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Moderna, Inc.

For the period ended Jun 30, 2025. Filed Aug 1, 2025.

View on SEC.gov

About 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.

Jun 30, 2025 · Filed Aug 1, 2025

MRNA$254.19+5.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-01.

0001682852-25-000034

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-01.

0001682852-25-000044

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 93 previous paragraphs and 93 current paragraphs.

47 unchanged; 30 reworded; 16 added; 16 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 9 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 (16)

Current report

We have three commercial products—Spikevax®, our original COVID vaccine, mRESVIA®, our vaccine against respiratory syncytial virus (RSV), and mNEXSPIKE®, our next-generation COVID vaccine. mNEXSPIKE, our newest commercial product, was approved by the U.S. Food and Drug Administration (FDA) in May 2025 for individuals aged 65 years and older, as well as individuals aged 12 through 64 years with at least one underlying risk factor. In June 2025, the FDA approved mRESVIA for adults aged 18 through 59 years who are at increased risk for RSV disease, expanding the previous indication for mRESVIA for adults 60 years and older. In July 2025, the FDA approved Spikevax for children six months through 11 years who are at increased risk for COVID-19 disease, expanding the previous indication for Spikevax for individuals 12 years and older.

Current report

In May 2025, the FDA approved mNEXSPIKE (mRNA-1283), our next-generation COVID-19 vaccine, for individuals aged 65 years and older and individuals aged 12 through 64 years with at least one underlying risk factor. The approval was based on a randomized, observer-blind, active-controlled Phase 3 study that enrolled approximately 11,400 participants aged 12 and older. The trial met its primary endpoint, with mRNA-1283 demonstrating non-inferior vaccine efficacy compared to Spikevax (mRNA-1273), and showed a 9.3% higher relative vaccine efficacy in the overall population, and a 13.5% higher relative efficacy in adults aged 65 and older. The safety profile of mRNA-1283 was consistent with mRNA-1273, with fewer local reactions and comparable systemic reactions. We expect to make mNEXSPIKE available in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA.

Current report

In June 2025, the FDA approved an expanded use of mRESVIA, our RSV vaccine, for the prevention of lower respiratory tract disease in adults aged 18 through 59 years with underlying health conditions that increase their risk for RSV disease. This approval builds on the initial authorization granted in May 2024 for adults aged 60 years and older. The expanded approval was supported by a Phase 3 study that demonstrated safety and immunogenicity in individuals with underlying health conditions, with immune responses meeting prespecified non-inferiority criteria compared to those observed in older adults. Neutralizing antibody levels were consistent across both the 18-49 and 50-59 age subgroups. We plan to supply mRESVIA for both approved adult populations in the U.S. for the 2025-2026 respiratory virus season.

Current report

In May 2025, we received notice from the U.S. Department of Health and Human Services (HHS) that our award for the late-stage development of mRNA-based pandemic influenza vaccines, funded through the Rapid Response Partnership Vehicle (RRPV) by the Biomedical Advanced Research and Development Authority (BARDA), would be terminated. The program was previously supported by two awards totaling up to $766 million to accelerate the development and licensure of mRNA-based pre-pandemic influenza vaccines targeting the H5 influenza virus and additional influenza subtypes. Funding received under the awards was immaterial as of June 30, 2025. Interim results from our Phase 1/2 study of mRNA-1018 demonstrated a rapid, potent, and durable immune response, with 97.8% of participants achieving HAI titers ≥1:40 at Day 43. The vaccine was generally well-tolerated. We will explore alternatives for late-stage development and manufacturing of the H5 program consistent with our strategic commitment to pandemic preparedness.

