Moderna, Inc. (MRNA) Business

Item 1. Business

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. Each mRNA molecule contains the instructions to produce a specific protein with a distinct function in the body. mRNA transmits those instructions to cellular machinery, called ribosomes, that make copies of the required protein.

We see mRNA functioning as the “software of life.” Every cell uses mRNA to provide real time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. This was codified as the central dogma of molecular biology over 60 years ago, and is exemplified in the schematic below.

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The structure of mRNA

mRNA is a linear polymer comprising four monomers called nucleotides: adenosine (A), guanosine (G), cytosine (C) and uridine (U). Within the region of the molecule that codes for a protein (the coding region), the sequence of these four nucleotides forms a language made up of three-letter words called codons. The first codon, or start codon (AUG), signals where the ribosome should start protein synthesis. To know what protein to make, the ribosome then progresses along the mRNA one codon at a time, appending the appropriate amino acid to the growing protein. To end protein synthesis, three different codons (UAA, UAG, and UGA) serve as stop signals, telling the ribosome where to terminate protein synthesis. In total, there are 64 potential codons, but only 20 amino acids that are used to build proteins; therefore, multiple codons can encode for the same amino acid.

The process of protein production is called translation because the ribosome is reading in one language (a sequence of codons) and outputting in another language (a sequence of amino acids). The coding region is analogous to a sentence in English. Much like a start codon, a capitalized word can indicate the start of a sentence. Codons within the coding region resemble groups of letters representing words. The end of the sentence is signaled by a period in English, or a stop codon for mRNA.

In every cell, hundreds of thousands of mRNAs make hundreds of millions of proteins every day. A typical protein contains 200-600 amino acids; therefore, a typical mRNA coding region ranges from 600-1,800 nucleotides. In addition to the coding region, mRNAs contain four other key features: (1) the 5’ untranslated region (5’-UTR); (2) the 3’ untranslated region (3’-UTR); (3) the 5’ cap; and (4) a 3’ polyadenosine (poly-A) tail. The sequence of nucleotides in the 5’-UTR influences how efficiently the ribosome initiates protein synthesis, whereas the sequence of nucleotides in the 3’-UTR contains information about which cell types should translate that mRNA and how long the mRNA should last. The 5’ cap and 3’ poly-A tail enhance ribosome engagement and protect the mRNA from attack by intracellular enzymes that digest mRNA from its ends.

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The intrinsic advantages of using mRNA as a medicine

mRNA possesses inherent characteristics that we believe position it to have a profound impact on human health:

•mRNA is used by every cell to produce all proteins: mRNA is used to make every type of protein, including secreted, membrane and intracellular proteins, in varying quantities over time, in different locations and in various combinations. Given the universal role of mRNA in protein production, we believe that mRNA medicines could have broad applicability across human disease.

•Making proteins inside one’s own cells mimics human biology: Tailored mRNA can be sent into cells to instruct them to produce specific protein therapeutics or vaccine antigens and provides certain advantages over traditional approaches to medicine, where a protein or chemical is introduced to the body.

•mRNA has a simple and flexible chemical structure: Each mRNA molecule comprises four chemically similar nucleotides to encode proteins made from up to 20 chemically different amino acids. To make the full diversity of possible proteins, only simple sequence changes are required in mRNA, instead of starting from scratch for each new vaccine or therapy.

•mRNA has classic pharmacologic features: mRNA possesses many of the attractive pharmacologic features of most modern medicines, including reproducible activity, predictable potency and well-behaved dose dependency; mRNA also provides the ability to adjust dosing based on an individual patient’s needs, including stopping or lowering the dose, to seek to promote safety and tolerability.

Our success in developing, manufacturing and commercializing mRNA medicines demonstrates the potential of our platform to help people and patients in far-reaching ways that could exceed the impact of traditional approaches to medicine.

We believe that the main advantages of mRNA as compared to traditional medicine are:

1.mRNA could create an unprecedented abundance and diversity of medicines. mRNA’s breadth of applicability has the potential to create an extraordinary number of new mRNA medicines that are currently beyond the reach of recombinant protein technology.

2.Advances in the development of our mRNA medicines reduce risks across our portfolio. mRNA medicines share fundamental features that can be leveraged across our portfolio. We believe that once safety and proof of protein production has been established in one program, the technology and biology risks of related programs that use similar mRNA technologies, delivery technologies and manufacturing processes will decrease significantly.

3.mRNA technology can accelerate discovery and development. The software-like features of mRNA enable rapid in silico design and the use of automated high-throughput synthesis processes that permit discovery to proceed in parallel rather than sequentially. We believe these mRNA features can also accelerate drug development by allowing the use of shared manufacturing processes and infrastructure.

4.The ability to leverage shared processes and infrastructure can drive significant capital efficiency over time. We believe the manufacturing requirements of different mRNA medicines are similar and that at commercial scale, a portfolio of mRNA medicines will benefit from shared capital expenditures.

OUR STRATEGY

We believe that the development of mRNA medicines represents a significant breakthrough for patients, our industry and human health globally. We are currently focused on four strategic priorities:

1.Deliver sales growth. Our commercial growth drivers include geographic expansion and new product launches. In 2026, we expect to drive revenue growth from the annualized impact of our long-term partnerships in the UK, Canada and Australia, as well as continued strong uptake of mNEXSPIKE in the U.S. In addition, we expect multiple growth opportunities in 2027 and 2028.

2.Deliver cost efficiency across the business. Throughout 2025, we maintained disciplined cost management, improving productivity across manufacturing, R&D and SG&A. We expect to further reduce costs in 2026 and 2027. We plan to leverage our global production network, artificial intelligence (AI) and digital tools to improve cost efficiency.

3.Execute on our prioritized pipeline. We anticipate pivotal trial data readouts in 2026 across our oncology, rare disease and infectious disease portfolios. We expect to launch several new infectious disease products over the next few years (flu, flu+COVID combination and Norovirus), which would expand our infectious disease vaccine franchise to as many as six approved products. We expect to invest the cash generated from these products into oncology and rare disease therapeutics.

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4.Continue to advance our early pipeline and platform technology. We continue to advance our early-stage pipeline. This includes our early-stage oncology programs, which expand our oncology portfolio across cancer antigen therapies, T-cell engagers and cell-therapy enhancers, as well as multiple early-stage vaccine programs.

OUR PLATFORM

Overview of our platform

Our mRNA “platform” refers to our accumulated knowledge and capabilities in basic and applied sciences. Our platform incorporates advances across three key components—mRNA, delivery and the manufacturing process— to advance our medicines. We integrate these components and combine different versions of mRNA delivery and process into each of our medicines.

Our platform: mRNA science advancements

We continue to invest in both basic and applied research, seeking to advance both the state of our technology and the state of the scientific community’s understanding of mRNA. Examples of advances in mRNA science that combine nucleotide chemistry, sequence engineering and targeting elements are described below.

mRNA chemistry: Modified nucleotides to mitigate immune system activation: The innate immune system has evolved to protect cells from foreign RNA, such as viral RNA, by inducing inflammation and suppressing mRNA translation once detected. Many cells surveil their environment through sensors called toll-like-receptors (TLRs). These include types that are activated by the presence of double-stranded RNA (TLR3) or uridine containing RNA fragments (TLR7, TLR8). Additionally, all cells have cytosolic double-stranded RNA, sensors, including retinoic acid inducible gene-I (RIG-I) that are sensitive to foreign RNA inside the cell.

The immune and cellular response to mRNA is complex, context specific, and often linked to the sensing of uridine. To minimize undesired immune responses to our potential mRNA medicines, our platform employs chemically-modified uridine nucleotides to minimize recognition by both immune cell sensors such as TLR3/7/8, and broadly-distributed cytosolic receptors such as RIG-I.

mRNA sequence engineering: Maximizing protein expression: mRNA exists transiently in the cytoplasm, during which time it can be translated into thousands of proteins before eventually being degraded. Our platform applies bioinformatic, biochemical, and biological screening capabilities, most of which have been invented internally that aim to optimize the amount of protein produced per mRNA. We have identified proprietary sequences for the 5’-UTR that have been observed to increase the likelihood that a ribosome bound to the 5’-end of the mRNA transcript will find the desired start codon and reliably initiate translation of the coding region. We additionally design the nucleotide sequence of the coding region to maximize its successful translation into protein.

Targeting elements: Enabling tissue-targeted translation: All nucleated cells in the body are capable of translating mRNA, resulting in pharmacologic activity in any cell in which mRNA is delivered and translated. To minimize or prevent potential off-target effects, our platform employs technologies that regulate mRNA translation in select cell types. Cells often contain short RNA sequences, called microRNAs or miRNAs, that bind to mRNA to regulate protein translation at the mRNA level. Different cell types have different concentrations of specific microRNAs, in effect giving cells a microRNA signature. microRNA binding directly to mRNA effectively silences or reduces mRNA translation and promotes mRNA degradation. We design microRNA binding sites into the 3’-UTR of our potential mRNA medicines so that if our mRNA is delivered to cells with such microRNAs, it will be minimally translated and rapidly degraded.

Our platform: Delivery science

Our mRNA can, in specific instances, be delivered by direct injection to a tissue in a simple saline formulation without lipid nanoparticles (LNPs) to locally produce small amounts of pharmacologically active protein. However, the blood and interstitial fluids in humans contain significant RNA degrading enzymes that rapidly degrade any extracellular mRNA and prevent broader distribution without LNPs. Additionally, cell membranes tend to act as a significant barrier to entry of large, negatively-charged molecules such as mRNA. We have therefore invested heavily in delivery science and have developed LNP technologies to enable delivery of larger quantities of mRNA to target tissues.

LNPs are generally composed of four components: an amino lipid, a phospholipid, cholesterol, and a pegylated-lipid (PEG-lipid). Each component, as well as the overall composition, or mix of components, contributes to the properties of each LNP system. LNPs containing mRNA injected into the body rapidly bind proteins that can drive uptake of LNPs into cells. Once internalized in endosomes within cells, the LNPs are designed to escape the endosome and release their mRNA cargo into the cell cytoplasm, where the mRNA can be translated to make a protein and have the desired therapeutic effect. Any mRNA and LNP components that do not escape the endosome are typically delivered to lysosomes where they are degraded by the natural process of cellular digestion.

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Examples of tools we developed by using our platform include proprietary LNP formulations that address the steps of mRNA delivery, including cell uptake, endosomal escape, and subsequent lipid metabolism, and for avoidance of counterproductive interactions with the immune system.

Chemistry: Novel lipid chemistry to potentially improve safety and tolerability: Our proprietary LNP systems are designed to be highly tolerated and minimize any LNP vehicle-related toxicities with repeat administration in vivo. To overcome limitations of previous LNP formulations, we have engineered amino lipids to avoid the immune system and to be rapidly biodegradable relative to prior lipids.

Composition: Proprietary LNPs enhance delivery efficiency: Our platform includes extensive in-house expertise in medicinal chemistry, which we have applied to design large libraries of novel lipids. Using these libraries in combination with our discovery biology capabilities, we have conducted high throughput screens for desired LNP properties and believe that we have made fundamental discoveries in preclinical studies about the relationships between structural motifs of lipids and LNP performance for protein expression.

Surface properties: Novel LNP design to avoid immune recognition: We have designed our proprietary LNP systems for sustained pharmacology upon repeat dosing by eliminating or altering features that activate the immune system. These are based on insights into the surface properties of LNPs. Upon repeated dosing, surface features on traditional LNPs such as amino lipids, phospholipids, and PEG-lipids, can be recognized by the immune system, leading to rapid clearance from the bloodstream, a decrease in potency upon repeat dosing, and an increase in inflammation. Based on our insights into these mechanisms, we have engineered our LNP systems to reduce or eliminate undesirable surface features. In clinical studies for our systemic therapeutic product candidates that use our novel LNP systems, we have been able to repeat dose with negligible or undetectable loss in potency, liver damage, and immune system activation.

Our platform: Manufacturing process science

We invest significantly in manufacturing process science to impart more potent features to our mRNA and LNPs, and to invent the technological capabilities necessary to manufacture our mRNA medicines at scales ranging from micrograms to kilograms, as well as achieve pharmaceutical properties such as solubility and shelf life. We view developing these goals of manufacturing and pharmaceutical properties as appropriate for each program, based on its stage of development.

mRNA manufacturing process: Improving pharmacology: Our platform creates mRNA using a cell-free approach called in vitro transcription in which an RNA polymerase enzyme binds to and transcribes a DNA template, adding the nucleotides encoded by the DNA to the growing RNA strand. Following transcription, we employ proprietary purification techniques to ensure that our mRNA is free from undesired synthesis components and impurities that could activate the immune system in an indiscriminate manner. Applying our understanding of the basic science underlying each step in the manufacturing process, we have designed proprietary manufacturing processes to impart desirable pharmacologic features, for example increasing potency in a vaccine.

LNP manufacturing process: Improving pharmacology: Our platform technology includes synthetic processes to produce LNPs. Traditionally LNPs are assembled by dissolving the four molecular components, amino lipid, phospholipid, cholesterol, and PEG-lipid, in ethanol and then mixing this with mRNA in an aqueous buffer. The resulting mixture is then purified to isolate LNPs from impurities. Such impurities include molecular components that have not been incorporated into particles, un-encapsulated mRNA that could activate the immune system, and particles outside of the desired size range. Going beyond optimization of traditional manufacturing processes, we have invested in understanding and measuring the various biochemical and physical interactions during LNP assembly and purification. We have additionally developed state-of-the-art analytical techniques necessary to characterize our LNPs and biological systems to analyze their in vitro and in vivo performance. With these insights, we have identified manufacturing process parameters that drive LNP performance, for example, the potency in a secreted therapeutic setting. These insights have allowed us to make significant improvements in the efficiency of our processing and the potency of our LNPs.

Harnessing the power of mRNA through modalities

Within our platform, we invest in science to invent novel ways to deliver mRNA into various cell types. Each novel delivery system is a new application, called a “modality.” While the programs within a modality may target diverse diseases, they share similar mRNA characteristics and manufacturing processes to achieve shared product features.

We believe that the high technological correlation within a modality allows us to rapidly accelerate the expansion of programs within that modality based on learnings from the earlier programs, while the lower technology correlation between modalities allows us to compartmentalize the technology risks. Additionally, because programs within a modality pursue diverse diseases, they often have uncorrelated biology risk. New modalities and product candidates can create a network effect by helping us gain additional insight into the other programs in our pipeline.

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Although developing a new modality is difficult, time-consuming and expensive, we believe our experience and technology provide us with unique advantages in the development of mRNA medicines. Over the last decade, we have developed a number of modalities, each with one or many product candidates in the clinic. We believe that our ongoing investments in our platform will lead to the identification of additional modalities and expand the utility of our existing modalities and the diversity of our pipeline.

