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2020 annual report 20
387938_MRNA002_AR_2020_COVER_HR.indd 1 213/3/21 3:09 AM 1 Our mission
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
2010 founding year 5 24 therapeutic development 1,300+ areas: programs team members • Infectious Diseases • Immuno-Oncology Cambridge, MA • Rare Diseases headquarters • Cardiovascular Diseases 13 • Autoimmune Diseases having entered the clinic
46% 32,000+ women in our participants enrolled in workforce clinical trials
$5.25B All figures as of December 31, 2020, cash, cash equivalents, except for development programs, which is to date. and investments
387938_MRNA002_AR_2020_COVER_HR.indd 2 3/3/21 3:09 AM Table of contents
4 A letter from our CEO
24 Pipeline
26 COVID-19 response timeline
28 Building our team, advancing our culture
30 Corporate citizenship
32 Leadership
33 Awards and recognition
34 Financials
moderna 2020 annual report | 3 A letter from our CEO JANUARY 4, 2021 Cambridge, Mass., USA
“ Moderna is now
a commercial Stéphane Bancel Chief Executive Officer company.”
4 | moderna 2020 annual report Dear fellow shareholders,
By nearly all measures, 2020 was a historic year in our lives. It was also a historic year for Moderna.
We started the year not knowing there was going to be a new virus, which would be declared a global pandemic—the first of its kind in 100 years since the Spanish flu. We ended the year with an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and an Interim Order from Health Canada for use of our COVID-19 vaccine.
Today, our team is working as hard as they can to manufacture with high quality as many doses of the vaccine as they can. We know that each additional dose we can make will be used to protect one more life.
It took our team less than 12 months to go from the sequence made available online by the Chinese authorities, to having completed a Phase 1, a Phase 2 and a 30,000-participant, placebo-controlled Phase 3 trial, and to get the vaccine authorized for use in the U.S. and Canada, with several other regulatory rolling reviews in process around the world. That is an extraordinary accomplishment for a biotech company of 1,300 people.
Moderna is now a commercial company.
moderna 2020 annual report | 5 A letter from our CEO
“ I would like to thank and congratulate our relentless team of employees, many quite new to Moderna.”
Our mid-stage pipeline doubled in size, As we close our books for 2020, we expect growing from two to four Phase 2 candidates, that cash, cash equivalents and investments building on significant clinical data from as of December 31, 2020, were approximately 2019 that validated our mRNA platform. $5.25 billion. This means that our cash In support of our strategy to accelerate position has been approximately multiplied new development candidates in our core by four compared to 12 months ago, and modalities, we introduced five development we generated positive cash flows from candidates in the first two months alone, operations in the third quarter for the first time adding to a rich, diversified pipeline of in the company’s history. programs across infectious diseases, immuno-oncology, cardiovascular diseases, Looking back to our 2019-2020 objectives, rare diseases, and autoimmune and we set out to generate human proof-of- inflammatory diseases. concept data for multiple medicines, execute on our current development We saw a transformation in the number of pipeline, create new development patients and healthy volunteers enrolled candidates in existing modalities, and invent in our studies from just above 2,000 a year new modalities. We made tremendous ago to more than 32,000 today. Thanks to progress against these objectives over the the hard work of many in support of our past two years and, at a time of unparalleled commitment to inclusion, our trial participants global disruption, we are emerging stronger are representative of the communities at than I could have imagined. highest risk and of our diverse society. I would like to thank and congratulate our The early investment we made in our relentless team of employees, many quite manufacturing and digital capabilities new to Moderna. They did all this and much prepared us to rapidly scale our production more to advance our Mission for patients to accommodate at least 500 million doses during a very complicated pandemic. and potentially up to 1 billion doses of our COVID-19 vaccine in 2021. With this scale-up, Indeed, the SARS-CoV-2 virus changed our talented team grew significantly to everything. The positive Phase 3 analysis support manufacturing, late-stage clinical of our vaccine against COVID-19 has development, regulatory and commercial meaningful implications for all of our vaccines readiness. As we expanded our geographic in development, all the vaccines in our footprint, we built and deepened our research pipeline, and all the vaccines relationships with partners across the globe, that we are not yet working on in the labs. including the National Institutes of Health (NIH), This is where the power of mRNA as an Lonza, Catalent, ROVI, Vertex and others. information molecule comes into play.
6 | moderna 2020 annual report A letter from our CEO
moderna 2020 annual report | 7 A letter from our CEO
We always said that it made no sense for Creating an mRNA Moderna to be a one-product company. We would be a zero-product company Vaccine Candidate if we failed to get a product approved Against COVID-19 before running out of cash or we would COVID-19 will forever be a part of have many dozens of products over time, Moderna’s history. changing medicine forever and impacting the lives of millions. The entire world has been focused on the pandemic and the race against the Moderna is entering 2021 as a commercial virus, both with therapeutics and vaccines. company, with a strong cash position, clear strategic priorities, and a team The Moderna team itself was incredibly poised to continue advancing mRNA focused in 2020 on getting mRNA-1273, vaccines and therapeutics into new areas our vaccine candidate against COVID-19, of high unmet need. I believe we have a to the market safely and in record time. very exciting journey ahead and we are pleased to have you with us. In January, just two days after the Chinese authorities shared the genetic sequence of When I reflect on what the team has the novel coronavirus, NIH and Moderna’s accomplished in the last 10 years since infectious disease research team finalized Moderna’s inception, going from a the sequence for mRNA-1273. revolutionary but unproven concept to a commercial organization with more We recognized important similarities to the than 20 programs in development and MERS virus and, based on good preclinical the ability to generate cash to invest data and analysis from the previous two years to rapidly scale our platform company, of collaboration with NIH, decided to encode I wonder what Moderna will look like for the full-length Spike (S) protein.
10 years from now, in 2030. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, also disclosed its intent to run a Phase 1 study using our mRNA-1273 vaccine in response to the coronavirus threat. We quickly mobilized toward clinical manufacture.
8 | moderna 2020 annual report A letter from our CEO
“ We always said that it made no sense for Moderna to be a one-product company. We would be a zero-product company if we failed to get a product approved before running out of cash or we would have many dozens of products over time, changing medicine forever and impacting the lives of millions.”
moderna 2020 annual report | 9 A letter from our CEO
10 | moderna 2020 annual report A letter from our CEO
“ It is very important To enable larger scale manufacture of to the Moderna team mRNA-1273 globally, we announced a 10-year strategic collaboration agreement that we ensure quality with Lonza on May 1. Lonza shared our and transparency so commitment to rapidly addressing the pandemic and enabled us to accelerate that the public has trust our manufacturing capacity for mRNA-1273—and our ability to help protect in COVID-19 vaccines.” as many people as possible.
