Moderna
Annual Report 2023

Plain-text annual report

annual report 2023 Table of Contents A letter from our CEO Advancing mRNA respiratory vaccines A new frontier in cancer care Pipeline Building our team Digitizing everywhere Responsibility Leadership Awards and recognition Financials by the numbers In 2023, we impacted more than 100 million people. moderna 2023 annual report 02 Delivering commercial impact $6.7B 48% in net product sales in 2023 U.S. COVID retail market share in fall 2023 $13.3B in cash, cash equivalents and investments as of December 31, 2023 Advancing our pipeline 45 4 therapeutic areas development programs 9 late-stage programs Creating a unique and diverse organization 5,600 49% 39% employees in 19 markets women in our workforce of executives are women Celebrating our culture 2nd 9 consecutive year of equal pay for equal work study showing no significant differences in pay years in a row as a Science top employer No. 1 ranked large company in BioSpace Best Places to Work 03 moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOTable of Contents A letter from our CEO Advancing mRNA respiratory vaccines A new frontier in cancer care Pipeline Building our team Digitizing everywhere Responsibility Leadership Awards and recognition Financials Table of contents 05 A letter from our CEO 22 Digitizing everywhere 14 Advancing mRNA respiratory vaccines 15 A new frontier in cancer care 17 Pipeline 20 Building our team 23 Responsibility 26 Leadership 27 Awards and recognition 28 Financials moderna 2023 annual report 04 A letter from our CEO January 2, 2024 Cambridge, Mass., U.S.A. “ As we reflect on the past year, our commitment to leveraging mRNA to deliver transformative medicines for patients has never been stronger. ” Stéphane Bancel, Chief Executive Officer Dear fellow shareholders, Our mRNA platform is working. Today, we are seeing the high-case scenario from our 2018 five-year, long- range plan unfold. We have demonstrated the potential for clinical benefit in multiple infectious disease vaccines, in skin cancer and in three different rare genetic diseases. Based on these clinical successes, we have advanced a broad and diverse pipeline. Now, it is up to us to bring these mRNA medicines to market for patients, and consequently to drive value for our shareholders. As we reflect on the past year, our commitment to leveraging mRNA to deliver transformative medicines for patients has never been stronger. We have the platform, technology, resources and the team to establish a new era of We advanced nine programs into late-stage development, including one approved, one filed for approval, and three more that have completed Phase 3 enrollment. We are many steps closer to reaching millions more people with unmet medical needs. medicine. A Year of Transition Through more than a decade of progress and investment in science, Moderna has led in establishing the field of mRNA medicine. The team has built a remarkable platform to scale Moderna at a pace not seen before in our industry. In 2023, SARS-CoV-2 continued to evolve. The virus that causes COVID-19 is clearly here to stay—just like influenza. Our business has also adapted to a more predictable, seasonal endemic market. 05 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOManaging the transition took significant effort in 2023. As you know, we rapidly Additionally, we announced a strategic partnership with the Coalition for scaled our manufacturing capabilities during the pandemic to play a critical role Epidemic Preparedness Innovations (CEPI), harnessing the power and speed of in combatting COVID-19 with our vaccine. We knew that this surge capacity Moderna's mRNA platform to accelerate the development of mRNA vaccines may not be required in the endemic market, but we felt obligated to ensure we against viral disease outbreaks that pose global public health threats. The protected as many lives as we could during the pandemic. expansion of our mRNA Access program reinforces our dedication to public During 2023, it became clear that demand for vaccines had entered a new stage of the endemic setting and we pivoted to significantly resize our manufacturing infrastructure to help ensure our COVID-19 franchise would be profitable in 2024 and beyond. Although undervaccination has been observed in health by providing researchers with our mRNA technology in the development of vaccines for emerging and neglected infectious diseases. We believe this program can play a key role in helping the next generation of researchers and engineers to advance mRNA science. the first endemic season, we believe this will settle out over the coming years as We also announced the acquisition of Japan-based OriCiro Genomics, which the impact of the virus and vaccine during endemic periods becomes evident we now have integrated into Moderna as Moderna Enzymatics. That technology and may affect future levels of vaccination. At the same time, we invested in our people, processes, and digital systems to help us build Moderna for the long term. We opened a technology hub in Seattle and welcomed Brad Miller as Chief Information Officer, emphasizing our continued focus on building digital-first and investing in AI because of the profound impact it will have on our Mission. To further advance our mRNA science, we also entered into a partnership with IBM to explore quantum computing and generative AI. We believe that AI will be as transformational to any business as the desktop computer was when it entered the corporate world. will enable us to reduce manufacturing cycle times and improve quality. We also established strategic collaborations with CytomX, Generation Bio, Immatics and Life Edit, to enhance our internal research and development. 