Moderna (MRNA) 10-K risk factor changes: FY2023 vs FY2022

Any of the risk factors we [removed: describe below could] [added: describe* *below* *could] adversely affect our business, financial condition or results of operations and the market price of our common stock.*

[removed: We] [added: necessary controls related to product development, manufacturing and quality, we] may encounter difficulties producing [removed: COVID-19 vaccines] [added: our products] on the timelines and in the quantities set forth in our supply [removed: agreements.][added: agreements or to meet potential future demand.]

Our ability to commercialize our [removed: vaccines] [added: products] depends on our manufacturing capability, both at our own facilities and those of our [removed: partners.][added: partners, particularly for fill-finish capabilities.]

If we cannot enter into such arrangements on favorable terms, or at all, our ability to develop, manufacture and distribute our [removed: COVID-19 vaccines] [added: products] would be adversely affected.

[removed: Adapting] [added: Further, adapting] our COVID-19 [removed: vaccines] [added: vaccine] to new variants requires significant coordination with our [removed: partners] [added: partners, including for the sourcing of raw materials] and [removed: rapid adaptation.][added: production.]

Any capacity or production issues or delays experienced by our [removed: partners, whether in connection with updates to our COVID-19 vaccines, satisfying regulatory or quality requirements or other issues,] [added: partners] may cause us to fail to meet [removed: certain product volume or delivery timing] obligations under our supply agreements.

We have limited sales, distribution and marketing [removed: experience,] [added: experience] and [removed: if we cannot] [added: may be unable to] effectively establish such capabilities or supplement our capabilities by entering into agreements with third [removed: parties, our ability to generate revenues may be adversely affected.][added: parties.]

[removed: Accordingly, we] [added: We] have limited experience [removed: with the commercialization of our products,] [added: as a commercial organization] and [removed: we] face risks and uncertainties as we [removed: likely] shift to an endemic [removed: market for] COVID-19 [removed: vaccines] [added: vaccine market] and [removed: as we] prepare for the commercial launch of other [removed: medicines.][added: medicines, including our anticipated RSV vaccine launch in 2024.]

[removed: We] [added: Additionally, we] may seek to enter into agreements with others to utilize their marketing and distribution capabilities, but may be unable to enter into agreements on favorable terms, if at all.

If we rely on others to commercialize our products, our revenues [removed: will] [added: may] be lower than if we commercialized these products ourselves.

In addition, we may have little or no control over [removed: the sales efforts of] such third [removed: parties.][added: parties’ sales efforts.]

Evolving dynamics in the market for COVID-19 vaccines are likely to impact our financial results, [removed: including increased production costs per dose and] [added: which are likely to result in] lower product revenues [added: in 2024] than we have experienced in recent years.

In addition, [removed: we will be exposed to market practices that characterize the] [added: certain] U.S. private [added: vaccine] market [removed: for vaccines,] [added: practices,] including [removed: practices] regarding discounts, rebates and returns, [removed: which can result in the realization of] [added: may cause us to realize] significantly lower revenues than list prices.

[removed: As] [added: In the third quarter of 2023,] we [removed: likely shift] [added: significantly resized our manufacturing infrastructure as we shifted] to an endemic [removed: market for] COVID-19 [removed: vaccines, we have in the past] [added: vaccine market,] and [added: we] may in the future [removed: experience increased] [added: incur additional] costs associated with exiting commitments with suppliers for raw materials and [removed: CMOs.][added: contract manufacturing organization (CMOs).]

As a result of [removed: potentially] lower demand, [removed: and shifting to a lower dose for boosters than our primary series,] we [added: have experienced, and] may [removed: experience] [added: in the future experience,] increased costs with [added: respect to] raw material suppliers as we seek to exit or modify our purchase commitments.

Further, we have [removed: entered] [added: entered,] and may in the future [removed: enter] [added: enter,] into [removed: significant] non-cancellable or take-or-pay purchase commitments for raw materials that require a long lead time to procure, [removed: which increases] [added: increasing] our commitment exposure.

[removed: The] [added: We expect the] market for [removed: our] [added: COVID-19] vaccines [removed: will depend] [added: to evolve based] on [removed: many evolving] [added: a number of] factors, [removed: such as] [added: including] medical need, viral evolution, public health authority recommendations and consumer motivation to vaccinate.

The pharmaceutical market is intensely competitive and [removed: rapidly changing.][added: evolving.]

Many companies, academic institutions, governmental agencies and public and private research organizations are [removed: pursuing the development of] [added: developing] products for the same diseases that we are targeting or expect to target and [removed: many of these institutions and competitors] [added: such other parties may] have:

- greater resources and experience than [removed: we have] [added: us] at every stage of [removed: the] [added: drug] discovery, development, testing, approval, manufacturing and [removed: commercialization of products;][added: commercialization;]

- arrangements in our target markets with purchasers, [added: governments,] leading companies and research institutions.

We face intense competition with respect to our COVID-19 [removed: vaccines, which] [added: vaccine, and it] may not continue to compete favorably with existing or future vaccines and treatments.

[removed: These] [added: Other] vaccines [removed: and other treatments, such as Pfizer’s antiviral pill, may] [added: or treatments could] prove to be safer, more effective, more convenient, have fewer side effects, be easier to ship or distribute or able to be developed at a lower cost than our [removed: vaccines.][added: vaccine.]

Even if our products demonstrate superiority to those of competitors, consumers and the public may fail to appreciate that [removed: benefit.][added: benefit, or existing purchase commitments for a competitor’s product may discourage them from purchasing from us.]

These factors, or the perception of these factors, could lead to a competitor’s vaccine or treatment being more successfully [removed: commercialized, and we may be unable to compete effectively for future sales of our COVID-19 vaccines.][added: commercialized.]

The actual or perceived success or failure of [removed: other entities] [added: others] may adversely impact our ability to commercialize our [removed: COVID-19 vaccines and future] products.

We also will face competition from products that have already been approved and accepted by the medical community [removed: for the treatment of] [added: to treat] certain conditions we target.

If we successfully develop and obtain approval for [removed: investigational medicines,] [added: other product candidates,] we [removed: will face competition] [added: may compete with products under development by competitors] based on many factors, including the [added: relative] safety and effectiveness of our [removed: products relative to any alternative therapies;] [added: products,] the ease with which our products can be administered and the extent to which patients accept relatively new routes of [removed: administration;] [added: administration,] the timing and scope of regulatory [removed: approvals;] [added: approvals,] the availability and cost of manufacturing, [removed: marketing,] [added: marketing] and sales [removed: capabilities; the price of any approved medicine;] [added: capabilities, price,] reimbursement [removed: coverage;] [added: coverage] and patent position.

[removed: If our] [added: Our] competitors [removed: are] [added: may be] more successful in commercializing their [removed: products than we are, our competitive position and business] [added: products, which] would [removed: be] adversely [removed: affected.][added: affect our business.]

We may be unsuccessful or delayed in [removed: developing updates to] [added: updating] our COVID-19 [removed: vaccines] [added: vaccine] to protect against future variants of the SARS-CoV-2 virus, [removed: or booster doses] [added: and updated versions] of our COVID-19 [removed: vaccines] [added: vaccine] may not protect against such [removed: variants, and a market for vaccines and boosters against these variants may not develop or be weaker than anticipated.][added: variants.]

As the [added: SARS-CoV-2] virus continues to evolve, new strains of the [removed: virus, or those that are already in circulation,] [added: virus] may prove more transmissible or cause more severe forms of COVID-19 [removed: disease] than earlier strains.

[removed: There is a risk that our] [added: Our] current COVID-19 vaccines [removed: and boosters will] [added: could] be ineffective, or less effective than desired, in protecting against these new variants.

Additionally, our decisions regarding [removed: booster] [added: vaccine] development [removed: may] [added: will] be [removed: directed] [added: informed] by guidance from the FDA [removed: or other] [added: and] foreign regulatory authorities, which may impact the timing of development for our COVID-19 vaccines.

[removed: In the future, we may not adequately anticipate demand for, or we] [added: We] may experience delays in [removed: producing,] [added: producing] variant-specific [removed: boosters.][added: vaccines.]

Further, different regulators may issue differing guidance regarding [added: vaccine] composition [removed: of variant-specific boosters.][added: or populations who should receive a vaccine.]

Additionally, we may expend significant resources adapting our vaccines or conducting clinical trials to protect against [removed: COVID-19] variants, but a market for our adapted vaccines [removed: fails] [added: may fail] to develop or demand [removed: does] [added: may] not align with our projections or cost expenditures.

[removed: These regulations] [added: Additionally, pharmacovigilance obligations under the regulatory regimes of the jurisdictions where our products are distributed] require us to collect, process, analyze and monitor safety data and to identify and evaluate adverse reactions to our [removed: vaccines] [added: products] as they are administered in those jurisdictions.

If we or [added: any of our partners assisting us in meeting] these [removed: third parties] [added: obligations] cannot comply with relevant regulations, [removed: including with respect to the timely processing of safety data,] we may be subject to sanctions, increased costs and reputational harm, or our regulatory authorizations to distribute our vaccines in the relevant jurisdiction may be revoked or curtailed.

The commercial success of [removed: any current or future investigational medicine, if approved,] [added: our products] will depend on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.

The degree of market acceptance of our [removed: investigational medicines] [added: products] will depend on numerous factors, including:

Through 2023, our only approved product and sole source of product sales has been our COVID-19 vaccine.

The global market is transitioning to an endemic, commercial market for COVID-19 vaccine sales, resulting in different market and production dynamics than during the pandemic, including a more fragmented customer base, less predictability in orders, greater seasonality of demand, increased distribution costs, and higher costs of goods sold.

Furthermore, our assumptions regarding the product presentation that will be accepted or preferred by the market (e.g., single-dose presentation), which could vary by market, may prove incorrect.

We may also be adversely affected by similar market practices outside of the United States.

We recognized $6.7 billion of sales for COVID-19 vaccines delivered in 2023, compared to $18.4 billion in 2022 and $17.7 billion in 2021, as demand for COVID-19 vaccines declined.

We anticipate that sales of COVID-19 vaccines are likely to be lower in 2024 than 2023.

Additionally, we may not see demand materialize for our products consistent with our projections.

This may lead to lower than expected commercial sales or requests to defer, renegotiate or cancel existing contracts.

Further, we may find that we need to dedicate greater resources to our commercial efforts than anticipated, and we may not realize a return on this investment.

We may encounter difficulties producing or shipping our products consistent with our projections or future contractual commitments.

We may encounter difficulties producing or shipping our products, including our COVID-19 vaccine or other future products, consistent with our current expectations or on the terms set forth in our supply agreements or future sales contracts.

As a result of this limited commercial experience, we may be unsuccessful in accurately anticipating future rates of return for our products, which may adversely impact our accounting estimates.

Our RSV vaccine, which we expect to launch beginning in 2024, will also face competition from existing RSV vaccines.

In markets that we enter after competitors have already introduced a competing product, we may have difficulty achieving market share.

Further, we may need to offer more favorable terms to gain market share in an existing market or to compete in a new market, which may negatively impact our profitability.

- the duration of protection provided by our products compared to those of competitors;

- acceptance of mRNA products generally and the availability of competing non-mRNA medicines that may be preferred by the medical community or the public;

- whether our product presentation meets customer demand (e.g., for single-dose presentations, or combination vaccines);

We may experience delays in enrolling participants in our clinical trials.

If similar observations are made in recipients of our other products or product candidates, or if other unexpected safety issues arise, we could suffer significant damage to our reputation and that of our mRNA platform.

- the efficacy or safety of a combination vaccine product candidate could be less than that seen with the administration of the vaccines separately, which could prevent the combination product from obtaining regulatory approval;

Emergency authorizations that we have received for our COVID-19 vaccine for certain demographics, including pediatrics, are temporary and could be revoked.

This has in the past and may in the future result in our having to resupply

If we are unable to institute

Regulatory authorities may also require us to register our facilities or those of another supplier if we terminate an existing third-party manufacturer relationship, which could lead to delays or our inability to supply a particular market.

The digitization of our facilities exposes us to the risk of process equipment malfunctions.

Our third-party contract

In addition, it may take longer than anticipated to scale up our facilities and to complete our Marlborough, Massachusetts facility (which we expect to dedicate to INTs) to meet commercial demand, if our INT product candidate is approved.

We cannot ensure that these suppliers will remain in business, have

- any equity investments we make in collaborators could decrease in value or become worthless; and

Failure of any third-party contractor to timely provide access to our data in a format that is acceptable to us may result in delays or impediments to our regulatory submissions or other development activities.

pending patent applications or that we were the first to file for patent protection of such inventions.

We have invested billions of dollars in creating our patented mRNA platform, which is integral to the development of our mRNA medicines, and we are involved in various intellectual property litigation as described under Part I, Item 3, “Legal Proceedings.” We expect to expend substantial financial and managerial resources in connection with these legal proceedings, and the ultimate outcome of each proceeding is uncertain.

rights, including exclusive ownership of, or right to use, valuable IP.

In December 2023, the Biden administration released a proposed framework specifying for the first time that price can be a factor in considering whether an invention is sufficiently available to the public.

The proposed framework could potentially enable march-in rights to be used as a tool to regulate drug pricing.

The potential inclusion of price as a factor in a march-in determination is expected to draw extensive criticism and challenge, and the ultimate impact is currently unknown.

While preparations are underway for additional potential product launches, including our anticipated RSV launch in 2024, the ultimate occurrence and timing of these launches is uncertain.

In addition, we incurred significant costs in 2023 as we resized our manufacturing capacity.