On May 18, we announced positive interim Phase 1 clinical trial data. By the end of the month, the first participant had been dosed In just 42 days from sequence identification, in the Phase 2 study and the Moderna team we released our first batch of mRNA-1273 for continued to focus on moving as fast and human use. Vials of mRNA-1273 were shipped as safely as possible to start our pivotal to NIAID to be used in the planned Phase 1 Phase 3 study. study in the U.S. July brought the publication of positive On March 11, the World Health Organization interim Phase 1 data in the New England (WHO) declared the novel coronavirus a Journal of Medicine and the initiation of pandemic and just days later, on March 16, our Phase 3 COVE study, which completed NIH announced that the first participant in enrollment of more than 30,000 total its Phase 1 study of mRNA-1273 was dosed— participants in October. It was another historic only 63 days from sequence selection to moment for our company. The subsequent first human dosing. Moderna was the first months also brought the presentation and company to launch a SARS-CoV-2 vaccine publication of Phase 1 data from older adult trial in humans. It was a historic moment. age cohorts, which gave us optimism in demonstrating mRNA-1273’s protection Exactly one month later, on April 16, in this high-risk population. we announced an award from the Biomedical Advanced Research and We are extremely grateful to the thousands Development Authority (BARDA) for up to of participants in our studies, as well as the $483 million to accelerate development staff at clinical trial sites who have been on of mRNA-1273. Time was of the essence the front lines of the fight against the virus. to provide a vaccine against this pandemic We thank them for putting their trust in us.
virus. We had already begun to prepare It is very important to the Moderna team supply for a Phase 2 trial at our own expense. that we ensure quality and transparency By investing in our manufacturing process to so that the public has trust in COVID-19 enable large-scale production for pandemic vaccines. To that end, we reported weekly response, we believed that we could enrollment progress in our COVE study, supply millions of doses per month in 2020 including enrollment numbers from diverse and, with further investments, tens of millions communities. And when we recognized a per month in 2021. shortcoming with minority representation
moderna 2020 annual report | 11 A letter from our CEO
in our Phase 3 study, we decided to slow globe: Europe, the United Kingdom, Israel, down the overall study enrollment to ensure Switzerland, Singapore and the WHO, which the participants were representative of the is important for middle- and low-income communities at highest risk for COVID-19 and countries. At the end of December, we of our diverse society. also published our Phase 3 data in the New England Journal of Medicine. In September, we signed the biopharma pledge to only submit for regulatory approval Looking ahead, we could receive a Biologics for mRNA-1273 when we had adequate License Application (BLA) approval for the safety and efficacy data. We were also the Moderna COVID-19 Vaccine in 2021. With first company to file the full, un-redacted a manufacturing base plan of 500 million to version of our Phase 3 protocol online to potentially 1 billion doses per year, we should ensure clinicians around the world could see, have a multi-billion-dollar revenue line in 2021. in full transparency, the design of our COVE If we execute and achieve this, it will allow study. We were pleased to set the standard us to invest in R&D, scale our development and have others in the industry follow pipeline, and maximize what we can do our lead. for patients, without the need for additional near-term capital raises. On November 30, the primary analysis of our Phase 3 COVE study demonstrated a vaccine efficacy of 94.1 percent and, Advancing mRNA importantly, mRNA-1273’s ability to prevent Medicines severe COVID-19 disease. This positive Moderna is not solely a COVID-19 vaccine data analysis confirmed the high efficacy company. It is a very large technology observed in the first Phase 3 interim analysis of platform company which has one of the best mRNA-1273, and the vaccine was generally COVID-19 vaccines. well-tolerated, with no serious safety concerns identified by an independent Data Safety While we have been advancing our Monitoring Board. It also confirmed our ability Moderna COVID-19 Vaccine toward a BLA to potentially change the course of this in just over a year, we have also continued to pandemic and help prevent severe disease, honor our existing commitments to patients hospitalizations and death. and communities by progressing the other 20 development candidates in our pipeline. In December, we received an Emergency Use Authorization from the FDA and an I am especially proud of the Moderna team Interim Order from Health Canada authorizing for their deep sense of responsibility and bold the vaccine in the U.S. and Canada. determination to execute on both of these We continue forging ahead with the rolling commitments. Under normal circumstances, reviews that have already been initiated delivering on either one would be an with several regulatory agencies across the unprecedented achievement in our industry.
12 | moderna 2020 annual report A letter from our CEO
The image above depicts Moderna’s pipeline as a cell map and reflects three new infectious disease vaccine candidates, RSV in young children, EBV, SARS-CoV 2, and two new autoimmune development candidates, PD-L1 and IL-2, added across our core modalities in 2020.
As you may know, our pipeline is organized program, we decided to nominate two of into six modalities based on similar mRNA our modalities as core modalities: technologies, delivery technologies, and 1. Prophylactic vaccines; and manufacturing processes. Our approach is 2. Systemic secreted & cell to leverage early programs within a modality surface therapeutics. to generate clinical data and insights that We decided to double down in these reduce the technology risk of subsequent modalities because we believe that programs and accelerate the expansion of they have been de-risked from a the pipeline in that modality. technology standpoint. In early 2020, due to the positive clinical I will highlight some of our team’s data generated by our infectious disease accomplishments across our core and vaccine portfolio and chikungunya antibody exploratory modalities to give you a better idea of our progress throughout 2020.
moderna 2020 annual report | 13 A letter from our CEO
Building Core Modalities At our annual R&D Day in September, we announced the positive Phase 2 readout Prophylactic Vaccines for mRNA-1647, our Cytomegalovirus (CMV) Vaccines continue to be the best hope to vaccine candidate. We are on track to control infectious diseases. We are focused start the pivotal Phase 3 study for CMV in on developing more innovative commercial 2021. There is no approved vaccine against vaccines—including complex vaccines with CMV and it is the number one cause of birth multiple antigens for common diseases, defects in the U.S. and the developed world. as well as public health vaccines—by Moderna owns global rights to mRNA-1647 collaborating with foundations and and we believe our CMV vaccine has government agencies. the potential for annual peak sales between 2 and 5 billion dollars.