06 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEODelivering the Greatest Possible Impact Last year, we provided external guidance for Spikevax sales of at least $6 billion. We continued to focus on public health efforts to increase vaccination rates globally, and in the U.S. we achieved 48 percent market share for the 2023 fall season, compared to 37 percent in fall 2022—demonstrating our ability to compete in the commercial market. Recognizing that COVID is not going away, we are making it an important piece of our business with our vaccines against COVID-19 and our investigational combination vaccine against flu and COVID. Spikevax U.S. Retail Administrations Market Share (%) 51 52 53 53 53 51 52 51 50 48 49 47 37 48 44 37 37 38 39 39 38 39 39 39 38 36 37 36 2023 2022 39 35 42 29 32 27 9/15 9/22 9/29 10/6 10/13 10/20 10/27 11/3 11/10 11/17 11/24 12/1 12/8 12/15 12/22 12/29 Source : Based on information licenced from IQVIA: IQVIA RAPID Weekly Audit for September-December 2022 and September-December 2023, reflecting estimates of real-word activity. 2022 figures have been aligned to closest corresponding 2023 figures, based on weeks following approval/launch. All rights reserved. Cumulative percentage (season to date) In parallel, we prepared for the potential 2024 launch of our investigational RSV on clinical trial data and ready-to-use pre-filled syringes when compared to two vaccine for adults, which is expected to further strengthen our financial position recently launched products. In addition, the mRNA vaccine technology that our and further demonstrate the commercial potential of our mRNA platform. We believe our RSV vaccine candidate has a potentially best-in-class profile based RSV vaccine uses has a well-established safety and tolerability profile, having been used in more than a billion COVID-19 vaccine doses. 07 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOTable of Contents A letter from our CEO Advancing mRNA respiratory vaccines A new frontier in cancer care Pipeline Building our team Digitizing everywhere Responsibility Leadership Awards and recognition Financials “ We have an exciting late-stage pipeline, and we expect to double the number of programs in Phase 3 by 2025 and launch up to 15 products in five years. ” moderna 2023 annual report 08 A letter from our CEO Turning to the rest of our pipeline, positive clinical trial results across cancer, rare disease and infectious disease were shared during our annual R&D Day in September, when we announced our intent to launch up to 15 products in five years. I will highlight a few notable 2023 milestones from across our 45 development programs. The image above depicts Moderna’s pipeline as a cell map, reflecting the new development candidates, Lyme, Mpox and Norovirus, added in 2023 to Moderna’s infectious disease vaccines modality. Respiratory Franchise In 2023, we advanced our COVID, RSV and flu respiratory disease programs to positive Phase 3 data. We received U.S. FDA approval of our updated COVID-19 vaccine and filed a Biologics License Application (BLA) for our RSV vaccine. Additionally, our seasonal flu vaccine candidate met its primary endpoint in a Phase 3 trial, and consultations with regulators on a potential licensing package are ongoing. Our combination vaccine candidates, which can also provide substantial public health benefits, address respiratory viruses associated with the largest disease burden in the category and are designed for higher compliance, increased uptake, consumer convenience and benefits to healthcare systems. Enrollment was completed in our combination trials for flu/COVID-19 (Phase 1/2), flu/RSV (Phase 1), and flu/COVID-19/ RSV (Phase 1). We also recently initiated a Phase 3 trial of our combination vaccine against seasonal flu and COVID-19 with the intention to have a combination vaccine available as early as 2025. 09 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO“ We were excited to see such a robust clinical benefit with our mRNA therapy, and to launch a new Phase 3 trial with non-small cell lung cancer patients in December. ” Latent Franchise We continued to develop vaccines against six latent and other viruses with unmet or underserved needs, including cytomegalovirus (CMV), Epstein-Barr virus, herpes simplex virus, varicella zoster virus, norovirus and HIV. The pivotal Phase 3 study, CMVictory, of our CMV vaccine candidate fully enrolled with adults to evaluate the efficacy, safety and immunogenicity of the vaccine in the prevention of primary infection in women of childbearing age. The Phase 3 study is event-based but given the number of cases we have already seen, we could have CMV Phase 3 data in 2024. CMV is the most common infectious cause of birth defects in the U.S. and CMV has been designated a top priority in new vaccine development by the U.S. National Academy of Medicine for more than two decades. Oncology Franchise In 2023, we reported additional data from our Phase 2b trial evaluating our individualized neoantigen therapy (INT) in combination with Merck’s KEYTRUDA® in melanoma patients compared to KEYTRUDA alone. The treatment continued to show significant and clinically meaningful improvement in recurrence-free survival and reduced the risk of recurrence or death by 49 percent. These data, with a median follow-up of approximately three years, demonstrate the durability of the therapy. We were excited to see such a robust clinical benefit with our mRNA therapy, and to launch a new Phase 3 trial with non-small cell lung cancer patients in December. To support this continued progress, we have been investing in building a factory in Marlborough, Massachusetts, and in building out our people capability, which will enable the commercial launch for INT. Rare Disease Franchise Our rare disease portfolio, which includes therapies targeting methylmalonic acidemia (MMA), propionic acidemia (PA), glycogen storage disease and Phenylketonuria, continued to show promise. The Phase 1/2 trial for our MMA therapy candidate has dosed 11 participants with a total of 221 doses administered and all participants have opted into the Open-Label Extension study. A global Phase 1/2 trial for our PA candidate, which is our most advanced rare disease program, is enrolling patients in the dose confirmation arm, and most patients who have completed the treatment period of the main study have opted to enter a long-term extension study. 