Current report

•Seasonal flu vaccine: In June 2025, we announced positive results from the Phase 3 efficacy study (P304) of mRNA-1010, our seasonal influenza vaccine candidate. The trial enrolled over 40,000 adults aged 50 years and older across 11 countries. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6% (95% CI: 16.7%, 35.4%) compared to a licensed standard-dose seasonal influenza vaccine. Strong rVE was also observed for each influenza strain contained in the vaccine, including A/H1N1 (29.6%), A/H3N2 (22.2%), and B/Victoria (29.1%). Efficacy was consistent across age groups, risk profiles, and prior influenza vaccination status, including an rVE of 27.4% in participants aged 65 years and older. Safety and tolerability of mRNA-1010 were consistent with prior Phase 3 results. We are submitting mRNA-1010 data for publication, presenting data at medical conferences and preparing to file mRNA-1010 for FDA approval.

Current report

As of June 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. As of June 30, 2025, we had not yet launched commercial sales of mNEXSPIKE.

Current report

For the three months ended June 30, 2025, total revenue decreased by $99 million, or 41%, compared to the same period in 2024, driven by declines in both net product sales and other revenue. Net product sales decreased by $70 million, or 38%, largely due to lower sales in the U.S. market, driven by both reduced sales volume, reflecting lower COVID vaccination rates, and a lower average selling price. Rest-of-World sales remained relatively stable compared to the prior year. Other revenue decreased by $29 million, or 51%, primarily due to the absence of upfront licensing revenue recognized in the prior year and a reduction in grant revenue as reimbursable activities under our BARDA contract progressively wound down, concluding in June 2025.

Current report

For the six months ended June 30, 2025, total revenue decreased by $158 million, or 39%, compared to the same period in 2024, primarily driven by a $151 million, or 43%, decline in net product sales. The decrease was mainly attributable to lower sales in the U.S. market, reflecting reduced sales volume due to lower COVID vaccination rates, as well as a lower average selling price. Rest-of-World sales also declined, to a lesser extent, primarily due to lower sales volume. Other revenue decreased by $7 million, or 12%, primarily due to lower licensing and grant revenue, consistent with the drivers noted in the three-month period. These decreases were partially offset by an increase in other revenue recognized in connection with our stand-ready obligation under long-term strategic agreements with certain government entities.

Current report

For the six months ended June 30, 2025, research and development expenses decreased by $728 million, or 32%, compared to the same period in 2024. The decrease was primarily driven by a $271 million reduction in clinical trial expenses, reflecting lower spending across our RSV, seasonal flu, COVID and combination vaccine programs, due to program wind-downs and timing of trial activities, partially offset by increased investment in our norovirus program. Clinical manufacturing expenses decreased by $105 million, driven by reduced production-related spending and lower allocation to clinical programs. Consulting and outside service costs declined by $93 million, and pre-clinical research expenses decreased by $74 million, both driven by reduced program activities and investment reprioritization. Personnel-related expenses declined by $48 million, primarily due to lower headcount. We also recognized a $62 million benefit from the Blackstone research and development funding in the current period, primarily from revisions to prior period estimates. Separately, the prior-year period included an expense related to the purchase of a priority review voucher.

Current report

Selling, general and administrative expenses decreased by $38 million, or 14%, for the three months ended June 30, 2025, compared to the same period in 2024. The decrease was primarily driven by broad-based reductions in consulting and outside service costs, compensation and other personnel-related expenses due to lower headcount, and commercial and marketing activities.

Current report

For the six months ended June 30, 2025, selling, general and administrative expenses decreased by $100 million, or 18%, compared to the same period in 2024. The decrease was mainly driven by a $29 million reduction in consulting and outside services across all functions, a $26 million reduction in personnel-related expenses due to lower headcount, and lower legal, marketing, and technology and facility-related costs, which together contributed to a $49 million reduction. The decrease in both periods reflects continued cost discipline and efforts to streamline operations.

Current report

Net cash provided by financing activities decreased by $35 million, or 73%, during the six months ended June 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 $30 million.
Removed paragraphs (16)

Previous report

Our approved COVID vaccine (mRNA-1273) is our first commercial product and is marketed under the name Spikevax®. mRNA-1273 was first developed to target the SARS-CoV-2 ancestral strain, and we have leveraged our mRNA platform to rapidly adapt our vaccine to emerging SARS-CoV-2 strains to provide protection as the virus evolves and regulatory guidance is updated. In May 2024, the U.S. Food and Drug Administration (FDA) granted approval for mRESVIA® (mRNA-1345), our mRNA vaccine against respiratory syncytial virus (RSV), to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection. This marks our second approved product developed using our mRNA platform.

