Slide 1: First Quarter 2023 Financial Results
First Quarter 2023 Financial Results May 4, 2023 © 2023 Moderna, Inc. All rights reserved.
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: anticipated sales, including the timing of sales, under advance purchase agreements
Slide 3: 1Q23 earnings call agenda
1Q23 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 Moderna, Inc. All rights reserved.
Slide 4: 1Q23 financial highlights
Quarter 1 2023 Update| Business Review 1Q23 financial highlights 1Q23 GAAP financial results Revenue: Net income: Diluted earnings Cash and $1.9 billion $79 million per share: investments: $0.19 $16.4 billion Capital allocation highlights Reinvest in the External investment Return capital to busines
Slide 5: Commercial 1Q23 updates
Quarter 1 2023 Update| Business Review Commercial 1Q23 updates 2023 COVID market RSV pre-launch and Individualized Neoantigen • Reiterating a minimum of ~$5 medical activity Therapy (INT) billion in COVID vaccine sales • Educating medical • Scaling manufacturing from previously announced community o
Slide 6: Pipeline highlights and advances
Quarter 1 2023 Update| Business Review Pipeline highlights and advances Respiratory Latent Emerging Therapeutics vaccines vaccines vaccines RSV: Topline data released in CMV: Phase 3 trial Norovirus: Program Individualized Q1; additional updates continued progress announced Neoantigen Therapy presen
Slide 7: Programs in development
Quarter 1 2023 Update| Business Review Moderna as of May 2023 5 in Phase 3 8 in Phase 2 47 development Pipeline Commercial COVID boosters, Flu, Moderna COVID-19 Vaccine/Spikevax® RSV, CMV, Next- generation COVID-19 INT, Zika, PA, VEGF-A, Next- gen Flu programs Respiratory vaccines Latent vaccines mR
Slide 8: 1Q23 earnings call agenda
1Q23 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 8 © 2023 Moderna, Inc. All rights reserved.
Slide 9: Respiratory vaccines pipeline overview
Quarter 1 2023 Update| R&D/Clinical Programs Respiratory vaccines pipeline overview Commercial and Phase 3 programs Next-gen programs Combination 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-1273.214/.222) COVID-19 variant boosters and COVI
Slide 10: FDA COVID-19 vaccination update
Quarter 1 2023 Update| R&D/Clinical Programs Current FDA COVID-19 vaccination update; new recommendations expected on June 15 FDA COVID-19 vaccines update • Omicron-targeting bivalent COVID-19 vaccine (targeting the original and BA.4/5 strains) is now the only authorized formulation in the U.S. • In
Slide 11: RSV: mRNA-1345 older adult program updates
Quarter 1 2023 Update| R&D/Clinical Programs RSV: mRNA-1345 older adult program updates Phase 3 RSV clinical data shared at recent medical meetings • mRNA-1345 showed consistently high efficacy across the clinical spectrum of RSV disease in adults aged ≥60 years − Demonstrated vaccine efficacy of 83
Slide 12: Flu: Preliminary immunogenicity data from Phase 3 P302
Quarter 1 2023 Update| R&D/Clinical Programs Flu: Preliminary immunogenicity data from Phase 3 P302 efficacy trial for mRNA-1010 confirm Phase 2 data P302 interim analysis did not accrue sufficient cases to declare early success and the independent DSMB P302 geometric mean titer ratio over recommend
Slide 13: Flu: mRNA-1010 Phase 3 P303 study dosing participants
Quarter 1 2023 Update| R&D/Clinical Programs Flu: mRNA-1010 Phase 3 P303 study dosing participants Design P303 will test the Randomized, observer-blind, active-controlled study immunogenicity of an Number of participants updated formulation of 2,400 medically stable adults ≥ 18 years old mRNA-1010 t
Slide 14: Latent vaccines
Quarter 1 2023 Update| R&D/Clinical Programs Latent vaccines Phase 3 CMVictory study is >50% enrolled; study of primary prevention in adolescents is enrolling 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 Com
Slide 15: mRNA therapeutics
Quarter 1 2023 Update| R&D/Clinical Programs mRNA therapeutics Detailed INT data presented at AACR; PA dose expansion ongoing Immuno-oncology Cardiovascular Rare Disease PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. PC Ph. 1 Ph. 2 Ph. 3 Comm. Individualized Neoantigen Therapy (INT) Relaxin P
Slide 16: INT: mRNA-4157 and pembrolizumab improved recurrence-free survival
Quarter 1 2023 Update| R&D/Clinical Programs INT: mRNA-4157 (V940) and pembrolizumab demonstrated an improvement in recurrence-free survival (RFS) vs pembrolizumab 100 + + 12-month RFS 18-month RFS + + + 83.4% + Censored ++ + +++++ + 78.6% 80 +++++++ ++ +++++ + +++++++ + +++ + ++ 77.1% +++++ + + 60
