Slide 1: Business Updates Third Quarter 2021 Financial Results
DNA mRNA Protein Business Updates Third Quarter 2021 Financial Results November 4, 2021
Slide 2: Forward-looking statements and Disclaimer
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); its efforts t
Slide 3: Moderna COVID-19 Vaccine: Authorized Use & Important Safety Information
Moderna COVID-19 Vaccine: Authorized Use & Important Safety Information Authorized Use in the United States: Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respira
Slide 4: Today's Agenda 3Q21 Earnings Call
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Financials – David Meline, CFO 3Q21 Earnings 3 COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 4
Slide 5: Third quarter and year-to-date 2021 highlights: Pipeline advances
Third quarter and year-to-date 2021 highlights: Pipeline advances • U.S. FDA granted Priority Review to the Moderna COVID-19 Vaccine Biologics License Application (BLA) • SpikevaxTM first full approval in Canada (United Kingdom, European Union: Conditional Marketing Authorization) • Moderna COVID-19
Slide 6: Third quarter 2021: Financial highlights
Third quarter 2021: Financial highlights ▪ Q3 financials summary: ̶ Revenue: $5B (208M doses delivered) ̶ Net income: $3.3B ̶ Cash and investments: $15B (as of 09/30/21) ▪ FY 2021 Moderna COVID-19 Vaccine/SpikevaxTM: ̶ 2021 range of delivered doses: 700 to 800M ̶ Key variables impacting FY 2021 outp
Slide 7: Moderna COVID-19 Vaccine 3Q: Delivered 208M doses
Moderna COVID-19 Vaccine 3Q: Delivered 208M doses Ramp-up challenges in 2021: ▪ 1Q: Drug substance (DS) Drug substance Drug product DP (DS) (DP) shipped ▪ 2Q: Drug product (DP) “in the bag” “in the vial” ▪ 3Q: Release of product Currently 901M 770M 566M (as of Nov. 3rd) doses doses doses We expect t
Slide 8: Moderna named top employer by Science for the seventh year in a row
Moderna named top employer by Science for the seventh year in a row ▪ Moderna ranked 7th in 2021 ▪ Annual survey evaluates companies in the biopharmaceutical industry in categories such as: ̶ Leadership and direction Add table once link is live ̶ Work culture and environment ̶ Academic and intellect
Slide 9: Programs in development
Moderna as of November 2021 Commercial Phase 3 Phase 2/3 Phase 2 37 development Pipeline Moderna COVID-19 Vaccine/SpikevaxTM CMV prep COVID-19 boosters, programs Zika, PCV, VEGF Flu, RSV across 34 development candidates Respiratory vaccines Latent vaccines mRNA therapeutics Programs in development •
Slide 10: Today's Agenda 3Q21 Earnings Call
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Financials – David Meline, CFO 3Q21 Earnings 3 COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 10
Slide 11: Third quarter 2021 update on product sales
Third quarter 2021 update on product sales $4.8B in Product Sales, 208M doses delivered Product Sales In USD Billions 4.8 ▪ Q3’21 Product Sales of $4.8B 4.2 ̶ $1.2B US, completed delivery of 300M doses 2.1 3.6 Rest of World to USG 1.7 ̶ $3.6B Rest of World, including EU, Canada, 0.4 2.1 Japan, Switz
Slide 12: Third quarter 2021 financial results
Third quarter 2021 financial results In $ millions, except per share amounts (unaudited) Q3 2021 Q2 2021 Q3 2020 QoQ Change QoQ Change (Q3'21 vs. Q2'21) (Q3'21 vs. Q2'21) Product sales1 $ 4,810 $ 4,197 $ — $ 613 15 % Grant revenue 140 139 145 1 1 % Collaboration revenue 19 18 12 1 6 % Total revenue
Slide 13: Year-to-date 2021 financial results
Year-to-date 2021 financial results 2021 YTD 2020 YTD YoY YoY In $ millions, except per share amounts (unaudited) ended 9/30/21 ended 9/30/20 Change Change Product sales1 $ 10,740 $ — $ 10,740 NM Grant revenue2 473 187 286 153 % Collaboration revenue 47 45 2 4 % Total revenue 11,260 232 11,028 4,753
Slide 14: Cash and selected cash flow information
Cash and selected cash flow information September 30, June 30, December 31, Balance Sheet Data 2021 2021 2020 (unaudited) (unaudited) Cash, cash equivalents and investments $15.3 billion $12.2 billion $5.2 billion 2021 YTD 2020 YTD Statements of Cash Flows Data ended 9/30/21 Q3 2021 Q2 2021 ended 9/
Slide 15: Cash/ investments and cash deposits