Previous report

mRESVIA has received regulatory approvals in the U.S. and European Union for use in adults aged 60 years and older and is commercially available. In the first quarter of 2025, additional approvals were granted in Australia, the United Kingdom, Switzerland and Taiwan, further expanding potential access to mRESVIA for older adults. We continue to pursue regulatory submissions in additional markets worldwide.

Previous report

In January 2025, we were awarded a multi-year tender agreement to compete to supply our mRNA COVID vaccine to 17 participating countries in the European Union, as well as Norway and North Macedonia. The agreement allows participating countries to access vaccine supply over a period of up to four years and supports diversity of supply, including multiple product formats such as prefilled syringes. Purchases under the agreement are subject to future country-level orders.

Previous report

•Next-generation COVID vaccine: We shared pivotal safety, immunogenicity and relative vaccine efficacy data for our next-generation COVID vaccine (mRNA-1283) at the Advisory Committee on Immunization Practices meeting in April 2025. We filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher in 2024. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.

Previous report

•RSV vaccine: We recently shared positive Phase 3 data for our RSV vaccine (mRNA-1345) in high-risk adults aged 18 to 59 at the ESCMID 2025 Global Congress. We filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024. The FDA has assigned a PDUFA goal date of June 12, 2025.

Previous report

•Seasonal flu vaccine: We have shared positive Phase 3 immunogenicity and safety data for our seasonal flu vaccine (mRNA-1010). We are conducting a two-season Phase 3 efficacy study (P304), which exceeded its case accrual target in the first season. We anticipate an interim data readout in summer 2025.

Previous report

Due to our strategic prioritization efforts, we have paused development of our mRNA-1011/1012 and mRNA-1020/1030 programs.

Previous report

•Phenylketonuria (PKU): We have discontinued development of our preclinical PKU candidate (mRNA-3210) due to our strategic prioritization efforts.

Previous report

As of March 31, 2025, we have two commercial products authorized for use, our COVID vaccine and our RSV vaccine. The RSV vaccine was approved by the FDA in May 2024 for adults aged 60 years and older.

Previous report

For the three months ended March 31, 2025, total revenue decreased by $59 million, or 35%, compared to the same period in 2024, mainly due to lower net product sales of our COVID vaccine.

Previous report

Net product sales for the three months ended March 31, 2025 decreased by $81 million, or 49%, compared to the same period in 2024, primarily due to lower sales in the U.S. market, driven by a reduced vaccination rate. International sales also declined, but to a lesser extent.

Previous report

Other revenue increased by $22 million, or 100%, for the three months ended March 31, 2025, compared to the same period in 2024. The increase for the three and three months ended was mainly due to an increase in licensing and royalty and other revenue.

Previous report

Selling, general and administrative expenses decreased by $62 million, or 23%, for the three months ended March 31, 2025, compared to the same period in 2024. The decline was primarily driven by broad-based reductions across digital, facility, marketing, personnel-related expenses, and external consulting and service costs, as we continue to streamline operations and prioritize cost management.
Reworded paragraphs (30)

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 have a diverse and extensive development pipeline of 31 development candidates across our 41 development programs, of which 38 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 have a diverse and extensive development pipeline of 30 development candidates across our 39 development programs, of which 35 are in clinical studies currently.

Previous wording

For the first quarter of 2025, we recognized net product sales of $86 million from sales of our COVID and RSV vaccines, compared to $167 million for the first quarter of 2024. Loss per share was $(2.52) for the first quarter of 2025, compared to $(3.07) for the first quarter of 2024.

Current wording

For the second quarter of 2025, we recognized net product sales of $114 million, compared to $184 million for the second quarter of 2024. Loss per share was $(2.13) for the second quarter of 2025, compared to $(3.33) for the second quarter of 2024.

