Moderna, Inc.
For the period ended Mar 31, 2026. Filed May 1, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 1, 2026
MRNA$254.19+5.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001682852-25-000075
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-01.
0001682852-26-000060
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 95 previous paragraphs and 92 current paragraphs.
32 unchanged; 35 reworded; 25 added; 27 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (25)
Current report
Strategic Collaboration with Recordati
Current report
In January 2026, we announced a strategic collaboration with Recordati S.p.A. (Recordati) to advance our investigational propionic acidemia (PA) therapeutic, mRNA-3927, through the final stages of clinical development and, upon approval, global commercialization. The transaction closed on March 16, 2026. Under the agreement, we will continue to lead clinical development of mRNA-3927 through approval, and Recordati will lead commercialization. Recordati has an established global commercial infrastructure and expertise in rare diseases, including PA, which is expected to support commercialization upon approval. mRNA-3927 targets a serious rare metabolic disease with significant unmet medical need and is currently being evaluated in a registrational study that has reached target enrollment, with potential data expected in 2026. Under the terms of the agreement, Recordati agreed to make an upfront payment of $50 million and are we are eligible to receive up to an additional $110 million in development and regulatory milestone payments, in addition to commercial and sales milestones and tiered royalties on net sales.
Current report
In February 2026, we signed a memorandum of understanding for a long-term strategic agreement with the Government of Mexico, Laboratorios de Biológicos y Reactivos de Mexico (BIRMEX), and Laboratorios Liomont (Liomont) to support the development of local mRNA manufacturing capabilities and strengthen pandemic preparedness. The agreement includes the supply of our respiratory vaccine portfolio and a technology transfer to Liomont to enable domestic manufacturing of our COVID vaccine, mRNA-1273. In addition, the collaboration is expected to support local clinical research and development activities aligned with Mexico’s public health priorities.
Current report
Settlement with Arbutus and Genevant
Current report
On March 3, 2026, we entered into a settlement agreement with Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant, and with Arbutus, Arbutus/Genevant) resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware. The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax and mRESVIA and provides certainty going forward for our full infectious disease portfolio, including mNEXSPIKE, mCOMBRIAX and our future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, we agreed to make a lump sum payment of $950 million, which is payable in the third quarter of 2026. Consistent with the terms of the settlement agreement, we have appealed the District Court’s decision related to 28 U.S.C. § 1498 to the Federal Circuit Court of Appeals and could be required to make an additional payment of up to $1.3 billion depending on the outcome.
Current report
European Commission Marketing Authorization for mCOMBRIAX
Current report
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 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. 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, subject to national regulatory and access procedures, and we are working with national authorities to support local access and implementation.
Current report
Infectious Disease Vaccines
Current report
•Seasonal flu + COVID vaccine: We received EC marketing authorization for mCOMBRIAX in the EU and our mRNA-1083 regulatory filings are under review in Canada and Australia. We are awaiting further guidance from the U.S. Food and Drug Administration (FDA) on refiling the submission for mRNA-1083. In addition, we recently presented mRNA-1083 data from a Japanese cohort at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress.
Current report
•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. We recently presented mRNA-1010 revaccination data at the 2026 ESCMID Global Congress.
Current report
•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.
Current report
Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. We expect Phase 3 adjuvant melanoma data potentially in 2026.
Current report
We recently announced an upcoming oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting highlighting positive five-year Phase 2b adjuvant melanoma data, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.
Current report
•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.
Current report
Rare Disease Therapeutics
Current report
•Methylmalonic acidemia (MMA) therapeutic: We are deferring our decision on a pivotal trial for mRNA-3705 until PA registrational data readout.
Current report
(1)Includes sales of Spikevax and mNEXSPIKE.
Current report
For the three months ended March 31, 2026, total revenue increased by $281 million, or 260%, compared to the same period in 2025, primarily driven by an increase in net product sales. Net product sales increased by $266 million, or 309%, mainly due to higher COVID vaccine sales in international markets, driven by deliveries under long-term strategic partnerships with government entities. Other revenue also increased compared to the same period in 2025, reflecting higher stand-ready manufacturing revenue from facilities under these partnerships, including those that became operational later in 2025.