OUR PIPELINE

Over the last decade, we have advanced in parallel a diverse development pipeline that currently consists of 35 therapeutic and vaccine programs, 6 of which are in late-stage development. The scope of our pipeline reflects the breadth of biology addressable using mRNA technology, and spans three franchises: infectious disease vaccines, oncology therapeutics, and rare disease therapeutics.

Our selection process for advancing new product candidates reflects both program-specific and portfolio-wide considerations. Program-specific criteria include, among other relevant factors, the severity of the unmet medical need, the biology risk of our chosen target or disease, the feasibility of clinical development, the costs of development and the commercial opportunity. Portfolio-wide considerations include the ability to demonstrate technical success for our platform components within a modality, thereby increasing the probability of success and learnings for subsequent programs.

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Our full pipeline is shown in the figure below:

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INFECTIOUS DISEASE FRANCHISE

Respiratory Vaccines

We have three commercial respiratory vaccines—Spikevax and mNEXSPIKE (our COVID vaccines) and mRESVIA (our RSV vaccine for older adults and high-risk adults ages 18-59). Additionally, we have regulatory filings under review for our seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for our seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia. Our current respiratory programs are summarized below.

COVID vaccines (Spikevax/mRNA-1273, mNEXSPIKE/mRNA-1283)

COVID-19 is caused by the SARS-CoV-2 virus that was first identified in humans in 2019, driving a global pandemic resulting in millions of deaths. The risk of mortality increases with age, and the risk of severe disease and mortality is higher among individuals with certain pre-existing conditions, including cardiovascular disease, diabetes, chronic lung disease and obesity. As the SARS-CoV-2 virus continues to evolve, our COVID vaccines continue to be key tools in fighting COVID-19.

We currently have two approved COVID vaccines: Spikevax (our original COVID vaccine) and mNEXSPIKE. 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. mNEXSPIKE focuses immune responses to the domains of the SARS-CoV-2 spike protein that are critical for neutralizing antibody and T cell responses. mNEXSPIKE’s mRNA dose is one-fifth that of Spikevax. In April 2025, we shared Phase 3 data showing non-inferior vaccine efficacy relative to Spikevax, and a 13.5% relative vaccine efficacy (rVE) compared to Spikevax in participants 65 years of age and older.

As part of our strategy to continue to combat COVID-19, we develop and assess variant-specific versions of our COVID vaccines. We pursue updated vaccine compositions based on guidance from the FDA, and other regulatory bodies including European Medicines Agency (EMA) and the World Health Organization (WHO), with the goal of broadening vaccine-induced immunity and providing protection against circulating SARS-CoV-2 variants. Our 2025-2026 formulas for Spikevax and mNEXSPIKE target the LP.8.1 variant of SARS-CoV-2. The FDA has approved our 2025-2026 Spikevax formula for high-risk individuals aged six months through 64 years and all adults 65 years of age and older. We have received approval of our 2025-2026 Spikevax formula in 40 countries. The FDA has approved our 2025-2026 mNEXSPIKE formula for high-risk individuals 12 through 64 years of age and all adults 65 years of age and older. We have also received approvals of mNEXSPIKE in Europe, Canada and Australia.

RSV vaccine (mRESVIA/mRNA-1345)

RSV is one of the most common causes of lower respiratory disease in children under the age of five and in older adults. Populations that are especially vulnerable to developing severe RSV infections include infants, young children, children and adults with chronic medical conditions and older adults. Most children are infected at least once by age two. In the United States, it is estimated that up to 80,000 children are hospitalized due to RSV infection annually. RSV infection causes up to 160,000 hospitalizations and up to 10,000 deaths per year in adults aged 65 years or older in the United States. Adults 18 to 59 years of age with certain comorbidities also face a significant disease burden that is similar to that of older adults.

We have developed an RSV vaccine (mRNA-1345 or mRESVIA) for adults. mRESVIA encodes an engineered form of the RSV F protein stabilized in the prefusion conformation and is formulated in our proprietary LNP. In May 2024, we announced the FDA approved mRNA-1345, brand name mRESVIA, for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults 60 years or older. Subsequently, the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for all unvaccinated people aged 75 years and older and unvaccinated people aged 60 to 74 who are at increased risk for RSV. In June 2025, we received FDA approval for use of mRESVIA in adults ages 18-59 who are at increased risk for RSV-LRTD. In April 2025, the ACIP expanded its RSV vaccination recommendation to include high-risk individuals ages 50-59. mRESVIA was approved in the EU in August 2024 and in Canada in November 2024. In Canada, mRESVIA is recommended for individuals 75 and over and high-risk individuals ages 50-74, while in Europe, the vaccine is recommended for individuals 60 and over as well as high-risk individuals ages 18-59. mRESVIA has been approved in 40 countries for all adults 60 years and older and also approved in 31 of those countries for high-risk adults aged 18-59.

We have completed additional Phase 3 studies in adults that have shown that mRNA-1345 restores immune response when revaccinated at 12 or 24 months, can be co-administered with a COVID mRNA vaccine, and is immunogenic in the solid organ transplant population.

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Seasonal influenza vaccine (mRNA-1010)

The WHO estimates that seasonal influenza viruses cause three to five million cases of severe illness and 290,000 to 650,000 deaths each year, resulting in a severe challenge to public health. Currently licensed seasonal influenza vaccines rarely exceed 60% overall effectiveness and can provide low effectiveness during years when the circulating viruses do not match the strains selected for the vaccine antigens.

Our seasonal influenza vaccine candidate (mRNA-1010) encodes for the hemagglutinin (HA) proteins of the strains recommended by the WHO. We aim to work with the WHO, regulators and public health authorities to enable strain selection closer to the influenza season to provide a better match to the circulating viruses.

In February 2023, we announced interim results from the P301 study of mRNA-1010. The results indicated that mRNA-1010 achieved higher seroconversion rates for A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer rations for A/H1N1. Non-inferiority was not met for either endpoints for the influenza B/Victoria- or B/Yamagata-lineage strains. mRNA-1010 showed an acceptable safety and tolerability profile. In April 2023, we announced the P302 study of mRNA-1010 did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial. In September 2023, we announced the P303 immunogenicity and safety study of mRNA-1010 met all eight co-primary endpoints with an updated composition that was able to generate an improved immune response to influenza B strains. mRNA-1010 also elicited higher titers than the licensed comparator against all strains in this study. In September 2024, we shared results in an older adult extension study of P303, where mRNA-1010 met all primary immunogenicity endpoints, including superiority for all strains, compared to a licensed enhanced flu vaccine and showed an acceptable reactogenicity profile. Consequently, we announced that we were planning to start a confirmatory vaccine efficacy study, P304, funded by project financing through Blackstone Life Sciences, a collaboration we announced in 2024. In October 2025, we presented the results of this study showing a 26.6% relative vaccine efficacy versus the standard dose comparator in adults 50 year of age and older.

mRNA-1010 has been filed for approval in the United States, Europe, Canada and Australia. In February 2026, in response to a prior Refusal-to-File letter, we engaged with the FDA in a Type A meeting and submitted an amended 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 PDUFA goal date of August 5, 2026.

We have paused development of mRNA-1011, mRNA-1012, mRNA-1020, and mRNA-1030, which were flu vaccines that included additional antigens relative to what is included in mRNA-1010.

Combination vaccines (mRNA-1083 and mRNA-1365)

We are developing combination vaccine candidates to simplify and facilitate protection against a range of respiratory diseases.

Our COVID and seasonal influenza combination vaccine (mRNA-1083), encodes the same antigens as our seasonal influenza vaccine (mRNA-1010) and mNEXSPIKE. In June 2024, we announced that our Phase 3 clinical trial of mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older. We filed for FDA approval for mRNA-1083 in November 2024 and also submitted regulatory applications in other geographies, including the EU, Canada, Australia and the UK. Demonstration of vaccine efficacy in our ongoing Phase 3 mRNA-1010 flu study was required by regulatory authorities in certain jurisdictions to support approval of mRNA-1083. As a result, we withdrew our application for mRNA-1083 in certain geographies until the mRNA-1010 Phase 3 study was completed. In October 2025, we reported full results of our mRNA-1010 vaccine efficacy study. mRNA-1083 is under regulatory review in Europe and Canada, and we are awaiting further guidance from the FDA for re-filing in the U.S. In addition, we plan to pursue regulatory submissions for mRNA-1083 in selected additional international markets.

We continue to evaluate the clinical development strategy for mRNA-1083, including the appropriate age populations and indications for future studies.

In addition, safety follow-up continues in our Phase 1 study for mRNA-1365, our RSV and human metapneumovirus (hMPV) combination vaccine, in children five to 23 months of age. We are also evaluating an updated version of mRNA-1365 in older adults.

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Pandemic influenza vaccine (mRNA-1018)

An influenza pandemic is a global outbreak of a new influenza A virus that is very different from recently circulating human seasonal influenza A viruses. Historically, pandemic strains have arisen by antigenic shift, which is a major change in an influenza A virus caused by the exchange of genetic segments between a non-human influenza virus with another influenza virus; this can occur through a simultaneous infection of an animal (e.g., swine) or humans with multiple influenza viruses.

We are developing a pandemic influenza vaccine candidate that encodes for hemagglutinin (HA) glycoproteins. In 2023, we initiated a Phase 1/2 study to generate safety and immunogenicity data of our investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. The study included vaccine candidates against H5 and H7 avian influenza viruses. In October 2025, we presented results of this study showing that mRNA-1018 demonstrated a rapid, potent and durable immune response. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection.

In December 2025, we announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $54.3 million to support a pivotal Phase 3 clinical trial that aims to help advance our investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure. The Phase 3 trial is expected to begin in early 2026.

Latent and Other Vaccines

Our current latent and other vaccines programs are summarized below.

Vaccines against latent viruses

CMV vaccine (mRNA-1647)

Cytomegalovirus (CMV) is member of the herpes virus family and a common human pathogen that causes complications for people who are immunosuppressed or can be passed to babies during pregnancy and result in congenital malformation.

Our CMV vaccine candidate, mRNA-1647, combines six mRNAs in one vaccine. These six mRNAs encode proteins located on the surface of CMV: five mRNAs encode the subunits that form the membrane-bound pentamer complex and one mRNA encodes the full-length membrane-bound glycoprotein B (gB). Both pentamer and gB are essential for CMV to infect barrier epithelial surfaces and gain access to the body, which is the first step in CMV infection. mRNA-1647 is designed to produce an immune response against both pentamer and gB for the prevention of CMV infection.

Congenital CMV (cCMV) results when infected mothers transmit the virus to their unborn child and it is the leading infectious cause of birth defects in the United States. We conducted a cCMV Phase 3 study of mRNA-1647 in women of childbearing age and announced in October 2025 that the study failed to reach its primary clinical endpoint. The program in women of childbearing age was discontinued.

In addition to the health burden of cCMV infection, CMV is a major health risk in the transplant population. There are approximately 47,000 solid organ transplants and 23,000 hematopoietic stem cell transplants in the U.S. annually. Each recipient faces a significant risk of CMV infection post-transplant, and this could result in graft rejection or end-organ CMV disease. mRNA-1647 has the potential to prevent CMV viral replication and/or disease in transplant populations. A Phase 2 proof-of-concept study for mRNA-1647 in allogeneic hematopoietic cell transplant (HCT) patients is ongoing. In interim data from our Phase 2 study, we reported robust CMV-specific T-Cell responses, and we expect to present full Phase 2 data after the study’s conclusion.

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EBV vaccines (mRNA-1189 and mRNA-1195)

Epstein-Barr virus (EBV) is a member of the herpesvirus family that infects approximately 90% of people in the U.S. by adulthood, with primary infection typically occurring during childhood or late adolescence (approximately 50% and 89% seropositivity, respectively). EBV is the major cause of infectious mononucleosis, accounting for over 90% of the cases in the U.S. each year. Infectious mononucleosis can debilitate patients for weeks to months and, in some cases, can lead to hospitalization due to complications such as splenic rupture. EBV infection is also associated with the development and progression of certain lymphoproliferative disorders, cancers and autoimmune diseases. In particular, EBV infection and infectious mononucleosis are associated with increased risk of developing multiple sclerosis (MS), an autoimmune disease of the central nervous system. MS is the most common neurodegenerative disorder of the central nervous system, affecting approximately 2.8 million individuals worldwide of which approximately 1 million live in the U.S. MS leads to progressive disability, with profound socioeconomic impact on the patients, caregivers and the healthcare system.

We are developing two mRNA candidates against EBV —a prophylactic vaccine to prevent infectious mononucleosis (mRNA-1189) and a therapeutic to treat multiple sclerosis (mRNA-1195). We believe that an effective EBV vaccine must generate an immune response against antigens that are required for viral entry and reactivation in susceptible cell types. mRNA-1189 is designed to elicit an immune response to EBV envelope glycoproteins, which are required for infection of both epithelial and B cells. mRNA-1195 encodes for entry glycoproteins and latent antigens aimed at inducing an antibody and T cell response, and will be investigated in the context of multiple sclerosis and post-transplant lymphoproliferative disorder.

We are currently conducting Phase 2, randomized, observer-blind, placebo-controlled studies of mRNA-1189 and mRNA-1195. The primary purpose of these studies is to assess the safety, tolerability and immunogenicity of these candidates, and to enable dose selection for further clinical development. In March 2024, we shared Phase 1 data for mRNA-1189, where the randomized, observer-blind, placebo-controlled study showed mRNA-1189 was immunogenic and generally well tolerated across all dose levels. We have since fully enrolled a dose finding Phase 2 study for mRNA-1189. Our Phase 1 study for mRNA-1195 is fully enrolled, and in November 2025 we shared data that showed mRNA-1195 was immunogenic and generally well tolerated across all dose levels. Our mRNA-1195 Phase 2 proof of concept trial in MS is ongoing, with an initial sentinel cohort fully enrolled as of December 2025.

HIV vaccine (mRNA-1645)

Human immunodeficiency virus (HIV) is responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV, with 1.2 million in the U.S. Approximately 1.5 million new infections of HIV are acquired worldwide every year and approximately 680,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden.

Our HIV vaccine candidate (mRNA-1645) is being studied in Phase 1 clinical trials, sponsored by IAVI, to determine the optimal design to induce broadly neutralizing antibodies capable of addressing the genetic diversity of HIV that is necessary in future proof of concept studies. In collaboration with the Gates Foundation, International AIDS Vaccine Initiative (IAVI), The Scripps Research Institute and the National Institutes of Health (NIH), Phase 1 studies of previous versions of our HIV vaccine have been completed.