10 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOTable of Contents A letter from our CEO Advancing mRNA respiratory vaccines A new frontier in cancer care Pipeline Building our team Digitizing everywhere Responsibility Leadership Awards and recognition Financials “ Staying true to our Mission, we will also continue to invest in science to expand the field of mRNA medicine into new frontiers. ” moderna 2023 annual report 11 A letter from our CEO Focusing on Execution Acting Responsibly As you can see, we have built significant momentum across our business and Our commitment to corporate social responsibility remains strong, as evidenced our pipeline. Across our respiratory, latent, oncology and rare franchises, we are by the publication of our second annual ESG Report in June. As a company, aiming to launch up to 15 new products over the next five years. We are excited we care deeply about our patients, our employees, the environment and by the near future and focused on execution to deliver for patients. our communities, and we recognize that we have an opportunity to change Staying true to our Mission, we will also continue to invest in science to expand the field of mRNA medicine into new frontiers. For example, in partnership with Vertex, we are advancing an investigational inhaled mRNA therapy in the lung medicine for all. We will continue to engage, listen and understand what our stakeholders expect from us as a sustainable, responsible business and leader in mRNA medicines. to treat the underlying cause of cystic fibrosis, which we expect to read out This leadership is made possible by our people, who are the driving force behind in 2024. Over the same five-year period, we expect to advance many new candidate medicines into clinical trials across established and new modalities. To do this, we will continue to lead with our Values, our Mindsets and a deep sense of purpose in everything we do. our progress and our culture. I am proud of our team and award-winning culture, which earned Moderna recognition from Science as a top employer for the ninth consecutive year, from BioSpace as the #1 large employer in its Best Places to Work report for the third year in a row, and from the Human Rights Campaign Foundation as an Equality 100 company for the first time in 2023. Download our 2022 ESG Report 12 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO“ This leadership is made possible by our people, who are the driving force behind our progress and our culture. ” Looking Ahead With these priorities, we are completing our strategy to accelerate the growth of our business, a journey we have been on since mid-2021. We expect to break Our focus for 2024 and 2025 is to drive sales growth and profitability. To achieve even in 2026, as revenue grows and late-stage R&D costs recede, when the that, we are focusing on three priorities. current large Phase 3 clinical trials wind down and result in many potential new Priority one is commercial execution. Our recent market share gain in the U.S. product launches. demonstrates that we can compete with large established players. We expect Along the way, we will continue to invest in our people—the changemakers COVID sales to stabilize in a fully endemic market, and we will build on our who help us maximize our impact on human health. I am so grateful for their current momentum to grow our market share for Spikevax in 2024. dedication to our Mission and their relentless work. I am also thankful to all To support this, we made the decision at the end of 2023 to flatten our commercial organization to help us accelerate decisions and increase customer understanding as we prepare for multiple product launches. With the expected the people and organizations that partner with us on this journey to advance our Mission to deliver the greatest possible impact to people through mRNA medicines. launch of our RSV vaccine candidate in 2024, and potential launch of our flu/ Thank you all for your ongoing trust and support as we work to deliver value to COVID combination vaccine as early as 2025, we believe Moderna will experience sales growth in 2025. all our stakeholders, and bring mRNA medicines to the world. We are excited about 2024. This is just the beginning… Priority two is disciplined investment. We will continue to review our manufacturing costs, product pipeline, and deliver efficiencies. Our upcoming respiratory product launches in 2024 and 2025 will also achieve efficiencies from Warmest regards, a growing pipeline. Priority three is executing on our late-stage pipeline to drive organic sales growth. We have an exciting late-stage pipeline, and we expect to double the number of programs in Phase 3 by 2025 and launch up to 15 products in five years. Up to four of those launches could come by 2025. Stéphane Bancel Chief Executive Officer 13 A letter from our CEO moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOAdvancing mRNA respiratory vaccines Follow-up data from a Phase 3 RSV study with a median follow-up duration of 8.6 months, with a range of 15 days to 530 days, and including subjects from the Northern and Southern Hemispheres was recently presented at the RSVVW'24 conference. In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95.88% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. VE was 74.6% (95% CI, 50.7-86.9) against RSV-LRTD with ≥2 symptoms, including shortness of breath and 63.0% (95% CI, 37.3-78.2) against RSV-LRTD including three of more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints.  RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover within a week or two, but infants and older adults, who are more vulnerable, can develop severe complications leading to hospitalization. The rising global incidence of severe RSV in older adults has highlighted the urgent need for better prevention strategies.  