Moderna, Inc. · NASDAQ:MRNA

Moderna — Q4 2023 Earnings Presentation

36 slides from Moderna's earnings presentation, Feb 22, 2024

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: Moderna’s expected revenues in 2024 and trends informing Moderna's 2024 sales outloo
Slide 3: 4Q23 earnings call agenda
4Q23 earnings call agenda 2023 Business Review Stéphane Bancel, CEO Financials Jamey Mock, CFO R&D/Clinical Programs Stephen Hoge, M.D., President 2024 Priorities Stéphane Bancel, CEO 3 © 2024 Moderna, Inc. All rights reserved.
Slide 4: Moderna 2023 Mission and impact
4Q 2023 Update| Business Review Moderna 2023 Mission and impact Our mission In 2023 Deliver the We impacted over 100 greatest million people. possible impact to people We advanced our pipeline across infectious diseases, through mRNA oncology and rare diseases. medicines. 4 © 2024 Moderna, Inc. All
Slide 5: Commercial Market: 2023 a difficult year of transition
4Q 2023 Update| Commercial Market 2023 was a difficult year of transition to a seasonal Moderna 2023 endemic market Sales at low end of framework at $6.1B, excluding the recognition of $0.6B in deferred revenue related to Gavi Actions taken Resized manufacturing to improve • Vaccination rate in the
Slide 6: Development team had a great year in 2023
4Q 2023 Update| Commercial Market While sales were challenging, our development team Moderna 2023 had a great year Respiratory Latent + other Oncology Rare disease External vaccines vaccines therapeutics therapeutics partnerships Advanced late-stage CMV Phase 3 • Phase 3 adjuvant • PA dose • OriCiro
Slide 7: 2023 GAAP financial summary
4Q 2023 Update| Business Review Moderna 2023 2023 GAAP financial summary Revenue1: Net income (loss): Cash and investments: $6.8B $(4.7)B $13.3B 1. Includes the recognition of $0.6B from deferred revenue related to Gavi. 7 © 2024 Moderna, Inc. All rights reserved.
Slide 8: 4Q23 earnings call agenda
4Q23 earnings call agenda 2023 Business Review Stéphane Bancel, CEO Financials Jamey Mock, CFO R&D/Clinical Programs Stephen Hoge, M.D., President 2024 Priorities Stéphane Bancel, CEO 8 © 2024 Moderna, Inc. All rights reserved.
Slide 9: Q4 2023 product sales of $2.8B, full year $6.7B
4Q 2023 Update| Financial Review Q4 2023 product sales of $2.8B, full year product sales of $6.7B met low end of sales range Note: Q4 and FY revenue figures include the recognition of $0.6B from deferred revenue related to Gavi. Europe includes EU, UK, and Switzerland 9 © 2024 Moderna, Inc. All righ
Slide 10: Fourth quarter 2023 financial results
4Q 2023 Update| Financial Review Fourth quarter 2023 financial results Change In $ millions, except per share amounts 4Q 2023 4Q 2022 (4Q'23 vs. 4Q'22) Net product sales $ 2,793 $ 4,859 $ (2,066) (43)% Other revenue1 18 225 (207) (92) % Total revenue 2,811 5,084 (2,273) (45)% Cost of sales 929 1,918
Slide 11: Full year 2023 financial results
4Q 2023 Update| Financial Review Full year 2023 financial results Change In $ millions, except per share amounts FY 2023 FY 2022 (FY'23 vs. FY'22) Net product sales $ 6,671 $ 18,435 $ (11,764) (64)% Other revenue1 177 828 (651) (79) % Total revenue 6,848 19,263 (12,415) (64)% Cost of sales 4,693 5,4
Slide 12: Full year 2023 results with and without key charges and benefit of Gavi
4Q 2023 Update| Financial Review Full year 2023 financial results with and without key charges and benefit of Gavi GAAP Non-GAAP Gavi product sales, Adjusted In $ millions FY 2023 Manufacturing resizing, and Tax FY 2023 related charges 6,671 (589) 6,082 Gavi product sales Net product sales • Include
Slide 13: 2024 financial framework
4Q 2023 Update| Financial Review 2024 financial framework Expectations for full year 2024 Net sales ~$4 billion (1H’24: ~$0.1 billion reflecting seasonality of the respiratory business) Cost of sales ~35% of product sales R&D ~$4.5 billion SG&A ~$1.3 billion Tax Negligible Capital ~$0.9 billion expe
Slide 14: 4Q23 earnings call agenda
4Q23 earnings call agenda 2023 Business Review Stéphane Bancel, CEO Financials Jamey Mock, CFO R&D/Clinical Programs Stephen Hoge, M.D., President 2024 Priorities Stéphane Bancel, CEO 14 © 2024 Moderna, Inc. All rights reserved.
Slide 15: Late-stage pipeline in four franchises provides foundation for growth
4Q 2023 Update| R&D/Clinical Programs Moderna’s late-stage pipeline in our four franchises provides foundation for growth 2024 - 2025 • RSV • Flu • Next-Gen COVID • Flu/COVID combo INT 2025 + • Adjuvant • PA CMV Melanoma • MMA • Adjuvant NSCLC 15 © 2024 Moderna, Inc. All rights reserved.
Slide 16: Clinical milestones achieved across infectious disease vaccines in 2023
4Q 2023 Update| R&D/Clinical Programs Clinical milestones achieved across infectious disease vaccines in 2023 RSV: Filed for approvals in key markets CMV: Fully enrolled Phase 3 study Flu: Phase 3 P303 study met primary endpoints against all strains Next-Gen COVID: Fully enrolled Phase 3 study Flu/C