Slide 17: INT: RFS improvement irrespective of TMB or PD-L1 status
INT: mRNA-4157 (V940) and pembrolizumab combination Quarter 1 2023 Update| R&D/Clinical Programs treatment demonstrated an improvement in RFS irrespective of tumor mutational burden (TMB) or PD-L1 status 1.00 TMB 1.00 PD-L1 0.75 0.75 RFS RFS 0.50 0.50 PD-L1–negative: pembro PD-L1–negative: 0.25 TMB–
Slide 18: INT: Additional Phase 2b data to be shared
Quarter 1 2023 Update| R&D/Clinical Programs INT: Additional Phase 2 mRNA-4157 (V940) data to be shared at upcoming medical meetings Analyses to include Breakthrough Therapy Distant metastasis-free survival at ASCO Designation from FDA and PRIME Treatment outcomes by BRAF status Designation from EMA
Slide 19: INT: Phase 3 adjuvant melanoma study to begin this year
Quarter 1 2023 Update| R&D/Clinical Programs INT: Phase 3 adjuvant melanoma study to begin this year; studies in additional tumor types to follow Initiate INT1 Phase 3 study in Plan to explore opportunities with adjuvant melanoma in 2023 strong biological rationale and and rapidly expand to unmet ne
Slide 20: PA: mRNA-3927 Phase 1/2 trial dose expansion ongoing
Quarter 1 2023 Update| R&D/Clinical Programs PA: mRNA-3927 Phase 1/2 trial dose expansion ongoing; interim clinical data to be presented at ASGCT on May 18 Program Updates Phase 1/2 Trial Design • The Paramount study is ongoing, currently enrolling patients in cohort 5 (0.9mg/kg) with no DLTs observ
Slide 21: 1Q23 earnings call agenda
1Q23 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 21 © 2023 Moderna, Inc. All rights reserved.
Slide 22: Recorded $1.8B of COVID-19 vaccine sales in 1Q23
Quarter 1 2023 Update| Commercial Market Recorded $1.8B of COVID-19 vaccine sales in 1Q23 1Q23 sales comprised mainly of ex-US regions: Europe: $0.6 billion RoW: $1.3 billion $1.8 billion1 of vaccine sales from previously announced APAs were delivered in 1Q23, representing the majority of the $2 bil
Slide 23: Reiterating 2023 minimum sales of ~$5B from COVID-19 APAs
Quarter 1 2023 Update| Commercial Market Reiterating 2023 minimum sales of ~$5B from previously announced COVID-19 APAs; positive ongoing discussions for additional contracts Previously Expected new sales announced APAs for 2H deliveries 1H deliveries 2H deliveries − United States (commercial & gove
Slide 24: COVID-19 is a substantial health burden in the United States
Quarter 1 2023 Update| Commercial Market COVID-19 is a substantial health burden in the United States In the most recent fall/winter season, COVID-19 was the leading cause of hospitalizations in the United States among viral respiratory infections COVID-19 was the third leading cause of death in the
Slide 25: Progress on 2023 U.S. COVID-19 commercial launch
Quarter 1 2023 Update| Commercial Market Progress on 2023 U.S. COVID-19 commercial launch In active supply discussions with customers throughout the U.S. ✓ National/regional pharmacies 2023 U.S. COVID market is ✓ Integrated delivery networks (IDNs) estimated to be ~100M ✓ Government health providers
Slide 26: COVID-19 fall launch marketing activities
Quarter 1 2023 Update| Commercial Market COVID-19 fall launch marketing activities Omni Channel Approach Partnering with Customer Base via tailored to assist with identifying patients digital messaging to and simplifying vaccination health care providers Launch experience preparations in progress Fa
Slide 27: 2024 RSV launch preparations
Quarter 1 2023 Update| Commercial Market 2024 RSV launch preparations Launch preparations in progress Phase 3 ConquerRSV trial delivered clinical evidence of Generating and communicating evidence on health & economic efficacy in vulnerable older burden of symptoms of RSV in older adults adult popula
Slide 28: Respiratory franchise addresses sizable markets
Quarter 1 2023 Update| Commercial Market Respiratory franchise addresses sizable markets Estimated global RSV Estimated global flu total Estimated global COVID total total addressable market addressable market1 addressable market1 (older adults)1 ~$15B ~$6-8B ~$6-9B Preparing for RSV and flu launche
Slide 29: INT: Identifying eligible populations
Quarter 1 2023 Update| Commercial Market INT: Identifying eligible populations to potentially benefit from Individualized Neoantigen Therapy Announced adjuvant indications Potential other tumor types in adjuvant for Phase 3 and neoadjuvant Neoadjuvant market opportunity ~30K Tumor Eligible patients
Slide 30: 1Q23 earnings call agenda
1Q23 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 30 © 2023 Moderna, Inc. All rights reserved.
