Exhibit 99.1
Moderna Reports Fourth Quarter and Fiscal Year 2021 Financial Results and Provides Business Updates
Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of$11.29
Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billionand GAAP diluted EPS of $28.29
Moderna increased its 2022 signed advance purchase agreements to approximately $19 billion,with additional signed options of approximately $3 billion; numerous discussions ongoing with governments for the fall of 2022 and 2023
Moderna received full U.S. FDA approval for COVID-19 vaccine, Spikevax
Moderna announces new bivalent booster candidate (mRNA-1273.214) combining Omicron-specific booster candidate (mRNA-1273.529) and theModerna COVID-19 vaccine (mRNA-1273)
Company now has 44 programs in development
Moderna announces a new $3 billion share repurchase plan
CAMBRIDGE, Mass.(ACCESS WIRE)February 24, 2022 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA)therapeutics and vaccines, today reported financial results and provided business updates for the fourth quarter of fiscal year 2021.
Spikevax isnow approved in more than 70 countries around the world protecting hundreds of millions of people and real-world evidence from multiple independent studies has confirmed its strong effectiveness, said Stéphane Bancel, Chief ExecutiveOfficer of Moderna. In 2021, we delivered 807 million doses with approximately 25% of those doses going to low- and middle-income countries, and we will continue to scale in 2022 to help end the COVID-19 pandemic. Moderna has experienced exponential growth and we have more than doubled the size of our team over the last year with a global team of 3,000. We also have announced plans to scale to 21 commercialsubsidiaries across the world, including four new locations in Asia and six new locations in Europe. We continue to expand and advance our industry-leading mRNA pipeline with 44 programs in development. We look forward to clinical readouts from ourtherapeutics development candidates later in 2022 in rare genetic diseases and oncology. We are entering 2022 with a remarkable team and strategic priorities to continue advancing mRNA vaccines and therapeutics to impact human health.
Updates and recent progress include:
COVID-19 Vaccine Development
| | | Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Spikevax® in a 50 µg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years |
| | | U.S. Food and Drug Administration (U.S. FDA) approved the Biologics License Application (BLA) for Spikevax® (COVID-19 Vaccine, mRNA-1273) to prevent COVID-19 in individuals in the U.S. 18 years of age and older; Spikevaxapproved or authorized in more than 70 countries |
| | | Pivotal studies are underway for Omicron-specific booster candidate (mRNA-1273.529) |
| | | Moderna announces bivalent booster candidate (mRNA-1273.214) combining mRNA-1273.529 and the Moderna COVID-19 vaccine (mRNA-1273) |