MRNA 10-K & 10-Q changes, risk factors and insider trading

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

We face risks and uncertainties related to successfully commercializing our products. ForIn example,the in 2024, we facedpast, commercial challenges thathave led to lower-than-expected sales and required us to adapt our business strategy. We experienced difficulties maintaining our COVID vaccine market share and gaining market share in the U.S. for our RSV vaccine, where we were third to market. Moving forward, we may need to dedicate greater resources to our commercial efforts than we anticipate, and we may not realize a return on this investment. Additionally, we may be unsuccessful in accurately anticipating future rates of return for our products, which may adversely impact our accounting estimates.

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

Even if a potential product displayscandidate shows a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may never be successful.

Sales of pharmaceutical products in general depends to a significant extentdepend on adequate coverage, pricing and reimbursement from third-party payors. When a new product is approved, the availability and extent of government and private reimbursement, and the pricing, for that product may be uncertain. Additionally, pricing and reimbursement for any product we develop may be adversely affected by various factors, including:

Additionally, target patient populations for some of our product candidates may be small (e.g., for rare genetic diseases) or require individual customization (e.g., for ourintismeran INTsautogene). The pricing and reimbursement of our medicines, if approved, must be adequate to support commercial infrastructure. If we cannot obtain adequate levels of reimbursement, we may be unable to successfully market and sell our products. TheFurther, manner and level at whichinadequate reimbursement is provided for services related to our products (e.g., for administration to patients) is also important. Inadequate reimbursement for such services may discourage physicians from prescribing or recommending our products, adversely affecting our ability to market or sell those products.

We focus certain of our research and product development activities on treatments for severe rare genetic diseases, where the patient populations are small and difficult to ascertain or small.ascertain. Additionally, our products may only be approved for certain populations or lines of treatment.

Our estimates of addressable patient populations are based on our beliefs,beliefs and have beenare derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of trial participants may be lower than expected and potential clinical trial participants or patients may not be otherwise amenable to treatment with our product candidates or products, or new clinical trial participants or patients may become increasingly difficult to identify or gain access to. Even if we obtain significant market share for our products, if approved, because the potential target populations are small, these medicines may never be profitable. Furthermore, the size of markets that we target may be impacted by health authority recommendations regarding who should receive our products, which may be impacted by the new U.S. federal government administration.

Additionally, the process of obtaining marketing approvals is expensive, time-consuming and uncertain, and can vary substantially based on many factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in law or changes in regulatory review may delay the review of a submitted product application. The FDA and foreign regulators have substantial discretion in the approval process and may refuse to accept any marketing approval application or may decide that our data are insufficient for marketing approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Additional delays or non-approval may result if an FDA advisory committee or other regulator recommends non-approval or restrictions on approval.

Clinical testing is expensive, complex and lengthy, and its outcome is inherently uncertain. Most product candidates that commence clinical trials are never approved as products. Although we have demonstrated historical success with our platform technology, we may not continue to realize the same levels of success with clinical trials in the future. We and our strategic collaborators also may experience unforeseen events during, or as a result of, any clinical trials that we or they conduct that could delay or prevent us or them from successfully developing our product candidates and gaining approval from regulators. EventsSuch that might prevent us from proceeding with clinical trialsevents could include:

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

There are many clinical and manufacturing challenges specific to ourintismeran INT product candidatesautogene and any other neoantigen cancer vaccinestherapies we may develop. These risks include a rapid production turn-around time measured in weeks in order to supply patients in our clinical trials before further progression and mutation of their tumors, the significant costs incurred in making individualized medicines and potential lack of immune responses due to the biology of the tumor or patient’s immune status of the patient.status. These risks apply to our INT product candidatesintismeran and other neoepitope investigational medicine programs.