We are well-prepared for the launch of our second respiratory vaccine, RSV (mRNA-1345), which will build upon the success of our commercial efforts in the fall COVID-19 market. We are encouraged by early indications of widespread consumer awareness and established demand in the RSV market, which we will enter with a strong competitive profile with robust efficacy data, a well-established safety and tolerability profile, and as the only pre-filled syringe (PFS) product available at the time of launch.   With a substantial number of U.S. RSV vaccines given to date in the pharmacy setting, PFS presentation offers ease of use, time savings and the potential to reduce medical errors. Given the labor shortage in the retail pharmacy channel, we anticipate our PFS presentation will be welcomed by pharmacists during the busy respiratory vaccine season, where pharmacists need, in addition to their regular tasks, to administer flu, COVID and RSV vaccines.  We have filed for regulatory approvals of our vaccine for the prevention of RSV- associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults ages 60 years or older. The regulatory applications are based on positive data from the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults, 60 years or older.  The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. Most solicited adverse reactions were mild to moderate, and no cases of Guillain- Barre Syndrome (GBS) have been reported with mRNA-1345 in the Phase 3 RSV trial. These data were published in the New England Journal of Medicine in December 2023.   14 Advancing mRNA respiratory vaccines moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOA new frontier in cancer care We, along with our partner Merck, are pioneering a new frontier in the fight against cancer by researching an mRNA-based investigational individualized neoantigen therapy (INT) with the goal of targeting each patient’s unique cancer cells. Our INT, mRNA-4157, marks an advancement at the intersection of immunology and cancer biology, leveraging a combination of technological, digital, and biological innovations. At its heart, this approach is patient-focused, utilizing next-generation sequencing to identify tumor-specific mutations from a patient’s blood sample. These mutations are analyzed by a proprietary algorithm to select up to 34 neoantigens, which are then used to create an individualized mRNA treatment aimed at training the patient's immune system to recognize and fight cancer cells. This entire process can be achieved within about six weeks. mRNA-4157 (V940) in combination with Pembrolizumab reduced the risk of recurrence or death by 44% compared to Pembrolizumab alone ) % ( S F R 100 80 60 40 20 0 0 12-month RFS 18-month RFS 83.4% 78.6% Events, % (n/N) Hazard Ratio (95% CI)a mRNA- 4157 (V940) + Pembrolizumab 22.4 (24/107) Pembrolizumab 40.0 (20/50) 0.561 (0.309-1.017) P = 0.0266 20 40 60 80 100 120 140 160 Time from first dose of Pembrolizumab (weeks) Number at risk mRNA-4157 (V940) + Pembrolizumab Pembrolizumab 107 50 92 42 85 40 73 37 49 28 24 13 20 6 8 1 1 0 1. Khattak A, et al. Presented at the American Association for Cancer Research® (AACR) Annual Meeting; April 14-19, 2023; Orlando, FL, USA. Oral presentation CT001. 2. Khattak A, et al. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL, USA. Oral presentation CI, confidence interval; mRNA, messenger RNA; RFS, recurrence-free survival.aThe hazard ratio and 95% CI for mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab is estimated using a Cox proportional hazards model with treatment group as a covariate, stratified by disease stage (stages IIIB or IIIC or IIID vs stage IV) used for randomization. The P value is based on a 1-sided log-rank test stratified by disease stage (stages IIIB or IIIC or IIID vs stage IV) used for randomization. 15 A new frontier in cancer care moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO We made great strides in our INT program in 2023. We announced that in our Phase 2 study, mRNA-4157, in combination with pembrolizumab, demonstrated a clinically meaningful improvement in recurrence-free survival and distant metastasis-free survival compared to standard of care in high-risk resected melanoma. We saw a 49% reduction in the risk of recurrence or death and a 62% reduction in the risk of distant metastasis or death compared to pembrolizumab alone with a median of three years of follow-up, and a Phase 3 pivotal study has begun enrolling. We have also initiated a Phase 3 trial in non-small cell lung cancer that is actively enrolling and plan to expand the development program to additional tumor types. To supply product to these trials and in preparation for the future, we announced that we are building a manufacturing site in Marlborough, MA as a commercial INT manufacturing facility. We believe an individualized neoantigen therapy can be a catalyst for innovation and drive us toward the next frontier of cancer care. By harnessing the power of mRNA, we hope to bring this potential therapy to the patients who need it as Manufacturing site in Marlborough, MA. quickly as possible. 