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What changed in Moderna's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Moderna's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+841 added−900 removedSource: 10-K (2026-02-20) vs 10-K (2025-02-21)

Top changes in Moderna's 2025 10-K

841 paragraphs added · 900 removed · 589 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

224 edited+112 added−185 removed164 unchanged
Biggest changeIn the United States, these laws include, among others: • The Anti-Kickback Statute, which makes it illegal for any person to knowingly and willfully solicit, receive, offer, or pay any remuneration, directly or indirectly, in cash or in kind, that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug or any other good or service, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. • The federal False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money to the federal government. • Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes criminal and civil liability for, among other things, knowingly and willfully executing a scheme, or attempting to execute a scheme, to defraud any healthcare benefit program, including private payors, or falsifying, concealing, or covering up a material fact or making any materially false statements in connection with the delivery of or payment for healthcare benefits, items or services. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their respective implementing regulations, which impose, among other things, requirements on covered entities and their business associates relating to the privacy and security of individually identifiable health information. • The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act (ACA), which requires certain pharmaceutical manufacturers with products reimbursed under certain government programs to disclose annually to the 42 Table of Contents federal government (for re-disclosure to the public) certain payments and other transfers of value provided to physicians, teaching hospitals and certain other licensed health care practitioners. • Federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs. • Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. • Analogous state fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply regardless of payor.
Biggest changeIn the United States, these laws include, among others: • The federal Anti-Kickback Statute, which prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or reward referrals or the purchase, recommendation, or prescription of products reimbursable under federal healthcare programs. • The federal False Claims Act, which imposes civil liability, including through whistleblower actions, for knowingly submitting or causing the submission of false or fraudulent claims for payment to federal healthcare programs or for avoiding or decreasing an obligation to pay the federal government. • Federal criminal healthcare fraud provisions, including those under the Health Insurance Portability and Accountability Act (HIPAA), which impose criminal and civil penalties for schemes to defraud healthcare benefit programs or for making false statements in connection with healthcare benefits, items, or services. • HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose obligations relating to the privacy and security of individually identifiable health information. • The Physician Payments Sunshine Act, enacted as part of the Patient Protection and Affordable Care Act (ACA), which requires certain manufacturers to disclose annually payments and other transfers of value made to physicians, teaching hospitals, and certain other healthcare professionals. • Federal government price reporting laws, which require manufacturers to calculate and report pricing metrics accurately and timely to government programs. • Federal consumer protection and unfair competition laws that regulate marketing and business practices. • Analogous state fraud and abuse laws, including state anti-kickback and false claims laws, which may be broader in scope and apply regardless of payor.
Vaccine development has been challenging to date for many reasons, including the lack of a robust cell culture system, no reliable immune markers of norovirus protection and the broad and shifting diversity of genotypes. A multivalent vaccine with broad genotype coverage is needed to maximize protection against the genotypes most frequently associated with AGE in young children and older adults.
Vaccine development has been challenging to date for many reasons, including the lack of a robust cell culture system, no reliable immune markers of norovirus protection and the broad and shifting diversity of genotypes. A multivalent vaccine with broad genotype coverage is needed to maximize protection against the genotypes most frequently associated with AGE in older adults and young children.
The open-label Phase 2 study is investigating a 1 mg dose of mRNA-4157 in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma. The study showed that mRNA-4157 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.02]; one-sided p value=0.0266) compared with KEYTRUDA alone.
The open-label Phase 2 study is investigating a 1 mg dose of mRNA-4157 in combination with Merck’s KEYTRUDA, compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma. The study showed that mRNA-4157 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.02]; one-sided p value=0.0266) compared with KEYTRUDA alone.
Methylmalonic acidemia (MMA) (mRNA-3705) MMA is a rare, inherited metabolic disorder with significant morbidity and mortality caused by a deficiency in an enzyme called methylmalonyl-CoA mutase (MUT). There are an estimated 500-2,000 people with MMA MUT deficiency in the United States based on estimated birth prevalence (0.3-1.2:100,000 newborns) and mortality rates.
Methylmalonic acidemia (mRNA-3705) Methylmalonic acidemia (MMA) is a rare, inherited metabolic disorder with significant morbidity and mortality caused by a deficiency in an enzyme called methylmalonyl-CoA mutase (MUT). There are an estimated 500-2,000 people with MMA MUT deficiency in the United States based on estimated birth prevalence (0.3-1.2:100,000 newborns) and mortality rates.
Mortality is significant, with mortality rates of 50% for those with complete MUT deficiency (mut 0) (median age of death 2 years) and 40% for MMA patients with partial MUT deficiency (mut -) (median age of death 4.5 years) reported in a large European study.
Mortality is significant, with rates of 50% for those with complete MUT deficiency (mut 0) (median age of death 2 years) and 40% for MMA patients with partial MUT deficiency (mut -) (median age of death 4.5 years) reported in a large European study.
The GDPR also imposes strict rules on the transfer of personal data out of the EU, provides an enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20.0 million or 4% of the annual global revenues of the infringer, whichever is greater.
The EU GDPR also imposes strict rules on the transfer of personal data out of the EU, provides an enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20.0 million or 4% of the annual global revenues of the infringer, whichever is greater.
COMPETITION The biotechnology and pharmaceutical industries utilize rapidly advancing technologies and are characterized by intense competition. There is also a strong emphasis on defense of intellectual property and proprietary products. mRNA Medicines We believe that mRNA as a medicine coupled with our capabilities across mRNA technology, drug discovery, development and manufacturing provide us with a competitive advantage.
COMPETITION The biotechnology and pharmaceutical industries utilize rapidly advancing technologies and are characterized by intense competition. There is also a strong emphasis on defense of intellectual property and proprietary products. We believe that mRNA as a medicine coupled with our capabilities across mRNA technology, drug discovery, development and manufacturing provide us with a competitive advantage.
Overview of our manufacturing operating model Our manufacturing activities generally focus on: • Commercial Production: Our manufacturing capabilities include state-of-the-art technologies for mRNA and drug substance manufacturing, as well as quality control testing to attain a robust and consistent supply that matches target product profiles. Our manufacturing technology is built to scale-up and support production of products for commercial approval.
Overview of our manufacturing operating model Our manufacturing activities generally focus on: • Commercial Production: Our manufacturing capabilities include state-of-the-art technologies for mRNA and drug product manufacturing, as well as quality control testing to attain a robust and consistent supply that matches target product profiles. Our manufacturing technology is built to scale-up and support production of products for commercial approval.
We believe that a career at Moderna provides opportunity for: • Impact : Our people will have the opportunity to do work that is unparalleled in terms of its innovation and scope of impact on people’s lives. • Growth : We provide incredible opportunities for growth and we obsess over learning (as demonstrated, in part, by our Mindsets (see below).
We believe that a career at Moderna provides opportunity for: • Impact : Our people have the opportunity to do work that is unparalleled in terms of its innovation and scope of impact on people’s lives. • Growth : We provide incredible opportunities for growth and we obsess over learning (as demonstrated, in part, by our Mindsets (see below).
New employees participate in our Moderna ONE onboarding program, which is an interactive learning experience designed to immerse our people in our culture and Mindsets from day one. Following onboarding, our employees continue to learn throughout their careers at Moderna and we deploy a digital learning management system to track and administer training programs for each of employee.
New employees participate in our Moderna ONE onboarding program, which is an interactive learning experience designed to immerse our people in our culture and Mindsets from day one. Following onboarding, our employees continue to learn throughout their careers at Moderna and we deploy a digital learning management system to track and administer training programs for each employee.
In September 2022, Merck exercised its option for personalized cancer vaccines, including mRNA-4157, pursuant to the terms of our existing PCV Collaboration and License Agreement with Merck, which was amended and restated in 2018 (PCV Agreement, also referred to as the INT Agreement).
In September 2022, Merck exercised its option for personalized cancer vaccines (PCVs), including mRNA-4157, pursuant to the terms of our existing PCV Collaboration and License Agreement with Merck, which was amended and restated in 2018 (PCV Agreement, also referred to as the INT Agreement).
In-licensed intellectual property While we develop and manufacture our potential mRNA medicines using our internally created mRNA technology platform, we also seek out and evaluate third party technologies and IP that may be complementary to our platform. 32 Table of Contents Patent sublicense agreements with Cellscript and mRNA RiboTherapeutics The Trustees of the University of Pennsylvania owns several issued U.S. patents, granted European patents and pending U.S. patent applications directed, in part, to nucleoside-modified mRNAs and their uses (the Penn Modified mRNA Patents). mRNA RiboTherapeutics, Inc.
In-licensed intellectual property While we develop and manufacture our potential mRNA medicines using our internally created mRNA technology platform, we also seek out and evaluate third party technologies and IP that may be complementary to our platform. 30 Table of Contents Patent sublicense agreements with Cellscript and mRNA RiboTherapeutics The Trustees of the University of Pennsylvania owns several issued U.S. patents, granted European patents and pending U.S. patent applications directed, in part, to nucleoside-modified mRNAs and their uses (the Penn Modified mRNA Patents). mRNA RiboTherapeutics, Inc.
We believe that an effective EBV vaccine must generate an immune response against antigens that are required for viral entry and reactivation in susceptible cell types. mRNA-1189 is designed to elicit an immune response to EBV envelope glycoproteins, which are required for infection of both epithelial and B cells. mRNA-1195 encodes for entry glycoproteins and latent antigens aimed at inducing an antibody and T cell response, and will be investigated in the context of post-transplant lymphoproliferative disorders and multiple sclerosis.
We believe that an effective EBV vaccine must generate an immune response against antigens that are required for viral entry and reactivation in susceptible cell types. mRNA-1189 is designed to elicit an immune response to EBV envelope glycoproteins, which are required for infection of both epithelial and B cells. mRNA-1195 encodes for entry glycoproteins and latent antigens aimed at inducing an antibody and T cell response, and will be investigated in the context of multiple sclerosis and post-transplant lymphoproliferative disorder.
Lyme disease affects approximately 120,000 people annually in the U.S. and Europe, with incidence increasing due to expanding tick territories driven by rising temperatures. The disease burden follows a bimodal age distribution, predominantly impacting children under 15 and older adults. Symptoms include rash, fever, headaches, fatigue, joint pain, swelling, stiffness, and headaches.
Lyme disease affects approximately 675,000 people annually in the U.S. and Europe, with incidence increasing due to expanding tick territories driven by rising temperatures. The disease burden follows a bimodal age distribution, predominantly impacting children under 15 and older adults. Symptoms include rash, fever, headaches, fatigue, joint pain, swelling, stiffness, and headaches.
In addition, multiple integrated algorithms that leverage artificial intelligence and machine learning optimize manufacturability, reduce failures and increase quality of mRNA sequences. Supply for Clinical Development We have established manufacturing capabilities that support the early development stage of product development in three key areas: GLP Tox, Clinical Studies and INTs. We supply formulated product to conduct IND-enabling GLP toxicology studies.
In addition, multiple integrated algorithms that leverage artificial intelligence and machine learning optimize manufacturability, reduce failures and increase quality of mRNA sequences. Supply for Clinical Development We have established manufacturing capabilities that support the early development stage of product development in three key areas: GLP Tox, Clinical Studies and intismeran. We supply formulated product to conduct IND-enabling GLP toxicology studies.
Unlike traditional process development, each INT batch is manufactured for a single patient and thus scaled-out (in parallel) with extensive use of automation and robotics to account for the larger number of patients involved in later phases of development and commercialization. We have shown consistent quality in our production of many patient batches, each with unique mRNA sequences.
Unlike traditional process development, each intismeran batch is manufactured for a single patient and thus scaled-out (in parallel) with extensive use of automation and robotics to account for the larger number of patients involved in later phases of development and commercialization. We have shown consistent quality in our production of many patient batches, each with unique mRNA sequences.
The continued growth of the mRNA field is leading to increased competitive pressure, including from large and more established pharmaceutical companies. We also face competition when entering into strategic alliances to advance and grow our pipeline. We largely compete against Pfizer and BioNTech for sales of our COVID vaccine, whose vaccine is also based on mRNA technology.
The continued growth of the mRNA field is leading to increased competitive pressure, including from large and more established pharmaceutical companies. We also face competition when entering into strategic alliances to advance and grow our pipeline. Seasonal vaccines We largely compete against Pfizer and BioNTech for sales of our COVID vaccines, whose vaccine is also based on mRNA technology.
(including granted European patents that have been validated in numerous European countries) covering certain of our proprietary platform technology, inventions and improvements, and covering key aspects of our clinical and most advanced development candidates. We have 700 additional pending patent applications that, in many cases, are counterparts to the foregoing U.S. and foreign patents.
(including granted European patents that have been validated in numerous European countries) covering certain of our proprietary platform technology, inventions and improvements, and covering key aspects of our clinical and most advanced development candidates. We have 485 additional pending patent applications that, in many cases, are counterparts to the foregoing U.S. and foreign patents.
Under the strategic alliance, we identify genetic mutations present in a particular patient’s tumor cells, synthesize mRNA for these mutations, encapsulate the mRNA in one of our proprietary LNPs and administer to each patient a unique INT designed to specifically activate the patient’s immune system against her or his own cancer cells.
Under the strategic alliance, we identify genetic mutations present in a particular patient’s tumor cells, synthesize mRNA for these mutations, encapsulate the mRNA in one of our proprietary LNPs and administer to each patient a unique intismeran designed to specifically activate the patient’s immune system against her or his own cancer cells.
These include our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K, and amendments to those reports. The SEC also maintains an Internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding us and other issuers that file electronically with the SEC. 44 Table of Contents
These include our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K, and amendments to those reports. The SEC also maintains an Internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding us and other issuers that file electronically with the SEC. 42 Table of Contents
Representative relationships and associated programs include those with Merck, for our INT programs (mRNA-4157), and Vertex, for our CF program (mRNA-3692). To maintain the integrity of our platform, our strategic collaboration agreements generally grant either us the rights to develop and commercialize potential mRNA medicines we design and manufacture, or grant our collaborators those rights.
Representative relationships and associated programs include those with Merck, for our intismeran programs (mRNA-4157), and Vertex, for our CF program (mRNA-3692). To maintain the integrity of our platform, our strategic collaboration agreements generally grant either us the rights to develop and commercialize potential mRNA medicines we design and manufacture, or grant our collaborators those rights.
For example, these patents and patent applications include claims directed to: • mRNA chemistry imparting improved properties for vaccine and therapeutic uses; • methods for mRNA sequence optimization to enhance the levels and fidelity of proteins expressed from our mRNA medicines; • methods for identifying epitopes having superior suitability in cancer vaccine contexts; • engineering elements tailored to enhance stability and the in vivo performance of mRNA medicines; 29 Table of Contents • LNP delivery systems, including novel lipid components designed for optimal delivery and expression of both therapeutic and vaccine nucleic acids, in particular, prophylactic infectious disease and cancer vaccine nucleic acids, intratumoral immuno-oncology therapeutics, local regenerative therapeutics, systemic therapeutics, and inhaled pulmonary therapeutics; and • innovative processes for the manufacture and analysis of mRNA drug substance and formulated drug product.
For example, these patents and patent applications include claims directed to: • mRNA chemistry imparting improved properties for vaccine and therapeutic uses; • methods for mRNA sequence optimization to enhance the levels and fidelity of proteins expressed from our mRNA medicines; • methods for identifying epitopes having superior suitability in cancer vaccine contexts; • engineering elements tailored to enhance stability and the in vivo performance of mRNA medicines; • LNP delivery systems, including novel lipid components designed for optimal delivery and expression of both therapeutic and vaccine nucleic acids, in particular, prophylactic infectious disease and cancer therapy nucleic acids, intratumoral immuno-oncology therapeutics, local regenerative therapeutics, systemic therapeutics, and inhaled pulmonary therapeutics; and • innovative processes for the manufacture and analysis of mRNA drug substance and formulated drug product.
Due to the specialized nature of personalized medicine (i.e., where a batch is specifically designed and manufactured for a single patient), the manufacturing process for INTs has unique requirements. We digitally integrate patient-specific data from sequencing tumor samples to automatically design INTs for patients.
Due to the specialized nature of personalized medicine (i.e., where a batch is specifically designed and manufactured for a single patient), the manufacturing process for intismeran has unique requirements. We digitally integrate patient-specific data from sequencing tumor samples to automatically design intismeran for patients.
This Phase 1 dose-escalation, open-label clinical trial is the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability and immunogenicity of a NiV mRNA vaccine candidate. The trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID).
This Phase 1 dose-escalation, open-label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability and immunogenicity of a NiV mRNA vaccine candidate. The trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID).
In addition, human clinical studies rely on supply to meet required cGMP standards. This is achieved via internal manufacturing at the MTC campus. Our MTC campus is also suited to enable rapid technology development and scale-up for future needs. Our manufacturing also produces cGMP INTs.
In addition, human clinical studies rely on supply to meet required cGMP standards. This is achieved via internal manufacturing at the MTC campus. Our MTC campus is also suited to enable rapid technology development and scale-up for future needs. Our manufacturing also produces cGMP intismeran.
Through certain of our strategic alliances, we share the rewards and risks of developing a new mRNA modality or program, where we may have early research data and desire a strategic collaborator to join us in advancing early development candidates within such modality into the clinic.
Through certain of our strategic alliances, we share the benefits and risks of developing a new mRNA modality or program, where we may have early research data and desire a strategic collaborator to join us in advancing early development candidates within such modality into the clinic.
Our estate also includes IP covering certain LNP-encapsulated mRNAs coding for infectious disease antigens for use in preventing or treating infectious diseases, including those caused by respiratory and latent viruses, as well as bacterial, viral and parasitic diseases known to threaten public health.
Our estate also includes IP covering certain LNP-encapsulated mRNAs coding for infectious disease antigens for use in preventing or treating infectious diseases, including those caused by respiratory and latent viruses, as well as bacterial diseases known to threaten public health.
Nipah vaccine (mRNA-1215) Nipah virus (NiV) is a zoonotic virus transmitted to humans from animals, contaminated food or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications from NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%.
Public health vaccines Nipah vaccine (mRNA-1215) Nipah virus (NiV) is a zoonotic virus transmitted to humans from animals, contaminated food or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications from NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%.
Our initial indications for mRNA-4359 are advanced or metastatic cutaneous melanoma and NSCLC. We presented data from the Phase 1a study of mRNA-4359 at the European Society for Medical Oncology (ESMO) Congress in 2024, where in a population of patients with heavily pre-treated, advanced stage cancers, eight of 16 response-evaluable patients achieved a best overall response (BOR) of stable disease.
Our initial indications for mRNA-4359 are advanced or metastatic cutaneous melanoma and NSCLC. 19 Table of Contents We presented data from the Phase 1a study of mRNA-4359 at the European Society for Medical Oncology (ESMO) Congress in 2024, where in a population of patients with heavily pre-treated, advanced stage cancers, eight of 16 response-evaluable patients achieved a best overall response (BOR) of stable disease.
We believe that our employees are highly engaged, and our company and team have been publicly recognized for our leadership, innovation and good corporate citizenship. Science magazine ranked us as a top employer for each of the last ten years.
We believe that our employees are highly engaged, and our company and team have been publicly recognized for our leadership, innovation and good corporate citizenship. Science magazine ranked us as a top employer for each of the last eleven years.
However, we face competition from others developing mRNA vaccines and therapeutics, as well as other medicines that compete or could compete with our products. We face competition from various sources, including large pharmaceutical companies, biotechnology companies, academic institutions, government agencies and public and private research institutions.
However, we face competition from others developing mRNA medicines, as well as other medicines that compete or could compete with our products. We face competition from various sources, including large pharmaceutical companies, biotechnology companies, academic institutions, government agencies and public and private research institutions.
We file additional U.S. and foreign patent applications in key markets as necessary to protect our evolving intellectual property positions. We also rely on trademarks, copyright, trade secrets and know-how relating to our proprietary technology and programs, continuing innovation, and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of mRNA therapeutic and vaccine technologies.
We file additional U.S. and foreign patent applications in key markets as necessary to protect our evolving intellectual property positions. 27 Table of Contents We also rely on trademarks, copyright, trade secrets and know-how relating to our proprietary technology and programs, continuing innovation, and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of mRNA therapeutic and vaccine technologies.