If any such cyber-attack or physical intrusion against us or those with whom we share confidential, protected or sensitive data or information, or upon which our business

We may encounter difficulties producing, shipping or successfully commercializing our COVID-19 vaccines consistent with our existing or potential contractual obligations, including due to delays or difficulties experienced by our third-party commercial partners.

We continue to pursue the rapid manufacture, distribution and clinical testing of our COVID-19 vaccines, which are our only commercial products and source of product revenues.

We may also be unsuccessful in entering into contracts for future sales of COVID-19 vaccines.

We are committing substantial financial resources and personnel to the development, manufacture and distribution of our COVID-19 vaccines, including updating our vaccines in response to new variants of concern, and these efforts may delay or otherwise negatively impact our other development programs.

Although we have expanded our internal manufacturing capacity, we rely on third-party manufacturing partners to produce our COVID-19 vaccines.

We have entered into strategic collaborations for the production, as well as for commercial fill-finish manufacturing, of our COVID-19 vaccines to supply markets both in and outside the United States.

We may need to engage additional partners in the future, including additional contract manufacturing organizations (CMOs), to assist in meeting our production needs.

During the height of the pandemic, we were also subject to challenges sourcing sufficient raw materials to produce our vaccine and other supply chain pressures, and we may experience such challenges again in the future.

Further, we will require significant additional investment, whether from our own capital resources or other sources of funding, as we continue to expand our commercial efforts.

Our commercial organization was only established in 2020 in connection with the launch of our COVID-19 vaccine.

We continue to invest in the development of sales, marketing, distribution, managerial and other non-technical capabilities in and out of the United States.

To date, our product sales have consisted of sales of our COVID-19 vaccines to the U.S. Government, other international governments and organizations.

We will face many factors that are likely to impact our results as we likely transition to an endemic, commercial market in the United States and globally, including a more fragmented customer base, less predictability in orders, greater seasonality of demand, increased distribution costs, higher costs of goods sold due to single-dose or lower-dose presentations and increased research and development costs, including for clinical trials, when updating our COVID-19 vaccines for new variants of concern.

Table of Content

Additionally, decreased overall demand for COVID-19 vaccines, as well as a shift in demand to the fall and winter seasons in each hemisphere, is also likely to result in our need to exit or modify commitments with certain CMOs, which could also result in increased costs.

Additionally, although we anticipate a decline in demand for COVID-19 vaccines compared to recent years, the medical burden for the likely shift to an endemic COVID-19 and annual booster volumes may not be as large as we currently expect.

We may be unsuccessful in entering into contracts for the supply of COVID-19 vaccines, and existing contracts may be subject to cancellation or deferrals.

Many COVID-19 vaccines have been authorized in various jurisdictions, including the mRNA COVID-19 vaccine produced by Pfizer/BioNTech.

We also may compete with products that are under development for the treatment of conditions we target, and these other products may be more effective, safer, less expensive or marketed and sold more effectively.

Our original COVID-19 vaccine was developed based upon the genetic sequence of the SARS-CoV-2 virus that was first detected in Wuhan, China.

For example, we developed mRNA-1273.222 in accordance with FDA guidance from June 2022 to develop a BA.4/BA.5-targeting bivalent COVID-19 vaccine.

We have only recently established capabilities to facilitate our compliance with global pharmacovigilance obligations, and failure to build out and maintain this infrastructure may result in increased costs, reputational harm or the loss of our ability to commercialize our products.

The commercialization and distribution of our COVID-19 vaccines subjects us to pharmacovigilance obligations under regulatory regimes in the jurisdictions where our vaccine is distributed, and we will also be subject to these requirements in connection with future products.

We partner with third-party organizations to assist us in collecting and processing this safety data as it is reported from healthcare providers, vaccine recipients and others.

There are a limited number of service providers who are qualified and capable of providing global pharmacovigilance services, and our inability to identify or contract with them may impede our commercial activities.

Third-party payor coverage and reimbursement for our COVID-19 vaccines is not currently available and there is no guarantee payors will provide coverage and reimbursement for the vaccine in the future.

Even if coverage is provided, we may be unable to establish or maintain pricing sufficient to realize a sufficient return on our investment.

While coverage is expected to be provided under Medicare Part B, it is unclear to what extent other payors, including certain federal entitlement programs, such as the Vaccines for Children Program, will provide coverage.

Drug prices are under significant scrutiny in many countries.

We expect drug pricing and other health care costs to continue to be subject to intense political and societal pressures on a global basis.

Competition may negatively impact our ability to maintain pricing and our market share.

New products marketed by competitors could cause our revenues to decrease due to potential price reductions and lower sales volumes.

Additionally, the introduction of competing versions of our products or products approved under abbreviated regulatory pathways may reduce the price that we are able to charge for our products and lower our sales volume.

The terms of certain of our supply agreements may require us to refund certain prepayments from customers of our COVID-19 vaccines if they reduce purchase commitments or if we fail to deliver the purchased volume.

Some customers for our COVID-19 vaccines prepay us for a portion of the product payment for the vaccine doses that they expect to receive from us.

Such prepayments can be substantial.

Under certain supply agreements, if we fail to deliver a portion or all of the committed number of doses by a certain date, or if we are unable to successfully obtain regulatory authorization or approval for the commercialization of the vaccine in the relevant jurisdiction, we may be required to pay refunds or other obligations based on the number of days we are late, or a customer may reduce the volume of vaccine doses that it commits to purchase or terminate the contract.

Upon termination, we may be required to refund a portion of that customer’s prepayment.

Customers may not agree to prepay us for our services in the future.

The regulatory pathway for COVID-19 vaccines is continually evolving and may result in unexpected or unforeseen challenges.

We are a biotechnology company [removed: pioneering] [added: advancing] a new class of medicines made of messenger RNA (mRNA).

mRNA medicines are designed to direct the body’s cells to produce intracellular, [removed: membrane,] [added: membrane] or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases.

We are developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare [removed: diseases, autoimmune] diseases and [removed: cardiovascular] [added: autoimmune] diseases, independently and with our strategic collaborators.

Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across [removed: seven] [added: six] modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale.

We have a diverse and extensive development pipeline of [removed: 45] [added: 42] development candidates across our [removed: 48] [added: 45] development programs, of which [removed: 38] [added: 40] are in clinical studies currently.

[removed: 2022] [added: 2023] Business Highlights

For the year ended [removed: 2022,] [added: December 31, 2023,] we recognized [added: net] product sales of [removed: $18.4] [added: $6.7] billion from sales of our COVID-19 vaccines, compared to [removed: $17.7] [added: $18.4] billion and [removed: $200 million] [added: $17.7 billion] for the years ended [removed: 2021] [added: December 31, 2022] and [removed: 2020,] [added: 2021,] respectively.

[removed: *Respiratory Vaccines*][added: Respiratory Vaccines]

[removed: *Latent Vaccines*][added: Latent and Other Vaccines]

[removed: *Rare Diseases*][added: Rare Diseases]

[removed: *Inhaled Pulmonary*][added: | Inhaled pulmonary therapeutics | | | 17 | | | | | | 18 | | | | | | 1 | | |]

The following table summarizes [added: other] revenue for the periods presented (in millions):

| | | | [added: | | | | | | | | |] Years Ended December 31, | | | | | | | | | | | | | | | [added: | | | | | |]

| | | | [removed: 2022] | | | | | | [removed: 2021] | | | | | | [removed: 2020] | | | [added: 2023 | | | | | | 2022 | | | | | | 2021 | | |]

[removed: | Revenue: | | | | | | | | | | | | | | | | | |][added: Other revenue]

| [removed: Product] [added: Gross product] sales | | | [added: | | | | | | | | | | | | | | |] $ | [removed: 18,435] [added: 8,203] | | | | | $ | [removed: 17,675] [added: 18,435] | | | | | $ | [removed: 200] [added: 17,675] | |

| Grant revenue | | | [removed: 388] | | | | | | [removed: 735] | | | | | | [removed: 529] | | | [added: $ | 94 | | | | | $ | 388 | | | | | $ | 735 | |]

| Collaboration revenue | | | [removed: 440] | | | | | | [removed: 61] | | | | | | [removed: 74] | | | [added: 83 | | | | | | 440 | | | | | | 61 | | |]

| Total revenue | | | [removed: $] [added: 6,848] | [added: | | | | |] 19,263 | | | | | [removed: $] | [removed: 18,471] [added: (12,415)] | | | | | [removed: $] | [removed: 803] [added: (64)] | | [added: % |]

As of December 31, [removed: 2022,] [added: 2023,] we had deferred revenue of [removed: $2.6 billion] [added: $613 million] associated with customer deposits received or billable under supply agreements [removed: of which we expect $2.0 billion] [added: for delivery] of our COVID-19 [removed: vaccines to be delivered] [added: vaccine primarily] in [removed: 2023.][added: 2024.]

Other than [added: net] product sales, our revenue [removed: in 2022, 2021, and 2020 was] [added: has been primarily] derived from government-sponsored and private organizations including [removed: BARDA, DARPA] [added: the Biomedical Advanced Research] and [added: Development Authority (BARDA),] the [added: Defense Advanced Research Projects Agency (DARPA) and the] Bill & Melinda Gates Foundation and from strategic alliances with [removed: AstraZeneca,] Merck [added: & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated] and Vertex [added: Pharmaceuticals (Europe) Limited (together, Vertex) and others] to discover, develop, and commercialize potential mRNA medicines.

The following table summarizes [removed: grant revenue] [added: product sales provision] for the periods presented (in millions):

The following table summarizes [removed: collaboration revenue] [added: our consolidated statements of operations] for the periods presented (in millions):

Please refer to [Note [removed: 5](#iffc0344c00444d7080375d0d85e64bb9_142)] [added: 3](#i9d825fa259284f989c73122fe917c977_145)] to our consolidated financial statements.

Cost of sales also includes shipping costs, indirect overhead costs associated with our product sales during the period, third-party royalties on net sales of our products, and charges for inventory [removed: valuation] [added: valuation, excess] and [added: obsolete inventory and] losses on firm purchase commitments.

- expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research [removed: organizations, or CROs,] [added: organizations (CROs),] that conduct our preclinical studies and clinical trials, and in-licensing arrangements;

- expenses associated with developing [removed: manufacturing capabilities] [added: manufacturing, modification of formulation or design of a product or process, advancing the design to meet specific functional] and [removed: acquiring] [added: economic requirements for manufacture and obtaining] materials for preclinical studies, clinical trials and pre-launch [removed: inventory, including both] [added: inventory from] internal [removed: manufacturing] and third-party contract manufacturing [removed: organizations, or CMOs;][added: organizations (CMOs);]

The following table reflects our research and development expenses, including direct program specific expenses summarized by modality and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, [added: 2023,] 2022, [removed: 2021,] and [removed: 2020] [added: 2021] (in millions):

| Infectious disease vaccines | | | $ | [removed: 1,734] [added: 2,344] | | | | | $ | [removed: 1,099] [added: 1,734] | | | | | $ | [removed: 707] [added: 1,099] | |

| Systemic secreted and cell surface therapeutics | | | [removed: 23] [added: 33] | | | | | | [removed: 3] [added: 23] | | | | | | [removed: 2] [added: 3] | | |

| Cancer vaccines [added: & therapeutics] | | | [removed: 14] [added: 70] | | | | | | [removed: 47] [added: 14] | | | | | | [removed: 29] [added: 47] | | |

| Intratumoral immuno-oncology | | | [removed: 10] [added: 23] | | | | | | [removed: 20] [added: 10] | | | | | | [removed: 9] [added: 20] | | |

| [removed: Systemic] [added: Rare disease] intracellular therapeutics | | | [removed: 42] [added: 75] | | | | | | [removed: 26] [added: 42] | | | | | | [removed: 21] [added: 26] | | |

| Total program-specific expenses by modality (1) | | | $ | [removed: 1,841] [added: 2,562] | | | | | $ | [removed: 1,196] [added: 1,841] | | | | | $ | [removed: 768] [added: 1,196] | |

| Discovery programs | | | $ | [removed: 69] [added: 106] | | | | | $ | [removed: 85] [added: 69] | | | | | $ | [removed: 56] [added: 85] | |

| Platform research | | | [removed: 169] [added: 254] | | | | | | [removed: 125] [added: 169] | | | | | | [removed: 93] [added: 125] | | |

| Technical development and unallocated manufacturing expenses | | | [removed: 464] [added: 821] | | | | | | [removed: 275] [added: 464] | | | | | | [removed: 279] [added: 275] | | |

| Shared discovery and development expenses | | | [removed: 658] [added: 945] | | | | | | [removed: 242] [added: 658] | | | | | | [removed: 118] [added: 242] | | |

| Stock-based compensation | | | [removed: 94] [added: 157] | | | | | | [removed: 68] [added: 94] | | | | | | [removed: 56] [added: 68] | | |

| Total research and development expenses | | | $ | [removed: 3,295] [added: 4,845] | | | | | $ | [removed: 1,991] [added: 3,295] | | | | | $ | [removed: 1,370] [added: 1,991] | |

Our COVID-19 vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®.

Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated.

On September 11, 2023, we received approval of the supplemental Biologics License Application from the U.S. Food and Drug Administration (FDA) for our updated COVID-19 vaccine, which targets the Omicron XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815), for individuals 12 years and older.

The FDA also issued an Emergency Use Authorization for mRNA-1273.815 for children aged 6 months to 11 years old.

We subsequently received authorization from regulatory authorities around the globe for mRNA-1273.815 and initiated the shipment of doses both in the U.S. and internationally.

In January 2023, we announced positive data from the interim analysis of our pivotal ConquerRSV study of our vaccine candidate against respiratory syncytial virus (RSV) (mRNA-1345).