Vaccines against enteric viruses

Norovirus vaccines (mRNA-1403 and mRNA-1405)

Norovirus is a leading cause of acute gastroenteritis (AGE), responsible for approximately 18% of all AGE cases worldwide and imposing a substantial global health care burden. Annually, norovirus causes an estimated 685 million illnesses and 200,000 deaths, including more than 50,000 deaths in children under the age of five. While the incidence of norovirus AGE is highest among children under five years of age, disease severity is most pronounced in infants, older adults, and individuals with underlying medical conditions. In high-income countries such as the United States, approximately 90% of norovirus-associated deaths occur among older adults.

Norovirus is highly infectious and difficult to control due to its environmental stability and persistence on contaminated surfaces, frequently leading to large, disruptive, and costly outbreaks in closed or semi-closed settings such as daycare centers, schools, cruise ships, long term care facilities and healthcare institutions. Globally, the economic impact of norovirus is estimated at $60 billion per year. In the United States alone, norovirus causes an estimated 20 million infections, 100,000 hospitalizations and 900 deaths each year, with associated costs of approximately $2 billion. As populations age and reliance on institutionalized care increases, the burden of norovirus disease among older adults is expected to rise further.

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Norovirus exhibits broad genetic diversity, with 10 genogroups and 49 genotypes identified to date, 30 of which infect humans. Vaccine development has been challenging to date for many reasons, including the lack of a robust cell culture system, no reliable immune markers of norovirus protection and the broad and shifting diversity of genotypes. A multivalent vaccine with broad genotype coverage is needed to maximize protection against the genotypes most frequently associated with AGE in older adults and young children.

We are currently developing pentavalent (mRNA-1405) and trivalent (mRNA-1403) vaccine candidates for norovirus. Both candidates were reviewed in a Phase 1 study to evaluate safety, reactogenicity and immunogenicity in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. In March 2024, we presented data demonstrating that a single dose of trivalent vaccine candidate mRNA-1403 was well-tolerated across all dose levels evaluated and elicited robust antibody responses against vaccine-matched norovirus genogroup I & II selected genotypes, including functional histo-blood group antigen (HBGA) blocking antibodies. In September 2024, we presented additional data that mRNA-1403 elicited robust HBGA blocking antibody titers against a second GII genotype in older and younger adults.

In September 2024, we began dosing participants in a Phase 3 study of mRNA-1403. This Phase 3 trial is a randomized, observer-blind, placebo-controlled trial evaluating the efficacy, safety and immunogenicity of mRNA-1403. The trial has enrolled approximately 38,000 participants 18 years of age and older globally, across countries in the Northern Hemisphere (U.S., Canada, UK and Japan), and Panama and Australia. Approximately 33,000 participants 60 years of age and older and approximately 5,000 participants between 18 and 59 years of age have been enrolled to assess the ability of mRNA-1403 to protect against vaccine genotype-matched moderate to severe norovirus AGE, with a focus on the older adult age group that is at greatest risk of severe outcomes including hospitalization and death.

The Phase 3 study of mRNA-1403 completed its first seasons in the Northern and Southern Hemispheres. A second Northern Hemisphere season cohort is fully enrolled and the study is ongoing.

Bacterial vaccines

Lyme vaccines (mRNA-1975 and mRNA-1982)

Lyme disease is an illness caused by Borrelia bacteria transmitted by the bite of infected ticks. Lyme disease affects approximately 675,000 people annually in the U.S. and Europe, with incidence increasing due to expanding tick territories driven by rising temperatures. The disease burden follows a bimodal age distribution, predominantly impacting children under 15 and older adults. Symptoms include rash, fever, headaches, fatigue, joint pain, swelling, stiffness, and headaches. While no vaccines are currently approved, prior Phase 3 trials of outer surface protein A (OspA) antigen-based vaccines achieved efficacy up to 92%, with protection linked to high levels of antigen-specific antibodies.

We are conducting a randomized, observer-blind, placebo-controlled, dose-ranging Phase 1/2 trial in healthy participants aged 18 to 70. This trial evaluates the safety and immunogenicity of a heptavalent (mRNA-1975) and monovalent (mRNA-1982) approach in parallel. mRNA-1982 targets Borrelia burgdorferi, responsible for nearly all Lyme cases in North America, while mRNA-1975 targets the four major Borrelia species causing disease in North America and Europe.

No safety concerns have been identified across the evaluated dose levels for three injections of mRNA-1975/1982. Furthermore, three injections of mRNA-1975/1982 elicit robust anti-OspA IgG antibody responses, with titers up to ~1,300 times above baseline for OspA serotype 1 of Borrelia burgdorferi. The program will progress to a Phase 2 dose ranging study of mRNA-1982.

Public health vaccines

Nipah vaccine (mRNA-1215)

Nipah virus (NiV) is a zoonotic virus transmitted to humans from animals, contaminated food or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications from NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India,

Bangladesh, Malaysia and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent research and development action.

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In collaboration with the NIH-Vaccine Research Center (VRC), we conducted a Phase 1 clinical trial of mRNA-1215, our vaccine candidate against NiV, and testing was focused on pandemic preparedness. This Phase 1 dose-escalation, open-label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability and immunogenicity of a NiV mRNA vaccine candidate. The trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID).

Mpox vaccine (mRNA-1769)

Mpox (formerly known as monkeypox) is an infectious disease caused by the mpox virus, a member of the Orthopoxvirus genus, which also includes Variola virus, the virus that caused smallpox. Although smallpox was eradicated in 1980, continued protection from smallpox is of great importance given the lethality of the infection and potential for use as an agent of bioterrorism. Other viruses associated with the Orthopoxvirus genus include cowpox, rabbitpox and camelpox.

There are two main types of the mpox virus, Clade I and Clade II, each with subtypes (a and b). Prior to 2022, mpox outbreaks were primarily sporadic, driven by zoonotic spillover in endemic regions. Mpox can infect humans and other animals and is spread mainly through close physical contact with an infected person or contaminated materials, as well as through contact with infected animals. Respiratory transmission via face-to-face interaction is also possible.

Clade II (subclade IIb) was responsible for the 2022 global mpox outbreak which led the WHO to declare a Public Health Emergency of International Concern (PHEIC). Transmission during the outbreak occurred primarily through sexual contact. In 2024, a second PHEIC was declared due to Clade I outbreak expansion in the Democratic Republic of the Congo and neighboring countries. Current epidemiology reports indicate that both Clade I and Clade II viruses continue to circulate globally, with recent expansions of Clade Ib transmission in some regions outside Africa, sometimes without direct travel links to endemic areas.

The incubation period for mpox typically ranges from 3 to 17 days. Initial symptoms include fever, headache, muscle aches, fatigue, and swollen lymph nodes, followed by a characteristic rash or skin lesions that may last 2-4 weeks. Most individuals recover fully, although severe disease can occur, particularly in people with weakened immune systems.

The current standard of care for mpox prevention is JYNNEOS, which is approved by the FDA for prevention of mpox and smallpox.

Our mpox vaccine candidate, mRNA-1769, is designed to express four antigens from the mpox virus. In preclinical studies using a stringent non-human primate model, vaccination with mRNA-1769 resulted in fewer lesions, reduced viral replication, and stronger neutralizing and functional antibody responses compared with existing treatments. The immune responses induced by mRNA-1769 also showed broad activity against several orthopoxviruses. These results were published in 2024.

We conducted a randomized, placebo-controlled, dose-ranging Phase 1/2 study to evaluate the safety, tolerability, and immune response of three dose levels of mRNA-1769 in healthy adult participants. Interim analysis showed that mRNA-1769 demonstrated a favorable safety profile and strong immunogenicity. These interim results were presented as an oral presentation at the 2025 ESCMID Global conference. The full study results are currently expected in 2026.

ONCOLOGY THERAPEUTICS FRANCHISE

Within our oncology therapeutics franchise, we are developing intismeran autogene (mRNA-4157) in collaboration with Merck. We and Merck are targeting a variety of tumor types, with eight Phase 2 and Phase 3 trials ongoing.

Separate from the collaboration with Merck, our Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. We have also expanded our oncology portfolio with early-stage programs, including mRNA-4106 (a cancer antigen therapy), mRNA-2808 (a T-cell engager), and mRNA-4203 (a cell-therapy enhancer). mRNA-4203 is being developed in collaboration with Immatics.

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Intismeran autogene (mRNA-4157)

As tumors grow, they acquire mutations which may lead to the creation of new protein segments (neoantigens) that can be presented on human leukocyte antigen (HLA) molecules in the tumor and recognized as non-self by T cells. While some neoantigens are shared across tumors, the majority are completely unique to an individual patient’s tumor and their presentation is dependent on a patient’s specific HLA type.

Intismeran autogene, mRNA-4157, uses next generation sequencing and a machine-learning based algorithm to design an mRNA that encodes up to 34 neoantigens against each individual patient’s tumor mutations with specificity to their HLA type, and is predicted to elicit both class I (CD8+ T cells) and class II (CD4+ T cells) responses. The neoantigens are encoded in a single mRNA sequence and formulated in our proprietary LNPs designed for intramuscular injection. Intismeran autogene is manufactured using an automated workflow to enable a rapid turnaround time.

We are developing mRNA-4157 in collaboration with Merck. In September 2022, Merck exercised its option for personalized cancer vaccines (PCVs), including mRNA-4157, pursuant to the terms of our existing PCV Collaboration and License Agreement with Merck, which was amended and restated in 2018 (PCV Agreement, also referred to as the INT Agreement). Pursuant to the PCV Agreement, we and Merck will collaborate on further development and commercialization of mRNA-4157, and we will share costs and any profits and losses worldwide related to mRNA-4157 equally.

In December 2022, we announced that the randomized Phase 2 trial of mRNA-4157 had met its primary endpoint. The open-label Phase 2 study is investigating a 1 mg dose of mRNA-4157 in combination with Merck’s KEYTRUDA, compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma. The study showed that mRNA-4157 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.02]; one-sided p value=0.0266) compared with KEYTRUDA alone. The results were the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial in melanoma. Adverse events observed were consistent with those previously reported in a Phase 1 clinical trial, which showed mRNA-4157 to be well-tolerated at all dose levels.

In February 2023, mRNA-4157 received a Breakthrough Therapy Designation from the FDA, and in April 2023, mRNA-4157 received PRIME Scheme Designation from the EMA.

In December 2023, we announced that at a planned median follow-up of approximately three years, mRNA-4157 in combination with KEYTRUDA showed sustained benefit, reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) and the risk of distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077) compared to KEYTRUDA alone in stage III/IV melanoma patients with high risk of recurrence following complete resection. These data were presented at the American Society of Clinical Oncology (ASCO) in June 2024, as well as translational biomarker data that suggests mRNA-4157 may benefit a broad patient population, irrespective of the status of PD-L1, TMB, ctDNA, and HLA heterozygosity. Three-year exploratory endpoint data also showed an encouraging trend in overall survival (OS) with the combination versus pembrolizumab monotherapy.

In January 2026, we announced that at a planned median follow-up of approximately five years, mRNA-4157 in combination with KEYTRUDA showed continued sustained benefit, reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.294-0.887]; one-sided nominal p=0.0075) compared to KEYTRUDA alone in stage III/IV melanoma patients with high risk of recurrence following complete resection.

We and Merck have expanded the intismeran autogene program, initiating Phase 3 studies in adjuvant melanoma, adjuvant non-small cell lung cancer (NSCLC), and adjuvant NSCLC post neoadjuvant treatment. We also have Phase 2 trials ongoing in adjuvant renal cell carcinoma (RCC), muscle-invasive bladder cancer (MIBC), non-muscle-invasive bladder cancer (NMIBC), metastatic melanoma, and first-line metastatic squamous NSCLC. In addition, we have an ongoing Phase 1 study in early and advanced solid tumors. Enrollment of the Phase 3 adjuvant melanoma study was completed in 2024 and enrollment of the Phase 2 RCC study was completed in 2025.

Cancer antigen therapy (mRNA-4359)

We are developing a cancer antigen therapy (mRNA-4359) that encodes Indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1) antigens. We designed mRNA-4359 with the goal of stimulating effector T cells that target and kill suppressive immune and tumor cells that express the target antigens. Our initial indications for mRNA-4359 are advanced or metastatic cutaneous melanoma and NSCLC.

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We presented data from the Phase 1a study of mRNA-4359 at the European Society for Medical Oncology (ESMO) Congress in 2024, where in a population of patients with heavily pre-treated, advanced stage cancers, eight of 16 response-evaluable patients achieved a best overall response (BOR) of stable disease. Translational data showed antigen-specific T-cell responses were elicited by mRNA-4359 treatment; a proportion of activated, cytotoxic, and memory T cells were elevated and a proportion of regulatory T cells and myeloid-derived suppressor cells (MDSCs) were diminished on treatment. mRNA-4359 monotherapy was tolerable at all dose levels tested with most adverse events of low grade (grade 1–2) and manageable.

We presented data from the Phase 1b study at ESMO in 2025, where in a population of 29 checkpoint inhibitor resistant/refractory melanoma patients, across all evaluable patients, mRNA-4359 in combination with pembrolizumab, the objective response rate (ORR) was 24%, and the disease control rate, or the combination of patients achieving tumor response and stable disease, was 60%. mRNA also demonstrated a consistently manageable safety profile. Responses were enriched in patients with PD-L1 ≥1% tumor proportion score (TPS), with an ORR of 67%, indicating encouraging activity in this difficult to treat patient population. Translational analyses demonstrated biological activity of mRNA-4359, including induction of PD-L1– and IDO1-specific T-cell responses and novel clonal T-cell expansion in the periphery, consistent with the proposed mechanism of action.

Additional translational analyses presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting further demonstrated that the magnitude of immune activation, including T-cell clonal expansion, correlated with clinical outcomes and was accompanied by early and substantial reductions in circulating tumor DNA. Tumor-based analyses showed that responders had higher baseline gene expression of PD-L1 and IDO1 and exhibited on-treatment increases in immune-inflamed gene expression signatures.

The Phase 1/2 study of mRNA-4349 is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC

Cancer antigen therapy (mRNA-4106)

mRNA-4106 is a cancer antigen therapy offering broad coverage across tumor types. It encodes for multiple tumor targets and is designed to broaden coverage across and within patients. Our Phase 1 study commenced in 2025.

T-cell engager (mRNA-2808)

mRNA-2808 is a T-cell engager targeting surface antigens in multiple myeloma and is currently dosing in a Phase 1 / 2 clinical study.

Cell therapy enhancer (mRNA-4203 and Anzu-cel (IMA203))

mRNA-4203 is a cell therapy enhancer that encodes for the target of an ex-vivo cell therapy to enhance the persistence and efficacy of the cell therapy. mRNA-4203 is being developed in collaboration with Immatics and is dosed in combination with Immatics’ IMA203. The Phase 1 study commenced in 2025.