16 A new frontier in cancer care moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOPipeline Below is Moderna’s pipeline as of February 22, 2024. RESPIRATORY VACCINES Program Indication ID # Preclinical Development Phase 1 Phase 2 Phase 3 Commercial Moderna rights RESPIRATORY VACCINES COVID-19 vaccine Spikevax® (mRNA-1273) Flu vaccine ADULTS Older adults RSV vaccine Flu + COVID vaccine mRNA-1283 mRNA-1010 mRNA-1020 mRNA-1030 mRNA-1011 mRNA-1012 mRNA-1345 mRNA-1083 Flu + COVID + RSV vaccine mRNA-1230 Flu + RSV vaccine Endemic HCoV vaccine Pandemic Flu RSV + hMPV vaccine mRNA-1045 mRNA-1287 mRNA-1018 mRNA-1365 ADOLESCENTS AND PEDIATRICS COVID-19 vaccine (adolescents) mRNA-1273.815 COVID-19 vaccine (pediatrics) mRNA-1273.815 TeenCOVE KidCOVE Pediatric RSV vaccine mRNA-1345 Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Abbreviations: BARDA: Biomedical Advanced Research and Development Authority CMV: cytomegalovirus CN-1: Crigler-Najjar syndrome type 1 EBV: Epstein-Barr Virus GSD1a: glycogen storage disease type 1a HCoV: human coronavirus HIV: human immunodeficiency virus hMPV: human metapneumovirus HSV: herpes simplex virus IAVI: International AIDS Vaccine Initiative IL-23: interleukin 23 IL-36 γγ: interleukin 36 gamma ILCM: Institute for Life Changing Medicine MMA: methylmalonic acidemia NIH: National Institutes of Health NSCLC: non-small cell lung cancer OTC: ornithine transcarbamylase deficiency PA: propionic acidemia PKU: phenylketonuria RSV: respiratory syncytial virus VZV: varicella-zoster virus moderna 2023 annual report 17 Pipeline Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOProgram Indication ID # Preclinical Development Phase 1 Phase 2 Phase 3 Commercial Moderna rights LATENT & OTHER VACCINES LATENT VACCINES & OTHER VACCINES LATENT VACCINES CMV vaccine EBV vaccine (to prevent infectious mononucleosis) EBV vaccine (to address EBV sequelae) HSV vaccine VZV vaccine HIV vaccines ENTERIC Norovirus vaccines BACTERIAL Lyme vaccines PUBLIC HEALTH VACCINES Zika vaccine Nipah vaccine Mpox vaccine mRNA-1647 mRNA-1189 mRNA-1195 mRNA-1608 mRNA-1468 mRNA-1644 mRNA-1574 mRNA-1403 mRNA-1405 mRNA-1975 mRNA-1982 mRNA-1893 mRNA-1215 mRNA-1769 Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide (IAVI funded) Worldwide (IAVI/others funded) Worldwide Worldwide Worldwide Worldwide Worldwide (BARDA funded) Worldwide (NIH funded) Worldwide Abbreviations: BARDA: Biomedical Advanced Research and Development Authority CMV: cytomegalovirus CN-1: Crigler-Najjar syndrome type 1 EBV: Epstein-Barr Virus GSD1a: glycogen storage disease type 1a HCoV: human coronavirus HIV: human immunodeficiency virus hMPV: human metapneumovirus HSV: herpes simplex virus IAVI: International AIDS Vaccine Initiative IL-23: interleukin 23 IL-36 γγ: interleukin 36 gamma ILCM: Institute for Life Changing Medicine MMA: methylmalonic acidemia NIH: National Institutes of Health NSCLC: non-small cell lung cancer OTC: ornithine transcarbamylase deficiency PA: propionic acidemia PKU: phenylketonuria RSV: respiratory syncytial virus VZV: varicella-zoster virus moderna 2023 annual report 18 Pipeline Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOProgram Indication ID # Preclinical Development Phase 1 Phase 2 Phase 3 Commercial Moderna rights THERAPEUTICS THERAPEUTICS SYSTEMIC SECRETED & CELL SURFACE THERAPEUTICS Relaxin Heart failure PD-L1 Autoimmune hepatitis CANCER VACCINES & THERAPEUTICS Individualized neoantigen therapy (INT) –adjuvant melanoma Individualized neoantigen therapy (INT) –adjuvant NSCLC KRAS vaccine mRNA-0184 mRNA-6981 mRNA-4157 mRNA-4157 mRNA-5671 Checkpoint vaccine mRNA-4359 INTRATUMORAL IMMUNO-ONCOLOGY OX40L/IL-23/IL-36 (Triplet) Solid tumors/lymphoma RARE DISEASE INTRACELLULAR THERAPEUTICS PA MMA GSD1a OTC PKU CN-1 INHALED PULMONARY THERAPEUTICS Cystic fibrosis mRNA-2752 mRNA-3927 mRNA-3705 mRNA-3745 mRNA-3139 mRNA-3210 mRNA-3351 mRNA-3692 / VX-522 Worldwide Worldwide 50-50 global profit sharing with Merck 50-50 global profit sharing with Merck Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Provided to ILCM free of charge Vertex to pay milestones and royalties Abbreviations: BARDA: Biomedical Advanced Research and Development Authority CMV: cytomegalovirus CN-1: Crigler-Najjar syndrome type 1 EBV: Epstein-Barr Virus GSD1a: glycogen storage disease type 1a HCoV: human coronavirus HIV: human immunodeficiency virus hMPV: human metapneumovirus HSV: herpes simplex virus IAVI: International AIDS Vaccine Initiative IL-23: interleukin 23 IL-36 γγ: interleukin 36 gamma ILCM: Institute for Life Changing Medicine MMA: methylmalonic acidemia NIH: National Institutes of Health NSCLC: non-small cell lung cancer OTC: ornithine transcarbamylase deficiency PA: propionic acidemia PKU: phenylketonuria RSV: respiratory syncytial virus VZV: varicella zoster virus moderna 2023 annual report 19 Pipeline Table of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOBuilding our team Creating a Unique Organization We continue to focus on the elements of our culture to create an environment where everyone can have an impact. Our Mission, Values and Mindsets support our ways of working and unite our people in our shared goal to change how medicines are made and delivered. As part of our efforts to scale our culture, we introduced the concept of our 'People Platform' in 2023. This concept involves regularly reviewing the programs we provide for our employees, the systems that underpin them, and the data and insights they generate. We aim to ensure that every employee, regardless of their location or level, experiences the same employee journey and that our culture is embedded throughout this journey. We emphasize learning and development. In 2023, we focused on upskilling our teams on topics such as artificial intelligence (AI) and how AI and machine learning can help ensure we are digitizing everywhere. Leading with Belonging In addition to system-level improvements, we focus heavily on the individual. Our strategy for diversity and inclusion starts with belonging. We believe that employees can only thrive and innovate when they feel they belong and can be their authentic selves. One achievement we take immense pride in is our commitment to pay equity. We ensure equal pay for equal work, a commitment we have upheld for the second year running. Race & Ethnicity 1 28.0% 21.2% 1/20 12/23 Asian 1. U.S. Only. 8.7% 5.1% 1/20 12/23 Hispanic/ Latinx 7.2% 3.5% 1/20 12/23 Black & African American We also care deeply about our employees' well-being and understand that each employee has unique needs that change over time. Therefore, we provide Our workforce demographics show that 49 percent of our employees are programs that focus on meeting employees where they are and that are tailored women, with 39 percent female representation in executive roles as of to their needs. Recently introduced programs include enhanced mental health December 2023. Although this represents a slight decline from the prior year, and life insurance benefits. we are proud of these figures, and have made significant strides in our race and ethnicity demographics by focusing on our early talent pipeline. Of our inaugural group of MBA interns, 43 percent identified with races or ethnicities that are underrepresented. Our focus remains on creating an inclusive environment where every individual can thrive and contribute to our mission. We are committed to continuous learning and improvement in this area, always striving to do better for our people. 