Translational data showed antigen-specific T-cell responses were elicited by mRNA-4359 treatment; a proportion of activated, cytotoxic, and memory T cells were elevated and a proportion of regulatory T cells 20 Table of Contents and myeloid-derived suppressor cells (MDSCs) were diminished on-treatment. mRNA-4359 monotherapy was tolerable at all dose levels tested with most adverse events of low grade (grade 1–2) and manageable.
Translational data showed antigen-specific T-cell responses were elicited by mRNA-4359 treatment; a proportion of activated, cytotoxic, and memory T cells were elevated and a proportion of regulatory T cells and myeloid-derived suppressor cells (MDSCs) were diminished on treatment. mRNA-4359 monotherapy was tolerable at all dose levels tested with most adverse events of low grade (grade 1–2) and manageable.
Our machine-learning based algorithms design the specific therapy for each individual patient and optimize the timely manufacture and delivery of INT to each patient. At the commercial stage, our digital and commercial organizations partner to drive performance and prepare for product launches.
Our machine-learning based algorithms design the specific therapy for each individual patient and optimize the timely manufacture and delivery of intismeran to each patient. At the commercial stage, our digital and commercial organizations partner to drive performance and prepare for product launches.
Most of the patents and applications (if issued) in our portfolio will not expire until 2033 at the earliest. Any patent that may issue from our most recently filed patent applications is projected to expire between 2043 and 2044, at the earliest.
Most of the patents and applications (if issued) in our portfolio will not expire until 2033 at the earliest. Any patent that may issue from our most recently filed patent applications is projected to expire between 2044 and 2045, at the earliest.
In December 2021, we launched our Artificial Intelligence (AI) Academy. The AI Academy is intended to educate and empower our employees to identify and integrate AI and machine learning solutions into every Moderna system and process to bring mRNA medicines to patients.
In December 2021, we launched our AI Academy. The AI Academy is intended to educate and empower our employees to identify and integrate AI and machine learning solutions into every Moderna system and process to bring mRNA medicines to patients.
In addition to patent applications filed in the United States, certain of these patent families have foreign counterparts, such as in Europe. 31 Table of Contents Public health vaccines We maintain a multi-program effort at developing vaccines for potential future pandemics and for use in parts of the world with less well-established health care systems.
In addition to patent applications filed in the United States, certain of these patent families have foreign counterparts, such as in Europe. Public health vaccines We maintain a multi-program effort at developing vaccines for potential future pandemics and for use in parts of the world with less well-established health care systems.
New modalities and product candidates can create a network effect by helping us gain additional insight into the other programs in our pipeline. Although developing a new modality is difficult, time-consuming and expensive, we believe our experience and technology provide us with unique advantages in the development of mRNA medicines.
New modalities and product candidates can create a network effect by helping us gain additional insight into the other programs in our pipeline. 10 Table of Contents Although developing a new modality is difficult, time-consuming and expensive, we believe our experience and technology provide us with unique advantages in the development of mRNA medicines.
Our substantial investments in recent years in technical development has enabled the breadth and depth of our pipeline, and laid the foundation to help meet the needs and requirements associated with late-stage development and the commercialization of our products.
Our substantial investments in recent years in technical development have enabled the breadth and depth of our pipeline, and laid the foundation to help meet the needs and requirements associated with late-stage development and the commercialization of our products.
Review and approval process In the EU/EEA, in order to obtain a marketing authorization from the applicable regulatory authority, a company may submit marketing authorization applications either under a centralized or decentralized procedure.
Review and approval process In the EU/EEA, in order to obtain a marketing authorization from the applicable regulatory authority, a company may submit marketing authorization applications either under a centralized or national procedure.
European regulatory data protection In the EU, new innovative products authorized for marketing qualify for regulatory data protection consisting of eight years of data exclusivity and an additional two years of market protection upon the grant of a marketing authorization.
European regulatory data protection In the EU, innovative medicinal products authorized for marketing qualify for regulatory data protection consisting of eight years of data exclusivity and an additional two years of market protection upon the grant of a marketing authorization.
This data was presented at the American Society of Clinical Oncology (ASCO) in June 2024, as well as translational biomarker data that suggests mRNA-4157 may benefit a broad patient population, irrespective of the status of PD-L1, TMB, ctDNA, and HLA heterozygosity. Three-year exploratory endpoint data also showed an encouraging trend in overall survival (OS) with the combination versus pembrolizumab monotherapy.
These data were presented at the American Society of Clinical Oncology (ASCO) in June 2024, as well as translational biomarker data that suggests mRNA-4157 may benefit a broad patient population, irrespective of the status of PD-L1, TMB, ctDNA, and HLA heterozygosity. Three-year exploratory endpoint data also showed an encouraging trend in overall survival (OS) with the combination versus pembrolizumab monotherapy.
In addition, we have at least 360 pending trademark applications in more than 55 jurisdictions, including in the aforementioned locations and additional countries throughout Africa, Asia, and South America.
In addition, we have at least 180 pending trademark applications in more than 55 jurisdictions, including in the aforementioned locations and additional countries throughout Africa, Asia, and South America.
These insights have allowed us to make significant improvements in the efficiency of our processing and the potency of our LNPs. 10 Table of Contents Harnessing the power of mRNA through modalities Within our platform, we invest in science to invent novel ways to deliver mRNA into various cell types.
These insights have allowed us to make significant improvements in the efficiency of our processing and the potency of our LNPs. Harnessing the power of mRNA through modalities Within our platform, we invest in science to invent novel ways to deliver mRNA into various cell types.
We are collaborating with Vertex on our CF candidate, mRNA-3692/VX-522, which is designed to treat the underlying cause of CF by enabling cells in the lungs to produce functional CFTR protein for the treatment of the 10% of patients who do not produce any modulator-responsive CFTR protein. This would be our first demonstration of a nebulized mRNA therapy.
We are collaborating with Vertex on our CF candidate, mRNA-3692/VX-522, which is designed to treat the underlying cause of CF by enabling cells in the lungs to produce functional CFTR protein for the treatment of the over 5,000 patients who do not produce any modulator-responsive CFTR protein. This would be our first demonstration of a nebulized mRNA therapy.
The neoantigens are encoded in a single mRNA sequence and formulated in our proprietary LNPs designed for intramuscular injection. INT is manufactured using an automated workflow to enable a rapid turnaround time. We are developing mRNA-4157 in collaboration with Merck.
The neoantigens are encoded in a single mRNA sequence and formulated in our proprietary LNPs designed for intramuscular injection. Intismeran autogene is manufactured using an automated workflow to enable a rapid turnaround time. We are developing mRNA-4157 in collaboration with Merck.
We have therefore invested heavily in delivery science and have developed LNP technologies to enable delivery of larger quantities of mRNA to target tissues. 9 Table of Contents LNPs are generally composed of four components: an amino lipid, a phospholipid, cholesterol, and a pegylated-lipid (PEG-lipid).
We have therefore invested heavily in delivery science and have developed LNP technologies to enable delivery of larger quantities of mRNA to target tissues. LNPs are generally composed of four components: an amino lipid, a phospholipid, cholesterol, and a pegylated-lipid (PEG-lipid).
At the product development stage, AI helps to improve the efficiency of our clinical trial operations by, for example, forecasting participant enrollment and automating clinical trial data processing. Our manufacturing processes likewise utilize the power of AI. For example, we leverage a series of fully autonomous, integrated AI algorithms in connection with manufacturing mRNA-4157, our INT candidate.
At the product development stage, AI helps to improve the efficiency of our clinical trial operations by, for example, forecasting participant enrollment and automating clinical trial data processing. Our manufacturing processes likewise utilize the power of AI. For example, we leverage a series of fully autonomous, integrated AI algorithms in connection with manufacturing intismeran autogene (mRNA-4157).
We operate in a highly competitive environment for talent, particularly as we seek to attract and retain talent with experience in the biotechnology and pharmaceutical sectors. Our workforce is highly educated, and as of December 31, 2024, 43% of our employees hold Ph.D., Doctorate, M.D., J.D. or Master’s degrees. Among our employees, as of December 31, 2024, 49% are female.
We operate in a highly competitive environment for talent, particularly as we seek to attract and retain talent with experience in the biotechnology and pharmaceutical sectors. Our workforce is highly educated, and as of December 31, 2025, 46% of our employees hold Ph.D., Doctorate, M.D., J.D. or Master’s degrees. Among our employees, as of December 31, 2025, 49% are female.
In September 2023, we announced the P303 immunogenicity and safety study of mRNA-1010 met all 8 co-primary endpoints with an updated formulation that was able to generate an improved immune response to influenza B strains. mRNA-1010 also elicited higher titers than the licensed comparator against all strains in this study.
In September 2023, we announced the P303 immunogenicity and safety study of mRNA-1010 met all eight co-primary endpoints with an updated composition that was able to generate an improved immune response to influenza B strains. mRNA-1010 also elicited higher titers than the licensed comparator against all strains in this study.
In addition, we have established an infrastructure to enable direct-to-customer shipments for our commercial products. We leverage third-party wholesalers and integrate with artificial intelligence-driven data analytics to ensure successful ordering and delivery. 25 Table of Contents Engineering Our global engineering organization is structured to deliver exceptional facilities and services.
In addition, we have established an infrastructure to enable direct-to-customer shipments for our commercial products. We leverage third-party wholesalers and integrate with artificial intelligence-driven data analytics to ensure successful ordering and delivery. Engineering Our global engineering organization is structured to deliver exceptional facilities and services.
These applications also relate to various vaccine design formats, in particular, polyepitopic vaccine formats, and methods of treating cancer with such INTs. We also possess substantial know-how and trade secrets relating to the development and commercialization of our cancer vaccine programs, including related manufacturing process and technology.
These applications also relate to various vaccine design formats, in particular, polyepitopic vaccine formats, and methods of treating cancer with intismeran. We also possess substantial know-how and trade secrets relating to the development and commercialization of our cancer therapy programs, including related manufacturing process and technology.
This period may be 40 Table of Contents reduced to six years if, at the end of the fifth year, it is established that the orphan drug designation criteria are no longer met.
This period may be reduced to six years if, at the end of the fifth year, it is established that the orphan drug designation criteria are no longer met.
Any U.S. and foreign patents that may issue from these patent families would be expected to expire in 2036 for the earliest of the MMA patents and 2038 to 2042 for the remaining MMA, PA, PKU, GSD1a and CN-1 patents, excluding any patent term adjustments, any patent term extensions and any terminal disclaimers.
Any U.S. and foreign patents that may issue from these patent families would be expected to expire in 2036 for the earliest of the MMA patents and 2038 to 2042 for the remaining MMA and PA patents, excluding any patent term adjustments, any patent term extensions and any terminal disclaimers.
In June 2024, we announced that our Phase 3 clinical trial of mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older. We filed for FDA approval for mRNA-1083 in November 2024.
In June 2024, we announced that our Phase 3 clinical trial of mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older.
Pursuant to the INT Agreement, we and Merck have agreed to collaborate on further development and potential commercialization of INTs, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement.
Pursuant to the PCV Agreement, we and Merck have agreed to collaborate on further development and potential commercialization of intismeran, with costs and any profits or losses generally shared equally on a worldwide basis, subject to certain exceptions as outlined in the agreement.
Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors.
Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. In the United States, there is no uniform policy for coverage and reimbursement among third-party payors.
In 2024, for the third year in a row, an outside statistical pay equity analysis confirmed zero statistically significant differences in pay across gender globally and across gender, race and ethnicity in the United States. 33 Table of Contents Our approach to attracting and retaining talent We are committed to ensuring that our employees find that their careers at Moderna are filled with purpose, growth and fulfillment.
In 2025, for the fourth year in a row, an outside statistical pay equity analysis confirmed zero statistically significant differences in pay across gender globally and across gender, race and ethnicity in the United States. 31 Table of Contents Our approach to attracting and retaining talent We are committed to ensuring that our employees find that their careers at Moderna are filled with purpose, growth and fulfillment.
This trial evaluates the safety and immunogenicity of a heptavalent (mRNA-1975) and monovalent (mRNA-1982) approach in parallel. mRNA-1982 targets Borrelia burgdorferi, responsible for nearly all Lyme cases in the U.S., while mRNA-1975 targets the four major Borrelia species causing disease in the U.S. and Europe.
This trial evaluates the safety and immunogenicity of a heptavalent (mRNA-1975) and monovalent (mRNA-1982) approach in parallel. mRNA-1982 targets Borrelia burgdorferi, responsible for nearly all Lyme cases in North America, while mRNA-1975 targets the four major Borrelia species causing disease in North America and Europe.
Although smallpox was eradicated in 1977, continued protection from smallpox is of great interest given the lethality of the infection and potential for use as an agent of bioterrorism. Other viruses associated with the Orthopoxvirus genus include cowpox, rabbitpox and camelpox.
Although smallpox was eradicated in 1980, continued protection from smallpox is of great importance given the lethality of the infection and potential for use as an agent of bioterrorism. Other viruses associated with the Orthopoxvirus genus include cowpox, rabbitpox and camelpox.
Our INT, mRNA-4157, uses next generation sequencing and a machine-learning based algorithm to design an mRNA that encodes up to 34 neoantigens against each individual patient’s tumor mutations with specificity to their HLA type, and is predicted to elicit both class I (CD8) and class II (CD4) responses.
Intismeran autogene, mRNA-4157, uses next generation sequencing and a machine-learning based algorithm to design an mRNA that encodes up to 34 neoantigens against each individual patient’s tumor mutations with specificity to their HLA type, and is predicted to elicit both class I (CD8+ T cells) and class II (CD4+ T cells) responses.
Proprietary methods around the making and therapeutic use of our INTs and resulting vaccine compositions are described and claimed in one granted U.S. patent, eight pending U.S. patent applications, six pending European patent applications, one granted patent and five pending patent applications in Japan, three pending patent applications and one granted patent in China, and several pending patent applications in New Zealand, South Africa, Asian and South American countries, as well as one PCT application.
Proprietary methods around the making and therapeutic use of our intismeran and resulting vaccine compositions are described and claimed in one granted and one allowed U.S. patent, eight pending U.S. patent applications, five pending European patent applications, two granted patent and five pending patent applications in Japan, three pending patent applications and one granted patent in China, and several pending patent applications in New Zealand, South Africa, Asian and South American countries, as well as two PCT applications.
Latent vaccines We have vaccine programs and patent applications directed to diseases caused by various latent viruses, including CMV, EBV, HSV and VZV, in some cases, using both preventative vaccines targeting the acute phase and therapeutic vaccines for treating the latent diseases in those who do become infected.
Latent vaccines We have vaccine programs and patent applications directed to diseases caused by various latent viruses, in some cases, using both preventative vaccines targeting the acute phase and therapeutic vaccines for treating the latent diseases in those who do become infected.
Trademarks Our trademark portfolio currently contains at least 1,250 trademark registrations, including at least 30 registrations in the United States and the remaining in Canada, the European Union, the United Kingdom, Israel, China, Japan, Australia, and elsewhere.
Trademarks Our trademark portfolio currently contains at least 1,400 trademark registrations, including at least 29 registrations in the United States and the remaining in Canada, the European Union, the United Kingdom, Israel, China, Japan, Australia, and elsewhere.
We consider the commercial terms of these licenses and their provisions regarding diligence, insurance, indemnification and other similar matters, to be reasonable and customary for our industry. HUMAN CAPITAL We had approximately 5,800 full-time employees in 18 countries as of December 31, 2024 .
We consider the commercial terms of these licenses and their provisions regarding diligence, insurance, indemnification and other similar matters, to be reasonable and customary for our industry. HUMAN CAPITAL We had approximately 4,700 full-time employees in 18 countries as of December 31, 2025 .
Combination vaccines (mRNA-1083 and mRNA-1365) We are developing combination vaccine candidates to simplify and facilitate protection against a range of respiratory diseases. mRNA-1083, our next-generation COVID and seasonal influenza combination vaccine, encodes the same antigens as our updated seasonal influenza vaccine (mRNA-1010) and our next-generation COVID vaccine (mRNA-1283).
Combination vaccines (mRNA-1083 and mRNA-1365) We are developing combination vaccine candidates to simplify and facilitate protection against a range of respiratory diseases. Our COVID and seasonal influenza combination vaccine (mRNA-1083), encodes the same antigens as our seasonal influenza vaccine (mRNA-1010) and mNEXSPIKE.
Checkpoint adaptive immune modulation therapy (mRNA-4359) We are developing a checkpoint adaptive immune modulation therapy (AIM-T) (mRNA-4359) that encodes Indoleamine 2,3 -dioxygenase (IDO) and programmed death-ligand 1 (PD-L1) antigens. We designed mRNA-4359 with the goal of stimulating effector T cells that target and kill suppressive immune and tumor cells that express the target antigens.
Cancer antigen therapy (mRNA-4359) We are developing a cancer antigen therapy (mRNA-4359) that encodes Indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1) antigens. We designed mRNA-4359 with the goal of stimulating effector T cells that target and kill suppressive immune and tumor cells that express the target antigens.
For further information on certain risks associated with the pricing and reimbursement of our products see “Risk Factors —Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules. ” Other healthcare laws Healthcare providers, physicians, and third-party payors, including governmental payors, such as Medicare and Medicaid in the United States, will play a primary role in the recommendation and prescription of any marketed products.
For further information on risks associated with pricing and reimbursement, see “Risk Factors—Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules.” 40 Table of Contents Other healthcare laws Healthcare providers, physicians, and third-party payors, including governmental payors such as Medicare and Medicaid in the United States, play a significant role in the recommendation, prescription, and reimbursement of pharmaceutical products.
We have developed proprietary bioinformatics designed algorithms linked to an automated manufacturing process for rapid production of formulated 24 Table of Contents mRNA, with a typical turnaround time of a few weeks. We have operationalized INT manufacturing at the MTC campus to meet our Phase 1 and 2 pipeline supply needs by using single-use systems with fast “needle-to-needle” turnaround times.
We have developed proprietary bioinformatics designed algorithms linked to an automated manufacturing process for rapid production of formulated mRNA, with a typical turnaround time of a few weeks. We have operationalized intismeran manufacturing to meet our Phase 1 and 2 pipeline supply needs by using single-use systems with fast “needle-to-needle” turnaround times.
RSV vaccine (mRESVIA/mRNA-1345) Respiratory syncytial virus (RSV) is one of the most common causes of lower respiratory disease in children under the age of five and in older adults. Populations that are especially vulnerable to developing severe RSV infections include infants, young children, children and adults with chronic medical conditions and older adults.
RSV vaccine (mRESVIA/mRNA-1345) RSV is one of the most common causes of lower respiratory disease in children under the age of five and in older adults. Populations that are especially vulnerable to developing severe RSV infections include infants, young children, children and adults with chronic medical conditions and older adults. Most children are infected at least once by age two.
Through the AI Academy, our employees learn how to leverage AI in their specific job functions to augment their capacity and capabilities, and to maximize our impact on patients. AI helps optimize each aspect of our value chain, from drug design to commercial manufacturing and beyond.
Through these initiatives, our employees learn how to leverage AI in their specific job functions to augment their capacity and capabilities, and to maximize our impact on patients. 24 Table of Contents AI helps optimize each aspect of our value chain, from drug design to commercial manufacturing and beyond.
The GDPR imposes strict requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of the personal data.
The EU GDPR imposes strict requirements relating to the consent of the individuals to whom the personal data relates, the collection and processing of sensitive data (such as health data), the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of the personal data.
No safety concerns have been identified across the evaluated dose levels for three injections of mRNA-1975/1982. Furthermore, three injections of mRNA-1975/1982 elicit robust anti-OspA IgG antibody responses, with titers up to ~1,300 times above baseline for OspA serotype 1 of Borrelia burgdorferi.
No safety concerns have been identified across the evaluated dose levels for three injections of mRNA-1975/1982. Furthermore, three injections of mRNA-1975/1982 elicit robust anti-OspA IgG antibody responses, with titers up to ~1,300 times above baseline for OspA serotype 1 of Borrelia burgdorferi. The program will progress to a Phase 2 dose ranging study of mRNA-1982.
Among our leadership (which we define as employees at the vice president level and above), as of December 31, 2024, approximately 38% are female. 45% of our U.S. employees identify as racially or ethnically diverse as of December 31, 2024.
Among our leadership (which we define as employees at the vice president level and above), as of December 31, 2025, approximately 39% are female. 44% of our U.S. employees identify as racially or ethnically diverse as of December 31, 2025.