14 | moderna 2020 annual report A letter from our CEO
“ We also announced our intention to enter the seasonal flu vaccine business.”
We also announced our intention to Our 2-dose regimen of chikungunya antibody enter the seasonal flu vaccine business. demonstrated our platform’s ability to safely The WHO reports there are 3 million to 5 million repeat dosing of a therapeutic in humans, severe cases of flu each year around the another milestone in the development of world, leading to between 290,000 and our mRNA platform. 650,000 deaths annually. We believe we We introduced two additional development have a chance to change that and develop candidates in our new autoimmune a more effective flu vaccine in light of the therapeutic area in 2020. We are planning elderly data we have generated across our to conduct Phase 1 studies for our IL-2 platform with COVID-19 and RSV. candidate, mRNA-6231, and our PD-L1 RSV, or respiratory syncytial virus, is also a candidate, mRNA-6981, as an initial step common cause of acute respiratory disease to addressing a range of autoimmune in children and is associated with a substantial indications. Both potential medicines are burden of hospitalizations and outpatient visits wholly owned by Moderna and share the throughout the first five years of life. Despite same delivery technology as mRNA-1944, the need, there is currently no approved reducing technology risk. vaccine for RSV. In October, we started Technology risk encompasses the Phase 1 dosing for our vaccine against RSV, challenges of developing the product mRNA-1345, which marked our eleventh features of mRNA medicines, including infectious disease vaccine to enter human delivery, controlling interactions with the trials and another exciting milestone for our immune system, pharmaceutical properties vaccines portfolio as we look to advance and manufacturing. We stage program mRNA-1345 in the pediatric population. development within a modality like this one, Systemic Secreted & Cell Surface leveraging the first program to generate Therapeutics insights that reduce the risk, and accelerate the development of subsequent programs In these therapeutics, mRNA is delivered within the modality. systemically to create proteins that are either secreted or expressed on the cell surface. The goal is to provide secreted proteins, Investigating Exploratory such as antibodies or enzyme replacement Modalities therapies, across a wide range of diseases, Cancer Vaccines & Intratumoral including heart failure, infectious diseases, Immuno-Oncology and rare genetic diseases. Moderna’s personalized cancer vaccine Our antibody against chikungunya virus, (PCV) programs focus on stimulating a mRNA-1944, for which we have enrolled patient’s immune system with antigens additional cohorts in the Phase 1 study, derived from tumor-specific mutations read out important new data as well. to enable the immune system to elicit
moderna 2020 annual report | 15 A letter from our CEO
a more effective anti-tumor response. coronary artery bypass grafting surgery with Our intratumoral immuno-oncology programs moderately impaired systolic function, led by aim to drive anti-cancer T cell responses by AstraZeneca, is ongoing. The Phase 1 data injecting mRNA therapies directly into tumors. showed the potential of mRNA encoding for vascular endothelial growth factor A We were encouraged by the interim data (VEGF-A) as a regenerative therapeutic. from our PCV program, which involves Based on these early data, this approach designing and manufacturing a unique may provide benefit to patients where proper vaccine for each patient based on blood flow is compromised in areas such as their specific tumor. The Phase 1 study heart disease and diabetes, as well as for demonstrated the ability of our PCV, other vascular complications. mRNA-4157, to elicit clinical activity when given in combination with Merck’s Keytruda®1. Systemic Intracellular Therapeutics We were also encouraged to see the In rare diseases, our programs aim to deliver preliminary data in HPV(-) head and neck mRNA into cells within target organs as a cancer that we presented at The Society therapeutic approach for diseases caused by for Immunotherapy of Cancer’s Annual a missing or defective protein. Meeting (SITC 2020). We are expanding the cohort to see if that early signal is confirmed. Study startup activities under an amended Additionally, the mutant KRAS vaccine, protocol for our Phase 1 Propionic Acidemia mRNA-5671 or V941, Phase 1 study to (PA) candidate, mRNA-3927, are underway evaluate safety and tolerability, led by Merck, following a COVID-19-related pause. is ongoing. Additionally, we received rare pediatric designation for our next-generation Our intratumoral OX40L program, Methylmalonic Acidemia (MMA) candidate, mRNA-2416, is now dosing patients in the mRNA-3705. Phase 2 expansion study. The Phase 1 trial evaluating OX40L/IL-23/IL-36γ (Triplet), We are implementing changes that we mRNA-2752, in patients with advanced believe will help to accelerate the clinical solid tumor malignancies and lymphoma is development of MMA, including the ongoing. Our collaborators at AstraZeneca introduction of a new drug product with better are progressing an mRNA encoding for IL-12 pharmacology as well as a protocol revision with durvalumab also in Phase 1. to enhance operational performance and patient outreach. I am particularly proud of our Localized Regenerative Therapeutics team’s efforts to develop our next-generation The Phase 2a study of AZD8601 VEGF-A, MMA candidate, for which we plan to file an which is being developed for patients investigational new drug (IND) application and with ischemic heart disease undergoing a clinical trial application (CTA).
