Moderna (MRNA) 10-K risk factor changes: FY2024 vs FY2023

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

[removed: We] [added: In 2024, we] recognized [removed: $6.7] [added: $3.1] billion of [removed: sales for COVID-19 vaccines delivered in 2023,] [added: product sales,] compared to [added: $6.7 billion,] $18.4 billion [removed: in 2022] and $17.7 billion in [added: 2023, 2022 and] 2021, [removed: as demand for COVID-19 vaccines declined.][added: respectively.]

[removed: We expect] [added: Vaccination rates in] the [removed: market for COVID-19 vaccines] [added: future may also be lower than our expectations, and are likely] to [removed: evolve based on] [added: be impacted by] a number of factors, including [removed: medical need, viral evolution,] public health authority [removed: recommendations] [added: recommendations, medical need, viral evolution] and consumer motivation to vaccinate.

[removed: In the third quarter of 2023, we significantly resized our manufacturing infrastructure as we shifted to an endemic COVID-19 vaccine market, and we] [added: This resizing] may [added: result] in [removed: the future incur additional] [added: our incurring] costs associated with exiting [removed: commitments] [added: commitments, such as] with suppliers for raw materials and contract manufacturing [removed: organization] [added: organizations] (CMOs).

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

If we cannot effectively manage evolving [removed: demand] [added: market] dynamics, our business, financial condition, results of operations and prospects may suffer.

[removed: Further,] [added: Moving forward,] we may [removed: find that we] need to dedicate greater resources to our commercial efforts than [removed: anticipated,] [added: we anticipate,] and we may not realize a return on this investment.

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

[removed: Additionally,] [added: Furthermore,] 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.

The [added: vaccine market, and] pharmaceutical market [added: more generally,] is intensely competitive, and we may not compete effectively in the market for existing [removed: products,] [added: or] new [added: products,] treatment methods [removed: and new] [added: or] technologies.

[removed: The] [added: More generally, the] pharmaceutical market is intensely competitive and evolving.

[removed: Many] [added: Other] companies, academic institutions, governmental agencies and public and private research organizations are developing products [removed: for the same diseases] that [removed: we are targeting or expect to target and such other parties] may [removed: have:][added: compete with programs in our development pipeline.]

Even if our products demonstrate superiority to those of competitors, [removed: consumers] [added: consumers, retailers] and the public may fail to appreciate that 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 [removed: vaccine or treatment] [added: product] being more successfully commercialized.

[removed: We also will face competition from] [added: These competitors may have] products that have already been approved and accepted by the medical community [removed: to treat certain conditions we target.][added: or are in later stages of development.]

[removed: Further, we] [added: We] may need to offer more favorable terms to gain market share [removed: in an existing market or] [added: (which we may be unable] to [removed: compete in a new market,] [added: do),] which may negatively impact our profitability.

[removed: If] [added: Additionally, any products that] we [removed: successfully] develop [removed: and obtain approval for other product candidates, we] may [added: struggle to] compete [removed: with products under development by] [added: against those of our] competitors [removed: based on many factors,] [added: for a variety of reasons,] including [removed: the] relative safety and [removed: effectiveness] [added: effectiveness, degree] of [removed: our products, the] [added: any side effects, shelf-life,] ease [removed: with which our products can be administered] [added: of administration] and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals, the availability and cost of manufacturing, [added: distribution,] marketing and sales capabilities, price, reimbursement coverage and patent [removed: position.][added: protection.]

[removed: Competitive] [added: Additionally, competitive] products may make any products we develop obsolete or noncompetitive before we can recover the expenses of developing and commercializing our [removed: products, if approved.][added: products.]

We may be unsuccessful or delayed in updating our [removed: COVID-19] [added: COVID] vaccine to protect against future variants of the SARS-CoV-2 [removed: virus, and updated versions of our COVID-19 vaccine may not protect against such variants.][added: virus.]

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

Our [removed: current COVID-19] [added: COVID] vaccines could be ineffective, or less effective than desired, in protecting against these new variants.

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

[removed: Further, different] [added: Different] regulators [added: have in the past and] may [added: in the future] issue [removed: differing] [added: varying] guidance regarding vaccine composition or populations who should receive a vaccine.

If our efforts to develop variant-specific vaccines [removed: against future variants] are [removed: unsuccessful, we are slower than competitors to develop such vaccines or] [added: not as successful as] our [removed: vaccines prove less effective than competitors’ vaccines,] [added: competitors’,] we could suffer reputational harm, loss of market share and adverse financial results.

The commercial success of our products [removed: will depend] [added: depends] on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.

- [removed: the potential] efficacy and [added: potential] advantages over alternative treatments;

- the duration of protection provided by our products compared to those of [added: our] competitors;

- [added: safety and] the prevalence and severity of any side effects, including any limitations, restrictions (including for use together with other medicines) or warnings contained in a product’s approved labeling;

- publicity [added: and health authority communications] concerning our products or competing products and treatments; and

- [added: product cost and] sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement.

Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant [removed: resources, especially due to the complexity of our programs,] [added: resources] and may never be successful.

Additionally, pricing and reimbursement for any product we develop may be adversely affected by [removed: a number of] [added: various] factors, including:

Coverage and reimbursement by a third-party payor may depend [removed: upon a number of] [added: on various] factors, including the third-party payor’s determination that use of a product is a covered benefit under its health plan, safe, effective and medically necessary, appropriate for the specific patient, cost-effective and neither experimental nor investigational.

Preclinical development is lengthy and uncertain, especially for mRNA [removed: medicines, and our preclinical programs or product candidates may be delayed or terminated.][added: medicines.]

- our product candidates, or other medicines in the same class as ours, may [removed: have] [added: cause significant adverse events or other] undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA or degradation products, any of which could lead to serious adverse events, or other effects;

- regulators may impose a complete or partial clinical hold on a clinical [removed: trial,] [added: trial (or a trial of another company working on mRNA medicines),] or we or our investigators, IRBs or ethics committees may suspend or terminate clinical research or trials for various reasons, including [added: quality events,] noncompliance with regulatory requirements or a finding that participants are being exposed to an unacceptable benefit-risk ratio;

- adverse side effects could be observed in future clinical trials where our product candidates are administered in combination with other therapies (such as the co-administration of our INT product candidate, mRNA-4157); [removed: and]

- a lack of adequate funding to continue a particular clinical [removed: trial.][added: trial, including due to higher-than-anticipated costs.]

Significant preclinical or nonclinical testing and studies or clinical trial delays for our product candidates could allow our competitors to bring products to market before we do and could harm our [removed: business, financial condition and prospects significantly.][added: business.]

[removed: These] [added: There are] risks [added: unique to each of our programs and modalities and risks applicable across programs and modalities, which] may [removed: impair] [added: delay or prevent] our ability to advance one or more of our programs in clinical development, obtain regulatory approval or commercialize our [removed: products, or cause us to experience significant delays in doing so.][added: products.]

Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines, and respiratory vaccines more generally, have in the past impacted and are likely to continue to impact our financial results.

There is significant uncertainty around the amount of future revenue we will recognize from sales of our COVID vaccine—which is our primary source of revenue—as well as sales of RSV and other respiratory vaccines.

Accurately forecasting vaccination rates for our products, which directly impacts overall market size, has been difficult, and these difficulties may persist.

Additionally, the recent Presidential election in the U.S. may impact policies and priorities related to our industry.

If demand for COVID vaccines continues to decline, we lose significant market share, or our products are subject to significant competitive pricing pressure, our product sales may not materialize consistent with our projections.

Beyond COVID vaccines, in 2024, the overall RSV vaccine market was smaller than anticipated, in part due to recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) regarding the frequency of vaccination and recommendations related to who, in terms of age or risk factors, should receive an RSV vaccine.

These recommendations were more limited than anticipated and future advisory committee recommendations (including with respect to RSV re-vaccination and age group recommendations) may continue to negatively impact the size of the market.

We have experienced commercial challenges and are likely to experience additional challenges in the future.

We face risks and uncertainties related to successfully commercializing our products.

For example, in 2024, we faced commercial challenges that led to lower-than-expected sales and required us to adapt our business strategy.

We experienced difficulties maintaining our COVID vaccine market share and gaining market share in the U.S. for our RSV vaccine, where we were third to market.

We compete with well-established, larger pharmaceutical companies for sales of our products, including against Pfizer and Sanofi for sales of our COVID vaccine and Pfizer and GSK for our RSV vaccine.

These competitors (and others against whom we may compete now or in the future) have greater resources and experience than us across all stages of drug development and commercialization.

For example, in 2024, our share of the COVID vaccine market declined due in part to increased commercial competition.

Additionally, we faced continued exclusion from many European markets by a pandemic-era competitor contract with the European Commission.

For RSV vaccines, we entered a market already occupied by two larger competitors and may continue to face difficulties achieving market share.

These competitors have exploited and may in the future exploit their greater size, infrastructure, resources and experience to gain advantages in contracting with customers by, among other things, bundling their products, leveraging larger supply chains and greater purchasing power and utilizing their global networks.

States.

In some instances, our competitors have been able to offer more attractive terms than we can, and they may continue to do so in the future.

We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts.

Our broad clinical success and recent commercial challenges have necessitated a more selective and paced approach to our research and development investment.

If we do not successfully implement our cost efficiency and prioritization programs, we may fail to meet our cash breakeven goals.

Furthermore, as we pursue and fund the development of our prioritized programs, we may forego or delay pursuit of other opportunities that could later prove to have greater commercial potential.

If our prioritized programs are unsuccessful, or not as successful as other programs could have been, we may be unable to realize a sustainable return on our investments and or achieve long-term growth.

We have in the past, and may in the future, seek to resize our manufacturing infrastructure to reflect anticipated demand for our products.

Additionally, our products may only be approved for certain populations or lines of treatment.

Furthermore, the size of markets that we target may be impacted by health authority recommendations regarding who should receive our products, which may be impacted by the new U.S. federal government administration.