Current report
Product sales are expected to return to growth in 2026, supported by the full-year impact of long-term strategic partnerships with government entities.
Current report
Cost of sales for the three months ended March 31, 2026 was $955 million, which included third-party royalties of $895 million, inventory write-downs of $38 million, primarily related to our finished and semi-finished COVID vaccine inventory and raw materials relative to updated demand forecasts, as well as shelf-life expiration and other adjustments. Third-party royalties included $878 million related to the litigation settlement with Arbutus and Genevant, as well as 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 reflected a combination of factors, including changes in demand expectations, expiration, scrap and other adjustments. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges.
Current report
Cost of sales for the three months ended March 31, 2026 increased by $865 million, or 961%, 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 March 31, 2026, compared to 92% for the corresponding period in 2025. The increase was primarily driven by litigation settlement-related expenses recognized in the first quarter of 2026. Excluding these expenses, cost of sales and cost of sales as a percentage of net product sales and stand-ready manufacturing revenue decreased by 14% and 72 percentage points, respectively, compared to the same period in 2025, primarily due to lower unutilized manufacturing capacity costs, losses on firm purchase commitments and inventory write-downs, partially offset by higher sales volume.
Current report
In 2026, we anticipate that 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 million in cost of sales in the first quarter 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 may decrease modestly.
Current report
We expect selling, general and administrative expenses in 2026 to remain at a level relatively consistent with 2025, reflecting an efficient and scalable operating structure. While we will continue to make selective investments to support our key priorities, including our global commercial and regulatory activities, we expect these investments to be largely offset by ongoing efficiency initiatives and disciplined resource allocation.
Current report
Other expense, net
Current report
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 December 31, 2025, 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 March 31, 2026. See Note 11 to our condensed consolidated financial statements for additional information.
Removed paragraphs (27)
Previous report
COVID Vaccines
Previous report
We have received approval in 40 countries for our 2025-2026 formula for Spikevax. We have also received U.S. Food and Drug Administration (FDA) approval of our 2025-2026 formula for mNEXSPIKE, our new COVID vaccine, in all adults aged 65 and older, as well as individuals aged 12 to 64 years with at least one underlying risk factor. mNEXSPIKE is also approved in Canada and we have filed and are targeting 2026 approvals in Australia, the EU, Japan and Taiwan.
Previous report
mRESVIA
Previous report
mRESVIA, our vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV, has been approved for adults aged 60 years and older in 40 countries. It is also approved in 31 of those countries for individuals 18 to 59 years of age who are at increased risk for disease.
Previous report
Moderna's International mRNA Manufacturing Facilities
Previous report
In the third quarter of 2025, our mRNA manufacturing facilities in Australia and the United Kingdom were licensed and became operational. These facilities were established under long-term strategic agreements with the respective governments to support domestic mRNA manufacturing and pandemic preparedness. The facilities will enable local supply of our mRNA vaccines and provide rapid response capabilities in the event of future public health emergencies.
Previous report
Respiratory Virus Vaccines
Previous report
•COVID: In September 2025, we announced positive preliminary immunogenicity data from ongoing Phase 4 clinical trials evaluating the 2025-2026 formulas of our COVID vaccines, Spikevax and mNEXSPIKE. The 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2, generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across individuals 12 through 64 years of age with at least one underlying condition that increases their risk for severe outcomes from COVID, and all adults 65 years of age and older. The 2025–2026 formula of mNEXSPIKE, which also targets the LP.8.1 variant, generated greater than a 16-fold increase in LP.8.1-neutralizing antibodies across the same age groups. The safety profiles for both vaccines were consistent with previous studies, with no new safety concerns identified.
Previous report
•Seasonal flu vaccine: In October 2025, we presented Phase 3 efficacy and safety data for our seasonal flu vaccine (mRNA-1010) at IDWeek 2025, and Phase 3 relative vaccine efficacy in a high-risk subset of patients at The European Scientific Working Group on Influenza (ESWI) Conference. We expect to complete submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe by January 2026.