In the study, mRNA-1345 met primary efficacy endpoints, demonstrating vaccine efficacy of 83.7% against RSV lower respiratory tract disease in older adults.

We have filed for a Biologics License Application to the FDA for our RSV vaccine for adults aged 60 years or older, and used a Priority Review Voucher to accelerate review.

We have also submitted marketing authorization applications for the vaccine for adults aged 60 years or older to medical authorities in several countries beyond the U.S. We have initiated the manufacturing of mRNA-1345 and are preparing for a marketing launch in 2024, subject to approval.

During the third quarter of 2023, we embarked on a strategic initiative to optimize the cost structure of our COVID-19 business, with a focus on resizing our manufacturing cost structure.

The launch of this initiative was prompted by the completion of our long-range planning within the third quarter of 2023, which incorporated revised forecasts of vaccination rates.

These projections accounted for the market’s transition from COVID-19 pandemic conditions towards an endemic seasonal market.

Consequently, this strategic shift resulted in charges of $1.4 billion for the quarter.

In the fourth quarter of 2023, we incurred additional charges of $169 million related to this initiative.

Despite the immediate impact to our financial statements, we believe this strategic initiative will enhance the efficiency of our manufacturing operations and equip us with the agility to better adjust our scale according to future market demands.

Program Developments

As of December 31, 2023, nine of our 45 development programs are in late-stage development, including seven programs in Phase 3 and two rare disease programs that are expected to enter pivotal studies in 2024.

*•Respiratory syncytial virus (RSV) vaccine:* We have filed for regulatory approvals for our vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults ages 60 years or older (mRNA-1345).

We expect regulatory approvals beginning in the first half of 2024.

We anticipate entering the RSV market with a strong competitive profile as the only pre-filled syringe product available at the time of launch, along with robust efficacy data, a well-established safety and tolerability profile, and widespread consumer awareness and demand established in 2023.

*•Next-generation COVID-19 vaccine:* Our next-generation COVID-19 vaccine candidate, which is designed to be refrigerator-stable (mRNA-1283), is currently in its pivotal Phase 3 study.

We anticipate data from the study in the first half of 2024.

- *Seasonal flu vaccine:* Our seasonal flu vaccine candidate (mRNA-1010) demonstrated consistently acceptable safety and tolerability across three Phase 3 trials.

In the most recent Phase 3 trial, mRNA-1010 met all immunogenicity endpoints, demonstrating higher titers compared to a currently licensed vaccine.

mRNA-1010 has also shown higher or comparable titers compared to a currently licensed enhanced vaccine (Fluzone HD®) in a separate Phase 1/2 study.

We are in discussions with regulators and intend to file in 2024.

- *Seasonal flu + COVID-19 vaccine:* The Phase 3 trial of our combination vaccine candidate against seasonal flu and COVID-19 (mRNA-1083) is fully enrolled.

We anticipate data from the study in 2024.

- *Cytomegalovirus (CMV) vaccine:* The pivotal Phase 3 study of our CMV vaccine candidate (mRNA-1647) is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age.

We anticipate potential efficacy data from the study in 2024.

Oncology Therapeutics

- *Individualized Neoantigen Therapy (INT):* We continue to demonstrate the potential clinical benefit of our INT program (mRNA-4157), which we are developing in collaboration with Merck.

Two separate Phase 3 trials continue to enroll patients with resected high-risk (stage III/IV) melanoma and completely resected stage II, IIIA or IIIB non-small cell lung cancer.

We and Merck plan to expand their clinical studies to additional tumor types in 2024.

In December 2023, we announced results of a three-year analysis of our Phase 2b study evaluating INT in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma.

Compared to KEYTRUDA alone, this combination continued to show an improvement in recurrence-free survival, reducing the risk of recurrence or death by 49%, as well as in distant metastasis-free survival, reducing the risk of developing distant metastasis or death by 62%.

- *Propionic acidemia (PA) & methylmalonic acidemia (MMA):* We expect to advance our rare disease therapeutic programs for PA (mRNA-3927) and MMA (mRNA-3705) into pivotal studies in 2024.

In January 2023, we acquired OriCiro Genomics K.K., a Japan-based, privately held biotech company primarily focused on cell-free DNA synthesis and amplification technologies, for $86 million.

With this acquisition, we obtained tools for cell-free synthesis and amplification of plasmid DNA, a key building block in mRNA manufacturing.

OriCiro’s technology strategically complements our manufacturing process, and we expect it will allow us to further accelerate our research and development efforts.

We have three authorized marketed products: (1) Spikevax, the Moderna COVID-19 vaccine (mRNA-1273), (2) our bivalent vaccine targeting the BA.1 Omicron variant, combined with Spikevax (mRNA-1273.214), and (3) our bivalent vaccine targeting the BA.4/BA.5 Omicron variants combined with Spikevax (mRNA-1273.222).

Moderna COVID-19 Vaccines

In January 2022, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for our COVID-19 vaccine, Spikevax.

Prior to that approval, our COVID-19 Vaccine was marketed in the U.S. subject to an Emergency Use Authorization (EUA) that was first granted in December 2020 and similar authorizations in other markets.

Spikevax is our first product to achieve licensure in the U.S., and it has been authorized for use or approved by regulators in more than 70 countries.

In August 2022, we received an EUA from the FDA for our Omicron BA.4/BA.5 targeting bivalent booster vaccine, mRNA-1273.222, for individuals 18 years and older, followed later by adolescent and pediatric approvals.

mRNA-1273.222 has been authorized as a booster vaccine for individuals 18 years and older in key markets, including the European Union, Canada and Japan, with the European Union, Japan and several other countries also authorizing boosters for adolescent populations.

During the third quarter of 2022, we also received authorizations for the use of our Omicron BA.1 targeting bivalent COVID-19 booster vaccine, mRNA-1273.214, in the European Union, Japan, United Kingdom, Canada, Australia, and other markets globally.

Program Development

As we build our respiratory franchise, we are applying our experience and using our mRNA platform to develop medicines that can help prevent hospitalizations and deaths from those respiratory viruses that impose the greatest burden on patients and healthcare systems.

By pursuing combination products to protect against a range of diseases, we can potentially help decrease morbidity and mortality from respiratory disease, lower healthcare costs and increase health security globally.

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Our late-stage respiratory vaccine pipeline continues to progress.

The Phase 3 study of our respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) in adults 60 years of age and older is fully enrolled, with more than 36,000 trial participants.

In January 2023, we announced that the Phase 3 study for our RSV vaccine candidate met its primary efficacy endpoints, including vaccine efficacy of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms.

Based on this positive topline data, the FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults 60 years or older.

We intend to submit our RSV vaccine candidate for regulatory approval by the FDA in the first half of 2023.

Since RSV also imposes a significant disease burden on children, we are studying our RSV vaccine candidate in an ongoing Phase 1 trial in pediatric populations.

In February 2023, we announced interim results from the Phase 3 immunogenicity and safety study in the Southern Hemisphere of mRNA-1010, our quadrivalent seasonal influenza vaccine candidate.

Interim results indicate that mRNA-1010 achieved superiority on seroconversion rates for influenza A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.

Non-inferiority was not met for either endpoint for the influenza B/Victoria- or B/Yamagata-lineage strains.

mRNA-1010 showed an acceptable safety and tolerability profile.

We are also conducting a Phase 3 efficacy trial of mRNA-1010 in the Northern Hemisphere to test the vaccine’s efficacy compared to a currently licensed seasonal influenza vaccine.

We are also progressing several combination respiratory vaccine candidates.

A Phase 1/2 study of our combination vaccine candidate targeting SARS-CoV-2 and influenza is fully enrolled and ongoing.

We further initiated a clinical trial for a combination vaccine candidate targeting SARS-CoV-2, influenza, and RSV in the beginning of 2023.

*Cancer*

PCVs target an individual patient’s unique tumor mutations to selectively treat their cancer.

Our PCV program is being developed in collaboration with Merck and is designed to stimulate an immune response by boosting T cells, which are believed to be necessary for recurrence-free survival.

Primary data from our Phase 2 study of mRNA-4157, which were released in December 2022, showed that the investigational personalized cancer vaccine in combination with KEYTRUDA® (pembrolizumab) can improve recurrence-free survival in patients with resected melanoma at high risk of recurrence, compared to KEYTRUDA alone.

Adjuvant treatment with mRNA-4157 in combination with KEYTRUDA reduced the risk of recurrence or death by 44%.

These results represent the first demonstration of the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma.

We expect to initiate a Phase 3 study in adjuvant melanoma in 2023 and rapidly expand to additional tumor types, including non-small cell lung cancer (NSCLC).

In February 2023, mRNA-4157 received a Breakthrough Therapy Designation from the FDA.

Once a human is infected by a latent virus, the virus remains in the body and can lead to lifelong medical complications.

We are committed to developing a portfolio of vaccine and therapeutic candidates against latent viruses, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV) and varicella-zoster virus (VZV).

To date, we have enrolled over 40% of anticipated participants in the Phase 3 study of our CMV vaccine candidate (mRNA-1647) and enrollment is ongoing in the U.S. and internationally.

We are enrolling in Phase 1 trials for our EBV vaccine candidate (to prevent infectious mononucleosis) (mRNA-1189) and our HIV vaccine candidates (mRNA-1644 & mRNA-1574).

We have also initiated a Phase 1/2 head-to-head study of our VZV vaccine candidate (mRNA-1468) against standard of care Shingrix.

The Phase 1/2 Paramount study of our propionic acidemia (PA) program is ongoing and the first two groups of patients are fully enrolled.

As of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] we had cash, cash equivalents, restricted cash, and investments in marketable securities of [removed: $18.2] [added: $13.3] billion and [removed: $17.6] [added: $18.2] billion, respectively.

If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, [removed: 2022,] [added: 2023,] the net fair value of our marketable securities would decrease by approximately [removed: $169] [added: $83] million.

[removed: Our] [added: For the year ended December 31, 2023, our] revenue generating activities and operations [removed: have been] [added: continued to be] primarily denominated in U.S. dollars.

[added: However, we maintained a significant exposure to foreign currency risk, particularly in the Euro, Japanese Yen and Swiss Franc markets,] Our significant foreign currency revenue exposure [removed: for the year ended December 31, 2022] was the equivalent of [removed: $5.4] [added: $1.4] billion in [removed: Euros] [added: Japanese Yen] and [removed: $1.0 billion] [added: $518 million] in [removed: Japanese Yen.][added: Euros for 2023.]

As we [removed: expand internationally] [added: pursue] our [added: international expansion strategy, our] results of operations and cash flows [removed: become increasingly] [added: remain] subject to fluctuations [removed: due to changes] in foreign currency exchange rates.

To [removed: help] manage the exposure to foreign currency exchange rate fluctuations, we have implemented cash flow hedging and balance sheet hedging programs.

We hedge [removed: our] [added: these] cash flow exposures to reduce the risk that our earnings and cash flows will be adversely affected by changes in exchange rates.

As of December 31, [removed: 2022,] [added: 2023,] our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than [removed: one month.][added: three months.]

[removed: We believe the counterparties to] our foreign currency forward contracts are creditworthy multinational commercial banks.

As of December 31, [removed: 2022,] [added: 2023,] a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in [removed: cash flow] [added: balance sheet] hedging of approximately [removed: $13] [added: $23] million.

We transact business in various foreign currencies and have international sales and expenses denominated in foreign currencies.

Therefore, we are exposed to certain risks arising from both our business operations and economic conditions.

We mitigate the foreign exchange risk arising from the fluctuations in foreign currency denominated product sales in Euro and Japanese Yen through a foreign currency cash flow hedging program, using forward contracts and foreign currency options that do not exceed 15 months in duration.

To receive hedge accounting treatment, all hedging relationships are formally documented at the inception of the hedge, and the hedges must be highly effective in offsetting changes to future cash flows on hedged transactions.

The derivative assets or liabilities associated with our hedging activities are recorded at fair value in prepaid expenses and other current assets or other current liabilities, respectively, in our consolidated balance sheets.

The gains or losses resulting from changes in the fair value of these hedges are initially recorded as a component of accumulated other comprehensive (loss) income (AOCI) in stockholders’ equity and subsequently reclassified to product sales in the period during which the hedged transaction affects earnings.

In the event the underlying forecasted transaction does not occur, or it becomes probable that it will not occur, within the defined hedge period, we reclassify the gains or losses on the related cash flow hedge from AOCI to other expense, net, in our consolidated statements of operations.

We evaluate hedge effectiveness at the inception of the hedge prospectively, and on an on-going basis both retrospectively and prospectively.

If we do not elect hedge accounting, or the contract does not qualify for hedge accounting treatment, the changes in fair value from period to period are recorded as a component of other expense, net, in our consolidated statements of operations.

We had no outstanding foreign currency forward contracts or foreign currency options as of December 31, 2023.

Foreign currency hedging activities were immaterial during 2023.

We enter into foreign currency forward contracts to hedge fluctuations associated with foreign currency denominated monetary assets and liabilities, primarily cash, accounts receivable, accounts payable and lease liabilities in Euro, Swiss Franc and Japanese Yen, that are not designated for hedge accounting treatment.

Therefore, these forward contracts are accounted for as derivatives whereby the fair value of the contracts are reported as prepaid expenses and other current assets or other current liabilities in our consolidated balance sheets, and gains and losses resulting from changes in the fair value are recorded as a component of other expense, net, in our consolidated statements of operations.

The gains and losses on these foreign currency forward contracts generally offset the gains and losses in the underlying foreign currency denominated assets and liabilities, which are also recorded to other expense, net, in our consolidated statements of operations.

