Moderna, Inc. Q4 2025 Earnings Call Summary Moby Intelligence Sat, February 14, 2026 at 5:15 AM GMT+8 3 min read In this article: - MRNA +5.29%
Moderna, Inc. Q4 2025 Earnings Call Summary - Moby Strategic Execution and Operational Pivot
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Achieved a significant financial turning point in 2025 by reducing operating expenses by $2.2 billion, exceeding original cost-reduction targets by over $1 billion.
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Attributed 2025 revenue performance to the successful U.S. launch of MNEXT Spike, which captured 24% of the total retail market despite declining overall COVID demand.
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Expressed strong disappointment with the FDA's Refusal to File letter for the mRNA-1010 flu vaccine, citing unpredictable regulatory environments as a threat to U.S. innovation leadership.
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Shifted strategic focus toward long-term sovereign partnerships in the U.K., Canada, and Australia to provide stable, annualized revenue streams starting in 2026.
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Advanced the oncology narrative by completing enrollment in three late-stage INT studies (melanoma, renal cell, and bladder cancer), reinforcing the platform's multi-histology potential.
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Leveraged AI integration across the business to drive productivity and maintain a disciplined $1.0 billion SG&A spend while expanding into new geographic markets.
2026 Outlook and Multi-Year Growth Drivers
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Projects up to 10% revenue growth in 2026, primarily driven by international markets and the full annualized impact of strategic government agreements.
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Assumes a conservative 2026 revenue framework that factors in potential COVID vaccination declines and excludes any revenue from flu or flu-COVID combination products.
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Identifies 2027 as a major expansion year due to the opening of the $1.8 billion European respiratory market following the expiration of a competitor's pandemic contract.
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Anticipates a shift in geographic revenue mix to a balanced 50/50 split between U.S. and international markets by 2026, up from 38% international in 2025.
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Targets 2026 clinical data catalysts for norovirus and propionic acidemia, alongside critical Phase 3 melanoma and Phase 2 renal cell carcinoma readouts.
Regulatory Challenges and Strategic Partnerships
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The FDA Refusal to File (RTF) for mRNA-1010 necessitates a Type A meeting to determine the U.S. path forward, though international filings remain under review.
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Signed a global commercialization agreement with Recordati for the propionic acidemia program to leverage specialized rare disease infrastructure for a potential 2028 launch.
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Maintains a strong liquidity position with $8.1 billion in cash and investments, supported by a $600 million initial draw from a $1.5 billion credit facility.
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Capital expenditures for 2026 are projected to be between $200 million and $300 million, which includes an investment in building internal fill-finish capacity at the company's existing site in Norwood, Massachusetts.
Q&A Session Key Insights
Impact of flu RTF on 2028 cash flow breakeven guidance-
Management stated it is too early to determine the impact on breakeven targets until the Type A meeting with the FDA provides clarity on the U.S. clinical path.
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Emphasized that the company has "10 large shots on goal" for revenue growth, suggesting the flu delay is only one variable in a broader growth strategy.
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Regulatory read-through from flu RTF to flu-COVID combination vaccine-
The U.S. refiling of the 1083 combination vaccine is currently gated by the resolution of the mRNA-1010 flu filing issues.
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Management noted that international reviews for the combination product are proceeding independently, with potential European approval as early as late 2026.
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Management identified the Phase 3 adjuvant melanoma study as having the highest probability of success based on durable five-year Phase 2b data.
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Confirmed that the melanoma study is event-driven, with an interim analysis expected in 2026 to look for primary endpoints of relapse-free survival.
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Moderna's norovirus candidate is trivalent and targets seropositive adults (65+) rather than children, focusing on boosting existing immunity to prevent severe dehydration.
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The Phase 3 trial uses a placebo control, which management believes avoids the comparator-related regulatory hurdles currently affecting the flu program.
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Anticipates significant market share gains in Europe starting in 2027 as pandemic-era restrictive contracts expire and the market shifts to competitive tenders.
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Highlighted that mRNA technology allows for later strain selection, which European regulators have shown interest in to better match circulating variants.
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