Previous report
•Seasonal flu + COVID vaccine: We presented Phase 3 immunogenicity subanalyses for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at the ESWI Conference. We expect to refile with Health Canada in 2025 and are awaiting further guidance from the FDA on refiling. Currently, our mRNA-1083 filing is under review with the European Medicines Agency (EMA).
Previous report
Latent and Other Virus Vaccines
Previous report
•Cytomegalovirus (CMV) vaccine: In October 2025, we announced topline results from the Phase 3 pivotal trial evaluating the efficacy of mRNA-1647, our investigational CMV vaccine. The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16 to 40 years of age). We will discontinue our congenital CMV clinical development program. The Phase 3 trial was a randomized, observer-blind, placebo-controlled study. The study included approximately 7,500 women 16 to 40 years of age from approximately 300 sites across 13 countries, representing the largest trial assessing the efficacy of a CMV vaccine to-date. Vaccine efficacy against primary CMV infection in healthy women was well below our target, ranging from 6% to 23%, depending on the case definition used.
Previous report
We plan to continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients.
Previous report
•Intismeran autogene (INT): We continue to make progress on advancing mRNA-4157 in the clinic. In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for individuals with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma is also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, we and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC.
Previous report
•Checkpoint adaptive immune modulation therapy (AIM-T). The Phase 1/2 study of mRNA-4359, our investigational mRNA-based therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells, is ongoing. Phase 1b data for mRNA-4359 was recently presented at the 2025 European Society for Medical Oncology (ESMO) Congress. The Phase 2 portion of the study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling patients.
Previous report
Rare Diseases
Previous report
•Methylmalonic acidemia (MMA) therapeutic: We recently shared interim data from the Phase 1/2 study of our investigational therapeutic for MMA (mRNA-3705) at ICIEM 2025. mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. We and the FDA have agreed on the pivotal study design. We expect to start a registrational study in 2026.
Previous report
•Glycogen storage disease type 1a (GSD1a): In October 2025, we decided to discontinue our Phase 1 study of mRNA-3745, our rare disease therapeutic targeting GSD1a, in order to evaluate how advancements in our mRNA platform technology can best be applied to this program.
Previous report
For the three and nine months ended September 30, 2025, total revenue decreased by $846 million, or 45%, and $1.0 billion, or 44%, respectively, compared to the same periods in 2024, driven by a decline in net product sales. Net product sales decreased by $847 million, or 47%, for the three-month period and $999 million, or 46%, for the nine-month period, primarily due to lower COVID vaccine sales in both the U.S. and international markets. The decrease was more pronounced in the U.S., reflecting lower overall COVID vaccination rates compared to the prior year, and the absence of an approximately $140 million positive adjustment related to sales provision estimates that was recorded in the third quarter of 2024. Outside the U.S., net product sales also declined, mainly due to the completion of certain advance purchase agreements with government customers and the timing of deliveries between the third and fourth quarters of 2025. Other revenue was relatively flat compared to the prior year for both periods, as lower royalty and collaboration revenue were largely offset by higher revenue related to our stand-ready obligation to maintain manufacturing readiness.
Previous report
We expect demand for our COVID and RSV vaccines to follow a seasonal pattern aligned with fall and winter vaccination campaigns in both hemispheres. As COVID has transitioned to a seasonal respiratory vaccine, we anticipate a decline in net product sales for the full year 2025 compared to 2024, primarily due to lower expected vaccination rates and a more competitive commercial market environment. Although we commenced sales of our RSV vaccine in the third quarter of 2024, product sales from our RSV vaccine are not expected to present a significant portion of total product sales in 2025.
Previous report
Cost of sales for the three months ended September 30, 2025 was $207 million, which included third-party royalties of $43 million, and inventory write-downs of $67 million. Cost of sales for the nine months ended September 30, 2025 was $416 million, which included third-party royalties of $54 million, inventory write-downs of $147 million, primarily related to our finished and semi-finished COVID vaccine inventory and certain raw materials, unutilized manufacturing capacity and wind-down costs of $50 million, and losses on firm purchase commitments of $24 million. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges. These charges in 2025, other than royalties, were largely driven by proactive production decisions to maintain supply flexibility and commitments related to manufacturing capacity.