Even once approved, products may be subject to recommendations from advisory committees, such as the ACIP, before or after they can be brought to market.

Regulators may require that we conduct additional clinical trials to support our applications for approval beyond our clinical development plans, which may result in increased expense and delays in bringing our products to market.

Although we have demonstrated historical success with our platform technology, we may not continue to realize the same levels of success with clinical trials in the future.

- delays in developing assays acceptable to the FDA or other regulators; and

In addition, the FDA and other regulators may interpret data from our

In addition, local legislatures may attempt to regulate or restrict the use of mRNA medicines in their jurisdictions.

Further, even if we achieve the pre-

labeling, or manufacturing process.

Additionally, the U.S. Supreme Court’s June 2024 decision in *Loper Bright Enterprises v.

Raimondo* overturned the longstanding *Chevron* doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.

The *Loper* decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA, on which we rely.

Additionally, the *Loper* decision may result in increased regulatory uncertainty, inconsistent judicial interpretations and other impacts to the agency rule-making process.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the United States or abroad.

Evolving dynamics in the market for COVID-19 vaccines are likely to impact our financial results, which are likely to result in lower product revenues in 2024 than we have experienced in recent years.

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 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.

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.

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

Further, adapting our COVID-19 vaccine to new variants requires significant coordination with our partners, including for the sourcing of raw materials and production.

Any capacity or production issues or delays experienced by our partners may cause us to fail to meet obligations under our supply agreements.

We have limited sales, distribution and marketing experience and may be unable to effectively establish such capabilities or supplement our capabilities by entering into agreements with third parties.

We have limited experience as a commercial organization and face risks and uncertainties as we shift to an endemic COVID-19 vaccine market and prepare for the commercial launch of other medicines, including our anticipated RSV vaccine launch in 2024.

- greater resources and experience than us at every stage of drug discovery, development, testing, approval, manufacturing and commercialization;

- multiple products that have been approved or are in late stages of development; and

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

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

Other vaccines 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 vaccine.

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.

Our competitors may be more successful in commercializing their products, which would adversely affect our business.

We may experience delays in producing variant-specific vaccines.

The commercial success of our products will depend in part on the medical community, patients and third-party or governmental payors accepting mRNA medicines, and our products in particular, as medically useful, cost-effective and safe.

- the ability to offer products at competitive prices;

For example, it is uncertain whether any combination respiratory vaccine we develop, if approved, would qualify for coverage under Medicare Part B.

Additionally, we expect to initially seek approval of our INT and intratumoral immuno-oncology product candidates for use by patients with relapsed or refractory advanced disease, i.e., the populations the FDA often approves new therapies for initially.

If any such medicines prove to be sufficiently beneficial, we would expect to seek approval in earlier lines of treatment and potentially as a first-line therapy.

There is no guarantee that our products, if approved, would be approved for earlier lines of therapy and, prior to any such approvals, we may have to conduct additional clinical trials.

We may be unable to initiate, may experience delays in or may have to discontinue clinical trials for our product candidates.

- administration of our LNPs could lead to systemic side effects related to the components of the LNPs and could contribute to immune reactions, infusion reactions, complement reactions, opsonization reactions, antibody reactions or reactions to PEG-lipids;

- significant adverse events or other side effects could be observed in our clinical trials;

- regulators may impose a complete or partial clinical hold on clinical trials of other companies working on mRNA medicines;

- the cost of preclinical or nonclinical testing and studies and clinical trials of product candidates may be greater than anticipated;

Before commencing later-stage clinical trials for our programs, we must develop assays to measure and predict the potency of a given dose of our product candidates.

Any delay in developing assays that are acceptable to the FDA or other regulators could delay the start of future clinical trials.

There are risks that are unique to each of our programs and modalities and risks that are applicable across programs and modalities.

These risks apply to all of our programs, including our systemic secreted therapeutics and systemic intracellular therapeutics modalities.

We may slow enrollment in a trial to focus on achieving greater diversity in the subject population, as we did in the Phase 3 clinical trial of our original COVID-19 vaccine.

Successful completion of clinical trials is a prerequisite to submitting a BLA to the FDA, a marketing authorization application (MAA) to the EMA, and similar marketing applications to comparable foreign regulators, for each product candidate and, consequently, the ultimate approval and commercial marketing of any product.

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: six] [added: several] 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: 42] [added: 34] development candidates across our [removed: 45] [added: 44] development programs, of which [removed: 40] [added: 41] are in clinical studies currently.

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

[removed: 2023] [added: 2024] Business Highlights

For the year ended December 31, [removed: 2023,] [added: 2024,] we recognized net product sales of [removed: $6.7] [added: $3.1] billion from sales of our [removed: COVID-19] [added: COVID and RSV] vaccines, compared to [removed: $18.4] [added: $6.7] billion and [removed: $17.7] [added: $18.4] billion for the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] respectively.

As of December 31, [removed: 2023, nine] [added: 2024, eleven] of our [removed: 45] [added: 44] development programs are in late-stage development, including [removed: seven] [added: nine] programs in Phase 3 and two rare disease programs that are expected to [removed: enter] [added: generate] pivotal [removed: studies] [added: data] in [removed: 2024.][added: 2025.]

We [added: remain blinded and] anticipate [added: final efficacy] data from the study in [removed: 2024.][added: 2025.]

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

| | | | | | | | | | | | | | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| United States | | | | | | | | | | | | | | | | | | $ | [removed: 1,720] [added: 1,726] | | | | | $ | [removed: 4,405] [added: 1,720] | | | | | $ | [removed: 5,393] [added: 4,405] | |

| Europe | | | | | | | | | | | | | | | | | | [removed: 1,353] [added: 573] | | | | | | [removed: 6,732] [added: 1,353] | | | | | | [removed: 6,834] [added: 6,732] | | |

| Rest of world | | | | | | | | | | | | | | | | | | [removed: 3,598] [added: 810] | | | | | | [removed: 7,298] [added: 3,598] | | | | | | [removed: 5,448] [added: 7,298] | | |

| Total | | | | | | | | | | | | | | | | | | $ | [removed: 6,671] [added: 3,109] | | | | | $ | [removed: 18,435] [added: 6,671] | | | | | $ | [removed: 17,675] [added: 18,435] | |

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

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

Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales [removed: returns,] [added: returns] and [added: government rebates, and] other related deductions.

Please refer to [Note [removed: 3](#i9d825fa259284f989c73122fe917c977_145)] [added: 10](#i936f1894ad9e4b3c8b6c404bf64d47b3_190)] to our consolidated financial [removed: statements.][added: statements for additional information.]

| Gross product sales | | | | | | | | | | | | | | | | | | $ | [removed: 8,203] [added: 4,517] | | | | | $ | [removed: 18,435] [added: 8,203] | | | | | $ | [removed: 17,675] [added: 18,435] | |

| Wholesaler chargebacks, discounts and fees | | | | | | | | | | | | | | | | | | [removed: (976)] [added: (1,141)] | | | | | | [removed: —] [added: (976)] | | | | | | — | | |

| [removed: Returns] [added: Returns, rebates] and other fees | | | | | | | | | | | | | | | | | | [removed: (556)] [added: (267)] | | | | | | [removed: —] [added: (556)] | | | | | | — | | |

| Total product sales [removed: provision] [added: provision(1)] | | | | | | | | | | | | | | | | | | $ | [removed: (1,532)] [added: (1,408)] | | | | | $ | [removed: —] [added: (1,532)] | | | | | $ | — | |

| Net product sales | | | | | | | | | | | | | | | | | | $ | [removed: 6,671] [added: 3,109] | | | | | $ | [removed: 18,435] [added: 6,671] | | | | | $ | [removed: 17,675] [added: 18,435] | |

As of December 31, [removed: 2023,] [added: 2024,] we had deferred revenue of [removed: $613] [added: $188] million associated with customer deposits received or billable under supply agreements for delivery of our [removed: COVID-19 vaccine primarily] [added: COVID vaccine, with the majority] in [removed: 2024.][added: 2025.]

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

| Grant revenue | | | | | | | | | | | | | | | | | | $ | [removed: 94] [added: 37] | | | | | $ | [removed: 388] [added: 94] | | | | | $ | [removed: 735] [added: 388] | |

| Collaboration revenue | | | | | | | | | | | | | | | | | | [removed: 83] [added: 48] | | | | | | [removed: 440] [added: 83] | | | | | | [removed: 61] [added: 440] | | |

| Total other revenue | | | | | | | | | | | | | | | | | | $ | [removed: 177] [added: 127] | | | | | $ | [removed: 828] [added: 177] | | | | | $ | [removed: 796] [added: 828] | |

Due to the number of ongoing programs and our ability to use resources across several projects, indirect or shared operating costs incurred for our research and development programs are generally not recorded or maintained on a program- or [removed: modality-specific] [added: therapeutic area-specific] basis.

The following table reflects our research and development expenses, including direct program specific expenses summarized by [removed: modality] [added: therapeutic area] and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021] [added: 2022] (in millions):

| | | | [removed: 2023] | | | [added: 2024] | | | [removed: 2022] | | | [added: 2023] | | | [removed: 2021] | | | [added: 2022 | | |]

| Rare disease [removed: intracellular] [added: and other] therapeutics | | | [removed: 75] [added: 82] | | | | | | [removed: 42] [added: 67] | | | | | | [removed: 26] [added: 12] | | |

| Technical development and [removed: unallocated] manufacturing expenses | | | [removed: 821] [added: 1,081] | | | | | | [removed: 464] [added: 1,116] | | | | | | [removed: 275] [added: 713] | | |

| Shared discovery and development expenses | | | [removed: 945] [added: 1,108] | | | | | | [removed: 658] [added: 789] | | | | | | [removed: 242] [added: 556] | | |

| Stock-based compensation | | | [removed: 157] [added: 264] | | | | | | [removed: 94] [added: 157] | | | | | | [removed: 68] [added: 93] | | |

| Total research and development expenses | | | $ | [removed: 4,845] [added: 4,543] | | | | | $ | [removed: 3,295] [added: 4,845] | | | | | $ | [removed: 1,991] [added: 3,295] | |

(1)Includes a total of [removed: 42] [added: 34] development candidates at December 31, [removed: 2023, 45] [added: 2024, 42] development candidates at December 31, [removed: 2022,] [added: 2023,] and [removed: 37] [added: 45] development candidates at December 31, [removed: 2021.][added: 2022.]