We believe the counterparties to

We hedge foreign currency product sales denominated in Euros and Japanese Yen, including the use of foreign exchange forward contracts or purchased options.

These transactions are designated and qualify as cash flow hedges.

Our foreign exchange contracts as of December 31, 2022, carried at fair value, had maturities of up to one month.

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We use foreign currency forward contracts to mitigate foreign currency exchange risk associated with foreign currency-denominated monetary assets and liabilities.

These contracts reduce the impact of currency exchange rate movements on our assets and liabilities.

As of December 31, 2022, a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in balance sheet hedging of approximately $51 million.

This was codified as the central dogma of molecular biology over [removed: 50] [added: 60] years ago, and is exemplified in the schematic below.

[removed: ][added: ]

[removed: ][added: ]

- mRNA is used by every cell to produce all proteins: mRNA is used to make every type of protein, including secreted, [removed: membrane,] [added: membrane] and intracellular proteins, in varying quantities over time, in different locations and in various combinations.

- mRNA has classic pharmacologic features: mRNA possesses many of the attractive pharmacologic features of most modern medicines, including reproducible activity, predictable [removed: potency,] [added: 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.

[removed: The Moderna] [added: Our] COVID-19 [removed: Vaccine/Spikevax has been] [added: vaccine is approved or] authorized for use [removed: or approved] in [removed: over] [added: more than] 70 countries.

[removed: As our] [added: Our] first [removed: approved] [added: commercial] product, Spikevax [added: (our COVID-19 vaccine),] has helped hundreds of millions of people worldwide combat [removed: the COVID-19 pandemic.][added: COVID-19.]

We are [removed: working to build] [added: building] a differentiated commercial model, with active commercial subsidiaries [added: in key markets] across North America, Europe and the Asia-Pacific [removed: region, providing us with local commercial teams in key markets around the world.][added: region.]

[added: 1.Deliver an unrivalled respiratory vaccine franchise.] We are [removed: currently] developing vaccines against COVID-19, seasonal flu and RSV individually, while pursuing parallel development of combination vaccines.

[added: 2.Advance multiple latent virus and other vaccines.] We are [removed: committed to] developing [removed: a portfolio of vaccine and therapeutic candidates] [added: vaccines] against latent [removed: viruses,] [added: and other viruses with unmet or underserved needs,] including [removed: CMV,] [added: cytomegalovirus (CMV),] Epstein-Barr virus (EBV), [removed: human immunodeficiency] [added: herpes simplex] virus [removed: (HIV) and varicella-zoster] [added: (HSV), varicella zoster] virus [removed: (VZV).][added: (VZV), norovirus, HIV and Lyme disease.]

[removed: We are investing internally and through strategic collaborations with other next-generation gene editing companies, such as our collaboration with Metagenomi, Inc. (Metagenomi)] [added: - Metagenomi,] focused on [added: discovering and] advancing new gene editing systems for *in vivo* human therapeutic applications.

[removed: By digitizing everywhere possible,] [added: Since our founding,] we [removed: seek] [added: have been a digital-first company, seeking] to use the power of digital information to maximize our impact on patients.

Examples of advances in mRNA science that combine nucleotide chemistry, sequence [removed: engineering,] [added: engineering] and targeting elements are described below.

[removed: 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 mRNA can, in specific instances, [removed: such as our VEGF therapeutic,] 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.

[added: Chemistry: Novel lipid chemistry to potentially improve safety and tolerability:] Our [removed: later-developed,] proprietary LNP systems are [removed: therefore] designed to be highly tolerated and minimize any LNP vehicle-related toxicities with repeat administration *in vivo*.

[removed: The changes] [added: To overcome limitations of previous LNP formulations,] we [removed: made] have [removed: included engineering] [added: engineered] amino lipids to avoid the immune system and to be rapidly biodegradable relative to prior lipids.

In clinical studies for our systemic therapeutic [removed: development] [added: 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.

Each time we add a modality and a new [removed: investigational medicine] [added: product candidate] to our portfolio, we create a network effect because each incremental program can help us gain additional insight into the other programs in our pipeline.

Over the last decade, we have developed [removed: seven] [added: a number of] modalities, each with one or many [removed: investigational medicines] [added: product candidates] in the clinic.

- Infectious disease [removed: vaccines:] [added: vaccines:] The goal of our infectious disease vaccines is to safely pre-expose the immune system to a small quantity of a protein from a pathogen, called an antigen, so that the immune system is prepared to fight the pathogen if exposed in the future, and prevent infection or disease.

Our infectious disease vaccines include those targeting respiratory viruses, latent viruses and [added: enteric viruses, as well as bacterial vaccines and] public health [removed: pathogens.][added: vaccines.]

- Cancer [removed: vaccines:] [added: vaccines and therapeutics:] The goal of a cancer [removed: vaccine] [added: therapy] is to safely expose the patient’s immune system to [removed: tumor related] [added: tumor-related] antigens, known as neoantigens, to enable the immune system to elicit a more effective antitumor response.

Our cancer [removed: vaccines] [added: therapies] modality is focused on the use of mRNA to express neoantigens found in a particular tumor in order to elicit an immune response via T cells that recognize those neoantigens, and therefore the tumor.

We believe that mRNA technology is an attractive approach for cancer [removed: vaccines] [added: therapies] for several reasons, including the ability to deliver multiple personalized neoantigens in a single mRNA molecule, and that mRNA encoding for neoantigens is translated and processed by patients’ endogenous cellular mechanisms for presentation to the immune system.

The outlook for any patients with advanced cancer remains poor, especially in patients with tumors that have little immune system engagement, sometimes termed immunologically [removed: “cold”.][added: “cold.” In conjunction with a checkpoint inhibitor, we aim to activate the immune system against these otherwise immunologically cold tumors.]

- [removed: Systemic] [added: Rare disease] intracellular therapeutics: The goal of this modality is to provide intracellular proteins, such as intracellular enzymes and organelle-specific proteins, as safe, tolerable, and efficacious therapies.

Intracellular therapeutics are not currently addressable with recombinant proteins, which are typically [removed: administered systematically and cannot reach inside of the cell.]

Our selection process for advancing new [removed: development] [added: product] candidates reflects both program-specific and portfolio-wide considerations.

The [added: scope of our pipeline reflects the] breadth of biology addressable using mRNA [removed: technology is reflected in our current development pipeline of 48 programs.][added: technology.]

[removed: ][added: ]

We have [removed: 33] [added: 31] different infectious disease vaccine programs, of which [removed: 27] [added: 30] have entered the clinic.

[removed: We separate our] [added: Our] infectious disease vaccines modality [removed: into three categories: (1)] [added: includes] vaccines against respiratory viruses, [removed: (2) vaccines against] latent viruses and [removed: (3)] [added: enteric viruses, as well as bacterial vaccines and] public health vaccines.

The risk of mortality increases with age and the risk of severe disease and mortality [removed: increase] [added: increases] for persons with certain pre-existing diseases or comorbid [removed: conditions (e.g.] [added: conditions, such as] cardiovascular disease, diabetes, chronic lung [removed: disease, obesity).][added: disease and obesity.]

[removed: The SARS-CoV-2 virus continues to evolve, and as] [added: As] part of our strategy to combat the virus, we have continued to develop and assess variant-specific versions of our COVID-19 [removed: vaccine, including versions aimed at targeting the Beta, Delta and Omicron variants of the virus.][added: vaccine.]

Forward-looking references to our COVID-19 vaccine in this Annual Report on Form 10-K may include future modifications to mRNA-1273 or other [removed: development] [added: product] candidates that are designed to provide protection against variants of the SARS-CoV-2 virus.

In addition to our approved or authorized COVID-19 [removed: vaccines and boosters,] [added: vaccines,] we have advanced [removed: several] other COVID-19 vaccine candidates into the clinic as part of [added: our] effort to fight the evolving SARS-CoV-2 virus.

[removed: mRNA-1273.222] [added: mRNA-1273.815] has [added: also] been authorized [removed: as a booster vaccine] for individuals [removed: 18 years] [added: six months] and older in [added: other] key markets, including the EU, Canada and [removed: Japan, with the EU, Japan and several other countries also authorizing boosters for adolescent populations.][added: Japan.]

[removed: Our] [added: We have taken several of these candidates to clinical trials, and our] monitoring activities allow for expedited delivery of new vaccines in the event that regulatory agencies request specific vaccine composition updates to address public health needs.

We anticipate that sales of our COVID-19 [removed: vaccines and boosters] [added: vaccine] in [removed: 2023] [added: 2024] will [removed: similarly] provide [removed: all] [added: a significant portion] of our commercial revenues for the coming year.

Moderna is a leader in the creation of the field of messenger RNA (mRNA) medicine.

By working at the intersection of science, technology and health for more than a decade, we have developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Our mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases.

With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, we strive to deliver the greatest possible impact to people through mRNA medicines.

SARS-CoV-2, the virus that causes COVID-19, continues to evolve and in 2023, the COVID-19 vaccine market transitioned to an endemic, seasonal commercial market.

To adapt to the evolving market, we significantly resized our manufacturing infrastructure to help position our COVID-19 franchise for future profitability.

We achieved 2023 net product sales of $6.7 billion, with $6.1 billion of COVID-19 vaccine sales, and recognition of approximately $0.6 billion of deferred revenue related to our efforts with Gavi, The Vaccine Alliance.

In the United States, we achieved 48% market share in the retail market for the 2023 fall season, compared to 37% in the 2022 fall season.

Beyond COVID-19, in 2023, we prepared for the potential 2024 launch of our investigational respiratory syncytial virus (RSV) vaccine for adults, which we expect to further demonstrate the commercial potential of our mRNA platform.

In cancer, we reported additional data from our Phase 2b trial evaluating our individualized neoantigen therapy (INT) in combination with Merck’s KEYTRUDA in melanoma patients compared to KEYTRUDA alone.

The treatment continued to show significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 49%.

We believe that these data, with a median follow-up of approximately three years, demonstrate the durability of the therapy, and we have initiated Phase 3 studies in the adjuvant setting in patients with high-risk melanoma and non-small cell lung cancer.

We and Merck plan to rapidly expand our clinical trials to additional tumor types.

Having demonstrated clinical benefit in multiple infectious disease areas and skin cancer, as well as potential clinical benefit for several rare genetic diseases, we continue to advance a broad and diverse pipeline and are focused on execution to deliver for patients.

Our pipeline includes 45 therapeutic and vaccine programs, nine of which are in late-stage development.

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Our success in developing one of the earliest and most effective COVID-19 vaccines, at unprecedented speed and efficiency, demonstrates the promise of mRNA medicine.

Our COVID-19 vaccine has helped hundreds of millions of people worldwide combat COVID-19.

Beyond COVID-19, our platform continues to be highly productive, with 45 programs currently in development, spanning infectious diseases, immuno-oncology, rare diseases and autoimmune diseases.

Across our respiratory vaccines, latent and other vaccines, oncology and rare disease franchises, we are aiming to launch up to 15 new products over the next five years.

We have formulated strategic objectives to help enable our near- and long-term goals:

Recognizing that COVID-19 is likely to pose an ongoing health burden, we are making it an important piece of our business with our vaccines against COVID-19 and our investigational combination vaccine against flu and COVID-19.

In parallel, we are preparing for the potential 2024 launch of our investigational RSV vaccine for older adults, which is expected to further demonstrate the commercial potential of our mRNA platform.

We expect that our anticipated respiratory product launches in 2024 and 2025 will allow us to recognize efficiencies from our growing pipeline.

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We anticipate potential efficacy data from the pivotal Phase 3 study of our CMV vaccine candidate in 2024.

CMV is the most common infectious cause of birth defects in the United States and has been designated as a top priority in new vaccine development by the U.S. National Academy of Medicine for more than two decades.

3.Accelerate a large portfolio of late-stage clinical trials in INT to deliver a transformative impact in cancer treatments. In 2023, we reported data from our Phase 2b trial evaluating our INT in combination with Merck’s KEYTRUDA in melanoma patients compared to KEYTRUDA alone, which we believe demonstrates the durability of the therapy.

We have launched Phase 3 trials for both adjuvant melanoma and non-small cell lung cancer (NSCLC), and plan to expand the development program to additional tumor types.

4.Accelerate investment in three rare disease programs to pursue potential launches. We have demonstrated the potential for clinical benefit in three different rare genetic diseases (propionic acidemia (PA), methylmalonic acidemia (MMA) and glycogen storage disease type 1a (GSD1a)), and expect to advance our PA and MMA programs into pivotal studies in 2024.

5.Deliver the next-generation pipeline and platform. We have demonstrated clinical benefit in multiple infectious disease vaccines and in skin cancer, as well as potential clinical benefit in three different rare genetic diseases.

Based on these clinical successes, we continue to advance a broad and diverse pipeline and are focused on execution to deliver for patients.

We plan to continue to invest in our science and our platform to expand mRNA applications and advance new programs into clinical studies.

We design microRNA binding sites into

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Our current modalities are described below.

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administered systematically and cannot reach inside of the cell.

Moderna is pioneering a new class of medicines made of messenger RNA (mRNA).

The potential advantages of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed, manufactured and administered.

Since our founding in 2010, we have transformed from a research-stage company advancing programs in the field of mRNA to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale.

We have established relationships with government and commercial collaborators, which has allowed us to pursue both groundbreaking science and rapid scaling of our manufacturing capabilities.

In 2020, mRNA technology emerged as a new class of medicines.

Moderna’s capabilities came together to secure the authorization and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic, progressing from vaccine design, through testing and to authorization and distribution in less than a year.

