Slide 1: Fourth Quarter & Full Year 2022 Financial Results
Fourth Quarter & Full Year 2022 Financial Results February 23rd, 2023 © 2023 M oderna, Inc. All rights reserved.
Slide 2: Forward-looking statements and disclaimer
Forward-looking statements and disclaimer This presentation contains forward-looking statements w ithin the meaning of the Priv ate Securities Litigation Reform Act of 1995, as amended, including statements regarding: anticipated sales, including the timing of sales, under adv ance purchase agreemen
Slide 3: 4Q22 earnings call agenda
4Q22 earnings call agenda Business Review Stéphane Bancel, CEO R&D/Clinical Programs Stephen Hoge, M.D., President Commercial Market Arpa Garay, CCO Financials Jamey Mock, CFO Looking Forward Stéphane Bancel, CEO 3 © 2023 M oderna, Inc. All rights reserved.
Slide 4: Fiscal year 2022 financial highlights
Fiscal year 2022 financial highlights Fiscal year 2022 GAAP financial results Revenue: Net income: Earnings Cash and $19.3 billion $8.4 billion per share: investments: $20.12 $18.2 billion Capital allocation highlights Reinvest in the External investment Return capital to business opportunities (lic
Slide 5: Moderna 2022
COVID booster (mRNA-1273.214 & mRNA-1273.222) Two authorized Omicron-targeting bivalent vaccines; mRNA-1273.222 on market in less than two months RSV vaccine (mRNA-1345) Phase 1 to Phase 3 in 13 months; pivotal Phase 3 trial met primary efficacy endpoint Moderna 2022 Personalized Cancer Vaccine (PCV
Slide 6: Executive Committee Transitions
Executive Committee Transitions Marcello Damiani Brad Miller Former Chief Digital & Chief Information Officer Operational Excellence Officer 6 © 2023 M oderna, Inc. All rights reserved.
Slide 7: Executive Committee Transitions
Executive Committee Transitions Juan Andres Jerh Collins President, Strategic Partnerships Chief Technical Operations and Enterprise Expansion and Quality Officer 7 © 2023 M oderna, Inc. All rights reserved.
Slide 8: Foundations and programs in development
Moderna as of February 2023 9 in Phase 2 Commercial 4 in Phase 3 48 development Pipeline PCV, Zika, PA, VEGF-A, programs ® Moderna COVI D-19 Vaccine/Spikevax , COVI D boosters, Flu, next generation mRNA-1273.222 and mRNA-1273.214 RSV, CMV COVI D boosters Respiratory vaccines Latent vaccines mRNA the
Slide 9: 4Q22 earnings call agenda
4Q22 earnings call agenda Business Review Stéphane Bancel, CEO R&D/Clinical Programs Stephen Hoge, M.D., President Commercial Market Arpa Garay, CCO Financials Jamey Mock, CFO Looking Forward Stéphane Bancel, CEO 9 © 2023 M oderna, Inc. All rights reserved.
Slide 10: Respiratory vaccines
Respiratory vaccines Announced positive topline RSV vaccine data, updates to flu and COVID programs Approved and Phase 3 Next generation respiratory Combination vaccine programs programs programs PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. COVID-19 (mRNA-1273.222
Slide 11: Preparing for endemic COVID in 2023 and beyond
Preparing for endemic COVID in 2023 and beyond VRBPAC meeting takeaways and implications for endemic COVID • At the recent VRBPAC meeting, the committee voted to harmonize the primary series and booster dose vaccines • FDA will likely convene to determine vaccine strain composition for the 2023/2024
Slide 12: mRNA-1345 RSV Pivotal Phase 3 trial met primary efficacy endpoint
mRNA-1345 RSV Pivotal Phase 3 trial met primary efficacy endpoint and received Breakthrough Designation from FDA Top line data Additional data presented presented today at RSVVW2 Next steps • mRNA-1345 demonstrated • mRNA-1345 was well-tolerated and had an acceptable BLA filing to the FDA is vaccine
Slide 13: mRNA-1010 Phase 3 flu vaccine update
mRNA-1010 Phase 3 flu vaccine update The influenza A/H3N2 subtype is responsible for most of the recent influenza outbreaks and excess morbidity caused by the virus P301: Southern Hemisphere P302: Northern Hemisphere immunogenicity study efficacy study • Demonstrated superiority on seroconversion •
Slide 14: Latent vaccines
Latent vaccines First participants dosed in Phase 1/2 trials with VZV vaccine Phase 3 programs Early clinical programs Pre-clinical programs PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. CMV vaccine (mRNA-1647) EBV vaccine (mRNA-1189, Phase 1; HSV vaccine (mRNA-160
Slide 15: VZV (mRNA-1468-P101) vaccine study
VZV (mRNA-1468-P101) vaccine study First participants dosed in Phase 1/2 randomized, active comparator-controlled, dose-ranging study against Shingrix 500 healthy adults ≥50 years of age without previous immunization against HZ1 or a history of HZ in the previous 10 years Purpose • ≥70 years of age
Slide 16: mRNA therapeutics
mRNA therapeutics PCV initiating multiple late-stage studies; PA selecting dose for expansion arm Immuno-oncology Cardiovascular PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. Personalized Cancer Vaccine Relaxin PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. Checkpoint vaccine VEGF PC
Slide 17: FDA Breakthrough Designation facilitates development of mRNA-4157/V940
FDA Breakthrough Designation facilitates development of mRNA-4157/V940 (personalized cancer vaccine) Top-line data Next steps • mRNA-4157/V940 in combination with • Full data from Keynote-942 will be KEYTRUDA reduced the risk of recurrence or presented at an upcoming oncology death by 44% (HR=0.56 [
Slide 18: PA Phase 1/2 trial advancing to dose expansion arm
PA Phase 1/2 trial advancing to dose expansion arm Program Updates Phase 1/2 Trial Design • The Paramount study is ongoing, currently enrolling patients in cohort 5 (0.9mg/kg) with no DLTs observed to date • Encouraging clinical benefit observed to date in 3-HP reductions and Metabolic Decompensatio
Slide 19: 4Q22 earnings call agenda
4Q22 earnings call agenda Business Review Stéphane Bancel, CEO R&D/Clinical Programs Stephen Hoge, M.D., President Commercial Market Arpa Garay, CCO Financials Jamey Mock, CFO Looking Forward Stéphane Bancel, CEO 19 © 2023 M oderna, Inc. All rights reserved.
