Moderna, Inc.

Moderna is a pioneer and leader in the field of mRNA medicine, operating within the biotechnology and pharmaceutical industries. The company's platform enables the development of vaccine and therapeutic candidates across infectious disease, oncology, rare disease and more. The industry is characterized by rapidly advancing technologies and intense competition, with a strong emphasis on defense of intellectual property and proprietary products.

The company faces competition from various sources, including large pharmaceutical companies, biotechnology companies, academic institutions, government agencies and public and private research institutions. Primary competitors named include Pfizer and BioNTech for COVID vaccines, Sanofi and Novavax for COVID vaccines, Pfizer and GlaxoSmithKline for RSV vaccines, and numerous large pharmaceutical and biotechnology companies in the oncology space. The company believes its mRNA platform coupled with its capabilities across mRNA technology, drug discovery, development and manufacturing provides a competitive advantage.

Moderna generates revenue primarily through net product sales of its three commercial products: Spikevax, mNEXSPIKE (COVID vaccines), and mRESVIA (RSV vaccine). Revenue is also generated from grant revenue, collaboration revenue, licensing and royalty revenue, and stand-ready manufacturing revenue. The company sells its COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. In the U.S., products are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.

The company's infectious disease vaccine franchise includes three commercial respiratory vaccines: Spikevax and mNEXSPIKE (COVID vaccines) and mRESVIA (RSV vaccine). mNEXSPIKE was approved by the FDA in May 2025 for individuals 65 years of age and older, and individuals 12 through 64 years of age who are at high risk for severe COVID-19. mRESVIA was approved by the FDA in May 2024 for adults 60 years or older, and in June 2025 received FDA approval for use in adults ages 18-59 who are at increased risk for RSV-LRTD. Net product sales from COVID vaccines were $1.810 billion ¹ in 2025, $3.084 billion ² in 2024, and $6.671 billion ³ in 2023. Net product sales from RSV were $8 million ⁴ in 2025 and $25 million ⁵ in 2024.

In oncology, the company is advancing intismeran autogene (mRNA-4157) in collaboration with Merck, with eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types. In January 2026, five-year data from the Phase 2b study demonstrated sustained improvement in recurrence-free survival in patients with high-risk melanoma (stage III/IV) following complete resection, reducing the risk of recurrence or death by 49% ⁶ (HR=0.510 [95% CI, 0.294-0.887]; one-sided nominal p=0.0075) compared to KEYTRUDA alone. In rare disease, the propionic acidemia therapeutic (mRNA-3927) has reached target enrollment in a registrational study, and in January 2026, the company entered into a strategic collaboration with Recordati to advance it through final stages of clinical development and, if approved, global commercialization.

In 2025, the company announced new drug product capabilities in the U.S. and added three Moderna-built and managed facilities in the UK, Canada and Australia. The Marlborough, Massachusetts facility was purpose-built for intismeran and began clinical batch supply in September 2025. In November 2025, the company entered into a five-year term loan facility providing for up to $1.5 billion ⁷ of capital, including a $600 million ⁸ initial term loan funded at closing. In December 2025, the Coalition for Epidemic Preparedness Innovations (CEPI) agreed to invest up to $54.3 million ⁹ to support a pivotal Phase 3 clinical trial for the investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018.

Total revenue for the year ended December 31, 2025 was $1.944 billion ¹⁰, compared to $3.236 billion ¹¹ in 2024 and $6.848 billion ¹² in 2023. Net loss was $2.822 billion ¹³ in 2025, compared to $3.561 billion ¹⁴ in 2024 and $4.714 billion ¹⁵ in 2023. Loss per share was $(7.26) ¹⁶ for 2025, compared to $(9.28) ¹⁷ in 2024 and $(12.33) ¹⁸ in 2023. The company had cash, cash equivalents and investments of $8.135 billion ¹⁹ as of December 31, 2025, compared to $9.519 billion ²⁰ as of December 31, 2024.

The company expects to drive revenue growth in 2026 from the annualized impact of long-term partnerships in the UK, Canada and Australia, as well as continued strong uptake of mNEXSPIKE in the U.S. Multiple growth opportunities are expected in 2027 and 2028. Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities, as well as continued uptake of mNEXSPIKE in the U.S.

