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Moderna Inc

For the period ended Mar 31, 2025. Filed May 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.

Mar 31, 2025 · Filed May 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 2024-09-30; filed 2024-11-07.

0001682852-24-000060

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

Current 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

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 98 previous paragraphs and 93 current paragraphs.

40 unchanged; 29 reworded; 24 added; 29 removed; 0 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 (24)

Current 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.

Current 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.

Current 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.

Current 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.

Current report

•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 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.

Current report

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

Current report

•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 report

•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 report

•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 report

•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 report

•Propionic acidemia (PA) therapeutic: In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, our investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. mRNA-3927 is in a registrational study.

Current report

•Methylmalonic acidemia (MMA) therapeutic: Our investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. We and the FDA have agreed on the pivotal study design. We expect to start a registrational study in 2025.

Current report

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

Current 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.

Current 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 increased competition. 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.

Current report

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 report

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 report

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 report

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 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.

Current report

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.
Removed paragraphs (29)

Previous report

Consistent with guidance from regulators, we updated our COVID-19 vaccine to target the KP.2 and JN.1 strains of the SARS-CoV-2 virus for the 2024-2025 season. During the third quarter of 2024, our vaccine targeting the KP.2 strain received approval from the FDA and Health Canada, while our vaccine targeting the JN.1 strain was approved by regulatory authorities in the European Union (EU), the United Kingdom, Japan, Taiwan and other jurisdictions. We have since commenced the supply of these vaccines to customers.

Previous report

In May 2024, the FDA approved mRESVIA to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation. Subsequently, the Advisory Committee on Immunization Practices (ACIP) issued a recommendation for all unvaccinated people 75 years of age and older and unvaccinated people ages 60-74 who are at increased risk. In August 2024, the European Commission (EC) granted marketing authorization for mRESVIA to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. We have also filed for mRNA-1345 approval with regulators in multiple markets worldwide and commenced sales in the U.S. in the third quarter of 2024.

Previous report

In September 2024, our manufacturing facility in Laval, Quebec, received a Drug Establishment License (DEL) from Health Canada, certifying the site’s compliance with the required safety and quality standards to produce drug substance. This certification marked a significant step in enabling our Canadian facility to become fully operational, supporting domestic manufacturing of mRNA vaccines, including COVID-19 vaccines, with production expected to begin in 2025.

Previous report

•RSV. In September 2024, we announced positive Phase 3 results for our RSV vaccine (mRNA-1345) for high-risk adults aged 18 to 59. In the trial, mRNA-1345 met all primary immunogenicity endpoints and the 50 µg dose, which is the same for the currently approved mRESVIA vaccine for adults 60 years and above, was well tolerated with no safety concerns identified.

Previous report

•Next-generation COVID-19. In September 2024, we shared positive Phase 3 vaccine efficacy and immunogenicity data for our next-generation COVID-19 vaccine (mRNA-1283).

Previous report

•Flu. In September 2024, we announced that we are no longer pursuing an accelerated approval pathway for the regulatory submission of our standalone flu vaccine, mRNA-1010, to focus our resources on the submission of a potentially more impactful Flu+COVID combination vaccine, mRNA-1083. In September 2024, we initiated a Phase 3 efficacy study (P304) for mRNA-1010, funded by previously announced project financing through Blackstone Life Sciences.

Previous report

•We intend to filein 2024 for approval of our next-generation COVID-19 vaccine (mRNA-1283) and our RSV vaccine (mRNA-1345) for high-risk adults ages 18 to 59. We intend to use priority review vouchers for those programs. For our Flu+COVID combination vaccine (mRNA-1083), we intend to file in 2024, subject to ongoing discussions with the FDA, and we have decided not to use a priority review voucher.

Previous report

•Cytomegalovirus (CMV). We expect to have accrued the 81 cases necessary to trigger the first interim analysis of the Phase 3 vaccine efficacy study of our CMV vaccine candidate (mRNA-1647) by the end of 2024.

Previous report

•Norovirus. In September 2024, we announced that the first participant in the U.S. had been dosed in the pivotal Phase 3 trial of our investigational mRNA trivalent norovirus vaccine, mRNA-1403. We had previously announced that an interim analysis had shown that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile. Additionally, robust histo-blood group antigen (HBGA) blocking antibody titers were observed against vaccine-matched norovirus genogroup I and II selected strains across all dose levels evaluated. Similar mRNA-1403-induced HBGA-blocking antibody titers were observed in younger adult and older adult age groups.