1 Keytruda® is a registered trademark of Merck & Co., Inc.
16 | moderna 2020 annual report A letter from our CEO
moderna 2020 annual report | 17 A letter from our CEO
Building Our Capabilities AIDS Vaccine Initiative (IAVI), NIAID and the Bill & Melinda Gates Foundation toward the Moderna entered 2020 with a strong cash development of an HIV vaccine using our position of approximately $1.3 billion. mRNA platform. We have built a diverse clinical portfolio of vaccines and therapeutics across six We entered into new collaborations with modalities. Our portfolio approach has partners across the globe. Our second helped us reduce risk as our pipeline has collaboration with Vertex aims to use our grown to 21 development candidates. mRNA technology and Vertex’s expertise and investment in gene editing technology, to try Over the 10 years since our inception, to bring together an innovative treatment we have sustained large investments in for cystic fibrosis patients. A new partnership platform science, including both mRNA and with Italian pharmaceutical company Chiesi Lipid Nanoparticle (LNP) formulation. And is aimed at the discovery and development we have established a large intellectual of mRNA therapeutics for the treatment of property (IP) portfolio that will protect and pulmonary arterial hypertension, a rare disease enhance our ability to continue to invest in with an incidence of 2-5 per million adults. innovative medicines. New manufacturing and fill-finish partners like We have also made large investments in Lonza, Catalent and ROVI helped us scale up process development. Further, we own our manufacturing capabilities on the global a fully integrated plant that has allowed stage. As I mentioned earlier, this worldwide us to go from raw materials to filled vials strategic collaboration will enable larger for all our clinical needs at scale and with scale manufacture of the Moderna COVID-19 unprecedented speed. Our integrated plant Vaccine and additional Moderna products in also has the capacity to flex into full-scale the future. commercial production and has been an important facility in manufacturing our U.S. While our IP portfolio and expertise uniquely supply of the Moderna COVID-19 Vaccine. positioned us to respond to the COVID-19 pandemic quickly, we felt a special During 2020, we built on this strong foundation obligation under the circumstances to to help secure our place as the most use our resources to pledge, while the advanced mRNA platform in the industry. pandemic continues, that we will not We continued to make substantial enforce our COVID-19-related patents investments in our basic science to advance against those making vaccines intended to our platform’s capabilities and our further combat the pandemic. Further, to eliminate understanding of how to use mRNA as a any perceived IP barriers to vaccine medicine. At our third annual Science Day in development during the pandemic period, June, we highlighted novel approaches to upon request we are also willing to license our LNP technology and provided an update our IP for COVID-19 vaccines to others for the on our collaboration with the International post-pandemic period.
18 | moderna 2020 annual report A letter from our CEO
“ During 2020, we built on this strong foundation to help secure our place as the most advanced mRNA platform in the industry.”
moderna 2020 annual report | 19 A letter from our CEO
We grew our workforce significantly in the U.S. virtual onboarding program, and seminars and across new geographies, welcoming on wellness and inclusion. I am proud colleagues in Canada, Spain and Switzerland, that Moderna was named a Science top as well as the UK, and announcing our first employer for the sixth year in a row and commercial organization outside North recognized for our commitment to continuous America in Switzerland. As we welcomed new innovation, corporate social responsibility, employees at all levels, we remained focused and fostering a culture of respect for on the health and safety of our people by the individual. implementing on-site COVID-19 testing, track I am also pleased to share that we and trace technology, thermal temperature strengthened our commitment to diversity screening, and a digital health screening app. and inclusion in our communities, specifically Additionally, Moderna adopted more through our work with our clinical research flexible work structures while fostering sites to reach communities that are collaboration and continuing to prioritize our representative of our diverse society. In a employees’ well-being. We also introduced year that has put a spotlight on inequality, a new employee assistance program, increasing equity for all is more important additional child and backup care, a new than ever.
20 | moderna 2020 annual report A letter from our CEO
Emerging Stronger doses of the Moderna COVID-19 Vaccine, bringing the total to 200 million doses. That As I look to the end of 2021, I believe that is unique market access. We are grateful for if we successfully launch the Moderna the trust the U.S. government and OWS has COVID-19 Vaccine as a commercial product, placed in our vaccine, our development we will emerge from the pandemic crisis as process and our technology. the strongest mRNA company in the world. We intend to re-invest the potential returns The U.S. government has taken a very from the sales of the vaccine into our pipeline thoughtful approach with Operation Warp development and hope to bring many more Speed (OWS). They decided to support three mRNA medicines to the market. I believe vaccine technologies, including mRNA, and the long-term strategic implications for this to back only two companies per technology are enormous. We expect to have a strong type. Moderna was one of the two mRNA cash balance at the end of 2021, building companies from which the U.S. government upon the expected $5.25 billion of cash, cash ordered an initial 100 million doses. equivalents and investments on hand as of In December, the U.S. government exercised year-end 2020, plus the cash flow that we its option to purchase an additional 100 million expect to generate in fiscal year 2021.
moderna 2020 annual report | 21 A letter from our CEO
“ I believe 2021 will be the most important inflection point in Moderna’s history.”
Moderna has been built to successfully scale Looking Ahead because mRNA is an information molecule. We have invested relentlessly in science I believe 2021 will be the most important at a pace that no other mRNA company inflection point in Moderna’s history.
could match—in robotics, in digital and Our strategic priorities for 2021 are clear. AI, in process development and in a large First priority: maximize the impact of Moderna manufacturing plant in Massachusetts. COVID-19 Vaccine access and the value creation of this product between now and What limited our ability to do more and the end of 2021. This will allow us to pursue scale faster in the last five years was cash. our second priority: accelerate vaccine We always kept several years of runway on development to advance our pipeline and our balance sheet to manage financing risk. bring new vaccines to market. To the extent we can eliminate this financing risk because we are commercial and are generating cash from our first year of 2021 PRIORITIES commercial operations, I believe that this will change—in a very material way—how we 1. Maximize the impact of Moderna operate during fiscal 2021 and beyond, and COVID-19 Vaccine access and the speed at which we scale moving forward. the value creation of this product between now and the end of 2021. Additionally, the approval of the Moderna 2. Accelerate vaccine development COVID-19 Vaccine for authorized use, and to advance our pipeline and bring ultimately for commercialization, would new vaccines to market. provide a unique de-risking of the entire Moderna vaccine platform. We use the same 3. Generate human proof-of-concept chemistry to make each mRNA vaccine; the data in autoimmune diseases, same manufacturing process to make the cardiovascular diseases, oncology and rare diseases. mRNA; the same chemistry for our lipid; the same manufacturing process to formulate 4. Continue to expand the use of the mRNA in our lipid. mRNA technology to maximize the potential impact we can Think about what our team can accomplish have on patients. over the next 10 years starting from a growing cash balance in excess of $5 billion, the knowledge that our mRNA vaccine can have In turn, this will make way for our third priority: high efficacy and be approved by regulators, generate human proof-of-concept data and the experience of having developed our in autoimmune diseases, cardiovascular technology into an approved product. diseases, oncology and rare diseases.
22 | moderna 2020 annual report A letter from our CEO
And this will allow for our fourth priority: My deepest gratitude goes to the incredible continue to expand the use of mRNA team at Moderna. Their commitment to technology to maximize the potential impact our Mission was exemplary in 2020. People we can have on patients. We continue to sacrificed vacations, weekends, evenings believe that Moderna will have, over time, and much more—and we all did it because it many modalities with commercial products. was our duty, our Mission.