Previous report
Cost of sales for the three and nine months ended September 30, 2025 decreased by $307 million and $309 million, or 60% and 43%, respectively, compared to the same periods in 2024. Cost of sales as a percentage of net product sales was 21% and 35% for the three and nine months ended September 30, 2025, respectively, compared to 28% and 33% for the corresponding periods in 2024. The decrease for the three-month period was primarily driven by lower inventory write-downs and reduced unutilized manufacturing capacity, while the increase for the nine-month period reflected the impact of lower net product sales.
Previous report
We expect full year 2025 cost of sales to be lower compared to 2024, primarily driven by a reduction in period charges, particularly lower wind-down costs related to contract manufacturing organization contracts and inventory write-downs, along with lower anticipated sales volume. We expect this decrease will be partially offset by costs associated with internal manufacturing sites commencing operations in 2025. However, cost of sales as a percentage of net product sales is expected to vary widely due to continued uncertainty around demand and increased market competition. This variability is primarily driven by the fixed nature of a significant portion of our manufacturing costs, which cannot be quickly adjusted in response to changes in sales volume. As part of our long-term strategy, we continue to invest in internal manufacturing capabilities to improve cost control and support potential future product launches.
Previous report
For the nine months ended September 30, 2025, research and development expenses decreased by $1.1 billion, or 31%, compared to the same period in 2024. Clinical trial spending declined by $403 million, primarily due to reduced activity in the RSV, COVID, and flu+COVID combination vaccine programs, consistent with trial wind-downs and the timing of trial activities, partially offset by increased investment in our norovirus program. Clinical manufacturing costs were $196 million lower, driven by reduced production-related spending due to reduced activity levels. Additionally, both clinical trial and clinical manufacturing expenses included a $62 million benefit from the Blackstone research and development funding related to the seasonal flu program in the second quarter of 2025, reflecting revisions to prior period estimates. Consulting and outside service costs declined by $110 million, and preclinical research expenses decreased by $96 million, both driven by reduced program activities and investment reprioritization. Separately, the prior-year period included an expense related to the purchase of two priority review vouchers.
Previous report
Selling, general and administrative expenses decreased by $13 million, or 5%, for the three months ended September 30, 2025, compared to the same period in 2024. The decrease primarily reflected reductions in consulting and outside services across multiple functions, as well as digital and facility-related costs.
Previous report
We continue to anticipate a reduction in selling, general and administrative expenses in 2025 compared to 2024. This reflects our ongoing commitment to operating efficiency as we expand our global commercial, regulatory, sales and marketing infrastructure, while continuing to invest in digital capabilities and leverage artificial intelligence technologies. In parallel, we are making organizational refinements to better align resources with the evolving needs of the business and support long-term scalability.
Previous report
Other income (expense), net
Reworded paragraphs (35)
Previous wording
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 four franchises: respiratory virus vaccines, latent and other virus vaccines, oncology therapeutics and rare disease therapeutics.
Current wording
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 infectious disease vaccines, oncology therapeutics and rare disease therapeutics.
Previous wording
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®, our original COVID vaccine, mRESVIA®, our vaccine against respiratory syncytial virus (RSV), and mNEXSPIKE®, our new COVID vaccine. Additionally, we have a diverse and extensive development pipeline of 30 development candidates across 40 development programs, of which 37 are in clinical studies currently.
Current wording
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 25 development candidates across our 35 development programs currently in clinical studies.
Previous wording
In September 2025, we delivered the first mRNA vaccines fully manufactured in Canada from our facility in Laval, Quebec, marking a significant milestone in our collaboration with the Government of Canada. The site, which received its Drug Establishment License from Health Canada in 2024, now produces the drug substance for our updated Spikevax targeting the LP.8.1 variant. Fill-and-finish of the vaccine, including the new single-use pre-filled syringes, is completed by Novocol Pharma in Cambridge, Ontario. This milestone demonstrates the execution of our end-to-end manufacturing strategy and our ability to provide timely access to locally manufactured mRNA vaccines through partnership with government and industry.