Cash/ investments and cash deposits Cash / Investments In USD Billions Cash, Cash equivalents and Investments 15.3 12.2 ▪ Cash, Cash equivalents and 8.2 Investments as of September 30, 2021 5.2 at $15.3B, up from $12.2B as of June 30, 2021 12/31/2020 3/31/2021 6/30/2021 9/30/2021 ▪ Net balance of Ca
Slide 16: 2021 updated financial framework
2021 updated financial framework Sales and ▪ FY 2021 Sales: Expect product sales range between $15-$18 billion Dose Volume ▪ FY 2021 dose capacity: approximately 700 million to 800 million doses (at 100μg / dose) Cost of sales ▪ We now expect Full year 2021 reported cost of sales between 16% -17% of
Slide 17: Today's Agenda 3Q21 Earnings Call
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Financials – David Meline, CFO 3Q21 Earnings 3 COVID-19 Vaccine Data Update – Paul Burton, M.D., Ph.D., CMO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 17
Slide 18: Government reports show mRNA-1273's high effectiveness of reducing COVID-19 infection and death
Government reports show mRNA-1273’s high effectiveness of reducing COVID-19 infection and death CDC These are not head-to-head randomized trials designed to compare the vaccines. Slide 18 https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status
Slide 19: Government reports show mRNA-1273's high effectiveness of reducing COVID-19 infection, hospitalization and death
Government reports show mRNA-1273’s high effectiveness of reducing COVID-19 infection, hospitalization and death Fully vaccinated people, Switzerland and Liechtenstein Switzerland: Number of breakthroughs by Dec. 21st, 2020 to Nov. 2nd, 2021 vaccine type per 100,000 Updated: November 2, 2021 Infecti
Slide 20: Real world data shows mRNA-1273 is highly effective at reducing the risk of COVID-19
Real world data shows mRNA-1273 is highly effective at reducing the risk of COVID-19 infection and hospitalization Narranbhai et al., US, Iceland, South Korea; n=37.7 million individuals Nordstrom et al., Sweden Risk of breakthrough infection among BNT162b2 Fully adjusted vaccine Vaccine schedule va
Slide 21: Real world data: effectiveness in high-risk populations
Real world data shows mRNA-1273 is highly effective at reducing the risk of COVID-19 infection in high-risk populations Embi et al., CDC VISION: VE Against Patient group VE VE Difference COVID-19 Hospitalization mRNA-1273 BNT162b2 Solid malignancy 85% 72% 13% Hematological 85% 62% 23% malignancy Rhe
Slide 22: Myocarditis events observed in analysis of 151 million individuals
Myocarditis events observed in an analysis of 151 million individuals receiving mRNA-1273 in the Moderna Global Safety Database Observed to expected rate ratio by age group ▪ Events of myocarditis occur very rarely ▪ Results are highly consistent with findings from other international databases, and
Slide 23: Analysis of 1.5 million individuals <18 years of age does not identify increased myocarditis risk
Analysis of 1.5 million individuals <18 years of age in the Moderna Global Safety Database does not identify an increase in the risk of myocarditis ▪ Higher expected rate in 18-24 years old males is consistent with other reported figures 1-3 dExpected cases among females 12–39 years of age were adju
Slide 24: Summary
Summary ▪ Government reports in the United States and Switzerland with high vaccination rates of Moderna’s COVID-19 Vaccine show that mRNA- 1273 is highly effective in reducing the risk of COVID-19 infections, breakthrough infections, hospitalizations and deaths ▪ Real world studies in millions of i
Slide 25: Today's Agenda 3Q21 Earnings Call
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Financials – David Meline, CFO 3Q21 Earnings 3 COVID-19 Vaccine Data Update – Paul Burton, M.D., Ph.D., CMO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 25
Slide 26: Moderna COVID-19 Vaccine: mRNA-1273 updates
Moderna COVID-19 Vaccine: mRNA-1273 updates ▪ U.S. FDA granted Priority Review to the Moderna COVID-19 Vaccine Biologics License Application (BLA) ▪ Received Emergency Use Authorization (EUA) from the U.S. FDA and the European Commission’s approval for a booster dose of the Moderna COVID-19 vaccine
