Company Description
Moderna, Inc. (NASDAQ: MRNA) is a biotechnology company focused on messenger RNA (mRNA) medicine. The company describes itself as a pioneer and leader in this field, using its mRNA technology platform to rethink how medicines are made and to transform how diseases are treated and prevented. Since its founding, Moderna’s mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases, latent and other virus vaccines, and autoimmune diseases.
According to its public disclosures, Moderna has evolved into a commercial-stage company with multiple approved products and an extensive development pipeline. Its first commercial product was Spikevax, an mRNA COVID-19 vaccine that became one of the earliest and widely used COVID vaccines. The company later received approval for mRESVIA, its respiratory syncytial virus (RSV) vaccine for older adults and certain high-risk adults, and for mNEXSPIKE, a new COVID-19 vaccine. These products form the foundation of Moderna’s respiratory vaccines portfolio and underpin its seasonal vaccine franchise targeting at-risk populations.
Moderna reports that its mRNA platform supports four main franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics, and rare disease therapeutics. The company has described a diverse and extensive development pipeline, with dozens of development candidates and programs in clinical studies. Its programs span infectious diseases, immuno-oncology, cardiovascular and rare genetic diseases, among other areas, reflecting the breadth of applications the company sees for mRNA technology.
Business focus and strategy
In its investor and proxy materials, Moderna outlines a strategy centered on three priorities: driving sales of its marketed products, advancing additional mRNA products to approval, and improving cost efficiency across the business. The company highlights Spikevax, mRESVIA and mNEXSPIKE as the commercial base of a seasonal vaccine franchise, and it is also pursuing regulatory approvals for additional candidates such as a seasonal influenza vaccine (mRNA-1010), a flu/COVID combination vaccine (mRNA-1083), and a Norovirus vaccine (mRNA-1403). These efforts are intended to expand its respiratory portfolio beyond COVID-19.
Beyond infectious disease, Moderna is investing in oncology therapeutics and rare disease therapeutics. For example, the company is advancing mRNA-4157 (intismeran autogene) in collaboration with Merck in multiple Phase 2 and Phase 3 clinical trials across tumor types such as melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. It is also developing mRNA-4359, an investigational mRNA-based therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells, in a Phase 1/2 study that includes cohorts in metastatic melanoma and metastatic non-small cell lung cancer.
In rare diseases, Moderna is studying mRNA-3927 as a therapeutic candidate for propionic acidemia (PA) in a registrational study, and mRNA-3705 as a therapeutic candidate for methylmalonic acidemia (MMA), which has been selected by the U.S. Food and Drug Administration for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program with a registrational study expected to begin based on agreed design. These programs illustrate how the company is applying its mRNA platform to inherited metabolic disorders.
Manufacturing and operational footprint
Moderna describes a global manufacturing network built around its mRNA platform. In the United States, the company’s facility in Norwood, Massachusetts, is used for scalable, end-to-end production of mRNA medicines and incorporates automation, robotics and AI to increase cost efficiency and reduce waste. The company has announced the onshoring of Drug Product manufacturing to this site, which it states will complete full end-to-end manufacturing for its mRNA medicines in the U.S.
Outside the U.S., Moderna has added company-built and managed facilities in Laval, Canada; Harwell, United Kingdom; and Clayton, Australia. These sites are intended to enable local access to mRNA medicines and support revenue diversification. The company has also referenced manufacturing and R&D facilities that have received licenses from regulators such as the UK Medicines and Healthcare products Regulatory Agency and Australia’s Therapeutic Goods Administration. Together, these facilities form a global production network that supports commercial supply, multi-year strategic partnerships, and clinical development.
Financial framework and capital structure
Moderna communicates a multi-year financial framework that includes a target of reaching cash breakeven on a cash cost basis by 2028. The company has reported that, in the post-pandemic endemic COVID-19 market, expenses have exceeded revenues in recent years and it anticipates net losses over certain periods as it invests in its pipeline. To support its plans, Moderna has focused on cost reductions in research and development, selling, general and administrative expenses, and cost of goods, including procurement savings, manufacturing efficiencies and headcount reductions.
In November 2025, Moderna entered into a Credit and Guaranty Agreement providing for a credit facility of up to $1.5 billion, consisting of an initial term loan and delayed draw term loans. The loans are guaranteed by certain subsidiaries and secured by an all-asset collateral grant, subject to customary exceptions and limitations. The agreement includes a minimum liquidity covenant based on cash and cash equivalents, with thresholds that can change depending on the amount drawn and the company’s market capitalization. This facility is described as non-dilutive financing that bolsters the company’s balance sheet and provides additional flexibility.