Please refer to our 2023 ESG Report under the “Responsibility—Corporate policies” section of our website, which can be found at www.modernatx.com/responsibility/corporate-policies, as well as our proxy statement related to our 2025 Annual Meeting of Stockholders that we will file with the SEC, for a description of some of the measures we have taken to progress our commitment to corporate social responsibility.
Please refer to our 2024 Impacting Human Health Report under the “Responsibility—Corporate policies & reporting” section of our website, which can be found at www.modernatx.com/responsibility/corporate-policies, as well as our proxy statement related to our 2026 Annual Meeting of Stockholders that we will file with the SEC, for a description of some of the measures we have taken to progress our commitment to corporate social responsibility.
Our success in developing, manufacturing and commercializing vaccines against COVID-19 and RSV demonstrates the potential of mRNA medicines to help people and patients in far-reaching ways that could exceed the impact of traditional approaches to medicine.
Our success in developing, manufacturing and commercializing mRNA medicines demonstrates the potential of our platform to help people and patients in far-reaching ways that could exceed the impact of traditional approaches to medicine.
Pandemic strains can arise by antigenic shift, which is the exchange of genetic segments between a (non-human) influenza virus with another influenza virus; this can occur through a simultaneous infection of an animal (e.g., swine) or humans with multiple influenza viruses.
Historically, pandemic strains have arisen by antigenic shift, which is a major change in an influenza A virus caused by the exchange of genetic segments between a non-human influenza virus with another influenza virus; this can occur through a simultaneous infection of an animal (e.g., swine) or humans with multiple influenza viruses.
Both pentamer and gB are essential for CMV to infect barrier epithelial surfaces and gain access to the body, which is the first step in CMV infection. mRNA-1647 is designed to produce an immune response against both pentamer and gB for the prevention of CMV infection, which could reduce the risk of birth defects and post-transplant infections.
Both pentamer and gB are essential for CMV to infect barrier epithelial surfaces and gain access to the body, which is the first step in CMV infection. mRNA-1647 is designed to produce an immune response against both pentamer and gB for the prevention of CMV infection.
The Gates Foundation In January 2016, we entered a global health project framework agreement with the Bill & Melinda Gates Foundation (n/k/a the Gates Foundation) to advance mRNA development projects for various infectious diseases.
ILCM will be responsible for the clinical development of mRNA-3351. The Gates Foundation In January 2016, we entered a global health project framework agreement with the Bill & Melinda Gates Foundation (n/k/a the Gates Foundation) to advance mRNA development projects for various infectious diseases.
We have a total of seven rare disease programs in our current portfolio, summarized below. Propionic acidemia (PA) (mRNA-3927) PA is a rare, inherited metabolic disorder with significant morbidity and mortality, affecting one in 100,000-150,000 individuals worldwide.
RARE DISEASE FRANCHISE Our current rare disease programs are summarized below. Propionic acidemia (mRNA-3927) Propionic acidemia (PA) is a rare, inherited metabolic disorder with significant morbidity and mortality, affecting one in 100,000-150,000 individuals worldwide.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeContracts and grants funded by the U.S. government and its agencies, including our agreements funded by BARDA and DARPA and our collaboration with NIAID, include provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: • terminate agreements, in whole or in part, for any or no reason; • reduce or modify the government’s obligations under such agreements without our consent; • claim rights, including IP rights, in products and data developed under such agreements; • audit contract-related costs and fees, including allocated indirect costs; • suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations; • impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; • suspend or debar the contractor or grantee from doing future business with the government; • control and potentially prohibit the export of products; • pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and • limit the government’s financial liability to amounts appropriated by the U.S.
Biggest changeOur reliance on government funding and collaboration from governmental and quasi-governmental entities for certain of our programs adds uncertainty to our research and development efforts with respect to those programs and may impose requirements related to IP rights and requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs. 61 Contracts and grants funded by the U.S. government and its agencies, including our agreements funded by BARDA and DARPA and our collaboration with NIAID, and with foreign governments and agencies, including in the United Kingdom, Canada and Australia, may include provisions that reflect the government’s substantial rights and remedies, many of which are not typically found in commercial contracts, including powers of the government to: • terminate agreements, in whole or in part, for any or no reason; • reduce or modify the government’s obligations under such agreements without our consent; • claim rights, including IP rights, in products and data developed under such agreements; • audit contract-related costs and fees, including allocated indirect costs; • suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations; • impose manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements; • suspend or debar the contractor or grantee from doing future business with the government; • control and potentially prohibit the export of products; • pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and • limit the government’s financial liability to amounts appropriated by the U.S.
That may require resupplying clinical material or making additional cGMP batches to keep up with clinical trial demand before such pharmaceutical property testing is completed. We utilize a number of raw materials and excipients that have a single source of supply, are new to the pharmaceutical industry and are being employed in a novel manner.
That may require resupplying clinical material or making additional cGMP batches to keep up with clinical trial demand before such pharmaceutical property testing is completed. We utilize a number of raw materials and excipients that may have a single source of supply, are new to the pharmaceutical industry and are being employed in a novel manner.
Lot failures have caused, and lot failures or product recalls in the future with respect to product produced by either our own or our third-party manufacturers’ facilities could cause, us and our strategic collaborators to delay clinical trials or product launches.
Lot failures have caused, and lot failures or product recalls in the future with respect to product produced by either our own or our third-party manufacturers’ facilities could cause, us and strategic collaborators to delay clinical trials or product launches.
We rely on third parties such as CROs to help manage certain preclinical work and our clinical trials, and on medical institutions, clinical investigators and CROs to assist in the design and review of, and to conduct, our clinical trials, including enrolling qualified patients.
We rely on third parties such as CROs to help manage certain preclinical work, and on medical institutions, clinical investigators and CROs to assist in the design, review and conduct of our clinical trials, including enrolling qualified patients.
Our internal computer systems and infrastructure and those of our strategic collaborators, vendors, contractors, consultants or regulators with whom we share confidential, protected or sensitive data or information, or upon which our business relies, are vulnerable to damage from computer viruses, unauthorized access, misuse, natural disasters, terrorism, cybersecurity threats, war and telecommunication and electrical failures, as well as security compromises or breaches, which may compromise our systems, infrastructure, data or that of those with whom we share such data or information or upon which our business relies, or lead to data compromise, misuse, misappropriation or leakage.
Our internal computer systems and infrastructure and those of our strategic collaborators, vendors, contractors, consultants or regulators with whom we share confidential, protected or sensitive data or information, or upon which our business relies, are vulnerable to damage from computer viruses, unauthorized access, misuse, natural disasters, terrorism, cybersecurity threats, war and telecommunication and electrical failures, as well as security compromises or data breaches, which may compromise our systems, infrastructure, data or that of those with whom we share such data or information or upon which our business relies, or lead to data compromise, misuse, misappropriation or leakage.
“Legal Proceedings.” We could incur substantial costs in defense of such litigation, or in defense of any future lawsuits that may be filed against us, and management’s attention and resources could be diverted. Our principal shareholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval.
“Legal Proceedings.” We could incur substantial costs in defense of such litigation or any future lawsuits that may be filed against us, and management’s attention and resources could be diverted. Our principal shareholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval.
Our existing and any future strategic alliances may pose a number of risks, including: • strategic collaborators may not perform their obligations as expected; • strategic collaborators may cease or deprioritize development or commercialization of our products due to unfavorable clinical trial results, changes in their focus or funding, or other factors that divert their resources or create competing priorities, such as potential competition with their own products or candidates; • strategic collaborators may delay, stop or provide insufficient funding or resources for clinical trials (whether as a result of a business decision or necessitated by financial difficulties of such collaborator); • a strategic collaborator with marketing and distribution rights to one or more of our products may commit insufficient resources to the marketing and distribution of any such product; • disagreements with strategic collaborators, including over proprietary rights, contract interpretation or the course of development of any product candidates, may cause delays or termination of the research, development or commercialization of such product candidates, lead to additional responsibilities for us with respect to such product candidates or result in litigation or arbitration, any of which would be time-consuming and expensive; • strategic collaborators may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our IP or proprietary information; • disputes may arise with respect to the ownership of IP developed pursuant to our strategic alliances; • strategic collaborators may infringe the IP rights of third parties, exposing us to potential litigation and liability; • future relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing shareholders or disrupt our management and business; • any equity investments we make in collaborators could decrease in value or become worthless; and • our international operations through any future collaborations, acquisitions or joint ventures may expose us to certain operating, legal and other risks not encountered in the United States.
Our strategic alliances may pose a number of risks, including: • strategic collaborators may not perform their obligations as expected; • strategic collaborators may cease or deprioritize development or commercialization of our products due to unfavorable clinical trial results, changes in their focus or funding, or other factors that divert their resources or create competing priorities, such as potential competition with their own products or candidates; • strategic collaborators may delay, stop or provide insufficient funding or resources for clinical trials (whether as a result of a business decision or necessitated by financial difficulties of such collaborator); • a strategic collaborator with marketing and distribution rights to one or more of our products may commit insufficient resources to the marketing and distribution of any such product; 56 • disagreements with strategic collaborators, including over proprietary rights, contract interpretation or the course of development of any product candidates, may cause delays or termination of the research, development or commercialization of such product candidates, lead to additional responsibilities for us with respect to such product candidates or result in litigation or arbitration, any of which would be time-consuming and expensive; • strategic collaborators may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our IP or proprietary information; • disputes may arise with respect to the ownership of IP developed pursuant to our strategic alliances; • strategic collaborators may infringe the IP rights of third parties, exposing us to potential litigation and liability; • future relationships may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing shareholders or disrupt our management and business; • any equity investments we make in collaborators could decrease in value or become worthless; and • our international operations through any future collaborations, acquisitions or joint ventures may expose us to certain operating, legal and other risks not encountered in the United States.
Our business may be adversely affected by many factors associated with our expanding global business, including: • efforts to develop an international commercial sales, marketing and supply chain and distribution organization, including efforts to mitigate longer accounts receivable collection times, longer lead times for shipping and potential language barriers; • our customers’ ability to obtain reimbursement for our products in foreign markets; • our inability to directly control commercial activities because we rely on third parties; • different medical practices and customs in foreign countries affecting acceptance in the marketplace; • changes in a specific country’s or region’s political and cultural climate or economic condition; • an increased legal and compliance burden to establish, maintain and operate legal entities in foreign countries; • the burden of complying with complex and changing foreign regulatory, tax, accounting, reporting and legal requirements, including the European General Data Protection Regulation 2016/679 (GDPR); 65 • the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute, and the difficulty of effective enforcement of contractual provisions in local jurisdictions; • inadequate IP protection in foreign countries and the existence of potentially relevant third-party IP rights; • trade-protection measures including trade restrictions, import or export licensing requirements such as Export Administration Regulations promulgated by the U.S.
Our business may be adversely affected by many factors associated with our expanding global business, including: • efforts to develop an international commercial sales, marketing and supply chain and distribution organization, including efforts to mitigate longer accounts receivable collection times, longer lead times for shipping and potential language barriers; • our customers’ ability to obtain reimbursement for our products in foreign markets; • our inability to directly control commercial activities because we rely on third parties; • different medical practices and customs in foreign countries affecting acceptance in the marketplace; • changes in a specific country’s or region’s political and cultural climate or economic condition; • an increased legal and compliance burden to establish, maintain and operate legal entities in foreign countries; • the burden of complying with complex and changing foreign regulatory, tax, accounting, reporting and legal requirements, including the European General Data Protection Regulation 2016/679 (GDPR); • the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute, and the difficulty of effective enforcement of contractual provisions in local jurisdictions; • inadequate IP protection in foreign countries and the existence of potentially relevant third-party IP rights; • trade-protection measures including trade restrictions, import or export licensing requirements such as Export Administration Regulations promulgated by the U.S.
Additionally, the FDA or other foreign regulators could require us to adopt Risk Evaluation and Mitigation Strategies (REMS) for any product to ensure that the benefits of treatment outweigh the risks for each potential patient, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan to health care practitioners, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry.
Additionally, the FDA or other regulators could require us to adopt Risk Evaluation and Mitigation Strategies (REMS) for any product to ensure that the benefits of treatment outweigh the risks for each potential patient, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan to health care practitioners, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry.
Any of these events could prevent us from achieving or maintaining market acceptance of any products we develop. Additionally, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.
Any of these events could prevent us from achieving or maintaining market acceptance of any products we develop. 51 Additionally, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. We employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. 60 We employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
Additionally, we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a strategic alliance. 67 If we are not successful in discovering, developing and commercializing additional products, our ability to expand our business and achieve our strategic objectives would be impaired.
Additionally, we may allocate internal resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a strategic alliance. If we are not successful in discovering, developing and commercializing additional products, our ability to expand our business and achieve our strategic objectives would be impaired.
Furthermore, advertising and promotional materials must comply with FDA rules and regulations and are subject to FDA review, in addition to other potentially applicable federal and state laws. In addition, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.
Furthermore, advertising and promotional materials must comply with FDA rules and regulations and are subject to FDA review, in addition to other applicable federal and state laws. In addition, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates.
Establishing additional or replacement suppliers for any of the components or processes used in our products or product candidates, if required, may not be accomplished quickly, if at all. Any replacement supplier (or us, if we produced directly) would need to be qualified and may require additional regulatory approval, resulting in further delay.
Establishing additional or replacement suppliers for any of the components or processes used in our products or product candidates may not be accomplished quickly, if at all. Any replacement supplier (or us, if we produced directly) would need to be qualified and may require additional regulatory approval, resulting in further delay.
Any such action could cause us to experience delays in the development, production, distribution or export of our products and product candidates and increased expenses. 71 Engaging in acquisitions, joint ventures or strategic collaborations may increase our capital requirements, dilute our shareholders and cause us to incur debt or assume contingent liabilities.
Any such action could cause us to experience delays in the development, production, distribution or export of our products and product candidates and increased expenses. Engaging in acquisitions, joint ventures or strategic collaborations may increase our capital requirements, dilute our shareholders and cause us to incur debt or assume contingent liabilities.
In addition, the FDA and other regulators may interpret data from our 50 clinical trials differently than we do and such agencies may require us to conduct additional studies or analyses, which could delay or prevent us from obtaining full regulatory approvals in certain jurisdictions or for certain demographics.
In addition, the FDA and other regulators may interpret data from our clinical trials differently than we do and such agencies may require us to conduct additional studies or analyses, which could delay or prevent us from obtaining full regulatory approvals in certain jurisdictions or for certain demographics.
In recent years, such changes have been made and changes are likely to occur in the future, which could have a material adverse effect on our business, cash flow, financial condition and results of operations. 76 The increasing use of social media platforms presents risks and challenges.
In recent years, such changes have been made and changes are likely to occur in the future, which could have a material adverse effect on our business, cash flow, financial condition and results of operations. The increasing use of social media platforms presents risks and challenges.
If we, our contract manufacturers or other strategic collaborators fail to comply with applicable post-approval regulatory requirements, a regulator may issue a warning letter asserting that we are in violation of the law, seek an injunction or impose civil or criminal penalties or monetary fines, suspend or withdraw regulatory approval or revoke a license, suspend any ongoing clinical trials, refuse to approve a pending BLA or supplements to a BLA submitted by us, seize or recall products or product candidates, or require field alerts to physicians, pharmacists and hospitals or refuse to allow us to enter into supply contracts.
If we, our contract manufacturers or other collaborators fail to comply with any post-approval regulatory requirements, a regulator may issue a warning letter asserting that we are in violation of the law, seek an injunction or impose civil or criminal penalties or monetary fines, suspend or withdraw regulatory approval or revoke a license, suspend any ongoing clinical trials, refuse to approve a pending BLA or supplements to a BLA submitted by us, seize or recall products or product candidates, or require field alerts to physicians, pharmacists and hospitals or refuse to allow us to enter into supply contracts.
We may not be able to retain these employees due to the competitive environment in the biotechnology industry, particularly in Cambridge, Massachusetts. 66 If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success.
We may not be able to retain these employees due to the competitive environment in the biotechnology industry, particularly in Cambridge, Massachusetts. If we cannot maintain our corporate culture, we could lose the innovation, teamwork and passion that we believe contribute to our success.
Arrangements with third-party payors and customers can expose pharmaceutical 69 manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products.
Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products.
These publications could also result in the disclosure of information to our competitors that we might otherwise deem confidential, which could harm our business. Our use of GenAI and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies.
These publications could also result in the disclosure of information to our competitors that we might otherwise deem confidential, which could harm our business. Our use of generative AI ("GenAI") and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies.
The GDPR and UK GDPR also impose strict rules on the transfer of personal data to countries outside the EEA that are not considered to provide “adequate” protection to personal data , including the United States, and permits data protection authorities to impose large penalties for violations.
The EU GDPR and UK GDPR also impose strict rules on the transfer of personal data to countries outside the EEA that are not considered to provide “adequate” protection to personal data , including the United States, and permits data protection authorities to impose large penalties for violations.
The FDA and foreign regulators have substantial discretion in the approval process and may refuse to accept any marketing approval application or may decide that our data are insufficient for marketing approval and require additional preclinical, clinical or other studies.
The FDA and comparable foreign regulators have substantial discretion in the approval process and may refuse to accept any marketing approval application or may decide that our data are insufficient for marketing approval and require additional preclinical, clinical or other studies.
We are generally also subject to all of the same risks with respect to protection of IP that we license as we are for IP that we own. If we or our licensors fail to adequately protect this IP, our ability to commercialize products could suffer.
We are generally also subject to the same risks with respect to protection of IP that we license as we are for IP that we own. If we or our licensors fail to adequately protect this IP, our ability to commercialize products could suffer.
In addition, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 59 months after filing, if at all.
In addition, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, if at all.
Our licensors may fail to 61 successfully prosecute the patent applications we license, fail to maintain these patents, determine not to pursue litigation against other companies that are infringing these patents or pursue such litigation less aggressively than we would.
Our licensors may fail to successfully prosecute the patent applications we license, fail to maintain these patents, determine not to pursue litigation against other companies that are infringing these patents or pursue such litigation less aggressively than we would.
Additionally, even if we maintain insurance coverage for a type of liability, a particular claim may not be covered if it is subject to a 68 coverage exclusion or we do not otherwise meet the conditions for coverage.
Additionally, even if we maintain insurance coverage for a type of liability, a particular claim may not be covered if it is subject to a coverage exclusion or we do not otherwise meet the conditions for coverage.
Our ability to establish additional strategic alliances will depend, among other things, on our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed strategic alliance and the proposed collaborator’s evaluation of a number of factors.
Our ability to establish additional strategic alliances will depend, among other things, on our assessment of the collaborator’s resources and expertise, proposed terms and conditions and the collaborator’s evaluation of a number of factors.
For example, provisions of the ACA have resulted in changes in the way health care is paid for by both governmental and private insurers, including increased rebates owed by manufacturers under the Medicaid Drug Rebate Program, annual fees and taxes on manufacturers of certain branded prescription drugs, the requirement that manufacturers participate in a discount program for certain outpatient drugs under Medicare Part D and the expansion of the number of hospitals eligible for discounts under Section 340B of the PHSA.
For example, provisions of the ACA resulted in changes in the way health care is paid for by governmental and private insurers, including increased rebates owed by manufacturers under the Medicaid Drug Rebate Program, annual fees and taxes on manufacturers of certain branded prescription drugs, the requirement that manufacturers participate in a discount program for certain outpatient drugs under Medicare Part D and the expansion of the number of hospitals eligible for discounts under Section 340B of the PHSA.
These regulations, which may differ across jurisdictions, could subject us to new or expanded carbon pricing or taxes, increased compliance costs, restrictions on greenhouse gas emissions, investment in new technologies, increased carbon disclosure and transparency, investments in data gathering and reporting systems, upgrades of facilities to meet new building codes and the redesign of utility systems, which could increase our operating costs, including the cost of electricity and energy we use.
These regulations, which may differ across jurisdictions, could subject us to new or expanded carbon pricing or taxes, increased compliance costs, restrictions on greenhouse gas emissions, investment in new technologies, increased carbon disclosure and transparency, investments in data gathering and reporting systems, upgrades of facilities to meet new building codes and the redesign of utility systems, which could increase our operating costs, including the cost of electricity and energy.
