Moderna, Inc. (MRNA) Q3 2025 Earnings Call Transcript
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Overview
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.
Key Financial Performance
Revenue $1 billion in Q3 2025, a 45% year-over-year decline due to lower COVID vaccine demand and absence of a $140 million true-up adjustment from Q3 2024.
Net Loss $200 million in Q3 2025 compared to net income of $13 million in Q3 2024, driven by reduced revenue and lower COVID vaccine demand.
Cash and Investments $6.6 billion at the end of Q3 2025, down from $7.5 billion at the end of Q2 2025, primarily due to seasonal working capital impacts.
Cost of Sales $207 million in Q3 2025, a 60% year-over-year decrease due to lower inventory write-downs, reduced unutilized manufacturing capacity, and lower volume.
R&D Expenses $801 million in Q3 2025, a 30% year-over-year decrease due to lower clinical trial costs and efficiency gains.
SG&A Expenses $268 million in Q3 2025, a 5% year-over-year decrease due to lower consulting and external service costs, along with reduced digital and facility spending.
Cost Reduction Achieved a $2.1 billion improvement in costs across cost of goods, SG&A, and R&D over the last 4 quarters (Q4 2024 to Q3 2025) compared to the prior 4 quarters.
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Operating Highlights
Spikevax: Received approval in 40 countries for the seasonal 2025-2026 strain update.
mNEXSPIKE: New COVID vaccine approved by the FDA and available in the U.S. for the first time this season. Also approved in Canada.
mRESVIA: RSV vaccine approved in 40 countries. Delivered first made-in-Canada mRNA vaccines to the Canadian government.
mRNA-1010: Positive Phase III flu efficacy data announced, advancing the flu vaccine program.
mRNA-1083: Flu plus COVID combination program under review by the European Medicines Agency.
mRNA-4359: Encouraging Phase Ib data for cancer antigen therapy presented.
Strategic partnerships: Established manufacturing facilities and secured multiyear offtake agreements with Canada, the U.K., and Australia. Delivered first made-in-Canada vaccines.
Market share: COVID retail market share increased to 42%, with mNEXSPIKE making up 55% of COVID vaccination volume.
Cost reduction: Achieved a 34% reduction in cost of sales, R&D, and SG&A combined compared to Q3 2024. Delivered a $2.1 billion improvement in costs over the last 4 quarters.
Financial discipline: Reduced projected 2025 cash costs by $900 million since the beginning of the year. Increased year-end cash guidance to $6.5 billion to $7 billion.
CMV program: Discontinued development of the CMV vaccine for congenital CMV due to not meeting primary efficacy endpoints.
Pipeline prioritization: Focused on advancing high-potential programs like intismeran in oncology and mRNA-4359 for cancer antigen therapy.
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Risk or Challenges
COVID vaccine demand: The 45% year-over-year decline in revenue was primarily due to lower COVID vaccine demand. This decline is a significant risk to the company's revenue and financial performance.
CMV vaccine program: The CMV program did not meet its primary efficacy endpoints for congenital CMV, leading to the discontinuation of development in this indication. This represents a setback in the company's pipeline and potential revenue streams.
Norovirus vaccine study: The ongoing Phase III norovirus study has not yet accrued sufficient cases needed to conduct the interim analysis, delaying the timeline for potential approval and commercialization.
COVID vaccination rates: COVID vaccination rates remain the largest variable impacting revenue projections, with a 20% to 40% decline in retail vaccinations compared to the previous year. This uncertainty poses a risk to achieving revenue targets.
Manufacturing efficiency: While there have been improvements, higher unutilized manufacturing charges are expected in Q4, which could impact cost efficiency and margins.
Regulatory approvals: Delays or uncertainties in regulatory approvals for key products, such as the combination flu plus COVID vaccine in the U.S., could impact future revenue and market positioning.
Economic uncertainties: Economic factors, including newly introduced tariffs, are being monitored but could pose risks to the company's global operations and cost structure.
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Guidance & Outlook
Revenue Outlook: The company has narrowed its full-year 2025 revenue guidance to $1.6 billion to $2 billion, down from the previous range of $1.5 billion to $2.2 billion. U.S. revenue is expected to be between $1 billion and $1.3 billion, while international revenue is projected at $600 million to $700 million.
COVID Vaccine Sales: U.S. COVID vaccine sales are expected to generate $100 million to $400 million in Q4 2025. The company anticipates a 20% to 40% decline in retail vaccinations compared to fall 2024.
International Sales: International sales are expected to be $300 million to $400 million in Q4 2025. Strategic partnerships with Canada, the U.K., and Australia will contribute to revenue growth in 2026 and beyond.
Cost Reduction: The company has reduced its 2025 cash cost projection by $900 million, with a new target of $4.6 billion. GAAP operating expenses are also reduced to $5.3 billion at the midpoint, down $700 million from prior guidance.
Cash Balance: Year-end 2025 cash balance is projected to be $6.5 billion to $7 billion, an increase of $0.5 billion to $1 billion from prior guidance.
Pipeline Developments: The company expects potential approvals for its combination flu plus COVID vaccine in Europe and Canada, with refiling in the U.S. pending FDA guidance. Regulatory submissions for the flu vaccine mRNA-1010 are expected in the U.S., Canada, Australia, and the EU by January 2026.