Previous wording

•Seasonal flu + COVID vaccine: We shared positive Phase 3 immunogenicity data for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at our 2024 R&D Day event. We submitted mRNA-1083 for regulatory approval in older adults in 2024. Based on FDA feedback confirming the need for Phase 3 flu efficacy data, we expect an extended review timeline and are now targeting approval in 2026. Recently, we updated our prioritized research and development portfolio, resulting in the deprioritization of mRNA-1083 for adults aged 18 to 49.

Current wording

•Seasonal flu + COVID vaccine: We shared positive Phase 3 immunogenicity data for our flu+COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at our 2024 R&D Day event. In May 2025, we announced that in consultation with the FDA, we had voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083 with the plan to resubmit after vaccine efficacy data from our mRNA-1010 Phase 3 trial were available. We are engaging with regulators on data requirements for resubmitting the BLA for mRNA-1083.

Previous wording

•Cytomegalovirus (CMV) vaccine: The pivotal Phase 3 study of our CMV vaccine candidate (mRNA-1647) is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. The Data Safety Monitoring Board (DSMB) met in December 2024 to review the initial study data and informed us that the criterion for early efficacy was not met. The DSMB recommended that the study continue as planned. We remain blinded and anticipate final efficacy data from the study in 2025.

Current wording

•Cytomegalovirus (CMV) vaccine: In April 2025, we shared 36-month durability data from a Phase 2 extension trial of our CMV vaccine candidate (mRNA-1647) at the ESCMID 2025 Global Congress. The pivotal Phase 3 study of mRNA-1647 is fully enrolled and has accrued sufficient cases for evaluation of the primary endpoint of the study, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. We are updating our analysis plan to add secondary endpoints. We remain blinded and anticipate a Phase 3 final analysis in 2025.

Previous wording

•Norovirus vaccine: The two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of our trivalent vaccine candidate against norovirus (mRNA-1403) is fully enrolled in the Northern Hemisphere and enrolling in the Southern Hemisphere. The FDA clinical hold following a single adverse event report of a case of Guillain-Barré syndrome has been lifted. The timing of the Phase 3 readout will be dependent on case accruals.

Current wording

•Norovirus vaccine: The Phase 3 study evaluating the efficacy, safety and immunogenicity of our trivalent vaccine candidate against norovirus (mRNA-1403) is accruing cases. The timing of the Phase 3 readout will be dependent on case accruals.

Previous wording

•Individualized Neoantigen Therapy (INT): We continue to demonstrate the potential clinical benefit of INT (mRNA-4157). In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two Phase 3 studies for non-small cell lung cancer (NSCLC) are enrolling. A randomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is enrolling. We and Merck have launched a new Phase 2 study for patients with high-risk non-muscle invasive bladder cancer.

Current wording

•Intismeran autogene (INT): We continue to demonstrate the potential clinical benefit of mRNA-4157. 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, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. We and Merck have also launched a new Phase 2 study of first-line treatment for patients with metastatic melanoma.

Previous wording

•Checkpoint adaptive immune modulation therapy (AIM-T). We have expanded the number of oncology development candidates in our prioritized pipeline with the addition of Checkpoint AIM-T (mRNA-4359). The Phase 1/2 study is ongoing and a Phase 2 study, which includes first-line melanoma and first-line metastatic NSCLC patients, is enrolling.

Current wording

•Checkpoint adaptive immune modulation therapy (AIM-T). The Checkpoint AIM-T (mRNA-4359) Phase 1/2 study in first-line melanoma and first-line metastatic NSCLC is ongoing, and is in the Phase 2 portion of the study. The first-line metastatic NSCLC arm is currently enrolling patients.

Previous wording

The following chart shows our current pipeline of 41 development programs across our several modalities.

Current wording

The following chart shows our current pipeline of 39 development programs across our several modalities.

Previous wording

We sell our COVID vaccine to commercial market as well as to foreign governments and international organizations. We launched commercial 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.

Current wording

We sell our COVID vaccine to the commercial market as well as to foreign governments and international organizations. We launched commercial 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.

