MRNA.NASDAQModerna, INC
10-K: Moderna's 2024 10-K Filing: Focus on Growth, Efficiency, and Pipeline Advancement
Moderna's 2024 10-K filing highlights a year of transition, marked by commercial challenges, strategic portfolio prioritization, and advancements in its mRNA platform and pipeline.
Summary
- Moderna's 10-K filing reports a net product sales of $3.1 billion in 2024, primarily from Spikevax sales.
- The company is focusing on ten product approvals over the next three years to drive sales growth.
- Moderna aims to achieve cost efficiency by reducing research and development expenses by approximately $1.0 billion by 2027 compared to 2024.
- The company achieved four positive Phase 3 data readouts across its respiratory portfolio.
- Moderna is expanding clinical studies for its individualized neoantigen therapy (INT) in collaboration with Merck.
- The company is moving two rare disease therapeutics programs targeting propionic acidemia (PA) and methylmalonic acidemia (MMA) toward registrational trials.
- Moderna initiated a Phase 3 study of its norovirus vaccine.
- The company expects to bring manufacturing plants online in Australia, Canada, and the United Kingdom in 2025.
- Moderna is facing intense competition in the vaccine and pharmaceutical markets.
- The company incurred net losses in 2024 and 2023 and expects to incur additional losses in the future.
Positives
- Approval of mRESVIA, the mRNA RSV vaccine, for adults 60 years and older.
- Positive Phase 3 data for next-generation COVID vaccine, RSV vaccine for high-risk adults, flu+COVID combination vaccine, and seasonal flu vaccine.
- Advancement of INT program with Merck, including enrollment completion for Phase 3 melanoma trial.
- Progress in rare disease programs with PA and MMA therapies moving toward registrational trials.
- Initiation of Phase 3 study for norovirus vaccine.
- Strategic collaboration with Blackstone Life Sciences for flu program development.
- Expansion of manufacturing capabilities with facilities expected to come online in Australia, Canada, and the United Kingdom in 2025.
Negatives
- Net losses incurred in 2024 and 2023, with expectations of future losses.
- Decline in COVID vaccine sales compared to previous years.
- Intense competition in the vaccine and pharmaceutical markets.
- Commercial challenges experienced in 2024, leading to lower-than-expected sales.
- Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines.
- Discontinuation of several programs in 2024 due to portfolio prioritization and emerging clinical data.
- Clinical trial for norovirus vaccine is currently on FDA clinical hold following a single adverse event report of Guillain-Barr syndrome.
Risks
- Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines could impact financial results.
- Intense competition in the vaccine and pharmaceutical markets may hinder Moderna's ability to compete effectively.
- Delays in obtaining regulatory approvals and advisory committee recommendations could delay commercialization.
- Clinical development is lengthy and uncertain, and clinical programs may be delayed or terminated.
- Difficulties in manufacturing, product release, shelf life, testing, storage, supply chain management, or shipping could impact product availability.
- Reliance on third-party service providers poses operational risks.
- Inability to obtain and enforce patent protection could impact the company's competitive position.
- Fluctuations in quarterly and annual operating results could cause stock price decline.
- Cybersecurity incidents could disrupt product development programs and manufacturing operations.
- The price of common stock has been volatile, which could result in substantial losses for shareholders.