Current wording
Strategic Agreement with the Government of Mexico
Previous wording
Net Product Sales and Net Loss Per Share
Current wording
Total Revenue and Net Loss Per Share
Previous wording
For the third quarter of 2025, we recognized net product sales of $973 million, compared to $1.8 billion for the third quarter of 2024. Net loss per share was $(0.51) for the third quarter of 2025, compared to net income per share of $0.03 for the third quarter of 2024.
Current wording
For the first quarter of 2026, we recognized total revenue of $389 million, compared to $108 million for the first quarter of 2025. Net loss per share was $(3.40) for the first quarter of 2026, compared to net loss per share of $(2.52) for the first quarter of 2025.
Previous wording
•Norovirus vaccine: Our ongoing Phase 3 safety and efficacy study of our trivalent vaccine candidate against norovirus (mRNA-1403) has not accrued sufficient cases and will enroll a second Northern Hemisphere season (2025-2026) for additional case accruals. The timing of the Phase 3 readout will continue to be dependent on case accruals.
Current wording
•Norovirus vaccine: Our ongoing Phase 3 safety and efficacy study of our trivalent vaccine candidate against norovirus (mRNA-1403) is fully enrolled in a second Northern Hemisphere season (2025-2026) with data expected in 2026, subject to case accruals.
Previous wording
•Propionic acidemia (PA) therapeutic: We recently presented final results from the Part 1 dose-escalation cohorts of our ongoing Phase 1/2 study and cumulative data from ongoing participants in the extension study of our investigational therapeutic for PA (mRNA-3927) at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. In the study, which is designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Previously presented results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. mRNA-3927 is in a registrational study and target enrollment has been reached.
Current wording
•Propionic acidemia (PA) therapeutic: Our investigational therapeutic for PA (mRNA-3927) is in a registrational study and target enrollment has been reached.
Previous wording
The following chart shows our current pipeline of 40 development programs across our several modalities.
Current wording
The following chart shows our current pipeline of 35 development programs across our several modalities.
Previous wording
Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; HR MIUC, high-risk muscle-invasive urothelial carcinoma; HR MIBC, high-risk muscle invasive bladder cancer; HR NMIBC, high-risk non-muscle invasive bladder cancer; HSV, herpes simplex virus; IM, infectious mononucleosis; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus; VZV, varicella-zoster virus.
Current wording
Abbreviations: CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; MIBC, muscle invasive bladder cancer; NMIBC, non-muscle invasive bladder cancer; NSCLC, non-small cell lung cancer; pCR, pathological complete response; RCC, renal cell carcinoma; RSV, respiratory syncytial virus.
Previous wording
As of September 30, 2025, we have three commercial products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA. mRESVIA was approved by the FDA in May 2024 for adults aged 60 years and older, and in June 2025, the approved use was expanded to include adults aged 18 through 59 years who are at increased risk for RSV disease. In May 2025, mNEXSPIKE was approved for use in adults aged 65 years and older, as well as individuals aged 12 through 64 years with at least one underlying risk factor. We launched commercial sales of mNEXSPIKE in the third quarter of 2025.
Current wording
As of March 31, 2026, we have three commercial products, our COVID vaccines, Spikevax and mNEXSPIKE, and our RSV vaccine, mRESVIA. We launched commercial sales of mNEXSPIKE in the third quarter of 2025.
Previous wording
We sell our COVID vaccines, Spikevax and mNEXSPIKE, to the commercial market as well as to foreign governments and international organizations. We launched commercial sales of our RSV vaccine, mRESVIA, 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.
Current wording
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.
Previous wording
The following table summarizes product sales provision for the periods presented (in millions):
Current wording
The following table summarizes product sales provision adjustments for the periods presented (in millions):
Previous wording
Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2025, we had deferred revenue of $144 million related to product sales, of which $79 million is expected to be realized in less than one year.