Additionally, there may be challenges in delivering an adequate quantity of active pharmaceutical ingredient (API) required to drive efficacy due to the limitation in volume of API that can be delivered to a specific location, like a tumor or injured tissue. Our investigational therapies for local injections often require specialized skills for conducting a clinical trial that could delay clinical trials or slow or impair commercialization of a product due to the poor adoption of injected local therapeutics. In addition, the uncertain translatability of target selection from preclinical animal models, including mouse and non-human primate models,models to successful clinical trial results is uncertain and may be impossible,fail, particularly for systemic therapies and cancer vaccines.antigen therapies. In general, several biological steps are required for delivery of mRNA to translate into therapeutically active medicines. These processing steps may differ between individuals or tissues, potentially leading to variable levels of therapeutic protein, variable activity, immunogenicity or variable distribution to tissues for a therapeutic effect. Gene therapies and mRNA medicines may activateelicit oneinnate or moreadaptive immune responses against any and all components ofto the drug product (e.g., the mRNA or themRNA, delivery vehicle,vehicle (such as an LNP) as well as againstor the encoded protein, givingwhich risecould toresult potentialin adverse events or reduced tolerability. In certain settings, immune reactionresponses related adverse events. Eliciting an immune response againstto the encoded protein maylimit impedethe oureffectiveness abilityor todurability achieveof atreatment, pharmacologic effectincluding upon repeat administrationadministration, or arequire sidechanges effect.to dosing, formulation or clinical development plans.

Enrolling participants in our clinical trials is critical to our success. Difficulties or delays in enrolling a sufficient number of clinical trial participants maycould result in increasedincrease costs or affectimpact the timing or outcome of our planned clinical trials, which could prevent trial completion and adversely affect our ability to advance the development of and obtain regulatory approval for our product candidates. Participant enrollment is affected by many factors, including:

•size of the patient population and eligibility criteria for the clinical trial in question, including age-based eligibility criteria limiting subject enrollment to adolescent or pediatric populations;

•adverse results or other adverse safety signals in our trials or related to other product candidates, and theany resulting negative publicity, which could discourage potential clinical trial participants and their doctorsphysicians from participating in our trials; and

Additionally, we may have limited or no ability to influence enrollment in clinical trials where our collaborators control clinical development. Even if we or our strategic collaborators cansuccessfully enroll clinical trial participants, theresome ismay no guarantee that such participants will ultimatelynot be dosed as part of, or complete,complete a clinicalthe trial.

mRNA drug development hasinvolves substantial clinical development and regulatory risksrisks, dueand tonegative the novel natureperceptions of thisour newplatform, class of medicines,products and the negative perception of the efficacy, safety or tolerability profile of any product candidates that we or others develop could adversely affect our business and ability to conduct our business, advance our product candidates or obtain regulatory approvals.

Very fewFew mRNA medicines have been authorized or approved to date by the FDA or other regulators, and efficacy, safetysafety, tolerability and immunogenicity data and real-world evidence with respect to mRNA medicines continue to accumulate. We may observe new, more frequent or more severe adverse events in subjects participating in ongoing clinical trialstrial participants or among individuals vaccinated with mRNA vaccines.individuals. For example, some studies have suggested that our COVID vaccineSpikevax may be associated with higher rates of myocarditis and pericarditis in young males compared to other COVID vaccines. Myocarditis and pericarditis have also been reported following vaccination with other COVID vaccines, including mNEXSPIKE. If similar observations are made in recipients of our other products or product candidates, or if other unexpected safety issues arise, we could suffer significant damage to our reputation and that of our mRNA platform. Such events could lead to other issues, including delays in our other programs, the need to re-design our clinical trials and the need for significant additional financial resources. In addition, the FDA and other regulators may interpret data from our clinical trials differently than we do and such agencies may require us to conduct additional studies or analyses, which could delay or prevent us from obtaining full regulatory approvals in certain jurisdictions or for certain demographics. For example, in October 2021, the FDA requested that we explore a lower dosage for our COVID vaccine in adolescents, which extended the length of clinical trials in this population prior to receiving regulatory authorization. In addition,Further, local legislatures may attempt to regulate or restrict the use of mRNA medicines in their jurisdictions.

Successful discovery and development of mRNA medicines by us or our strategic collaborators is highly uncertain and depends on many factors beyond our or their control.control, Weand constantly makeour business decisions and take calculated risks to advance our development efforts and pipeline, including those relatedrelating to mRNA technology, delivery technologysystems and manufacturing processes,processes whichmay ultimately may be unsuccessful. Promising early-phase product candidates may fail to advance, be delayed in the clinic, be subject to clinical holds or fail to reach the market for many reasons, including:

•nonclinical ornonclinical, preclinical study, or clinical trial,trial results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects or toxicities;

There are no pharmacologic therapies approved to treat the underlying causes of many diseases that we are currently attempting to address or may address in the future. For instance, for many of the rare diseases for which we are developing treatments,diseases, few clinical trials have been attempted, and there are no approved drugs to treat these diseases.attempted. As a result, the design and conduct of clinical trials of product candidates for the treatment of these disorders may take longer, be more costly or be less effective due to the novelty of development in these diseases.effective.