Hundreds of millions of doses of our COVID-19 vaccines were distributed in each of 2021 and 2022, providing countries around the globe a key tool to combat the pandemic.

In January 2022, our original COVID-19 vaccine, Spikevax*®*, for individuals 18 years of age and older in the United States, received our first Biologics License Application (BLA) approval from the U.S. Food and Drug Administration (FDA).

In December 2022, we announced positive Phase 2b results for mRNA-4157, our personalized cancer vaccine (PCV), as well as positive Phase 3 results in older adults for mRNA-1345, our vaccine for respiratory syncytial virus (RSV), in January 2023.

Looking forward, we are continuing to advance a broad pipeline of mRNA medicines, with three programs beyond COVID-19 undergoing Phase 3 trials as of February 2023: RSV, cytomegalovirus (CMV) and seasonal flu.

Our commercial priorities for 2023 include planning for the potential of an endemic COVID-19 market, advancing our respiratory vaccine portfolio of single-agent and combination vaccines for RSV, seasonal flu and COVID-19, executing on our bold campaign of cancer vaccine studies, advancing our rare metabolic disease programs and driving advancement and growth in our latent vaccine portfolio.

To support our growing pipeline and our commercial activities, we are expanding our manufacturing and research and development footprint around the world.

For example, we have entered into agreements with the governments of Australia, Canada and the United Kingdom, and entered into a Memorandum of Understanding with the Government of the Republic of Kenya, to establish state-of-the-art mRNA manufacturing facilities in those countries, which we expect will provide direct access to rapid pandemic response capabilities for future pandemics.

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Our success in developing a highly effective vaccine against COVID-19, going from sequence selection, conducting clinical trials and to receipt of regulatory authorization for emergency use, all in less than a year, and subsequently receiving BLA approval from the FDA, provides a visible example of the promise of mRNA medicine.

We believe our success in developing our COVID-19 vaccines has positive implications beyond infectious disease vaccines and across our entire pipeline.

We currently have 48 programs in development, and our pipeline spans infectious diseases, including vaccines against respiratory diseases, latent diseases and public health pathogens, as well as four therapeutic areas: immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.

In order to deliver on the full scope of the mRNA opportunity and maximize long-term value for patients and investors, we have formulated strategic priorities that guide our near-term and long-term goals:

1.Execute our commercialization plans for our COVID-19 vaccines. Our COVID-19 vaccines have been approved in more than 70 countries.

We are transitioning to prepare for an endemic, commercial market for COVID-19 vaccines in the United States and other countries.

2.Build an unrivaled seasonal respiratory vaccine franchise. As we build our respiratory franchise, we are applying our experience and using our mRNA platform to develop medicines that can help prevent hospitalizations and deaths from the most prevalent respiratory viruses.

In January 2023, we announced that our older adult RSV vaccine candidate had met its primary efficacy endpoints in a Phase 3 trial.

Our long-term vision is to develop, and seek regulatory approval for, a convenient, annual, single-dose booster against as many respiratory viruses as possible.

mRNA vaccines have the ability to combine multiple different antigens into one vaccine.

We believe that combination vaccines have the potential to improve health outcomes at lower costs due to higher compliance, better uptake, a larger benefit to the healthcare system (including through reduced vaccine administration costs) and increased consumer convenience.

We have preparations underway for multiple potential vaccine launches globally over the next several years.

3.Execute on a bold campaign of cancer vaccine studies. In 2022, our platform technology delivered the world’s first-ever investigational mRNA cancer treatment to show efficacy in a randomized Phase 2 clinical study in melanoma.

Our personalized cancer vaccines, which we are developing with Merck Sharp & Dohme LLC (Merck), target an individual patient’s unique tumor mutations to selectively treat their cancer.

By making an individualized medicine for each unique patient, we are pioneering a new frontier in the fight against cancer.

Under our strategic alliance, we and Merck expect to begin additional studies in melanoma, non-small cell lung carcinoma (NSCLC) and other forms of cancer with the goal of bringing truly individualized cancer treatment to patients.

4.Advance rare metabolic disease programs. We are seeing early promise in two of our rare disease programs targeting propionic acidemia (PA) and glycogen storage disease 1a (GSD1a).

Our development candidate for methylmalonic acidemia (MMA) is also in the clinic.

Based on proof-of-concept data and leveraging our learnings from our other rare disease programs, we recently announced a new development candidate for ornithine transcarbamylase (OTC) deficiency, which uses the same lipid nanoparticle (LNP) as our GSD1a program.

5.Drive rapid advancement and growth in our latent vaccine portfolio. Once a human is infected by a latent virus, the virus remains in the body and can lead to lifelong medical complications.

CMV infection is the leading infectious cause of birth defects in children in the U.S. and is a major driver of immune dysfunction with aging, including cardiovascular diseases, cancer and cognitive impairment.

EBV infection is a major cause of infectious mononucleosis (IM), has been tied to increased risk of developing multiple sclerosis, and is associated with certain lymphoproliferative disorders and higher risk of developing cancer/autoimmune diseases.

Untreated HIV infection causes impairment of the immune system, leading to acquired immunodeficiency syndrome (AIDS).

VZV causes shingles, which occurs in one of three adults in their lifetime.

6.Deliver the next-generation pipeline and platform. Our platform goes beyond a single pathogen, disease or pandemic.

Our platform is about maximizing the impact of mRNA medicines on global human health.

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including the [removed: intellectual property litigation described below.]

For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A, “Risk Factors,” including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial [removed: products, development candidates, investigational medicines] [added: products] and [removed: our future pipeline.”][added: product candidates.”]

In March [added: 2022 and July] 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed [removed: a complaint] [added: two complaints] against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID-19 vaccine infringes [removed: a] [added: certain] U.S. [removed: patent] [added: patents] concerning cationic lipids.

The [removed: complaint seeks a judgment] [added: complaints seek judgments] of infringement of the asserted [removed: patent] [added: patents] and monetary damages, but [removed: does] [added: do] not seek to prevent or stop the marketing or sales of our COVID-19 vaccines.

intellectual property litigation described below.

In May 2023, we initiated patent infringement proceedings in Ireland (in the High Court) and Belgium (Brussels Business Court) against Pfizer, BioNTech and related entities with respect to the same European patents.

On August 25, 2023, the Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits.

Alnylam has appealed this judgment to the Federal Circuit Court of Appeals.

In May 2023, Alnylam filed a third complaint against us in the U.S. District Court for the District of Delaware asserting three additional U.S. patents concerning cationic lipids.

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For the fiscal year ended December 31, [removed: 2022][added: 2023]

[removed: ][added: ]

As of June 30, [removed: 2022,] [added: 2023,] the aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant was approximately [removed: $48.8] [added: $40.2] billion based on the closing sale price on that date of [removed: $142.85.][added: $121.50.]

As of February [removed: 17, 2023,] [added: 16, 2024,] there were [removed: 386,339,594] [added: 382,073,208] shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

Portions of the registrant’s Definitive Proxy Statement relating to its [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed hereafter are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.

| Item 1. | | | Business | | | [removed: [7](#iffc0344c00444d7080375d0d85e64bb9_19)] [added: [6](#i9d825fa259284f989c73122fe917c977_19)] | | |

| Item 1A. | | | Risk Factors | | | [removed: [59](#iffc0344c00444d7080375d0d85e64bb9_549755815790)] [added: [46](#i9d825fa259284f989c73122fe917c977_2079)] | | |

| Item 1B. | | | Unresolved Staff Comments | | | [removed: [93](#iffc0344c00444d7080375d0d85e64bb9_73)] [added: [79](#i9d825fa259284f989c73122fe917c977_79)] | | |

| Item 2. | | | Properties | | | [removed: [93](#iffc0344c00444d7080375d0d85e64bb9_76)] [added: [80](#i9d825fa259284f989c73122fe917c977_82)] | | |

| Item 3. | | | Legal Proceedings | | | [removed: [93](#iffc0344c00444d7080375d0d85e64bb9_79)] [added: [80](#i9d825fa259284f989c73122fe917c977_85)] | | |

| Item 4. | | | Mine Safety Disclosures | | | [removed: [94](#iffc0344c00444d7080375d0d85e64bb9_82)] [added: [81](#i9d825fa259284f989c73122fe917c977_88)] | | |

| Item 5. | | | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | | [removed: [95](#iffc0344c00444d7080375d0d85e64bb9_88)] [added: [82](#i9d825fa259284f989c73122fe917c977_94)] | | |

| Item 6. | | | \[Reserved\] | | | [removed: [96](#iffc0344c00444d7080375d0d85e64bb9_91)] [added: [83](#i9d825fa259284f989c73122fe917c977_97)] | | |

| Item 7. | | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | | [removed: [97](#iffc0344c00444d7080375d0d85e64bb9_94)] [added: [84](#i9d825fa259284f989c73122fe917c977_100)] | | |

| Item 7A. | | | Quantitative and Qualitative Disclosures about Market Risk | | | [removed: [109](#iffc0344c00444d7080375d0d85e64bb9_100)] [added: [99](#i9d825fa259284f989c73122fe917c977_109)] | | |

| Item 8. | | | Financial Statements and Supplementary Data | | | [removed: [111](#iffc0344c00444d7080375d0d85e64bb9_103)] [added: [101](#i9d825fa259284f989c73122fe917c977_112)] | | |

| Item 9. | | | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | | [removed: [149](#iffc0344c00444d7080375d0d85e64bb9_199)] [added: [140](#i9d825fa259284f989c73122fe917c977_208)] | | |

| Item 9A. | | | Controls and Procedures | | | [removed: [149](#iffc0344c00444d7080375d0d85e64bb9_202)] [added: [141](#i9d825fa259284f989c73122fe917c977_211)] | | |

| Item 9B. | | | Other Information | | | [removed: [152](#iffc0344c00444d7080375d0d85e64bb9_205)] [added: [143](#i9d825fa259284f989c73122fe917c977_214)] | | |

| Item 9C. | | | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | | [removed: [152](#iffc0344c00444d7080375d0d85e64bb9_208)] [added: [143](#i9d825fa259284f989c73122fe917c977_217)] | | |

| Item 10. | | | Directors, Executive Officers and Corporate Governance | | | [removed: [153](#iffc0344c00444d7080375d0d85e64bb9_214)] [added: [144](#i9d825fa259284f989c73122fe917c977_223)] | | |

| Item 11. | | | Executive Compensation | | | [removed: [153](#iffc0344c00444d7080375d0d85e64bb9_217)] [added: [144](#i9d825fa259284f989c73122fe917c977_226)] | | |

| Item 12. | | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | | [removed: [153](#iffc0344c00444d7080375d0d85e64bb9_220)] [added: [144](#i9d825fa259284f989c73122fe917c977_229)] | | |

| Item 13. | | | Certain Relationships and Related Transactions, and Director Independence | | | [removed: [153](#iffc0344c00444d7080375d0d85e64bb9_223)] [added: [144](#i9d825fa259284f989c73122fe917c977_232)] | | |

| Item 14. | | | Principal Accountant Fees and Services | | | [removed: [153](#iffc0344c00444d7080375d0d85e64bb9_226)] [added: [144](#i9d825fa259284f989c73122fe917c977_235)] | | |

| Item 15. | | | Exhibits, Financial Statement Schedules | | | [removed: [154](#iffc0344c00444d7080375d0d85e64bb9_232)] [added: [145](#i9d825fa259284f989c73122fe917c977_241)] | | |

| Item 16. | | | Form 10-K Summary | | | [removed: [157](#iffc0344c00444d7080375d0d85e64bb9_235)] [added: [148](#i9d825fa259284f989c73122fe917c977_244)] | | |

- We have limited sales, distribution and marketing [removed: experience,] [added: experience] and [removed: if we cannot] [added: may be unable to] effectively establish such capabilities or supplement our capabilities by entering into agreements with third [removed: parties, our ability to generate revenues may be adversely affected;][added: parties;]

- Evolving dynamics in the market for COVID-19 vaccines are likely to impact our financial results, [removed: including increased production costs per dose and] [added: which are likely to result in] lower product revenues [added: in 2024] than we have experienced in recent years;

- We may be unsuccessful or delayed in [removed: developing updates to] [added: updating] our COVID-19 [removed: vaccines] [added: vaccine] to protect against future variants of the SARS-CoV-2 virus, [removed: or booster doses] [added: and updated versions] of our COVID-19 [removed: vaccines] [added: vaccine] may not protect against such [removed: variants, and a market for vaccines and boosters against these variants may not develop or may be weaker than anticipated;][added: variants;]

- The commercial success of [removed: any current or future investigational medicine, if approved,] [added: our products] will depend on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community;

- Preclinical development is lengthy and uncertain, especially for mRNA medicines, and our preclinical programs or [removed: development] [added: product] candidates may be delayed or [removed: terminated, which may have a material adverse impact on our platform or our business;][added: terminated;]

- Clinical development is lengthy and uncertain, and our clinical programs may be delayed or terminated, or may be more costly to conduct than we [removed: anticipate, any of which could have a material adverse impact on our platform or our business;][added: anticipate;]

- Our mRNA [removed: products, including our COVID-19 vaccine, development candidates] [added: products] and [removed: investigational medicines] [added: product candidates] are based on novel technologies and are complex and difficult to manufacture.

We rely on [removed: many] third-party service providers, all of whom have inherent risks in their [removed: operations that may adversely impact our] operations;

- Our [removed: personalized cancer vaccine (PCV) investigational medicine is] [added: individualized neoantigen therapy (INT) product candidates are] uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in [removed: production;][added: producing INT;]

- We have entered into, and in the future may enter into, strategic alliances with third parties for the development and commercialization of [removed: our and their products, development candidates] [added: products] and [removed: investigational medicines.][added: product candidates.]