Slide 17: RSV vaccine efficacy met primary and key secondary endpoints
4Q 2023 Update| R&D/Clinical Programs RSV vaccine efficacy met primary and key secondary endpoints in primary analysis Study 301 per protocol analysis, median follow up of 3.7 months (14 days – 12 months range) after vaccine/placebo Cases, n (%) (mRNA-1345) Placebo Vaccine Efficacy (%) (N = 17,572)
Slide 18: Sustained efficacy against RSV LRTD in additional analysis
4Q 2023 Update| R&D/Clinical Programs Sustained efficacy against RSV LRTD in additional analysis of mRNA-1345 Unblinded analysis, median follow of 8.6 months (15 days – 17.7 months range) after vaccine/placebo Cases, n (%) mRNA-1345 Placebo Vaccine Efficacy (%) (N = 18,112) (N = 18,045) Based on Haz
Slide 19: Durable protection through full 2022-2023 RSV season for mRNA-1345
4Q 2023 Update| R&D/Clinical Programs Primary and additional analyses confirm durable protection through full 2022-2023 RSV season for mRNA-1345 US 2021-2023 RSV Hospitalization Rates (RSV-NET) in Adults ≥65 Years1,2 • RSV efficacy study Vaccination Period conducted across November 2021 – December 2
Slide 20: Clinical milestones achieved in therapeutics in 2023
4Q 2023 Update| R&D/Clinical Programs Clinical milestones achieved in therapeutics in 2023 Individualized Neoantigen Therapy (INT) PA and MMA • Started Phase 3 clinical studies in two Continued to demonstrate cancer indications, adjuvant melanoma early positive clinical data and non-small cell lung
Slide 21: INT: 3 year follow-up data
4Q 2023 Update| R&D/Clinical Programs Clinical milestones achieved in therapeutics in 2023 INT: 3 year follow-up data Adjuvant treatment with mRNA- mRNA-4157 (V940) in 4157 (V940) in combination with combination with KEYTRUDA KEYTRUDA continued to also continued to demonstrate demonstrate a clinical
Slide 22: Anticipated milestones for late-stage programs in 2024
4Q 2023 Update| R&D/Clinical Programs Anticipated milestones for late-stage programs in 2024 Respiratory vaccines • RSV vaccine (mRNA-1345): approvals beginning in 1H24 and subsequent commercial launches globally • Flu vaccine (mRNA-1010): in discussions with regulators and intend to file in 2024 •
Slide 23: 4Q23 earnings call agenda
4Q23 earnings call agenda 2023 Business Review Stéphane Bancel, CEO Financials Jamey Mock, CFO R&D/Clinical Programs Stephen Hoge, M.D., President 2024 Priorities Stéphane Bancel, CEO 23 © 2024 Moderna, Inc. All rights reserved.
Slide 25: Commercial execution
4Q 2023 Update| Conclusion Commercial execution COVID RSV Our focus is working with public health to increase vaccination coverage rates for FDA PDUFA date1 is May 12; the 2024/2025 season to reduce ACIP meeting is June 26-28 U.S. U.S. the substantial burden of COVID New tender published in January
Slide 26: Expecting a strong RSV vaccine launch into a large market in 2024
4Q 2023 Update| Conclusion Expecting a strong RSV vaccine launch into a large market in 2024 RSV peak global market size1,2 Observed strong consumer awareness and demand in first year of RSV market ~$2.5B total market sales in 20233 1. Analyst reports: Leerink investor report: RSV could be next $10B
Slide 27: Strong value proposition for our RSV vaccine
4Q 2023 Update| Conclusion We have a strong value proposition for our RSV vaccine Only mRNA RSV investigational vaccine with positive Phase 3 data Study demonstrated consistently strong efficacy across vulnerable and older populations1 83.7% efficacy in overall study population Well-established safe
Slide 28: Late-stage pipeline execution
4Q 2023 Update| Conclusion Late-stage pipeline execution Respiratory Latent + other Oncology Rare disease vaccines vaccines therapeutics therapeutics • Flu (mRNA-1010) • CMV (mRNA-1647) • Individualized • PA (mRNA-3927) and start regulatory filing Potential efficacy Neoantigen Therapy MMA (mRNA-3705
Slide 29: Financial discipline
4Q 2023 Update| Conclusion Financial discipline Manufacturing R&D SG&A Capital Working cost savings prioritization prioritization expenditures capital In-house and Primarily to complete improvement suppliers our footprint build-out AI across all teams: saving time, increasing productivity, driving s
Slide 34: 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 COVID-19 vaccine mRNA-1273/Spikevax® Worldwide COVID-19 vaccine (next generation) mRNA-1283 Worldwide mRNA-1010 Worldwide Adults mRNA-1020 Worldwide Flu vacci
Slide 35: 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 EBV vaccine (to prevent Latent infectious mononucleosis) mRNA-1189 Worldwide EBV vaccine (to address EBV mRNA-1195 Worldwid
Slide 36: 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