Key Dates
| Date | Description |
|---|---|
| 2000 | Nipah virus (NiV) has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia and Singapore since 2000 |
| 2003 | Under the Pediatric Research Equity Act of 2003, all marketing applications for new active ingredients, indications, dosage forms, dosing regimens or routes of administration must contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred or inapplicable. |
| 2007 | In 2007, a Zika infection outbreak progressed across the Pacific islands. |
| 2009 | Moderna Therapeutics, Inc., a Delaware corporation incorporated in 2009 as Newco LS18, Inc. by Flagship Pioneering. |
| 2009 | An abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product was created by the Biologics Price Competition and Innovation Act of 2009 (the BPCI Act). |
| 2010 | Moderna was founded in 2010. |
| 2011 | Additionally, other federal health reform measures have been proposed and adopted in the United States since the ACA was enacted, including the Budget Control Act of 2011, which includes provisions to reduce the federal deficit. |
| 2012 | These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the EU Member States. This provision has been transposed into the Human Medicines Regulations 2012 and so remains applicable in the UK despite its departure from the EU. |
| 2013 | Moderna LLC, a limited liability company formed under the laws of the State of Delaware in 2013. |
| 2013 | The Budget Control Act, as amended, resulted in the imposition of 2% reductions in Medicare payments to providers, which began in April 2013 and will remain in effect through 2031 unless additional Congressional action is taken. |
| 2014 | Effective since January 2022, the Clinical Trials Regulation (EC) No. 536/2014 aims to streamline and harmonize the procedures for assessment and governance of clinical trials throughout the EU and to require that information on the authorization, conduct and results of each clinical trial conducted in the EU be publicly available. |
| 2015 | An outbreak observed in Brazil in 2015 soon spread across the Americas, which led the WHO to declare Zika a public health emergency of international concern in 2016. |
| 2016 | In June 2016, we entered into a Collaboration and License Agreement with Merck for the development and commercialization of personalized mRNA cancer vaccines (also known as INTs), which was subsequently amended and restated in 2018 (the INT Agreement), to develop and commercialize INTs for individual patients using our mRNA vaccine and formulation technology. |
| 2016 | 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. |
| 2016 | In July 2016, we entered into a Strategic Collaboration and License Agreement (Vertex Agreement) with Vertex Pharmaceuticals Incorporated, and Vertex Pharmaceuticals (Europe) Limited (together, Vertex). |
| 2017 | In June 2017, we entered into two sublicense agreements, one with Cellscript, and one with MRT, which agreements we collectively refer to as the Cellscript-MRT Agreements. |
| 2017 | 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. |
| 2018 | In August 2018, we changed our name from Moderna Therapeutics, Inc. to Moderna, Inc. |
| 2018 | In September 2018, we entered into a Collaboration and License Agreement with Merck for the development and commercialization of personalized mRNA cancer vaccines (also known as INTs), which was subsequently amended and restated in 2018 (the INT Agreement), to develop and commercialize INTs for individual patients using our mRNA vaccine and formulation technology. |
| 2018 | In November 2018, we adopted the 2018 Stock Option and Incentive Plan (the 2018 Equity Plan). |
| 2019 | In July 2019, we amended the Vertex Agreement (2019 Vertex Amendment). |
| 2019 | COVID-19 is caused by the SARS-CoV-2 virus that was first identified in humans in 2019, driving a global pandemic resulting in millions of deaths. |
| 2020 | In September 2020, we entered into an agreement with DARPA to fund development of a mobile manufacturing prototype leveraging our existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics. |
| 2020 | In April 2020, we entered into an agreement with BARDA for an award of up to $483 million to accelerate development of mRNA-1273, our original COVID vaccine. |
| 2020 | On March 17, 2020, the Secretary of HHS issued a declaration under the PREP Act and has issued subsequent amendments thereto to provide liability immunity for activities related to certain countermeasures against COVID-19. |
| 2021 | In September 2021, we entered into a collaboration agreement with the ILCM to develop a new mRNA therapeutic (mRNA-3351) for type 1 Crigler-Najjar syndrome (CN-1). |
| 2021 | In 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drugs average manufacturer price, for single source and innovator multiple source drugs, beginning in 2024. |
| 2021 | In December 2021, we launched our Artificial Intelligence (AI) Academy. |
| 2022 | In December 2022, we announced that the randomized Phase 2 trial of mRNA-4157 had met its primary endpoint. |
| 2022 | In August 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law. |
| 2022 | In 2022, a global outbreak of the Clade II mpox virus was declared a Public Health Emergency of International Concern by the WHO. |