Slide 27: KidCOVE P204 study: Efficacy data in children ages 6 to <12 years
KidCOVE P204 study: Efficacy data in children ages 6 to <12 years old after Dose 1 at 50 µg Summary of Secondary Efficacy Endpoint Analysis Results Starting 14 Days after Dose 1 in Part 2 (mITT1) mRNA-1273 50 µg Placebo Endpoint N=2678 N=878 P301 case definition of COVID-19 Cases, n/N1 (%) 0/2672 13
Slide 28: Variant-specific and next generation COVID-19 vaccine updates
COVID-19 Vaccine: Variant-specific and next generation COVID-19 vaccine updates Variant-specific Next generation COVID-19 vaccines COVID-19 Vaccine ▪ Four development candidates against ▪ mRNA-1283 Phase 1 ongoing variants of concern ▪ Interim analysis of Phase 1 data at three dose levels ▪ Multival
Slide 29: SARS-CoV-2 is following the evolution of other respiratory viruses
SARS-CoV-2 is following the evolution of other respiratory viruses ILLUSTRATIVE Stage Focus for vaccines Pandemic • Heavy focus on protecting high-risk Initial waves populations Pandemic Endemic • Mostly ancestral virus vaccine 2020 Variant • Focus to suppressing transmission of epidemics variants M
Slide 30: Ongoing respiratory vaccine trials
Ongoing respiratory vaccine trials hMPV SARS- RSV PIV3 CoV-2 Flu ▪ Flu: Phase 1 trial of seasonal quadrivalent flu vaccine (mRNA-1010) is fully enrolled ▪ RSV: Positive interim Phase 1 data announced at R&D Day on September 9th ̶ Phase 1 pediatric and adult vaccine trials are ongoing ̶ Pivotal Phase
Slide 31: First participant dosed in Phase 3 Study of our CMV Vaccine
First participant dosed in Phase 3 Study of our CMV Vaccine ▪ Phase 3 study will evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women ages 16-40 years ▪ Pivotal Phase 3 trial will test the 100 μg dose level ▪ Expected enrollment of up to ~8,000 participants, including
Slide 32: Advancing mRNA therapeutics
Advancing mRNA therapeutics Eight programs with ongoing clinical trials Modalities Cancer Intratumoral Localized Systemic secreted Systemic Inhaled vaccines immuno- regenerative & cell surface intracellular pulmonary oncology therapeutics therapeutics therapeutics therapeutics • PCV in Phase 1 and •
Slide 33: Vertex collaborations to address Cystic Fibrosis
Vertex collaborations to address Cystic Fibrosis Two parallel approaches to addressing the unmet Collaboration: mRNA for CFTR need Collaboration: mRNA for gene therapy (Approximately 10% of Cystic Formulation Fibrosis patients are not CFTR-encoded mRNA addressable with a CFTR modulator) Formulation
Slide 34: mRNA for CFTR collaboration expected to submit IND in 2022
mRNA for CFTR collaboration expected to submit IND in 2022 Collaboration: mRNA for CFTR ▪ Collaboration to evaluate CF mRNA therapeutics designed to treat the underlying cause of CF by enabling cells in the Formulation lungs to produce functional cystic fibrosis transmembrane CFTR-encoded mRNA condu
Slide 35: Moderna's Respiratory Vaccines (Pipeline 1/3)
Moderna’s Respiratory Vaccines (Pipeline 1/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights mRNA-1273 Worldwide mRNA-1273.351 Beta variant Worldwide mRNA-1273.617 Delta variant Worldwide COVID-19 vaccine Adults mRNA-1273.211 Beta variant + wild-type
Slide 36: Moderna's Latent & Other Vaccines (Pipeline 2/3)
Moderna’s Latent & Other Vaccines (Pipeline 2/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights CMV vaccine mRNA-1647 Worldwide Latent mRNA-1189 Worldwide vaccines EBV prophylactic vaccine EBV therapeutic vaccine mRNA-1195 Worldwide Worldwide mRNA-164
Slide 37: Moderna's Therapeutics (Pipeline 3/3)
Moderna’s Therapeutics (Pipeline 3/3) Preclinical Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial Moderna rights development IL-2 Systemic mRNA-6231 Worldwide Autoimmune disorders secreted & cell Relaxin surface mRNA-0184 Worldwide Heart failure therapeutics PD-L1 mRNA-6981 Worldwide Autoim
Slide 38: Today's Agenda 3Q21 Earnings Call
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Financials – David Meline, CFO 3Q21 Earnings 3 COVID-19 Vaccine Data Update – Paul Burton, M.D., Ph.D., CMO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 38