Moderna — Q4 2023 Earnings Presentation on 6ix

Moderna — Q4 2023 Earnings Presentation

Slide 1: Fourth Quarter & Full Year 2023 Financial Results

Slide 2: Forward-looking statements and disclaimer

Slide 3: 4Q23 earnings call agenda

Slide 4: Moderna 2023 Mission and impact

Slide 5: Commercial Market: 2023 a difficult year of transition

Slide 6: Development team had a great year in 2023

Slide 7: 2023 GAAP financial summary

Slide 8: 4Q23 earnings call agenda

Slide 9: Q4 2023 product sales of $2.8B, full year $6.7B

Slide 10: Fourth quarter 2023 financial results

Slide 11: Full year 2023 financial results

Slide 12: Full year 2023 results with and without key charges and benefit of Gavi

Slide 13: 2024 financial framework

Slide 14: 4Q23 earnings call agenda

Slide 15: Late-stage pipeline in four franchises provides foundation for growth

Slide 16: Clinical milestones achieved across infectious disease vaccines in 2023

Slide 17: RSV vaccine efficacy met primary and key secondary endpoints

Slide 18: Sustained efficacy against RSV LRTD in additional analysis

Slide 19: Durable protection through full 2022-2023 RSV season for mRNA-1345

Slide 20: Clinical milestones achieved in therapeutics in 2023

Slide 21: INT: 3 year follow-up data

Slide 22: Anticipated milestones for late-stage programs in 2024

Slide 23: 4Q23 earnings call agenda

Slide 24: 2024 is all about execution

Slide 25: Commercial execution

Slide 26: Expecting a strong RSV vaccine launch into a large market in 2024

Slide 27: Strong value proposition for our RSV vaccine

Slide 28: Late-stage pipeline execution

Slide 29: Financial discipline

Slide 30: 2024 is all about execution

Slide 31: Our Mission

Slide 32: Save the Date: Events in 2024

Slide 33: Thank you

Slide 34: Moderna's Respiratory Vaccines (Pipeline 1/3)

Slide 35: Moderna's Latent & Other Vaccines (Pipeline 2/3)

Slide 36: Moderna's Therapeutics (Pipeline 3/3)