The market price for our common stock may be influenced by many factors, including: • our product sales and anticipated product revenue; • our ability to effectively reduce costs; • the commercial launch of any additional products; • timing and results of clinical trials or progress of our product candidates or those of our competitors; • the exclusion or removal of our stock from market indices; • the success of competitive products or technologies; • the emergence or decline of new or existing variants of the SARS-CoV-2 virus; • developments regarding our manufacturing, regulatory and commercialization efforts, or information regarding such efforts by competitors; 73 • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • expenses related to any of our products or clinical development programs; • the results of our efforts to discover, develop, acquire or in-license additional product candidates; • actual or anticipated changes in estimates of financial results, development timelines or recommendations by securities analysts; • variations in our financial results or those of companies that are perceived to be similar to us; • changes in the structure of healthcare payment systems; • economic, industry and market conditions generally, and in the biopharmaceutical sector specifically; and • announcement by us or our competitors of the commencement or termination of significant acquisitions, strategic partnerships, joint ventures or capital commitments.
Our stock price may be influenced by many factors, including: • our product sales and anticipated product revenue; • our ability to effectively reduce costs; • the commercial launch of any additional products; • timing and results of clinical trials or progress of our product candidates or those of our competitors; • the exclusion or removal of our stock from market indices; • the success of competitive products or technologies; • the emergence or decline of new or existing variants of the SARS-CoV-2 virus; • developments regarding our manufacturing, regulatory and commercialization efforts, or information regarding such efforts by competitors; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • expenses related to any of our products or clinical development programs; • the results of our efforts to discover, develop, acquire or in-license additional product candidates; • actual or anticipated changes in estimates of financial results, development timelines or recommendations by securities analysts; • variations in our financial results or those of companies that are perceived to be similar to us; • changes in the structure of healthcare payment systems; • economic, industry and market conditions generally, and in the biopharmaceutical sector specifically; and • announcement by us or our competitors of the commencement or termination of significant acquisitions, strategic collaborations, joint ventures or capital commitments.
Our product candidates that appear promising in the early phases of development may fail to advance, experience delays in the clinic, experience clinical holds or fail to reach the market for many reasons, including: • nonclinical or preclinical study, or clinical trial, results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects or toxicities; • adverse results in our clinical trials, or in those of others developing similar products, or adverse effects relating to mRNA, or our LNPs, may lead to negative publicity or delays in or termination of our programs; • the efficacy or safety of a combination vaccine product candidate could be less than that seen with the administration of the vaccine s separately, which could prevent the combination product from obtaining regulatory approval; • adverse events related to products that are perceived to be similar to mRNA medicines, such as those related to gene therapy or gene editing, could result in a decrease in the perceived benefit of one or more of our programs, increased regulatory scrutiny, decreased confidence by patients and clinical trial collaborators in our product candidates and less demand for any product that we may develop; • the insufficient ability of our translational models to reduce risk or predict outcomes in humans, particularly given that each component of our product candidates may have a dependent or independent effect on safety, tolerability and efficacy, which may be species-dependent; • manufacturing failures or insufficient supply of current Good Manufacturing Practice (cGMP) materials for clinical trials, or higher than expected cost could delay or set back clinical trials, or make mRNA medicines commercially unattractive; • changes that we make to optimize our manufacturing, testing or formulating of cGMP materials could impact the safety, tolerability and efficacy profile of our product candidates; • pricing or reimbursement issues or other factors that delay clinical trials or make any mRNA medicine uneconomical or noncompetitive with other therapies; • our large pipeline of product candidates could result in a greater quantity of reportable adverse events, including suspected unexpected serious adverse reactions, other reportable negative clinical outcomes, manufacturing reportable events or material clinical events that could lead to clinical delay or hold by the FDA or applicable regulatory authority or other clinical delays, any of which could negatively impact the perception of one or more of our programs, as well as our business as a whole; • failure to timely advance our programs or a failure or delay in receiving necessary regulatory approvals due to, among other factors, slow or failure to complete enrollment in clinical trials, withdrawal by trial participants from trials, failure to achieve trial endpoints, additional time requirements for data analysis, data integrity issues, preparation of a BLA or the equivalent application, discussions with the FDA or EMA, a regulatory request for additional nonclinical or clinical data or safety formulation or manufacturing issues may lead to our inability to obtain sufficient funding; • new legislation or regulations passed by U.S., state or foreign governments in response to negative public perception of mRNA medicines; and • the proprietary rights of others and their competing products and technologies that may prevent our mRNA medicines from being commercialized.
Promising early-phase product candidates may fail to advance, be delayed in the clinic, be subject to clinical holds or fail to reach the market for many reasons, including: • nonclinical, preclinical or clinical trial results may show potential mRNA medicines to be less effective than desired or to have harmful or problematic side effects or toxicities; • adverse results in our clinical trials, or in those of others developing similar products, or adverse effects relating to mRNA, or our LNPs, may lead to negative publicity or delays in or termination of our programs; • the efficacy or safety of a combination vaccine product candidate could be less than that seen with the administration of the vaccine s separately, which could prevent the combination product from obtaining regulatory approval; • adverse events related to products that are perceived to be similar to mRNA medicines, such as those related to gene therapy or gene editing, could result in a decrease in the perceived benefit of one or more of our programs, increased regulatory scrutiny, decreased confidence by patients and clinical trial collaborators in our product candidates and less demand for any product that we may develop; • the insufficient ability of our translational models to reduce risk or predict outcomes in humans, particularly given that each component of our product candidates may have a dependent or independent effect on safety, tolerability and efficacy, which may be species-dependent; • manufacturing failures or insufficient supply of current Good Manufacturing Practice (cGMP) materials for clinical trials, or higher than expected cost could delay or set back clinical trials, or make mRNA medicines commercially unattractive; • changes that we make to optimize our manufacturing, testing or formulating of cGMP materials could impact the safety, tolerability and efficacy profile of our product candidates; • pricing or reimbursement issues or other factors that delay clinical trials or make any mRNA medicine uneconomical or noncompetitive with other therapies; • our large pipeline of product candidates could result in a greater quantity of reportable adverse events, including suspected unexpected serious adverse reactions, other reportable negative clinical outcomes, manufacturing reportable events or material clinical events that could lead to clinical delay or hold by the FDA or applicable regulatory authority or other clinical delays, any of which could negatively impact the perception of one or more of our programs, as well as our business as a whole; • failure to timely advance our programs or a failure or delay in receiving necessary regulatory approvals due to, among other factors, slow or failure to complete enrollment in clinical trials, withdrawal by trial participants from trials, failure to achieve trial endpoints, additional time requirements for data analysis, data integrity issues, preparation of a BLA or the equivalent application, discussions with the FDA or EMA, a regulatory request for additional nonclinical or clinical data or safety formulation or manufacturing issues may lead to our inability to obtain sufficient funding; 49 • new legislation or regulations passed by U.S., state or foreign governments in response to negative public perception of mRNA medicines; and • the proprietary rights of others and their competing products and technologies that may prevent our mRNA medicines from being commercialized.
Events that might prevent us from proceeding with clinical trials could include: • regulators, Institutional Review Boards (IRBs) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on favorable terms with prospective trial sites and prospective contract research organizations (CROs); • changes to the scale or site of our manufacturing could cause significant delays or changes in our clinical trial designs; • the outcome of our preclinical studies and our early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; • we may be unable to establish or achieve clinically meaningful endpoints for our studies; • if we make changes to our product candidates after clinical trials have commenced (which we have done in the past), we may be required to repeat earlier stages or delay later stages of clinical testing; • clinical trials of any product candidates may fail to show safety or efficacy, or may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional nonclinical studies or clinical trials, or we may decide to abandon product development programs; 48 • our product candidates, or other medicines in the same class as ours, may cause significant adverse events or other undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA or degradation products, any of which could lead to serious adverse events, or other effects; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the applicable clinical trial protocol or withdraw from the applicable clinical trial, which may require that we add new clinical trial sites; • regulators may impose a complete or partial clinical hold on a clinical trial (or a trial of another company working on mRNA medicines), or we or our investigators, IRBs or ethics committees may suspend or terminate clinical research or trials for various reasons, including quality events, noncompliance with regulatory requirements or a finding that participants are being exposed to an unacceptable benefit-risk ratio; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials may be insufficient or inadequate; • safety and efficacy concerns regarding our product candidates will be considered by us and by the FDA and other regulators as we pursue clinical trials of new product candidates, develop effective informed consent documentation and work with IRBs and scientific review committees (SRCs); • safety or efficacy concerns could arise from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours; • adverse side effects could be observed in future clinical trials where our product candidates are administered in combination with other therapies (such as the co-administration of our INT product candidate, mRNA-4157 ); • delays in developing assays acceptable to the FDA or other regulators; and • a lack of adequate funding to continue a particular clinical trial, including due to higher-than-anticipated costs.
Such events could include: • regulators, Institutional Review Boards (IRBs) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; • we may experience delays in reaching, or fail to reach, agreement on favorable terms with prospective trial sites and prospective contract research organizations (CROs); • changes to the scale or site of our manufacturing could cause significant delays or changes in our clinical trial designs; • the outcome of our preclinical studies and our early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; • we may be unable to establish or achieve clinically meaningful endpoints for our studies; • if we make changes to our product candidates after clinical trials have commenced (which we have done in the past), we may be required to repeat earlier stages or delay later stages of clinical testing; • clinical trials of any product candidates may fail to show safety or efficacy, or may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional nonclinical studies or clinical trials, or we may decide to abandon product development programs; • our product candidates, or other medicines in the same class as ours, may cause significant adverse events or other undesirable side effects, such as the immunogenicity of the LNPs or their components, the immunogenicity of the protein made by the mRNA or degradation products, any of which could lead to serious adverse events, or other effects; • our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the applicable clinical trial protocol or withdraw from the applicable clinical trial, which may require that we add new clinical trial sites; • regulators may impose a complete or partial clinical hold on a clinical trial (or a trial of another company working on mRNA medicines), or we or our investigators, IRBs or ethics committees may suspend or terminate clinical research or trials for various reasons, including quality events, noncompliance with regulatory requirements or a finding that participants are being exposed to an unacceptable benefit-risk ratio; • the supply or quality of our product candidates or other materials necessary to conduct clinical trials may be insufficient or inadequate; • safety and efficacy concerns regarding our product candidates will be considered by us and by the FDA and other regulators as we pursue clinical trials of new product candidates, develop effective informed consent documentation and work with IRBs and scientific review committees (SRCs); • safety or efficacy concerns could arise from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived as similar to ours; • adverse side effects could be observed in future clinical trials where our product candidates are administered in combination with other therapies (such as the co-administration of intismeran autogene ); • delays in developing assays acceptable to the FDA or other regulators; and • a lack of adequate funding to continue a particular clinical trial, including due to higher-than-anticipated costs.
In addition, to the extent that 56 we rely on foreign contract manufacturers, we are subject to additional risks, including the need to comply with import and export regulations.
In addition, to the extent that we rely on foreign contract manufacturers, we are subject to additional risks, including the need to comply with import and export regulations.
Manufacturing unique lots of INTs is susceptible to product loss or failure due to issues with: • logistics associated with the collection and shipping of a patient’s tumor, blood or other tissue sample; • next-generation sequencing of the tumor mRNA and identification of appropriate tumor-specific mutations; • the use of a software program, including proprietary and open source components, which is hosted in the cloud and a part of our product candidate, to assist with the design of the patient-specific mRNA, which software must be maintained and secured; • effective design of the patient-specific mRNA that encodes for the required neoantigens; • batch specific manufacturing failures or issues that arise due to the uniqueness of each patient-specific batch; • quality control testing failures; • unexpected failures of batches placed on stability; • shortages or quality control issues with single-use assemblies, consumables or critical parts sourced from third-party vendors that must be changed out for each patient-specific batch; • significant costs associated with individualized manufacturing that may adversely affect our ability to continue development; • successful and timely manufacture and release of the patient-specific batch; • shipment issues encountered during transport of the batch to the patient site of care; and • the ability to define a consistent safety profile at a given dose when each participant receives a unique therapy.
As a result, manufacturing is susceptible to product loss or failure due to issues with: • logistics associated with the collection and shipping of a patient’s tumor, blood or other tissue sample; • next-generation sequencing of the tumor mRNA and identification of appropriate tumor-specific mutations; • the use of a software program, including proprietary and open source components, which is hosted in the cloud and a part of our product candidate, to assist with the design of the patient-specific mRNA, which software must be maintained and secured; • effective design of the patient-specific mRNA that encodes for the required neoantigens; • batch specific manufacturing failures or issues that arise due to the uniqueness of each patient-specific batch; • quality control testing failures; • unexpected failures of batches placed on stability; 55 • shortages or quality control issues with single-use assemblies, consumables or critical parts sourced from third-party vendors that must be changed out for each patient-specific batch; • significant costs associated with individualized manufacturing that may adversely affect our ability to continue development; • successful and timely manufacture and release of the patient-specific batch; • shipment issues encountered during transport of the batch to the patient site of care; and • the ability to define a consistent safety profile at a given dose when each participant receives a unique therapy.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business. Item 1B.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business.
Different EEA Member States have interpreted the GDPR differently and many have imposed additional requirements, adding to the complexity of processing personal data in the EEA.
Different EEA Member States have interpreted the EU GDPR differently and many have imposed additional requirements, adding to the complexity of processing personal data in the EEA.
If clinical trials are not conducted in accordance with our contractual expectations or regulatory requirements, action by regulators may significantly and adversely affect the conduct or progress of such trials or even require a clinical trial to be redone. Accordingly, our efforts to obtain regulatory approvals for and commercialize our drug candidates could be delayed.
If clinical trials are not conducted in accordance with our contractual expectations or regulatory requirements, action by regulators may significantly and adversely affect the conduct or progress of such trials or require a clinical trial to be redone. Accordingly, our efforts to obtain regulatory approvals and commercialize our drug candidates could be delayed.
This has led and could lead to additional manufacturing costs and delays in our ability to supply required quantities for clinical trials or commercial sale. In addition, the cost associated with such transportation services and the limited pool of vendors could cause supply disruptions.
This has led and could lead to added manufacturing costs and delays in our ability to supply required quantities for clinical trials or commercial sale. In addition, the cost associated with such transportation services and the limited pool of vendors could cause supply disruptions.
Our failure to maintain our enterprise resource planning (ERP) system could adversely impact our business and results of operations. A ny disruptions or difficulties using our newly upgraded global ERP system could adversely affect our controls, resulting in harm to our business, including our ability to forecast or make sales and collect our receivables.
Our failure to maintain our enterprise resource planning (ERP) system could adversely impact our business and results of operations. A ny disruptions or difficulties using our global ERP system could adversely affect our controls, resulting in harm to our business, including our ability to forecast or make sales and collect our receivables.
Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment. We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could result in fines or criminal penalties and damage our reputation.
Failure to comply with these requirements could result in reputational harm, public reprimands, administrative penalties, fines or imprisonment. We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could result in fines or criminal penalties and damage our reputation.
Each law is also subject to various interpretations by courts and regulatory agencies, creating additional uncertainty, and any failure or perceived failure to comply with the evolving data protection laws could expose us to risk of enforcement actions taken by authorities, private rights of action in some jurisdictions and potential significant penalties if we are found to be non-compliant.
Each law is also subject to various interpretations by courts and regulatory agencies, creating additional uncertainty, and any failure or perceived failure to comply with the evolving data protection laws could expose us to risk of enforcement actions taken by authorities, private rights of action in some jurisdictions and potential significant penalties, including criminal sanctions, if we are found to be non-compliant.
If we cannot enter into new strategic alliances on a timely basis, on favorable terms or at all, we may need to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we cannot enter alliances on a timely basis, on favorable terms or at all, we may need to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
For example, if they were to act together, they could exert significant influence over matters such as elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction.
For example, if t hey were to act together, they could exert significant influence over matters such as elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction.
Deviations in the manufacturing process, including those affecting quality attributes and stability, may cause unacceptable changes in the product, resulting in lot failures or product recalls. Our third-party contract manufacturers have experienced lot failures resulting in product recalls of our COVID vaccine.
Deviations in the manufacturing process, including those affecting quality attributes and stability, may cause unacceptable changes in the product, resulting in lot failures or product recalls. In the past, our third-party contract manufacturers experienced lot failures resulting in product recalls of our COVID vaccine.
These risks can be either acute (short-term) or chronic (long-term). Climate-related physical risks to our facilities and those of our suppliers could disrupt our operations and supply chain, which may result in increased costs. New legal or regulatory requirements may be enacted to prevent, mitigate or adapt to the implications of a changing climate and its effects on the environment.
These risks can be either acute (short-term) or chronic (long-term). Climate-related physical risks to our facilities and those of our suppliers could disrupt our operations and supply chain, which may result in increased costs. New legal or regulatory requirements may be enacted to prevent, mitigate or adapt to the implications of climate change and its effects on the environment.
In addition, we engage third-party contractors and collaborators to support numerous other research, commercial and administrative activities, which reduces our control over these activities but does not relieve us of our responsibilities, such as ensuring that each of our clinical trials is conducted in accordance with its general investigational plan and protocols.
In addition, we engage third-party contractors and collaborators to support other research, commercial and administrative activities, which reduces our control over these activities but does not relieve us of our responsibilities, such as ensuring that each clinical trial is conducted in accordance with its general investigational plan and protocols.
The association of our products with gene therapies could result in increased regulatory burdens, impair the reputation of our products or negatively impact our platform or our business. There are only a few approved gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use.
The association of our products with gene therapies could result in increased regulatory burdens, impair the reputation of our products or negatively impact our platform or our business. There are only a few approved gene therapy products in the United States and other jurisdictions, and significant adverse events associated with their testing and use have been reported.
If we fail to maintain compliance with those obligations, we may be subject to potential liability and to termination of our contracts. Risks related to our financial condition and results of operations We incurred net losses in 2024 and 2023, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability.
If we fail to maintain compliance with those obligations, we may be subject to potential liability and to termination of our contracts. 62 Risks related to our financial condition and results of operations We incurred net losses in 2025 and 2024, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability.
In the United States, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance programs and increasing pressure from social sources could significantly influence the manner in which our products are prescribed and purchased.
In the United States, federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of health care. Legislative and regulatory proposals, enactments to reform health care insurance programs and increasing pressure from social sources could significantly influence how our products are prescribed and purchased.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, is time- and resource-consuming and can divert a company’s attention from the business.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible government investigations, is time- and resource-consuming and can divert a company’s attention from the business.
The degree of market acceptance of our products will depend on numerous factors, including: • efficacy and potential advantages over alternative treatments; • the duration of protection provided by our products compared to those of our competitors; • acceptance of mRNA products generally and the availability of competing non-mRNA medicines that may be preferred by the medical community or the public; • safety and the prevalence and severity of any side effects, including any limitations, restrictions (including for use together with other medicines) or warnings contained in a product’s approved labeling; 46 • the prevalence and severity of any side effects resulting from checkpoint inhibitors or other products or therapies with which our products are co-administered; • relative convenience and ease of administration; • the willingness of the target patient population to try, and physicians to prescribe, new therapies; • the strength of marketing and distribution support and timing of market introduction of competitive products; • whether our product presentation meets customer demand (e.g., for single-dose presentations, or combination vaccines ); • publicity and health authority communications concerning our products or competing products and treatments; and • product cost and sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement.
The degree of market acceptance of our products will depend on numerous factors, including: • efficacy and potential advantages over alternative treatments; • the duration of protection provided by our products compared to those of our competitors; • acceptance of mRNA products generally and the availability of competing non-mRNA medicines that may be preferred by the medical community or the public; • safety and the prevalence and severity of any side effects, including any limitations, restrictions (including for use together with other medicines) or warnings contained in a product’s approved labeling; • the prevalence and severity of any side effects resulting from checkpoint inhibitors or other products or therapies with which our products are co-administered; • relative convenience and ease of administration; • the willingness of the target patient population to try, and physicians to prescribe, new therapies; • the strength of marketing and distribution support and timing of market introduction of competitive products; • whether our product presentation meets customer demand ; • publicity and health authority communications concerning our products or competing products and treatments; and 44 • product cost and sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement.
Additionally, our products may only be approved for certain populations or lines of treatment. 47 Our estimates of addressable patient populations are based on our beliefs, and have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect.
Additionally, our products may only be approved for certain populations or lines of treatment. Our estimates of addressable patient populations are based on our beliefs and are derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect.