RARE DISEASE FRANCHISE

Our current rare disease programs are summarized below.

Propionic acidemia (mRNA-3927)

Propionic acidemia (PA) is a rare, inherited metabolic disorder with significant morbidity and mortality, affecting one in 100,000-150,000 individuals worldwide. PA is caused by pathogenic variants in the propionyl-coenzyme A carboxylase (PCC) α or β subunits (PCCA and PCCB genes, respectively), leading to PCC deficiency and subsequent accumulation of toxic metabolites. PA is characterized by recurrent life-threatening metabolic decompensation events (MDEs) and multisystemic complications. Multisystemic complications include neurological manifestations, cardiomyopathy, arrythmias, growth retardation, recurrent pancreatitis, bone marrow suppression and predisposition to infection. Long-term, insults by toxic metabolites cause complications in various organs, and cognitive outcome is negatively correlated with the number of MDEs. Currently, there is no approved therapy for PA that targets the underlying root cause of the disease.

Our PA therapy candidate, mRNA-3927, is a novel, IV-administered, LNP-encapsulated dual mRNA therapy that encodes for PCCA and PCCB subunit proteins to restore functional PCC enzyme activity in the liver. By encoding for intracellular proteins, mRNA therapy has a potential role in preventing and treating acute metabolic decompensations.

We have received Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Designation from the FDA and Orphan Designation from the European Commission for the PA program.

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At the International Congress of Inborn Errors of Metabolism (ICIEM) in September 2025, we reported data from the ongoing global Phase 1 / 2 clinical trial for mRNA-3927 in patients one year and older with PA. In part one, 22 patients were dosed and mRNA-3927 was well tolerated in all doses administered. Treatment continued to demonstrate sustained reduction in MDEs, with benefit highest for patients receiving doses of 0.6 mg/kg or greater.

mRNA-3927 is in a registrational study and target enrollment has been reached. An infant dose-finding study is also ongoing.

Methylmalonic acidemia (mRNA-3705)

Methylmalonic acidemia (MMA) is a rare, inherited metabolic disorder with significant morbidity and mortality caused by a deficiency in an enzyme called methylmalonyl-CoA mutase (MUT). There are an estimated 500-2,000 people with MMA MUT deficiency in the United States based on estimated birth prevalence (0.3-1.2:100,000 newborns) and mortality rates. Mortality is significant, with rates of 50% for those with complete MUT deficiency (mut 0) (median age of death 2 years) and 40% for MMA patients with partial MUT deficiency (mut -) (median age of death 4.5 years) reported in a large European study. MMA mainly affects the pediatric population and usually presents in the first few days or weeks of life.

The occurrence of acute metabolic decompensations is the hallmark of the disorder, and decompensations are typically more frequent in the first few years of life. Each decompensation is life-threatening and often requires hospitalization and management at an intensive care unit. Survivors often suffer from numerous complications including chronic renal failure and neurologic complications such as movement disorders, developmental delays, and seizures. Consequently, the health-related quality of life for MMA patients and their families is significantly impaired. There are currently no approved therapies that address the underlying defect for MMA.

Our MMA therapy candidate, mRNA-3705, is an investigational, lipid nanoparticle-encapsulated therapy administered intravenously that codes for the human MUT (hMUT) enzyme and is hypothesized to restore normal MUT production.

In 2024, the FDA announced that it had selected our MMA therapy candidate, mRNA-3705, for the Support for Clinical trials Advancing Rare Disease Therapeutics (START) program.

In September 2025, we reported MMA data at the International Congress for Inborn Errors of Metabolism (ICIEM). In an ongoing Phase 1/2 study, eighteen participants have been dosed. All eligible participants opted to participate in the Open-Label Extension study. mRNA-3705 was generally well-tolerated. Initial data are encouraging, with reductions in methylmalonic acid and other pathway biomarkers. The registrational study is expected to begin in 2026.

Cystic Fibrosis (mRNA-3692/VX-522)

Cystic Fibrosis (CF) is a rare genetic disease, which is progressive from birth and leads to multi-organ damage and early death due to lung dysfunction. It is caused by the mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which results in the loss of CFTR chloride ion channel function. This decreased function of CFTR at the cell surface leads to thick, sticky mucus in multiple organ systems but most pathologically the lungs. There are approximately 92,000 patients living with cystic fibrosis in the United States, Europe, Australia and Canada, with over 5,000 of these patients not being able to benefit from the approved CFTR modulators.

We are collaborating with Vertex on our CF candidate, mRNA-3692/VX-522, which is designed to treat the underlying cause of CF by enabling cells in the lungs to produce functional CFTR protein for the treatment of the over 5,000 patients who do not produce any modulator-responsive CFTR protein. This would be our first demonstration of a nebulized mRNA therapy. The FDA has granted VX-522 Fast Track designation.

The multiple ascending dose portion of the Phase 1/2 study of VX-522 is underway, with data expected in the second half of 2026.

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PROGRAMS DISCONTINUED IN 2025

As a result of portfolio prioritization and emerging clinical data, we discontinued a number of programs in 2025 as we focus our research and development efforts. We do not have current plans for future development of the following programs:

•mRNA-1647: CMV in congenital CMV (we plan to continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients)

•mRNA-1608: Herpes simplex virus (HSV) vaccine

•mRNA-1468: Varicella-Zoster virus (VZV) vaccine

•mRNA-3745: Glycogen Storage Disease Type 1a (GSD1a) therapeutic

•mRNA-3210: Phenylketonuria (PKU) therapeutic

MANUFACTURING

Our manufacturing capabilities play a critical role in our value chain and support every stage of the development of our products, from discovery to commercialization. During the research stage of product development, manufacturing provides mRNA drug substance and drug product for platform research and therapeutic area drug discovery. During early development of our product candidates, we manufacture drug substance and drug product for IND-enabling GLP toxicology studies and initial human clinical studies. For late clinical development, we produce mRNA and drug product for Phase 3 trials. At the commercial stage, we manufacture drug substance and drug product in collaboration with our contract manufacturing organizations (CMOs), both in the United States and internationally.

Overview of our manufacturing operating model

Our manufacturing activities generally focus on:

•Commercial Production: Our manufacturing capabilities include state-of-the-art technologies for mRNA and drug product manufacturing, as well as quality control testing to attain a robust and consistent supply that matches target product profiles. Our manufacturing technology is built to scale-up and support production of products for commercial approval. Our platform allows for efficient manufacturing at scale.

•Research and Development Support: The product supply enables platform research and drug discovery in our therapeutic and vaccine areas, in addition to activities related to clinical studies of our product candidates.

We have built a dedicated in-house, multi-building manufacturing campus in Norwood, Massachusetts, the Moderna Technology Center (MTC). In December 2024, we purchased the MTC campus to provide greater operational flexibility and long-term stability in supporting our manufacturing and development capabilities. The MTC provides supply for our preclinical research, IND-enabling GLP toxicology study supplies, our Phase 1 and Phase 2 pipeline activities, later-stage clinical development activities, as well as drug substance commercial production for vaccines. The MTC campus has been designed with a high level of automation and state-of-the-art digital integration to handle manufacturing execution, product testing and release, and regulatory filings. In 2025, we began construction at the MTC campus for new commercial drug product manufacturing and packaging capability to enable full end-to-end manufacturing for our mRNA medicines in the U.S.

In the second quarter of 2023, we acquired a biomanufacturing facility in Marlborough, Massachusetts. In 2025, we completed construction of the facility, which was purpose-built for intismeran autogene. Designed for speed and scalability with advanced automation and robotics, the site was approved for clinical supply and began shipping patient batches in September 2025. We are on track for potential commercial launch, pending regulatory approvals.

Internationally, we have built and manage mRNA manufacturing facilities in the United Kingdom, Canada and Australia. These facilities were fully licensed in 2025, and the government in each of these countries has entered into a multi-year commitment to purchase mRNA products from us. These local manufacturing facilities will provide direct access to rapid pandemic response capabilities and our respiratory vaccine candidates. We may seek to enter into future agreements with other governments to provide similar manufacturing capabilities in other geographies.

In addition to our internal manufacturing facilities, we also maintain relationships with CMOs in the United States and abroad, providing critical raw material production and fill-finish capacity for our vaccines.

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Manufacturing technology development

To support our broad pipeline of products, which spans multiple therapeutic areas and routes of administration, our platform research and technical development teams closely collaborate to facilitate rapid and seamless clinical translation of scientific breakthroughs. This enables us to develop potential medicines to serve a broad patient population.

Technical development encompasses the design and optimization of robust and consistent manufacturing processes, product characterization, fit-for-purpose formulations and product presentations. For instance, our novel hardware platforms’ automation and robotics, coupled with the flexibility of our in-house digital development systems, allows for thousands of experiments and process parameters across our projects, thus supporting our drug product pharmaceutical readiness. Moreover, our technical manufacturing advances have enabled internalization of new key capabilities, including DNA plasmids and small molecules.

In parallel, we continue to refine existing processes, resulting in increased manufacturing capabilities. These improvements may allow us better control over our supply chain, resulting in larger production yields and longer shelf life of our products.

Our substantial investments in recent years in technical development have enabled the breadth and depth of our pipeline, and laid the foundation to help meet the needs and requirements associated with late-stage development and the commercialization of our products.

Supply of mRNA for All Stages of Product Development and Commercialization

Supply for Research

High-throughput automation and custom engineered equipment allow us to produce and deliver high quality mRNA and formulated constructs in a short period of time: our proprietary platform is capable of producing up to 1,000 lots of mRNA sequences and formulations per month with a turnaround time of a few weeks from sequence to final product. The typical scale of mRNA manufactured by this team is 1-1,000 mg. This has been possible, in part, due to the ability of researchers in the Moderna ecosystem to order constructs through an integrated digital portal that tracks materials end-to-end in less than 45 days. In addition, multiple integrated algorithms that leverage artificial intelligence and machine learning optimize manufacturability, reduce failures and increase quality of mRNA sequences.

Supply for Clinical Development

We have established manufacturing capabilities that support the early development stage of product development in three key areas: GLP Tox, Clinical Studies and intismeran. We supply formulated product to conduct IND-enabling GLP toxicology studies. In addition, human clinical studies rely on supply to meet required cGMP standards. This is achieved via internal manufacturing at the MTC campus. Our MTC campus is also suited to enable rapid technology development and scale-up for future needs.

Our manufacturing also produces cGMP intismeran. Due to the specialized nature of personalized medicine (i.e., where a batch is specifically designed and manufactured for a single patient), the manufacturing process for intismeran has unique requirements. We digitally integrate patient-specific data from sequencing tumor samples to automatically design intismeran for patients. We have developed proprietary bioinformatics designed algorithms linked to an automated manufacturing process for rapid production of formulated mRNA, with a typical turnaround time of a few weeks. We have operationalized intismeran manufacturing to meet our Phase 1 and 2 pipeline supply needs by using single-use systems with fast “needle-to-needle” turnaround times. Unlike traditional process development, each intismeran batch is manufactured for a single patient and thus scaled-out (in parallel) with extensive use of automation and robotics to account for the larger number of patients involved in later phases of development and commercialization. We have shown consistent quality in our production of many patient batches, each with unique mRNA sequences. Our new Marlborough facility has state-of-the-art mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, and a just-in-time satellite warehouse.

Our manufacturing capabilities have allowed us to build our broad pipeline of development programs, including the output required to supply related toxicological and human clinical studies. While the technology that underpins these programs is the same, each program typically requires customization based on target product profiles. These custom features range from varying molecular architecture to different routes of administration, often requiring multivalent products. All programs, except for intismeran, require that we progressively scale up supply to meet clinical demand requirements across development phases, in addition to the necessary preparation for regulatory approval and commercial production, which demand larger batch sizes. In contrast, the intismeran program seeks to develop a cancer therapeutic that is designed and manufactured for a specific patient, thus increasing the number of unique batches. As we scale manufacturing output for each program, we plan to continuously improve yield, purity and the pharmaceutical properties of our product candidates.

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Supply for Late-Stage Development and Commercialization

Our development pipeline continues to advance to later-stage development and towards commercialization. Our platform approach allows us to continue to evolve our manufacturing suites and other capabilities at our manufacturing facilities. mRNA manufacturing is flexible and one plant can manufacture multiple vaccines and therapeutics. Our manufacturing facilities also permit us to manufacture products in parallel.

Quality Unit

Quality is core to the way we operate. We seek to ensure quality at Moderna through a combination of a robust Quality Management System (QMS), our quality culture and our people. In accordance with applicable regulations, we have established, documented and implemented a QMS to assure continued compliance with the requirements therein. The QMS facilitates cGMP compliance by implementing practices that identify the various required processes, their application throughout the organization and the sequence of interaction of these processes.

The primary mode of documenting these key practices is through policies, standard operating procedures (SOPs), forms and other quality records, which include an overarching Quality Policy and Quality Manual. We have implemented tools and metrics to monitor, measure, and analyze these practices to support cGMP operations, achieve planned results, and support continuous improvement. We monitor these quality metrics through formal governance processes, including Quality Management Review (QMR), to enable continuous improvement. We have also established an independent Quality Unit that fulfills quality assurance and quality control responsibilities.

Environment, Health, and Safety

We have established a global Environment, Health, and Safety (EHS) organization to foster a safe and healthy work environment with a focus on sustainability and compliance. Our approach integrates environmentally responsible practices with health and safety measures focused on risk reduction to promote long-term workplace well-being and environmental stewardship. We achieve this through a combination of training, procedures, digital data collection and reporting tools, and corporate programs that drive towards continuous improvement.

Supply Chain Unit

We have established a global supply chain to enable supply of the raw materials and components used to produce our products, consistent with clinical and preclinical demands. We have worked with our external vendors to characterize critical raw materials and to understand their impact on the quality of drug substance and formulated drug product. We also assess the quality system and performance of our external vendors and work with them to comply with regulatory requirements. In addition, we have established an infrastructure to enable direct-to-customer shipments for our commercial products. We leverage third-party wholesalers and integrate with artificial intelligence-driven data analytics to ensure successful ordering and delivery.

Engineering

Our global engineering organization is structured to deliver exceptional facilities and services. We partner closely with external and internal service providers to incorporate robotics, automation and predictive analysis for equipment operation. Engineering plays a critical role in the design, build, operation and maintenance of our facilities.

DIGITAL AND AI STRATEGY

Since our founding, we have been a digital-first company, seeking to use the power of digital information to maximize our impact on patients. mRNA is an information molecule, and our company was built on the premise that the natural flow of information in life can be used to develop medicines. Leveraging over a decade of experience developing mRNA medicines, we have built a large library of data that, combined with our platform approach and cloud-native infrastructure, positions us well to scale a digital operating model using artificial intelligence (AI).