Even if the FDA does findfinds our success criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoint to a degree of statistical significance in our pivotal or other clinical trials.trials, Further, even if we achieve the pre-specified criteria,or our clinical trialsresults may producebe inconsistent or unpredictable or inconsistent results compared against the moreto traditional efficacy endpointsendpoints. inFurther, the trial. The FDA couldmay give overriding weight to other efficacy endpoints over a primary endpoint, even if we achieve statistically significant results on that endpoint, if we do not do so on our secondary efficacy endpoints. The FDA also weighs the benefits of a product against its risks and may view the efficacy results in the context of safety as not being supportive of licensure. Regulators in other countries may make similar findings with respect to these endpoints.

There are only a few approved gene therapy products in the United States orand foreignother jurisdictions, and there have been well-reported significant adverse events associated with their testing and use.use have been reported. Regulatory requirements governing gene therapythese products have evolved and may continue to change in the future, and the implications for mRNA therapies are unknown. For example, the FDA has established an office, now called the Office of Therapeutics Products (OTP), within its Center for Biologics Evaluation and Research (CBER) to consolidate the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review.CBER. In the EU, certain mRNA therapies have been characterized as gene therapy medicinal products, which falls within a broader category known as Advanced Therapy Medicinal Products (ATMPs), which are subject to additional regulatory requirements. In certain other countries, such as Japan, mRNA therapies have not yet been classified or any such classification is not known to us; for example, in Japan, the Pharmaceuticals and Medical Devices Agency has not taken a position on the regulatory classification of mRNA therapies.classified. Notwithstanding the differences between mRNA medicines and gene therapies, the classification of some of our mRNA product candidates as gene therapies in the U.S., the EU and potentially other countries could adversely impact our ability to develop our product candidates.candidates, Forincluding instance,if a clinical hold onapplicable to gene therapy products maywere applyapplied to our mRNA product candidates irrespective of the differences between gene therapies and mRNA.candidates.

Additionally, if any such therapeutic is approved, physiciansphysicians, health care providers, third-party payors and patients may be slow or fail to accept these novel and personalized treatments. Physicians, health care providers and third-party payors often are slow to adopt new products, technologies and treatment practices, particularly those that may also require additional upfront costs and training. Physicians may not be willingunwilling to undergo trainingnecessary totraining, adoptview these novel and potentially personalized therapies, may decide thea particular therapy isas too complex or potentially risky to adopt without appropriate training and may choose not to administer the therapy. Further, due to health conditions, genetic profile or other reasons, certain patients may not be candidates for the therapies.therapies, for many reasons, including due to health conditions or genetic profile. In addition, responses by federal and state agencies, congressional committees and foreign governments to negative public perception, ethical concerns or financial considerations may result in new legislation, regulations or medical standards that could limit our ability to develop or commercialize any product candidates, obtain or maintain regulatory approval or otherwise achieve profitability. Based on these and other factors, health care providers and payors may decide that the benefits of these new therapies do not or will not outweigh their costs.

Even if we obtain regulatory approval in a jurisdiction, we may remain subject to significant restrictions on the indicated uses or marketing of our product and ongoing requirements for potentially costly post-approval studies-suchstudies, such as those required under an accelerated approval by the FDA or other similar type of approval-orapproval, or post-market surveillance. For example, thea BLA holder of an approved BLA must monitor and report adverse events and monitor and report any failure of a product to meet theapplicable specifications in the BLA,specifications, as well as submit new or supplemental applications and obtain FDA approval for certain changesnew or supplemental applications relating to the approved product, product labeling,labeling or manufacturing process. Additionally, pharmacovigilance obligations under the regulatory regimes of the jurisdictions where our products are distributed require us to collect, process, analyze and monitor safety data and to identify and evaluate adverse reactions to our products as they are administered in those jurisdictions. If we or any of our partners assisting us in meeting these obligations cannot comply with relevant regulations, we may be subject to sanctions, increased costs and reputational harm, or our regulatory authorizations to distribute our vaccines in the relevant jurisdiction may be revoked or curtailed. In addition, regulators may increasingly rely on post-approval studies or real-world evidence to determine whether to maintain, modify or expand approved indications or population eligibility, which could increase costs, delay commercialization or limit the scope of approved use of our products.