Slide 39: Moderna's strategic pillars
Moderna’s strategic pillars 1 Bring to market a pan-respiratory annual booster vaccine (which we will continuously customize) 2 Bring to market first-in-class vaccines for latent viruses 3 Bring to market therapeutics based on mRNA-encoded proteins 4 Bring to market therapeutics based on mRNA-encode
Slide 40: SARS-CoV-2 is following the evolution of other respiratory viruses
SARS-CoV-2 is following the evolution of other respiratory viruses ILLUSTRATIVE Stage Focus for vaccines Pandemic • Heavy focus on protecting high-risk Initial waves populations Pandemic Endemic • Mostly ancestral virus vaccine 2020 Variant • Focus to suppressing transmission of epidemics variants M
Slide 41: We are actively preparing for different markets in 2022
We are actively preparing for different markets in 2022 COVID-19 market structure in Customer demands differ depending on 2022 by geography pandemic and endemic market 1H22 2H22 OECD ▪ Presentation of product (number of doses for vial) Pandemic Endemic ▪ Optimal booster for Fall 2022: Current booste
Slide 42: 2022 revenue drivers in a dynamic and evolving market
2022 revenue drivers in a dynamic and evolving market APAs signed: $ 17 B APAs with options: up to $ 3 B US Fall 2022 booster market*: Up to $ 2 B $ 17 – 22 B Slide 42 * Assumes a BLA or sBLA for booster prior to Fall boosting season
Slide 43: Respiratory vaccines: Multiple programs advancing quickly
Respiratory vaccines: Multiple programs advancing quickly ▪ Moderna COVID-19 Vaccine ̶ COVID primary series hMPV SARS- Flu CoV-2 RSV PIV3 ̶ Fall 2021 booster ̶ Fall 2022 booster ̶ COVID + Flu booster ̶ COVID + Flu + RSV booster ▪ Quadrivalent seasonal flu vaccine Phase 1 data is coming soon (4Q ’21)
Slide 44: Latent viruses: Cause acute infections and longer-term sequelae
Latent viruses: Cause acute infections and longer-term sequelae ▪ Latent viruses are typically DNA viruses ▪ Acute infection from latent viruses: Disease Burden ̶ EBV is a major cause of infectious mononucleosis syndrome1 ̶ Acute CMV and HIV symptoms may also present as a mononucleosis-like illness
Slide 45: mRNA therapeutics: Next steps on select programs
mRNA therapeutics: Next steps on select programs Cancer ▪ PCV program Phase 2 readout expected in 4Q22 vaccines Intratumoral ▪ Triplet program to share poster presentation at SITC1 on November 12th immuno-oncology Localized regenerative ▪ AstraZeneca to present data from VEGF-A program on November 1
Slide 46: Metagenomi and Moderna: Collaboration on in vivo gene editing therapeutics
Metagenomi and Moderna: Collaboration to develop next- generation in vivo gene editing therapeutics ▪ Combining Metagenomi’s next-generation CRISPR-based and other novel gene editing systems with our technology platform ▪ Metagenomi’s discovery platform and expertise will expand Moderna Genomics’ (M
Slide 47: Moderna's strategic pillars
Moderna’s strategic pillars 1 Bring to market a pan-respiratory annual booster vaccine (which we will continuously customize) 2 Bring to market first-in-class vaccines for latent viruses 3 Bring to market therapeutics based on mRNA-encoded proteins 4 Bring to market therapeutics based on mRNA-encode
Slide 48: Moderna Mindsets
We act with urgency. Action today compounds the lives saved tomorrow. Moderna Mindsets We pursue options in parallel to make the best choice later. We accept risk as the only path to impact. We obsess over learning. We don’t have to be the smartest – we have What are Moderna Mindsets? to learn the f
Slide 49: Pledge to achieve net-zero carbon emissions globally by 2030
Pledge to achieve net-zero carbon emissions globally by 2030 ▪ Committing to the direct use of renewable energy in U.S. facilities beginning in 2021 ▪ Investing in the new Moderna Science Center at 325 Binney Street in Cambridge, Massachusetts ̶ Designed to be the most sustainable commercial lab bui
Slide 50: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 50
Slide 51: Events in 2022: Vaccines Day, Science Day, R&D Day
Vaccines Day March 24th Science Day Save the Date May 17th Events in 2022 R&D Day September 8th Slide 51