Previous report

•Individualized neoantigen therapy (INT). In October 2024, we and Merck initiated a Phase 3 study evaluating adjuvant INT (mRNA-4157) in combination with KEYTRUDA after neoadjuvant KEYTRUDA and chemotherapy in patients with certain types of resected non-small cell lung cancer. This is the third Phase 3 trial for the investigational INT focused on earlier stages of cancer.

Previous report

In the third quarter of 2024, we announced that five programs in our pipeline have been discontinued due to our strategic prioritization efforts:

Previous report

•Endemic HCoV (mRNA-1287): The preclinical program will not advance into Phase 1.

Previous report

•RSV infants (seronegative, <2 years) (mRNA-1345): We do not expect the program to advance beyond the ongoing Phase 1 based on emerging clinical data.

Previous report

•KRAS antigen-specific therapy (mRNA-5671): We have no further development plans.

Previous report

•Triplet (OX40L/IL-23/IL-36γ) (mRNA-2752): We have deprioritized further development based on emerging clinical data.

Previous report

•Relaxin (mRNA-0184): The program is wrapping up Phase 1.

Previous report

(1)Includes an adjustment of approximately $140 million in the third quarter of 2024, reflecting a reduction in prior period provision estimates, primarily related to returns for the previous COVID-19 vaccine season that closed during the quarter.

Previous report

Net product sales for the three months ended September 30, 2024 increased by $63 million, or 4%, compared to the same period in 2023, primarily driven by higher sales in the U.S. market following the earlier launch of our updated COVID-19 vaccine for the season, and an approximately $140 million adjustment related to the reduction in prior period sales provision estimates. With FDA approval granted three weeks earlier than in the previous year, we were able to meet demand more effectively. This increase was partially offset by lower international sales, which in 2023 had benefited from the fulfillment of orders deferred from 2022. For the nine months ended September 30, 2024, net product sales decreased by $1.7 billion, or 44%, compared to the same period in 2023. This decline reflects the transition of the COVID-19 vaccine market from pandemic-driven demand to a more seasonal commercial pattern, with sales in 2024 exhibiting greater seasonality and reduced overall demand.

Previous report

We expect higher demand for our COVID-19 and RSV vaccines in the fall and winter seasons each year across both hemispheres, as countries prepare for seasonal vaccination campaigns. For the full year of 2024, we anticipate further reductions in net product sales for our COVID-19 vaccine compared to 2023 as the market continues to evolve into a seasonal commercial model. Although we commenced sales of our RSV vaccine in the third quarter of 2024, these sales are not expected to have a significant impact on our overall product sales for the year.

Previous report

Cost of sales for the three months ended September 30, 2024 decreased by $1.7 billion, or 77%, compared to the same period in 2023. Cost of sales as a percentage of net product sales for the three months ended September 30, 2024 was 28%, compared to 128% for the same period in 2023. Cost of sales for the nine months ended September 30, 2024 decreased by $3.0 billion, or 81%, compared to the same period in 2023. Cost of sales as a percentage of net product sales for the nine months ended September 30, 2024 was 33%, compared to 97% for the same period in 2023. The decrease in cost of sales for both the three- and nine-month periods in 2024 was primarily driven by reduced inventory write-downs, unutilized manufacturing capacity, and purchase commitment related cancellation fees. In addition, the reduction reflects the impact of a strategic cost initiative launched in the third quarter of 2023 to optimize our COVID-19 business by resizing manufacturing operations in response to the shift toward an endemic seasonal market. This initiative, which incurred $1.4 billion in charges during the third quarter of 2023, helped drive improved manufacturing efficiency and cost reductions in 2024. The decrease in cost of sales as a percentage of net product sales for both the three- and nine-month periods in 2024 was mainly driven by reduced costs, while the decrease for the nine-month period was partially offset by the lower sales volume, reflecting a decline in product demand and increased seasonality.

Previous report

We anticipate that the full year cost of sales as a percentage of net product sales for 2024 will be lower than the 70% experienced in 2023. This expectation is based on projected improvements in our manufacturing efficiency and expected reductions in inventory write-downs. However, due to the strong seasonality of our business, we expect this percentage to be higher in the first half of the year than the second half of the year, with the fourth quarter anticipated to be higher than the third quarter.