Current wording
Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of March 31, 2026, we had deferred revenue of $95 million related to product sales, of which $37 million is expected to be realized in less than one year.
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Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and other miscellaneous revenue.
Current wording
Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and stand-ready manufacturing revenue.
Previous wording
Research and development expenses decreased by $336 million, or 30%, for the three months ended September 30, 2025, compared to the same period in 2024. Clinical trial expenses declined by $117 million, driven by lower activity in the RSV, COVID, and seasonal flu programs as a result of trial wind-downs and higher research and development funding from Blackstone for the seasonal flu program, partially offset by increased investment in our norovirus program. Clinical manufacturing costs decreased by $44 million, reflecting lower production-related spending due to reduced activity levels. Preclinical research expenses decreased by $22 million due to investment reprioritization, and consulting and outside service costs declined by $17 million, consistent with the lower level of clinical and manufacturing activities. The prior-year period also included an expense related to the purchase of a priority review voucher.
Current wording
Research and development expenses decreased by $207 million, or 24%, for the three months ended March 31, 2026, compared to the same period in 2025. The decrease was mainly driven by a $48 million reduction in clinical manufacturing costs, driven by higher research and development funding from Blackstone for our seasonal flu program, a $48 million decrease in consulting and outside service costs, consistent with the lower level of clinical and manufacturing activities, and a $43 million reduction in personnel-related expenses due to lower headcount. Clinical trial expenses decreased by $42 million, reflecting lower activity in our seasonal flu, CMV, Norovirus, and RSV programs due to trial wind-downs, as well as the timing of clinical trial activities, partially offset by higher costs related to postmarketing commitments for our COVID products.
Previous wording
We continue to anticipate a reduction in research and development expenses in 2025 compared to 2024, driven by disciplined cost management, portfolio prioritization, and a focused approach to pipeline execution. While we remain committed to advancing our pipeline and late-stage programs, including our intismeran autogene, norovirus, seasonal flu and combination vaccine programs, we are also implementing operational efficiencies across the organization, including meaningful resourcing adjustments to align with the current stage of our pipeline and to support long-term sustainability.
Current wording
We anticipate a modest reduction in research and development expenses in 2026 compared to 2025, driven by 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 intismeran autogene and norovirus vaccine programs, while continuing to manage research and development investment levels in line with our long-term objectives.
Previous wording
For the nine months ended September 30, 2025, selling, general and administrative expenses decreased by $113 million, or 14%, compared to the same period in 2024. The decrease was mainly driven by a $42 million broad-based reduction in consulting and outside services, lower digital and facility-related costs of $21 million, a $21 million decrease in legal expenses, and a $20 million decrease in personnel-related expenses due to lower headcount. The decreases in both periods largely reflects continued cost discipline and ongoing efforts to streamline operations.
Current wording
For the three months ended March 31, 2026, selling, general and administrative expenses decreased by $39 million, or 18%, compared to the same period in 2025. The decrease was mainly driven by a $19 million decrease in personnel-related expenses, a $9 million decrease in marketing expenses, and an $8 million broad-based reduction in consulting and outside services. The decrease in the period largely reflects continued cost discipline and efforts to streamline operations.
Previous wording
For the three months ended September 30, 2025, interest income decreased by $30 million, or 29%, compared to the same period in 2024. For the nine months ended September 30, 2025, interest income decreased by $90 million, or 27%, compared to the same period in 2024. The decreases were primarily due to lower average investment balances.
Current wording
For the three months ended March 31, 2026, interest income decreased by $18 million, or 20%, compared to the same period in 2025. The decrease was primarily due to lower average investment balances and interest rates.
Previous wording
The following tables summarize other income (expense), net for the periods presented (in millions):
Current wording
The following tables summarize other expense, net for the periods presented (in millions):
Previous wording
For the three and nine months ended September 30, 2025, total other income, net, was immaterial and $4 million, respectively, compared to total other expense, net, of $12 million and $58 million for the same periods in 2024. The improvement was largely driven by lower equity investment losses and a reduction in interest expense. Interest expense is primarily related to our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, and certain contract manufacturing service agreements. Please refer to Note 10 to our condensed consolidated financial statements for additional information.