Led by our Chief People and Digital Technology Officer, our digital organization partners across all Moderna functions to perpetuate and grow Moderna's AI-native culture. To that end, we have implemented cross-organization AI training initiatives to support our employees in transforming the way we work. Through these initiatives, our employees learn how to leverage AI in their specific job functions to augment their capacity and capabilities, and to maximize our impact on patients.

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AI helps optimize each aspect of our value chain, from drug design to commercial manufacturing and beyond. At the research stage, our digital and AI infrastructure allows our scientists to design novel mRNA constructs, use AI algorithms to optimize them and order them from our high throughput preclinical scale production line. Our capabilities allow us to design mRNA, protein and LNP components with desired properties, such as reduced toxicity or increased stability. At the product development stage, AI helps to improve the efficiency of our clinical trial operations by, for example, forecasting participant enrollment and automating clinical trial data processing.

Our manufacturing processes likewise utilize the power of AI. For example, we leverage a series of fully autonomous, integrated AI algorithms in connection with manufacturing intismeran autogene (mRNA-4157). Our machine-learning based algorithms design the specific therapy for each individual patient and optimize the timely manufacture and delivery of intismeran to each patient.

At the commercial stage, our digital and commercial organizations partner to drive performance and prepare for product launches. Digital and AI are key components of our commercialization strategy and are vital to our ability to increase our speed to market, enhance our commercial capabilities and continuously improve the quality of our products. We believe that our ability to move with both scale and speed positions us well to pursue our goals related to future product launches.

In early 2023, we began a collaboration with OpenAI to co-innovate with a shared vision of AI’s transformative potential in the future of business and healthcare. In 2024, our AI culture led to the deployment across the company of ChatGPT Enterprise and its enhanced capabilities such as Advanced Analytics, Image Generation and GPTs. These GPTs are now embedded across our business functions, including legal, research, manufacturing and commercial, helping to drive productivity. For example, our Dose ID GPT uses ChatGPT Enterprise’s Advanced Data Analytics feature to further evaluate the optimal vaccine dose selected by the clinical study team. By applying standard dose selection criteria and principles, Dose ID provides a rationale, references its sources, and generates informative charts illustrating the key findings. This allows for a detailed review, led by humans and augmented with AI input, while prioritizing safety and optimizing the vaccine dose profile prior to further development in late-stage clinical trials.

In 2025, we continued to scale our use of generative AI across the enterprise while further strengthening governance, security and responsible AI controls to support safe and compliant adoption. We also expanded the use of customized GPTs and advanced analytics in additional workflows, with a continued emphasis on human oversight, data integrity and alignment with our scientific, regulatory and ethical standards.

We believe that the integrated AI ecosystem we are building at Moderna will accelerate our mission to deliver the greatest possible impact to people through mRNA medicines.

COMMERCIAL

We continue to build our differentiated commercial model, with active commercial subsidiaries in key markets across North America, Europe and the Asia-Pacific region. Our commercial footprint provides us with local commercial teams in major markets where respiratory vaccines have high utilization rates and sales. To support the build out of our commercial activities in markets worldwide, we have hired talent with extensive pharmaceutical company experience. Our commercial teams also work with third-party distributors and other commercial alliances in countries where we do not have a direct presence. Our commercial activities are dependent on regulatory approvals and on agreements that we have made or may make in the future with strategic collaborators.

We currently have three commercial products—Spikevax and mNEXSPIKE (our COVID vaccines) and mRESVIA (our RSV vaccine). The commercial markets for these vaccines are seasonal and characterized, particularly in the U.S. (our largest market), by a fragmented end customer base, unpredictability in orders and seasonality of deliveries. The private vaccine market is also characterized by market practices regarding rebates, discounts and returns. The respiratory vaccine market, and markets for COVID and RSV vaccines in particular, depends on many factors such as medical need, viral evolution, public health authority recommendations and consumer motivation to vaccinate.

In addition, we have built and manage mRNA manufacturing facilities in the United Kingdom, Canada and Australia. These facilities were fully licensed in 2025, and the government in each of these countries has entered into a multi-year commitment to purchase mRNA products from us. See “—Manufacturing” above for further detail.

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THIRD-PARTY STRATEGIC ALLIANCES

Strategic alliances

We are party to strategic alliances with a diverse group of collaborators, including pharmaceutical and biotechnology companies, government agencies, academic laboratories, foundations and research institutes with therapeutic area expertise and resources. Through our collaborations, we seek to advance our discovery and development programs, while leveraging our platform and our research and early development capabilities. From time to time, we also partner with and invest in companies developing other types of therapeutics where we believe we can leverage our core mRNA and LNP capabilities to expand the reach of our technology.

Through certain of our strategic alliances, we share the benefits and risks of developing a new mRNA modality or program, where we may have early research data and desire a strategic collaborator to join us in advancing early development candidates within such modality into the clinic. Representative relationships and associated programs include those with Merck, for our intismeran programs (mRNA-4157), and Vertex, for our CF program (mRNA-3692).

To maintain the integrity of our platform, our strategic collaboration agreements generally grant either us the rights to develop and commercialize potential mRNA medicines we design and manufacture, or grant our collaborators those rights. These agreements do not allow collaborators to use our platform to generate new mRNA technologies, and we generally retain ownership of intellectual property related to our platform arising from research conducted under the alliance. We may continue to identify potential strategic collaborators who can contribute meaningful technology and insights to our programs and allow us to expand our impact more rapidly to broader patient populations.

Below are brief descriptions of certain of our ongoing collaborations.

Merck—Strategic Alliance for Personalized mRNA Cancer Vaccines (Intismeran Autogene)

In June 2016, we entered into a Collaboration and License Agreement, which was subsequently amended in 2018, with Merck (the PCV Agreement) for the development and commercialization of personalized mRNA cancer vaccines (PCV), also known as Individualized Neoantigen Therapy (INT), which has been assigned the generic name intismeran autogene. Under the strategic alliance, we identify genetic mutations present in a particular patient’s tumor cells, synthesize mRNA for these mutations, encapsulate the mRNA in one of our proprietary LNPs and administer to each patient a unique intismeran designed to specifically activate the patient’s immune system against her or his own cancer cells.

Pursuant to the PCV Agreement, we received an upfront payment of $200 million from Merck and we were responsible for designing and researching intismeran, providing manufacturing capacity and manufacturing intismeran and conducting Phase 1 and Phase 2 clinical trials for intismeran, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, all in accordance with an agreed upon development plan and budget.

In September 2022, Merck exercised its option for intismeran, including mRNA-4157, pursuant to the terms of the PCV Agreement and in October 2022 paid us an option exercise fee of $250 million. Pursuant to the PCV Agreement, we and Merck have agreed to collaborate on further development and potential commercialization of intismeran, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement.

Vertex—2016 Strategic Alliance in Cystic Fibrosis

In July 2016, we entered into a Strategic Collaboration and License Agreement (Vertex Agreement) with Vertex Pharmaceuticals Incorporated, and Vertex Pharmaceuticals (Europe) Limited (together, Vertex). The Vertex Agreement is aimed at the discovery and development of potential mRNA medicines for the treatment of CF by enabling cells in the lungs of people with CF to produce functional CFTR proteins.

Other Collaborations

We have entered into additional collaborations where we have agreed to provide funding in areas where we believe we can leverage our mRNA technology, such as our collaboration with Immatics N.V. to pioneer novel and transformative therapies for cancer patients with high unmet medical need. We have also entered into agreements with other parties under which we have received licenses of certain technology.

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Further, in January 2026, we entered into a collaboration with Recordati, an international pharmaceutical group, to advance our investigational PA therapeutic (mRNA-3927) through the final stages of clinical development and, if approved, global commercialization. We will continue to lead the clinical development of mRNA-3927 through approval and Recordati will lead commercialization.

Strategic alliances with government organizations and foundations

Biomedical Advanced Research and Development Authority (BARDA)

In April 2020, we entered into an agreement with BARDA for an award of up to $483 million to accelerate development of mRNA-1273, our original COVID vaccine. The agreement has been subsequently amended to provide for additional commitments to support various late-stage clinical development efforts of mRNA-1273, including a 30,000 participant Phase 3 study, pediatric clinical trials, adolescent clinical trials and pharmacovigilance studies. The maximum award from BARDA, inclusive of all amendments, was approximately $1.8 billion. All contract options have been exercised. The BARDA contract concluded on June 15, 2025, upon completion of all contractual deliverables. As of December 31, 2025, the remaining available funding, net of revenue earned, was approximately $62 million, and we do not expect to utilize a material portion of this amount following the conclusion of the contract.

Coalition for Epidemic Preparedness Innovations (CEPI)

In December 2025, CEPI agreed to invest up to $54.3 million to support a pivotal Phase 3 clinical trial that aims to help advance our investigational mRNA-based H5 pandemic influenza vaccine candidate, mRNA-1018, to licensure.

Institute for Life Changing Medicines (ILCM)

In September 2021, we entered into a collaboration agreement with the ILCM to develop a new mRNA therapeutic (mRNA-3351) for type 1 Crigler-Najjar syndrome (CN-1). Under the terms of the agreement, we agreed to license mRNA-3351 to ILCM with no upfront fees, and without any downstream payments. ILCM will be responsible for the clinical development of mRNA-3351.

The Gates Foundation

In January 2016, we entered a global health project framework agreement with the Bill & Melinda Gates Foundation (n/k/a the Gates Foundation) to advance mRNA development projects for various infectious diseases. Under the framework agreement, the Gates Foundation committed funding to support certain preclinical and clinical development activities, including a program evaluating mRNA-based approaches for the prevention of HIV infection. The funded activities under the framework agreement concluded during 2025, following completion of the agreed-upon program scope. The collaboration supported multiple preclinical and early-stage clinical studies; results from these efforts were published in peer-reviewed scientific journals in 2022-2025 and additional publications are in preparation. As of December 31, 2025, there were no remaining funding commitments under the framework agreement. We continue to engage in scientific dialogue with the Gates Foundation regarding potential future areas of collaboration.

INTELLECTUAL PROPERTY

We rely on a combination of intellectual property laws, including patent, trademark, copyright and trade secret, as well as confidentiality and license agreements, to protect our intellectual property and proprietary rights.

Protecting our platform, modality and program investments: Building an expansive, multi-layered IP estate

We have built a substantial IP estate that includes numerous patents and patent applications related to the development and commercialization of mRNA vaccine and therapeutic development candidates, including related platform technologies. Our platform IP protects advances in mRNA design and engineering, proprietary LNP components, delivery systems, processes for the manufacture and purification of drug substances and products and analytical methods. A significant portion of our platform IP estate further provides multi-layered protection for our modalities and programs.

With respect to our IP estate, our solely-owned patent portfolio consists of more than 260 issued or allowed U.S. patents or patent applications and more than 140 granted or allowed patents in jurisdictions outside of the U.S. (including granted European patents that have been validated in numerous European countries) covering certain of our proprietary platform technology, inventions and improvements, and covering key aspects of our clinical and most advanced development candidates. We have 485 additional pending patent applications that, in many cases, are counterparts to the foregoing U.S. and foreign patents.

Most of the patents and applications (if issued) in our portfolio will not expire until 2033 at the earliest. Any patent that may issue from our most recently filed patent applications is projected to expire between 2044 and 2045, at the earliest. We file additional U.S. and foreign patent applications in key markets as necessary to protect our evolving intellectual property positions.

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We also rely on trademarks, copyright, trade secrets and know-how relating to our proprietary technology and programs, continuing innovation, and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of mRNA therapeutic and vaccine technologies. We take additional steps, such as entering into confidentiality and license agreements, to protect our intellectually property and proprietary rights. We additionally plan to rely on data exclusivity, market exclusivity and patent term extensions when and where available, and plan to seek and rely on regulatory protection afforded through orphan drug designations. We also possess substantial proprietary know-how associated with related manufacturing processes and expertise.

IP protecting our platform

We have a broad IP estate covering key aspects of our platform. This estate provides multiple layers of protection covering the making and use of the mRNA drug substance and delivery technologies.

With respect to our platform, we have a portfolio that includes U.S. and foreign patents or patent applications covering platform innovations that are related to the design, manufacturing and formulating of mRNA medicines. For example, these patents and patent applications include claims directed to:

•mRNA chemistry imparting improved properties for vaccine and therapeutic uses;

•methods for mRNA sequence optimization to enhance the levels and fidelity of proteins expressed from our mRNA medicines;

•methods for identifying epitopes having superior suitability in cancer vaccine contexts;

•engineering elements tailored to enhance stability and the in vivo performance of mRNA medicines;

•LNP delivery systems, including novel lipid components designed for optimal delivery and expression of both therapeutic and vaccine nucleic acids, in particular, prophylactic infectious disease and cancer therapy nucleic acids, intratumoral immuno-oncology therapeutics, local regenerative therapeutics, systemic therapeutics, and inhaled pulmonary therapeutics; and

•innovative processes for the manufacture and analysis of mRNA drug substance and formulated drug product.

IP protection

Our IP estate provides protection for the multiple programs both at the product-specific level and at various broader levels. For example, we have patent coverage for LNP-encapsulated mRNAs having specific chemical modification suited for vaccine and therapeutic mRNA use. Our estate also includes IP covering certain LNP-encapsulated mRNAs coding for infectious disease antigens for use in preventing or treating infectious diseases, including those caused by respiratory and latent viruses, as well as bacterial diseases known to threaten public health. Our mRNA chemistry, formulation and manufacturing patent applications and related know-how, along with trade secrets, may also provide us with additional IP protection relating to our development candidates.

Respiratory vaccines

For our respiratory vaccines programs, we have pursued patent protection featuring composition of matter and method of use claims. Where we may pursue patent protection may vary based on the unique geographic prevalence of various infectious diseases.

Approved products

We have filed several patent applications covering our betacoronavirus vaccine program. We are pursuing patent protection for both our existing and new betacoronavirus vaccines. We have also filed several patent applications covering our RSV vaccine. Our RSV patent portfolio includes multiple families of differing patent breadth.

The table below sets forth the year of projected expiration for the latest to expire, currently granted patents covering each of our approved products or a component thereof. Patent term extensions, supplementary protection certificates, and pediatric exclusivity periods (if any) are not reflected in the expiration dates listed in the table below. We also have additional patents covering each product.

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Influenza

We have multiple patent families spanning different levels of breadth, design and antigen valency pending in the U.S., Europe and around the world, including several granted patents.

hMPV

Human metapneumovirus (hMPV) is a single-stranded RNA virus that is used in a combination program. We have patent applications covering our hMPV vaccine pending in the U.S. and Europe, with a granted patent in the U.S.

Latent vaccines

We have vaccine programs and patent applications directed to diseases caused by various latent viruses, in some cases, using both preventative vaccines targeting the acute phase and therapeutic vaccines for treating the latent diseases in those who do become infected.