Program-specific expenses are reflected as of the beginning of the period in which the program was internally advanced to [removed: development or removed if development was ceased.][added: development.]

The program-specific expenses by [removed: modality] [added: therapeutic area] summarized in the table above include [removed: expenses we directly attribute to our programs, which consist primarily of] external [added: development] costs, such as fees paid to outside consultants, central laboratories, investigative sites, and CROs in connection with our preclinical studies and clinical [removed: trials, CMOs, and allocated manufacturing costs of pre-launch inventory, mRNA supply and consumables.][added: trials.]

These costs were therefore excluded from the summary of program-specific expenses by [removed: modality.][added: therapeutic area.]

[removed: Platform] [added: Discovery and platform] research expenses [removed: are mainly] [added: include] costs [removed: to develop] [added: associated with early-stage research activities for preclinical programs and the development of] technical advances in mRNA science, delivery science, and manufacturing process design.

We are developing medicines across four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics and rare disease therapeutics.

In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA® (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection.

This marks our second approved mRNA product and underscores our ongoing commitment to delivering solutions for patients by addressing global public health threats related to infectious diseases.

*Respiratory Vaccines*

During the fourth quarter of 2024, we achieved significant milestones in our respiratory vaccine portfolio.

We filed for regulatory approval with the FDA for our next-generation COVID vaccine (mRNA-1283), supported by positive Phase 3 efficacy and immunogenicity data, leveraging a priority review voucher, and have been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.

We also submitted a regulatory application for our respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), for high-risk adults aged 18 to 59, following positive Phase 3 data and using a priority review voucher, and have been assigned a PDUFA goal date of June 12, 2025.

Additionally, we filed for FDA approval of our flu+COVID combination vaccine (mRNA-1083), based on positive Phase 3 immunogenicity data in adults aged 50 years and older.

*Net Product Sales and Net (Loss) Earnings Per Share*

Loss per share was $(9.28) for the year ended December 31, 2024, compared to (loss) earnings per share of $(12.33) and $20.12 for the years ended December 31, 2023 and 2022, respectively.

*•Next-generation COVID vaccine:* We shared positive Phase 3 vaccine efficacy and immunogenicity data for our next-generation COVID vaccine (mRNA-1283) at our 2024 R&D Day event in September 2024.

We have filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher.

The FDA has accepted our Biologics License Application (BLA) for mRNA-1283 and has assigned a PDUFA goal date of May 31, 2025.

*•RSV vaccine:* We received regulatory approval of our RSV vaccine mRESVIA (mRNA-1345) for adults aged 60 years and older in 2024.

We shared positive Phase 3 data for mRNA-1345 in high-risk adults aged 18 to 59 at our 2024 R&D Day event and have since submitted an application to the FDA for regulatory approval using a priority review voucher, and have been assigned a PDUFA goal date of June 12, 2025.

- *Seasonal flu + COVID vaccine:* We shared positive Phase 3 immunogenicity data for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at our 2024 R&D Day event.

We have filed with the FDA for regulatory approval of mRNA-1083, which may require vaccine efficacy data from our ongoing Phase 3 seasonal flu vaccine study.

- *Seasonal flu vaccine:* We have shared positive Phase 3 immunogenicity and safety data for our seasonal flu vaccine (mRNA-1010).

We are conducting a two-season Phase 3 efficacy study (P304), where the timing of the efficacy readout depends on case accrual and could happen in the current season.

The Data Safety Monitoring Board (DSMB) met to review the initial study data and has informed us that the criterion for early efficacy was not met.

The DSMB recommended that the study continue as planned.

- *Norovirus vaccine:* The two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of our trivalent vaccine candidate against norovirus (mRNA-1403) is fully enrolled in the Northern Hemisphere and we are preparing second season enrollment in the Southern Hemisphere.

The trial is currently on FDA clinical hold following a single adverse event report of Guillain-Barré syndrome, which is currently under investigation.

We do not expect an impact on the study's efficacy readout timeline as enrollment in the Northern Hemisphere has already been completed.

The timing of the Phase 3 readout will be dependent on case accruals.

In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled.

Two Phase 3 studies for non-small cell lung cancer are enrolling.

A randomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is enrolling.

- *Propionic acidemia (PA) therapeutic:* In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, our investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria.

Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study.

We began generating registrational trial data in 2024.

*•Methylmalonic acidemia (MMA) therapeutic:* Our investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program.

We and the FDA have agreed on the pivotal study design.

We expect to start a registrational study in the first half of 2025.

In March 2024, we entered into a development and commercialization funding agreement with Blackstone Life Sciences (Blackstone) to advance our flu program.

As part of the agreement, Blackstone has committed up to $750 million in funding to support development efforts.

Blackstone will be eligible for low-single digit royalties and milestone payments based on cumulative net sales of

our future flu and combination vaccines, contingent upon regulatory approval in the U.S. and the success of the funded activities.

The funding is recognized as a reduction to the expenses of our flu program.

We will retain full rights and control of our flu program.

We are developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases, independently and with our strategic collaborators.

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.

*•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 potential efficacy data from the study in 2024.

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.

In February 2023, we entered into a strategic collaboration and license agreement with Life Edit Therapeutics Inc. (Life Edit) to collaborate on the discovery and development of *in vivo* mRNA gene editing therapies.

The partnership will combine Life Edit’s suite of proprietary gene editing technologies, including base editing, with our mRNA platform to advance *in vivo* gene editing therapies against a select set of therapeutic targets.

In March 2023, we entered into a strategic collaboration and license agreement with Generation Bio Co. (GBIO).

The collaboration aims to expand the application of each company’s platform by developing novel nucleic acid therapeutics, including those capable of reaching immune cells, to accelerate our respective pipelines of non-viral genetic medicines.

Under the agreement, we have the option to license GBIO’s proprietary cell-targeted lipid nanoparticle (ctLNP) and closed-ended DNA (ceDNA) technology for two immune cell programs and two liver programs, with an additional option for either a third immune cell or liver program.

In September 2023, we announced a strategic research and development collaboration agreement with Immatics, a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies.

Upon effectiveness of the agreement in October 2023, we made an upfront payment of $120 million to Immatics.

As of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] we had cash, cash equivalents, restricted cash, and investments in marketable securities of [removed: $13.3] [added: $9.5] billion and [removed: $18.2] [added: $13.3] billion, respectively.

If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, [removed: 2023,] [added: 2024,] the net fair value of our marketable securities would decrease by approximately [removed: $83] [added: $53] million.

For the year ended December 31, [removed: 2023,] [added: 2024,] our revenue generating activities and operations continued to be primarily denominated in U.S. dollars.

We enter into foreign currency forward contracts to hedge fluctuations associated with foreign currency denominated monetary assets and liabilities, primarily cash, [removed: accounts receivable, accounts payable] [added: receivables, payables] and lease liabilities in [removed: Euro, Swiss Franc] [added: the Australian dollar, Brazilian real, British pound,] and [removed: Japanese Yen,] [added: Canadian dollar,] that are not designated for hedge accounting treatment.

As of December 31, [removed: 2023,] [added: 2024,] our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than three months.

We enter into these foreign exchange contracts to hedge our [removed: forecasted revenue and] monetary assets and liabilities denominated in foreign currency in the normal course of business and accordingly, they are not speculative in nature.

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

As of December 31, [removed: 2023,] [added: 2024,] 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 [removed: $23] [added: $36] million.

However, we maintained a significant exposure to foreign currency risk, particularly in the Australian dollar, Brazilian real, British pound, and Canadian dollar markets.

As our business evolves, we have transitioned to receiving payments in local currencies rather than U.S. dollars.

In addition, we operate in foreign countries and are establishing manufacturing facilities in Canada, Australia, and the United Kingdom, where we also transact in foreign currencies.

Collectively, these factors expose us to risks associated with fluctuations in foreign currency exchange rates, which may impact our results of operations and cash flows.

To manage this exposure, we have focused on balance sheet hedging activities as part of our strategy to address foreign currency fluctuations.

While cash flow hedging programs are in place, there were no foreign currency cash flow hedging activities during 2024.

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 was the equivalent of $1.4 billion in Japanese Yen and $518 million in Euros for 2023.

As we pursue our international expansion strategy, our results of operations and cash flows remain subject to fluctuations in foreign currency exchange rates.

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

*Cash Flow Hedging Activities*

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.

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

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 believe the counterparties to

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 [removed: COVID-19] [added: COVID] vaccines.

Our mRNA platform has enabled the development of [added: medicines across four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology] therapeutics and [removed: vaccines for infectious diseases, immuno-oncology,] rare [removed: diseases and autoimmune diseases.][added: disease therapeutics.]

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

SARS-CoV-2, the virus that causes COVID-19, continues to [removed: evolve] [added: evolve,] and in 2023, the [removed: COVID-19] [added: COVID] vaccine market [removed: transitioned] [added: shifted from a pandemic] to an endemic, seasonal commercial market.

][added: (26).jpg](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/mrna-20241231_g2.jpg)]

[removed: ][added: ]

Our [removed: ability to rapidly develop, manufacture] [added: success in developing, manufacturing] and [removed: commercialize] [added: commercializing] vaccines against COVID-19 [added: and RSV] demonstrates the potential [added: of] mRNA medicines [removed: have] to help people and patients in far-reaching ways that could exceed the impact of traditional approaches to medicine.

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

Our [removed: COVID-19] [added: COVID] vaccine has helped hundreds of millions of people worldwide combat COVID-19.

[added: 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.