Current wording
For the three months ended March 31, 2026, total other expense, net increased by $14 million, or 350%, compared to the same period in 2025. The increase was largely driven by higher interest expense. Interest expense is primarily related to our finance leases related to certain contract manufacturing service agreements and, beginning in November 2025, interest associated with our long-term debt. Please refer to Note 10 and Note 11 to our condensed consolidated financial statements for additional information.
Previous wording
Provision for income taxes for the three and nine months ended September 30, 2025, remained immaterial and consistent with the same periods in 2024. The effective tax rates for both periods in 2025 continue to reflect the maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the losses. Please refer to Note 13 to our condensed consolidated financial statements for additional details.
Current wording
Provision for income taxes for the three months ended March 31, 2026, remained immaterial and consistent with the same periods in 2025. 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.
Previous wording
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 September 30, 2025 decreased by $2.9 billion, or 30%, compared to December 31, 2024. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $2.8 billion and purchases of property and equipment of $153 million during the nine months ended September 30, 2025.
Current wording
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 March 31, 2026 decreased by $679 million, or 8%, 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 million and purchases of property and equipment of $62 million during the three months ended March 31, 2026.
Previous wording
Working capital, defined as current assets less current liabilities, decreased by $1.0 billion, or 17%, as of September 30, 2025, compared to December 31, 2024. This was primarily driven by a decrease in cash, cash equivalents and current investments of $2.5 billion to fund operations, partially offset by an increase in accounts receivable of $688 million, mainly due to timing of collections, a decrease in accrued liabilities and accounts payable of $387 million, driven by lower spend during the period, and an increase in inventory of $215 million, driven by manufacturing of our COVID vaccines.
Current wording
Working capital, defined as current assets less current liabilities, decreased by $1.2 billion, or 26%, as of March 31, 2026, compared to December 31, 2025. This was primarily driven by a decrease in cash, cash equivalents and current investments of $594 million to fund operations, an increase in accrued liabilities and accounts payable of $370 million, including $950 million related to the litigation settlement, partially offset by lower spend during the period, and a decrease in accounts receivable of $113 million primarily driven by timing of collections.
Previous wording
As of September 30, 2025, we did not have any off-balance sheet arrangements, other than those obligations and commitments disclosed herein.
Current wording
As of March 31, 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.
Previous wording
We sell our vaccines to the commercial market as well as to foreign governments and international organizations. In the U.S., our 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. Certain agreements may include upfront payments for our vaccine supply, initially recorded as deferred revenue. As of September 30, 2025, we had $144 million in deferred revenue related to product sales.
Current wording
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 March 31, 2026, we had $256 million in deferred revenue related to customer advance payments received or billable.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $2.8 billion and consisted of net loss of $2.0 billion, non-cash adjustments of $519 million and a net change in assets and liabilities of $1.3 billion. Non-cash items primarily included stock-based compensation of $370 million, and depreciation and amortization of $148 million. The net change in assets and liabilities was mainly due to an increase in accounts receivable of $703 million, driven by timing of collections, a decrease in accrued liabilities and accounts payable of $310 million and other liabilities of $137 million, driven by overall lower spend in the period, and an increase in inventory of $213 million, driven by increased manufacturing of our COVID vaccines, partially offset by an increase in deferred revenue of $108 million due to upfront payments received in excess of revenue recognized.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 was $630 million and consisted of net loss of $1.3 billion, non-cash adjustments of $160 million and a net change in assets and liabilities of $553 million. Non-cash items primarily included stock-based compensation of $104 million, and depreciation and amortization of $59 million. The net change in assets and liabilities was mainly due to an increase in accrued liabilities and accounts payable of $344 million, including $950 million related to the litigation settlement, partially offset by lower spend during the period, a decrease in accounts receivables, net of $114 million due to timing of collections, and a decrease in prepaid and other assets of $54 million, driven by a decrease in vendor prepayments.