Slide 31: First quarter 2023 financial results
Quarter 1 2023 Update| Financials First quarter 2023 financial results Change In $ millions, except per share amounts Q1 2023 Q1 2022 (Q1'23 vs. Q1'22) Product sales $ 1,828 $ 5,925 $ (4,097) (69) % Other revenue 1 34 141 (107) (76) % Total revenue 1,862 6,066 (4,204) (69) % Cost of sales 792 1,017
Slide 32: Cash / investments and cash deposits
Quarter 1 2023 Update| Financials Cash / investments and cash deposits Cash / investments In USD Billions Cash, cash equivalents and investments 17.6 18.2 16.4 Cash, cash equivalents and investments as of March 31, 2023, at $16.4 billion, down from $18.2 billion as of December 31, 2022 12/31/2021 12
Slide 33: Moderna's capital allocation priorities
Quarter 1 2023 Update| Financials Moderna’s capital allocation priorities R&D Investment (in $B) Reinvest in the business and ~4.5 • Phase 3 trials: COVID boosters, Flu, accelerate investment in R&D, RSV, CMV, Next-generation COVID 3.3 2.0 • Individualized Neoantigen Therapy manufacturing infrastruc
Slide 34: 2023 updated financial framework
Quarter 1 2023 Update| Financials 2023 updated financial framework • Reiterating 2023 minimum sales of ~$5 billion from previously announced COVID-19 APAs Sales • Active negotiations for additional sales in the U.S., Japan, EU and other key markets • Continue to expect product sales in 1H 2023 of ~$
Slide 35: Respiratory franchise expected to become significant source of cash by 2027
Quarter 1 2023 Update| Financials Our respiratory franchise (COVID, RSV, flu) is expected to become a significant source of cash generation by 2027 Estimated 2027 Respiratory Product Sales Range Factors affecting revenue range: $15B • Vaccination rates • Strong vaccine efficacy • Standalone versus c
Slide 36: 1Q23 earnings call agenda
1Q23 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 36 © 2023 Moderna, Inc. All rights reserved.
Slide 37: Conclusion: Commercial outlook
Quarter 1 2023 Update| Conclusion Commercial outlook COVID sales RSV pre-launch Oncology In active negotiations Generating and Comprehensive plan to with key customers in communicating expand manufacturing scale major markets evidence on health while reducing needle-to- • U.S. and economic needle ti
Slide 38: Anticipated pipeline milestones in 2023
Quarter 1 2023 Update| Conclusion Anticipated pipeline milestones in 2023 COVID booster vaccines VRBPAC will meet on June 15 for new strain selection Expect to launch a new strain-matched vaccine for fall 2023 RSV vaccine Plan to submit for regulatory approval globally Flu vaccines mRNA-1010 P303 st
Slide 39: Save the Date: Events in 2023
R&D Day September 13th Save the Date ESG Day Events in 2023 December 7th © 2023 Moderna, Inc. All rights reserved.
Slide 40: Our Mission
Our Mission Deliver the greatest possible impact to people through mRNA medicines. © 2023 Moderna, inc. Confidential. All rights reserved.
Slide 41: Q&A Thank you
Q&A Thank you © 2023 Moderna, 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 Spikevax®/mRNA-1273.214/.222 Worldwide COVID-19 vaccine mRNA-1283 Next generation (2-5 °C) Worldwide mRNA-1010 Worldwide Adults mRNA-1020 Worldwide Flu vaccin
Slide 43: Moderna's Latent & Emerging Vaccines (Pipeline 2/3)
Moderna’s Latent & Emerging Vaccines (Pipeline 2/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights CMV vaccine mRNA-1647 Worldwide EBV vaccine (to prevent Latent infectious mononucleosis) mRNA-1189 Worldwide EBV vaccine (to address EBV mRNA-1195 World
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 Worldwide Autoimmune hepatitis mRNA-6981 therapeutics Individualized neoantigen 50-50