Business Updates

Fourth Quarter & Full Year 2020 Financial Results

February 25, 2021

Forward-looking statements and Disclaimer

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's development of the Moderna COVID-19 Vaccine (mRNA-1273); the accounting treatment for individual items related to the Company's financial statements; anticipated cost of sales for the Moderna COVID-19 Vaccine; anticipated selling, general and administrative costs and research and developme nt costs; trends with respect to the Company's costs and expenses; orders for the Company's Moderna COVID-19 Vaccine, both inside and outside the U.S., anticipated doses to be delivered under advance purchase agreements in 2021 and the associated dollar amounts to be received, which should not be construed as expected 2021 revenue; expected timing of execution of the Purchase Agreement by the European Commission for additional vaccine doses; negotiations for future sales of the COVID -19 vaccine; the Company's future tax rate and status as a tax- paying entity; the status of regulatory approvals for the Moderna COVID-19 Vaccine; potential future cash flows, profitability and balance sheet strength; the Company's ability to invest in and scale operations; the number of doses of the Moderna COVID-19 Vaccine that the Company anticipates being able to manufacture in 2021 and 2022 and on a quarterly basis, and investments to facilitate that manufacturing; the Company's establishment of additional subsidiaries and development of its commercial network; the Company's efforts to continue developing vaccines against COVID-19, including efforts to develop vaccines against variant strains of SARS-CoV-2 and for booster doses; the status of developments for programs in the Company's pipeline, including with respect to the timing, enrollment and potential results of clinical trials; and the ability of mRNA-based technology to be utilized for the development of SARS-CoV-2 variant vaccines. 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," "c ontinue," 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 presentation 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, among others: the fact that there has never been a commercial product utilizing mRNA technology approv ed 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 Mode rna 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 hav ing ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategie s, 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 gl obal economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10 -Q 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 atwww.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation 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 COVID-19 Vaccine: Indication & Safety Information

Authorized Use in the United States:

The Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (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.

Important Safety Information:

  • Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxi s) to any component of the Moderna COVID-19 Vaccine.

  • Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anap hylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions accordin g to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).

  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.

  • The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

  • Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. Ad ditional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

  • Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine -associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

  • There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

  • Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID -19 Vaccine.

  • Vaccination providers must complete and submit reports to VAERS online athttps://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words " Moderna COVID- 19 Vaccine EUA " in the description section of the report.

4Q20 earnings call agenda

Business Review - Stéphane Bancel - CEO Financials - David Meline - CFO

2021: An inflection year

Business Objectives - Stéphane Bancel - CEO

Clinical Objectives - Stephen Hoge (President) & Tal Zaks (CMO)

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Moderna Inc. published this content on 25 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 February 2021 13:06:08 UTC.