[removed: Our vision for harnessing] [added: Harnessing] the power of mRNA through modalities

Each novel delivery system is a new application, [removed: which we call] [added: called] a “modality.” While the programs within a modality may target diverse diseases, they share similar mRNA characteristics and manufacturing processes to achieve shared product features.

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

Over the last decade, we have advanced in parallel a diverse development pipeline that currently consists of [removed: 45] [added: 44] therapeutic and vaccine programs, [removed: nine] [added: eleven] of which are in late-stage development.

Portfolio-wide considerations include the ability to demonstrate technical success for our platform components within a modality, thereby increasing the probability of success and learnings for subsequent [removed: programs in the modality and in some cases in other modalities.][added: programs.]

[removed: ][added: ]

Our full [removed: pipeline, grouped by modalities,] [added: pipeline] is shown in the figure below:

][added: 4Q24_02142025_KS.jpg](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/mrna-20241231_g5.jpg)]

[removed: Infectious disease vaccines: Vaccines] [added: Vaccines] against [removed: respiratory] [added: latent] viruses

[removed: COVID-19] [added: COVID] vaccines [removed: (mRNA-1273/Spikevax®,] [added: (Spikevax/mRNA-1273,] next-generation mRNA-1283)

[removed: Our COVID-19 vaccine] [added: As the SARS-CoV-2 virus] continues to [added: evolve, Spikevax continues to] be a key tool in fighting [removed: COVID-19 as the SARS-CoV-2 virus evolves.][added: COVID-19.]

As part of our strategy to [added: continue to] combat [removed: the virus,] [added: COVID-19,] we [removed: have continued to] develop and assess variant-specific versions of our [removed: COVID-19] [added: COVID] vaccine.

We developed [removed: mRNA-1273.815] [added: JN.1 and KP.2 formulations of mRNA-1273] in accordance with regulatory guidance, with the goal of broadening vaccine-induced immunity and providing protection against circulating SARS-CoV-2 [removed: XBB lineage] variants.

We have also observed preliminary clinical trial data showing that [removed: mRNA-1273.815 generates] [added: these vaccines generate] a robust immune response [added: (cross-neutralization)] against [removed: other] [added: currently circulating] variants of SARS-CoV-2.

The FDA has approved [removed: mRNA-1273.815] [added: Spikevax] for individuals [removed: ages] 12 years and older, and granted Emergency Use Authorization for individuals [added: aged] six months through 11 [removed: years of age.][added: years.]

[removed: mRNA-1273.815] [added: Spikevax] has also been authorized for individuals six months and older in other key markets, including the [removed: EU,] [added: European Union (EU),] Canada and Japan.

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

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

Our goal with mRNA-1283 is to facilitate easier distribution and administration by healthcare [removed: providers.][added: providers, as it is designed to have enhanced stability in refrigerated conditions and packaged in pre-filled syringes.]

[removed: Further, as] [added: As] SARS-CoV-2 evolves, we continue to perform continuous epidemiological monitoring, genomic surveillance and risk assessments of variants of concern to determine which new variants may have the ability to circumvent immunity provided by currently approved [removed: COVID-19] [added: COVID] vaccines.

RSV vaccine [removed: (mRNA-1345)][added: (mRESVIA/mRNA-1345)]

[removed: mRNA-1345] [added: Key findings from the main study showed that mRNA-1893] was generally [removed: well-tolerated] [added: safe and well tolerated,] with no [added: new] safety concerns identified.

We have additional Phase 3 studies [removed: ongoing] [added: that have generated data] in adults to explore co-administration with licensed flu or [removed: COVID-19] [added: COVID] vaccines, revaccination with [removed: mRNA-1345] [added: mRNA-1345,] and expansion to adults aged 18 and older who are [removed: at high risk for severe RSV disease.][added: immunocompromised due to solid organ transplant.]

In pediatrics, mRNA-1345 [removed: is] [added: has] ongoing [added: safety follow up] in Phase 1 and Phase 2 studies, and we are conducting a Phase 2 study in maternal populations.

Combination vaccines [removed: (mRNA-1083, mRNA-1230, mRNA-1045] [added: (mRNA-1083] and mRNA-1365)

We are developing combination vaccine candidates to [removed: protect] [added: simplify and facilitate protection] against a range of respiratory diseases.

mRNA-1083, our next-generation [removed: COVID-19] [added: COVID] and seasonal influenza combination vaccine, encodes the same antigens as our [removed: first-generation] [added: updated] seasonal influenza vaccine (mRNA-1010) and our next-generation [removed: COVID-19] [added: COVID] vaccine (mRNA-1283).

We [removed: are also conducting Phase 1 studies for] [added: have discontinued development of] mRNA-1230, our [removed: COVID-19,] [added: first-generation COVID,] seasonal flu and RSV combination vaccine, and mRNA-1045, our seasonal flu and RSV combination vaccine.

[removed: Infectious disease vaccines: Vaccines] [added: Vaccines] against [removed: latent] [added: enteric] viruses

[removed: Human cytomegalovirus (CMV)] [added: CMV] is a common human pathogen and member of the herpes virus family.

Through the advancement of mRNA technology, we are reimagining how medicines are made and transforming how we treat and prevent disease for everyone.

In 2024, we became a multi-product company with the approval of our second commercial product, mRESVIA, our mRNA respiratory syncytial virus (RSV) vaccine for older adults.

In 2024, we achieved net product sales of $3.1 billion, largely from sales of Spikevax.

Beyond our commercial products, we continue to demonstrate the potential of our platform technology.

In 2024, we shared four positive Phase 3 data readouts across our respiratory portfolio—for our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, our seasonal flu+COVID combination vaccine and our seasonal flu vaccine.

In the area of oncology therapeutics, we continue to demonstrate the potential clinical benefit of our individualized neoantigen therapy (INT) (mRNA-4157), which is being developed in collaboration with Merck.

We and Merck have rapidly expanded clinical studies to several tumor types and completed enrollment of the Phase 3 clinical trial for adjuvant melanoma in 2024.

Additionally, in 2024, we also took steps to move two of our rare disease therapeutics programs—targeting propionic acidemia (PA) and methylmalonic acidemia (MMA)—toward registrational trials.

We also achieved milestones in our latent and other vaccines franchise, including the initiation of a Phase 3 study of our norovirus vaccine.

Our success in research and development is a testament to our platform.

Moving forward, we are taking a paced approach to our research and development investment.

We entered 2025 with a focus on a prioritized portfolio addressing our four franchises where there is unmet need.

Beyond COVID, our platform continues to be highly productive, with our RSV vaccine representing our second commercial product and eleven programs in late-stage development.

We are currently focused on three strategic priorities:

1.Driving use of Spikevax and mRESVIA. Spikevax and mRESVIA are the foundation of our respiratory vaccine portfolio and we expect to participate in the full contracting season in the United States for both in 2025 for the first time.

We will continue to work with all market channels to maximize the availability of Spikevax.

Internationally, we plan to bring manufacturing plants online in Australia, Canada and the United Kingdom (UK) in 2025, subject to execution of manufacturing plant licensures.

With a full season of RSV contracting in 2025, our goal is to increase mRESVIA’s market share in the United States and market access globally.

2.Focusing on ten product approvals over the next three years to drive sales growth. Our prioritized programs span our four franchises: respiratory, latent and other virus, oncology and rare diseases.

We expect execution of this priority to drive

sales growth and fund our next wave of research and development investment.

For nine of these programs, we have near-term milestones, including up to three potential 2025 approvals for our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older.

We also anticipate up to six upcoming registrational data readouts for our cytomegalovirus (CMV), seasonal flu, norovirus, INT for adjuvant melanoma, PA and MMA product candidates.

3.Delivering cost efficiency across the business. We plan to continue improving efficiency by further reducing our research and development and selling, general and administrative expenses in 2025.

By 2027, we expect to decrease annual research and development expenses by approximately $1.0 billion compared to 2024.

On cost of sales, we will work to continue to drive efficiency through manufacturing productivity improvements to achieve operating leverage.

The scope of our pipeline reflects the breadth of biology addressable using mRNA technology, and spans four franchises: respiratory virus vaccines, latent and other vaccines, oncology therapeutics, and rare disease therapeutics.

We are currently focusing our efforts on delivering up to ten prioritized products over the next three years to drive sales growth and fund the next wave of research and development investment.

RESPIRATORY FRANCHISE

We have two commercial respiratory virus vaccines—Spikevax (our COVID vaccine) and mRESVIA (our RSV vaccine for older adults).

Additionally, we have achieved four positive Phase 3 data readouts for our next-generation COVID vaccine (mRNA-1283), our RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), our seasonal flu+COVID vaccine (mRNA-1083), and our seasonal flu vaccine (mRNA-1010).

We have a total of 15 respiratory programs in our current portfolio, summarized below.

Spikevax is approved for use in jurisdictions globally.

In August and September 2024, we received regulatory approvals in major markets for our updated COVID vaccine, targeting the JN.1 (mRNA-1273.167) and KP.2 (mRNA-1273.712) subvariants of SARS-CoV-2, based on the new variant composition requests from different public health bodies.

In June 2024, we announced positive Phase 3 efficacy data for our next-generation COVID vaccine, mRNA-1283.

In September 2024, we shared additional data for mRNA-1283, which included non-inferior relative vaccine efficacy (rVE) compared to Spikevax.

We filed for FDA approval for mRNA-1283 in 2024 using a priority review voucher, and have been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.

In May 2024, we announced the FDA approved mRNA-1345, brand name mRESVIA, for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults 60 years or older.

Subsequently, the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for all unvaccinated people aged 75 years and older and unvaccinated people aged 60 to 74 who are at increased risk for RSV to receive the vaccine for the prevention of RSV-associated LRTD and acute respiratory disease.

mRESVIA was approved in

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.

Table of Contents

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:

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

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.

2.Advance multiple latent virus and other vaccines. We are developing vaccines against latent and other viruses with unmet or underserved needs, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV), varicella zoster virus (VZV), norovirus, HIV and Lyme disease.

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

OUR MODALITIES

Our current modalities

Our current modalities are described below.