By executing on these priorities, we will I would also like to thank the members of continue to advance our Mission for patients our board of directors, who have worked and deliver value to our shareholders, our relentlessly to guide us, to support us and to employees, our communities and our partners. help us navigate the many complex decisions we made in real time with incomplete I am extremely grateful for what the team has information over the years, but especially done to get us to this point. in 2020 during the development of our Thank you to our long-term investors who COVID-19 vaccine. have provided capital over the years, so that I am saddened by the tragic loss of life the we could build the best version of Moderna world has experienced due to this pandemic, possible. The scale of investment in science by the increase in mental health challenges and the manufacturing process development due to joblessness and lockdowns, and by that we have made in the last decade is the lost educational opportunities for many unique, based on the trust our shareholders children in 2020. It is our responsibility as an have put in us. It took several billion dollars industry, as a company and as global citizens of capital to get to this point. We could not to help ensure a pandemic of this magnitude have built this version of Moderna on a billion never happens again. More on that in 2021. dollars or less. As a company, we are closer than ever before I also want to thank the thousands of to launching several first-in-class medicines for participants in our clinical studies, as well patients where there are no treatments today. as the staff at clinical trial sites who have The next period of Moderna’s history is just been on the frontlines of the fight against beginning. I cannot wait to see what Moderna COVID-19. I would again like to thank our looks like 10 years from now. partners at NIH, NIAID, BARDA and OWS who have helped us advance the clinical Thank you for your trust and support over development of the Moderna COVID-19 the years. Vaccine. We are very appreciative of our suppliers and partners for their work on the Warmest regards, research, development and manufacturing that helped position Moderna to respond to the COVID-19 pandemic quickly. Stéphane Bancel Chief Executive Officer
moderna 2020 annual report | 23 Pipeline*
Below is Moderna’s pipeline at year-end 2020. We finished the year with 21 development programs across multiple therapeutic areas and six modalities. In early 2021, we announced three new development programs, bringing the total to 24, and including vaccine candidates against seasonal flu, HIV and Nipah virus, all within our prophylactic vaccines modality.
Preclinical Modality ID # Program Indication Phase 1 development Core modalities
mRNA-1273 COVID-19 vaccine
mRNA-1647 Cytomegalovirus (CMV) vaccine
Phase 1 Phase 1b mRNA-1653 Human metapneumovirus and parainfluenza virus 3 (hMPV/PIV3) vaccine (Healthy volunteers) (Seropositives) Prophylactic mRNA-1893 Zika vaccine vaccines Pediatric respiratory syncytial virus (RSV) vaccine mRNA-1345 Future respiratory combo
mRNA-1189 Epstein-Barr virus (EBV) vaccine
mRNA-1851 Influenza H7N9 vaccine
mRNA-1944 Antibody against Chikungunya virus
Systemic AZD7970 Relaxin Heart failure secreted & cell surface therapeutics mRNA-6981 PD-L1 Autoimmune hepatitis
mRNA-6231 IL-2 Autoimmune disorders
Exploratory modalities
mRNA-4157 Personalized cancer vaccine (PCV) Cancer vaccines mRNA-5671 KRAS vaccine
OX40L Solid tumors/lymphoma mRNA-2416 Solid tumors/lymphoma Advanced ovarian carcinoma (Ph 2 cohort) Intratumoral- OX40L/IL-23/IL-36γ (Triplet) immuno- mRNA-2752 Solid tumors/lymphoma oncology MEDI1191 IL-12 Solid tumors
Localized regenerative AZD8601 VEGF-A Myocardial ischemia therapeutics
mRNA-3927 PCCA/PCCB Propionic Acidemia (PA)
Systemic mRNA-3705 MUT Methylmalonic Acidemia (MMA) intracellular therapeutics mRNA-3283 PAH Phenylketonuria (PKU)
mRNA-3745 G6Pase Glycogen Storage Disease Type 1a (GSD1a)
*As of December 31, 2020 Abbreviations: AZ, AstraZeneca; CMV, cytomegalovirus; hMPV, human metapneumovirus; IL-2, interleukin 2; IL-12, interleukin 12; IL-23, interleukin 23; IL-36γ, interleukin 36 gamma; MUT, methylmalonyl-CoA mutase; PAH, phenylalanine hydroxylase; PCCA/PCCB, Propionyl-CoA Carboxylase subunit A/B;
24 | moderna 2020 annual report Pipeline
Phase 2 Phase 3 Commercial Moderna rights
Worldwide BARDA funded
Worldwide
Worldwide
Worldwide BARDA funded
Worldwide
Worldwide
Worldwide; advancing subject to outside funding
Worldwide DARPA funded
Worldwide
Worldwide
Worldwide
50-50 global profit sharing with Merck
50-50 global profit sharing with Merck
Ovarian Worldwide
Worldwide
50-50 U.S. profit sharing; AZ to pay royalties on ex-U.S. sales
AZ to pay milestones and royalties
Worldwide
Worldwide
Worldwide
Worldwide
PCV, personalized cancer vaccine; PIV3, human parainfluenza 3; RSV, respiratory syncytial virus; VEGF-A, vascular endothelial growth factor A
moderna 2020 annual report | 25 COVID-19 response timeline
We are proud to be among the many groups working to respond to the continuing global health emergency. This timeline summarizes key milestones in our work to advance our vaccine against COVID-19.
COVID-19 vaccine May 1, 2020 January 11, 2020 Collaboration announced (mRNA-1273) Chinese authorities with Lonza Ltd. to shared the genetic March 16, 2020 manufacture mRNA-1273 sequence of the novel First participant dosed in (goal of up to one billion timeline coronavirus NIH-led Phase 1 study doses per year) (through December 2020)
April 16, 2020 May 18, 2020 JanuarySequence 13, 2020 for Award from U.S. Announcement of positivePhase interim 1 data government agency mRNA-1273 against the
novel coronavirus finalized BARDA for up to $483 million to accelerate development
The Moderna COVID-19 Vaccine has been authorized for emergency use by the FDA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older and has been authorized by Health Canada for the immunization of Canadians 18 years of age and older under an Interim Order. The Moderna COVID-19 Vaccine (referred to as the COVID-19 Vaccine Moderna outside the U.S. and Canada) is also subject to emergency, conditional or other authorizations in the European Union, Switzerland, the United Kingdom, Israel, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.