Pipeline and development highlights
Moderna regularly reports on its late-stage pipeline and approved product milestones. In respiratory vaccines, the company notes that Spikevax is approved in multiple countries, mNEXSPIKE has received approvals in the U.S. and Canada and has been filed in additional markets, and mRESVIA is approved in many countries for adults aged 60 and older and, in a subset of those countries, for certain adults aged 18–59 at increased risk. The company is pursuing approvals for mRNA-1010 in the U.S., European Union, Canada and Australia, and its mRNA-1083 flu/COVID combination vaccine has filings under review with regulators such as the European Medicines Agency and Health Canada.
For Norovirus, Moderna is conducting a Phase 3 study of mRNA-1403, enrolling across multiple respiratory seasons to accrue sufficient cases, with an interim analysis expected based on trial progress. In pandemic influenza, the Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to invest up to $54.3 million to support a pivotal Phase 3 trial of Moderna’s H5 pandemic influenza vaccine candidate, mRNA-1018, with the goal of advancing it toward licensure and enhancing global pandemic preparedness.
In oncology, mRNA-4157 (intismeran autogene) is being studied in multiple Phase 2 and Phase 3 trials across several tumor types, including adjuvant melanoma and non-small cell lung cancer, as well as bladder and renal cell carcinoma. The company has indicated that some of these studies are fully enrolled and others are actively enrolling. mRNA-4359 has generated Phase 1b data presented at a major oncology congress, and the Phase 2 portion of its study is enrolling patients in metastatic melanoma and metastatic non-small cell lung cancer.
In rare diseases, Moderna has presented data suggesting that mRNA-3927 has been generally well tolerated to date in clinical studies for propionic acidemia, with trial participants electing to continue in an open-label extension. For mRNA-3705 in methylmalonic acidemia, the company has shared interim Phase 1/2 data and is working with regulators on a pivotal study design under the FDA’s START program.
Corporate governance and shareholder matters
Moderna is incorporated as Moderna, Inc. and files reports with the U.S. Securities and Exchange Commission (SEC), including Forms 8-K and proxy statements. In 2025, the company called a Special Meeting of Shareholders to consider, among other items, a one-time stock option exchange program for non-Executive Committee employees. The program allows eligible employees to exchange underwater stock options—those with exercise prices significantly above the market price—for new options with fewer shares, a new exercise price equal to fair market value on the grant date, and new vesting terms. Executive Committee members, consultants, advisors and directors are excluded from participation.
The company states that this option exchange is intended to restore equity value for non-Executive Committee employees, increase retention and motivation, and better align employee and shareholder interests while being designed to be fair-value neutral and anti-dilutive to shareholders. The proposal was approved by shareholders, according to the reported voting results.
Company mission and culture
Across its public communications, Moderna emphasizes its mission to deliver the greatest possible impact to people through mRNA medicines. The company highlights a global team and a culture driven by its values and mindsets, and notes recognition in industry rankings as a biopharmaceutical employer. Moderna describes its work as operating at the intersection of science, technology and health, with the aim of developing medicines at speed and scale for a range of serious diseases.
Key segments and focus areas
- Respiratory virus vaccines: COVID-19 vaccines (Spikevax, mNEXSPIKE), RSV vaccine (mRESVIA), seasonal influenza vaccine candidate (mRNA-1010), flu/COVID combination vaccine candidate (mRNA-1083), and Norovirus vaccine candidate (mRNA-1403).
- Latent and other virus vaccines: Programs targeting viruses such as cytomegalovirus (CMV) have been part of the portfolio, with certain programs discontinued or refocused based on clinical results and strategic prioritization.
- Oncology therapeutics: Personalized and antigen-based mRNA cancer therapies including mRNA-4157 (intismeran autogene) and mRNA-4359 in multiple tumor types and stages.
- Rare disease therapeutics: mRNA-based treatments for inherited metabolic disorders, including propionic acidemia (mRNA-3927) and methylmalonic acidemia (mRNA-3705), progressing through clinical development.
Moderna’s disclosures indicate that it continues to refine its pipeline, discontinuing some programs that do not meet efficacy or strategic thresholds while concentrating resources on late-stage and high-priority candidates in infectious disease, oncology and rare diseases.