20 Building our team moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOCelebrating Our Culture Moderna ranked 9th among biopharmaceutical companies in this year’s Science survey. Marking our ninth consecutive year on this list, we were recognized for our commitment to innovative leadership, respect for employees and corporate social responsibility. Additionally, BioSpace named Moderna the number one large employer in its Best Places to Work report for the third year in a row. We were also recognized by the Human Rights Campaign Foundation as an Equality 100 company for the first time in 2023—a proud moment for Moderna as we continue to build a culture of belonging. “ We believe that employees can only thrive and innovate when they feel they belong and can be their authentic selves. ” 21 Building our team moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEODigitizing everywhere In 2021, when we developed the Moderna Mindsets to help encode our culture, We are well-positioned to scale our manufacturing and our business overall using we articulated our commitment to digitizing everywhere possible. Digital AI because we are a platform company. AI training is required of all Moderna technology has been part of our programs since our early days and we have team members and we facilitate this training at a corporate level through our built our own AI models for protein and mRNA engineering, assay data analyses, AI Academy. We have challenged everyone across all our business functions regulatory interaction and many other use cases. As a recent example, we used to incorporate AI into their everyday workflows. Our AI implementation is AI to develop an internal scheduling algorithm to optimize our manufacturing accelerating throughout Moderna, where our secure large language model usage process for our investigational INT program to account for manufacturing has grown rapidly to approximately 81 percent of our employee base since its capacity and target dosing dates for all active patients in our Phase 3 trials introduction in May 2023. targeting melanoma and non-small cell lung cancer globally, taking a highly patient-centric approach. Percentage of Moderna employees who are active mChat users 100% 80% 60% 40% 20% 81% at the end of 2023 4/30 5/14 5/28 6/11 6/25 7/9 7/23 8/6 8/20 9/3 9/17 10/1 10/15 10/29 11/12 11/26 12/10 12/24 22 Digitizing everywhere moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOResponsibility We are guided by our unwavering belief that our mRNA platform can solve we design our clinical trials to reflect the global community, particularly those the world’s greatest health challenges—from diseases impacting millions to disproportionately affected by diseases. We continue to make significant strides medicines personalized to the individual level. We also operate with a deep in including medically underserved communities and diverse populations and sense of purpose and care for our patients, our employees, the environment, and our communities. We underscored our commitment to responsible corporate citizenship through the publication of our second annual ESG Report in June 2023. Prioritizing Inclusive Research have set a standard in our healthy volunteer clinical trials with at least 37 percent of trial participants from global ethnic majority groups, at least half being female, and representation across all age groups. We are proud to not just meet industry expectations but set and exceed them in every demographic category. To sustain our drive toward inclusive research, we concentrate our efforts around three pillars: increasing awareness, bringing trials into communities, and providing In 2023, we remained steadfast in our commitment to inclusive research, flexible participation options. This approach has led to increased enrollment, developing mRNA-based investigational therapies and vaccines that are retention, and participant satisfaction. At its core, our commitment to innovative equitable for all. Recognizing the importance of diversity for scientific excellence, and inclusive clinical trials helps to ensure that potential medicines of tomorrow are accessible to all. Focusing on Global Public Health In 2023, we continued to leverage our mRNA platform to address potential global public health threats and build pandemic preparedness, addressing priority pathogens that represent high disease burden, especially in low- and middle- income countries. 23 Responsibility moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOOur mRNA Access global partners1: 1. non-exhaustive Moderna's global public health portfolio, launched in 2022, continues to evolve, with advanced clinical trials against diseases such as Zika, Mpox, HIV, and Nipah. Our focus has expanded to include other respiratory threats like pandemic influenza, with our mRNA-1018 program making strides in clinical testing. Through our mRNA Access program, we have increased collaborations and opened preclinical production capabilities to more academic institutions worldwide, decentralizing the research and development of mRNA vaccines. We are also developing new manufacturing sites in Australia, Canada and the U.K. to enhance our ability to swiftly respond to potential regional and global pandemic outbreaks. In October 2023, we entered into a strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) with the goal of harnessing Moderna's mRNA platform to accelerate the development