- We may seek to establish additional strategic alliances and, if we are [removed: not able] [added: unable] to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

- [removed: If we are not able] [added: We may be unable] to obtain and enforce patent protection for our discoveries and the intellectual property rights therein, or protect the confidentiality of our trade [removed: secrets, our ability to effectively compete using our development candidates will be harmed;][added: secrets;]

- We [added: incurred net losses in 2023 and we are likely to incur losses again in the future; we] have a limited history of recognizing revenue from product sales and may be unable to achieve long-term sustainable profitability;

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

| Item 1C. | | | Cybersecurity | | | [79](#i9d825fa259284f989c73122fe917c977_2072) | | |

| Signatures | | | | | | [149](#i9d825fa259284f989c73122fe917c977_247) | | |

- We may encounter difficulties producing or shipping our products consistent with our projections or future contractual commitments;

- 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;

- If we cannot obtain, or are delayed in obtaining, required regulatory approvals, we will be unable to commercialize, or will be delayed in commercializing, product candidates we may develop;

- We are subject to operational risks associated with the physical and digital infrastructure at our manufacturing facilities and those of our external service providers;

- We are dependent on single-source suppliers for some of the components and materials used in, and the processes required to develop, our products and product candidates;

- Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes, which is inherently costly and unpredictable and can have adverse financial and freedom-to-operate consequences;

- our expectations regarding the future profitability of our COVID-19 vaccine franchise, as well as our ability to grow and maintain market share;

- our expectations regarding the evolution of the endemic, commercial COVID-19 vaccine market and future demand for COVID-19 vaccines;

- our ability to continue to develop variant-specific versions of our COVID-19 vaccine that are able to effectively combat COVID-19 as the SARS-CoV-2 virus continues to evolve;

- our goal to launch up to 15 new products over the next five years;

- our discussions with regulators regarding our first-generation seasonal influenza vaccine candidate (mRNA-1010), and our intent to file for regulatory approval in 2024;

- the potential of our platform to address rare genetic diseases, and our plans to advance propionic acidemia (PA) and methylmalonic acidemia (MMA) programs into pivotal studies in 2024;

- our ability to deliver on the next-generation pipeline and platform, including the commencement of additional clinical trials;

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| Signatures | | | | | | [158](#iffc0344c00444d7080375d0d85e64bb9_238) | | |

- We may encounter difficulties producing, shipping or successfully commercializing our COVID-19 vaccines consistent with our existing or potential contractual obligations, including due to delays or difficulties experienced by our third-party commercial partners;

- We have only recently established capabilities to facilitate our compliance with global pharmacovigilance obligations, and failure to build out and maintain this infrastructure may result in increased costs, reputational harm or the loss of our ability to commercialize our products;

- The regulatory pathway for COVID-19 vaccines is continually evolving and may result in unexpected or unforeseen challenges;

- mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines, and the negative perception of the efficacy, safety or tolerability profile of any investigational medicines that we or others develop could adversely affect our ability to conduct our business, advance our investigational medicines or obtain regulatory approvals;

- We are subject to significant regulatory oversight with respect to manufacturing our COVID-19 vaccines and investigational medicines.

Our manufacturing facilities or those of our third-party manufacturers or suppliers may not meet regulatory requirements.

Failure to meet current Good Manufacturing Practice (cGMP) requirements could result in significant delays in any approval of and costs of our products;

- Our reliance on government funding and collaboration from governmental and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements related to intellectual property rights and requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs;

- We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could adversely affect our business, result in fines or criminal penalties and damage our reputation;

- Unfavorable U.S. or global economic conditions, including as a result of disease outbreak, war, conflict or other political instability, could adversely affect our business, financial condition or results of operations.

- our activities with respect to our COVID-19 vaccines, and our plans and expectations regarding future generations of our COVID-19 vaccines that we may develop in response to variants of the SARS-CoV-2 virus, ongoing clinical development, manufacturing and supply, pricing, commercialization, regulatory matters and third-party and governmental arrangements and potential arrangements;

- our expectations regarding an endemic, commercial market for COVID-19 and our preparations for and ability to effectively compete in such a market, as well as the impact that the evolving market will have on our financial returns;

- expected sales and delivery of our COVID-19 vaccines in 2023;

- our ability to identify research priorities and apply a risk-mitigated strategy to efficiently discover and develop development candidates and investigational medicines, including by applying learnings from one program to our other programs and from one modality to our other modalities;

- the implementation of our business model and strategic plans for our business, investigational medicines and technology, including our expectations for ongoing pipeline expansion;

- potential product launches;

- our financial performance;

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*Cyber Risk Management and Strategy*

Our cybersecurity organization’s mission is to provide a targeted set of services, support and capabilities to reduce the risk of cyberattacks, rapidly detect and contain threats, and mitigate risks to critical data.

Recognizing the threat of security breaches and cyberattacks globally, we have developed a cybersecurity program, overseen by our Chief Information Security Officer (CISO) and Chief Information Officer (CIO), that is designed to protect patient trust, defend the Moderna brand, and reduce the risk and impact of cyber-attacks.

Our cybersecurity program is informed by industry standards and includes periodic risk assessments and security testing supported by cybersecurity technologies, including third-party security solutions, vulnerability management, and monitoring tools, designed to monitor, identify, and manage risks from cyber threats.

In addition, we have implemented employee security and awareness training.

Management has established a cyber incident response plan (CIRP) designed to assess, identify and manage risks from cybersecurity threats and enable prompt response in the event that a cybersecurity incident is detected.

We have a process in place for notification to our leadership response team in the event of a significant cyber incident, and for escalation of these events to our Audit Committee and Board, as appropriate.

To date, we have not experienced a cybersecurity incident that has had a material impact on our business strategy, results of operations, or financial condition.

We undergo several annual internal compliance audits and external reviews to evaluate our controls, including cybersecurity controls.

In an effort to minimize third-party risk, we have established a process to assess the security practices of third-party suppliers and related risks, including through review of relevant supplier certifications and security and responses to standardized information gathering (SIG) questionnaires, as applicable and appropriate.

*Governance Related to Cybersecurity Risks*

Our Board of Directors oversees Moderna’s overall risk management strategy.

The Board exercises oversight of risks from cybersecurity threats primarily through its Audit Committee, which oversees our risk management processes for information security and technology risks.

Our cybersecurity risk management processes are integrated into our overall risk management strategy, which is overseen by the Audit Committee.

At least annually, the Audit Committee discusses our risk management program, including information security and technology risks and findings from any audits, with our internal audit staff.

The Audit Committee receives cyber-related updates from management, including our CISO at committee meetings.

During meetings, our CISO updates the committee on Moderna’s cybersecurity posture, potential threats and risk mitigation strategies, and the progress of the Company’s cybersecurity initiatives, as appropriate.

The Chair of the Audit Committee and management provide regular briefings on such matters to the full Board of Directors, as appropriate.

At the management level, our CISO is primarily responsible for leading our cybersecurity strategy for assessing and managing material risks from cybersecurity threats.

Our current CISO has over 25 years of cybersecurity experience across a wide array of industries, most recently serving in leadership positions at two different public companies and previous roles of increasing responsibility at multinational technology companies.

Our CISO reports directly to our CIO, who is a member of our Executive Committee and reports to our Chief Executive Officer.

We have built a cybersecurity leadership team designed to align with key services, with a separate lead overseeing each service offering, all reporting to the CISO.

We also maintain relationships with law enforcement and industry groups to support our cybersecurity intelligence and risk management efforts.

We have two [added: main] campuses in Massachusetts.

[removed: We] [added: Additionally, we] occupy a multi-building campus [added: at Technology Square] in Cambridge, [removed: Massachusetts (Cambridge campus),] [added: Massachusetts,] consisting of a mix of offices and research laboratory [removed: space] [added: space,] totaling approximately 292,000 square feet.

The Moderna Technology Center [removed: (MTC campus)] [added: (MTC)] is located in Norwood, Massachusetts and is primarily comprised of three buildings (MTC South, MTC North and MTC East).

The MTC campus is approximately 686,000 square feet which includes lab and office space, directly supporting [removed: improvement in] our manufacturing capabilities and [removed: expansion of our] commercial and clinical activities.

The MTC campus is leased through 2042 and we have the option to extend it for three [added: additional] five-year terms.

We also own and lease [added: various parcels of] land, office and lab spaces [removed: globally] [added: across the globe] for our business operations.

[removed: We are also investing in a] [added: This building, spanning approximately 462,000 square feet, is designated as our] new Moderna Science Center [removed: (MSC) in Cambridge, Massachusetts, totaling approximately 462,000 square feet of leased space.][added: (MSC).]

We expect to begin a phased move-in process [added: starting] in [removed: the fourth quarter of 2023.][added: early 2024.]

[removed: Following completion of the building project, the] [added: The] lease [added: has a] term [removed: is] [added: of] 15 years, [removed: subject to our right] [added: with options for us] to extend the lease for up to two [added: additional] seven-year terms.

During the third quarter of 2023, we commenced a lease for a property in Cambridge, Massachusetts.

The MSC will accommodate a combination of scientific and office spaces, including our principal executive offices.

The lease will expire in early 2025.

In the second quarter of 2023, we acquired a newly constructed biomanufacturing facility, encompassing 140,000 square feet, in Marlborough, Massachusetts.

This facility is undergoing enhancements, including the addition of 60,000 square feet to the existing structure.

Upon completion, the facility will feature office and mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, a just-in-time satellite warehouse, and additional office spaces.

We expect the facility to be operational in 2025.

This new site is strategically intended to support our INT program.

The Cambridge campus is leased with the majority of the space being leased through 2029.

The MSC is expected to house scientific and non-scientific spaces, including our principal executive offices, and is built to support our growth as we continue to advance our pipeline of mRNA medicines.

The building construction is currently on-going.

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Our common stock [removed: began trading] [added: trades] on the Nasdaq Global Select Market under the symbol [removed: “MRNA” on December 7, 2018.][added: “MRNA”.]

The following graph [removed: shows] [added: illustrates] a comparison [removed: from December 7, 2018, the date on which our common stock first began trading on] [added: for] the [removed: Nasdaq Global Select Market, through] [added: five years ended] December 31, [removed: 2022] [added: 2023] of the cumulative total return for our common stock, the Nasdaq Biotechnology Index, and the Standard & Poor’s 500 Stock Index (the [removed: “S&P 500”)] [added: S&P 500)] each of which assumes an initial investment of $100 and reinvestment of all dividends.

[removed: ][added: ]

We had approximately [removed: 79] [added: 75] stockholders of record as of February [removed: 17, 2023.][added: 16, 2024.]

[removed: (2)] On [removed: February 22,] [added: August 1,] 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date.

Refer to [Note [removed: 14](#iffc0344c00444d7080375d0d85e64bb9_172)] [added: 12](#i9d825fa259284f989c73122fe917c977_181)] to consolidated financial statements for information regarding our share repurchase programs.

During the three months ended December 31, 2023, there were no shares repurchased.

As of December 31, 2023, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remains outstanding, with no expiration date.

Prior to that time, there was no public market for our common stock.

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The following table provides information with respect to the shares of common stock repurchased by us during the three months ended December 31, 2022:

| | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Period | | | | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share (1) | | | | | | Total Number of Shares Purchased as Part of Publicly Announced Program | | | | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program (in millions) (2) | | |

| October 1 - October 31, 2022 | | | | | | 3,024,505 | | | | | | $ | 124.27 | | | | | 22,523,999 | | | | | | $ | 2,840 | |

| November 1 - November 30, 2022 | | | | | | 177,169 | | | | | | $ | 147.77 | | | | | 22,701,168 | | | | | | $ | 2,814 | |

| December 1 - December 31, 2022 | | | | | | — | | | | | | $ | — | | | | | 22,701,168 | | | | | | $ | 2,814 | |

| Total | | | | | | 3,201,674 | | | | | | | | | | | | | | | | | | | | |

_______

(1) Average price paid per share includes related expenses.

This share repurchase program was increased by the Board of Directors by an additional $3.0 billion on August 1, 2022, also with no expiration date.

Table of Content

| [Report of Independent Registered Public Accounting [removed: Firm](#iffc0344c00444d7080375d0d85e64bb9_106)] [added: Firm](#i9d825fa259284f989c73122fe917c977_115)] | | | | | | [removed: [112](#iffc0344c00444d7080375d0d85e64bb9_106)] [added: [102](#i9d825fa259284f989c73122fe917c977_115)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2022] [added: 2023] and [removed: 2021](#iffc0344c00444d7080375d0d85e64bb9_109)] [added: 2022](#i9d825fa259284f989c73122fe917c977_118)] | | | | | | [removed: [114](#iffc0344c00444d7080375d0d85e64bb9_109)] [added: [104](#i9d825fa259284f989c73122fe917c977_118)] | | |

| [Consolidated Statements of Operations for the years ended December 31, [added: 2023,] 2022, [removed: 2021] and [removed: 2020](#iffc0344c00444d7080375d0d85e64bb9_112)] [added: 2021](#i9d825fa259284f989c73122fe917c977_121)] | | | | | | [removed: [115](#iffc0344c00444d7080375d0d85e64bb9_112)] [added: [105](#i9d825fa259284f989c73122fe917c977_121)] | | |

| [Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, [added: 2023,] 2022, [removed: 2021] and [removed: 2020](#iffc0344c00444d7080375d0d85e64bb9_115)] [added: 2021](#i9d825fa259284f989c73122fe917c977_124)] | | | | | | [removed: [116](#iffc0344c00444d7080375d0d85e64bb9_115)] [added: [106](#i9d825fa259284f989c73122fe917c977_124)] | | |

| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [added: 2023,] 2022, [removed: 2021] and [removed: 2020](#iffc0344c00444d7080375d0d85e64bb9_118)] [added: 2021](#i9d825fa259284f989c73122fe917c977_127)] | | | | | | [removed: [117](#iffc0344c00444d7080375d0d85e64bb9_118)] [added: [107](#i9d825fa259284f989c73122fe917c977_127)] | | |

| [Consolidated Statements of Cash Flows for the years ended December 31, [added: 2023,] 2022, [removed: 2021] and [removed: 2020](#iffc0344c00444d7080375d0d85e64bb9_121)] [added: 2021](#i9d825fa259284f989c73122fe917c977_130)] | | | | | | [removed: [119](#iffc0344c00444d7080375d0d85e64bb9_121)] [added: [109](#i9d825fa259284f989c73122fe917c977_130)] | | |

| [Notes to Consolidated Financial [removed: Statements](#iffc0344c00444d7080375d0d85e64bb9_124)] [added: Statements](#i9d825fa259284f989c73122fe917c977_133)] | | | | | | [removed: [120](#iffc0344c00444d7080375d0d85e64bb9_124)] [added: [110](#i9d825fa259284f989c73122fe917c977_133)] | | |

We have audited the accompanying consolidated balance sheets of Moderna, Inc. (the Company) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February [removed: 24, 2023,] [added: 23, 2024,] expressed an unqualified opinion thereon.

