Moderna (MRNA) 10-K risk factor changes: FY2022 vs FY2021

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

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

[removed: In response to the global COVID-19 pandemic, we are continuing] [added: We continue] to pursue the rapid manufacture, distribution and clinical testing of our COVID-19 [removed: vaccine (mRNA-1273),] [added: vaccines,] which [removed: is] [added: are] our only commercial [removed: product] [added: products] and source of product revenues.

We may encounter difficulties producing [removed: the vaccine] [added: COVID-19 vaccines] on the timelines and in the quantities set forth in our [removed: existing or future] supply agreements.

Our ability to commercialize [removed: an effective vaccine] [added: our vaccines] depends on our manufacturing capability, both at our own [removed: manufacturing facility] [added: facilities] and those of our [removed: manufacturing partners, which we rapidly scaled in response to the pandemic.][added: partners.]

We are committing substantial financial resources and personnel to the development, manufacture and distribution of our COVID-19 [removed: vaccine,] [added: vaccines,] including [added: updating our vaccines in response] to [removed: support the scale-up] [added: new variants] of [removed: manufacturing to enable our pandemic response, which] [added: concern, and these efforts] may [removed: cause delays in] [added: delay] or otherwise negatively impact our other development programs.

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

We may need to engage additional [removed: collaborators] [added: partners] in the future, including [added: additional] contract manufacturing organizations (CMOs), [removed: government and non-government organizations, and other manufacturing partners,] to assist in meeting our [removed: capacity] [added: production] needs.

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

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

[removed: Furthermore,] [added: Further,] we will require significant additional investment, whether from our own capital resources or other sources of funding, as we continue to expand our commercial [removed: launch] efforts.

[removed: We] [added: The pharmaceutical market is intensely competitive, and we] may [removed: be unsuccessful in competing] [added: not compete] effectively in the market for existing products, new treatment [removed: methods,] [added: methods] and new [removed: technologies, including for COVID-19 vaccines.][added: technologies.]

Many [removed: pharmaceutical and biotechnology] companies, academic institutions, governmental [removed: agencies,] [added: agencies] and public and private research organizations are pursuing the development of products for the same diseases that we are targeting or expect to [removed: target, including COVID-19 vaccines,] [added: target] and [added: many of] these institutions and competitors [removed: may] have:

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

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

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

[removed: Over two dozen] [added: Many] COVID-19 vaccines have been authorized in various jurisdictions, including [removed: those] [added: the mRNA COVID-19 vaccine] produced by [removed: AstraZeneca, Johnson & Johnson, and Pfizer/BioNTech, and many more remain in development.][added: Pfizer/BioNTech.]

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

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

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

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

[removed: We may be delayed] [added: These factors could delay] or [removed: prevented] [added: prevent us] from receiving full regulatory approval of our COVID-19 [removed: vaccine] [added: vaccines] in certain jurisdictions or for certain [removed: demographics.][added: demographics.]

[removed: Efficacy, effectiveness, safety,] [added: COVID-19 vaccines are the only mRNA medicines that have been authorized or approved to date by the FDA or other regulators,] and [added: efficacy, safety and] immunogenicity data with respect to our COVID-19 [removed: vaccine,] [added: vaccines,] as well as real-world evidence, continue to accumulate.

Further results from clinical trials, as well as the experience of vaccinated individuals, could show diminished protection compared to the results released to [removed: date, as efficacy and antibody persistence wane over time.][added: date.]

Additionally, we may observe new, more frequent or [added: more severe] adverse events [removed: of greater severity] in subjects participating in ongoing clinical trials or [removed: among those] individuals vaccinated with our COVID-19 [removed: vaccine.][added: vaccines.]

For example, some studies have suggested that our [added: COVID-19] vaccine may be associated with higher rates of myocarditis and pericarditis in young males compared to other COVID-19 vaccines.

In addition, the [removed: interpretation of the data from our clinical trials of our COVID-19 vaccine by the] FDA and other regulators may [removed: differ] [added: interpret data] from our [removed: interpretation] [added: clinical trials differently than we do] and such agencies may require us to conduct additional studies or analyses, which [removed: may lead to] [added: could cause] delays in obtaining [removed: authorization for these medicines.][added: regulatory authorizations.]

For example, in October 2021, the FDA requested that we explore a lower dosage for our COVID-19 vaccine in adolescents, which extended the length of clinical trials in this [removed: population, delaying potential authorization in the U.S. These factors could delay or prevent us from] [added: population prior to] receiving regulatory [removed: approval of our COVID-19 vaccine in certain jurisdictions or for certain demographics.][added: authorization.]

[removed: The] [added: Further, the] assays used to estimate the effectiveness of [added: our] COVID-19 vaccines [removed: have only recently been developed and] continue to evolve.

Results obtained in clinical [removed: studies] [added: trials] of [removed: mRNA-1273] [added: our COVID-19 vaccines] with later versions of these assays may be less positive than the results [removed: we have obtained] [added: observed] to date.

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

Our original COVID-19 [removed: vaccine, mRNA-1273,] [added: vaccine] was developed based upon the genetic sequence of the SARS-CoV-2 virus that was first detected in Wuhan, China.

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

If [removed: these] [added: our] efforts [added: to develop variant-specific vaccines against future variants] are unsuccessful, we are slower [added: than competitors] to develop [removed: variant-specific] [added: such] vaccines [removed: than competitors,] or [removed: these vaccine candidates] [added: our vaccines] prove less effective than competitors’ vaccines, [removed: these shortcomings may lead to] [added: we could suffer] reputational harm, loss of market [removed: share,] [added: share] and adverse financial results.

[removed: It is also possible that] [added: Additionally,] we may expend significant resources adapting our [removed: COVID-19 vaccine] [added: vaccines] or conducting clinical trials to protect against [removed: variants of the SARS-CoV-2 virus,] [added: COVID-19 variants,] but [removed: that] a market for [removed: this] [added: our] adapted [removed: vaccine does not] [added: vaccines fails to] develop or demand does not align with our projections or cost expenditures.

The regulatory pathway for COVID-19 vaccines is continually [removed: evolving,] [added: evolving] and may result in unexpected or unforeseen challenges.

Our COVID-19 [removed: vaccine has moved] [added: vaccines have advanced] rapidly through the regulatory [removed: review and] [added: review,] authorization and approval processes in the U.S. and other jurisdictions.

[removed: The speed at which COVID-19 vaccines and therapeutics are being created and tested is atypical, and evolving] [added: Evolving] or changing plans or priorities within the FDA or other regulatory authorities, including changes based on new knowledge of [removed: COVID-19 and] how the [removed: disease,] [added: SARS-CoV-2 virus,] and new variants [removed: of the virus,] [added: thereof,] affect the human body, may significantly affect the regulatory timeline for further authorizations or approvals for our COVID-19 [removed: vaccine,] [added: vaccines,] including variant-specific [removed: versions of the vaccine.][added: versions.]

We cannot [removed: anticipate or] predict with certainty the timelines or [added: types of clinical trials or] regulatory processes that may be required for the authorization or approval of updated versions of our COVID-19 [removed: vaccine, or vaccines that may be developed to fight against variants of the SARS-CoV-2 virus.][added: vaccines.]

Although a conditional marketing authorization is a formal marketing authorization and covers all [removed: batches] [added: of our current COVID-19 vaccines] produced for the EU, we [removed: are obliged to] [added: must] provide certain additional information and data by specified timelines as conditions of the [removed: authorization,] [added: conditional authorization in the EU,] and the EMA can take regulatory action if we fail to comply.

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

Adapting our COVID-19 vaccines to new variants requires significant coordination with our partners and rapid adaptation.

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

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

Accordingly, we have limited experience with the commercialization of our products, and we face risks and uncertainties as we likely shift to an endemic market for COVID-19 vaccines and as we prepare for the commercial launch of other medicines.

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

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

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

In addition, we will be exposed to market practices that characterize the U.S. private market for vaccines, including practices regarding discounts, rebates and returns, which can result in the realization of significantly lower revenues than list prices.

As we likely shift to an endemic market for COVID-19 vaccines, we have in the past and may in the future experience increased costs associated with exiting commitments with suppliers for raw materials and CMOs.

As a result of potentially lower demand, and shifting to a lower dose for boosters than our primary series, we may experience increased costs with raw material suppliers as we seek to exit or modify our purchase commitments.

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

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

If we cannot effectively manage evolving demand dynamics, our business, financial condition, results of operations and prospects may suffer.

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

The market for our vaccines will depend on many evolving factors, such as medical need, viral evolution, public health authority recommendations and consumer motivation to vaccinate.

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

Even if our products demonstrate superiority to those of competitors, consumers and the public may fail to appreciate that benefit.

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

Further, the mRNA medicines field is growing rapidly, with increased competitive pressure from large and more established pharmaceutical companies.

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

Additionally, our decisions regarding booster development may be directed by guidance from the FDA or other foreign regulatory authorities, which may impact the timing of development for our COVID-19 vaccines.

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

In the future, we may not adequately anticipate demand for, or we may experience delays in producing, variant-specific boosters.

Further, different regulators may issue differing guidance regarding composition of variant-specific boosters.

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

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

The speed at which COVID-19 vaccines have been created and tested is atypical as compared to other vaccine development processes.

We currently operate under a BLA approved by the FDA for our COVID-19 vaccine in certain demographics and an EUA provided by the FDA for our COVID-19 vaccines that are administered as boosters and as a primary series in certain demographics.

The FDA may revoke these authorizations for a variety of reasons, including if it determines that the underlying health emergency no longer exists or warrants such authorization.

Additionally, we have received certain conditional marketing authorizations in the EEA.