of vaccines against viral disease outbreaks that threaten global health. The work undertaken as part of this partnership could expand the infectious disease targets for mRNA vaccine technology and strengthen pandemic preparedness and public health efforts in alignment with the 100 Days Mission, a global goal to compress vaccine development timelines to 100 days. Building the Moderna Charitable Foundation The Moderna Charitable Foundation continues to make a positive impact in our communities locally and globally. Through philanthropic giving, employee gift matching, and humanitarian relief, the Moderna Foundation supported nonprofit organizations with $8.5 million in grants in 2023, with a significant focus on improving health systems in sub-Saharan Africa. Partnerships with organizations such as Science Club for Girls, CDC Foundation, Imperial College London, and Amref Health Africa further advance the Foundation’s mission to promote public health, advance scientific education, and advocate for diversity and inclusion. 24 Responsibility moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOGiving Back to the Community Protecting the Environment Our commitment to serve the communities where we live and work has always In 2023, we advanced our environmental sustainability efforts underlined by a been part of our identity, and we constantly strive to extend our impact on strategy focused on Sustainability by Design, Natural Resource Conservation, society. Each year between Giving Tuesday and International Volunteer Day, and Value Chain Decarbonization. We have launched initiatives like a climate we organize a company-wide Volunteer Week. 2023 marked our fifth annual risk and scenario analysis, increased public greenhouse gases (GHG) emissions Volunteer Week, and hundreds of Moderna team members participated in disclosures, and incorporated energy-saving technologies in new constructions. organized activities across 15 countries, up from six in 2022, to make a substantial We are also working to reduce Scope 3 emissions with suppliers and promoting impact with community partners around the world. green employee transport. As Moderna prepares for 2024, we aim to further All our team members receive eight hours of paid time off each year to dedicate toward volunteering, and our Dollars for Doers program matches additional volunteer time at a specific hourly rate. Additionally, the Moderna Charitable Foundation matches monetary donations that employees have made to qualified charitable organizations. In 2023, our collective efforts supported more than 2,000 nonprofits around the world, with 70 percent of our workforce engaging in giving and/or volunteering. integrate climate risk management, validate our GHG emissions reduction roadmap by Science Based Targets initiative (SBTi), and enhance energy, emissions, and waste programs, reinforcing our commitment to environmental stewardship as part of our healthcare mission. 25 Responsibility moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOLeadership Executive Committee In order left to right Stephen Hoge, MD | President Stéphane Bancel | Chief Executive Officer Tracey Franklin | Chief Human Resources Officer Kate Cronin | Chief Brand Officer Jerh Collins, PhD | Chief Technical Operations and Quality Officer Shannon Thyme Klinger | Chief Legal Officer and Corporate Secretary Brad Miller | Chief Information Officer Jamey Mock | Chief Financial Officer Board of Directors Noubar Afeyan, PhD | Co-founder and Chairman, Moderna; Chief Executive Officer, Flagship Pioneering Stéphane Bancel | Chief Executive Officer, Moderna Stephen Berenson | Managing Partner, Flagship Pioneering Sandra Horning, MD | Former Chief Medical Officer and Global Head of Product Development, Roche Robert Langer, ScD | Academic Co-Founder, Moderna; David H. Koch Institute Professor, MIT Elizabeth Nabel, MD | Former President, Brigham Health François Nader, MD | Former President, CEO and Executive Director, NPS Pharmaceuticals Paul Sagan | Catalyst Advisor, General Catalyst Elizabeth Tallett | Former Principal, Hunter Partners In Memoriam, Henri Termeer | Retired Chairman, President and CEO of Genzyme 26 Leadership moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOTable of Contents A letter from our CEO Advancing mRNA respiratory vaccines A new frontier in cancer care Pipeline Building our team Digitizing everywhere Responsibility Leadership Awards and recognition Financials Awards and recognition highlights BioSpace Best Places to Work Ranked no. 1 large company on 2024 list Boston Consulting Group’s 50 Most Innovative Report Ranked no. 6 on 2023 list Deloitte's Technology Fast 500 List Ranked no. 4 on the 2023 list Disability Equality Index’s Best Places to Work Scored 100/100 in 2023 Edison Gold Award Awarded in 2023 for Advanced Drug Delivery: COVID-19 Vaccine Financial Times Americas’ Fastest Growing Companies Ranked no. 5 in 2023 Fortune 500 List Ranked no. 211 on the 2023 list Fortune’s World’s Most Admired Companies Ranked no. 37 on 2024 list Great Place to Work Certified in U.S. in 2023 Human Rights Campaign Foundation’s Corporate Equality Index Scored 100/100 in 2023 Science Careers’ Top Employers Ranked for nine consecutive years; no. 9 on 2023 list Vaccine Industry Excellence Award Awarded for Best COVID Vaccine in 2023 Moderna's locations around the world Canada United States Norway Sweden Denmark Poland Germany Switzerland Netherlands United Kingdom France Spain Italy South Korea Japan Hong Kong Taiwan Singapore Australia moderna 2023 annual report 27 Awards and recognition highlights Consolidated Balance Sheets (in millions) Assets Current assets: Cash and cash equivalents Investments Accounts receivable, net Inventory Prepaid expenses and other current assets Total current assets Investments, non-current Property, plant and equipment, net Right-of-use assets, operating leases Deferred tax assets Other non-current assets Total assets Liabilities and Stockholders’ Equity Current liabilities: Accounts