Previous wording

Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S. Government, foreign governments and international organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns. Certain of these agreements entitle us to upfront deposits for our COVID vaccine supply, initially recorded as deferred revenue. As of March 31, 2025, we had deferred revenue of $154 million associated with customer deposits received or billable under supply agreements, of which $96 million is expected to be realized in less than one year.

Current wording

Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S. Government, foreign governments and international organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns. Certain of these agreements entitle us to upfront deposits for our COVID vaccine supply, initially recorded as deferred revenue. As of June 30, 2025, we had deferred revenue of $221 million associated with customer deposits received or billable under supply agreements, of which $156 million is expected to be realized in less than one year.

Previous wording

Cost of sales for the three months ended March 31, 2025 was $90 million, which included third-party royalties of $5 million, inventory write-downs of $42 million, primarily related to our finished and semi-finished COVID vaccine inventory and certain raw materials, unutilized manufacturing capacity and wind-down costs of $21 million, and losses on firm purchase commitments of $10 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 customer demand forecast adjustments and commitments related to manufacturing capacity.

Current wording

Cost of sales for the three months ended June 30, 2025 was $119 million, which included third-party royalties of $6 million, inventory write-downs of $38 million, unutilized manufacturing capacity and wind-down costs of $52 million. Cost of sales for the six months ended June 30, 2025 was $209 million, which included third-party royalties of $11 million, inventory write-downs of $80 million, primarily related to our finished and semi-finished COVID vaccine inventory and certain raw materials, unutilized manufacturing capacity and wind-down costs of $73 million, and losses on firm purchase commitments of $17 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 customer demand forecast adjustments and commitments related to manufacturing capacity.

Previous wording

Cost of sales for the three months ended March 31, 2025 decreased by $6 million, or 6%, compared to the same period in 2024, primarily due to lower sales volume. The decrease also reflects the seasonal nature of our COVID vaccine business, with limited product sales in both periods. Despite the overall decrease in cost of sales, cost of sales as a percentage of net product sales for the three months ended March 31, 2025 increased to 104%, compared to 58% for the same period in 2024, reflecting the impact of lower net product sales.

Current wording

Cost of sales was relatively flat for both the three and six months ended June 30, 2025, compared to the same periods in 2024. Cost of sales as a percentage of net product sales was 105% and 104% for the three and six months ended June 30, 2025, respectively, compared to 62% and 60% for the corresponding periods in 2024. The increases were primarily due to the impact of lower net product sales.

Previous wording

We expect full year 2025 cost of sales to be lower compared to 2024, reflecting lower anticipated production and inventory-related charges. 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 are continuing to invest in internal manufacturing capabilities to improve cost control and support potential future product launches.

Current wording

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, 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 are continuing to invest in internal manufacturing capabilities to improve cost control and support potential future product launches.

Previous wording

Research and development expenses decreased by $207 million, or 19%, for the three months ended March 31, 2025, compared to the same period in 2024. The reduction was primarily driven by a $134 million decrease in clinical trial and manufacturing expenses, reflecting lower spend across our RSV, seasonal flu, COVID, and combination vaccine programs due to timing of trial activities and program wind-downs. This reduction was partially offset by increased investment in our INT and norovirus programs. Consulting and outside services expenses declined by $42 million as a result of cost management initiatives, while pre-clinical research expenses decreased by $35 million due to investment reprioritization.

Current wording

Research and development expenses decreased by $521 million, or 43%, for the three months ended June 30, 2025, compared to the same period in 2024. The reduction was primarily driven by a $161 million decrease in clinical manufacturing expenses, reflecting lower production-related spending and reduced allocation to clinical programs. Clinical trial expenses decreased by $106 million, primarily due to lower spending across our RSV, seasonal flu, and COVID programs, driven by program wind-downs and timing of trial activities, partially offset by increased investment in our norovirus program. Pre-clinical research expenses declined by $53 million due to investment reprioritization, and consulting and outside service costs declined by $51 million, consistent with the lower level of clinical study activities. In addition, research and development funding under the Blackstone arrangement resulted in a $62 million benefit in the current period, primarily from revisions to prior period estimates. The prior-year period also included an expense related to the purchase of a priority review voucher.