If such authorizations were revoked, without receiving final approval to distribute our COVID-19 vaccines, our business would be adversely impacted.

There are many clinical and manufacturing challenges specific to our PCV candidate, mRNA-4157, and any other neoantigen cancer vaccines we may develop.

We expect to continue to make significant investments in our manufacturing capacity and commercial network as we continue to expand our commercial launch efforts.

We are building regional manufacturing capability globally and are subject to risks associated with building and operating in foreign jurisdictions.

To supplement our internal manufacturing infrastructure, we have entered into agreements for the production, as well as for commercial fill-finish manufacturing, of our products to supply markets globally.

We may need to engage additional third parties in the future to assist in meeting our capacity needs.

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

Upgrades or changes to our systems, infrastructure or the software that we implement, use, or upon which our business relies, may result in the introduction of new cybersecurity vulnerabilities and risks.

Additionally, as we prepare for a potential Phase 3 trial for our PCV candidate, we anticipate an increase in manufacturing demand that will require significant additional investments.

Risks related to COVID-19, mRNA-1273 and our other vaccine candidates against the SARS-CoV-2 virus

We may need to, or the U.S. government may require us to, divert resources and capital from our other programs to the production of COVID-19 vaccines.

We do not have sufficient internal manufacturing infrastructure to support the global roll-out of our COVID-19 vaccine on our own.

Prior to 2020, we had not ramped up our organization for a commercial launch of any product, and doing so during a pandemic with an urgent, critical global need poses additional challenges, such as setting up distribution channels, building global teams with specialized skills, and managing potential intellectual property disputes or challenges.

We may also face challenges sourcing a sufficient amount of raw materials to support the demand for our COVID-19 vaccine.

We may be unable to effectively create a supply chain for the vaccine to adequately support demand as we rely on our third-party collaborators being able to fulfill demand.

For example, we have in the past and may in the future experience international shipping delays as our supply chain expands and grows more complex.

We cannot guarantee that any of these challenges and requirements will be met in a timely manner or at all.

The pharmaceutical market is intensely competitive.

- more extensive experience in preclinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing, and selling products;

These vaccines or other treatments, such as antiviral pills produced by Pfizer and Merck, may prove to be safer, more

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These factors, or the perception of these factors, among others, could lead to a competitor’s vaccine or other treatment to become the standard of care for COVID-19, have broader market acceptance, or be more successfully commercialized.

Our competitors may commercialize products with significant advantages over any products we develop, and may benefit from strategic alliances with or funding from larger pharmaceutical or biotechnology companies.

Moreover, blood samples from people who have recovered from COVID-19, used to benchmark the level of antibodies produced by subjects receiving mRNA-1273 in clinical studies, have been taken from a small number of people and may not be representative of the antibody levels in a broader population of people who have recovered from COVID-19, particularly as variant strains continue to emerge.

The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other blood samples.

For example, the Omicron and Delta variants have been observed to be more transmissible, or contagious, than previous variants.

There is a risk that mRNA-1273 will not be as effective in protecting against these or other future variant strains.

For example, a standard two-dose inoculation of mRNA-1273 appears to be less effective at neutralizing the Omicron variant, which emerged in November 2021, than against the ancestral strain of SARS-CoV-2.

Additionally, administration of booster doses of our vaccine may prove to be

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ineffective, or less effective than desired, against certain variants.

We have several development candidates against variants of concern, and may develop others in the future.

Although we currently operate under an EUA provided by the FDA for mRNA-1273 for as a booster dose for adults 18 years and older at least five months after completing a primary series of the vaccine, and as a third dose in immunocompromised individuals 18 years of age or older who have undergone solid organ transplantation, the FDA may revoke such authorization if it determines that the underlying health emergency no longer exists or warrants such authorization, and we cannot predict how long the EUA will remain in place.

Such revocation could adversely impact our business in a variety of ways.

The EMA has made a positive recommendation for the administration of Spikevax for children ages 6 to 11, in addition to the existing conditional marketing authorization from the EMA for Spikevax in adults and adolescents ages 12 and older.

Any such revocation of the temporary authorization to distribute mRNA-1273, without receiving final approval to distribute the vaccine, could adversely impact our ability to realize the full financial benefit of our existing or future supply agreements.

Our ability to deliver our vaccine to customers may be curtailed by one or more government actions or interventions, which may be more likely during a global health crisis, such as the COVID-19 pandemic.

It is possible that one or more government entities may take actions that directly or indirectly diminish our rights or opportunities with respect to our COVID-19 vaccine, limiting our economic prospects.

In the United States, the Defense Production Act of 1950, as amended (the Defense Production Act), gives the U.S. government rights and authorities that may directly or indirectly diminish such rights or economic opportunities.

Government entities imposing restrictions or limitations on our third-party service providers may require us to obtain alternative service sources for our COVID-19 vaccine or our vaccine candidates.

If we are unable to timely enter into alternative arrangements on satisfactory terms, we will experience delays in the development or production of our COVID-19 vaccine and our vaccine candidates, increased expenses, and delays in distribution or commercialization of our COVID-19 vaccine, or, when and if approved, our vaccine candidates.

In addition, our supply contracts with the U.S. government for our COVID-19 vaccine restrict our ability to export vaccine that is produced from our U.S.-dedicated supply chain to markets outside the United States prior to satisfying our delivery obligations to the U.S. government.

Furthermore, governments have threatened to block or limit the export of COVID-19 vaccines manufactured in their territories in instances where manufacturers have been delayed or have not fully satisfied their delivery obligations to those governments.

Governments of the jurisdictions in which we or our contract manufacturing partners produce our COVID-19 vaccine may impose export restrictions, prohibiting us from delivering our COVID-19 vaccine to customers in other jurisdictions.

The imposition of export controls could severely and adversely impact our manufacturing activities, commercial activities and financial results.

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In addition, during a global health crisis, such as the COVID-19 pandemic, where the spread of a disease needs to be controlled, closed or heavily regulated, national borders create challenges and potential delays in our development and production activities and may necessitate that we pursue strategies to develop and produce our vaccines and vaccine candidates within self-contained national or international borders, at potentially much greater expense and with longer timeframes for public distribution.

For instance, batch failures as we scale up our manufacturing have occurred and may continue to occur.

Clinical development is lengthy and uncertain, especially with a new class of medicines such as mRNA medicines.

We are a biotechnology company pioneering [removed: messenger RNA (mRNA) therapeutics and vaccines to create] a new [removed: generation] [added: class] of [removed: transformative] medicines [removed: to improve the lives] [added: made] of [removed: patients.][added: messenger RNA (mRNA).]

In January 2022, the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for our COVID-19 vaccine, [removed: Spikevax, for individuals 18 years of age and older in the United States.][added: Spikevax.]

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

[removed: - systemic] [added: | Systemic] secreted and cell surface [removed: therapeutics;][added: therapeutics | | | 23 | | | | | | 3 | | | | | | 2 | | |]

[removed: - cancer vaccines;][added: | Cancer vaccines | | | 14 | | | | | | 47 | | | | | | 29 | | |]

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

[removed: - systemic] [added: | Systemic] intracellular [removed: therapeutics; and][added: therapeutics | | | 42 | | | | | | 26 | | | | | | 21 | | |]

[removed: - inhaled pulmonary therapeutics.][added: *Inhaled Pulmonary*]

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

[removed: 2021] [added: 2022] Business Highlights

Moderna COVID-19 [removed: Vaccine][added: Vaccines]

[removed: We have] [added: Beginning in the third quarter of 2020, we] entered into supply agreements with the U.S. Government, other international [removed: governments, Gavi (on behalf of the COVAX Facility),] [added: governments] and [removed: the African Union] [added: organizations] for the supply of our COVID-19 [removed: vaccine.][added: vaccines and received upfront deposits.]

| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Product sales | | | $ | [removed: 17,675] [added: 18,435] | | | | | $ | [removed: 200] [added: 17,675] | | | | | $ | [removed: —] [added: 200] | |

| Grant revenue | | | [removed: 735] [added: 388] | | | | | | [removed: 529] [added: 735] | | | | | | [removed: 12] [added: 529] | | |

| Collaboration revenue | | | [removed: 61] [added: 440] | | | | | | [removed: 74] [added: 61] | | | | | | [removed: 48] [added: 74] | | |

| Total revenue | | | $ | [removed: 18,471] [added: 19,263] | | | | | $ | [removed: 803] [added: 18,471] | | | | | $ | [removed: 60] [added: 803] | |

We began to record product sales for our COVID-19 [removed: vaccine] [added: vaccines] subsequent to its authorization for emergency use by the FDA and Health Canada in December 2020.