Critical Audit [removed: Matter][added: Matters]

The critical audit [removed: matter] [added: matters] communicated below [removed: is a matter] [added: are matters] arising from the current period audit of the financial statements that [removed: was] [added: were] communicated or required to be communicated to the audit committee and that: (1) [removed: relates] [added: relate] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The communication of [removed: the] critical audit [removed: matter] [added: matters] does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matter] [added: matters] below, providing [removed: a] separate [removed: opinion] [added: opinions] on the critical audit [removed: matter] [added: matters] or on the accounts or disclosures to which [removed: it relates.][added: they relate.]

[removed: | | | | | | | Product Sales Revenue Recognition | | |][added: *Net Product Sales*]

| | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |

| Cash and cash equivalents | | | [added: | | |] $ | [added: 2,907 | | | | | $ |] 3,205 | | | | | $ | 6,848 | |

| Investments | | | [removed: 6,697] [added: 5,697] | | | | | | [removed: 3,879] [added: 6,697] | | |

| Accounts receivable | | | [removed: 1,385] | | | [added: $] | [added: 1,584] | | [removed: 3,175] | | | [added: $ | 1,385 | |]

| Inventory | | | [removed: 949] [added: 202] | | | | | | [removed: 1,441] [added: 949] | | |

| Prepaid expenses and other current assets | | | [removed: 1,195] [added: 627] | | | | | | [removed: 728] [added: 1,195] | | |

| Total current assets | | | [removed: 13,431] [added: 10,325] | | | | | | [removed: 16,071] [added: 13,431] | | |

| Investments, non-current | | | [removed: 8,318] [added: 4,677] | | | | | | [removed: 6,843] [added: 8,318] | | |

| Property, plant and equipment, net | | | [removed: 2,018] [added: 1,945] | | | | | | [removed: 1,241] [added: 2,018] | | |

| Right-of-use assets, operating leases | | | [removed: 121] [added: 713] | | | | | | [removed: 142] [added: 121] | | |

| Deferred tax assets | | | [removed: 982] [added: 81] | | | | | | [removed: 326] [added: 982] | | |

| Other non-current assets | | | [removed: 988] [added: 685] | | | | | | [removed: 46] [added: 988] | | |

| Total assets | | | $ | [removed: 25,858] [added: 18,426] | | | | | $ | [removed: 24,669] [added: 25,858] | |

| Accounts payable | | | $ | [removed: 487] [added: 520] | | | | | $ | [removed: 302] [added: 487] | |

| Accrued liabilities | | | [removed: 2,101] [added: 1,798] | | | | | | [removed: 1,472] [added: 2,101] | | |

| Deferred revenue | | | [removed: 2,038] [added: 568] | | | | | | [removed: 6,253] [added: 2,038] | | |

| Income taxes payable | | | [removed: 48] [added: 15] | | | | | | [added: (828) | | | | | |] 876 | | |

| Other current liabilities | | | [removed: 249] [added: 66] | | | | | | [removed: 225] [added: 249] | | |

| Total current liabilities | | | [removed: 4,923] [added: 3,015] | | | | | | [removed: 9,128] [added: 4,923] | | |

| Deferred revenue, non-current | | | [removed: 673] [added: 83] | | | | | | [removed: 615] [added: 673] | | |

| Operating lease liabilities, non-current | | | [removed: 92] [added: 643] | | | | | | [removed: 106] [added: 92] | | |

| Financing lease liabilities, non-current | | | [removed: 912] [added: 575] | | | | | | [removed: 599] [added: 912] | | |

| Other non-current liabilities | | | [removed: 135] [added: 256] | | | | | | [removed: 76] [added: 135] | | |

| Total liabilities | | | [removed: 6,735] [added: 4,572] | | | | | | [removed: 10,524] [added: 6,735] | | |

| Commitments and contingencies ([Note [removed: 12](#iffc0344c00444d7080375d0d85e64bb9_166))] [added: 11](#i9d825fa259284f989c73122fe917c977_175))] | | | | | | | | | | | |

| Preferred stock, $0.0001; 162 shares authorized as of December 31, [removed: 2022] [added: 2023] and [removed: 2021;] [added: 2022;] no shares issued or outstanding at December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] | | | — | | | | | | — | | |

| | | | | | | Reserves for returns on product revenue | | |

| *Description of the Matter* | | | | | | During the year ended December 31, 2023, the Company’s net product revenues for Spikevax were $6.7 billion. As explained in Note 2 of the consolidated financial statements, revenue from product sales includes estimates of variable consideration for which reserves are established, including reserves for product returns. Auditing the Company’s measurement of reserves for product returns under its contracts with wholesalers, distributors and retail customers (collectively, “Customers”) was especially challenging because (1) it involves management assumptions about inventory remaining in the distribution channel as of the balance sheet date that could be subject to return in future periods and projected market demand, and (2) the Company has limited returns history on which to base its assumptions. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of internal controls over the Company’s process to determine reserves for returns on product revenue. For example, we tested controls over management’s review of the completeness and accuracy of the data used in the process and the assumptions about the amount of inventory in the distribution channel that could be subject to return in future periods. To test the Company’s reserves for returns on product revenue, our audit procedures included, among other procedures, testing the accuracy and completeness of the underlying data used in the calculations and evaluating the assumptions used by management to estimate its reserves. To test management’s assumptions, we inspected agreements with significant Customers to validate the rights of return, made inquiries of members of the commercial function regarding any changes to the terms and conditions of commercial contracts. We also examined credit memos issued during and after year end for unusual items or trends not consistent with the Company’s analysis of product returns and performed revenue cutoff testing at period end to assess whether there were unusual trends that should have been considered in the Company analysis of product returns. In addition, we reviewed inventory on hand-reporting from significant Customers at the balance sheet date and subsequent to the balance sheet date and inspected vaccination data from third-party sources through the report date. We also performed sensitivity analyses over the Company’s return rate to assess the effect of changes in assumptions. | | |

| | | | | | | Raw Material Inventory Write-downs | | |

| *Description of the Matter* | | | | | | As of December 31, 2023, the Company had $0.4 billion of inventory. As disclosed in Note 2, inventory is recorded at the lower of cost or net realizable value. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise unsaleable items. For the year ended December 31, 2023, inventory write-downs were $2.2 billion, which included $903 million in raw material inventory write-downs resulting from the Company’s long-range financial planning process in the third quarter of 2023. Auditing management's estimates for raw material inventory write-downs involved especially subjective auditor judgment because the estimates rely on a number of factors that are affected by market and economic conditions outside the Company’s control. In particular, raw material inventory write-downs are sensitive to significant assumptions, including the expected demand for the Company’s products and the expiration dates of the raw materials. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design, and tested the operating effectiveness of internal controls over the Company's raw material inventory write-down process including management’s review of the significant assumptions described above and controls over the completeness and accuracy of the information used to develop the estimates. To test the Company’s raw material inventory write-downs, our audit procedures included, among other procedures, testing the accuracy and completeness of the underlying data used in the calculations and evaluating the assumptions used by management in its estimates. Our testing of the data used in the Company’s estimates included the accuracy of the raw material expiration dates used, materials required in the Company’s products, and any alternate uses. We evaluated the Company’s forecast of future demand, including testing of the significant assumptions within its forecast, and evaluating the consistency of the forecast with that used by management for other purposes. We also performed sensitivity analyses to assess the impact of changes in significant assumptions to the raw material inventory write-downs and evaluated any contrary evidence identified. | | |

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| | | | | | | | | |

February 23, 2024

| | | | 2023 | | | | | | 2022 | | |

| Accounts receivable, net | | | 892 | | | | | | 1,385 | | |

| Other revenue | | | 177 | | | | | | 828 | | | | | | 796 | | |

| Net (loss) income | | | $ | (4,714) | | | | | $ | 8,362 | | | | | $ | 12,202 | |

| Pension and postretirement benefit plans: | | | | | | | | | | | | | | | | | |

| Pension and postretirement obligation adjustments | | | (9) | | | | | | — | | | | | | — | | |

| Balance at December 31, 2022 | | | | | | | | | | | | | | | | | | | | | 385 | | | | | | $ | — | | | | | $ | 1,173 | | | | | $ | (370) | | | | | $ | 18,320 | | | | | $ | 19,123 | |

| Vesting of restricted common stock | | | | | | | | | | | | | | | | | | | | | 1 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| Repurchase of common stock, including excise tax | | | | | | | | | | | | | | | | | | | | | (8) | | | | | | — | | | | | | (1,153) | | | | | | — | | | | | | — | | | | | | (1,153) | | |

| Balance at December 31, 2023 | | | | | | | | | | | | | | | | | | | | | 382 | | | | | | $ | — | | | | | $ | 371 | | | | | $ | (123) | | | | | $ | 13,606 | | | | | $ | 13,854 | |

| Net (loss) income | | | $ | (4,714) | | | | | $ | 8,362 | | | | | $ | 12,202 | |

| Loss on equity investments, net | | | 35 | | | | | | — | | | | | | — | | |

| Acquisition of business, net of cash acquired | | | (85) | | | | | | — | | | | | | — | | |

mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases.

Our COVID-19 vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®.

Our original vaccine, mRNA-1273, targeted the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated.

We have a diverse and extensive development pipeline of 42 development candidates across our 45 development programs, of which 40 are in clinical studies currently.

Other revenue in the consolidated statements of operations comprises grant revenue and collaboration revenue that were previously presented as separate line items in our consolidated statements of operations in our 2022 Form 10-K.

The associated prior period amounts in the consolidated financial statements, as well as in the notes thereto, have been reclassified to conform to the current presentation.

Changes in our estimates are recorded in the financial results of the period in which the new information becomes available.

To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following five steps (the five-step model): (i) identify the contract(s) with our customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as each performance obligation is satisfied.

Prior to the third quarter of 2023, we sold our COVID-19 vaccine to the U.S. Government, foreign governments and organizations.

In the third quarter of 2023, we commenced sales of our latest COVID-19 vaccine to the U.S. commercial market, in addition to continuing sales to international governments and organizations.

In the U.S., our COVID-19 vaccine is sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.

Wholesalers and distributors typically do not make upfront payments to us.

We recognize net product sales when control of the product transfers to the customer, typically upon delivery.

Payment terms generally range from 30 to 60 days, in line with customary practices in each country.

Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, and other related deductions.

These provisions are recorded based on contractual terms and our estimate of returns for product sold during the period, using the expected value method or the most likely amount method.

We update our estimates quarterly and record necessary adjustments in the period when we identify the adjustments.

Product sales, net of provisions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable when the uncertainty associated with the provisions is subsequently resolved.

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| *Description of the Matter* | | | | | | As discussed in [Note 2](#iffc0344c00444d7080375d0d85e64bb9_130) to the consolidated financial statements, the Company has entered into supply agreements with the U.S. Government, other international governments and organizations. Under the supply agreements, including related amendments, the Company is entitled to upfront deposits for COVID-19 vaccine supply, which are initially recorded as deferred revenue. Revenue is recognized pursuant to Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, based on the fixed price per dose when control of the product has transferred and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory. The Company must evaluate the contractual terms and conditions in its supply agreements to determine the timing of revenue recognition. For the year ended December 31, 2022, product sales revenue totaled $18.4 billion. Auditing the Company's revenue recognition was especially challenging due to the volume of executed supply agreements, including related amendments, the varying contractual terms within the agreements, and because the amounts are material to the consolidated financial statements and related disclosures. | | |

| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design, and tested the operating effectiveness of the Company's internal controls over the recognition of revenue related to product sales. This included testing controls over the Company's process to evaluate the contractual terms of the supply agreements, including related amendments, and determine the appropriate revenue recognition. We also tested the Company’s controls over evaluating transfer of control and customer acceptance, as applicable, and controls over the Company’s IT systems that are important to the initiation, processing and recording of revenue transactions. To test the recognition of revenue associated with supply agreements, including related amendments, our audit procedures included, among others, evaluating the contractual terms of supply agreements, testing the transfer of control, and assessing the timing of revenue recognition. For example, we performed procedures to test the completeness and accuracy of the underlying data in the Company’s revenue calculations, including testing the mathematical accuracy of the Company’s calculations, and testing the accuracy of revenue recognized by tracing key terms to the supply agreements, including related amendments, and agreeing a sample of revenue transactions to supporting documentation, including evidence of control transfer. We also assessed the appropriateness of the related disclosures in the consolidated financial statements. | | |

February 24, 2023

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| Balance at December 31, 2019 | | | | | | | | | | | | | | | | | | | | | 337 | | | | | | $ | — | | | | | $ | 2,670 | | | | | $ | 2 | | | | | $ | (1,497) | | | | | $ | 1,175 | |

| Proceeds from public offering of common stock, net of issuance costs of $2 | | | | | | | | | | | | | | | | | | | | | 48 | | | | | | — | | | | | | 1853 | | | | | | — | | | | | | — | | | | | | 1,853 | | |

| Balance at December 31, 2020 | | | | | | | | | | | | | | | | | | | | | 399 | | | | | | $ | — | | | | | $ | 4,802 | | | | | $ | 3 | | | | | $ | (2,244) | | | | | $ | 2,561 | |

| Leased assets expensed | | | — | | | | | | — | | | | | | 62 | | |

| Proceeds from offerings of common stock, net of issuance costs | | | — | | | | | | — | | | | | | 1,853 | | |

On December 18, 2020, we received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the emergency use of the Moderna COVID-19 Vaccine (also referred to as mRNA-1273 and marketed under the brand name Spikevax®).