The FDA, the EMA and other foreign regulators may require us to submit product samples of any lot of any approved product, together with the protocols showing the results of applicable tests, at any time. In some cases, regulators may prohibit us from distributing a lot or lots until it authorizes release.
The FDA, the EMA and other regulators may require us to submit product samples of any lot of any approved product, together with the protocols showing the results of applicable tests, at any time. In some cases, regulators may prohibit us from distributing a lot until it authorizes release.
With respect to our COVID vaccine, although the U.S. and certain foreign governments contractually agreed to indemnify us or make statutory immunity available to us for sales during the pandemic public health emergency, such indemnification or statutory immunity may be unavailable to cover potential claims or liabilities resulting from the research, development, manufacture, distribution or commercialization of the vaccine.
With respect to our COVID vaccine, although the U.S. and certain foreign governments contractually agreed to indemnify us or make statutory immunity available to us for sales during the pandemic public health emergency, which has since ended, such indemnification or statutory immunity may be unavailable to cover potential claims or liabilities resulting from the research, development, manufacture, distribution or commercialization of the vaccine.
We have issued patents and pending patent applications in the United States and in key markets around the world that claim many different methods, compositions and processes relating to the discovery, development, manufacture and commercialization of mRNA medicines and our delivery technology, including LNPs.
We have issued patents and pending patent applications in the United States and in key markets globally that claim many different methods, compositions and processes relating to the discovery, development, manufacture and commercialization of mRNA medicines and our delivery technology, including LNPs.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result.
The FDA’s ability to review and approve new products can be affected by a variety of factors, including government priorities, budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average FDA review times have fluctuated in recent years as a result.
We and our strategic collaborators also may experience unforeseen events during, or as a result of, any clinical trials that we or they conduct that could delay or prevent us or them from successfully developing our product candidates and gaining approval from regulators.
We and our strategic collaborators also may experience unforeseen events during, or as a result of, clinical trials that could delay or prevent us or them from successfully developing our product candidates and gaining approval from regulators.
Even if a potential product displays a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may never be successful.
Even if a product candidate shows a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may never be successful.
Oppositions and inter partes review petitions have been filed against some of 60 our patents, and we expect that further proceedings will be filed in the European Patent Office (EPO), USPTO and elsewhere relating to patents and patent applications in our portfolio.
Oppositions and inter partes review petitions have been filed against some of our patents, and we expect that further proceedings will be filed in the EPO, USPTO and elsewhere relating to patents and patent applications in our portfolio.
We are required by the FDA to conduct post-marketing studies for our COVID vaccine (mRNA-1273), including to assess the risk of myocarditis and pericarditis and to evaluate outcomes in pregnant women and infants post-vaccination.
We are required by the FDA to conduct post-marketing studies for mRNA-1273, including to assess the risk of myocarditis and pericarditis and to evaluate outcomes in pregnant women and infants post-vaccination.
The FDA could give overriding weight to other efficacy endpoints over a primary endpoint, even if we achieve statistically significant results on that endpoint, if we do not do so on our secondary efficacy endpoints.
Further, the FDA may give overriding weight to other efficacy endpoints over a primary endpoint, even if we achieve statistically significant results on that endpoint, if we do not do so on our secondary efficacy endpoints.
Additionally, any products that we develop may struggle to compete against those of our competitors for a variety of reasons, including relative safety and effectiveness, degree of any side effects, shelf-life, ease of administration and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals, the availability and cost of manufacturing, distribution, marketing and sales capabilities, price, reimbursement coverage and patent protection.
Additionally, our products may struggle to compete against competitors’ products for a variety of reasons, including relative safety and effectiveness, degree of any side effects, shelf-life, ease of administration and the extent to which patients accept relatively new routes of administration, the timing and scope of regulatory approvals, the availability and cost of manufacturing, distribution, marketing and sales capabilities, price, reimbursement coverage and patent protection.
Because our INTs are manufactured for each individual patient, we are required to maintain a chain of identity with respect to each patient’s tissue sample, sequence data derived from such tissue sample, results of analysis of such patient’s genomic analysis and the custom manufactured product for each patient.
Because intismeran is manufactured for each individual patient, we are required to maintain a chain of identity with respect to each patient’s tissue sample, sequence data derived from such tissue sample, results of analysis of such patient’s genomic analysis and the custom manufactured product for each patient.
Even if our products demonstrate superiority to those of competitors, consumers, retailers and the public may fail to appreciate that benefit, or existing purchase commitments for a competitor’s product may discourage them from purchasing from us. These factors, or the perception of these factors, could lead to a competitor’s product being more successfully commercialized.
Even if our products demonstrate superiority to competitors’ products, consumers and retailers may fail to appreciate that benefit, or existing purchase commitments with competitors may discourage them from purchasing from us. These factors, or the perception of these factors, could lead to a competitor’s product being more successfully commercialized.
Shelf life for our products and product candidates is variable, and they may expire prior to use. Cold-chain logistics are required for certain of our products and product candidates. If we or third-party distributors do not maintain effective cold-chain supply logistics, then we may experience returned or out of date products and product may be rendered unusable.
Shelf life for our products and product candidates is variable, and they may expire prior to use. Further, if we or third-party distributors do not maintain effective cold-chain supply logistics required for certain of our products and product candidates, products may be returned, become out-of-date or be rendered unusable.
Likewise, if insurance coverage should become unavailable to us or become economically impractical, we would be required to operate our business without indemnity from commercial insurance providers.
Likewise, if insurance coverage became unavailable to us or economically impractical, we would be required to operate our business without indemnity from commercial insurance providers.
Difficulties or delays in enrolling a sufficient number of clinical trial participants may result in increased costs or affect the timing or outcome of our planned clinical trials, which could prevent trial completion and adversely affect our ability to advance the development of and obtain regulatory approval for our product candidates.
Difficulties or delays in enrolling a sufficient number of participants could increase costs or impact the timing or outcome of our planned clinical trials, which could prevent trial completion and adversely affect our ability to advance the development of and obtain regulatory approval for our product candidates.
If we cannot enter into such arrangements on favorable terms, or at all, our ability to develop, manufacture and distribute our products would be adversely affected. Further, efforts to establish these capabilities may not meet initial expectations as to scheduling, scale-up, reproducibility, yield, purity, cost, potency or quality.
If we cannot enter into or maintain such arrangements on favorable terms, or at all, our ability to develop, manufacture and distribute our products could be adversely affected. Further, efforts to establish and scale these capabilities may not meet expectations regarding scheduling, scale-up, reproducibility, yield, purity, cost, potency or quality.
Our expenses could increase for many reasons, including if and as we: • initiate additional clinical trials, particularly large pivotal trials; • continue to build out our manufacturing capabilities; • build out a sales, marketing and distribution infrastructure to commercialize any products; • acquire or in-license other product candidates and technologies; and • experience any delays or encounter issues with any of the above. 64 Our quarterly and annual operating results may fluctuate.
Our expenses could increase for many reasons, including if and as we: • initiate additional clinical trials, particularly large pivotal trials; • continue to build out our manufacturing capabilities; • build out a sales, marketing and distribution infrastructure to commercialize any products; • acquire or in-license other product candidates and technologies; and • experience any delays or encounter issues with any of the above.
Privacy and data security are significant issues in the United States, Europe and many other jurisdictions where we operate or collect personal information. We are subject to data privacy and security laws and regulations in various jurisdictions that apply to the collection, storage, use, sharing and security of personal data, including health information, and impose significant compliance obligations.
We are subject to data privacy and security laws and regulations in the United States, Europe and other jurisdictions where we operate or collect personal information. These laws and regulations apply to the collection, storage, use, sharing and security of personal data, including health information, and impose significant compliance obligations.
Regulatory requirements governing gene therapy products have evolved and may continue to change in the future, and the implications for mRNA therapies are unknown.
Regulatory requirements governing these products have evolved and may continue to change in the future, and the implications for mRNA therapies are unknown.
As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline and negatively impact our financing or funding ability, as well as our ability to exist as a standalone company.
Our quarterly and annual operating results may fluctuate. As a result, we may fail to meet or exceed the expectations of research analysts or investors, which could cause our stock price to decline and negatively impact our financing or funding ability, as well as our ability to exist as a standalone company.
Our resource allocation decisions, or our contractual commitments to provide resources to our strategic collaborators, may cause us to fail to capitalize on certain other commercial products or profitable market opportunities. Additionally, spending on research and development programs for product candidates may not yield commercially viable products.
Our resource allocation decisions, or our contractual commitments to provide resources to our strategic collaborators, may cause us to fail to capitalize on other commercial products or market opportunities. Additionally, spending on research and development programs may not yield commercially viable products.
Any disruption in our or our contract manufacturers’ manufacturing capabilities could delay scaling up production capacity for our drug substances or products or shut down facilities, impose additional 55 costs, cause us to fail to meet certain product volume or delivery timing obligations, or may require us to identify, qualify and establish an alternative manufacturing site, which could adversely affect our business.
Any disruption in these manufacturing capabilities could delay scaling up production capacity for our drug substances or products or shut down facilities, add costs, cause us to fail to meet certain product volume or delivery timing obligations, or may require us to identify, qualify and establish an alternative manufacturing site, which could adversely affect our business.
For example, the FDA has established an office, now called the Office of Therapeutics Products (OTP), within its Center for Biologics Evaluation and Research (CBER) to consolidate the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review.
For example, the FDA has established the Office of Therapeutics Products within its Center for Biologics Evaluation and Research (CBER) to consolidate review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER.
Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules. Sales of pharmaceutical products in general depends to a significant extent on adequate coverage, pricing and reimbursement from third-party payors.
Sales of pharmaceutical products depend on the availability and extent of reimbursement from third-party payors, and we may be adversely impacted by changes to such reimbursement policies or rules. Sales of pharmaceutical products depend on adequate coverage, pricing and reimbursement from third-party payors.
The regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of products and materials used in clinical trials.
These regulations govern manufacturing processes and procedures, including record keeping and the implementation and operation of quality systems to control and assure the quality of products and materials used in clinical trials and for commercial supply.
For example, the holder of an approved BLA must monitor and report adverse events and monitor and report any failure of a product to meet the specifications in the BLA, as well as submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product 52 labeling, or manufacturing process.
For example, a BLA holder must monitor and report adverse events and any failure of a product to meet applicable specifications, as well as submit and obtain FDA approval for certain new or supplemental applications relating to the approved product, labeling or manufacturing process.
Our broad clinical success and recent commercial challenges have necessitated a more selective and paced approach to our research and development investment. If we do not successfully implement our cost efficiency and prioritization programs, we may fail to meet our cash breakeven goals.
Furthermore, our broad clinical success and post-pandemic commercial challenges have necessitated a more selective and paced approach to our research and development investment. If we do not successfully implement our cost efficiency and prioritization programs, we may fail to meet our cash breakeven goal.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeRecognizing the threat of security breaches and cyberattacks globally, we have developed a cybersecurity program, overseen by our Chief Information Security Officer (CISO), that is designed to protect patient trust, defend the Moderna brand, and reduce the risk and impact of cyber-attacks.
Biggest changeRecognizing the threat of security breaches and cyberattacks globally, we have developed a cybersecurity program, overseen by our Chief Technology and Information Security Officer (CISO), that is designed to protect patient trust, defend the Moderna brand, and reduce the risk and impact of cyber-attacks.
Our CISO reports directly to our Chief People and Digital Technology Officer, who is a member of our Executive Committee and reports to our Chief Executive Officer. 77 We have built a cybersecurity leadership team designed to align with key services, with a separate lead overseeing each service offering, all reporting to the CISO.
Our CISO reports directly to our Chief People and Digital Technology Officer, who is a member of our Executive Committee and reports to our Chief Executive Officer. We have built a cybersecurity leadership team designed to align with key services, with a separate lead overseeing each service offering, all reporting to the CISO.
We also maintain relationships with law enforcement and industry groups to support our cybersecurity intelligence and risk management efforts.
We also maintain relationships with law enforcement and industry groups to support our cybersecurity intelligence and risk management efforts. 77

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeUpon completion, the facility will have state-of-the-art mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, and a just-in-time satellite warehouse. We expect the facility to be operational in 2025. This new site is strategically intended to support our INT program.
Biggest changeIn the second quarter of 2023, we acquired a newly constructed biomanufacturing facility, encompassing 140,000 square feet, in Marlborough, Massachusetts. This facility underwent enhancements, including the addition of 60,000 square feet to the existing structure. The facility includes state-of-the-art mRNA manufacturing areas, including a full manufacturing clean room, quality control laboratories, and a just-in-time satellite warehouse.
Item 2. Properties We have two main campuses in Massachusetts. During the third quarter of 2023, we commenced a lease for a property in Cambridge, Massachusetts. This building, spanning approximately 462,000 square feet, is designated as our Moderna Science Center (MSC). The MSC accommodates a combination of scientific and office spaces, including our principal executive offices.
Item 2. Properties We have two main campuses in Massachusetts. During the third quarter of 2023, we commenced a lease for a property in Cambridge, Massachusetts. This building, spanning approximately 462,000 square feet, is designated as our Moderna Science Center (MSC).
The site strengthens our global manufacturing capabilities and supports the Government of Canada’s pandemic readiness and vaccine supply objectives. We also own and lease various parcels of land, office and lab spaces across the globe for our business operations.
We also own and lease various parcels of land, office and lab spaces across the globe for our business operations.
The MTC campus is approximately 722,000 square feet which includes lab and office space, directly supporting our manufacturing capabilities and commercial and clinical activities. In December 2024, we completed the acquisition of the MTC campus, including the underlying land and buildings.
The Moderna Technology Center (MTC) is located in Norwood, Massachusetts and is primarily comprised of three buildings (MTC South, MTC North and MTC East). The MTC campus is approximately 722,000 square feet and includes lab and office space, directly supporting our manufacturing capabilities and commercial and clinical activities.
This acquisition transitioned the facilities from leased to owned properties, providing greater operational flexibility and long-term stability in supporting our manufacturing and development capabilities. In the second quarter of 2023, we acquired a newly constructed biomanufacturing facility, encompassing 140,000 square feet, in Marlborough, Massachusetts. This facility is undergoing enhancements, including the addition of 60,000 square feet to the existing structure.
In December 2024, we completed the acquisition of the MTC campus, including the underlying land and buildings. This acquisition transitioned the facilities from leased to owned properties, providing greater operational flexibility and long-term stability in supporting our manufacturing and development capabilities.
In September 2024, we completed our manufacturing facility in Laval, Quebec, Canada, which received a Drug Establishment License (DEL) from Health Canada. This certification enables the facility to produce drug substance and positions it to manufacture mRNA vaccines, including COVID, RSV, and seasonal influenza, contingent on Health Canada’s approval, starting in 2025.
The Marlborough facility became operational in August 2025 and is intended to support our intismeran autogene program. In September 2024, we completed construction of our mRNA manufacturing facility in Laval, Quebec, Canada, which we own, and the facility received a Drug Establishment License from Health Canada authorizing the production of mRNA vaccine drug substance.
The lease has a term of 15 years, with options for us to extend the lease for up to two additional seven-year terms. As of December 31, 2024, we have substantially exited our leased spaces at Technology Square in Cambridge, Massachusetts, completing the consolidation of our Cambridge operations into the MSC.
The MSC accommodates a combination of scientific and office spaces, including our principal executive offices, and is the location of our corporate headquarters and platform, drug discovery, and clinical development activities. The lease has a term of 15 years, with options for us to extend the lease for up to two additional seven-year terms.
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The MSC campus is the location of our corporate headquarters, platform, drug discovery and clinical development. The Moderna Technology Center (MTC) is located in Norwood, Massachusetts and is primarily comprised of three buildings (MTC South, MTC North and MTC East).
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The facility encompasses approximately 100,000 square feet of manufacturing space and has the capacity to produce up to 100 million doses annually. In 2025, the facility began manufacturing drug substance for our Spikevax, supporting domestic mRNA vaccine production for Canada.
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In December 2025, Health Canada approved the addition of the Laval drug substance site for mRESVIA production, representing the second product approval for the Canadian supply chain. We own a large-scale mRNA manufacturing facility, the Moderna Technology Centre – Melbourne (MTC-M), located in Clayton, Victoria, Australia, within Monash University’s Technology Precinct.
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The facility encompasses approximately 130,000 square feet of manufacturing space and is designed to support end-to-end mRNA vaccine manufacturing, with the capacity to produce up to 100 million doses annually. In August 2025, the facility received full Good Manufacturing Practice (GMP) licensing, authorizing the manufacture of mRNA vaccine drug substance and finished drug product in compliance with applicable regulatory standards.
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We own the Moderna Innovation and Technology Centre (MITC), a manufacturing and research facility located at the Harwell Science and Innovation Campus in Oxfordshire, United Kingdom. The facility, which officially opened in September 2025, encompasses approximately 100,000 square feet and is designed to support mRNA vaccine manufacturing and related research activities.
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The MITC has the capacity to produce up to 100 million doses annually and up to approximately 250 million doses in the event of a pandemic. The facility is intended to produce British-made mRNA respiratory vaccines to support the National Health Service (NHS) seasonal vaccination programs and also supports research into the application of mRNA technology in additional disease areas.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe complaint asserts claims under the Securities Exchange Act of 1934 regarding statements about our RSV vaccine (mRNA-1345) and seeks unspecified damages. Derivative Litigation Between September and November 2024, purported shareholder derivative complaints were filed in the U.S. District Court for the District of Massachusetts against certain of our officers and directors and against the Company as a nominal defendant.
Biggest changeDistrict Court for the District of Massachusetts against certain of our officers and directors and against us as a nominal defendant. The complaints allege breaches of fiduciary duty and claims under the Securities Exchange Act of 1934 regarding statements about mRNA-1345 and seek declaratory and injunctive relief and unspecified damages payable to us.
In May 2023, we initiated patent infringement proceedings in Ireland (in the High Court) and Belgium (Brussels Business Court) against Pfizer, BioNTech and related entities with respect to the same European patents. As in the U.S. action, we seek a judgment of infringement of the asserted patents and monetary damages.
In May 2023, we initiated patent infringement proceedings in Ireland (in the High Court) and Belgium (in the Brussels Business Court) against Pfizer, BioNTech and related entities with respect to the same European patents. As in the U.S. action, we seek a judgment of infringement of the asserted patents and monetary damages.
District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine willfully infringes certain U.S. patents concerning lipid nanoparticles. The complaint seeks a judgment of infringement of the asserted patents and monetary damages, but does not seek to prevent or stop the marketing or sales of our COVID vaccines.
District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine willfully infringes certain U.S. patents concerning lipid nanoparticles but does not seek to prevent or stop the marketing or sales of our COVID vaccines. The complaint seeks a judgment of infringement of the asserted patents and monetary damages.
Also in August 2022, we initiated patent infringement proceedings in Germany (in the Dusseldorf Regional Court), the Netherlands (in the District Court of The Hague) and the UK (in the High Court of Justice of England & Wales) against Pfizer, BioNTech and 78 related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.
European Proceedings Also in August 2022, we initiated patent infringement proceedings in the UK (in the High Court of Justice of England & Wales), the Netherlands (in the District Court of The Hague) and Germany (in the Dusseldorf Regional Court), against Pfizer, BioNTech and related entities with respect to certain European patents that also concern our mRNA platform technology and disease-specific vaccine designs, including coronaviruses.
We describe below those legal matters for which a material loss is either (i) possible but not probable, and/or (ii) not reasonably estimable at this time. Pfizer/BioNTech Patent Litigation In August 2022, we filed a lawsuit in the U.S. District Court for the District of Massachusetts against Pfizer Inc. (Pfizer) and BioNTech SE, BioNTech Manufacturing GmbH and BioNTech US Inc.
We describe below those legal matters for which a material loss is either (i) possible but not probable, and/or (ii) not reasonably estimable at this time. 78 Pfizer/BioNTech Patent Litigation U.S. Proceedings In August 2022, we filed a lawsuit in the U.S. District Court for the District of Massachusetts against Pfizer Inc.
(collectively, BioNTech), asserting infringement of certain U.S. patents concerning our mRNA platform technology and disease-specific vaccine designs in Pfizer and BioNTech’s manufacture and sale of their mRNA COVID vaccines. The complaint seeks a judgment of infringement of the asserted patents and monetary damages.