We are a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA). mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across fourinfectious franchises: respiratory virus vaccines, latent and other virusdisease vaccines, oncology therapeutics and rare disease therapeutics.

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 several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We currently have three commercial products—Spikevax® and mNEXSPIKE®, our COVID vaccines, and mRESVIA®, our vaccine against respiratory syncytial virus (RSV). We also have a diverse and extensive development pipeline of 3425 development candidates across our 4435 development programs,programs of which 41 arecurrently in clinical studies currently.studies.

NetTotal Product SalesRevenue and Net (Loss) Earnings Per Share

For the year ended December 31, 2024,2025, we recognized nettotal product salesrevenue of $3.1$1.9 billion from sales of our COVID and RSV vaccines, compared to $6.7$3.2 billion and $18.4$6.8 billion for the years ended December 31, 20232024 and 2022,2023, respectively. Loss per share was $(9.287.26) for the year ended December 31, 2024,2025, compared to (loss) earnings per share of $(12.339.28) and $20.12$(12.33) for the years ended December 31, 20232024 and 2022,2023, respectively.

RespiratoryInfectious Disease Vaccines

Rare DiseasesDisease Therapeutics

•Methylmalonic acidemia (MMA) therapeutic: Our investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program.program, We and the FDA have agreed on the pivotal study design. We expect to startwith a registrational study expected to begin in the first half of 2025.2026.

InWe the third quarter of 2023, we commenced sales ofsell our COVID vaccineand RSV vaccines to the U.S. commercial market,market inas additionwell to continuing salesas to foreign governments and international organizations. We also commenced sales of our RSV vaccine in the third quarter of 2024. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions.

(1)Includes an adjustment of approximately $216 million for the full yearin 2024, reflecting a reduction in prior year provision estimates, primarily related to returns and chargebacks for the previous COVID vaccine season. Adjustments recorded in 2025 related to prior year provision estimates were not material.

Other revenue comprises grant revenue, collaboration revenue, and licensing and royalty revenue and stand-ready manufacturing revenue. Grant and collaboration revenues have been primarily derived from government-sponsored and private organizations including the Biomedical Advanced Research and Development Authority (BARDA), the Defense Advanced Research Projects Agency (DARPA) and the Gates Foundation and from strategic alliances with Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex) and others to discover, develop, and commercialize potential mRNA medicines. Licensing and royalty revenue is related to our out-licensing agreement for mRNA COVID related intellectual property in Japan, executed in 2024. Stand-ready manufacturing revenue relates to long-term strategic agreements with certain government entities to maintain manufacturing readiness, while the remaining consideration under these agreements is related to product sales.

Cost of sales includes raw materials, personnel andpersonnel, facility and other indirect overhead costs associated with manufacturing our commercial products. These costs include production materials, production costs at our manufacturing facilities, third-party manufacturing costs, and final formulation and packaging costs. Cost of sales also includes shipping costs, indirect overhead costs associated with our product sales during the period, third-party royalties on net sales of our products, and charges for inventory valuation, excess and obsolete inventory and losses on firm purchase commitments.

Discovery and platform research expenses include costs associated with early-stage research activities for preclinical programs and the development of technical advances in mRNA science, delivery science, and manufacturing process design. These costs include external CRO and lab services, personnel-related costs, computertechnology equipment,and digital, facilities, and other administrativedirectly attributable research support costs.

Changes in expectations or outcomes of any of the known or unknown risks and uncertainties may materially impact our expected research and development expenditures. Continued research and development is central to the ongoing activities of our business. Investigational medicines in later stages of clinical development, such as our norovirusintismeran vaccine,autogene, seasonalnorovirus, and flu+COVID vaccine,combination vaccine candidates, and development of any new generationsCOVID vaccines against variants of COVID vaccines, combination vaccines, CMV vaccine, and our INT program,SARS-CoV-2, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. In addition, we may incur research and development costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. We expect our research and development costs to be substantial in the near term as our investigational medicines advance through development phases and as we identify and develop additional programs.

Selling, general and administrative expenses consist primarily of personnel-related costs, including stock-based compensation, for executives, finance, legal, human resources, business development, commercial, marketing, and other administrative and operational functions, professional fees, accounting and legal services, informationtechnology technologyand digital and facility-related costs, and expenses associated with obtaining, maintaining, and defending intellectual property (IP). These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.