In January 2022, we received full commercial approval for Spikevax in the United States.

As of December 31, 2022, Spikevax is authorized by the FDA and global regulators in more than 70 countries.

In addition, our Omicron-targeting bivalent boosters, targeting the BA.1 Omicron variant combined with Spikevax (mRNA-1273.214) and targeting the BA.4/BA.5 Omicron variant combined with Spikevax (mRNA-1273.222), are authorized by regulatory agencies around the globe.

We generate worldwide product sales from Spikevax and the two authorized Omicron-targeting boosters.

Significant estimates relied upon in preparing these financial statements include, but are not limited to, critical accounting policies or estimates related to revenue recognition, income taxes, valuation of deferred tax assets, inventory valuation, firm purchase commitment liabilities, fair value of financial instruments, derivative financial instruments, leases, useful lives of property, plant and equipment, research and development expense, and stock-based compensation.

Our revenue is primarily generated through product sales.

We also generate grant revenue from government-sponsored and private organizations, and collaboration revenue through collaboration arrangements.

Product sales are associated with our COVID-19 vaccine supply agreements with the U.S. Government, other international governments and organizations.

We recognize revenue from product sales, using the five-step model under ASC 606 (*Revenue from Contracts with Customers*), based on the fixed price per dose according to the contracts when control of the product transfers to the customer and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory.

We pay distribution fees to certain customers in connection with the sales of our product.

We record distribution fees paid to our customers as a reduction of revenue, unless the payment is for a distinct good or service from the customer and we can reasonably estimate the fair value of the goods or services received.

If both conditions are met, we record the consideration paid to the customer as an operating expense.

These costs are typically known at the time of sale, resulting in minimal adjustments subsequent to the period of sale.

We did not have any distribution fees for the year ended December 31, 2020.

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Accounts Receivable and Allowance for Doubtful Accounts

We have accounts receivable amounts due from our product sales and related vaccine supply agreements and our grant agreements.

We also have accounts receivable amounts due from strategic collaborators as a result of manufacturing and research and development services provided under collaboration arrangements, or milestones achieved, but not yet paid.

To estimate the allowance for doubtful accounts, we make judgments about the creditworthiness of our customers based on ongoing credit evaluation and historical experience.

| BARDA | | | * | | | | | | * | | | | | | 65 | | % | | | | * | | | | | | 16 | | % |

We record all derivatives on our consolidated balance sheets at fair value.

The accounting for changes in the fair value of a derivative depends on whether the derivative has been designated and qualifies for hedge accounting.

Derivatives designated and qualifying as a hedge of the exposure to variability in expected future cash flows, or other types of forecasted transactions, are considered cash flow hedges.

Hedge accounting generally provides for the matching of the timing of gain or loss recognition on the hedging instrument with the recognition of the changes in the fair value of the hedged asset or liability that are attributable to the hedged risk in a fair value hedge or the earnings effect of the hedged forecasted transactions in a cash flow hedge.

The gains or losses resulting from changes in the fair value of cash flow hedges are initially recorded as a component of accumulated other comprehensive (loss) income (AOCI) in stockholders’ equity and subsequently reclassified to product sales in the period during which the hedged transaction affects earnings.

In the event the underlying forecasted transaction does not occur, or it becomes probable that it will not occur, within the defined hedge period, we reclassify the gains or losses on the related cash flow hedge from AOCI to other expense, net, in our consolidated statements of operations.

We may enter into derivative contracts that are intended to economically hedge certain risk, even though hedge accounting does not apply or we elect not to apply hedge accounting.

Gains or losses associated with foreign currency derivatives that are not designated as hedging instruments for accounting purposes are recorded within other expense, net, in our consolidated statements of operations.

| Other comprehensive loss | | | (322) | | | | | | (24) | | | | | | (346) | | |

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Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2022.][added: 2023.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2022,] [added: 2023,] our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management assessed our internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]

Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2022.][added: 2023.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in their report included in this Annual Report on Form 10-K.

During the three months ended December 31, [removed: 2022,] [added: 2023,] there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act), which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

We have audited Moderna, Inc.’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Moderna, Inc. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes and our report dated February [removed: 24, 2023] [added: 23, 2024] expressed an unqualified opinion thereon.

February 23, 2024

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February 24, 2023

The [removed: above summary is] [added: foregoing description does] not [added: purport to be] complete and is qualified in its entirety by [added: reference to] the [removed: Amended and Restated Executive Severance Plan,] [added: full text of the By-laws,] a copy of which is attached hereto as Exhibit [removed: 10.11] [added: 3.2] and is incorporated herein by reference.

*10b5-1 Plans*

On November 7, 2023, Noubar Afeyan, our Chairman, amended a trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Afeyan 10b5-1 Plan).

The Afeyan 10b5-1 Plan was amended to increase certain price triggers under the plan.

The Afeyan 10b5-1 Plan, as amended, is scheduled to commence on February 28, 2024, and will run through August 20, 2025.

The aggregate maximum number of shares of common stock that may be sold pursuant to the Afeyan 10b5-1 Plan is 745,000, which represents the shares remaining under the original plan that have not been sold to date.

On November 6, 2023, Arpa Garay, our former Chief Commercial Officer, terminated a trading arrangement that was intended to satisfy the affirmative defense of Rule 10b5-1(c) (the Garay 10b5-1 Plan).

The Garay 10b5-1 Plan was entered into on August 24, 2023, and was scheduled to commence on November 27, 2023, with a termination date of August 30, 2024.

The Garay 10b5-1 Plan provided for the potential sale of approximately 4,540 shares of common stock and for the potential exercise of vested stock options and the associated sale of up to 24,897 shares.

No shares of common stock were sold, and no options to purchase shares of common stock were exercised, under the Garay 10b5-1 Plan prior to its termination.

*Amended and Restated By-laws*

On February 21, 2024, our Board of Directors approved and adopted the Company’s Second Amended and Restated By-laws (the “By-laws”), which became effective immediately.

The By-laws supersede and replace in their entirety the Company's Amended and Restated By-laws in effect immediately prior to effectiveness of the By-laws.

The By-laws, among other things:

- implement a majority voting standard in uncontested director elections;

- implement a proxy access provision, which permits a stockholder, or a group of up to 20 stockholders, owning 3% of our outstanding common stock continuously for at least three years to nominate and include in our proxy materials director candidates constituting up to the greater of two nominees or 20% of the Board of Directors, subject to the terms and conditions set forth in the By-laws;

- update our advance notice provisions to take into account recent rules adopted by the SEC regarding usage of universal proxies;

- reflect recent amendments and updates to the Delaware General Corporation Law; and

- incorporate certain other administrative, technical, clarifying and conforming changes.

Effective February 23, 2023, the Compensation and Talent Committee of the Board of Directors approved a new form of Executive Severance Plan (the Amended and Restated Executive Severance Plan) that would be applicable to the Company’s Executive Committee members.

Under the Amended and Restated Executive Severance Plan, Executive Committee members covered by the plan would continue to be eligible for the benefits previously provided for under the predecessor plan, except that in the event of termination (or than for Cause, death or Disability) other than in connection with a Change of Control (in each case as defined in the Amended and Restated Executive Severance Plan), eligible participants would be entitled to receive their full annual bonus at target, rather than a pro-rated bonus based upon weeks lapsed during the year.

The Amended and Restated Executive Severance Plan also includes an expanded definition of the circumstances that would constitute termination for Cause and that would render a participant ineligible for benefits under the plan.

On February 21, 2023, Juan Andres, the Company’s President, Strategic Partnerships and Enterprise Expansion, announced his decision to retire from the Company in May 2023.

Until December 31, 2022, Mr. Andres had served as the Company’s Chief Technical Operations and Quality Officer.

In connection with his retirement, Mr. Andres will be granted a period of one year from his date of retirement to exercise any stock options that are vested, but unexercised as of his retirement date.

Table of Content

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.

The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the [removed: 2023] [added: 2024] Annual Meeting of Stockholders, which we intend to file with the Securities and Exchange Commission within 120 days of the end of our fiscal year pursuant to General Instruction G(3) of Form 10-K.

Table of Content

| [removed: 3.2] [added: 3.2*] | | | | | | [added: [Second](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32secondamendedandr.htm)] [Amended and Restated By-laws of the [removed: Registrant. (2)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518349938/d677222dex32.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32secondamendedandr.htm)] | | |

| [removed: 4.3] [added: 4.2] | | | | | | [Description of Capital [removed: Stock.](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm) [(](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[6](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)] [added: Stock. (](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[4](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)] | | |

| 10.7 | | | | | | [removed: [Lease Agreement,] [added: [Net Lease] by and between Moderna Therapeutics, Inc. and [removed: ARE-Tech Square,] [added: Campanelli-TriGate Norwood Upland,] LLC, dated as of [removed: May 26,] [added: August 29,] 2016, as amended by Amendment No. 1 dated as of [removed: August 31, 2016, Amendment No. 2 dated as of December 31, 2016, Amendment No. 3 dated as of] April [removed: 24, 2017,] [added: 10, 2017 and] Amendment No. [removed: 4] [added: 2] dated as of [removed: April 13,] [added: March 16,] 2018. [removed: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex109.htm)] [added: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1010.htm)] | | |

| [removed: 10.10] [added: 10.8] | | | | | | [Third Amendment, dated September 11, 2018, Fourth Amendment, dated March 28, 2019, and Omnibus Amendment, dated December 30, 2021, to Net Lease, dated as of August 29, 2016, as amended. [removed: (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[5](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)] | | |

| [removed: 10.11#*] [added: 10.9#] | | | | | | [Amended and Restated Executive Severance Plan and Form of Participation Letter, as amended on [removed: February](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm) [23](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[, 2023.](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)] [added: February 23, 2023](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[. (](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[9](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)] | | |

| [removed: 10.12#] [added: 10.10#] | | | | | | [Letter Agreement by and between the Company and Stéphane Bancel, dated as of June 13, 2018, as amended by Amendment No. 1 dated as of November 4, 2018. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm) | | |

| [removed: 10.13#] [added: 10.11#] | | | | | | [Letter Agreement by and between the Company and Stephen Hoge, dated as of October 17, 2017. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1016.htm) | | |

| [removed: 10.14#] [added: 10.12#] | | | | | | [Employment Letter Agreement between ModernaTX, Inc. and Shannon Klinger, dated as of March 4, 2021. [removed: (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)[5](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)] | | |

| [removed: 10.15#] [added: 10.13#] | | | | | | [Offer Letter by and between ModernaTX, Inc. and James Mock, dated as of August 15, 2022. [removed: (10)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)[8](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)] | | |

| [removed: 10.16#*] [added: 10.14#] | | | | | | [Offer Letter by and between ModernaTX, Inc. and Arpa Garay, dated as of April 21, [removed: 2022.](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)] [added: 2022](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)[. (](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)[9](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)] | | |

| [removed: 10.17#] [added: 10.16#] | | | | | | [Updated Executive Retirement and Strategic Consulting Agreement, dated May 27, 2022, between ModernaTX, Inc. and David Meline. [removed: (9)](https://www.sec.gov/Archives/edgar/data/1682852/000119312522165220/d364287dex101.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000119312522165220/d364287dex101.htm)[7](https://www.sec.gov/Archives/edgar/data/1682852/000119312522165220/d364287dex101.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000119312522165220/d364287dex101.htm)] | | |

| [removed: 10.18#] [added: 10.17#] | | | | | | [Executive Separation Agreement and Release, dated May 13, 2022, between [removed: ModernaTx,] [added: ModernaT](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)[X](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)[,] Inc. and Jorge Gomez. [removed: (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)[6](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000029/exhibit10151022.htm)] | | |

| [removed: 10.19#] [added: 10.18#] | | | | | | [Senior Executive Cash Incentive Bonus Plan. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1017.htm) | | |

| [removed: 10.20#] [added: 10.19#] | | | | | | [Amended and Restated Non-Employee Director Compensation Policy, effective October 1, 2022. [removed: (10)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)[8](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)] | | |

| [removed: 10.21#] [added: 10.20#] | | | | | | [Form of Indemnification Agreement between the Registrant and each of its officers. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1019.htm) | | |

| [removed: 10.22#] [added: 10.21#*] | | | | | | [2018 Employee Stock Purchase [removed: Plan. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1020.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit10212018employeesto.htm)] | | |