Headcount: 3,900
Revenues: $19,263 (+4%)
Net Income: $8,362 (-31%)
R&D: $3,295 (+65%)

Moderna, an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale, reported revenues of $19.3 billion for the full year 2022, compared to $18.5 billion in 2021, driven primarily by sales of the company’s COVID-19 vaccines.

The Moderna COVID-19 vaccine, which is also marketed under the brand name Spikevax, is the company’s first commercial product. Hundreds of millions of doses of its COVID-19 vaccines were distributed in both 2021 and 2022, providing countries around the globe a key tool to combat the pandemic. Furthermore, in 2022, Moderna delivered two authorized Omicron-targeting bivalent vaccines, mRNA-1273.214 and mRNA-1273.222, bringing the latter to market in less than two months. Today, the company’s COVID-19 vaccines have been approved in more than 70 countries.

The FDA approved the Biologics License Application (BLA) for Spikevax to prevent COVID-19 in individuals 18 years of age and older in January 2022. In June 2022, Moderna received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg.

In order to further combat the COVID-19 pandemic globally, Moderna announced plans to build an mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level. In March 2023, the company finalized an agreement to establish the mRNA manufacturing facility in the Republic of Kenya. This will be the company’s first mRNA manufacturing facility in Africa. Moderna expects the new facility to enable drug substance and drug product manufacturing for Kenya and the African continent. In addition, this facility will have surge capacity to rapidly scale and respond to public health emergencies on the continent and around the world.

Beyond its COVID-19 vaccine, Moderna currently has 48 programs in development and its pipeline spans infectious diseases, including vaccines against respiratory diseases, latent diseases and public health pathogens, as well as four therapeutic areas: immune-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.

The Phase 3 immunogenicity and safety study of one of Moderna’s seasonal influenza vaccine candidates in the Southern Hemisphere is fully enrolled with approximately 6,000 participants. The company also initiated a Phase 3 efficacy trial in the Northern Hemisphere to test the vaccine’s efficacy compared to a currently licensed seasonal influenza vaccine.

The Phase 3 study of Moderna’s RSV vaccine candidate in adults over 60 years of age has enrolled more than 36,000 of the 37,000-participant target. The study has been designed to provide an efficacy readout expected in the 2023 winter season.

To date, Moderna has enrolled approximately 40 percent of anticipated participants in the Phase 3 study of its CMV vaccine candidate and enrollment is ongoing in the U.S. and internationally.

Moderna’s personalized cancer vaccine program is being developed in partnership with Merck and is designed to stimulate an immune response by boosting T cells, which are believed to be necessary for recurrence-free survival.

In April 2022, Moderna announced plans to build an mRNA vaccine manufacturing facility in Quebec that will support a long-term strategic partnership with the Government of Canada to enhance pandemic preparedness. In other facility news, in December 2022, Moderna finalized a strategic partnership with the UK government to establish an mRNA research, development, and manufacturing facility in the UK.

Headcount: 2,700
Pharma Revenues: $18,471 ($803 in 2020)
Net Income: $12,202 (loss of $747 in 2020)
R&D: $1,991 (+45%)

TOP SELLING DRUGS 

Moderna, an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale, reported revenues of $18.5 billion for the full year 2021 compared to $803 million in 2020, driven by commercial sales of the company’s COVID-19 vaccine.

The Moderna COVID-19 Vaccine, which is also marketed under the brand name Spikevax, is the company’s first commercial product. From the beginning of the COVID-19 pandemic through December 31, 2021, Moderna delivered approximately 824 million doses of its vaccine globally, with approximately 807 million of those doses shipped in 2021. The Moderna COVID-19 vaccine has received approval by regulators in more than 70 countries, including full Biologics License Application approval for Spikevax in the U.S., which was granted by the FDA in January 2022.

Furthermore, in June 2022, Moderna received emergency use authorization (EUA) from the FDA for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg. The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273 for children ages 6 through 11 years old and a 100 μg two-dose regimen for adolescents aged 12 through 17 years old.

In order to further combat the COVID-19 pandemic globally, Moderna announced plans to build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level. The company anticipates investing up to $500 million in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. In March 2022, the company established Kenya as the location for the new facility. Notably, Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic.

Beyond its COVID-19 vaccine, Moderna launched the second pivotal trial in the company’s history with CMVictory, a Phase 3 study of its vaccine to prevent congenital cytomegalovirus, or CMV, which is the number one cause of birth defects in the U.S. This brought the company one step closer to getting another important vaccine to millions of people.

The company is making significant advances across other programs, as well. Its flu vaccine showed positive interim Phase 1 data, and its respiratory syncytial virus, or RSV, vaccine moved fast to a Phase 2/3 trial of 34,000 participants. In Oncology, its Personalized Cancer Vaccine Phase 2 trial is now fully enrolled, and it expects a readout as early as Q4 of 2022. The company also saw early positive data from the Phase 2 study of its mRNA VEGF-A therapeutic with AstraZeneca moving it to the next stage of clinical development.

Moderna continues to expand and advance its mRNA pipeline with 44 programs in development. New development candidates announced in early 2022 include vaccines against herpes simplex virus (HSV) (mRNA-1608), varicella-zoster virus (VZV), which causes shingles (mRNA-1468), a new checkpoint cancer vaccine (mRNA-4359), and a bivalent vaccine against the ancestral strain of SARSCoV-2 and the Omicron variant (mRNA-1273.214).

In September 2021, Moderna entered into a collaboration agreement with the Institute for Life Changing Medicines (ILCM) to develop a new mRNA therapeutic (mRNA-3351) for CN-1. In November, it entered into a research and development collaboration with Metagenomi Inc., focused on advancing new gene editing systems for in vivo human therapeutic applications. Lastly, in January 2022, Moderna entered into a new strategic collaboration agreement with Carisma Therapeutics Inc. to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.