| 2022 | In September 2022, Merck exercised its option for INTs, including mRNA-4157, pursuant to the terms of the INT Agreement and in October 2022 paid us an option exercise fee of $250 million. |
| 2022 | In December 2022, we entered into a non-exclusive patent license agreement with the National Institute of Allergy and Infectious Diseases (NIAID), an Institute or Center of the National Institutes of Health (NIH), to license certain patent rights concerning stabilizing prefusion coronavirus spike proteins and the resulting stabilized proteins for use in COVID vaccine products. |
| 2023 | In February 2023, mRNA-4157 received a Breakthrough Therapy Designation from the FDA, and in April 2023 mRNA-4157 received PRIME Scheme Designation from the EMA. |
| 2023 | In December 2023, we announced that at a planned median follow-up of approximately three years, mRNA-4157 in combination with KEYTRUDA showed sustained benefit, reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) and the risk of distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077) compared to KEYTRUDA alone in stage III/IV melanoma patients with high risk of recurrence following complete resection. |
| 2023 | In the second quarter of 2023, we acquired a newly constructed, 140,000 square feet biomanufacturing facility in Marlborough, Massachusetts. |
| 2023 | In 2023, we initiated a Phase 1/2 study to generate safety and immunogenicity data of our investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. |
| 2023 | In February 2023, we announced interim results from the P301 study of mRNA-1010. |
| 2023 | In April 2023, we announced the P302 study of mRNA-1010 did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial. |
| 2023 | 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. |
| 2023 | In February 2023, we presented initial data from a Phase 1/2 trial, which showed that mRNA-1468 elicited strong antigen-specific T cell responses at one month after the second dose and was generally well-tolerated. |
| 2023 | The first participant was dosed in February 2023 and enrollment of 500 participants was completed in June 2023. |
| 2023 | In December 2023, we began dosing participants in a Phase 3 study of mRNA-1403. |
| 2023 | In 2023, we initiated a Phase 1/2 study to generate safety and immunogenicity data of our investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. |
| 2023 | In September 2023, we entered into a strategic collaboration with Immatics to jointly develop cancer vaccines and TCER therapeutics, with Immatics leading preclinical and early clinical studies and Moderna leading later-stage development and commercialization. |
| 2024 | In 2024, we became a multi-product company with the approval of our second commercial product, mRESVIA, our mRNA respiratory syncytial virus (RSV) vaccine for older adults. |
| 2024 | In 2024, we achieved net product sales of $3.1 billion, largely from sales of Spikevax. |
| 2024 | In 2024, we shared four positive Phase 3 data readouts across our respiratory portfoliofor our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, our seasonal flu+COVID combination vaccine and our seasonal flu vaccine. |
| 2024 | In 2024, we and Merck have rapidly expanded clinical studies to several tumor types and completed enrollment of the Phase 3 clinical trial for adjuvant melanoma in 2024. |
| 2024 | Additionally, in 2024, we also took steps to move two of our rare disease therapeutics programstargeting propionic acidemia (PA) and methylmalonic acidemia (MMA)toward registrational trials. |
| 2024 | In 2024, our AI culture led to the deployment across the company of ChatGPT Enterprise and its enhanced capabilities such as Advanced Analytics, Image Generation and GPTs. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024 we further expanded development into a Phase 3 allowing neoadjuvant treatment in patients with NSCLC; a Phase 2 adjuvant treatment in patients with renal cell carcinoma (RCC), or kidney cancer; a Phase 2 adjuvant treatment in patients with high-risk muscle-invasive bladder cancer (MIBC); and a Phase 2/3 neoadjuvant and adjuvant treatment in patients with cutaneous squamous cell carcinoma (cSCC). |
| 2024 | In 2024, our voluntary turnover rate was approximately 6%. |
| 2024 | In 2024, Biospace ranked us the number one large employer in its 2025 Best Places to Work in Biopharma report for the fourth consecutive year. |
| 2024 | Additionally, in 2024, Biospace ranked us the number one large employer in its 2025 Best Places to Work in Biopharma report for the fourth consecutive year. |
| 2024 | We also received a perfect score from the Human Rights Campaign's Corporate Equality Index for 2025. |
| 2024 | In 2024, we enhanced the AI Academy with a required GPT training to empower employees to transform the way they work with the power of AI. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine, our RSV vaccine for high-risk adults aged 18 to 59, and our flu+COVID combination vaccine for adults 50 years and older. |
| 2024 | In 2024, we filed for regulatory approval of our next-generation COVID vaccine |
Keywords
mRNA, vaccines, Spikevax, mRESVIA, COVID-19, RSV, clinical trials, regulatory approvals, manufacturing, intellectual property, oncology, rare diseases, financial results, risk factors, pipeline
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