CMV

The patent coverage for our human CMV vaccine candidate is extensive and is based on a vaccine with six mRNAs encoding a pentamer surface glycoprotein complex and the gB surface glycoprotein. Both pentamer and gB facilitate entry of the virus into different cell types and therefore immune responses targeting these proteins can block virus entry, spread and reactivation. The current patent portfolio contains both compositions of matter and methods of treating subjects using the vaccine. In the U.S., our CMV vaccine is covered by multiple issued U.S. patents of differing breadth. Each family has counterparts consisting of pending applications and issued patents in non-U.S. jurisdictions, including, in some cases, Europe and Japan. A separate family of CMV patents, which includes mRNA-1647 for use in CMV vaccines for transplant indications, is also yielding patents and applications in foreign jurisdictions are pending.

EBV, HSV and VZV

Similar to CMV, we have filed patent applications, and in some cases multiple patent families, for each of EBV, HSV and VZV, e.g., covering prophylactic and/or therapeutic indications. In addition to patent applications filed in the United States, certain of these patent families have foreign counterparts, such as in Europe.

Public health vaccines

We maintain a multi-program effort at developing vaccines for potential future pandemics and for use in parts of the world with less well-established health care systems. This group of programs include infectious diseases such as flaviviruses such as Zika and dengue viruses, HIV, Nipah virus, and the Mpox virus. In addition, programs are ongoing in many bacterial diseases. While patent applications are filed on some potential public health targets, in some scenarios, platform patents rather than target specific patents may be used to provide patent protection for public health target vaccines.

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Oncology

For our oncology programs, we are pursuing patent protection in numerous jurisdictions. The scope and geographic extent of patent protection may vary based on factors such as differences in regulatory regimes, competitive landscapes, and market considerations across these jurisdictions.

Intismeran

Composition of matter and method claims are being pursued to protect intismeran. Proprietary methods around the making and therapeutic use of our intismeran and resulting vaccine compositions are described and claimed in one granted and one allowed U.S. patent, eight pending U.S. patent applications, five pending European patent applications, two granted patent and five pending patent applications in Japan, three pending patent applications and one granted patent in China, and several pending patent applications in New Zealand, South Africa, Asian and South American countries, as well as two PCT applications. These applications also relate to various vaccine design formats, in particular, polyepitopic vaccine formats, and methods of treating cancer with intismeran. We also possess substantial know-how and trade secrets relating to the development and commercialization of our cancer therapy programs, including related manufacturing process and technology.

Cancer antigen therapy

For our checkpoint cancer antigen therapy program (mRNA-4359), we are pursuing patent protection in various jurisdictions. Any U.S. and foreign patents that may issue from these patent applications would be expected to expire in 2043, excluding any patent term adjustments, any patent term extensions and/or any terminal disclaimers.

Rare diseases

We have programs featuring expression of therapeutic proteins, e.g., intracellular enzymes for the treatment of rare diseases. For our rare disease programs, we generally pursue patent protection featuring composition of matter and method of use claims, for example, pharmaceutical composition and method of treatment claims. We have patent applications granted, pending and/or published for our most advanced rare disease development candidates targeting PA and MMA. In addition, we have patent applications granted, pending and/or published for our other rare disease candidates.

Any U.S. and foreign patents that may issue from these patent families would be expected to expire in 2036 for the earliest of the MMA patents and 2038 to 2042 for the remaining MMA and PA patents, excluding any patent term adjustments, any patent term extensions and any terminal disclaimers.

As further described below, as we continue the development of our intended products, we continue to identify additional means of protecting our assets that would potentially enhance commercial success, including possible patent protection for additional methods of use, formulation, or manufacture.

Cystic fibrosis

Our CF development candidate is covered by pending U.S., European and PCT patent applications.

Trademarks

Our trademark portfolio currently contains at least 1,400 trademark registrations, including at least 29 registrations in the United States and the remaining in Canada, the European Union, the United Kingdom, Israel, China, Japan, Australia, and elsewhere. In addition, we have at least 180 pending trademark applications in more than 55 jurisdictions, including in the aforementioned locations and additional countries throughout Africa, Asia, and South America.

In-licensed intellectual property

While we develop and manufacture our potential mRNA medicines using our internally created mRNA technology platform, we also seek out and evaluate third party technologies and IP that may be complementary to our platform.

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Patent sublicense agreements with Cellscript and mRNA RiboTherapeutics

The Trustees of the University of Pennsylvania owns several issued U.S. patents, granted European patents and pending U.S. patent applications directed, in part, to nucleoside-modified mRNAs and their uses (the Penn Modified mRNA Patents). mRNA RiboTherapeutics, Inc. (MRT) obtained an exclusive license to the Penn Modified mRNA Patents and granted its affiliate, Cellscript, LLC (Cellscript), a sublicense to the Penn Modified mRNA Patents in certain fields of use.

In June 2017, we entered into two sublicense agreements, one with Cellscript, and one with MRT, which agreements we collectively refer to as the Cellscript-MRT Agreements. Together, the Cellscript-MRT Agreements grant us a worldwide, sublicensable sublicense to the Penn Modified mRNA Patents to research, develop, make, and commercialize products covered by the Penn Modified mRNA Patents (licensed products), for all in vivo uses in humans and animals, including therapeutic, prophylactic, and diagnostic applications. The Cellscript-MRT Agreements are non-exclusive, although Cellscript and MRT are subject to certain time restrictions on granting additional sublicenses for in vivo uses in humans under the Penn Modified mRNA Patents. The Cellscript-MRT Agreements require us to pay royalties based on annual net sales of licensed products at rates in the low single digits for therapeutic, prophylactic, and diagnostic uses, and royalties based on annual net sales of licensed products sold for research uses at rates in the mid-single digits, subject to certain reductions, with an aggregate minimum floor.

The Cellscript-MRT Agreements will terminate upon the expiration or abandonment of the last to expire or become abandoned of the Penn Modified mRNA Patents. Cellscript or MRT, as applicable, may terminate its respective Cellscript-MRT Agreement if we fail to make required payments or otherwise materially breach the applicable agreement, subject to specified notice and cure provisions. Cellscript or MRT, as applicable, may also terminate the applicable Cellscript-MRT Agreement upon written notice in the event of our bankruptcy or insolvency or if we challenge the validity or enforceability of the Penn Modified mRNA Patents. We have the right to terminate each Cellscript-MRT Agreement at will upon 60 days’ prior notice to Cellscript or MRT, as applicable, provided that we cease all development and commercialization of licensed products upon such termination. If rights to MRT or Cellscript under the Penn Modified mRNA Patents are terminated (e.g., due to bankruptcy of MRT or Cellscript), the terminated party will assign its interest in the respective Cellscript-MRT Agreement to the licensor from which it received rights under the Penn Modified mRNA Patents and our rights will continue under the new licensor.

Patent license agreements with NIAID

In December 2022, we entered into a non-exclusive patent license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), an Institute or Center of the National Institutes of Health (NIH), to license certain patent rights concerning stabilizing prefusion coronavirus spike proteins and the resulting stabilized proteins for use in COVID vaccine products. Pursuant to the agreement, we have agreed to pay low single-digit royalties on future net sales, a minimum annual royalty payment and certain contingent development, regulatory and commercial milestone payments on a licensed product-by-licensed product basis.

In January 2025, we entered into a non-exclusive patent license agreement with NIAID to license certain patent rights concerning prefusion RSV F proteins and their use. Pursuant to the agreement, we have agreed to pay tiered, low-to-mid single-digit royalties on net sales of our RSV vaccine, a minimum annual royalty payment, and certain contingent development, regulatory and commercial milestone payments on a licensed product-by-licensed product basis.

Formulation technology in-licenses

Our development candidates use internally developed formulation technology that we own. We do, however, have rights to use and exploit multiple issued and pending patents covering formulation technologies under licenses from other entities. If in the future we elect to use or to grant our strategic collaborators sublicenses to use these in-licensed formulation technologies, we or our strategic collaborators may be liable for milestone and royalty payment obligations arising from such use. We consider the commercial terms of these licenses and their provisions regarding diligence, insurance, indemnification and other similar matters, to be reasonable and customary for our industry.

HUMAN CAPITAL

We had approximately 4,700 full-time employees in 18 countries as of December 31, 2025. We operate in a highly competitive environment for talent, particularly as we seek to attract and retain talent with experience in the biotechnology and pharmaceutical sectors. Our workforce is highly educated, and as of December 31, 2025, 46% of our employees hold Ph.D., Doctorate, M.D., J.D. or Master’s degrees. Among our employees, as of December 31, 2025, 49% are female. Among our leadership (which we define as employees at the vice president level and above), as of December 31, 2025, approximately 39% are female. 44% of our U.S. employees identify as racially or ethnically diverse as of December 31, 2025. In 2025, for the fourth year in a row, an outside statistical pay equity analysis confirmed zero statistically significant differences in pay across gender globally and across gender, race and ethnicity in the United States.

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Our approach to attracting and retaining talent

We are committed to ensuring that our employees find that their careers at Moderna are filled with purpose, growth and fulfillment. We believe that a career at Moderna provides opportunity for:

•Impact: Our people have the opportunity to do work that is unparalleled in terms of its innovation and scope of impact on people’s lives.

•Growth: We provide incredible opportunities for growth and we obsess over learning (as demonstrated, in part, by our Mindsets (see below). We invest substantially in the development of our people.

•Well-being: We are deeply invested in the health and wellness of our employees and provide benefits and resources that support each person at work, at home and in their communities.

•Belonging: We believe that innovation happens through bringing together a broad set of perspectives and backgrounds, and creating an environment where differences are celebrated.

•Compelling rewards: To attract and retain the best talent, we provide competitive rewards that help to drive groundbreaking work and allow employees to share in the value we will create together, including through our equity programs.

•Giving and volunteering: Our people have the opportunity to give back to their communities and directly support causes that they are passionate about through volunteer and employee matching donation programs.

To help promote alignment between our employees and our shareholders, all employees participate in our corporate equity programs through the receipt of equity awards, and the percentage of equity as a component of overall pay mix increases with seniority. We also allow our employees to select how they want the value of their award to be split between stock options and restricted stock units (RSUs). We believe that in addition to incentivizing growth that leads to shareholder value, broad eligibility for our equity programs further embeds our "We behave like owners" mindset and helps promote employee retention as these awards generally vest over a four-year period.

None of our employees have entered into a collective bargaining agreement with us. A small number of employees in France, Italy and Spain are covered by statutory collective bargaining agreements governing certain benefits and working conditions. Employees in our Madrid work center are represented by a works council. None of our other employees are represented by a labor union or a works council. We consider our employee relations to be good.

We believe that our employees are highly engaged, and our company and team have been publicly recognized for our leadership, innovation and good corporate citizenship. Science magazine ranked us as a top employer for each of the last eleven years. Additionally, in 2025, Biospace ranked us a top large employer in its 2026 Best Places to Work in Biopharma report for the fifth consecutive year. We measure employee engagement through a vendor-supplied engagement software, using validated external benchmarks to track employee engagement factors.

We continually monitor employee turnover rates, as our success depends upon retaining our highly trained personnel. We believe that the competitive compensation we offer, along with the combination of the factors listed above, among other factors, have helped reduce voluntary turnover. In 2025, our voluntary turnover rate was approximately 11%.

Our approach to training our employees

To further invest in our teams, we have established a structured training curriculum for our employees so that every employee becomes deeply familiar with our core technology and technologies that might further enable our innovation. In addition, we are focused on creating strong leaders through various management and leadership trainings. We have also built an online library of videos of a variety of scientific material that our employees can access flexibly. This content includes presentations by external speakers at in-house scientific seminars, scientific courses at external universities and peer-to-peer video series in which in-house experts provide an introductory view of complex topics they tackle within their teams.

New employees participate in our Moderna ONE onboarding program, which is an interactive learning experience designed to immerse our people in our culture and Mindsets from day one. Following onboarding, our employees continue to learn throughout their careers at Moderna and we deploy a digital learning management system to track and administer training programs for each employee.

In December 2021, we launched our AI Academy. The AI Academy is intended to educate and empower our employees to identify and integrate AI and machine learning solutions into every Moderna system and process to bring mRNA medicines to patients. In 2025, we delivered a targeted learning portfolio focused on practical AI skills designed to build durable habits and fundamentally change how employees work.

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Our culture

As an organization, we are bold, collaborative, curious and relentless. These values are underpinned by a core set of what we call “basecamp” values— integrity, quality, respect. Additionally, with the continued rapid growth of our company, we articulated the Moderna Mindsets, which define how we behave, lead and make decisions. We believe our Mindsets will be integral to our future success, and we integrate them into every facet of how we identify, onboard, grow and manage our talent.

To further develop and retain our workforce, we conduct periodic talent reviews that identify key talent within the organization. We use that data to inform specific development opportunities for key current and potential future leaders, and to support our periodic succession planning activities for key roles. These steps together ensure we have a robust understanding of our workforce and a talent pipeline to grow future leaders, and provide our employees an opportunity to continuously grow and advance in a way that meets their aspirations and talents.

CORPORATE SOCIAL RESPONSIBILITY

As we pursue our mission to deliver the greatest possible impact to people through mRNA medicines, we have developed a corporate social responsibility (CSR) program that demonstrates our commitment to patients, employees, the environment and local communities. Our CSR framework consists of five key focus areas: medicines for patients, community, governance and ethics, employees and environment. Please refer to our 2024 Impacting Human Health Report under the “Responsibility—Corporate policies & reporting” section of our website, which can be found at www.modernatx.com/responsibility/corporate-policies, as well as our proxy statement related to our 2026 Annual Meeting of Stockholders that we will file with the SEC, for a description of some of the measures we have taken to progress our commitment to corporate social responsibility.

COMPETITION

The biotechnology and pharmaceutical industries utilize rapidly advancing technologies and are characterized by intense competition. There is also a strong emphasis on defense of intellectual property and proprietary products.

We believe that mRNA as a medicine coupled with our capabilities across mRNA technology, drug discovery, development and manufacturing provide us with a competitive advantage. However, we face competition from others developing mRNA medicines, as well as other medicines that compete or could compete with our products. We face competition from various sources, including large pharmaceutical companies, biotechnology companies, academic institutions, government agencies and public and private research institutions. The continued growth of the mRNA field is leading to increased competitive pressure, including from large and more established pharmaceutical companies. We also face competition when entering into strategic alliances to advance and grow our pipeline.