Previous wording

We anticipate a reduction in research and development expenses in 2025 compared to 2024, driven by disciplined cost management and a focused approach to pipeline execution. While we continue to advance our pipeline, we are maintaining investments in late-stage programs, including our INT, norovirus, CMV, and combination vaccine programs.

Current 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 INT, norovirus, CMV, 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.

Previous wording

We anticipate a modest reduction in selling, general and administrative expenses in 2025 compared to 2024. This reflects our ongoing commitment to efficiency as we expand our global commercial, regulatory, sales and marketing infrastructure, while continuing to invest in digital capabilities and leverage artificial intelligence technologies. These efforts align with our strategic focus on advancing our program development and enhancing our overall business processes.

Current wording

We continue to anticipate a modest 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 wording

For the three months ended March 31, 2025, interest income decreased by $30 million, or 25%, compared to the same period in 2024. The decrease in the three-month period was primarily due to lower average investment balances.

Current wording

For the three months ended June 30, 2025, interest income decreased by $30 million, or 27%, compared to the same period in 2024. For the six months ended June 30, 2025, interest income decreased by $60 million, or 26%, compared to the same period in 2024. The decreases were primarily due to lower average investment balances.

Previous wording

The following tables summarize other expense, net for the periods presented (in millions):

Current wording

The following tables summarize other income (expense), net for the periods presented (in millions):

Previous wording

For the three months ended March 31, 2025, total other expense, net decreased by $15 million, or 79%, compared to the same period in 2024. The decrease was primarily driven by lower interest expense and reduced losses on equity investments. 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 and six months ended June 30, 2025, we recorded total other income, net of $8 million and $4 million, respectively, compared to total other expense, net of $27 million and $46 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.

Previous wording

Provision for income taxes decreased by $3 million, or 30%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to the continued maintenance of our global valuation allowance, which limits our ability to recognize tax benefits from the loss. The effective tax rate remained consistent with the prior year and continues to be immaterial. Please refer to Note 13 to our condensed consolidated financial statements for additional details.

Current wording

Provision for income taxes for the three and six months ended June 30, 2025, remained immaterial and consistent with the same periods in 2024. The effective tax rates also remained consistent and continues to be immaterial. Both reflect the continued 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.

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 March 31, 2025 decreased by $1.1 billion, or 12%, 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 $1.0 billion and purchases of property and equipment of $117 million during the three months ended March 31, 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 June 30, 2025 decreased by $2.0 billion, or 21%, 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 $2.0 billion and purchases of property and equipment of $120 million during the six months ended June 30, 2025.

Previous wording

Working capital, defined as current assets less current liabilities, as of March 31, 2025 decreased by $731 million, or 12%, compared to December 31, 2024. This was primarily driven by a decrease in cash, cash equivalents and current investments of $1.1 billion to fund operations, and a decrease in accounts receivable of $280 million, mainly due to timing of collections, partially offset by a decrease in accrued liabilities and accounts payable of $605 million, driven by lower spend during the period.

Current wording

Working capital, defined as current assets less current liabilities, as of June 30, 2025 decreased by $1.3 billion, or 22%, compared to December 31, 2024. This was primarily driven by a decrease in cash, cash equivalents and current investments of $1.9 billion to fund operations, partially offset by a decrease in accrued liabilities and accounts payable of $670 million, driven by lower spend during the period.

Previous wording

Beginning in the third quarter of 2020, we entered into supply agreements with the U.S. Government, foreign governments and international organizations for the supply of our COVID vaccine and received upfront deposits. In the third quarter of 2023, we commenced sales of our COVID vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and international organizations. In the U.S., our COVID vaccine is sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. We also commenced sales of our RSV vaccine in the third quarter of 2024. Wholesalers and distributors typically do not make upfront payments to us. As of March 31, 2025, we had $154 million in deferred revenue related to customer deposits received or billable.