payable Accrued liabilities Deferred revenue Income taxes payable Other current liabilities Total current liabilities Deferred revenue, non-current Operating lease liabilities, non-current Financing lease liabilities, non-current Other non-current liabilities Total liabilities Stockholders’ equity: Additional paid-in capital Accumulated other comprehensive loss Retained earnings Total stockholders’ equity Total liabilities and stockholders’ equity $ $ $ December 31, 2023 2022 2,907 $ 5,697 892 202 627 10,325 4,677 1,945 713 81 685 3,205 6,697 1,385 949 1,195 13,431 8,318 2,018 121 982 988 18,426 $ 25,858 520 $ 1,798 568 63 66 3,015 83 643 575 256 4,572 371 (123) 13,606 13,854 487 2,101 2,038 48 249 4,923 673 92 912 135 6,735 1,173 (370) 18,320 19,123 $ 18,426 $ 25,858 The Consolidated Balance Sheets have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K. 28 Consolidated Balance Sheets moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOConsolidated Statements of Operations (in millions, except per share data) Revenue: Net product sales Other revenue1 Total revenue Operating expenses: Cost of sales Research and development Selling, general and administrative Total operating expenses (Loss) income from operations Interest income Other expense, net (Loss) income before income taxes (Benefit from) provision for income taxes Net (loss) income (Loss) earnings per share: Basic Diluted Weighted average common shares used in calculation of (loss) earnings per share: Basic Diluted 1. Includes grant revenue and collaboration revenue Years Ended December 31, 2023 2022 $ 6,671 $ 177 6,848 4,693 4,845 1,549 11,087 (4,239) 421 (124) (3,942) 772 (4,714) $ (12.33) $ (12.33) $ 382 382 $ $ $ 18,435 828 19,263 5,416 3,295 1,132 9,843 9,420 200 (45) 9,575 1,213 8,362 21.26 20.12 394 416 The Consolidated Statements of Operations have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K. 29 Consolidated Statements of Operations moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOConsolidated Statements of Cash Flows Years Ended December 31, (in millions) Operating activities Net (loss) income Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: 2023 $ (4,714) $ Stock-based compensation Depreciation and amortization Amortization/accretion of investments Loss on equity investments, net Deferred income taxes Other non-cash items Changes in assets and liabilities, net of acquisition of business: Accounts receivable, net Prepaid expenses and other assets Inventory Right-of-use assets, operating leases Accounts payable Accrued liabilities Deferred revenue Income taxes payable Operating lease liabilities Other liabilities Net cash (used in) provided by operating activities Investing activities Purchases of marketable securities Proceeds from maturities of marketable securities Proceeds from sales of marketable securities Purchases of property, plant and equipment Acquisition of business, net of cash acquired Investment in convertible notes and equity securities Net cash provided by (used in) investing activities Financing activities Proceeds from issuance of common stock through equity plans Repurchase of common stock, including excise tax Changes in financing lease liabilities Net cash used in financing activities Net decrease in cash, cash equivalents and restricted cash Cash, cash equivalents and restricted cash, beginning of year Cash, cash equivalents and restricted cash, end of period 305 621 (61) 35 828 7 493 974 747 (605) 13 (340) (2,060) 15 551 73 (3,118) (3,760) 5,575 3,206 (707) (85) (23) 4,206 46 (1,153) (270) (1,377) (289) 3,217 2,928 $ $ 2022 8,362 226 348 31 — (559) 28 1,790 (1,699) 492 21 240 612 (4,157) (828) (14) 88 4,981 (11,435) 3,151 3,548 (400) — (40) (5,176) 65 (3,329) (184) (3,448) (3,643) 6,860 3,217 The Consolidated Statements of Cash Flows have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K. 30 Consolidated Statements of Cash Flows moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEOForward-Looking Statements Disclaimer This annual report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential of Moderna’s mRNA platform; Moderna’s ability to bring medicines to market; Moderna’s expectation that its COVID-19 franchise will be profitable for 2024 and beyond; Moderna’s ability to compete in the commercial market and future market share; the potential 2024 launch of Moderna’s RSV vaccine for adults with a potentially best-in-class profile; our ability to compete in the RSV market, and the advantages of our PFS presentation; the safety and tolerability profile of Moderna’s mRNA vaccine technology; Moderna’s intent to launch up to 15 products in five years; the potential for approval of Moderna’s seasonal flu vaccine candidate and the timing for that approval; the anticipated benefits of combination vaccines, and Moderna’s intent to have a flu/COVID combination vaccine available as early as 2025; the clinical benefit observed with Moderna’s mRNA cancer therapy; Moderna's plans to expand INT to additional tumor types; Moderna’s construction of a factory to support INT; the promise of Moderna’s rare disease franchise; the expected read out in 2024 for Moderna’s mRNA therapy for cystic fibrosis and potential readout for CMV; Moderna’s ability to scale its manufacturing and business overall using AI; Moderna’s expectation to be in sales growth by 2025 and to break even in 2026; Moderna’s expectation to double the number of programs in Phase 3 by 2025; and the timing and scale for Moderna’s planned investments in research and development. The forward-looking statements in this annual report are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this annual report in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this annual report. 31 moderna 2023 annual reportTable of ContentsPipelineA new frontier in cancer careAdvancing mRNA respiratory vaccinesBuilding our teamDigitizing everywhereResponsibilityLeadershipAwards and recognitionFinancialsA letter from our CEO

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