(Pfizer) and BioNTech SE, BioNTech Manufacturing GmbH and BioNTech US Inc. (collectively, BioNTech), asserting infringement of certain U.S. patents concerning our mRNA platform technology and disease-specific vaccine designs in Pfizer and BioNTech’s manufacture and sale of their mRNA COVID vaccines. The complaint seeks a judgment of infringement of the asserted patents and monetary damages.
The case has been stayed pending the outcome of two Inter Partes Proceedings (IPRs) pending before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) regarding the validity of two of the three asserted patents in this lawsuit.
The case has been stayed pending the outcome of two Inter Partes Review proceedings (IPRs) before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) regarding the validity of two of the three asserted patents. In March 2025, the PTAB found the patents invalid and we appealed to the U.S.
District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccines infringe certain U.S. patents directed to lipid-mRNA vaccine formulation technology. The complaint seeks a judgment of infringement of the asserted patents and unspecified damages, but does not seek injunctive relief.
District Court for the District of Delaware asserting that our manufacture and sale of our COVID and RSV vaccines willfully infringe certain U.S. patents directed to lipid-mRNA vaccine formulation technology. Each complaint seeks a judgment of infringement of the asserted patents and unspecified damages, and injunctive relief related to RSV after any appeals are decided.
District Court for the District of Delaware asserting that our COVID and RSV vaccines infringe several U.S. patents concerning lipid nanoparticle technology. The complaint seeks a judgment of infringement of the asserted patents and unspecified damages. The complaint does not seek injunctive relief.
Northwestern University Patent Litigation In October 2024, Northwestern University filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our COVID and RSV vaccines infringe several U.S. patents concerning lipid nanoparticle technology. The complaint seeks a judgment of infringement of the asserted patents and unspecified damages.
In November 2023, the District Court entered an order of partial dismissal with respect to two of the patents at issue. Subsequently, in October 2024, the District Court entered a final judgment of non-infringement in our favor with respect to the third patent at issue. The decision is subject to appeal. Item 4.
Subsequently, in October 2024, the District Court entered a final judgment of non-infringement in our favor with respect to the third patent at issue.
Securities Class Action Litigation In August 2024, a putative shareholder class action complaint was filed against the Company and certain officers in the U.S. District Court for the District of Massachusetts. The action is purportedly brought on behalf of a class of shareholders who purchased Moderna common stock between January 18, 2023 and June 25, 2024.
The complaint seeks a judgment of infringement of the asserted patent and unspecified damages. 80 Securities Class Action Litigation In August 2024, a putative shareholder class action complaint was filed against us and certain officers in the U.S. District Court for the District of Massachusetts.
In July 2024, the High Court of Justice of England & Wales issued a judgment confirming the validity of the ‘949 patent and finding that Pfizer and BioNTech had infringed the patent. The court further determined that the ‘565 patent was invalid. The High Court’s decision related to the ‘949 patent is subject to appeal.
In July 2024, the High Court of Justice of England & Wales ruled that EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA, was valid and infringed by Pfizer and BioNTech. The court further ruled that EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines, was invalid.
District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine infringes certain U.S. patents concerning cationic lipids. On August 25, 2023, the Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. Alnylam has appealed this judgment to the Federal Circuit Court of Appeals.
On August 25, 2023, the Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit decided the appeal in our favor in June 2025. Relatedly, in May 2023, Alnylam filed a third complaint against us in the U.S.
In addition, there remain ongoing Opposition Proceedings at the European Patent Office by a number of opponents, including Pfizer and BioNTech related to these two patents. Proceedings Related to Patents Owned by Arbutus In February 2022, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S.
Arbutus Patent Litigation In February 2022, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S.
In May 2023, Alnylam filed a third complaint against us in the U.S. District Court for the District of Delaware asserting three additional U.S. patents concerning cationic lipids. The complaints seek judgments of infringement of the asserted patents and monetary damages, but do not seek to prevent or stop the marketing or sales of our COVID vaccines.
District Court for the District of Delaware asserting three additional U.S. patents concerning cationic lipids. The complaint sought judgments of infringement of the asserted patents and monetary damages. In November 2023, the District Court entered an order of partial dismissal with respect to two of the patents at issue.
RSV Vaccine Also in October 2024, GSK filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our RSV vaccine infringes certain U.S. patents directed to lipid-mRNA vaccine formulation technology.
The complaint seeks a judgment of infringement of the asserted patent and unspecified damages. BioNTech Patent Litigation In February 2026, BioNTech SE filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of mNEXSPIKE willfully infringes a U.S. patent directed to modified mRNA compositions encoding a spike protein fragment.
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The PTAB is expected to issue a decision on the IPRs on or before March 6, 2025, which would be subject to appeal.
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Court of Appeals for the Federal Circuit (Federal Circuit).
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Pfizer Inc. and BioNTech SE have also filed an action seeking revocation of certain Moderna patents in the UK. In addition, the Moderna patents being asserted in the European actions are subject to notices of opposition, including by Pfizer and BioNTech SE and others. These actions seek to revoke the patents, which have been filed at the European Patent Office.
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In August 2025, the UK Court of Appeal upheld the High Court’s decision that the ‘949 patent is valid and infringed by Pfizer and BioNTech. In December 2025, the UK Supreme Court denied permission for appeal by Pfizer and BioNTech. In December 2023, the District Court of The Hague ruled that the ‘949 patent was invalid.
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There are two patents at issue in the European patent infringement proceedings–EP3590949 (the ‘949 patent), which relates to chemically-modified mRNA and EP3718565 (the ‘565 patent), which relates to coronavirus mRNA vaccines.
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We appealed to the Court of Appeal of The Hague, which held a hearing on September 22, 2025, and is expected to issue its decision on March 31, 2026. In March 2025, the Dusseldorf Regional Court in Germany ruled that Pfizer and BioNTech infringed the ‘949 patent.
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In December 2023, the District Court of The Hague issued a first instance decision determining that the ‘949 patent was invalid in the Netherlands. Moderna has appealed this decision to the Court of Appeal of The Hague, with a second instance decision expected in 2025.
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Pfizer and BioNTech have appealed to the Higher Regional Court of Dusseldorf, which will hold a hearing November 26, 2026. Pfizer Inc. and BioNTech SE have filed oppositions seeking revocation of the ‘949 and ‘565 patents at the European Patent Office.
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The Court has set trial to begin September 24, 2025, subject to the Court’s availability. Proceedings Related to Patents Owned by GSK COVID-19 Vaccines In October 2024, GlaxoSmithKline Biologicals SA (GSK) filed a complaint against us in the U.S.
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In May 2024, the Opposition Division (OD) ruled that the ‘949 patent was valid, and Pfizer and BioNTech appealed to the Technical Appeal Board (TBA), which will hold a hearing on September 8-10, 2026. In November 2023, the OD ruled that the ‘565 patent was invalid and we appealed to the TBA, which confirmed the invalidity on January 27, 2026.
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The complaint seeks a judgment of infringement of the asserted patents, unspecified damages and injunctive relief in the United States. Proceedings Related to Patents Owned by Northwestern University In October 2024, Northwestern University filed a complaint against us in the U.S.
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The Court has set trial to begin March 9, 2026. In March 2025, Arbutus and Genevant filed five international lawsuits asserting that our manufacture and sale of Spikevax and/or mRESVIA infringes certain patents concerning lipid nanoparticles.
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The complaints allege breaches of fiduciary duty and claims under the Securities Exchange Act of 1934 regarding statements about mRNA-1345 and seek declaratory and injunctive relief and unspecified damages payable to us. 79 Proceedings Related to Patents Owned by Alnylam In March 2022 and July 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed two complaints against us in the U.S.
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The companies filed lawsuits in the Canadian Federal Court, the Tokyo District Court in Japan and the Swiss Federal Patent Court and submitted two lawsuits to the Unified Patent Court (UPC). The UPC actions seek relief in all UPC member states and in ten additional European Patent Convention contracting states.
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Mine Safety Disclosures Not applicable. 80 PART II
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Each proceeding identifies Spikevax and mRESVIA as accused products except for the Canadian proceeding, which only identifies Spikevax. The complaints seek monetary relief and injunctive relief after a trial decision and before any appeals are decided. Hearings for the UPC actions are set for May 19 and 20, 2026.
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The Canadian lawsuit is scheduled for trial beginning in September 2027. 79 GSK Patent Litigation In October 2024, GlaxoSmithKline Biologicals SA (GSK) filed two separate complaints against us in the U.S.
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The Court has set trial to begin on July 19, 2027 with respect to our COVID vaccines, and on August 23, 2027 with respect to our RSV vaccine.
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In July 2025, GSK submitted two lawsuits to the UPC asserting that our manufacture and sale of our COVID and RSV vaccines infringe three European patents related to liposomes with specified characteristics for RNA delivery. The complaints seek monetary and injunctive relief after appeal. Hearings are set for September 2026.
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In December 2025, GSK served us with two separate complaints in the Barcelona Commercial Court and the Madrid Commercial Court (the Spanish Courts) asserting that our manufacture and sale of our COVID and RSV vaccines infringe the same patents asserted in the UPC actions. The complaints seek monetary and injunctive relief after an appeal decision.
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Alnylam Patent Litigation In March 2022 and July 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed two complaints against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine infringed certain U.S. patents concerning cationic lipids.
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Following the June 2025 Federal Circuit decision in our favor, we and Alnylam entered into an agreement in September 2025 to settle all disputes between the parties, including filing a stipulated dismissal of Alnylam’s claims with prejudice. The settlement did not include payments of any kind by us.
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Bayer CropSciences Patent Litigation In January 2026, Bayer CropScience LLC, Monsanto Company and Monsanto Technology, LLC (collectively, Bayer) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccines infringe a U.S. patent directed to methods of modifying gene sequences.
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The complaint seeks a judgment of infringement of the asserted patent and unspecified damages. mNG Bio Patent Litigation In January 2026, mNG Bio, LLC (mNG) filed a complaint against us in the U.S. District Court for the District of Massachusetts asserting that certain tests of our COVID vaccines willfully infringe a U.S. patent directed to a yellow-green fluorescent protein.
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The action was purportedly brought on behalf of a class of shareholders who purchased Moderna common stock between January 18, 2023 and June 25, 2024. The complaint asserts claims under the Securities Exchange Act of 1934 regarding statements about our RSV vaccine (mRNA-1345) and seeks unspecified damages.
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On August 25, 2025, plaintiff filed an amended complaint, which, among other things, narrowed the asserted class period to February 15, 2024 to May 31, 2024. On October 24, 2025, the Company filed a motion to dismiss, which remains pending. Derivative Litigation Between September and November 2024, purported shareholder derivative complaints were filed in the U.S.
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The cases were stayed pending a decision on defendants’ motion to dismiss the putative securities class action described above. Item 4. Mine Safety Disclosures Not applicable. 81 PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 80 PART II . Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 81 Item 6. [Reserved] 82 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 83 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 96 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 81 PART II . Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 82 Item 6. [Reserved] 83 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 84 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 97 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeInvestors should not purchase our common stock with the expectation of receiving cash dividends. Securities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans in Item 12 of Part III of this Annual Report on Form 10-K is incorporated herein by reference. Recent Sales of Unregistered Securities None.
Biggest changeSecurities Authorized for Issuance Under Equity Compensation Plans Information about our equity compensation plans in Item 12 of Part III of this Annual Report on Form 10-K is incorporated herein by reference. Recent Sales of Unregistered Securities None.
This number of holders of record also does not include stockholders whose shares may be held in trust by other entities. 81 Dividend Policy We have never declared or paid cash dividends on our common stock and do not expect to pay dividends on our common stock for the foreseeable future.
This number of holders of record also does not include stockholders whose shares may be held in trust by other entities. 82 Dividend Policy We have never declared or paid cash dividends on our common stock and do not expect to pay dividends on our common stock for the foreseeable future.
Issuer Purchases of Equity Securities On August 1, 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date. During the three months ended December 31, 2024, there were no shares repurchased.
Issuer Purchases of Equity Securities On August 1, 2022, our Board of Directors authorized a share repurchase program for our common stock of up to $3.0 billion, with no expiration date. During the three months ended December 31, 2025, there were no shares repurchased.
The following graph illustrates a comparison for the five years ended December 31, 2024 of the cumulative total return for our common stock, the Nasdaq Biotechnology Index, and the Standard & Poor’s 500 Stock Index (the S&P 500) each of which assumes an initial investment of $100 and reinvestment of all dividends.
The following graph illustrates a comparison for the five years ended December 31, 2025 of the cumulative total return for our common stock, the Nasdaq Biotechnology Index, and the Standard & Poor’s 500 Stock Index (the S&P 500) each of which assumes an initial investment of $100 and reinvestment of all dividends.
Stockholders We had approximately 63 stockholders of record as of February 14, 2025. Because many of our outstanding shares are held in accounts with brokers and other institutions, the number of beneficial owners is significantly greater than the number of record holders.
Stockholders We had approximately 62 stockholders of record as of February 13, 2026. Because many of our outstanding shares are held in accounts with brokers and other institutions, the number of beneficial owners is significantly greater than the number of record holders.
As of December 31, 2024, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remained outstanding, with no expiration date. Refer to Note 12 to consolidated financial statements for information regarding our share repurchase programs.
As of December 31, 2025, $1.7 billion of our Board of Directors’ authorization for repurchases of our common stock remained outstanding, with no expiration date. See Note 13 to consolidated financial statements for information regarding our share repurchase programs.
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In addition, our Credit Agreement with lenders led by Ares Capital Corporation includes covenants that, subject to certain exceptions, restrict our ability and the ability of our subsidiaries to pay dividends or distributions. Investors should not purchase our common stock with the expectation of receiving cash dividends.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeIn addition, the funding will enable the expansion of clinical studies for up to five additional subtypes of pandemic influenza, enhancing our preparedness to address emerging public health threats. 85 Financial Operations Overview Revenue Net product sales Net product sales by customer geographic location were as follows for the periods presented (in millions): Years Ended December 31, 2024 2023 2022 United States $ 1,726 $ 1,720 $ 4,405 Europe 573 1,353 6,732 Rest of world 810 3,598 7,298 Total $ 3,109 $ 6,671 $ 18,435 Net product sales by product were as follows (in millions): Years Ended December 31, 2024 2023 2022 COVID $ 3,084 $ 6,671 $ 18,435 RSV 25 — — Total $ 3,109 $ 6,671 $ 18,435 As of December 31, 2024, we have two commercial products authorized for use, our COVID vaccine and our RSV vaccine.
Biggest changeIf licensure is granted and in the event of an influenza pandemic, Moderna is committed to working to provide people around the world with rapid, equitable access to the resulting H5 vaccine, including, as part of this agreement, allocating 20% of its H5 pandemic vaccine manufacturing capacity for timely supply to low- and middle-income countries at affordable pricing. 85 Financial Operations Overview Revenue Net product sales Net product sales by customer geographic location were as follows for the periods presented (in millions): Years Ended December 31, 2025 2024 2023 United States $ 1,165 $ 1,726 $ 1,720 Europe 50 573 1,353 Rest of world 603 810 3,598 Total $ 1,818 $ 3,109 $ 6,671 Net product sales by product were as follows (in millions): Years Ended December 31, 2025 2024 2023 COVID (1) $ 1,810 $ 3,084 $ 6,671 RSV 8 25 — Total $ 1,818 $ 3,109 $ 6,671 _______ (1) Includes sales of Spikevax and mNEXSPIKE.
Grant and collaboration revenues have been primarily derived from government-sponsored and private organizations including the Biomedical Advanced Research and 86 Development Authority (BARDA), the Defense Advanced Research Projects Agency (DARPA) and the Gates Foundation and from strategic alliances with Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex) and others to discover, develop, and commercialize potential mRNA medicines.
Grant and collaboration revenues have been primarily derived from government-sponsored and private organizations including the Biomedical Advanced Research and Development Authority (BARDA), the Defense Advanced Research Projects Agency (DARPA) and the Gates Foundation and from strategic alliances with Merck & Co., Inc (Merck), Vertex Pharmaceuticals Incorporated and Vertex Pharmaceuticals (Europe) Limited (together, Vertex) and others to discover, develop, and commercialize potential mRNA medicines.
We reported a net loss of $3.6 billion and $4.7 billion for the years ended December 31, 2024 and 2023, respectively. In contrast, we generated net income of $8.4 billion and $12.2 billion for the years ended December 31, 2022 and 2021, respectively, following the authorization of our first commercial product in December 2020.
We reported a net loss of $2.8 billion, $3.6 billion and $4.7 billion for the years ended December 31, 2025, 2024 and 2023, respectively. In contrast, we generated net income of $8.4 billion and $12.2 billion for the years ended December 31, 2022 and 2021, respectively, following the authorization of our first commercial product in December 2020.
Selling, general and administrative expenses Selling, general and administrative expenses consist primarily of personnel-related costs, including stock-based compensation, for executives, finance, legal, human resources, business development, commercial, marketing, and other administrative and operational functions, professional fees, accounting and legal services, information technology and facility-related costs, and expenses associated with obtaining, maintaining, and defending intellectual property (IP).
Selling, general and administrative expenses Selling, general and administrative expenses consist primarily of personnel-related costs, including stock-based compensation, for executives, finance, legal, human resources, business development, commercial, marketing, and other administrative and operational functions, professional fees, accounting and legal services, technology and digital and facility-related costs, and expenses associated with obtaining, maintaining, and defending intellectual property (IP).
In the U.S., our COVID vaccine and RSV vaccine are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers. We recognize net product sales when control of the product transfers to the customer, typically upon delivery.
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. We recognize net product sales when control of the product transfers to the customer, typically upon delivery.
Recently issued accounting pronouncements See Note 2 - Summary of Significant Accounting Policies, to the consolidated financial statements, under the caption “Recently Issued Accounting Standards”. Results of operations A discussion regarding our results of operations for the year ended December 31, 2024 compared to 2023 is presented below.
Recently issued accounting pronouncements See Note 2 - Summary of Significant Accounting Policies, to the consolidated financial statements, under the caption “Recently Issued Accounting Standards”. 90 Results of operations A discussion regarding our results of operations for the year ended December 31, 2025 compared to 2024 is presented below.
The costs above comprise the following categories: • personnel-related expenses, including salaries, benefits, and stock-based compensation expense; • expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research organizations (CROs), that conduct our preclinical studies and clinical trials, and in-licensing arrangements; • expenses associated with developing manufacturing, modification of formulation or design of a product or process, advancing the design to meet specific functional and economic requirements for manufacture and obtaining materials for preclinical studies, clinical trials and pre-launch inventory from internal and third-party contract manufacturing organizations (CMOs); • expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process; • upfront fees and milestones paid to third-parties for licenses and technologies that had not reached technological feasibility and did not have an alternative future use; and • facilities, depreciation, and amortization, and other direct and allocated expenses incurred as a result of research and development activities.
The costs above comprise the following categories: • personnel-related expenses, including salaries, benefits, and stock-based compensation expense; • expenses incurred under agreements with third parties, such as consultants, investigative sites, contract research organizations (CROs), that conduct our preclinical studies and clinical trials, and in-licensing arrangements; • expenses associated with developing manufacturing, modification of formulation or design of a product or process, advancing the design to meet specific functional and economic requirements for manufacture and obtaining materials for preclinical studies, clinical trials and pre-launch inventory from internal and third-party contract manufacturing organizations (CMOs); • expenses incurred for the procurement of materials, laboratory supplies, and non-capital equipment used in the research and development process; • upfront fees and milestones paid to third-parties for licenses and technologies that had not reached technological feasibility and did not have an alternative future use; and • facilities, depreciation, and amortization, and other direct and allocated expenses incurred as a result of research and development activities. 87 We use our employee and infrastructure resources for the advancement of our platform, and for discovering and developing programs.
A discussion regarding our results of operations for the year ended December 31, 2023 compared to 2022 can be found under Part II -Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 23, 2024.
A discussion regarding our results of operations for the year ended December 31, 2024 compared to 2023 can be found under Part II -Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the Securities and Exchange Commission (SEC) on February 21, 2025.
As of December 31, 2024, we did not have any off-balance sheet arrangements, other than those obligations and commitments disclosed herein, that were material or reasonably likely to become material to our financial condition or results of operations. 95
As of December 31, 2025, we did not have any off-balance sheet arrangements, other than those obligations and commitments disclosed herein, that were material or reasonably likely to become material to our financial condition or results of operations. 96
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.