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

Other than product sales, our revenue in [removed: 2021] [added: 2022, 2021,] and 2020 was derived from government-sponsored and private organizations including BARDA, DARPA and the Bill & Melinda Gates Foundation and from strategic alliances with AstraZeneca, Merck and Vertex to discover, develop, and commercialize potential mRNA medicines.

| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| BARDA | | | $ | [removed: 713] [added: 372] | | | | | $ | [removed: 522] [added: 713] | | | | | $ | [removed: 8] [added: 522] | |

| Other grant revenue | | | [removed: 22] [added: 16] | | | | | | [removed: 7] [added: 22] | | | | | | [removed: 4] [added: 7] | | |

| Total grant revenue | | | $ | [removed: 735] [added: 388] | | | | | $ | [removed: 529] [added: 735] | | | | | $ | [removed: 12] [added: 529] | |

| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| AstraZeneca | | | [removed: $] [added: 80] | [removed: 7] | | | | | [removed: $] [added: 7] | [removed: 33] | | | | | [removed: $] [added: 33] | [removed: 5] | |

| Merck | | | [removed: 23] [added: $] | [added: 309] | | | | | [removed: 26] [added: $] | [added: 23] | | | | | [removed: 37] [added: $] | [added: 26] | |

| Vertex | | | [removed: 26] [added: 48] | | | | | | [removed: 15] [added: 26] | | | | | | [removed: 6] [added: 15] | | |

| Other | | | [removed: 5] [added: 3] | | | | | | [removed: —] [added: 5] | | | | | | — | | |

| Total collaboration revenue | | | $ | [removed: 61] [added: 440] | | | | | $ | [removed: 74] [added: 61] | | | | | $ | [removed: 48] [added: 74] | |

As of December 31, [removed: 2021,] [added: 2022,] we had [removed: signed supply agreements of approximately $20.6 billion for the future supply of our COVID-19 vaccine to be delivered in 2022 and 2023 and had] deferred revenue of [removed: $6.7] [added: $2.6] billion associated with customer deposits received or billable under [removed: these agreements.][added: supply agreements of which we expect $2.0 billion of our COVID-19 vaccines to be delivered in 2023.]

We believe that the SARS-CoV-2 virus [removed: will evolve] [added: is likely evolving] to an endemic phase [removed: in 2022] and as a result, we expect [added: that COVID-19 vaccine market will likely shift to an endemic seasonal market and] our product sales [removed: to be larger in the second half of 2022 than] [added: will decline] in [removed: the first half.][added: 2023 compared to 2022.]

As of December 31, [removed: 2021,] [added: 2022,] the remaining available funding, net of revenue earned was [removed: $189] [added: $137] million under the BARDA contract.

Cost of sales includes raw materials, personnel and facility and other costs associated with manufacturing our commercial [removed: product.][added: products.]

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

- expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process; [removed: and]

The following table reflects our research and development expenses, including direct program specific expenses summarized by modality and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019] [added: 2020] (in millions):

| | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| [removed: Prophylactic] [added: Infectious disease] vaccines | | | $ | [removed: 1,099] [added: 1,734] | | | | | $ | [removed: 707] [added: 1,099] | | | | | $ | [removed: 48] [added: 707] | |

[removed: | Cancer vaccines | | | 47 | | | | | | 29 | | | | | | 44 | | |][added: *Cancer*]

We have a diverse and extensive development pipeline of 45 development candidates across our 48 development programs, of which 38 are in clinical studies currently.

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

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

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

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

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

For the year ended 2022, we recognized product sales of $18.4 billion from sales of our COVID-19 vaccines, compared to $17.7 billion and $200 million for the years ended 2021 and 2020, respectively.

*Respiratory Vaccines*

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

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

Our late-stage respiratory vaccine pipeline continues to progress.

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

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

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

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

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

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

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

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

mRNA-1010 showed an acceptable safety and tolerability profile.

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

We are also progressing several combination respiratory vaccine candidates.

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

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

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

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

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

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

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

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

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

*Latent Vaccines*

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

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

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

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

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

*Rare Diseases*

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

Encouraging early data have shown a decrease in the number of metabolic decompensation events (MDEs) among participants and initial discussions with regulators are supportive of MDE as a primary endpoint for a pivotal study.

Within our platform, we develop technologies that enable the development of mRNA medicines for diverse applications.

When we identify technologies that we believe could enable a new group of potential mRNA medicines with shared product features, we call that group a “modality.” While the programs within a modality may target diverse diseases, they share similar mRNA technologies, delivery technologies, and manufacturing processes to achieve shared product features.

The programs within a modality will also generally share similar pharmacology profiles, including the desired dose response, the expected dosing regimen, the target tissue for protein expression, safety and tolerability goals, and pharmaceutical properties.

Programs within a modality often have correlated technology risk, but because they pursue diverse diseases they often have uncorrelated biology risk.

We have created seven modalities to date:

- prophylactic vaccines;

- localized regenerative therapeutics;

We have designated our prophylactic vaccines and systemic secreted and cell surface therapeutics modalities as our “core modalities.” In these core modalities, our strategy is to invest in additional development candidates using our accumulated innovations in technology, our process insights and our preclinical and clinical experience.

Our exploratory modalities continue to be a critical part of advancing our strategy to maximize the application of our potential mRNA medicines.

We have established relationships with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of our manufacturing capabilities.

Most recently, our capabilities have come together to allow the authorization and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

On December 18, 2020, we received an Emergency Use Authorization (EUA) from the FDA for the emergency use of the Moderna COVID-19 Vaccine (also referred to as mRNA-1273 and marketed under the brand name Spikevax) in individuals 18 years of age or

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older.

Subsequently, we have also received authorization for our COVID-19 vaccine from health agencies in more than 70 countries and from the World Health Organization (WHO).

Additional authorizations are currently under review in other countries.

In addition, we have received authorization for our COVID-19 vaccine for use in adolescents in the European Union, the United Kingdom, Australia, Canada, Switzerland and other countries, and have pending applications for authorization to administer the vaccine to adolescents with regulatory agencies in the United States and other countries.

In January 2022, we received full FDA approval for Spikevax to prevent COVID-19 in individuals 18 years of age and older in the United States.

A booster dose of our COVID-19 vaccine at the 50 µg dose level is authorized for use under an EUA for adults 18 years and older.

A third dose of our COVID-19 vaccine at the 100 µg dose level is authorized for use under an EUA in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The European Medicines Agency (EMA) has also authorized a third dose of the Moderna COVID-19 vaccine given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older, as well as the administration of 50 µg booster doses for individuals 18 years of age and older.

Manufacturing Scaling

In 2021, we rapidly scaled our manufacturing capabilities for our COVID-19 vaccine.

By June, we had delivered 200 million doses of the Moderna COVID-19 Vaccine to the U.S. government.

By end of September, we and our partners ramped up our capacity worldwide and supplied more than 500 million doses of our COVID-19 vaccine globally.

We took measures to scale capacity at a significant pace, including the expansion of our Moderna Technology Center (MTC) in Norwood, Massachusetts.

By the end of 2021, we had shipped approximately 800 million doses of our COVID-19 vaccine worldwide.

In April 2021, we announced new funding commitments to increase supply at our owned and partnered manufacturing facilities.

We expect these investments will allow for a doubling of drug substance manufacturing at Lonza’s Switzerland-based facility, a more than doubling of formulation, fill and finish and drug substance manufacturing at Rovi’s Spain-based facility, as well as a 50 percent increase of drug substance at Moderna’s facilities in the U.S. When completed, the investments are also expected to result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.

Access Expansion

We recognize that vaccine availability continues to be a challenge in many parts of the world, and we remain focused on ensuring that low-income countries have access to our vaccine.

In April, we announced additional investments to increase global supply of our COVID-19 vaccine and in May we announced an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of our vaccine at our lowest tiered price, in line with our global access commitments.

This agreement has subsequently been revised to provide up to 650 million doses to be delivered across 2021 and 2022.

Additionally, in October, we announced that Moderna will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level.

We also announced the first step in our long-term partnership with the African Union with a Memorandum of Understanding to supply up to 110 million doses of our COVID-19 vaccine to address the needs of low-income countries in Africa.

In January 2022, African Union informed us that it will not exercise its option for 60 million doses in the second quarter of 2022, due to its expectation that existing supplies will be sufficient to meet its vaccination targets.

Throughout the year, we continued to build a diverse clinical portfolio of vaccines and therapeutics across our seven modalities.

Our longstanding approach to portfolio development, pursuing programs that have shared technology or biology, has helped us reduce risk as our pipeline has grown to 40 programs in development, including 23 in clinical studies as of December 31, 2021.

Beyond our COVID-19 vaccine, in 2021 we launched the second pivotal trial in our company’s history with CMVictory, a Phase 3 study of our vaccine to prevent congenital cytomegalovirus (CMV), which is the number one cause of birth defects in the U.S. This milestone takes us one step closer to potentially bringing another important vaccine to millions of people.

We are making other significant advances across our programs.

As of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] we had cash, cash equivalents, restricted cash, and investments in marketable securities of [removed: $17.6] [added: $18.2] billion and [removed: $5.2] [added: $17.6] billion, respectively.

If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, [removed: 2021,] [added: 2022,] the net fair value of our marketable securities would decrease by approximately [removed: $146] [added: $169] million.

Our significant foreign currency revenue exposure for the year ended December 31, [removed: 2021] [added: 2022] was the equivalent of [removed: $5.9] [added: $5.4] billion in [removed: Euros.][added: Euros and $1.0 billion in Japanese Yen.]

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

Our foreign exchange contracts as of December 31, [removed: 2021,] [added: 2022,] carried at fair value, had maturities of up to [removed: 9 months.][added: one month.]

As of December 31, [removed: 2021,] [added: 2022,] our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than [removed: three months.][added: one month.]

As of December 31, [removed: 2021,] [added: 2022,] a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in cash flow hedging of approximately [removed: $54] [added: $13] million.

As of December 31, [removed: 2021,] [added: 2022,] a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in balance sheet hedging of approximately [removed: $115] [added: $51] million.

Moderna is pioneering a new class of medicines made of messenger [removed: RNA, or mRNA.][added: RNA (mRNA).]

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

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

[removed: Moderna has] [added: We have] established relationships with [removed: a broad range of domestic and overseas] government and commercial collaborators, which has allowed [removed: for the pursuit of] [added: us to pursue] both groundbreaking science and rapid scaling of our manufacturing capabilities.

[removed: Most recently,] Moderna’s capabilities [removed: have come] [added: came] together to [removed: allow] [added: secure] the authorization and approval of one of the earliest and most-effective vaccines against the COVID-19 [removed: pandemic.][added: pandemic, progressing from vaccine design, through testing and to authorization and distribution in less than a year.]

