growth and strategic objectives.
Geographic Revenue Dependence: In 2025, 62% of revenue came from the U.S., with only 38% from international markets. This geographic imbalance could pose risks if U.S. market conditions worsen.
Supply Chain and Manufacturing Challenges: The company is investing in local manufacturing in the U.K. and Australia, but any delays or inefficiencies in these facilities could impact international growth and revenue targets.
Competitive Pressures: The expiration of a competitor's pandemic contract in Europe in 2026 opens opportunities but also increases competition in the respiratory vaccine market.
You have reached the limit. Sign up to access full content
Get started
Guidance & Outlook
Revenue Growth: Moderna expects total revenue growth of up to 10% in 2026, primarily driven by international markets. Revenue is anticipated to be balanced between the U.S. and international markets, with significant contributions from locally manufactured products in the U.K. and Australia.
Product Launches and Approvals: Moderna plans to launch mNEXSPIKE, its stand-alone flu vaccine (mRNA-1010), and its combination flu/COVID vaccine in the European region by the 2027 winter season. The company also anticipates approvals for mNEXSPIKE in Europe, Japan, and Taiwan in 2026, as well as potential approvals for its flu vaccine and flu/COVID combination vaccine in Europe and Canada.
Pipeline Developments: Moderna expects Phase III data for its norovirus vaccine and pivotal data for its propionic acidemia (PA) program in 2026. The company also anticipates clinical milestones in its oncology programs, including Phase III adjuvant melanoma data, Phase II adjuvant renal cell carcinoma data, and Phase I data in adjuvant pancreatic and perioperative gastric cancers.
Strategic Partnerships: Moderna expects full-year contributions from strategic partnerships in the U.K., Canada, and Australia in 2026. These partnerships include local manufacturing and domestic R&D commitments, with the U.K. expected to fulfill a $200 million COVID order in the first half of 2026.
Cost Management: The company projects cost of sales to be approximately $900 million in 2026, with gross margin improvements from manufacturing efficiency gains. R&D expenses are expected to be around $3 billion, and SG&A expenses are projected to remain flat at $1 billion. Total cash costs are anticipated to decline to $4.2 billion.
Capital Expenditures: Capital expenditures are projected to be between $200 million and $300 million in 2026, including investments in building fill/finish capacity in the U.S.
You have reached the limit. Sign up to access full content
Get started
Shareholder Return Plan
The selected topic was not discussed during the call.
You have reached the limit. Sign up to access full content
Get started
Key Q&A
Q:What are the implications of the flu RTF for the 2028 cash flow breakeven guidance and the timing of the Type A meeting?
A:The flu file is under review in Europe, Canada, and Australia, with plans to file in additional countries this year. The Type A meeting with the FDA, which typically takes 30 days, will determine the next steps for the U.S. market. The company is optimistic about the flu/COVID combination product's progress in Europe. However, without the Type A meeting, the timeline for moving forward in the U.S. remains uncertain.
Q:Can you refine the timing of the INT program in adjuvant melanoma data?
A:The adjuvant melanoma study is expected to read out this year, but the timing depends on event accrual. Other studies, such as RCC and bladder, are fully enrolled and also event-driven. The company does not have more specific guidance due to the event-driven nature of the trials.
Q:What is the status of the flu and COVID combination vaccine refiling in the U.S. and the study data that went into the initial submission?
A:The company is holding back on refiling the combination vaccine until the flu vaccine review progresses. The initial submission included a Phase III study with 41,000 participants showing 27% superior vaccine efficacy compared to the standard dose control. The company awaits feedback from the Type A meeting to determine next steps for the U.S. market.
Q:Which of the five histologies in the INT program has the highest probability of success?
A:The adjuvant melanoma study has the highest probability of success, supported by strong Phase IIb results showing a 50% reduction in relapse or death rates over five years. Renal cell and bladder cancers are also promising due to their quick read-through potential.
Q:How is the company thinking about the European COVID vaccination market and the flu/COVID combination vaccine approval pathway outside the U.S.?
A:The European COVID market is estimated at $700 million, with potential for growth. The company is optimistic about the mNEXSPIKE product and the flu/COVID combination vaccine, which is under review in Europe and Canada. Approval in Europe is expected this year, with a potential launch in 2027.
Q:Has there been any discussion around potential strain selection for flu vaccines in Europe and Canada?
A:Yes, there is strong interest in better strain matching and later strain selection for flu vaccines, inspired by the COVID vaccine approach. This could lead to improved efficacy and regional customization.
Q:Why was the year-end cash balance higher than expected, and what are the levers to lower cash costs moving forward?
A:The higher cash balance was due to lower-than-expected cash costs, a $600 million loan draw, reduced capital expenditures, and strong working capital performance. The company is focused on productivity and cost management to maintain financial momentum.