Prior to 2024, selling, general and administrative expenses increased annually as we expanded our commercial infrastructure to support the global commercialization of our COVID vaccine. These increases were driven by investments in building regulatory, sales, and marketing teams, establishing subsidiaries in multiple countries, and supporting operational growth. In 2025 and 2024, selling, general and administrative expenses decreased significantly year over year by $156 million and $375 million, or 13% and 24%, compared to 2023.respectively. This decline reflects our focus on productivity improvements, cost-saving initiatives, and targeted investments that strengthen our overall efficiency.

Other expense, net consists of interest expense, gains or losses related to the sale of investments in marketable securities, changes in fair value of investments in equity securities, foreign currency transactions, remeasurements and hedges, and other income and expense unrelated to our core operations. Interest expense is primarily derived from our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, and certain contract manufacturing service agreements.agreements, and, beginning in November 2025, interest associated with our long-term debt (see Note 10 and Note 11 to the consolidated financial statements).

While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policy used in the preparation of our consolidated financial statements requirerequires the most significant judgments and estimates.

Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S. Government, foreign governments and organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns. In the third quarter of 2023, we commenced sales of our latest COVID vaccineSpikevax to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations.organizations, and subsequently expanded our commercial COVID vaccine portfolio with the launch of mNEXSPIKE in the third quarter of 2025. We also commenced sales of our RSV vaccine in the third quarter of 2024. In the U.S., our COVID vaccine and RSV vaccinevaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.

We recognize net product sales when control of the product transfers to the customer, typically upon delivery. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, government rebates, and other related deductions. These provisions are recorded based on contractual terms, our estimate of returns for product sold, and other relevant considerations, during the period, using the expected value method or the most likely amount method. Estimates are assessed each period and adjusted as required to revise information or actual experience. Please refer toSee Note 2 to our consolidated financial statements for further discussion and analysis of each significant category of product sales provisions and the accounting policy.

The application of our critical accounting policies necessitates substantial management judgment and estimation, particularly when determining the amount of variable consideration to recognize. The subjectivity of this process is heightened when assessing factors outside our direct control such as the limited historical data, constrained third-party information, and evolving market dynamics. Among all variables, estimating returns presents the most significant judgment due to the broad range of potential outcomes and the current lack of established return trends. While we now have onetwo yearyears of data on our product returns, this remains insufficientlimited toand establishsubject reliablesignificant patterns.variability given current market conditions. We will continue to enhancerefine our projections as additional information becomes available. The actual results could differ from our estimates, and such differences could have a material impact to our financial statements.

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 several modalities, a broad intellectual property portfolio and integrated manufacturing capabilities that allow for rapid clinical and commercial production at scale. We currently have four approved products—Spikevax® and mNEXSPIKE®, our COVID vaccines; mRESVIA®, our vaccine against respiratory syncytial virus (RSV); and mCOMBRIAX®, our flu plus COVID combination vaccine, which was recently approved in Europe for individuals 50 years of age and older. We also have a diverse development pipeline of 2526 development candidates across our 3536 development programs currently in clinical studies.

In April 2026, we received marketing authorization from the European Commission (EC) for mCOMBRIAX (mRNA-1083), our mRNA combination vaccine for the prevention of influenza disease and COVID-19 in individuals 50 years of age and older. The marketing authorization follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is our fourth authorized product and further strengthens our respiratory portfolio and commitment to the European Union.EU. The vaccine builds on advances from the clinical development of mNEXSPIKE and mRNA-1010, our investigational seasonal influenza vaccine. mCOMBRIAX will be made available across the European Union,EU, subject to national regulatory and access procedures, and we are working with national authorities to support local access and implementation.

For the firstsecond quarter of 2026, we recognized total revenue of $389$145 million, compared to $108$142 million for the firstsecond quarter of 2025. Net loss per share was $(3.401.97) for the firstsecond quarter of 2026, compared to net loss per share of $(2.522.13) for the firstsecond quarter of 2025.

•Seasonal flu + COVID vaccine: We received EC marketing authorization for mCOMBRIAX in the EU and our mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. We are awaiting further guidance from the U.S. Food and Drug Administration (FDA) on refiling the submission for mRNA-1083.our Influ addition,plus weCOVID recentlycombination presented mRNA-1083 data from a Japanese cohort at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress.vaccine.