26 | moderna 2020 annual report COVID-19 response timeline
December 23, 2020 July 26, 2020 November 30, 2020 May 29, 2020 August 26, 2020 Health Canada authorized Expansion of BARDA award to October 22, 2020 Phase 3 study primary analysis Moderna COVID-19 First participant dosed approx. $955 million in supportPresentation of of older Phase 3 COVE study indicated vaccine efficacy of 94.1%Vaccine under an in Phase 2 study larger Phase 3 program adults Phase 1 data completed enrollment and filing with U.S. FDA for EUA Interim Order
July 14, 2020 July 27, 2020
September 29, 2020 NovemberPhase 16,3 study 2020 first December 18, 2020 Publication of older U.S. FDA authorizedVaccine for Publication of positive interim Phase 1 data adults Phase 1 data interimstatistical analysis criteria met Moderna COVID-19 emergency use Phase30,000 3 COVE participants study of approx. initiated
A Vaccine for Everyone Moderna worked to develop a vaccine for everyone, This included more than 6,000 participants who identify including communities that have historically as Hispanic or LatinX, and more than 3,000 participants been under-represented in clinical research and who identify as Black or African American. are disproportionately impacted by COVID-19. The COVE study also included more than In early September, we announced a slowing of clinical 7,000 Americans over the age of 65, as well as more trial enrollment to ensure the representation of those communities of color in our Phase 3 COVE study. than 5,000 Americans who are under the age of 65 When trial enrollment was completed in October 2020, but have high-risk chronic diseases that put them at we were pleased to share that the study included increased risk of severe COVID-19, such as diabetes, more than 11,000 participants from communities of severe obesity and cardiac disease. These medically color, representing 37 percent of the study population high-risk groups represented 42 percent of the total and similar to the diversity of the U.S. at large. participants in the study.
moderna 2020 annual report | 27 Building our team, advancing our culture
Welcoming new leaders
Elizabeth Tallett 48 markets. Prior to Amgen, Corinne Melanie Ivarsson, held a number of senior international Board of Directors PhD roles at Roche, including President of Elizabeth joined Chief Development Moderna’s board in Roche France, a major affiliate of the Roche Group, and Global Product Officer July 2020. She spent Melanie had more more than 35 years in Strategy Head of Neuroscience & Rare Diseases. Earlier in her career, Corinne than 20 years of strategic leadership and operational experience in the pharmaceutical roles in worldwide biopharmaceutical spent 11 years in various leadership roles at Sanofi and Pfizer in the U.S. industry when she joined Moderna in and consumer products industries. this new role in January 2020, reporting Elizabeth served as principal of Hunter to our Chief Medical Officer. She Partners, President and CEO of Transcell David Meline came from Takeda, where she was Technologies Inc., President of Centocor Chief Financial Vice President, Head of Global Clinical Pharmaceuticals, and member of the Officer Operations and oversaw 130 clinical Parke-Davis Executive Committee. She David joined Moderna operations experts, with responsibility currently serves as the Chair of Anthem, in June 2020 after for the delivery of all clinical trials across Inc. and as a director of Principal serving as Chief oncology, neuroscience, rare disease, Financial Group, Meredith Corp. and Financial Officer and EVP at Amgen gastroenterology and plasma-derived Qiagen, Inc. from 2014 through 2019, where he was therapies. Melanie has also served as responsible for all finance, information Senior Director, Head of Clinical Strategy Ray Jordan systems and global business services and Operations at Pfizer, where she led Chief Corporate activities across 100 countries. Prior to strategic and business operations for the Affairs Officer Amgen, David spent six years at 3M clinical organization. Prior to joining Company, where he most recently served as CFO and Senior Vice Moderna in June 2020, Jacqueline Miller, Ray served as Senior President and was responsible for all 3M financial activities across 70 countries MD Vice President, Corporate Affairs at SVP, Infectious Amgen, where he was responsible for all of operation. David also held numerous Disease internal and external communications, leadership positions at General Motors, Development issues management and philanthropy. including Vice President and CFO for Jacqueline joined Ray also spent nine years at Johnson GM North America. Moderna in May 2020 after working in & Johnson, where he led corporate the field of vaccine development for 20 communications and public affairs for Sandra Horning, years. She came from GlaxoSmithKline more than 250 operating companies MD where she held a variety of leadership in 60 countries. Previously, Ray held Board of Directors roles since 2005. Most recently, a range of positions over the course Sandra joined Jacqueline was the Vice President and of 17 years at Pfizer, most recently as Moderna’s board Head, Clinical R&D and Epidemiology Vice President, Communications and in April 2020. She is where she built and led the clinical Information. an academic and industry veteran, and epidemiology research teams at most recently serving as Chief Medical the first GSK vaccines research and Corinne Le Goff, Officer and Head of Global Product development center in the U.S. PharmD Development at Genentech/Roche. Prior to joining Genentech, she spent Chief Commercial more than 20 years as a Professor Officer of Medicine, Oncology and Blood Corinne joined and Bone Marrow Transplantation Moderna in January at Stanford University School of 2021 as our first Chief Commercial Medicine, where she remains an Officer, after nearly six years at Amgen, Emerita Professor. Sandra is currently where she most recently served as a co-founder and advisor for EQRx SVP and President of the U.S. Business and serves on the Board of Directors Organization. Previously, she served as of Gilead Sciences, Inc. and Olema SVP of the Europe Region and oversaw Pharmaceuticals, Inc.
28 | moderna 2020 annual report Building our team, advancing our culture
Supporting our team members
Since Moderna’s inception, we have been committed To welcome hundreds of new colleagues this year, to building diverse and inclusive teams and fostering and to help set them up for success, we instituted a an environment where everyone belongs and can fully virtual onboarding experience using collaboration do their best work. In response to the COVID-19 technology, and hosted seminars on wellness and pandemic in 2020, we adopted more flexible work inclusion for everyone at Moderna. We remain structures while fostering collaboration and continuing focused on the health and safety of our employees to prioritize employees’ well-being. We also introduced with on-site COVID-19 testing, track and trace a new employee assistance program, access to a technology, digital health screening and an optional mindfulness app, take-home meals for those working vaccine program. on-site, and additional child and backup care.
WORKFORCE GROWTH 8 COMMERICAL SUBSIDIARIES ACROSS NORTH AMERICA AND EUROPE
1,300 Canada United End of 2020 Kingdom Germany Switzerland United States France Spain 820 Italy End of 2019
moderna 2020 annual report | 29 Corporate citizenship
Spotlighting our focus on Medicines for Patients
At Moderna, our commitment to corporate citizenship is built on a foundation of integrity, quality and respect. These values provide solid footing for the creation and support of long-term programs that focus on patients, employees, the environment, our local communities and ethics.