Oncology Programs: Phase III efficacy data for the intismeran adjuvant melanoma study and Phase II data for the cancer antigen therapy mRNA-4359 are expected in 2026.
Rare Disease Programs: Phase III efficacy data for the norovirus vaccine and registrational efficacy study data for the propionic acidemia (PA) program are anticipated in 2026.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What changes are being made to expense management and strategy for 2026?
A:The company has reduced cash costs by 50% over the last few years, with a recent $500-$700 million reduction split evenly across R&D and cost of sales. Cost of sales reductions are driven by efficiencies in manufacturing, materials, and labor productivity. R&D reductions involve more efficient clinical trial execution and deprioritization of some Phase II and III trials. The company is prioritizing its late-stage pipeline of 9-10 programs and expects further cost reductions in the coming years.
Q:What is the company's stance on the Arbutus trial and IP dynamics?
A:The company is confident in its lipid nanoparticle delivery system and believes its technology does not infringe on any valid patents asserted by Arbutus. The U.S. trial is scheduled for March 9, 2026, and the company is vigorously defending its case.
Q:What is the status of U.S. COVID revenue and inventory tracking?
A:U.S. COVID revenue for the quarter was $781 million, primarily from inventory buildup and delivery to pharmacies. Vaccination rates in the U.S. are down 30% season-to-date through October 24. The company has revised its U.S. sales guidance to $1 billion-$1.3 billion, reflecting a 20%-40% decline in vaccination rates. Inventory and vaccination rates are tracked daily.
Q:What are the learnings from the CMV vaccine trial?
A:The CMV vaccine trial's top-line data showed that pentamer neutralizing antibodies were not sufficient to prevent infection. The company will analyze detailed data in the coming months to generate hypotheses and share findings with the medical community. The prevention of infection with CMV remains a high bar.
Q:What is the status of the norovirus program and its commercial potential?
A:The norovirus program experienced low case accruals, which was anticipated as a possibility. The study was designed as a potential two-season study, and the company is optimistic about accruing enough cases in the second season. The commercial potential remains strong, with a focus on preventing severe to moderate infections in high-risk populations.
Q:What gives the company confidence in achieving cash breakeven by 2028?
A:The company plans to achieve breakeven through a mix of revenue growth and cost reductions. Revenue growth will come from geographic expansion, strategic partnerships, and new product introductions. Cost reductions will continue, and the company will provide more details at Analyst Day.
Q:What is the company's approach to potential large deals with pharma?
A:The company is in discussions with pharma companies and financial sponsors to fund Phase III trials for products like the latent vaccine for EBV. It has a partnership with Blackstone for flu vaccines and will announce deals when finalized.
Q:What is the feedback on mNEXSPIKE and its market performance?
A:mNEXSPIKE has become the leading product in the COVID franchise, exceeding expectations. It is gaining traction among older adults and high-risk populations. Spikevax remains important for pediatric use. The company plans to launch mNEXSPIKE outside the U.S. for the next season.
Q:How is U.S. and ex-U.S. COVID vaccine demand tracking?
A:U.S. demand is tracking within the revised guidance of $1 billion-$1.3 billion, with vaccination rates down 20%-40%. Ex-U.S. demand guidance has been raised to $600-$700 million, with most revenue already contracted or delivered. Strategic partnerships in the U.K., Canada, and Australia are expected to contribute to revenue growth in 2026.
Q:How has the pipeline evaluation process evolved to maximize ROI?
A:The company is optimizing cash investments rather than maximizing ROI. Large Phase III investments in infectious diseases are deferred until cash breakeven in 2028. Oncology and rare disease programs are prioritized for their lower cash requirements and potential ROI.
Q:What is the capacity for adding more programs in the rare disease platform?
A:The company is focusing on PA and MMA programs, which are in or nearing registrational studies. Further investments in rare diseases will depend on the success of these programs and achieving cash breakeven by 2028. The company may consider adding more programs in the next 1-2 years.
Q:Are there more R&D cuts planned?
A:Yes, further R&D cost reductions are expected as large Phase III programs in infectious diseases wind down. These reductions will not require stopping programs and will focus on completing existing investments and early-stage research.
Q:Does the CMV trial outcome affect other latent vaccine programs?
A:No, the CMV trial outcome does not affect other latent vaccine programs, as it was the only program targeting prevention of infection. Other programs focus on preventing diseases rather than infections, and the company sees potential for CMV vaccines in specific indications like bone marrow transplant reactivation.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on the potential large deals with pharma, stating only that discussions are ongoing and announcements will be made when finalized. Additionally, while they expressed confidence in achieving cash breakeven by 2028, they did not provide detailed projections or specific near-term products that would drive top-line growth.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Congress
ESWI
European Medicines
Formula
ID Week
II study
II trial
Medicines Agency
Oncology
Phase Ib
RD
SGA
Society
UK Australia
analysis Phase
candidate
channel
combination program
cost plan
development CMV
efficiency gain
end cash
fall vaccination
government
improvement cost
increase
investment prioritization
line metastatic
mNEXSPIKE
mRESVIA
manufacturing facility
market sale
moment
momentum
partnership
rate variable
review European
study line
therapy
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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.
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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”?
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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.