•Seasonal flu vaccine: The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026. Our mRNA-1010 regulatory filings are also under review in Europe, Canada and Australia, and potential approvals are expected to begin in 2026. WeThe recentlyFDA presentedhas assigned a PDUFA date for mRNA-1010 revaccinationof dataAugust at5, the 2026 ESCMID Global Congress.2026.

•Intismeran autogene: We are advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC.

We recently announcedpresented anpositive upcomingfive-year oralPhase presentation2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) Annual MeetingMeeting. highlightingThe positive five-year Phase 2b adjuvant melanoma data, whichdata showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.

•mRNA-4359. Our Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. We recently presented mRNA-4359 data at the American Association for Cancer Research (AACR) 2026 Annual Meeting. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and we expect a potential Phase 2 data readout in 2026.NSCLC.

•Propionic acidemia (PA) therapeutic: Our investigational therapeutic for PA (mRNA-3927) is in a registrational study and target enrollment has been reached. We expect potential data in 2026.

•Methylmalonic acidemia (MMA) therapeutic: We are deferringdeferred our decision on a pivotal trial for mRNA-3705 until PA registrational data readout.

As of MarchJune 31,30, 2026, we have threefour commercialapproved products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA.mRESVIA, and our flu and COVID combination vaccine, mCOMBRIAX, which has received EC marketing authorization in the EU. We launched commercial sales of mNEXSPIKE in the third quarter of 2025. As of June 30, 2026, mCOMBRIAX had not been commercialized.

We sell our COVID vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to foreign governments and international organizations. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns and government rebates, and other related deductions.

Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of MarchJune 31,30, 2026, we had deferred revenue of $95$265 million related to product sales, of which $37$207 million is expected to be realized in less than one year.

For the threesix months ended MarchJune 31,30, 2026, total revenue increased by $281$284 million, or 260%,114%, compared to the same period in 2025, primarily driven by an increase in net product sales.2025. Net product sales increased by $266$246 million, or 309%,123%, mainlyprimarily due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Other revenue also increasedincreased, compared to the same period in 2025,primarily reflecting higher stand-ready manufacturing revenuerevenue, including from facilities under these partnerships, including those that became operational laterduring inthe 2025.second half of 2025, and higher collaboration revenue.

Cost of sales for the three months ended MarchJune 31,30, 2026 was $955$93 million, which included inventory write-downs of $41 million, unutilized manufacturing capacity costs of $23 million, and third-party royalties of $11 million. Cost of sales for the six months ended June 30, 2026 was $1.0 billion, which included third-party royalties of $895$906 million, inventory write-downs of $38$79 million, primarily related to our finished and semi-finishedunutilized COVIDmanufacturing vaccinecapacity inventorycosts andof raw$25 materials relative to updated demand forecasts, as well as shelf-life expiration and other adjustments.million. Third-party royalties included $878$6 million and $884 million for the three and six months ended June 30, 2026, respectively, related to the litigation settlement with Arbutus and Genevant,Genevant as well asand amortization of the associated intangible asset. Please refer to Note 12, Commitments and Contingencies, to our condensed consolidated financial statements for additional information. Inventory write-downs in 2026 reflectedprimarily arelated combinationto ofour factors,finished includingand changessemi-finished invaccine inventory and raw materials relative to updated demand expectations,forecasts, expiration,shelf-life scrapexpiration and other adjustments. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges.

Cost of sales for the three months ended MarchJune 31,30, 2026 increaseddecreased by $865$26 million, or 961%,22%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue was 249% for the three months ended MarchJune 31,30, 2026,2026 was 74%, compared to 92%91% for the correspondingsame period in 2025. The decreases were primarily due to lower unutilized manufacturing capacity costs. Cost of sales for the six months ended June 30, 2026 increased by $839 million, or 401%, compared to the same period in 2025. Cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the six months ended June 30, 2026 was 206%, compared to 91% for the same period in 2025. The increase was primarily driven by litigation settlement-related expenses recognized in the first quarter of 2026.expenses. Excluding these expenses, cost of sales and cost of sales as a percentage of net product sales and stand-ready manufacturing revenue for the six months ended June 30, 2026 decreased by 14%59% and 7265 percentage points, respectively, compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs,costs and losses on firm purchase commitments and inventory write-downs,commitments, partially offset by higher sales volume.