More detail regarding our current programs in each modality is provided below under “—Our Pipeline.”

- Infectious disease 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 enteric viruses, as well as bacterial vaccines and public health vaccines.

We believe mRNA vaccines have several advantages, including the ability to mimic many aspects of various infections, the ability to combine antigens for compelling product profiles, the rapid discovery and advancement of programs into the clinic and the capital efficiency and speed from shared manufacturing processes and infrastructure.

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

Our cancer 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.

These neoantigens can either be unique to a patient or can be related to a driver oncogene found across subsets of patients.

Recent breakthroughs in cancer immunotherapy, such as checkpoint inhibitors and chimeric antigen receptor T cell therapies, have demonstrated that powerful antitumor responses can be achieved by activating antigen specific T cells.

We believe one approach to improve the efficacy of checkpoint inhibitors is to develop vaccines that increase both the number and antitumor activity of a patient’s T cells that recognize tumor neoantigens.

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

In August 2022, we filed a lawsuit in the U.S. District Court for the District of Massachusetts against Pfizer Inc. (Pfizer) and BioNTech SE, BioNTech Manufacturing GmbH and BioNTech US Inc. (collectively, BioNTech), asserting infringement of certain U.S. patents concerning our mRNA platform technology and disease-specific vaccine designs in Pfizer and BioNTech’s manufacture and sale of their mRNA [removed: COVID-19] [added: COVID] vaccines.

Also in August 2022, we initiated patent infringement proceedings in Germany (in the Dusseldorf Regional Court), the Netherlands (in the District Court of The Hague) and the UK (in the High Court of Justice of England & Wales) against Pfizer, BioNTech and [removed: related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.]

In February 2022, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our [removed: COVID-19] [added: COVID] vaccine willfully infringes certain U.S. patents concerning lipid nanoparticles.

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

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

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

The case has been stayed pending the outcome of two Inter Partes Proceedings (IPRs) pending before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) regarding the validity of two of the three asserted patents in this lawsuit.

The PTAB is expected to issue a decision on the IPRs on or before March 6, 2025, which would be subject to appeal.

related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.

There are two patents at issue in the European patent infringement proceedings–EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA and EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines.

In July 2024, the High Court of Justice of England & Wales issued a judgment confirming the validity of the ‘949 patent and finding that Pfizer and BioNTech had infringed the patent.

The court further determined that the ‘565 patent was invalid.

The High Court’s decision related to the ‘949 patent is subject to appeal.

In December 2023, the District Court of The Hague issued a first instance decision determining that the ‘949 patent was invalid in the Netherlands.

Moderna has appealed this decision to the Court of Appeal of The Hague, with a second instance decision expected in 2025.

In addition, there remain ongoing Opposition Proceedings at the European Patent Office by a number of opponents, including Pfizer and BioNTech related to these two patents.

The Court has set trial to begin September 24, 2025, subject to the Court’s availability.

*Proceedings Related to Patents Owned by GSK*

COVID-19 Vaccines

In October 2024, GlaxoSmithKline Biologicals SA (GSK) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccines infringe certain U.S. patents directed to lipid-mRNA vaccine formulation technology.

The complaint seeks a judgment of infringement of the asserted patents and unspecified damages, but does not seek injunctive relief.

RSV Vaccine

Also in October 2024, GSK filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our RSV vaccine infringes certain U.S. patents directed to lipid-mRNA vaccine formulation technology.

The complaint seeks a judgment of infringement of the asserted patents, unspecified damages and injunctive relief in the United States.

*Proceedings Related to Patents Owned by Northwestern University*

In October 2024, Northwestern University filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our COVID and RSV vaccines infringe several U.S. patents concerning lipid nanoparticle technology.

The complaint seeks a judgment of infringement of the asserted patents and unspecified damages.

The complaint does not seek injunctive relief.

*Securities Class Action Litigation*

In August 2024, a putative shareholder class action complaint was filed against the Company and certain officers in the U.S. District Court for the District of Massachusetts.

The action is purportedly brought on behalf of a class of shareholders who purchased Moderna common stock between January 18, 2023 and June 25, 2024.

The complaint asserts claims under the Securities Exchange Act of 1934 regarding statements about our RSV vaccine (mRNA-1345) and seeks unspecified damages.

*Derivative Litigation*

Between September and November 2024, purported shareholder derivative complaints were filed in the U.S. District Court for the District of Massachusetts against certain of our officers and directors and against the Company as a nominal defendant.

The complaints allege breaches of fiduciary duty and claims under the Securities Exchange Act of 1934 regarding statements about mRNA-1345 and seek declaratory and injunctive relief and unspecified damages payable to us.

In November 2023, the District Court entered an order of partial dismissal with respect to two of the patents at issue.

Subsequently, in October 2024, the District Court entered a final judgment of non-infringement in our favor with respect to the third patent at issue.

The decision is subject to appeal.

intellectual property litigation described below.

For the fiscal year ended December 31, [removed: 2023][added: 2024]

[removed: ][added: ]

[removed: Shares] [added: This excludes shares] of common stock held by each executive officer and director and by each other person who may be deemed to be an affiliate of the [removed: Registrant have been excluded from this computation.][added: registrant.]

As of February [removed: 16, 2024,] [added: 14, 2025,] there were [removed: 382,073,208] [added: 385,815,877] 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: 2024] [added: 2025] 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: [6](#i9d825fa259284f989c73122fe917c977_19)] [added: [6](#i936f1894ad9e4b3c8b6c404bf64d47b3_19)] | | |

| Item 1A. | | | Risk Factors | | | [removed: [46](#i9d825fa259284f989c73122fe917c977_2079)] [added: [45](#i936f1894ad9e4b3c8b6c404bf64d47b3_73)] | | |

| Item 1B. | | | Unresolved Staff Comments | | | [removed: [79](#i9d825fa259284f989c73122fe917c977_79)] [added: [77](#i936f1894ad9e4b3c8b6c404bf64d47b3_82)] | | |

| Item 1C. | | | Cybersecurity | | | [removed: [79](#i9d825fa259284f989c73122fe917c977_2072)] [added: [77](#i936f1894ad9e4b3c8b6c404bf64d47b3_85)] | | |

| Item 2. | | | Properties | | | [removed: [80](#i9d825fa259284f989c73122fe917c977_82)] [added: [78](#i936f1894ad9e4b3c8b6c404bf64d47b3_88)] | | |

| Item 3. | | | Legal Proceedings | | | [removed: [80](#i9d825fa259284f989c73122fe917c977_85)] [added: [78](#i936f1894ad9e4b3c8b6c404bf64d47b3_91)] | | |

| Item 4. | | | Mine Safety Disclosures | | | [removed: [81](#i9d825fa259284f989c73122fe917c977_88)] [added: [80](#i936f1894ad9e4b3c8b6c404bf64d47b3_94)] | | |

| Item 5. | | | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | | [removed: [82](#i9d825fa259284f989c73122fe917c977_94)] [added: [81](#i936f1894ad9e4b3c8b6c404bf64d47b3_100)] | | |

| Item 6. | | | \[Reserved\] | | | [removed: [83](#i9d825fa259284f989c73122fe917c977_97)] [added: [82](#i936f1894ad9e4b3c8b6c404bf64d47b3_106)] | | |

| Item 7. | | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | | [removed: [84](#i9d825fa259284f989c73122fe917c977_100)] [added: [83](#i936f1894ad9e4b3c8b6c404bf64d47b3_109)] | | |

| Item 7A. | | | Quantitative and Qualitative Disclosures about Market Risk | | | [removed: [99](#i9d825fa259284f989c73122fe917c977_109)] [added: [96](#i936f1894ad9e4b3c8b6c404bf64d47b3_121)] | | |

| Item 8. | | | Financial Statements and Supplementary Data | | | [removed: [101](#i9d825fa259284f989c73122fe917c977_112)] [added: [97](#i936f1894ad9e4b3c8b6c404bf64d47b3_124)] | | |

| Item 9. | | | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | | [removed: [140](#i9d825fa259284f989c73122fe917c977_208)] [added: [137](#i936f1894ad9e4b3c8b6c404bf64d47b3_238)] | | |

| Item 9A. | | | Controls and Procedures | | | [removed: [141](#i9d825fa259284f989c73122fe917c977_211)] [added: [137](#i936f1894ad9e4b3c8b6c404bf64d47b3_241)] | | |

| Item 9B. | | | Other Information | | | [removed: [143](#i9d825fa259284f989c73122fe917c977_214)] [added: [139](#i936f1894ad9e4b3c8b6c404bf64d47b3_244)] | | |

| Item 9C. | | | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | | [removed: [143](#i9d825fa259284f989c73122fe917c977_217)] [added: [139](#i936f1894ad9e4b3c8b6c404bf64d47b3_250)] | | |

| Item 10. | | | Directors, Executive Officers and Corporate Governance | | | [removed: [144](#i9d825fa259284f989c73122fe917c977_223)] [added: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_256)] | | |

| Item 11. | | | Executive Compensation | | | [removed: [144](#i9d825fa259284f989c73122fe917c977_226)] [added: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_259)] | | |

| Item 12. | | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | | [removed: [144](#i9d825fa259284f989c73122fe917c977_229)] [added: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_262)] | | |

| Item 13. | | | Certain Relationships and Related Transactions, and Director Independence | | | [removed: [144](#i9d825fa259284f989c73122fe917c977_232)] [added: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_265)] | | |

| Item 14. | | | Principal Accountant Fees and Services | | | [removed: [144](#i9d825fa259284f989c73122fe917c977_235)] [added: [140](#i936f1894ad9e4b3c8b6c404bf64d47b3_268)] | | |

| Item 15. | | | Exhibits, Financial Statement Schedules | | | [removed: [145](#i9d825fa259284f989c73122fe917c977_241)] [added: [141](#i936f1894ad9e4b3c8b6c404bf64d47b3_274)] | | |

| Item 16. | | | Form 10-K Summary | | | [removed: [148](#i9d825fa259284f989c73122fe917c977_244)] [added: [143](#i936f1894ad9e4b3c8b6c404bf64d47b3_277)] | | |