Our priority as a newly commercialized company is Just as we worked to ensure representation of to continue to accelerate the development of safe communities of color and vulnerable populations and effective mRNA medicines for patients. To do in our Phase 3 COVE study, we have an ongoing so, we undertake sustained, long-term investment commitment to increasing diversity in our clinical in technology creation, which is reflected in our trials. Additionally, we are continuing to explore R&D expenses of $1.37 billion for the year ended ways to speed the production of our COVID-19 December 31, 2020. vaccine, leading us to increase our base-case global production estimate from 500 million to 700 million Additionally, our ongoing investment in our preclinical between early January and the end of February 2021. and clinical research engine will help us continue to advance potentially life-changing therapeutics and It is our responsibility as an industry, as a company vaccines where there are few or, in many cases, no and as global citizens to help ensure a pandemic of treatment options for patients. These areas include this magnitude never happens again. Moderna has infectious disease vaccines, public health vaccines, already launched a clinical program to boost immunity and rare disease indications. to emerging variants of SARS-CoV-2, as we advance other infectious disease vaccines and therapies for the In 2020, our mRNA platform played an important prevention and treatment of infectious disease threats role in supporting a rapid response to the global that can place millions of people at risk around the world. pandemic, and the Moderna COVID-19 Vaccine is now authorized for use in more than 30 countries. We We are also partnering with foundations, government are actively participating in discussions with multilateral organizations and universities to develop mRNA organizations, such as COVAX, to help expand access solutions to critical global public health challenges. and protect populations around the world. This includes a new partnership with the International
30 | moderna 2020 annual report Corporate citizenship
AIDS Vaccine Initiative and the Bill & Melinda Gates 4. Moderna aims to provide effective and affordable Foundation to accelerate human validation of novel vaccines and therapeutics to all populations. HIV vaccination strategies, as well as a second mRNA- 5. Moderna will price its products through differential based approach to HIV vaccination in collaboration pricing frameworks. with the National Institutes of Health. 6. Moderna is committed to participating Our pipeline also includes potential therapeutics to in key public-private partnerships such as Gavi, address rare diseases, such as propionic acidemia, the Vaccine Alliance. methylmalonic acidemia, phenylketonuria, glycogen 7. Gavi-eligible countries will get Moderna’s lowest storage disease type 1a and autoimmune diseases, prices, and Moderna commits to an annual that cannot be addressed by traditional approaches. independent third-party audit on this commitment. Additionally, partnerships with Vertex Pharmaceuticals and the Chiesi Group aim to address cystic fibrosis and Looking ahead, we are actively considering the pulmonary arterial hypertension, respectively. impact we can have with our COVID-19 vaccine, as well as our other mRNA medicines in development, As we advance our pipeline, our commitment to to help fight global pandemics and support public working on multiple levels to optimize the impact of health planning. mRNA vaccines and therapeutics is reflected in our Access Principles: We look forward to the continued use of our mRNA 1. Moderna is committed to developing a broad science, innovative platform, partnerships and portfolio of vaccines and therapeutic solutions to resources to contribute to environmental sustainability address epidemiological challenges worldwide. and the health and welfare of our patients, employees, and the communities where we work and live. 2. Moderna will invest in R&D in areas of unmet need. 3. Moderna will work to include communities that have historically been under-represented in clinical research in our development programs, as well as those that are disproportionately impacted by the respective diseases.
moderna 2020 annual report | 31 2020 Leadership
Executive committee
In order left to right: Stéphane Bancel | Chief Executive Officer Lori Henderson, Esq | General Counsel and Corporate Secretary Stephen Hoge, MD | President Ray Jordan | Chief Corporate Affairs Officer Juan Andres | Chief Technical Operations and Quality Officer Corinne Le Goff, PharmD | Chief Commercial Officer*
Marcello Damiani | Chief Digital and Operational David Meline | Chief Financial Officer Excellence Officer Tal Zaks, MD, PhD | Chief Medical Officer Tracey Franklin | Chief Human Resources Officer
* joined January 2021
Board of directors
Noubar Afeyan, PhD | Co-founder and Chairman, François Nader, MD | Former President, CEO and Moderna; Chief Executive Officer, Flagship Pioneering Executive Director, NPS Pharmaceuticals
Stéphane Bancel | Chief Executive Officer, Moderna Paul Sagan | Senior Advisor and Executive-in-Residence, General Catalyst Stephen Berenson | Managing Partner, Flagship Pioneering Elizabeth Tallett | Former Principal, Hunter Partners Sandra Horning, MD | Co-founder and Advisor, EQRx
Robert Langer, ScD | Academic Co-Founder, Moderna; Henri Termeer | Retired Chairman, President and CEO David H. Koch Institute Professor, MIT of Genzyme; In Memoriam
32 | moderna 2020 annual report Awards and recognition
Science Careers’ Fast Company’s Research!America Clinical Top Employers World’s Most Outstanding Research Six consecutive Innovative Achievement Forum years on list Companies in Public Health Extraordinary Debuted on Award Impact Award 2021 list
In 2020, we were thrilled to celebrate the publication of our 66th scientific paper, underscoring our commitment to scientific excellence and transparency.
Forward-Looking Statements
This annual report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna’s development of a vaccine against the novel coronavirus; the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2; the safety profile for the Moderna COVID-19 Vaccine; the scale and timing of manufacturing of the Moderna COVID-19 Vaccine; efforts to increase the number of doses of the Moderna COVID-19 Vaccine that the Company is capable of producing; the process for obtaining regulatory review and approval for the use and distribution of the Moderna COVID-19 Vaccine in the U.S. and other jurisdictions; potential licensing of the technology related to the Moderna COVID-19 Vaccine; anticipated clinical next steps and catalysts for each of Moderna’s development programs; Moderna’s financial operations; expectations regarding future cash balances, cash flow generation and capital efficiency; future growth of Moderna’s pipeline and development programs, investments therein, as well as the company’s intellectual property portfolio and future prospects; initiatives to promote the health and safety of the Company’s employees; efforts to recruit diverse populations into clinical trials; efforts to develop vaccines in response to variants of the SARS-CoV-2 virus; partnerships with third party organizations and companies; and implementation of the Company’s Access Principles. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this statement 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, 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, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the U.S. Food and Drug Administration (FDA) or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s accompanying Annual Report on Form 10-K for the year ended December 31, 2020, 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 hereof.