In 2026, we anticipate thata modest decrease in cost of sales will remain at a relatively consistent level compared to 2025, reflecting continued manufacturing productivity improvements and operational efficiencies. This expectation excludes the impact of the settlement with Arbutus and Genevant, for which we recorded a charge of $878$884 million in cost of sales induring the first quarterhalf of 2026 and expect additional amortization expense in the remainder of the year. Excluding this impact, to the extent net product sales increase, cost of sales as a percentage of net product sales and stand-ready revenue maywill decrease modestly.moderately.

We anticipate a modest reduction in research and development expenses in 2026 compared to 2025, primarily driven by the wind-down of several late-stage programs, continued portfolio prioritization, disciplined cost management, and a focused approach to pipeline execution. These reductions are expected to be partially offset by certain clinical trial activities shifting from 2025 into 2026 and additional costs related to post-marketing commitments. We remain committed to advancing our pipeline and late-stage programs, including intismeranour autogeneoncology and norovirusrare vaccinedisease programs, while continuing to manage research and development investment levels in line with our long-term objectives.

For the three months ended MarchJune 31,30, 2026, interest income decreased by $18$14 million, or 20%,17%, compared to the same period in 2025. For the six months ended June 30, 2026, interest income decreased by $32 million, or 19%, compared to the same period in 2025. The decrease in each period was primarily due to lower average investment balances and interest rates.

For the three and six months ended MarchJune 31,30, 2026, we recorded total other expense, net increasedof by$19 $14million and $37 million, or 350%,respectively, compared to total other income, net of $8 million and $4 million for the same periodperiods in 2025. The increase in other expense, net for the three and six months ended June 30, 2026, was largely driven by higher interest expense.expense and lower net gains on foreign currency transactions. Interest expense is primarily related to our long-term debt issued in November 2025 and finance leases related to certain contract manufacturing service agreements and, beginning in November 2025, interest associated with our long-term debt.agreements. Please refer to Note 10 and Note 11 to our condensed consolidated financial statements for additional information.

Provision for income taxes increased by $8 million and $10 million, or 114% and 71%, for the three and six months ended MarchJune 31,30, 2026, remainedcompared immaterial and consistent withto the same periods in 2025.2025, primarily because certain of our foreign subsidiaries generated higher taxable income while we incurred a consolidated pre-tax loss. The effective tax rate continues to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the losses. Please refer to Note 14 to our condensed consolidated financial statements for additional details.

The following table summarizes our cash, cash equivalents, investments and working capital as of MarchJune 31,30, 2026 and December 31, 2025 (in millions):

Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of MarchJune 31,30, 2026 decreased by $679$1.2 million,billion, or 8%,15%, compared to December 31, 2025. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $630$1.2 millionbillion and purchases of property and equipment of $62$99 million during the threesix months ended MarchJune 31,30, 2026.

Working capital, defined as current assets less current liabilities, decreased by $1.2$1.3 billion, or 26%,28%, as of MarchJune 31,30, 2026, compared to December 31, 2025. This was primarily driven by a decrease in cash, cash equivalents and current investments of $594$661 million to fund operations, an increase in accrued liabilities and accounts payable of $370$523 million, includinglargely driven by the $950 million related to the litigation settlement,settlement accrual partially offset by lower spend duringin the period, and a $196 million increase in deferred revenue primarily associated with advance payments for products, partially offset by a decrease in accounts receivablepayable of $113$150 million primarily driven by timing of collections.million.

As of MarchJune 31,30, 2026, we did not have any off-balance sheet arrangements. For a discussion of our contractual obligations and commitments, refer to our 2025 Form 10-K.

We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements. Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. Wholesalers and distributors typically do not make upfront payments to us. In addition, we receive customer advance payments related to certain other revenue arrangements. As of MarchJune 31,30, 2026, we had $256$442 million in deferred revenue related to customer advance payments received or billable.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $630$1.2 millionbillion and consisted of net loss of $1.3$2.1 billion, non-cash adjustments of $160$337 millionmillion, and a net change in assets and liabilities of $553$632 million. Non-cash items primarily included stock-based compensation of $104$224 million,million and depreciation and amortization of $59$122 million. The net change in assets and liabilities was mainly due to an increase in accrued liabilities and accounts payable of $344$347 million, includingdriven by the $950 million related to the litigation settlement,settlement accrual, partially offset by lower spend during the period, an increase in deferred revenue of $195 million driven by customer advance payments, and a decrease in accounts receivables,receivable, net of $114$167 million due to timing of collections, andpartially aoffset decreaseby an increase in prepaid and other assetsinventory of $54$126 million,million driven by aincreased decreaseproduction infor vendorthe prepayments.upcoming season.