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 manufacturers and suppliers.
As of December 31, 2024, $60 million of the purchase commitments related to raw materials was recorded as an accrued liability for loss on future firm purchase commitments and is included in the purchase obligations line above.
As of December 31, 2025, $5 million of the purchase commitments related to raw materials was recorded as an accrued liability for loss on future firm purchase commitments and is included in the purchase obligations line above.
We believe that our cash, cash equivalents, and investments as of December 31, 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 the financial statements included in this Annual Report on Form 10-K.
We believe that our cash, cash equivalents, and investments as of December 31, 2025, together with cash expected to be generated from product sales and available borrowings under our credit facility, will be sufficient to enable us to fund our projected operations and capital expenditures through at least the next 12 months from the issuance of the financial statements included in this Annual Report on Form 10-K.
Our ongoing work on our norovirus, flu+COVID combination, CMV, RSV, and next-generation COVID vaccine candidates, INT, 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 may not be reimbursed or otherwise paid for by our partners or collaborators.
Our ongoing work on our intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, development of any new COVID vaccines against variants of SARS-CoV-2, late-stage clinical development, investments in digital capabilities and artificial intelligence technologies, and buildout of global commercial, regulatory, sales and marketing infrastructure and manufacturing facilities will require significant cash outflows in future periods, most of which may not be reimbursed or otherwise paid for by our collaborators or alliances.
The following table summarizes product sales provision for the periods presented (in millions): Years Ended December 31, 2024 2023 2022 Gross product sales $ 4,517 $ 8,203 $ 18,435 Product sales provision: Wholesaler chargebacks, discounts and fees (1,141) (976) — Returns, rebates and other fees (267) (556) — Total product sales provision (1) $ (1,408) $ (1,532) $ — Net product sales $ 3,109 $ 6,671 $ 18,435 _______ (1) Includes an adjustment of approximately $216 million for the full year 2024, reflecting a reduction in prior year provision estimates, primarily related to returns and chargebacks for the previous COVID vaccine season.
The following table summarizes product sales provision for the periods presented (in millions): Years Ended December 31, 2025 2024 2023 Gross product sales $ 3,304 $ 4,517 $ 8,203 Product sales provision: Wholesaler chargebacks, discounts and fees (1,037) (1,141) (976) Returns, rebates and other fees (449) (267) (556) Total product sales provision (1) $ (1,486) $ (1,408) $ (1,532) Net product sales $ 1,818 $ 3,109 $ 6,671 _______ (1) Includes an adjustment of approximately $216 million in 2024, reflecting a reduction in prior year provision estimates, primarily related to returns and chargebacks for the previous COVID vaccine season.
From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. We have retained earnings of $10.0 billion as of December 31, 2024. We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs.
From our inception to the end of 2020, we incurred significant losses from operations due to our significant research and development expenses. We have retained earnings of $7.2 billion as of December 31, 2025. We have significant future capital requirements including expected operating expenses to conduct research and development activities, operate our organization, and meet capital expenditure needs.
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.
Our platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing us the capability to pursue in parallel a robust pipeline of new development candidates. We are developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics.
Discovery and platform research expenses include costs associated with early-stage research activities for preclinical programs and the development of technical advances in mRNA science, delivery science, and manufacturing process design. These costs include external CRO and lab services, personnel-related costs, computer equipment, facilities, and other administrative costs.
Discovery and platform research expenses include costs associated with early-stage research activities for preclinical programs and the development of technical advances in mRNA science, delivery science, and manufacturing process design. These costs include external CRO and lab services, personnel-related costs, technology and digital, facilities, and other directly attributable research support costs.
We have agreements with certain vendors for various services, including services related to clinical operations and support and contract manufacturing, which we are not contractually able to terminate for convenience. Certain agreements provide for termination rights subject to termination fees or wind down costs.
See Note 11 to the consolidated financial statements for additional details. We have agreements with certain vendors for various services, including services related to clinical operations and support and contract manufacturing, which we are not contractually able to terminate for convenience. Certain agreements provide for termination rights subject to termination fees or wind down costs.
Our investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of December 31, 2024 decreased by $3.8 billion, or 28%, compared to December 31, 2023.
Our investments, consisting primarily of government and corporate debt securities, are stated at fair value. Cash, cash equivalents and investments as of December 31, 2025 decreased by $1.4 billion, or 15%, compared to December 31, 2024.
The following table summarizes other revenue for the periods presented (in millions): Years Ended December 31, 2024 2023 2022 Grant revenue $ 37 $ 94 $ 388 Collaboration revenue 48 83 440 Licensing and royalty revenue 42 — — Total other revenue $ 127 $ 177 $ 828 Cost of sales Cost of sales includes raw materials, personnel and facility and other costs associated with manufacturing our commercial products.
The following table summarizes other revenue for the periods presented (in millions): Years Ended December 31, 2025 2024 2023 Grant revenue $ 22 $ 37 $ 94 Collaboration revenue 13 48 83 Licensing and royalty revenue 11 42 — Stand-ready manufacturing revenue 80 $ — $ — Total other revenue $ 126 $ 127 $ 177 Cost of sales Cost of sales includes raw materials, personnel, facility and other indirect overhead costs associated with manufacturing our commercial products.
In the third quarter of 2023, we commenced sales of our latest COVID vaccine to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations. We also commenced sales of our RSV vaccine in the third quarter of 2024.
In the third quarter of 2023, we commenced sales of Spikevax to the U.S. commercial market, in addition to continuing sales to foreign governments and organizations, and subsequently expanded our commercial COVID vaccine portfolio with the launch of mNEXSPIKE in the third quarter of 2025. We also commenced sales of our RSV vaccine in the third quarter of 2024.
These charges in 2024, other than royalties, were largely driven by customer demand forecast adjustments, termination of third-party contract manufacturing service agreements, and commitments for manufacturing capacity and raw material purchase agreements.
These charges in both 2025 and 2024, other than royalties, were largely driven by customer demand forecast adjustments related to the seasonal nature of the COVID vaccine market, termination of third-party contract manufacturing service agreements, and commitments for 91 manufacturing capacity and raw material purchase agreements.
Liquidity and capital resources The following table summarizes our cash, cash equivalents, investments and working capital for each period presented (in millions): December 31, 2024 2023 Financial assets: Cash and cash equivalents $ 1,927 $ 2,907 Investments 5,098 5,697 Investments, non-current 2,494 4,677 Total $ 9,519 $ 13,281 Working capital: Current assets $ 8,099 $ 10,325 Current liabilities 2,206 3,015 Total $ 5,893 $ 7,310 92 Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
Liquidity and capital resources The following table summarizes our cash, cash equivalents, investments and working capital for each period presented (in millions): December 31, 2025 2024 Financial assets: Cash and cash equivalents $ 2,595 $ 1,927 Investments 3,204 5,098 Investments, non-current 2,336 2,494 Total $ 8,135 $ 9,519 Working capital: Current assets $ 6,544 $ 8,099 Current liabilities 1,987 2,206 Total $ 4,557 $ 5,893 Our cash, cash equivalents and investments are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policy used in the preparation of our consolidated financial statements require the most significant judgments and estimates.
While our significant accounting policies are described in more detail in the notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policy used in the preparation of our consolidated financial statements requires the most significant judgments and estimates. 89 Net product sales Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S.
Investigational medicines in later stages of clinical development, such as our norovirus vaccine, seasonal flu vaccine, new generations of COVID vaccines, combination vaccines, CMV vaccine, and our INT program, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Investigational medicines in later stages of clinical development, such as our intismeran autogene, norovirus, and flu+COVID combination vaccine candidates, and development of any new COVID vaccines against variants of SARS-CoV-2, generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later- 88 stage clinical trials.
We expect our research and development costs to be substantial in the near term as our investigational medicines advance through development phases and as we identify and develop additional programs. 88 There are numerous factors associated with the successful commercialization of any of our investigational medicines, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time due to the early stage of development of many of our investigational medicines.
There are numerous factors associated with the successful commercialization of any of our investigational medicines, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time due to the early stage of development of many of our investigational medicines.
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. 94 Contractual obligations and commitments The following table summarizes our contractual obligations as of December 31, 2024 and the effects that such obligations are expected to have on our liquidity and cash flows in future periods (in millions): Payments Due by Period Total Less than 1 year 1 - 3 years 3 - 5 years More than 5 years Operating leases $ 1,129 $ 64 $ 149 $ 162 $ 754 Financing leases 67 26 41 — — Purchase obligations (1) 1,045 601 439 5 — Total contractual cash obligations $ 2,241 $ 691 $ 629 $ 167 $ 754 _______ (1) The amounts represent non-cancelable fixed payment obligations related to purchases of raw materials, contract manufacturing services, research and development and other goods or services in the normal course of business.
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. 95 Contractual obligations and commitments The following table summarizes our contractual obligations as of December 31, 2025, and the effects that such obligations are expected to have on our liquidity and cash flows in future periods (in millions): Payments Due by Period Total Less than 1 year 1 - 3 years 3 - 5 years More than 5 years Operating leases $ 1,066 $ 65 $ 159 $ 162 $ 680 Financing leases 47 27 20 — — Purchase obligations (1) 1,438 481 441 343 173 Long-term debt (2) 900 62 130 708 — Total contractual cash obligations $ 3,451 $ 635 $ 750 $ 1,213 $ 853 _______ (1) The amounts represent non-cancelable fixed payment obligations related to purchases of raw materials, contract manufacturing services, research and development and other goods or services in the normal course of business.
Our cost of sales was $4.7 billion, or 70% of our net product sales, in 2023, including third-party royalties of $301 million, inventory write-downs of $2.2 billion, unutilized manufacturing capacity and wind down costs of $981 million, and losses on firm purchase commitments and cancellation fees of $205 million.
Our cost of sales was $1.5 billion, or 47% of our net product sales, in 2024, including third-party royalties of $155 million, inventory write-downs of $495 million, unutilized manufacturing capacity and wind down costs of $368 million, and losses on firm purchase commitments and cancellation fees of $60 million.
Net cash provided by financing activities increased by $1.4 billion, or 104%, in 2024 compared to 2023, mainly due to a decrease in repurchases of common stock. Operation and funding requirements Our principal sources of funding as of December 31, 2024 consisted of cash and cash equivalents, investments, and cash we may generate from operations.
Net cash provided by financing activities increased by $537 million, or 959%, in 2025 compared to 2024, mainly due to the net proceeds from our credit facility. Operation and funding requirements Our principal sources of funding as of December 31, 2025 consisted of cash and cash equivalents, investments, and cash we may generate from operations.
The terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services.
In addition to the above obligations, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services.
Interest expense is primarily derived from our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, and certain contract manufacturing service agreements.
Interest expense is primarily derived from our finance leases related to our Moderna Technology Center prior to its acquisition in December 2024, certain contract manufacturing service agreements, and, beginning in November 2025, interest associated with our long-term debt (see Note 1 0 and Note 1 1 to the consolidated financial statements).
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 sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.
While we now have one year of data on our product returns, this remains insufficient to establish reliable patterns. We will continue to enhance our projections as additional information becomes available. The actual results could differ from our estimates, and such differences could have a material impact to our financial statements.
We will continue to refine our projections as additional information becomes available. The actual results could differ from our estimates, and such differences could have a material impact to our financial statements.
Net cash provided by financing activities in 2024 was $56 million, consisting of net proceeds from the issuance of common stock in connection with the exercise of stock options and employee stock purchases under our equity plans of $66 million.
Financing activities Our primary financing activities consist of issuance of common stock related to our equity plans, repurchases of common stock, borrowings under our credit facility, and finance leases. 94 Net cash provided by financing activities in 2025 was $593 million, consisting of $578 million of net proceeds from our credit facility and net proceeds from the issuance of common stock in connection with the exercise of stock options and employee stock purchases under our equity plans of $35 million.
Net product sales Prior to the third quarter of 2023, we sold our COVID vaccine to the U.S. Government, foreign governments and organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns.
Government, foreign governments and organizations. The agreements and related amendments with these entities generally do not include variable consideration, such as discounts, rebates or returns.
This was primarily due to a $1.6 billion decrease in cash, cash equivalents and short-term investments, mainly used to fund our operating activities, and a $534 million decrease in accounts receivable, primarily driven by timing of collections.
This was primarily due to a $1.2 billion decrease in cash, cash equivalents and short-term investments, mainly used to fund our operating activities, a $191 million decrease in prepaid expenses and other current assets driven by reduced manufacturing and capital spend, and a $174 million decrease in accounts receivable, primarily driven by lower revenue and invoice volumes as well as timing of collections.
Operating expenses Cost of sales Our cost of sales was $1.5 billion, or 47% of our net product sales, in 2024, including third-party royalties of $155 million, inventory write-downs of $495 million, primarily for raw materials and our finished and semi-finished COVID vaccine inventory, wind-down costs of $263 million, unutilized manufacturing capacity of $105 million, and losses from non-cancellable raw material purchase commitments of $60 million.
Operating expenses Cost of sales Our cost of sales was $868 million, or 48% of our net product sales, in 2025, including third-party royalties of $88 million, inventory write-downs of $291 million, primarily for raw materials and our finished and semi-finished COVID vaccine inventory, and unutilized manufacturing capacity and wind-down costs of $93 million.
Cost of sales also includes shipping costs, indirect overhead costs associated with our product sales during the period, third-party royalties on net sales of our products, and charges for inventory valuation, excess and obsolete inventory and losses on firm purchase commitments.
These costs include production materials, production costs at our manufacturing facilities, third-party manufacturing costs, and final formulation and packaging costs. Cost of sales also includes shipping costs, third-party royalties on net sales of our products, and charges for inventory valuation, excess and obsolete inventory and losses on firm purchase commitments.
Net cash flows provided by investing activities decreased by $2.3 billion, or 54%, in 2024 compared to 2023, primarily due to increases in purchases of marketable securities of $2.8 billion, and purchases of property, plant and equipment of $344 million, partially offset by an increase in proceeds from sale of marketable securities of $761 million.
Net cash flows provided by investing activities were relatively consistent in 2025 compared to 2024, primarily due to a decrease in proceeds from sale of marketable securities of $1.6 billion, which was partially offset by a decrease of $859 million in purchases of property, plant, and equipment, and a $761 million decrease in purchases of marketable securities.
At December 31, 2024, we had cancelable open purchase orders of $2.9 billion in total under such agreements for our clinical operations and support and contract manufacturing. These amounts represent only our estimate of those items for which we had a contractual commitment to pay at December 31, 2024, assuming we would not cancel these agreements.
These amounts represent only our estimate of those items for which we had a contractual commitment to pay at December 31, 2025, assuming we would not cancel these agreements. The actual amounts we pay in the future to the vendors under such agreements may differ from purchase order amounts.
For example, we experienced a decline in customer demand for our COVID vaccine in 2023, and this trend continued into 2024, reflecting the market's ongoing transition to a seasonal commercial pattern in the endemic COVID vaccine market.
For example, we experienced a decline in customer demand for our COVID vaccine in 2023 and 2024, and this trend has continued into 2025 as the market transitions to a more competitive and commercially driven environment.
Interest income Interest income consists of interest generated from our investments in cash and cash equivalents, money market funds, and high-quality fixed income securities.
This decline reflects our focus on productivity improvements, cost-saving initiatives, and targeted investments that strengthen our overall efficiency. Interest income Interest income consists of interest generated from our investments in cash and cash equivalents, money market funds, and high-quality fixed income securities.
These increases were driven by investments in building regulatory, sales, and marketing teams, establishing subsidiaries in multiple countries, and supporting operational growth. In 2024, selling, general and administrative expenses decreased significantly by $375 million, or 24%, compared to 2023. This decline reflects our focus on productivity improvements, cost-saving initiatives, and targeted investments that strengthen our overall efficiency.
These increases were driven by investments in building regulatory, sales, and marketing teams, establishing subsidiaries in multiple countries, and supporting operational growth. In 2025 and 2024, selling, general and administrative expenses decreased significantly year over year by $156 million and $375 million, or 13% and 24%, respectively.
Investing activities Our primary investing activities consist of purchases, sales, and maturities of our investments, capital expenditures for land, building, leasehold improvements, manufacturing, laboratory, computer equipment and software, and business development. 93 Net cash provided by investing activities in 2024 was $1.9 billion, which primarily included proceeds from maturities of marketable securities of $5.6 billion and proceeds from sales of marketable securities of $4.0 billion, partially offset by purchases of marketable securities of $6.5 billion, and purchases of property, plant and equipment of $1.1 billion.
Net cash provided by investing activities in 2025 was $1.9 billion, which primarily included proceeds from maturities of marketable securities of $5.6 billion and proceeds from sales of marketable securities of $2.4 billion, partially offset by purchases of marketable securities of $5.8 billion, and purchases of property, plant and equipment of $192 million.
Due to the number of ongoing programs and our ability to use resources across several projects, indirect or shared operating costs incurred for our research and development programs are generally not recorded or maintained on a program- or therapeutic area-specific basis. 87 The following table reflects our research and development expenses, including direct program specific expenses summarized by therapeutic area and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, 2024, 2023, and 2022 (in millions): Years Ended December 31, 2024 2023 2022 Program-specific expenses by therapeutic area: Respiratory vaccines $ 837 $ 1,554 $ 1,363 Latent and other virus vaccines 460 349 133 Oncology 154 62 28 Rare disease and other therapeutics 82 67 12 Total program-specific expenses by therapeutic area (1) $ 1,533 $ 2,032 $ 1,536 Other research and development expenses: Discovery and platform research $ 557 $ 751 $ 397 Technical development and manufacturing expenses 1,081 1,116 713 Shared discovery and development expenses 1,108 789 556 Stock-based compensation 264 157 93 Total research and development expenses $ 4,543 $ 4,845 $ 3,295 __________ (1) Includes a total of 34 development candidates at December 31, 2024, 42 development candidates at December 31, 2023, and 45 development candidates at December 31, 2022.
The following table reflects our research and development expenses, including direct program specific expenses summarized by therapeutic area and indirect or shared operating costs summarized under other research and development expenses during the years ended December 31, 2025, 2024, and 2023 (in millions): Years Ended December 31, 2025 2024 2023 Program-specific expenses by therapeutic area: Infectious disease vaccines $ 652 $ 1,297 $ 1,903 Oncology 201 154 62 Rare disease therapeutics 43 82 67 Total program-specific expenses by therapeutic area (1) $ 896 $ 1,533 $ 2,032 Other research and development expenses: Discovery and platform research $ 356 $ 520 $ 751 Technical development and manufacturing expenses 792 1,081 1,116 Shared discovery and development expenses 797 1,145 789 Stock-based compensation 291 264 157 Total research and development expenses $ 3,132 $ 4,543 $ 4,845 __________ (1) Includes a total of 25 development candidates at December 31, 2025, 34 development candidates at December 31, 2024, and 42 development candidates at December 31, 2023.
However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.
These arrangements collectively encompass the funding of specific research and development activities, with the distinction that under the research and development funding arrangements, we receive funding. However, for all these arrangements, we may be obligated to make potential future milestone and royalty payments.
Net Product Sales and Net (Loss) Earnings Per Share For the year ended December 31, 2024, we recognized net product sales of $3.1 billion from sales of our COVID and RSV vaccines, compared to $6.7 billion and $18.4 billion for the years ended December 31, 2023 and 2022, respectively.
Total Revenue and Loss Per Share For the year ended December 31, 2025, we recognized total revenue of $1.9 billion compared to $3.2 billion and $6.8 billion for the years ended December 31, 2024 and 2023, respectively.
In addition, we have substantial facility, lease and purchase obligations. We have also 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.
We may also incur additional costs related to postmarketing commitments, though the timing and scope of such commitments remain uncertain. In addition, we have substantial facility, lease and purchase obligations. We have also entered into various collaboration and licensing agreements, as well as a research and development funding arrangement with a third party.
These provisions are recorded based on contractual terms, our estimate of returns for product sold, and other relevant considerations, during the period, using the expected value method or the most likely amount method. Estimates are assessed each period and adjusted as required to revise information or actual experience.
Net product sales are recognized net of estimated wholesaler chargebacks, invoice discounts for prompt payments and pre-orders, provisions for sales returns, government rebates, and other related deductions. These provisions are recorded based on contractual terms, our estimate of returns for product sold, and other relevant considerations, during the period, using the expected value method or the most likely amount method.