- The [added: vaccine market, and] pharmaceutical market [added: more generally,] is intensely competitive, and we may not compete effectively in the market for existing [removed: products,] [added: or] new [added: products,] treatment methods [removed: and new] [added: or] technologies;

- We may be unsuccessful or delayed in updating our [removed: COVID-19] [added: COVID] vaccine to protect against future variants of the SARS-CoV-2 [removed: virus, and updated versions of our COVID-19 vaccine may not protect against such variants;][added: virus;]

- The commercial success of our products [removed: will depend] [added: depends] on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community;

- If we cannot obtain, or are delayed in obtaining, [removed: required] regulatory [removed: approvals,] [added: approvals and advisory committee recommendations,] we will be unable to commercialize, or will be delayed in commercializing, [added: our] product [removed: candidates we may develop;][added: candidates;]

[added: -] We or our third-party manufacturers may encounter difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management or shipping for any of our products;

- Our 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: producing INT;][added: production;]

- We are dependent on single-source suppliers for some of the components and materials used in, and the [added: manufacturing] processes required to [removed: develop,] [added: develop and commercialize,] our products and product candidates;

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

If these [removed: strategic] alliances are [removed: not successful,] [added: unsuccessful,] our business could be adversely affected;

- We incurred net losses in [removed: 2023] [added: 2024] and [removed: we are likely] [added: 2023, and expect] to incur [added: additional] losses [removed: again] in the future; we have a limited history of recognizing revenue from product sales and may [removed: be unable to] [added: note] achieve long-term sustainable profitability;

- The price of our common stock has been volatile, which could result in substantial losses for [removed: stockholders.][added: shareholders.]

- our expectations regarding the [removed: evolution] [added: size and durability] of the [removed: endemic,] commercial [removed: COVID-19 vaccine market] [added: COVID] and [added: RSV vaccines markets and] future demand for [removed: COVID-19 vaccines;][added: and sales of our products;]

| 325 Binney Street Cambridge, Massachusetts | | | | | | 02142 | | |

The aggregate market value of voting stock held by non-affiliates of the registrant, computed by reference to the closing price as of the last business day of the registrant's most recently completed second fiscal quarter, was approximately $42.1 billion.

The registrant has no non-voting common stock.

| Signatures | | | | | | [144](#i936f1894ad9e4b3c8b6c404bf64d47b3_280) | | |

- Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines, and respiratory vaccines more generally, have in the past impacted and are likely to continue to impact our financial results;

- We have experienced commercial challenges and are likely to experience additional challenges in the future;

- We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts;

- The market opportunities for our products and product candidates may be smaller than we believe, or we may be unable to successfully identify clinical trial participants;

- Our products are, and any future products will be, subject to regulatory scrutiny;

- Our quarterly and annual operating results may fluctuate.

As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline;

- our ability to drive use of Spikevax and mRESVIA and to increase market share;

- our focus on ten product approvals over the next three years;

- our ability to delivery cost efficiency across our business;

- the potential and timing for future data readouts, regulatory filings, regulatory approvals and commercial launches;

- the buildout of our manufacturing and commercial operations, including our expectations regarding the completion and licensing of manufacturing facilities in Australia, Canada and the United Kingdom;

| 200 Technology Square Cambridge, Massachusetts | | | | | | 02139 | | |

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

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

- Evolving dynamics in the market for COVID-19 vaccines are likely to impact our financial results, which are likely to result in lower product revenues in 2024 than we have experienced in recent years;

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

- We have limited sales, distribution and marketing experience and may be unable to effectively establish such capabilities or supplement our capabilities by entering into agreements with third parties;

- Preclinical development is lengthy and uncertain, especially for mRNA medicines, and our preclinical programs or product candidates may be delayed or terminated;

- Our mRNA products and product candidates are based on novel technologies and are complex and difficult to manufacture.

- 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 sales of our COVID-19 vaccine in 2024 and beyond;

- the potential launch, following regulatory approvals, of our respiratory syncytial virus (RSV) vaccine for adults in the first half of 2024, as well as additional respiratory product launches in 2024 and 2025;

- the durability of our individualized neoantigen therapy (INT) candidate, the ability of our INT candidate to address different types of cancer, our Phase 3 clinical trials in adjuvant melanoma and non-small cell lung cancer (NSCLC) and our plans to rapidly expand to additional tumor types;

- 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;

- our ability to obtain and maintain regulatory approval for our products;

- the buildout of our manufacturing and commercial operations, including our partnerships with various governments to establish mRNA vaccine manufacturing facilities;

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

Our CISO reports directly to our [removed: CIO,] [added: Chief People and Digital Technology Officer,] who is a member of our Executive Committee and reports to our Chief Executive Officer.

This building, spanning approximately 462,000 square feet, is designated as our [removed: new] Moderna Science Center (MSC).

The MSC [removed: will accommodate] [added: accommodates] a combination of scientific and office spaces, including our principal executive offices.

The [removed: Cambridge] [added: MSC] campus is the location of our corporate headquarters, platform, drug discovery and clinical development.

The MTC campus is approximately [removed: 686,000] [added: 722,000] square feet which includes lab and office space, directly supporting our manufacturing capabilities and commercial and clinical activities.

Upon completion, the facility will [removed: feature office and] [added: have state-of-the-art] mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, [added: and] a just-in-time satellite [removed: warehouse, and additional office spaces.][added: warehouse.]

As of December 31, 2024, we have substantially exited our leased spaces at Technology Square in Cambridge, Massachusetts, completing the consolidation of our Cambridge operations into the MSC.

In December 2024, we completed the acquisition of the MTC campus, including the underlying land and buildings.

This acquisition transitioned the facilities from leased to owned properties, providing greater operational flexibility and long-term stability in supporting our manufacturing and development capabilities.

In September 2024, we completed our manufacturing facility in Laval, Quebec, Canada, which received a Drug Establishment License (DEL) from Health Canada.

This certification enables the facility to produce drug substance and positions it to manufacture mRNA vaccines, including COVID, RSV, and seasonal influenza, contingent on Health Canada’s approval, starting in 2025.

The site strengthens our global manufacturing capabilities and supports the Government of Canada’s pandemic readiness and vaccine supply objectives.

We expect to begin a phased move-in process starting in early 2024.

Additionally, we occupy a multi-building campus at Technology Square in Cambridge, Massachusetts, consisting of a mix of offices and research laboratory space, totaling approximately 292,000 square feet.

The lease will expire in early 2025.

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

The following graph illustrates a comparison for the five years ended December 31, [removed: 2023] [added: 2024] of the cumulative total return for our common stock, the Nasdaq Biotechnology Index, and the Standard & Poor’s 500 Stock Index (the S&P 500) each of which assumes an initial investment of $100 and reinvestment of all dividends.

[removed: ][added: ]

We had approximately [removed: 75] [added: 63] stockholders of record as of February [removed: 16, 2024.][added: 14, 2025.]

During the three months ended December 31, [removed: 2023,] [added: 2024,] there were no shares repurchased.

As of December 31, [removed: 2023,] [added: 2024,] $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock [removed: remains] [added: remained] outstanding, with no expiration date.

Refer to [Note [removed: 12](#i9d825fa259284f989c73122fe917c977_181)] [added: 12](#i936f1894ad9e4b3c8b6c404bf64d47b3_199)] to consolidated financial statements for information regarding our share repurchase programs.

| [Report of Independent Registered Public Accounting [removed: Firm](#i9d825fa259284f989c73122fe917c977_115)] [added: Firm](#i936f1894ad9e4b3c8b6c404bf64d47b3_127)] | | | | | | [removed: [102](#i9d825fa259284f989c73122fe917c977_115)] [added: [98](#i936f1894ad9e4b3c8b6c404bf64d47b3_127)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2023] [added: 2024] and [removed: 2022](#i9d825fa259284f989c73122fe917c977_118)] [added: 2023](#i936f1894ad9e4b3c8b6c404bf64d47b3_130)] | | | | | | [removed: [104](#i9d825fa259284f989c73122fe917c977_118)] [added: [100](#i936f1894ad9e4b3c8b6c404bf64d47b3_130)] | | |

| [Consolidated Statements of Operations for the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021](#i9d825fa259284f989c73122fe917c977_121)] [added: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_133)] | | | | | | [removed: [105](#i9d825fa259284f989c73122fe917c977_121)] [added: [101](#i936f1894ad9e4b3c8b6c404bf64d47b3_133)] | | |

| [Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021](#i9d825fa259284f989c73122fe917c977_124)] [added: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_136)] | | | | | | [removed: [106](#i9d825fa259284f989c73122fe917c977_124)] [added: [102](#i936f1894ad9e4b3c8b6c404bf64d47b3_136)] | | |

| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021](#i9d825fa259284f989c73122fe917c977_127)] [added: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_139)] | | | | | | [removed: [107](#i9d825fa259284f989c73122fe917c977_127)] [added: [103](#i936f1894ad9e4b3c8b6c404bf64d47b3_139)] | | |

| [Consolidated Statements of Cash Flows for the years ended December 31, [added: 2024,] 2023, [removed: 2022,] and [removed: 2021](#i9d825fa259284f989c73122fe917c977_130)] [added: 2022](#i936f1894ad9e4b3c8b6c404bf64d47b3_142)] | | | | | | [removed: [109](#i9d825fa259284f989c73122fe917c977_130)] [added: [105](#i936f1894ad9e4b3c8b6c404bf64d47b3_142)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i9d825fa259284f989c73122fe917c977_133)] [added: Statements](#i936f1894ad9e4b3c8b6c404bf64d47b3_145)] | | | | | | [removed: [110](#i9d825fa259284f989c73122fe917c977_133)] [added: [106](#i936f1894ad9e4b3c8b6c404bf64d47b3_145)] | | |

We have audited the accompanying consolidated balance sheets of Moderna, Inc. (the Company) as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: 2023,] [added: 2024,] 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: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] 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: 2023,] [added: 2024,] 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: 23, 2024,] [added: 21, 2025,] expressed an unqualified opinion thereon.