Slide 20: Q4 2022 Product Sales of $4.9B, Full Year Product Sales of $18.4B
Q4 2022 Product Sales of $4.9B, Full Year Product Sales of $18.4B Product Sales YoY Comparison Q4 2022 Product Sales: $4.9 billion In USD Billions $17.7B $18.4B • United States: $1.0 billion 4.4 5.4 • Europe: $2.2 billion • RoW: $1.6 billion $6.9B 0.7 $4.9B 14.0 12.3 Full year 2022 Product Sales: $1
Slide 21: Reiterating COVID vaccine sales of ~$5 billion from contracted 2023 deliveries
Reiterating COVID vaccine sales of ~$5 billion from currently contracted 2023 deliveries; expecting additional sales Advance Purchase Deferrals from Expected new sales Agreements ’22 contracts • U.S. commercial contracting Canada European Union ongoing Kuwait • Potential for additional sales: Japan
Slide 22: COVID is a substantial health burden in the United States
COVID is a substantial health burden in the United States Throughout 2022, COVID continued to be a leading cause of hospitalizations and deaths in the United States COVID-19 was the third leading cause of death in the U.S. from Total hospitalizations in current 22/23 January to September 2022 season
Slide 23: 2023 U.S. COVID market estimated to be ~100M doses
2023 U.S. COVID market estimated to be ~100M doses Potential 2023 U.S. COVID vaccination volume Key variables that will impact COVID volumes in 2023 Assumed volume (million Viral evolution ~84 ~101 ~118 ~135 ~169 doses) Doses administered as a Regulatory 25% 30% 35% 40% 50% % US Population* recommen
Slide 24: Prepared for U.S. commercial market
Prepared for U.S. commercial market Coverage Awareness & Education Payer - Private & Public HCP & Consumer Education • Engagement with private and public • Educate in alignment with V RBPAC, payers to ensure coverage of Moderna CDC, ACIP recommendations COVID-19 vaccines • Innovative digital engagem
Slide 25: Moderna is committed to patient access in the U.S.
Moderna is committed to patient access in the U.S. ACIP recommendations will drive reimbursement with zero out-of-pocket costs to consumers Insured Uninsured/Under-insured Moderna’s COVID-19 vaccines For uninsured or under-insured will continue to be available at people, Moderna’s patient no out-of-
Slide 26: COVID vaccine 2023 outlook
COVID vaccine 2023 outlook 2023 COVID confirmed contracts and deferrals of ~$5 billion; additional orders expected in US, EU, Japan and other countries COVID continues to be a burden to healthcare systems In 2023, we expect the United States commercial market to be ~100 million doses We are prepared
Slide 27: 2024 RSV launch
2024 RSV launch Build on existing commercial and medical infrastructure with additional investment to support launch Leverage overlap between key customers for RSV older adult launch and COVID endemic markets Ensure understanding of disease and economic burden of RSV in older adults across key stake
Slide 28: 4Q22 earnings call agenda
4Q22 earnings call agenda Business Review Stéphane Bancel, CEO R&D/Clinical Programs Stephen Hoge, M.D., President Commercial Market Arpa Garay, CCO Financials Jamey Mock, CFO Looking Forward Stéphane Bancel, CEO 28 © 2023 M oderna, Inc. All rights reserved.