Previous report

Research and development expenses decreased by $23 million, or 2%, for the three months ended September 30, 2024, compared to the same period in 2023. This reduction was primarily due to decreases in clinical trial expenses of $182 million and clinical manufacturing expenses of $92 million. These decreases were partially offset by the purchase of a priority review voucher, along with a $38 million increase in personnel-related costs and stock-based compensation. For the nine months ended September 30, 2024, research and development expenses decreased by $18 million, or 1%, compared to the same period in 2023. This reflects a $332 million reduction in clinical trial expenses, a $150 million reduction in clinical manufacturing expenses, and an $85 million reduction in upfront license payments. These reductions were offset by a $193 million increase in personnel-related costs and stock-based compensation, as well as the purchase of two priority review vouchers. The increase in personnel-related costs and stock-based compensation for both periods was driven by higher headcount to support our continued research and development efforts. The decrease in clinical trial expenses for the three months ended September 30, 2024, was mainly due to reduced spending on our COVID-19 and RSV programs. For the nine-month period, the decrease was largely attributable to reduced spending on our COVID-19, RSV and seasonal flu programs, in line with our planned trial schedules.

Previous report

We anticipate a modest reduction in research and development expenses in 2024 compared to 2023 levels. We continue to develop our pipeline and advance our product candidates into later-stage development, particularly our ongoing Phase 3 studies. These include our next-generation COVID-19, seasonal flu, CMV, norovirus and combination vaccine programs, as well as our INT program.

Previous report

Selling, general and administrative expenses decreased by $161 million, or 36%, for the three months ended September 30, 2024, compared to the same period in 2023. This decrease was primarily due to a reduction of $105 million in consulting and outside services across all functions, as well as a $36 million reduction in commercial and marketing related expenses. For the nine months ended September 30, 2024, selling, general and administrative expenses decreased by $256 million, or 24%, compared to the same period in 2023. The decline for the nine-month period was mainly due to a $250 million reduction in consulting and outside services across all functions, along with a $51 million reduction in commercial and marketing related expenses. These decreases were partially offset by a $48 million increase in personnel-related costs and stock-based compensation, primarily driven by an expanded headcount in digital, medical affairs and commercial functions to support our digital and artificial intelligence initiatives, as well as our marketed products. The decrease in both periods reflects cost discipline and efficiencies gained by reducing reliance on external consultants and bringing more functions in-house.

Previous report

Provision for income taxes decreased by $1.7 billion and $901 million, or 100% and 98%, for the three and nine months ended September 30, 2024, compared to the same periods in 2023. The decrease in both periods was primarily due to the establishment of a $1.7 billion valuation allowance on deferred tax assets in the third quarter of 2023. This valuation allowance has been applied consistently since its initial recognition in the third quarter of 2023. As a result, we are unable to recognize tax benefits from the loss due to our global valuation allowance. Consequently, the effective tax rates for the three and nine months ended September 30, 2024 are not comparable to the same periods in the prior year. Please refer to Note 13 to our condensed consolidated financial statements.

Previous report

Net cash provided by financing activities increased by $1.3 billion, or 105%, during the nine months ended September 30, 2024, compared to the same period in 2023, mainly due to a decrease in repurchases of common stock of $1.2 billion.
Reworded paragraphs (29)

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

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 four franchises: respiratory virus vaccines, latent and other virus 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 have a diverse and extensive development pipeline of 36 development candidates across our 45 development programs, of which 42 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 31 development candidates across our 41 development programs, of which 38 are in clinical studies currently.

Previous wording

Our COVID-19 vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®. Our original vaccine, mRNA-1273, targeted 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 mRNA product and underscores our ongoing commitment to delivering solutions for patients by addressing global public health threats related to infectious diseases.

Current wording

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 wording

For the third quarter of 2024, we recognized net product sales of $1.8 billion from sales of our COVID-19 and RSV vaccines, compared to $1.8 billion for the third quarter of 2023. Earnings per share was $0.03 for the third quarter of 2024, compared to loss per share of $(9.53) for the third quarter of 2023.

Current 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.

Previous wording

The following chart shows our current pipeline of 45 development programs across our several modalities.