In 2020, mRNA technology emerged as a new class of [removed: medicine.][added: medicines.]

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

DNA serves as a hard drive, safely storing these instructions in the [added: cell’s] nucleus until they are needed by the cell.

[removed: Messenger RNA] [added: mRNA] is a linear polymer comprising four monomers called nucleotides: adenosine (A), guanosine (G), cytosine [removed: (C),] [added: (C)] and uridine (U).

Within the region of the molecule that codes for a [removed: protein, or the] [added: protein (the] coding [removed: region,] [added: region),] the sequence of these four nucleotides forms a language made up of three-letter words called codons.

To end protein synthesis, three different codons (UAA, UAG, and UGA) [added: serve as stop signals, telling the ribosome where to terminate protein synthesis.]

In addition to the coding region, mRNAs contain four other key features: (1) the 5’ untranslated region [removed: or 5’-UTR;] [added: (5’-UTR);] (2) the 3’ untranslated region [removed: or 3’-UTR;] [added: (3’-UTR);] (3) the 5’ cap; and (4) a 3’ [removed: polyadenosine, or poly-A,] [added: polyadenosine (poly-A)] tail.

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

- Making proteins inside one’s own cells mimics human biology: [removed: Using a person’s own] [added: Tailored mRNA can be sent into] cells to [added: instruct them to] produce [added: specific] protein therapeutics or vaccine antigens [added: and] provides certain advantages over [removed: existing technologies such as recombinant proteins, which are manufactured using processes that are foreign] [added: traditional approaches] to [added: medicine, where a protein or chemical is introduced to] the [removed: human] body.

To make the full diversity of possible proteins, only simple sequence changes are required in [removed: mRNA.][added: mRNA, instead of starting from scratch for each new vaccine or therapy.]

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

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

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

2.Advances in the development of our mRNA medicines reduce risks across our portfolio. mRNA medicines share fundamental features that can be [removed: used to learn quickly] [added: leveraged] across [removed: a] [added: our] portfolio.

We believe that once safety and proof of protein production has been established in one program, the technology and biology risks of related programs that use similar mRNA technologies, delivery [removed: technologies,] [added: technologies] and manufacturing processes will decrease significantly.

We believe that the development of mRNA [removed: as a new class of medicines, as evidenced by the development of mRNA-based vaccines during 2020,] [added: medicines] represents a significant breakthrough for [removed: patients and] [added: patients,] our [removed: industry.][added: industry and human health globally.]

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

We believe our success in developing [removed: this vaccine] [added: our COVID-19 vaccines] has positive implications beyond infectious disease vaccines and across our entire pipeline.

We currently have [removed: 44] [added: 48] programs in development, and our pipeline spans [removed: five therapeutic areas:] infectious diseases, [added: including vaccines against respiratory diseases, latent diseases and public health pathogens, as well as four therapeutic areas:] immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.

In order to deliver on the full scope of the mRNA opportunity and maximize long-term value for patients and investors, we have [removed: developed four pillars underlying our product strategy] [added: formulated strategic priorities] that guide our near-term and long-term goals:

[removed: 1.Continue to advance our COVID-19 program and bring to market a pan-respiratory annual booster vaccine.] Our long-term vision is to develop, and seek regulatory approval for, a convenient, annual, single-dose booster against as many respiratory viruses as possible.

We are [added: currently] developing vaccines against [removed: each of these diseases] [added: COVID-19, seasonal flu and RSV] individually, while [removed: also] pursuing parallel development of combination vaccines.

[removed: We have announced positive] Phase 1 [removed: data] [added: studies have started] for both [added: mRNA-1230,] our [added: COVID-19, seasonal] flu [removed: vaccine (mRNA-1010)] and RSV [removed: vaccine (mRNA-1345).][added: combination vaccine, and mRNA-1045, our seasonal flu and RSV combination vaccine.]

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

[removed: In December 2021, we announced a collaboration with Metagenomi, Inc., a genetic medicines company] [added: We are investing internally and through strategic collaborations] with [removed: a versatile portfolio of] [added: other] next-generation gene editing [removed: tools,] [added: companies, such as our collaboration with Metagenomi, Inc. (Metagenomi)] focused on advancing new gene editing systems for *in vivo* human therapeutic applications.

[removed: -] We [removed: undertake sustained, long-term investment in technology creation. We] aim to improve the performance of mRNA medicines in our current modalities, and to unlock new modalities, through investments within basic and applied science.

[removed: -] We [removed: focus on the pace and scale of our learning. We] seek to accelerate our progress by solving numerous technical problems in parallel rather than in sequence.

We make significant investments in digital assets and research infrastructure to accelerate the pace and scale of our [removed: learning.][added: learnings.]

[removed: There are] [added: Our platform incorporates advances across] three key [removed: components to our platform: mRNA, delivery,] [added: components—mRNA, delivery] and the manufacturing [removed: process.][added: process— to advance our medicines.]

[removed: It is the integration of] [added: We integrate] these components [removed: that allows us to make our medicines] and [removed: we] combine different versions of mRNA delivery and process into each of our medicines.

[removed: Programs] [added: Additionally, because programs] within a modality [removed: often have correlated technology risk, but because they] pursue diverse diseases, they often have uncorrelated biology risk.

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

We have [removed: created] [added: developed] seven modalities to [removed: date:][added: date, as described below.]

[removed: - Cancer vaccines][added: *Personal cancer vaccines*]

Our mRNA can, in specific instances, such as our VEGF therapeutic, be delivered by direct injection to a tissue in a simple saline formulation without [removed: LNPs] [added: lipid nanoparticles (LNPs)] to locally produce small amounts of pharmacologically active protein.

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

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

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

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

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

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

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

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

As our first approved product, Spikevax has helped hundreds of millions of people worldwide combat the COVID-19 pandemic.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This also includes developing and advancing innovative LNP delivery technologies.

We currently have 48 mRNA development programs in our pipeline and 38 development programs in active clinical trials.

Next on the horizon are innovative therapeutics based on mRNA-encoded gene editing enzymes.

Moderna Genomics is our effort to expand the use of our platform to help patients with new cures for diseases.

Our vision is to be a leader in large, complex genomic editing.

7.Build a culture of perpetual learning, and strengthen our processes and digital systems. The Moderna Mindsets are a set of beliefs by which we govern Moderna.

Two of the Mindsets are “We obsess over learning” and “We digitize everywhere possible.” Having a learning Mindset brings us new opportunities to get smarter and innovate faster.

By digitizing everywhere possible, we seek to use the power of digital information to maximize our impact on patients.

See “—Manufacturing.”

Our vision for harnessing the power of mRNA through modalities

Within our platform, we invest in science to invent novel ways to deliver mRNA into various cell types.

Although developing a new modality is difficult, time-consuming and expensive, we believe our experience and technology provide us with unique advantages in the development of mRNA medicines.

Over the last decade, we have developed seven modalities, each with one or many investigational medicines in the clinic.

In under a year, we designed our vaccine against COVID-19 (mRNA-1273) using mRNA-based technology, conducted clinical trials, which demonstrated that the vaccine was highly effective at preventing COVID-19, and obtained an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and authorizations from other regulators around the world.

During 2021, we shipped more than 800 million doses of our COVID-19 vaccine to countries around the globe to help fight the pandemic, with approximately 25% of those doses going to low- and middle-income countries.

serve as stop signals, telling the ribosome where to terminate protein synthesis.

mRNA possesses inherent characteristics that we believe provide it with a strong foundation as a new class of medicines.

These characteristics include:

mRNA as a new class of medicines

Unlike traditional approaches to medicine, where a protein or chemical is introduced to the body, we send tailored mRNA into cells to instruct them to produce specific proteins.

Instead of starting from scratch for each new vaccine or therapy, our mRNA approach

leverages the technology and fundamental components that we have been researching and developing since our founding.

We have developed four core beliefs about the value drivers of mRNA as a new class of medicines:

In January 2022, the FDA approved the BLA for Spikevax for individuals 18 years of age and older in the United States.

From the beginning of the pandemic through December 31, 2021, we delivered 824 million doses of our vaccine, helping to vaccinate millions of people worldwide and combat the pandemic.

We believe a single-dose booster would provide significant value to patients and healthcare systems, as compliance and convenience would increase and there would be a reduction in vaccine administration costs.

This vision includes a single-dose booster vaccine against COVID-19, seasonal flu and respiratory syncytial virus (RSV).

We are committed to bringing COVID-19 booster shots (variant-specific, if needed) to the market until the pandemic is under control.

mRNA-1010 is preparing for a Phase 3 trial to start in 2022 and mRNA-1345 has started the Phase 3 portion of a pivotal Phase 2/3 study.

We are also exploring agreements with governments around the world to establish local manufacturing capabilities in their countries, which would provide those governments with access to these annual vaccines, as well as future pandemic preparedness capabilities.

2.Bring to market first-in-class vaccines against latent viruses. Latent viruses, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV) and human immunodeficiency virus (HIV), cause acute infections and significant long-term effects, or sequelae.

EBV infection is a

Our CMV vaccine (mRNA-1647) is in an ongoing pivotal Phase 3 study to evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women ages 16-40 years.

Our prophylactic EBV vaccine (mRNA-1189) is in an ongoing Phase 1 study.

We have two partnered HIV programs, one that is in an ongoing Phase 1 study (mRNA-1644) and another that is preparing to enter the clinic (mRNA-1547).

In February 2022, we announced two new development candidates against herpes simplex virus (HSV) and varicella-zoster virus (VZV).

Both of these candidates are in preclinical development.

