Executive Summary
Moderna reported total revenue of $1.9 billion for 2025, down 40% from $3.2 billion in 2024, driven primarily by declining COVID vaccine sales across all regions. Despite the revenue decline, net loss narrowed to $2.8 billion from $3.6 billion as the company reduced operating expenses by 30% through cost discipline and portfolio prioritization.
What happened
Moderna's business contracted significantly in 2025 as COVID vaccine demand declined in what management characterized as a transition to a more competitive and commercially driven market. Net product sales fell from $3.1 billion to $1.8 billion, driven by lower COVID vaccine volumes across all regions. The U.S. market experienced declining overall demand despite Moderna gaining retail market share through the successful launch of mNEXSPIKE, its second COVID vaccine approved in May 2025. European sales collapsed from $573 million to $50 million as advance purchase agreements with governments concluded. The company's RSV vaccine mRESVIA generated only $8 million in sales despite regulatory approvals in 40 countries, reflecting commercial challenges in that market. Cost of sales as a percentage of net product sales remained elevated at 48%, including $291 million in inventory write-downs, $93 million in unutilized manufacturing capacity costs, and $88 million in third-party royalties. The company significantly reduced its operating expense base, cutting research and development spending by $1.4 billion through clinical trial wind-downs and portfolio prioritization, while selling, general and administrative expenses fell $156 million through broad-based reductions in consulting, outside services, and commercial activities. Operating cash flow was negative $1.9 billion, leading management to establish a $1.5 billion credit facility in November 2025.
Why it matters for investors
The results reflect Moderna's transition from pandemic-era COVID vaccine revenues to a normalized commercial environment where demand has structurally declined and competition has intensified. The 40% revenue decline demonstrates the challenge of sustaining sales without government purchase agreements and in a market where vaccination rates remain uncertain due to viral evolution, consumer motivation, and shifting public health guidance. While the company successfully reduced its cost structure by 30%, the persistent negative operating margin and $1.9 billion cash burn indicate that Moderna has not yet achieved sustainable profitability at current revenue levels. The company's ability to return to cash flow breakeven depends on successfully launching multiple pipeline products over the next several years, including its seasonal flu vaccine (pending FDA review with August 2026 PDUFA date), flu+COVID combination vaccine, norovirus vaccine, and oncology therapeutic intismeran autogene. The establishment of the credit facility and the decline in cash and investments from $9.5 billion to $8.1 billion underscore the capital intensity of operating a scaled biopharmaceutical infrastructure while awaiting new product approvals. Management's expectation that product sales will return to growth in 2026 is contingent on the full-year impact of strategic manufacturing partnerships and continued mNEXSPIKE uptake, though visibility remains limited given evolving market dynamics and the absence of established demand patterns for newer products.
Bullish points
Net loss narrowed by $739 million to $2.8 billion in 2025 from $3.6 billion in 2024, and loss per share improved to $(7.26) from $(9.28), demonstrating meaningful progress toward profitability as cost reductions outpaced the rate of revenue decline.
The company successfully launched mNEXSPIKE, its second COVID vaccine, which gained market share in the U.S. retail channel during the 2025/2026 respiratory season, providing commercial validation of its ability to compete with two distinct COVID vaccine offerings.
Management secured regulatory approvals for mRESVIA (RSV vaccine) in 40 countries and expanded the approved use to include adults aged 18 through 59 years at increased risk, broadening the addressable market beyond the initial 60+ population.
The seasonal flu vaccine regulatory filing was accepted by the FDA with a PDUFA goal date of August 5, 2026, after the company submitted a revised regulatory pathway seeking full approval for adults 50 to 64 years and accelerated approval for adults 65 and older, positioning the company for potential entry into the well-established flu vaccine market.
Intismeran autogene, the company's mRNA-based individualized neoantigen therapy developed with Merck, demonstrated sustained improvement in recurrence-free survival in five-year data from the Phase 2b study in high-risk melanoma, supporting continued advancement across eight Phase 2 and Phase 3 clinical trials in multiple tumor types.
Bearish points
Net product sales declined 42% to $1.8 billion as COVID vaccine demand contracted across all geographies, with European sales collapsing 91% to $50 million due to the completion of government advance purchase agreements and lower overall demand, exposing the company's dependence on a single product franchise facing structural market headwinds.
RSV vaccine sales totaled only $8 million in 2025 despite regulatory approvals in 40 countries, reflecting significant commercial challenges including advisory committee recommendations that were more limited than anticipated and difficulties achieving market share against two established larger competitors (Pfizer and GSK) that entered the market first.