Q:What is the design and interim analysis process for the adjuvant Phase III melanoma study?
A:The study includes interim analyses based on event accrual, with the first analysis expected this year. If the interim does not show statistical power, subsequent analyses will follow. The Phase II study stopped at an interim, and the Phase III is conservatively designed to detect similar results.
Q:What is the status and confidence level in the norovirus vaccine program?
A:The norovirus vaccine trial is a large placebo-controlled study targeting older adults. The trivalent composition covers 66-70% of circulating strains. The company is optimistic about the trial's design and its focus on a high-need population.
Q:What is the regulatory path for the norovirus vaccine compared to the flu vaccine?
A:The norovirus vaccine trial uses a placebo comparator, avoiding the issues faced with the flu vaccine's comparator. The company expects a clearer regulatory path for norovirus.
Q:Why was overall survival (OS) data not included in the recent 5-year melanoma data release?
A:The company plans to present OS data at an upcoming medical meeting. Relapse-free survival data remains strong, and OS data will be shared in a comprehensive format later.
Q:What percentage of patients in the flu vaccine efficacy study were over 65, and how does this impact the study's findings?
A:More than 50% of the 41,000 participants were over 65, with over 10% above 75. The study showed strong superior efficacy across all age groups, with higher point estimates for severe outcomes.
Q:What feedback has the company received on the INT clinical trial design, and who will file the BLA?
A:The company has had productive discussions with regulators, including the FDA's CBER. Merck, as the trial sponsor, will file the BLA. The design aligns with regulatory expectations for this novel therapy.
Q:What makes the Phase II RCC study potentially registrational, and how does the evolving standard of care impact future plans?
A:The Phase II RCC study could be registrational if it shows significant benefit. The evolving standard of care, including belzutifan, may influence future trial designs and combinations.
Q:How will the adjuvant melanoma therapy be used across the PD-1/PD-L1 class, and will subcutaneous PD-1 options impact uptake?
A:The therapy is expected to be used broadly across the PD-1/PD-L1 class. Subcutaneous PD-1 options are not expected to impact the unique benefits of the adjuvant melanoma therapy.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers on the following topics: 1. The specific timing for the Type A meeting and its impact on the U.S. flu vaccine timeline. 2. Detailed guidance on the timing of INT program data readouts due to the event-driven nature of the trials. 3. Specific hazard ratios or benefits needed for the RCC Phase II study to be considered registrational. 4. Overall survival (OS) data for the melanoma study, which was deferred to a future medical meeting.
You have reached the limit. Sign up to access full content
Get started
Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Australia approval
Australia flu
Canada Australia
Europe Canada
FDA refusal
II Phase
II study
III study
Intismeran cancer
Merck Phase
Mexico
Phase cancer
Recordati
Slide result
Stephen
adult age
age country
campaign
cancer antigen
cancer therapy
cancer type
combination flu
commercialization
credit facility
draw
enrollment Phase
expertise
file letter
loss share
market majority
momentum
oncology program
partnership
refusal file
region
review Europe
share loss
study cancer
vaccine UK
vaccine market
vaccine review
week agreement
MRNA Transcript
Moderna, Inc. (MRNA) Q4 2025 Earnings Call Transcript
Unknown2-13
The earnings call presented a mixed outlook. Financial performance showed cost reductions and a higher cash balance, but revenue guidance was narrowed. Product development updates were promising, with potential approvals and partnerships, but guidance was cautious. The Q&A highlighted optimism in certain areas but also noted management's avoidance of direct answers on key timelines and data. The combination of strong financial metrics and cautious guidance, along with strategic partnerships, suggests a neutral impact on the stock price over the next two weeks.
Moderna, Inc. (MRNA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Neutral1-12
Moderna, Inc. (MRNA) Presents at Piper Sandler 37th Annual Healthcare Conference Transcript
Neutral12-2
Moderna, Inc. (MRNA) Q3 2025 Earnings Call Transcript
Unknown11-6
The earnings call summary and Q&A reveal concerns about declining vaccination rates, reduced revenue projections, and unclear guidance on future large deals. Despite cost reduction plans and strategic partnerships, the market may react negatively to the reduced revenue guidance and lack of detailed future growth projections. The negative sentiment is reinforced by declining COVID vaccine demand and the cautious outlook on new product launches. These factors suggest a likely negative stock price movement in the short term.
MRNA Slides
MRNA Report
Frequently Asked Questions
Where does this earnings call transcript come from?
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
How soon is the transcript available after the earnings call ends?
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
Is the transcript edited or altered in any way?
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
Why do some answers appear as “Unclear” or “Inaudible”?
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
Who creates the AI Summary and Key Q&A highlights shown above the transcript?
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