Current wording

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

Previous wording

Abbreviations: BARDA, Biomedical Advanced Research and Development Authority; CMV, cytomegalovirus; cSCC, cutaneous squamous cell carcinoma; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; HSV, herpes simplex virus; IAVI, International AIDS Vaccine Initiative; ILCM, Institute for Life Changing Medicines; IM, infectious mononucleosis; NIH, National Institutes of Health; NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma; RSV, respiratory syncytial virus; VZV, varicella-zoster virus.

Current wording

Abbreviations: BARDA, Biomedical Advanced Research and Development Authority; CMV, cytomegalovirus; EBV, Epstein-Barr virus; HIV, human immunodeficiency virus; hMPV, human metapneumovirus; HR MIUC, high-risk muscle-invasive urothelial carcinoma; HR NMIBC, high-risk non-muscle invasive bladder cancer; HSV, herpes simplex virus; IAVI, International AIDS Vaccine Initiative; ILCM, Institute for Life Changing Medicines; IM, infectious mononucleosis; NIH, National Institutes of Health; NSCLC, non-small cell lung cancer; RCC, renal cell carcinoma; RSV, respiratory syncytial virus; VZV, varicella-zoster virus.

Previous wording

As of September 30, 2024, we have two commercial products authorized for use, our COVID-19 vaccine and our RSV vaccine. The RSV vaccine was approved by the FDA in May 2024 for adults aged 60 years and older.

Current wording

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 wording

In the third quarter of 2023, we commenced sales of our COVID-19 vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and international organizations. We also commenced sales of our RSV vaccine in the third quarter of 2024. In the U.S., our COVID-19 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 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-19 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-19 vaccine supply, initially recorded as deferred revenue. As of September 30, 2024, we had deferred revenue of $443 million associated with customer deposits received or billable under supply agreements, with the majority of our COVID-19 vaccine deliveries scheduled in 2024.

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 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.

Previous wording

Other revenue comprises grant revenue, collaboration revenue, and licensing and royalty revenue.

Current wording

Other revenue comprises grant revenue, collaboration revenue, licensing and royalty revenue, and other miscellaneous revenue.

Previous wording

Total revenue for the three months ended September 30, 2024 remained relatively flat compared to the same period in 2023. For the nine months ended September 30, 2024, total revenue decreased by $1.8 billion, or 44%, compared to the same period in 2023, mainly due to lower net product sales of our COVID-19 vaccine.

Current wording

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 wording

Other revenue decreased by $32 million, or 43%, and $60 million, or 38%, for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023. The decrease for the three and nine months ended was mainly due to a reduction in grant revenue under our agreement with Biomedical Advanced Research and Development Authority (BARDA) for the development of our COVID-19 vaccine, partially offset by an increase in licensing and royalty revenue.

Current wording

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 wording

Cost of sales for the three months ended September 30, 2024 was $514 million, which included third-party royalties of $92 million, inventory write-downs of $214 million, unutilized manufacturing capacity and wind-down costs of $27 million. Cost of sales for the nine months ended September 30, 2024 was $725 million, which included third-party royalties of $110 million, inventory write-downs of $302 million, primarily related to our finished and semi-finished COVID-19 vaccine inventory and certain raw materials, unutilized manufacturing capacity and wind-down costs of $109 million, and a $57 million benefit from the sale of previously written-down zero-cost inventory. Please refer to Note 7 to our condensed consolidated financial statements for inventory related charges. These charges in 2024, 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 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.

Previous wording

We anticipate that selling, general and administrative expenses in 2024 will be lower than the levels experienced in 2023. 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 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.

Previous wording

For the three months ended September 30, 2024, interest income decreased by $2 million, or 2%, compared to the same period in 2023. For the nine months ended September 30, 2024, interest income increased by $16 million, or 5%, compared to the same period in 2023. Overall, interest income from our investments in marketable securities remained relatively flat across both periods. The decrease in the three-month period was primarily due to lower average investment balances, while the increase for the nine-month period was driven by the overall higher interest rate environment.

Current 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.

Previous wording

For the three and nine months ended September 30, 2024, total other expense, net decreased by $39 million and $27 million, or 76% and 32%, respectively, compared to the same periods in 2023. The decrease in total other expense, net for the three-month period was primarily driven by a reduction in losses on equity investments. For the nine-month period, the decrease was mainly due to lower losses on available-for-sale debt securities and reduced interest expense, partially offset by an increase in losses on equity investments. Our interest expense is primarily related to our finance leases. Please refer to Note 10 to our condensed consolidated financial statements.