Operating cash flow was negative $1.9 billion in 2025, requiring the company to draw $600 million from a new $1.5 billion credit facility established in November 2025 to enhance financial flexibility, indicating that current revenue levels are insufficient to sustain operations without external financing.
Cost of sales as a percentage of net product sales remained elevated at 48%, including $291 million of inventory write-downs for raw materials and finished COVID vaccine inventory and $93 million of unutilized manufacturing capacity costs, reflecting the difficulty of aligning production with volatile seasonal demand and the risk of continued excess capacity charges.
The company faces intensifying regulatory uncertainty as changes at U.S. agencies in 2025 impacted policies related to the vaccine industry, including new post-marketing commitments that have increased costs, and the FDA initially refused to file the seasonal flu vaccine application before later accepting a revised submission, creating potential delays in critical pipeline products that are essential for revenue diversification.
Key highlights
Moderna operates three commercial products as of December 31, 2025: COVID vaccines Spikevax and mNEXSPIKE, and RSV vaccine mRESVIA. The company has 25 development candidates across 35 development programs currently in clinical studies, spanning infectious disease vaccines, oncology therapeutics, and rare disease therapeutics. During 2025, the company expanded U.S. manufacturing capabilities through onshoring of drug product manufacturing to its Norwood, Massachusetts facility, with completion targeted for the first half of 2027 to enable end-to-end mRNA manufacturing domestically. Manufacturing facilities in Australia and the United Kingdom became operational during the third quarter of 2025 under long-term strategic agreements with respective governments to support domestic mRNA manufacturing and pandemic preparedness. In December 2025, Moderna entered into an agreement with CEPI providing up to $54 million in funding to support a pivotal Phase 3 trial for its H5 pandemic influenza vaccine candidate mRNA-1018, with Moderna committing to allocate 20% of pandemic vaccine manufacturing capacity for low- and middle-income countries at affordable pricing if licensure is granted. The company entered into a strategic collaboration with Recordati in January 2026 to advance mRNA-3927 (propionic acidemia therapeutic) through final clinical development stages and, if approved, global commercialization. Retained earnings totaled $7.2 billion as of December 31, 2025, down from prior period profitability achieved in 2021 and 2022.
Management commentary
Management stated that product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities and continued uptake of mNEXSPIKE in the U.S. The company anticipates that cost of sales will remain at a relatively consistent level compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies, though cost of sales as a percentage of net product sales may decrease modestly if net product sales increase. Management expects a modest reduction in research and development expenses in 2026 driven by continued portfolio prioritization, disciplined cost management, and a focused approach to pipeline execution, partially offset by certain clinical trial activities shifting into 2026 and additional costs related to post-marketing commitments. Selling, general and administrative expenses in 2026 are expected to remain relatively consistent with 2025, reflecting an efficient and scalable operating structure, with selective investments to support global commercial and regulatory activities largely offset by ongoing efficiency initiatives. Management believes that cash, cash equivalents, and investments as of December 31, 2025, together with cash expected to be generated from product sales and available borrowings under the credit facility, will be sufficient to fund projected operations and capital expenditures through at least the next 12 months from the issuance of the financial statements.
What to watch next
Investors should monitor:
FDA decision on the seasonal flu vaccine BLA by the August 5, 2026 PDUFA date, as approval would enable entry into the well-established flu vaccine market and represent critical revenue diversification beyond COVID vaccines, though the company may face challenges offering competitive terms to gain market share against established players.
Regulatory outcomes for the flu+COVID combination vaccine mRNA-1083, currently under review in Europe and Canada, as the company awaits further FDA guidance on refiling in the U.S., with different regulators potentially issuing varying guidance on vaccine composition or target populations.
Enrollment completion and data readout from the Phase 3 norovirus vaccine study (mRNA-1403), which recently completed enrollment of a second Northern Hemisphere season cohort, as this represents another potential commercial franchise in the infectious disease vaccine portfolio.
Clinical data and regulatory progress for intismeran autogene across eight ongoing Phase 2 and Phase 3 trials in multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma, as this individualized neoantigen therapy could establish the company's presence in oncology therapeutics if successfully developed.
Ability to reduce operating cash burn and approach cash flow breakeven as management stated this as a goal requiring successful implementation of cost efficiency and prioritization programs, with achievement dependent on stabilizing revenue and managing the capital-intensive manufacturing infrastructure.
This summary is based solely on excerpts from the company's Form 10-K filing.