Seasonal vaccines

We largely compete against Pfizer and BioNTech for sales of our COVID vaccines, whose vaccine is also based on mRNA technology. We also compete against other vaccines, including Sanofi and Novavax’s. Additionally, some competitors have developed COVID treatments, including Pfizer’s antiviral pill, which may reduce demand for vaccines. With respect to our RSV vaccine, we compete against Pfizer and GlaxoSmithKline, who entered the U.S. market prior to us, and our RSV sales have been minimal to date. We will also face competition for other seasonal vaccines we expect to launch in the future; for example, we are developing a seasonal flu vaccine for which there is a well-developed market.

Competition for the sale of our products is impacted by many factors, including, among others, actual and perceived vaccine efficacy, safety and tolerability, perceptions of mRNA technology, storage and handling conditions and the relative ease of distribution and administration, the timing and scope of regulatory approvals, reimbursement coverage and production and distribution costs.

In markets that we enter after competitors have already introduced a competing product, we may have difficulty achieving market share, as was the case in connection with the launch of our RSV vaccine. See “Risk Factors—The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may be unable compete effectively in the market for existing or new products, treatment methods or technologies.”

Oncology

We face intense competition in the oncology space, including from large pharmaceutical and biotechnology companies developing a broad range of oncology products and platforms. Oncology markets evolve rapidly and are subject to significant clinical and regulatory uncertainty; competitors may generate superior data, advance more quickly, and establish new standards of care. As a result, competition could reduce the commercial opportunity and adversely affect development timelines.

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Collaborations

We and our strategic collaborators also face competition in therapeutic areas beyond seasonal vaccines and oncology. These competitors include a number of pharmaceutical and biotechnology companies and academic and research institutions developing a broad range of therapeutic approaches and platforms that may compete with our current or future programs.

GOVERNMENT REGULATION

Government authorities in the United States and in other countries and regions, such as in the EU, regulate the research, development, manufacture and marketing of our products. Before a new medicine is marketed, data demonstrating its quality, safety and efficacy must be generated, submitted for review, and approved by the competent regulatory authority.

U.S. drug and biologic development and approval

In the United States, the FDA regulates drugs and biologics under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, together with their implementing regulations and other applicable federal, state, and local laws. Failure to comply with these requirements at any stage of development, approval, or post-approval may result in administrative or judicial sanctions, including the FDA’s refusal to approve pending applications, license revocation, clinical holds, untitled or warning letters, product recalls, market withdrawals, product seizures, suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, and civil or criminal penalties.

Our product candidates must be approved through a biologics license application (BLA) or new drug application (NDA), or a supplement, before they may be marketed in the United States.

Preclinical studies

Before testing in humans, our development candidates undergo preclinical studies that include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies designed to assess safety and, in some cases, establish a rationale for therapeutic use. Preclinical safety and toxicology studies are subject to GLP requirements.

To begin human clinical trials, a sponsor must submit an IND to the FDA containing, among other things, the results of preclinical studies, manufacturing and analytical information, any available clinical data or literature, and proposed clinical trial protocols. An IND must become effective before human clinical trials may begin. Unless the FDA raises concerns, an IND generally becomes effective 30 days after receipt. If the FDA identifies deficiencies, the sponsor and the FDA must resolve those issues before clinical trials may proceed.

Clinical trials

Clinical trials involve the administration of an investigational product to volunteers or patients under the supervision of qualified investigators and in accordance with Good Clinical Practice ( GCP) requirements. Clinical trials are conducted pursuant to protocols that specify, among other things, trial objectives, dosing, subject eligibility criteria, and safety and efficacy assessments. Each protocol and any amendments must be submitted to the FDA under the IND.

Each clinical trial must also be reviewed and approved by an Institutional Review Board (IRB) at each participating institution to ensure that risks to subjects are minimized and reasonable in relation to anticipated benefits. IRBs approve informed consent documents and provide ongoing oversight of the trial. Sponsors must submit periodic reports to the FDA, including safety reports and annual progress reports, and must report serious adverse events on an expedited basis. Information regarding certain clinical trials must be submitted for posting on the clinicaltrials.gov website within required timeframes.

Certain gene-based clinical trials are subject to oversight under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, including review by an institutional biosafety committee. Although the NIH Guidelines are mandatory only for institutions receiving NIH funding, many sponsors voluntarily follow these guidelines.

Foreign clinical studies conducted under an IND must comply with the same requirements applicable to U.S. studies. Data from foreign studies not conducted under an IND may be submitted in support of a BLA if the studies were conducted in accordance with GCP and the FDA is able to validate the data.

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Clinical development generally proceeds in three sequential phases, which may overlap. Phase 1 clinical trials typically assess safety, tolerability, and pharmacology of the investigational product in a small number of healthy volunteers or disease-affected patients. Phase 2 clinical trials generally evaluate dosing and preliminary efficacy of an investigational product in disease-affected patients while continuing to assess safety. Phase 3 clinical trials are designed to generate the pivotal evidence of safety and efficacy of an investigational product for its intended use in a large number of disease-affected patients at multiple sites to support regulatory approval and labeling.

The FDA may also require post-approval Phase 4 non-registrational studies to further characterize safety, efficacy, or other scientific questions during commercial use.

The FDA, an IRB, or a clinical trial site may suspend or terminate a clinical trial at any time for safety, protocol compliance, or other reasons. In addition, certain trials are overseen by an independent data safety monitoring board or committee that periodically reviews accumulating data and may recommend continuation, modification, or termination of the trial.

FDA review process

Following completion of the clinical trials, data are analyzed to determine whether the investigational product is safe and effective for its proposed indication. The results of preclinical and clinical studies, together with proposed labeling, chemistry, manufacturing, and controls information, and other required data, are submitted to the FDA as part of a BLA or NDA.

A BLA seeks approval to market a biologic and must demonstrate the product’s safety, purity, and potency. An NDA seeks approval to market a drug and must demonstrate safety and efficacy. In all cases, the submission must contain sufficient evidence to satisfy the FDA’s standards for approval. FDA approval must be obtained before a product may be marketed in the United States.

As part of its review, the FDA conducts pre-approval inspections of manufacturing facilities to assess compliance with cGMP requirements and may audit clinical trial data to confirm compliance with GCP. The FDA may also convene an advisory committee to review applications that present novel scientific or regulatory issues. Advisory committee recommendations are not binding but are often considered by the FDA in its decision-making.

Following review, the FDA may approve the application, request additional information, or issue a complete response letter identifying deficiencies that must be addressed before approval can be granted. A complete response letter may require additional preclinical or clinical studies or other data, and submission of such information does not guarantee eventual approval. If approved, the FDA issues an approval letter authorizing commercial marketing for specified indications and with approved labeling.

Expedited development and review programs

The FDA has several programs to facilitate and expedite the development and review of medicines intended to treat serious or life-threatening conditions, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review. Fast track designation is designed to facilitate the development and review of medicines that address unmet medical needs. Breakthrough therapy designation is designed to expedite the development and review of medicines for which preliminary clinical evidence demonstrates substantial improvement over available therapies. Priority review designation establishes a goal of FDA action on an application within six months of filing and may be granted for medicines that offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.

A product may be eligible for accelerated approval if it treats a serious or life-threatening condition and generally provides a meaningful advantage over available therapies based on an effect on a surrogate endpoint or an intermediate clinical endpoint reasonably likely to predict clinical benefit. As a condition of approval, the FDA may require post-marketing confirmatory clinical trials and may impose additional post-approval requirements or restrictions on distribution or use to assure safe use of the product. Pursuant to the Food and Drug Omnibus Reform Act of 2022, the FDA may require, as appropriate, that confirmatory trials be underway prior to approval or completed within specified timelines and has enhanced authority to expedite withdrawal of accelerated approval if clinical benefit is not verified or trials are not conducted with due diligence.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the applicable criteria or that review timelines will not be shortened. Participation in these programs does not change the statutory standards for approval.

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Emergency Use Authorization and PREP Act

The Secretary of Health and Human Services (HHS) may authorize unapproved medical products , or unapproved uses of approved medical products, during a declared public health emergency. Following such a declaration, the FDA may issue Emergency Use Authorizations (EUA) for specific products if statutory criteria are met, including a determination that the product may be effective in diagnosing, treating, or preventing serious or life-threatening disease and that no adequate, approved, and available alternatives exist. An Emergency Use Authorization terminates when the underlying emergency declaration ends and is not a long-term substitute for FDA approval or licensure. The FDA may revoke an EUA at any time, including if the public health emergency no longer warrants such authorization. In August 2025, the FDA revoked the EUA for emergency use of our COVID vaccine.

In the United States, the Public Readiness and Emergency Preparedness Act (PREP Act) provides liability immunity for manufacturers and other covered persons against certain claims arising from the administration or use of covered countermeasures during a declared public health emergency, subject to a limited exception for willful misconduct. Covered countermeasures include qualified pandemic or epidemic products, such as vaccines intended to diagnose, prevent, or treat pandemic or epidemic diseases. To qualify for immunity, the Secretary of HHS must issue a declaration identifying the applicable emergency or credible risk of a future emergency. The Secretary issued a PREP Act declaration in March 2020 relating to COVID-19 and has issued subsequent amendments. While we believe our products sold to the U.S. Government continue to fall within the scope of applicable PREP Act declarations, this cannot be assured.

Pediatric information

Under the Pediatric Research Equity Act of 2003, all marketing applications for new active ingredients, indications, dosage forms, dosing regimens or routes of administration must contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred or inapplicable.

Under the Best Pharmaceuticals for Children Act, a product may be eligible for pediatric exclusivity, which adds six months to existing exclusivity periods and patent terms. This exclusivity may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued written request for such a study.

Rare Pediatric Disease Designation and Priority Review Vouchers

Under the Federal Food, Drug, and Cosmetic Act, as amended, the FDA incentivizes the development of product candidates that meet the definition of a “rare pediatric disease,” defined to mean a serious or life-threatening disease in which the serious of life-threatening manifestations primarily affect individuals aged from birth to 18 years and the disease affects fewer than 200,000 individuals in the United States or affects 200,000 or more in the United States and for which there is no reasonable expectation that the cost of developing and making in the United States a drug or biologic for such disease or condition will be received from sales in the United States of such drug or biologic. The sponsor of a product candidate for a rare pediatric disease may be eligible for a voucher that can be used to obtain a priority review for a subsequent marketing application after the date of approval of the rare pediatric disease drug product. A sponsor may request rare pediatric disease designation from the FDA prior to the submission of its BLA. A rare pediatric disease designation does not guarantee that a sponsor will receive a priority review voucher (“PRV”) upon approval of its BLA. Moreover, a sponsor who chooses not to submit a rare pediatric disease designation request may nonetheless receive a PRV upon approval of their marketing application if they request such a voucher in their original marketing application and meet all of the eligibility criteria. If a PRV is received, it may be sold or transferred an unlimited number of times. Under current law, after September 30, 2029, the FDA may not award any rare pediatric disease priority review vouchers, although the FDA’s authority to do so could be extended by Congress in the future.

Post-approval requirements

Following approval, manufacturers and approved products remain subject to ongoing FDA regulation. These requirements include, among other things, adverse event reporting, recordkeeping, pharmacovigilance, compliance with promotional and advertising restrictions, and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe approved products for off-label uses, manufacturers are prohibited from marketing or promoting products for unapproved indications. Certain prescription drug and biologic promotional materials must be submitted to the FDA in connection with their initial use.

Changes to an approved product, including changes to indications, labeling, manufacturing processes, or manufacturing facilities, may require the submission and approval of a new application or a supplemental BLA or NDA and may necessitate the generation of additional preclinical or clinical data.

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The FDA may impose post-approval conditions to ensure that a product’s benefits outweigh its risks, including the requirement to implement a Risk Evaluation and Mitigation Strategy (REMS). A REMS may include medication guides, communication plans, restricted distribution systems, patient registries, or other measures designed to mitigate specific risks. Newly identified safety or effectiveness information may require labeling updates, additional risk management measures, or post-marketing studies. Failure to comply with regulatory requirements or the emergence of post-marketing safety issues may result in enforcement actions, including withdrawal of approval.

Approved drugs and biologics must be manufactured in registered facilities in compliance with current good manufacturing practice requirements. Manufacturers and third-party contractors involved in manufacturing or distribution must maintain quality systems, documentation, and procedures to investigate and correct deviations. Facilities are subject to periodic, unannounced FDA inspections. Identified violations or post-approval product issues may result in enforcement actions, including manufacturing restrictions or product recalls.

U.S. patent term restoration and regulatory data exclusivity

In certain circumstances, some U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch Waxman Amendments. Patent term restoration is intended to compensate for patent life lost during product development and the FDA review process and may extend a patent term by up to five years, subject to a maximum remaining patent term of 14 years from the product’s approval date. Only one patent per approved product may be eligible for such restoration, and any application for patent term restoration must be submitted prior to patent expiration. The U.S. Patent and Trademark Office, in consultation with the FDA, determines eligibility for patent term restoration.

Certain drug products may also qualify for periods of non-patent regulatory data exclusivity. A drug product containing an active ingredient not previously approved by the FDA is generally entitled to five years of regulatory data exclusivity. Products approved based on the FDA’s reliance on new clinical investigations essential to approval may receive three years of regulatory data exclusivity. If pediatric studies are conducted in response to an FDA request, pediatric exclusivity may be granted, which for drugs extends existing patent and regulatory exclusivities by six months and for biologics extends existing regulatory exclusivities by six months.

The Biologics Price Competition and Innovation Act of 2009 established an abbreviated licensure pathway for biological products demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. A biosimilar product must be shown to be highly similar to the reference product and to have no clinically meaningful differences in safety, purity, or potency. An interchangeable product must additionally be shown to produce the same clinical result in any given patient and, for products administered more than once, to be capable of alternating or switching with the reference product without increased risk. A reference biological product is entitled to 12 years of regulatory data exclusivity from the date of first licensure, and the FDA may not accept an application for a biosimilar or interchangeable product until four years after that date.

Pursuant to the Orphan Drug Act, certain product candidates may also receive orphan drug designation for the treatment of rare diseases or conditions. In the United States, a rare disease or condition is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available the biologic for the disease or condition will be recovered from sales of the product in the United States.

Orphan drug designation qualifies a company for tax credits and market exclusivity for seven years following the date of the product's marketing approval if granted by the FDA. A sponsor may apply for orphan designation at any time prior to submitting a marketing application. Designation is granted by the FDA’s Office of Orphan Products Development (OOPD) based on a confidential request, after which the product must undergo the standard review and approval process for commercial distribution.

A sponsor may seek orphan designation for an unapproved product, a new orphan indication for an approved product, or, in limited circumstances, for a product that is the same as an already approved orphan drug if they can demonstrate a plausible hypothesis of clinical superiority. Multiple sponsors may receive orphan designation for the same product and indication, provided each submits a complete request.

Orphan drug exclusivity begins on the date of FDA approval and applies only to the designated indication. During the exclusivity period, the FDA generally may not approve the same product by another manufacturer for the same indication unless the original sponsor consents, cannot supply sufficient quantities, or the subsequent product is clinically superior.