Previous wording
Net cash used in operating activities decreased by $1.0 billion, or 27%, during the nine months ended September 30, 2025, compared to the same period in 2024, primarily attributable to a decrease in net loss of $445 million, a change in deferred revenue of $285 million driven by collections of upfront payment in excess of revenue recognized, and a change in accrued liabilities and accounts payable of $208 million driven by continued decrease in spend.
Current wording
Net cash used in operating activities decreased by $407 million, or 39%, during the three months ended March 31, 2026, compared to the same period in 2025, primarily attributable to a change in accrued liabilities and accounts payable of $881 million, including $950 million related to the litigation settlement. This decrease was partially offset by an increase in net loss of $372 million and a decrease in accounts receivable, net of $166 million, driven by timing of collections.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2025 was $2.0 billion, driven primarily by proceeds from maturities and sales of marketable securities of $6.4 billion, partially offset by purchases of marketable securities of $4.2 billion, and purchases of property and equipment of $153 million.
Current wording
Net cash used in investing activities for the three months ended March 31, 2026 was $76 million, driven primarily by purchases of marketable securities of $1.3 billion, and purchases of property and equipment of $62 million, partially offset by proceeds from maturities and sales of marketable securities of $1.3 billion.
Previous wording
Net investing cash flows decreased by $494 million, or 20%, during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $1.3 billion, partially offset by a decrease in purchases of marketable securities of $420 million, and a decrease in purchases of plant, property and equipment of $376 million.
Current wording
Net investing cash flows decreased by $806 million, or 110%, during the three months ended March 31, 2026, compared to the same period in 2025, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $1.3 billion, partially offset by a decrease in purchases of marketable securities of $416 million, and a decrease in purchases of plant, property and equipment of $55 million.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $12 million, primarily related to proceeds from issuance of common stock through equity plans.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2026 was $17 million, primarily related to proceeds from issuance of common stock through equity plans.
Previous wording
Net cash provided by financing activities decreased by $47 million, or 80%, during the nine months ended September 30, 2025, compared to the same period in 2024, mainly due to a decrease in proceeds from issuance of common stock through equity plans of $36 million.
Current wording
Net cash provided by financing activities increased by $13 million, or 325%, during the three months ended March 31, 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 million.
Previous wording
Our principal sources of funding as of September 30, 2025 consisted of cash and cash equivalents, investments, and cash we may generate from operations. From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. Following authorization of our first commercial product in December 2020, we generated significant net income in both 2022 and 2021. We also incurred a net loss of $2.0 billion for the nine months ended September 30, 2025 and net losses of $3.6 billion and $4.7 billion for the years 2024 and 2023, respectively. We have retained earnings of $8.0 billion as of September 30, 2025.
Current wording
Our principal sources of funding as of March 31, 2026 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We reported a net loss of $1.3 billion for the three months ended March 31, 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 billion as of March 31, 2026.
Previous wording
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 advancing research and development 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+COVID combination vaccine candidates, 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 partners or collaborators. 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 (refer to Note 10 and Note 11 to our condensed consolidated financial statements). We have entered into various collaboration and licensing agreements, as well as a research and development funding arrangement with a third party. 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.
Current wording
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+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. 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.
Previous wording
We believe that our cash, cash equivalents, and investments as of September 30, 2025, together with cash expected to be generated from product sales, 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. 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 has continued into 2025 as the market transitions to a more competitive and commercially driven environment. 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.
Current wording
We believe that our cash, cash equivalents, and investments as of March 31, 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. 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.
Previous wording
As of September 30, 2025, other than disclosed within Note 10 and Note 11 to our condensed consolidated financial statements, 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 2024 Form 10-K.
Current wording
As of March 31, 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We derive cash flows from operations primarily from cash collected from accounts receivable and customer deposits related to our product sales and other revenue, as well as certain government-sponsored and private organizations, strategic alliances and funding arrangements. Our operating cash flows are significantly affected by our use of cash for operating expenses and working capital to support the business.