Business Description

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of our technology platform, we are reimagining how medicines are made to transform how we treat and prevent diseases. Since our founding, our mRNA platform has enabled the development of vaccine and therapeutic candidates across infectious disease, oncology, rare disease and more. With a global team and a unique culture, driven by our values and mindsets, our mission is to deliver the greatest possible impact to people through mRNA medicines. We currently have three commercial products—Spikevax and mNEXSPIKE (our COVID vaccines) and mRESVIA (our vaccine against respiratory syncytial virus (RSV)). mNEXSPIKE, which we launched commercially in the third quarter of 2025, is now our leading product in the U.S. retail channel. In 2025, we achieved total revenue of $1.9 billion, largely from sales of our COVID vaccines. Beyond our commercial products, we continue to demonstrate the potential of our platform technology and are advancing a pipeline of development candidates across oncology, rare disease and infectious disease. In January 2026, we and Merck announced five-year data from the Phase 2b study of intismeran autogene (mRNA-4157), our mRNA-based individualized neoantigen therapy, in combination with Merck’s pembrolizumab (KEYTRUDA®), which demonstrated sustained improvement in recurrence-free survival in patients with high-risk melanoma (stage III/IV) following complete resection. We are advancing intismeran in collaboration with Merck, with eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types. In oncology, we are also advancing mRNA-4359, a cancer antigen therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells. In infectious disease, we have regulatory filings under review for our seasonal flu+COVID combination vaccine candidate (mRNA-1083) in Europe and Canada, and for our seasonal flu vaccine candidate (mRNA-1010) in the United States, Europe, Canada and Australia. For mRNA-1010, in response to a prior Refusal-to-File letter, we engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and submitted an amended biologics license application (BLA) outlining a revised regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults. Following the meeting and submission of the amended application, the FDA accepted our BLA for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. In addition, we recently completed enrollment of a second Northern Hemisphere season (2025-2026) cohort in our ongoing Phase 3 study for our norovirus candidate (mRNA-1403). In rare disease, our propionic acidemia therapeutic (mRNA-3927) has reached target enrollment in a registrational study. In January 2026, we entered into a strategic collaboration with Recordati, an international pharmaceutical group, to advance mRNA-3927 through the final stages of clinical development and, if approved, global commercialization. In addition, we expect the registrational study for our methylmalonic acidemia therapeutic (mRNA-3705) to begin in 2026. Since 2022, we have streamlined our production sites into a global manufacturing network to support new product launches and deliver products for multi-year collaborations. In 2025, we announced new drug product capabilities in the U.S. and we have added three Moderna-built and managed facilities in the UK, Canada and Australia to enable local access to mRNA vaccines. Additionally, our Marlborough, Massachusetts facility was purpose-built for intismeran and began clinical batch supply in September 2025. THE mRNA OPPORTUNITY mRNA, the software of life mRNA transfers the information stored in our genes to the cellular machinery that makes all the proteins required for life. Our genes are stored as sequences of DNA which contain the instructions to make specific proteins. DNA serves as a hard drive, safely storing these instructions in the cell’s nucleus until they are needed by the cell. When a cell needs to produce a protein, the instructions to make that protein are copied from the DNA to mRNA, which serves as the template for protein production.…