Net cash used in operating activities decreased by $407$800 million, or 39%,41%, during the threesix months ended MarchJune 31,30, 2026, compared to the same period in 2025, primarily attributable to a change in accrued liabilities and accounts payable of $881$945 million, includinglargely driven by the $950 million related to the litigation settlement.settlement This decrease wasaccrual, partially offset by an increase in net loss of $372$329 million and a decrease in accounts receivable, net of $166 million, driven by timing of collections.million.

Net cash provided by investing cashactivities flows decreased by $806 million, or 110%, duringfor the threesix months ended MarchJune 31,30, 2026,2026 comparedwas to$253 themillion, same period in 2025,driven primarily due to a decrease inby proceeds from maturities and sales of marketable securities of $1.3$2.3 billion, partially offset by a decrease in purchases of marketable securities of $416$1.9 million,billion, and a decrease in purchases of plant, property and equipment of $55$99 million.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 was $17$31 million, primarily related to proceeds from issuance of common stock through equity plans.

Net cash provided by financing activities increased by $13$18 million, or 325%,138%, during the threesix months ended MarchJune 31,30, 2026, compared to the same period in 2025, mainly due to an increase in proceeds from issuance of common stock through equity plans of $16$25 million.

Our principal sources of funding as of MarchJune 31,30, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $1.3$2.1 billion for the threesix months ended MarchJune 31,30, 2026 and net losses of $2.8 billion and $3.6 billion for the years 2025 and 2024, respectively. Historically, from our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following the authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We have retained earnings of $5.9$5.1 billion as of MarchJune 31,30, 2026.

We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs. We anticipate maintaining substantial expenses across all areas of our ongoing activities, particularly as we continue research and development of our development candidates and clinical activities for our investigational medicines. This also extends to our manufacturing costs, including our arrangements with our supply and manufacturing partners. Our ongoing work on our intismeran autogene, norovirus, and flu+ plus COVID combination vaccine candidates, our other oncology programs, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which will not be reimbursed or otherwise paid for by our collaborators or alliances. We may also incur additional costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. In addition, we have substantial facility, lease and purchase obligations.obligations, as well as the $950 million litigation settlement obligation accrued as of June 30, 2026, which was paid in July 2026. We have entered into various collaboration and licensing agreements, as well as research and development funding arrangements with third parties. These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangement, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.

In November 2025, we entered into a Credit and Guaranty Agreement (Credit Agreement) with lenders led by Ares Capital Corporation, as administrative agent, providing for a term loan facility with aggregate commitments of $1.5 billion. As of DecemberJune 31,30, 2025,2026, we had drawn $600 million under the initial term loan. The Credit Agreement also provides for $900 million of delayed draw term loan commitments, consisting of $400 million available, subject to applicable conditions, through November 2027 and $500 million available, subject to applicable conditions and specified regulatory approval milestones, through November 2028. Borrowings under the Credit Agreement bear interest at a variable rate based on Term SOFR or a base rate, at our option, plus an applicable margin, with interest payable periodically and the principal amount due in full at maturity in November 2030. The Credit Agreement includes customary affirmative and negative covenants, with which we were in compliance as of MarchJune 31,30, 2026. See Note 11 to our condensed consolidated financial statements for additional information.

We believe that our cash, cash equivalents, and investments as of MarchJune 31,30, 2026, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of these financial statements included in this Form 10-Q. In July 2026, we paid the $950 million litigation settlement that was accrued as of June 30, 2026. We are subject to all the risks related to the development and commercialization of novel medicines, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors, which may adversely affect our business. For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend continued in 2025 as the market transitions to a more competitive and commercially driven environment, with broader external factors continuing to affect market dynamics. We foresee that our commitment to investing in our business for future product launches may lead to continued negative cash flows from operations in upcoming periods. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

There have been no material changes in our critical accounting policies and estimates in the preparation of our condensed consolidated financial statements during the three months ended MarchJune 31,30, 2026 compared to those disclosed in our 2025 Form 10-K.

As of MarchJune 31,30, 2026, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2025 Form 10-K.