Cash flow The following table summarizes the primary sources and uses of cash for the periods presented (in millions): Years Ended December 31, 2024 2023 Net cash (used in) provided by: Operating activities $ (3,004) $ (3,118) Investing activities 1,949 4,206 Financing activities 56 (1,377) Net decrease in cash and cash equivalents $ (999) $ (289) Operating activities 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.
These decreases were partially offset by a $129 million reduction in accounts payable and accrued liabilities, reflecting an overall reduction in operating expenses, and a $54 million reduction in short-term deferred revenue, mainly resulting from revenue recognized from deferred revenue in excess of customer advance payments received. 93 Cash flow The following table summarizes the primary sources and uses of cash for the periods presented (in millions): Years Ended December 31, 2025 2024 Net cash (used in) provided by: Operating activities $ (1,873) $ (3,004) Investing activities 1,946 1,949 Financing activities 593 56 Operating activities We derive cash flows from operations primarily from cash collected from customer advance payments and accounts receivable related to our product sales, as well as other revenue and funding arrangements.
Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. 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.
Our cash flows from operating activities are significantly affected by our use of cash for operating expenses and working capital to support the business. We sell our COVID and RSV vaccines to the commercial market as well as to foreign governments and international organizations. Certain supply agreements include upfront payments, which are initially recorded as deferred revenue.
Other expense, net The following table summarizes other expense, net for the periods presented (in millions): Years Ended December 31, Change 2024 vs. 2023 2024 2023 Change % Loss on investments $ (56) $ (72) $ 16 (22) % Interest expense (24) (38) 14 (37) % Other expense, net (7) (14) 7 (50) % Total other expense, net $ (87) $ (124) $ 37 (30) % Total other expense, net decreased by $37 million, or 30%, in 2024.
Interest income Interest income generated from our investments in marketable securities decreased by $111 million in 2025, mainly due to lower average investment balances. 92 Other expense, net The following table summarizes other expense, net for the periods presented (in millions): Years Ended December 31, Change 2025 vs. 2024 2025 2024 Change % Loss on investments $ (5) $ (56) $ 51 (91) % Interest expense (10) (24) 14 (58) % Other income (expense), net 7 (7) 14 (200) % Total other expense, net $ (8) $ (87) $ 79 (91) % Total other expense, net decreased by $79 million, or 91%, in 2025.
The net change in assets and liabilities was primarily due to a decrease in deferred revenue of $439 million due to revenue recognized from deferred revenue in excess of customer deposits received, and a decrease in accounts payable and accrued liabilities of $454 million resulting from overall lower spend in the period.
The net change in assets and liabilities was primarily due to a decrease in accounts receivable of $156 million, mainly due to lower invoice volumes and timing of collections, a $153 million decrease in prepaid expenses and other current assets, primarily due to reduced manufacturing and capital spend, and a $41 million decrease in deferred revenue due to revenue recognized from deferred revenue in excess of customer advance payments received.
We also commenced sales of our RSV vaccine in the third quarter of 2024. In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers.
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, which typically do not make upfront payments. In addition, we receive customer advance payments related to certain other revenue arrangements.
The following table summarizes our consolidated statements of operations for the periods presented (in millions): Years Ended December 31, Change 2024 vs. 2023 2024 2023 Change % Revenue: Net product sales $ 3,109 $ 6,671 $ (3,562) (53) % Other revenue 127 177 (50) (28) % Total revenue 3,236 6,848 (3,612) (53) % Operating expenses: Cost of sales 1,464 4,693 (3,229) (69) % Research and development 4,543 4,845 (302) (6) % Selling, general and administrative 1,174 1,549 (375) (24) % Total operating expenses 7,181 11,087 (3,906) (35) % Loss from operations (3,945) (4,239) 294 (7) % Interest income 425 421 4 1 % Other expense, net (87) (124) 37 (30) % Loss before income taxes (3,607) (3,942) 335 (8) % (Benefit from) provision for income taxes (46) 772 (818) (106) % Net loss $ (3,561) $ (4,714) $ 1,153 (24) % Revenue Total revenue decreased by $3.6 billion, or 53%, in 2024, primarily attributable to a significant reduction in net product sales of our COVID vaccine.
The following table summarizes our consolidated statements of operations for the periods presented (in millions): Years Ended December 31, Change 2025 vs. 2024 2025 2024 Change % Revenue: Net product sales $ 1,818 $ 3,109 $ (1,291) (42) % Other revenue 126 127 (1) (1) % Total revenue 1,944 3,236 (1,292) (40) % Operating expenses: Cost of sales 868 1,464 (596) (41) % Research and development 3,132 4,543 (1,411) (31) % Selling, general and administrative 1,018 1,174 (156) (13) % Total operating expenses 5,018 7,181 (2,163) (30) % Loss from operations (3,074) (3,945) 871 (22) % Interest income 314 425 (111) (26) % Other expense, net (8) (87) 79 (91) % Loss before income taxes (2,768) (3,607) 839 (23) % Provision for (benefit from) tax provision 54 (46) 100 (217) % Net loss $ (2,822) $ (3,561) $ 739 (21) % Revenue Total revenue decreased by $1.3 billion, or 40%, in 2025, primarily driven by a decline in net product sales.
The subjectivity of this process is heightened when assessing factors outside our direct control such as the limited historical data, constrained third-party information, and evolving market dynamics. Among all variables, estimating returns presents the most significant judgment due to the broad range of potential outcomes and the current lack of established return trends.
The application of our critical accounting policies necessitates substantial management judgment and estimation, particularly when determining the amount of variable consideration to recognize. The subjectivity of this process is heightened when assessing factors outside our direct control such as the limited historical data, constrained third-party information, and evolving market dynamics.
For the year ended December 31, 2024, we had a net cash outflow from operations of $3.0 billion, and purchases of property, plant and equipment of $1.1 billion. Working capital, defined as current assets less current liabilities, as of December 31, 2024 decreased by $1.4 billion, or 19%, compared to December 31, 2023.
Working capital, defined as current assets less current liabilities, as of December 31, 2025 decreased by $1.3 billion, or 23%, compared to December 31, 2024.
Licensing and royalty revenue is related to our out-licensing agreement for mRNA COVID related intellectual property in Japan, executed in 2024.
Licensing and royalty revenue is related to our out-licensing agreement for mRNA COVID related intellectual property in Japan, executed in 2024. Stand-ready manufacturing revenue relates to long-term strategic agreements with certain government entities to maintain manufacturing readiness, while the remaining consideration under these agreements is related to product sales.
Loss per share was $(9.28) for the year ended December 31, 2024, compared to (loss) earnings per share of $(12.33) and $20.12 for the years ended December 31, 2023 and 2022, respectively.
Loss per share was $(7.26) for the year ended December 31, 2025, compared to loss per share of $(9.28) and $(12.33) for the years ended December 31, 2024 and 2023, respectively. Program Developments Infectious Disease Vaccines • COVID vaccines: We have received approval in 40 countries for our 2025-2026 formula for Spikevax. We have also received U.S.
Net cash used by operating activities decreased by $114 million, or 4%, in 2024 compared to 2023. This decrease was primarily driven by a decrease in net loss of $1.2 billion, a change in deferred revenue of $1.6 billion, reflecting less revenue recognized from deferred revenue in excess of customer deposits received in 2024.
This decrease was primarily driven by a decrease in net loss of $739 million, a change in deferred revenue of $480 million, reflecting less revenue recognized from deferred revenue in excess of customer advance payments received in 2025, and a change in accounts payable and accrued liabilities of $360 million, driven by decreased clinical and manufacturing spend.
Please refer to Note 2 to our consolidated financial statements for further discussion and analysis of each significant category of product sales provisions and the accounting policy. The application of our critical accounting policies necessitates substantial management judgment and estimation, particularly when determining the amount of variable consideration to recognize.
Estimates are assessed each period and adjusted as required to revise information or actual experience. See Note 2 to our consolidated financial statements for further discussion and analysis of each significant category of product sales provisions and the accounting policy.
We began generating registrational trial data in 2024. • 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.
In January 2026, we entered into a strategic collaboration with Recordati, an international pharmaceutical group, to advance mRNA-3927 through the final stages of clinical development and, if approved, global commercialization. • Methylmalonic acidemia (MMA) therapeutic: mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.
We remain blinded and anticipate final efficacy data from the study in 2025. • 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 we are preparing second season enrollment in the Southern Hemisphere.
We are awaiting further guidance from the FDA on refiling. • Norovirus vaccine: We recently completed enrollment of a second Northern Hemisphere season (2025-2026) cohort in our ongoing Phase 3 study for our norovirus vaccine candidate (mRNA-1403).
Oncology Therapeutics • Individualized Neoantigen Therapy (INT): We continue to demonstrate the potential clinical benefit of our 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 are enrolling.
Oncology Therapeutics • Intismeran autogene: We are advancing intismeran (mRNA-4157), our mRNA-based individualized neoantigen therapy, in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma.
We have a diverse and extensive development pipeline of 34 development candidates across our 44 development programs, of which 41 are in clinical studies currently. Our COVID vaccine is our first commercial product and is marketed, where approved, under the name Spikevax®.
We currently have three commercial products—Spikevax® and mNEXSPIKE®, our COVID vaccines, and mRESVIA®, our vaccine against respiratory syncytial virus (RSV). We also have a diverse development pipeline of 25 development candidates across our 35 development programs currently in clinical studies. 2025 Business Highlights U.S.
Provision for income taxes Provision for income taxes decreased by $818 million, or 106%, in 2024, 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.
See Note 10 and N ote 11 to our consolidated financial statements for additional information. Provision for income taxes Provision for income taxes for 2025 remained immaterial and consistent with 2024 and 2023, reflecting the valuation allowance established on deferred tax assets in 2023, which has been applied consistently since its initial recognition.
The decrease in cost of sales was primarily driven by reduced inventory write-downs, unutilized manufacturing capacity, purchase commitment and cancellation fees, and lower sales volume. Additionally, the reduction reflects the impact of our strategic initiative launched, which incurred $1.6 billion in charges during 2023, contributed to improved manufacturing efficiency and cost reductions in 2024.
The decrease in cost of sales was primarily driven by reduced inventory write-downs, reduced unutilized manufacturing capacity and wind-down costs, lower losses on purchase commitments, and lower sales volume. In 2024, cost of sales included $238 million of wind-down costs related to the termination of a contract manufacturing agreement, whereas wind-down costs incurred in 2025 were significantly lower.
The decrease was mainly due to a $342 million reduction in consulting and outside services across all functions, along with a $72 million reduction in commercial and marketing expenses. The decrease reflects cost discipline and operational efficiencies gained by reducing reliance on external consultants and bringing more functions in-house.
The decrease was mainly due to a $57 million broad-based reduction in consulting and outside services, along with a $59 million reduction in commercial, marketing and distribution costs. These decreases were attributable to continued cost discipline and ongoing efforts to streamline operations.
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.
As of December 31, 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 lower respiratory tract disease (LRTD) caused by RSV.
Net cash used by operating activities in 2024 was $3.0 billion and consisted of net loss of $3.6 billion and non-cash adjustments of $635 million, plus a net change in assets and liabilities of $78 million. Non-cash items primarily included stock-based compensation of $429 million and depreciation and amortization of $189 million.
As of December 31, 2025, we had $252 million in deferred revenue related to customer advance payments received or billable. Net cash used by operating activities in 2025 was $1.9 billion and consisted of net loss of $2.8 billion and non-cash adjustments of $716 million, plus a net change in assets and liabilities of $233 million.
Removed
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.
Added
Manufacturing Capabilities Expansion In November 2025, we announced the expansion of our U.S. manufacturing capabilities through the onshoring of drug product manufacturing to our existing Moderna Technology Center in Norwood, Massachusetts. Upon completion, this expansion will enable end-to-end mRNA manufacturing in the United States, supporting both commercial and clinical supply needs.
Removed
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.
Added
This expansion is part of our continued investment in U.S.-based manufacturing infrastructure to support our mRNA vaccine and therapeutic pipeline.
Removed
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. 2024 Business Highlights Respiratory Vaccines During the fourth quarter of 2024, we achieved significant milestones in our respiratory vaccine portfolio.
Added
Construction for the new drug product manufacturing capability has commenced, with completion targeted in the first half of 2027. $1.5 Billion Five-Year Credit Facility In November 2025, we entered into a five-year term loan facility providing for up to $1.5 billion of capital to enhance our balance sheet and provide increased financial flexibility.
Removed
We filed for regulatory approval with the FDA for our next-generation COVID vaccine (mRNA-1283), supported by positive Phase 3 efficacy and immunogenicity data, leveraging a priority review voucher, and have been assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.
Added
The facility includes a $600 million initial term loan funded at closing, a $400 million delayed draw term loan facility available through November 2027, and an additional $500 million delayed draw term loan facility available through November 2028, subject to the achievement of specified regulatory milestones.
Removed
We also submitted a regulatory application for our respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), for high-risk adults aged 18 to 59, following positive Phase 3 data and using a priority review voucher, and have been assigned a PDUFA goal date of June 12, 2025.
Added
Food and Drug Administration (FDA) approval of our 2025-2026 formula for mNEXSPIKE, our second COVID vaccine, in all adults aged 65 and older, as well as individuals aged 12 to 64 years with at least one underlying risk factor. mNEXSPIKE is also approved in Europe, Canada and Australia and we have filed and are targeting 2026 approvals in Japan and Taiwan. 84 • mRESVIA : Our RSV vaccine has been approved for adults aged 60 years and older in 40 countries.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

12 edited+5 added−2 removed2 unchanged
Biggest changeWe believe the counterparties to our foreign currency forward contracts are creditworthy multinational commercial banks. While we believe the risk of counterparty nonperformance is not material, a sustained decline in the financial stability of financial institutions as a result of disruption in the financial markets could affect our ability to secure creditworthy counterparties for our foreign currency hedging programs.
Biggest changeWhile we believe the risk of counterparty nonperformance is not material, a sustained decline in the financial stability of financial institutions as a result of disruption in the financial markets could affect our ability to secure creditworthy counterparties for our foreign currency hedging programs. 97 Notwithstanding our efforts to mitigate some foreign currency exchange risks, there can be no assurance that our hedging activities will adequately protect us against the risks associated with foreign currency fluctuations.
Therefore, these forward contracts are accounted for as derivatives whereby the fair value of the contracts are reported as prepaid expenses and other current assets or other current liabilities in our consolidated balance sheets, and gains and losses resulting from changes in the fair value are recorded as a component of other expense, net, in our consolidated statements of operations.
Therefore, these forward contracts are accounted for as derivatives whereby the fair value of the contracts are reported as prepaid expenses and other current assets or other current liabilities in our consolidated balance sheets, and gains and losses resulting from changes in the fair value are recorded as a component of other income (expense), net, in our consolidated statements of operations.
The gains and losses on these foreign currency forward contracts generally offset the gains and losses in the underlying foreign currency denominated assets and liabilities, which are also recorded to other expense, net, in our consolidated statements of operations.
The gains and losses on these foreign currency forward contracts generally offset the gains and losses in the underlying foreign currency denominated assets and liabilities, which are also recorded to other income (expense), net, in our consolidated statements of operations.
As of December 31, 2024, our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than three months. We enter into these foreign exchange contracts to hedge our monetary assets and liabilities denominated in foreign currency in the normal course of business and accordingly, they are not speculative in nature.
As of December 31, 2025, our outstanding balance sheet hedging derivatives, carried at fair value, had maturities of less than three months. We enter into these foreign exchange contracts to hedge our monetary assets and liabilities denominated in foreign currency in the normal course of business and accordingly, they are not speculative in nature.
Balance Sheet Hedging Activities We enter into foreign currency forward contracts to hedge fluctuations associated with foreign currency denominated monetary assets and liabilities, primarily cash, receivables, payables and lease liabilities in the Australian dollar, Brazilian real, British pound, and Canadian dollar, that are not designated for hedge accounting treatment.
Balance Sheet Hedging Activities We enter into foreign currency forward contracts to hedge fluctuations associated with foreign currency denominated monetary assets and liabilities, primarily cash, receivables, payables and lease liabilities in the Australian dollar, British pound, Canadian dollar, and Euro that are not designated for hedge accounting treatment.
We expect that any increase or decrease in the fair value of the portfolio would be substantially offset by increases or decreases in the underlying exposures being hedged. 96
We expect that any increase or decrease in the fair value of the portfolio would be substantially offset by increases or decreases in the underlying exposures being hedged. 98
As of December 31, 2024, a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in balance sheet hedging of approximately $36 million.
As of December 31, 2025, a hypothetical adverse movement of 10 percent in foreign currency exchange rates compared to the U.S. dollars across all maturities would have resulted in potential declines in the fair value on our foreign currency forward contracts used in balance sheet hedging of approximately $58 million.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk Interest Rate Risk As of December 31, 2024 and 2023, we had cash, cash equivalents, restricted cash, and investments in marketable securities of $9.5 billion and $13.3 billion, respectively. Our investment portfolio comprises money market funds and marketable debt securities (including U.S.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk Interest Rate Risk As of December 31, 2025 and 2024, we had cash, cash equivalents, restricted cash, and investments in marketable securities of $8.1 billion and $9.5 billion, respectively. Our investment portfolio comprises money market funds and marketable debt securities (including U.S.
If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, 2024, the net fair value of our marketable securities would decrease by approximately $53 million. Foreign Currency Risk We transact business in various foreign currencies and have international sales and expenses denominated in foreign currencies.
If market interest rates were to increase immediately and uniformly by one percentage point from levels at December 31, 2025, the net fair value of our marketable securities would decrease by approximately $47 million.
Therefore, we are exposed to certain risks arising from both our business operations and economic conditions. For the year ended December 31, 2024, our revenue generating activities and operations continued to be primarily denominated in U.S. dollars. However, we maintained a significant exposure to foreign currency risk, particularly in the Australian dollar, Brazilian real, British pound, and Canadian dollar markets.
As a result, we are exposed to risks arising from changes in foreign currency exchange rates driven by both our business operations and economic conditions. For the year ended December 31, 2025, approximately 27% of our revenue was denominated in foreign currencies, although our revenue generating activities and operations continued to be primarily denominated in U.S. dollars.
Collectively, these factors expose us to risks associated with fluctuations in foreign currency exchange rates, which may impact our results of operations and cash flows. To manage this exposure, we have focused on balance sheet hedging activities as part of our strategy to address foreign currency fluctuations.
To manage this exposure, we have focused on balance sheet hedging activities as part of our strategy to address foreign currency fluctuations. While cash flow hedging programs are in place, there were no foreign currency cash flow hedging activities during 2025.
As our business evolves, we have transitioned to receiving payments in local currencies rather than U.S. dollars. In addition, we operate in foreign countries and are establishing manufacturing facilities in Canada, Australia, and the United Kingdom, where we also transact in foreign currencies.
Our foreign currency revenue exposure in 2025 was primarily associated with the Canadian dollar, Euro, Korean won, and Mexican peso markets. As our business evolves, we have transitioned to receiving payments in local currencies rather than U.S. dollars.
Removed
While cash flow hedging programs are in place, there were no foreign currency cash flow hedging activities during 2024.
Added
In November 2025, we entered into a variable-rate Credit Agreement providing for borrowings of up to $1.5 billion, under which outstanding amounts bear interest at rates based on Term SOFR plus a margin of 5.50% or a base rate plus a margin of 4.50%, at our option.
Removed
Notwithstanding our efforts to mitigate some foreign currency exchange risks, there can be no assurance that our hedging activities will adequately protect us against the risks associated with foreign currency fluctuations.
Added
As a result, our interest expense is exposed to changes in market interest rates. As of December 31, 2025, we had $600 million outstanding under this facility. See Note 11 to the consolidated financial statements for additional details. Foreign Currency Risk We transact business in various foreign currencies and have international sales and expenses denominated in foreign currencies.
Added
In addition, during 2025 we established and expanded manufacturing operations in the United Kingdom, Canada and Australia, where we also transact in foreign currencies.
Added
These developments are expected to result in higher levels of foreign currency denominated revenues and expenses on an annualized basis in the future, which may increase our exposure to fluctuations in foreign currency exchange rates and could impact our results of operations and cash flows.
Added
We believe the counterparties to our foreign currency forward contracts are creditworthy multinational commercial banks.

Other MRNA 10-K year-over-year comparisons