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Drug development in the European Economic Area

Medicinal products can be marketed in the European Economic Area (EEA), which is comprised of the 27 Member States of the EU and Norway, Iceland and Liechtenstein, only if a marketing authorization from the competent regulatory authority has been obtained. Similar to the United States, the various phases of preclinical and clinical research in the EU/EEA are subject to significant regulatory controls. Effective since January 2022, the Clinical Trials Regulation (EC) No. 536/2014 aims to streamline and harmonize the procedures for assessment and governance of clinical trials throughout the EU and to require that information on the authorization, conduct and results of each clinical trial conducted in the EU be publicly available.

Pediatric investigation plan

An application for marketing authorization of a medicinal product for human use that is not yet authorized in the EU must include a Pediatric Investigational Plan (PIP) pursuant to the Regulation No. 1901/2006 on medicinal products for pediatric use (known as the Paediatric Regulation), unless a waiver applies. A scientific committee established at the European Medicines Agency (EMA), the Paediatric Committee (PDCO) assesses the content of any PIP, waivers, and deferrals for a medicinal product submitted to it and formulates an opinion thereon.

Review and approval process

In the EU/EEA, in order to obtain a marketing authorization from the applicable regulatory authority, a company may submit marketing authorization applications either under a centralized or national procedure. The centralized procedure is mandatory for certain categories of medicinal products, including those developed using specified biotechnological processes, advanced therapy medicinal products, orphan medicinal products, and certain innovative medicinal products, and is optional for other medicinal products that are considered highly innovative or contain a new active substance. The centralized procedure results in a single marketing authorization that is valid throughout the EU and EEA.

In addition, a marketing authorization may be obtained through a national procedure, which requires separate applications to and approvals by individual Member States, through a decentralized procedure under which applications are submitted simultaneously to multiple Member States, or through a mutual recognition procedure, under which a marketing authorization granted in one Member State may be recognized by others.

A conditional marketing authorization may be granted in the EU when comprehensive clinical data for the safety and efficacy of the medicinal product have not been supplied but all the following requirements are met: (i) the risk-benefit balance of the medicine is positive; (ii) it is likely that the applicant will be in a position to provide the comprehensive clinical data post-authorization; (iii) the medicine fulfills an unmet medical need; and (iv) the benefit to public health of the immediate availability on the market of the medicine outweighs the risk that additional data is still required. Conditional marketing authorizations are valid for one year, on a renewable basis. The marketing authorization holder will be required to fulfil specific obligations within certain timeframes, which may include completing ongoing trials or conducting new trials to confirm that the benefit-risk balance is positive. Once such obligations are fulfilled, provided the benefit-risk balance is still positive, a conditional marketing authorization can be converted into a standard marketing authorization.

European regulatory data protection

In the EU, innovative medicinal products authorized for marketing qualify for regulatory data protection consisting of eight years of data exclusivity and an additional two years of market protection upon the grant of a marketing authorization. Data exclusivity prevents generic or biosimilar applicants from referencing the innovator’s data when applying for a generic or biosimilar marketing authorization. During the additional two-year period of market protection, a generic or biosimilar marketing authorization application can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed until the expiration of the market protection period. There is no guarantee that a product will be considered by the EU’s regulatory authorities to be an innovative medicinal product, and products may not qualify for regulatory data protection.

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European orphan designation and exclusivity

Orphan medicinal product designation is available in the EU to promote the development of products that are intended for the diagnosis, prevention, or treatment of life threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the EU community, or where it is unlikely that the development of the medicine would generate sufficient return to justify the necessary investment in its development, and in each case for which no satisfactory method of diagnosis, prevention, or treatment has been authorized (or, if a method exists, the product would be a significant benefit to those affected). Medicinal products that receive and maintain orphan drug designation following approval are entitled to 10 years of market exclusivity, which protects against applications for and the grant of marketing authorizations for similar medicinal products in the same therapeutic indication. This period may be reduced to six years if, at the end of the fifth year, it is established that the orphan drug designation criteria are no longer met. During the period of market exclusivity, a marketing authorization for a similar medicinal product for the same therapeutic indication may only be granted if the subsequent product is demonstrated to be clinically superior, the marketing authorization holder consents, or the holder of the authorized orphan medicinal product is unable to supply sufficient quantities of the product to meet patient needs.

The aforementioned EU rules are generally applicable in the EEA.

Reform of the Regulatory Framework in the European Union

The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children). In April 2024, the European Parliament adopted its position on the legislative proposals and, in June 2025, the Council of the European Union adopted its position. A common position on the text has been agreed upon on December 11, 2025, in the context of subsequent inter-institutional trilogue negotiations. The proposed revisions remain to be adopted, and are not expected to become applicable before 2028.

European data protection regulations

The EU General Data Protection Regulation (EU GDPR) governs the collection and use of personal data in the EU. The EU GDPR imposes strict requirements relating to the consent of the individuals to whom the personal data relates, the collection and processing of sensitive data (such as health data), the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of the personal data. The EU GDPR also imposes strict rules on the transfer of personal data out of the EU, provides an enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20.0 million or 4% of the annual global revenues of the infringer, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with competent national data protection authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. Non-compliance could also result in the imposition of orders to stop data processing activities.

The UK has incorporated the GDPR into UK law (the UK GDPR). The UK GDPR and the UK Data Protection Act 2018 set out the UK’s data protection regime, which is independent from but aligned to the EU’s data protection regime. Although the UK is regarded as a third country under the EU’s GDPR, the European Commission has issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EU to the UK remain unrestricted. Like the GDPR, the UK GDPR restricts personal data transfers outside the UK to countries not regarded by the UK as providing adequate protection. The UK government has confirmed that personal data transfers from the UK to the EEA remain free flowing. Non-compliance with the UK GDPR may result in monetary penalties of up to £17.5 million or 4% of worldwide revenue, whichever is higher.

Marketing of medicines in the EU

Similar to the Anti-Kickback Statute prohibition in the United States discussed below, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the EU. Infringement of relevant EU laws could result in substantial fines and imprisonment. Payments may be made to physicians in limited circumstances, and in certain EU Member States such payments must be publicly disclosed. Moreover, agreements with physicians for the provision of services often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization, and/or the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in the EU Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines, or imprisonment.

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Rest of the world regulation

Outside of the United States and the EU, the requirements governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary from country to country. If we fail to comply with such requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, or criminal prosecution.

Coverage and reimbursement

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement.

In the United States, there is no uniform policy for coverage and reimbursement among third-party payors. As a result, obtaining coverage and reimbursement approvals can be time-consuming and costly and may require submission of scientific, clinical, and economic data to individual payors on a case-by-case basis, with no assurance of favorable outcomes. Coverage and reimbursement decisions for new medicines are often influenced by determinations made by the Centers for Medicare and Medicaid Services, and private payors frequently follow CMS policies. Even if coverage is obtained, reimbursement rates may be inadequate to achieve or sustain profitability or may require patient cost sharing that limits access or utilization. In addition, third-party payors may limit or exclude coverage for follow-up care or monitoring associated with the use of approved products. For vaccines, coverage decisions may be influenced by recommendations of the Advisory Committee on Immunization Practices, although such recommendations do not guarantee coverage or reimbursement. It is therefore difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for our product candidates.

Beginning in 2026, the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act of 2022 requires CMS to implement negotiated prices for certain high-expenditure Medicare Part D drugs. CMS has issued guidance for multiple cycles of the negotiation program, and additional negotiated pricing rounds are expected in future years. The scope, timing, and impact of this program, including its potential application to additional drugs or coverage categories, remain subject to change and could affect pricing benchmarks, reimbursement levels, and net realized prices for our products.

Net prices for drugs may also be reduced by mandatory discounts or rebates required by government healthcare programs or negotiated by private payors. Manufacturers are subject to complex price reporting obligations, including reporting of metrics such as average sales price and best price, and may be subject to penalties for failure to report accurately or timely. Changes in laws or policies affecting drug importation or pricing methodologies could further pressure pricing in the United States.

Current and future healthcare reform initiatives may result in more restrictive coverage criteria, additional pricing pressure, expanded post-approval requirements, or further limitations on sales and promotional activities for pharmaceutical products. The impact of these measures on coverage, reimbursement, and pricing for our products remains uncertain.

In addition, in certain foreign jurisdictions, proposed pricing for a drug must be approved before the product may be marketed. Pricing and reimbursement requirements vary widely by country. In the EU, Member States may limit the medicinal products eligible for reimbursement under national health insurance systems and may impose direct or indirect controls on pricing or profitability. To obtain reimbursement or pricing approval, some Member States may require clinical or health economic data, including comparative cost effectiveness analyses, relative to existing therapies. A Member State may approve a specific price for a medicinal product or instead apply other pricing or profitability controls.

There can be no assurance that any country with price controls or reimbursement limitations will permit favorable pricing or reimbursement for any of our products or product candidates. Prices for pharmaceutical products in the EU are generally lower than prices in the United States.

For further information on risks associated with pricing and reimbursement, see “Risk Factors—Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules.”

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Other healthcare laws

Healthcare providers, physicians, and third-party payors, including governmental payors such as Medicare and Medicaid in the United States, play a significant role in the recommendation, prescription, and reimbursement of pharmaceutical products. Our arrangements with these parties are subject to extensive federal, state, and foreign healthcare laws and regulations. In the United States, these laws include, among others:

•The federal Anti-Kickback Statute, which prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or reward referrals or the purchase, recommendation, or prescription of products reimbursable under federal healthcare programs.

•The federal False Claims Act, which imposes civil liability, including through whistleblower actions, for knowingly submitting or causing the submission of false or fraudulent claims for payment to federal healthcare programs or for avoiding or decreasing an obligation to pay the federal government.

•Federal criminal healthcare fraud provisions, including those under the Health Insurance Portability and Accountability Act (HIPAA), which impose criminal and civil penalties for schemes to defraud healthcare benefit programs or for making false statements in connection with healthcare benefits, items, or services.

•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations relating to the privacy and security of individually identifiable health information.

•The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act (ACA), which requires certain manufacturers to disclose annually payments and other transfers of value made to physicians, teaching hospitals, and certain other healthcare professionals.

•Federal government price reporting laws, which require manufacturers to calculate and report pricing metrics accurately and timely to government programs.

•Federal consumer protection and unfair competition laws that regulate marketing and business practices.

•Analogous state fraud and abuse laws, including state anti-kickback and false claims laws, which may be broader in scope and apply regardless of payor.

Additionally, certain state and foreign data privacy and security laws govern the processing and protection of personal information and may impose requirements that differ from, and are not preempted by, HIPAA. For example, the California Consumer Privacy Act and the California Privacy Rights Act establish comprehensive privacy obligations and enforcement mechanisms, including expanded consumer rights and potential statutory damages. While certain clinical trial data governed by HIPAA are exempt, other personal information we process may be subject to these laws. Similar privacy laws have been enacted or proposed in other U.S. states and foreign jurisdictions. The scope and enforcement of these laws continue to evolve, increasing compliance complexity and risk.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform.

Current and future healthcare reform legislation

In the United States and internationally, legislative and regulatory changes affecting the healthcare system may prevent or delay marketing approval, restrict post-approval activities, or affect our ability to commercialize products profitably. Existing healthcare reform laws and future reforms may result in more restrictive coverage criteria, increased pricing pressure, or expanded compliance obligations.

In the United States, the ACA introduced measures intended to increase competition and reduce healthcare costs, including provisions affecting biosimilar competition, Medicaid rebate obligations, Medicare discounts, and industry fees. Other federal laws have further affected reimbursement dynamics. The Budget Control Act of 2011 resulted in reductions to Medicare payments that are currently scheduled to remain in effect through 2031 absent further legislative action. The American Rescue Plan Act eliminated the statutory Medicaid drug rebate cap beginning in 2024, which may increase rebate liabilities for certain drugs.

In August 2022, the Inflation Reduction Act was enacted and includes provisions that are being implemented over time and are expected to affect pharmaceutical pricing and reimbursement. These provisions include a cap on Medicare Part D beneficiary out-of-pocket spending, increased manufacturer financial liability under Medicare Part D, inflation-based rebates, and a program allowing the federal government to negotiate prices for certain high-expenditure drugs and biologics without generic or biosimilar competition, with negotiated prices taking effect beginning in 2026. The scope and impact of these measures, including future negotiation cycles, remain subject to change and uncertainty.

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In addition, pharmaceutical pricing practices continue to be subject to heightened scrutiny by federal and state governments, including legislative proposals and investigations focused on pricing transparency, patient assistance programs, and reimbursement methodologies. Governments in the United States and abroad have also implemented or proposed cost-containment measures, such as price controls, reference pricing, reimbursement restrictions, upper-payment limits, drug price transparency reporting and substitution requirements, which could further affect pricing, coverage, and utilization of pharmaceutical products.

Environment

We are subject to state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act. These and other laws govern the use, handling and disposal of various biologic, chemical and radioactive substances used in, and wastes generated by, operations. If our operations result in contamination of the environment, breach of our regulatory obligations or expose individuals to harm, we could be liable for damages and governmental fines. Equivalent laws have been adopted in foreign countries that impose similar obligations.

CORPORATE INFORMATION

We were incorporated under the laws of the State of Delaware on July 22, 2016. We are the successor in interest to Moderna LLC, a limited liability company formed under the laws of the State of Delaware in 2013. Moderna LLC was the successor in interest to Moderna Therapeutics, Inc., a Delaware corporation incorporated in 2009 as Newco LS18, Inc. by Flagship Pioneering. In August 2018, we changed our name from Moderna Therapeutics, Inc. to Moderna, Inc. Our principal corporate office is located at 325 Binney Street, Cambridge, MA 02142, and our telephone number is (617) 714-6500.

Our website, www.modernatx.com, including the Investor Relations section, www.investors.modernatx.com; corporate blog www.modernatx.com/moderna-blog, and our Statements and Perspectives webpage, https://investors.modernatx.com/Statements--Perspectives/default.aspx; as well as our social media channels: Facebook, www.facebook.com/modernatx; X, www.x.com/moderna_tx; and LinkedIn, www.linkedin.com/company/modernatx; contain a significant amount of information about us, including financial and other information for investors. We encourage investors to visit these websites and social media channels as information is frequently updated and new information is shared. The information on our website and that we disclose through social media channels is not incorporated by reference in this Annual Report on Form 10-K or in any other filings we make with the Securities and Exchange Commission (the SEC).

We make available free of charge on or through our website certain reports and amendments to those reports that we file with or furnish to the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. These include our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K, and amendments to those reports.

The SEC also maintains an Internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding us and other issuers that file electronically with the SEC.