The company expects multiple growth opportunities in 2027 and 2028, including the anticipated launch of several new infectious disease products over the next few years (flu, flu+COVID combination and Norovirus), which would expand the infectious disease vaccine franchise to as many as six approved products. The company expects to invest the cash generated from these products into oncology and rare disease therapeutics. Pivotal trial data readouts are anticipated in 2026 across the oncology, rare disease and infectious disease portfolios.

The company expects to further reduce costs in 2026 and 2027, leveraging its global production network, artificial intelligence (AI) and digital tools to improve cost efficiency. Cost of sales as a percentage of net product sales was 48% ²¹ in 2025 compared to 47% ²² in 2024. In 2026, 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. To the extent net product sales increase, cost of sales as a percentage of net product sales may decrease modestly.

The company's manufacturing facilities in Australia and the United Kingdom were licensed and became operational during the third quarter of 2025. These facilities were established under long-term strategic agreements with the respective governments to support domestic mRNA manufacturing and pandemic preparedness. The facilities will enable local supply of mRNA vaccines and provide rapid response capabilities in the event of future public health emergencies. In September 2025, the company delivered the first mRNA vaccines fully manufactured in Canada from its facility in Laval, Quebec.

Research and development expenses were $3.132 billion ²³ in 2025, compared to $4.543 billion ²⁴ in 2024. The company anticipates a modest reduction in research and development expenses in 2026 compared to 2025, driven by continued portfolio prioritization, disciplined cost management, and a focused approach to pipeline execution. Selling, general and administrative expenses were $1.018 billion ²⁵ in 2025, compared to $1.174 billion ²⁶ in 2024. The company expects selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025.

Capital expenditure plans included purchases of property, plant and equipment of $192 million ²⁷ in 2025, compared to $1.051 billion ²⁸ in 2024. As of December 31, 2025, $1.7 billion ²⁹ of the Board of Directors' authorization for repurchases of common stock remained outstanding, with no expiration date. The company does not expect to pay cash dividends on its common stock for the foreseeable future.

The company faces structural headwinds including regulatory and market uncertainty that have and may continue to impact the business and the markets for its products. Changes in FDA regulatory policies, CDC and ACIP recommendations regarding eligibility, target populations, and vaccination practices may affect demand for vaccines. Vaccination rates may be lower than expectations due to factors including viral evolution, medical need and consumer motivation to vaccinate. The company has experienced commercial challenges in the RSV market, in part due to advisory committee recommendations that were more limited than anticipated.

The company has been excluded from selling its COVID vaccines in many European markets due to a competitor's contract with the European Commission, which does not lapse until year-end 2026. For RSV vaccines, the company entered a market already occupied by two larger competitors and may continue to face difficulties achieving market share. The company may need to dedicate greater resources to commercial efforts than anticipated and may not realize a return on this investment.

The company faces significant risks including regulatory and market uncertainty impacting product demand, with changes in FDA policies and ACIP recommendations potentially affecting vaccine uptake. The vaccine market is intensely competitive, with the company competing against Pfizer, BioNTech, Sanofi, Novavax, GSK and others, and the company has been excluded from many European COVID vaccine markets due to a competitor's contract with the European Commission through year-end 2026. The company incurred net losses of $2.8 billion ³⁰ in 2025 and $3.6 billion ³¹ in 2024, and expects to incur additional losses in the future. The company's ability to achieve profitability depends on successfully developing and obtaining regulatory approvals to commercialize products. The company faces risks related to manufacturing complex mRNA medicines, including dependence on single-source suppliers and potential difficulties in production, product release, shelf life, testing, storage, supply chain management or shipping. Intellectual property litigation is ongoing with multiple parties including Pfizer/BioNTech, Arbutus, GSK, Northwestern University, and others, which is inherently costly and unpredictable.

Management's message emphasizes four strategic priorities: deliver sales growth, deliver cost efficiency across the business, execute on the prioritized pipeline, and continue to advance the early pipeline and platform technology. The company expects to drive revenue growth in 2026 from the annualized impact of long-term partnerships in the UK, Canada and Australia, as well as continued strong uptake of mNEXSPIKE in the U.S. Management expects to further reduce costs in 2026 and 2027, and anticipates pivotal trial data readouts in 2026 across oncology, rare disease and infectious disease portfolios. The company expects to launch several new infectious disease products over the next few years (flu, flu+COVID combination and Norovirus), which would expand the infectious disease vaccine franchise to as many as six approved products.