3.Bring to market therapeutics based on mRNA-encoded proteins. We believe that mRNA medicines have the potential to provide patients with any therapeutic protein, including those targeting intracellular or membrane proteins.

Across our therapeutics pipeline, we have 15 development programs across four therapeutic areas: oncology, cardiovascular, rare disease and autoimmune diseases.

We have had positive, early signals in clinical studies in oncology, cardiovascular and rare diseases, demonstrating early proof-of-concept.

However, we are still waiting to advance these programs through full clinical development and regulatory review, as we have done with our COVID-19 vaccine.

4.Expand our portfolio through strategic investments that leverage or enhance our platform. As we advance our existing technologies in mRNA and LNP delivery as well as our biology expertise, we believe we can expand our portfolio through collaborations.

This strategy includes bringing forward novel nucleic acid editing capabilities through Moderna Genomics (MGX), which is our effort to expand the use of our platform to create more innovative drugs to help patients through complex gene editing.

We are committed to advancing this research responsibly and are working toward identifying the right combinations of technologies that can leverage our platform and lead to further breakthroughs in this area.

In January 2022, we announced a collaboration with Carisma Therapeutics, Inc. to discover, develop and commercialize *in vivo* engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.

The strategic principles that guide our approach are:

- We seek to discover and develop a large pipeline in parallel. Our goal is to address or prevent as many human diseases as our technology, talent, capital, and other resources permit.

We do so as rapidly as we can, understanding both the urgency for patients and the need to be disciplined in our approach.

- We integrate across the most critical parts of our value chain. mRNA is a complex multicomponent system and we believe it demands integration.

We believe that we must be directly engaged in research, drug discovery, drug development, process and analytical development, and manufacturing to accelerate our learning, reduce our risk, and protect our critical know-how.

- We forward invest in core enabling capabilities and infrastructure. To execute across a broad pipeline, we need to invest at risk before we have all the answers.

Our forward investments focus on areas where lead times are long and where early investments can reduce execution risk and accelerate future progress.

We proactively invested in a dedicated manufacturing facility, the Moderna Technology Center (MTC), in Norwood, Massachusetts, to support the anticipated growth of our pipeline, and this early investment greatly facilitated our ability to respond to the COVID-19 pandemic by allowing us to begin production of our vaccine even before we received regulatory authorization for its distribution.

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

Most of the issues raised by these claims are highly complex and subject to substantial uncertainties.

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

The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

We describe below those legal matters for which a material loss is either (i) possible but not probable, and/or (ii) not reasonably estimable at this time.

*Pfizer/BioNTech Patent Litigation*

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 COVID-19 vaccines.

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

Table of Content

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

As in the U.S. action, we seek a judgment of infringement of the asserted patents and monetary damages.

Pfizer Inc. and BioNTech SE have also filed an action seeking revocation of certain Moderna patents in the UK.

In addition, the Moderna patents being asserted in the European actions are subject to notices of opposition, including by Pfizer and BioNTech SE and others.

These actions seek to revoke the patents, which have been filed at the European Patent Office.

*Proceedings Related to Patents Owned by Arbutus*

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 COVID-19 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 COVID-19 vaccines.

*Proceedings Related to Patents Owned by Alnylam*

In March 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) 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-19 vaccine infringes a U.S. patent concerning cationic lipids.

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

We are not currently a party to any material legal proceedings.

For the fiscal year ended December 31, [removed: 2021][added: 2022]

As of June 30, [removed: 2021,] [added: 2022,] the aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant was approximately [removed: $80.8] [added: $48.8] billion based on the closing sale price on that date of [removed: $234.98.][added: $142.85.]

As of February [removed: 18, 2022,] [added: 17, 2023,] there were [removed: 402,872,986] [added: 386,339,594] 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: 2022] [added: 2023] Annual Meeting of Stockholders to be filed hereafter are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.

| Item 1. | | | Business | | | [removed: [7](#i7a7cdf3fe3c348059a6b0a57c2f167fe_2201)] [added: [7](#iffc0344c00444d7080375d0d85e64bb9_19)] | | |

| Item 1A. | | | Risk Factors | | | [removed: [58](#i7a7cdf3fe3c348059a6b0a57c2f167fe_2385)] [added: [59](#iffc0344c00444d7080375d0d85e64bb9_549755815790)] | | |

| Item 1B. | | | Unresolved Staff Comments | | | [removed: [95](#i7a7cdf3fe3c348059a6b0a57c2f167fe_70)] [added: [93](#iffc0344c00444d7080375d0d85e64bb9_73)] | | |

| Item 2. | | | Properties | | | [removed: [95](#i7a7cdf3fe3c348059a6b0a57c2f167fe_73)] [added: [93](#iffc0344c00444d7080375d0d85e64bb9_76)] | | |

| Item 3. | | | Legal Proceedings | | | [removed: [95](#i7a7cdf3fe3c348059a6b0a57c2f167fe_76)] [added: [93](#iffc0344c00444d7080375d0d85e64bb9_79)] | | |

| Item 4. | | | Mine Safety Disclosures | | | [removed: [95](#i7a7cdf3fe3c348059a6b0a57c2f167fe_79)] [added: [94](#iffc0344c00444d7080375d0d85e64bb9_82)] | | |

| Item 5. | | | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | | [removed: [96](#i7a7cdf3fe3c348059a6b0a57c2f167fe_85)] [added: [95](#iffc0344c00444d7080375d0d85e64bb9_88)] | | |

| Item 6. | | | \[Reserved\] | | | [removed: [97](#i7a7cdf3fe3c348059a6b0a57c2f167fe_88)] [added: [96](#iffc0344c00444d7080375d0d85e64bb9_91)] | | |

| Item 7. | | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | | [removed: [98](#i7a7cdf3fe3c348059a6b0a57c2f167fe_91)] [added: [97](#iffc0344c00444d7080375d0d85e64bb9_94)] | | |

| Item 7A. | | | Quantitative and Qualitative Disclosures about Market Risk | | | [removed: [111](#i7a7cdf3fe3c348059a6b0a57c2f167fe_97)] [added: [109](#iffc0344c00444d7080375d0d85e64bb9_100)] | | |

| Item 8. | | | Financial Statements and Supplementary Data | | | [removed: [113](#i7a7cdf3fe3c348059a6b0a57c2f167fe_100)] [added: [111](#iffc0344c00444d7080375d0d85e64bb9_103)] | | |

| Item 9. | | | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | | [removed: [151](#i7a7cdf3fe3c348059a6b0a57c2f167fe_190)] [added: [149](#iffc0344c00444d7080375d0d85e64bb9_199)] | | |

| Item 9A. | | | Controls and Procedures | | | [removed: [151](#i7a7cdf3fe3c348059a6b0a57c2f167fe_193)] [added: [149](#iffc0344c00444d7080375d0d85e64bb9_202)] | | |

| Item 9B. | | | Other Information | | | [removed: [153](#i7a7cdf3fe3c348059a6b0a57c2f167fe_196)] [added: [152](#iffc0344c00444d7080375d0d85e64bb9_205)] | | |

| Item 9C. | | | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | | | [removed: [153](#i7a7cdf3fe3c348059a6b0a57c2f167fe_2705)] [added: [152](#iffc0344c00444d7080375d0d85e64bb9_208)] | | |

| Item 10. | | | Directors, Executive Officers and Corporate Governance | | | [removed: [154](#i7a7cdf3fe3c348059a6b0a57c2f167fe_202)] [added: [153](#iffc0344c00444d7080375d0d85e64bb9_214)] | | |

| Item 11. | | | Executive Compensation | | | [removed: [154](#i7a7cdf3fe3c348059a6b0a57c2f167fe_205)] [added: [153](#iffc0344c00444d7080375d0d85e64bb9_217)] | | |

| Item 12. | | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | | [removed: [154](#i7a7cdf3fe3c348059a6b0a57c2f167fe_208)] [added: [153](#iffc0344c00444d7080375d0d85e64bb9_220)] | | |

| Item 13. | | | Certain Relationships and Related Transactions, and Director Independence | | | [removed: [154](#i7a7cdf3fe3c348059a6b0a57c2f167fe_211)] [added: [153](#iffc0344c00444d7080375d0d85e64bb9_223)] | | |

| Item 14. | | | Principal Accountant Fees and Services | | | [removed: [154](#i7a7cdf3fe3c348059a6b0a57c2f167fe_214)] [added: [153](#iffc0344c00444d7080375d0d85e64bb9_226)] | | |

| Item 15. | | | Exhibits, Financial Statement Schedules | | | [removed: [155](#i7a7cdf3fe3c348059a6b0a57c2f167fe_220)] [added: [154](#iffc0344c00444d7080375d0d85e64bb9_232)] | | |

| Item 16. | | | Form 10-K Summary | | | [removed: [158](#i7a7cdf3fe3c348059a6b0a57c2f167fe_223)] [added: [157](#iffc0344c00444d7080375d0d85e64bb9_235)] | | |

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

[removed: We] [added: - The pharmaceutical market is intensely competitive, and we] may [removed: be unsuccessful in competing] [added: not compete] effectively in the market for existing products, new treatment [removed: methods,] [added: methods] and new [removed: technologies, including for COVID-19 vaccines;][added: technologies;]

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

- Preclinical development is lengthy and uncertain, especially for [removed: a new class of medicines such as mRNA,] [added: mRNA medicines,] and [removed: therefore] our preclinical programs or development candidates may be [removed: delayed, terminated,] [added: delayed] or [removed: may never advance to the clinic, any of] [added: terminated,] which may have a material adverse impact on our platform or our business;

[added: -] Clinical [removed: trials of] [added: development is lengthy and uncertain, and] our [removed: investigational medicines] [added: clinical programs] may be delayed [removed: and certain programs may never advance in the clinic] or [added: terminated, or] may be more costly to conduct than we anticipate, any of which could have a material adverse impact on our platform or our business;

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

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

- As [added: we grow as a commercial company and] our drug development pipeline increases and matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate.