Current 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.

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, 2024 decreased by $4.1 billion, or 31%, compared to December 31, 2023. The decrease in cash, cash equivalents and investments was primarily due to a net cash outflow from operating activities of $3.8 billion and purchases of property and equipment of $529 million during the nine months ended September 30, 2024.

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, 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.

Previous wording

Working capital, which is current assets less current liabilities, as of September 30, 2024 increased by $155 million, compared to December 31, 2023, primarily due to an increase in accounts receivable of $672 million, mainly due to timing of collections, a decrease in accrued liabilities and accounts payable of $569 million, driven by lower spend during the period, and an increase in inventory of $210 million, driven by manufacturing of COVID-19 product, partially offset by a decrease in cash and cash equivalents of $1.3 billion.

Current 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.

Previous wording

We derive cash flows from operations primarily from cash collected from customer deposits and accounts receivable related to our product sales, as well as certain government-sponsored and private organizations, strategic alliances 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.

Current wording

We derive cash flows from operations primarily from cash collected from customer deposits and accounts receivable 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.

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-19 vaccine and received upfront deposits. In the third quarter of 2023, we commenced sales of our COVID-19 vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and international organizations. In the U.S., our COVID-19 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 September 30, 2024, we had $443 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 March 31, 2025, we had $154 million in deferred revenue related to customer deposits received or billable.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $3.8 billion and consisted of net loss of $2.4 billion, non-cash adjustments of $427 million and a net change in assets and liabilities of $1.8 billion. Non-cash items primarily included stock-based compensation of $325 million, and depreciation and amortization of $129 million. The net change in assets and liabilities was mainly due to an increase in accounts receivable of $672 million driven by timing of invoicing, a decrease in accrued liabilities and accounts payable of $518 million, driven by overall lower spend in the period, an increase in inventory of $208 million, driven by manufacturing of COVID-19 products, and a decrease in deferred revenue of $177 million due to revenue recognized in excess of customer deposits received.

Current 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.

Previous wording

Net cash used in operating activities increased by $89 million, or 2%, during the nine months ended September 30, 2024, compared to the same period in 2023, primarily attributable to a change in deferred income taxes of $934 million driven by an increase in valuation allowance, a change in prepaid expense and other assets of $919 million mainly related to prepayment of clinical studies and contract manufacturing organization activities, a change in inventory of $670 million driven by less inventory write-downs, partially offset by a decrease in net loss of $2.5 billion.

Current 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.

Previous wording

Net cash provided by investing activities for the nine months ended September 30, 2024 was $2.5 billion, which primarily included proceeds from maturities and sales of marketable securities of $7.7 billion, partially offset by purchases of marketable securities of $4.6 billion, and purchases of property and equipment of $529 million.

Current 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.

Previous wording

Net investing cash flows decreased by $2.3 billion, or 48%, during the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to an increase in purchases of marketable securities of $2.5 billion.

Current 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.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $59 million, primarily due to proceeds from issuance of common stock through equity plans of $55 million.

Current 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.

Previous wording

Our principal sources of funding as of September 30, 2024 consisted of cash and cash equivalents, investments, and cash we may generate from operations. We generated net income of $8.4 billion and $12.2 billion for the years ended in 2022 and 2021, respectively, following the authorization of our first commercial product in December 2020. From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. We also incurred a net loss of $2.4 billion for the nine months ended September 30, 2024 and a net loss of $4.7 billion for the year ended 2023. We have retained earnings of $11.2 billion as of September 30, 2024.

Current 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.

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 RSV, seasonal flu, CMV and norovirus vaccine candidates, individualized neoantigen therapy, next generation COVID-19 vaccine, combination vaccines, 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 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.

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, 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.

Previous wording

We believe that our cash, cash equivalents, and investments as of September 30, 2024, 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-19 vaccine in 2023, and this trend continued into 2024, reflecting the market's ongoing transition to a seasonal commercial pattern in the endemic COVID-19 vaccine market. 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, 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, reflecting the market's ongoing transition to a seasonal commercial pattern in the endemic COVID vaccine market. 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, 2024, other than disclosed within Note 5, 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 2023 Form 10-K.

Current wording

As of March 31, 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.