Current wording

Beginning in the third quarter of 2020, we entered into supply agreements with the U.S. Government, foreign governments and international organizations for the supply of our COVID vaccine and received upfront deposits. In the third quarter of 2023, we commenced sales of our COVID vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and international organizations. In the U.S., our COVID vaccine is sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. We also commenced sales of our RSV vaccine in the third quarter of 2024. Wholesalers and distributors typically do not make upfront payments to us. As of June 30, 2025, we had $221 million in deferred revenue related to customer deposits received or billable.

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $1.0 billion and consisted of net loss of $1.0 billion, non-cash adjustments of $145 million and a net change in assets and liabilities of $211 million. Non-cash items primarily included stock-based compensation of $115 million, and depreciation and amortization of $39 million. The net change in assets and liabilities was mainly due to a decrease in accrued liabilities and accounts payable of $537 million, driven by overall lower spend in the period, partially offset by a decrease in accounts receivable of $280 million, driven by timing of collections.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 was $2.0 billion and consisted of net loss of $1.8 billion, non-cash adjustments of $348 million and a net change in assets and liabilities of $508 million. Non-cash items primarily included stock-based compensation of $245 million, and depreciation and amortization of $96 million. The net change in assets and liabilities was mainly due to a decrease in accrued liabilities and accounts payable of $598 million, driven by overall lower spend in the period, an increase in prepaid expenses and other assets of $150 million, driven by collaboration receivables, an increase in inventory of $122 million, driven by increased manufacturing of our COVID vaccine for the upcoming season, and partially offset by a decrease in accounts receivable of $310 million, driven by timing of collections.

Previous wording

Net cash used in operating activities increased by $48 million, or 5%, during the three months ended March 31, 2025, compared to the same period in 2024, primarily attributable to a change in accounts receivable of $475 million, driven by declined product sales, partially offset by a decrease in net loss of $204 million, and a change in accrued liabilities and accounts payable of $164 million, primarily driven by lower spend in the period.

Current wording

Net cash used in operating activities decreased by $307 million, or 14%, during the six months ended June 30, 2025, compared to the same period in 2024, primarily attributable to a decrease in net loss of $658 million, partially offset by a change in accounts receivable of $419 million, driven by declined product sales.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025 was $730 million, driven primarily by proceeds from maturities and sales of marketable securities of $2.6 billion, partially offset by purchases of marketable securities of $1.8 billion, and purchases of property and equipment of $117 million.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $1.3 billion, driven primarily by proceeds from maturities and sales of marketable securities of $4.5 billion, partially offset by purchases of marketable securities of $3.1 billion, and purchases of property and equipment of $120 million.

Previous wording

Net investing cash flows increased by $612 million, or 519%, during the three months ended March 31, 2025, compared to the same period in 2024, primarily due to a decrease in purchases of marketable securities of $780 million.

Current wording

Net investing cash flows decreased by $473 million, or 27%, during the six months ended June 30, 2025, compared to the same period in 2024, primarily due to a decrease in proceeds from maturities and sales of marketable securities of $1.1 billion, partially offset by a decrease in purchases of marketable securities of $331 million, and a decrease in purchases of plant, property and equipment of $258 million.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $4 million, primarily related to proceeds from issuance of common stock through equity plans. Financing cash flows remained immaterial and were consistent with the same period in 2024.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $13 million, primarily related to proceeds from issuance of common stock through equity plans.

Previous wording

Our principal sources of funding as of March 31, 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 $1.0 billion for the three months ended March 31, 2025 and net losses of $3.6 billion and $4.7 billion for 2024 and 2023, respectively. We have retained earnings of $9.1 billion as of March 31, 2025.

Current wording

Our principal sources of funding as of June 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 $1.8 billion for the six months ended June 30, 2025 and net losses of $3.6 billion and $4.7 billion for 2024 and 2023, respectively. We have retained earnings of $8.2 billion as of June 30, 2025.

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 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 INT, norovirus, flu+COVID combination, CMV, RSV, and next-generation COVID 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. 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 INT, norovirus, flu+COVID combination, and CMV 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.