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01/11 13:58
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
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.
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.
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.
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.
The selected topic was not discussed during the call.
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.
The earnings call suggests a positive outlook with strong financial metrics, ongoing product development, and strategic cost-cutting measures. The company is optimistic about its pipeline and regulatory interactions, despite some uncertainties in demand. The focus on partnerships and expansion in oncology and vaccines indicates growth potential. No significant negative trends were highlighted, and management's cautious optimism suggests a positive sentiment. However, the lack of specific guidance on some aspects prevents a stronger positive rating.
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