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

- We are subject to significant regulatory oversight with respect to manufacturing our COVID-19 [removed: vaccine] [added: vaccines] and [removed: our mRNA] investigational medicines.

Our manufacturing facilities or [removed: the manufacturing facilities] [added: those] of our third-party manufacturers or suppliers may not meet regulatory requirements.

Failure to meet [removed: cGMP] [added: current Good Manufacturing Practice (cGMP)] requirements [removed: set forth in regulations promulgated by the FDA, EMA, and other global health authorities] could result in significant delays in any approval of and costs of our products;

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

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

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

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

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

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

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

- Our personalized cancer vaccine (PCV) investigational medicine is uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production;

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

- our expectations regarding execution of new COVID-19 vaccine sales contracts;

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

- our ability to successfully contract with third-party suppliers, distributors and manufacturers;

- our intention to submit our respiratory syncytial virus (RSV) vaccine candidate to the FDA for regulatory approval for older adults in the first half of 2023;

- our plans with respect to our PCV candidate, including our plan to initiate a Phase 3 study in adjuvant melanoma in 2023 and rapidly expand to additional tumor types, including non-small cell lung cancer;

- participant enrollment in our clinical trials, including enrollment demographics and timing;

- potential advantages of mRNA as compared to traditional medicine;

- potential product launches;

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

| Signatures | | | | | | [159](#i7a7cdf3fe3c348059a6b0a57c2f167fe_226) | | |

- The pharmaceutical market is intensely competitive.

- We may be delayed or prevented from receiving full regulatory approval of our COVID-19 vaccine in certain jurisdictions or for certain demographics;

- Clinical development is lengthy and uncertain, especially with a new class of medicines such as mRNA medicines.

- We have limited sales, distribution, and marketing experience, and have only recently invested significant financial and management resources to establish these capabilities.

- Certain of our customers for our COVID-19 vaccine prepay us for a portion of the product payment for the vaccine doses that they expect to receive from us, and under the terms of certain of our supply agreements, we may be required to refund some or all of those prepayments if a customer reduces its purchase commitment or if we fail to deliver the purchased volume;

- our ability to contract with third-party suppliers, distributors and manufacturers and their ability to perform adequately, particularly with respect to the timely production and delivery of our COVID-19 vaccine, including any variant booster vaccine candidates, if authorized;

- risks related to the direct or indirect impact of the COVID-19 pandemic or any future large-scale adverse health event, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses, initiation or continuation of treatment for diseases that may be addressed by our development candidates and investigational medicines, or in patient enrollment in clinical trials, potential clinical trials, regulatory review or supply chain disruptions, and other potential impacts to our business, the effectiveness or timeliness of steps taken by us to mitigate the impact of the pandemic, and our ability to execute business continuity plans to address disruptions caused by the COVID-19 pandemic or future large-scale adverse health event;

- our anticipated next steps for our development candidates and investigational medicines that may be slowed down due to the impact of the COVID-19 pandemic, including our resources being significantly diverted towards our COVID-19 vaccine efforts, particularly if the federal government seeks to require us to divert such resources;

- our ability to commercialize our products, if approved;

- the scope of protection we are able to establish and maintain for intellectual property rights covering our investigational medicines and technology;

- future agreements with third parties in connection with the commercialization of our investigational medicines, if approved;

- the rate and degree of market acceptance of our investigational medicines;

- the success of competing therapies that are or may become available;

Industry publications and third-party research, surveys, and studies

We occupy a multi-building campus in Cambridge, Massachusetts (Cambridge campus), consisting of a mix of offices and research laboratory space totaling approximately [removed: 261,000] [added: 292,000] square feet.

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

[added: The] MTC [removed: North] [added: campus] is approximately [removed: 200,000] [added: 686,000] square feet [removed: and provides] [added: which includes] lab and office space, directly supporting improvement in our manufacturing [removed: capabilities.][added: capabilities and expansion of our commercial and clinical activities.]

We also [added: own and] lease [removed: other] [added: land,] office and lab spaces globally for our business operations.

We are also investing in a new Moderna Science Center (MSC) in Cambridge, Massachusetts, totaling approximately 462,000 square feet of leased space.

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

The building construction is currently on-going.

We expect to begin a phased move-in process in the fourth quarter of 2023.

Following completion of the building project, the lease term is 15 years, subject to our right to extend the lease for up to two seven-year terms.

MTC South is approximately 200,000 square feet.

MTC East is approximately 240,000 square feet for expansion of our commercial and clinical activities.

The following graph shows a comparison from December 7, 2018, the date on which our common stock first began trading on the Nasdaq Global Select Market, through December 31, [removed: 2021] [added: 2022] of the cumulative total return for our common stock, the Nasdaq [removed: Composite Total Return Index and the Nasdaq] Biotechnology Index, [added: 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.

We had approximately [removed: 85] [added: 79] stockholders of record as of February [removed: 18, 2022.][added: 17, 2023.]

The following table provides information with respect to the shares of common stock repurchased by us during the three months ended December 31, [removed: 2021:][added: 2022:]

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

[added: (2)] On [removed: August 2, 2021,] [added: February 22, 2022,] our Board of Directors authorized a [removed: Share Repurchase Program (2021 Repurchase Program) of] [added: share repurchase program for] our common [removed: stock,] [added: stock of up to $3.0 billion,] with [removed: an expiration date] no [removed: later than August 2, 2023.][added: expiration date.]

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

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

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

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

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

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

In 2021, we became part of the Standard & Poor’s 500 Stock Index (the “S&P 500”).

As a result, this year we are including the cumulative total return of that index in addition to the broad equity market indices that we included in our Annual Report on Form-10-K for the year ended December 31, 2020.

| October 1 - October 31, 2021 | | | | | | 189,212 | | | | | | $ | 317.10 | | | | | 189,212 | | | | | | $ | 940,000,261 | |

| November 1 - November 30, 2021 | | | | | | 2,249,198 | | | | | | $ | 240.08 | | | | | 2,438,410 | | | | | | $ | 400,003,774 | |

| December 1 - December 31, 2021 | | | | | | 1,049,732 | | | | | | $ | 245.06 | | | | | 3,488,142 | | | | | | $ | 142,751,231 | |

| Total | | | | | | 3,488,142 | | | | | | | | | | | | | | | | | | | | |

Pursuant to the 2021 Repurchase Program, we may repurchase up to $1.0 billion of our outstanding common stock.

Since inception of the 2021 Repurchase Program through December 31, 2021, we repurchased a total of 3.5 million shares of our common stock for an aggregate purchase price of $857 million.

Subsequent to December 31, 2021, the remaining amounts authorized under the 2021 Repurchase Program have been fully utilized.

| [Report of Independent Registered Public Accounting [removed: Firm](#i7a7cdf3fe3c348059a6b0a57c2f167fe_103)] [added: Firm](#iffc0344c00444d7080375d0d85e64bb9_106)] | | | | | | [removed: [114](#i7a7cdf3fe3c348059a6b0a57c2f167fe_103)] [added: [112](#iffc0344c00444d7080375d0d85e64bb9_106)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020](#i7a7cdf3fe3c348059a6b0a57c2f167fe_106)] [added: 2021](#iffc0344c00444d7080375d0d85e64bb9_109)] | | | | | | [removed: [116](#i7a7cdf3fe3c348059a6b0a57c2f167fe_106)] [added: [114](#iffc0344c00444d7080375d0d85e64bb9_109)] | | |

| [Consolidated Statements of Operations for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#i7a7cdf3fe3c348059a6b0a57c2f167fe_109)] [added: 2020](#iffc0344c00444d7080375d0d85e64bb9_112)] | | | | | | [removed: [117](#i7a7cdf3fe3c348059a6b0a57c2f167fe_109)] [added: [115](#iffc0344c00444d7080375d0d85e64bb9_112)] | | |

| [Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#i7a7cdf3fe3c348059a6b0a57c2f167fe_112)] [added: 2020](#iffc0344c00444d7080375d0d85e64bb9_115)] | | | | | | [removed: [118](#i7a7cdf3fe3c348059a6b0a57c2f167fe_112)] [added: [116](#iffc0344c00444d7080375d0d85e64bb9_115)] | | |

| [Consolidated Statements of Stockholders’ Equity for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#i7a7cdf3fe3c348059a6b0a57c2f167fe_115)] [added: 2020](#iffc0344c00444d7080375d0d85e64bb9_118)] | | | | | | [removed: [119](#i7a7cdf3fe3c348059a6b0a57c2f167fe_115)] [added: [117](#iffc0344c00444d7080375d0d85e64bb9_118)] | | |

| [Consolidated Statements of Cash Flows for the years ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#i7a7cdf3fe3c348059a6b0a57c2f167fe_118)] [added: 2020](#iffc0344c00444d7080375d0d85e64bb9_121)] | | | | | | [removed: [121](#i7a7cdf3fe3c348059a6b0a57c2f167fe_118)] [added: [119](#iffc0344c00444d7080375d0d85e64bb9_121)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i7a7cdf3fe3c348059a6b0a57c2f167fe_121)] [added: Statements](#iffc0344c00444d7080375d0d85e64bb9_124)] | | | | | | [removed: [122](#i7a7cdf3fe3c348059a6b0a57c2f167fe_121)] [added: [120](#iffc0344c00444d7080375d0d85e64bb9_124)] | | |