Slide 29: Fourth quarter 2022 financial results
Fourth quarter 2022 financial results Change In $ millions, except per share amounts Q4 2022 Q4 2021 (Q4'22 vs. Q4'21) Product sales $ 4,859 $ 6,935 $ (2,076) (30) % Other rev enue 1 225 276 (51) (18) % Total revenue 5,084 7,211 (2,127) (29) % Cost of sales 1,918 952 966 101 % Research and dev elopm
Slide 30: Full year 2022 financial results
Full year 2022 financial results FY 2022 FY 2021 Change In $ millions, except per share amounts (unaudited) (FY'22 vs. FY'21) Product sales $ 18,435 $ 17,675 $ 760 4 % Other rev enue 1 828 796 32 4 % Total revenue 19,263 18,471 792 4 % Cost of sales 5,416 2,617 2,799 107 % Research and dev elopment
Slide 31: Cash/investments and cash deposits
Cash/ investments and cash deposits Cash / Investments In USD Billions Cash, Cash equivalents and Investments 17.6 17.0 18.2 Cash, Cash equivalents and Investments as of December 31, 2022, at $18.2 billion, up from $17.0 billion as of September 30, 2022 12/31/2021 9/30/2022 12/31/2022 Balance of Cas
Slide 32: Moderna's capital allocation priorities
Moderna’s capital allocation priorities R&D Investment (in $B) • Phase 3 trials: Reinvest in the business and ~4.5 Flu, RSV , and CMV accelerate investment in R&D, 3.3 • Personalized Cancer Vaccine 2.0 manufacturing infrastructure 0.5 1.4 investments and company buildout • 48 development programs 20
Slide 33: 2023 updated financial framework
2023 updated financial framework • COVID vaccine sales of ~$5 billion currently contracted for 2023 delivery • Potential additional sales in the United States (endemic private and government markets), Sales Europe, Japan, and other key markets • We expect product sales in H1 2023 of ~$2.0 billion •
Slide 34: 4Q22 earnings call agenda
4Q22 earnings call agenda Business Review Stéphane Bancel, CEO R&D/Clinical Programs Stephen Hoge, M.D., President Commercial Market Arpa Garay, CCO Financials Jamey Mock, CFO Looking Forward Stéphane Bancel, CEO 34 © 2023 M oderna, Inc. All rights reserved.
Slide 35: Anticipated pipeline milestones: Respiratory Vaccines
Anticipated pipeline milestones: Respiratory Vaccines COVID booster vaccines Anticipating commercial market in 2023 and beyond. VRBPAC will meet in Q2 2023 for new strain selection RSV vaccine Plan to submit for regulatory approval in the first half of 2023 Flu vaccines Northern Hemisphere mRNA-1010
Slide 36: Anticipated pipeline milestones: Latent Vaccines
Anticipated pipeline milestones: Latent Vaccines CMV Complete enrollment of Phase 3 CMVictory trial with mRNA -1647 EBV Phase 1 data VZV Phase 1 data HIV Phase 1 data 36 © 2023 M oderna, Inc. All rights reserved.
Slide 37: Anticipated pipeline milestones: Therapeutics
Anticipated pipeline milestones: Therapeutics Personalized cancer vaccine (PCV) Initiate a Phase 3 study in adjuvant melanoma in 2023 and rapidly expand to additional tumor types including NSCLC. Full Phase 2 data will be presented at an upcoming oncology meeting / peer review publication in 2023 PA
Slide 38: 2023 Priorities
2023 Priorities 1 Execute the operational and sales plan for COVID 2 Build an unrivaled seasonal respiratory vaccine franchise 3 Execute on a bold campaign of cancer vaccine studies 4 Advance rare metabolic disease programs 5 Drive rapid advancement and growth in our latent vaccine portfolio 6 Deliv
Slide 39: Save the Date
Vaccines Day April 11th R&D Day September 13th Save the Date Events in 2023 ESG Day December 7th © 2023 M oderna, Inc. All rights reserved.
Slide 40: Our Mission
Our Mission Deliver the greatest possible impact to people through mRNA medicines. © 2023 M oderna, inc. Confidential. All rights reserved.
Slide 41: Q&A Thank you
Q&A Thank you © 2023 M oderna, inc. Confidential. All rights reserved.
Slide 42: Moderna's Respiratory Vaccines (Pipeline 1/3)
Moderna’s Respiratory Vaccines (Pipeline 1/3) Preclinical Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial Moderna rights development mRNA-1273/Spikevax ® Worldw ide mRNA-1273.214 Omicron (BA.1) variant + w ild-type Worldw ide mRNA-1273.222 Omicron (BA.4/5) variant + w ild-type Worldw ide mR
Slide 43: Moderna's Latent & Public Health Vaccines (Pipeline 2/3)
Moderna’s Latent & Public Health Vaccines (Pipeline 2/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights CMV vaccine mRNA-1647 W orldwide EBV vaccine (to prevent mRNA-1189 W orldwide infectious mononucleosis) Latent vaccines EBV vaccine (to prevent EBV
Slide 44: 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 Systemic Relaxin mRNA-0184 Worldwide secreted & cell Heart failure surface PD-L1 Autoimmune hepatitis mRNA-6981 Worldwide therapeutics Personalized cancer vaccine 50-