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

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

The communication of [added: the] critical audit [removed: matters] [added: matter] 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: matters] [added: matter] below, providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or [removed: disclosures] [added: disclosure] to which [removed: they relate.][added: it relates.]

| | | | | | | [removed: Reserves] [added: Provisions] for returns on product [removed: revenue] [added: sales] | | |

| *Description of the Matter* | | | | | | During the year ended December 31, [removed: 2023,] [added: 2024,] the Company’s net product [removed: revenues for Spikevax] [added: sales] were [removed: $6.7] [added: $3.1] billion. As explained in Note 2 of the consolidated financial statements, revenue from product sales includes estimates of variable consideration for which [removed: reserves] [added: provisions] are established, including [removed: reserves] [added: provisions] for product [added: sales] returns. Auditing the Company’s measurement of [removed: reserves] [added: provisions] for product [added: sales] 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 [removed: reserves] [added: provisions] for returns on product [removed: revenue.] [added: sales.] 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 [removed: reserves] [added: provisions] for returns on product [removed: revenue,] [added: sales,] 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 [removed: reserves.] [added: provisions.] 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 [removed: contracts.] [added: contracts, and assessed the historical accuracy of management’s estimate.] 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. | | |

| | | | [added: 2024 | | | | | |] 2023 | | | | | | 2022 | | |

| Cash and cash equivalents | | | [added: | | |] $ | [added: 1,927 | | | | | $ |] 2,907 | | | | | $ | 3,205 | |

| Investments | | | [removed: 5,697] [added: 5,098] | | | | | | [removed: 6,697] [added: 5,697] | | |

| Accounts receivable, net | | | [removed: 892] [added: 358] | | | | | | [removed: 1,385] [added: 892] | | |

| Inventory | | | [removed: 202] [added: 117] | | | | | | [removed: 949] [added: 202] | | |

| Prepaid expenses and other current assets | | | [removed: 627] [added: 599] | | | | | | [removed: 1,195] [added: 627] | | |

| Total current assets | | | [removed: 10,325] [added: 8,099] | | | | | | [removed: 13,431] [added: 10,325] | | |

| Investments, non-current | | | [removed: 4,677] [added: 2,494] | | | | | | [removed: 8,318] [added: 4,677] | | |

| Property, plant and equipment, net | | | [removed: 1,945] [added: 2,196] | | | | | | [removed: 2,018] [added: 1,945] | | |

| Right-of-use assets, operating leases | | | [removed: 713] [added: 759] | | | | | | [removed: 121] [added: 713] | | |

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

| Other non-current assets | | | [removed: 685] [added: 594] | | | | | | [removed: 988] [added: 766] | | |

| Total assets | | | $ | [removed: 18,426] [added: 14,142] | | | | | $ | [removed: 25,858] [added: 18,426] | |

| Accounts payable | | | $ | [removed: 520] [added: 405] | | | | | $ | [removed: 487] [added: 520] | |

| Accrued liabilities | | | [removed: 1,798] [added: 1,427] | | | | | | [removed: 2,101] [added: 1,798] | | |

| Deferred revenue | | | [removed: 568] [added: 153] | | | | | | [removed: 2,038] [added: 568] | | |

| Income taxes payable | | | [removed: 63] | | | [added: 3] | | | [removed: 48] | | | [added: 63 | | |]

[removed: | Other current liabilities | | | 66 | | | | | | 249 | | |][added: Other Non-Current Liabilities]

| Total current liabilities | | | [removed: 3,015] [added: 2,206] | | | | | | [removed: 4,923] [added: 3,015] | | |

| Deferred revenue, non-current | | | [removed: 83] [added: 58] | | | | | | [removed: 673] [added: 83] | | |

| Operating lease liabilities, non-current | | | [removed: 643] [added: 671] | | | | | | [removed: 92] [added: 643] | | |

| Financing lease liabilities, non-current | | | [removed: 575] [added: 39] | | | | | | [removed: 912] [added: 575] | | |

| Other non-current liabilities | | | [removed: 256] [added: 267] | | | | | | [removed: 135] [added: 256] | | |

| Total liabilities | | | [removed: 4,572] [added: 3,241] | | | | | | [removed: 6,735] [added: 4,572] | | |

February 21, 2025

| Net (loss) income | | | $ | (3,561) | | | | | $ | (4,714) | | | | | $ | 8,362 | |

| Losses on foreign currency translation | | | (8) | | | | | | — | | | | | | — | | |

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

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

| Net loss | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (3,561) | | | | | | (3,561) | | |

| Balance at December 31, 2024 | | | | | | | | | | | | | | | | | | | | | 386 | | | | | | $ | — | | | | | $ | 866 | | | | | $ | (10) | | | | | $ | 10,045 | | | | | $ | 10,901 | |

| Net (loss) income | | | $ | (3,561) | | | | | $ | (4,714) | | | | | $ | 8,362 | |

We are developing medicines across four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics and rare disease therapeutics.

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA® (mRNA-1345), our mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.

Deferred tax assets, previously presented as a separate line item in our 2023 Form 10-K, are presented within other non-current assets in the consolidated balance sheets.

Income taxes payable, previously presented as a separate line item in our 2023 Form 10-K, is presented within other current liabilities in the consolidated balance sheets.

The Company operates as a single operating and reportable segment, reflecting the integrated nature of our business focused on the research, development, and commercialization of mRNA-based medicines.

Our Chief Executive Officer serves as the Chief Operating Decision Maker (CODM), responsible for assessing the Company's performance and making resource allocation decisions.

The CODM evaluates financial information on a consolidated basis, focusing on key metrics such as total revenue, operating expenses, and net income or loss.

The CODM allocates resources based on the Company's available cash resources, forecasted cash flow, and expenditures on a consolidated basis, as well as an assessment of the probability of success of its research and development activities.

Resource allocation decisions are informed by budgeted and forecasted expense information, along with actual expenses incurred to

date.

Disaggregated profit or loss information at the program or functional level is not regularly provided to or relied upon by the CODM, as our integrated operating model emphasizes shared resources and centralized decision-making.

The interdependent nature of our research, development, and commercialization activities, supported by common infrastructure such as our mRNA platform, makes further disaggregation of expenses less meaningful for assessing performance.

We also commenced sales of our RSV vaccine in the third quarter of 2024.

*Government rebates and other fees*

In 2024, we began recognizing Medicare rebates associated with our RSV product.

The estimation of Medicare rebates requires judgment and is based on historical utilization trends, and the mix of customers and payers.

The estimated liability for unpaid or unbilled rebates is presented as accrued liabilities on our consolidated balance sheets.

For 2024, the product sales subject to Medicare rebates were immaterial.

While we now have one year of data on our product returns, this remains insufficient to establish reliable patterns.

We will continue to enhance our projections as additional information becomes available.

*Licensing and Royalty Revenue*

License revenue is recognized when the license is granted to the licensee, provided no significant performance obligations remain.

Royalty revenue is recognized based on sales by licensees when the underlying sales occur, in accordance with the terms of the licensing agreement and when collectibility is reasonably assured.

Bank accounts in the United

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| | | | | | | 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. | | |

February 23, 2024

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

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

| Repurchase of common stock | | | | | | | | | | | | | | | | | | | | | (3) | | | | | | — | | | | | | (857) | | | | | | — | | | | | | — | | | | | | (857) | | |

| Net income | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 12,202 | | | | | | 12,202 | | |

| Balance at December 31, 2021 | | | | | | | | | | | | | | | | | | | | | 403 | | | | | | $ | — | | | | | $ | 4,211 | | | | | $ | (24) | | | | | $ | 9,958 | | | | | $ | 14,145 | |

| Deferred income taxes | | | 828 | | | | | | (559) | | | | | | (318) | | |

| Income taxes payable | | | 15 | | | | | | (828) | | | | | | 876 | | |

We are developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases, independently and with our strategic collaborators.

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.

We have determined that our chief executive officer is the chief operating decision maker (CODM).

The CODM reviews financial information presented on a consolidated basis.

Resource allocation decisions are made by the CODM based on consolidated results.

As such, we have concluded that we operate as one segment.

As we receive more historical data on our product returns, we will integrate this information to refine our estimates and enhance the precision of our financial projections.

period of greater than 12 months.

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Acquisitions

We account for acquisitions either as business combinations or asset acquisitions, based on whether the set of assets acquired meets the definition of a business.

When an acquisition is determined to be a business combination, we apply the acquisition method of accounting.

This method requires that the assets acquired and liabilities assumed be recorded at their fair values as of the acquisition date on our consolidated balance sheets.

Any excess of the consideration transferred over the fair value of the net identifiable assets acquired is recognized as goodwill.

The process of determining the fair value of assets and liabilities involves significant estimates and assumptions.

During the measurement period, which may extend up to one year from the acquisition date, we may record adjustments to these fair values.

Any such adjustments are recorded with a corresponding change to goodwill.

Transaction costs incurred in connection with business combinations are expensed as incurred.

On January 31, 2023, we completed a business combination by acquiring all outstanding shares of OriCiro Genomics K.K. for a cash consideration of $86 million.

As a result of this acquisition, we recognized $52 million in goodwill and an intangible asset related to acquired technology valued at $48 million, which are included within other non-current assets in our consolidated balance sheets.

This acquisition provided us with 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 further accelerates our research and development efforts.

We make adjustments

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

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: 2023.][added: 2024.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2023,] [added: 2024,] 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: 2023.][added: 2024.]

Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2023.][added: 2024.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] 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: 2023,] [added: 2024,] 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.

[removed: Inherent] [added: Inherent] Limitations on the Effectiveness of [removed: Controls][added: Controls]

We have audited Moderna, Inc.’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] 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: 2023,] [added: 2024,] 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: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] 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: 2023,] [added: 2024,] and the related notes and our report dated February [removed: 23, 2024] [added: 21, 2025] expressed an unqualified opinion thereon.