moderna 2020 annual report | 33 Consolidated Balance Sheets*
December 31,
(In thousands, except share and per share data) 2020 2019 Assets Current assets: Cash and cash equivalents $ 2,623,850 $ 235,876 Investments 1,983,758 867,124 Accounts receivable 1,390,560 5,369 Inventory 46,527 — Prepaid expenses and other current assets 252,152 19,403 Restricted cash 1,032 1,032 Total current assets 6,297,879 1,128,804 Investments, non-current 638,848 159,987 Property and equipment, net 296,889 201,495 Right-of-use assets, operating leases 90,201 86,414 Restricted cash, non-current 11,053 10,791 Other non-current assets 1,880 1,931 Total assets $ 7,336,750 $ 1,589,422 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 18,359 $ 7,090 Accrued liabilities 469,591 67,652 Deferred revenue 3,867,193 63,310 Other current liabilities 33,665 5,063 Total current liabilities 4,388,808 143,115 Deferred revenue, non-current 177,419 138,995 Operating lease liabilities, non-current 97,421 93,675 Financing lease liabilities, non-current 109,874 38,689 Other non-current liabilities 1,853 138 Total liabilities 4,775,375 414,612 Commitments and contingencies (Note 12) Stockholders’ equity: Preferred stock, $0.0001 par value; 162,000,000 shares authorized at December 31, 2020 and 2019; 0 shares issued or outstanding at December 31, 2020 and 2019 — — Common stock, par value $0.0001; 1,600,000,000 shares authorized as of December 31, 2020 and 2019; 398,787,678 and 336,536,985 shares issued and outstanding as of December 31, 2020 and 2019, respectively 40 34 Additional paid-in capital 4,801,849 2,669,426 Accumulated other comprehensive gain 3,004 1,804 Accumulated deficit (2,243,518) (1,496,454) Total stockholders’ equity 2,561,375 1,174,810 Total liabilities and stockholders’ equity $ 7,336,750 $ 1,589,422
*The consolidated Balance Sheets have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K.
34 | moderna 2020 annual report Consolidated Statements of Operations*
Years Ended December 31,
(In thousands, except share and per share data) 2020 2019 2018 Revenue: Grant revenue $ 528,905 $ 12,173 $ 12,556 Product sales 199,872 — — Collaboration revenue 74,618 48,036 122,512 Total revenue 803,395 60,209 135,068 Operating expenses: Cost of sales 7,933 — — Research and development 1,370,339 496,309 454,082 Selling, general and administrative 188,267 109,620 94,252 Total operating expenses 1,566,539 605,929 548,334 Loss from operations (763,144) (545,720) (413,266) Interest income 24,715 38,530 27,023 Other (expense) income, net (6,084) (7,526) 1,835 Loss before provision for (benefit from) income taxes (744,513) (514,716) (384,408) Provision for (benefit from) income taxes 2,551 (695) 326 Net loss (747,064) (514,021) (384,734) Reconciliation of net loss to net loss attributable to common stockholders: Premium paid on repurchase of preferred stock — — (4,127) Cumulative preferred stock dividends — — (12,996) Net loss attributable to common stockholders $ (747,064) $ (514,021) $ (401,857) Net loss per share attributable to common stockholders, basic and diluted $ (1.96) $ (1.55) $ (4.95) Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 381,333,059 330,802,136 81,114,183
*The consolidated Statements of Operations have been derived from our audited consolidated financial statements included in Moderna’s Annual Report on Form 10-K.
moderna 2020 annual report | 35 Consolidated Statements of Cash Flows*
Years Ended December 31, (in thousands) 2020 2019 2018 Operating activities Net loss $ (747,064) $ (514,021) $ (384,734) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 93,021 81,122 72,565 Depreciation and amortization 31,251 31,021 24,862 Leased assets expensed 62,286 — — Amortization/accretion of investments 10,185 (3,742) (1,866) Loss on disposal of property and equipment 238 316 891 Changes in assets and liabilities: Accounts receivable (1,385,191) 7,216 832 Inventory (46,527) — — Prepaid expenses and other assets (241,041) 9,751 (5,289) Right-of-use assets, operating leases (10,542) (5,664) — Accounts payable 11,875 (23,964) 15,017 Accrued liabilities 388,392 (3,362) 8,787 Deferred revenue 3,842,307 (44,119) (65,260) Deferred lease obligation — — 2,420 Operating lease liabilities 11,792 12,647 — Other liabilities 5,989 (6,169) 910 Net cash provided by (used in) operating activities 2,026,971 (458,968) (330,865) Investing activities Purchases of marketable securities (2,956,295) (1,145,226) (1,227,709) Proceeds from maturities of marketable securities 1,137,129 993,181 783,373 Proceeds from sales of marketable securities 214,686 168,654 177,008 Purchases of property and equipment (67,448) (31,554) (105,766) Net cash used in investing activities (1,671,928) (14,945) (373,094) Financing activities Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs — — 661,111 Proceeds from offering of common stock, net of issuance costs 1,852,725 — 563,026 Repurchases of redeemable convertible preferred stock — — (8,182) Proceeds from issuance of common stock under equity plans 179,643 47,259 1,427 Proceeds from purchase of common stock under employee stock purchase plan 7,040 2,891 — Charges to financing lease liabilities (6,215) 971 — Reimbursement of assets under financing lease obligation — — 11,635 Payments on financing lease obligation — — (2,175) Net cash provided by financing activities 2,033,193 51,121 1,226,842 Net increase (decrease) in cash, cash equivalents and restricted cash 2,388,236 (422,792) 522,883 Cash, cash equivalents and restricted cash, beginning of year 247,699 670,491 147,608 Cash, cash equivalents and restricted cash, end of year $ 2,635,935 $ 247,699 $ 670,491 Supplemental cash flow information Cash paid for income taxes $ 572 $ 416 $ 294 Cash paid for interest $ 8,528 $ 5,585 $ 2,998 Non-cash investing and financing activities Issuance costs included in accounts payable and accrued liabilities $ — $ — $ 2,638 Purchases of property and equipment included in accounts payable and accrued liabilities $ 17,617 $ 4,676 $ 12,892 Leasehold improvements included in prepaid and other current assets $ — $ — $ 10,089 Lease financing obligation $ — $ — $ 10,089
*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.
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