We have audited the accompanying consolidated balance sheets of Moderna, Inc. (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 25, 2022] [added: 24, 2023,] expressed an unqualified opinion thereon.

| *Description of the Matter* | | | | | | As discussed in [removed: Note 2] [added: [Note 2](#iffc0344c00444d7080375d0d85e64bb9_130)] to the consolidated financial statements, the Company has entered into supply agreements with the U.S. Government, other international [removed: governments, Gavi (on behalf of the COVAX facility),] [added: governments] and [removed: the African Union.] [added: organizations.] Under the supply agreements, [added: including related amendments,] the Company is entitled to upfront deposits for COVID-19 vaccine supply, which are initially recorded as deferred revenue. Revenue is recognized pursuant to Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, based on the fixed price per dose when control of the product has transferred and customer acceptance has occurred, unless such acceptance provisions are deemed perfunctory. The Company must evaluate the contractual terms and conditions in its supply agreements to determine the timing of revenue recognition. For the year ended December 31, [removed: 2021,] [added: 2022,] product sales revenue totaled [removed: $17.7 billion and related deferred revenue totaled $6.7] [added: $18.4] billion. Auditing the Company's revenue recognition was especially challenging due to the volume of executed supply agreements, [added: including related amendments,] the varying contractual terms within the agreements, and because the amounts are material to the consolidated financial statements and related disclosures. | | |

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

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

| Cash and cash equivalents | | | [added: | | |] $ | [added: 3,205 | | | | | $ |] 6,848 | | | | | $ | 2,624 | |

| Investments | | | [removed: 3,879] [added: 6,697] | | | | | | [removed: 1,984] [added: 3,879] | | |

| Accounts receivable | | | [removed: 3,175] [added: 1,385] | | | | | | [removed: 1,391] [added: 3,175] | | |

| Inventory | | | [removed: 1,441] [added: 949] | | | | | | [removed: 47] [added: 1,441] | | |

| Prepaid expenses and other current assets | | | [removed: 728] [added: 1,195] | | | | | | [removed: 252] [added: 728] | | |

| Total current assets | | | [removed: 16,071] [added: 13,431] | | | | | | [removed: 6,298] [added: 16,071] | | |

| Investments, non-current | | | [removed: 6,843] [added: 8,318] | | | | | | [removed: 639] [added: 6,843] | | |

| [removed: Property] [added: Property, plant] and equipment, net | | | [removed: 1,241] [added: 2,018] | | | | | | [removed: 297] [added: 1,241] | | |

| Right-of-use assets, operating leases | | | [removed: 142] [added: 121] | | | | | | [removed: 90] [added: 142] | | |

| Restricted cash, non-current [added: (2)] | | | [added: | | |] 12 | | | | | | [added: 12 | | | | | |] 11 | | |

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

[removed: | Other non-current assets | | | 34 | | | | | | 2 | | |][added: Other Non-Current Assets]

| Total assets | | | $ | [removed: 24,669] [added: 25,858] | | | | | $ | [removed: 7,337] [added: 24,669] | |

| Accounts payable | | | $ | [removed: 302] [added: 487] | | | | | $ | [removed: 18] [added: 302] | |

| Accrued liabilities | | | [removed: 1,472] [added: 2,101] | | | | | | [removed: 470] [added: 1,472] | | |

| Deferred revenue | | | [removed: 6,253] [added: 2,038] | | | | | | [removed: 3,867] [added: 6,253] | | |

| Income taxes payable | | | [removed: 876] [added: 48] | | | | | | [removed: —] [added: 876] | | |

| Other current liabilities | | | [removed: 225] [added: 249] | | | | | | [removed: 34] [added: 225] | | |

| Total current liabilities | | | [removed: 9,128] [added: 4,923] | | | | | | [removed: 4,389] [added: 9,128] | | |

| Deferred revenue, non-current | | | [removed: 615] [added: 673] | | | | | | [removed: 177] [added: 615] | | |

| Operating lease liabilities, non-current | | | [removed: 106] [added: 92] | | | | | | [removed: 97] [added: 106] | | |

| Financing lease liabilities, non-current | | | [removed: 599] [added: 912] | | | | | | [removed: 110] [added: 599] | | |

| Other non-current liabilities | | | [removed: 76] [added: 135] | | | | | | [removed: 3] [added: 76] | | |

| Total liabilities | | | [removed: 10,524] [added: 6,735] | | | | | | [removed: 4,776] [added: 10,524] | | |

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

| Preferred stock, $0.0001; 162 shares authorized as of December 31, [removed: 2021] [added: 2022] and [removed: 2020;] [added: 2021;] no shares issued or outstanding at December 31, [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] | | | — | | | | | | — | | |

| Common stock, par value $0.0001; 1,600 shares authorized as of December 31, [removed: 2021] [added: 2022] and [removed: 2020; 403] [added: 2021; 385] and [removed: 399] [added: 403] shares issued and outstanding as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively | | | — | | | | | | — | | |

| Other non-current assets | | | 988 | | | | | | 46 | | |

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

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

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

| Net income | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 8,362 | | | | | | 8,362 | | |

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

| Other non-cash items | | | 28 | | | | | | — | | | | | | — | | |

| Repurchases of common stock | | | (3,329) | | | | | | (857) | | | | | | — | | |

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

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

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

(2) Included in other non-current assets in the consolidated balance sheets.

Investments in publicly traded equity securities with readily determinable fair values are recorded at quoted market prices for identical securities, with changes in fair value recorded in other expense, net, in our consolidated statements of operations.

Investments in equity securities without readily determinable fair values are recorded at cost minus impairment, if any, adjusted for changes resulting from observable price changes in orderly transactions for identical or similar securities.

Such adjustments are recorded in other expense, net, in our consolidated statements of operations.

We are also subject to credit risk from our accounts receivable related to our product sales and collaborators.

We sell our products primarily to U.S. Government, other international governments and organizations.

We do not require collateral or other security to support accounts receivable.

To date, we have not experienced any losses with respect to the collection of our accounts receivable.

| Takeda Pharmaceutical Company | | | 10 | | % | | | | * | | | | | | * | | | | | | * | | | | | | * | | |

| Ministry of Health, Labor, and Welfare of Japan | | | * | | | | | | * | | | | | | * | | | | | | 30 | | % | | | | * | | |

| UK Health Security Agency | | | * | | | | | | * | | | | | | * | | | | | | 11 | | % | | | | * | | |

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

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

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

We also assess whether we have any excess firm, non-cancelable, purchase commitment liabilities, resulting from our supply agreements with third-party vendors, on a quarterly basis.

We hold raw materials beyond our one year forecasted production plan, which were classified as non-current and included in other non-current assets in our consolidated balance sheets.

*Pre-launch Inventory*

Costs relating to raw materials and production of inventory in preparation for product launch prior to regulatory approval are capitalized when future commercialization is considered probable, the future economic benefit is expected to be realized, and we believe that material uncertainties related to the ultimate regulatory approval have been significantly reduced.

For pre-launch inventory that is capitalized, we consider a number of factors based on the information available at the time, including the product candidate’s current status in the drug development and regulatory approval process, results from the related clinical trials, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, potential impediments to the approval process such as product safety or efficacy, historical experience, viability of commercialization and market trends.

As of December 31, 2022, we did not have any capitalized pre-launch inventory on our consolidated balance sheets.

| Land and land improvements | | | | | | Not depreciated | | |

Collaboration Arrangements

We analyze our collaboration arrangements to assess whether they are within the scope of ASC 808 (*Collaborative Arrangements*) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities.

To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature.

If we conclude that some or all aspects of the arrangement represent a transaction with a customer, we account for those aspects of the arrangement within the scope of ASC 606.

Please refer to our "Revenue Recognition" policy within Note 2 for additional discussion of revenue recognition under these types of arrangements.

If we conclude that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, we recognize our allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred.

Research and development costs also include costs and shared cost associated with third-party collaboration arrangements, including upfront fees and milestones paid to third-parties in connection with technologies that had not reached technological feasibility and did not have an alternative future use.

We estimate the expected term of our stock options granted to employees and non-employees using the simplified method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option.

| | | | | | | | | |

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February 25, 2022

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

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

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

| Balance at December 31, 2018 | | | | | | | | | | | | | | | | | | | | | 329 | | | | | | $ | — | | | | | $ | 2,538 | | | | | $ | (1) | | | | | $ | (1,007) | | | | | $ | 1,530 | |

| Transition adjustment from adoption of ASC 606 | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 28 | | | | | | 28 | | |

| Transition adjustment from adoption of ASC 842 | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (4) | | | | | | (4) | | |

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

Moderna, Inc. (collectively, with its consolidated subsidiaries, any of Moderna, we, us, our or the Company) was incorporated in Delaware on July 22, 2016.

We are the successor in interest to Moderna LLC, a limited liability company formed under the laws of the State of Delaware in 2013.

Our principal executive office is located at 200 Technology Square, Cambridge, MA.

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

We have also received authorization for our COVID-19 vaccine from health agencies in more than 70 countries and from the World Health Organization (WHO).

Additional authorizations are currently under review in other countries.

In addition, we have received authorization for our COVID-19 vaccine for use in adolescents in the United Kingdom, European Union, Japan, Canada, Switzerland, Taiwan, Saudi Arabia, Australia, and the Philippines, and have pending applications for authorization to administer the vaccine to adolescents with regulatory agencies in the United States and other countries.

In February 2022, we received approval for the administration of Spikevax to children ages 6-11 in Australia and a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the administration of Spikevax in children ages 6-11 years.

On January 1, 2019, we adopted ASC 606 *(Revenue from Contracts with Customers*) using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2019.

ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

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

| Restricted cash, non-current | | | | | | 12 | | | | | | 11 | | | | | | 11 | | |

grants made by government-sponsored and private organizations, and to a lesser extent, strategic alliances in 2021 and 2020.

Historically, we generated revenue primarily from strategic alliances.

| United Kingdom Government | | | * | | | | | | * | | | | | | * | | | | | | * | | | | | | 11 | | % |

| South Korea Government | | | * | | | | | | * | | | | | | * | | | | | | * | | | | | | 24 | | % |

We maintained letters of credit of $12 million as of December 31, 2021 and 2020, related to our lease arrangements, which are secured by money market accounts in accordance with certain of our lease agreements.

The amounts are recorded at fair value using Level 1 inputs and included as restricted cash in our consolidated balance sheets.

Prior to an initial regulatory approval for our investigational medicines, we expense costs relating to raw materials and production of inventory as research and development expense in our consolidated statements of operations, in the period incurred.

Upon the authorization of distribution and use of our COVID-19 vaccine under an EUA in December 2020, we began to capitalize inventory costs associated with our COVID-19 vaccine, as it was determined that inventory costs incurred subsequent to the EUA had a probable future economic benefit.

| Internally developed software | | | | | | 3 years | | |

Construction in progress includes costs incurred under construction contracts including project management services, engineering services, design services and development, construction services and other construction-related fees and services.

Such costs are not depreciated until the asset is completed and placed into service.

Expenditures for maintenance and repairs are charged to expense as incurred.

Upon retirement or sale, the cost of the assets disposed of, and the related accumulated depreciation, are removed from the accounts, and any resulting gain or loss is recorded to other expense, net in our consolidated statements of operations.

Cost of sales includes cost of raw materials, production, transportation, freight and indirect overhead costs associated with our product sales during the period and third-party royalties on net sales of our product.

Cost of sales also includes adjustments for excess and obsolete inventory to the extent management determines that the cost cannot be recovered based on estimates about future demand.

There were no product sales in 2019.

In June 2021, the agreement with BARDA was further amended to award additional funding of $144 million to support pediatric clinical trials for mRNA-1273.

Table of Content

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: 2021.][added: 2022.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2021,] [added: 2022,] 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: 2021.][added: 2022.]

Based on that evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, [removed: 2021.][added: 2022.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] 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.

Opinion on [removed: the] Internal Control Over Financial Reporting

We have audited Moderna, Inc.’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal [removed: Control—Integrated] [added: 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: December 31, 2020,] [added: 2021,] 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: 2021,] [added: 2022,] and the related notes and our report dated February [removed: 25, 2022] [added: 24, 2023] expressed an unqualified opinion thereon.

February 24, 2023

February 25, 2022

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

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

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

The above summary is not complete and is qualified in its entirety by the Amended and Restated Executive Severance Plan, a copy of which is attached hereto as Exhibit 10.11 and is incorporated herein by reference.

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

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

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

None.

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: 2022] [added: 2023] 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: 2022] [added: 2023] 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: 2022] [added: 2023] 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: 2022] [added: 2023] 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: 2022] [added: 2023] 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.

For a list of the consolidated financial statements included herein, see “Index to Consolidated Financial Statements” under Part [removed: I,] [added: II,] Item 8 of this Annual Report on Form 10-K.

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

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

| 4.3 | | | | | | [Description of Capital [removed: Stock](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[.](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm) [](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm) (10)] [added: Stock.](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm) [(](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[6](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000006/exhibit4312312020.htm)] | | |

| 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 [removed: No.](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex104.htm) [4] [added: No. 4] dated as of June 28, 2016. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex104.htm) | | |

| [removed: 10.6†] [added: 10.12#] | | | | | | [removed: [Amended and Restated Option] [added: [Letter] Agreement by and between [removed: ModernaTX, Inc.] [added: the Company] and [removed: AstraZeneca AB,] [added: Stéphane Bancel,] dated as of June [removed: 15,] [added: 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/d577473dex106.htm)] [added: (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm)] | | |

| [removed: 10.8†] [added: 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. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex108.htm) | | |

| [removed: 10.9] [added: 10.7] | | | | | | [Lease Agreement, by and between Moderna Therapeutics, Inc. and ARE-Tech Square, LLC, dated as of May 26, 2016, as amended by Amendment No. 1 dated as of August 31, 2016, Amendment No. 2 dated as of December 31, [removed: 2016,](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex109.htm) [](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex109.htm)[Amendment] [added: 2016, Amendment] No. 3 dated as of April 24, 2017, Amendment No. 4 dated as of April 13, 2018. (1)](https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex109.htm) | | |

| [removed: 10.10] [added: 10.8] | | | | | | [Fifth Amendment to Lease Agreement, by and between ModernaTX, Inc. and ARE-Tech Square, LLC, dated as of August 28, 2019. [removed: (](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000036/a101fifthamendmentto200tec.htm)[3](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000036/a101fifthamendmentto200tec.htm)[)](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000036/a101fifthamendmentto200tec.htm)] [added: (3)](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000036/a101fifthamendmentto200tec.htm)] | | |

| [removed: 10.11] [added: 10.9] | | | | | | [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) | | |

| [removed: 10.12*] [added: 10.10] | | | | | | [removed: [Third](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm) [A](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[m](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[endment](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[,] [added: [Third Amendment,] dated September 11, [removed: 2018](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[,](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm) [Fourth] [added: 2018, Fourth] Amendment, dated March 28, [removed: 2019](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[,](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm) [and] [added: 2019, and] Omnibus Amendment, dated December 30, 2021, [removed: to](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm) [Net Lease](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)[,] [added: to Net Lease,] dated as of August 29, 2016, as [removed: amended.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)] [added: amended. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1012-norwoodleaseam.htm)] | | |

| [removed: 10.13#] [added: 10.11#*] | | | | | | [Amended and Restated Executive Severance Plan and Form of Participation Letter, as amended on [removed: November 4, 2018. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1011.htm)] [added: February](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm) [23](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)[, 2023.](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1011-amendedandrest.htm)] | | |

| [removed: 10.14#] [added: 10.13#] | | | | | | [Letter Agreement by and between the Company and [removed: Stéphane Bancel, dated as of June](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm) [13, 2018, as amended by Amendment No. 1] [added: Stephen Hoge,] dated as of [removed: November 4, 2018. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1015.htm)] [added: October 17, 2017. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1016.htm)] | | |

| 10.16#* | | | | | | [Offer Letter by and between ModernaTX, Inc. and [removed: Corin](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1016-legoffcorinneo.htm)[ne Le Goff,] [added: Arpa Garay,] dated as [removed: of](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1016-legoffcorinneo.htm) [December 28](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1016-legoffcorinneo.htm)[, 2020](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1016-legoffcorinneo.htm)[.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1016-legoffcorinneo.htm)] [added: of April 21, 2022.](https://www.sec.gov/Archives/edgar/data/1682852/000168285223000011/exhibit1016-arpaofferletter.htm)] | | |

| [removed: 10.19#*] [added: 10.14#] | | | | | | [Employment Letter Agreement between ModernaTX, Inc. and Shannon Klinger, dated as of March 4, [removed: 2021.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)] [added: 2021. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1019-offerlettersha.htm)] | | |

| [removed: 10.20#] [added: 10.19#] | | | | | | [Senior Executive Cash Incentive Bonus Plan. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1017.htm) | | |

| [removed: 10.21#] [added: 10.20#] | | | | | | [Amended and Restated Non-Employee Director Compensation [removed: Policy. (](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000023/exhibit101amendedandrestat.htm)[4](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000023/exhibit101amendedandrestat.htm)[)](http://www.sec.gov/Archives/edgar/data/1682852/000168285219000023/exhibit101amendedandrestat.htm)] [added: Policy, effective October 1, 2022. (10)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000051/exhibit101-directorcompens.htm)] | | |

| [removed: 10.22#] [added: 10.21#] | | | | | | [Form of Indemnification Agreement between the Registrant and each of its officers. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1019.htm) | | |

| [removed: 10.23#] [added: 10.22#] | | | | | | [2018 Employee Stock Purchase Plan. (1)](http://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473dex1020.htm) | | |

| [removed: 10.24#*] [added: 10.23#] | | | | | | [Form [removed: of](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm) [Employee](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm) [Restricted Stock](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm) [Unit](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm) [Award Agreement.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm)] [added: of Employee Restricted Stock Unit Award Agreement. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1024-modernarsuagre.htm)] | | |

| [removed: 10.25#*] [added: 10.24#] | | | | | | [Form [removed: of](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1025-nqsoagreementf.htm) [Employee](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1025-nqsoagreementf.htm) [Non-Qualified] [added: of Employee Non-Qualified] Stock Option [removed: Agreement.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1025-nqsoagreementf.htm)] [added: Agreement. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1025-nqsoagreementf.htm)] | | |

| [removed: 10.26#*] [added: 10.25#] | | | | | | [Form of Non-Employee Director Restricted Stock Unit Award [removed: Agreement.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)] [added: Agreement. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1026-modernarsuagre.htm)] | | |

| [removed: 10.27#*] [added: 10.26#] | | | | | | [Form of Non-Employee Director Non-Qualified Stock Option [removed: Agreement.](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)] [added: Agreement. (7)](https://www.sec.gov/Archives/edgar/data/1682852/000168285222000012/exhibit1027-nqsoagreementf.htm)] | | |

| [removed: 10.28#] [added: 10.27#] | | | | | | [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)[4](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)[)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)] [added: (4)](https://www.sec.gov/Archives/edgar/data/1682852/000168285221000017/exhibit103formofpsuagreeme.htm)] | | |