February 21, 2025

February 23, 2024

On November [removed: 7, 2023, Noubar Afeyan,] [added: 8, 2024, Stephane Bancel,] our [removed: Chairman, amended] [added: Chief Executive Officer, terminated] a trading arrangement [added: that was] intended to satisfy the affirmative defense of Rule 10b5-1(c) (the [removed: Afeyan] [added: Bancel] 10b5-1 Plan).

The [removed: Garay] [added: Bancel] 10b5-1 Plan was entered into on [removed: August 24, 2023,] [added: June 10, 2024,] and was scheduled to commence [removed: on November 27, 2023,] [added: as early as September 25, 2024,] with a termination date of [removed: August 30, 2024.][added: February 27, 2025.]

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

The Bancel 10b5-1 Plan provided for the potential sale of up to 150,000 shares of common stock.

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 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.

*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.

The foregoing description does not purport to be complete and is qualified in its entirety by reference to the full text of the By-laws, a copy of which is attached hereto as Exhibit 3.2 and is incorporated herein by reference.

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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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.

| 3.1 | | | | | | [removed: [Amended and Restated] [added: [Restated] Certificate of Incorporation of the Registrant. [removed: (2)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518349938/d677222dex31.htm)] [added: (2)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit3158248-k.htm)] | | |

| [removed: 3.2*] [added: 3.2] | | | | | | [removed: [Second](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32secondamendedandr.htm) [Amended] [added: [Second Amended] and Restated By-laws of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32secondamendedandr.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit325820248-k.htm) [(2)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000031/exhibit325820248-k.htm)] | | |

| 4.1 | | | | | | [Specimen Common Stock Certificate. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex41.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex41.htm)] | | |

| [removed: 4.2] [added: 4.2*] | | | | | | [Description of Capital [removed: 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)] [added: Stock.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit4212312024.htm)] | | |

| 10.1# | | | | | | [2016 Stock Option and Grant Plan, as amended, and forms of award agreements thereunder. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex101.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex101.htm)] | | |

| 10.2# | | | | | | [2018 Stock Option and Incentive [removed: Plan and forms of award agreements thereunder. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex102.htm)] [added: Plan](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex102.htm)[. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex102.htm)] | | |

| 10.3# | | | | | | [Form of Indemnification Agreement between the Registrant and each of its directors. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex103.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex103.htm)] | | |

| 10.4† | | | | | | [Master Collaboration and License Agreement, by and between Moderna Therapeutics, Inc. and Merck Sharp & Dohme Corp., dated as of January 12, 2015, as amended by Amendment No. 1 dated as of January 8, 2016, Amendment No. 2 dated as of June 28, 2016, Amendment No. 3 dated as of June 28, 2016 and Amendment No. 4 dated as of June 28, 2016. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex104.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex104.htm)] | | |

| 10.5† | | | | | | [Amended and Restated mRNA Cancer Vaccine Collaboration and License Agreement, by and between ModernaTX, Inc. and Merck Sharp & Dohme Corp., dated as of April 17, 2018. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex105.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex105.htm)] | | |

| 10.6† | | | | | | [Patent Sublicense Agreement, by and among ModernaTX, Inc. and Cellscript, LLC and mRNA RiboTherapeutics, Inc. (solely with respect to certain provisions), dated as of June 26, 2017. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex108.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex108.htm)] | | |

| [removed: 10.9#] [added: 10.7#] | | | | | | [Amended and Restated Executive Severance Plan and Form of Participation Letter, as amended on February 23, [removed: 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)] [added: 2023. (](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[7](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: 10.10#] [added: 10.8#] | | | | | | [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. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm)] | | |

| [removed: 10.11#] [added: 10.9#] | | | | | | [Letter Agreement by and between the Company and Stephen Hoge, dated as of October 17, 2017. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1016.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1016.htm)] | | |

| [removed: 10.12#] [added: 10.10#] | | | | | | [Employment Letter Agreement between ModernaTX, Inc. and Shannon Klinger, dated as of March 4, 2021. [removed: (](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)] [added: (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)] | | |

| [removed: 10.13#] [added: 10.11#] | | | | | | [Offer Letter by and between ModernaTX, Inc. and James Mock, dated as of August 15, 2022. [removed: (](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)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit102-mockofferletter.htm)[6](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: 10.18#] [added: 10.12#] | | | | | | [Senior Executive Cash Incentive Bonus Plan. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1017.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1017.htm)] | | |

| [removed: 10.19#] [added: 10.13#] | | | | | | [Amended and Restated Non-Employee Director Compensation Policy, effective October 1, 2022. [removed: (](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)] [added: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)[6](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: 10.20#] [added: 10.14#] | | | | | | [Form of Indemnification Agreement between the Registrant and each of its officers. [removed: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1019.htm)] [added: (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1019.htm)] | | |

| [removed: 10.21#*] [added: 10.15#] | | | | | | [2018 Employee Stock Purchase [removed: Plan.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit10212018employeesto.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000060/exhibit1019302024.htm) (4)] | | |

| [removed: 10.22#*] [added: 10.16#] | | | | | | [Form of Employee Restricted Stock Unit Award [removed: Agreemen](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1022formofemployeer.htm)[t.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1022formofemployeer.htm)] [added: Agreement. (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1022formofemployeer.htm)] | | |

| [removed: 10.23#*] [added: 10.17#] | | | | | | [Form of Employee Non-Qualified Stock Option [removed: Agreement.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1023formofemployeen.htm)] [added: Agreement. (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1023formofemployeen.htm)] | | |

| [removed: 10.24#] [added: 10.18#] | | | | | | [Form of Non-Employee Director Restricted Stock Unit Award Agreement. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)[5](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)] [added: (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)] | | |

| [removed: 10.25#] [added: 10.19#] | | | | | | [Form of Non-Employee Director Non-Qualified Stock Option Agreement. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)[5](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)] [added: (5)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)] | | |

| [removed: 10.26#] [added: 10.20#] | | | | | | [Form of Performance-Based Restricted Stock Unit Award Agreement under the 2018 Stock Option and Incentive Plan. [removed: (](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)[3](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)] [added: (3)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)] | | |

| 21.1* | | | | | | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit211subsidiaries2023.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit211subsidiaries2024.htm)] | | |

| 23.1* | | | | | | [Consent of Ernst & Young LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit23112312023.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit23112312024.htm)] | | |

| 31.1* | | | | | | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit31112312023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit31112312024.htm)] | | |

| 31.2* | | | | | | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit31212312023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit31212312024.htm)] | | |

| 32.1+ | | | | | | [Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32112312023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit32112312024.htm)] | | |

| 32.2+ | | | | | | [Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit32212312023.htm)] [added: 2002](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit32212312024.htm)] | | |

| [removed: 97*] [added: 97] | | | | | | [removed: [Moderna](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit97modernaincpolicyf.htm)[,] [added: [Moderna,] Inc. Policy for Recoupment of Executive Incentive [removed: Com](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit97modernaincpolicyf.htm)[pensation.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit97modernaincpolicyf.htm)] [added: Compensation. (8)](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit97modernaincpolicyf.htm)] | | |

| (2) | | | Incorporated by reference to the Current Report on Form 8-K (File No. 001-38753) filed with the Securities and Exchange Commission on [removed: December 14, 2018.] [added: May 9, 2024.] | | |

| [removed: (4)] [added: (7)] | | | Incorporated by reference to the Annual Report on Form 10-K (File No. 001-38753) filed with the Securities and Exchange Commission on February [removed: 27, 2020.] [added: 24, 2023.] | | |

| (6) | | | Incorporated by reference to the [removed: Current] [added: Quarterly] Report on Form [removed: 8-K/A] [added: 10-Q] (File No. 001-38753) filed with the Securities and Exchange Commission on [removed: May 13,] [added: November 3,] 2022. | | |

| [removed: (7)] [added: (4)] | | | Incorporated by reference to the [removed: Current] [added: Quarterly] Report on Form [removed: 8-K/A] [added: 10-Q] (File No. 001-38753) filed with the Securities and Exchange Commission on [removed: June 1, 2022.] [added: November 7, 2024.] | | |

| (8) | | | Incorporated by reference to the [removed: Quarterly] [added: Annual] Report on Form [removed: 10-Q] [added: 10-K] (File No. 001-38753) filed with the Securities and Exchange Commission on [removed: November 3, 2022.] [added: February 23, 2024.] | | |

| 19* | | | | | | [Moderna, Inc. Insider Trading Policy](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000022/exhibit19insidertradingpol.htm) | | |

| | | | | | | | | |

| 10.7 | | | | | | [Net Lease by and between Moderna Therapeutics, Inc. and Campanelli-TriGate Norwood Upland, LLC, dated as of August 29, 2016, as amended by Amendment No. 1 dated as of April 10, 2017 and Amendment No. 2 dated as of March 16, 2018. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1010.htm) | | |

| 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. (](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) | | |

| 10.14# | | | | | | [Offer Letter by and between ModernaTX, Inc. and Arpa Garay, dated as of April 21, 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) | | |

| 10.15#* | | | | | | [Executive Separation](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm) [and Transitional Services](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm) [Agreemen](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm)[t](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm)[, January 2, 2024](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm)[, between Moderna](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm)[TX, Inc. and Arpa Garay.](https://www.sec.gov/Archives/edgar/data/1682852/000168285224000015/exhibit1015redactedgarayar.htm) | | |

| 10.16# | | | | | | [Updated Executive Retirement and Strategic Consulting Agreement, dated May 27, 2022, between ModernaTX, Inc. and David Meline. (](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) | | |

| 10.17# | | | | | | [Executive Separation Agreement and Release, dated May 13, 2022, between 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. (](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) | | |

| (9) | | | Incorporated by reference to the Annual Report on Form 10-K (File No. 001-38753) filed with the Securities and Exchange Commission on February 24, 2023. | | |