Moderna, Inc. · NASDAQ:MRNA
Moderna — Q2 2023 Earnings Presentation
38 slides from Moderna's earnings presentation, Aug 3, 2023
Slide 1: Second Quarter 2023 Financial Results
Second Quarter 2023 Financial Results August 3, 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: Moderna’s submissions to regulators globally for the approval or authorization of mR
Slide 3: 2Q23 earnings call agenda
2Q23 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: 2Q23 financial highlights
2Q 2023 Update| Business Review 2Q23 financial highlights 2Q23 GAAP financial results Revenue: Net income (loss): Earnings per Cash and $0.3 billion $(1.4) billion share (loss): investments: $(3.62) $14.6 billion Capital allocation highlights Reinvest in External investment Return capital the busine
Slide 5: 2Q23 commercial and late-stage clinical updates
2Q 2023 Update| Business Review 2Q23 commercial and late-stage clinical updates 2023 COVID-19 RSV regulatory Individualized Neoantigen market pre-launch activity Therapy (INT) • Submitted updated • Rolling submission started in • Initiated Phase 3 study in COVID-19 vaccine to the United States adjuv
Slide 6: Programs in development
2Q 2023 Update| Business Review Moderna as of August 2023 6 in Phase 3 7 in Phase 2 47 development Pipeline Commercial COVID-19 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 mRN
Slide 7: Accelerating AI at Moderna
2Q 2023 Update| Business Review Accelerating AI at Moderna Moderna named one of the world’s most innovative companies for MODERNA MINDSET We digitize everywhere possible using the power of “pioneering AI-driven innovation” digital information to maximize our impact on patients. Use of large language
Slide 8: 2Q23 earnings call agenda
2Q23 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
2Q 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-1273.222/.815) COVID-19 next-gen booster COVID-19 + flu
Slide 10: Updated XBB.1.5 COVID-19 vaccine submitted globally for regulatory approval
2Q 2023 Update| R&D/Clinical Programs Updated XBB.1.5 COVID-19 vaccine submitted globally for regulatory approval ahead of Fall 2023 season COVID-19 updated regulatory recommendations • On its June 15th meeting, VRBPAC unanimously recommended a monovalent XBB lineage vaccine, with a preference for s
Slide 11: Phase 2/3 data with monovalent XBB.1.5 vaccine
2Q 2023 Update| R&D/Clinical Programs Clinical data from our Phase 2/3 study with a monovalent XBB.1.5 vaccine (mRNA-1273.815) demonstrated potent neutralization and cross-reactivity Monovalent XBB.1.5 Neutralizing Antibody Titer (ID50) 100000 XBB.1.5 XBB.1.16 XBB.2.3.2 10.0-fold rise 9.7-fold rise
Slide 12: RSV: mRNA-1345 on track for approvals in 2024
2Q 2023 Update| R&D/Clinical Programs RSV: mRNA-1345 older adult on track for expected global regulatory approvals in 2024 with potential best-in-class profile U.S. regulatory submission Initiated a rolling submission process for a Biologics License Application (BLA) to the FDA, with the option to u
Slide 13: Flu: mRNA-1010 P303 study fully enrolled
2Q 2023 Update| R&D/Clinical Programs Flu: mRNA-1010 P303 Phase 3 study is fully enrolled; update expected in 3Q23 Design Randomized, observer-blind, active-controlled study • P303 will test the immunogenicity of an Number of participants updated formulation of 2,400 medically stable adults ≥ 18 yea
Slide 14: Latent vaccines
2Q 2023 Update| R&D/Clinical Programs Latent vaccines Phase 3 CMVictory study is >80% enrolled 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 (mRNA-1647) EBV (mRNA-1189; mRNA-1195) HSV (mRNA-1608) PC
Slide 15: mRNA therapeutics
2Q 2023 Update| R&D/Clinical Programs mRNA therapeutics INT enrolling patients in Phase 3 adjuvant melanoma study; PA dose confirmation cohort 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 Neoantige
Slide 16: INT: adjuvant melanoma Phase 3 trial now enrolling
2Q 2023 Update| R&D/Clinical Programs INT: adjuvant melanoma Phase 3 trial is now enrolling Primary endpoint is recurrence free survival compared to pembrolizumab Randomized, double-blind placebo controlled, INT + pembrolizumab (KEYTRUDA®) vs. placebo + pembrolizumab (1:1) Resected melanoma patients
Slide 17: 2Q23 earnings call agenda
2Q23 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 17 © 2023 Moderna, Inc. All rights reserved.
Slide 18: 2Q23 COVID-19 vaccine sales of $0.3B
2Q 2023 Update| Commercial Market 2Q23 COVID-19 vaccine sales of $0.3B $2.1B Achieved expectations of ~$2B 1H23 APA $0.3B deliveries • $0.3 billion of vaccine sales from previously announced APAs were delivered in 2Q23 • $2.1 billion in vaccine sales reported in 1H23 $1.8B Additional sales expected
Slide 19: Expecting 2023 COVID-19 sales of $6-8B
2Q 2023 Update| Commercial Market Expecting 2023 COVID-19 sales of $6-8B, dependent on U.S. vaccination rates Previously Expected additional announced APAs sales for 2H deliveries 1H deliveries 2H deliveries United States European Union Canada Kuwait Japan Japan Switzerland South Korea European Unio
Slide 20: Expecting 2023 COVID-19 sales of $6-8B
2Q 2023 Update| Commercial Market Expecting 2023 COVID-19 sales of $6-8B, dependent on U.S. vaccination rates Previously Expected additional announced APAs sales for 2H deliveries 1H deliveries 2H deliveries United States European Union Canada Commercial contracts signed Kuwait Japan • Retail pharma
Slide 21: U.S. Fall 2023 COVID-19 market size
2Q 2023 Update| Commercial Market U.S. Fall 2023 COVID-19 market size is dependent on vaccination rates Parameters informing 2023 COVID-19 volume forecast 2022 Fall season doses Average annual flu doses Initial 2023 forecast administered in the U.S administered in the U.S.1 ~50 million ~100 million
Slide 22: 2023 Fall vaccine campaign
2Q 2023 Update| Commercial Market 2023 Fall vaccine campaign focused on increasing market doses administered and solidifying Moderna’s market share 22 © 2023 Moderna, Inc. All rights reserved.
Slide 23: Strong product profile for expected RSV 2024 launch
2Q 2023 Update| Commercial Market Strong product profile for expected RSV 2024 launch Only mRNA RSV investigational vaccine with positive Phase 3 data High efficacy across vulnerable and older populations1 83.7% efficacy in overall study population Well-established safety and Ease of administration
Slide 24: 2Q23 earnings call agenda
2Q23 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 24 © 2023 Moderna, Inc. All rights reserved.
Slide 25: Second quarter 2023 financial results
2Q 2023 Update| Financial Review Second quarter 2023 financial results Change In $ millions, except per share amounts 2Q 2023 2Q 2022 (2Q23 vs. 2Q22) Product sales $ 293 $ 4,531 $ (4,238) (94) % Other revenue1 51 218 (167) (77) % Total revenue 344 4,749 (4,405) (93) % Cost of sales 731 1,381 (650) (
Slide 26: Cash / investments and cash deposits
2Q 2023 Update| Financial Review Cash / investments and cash deposits Cash / investments In USD Billions Cash, cash equivalents and investments 18.2 16.4 14.6 Cash, cash equivalents and investments as of June 30, 2023, at $14.6 billion, down from $16.4 billion as of March 31, 2023 12/31/2022 3/31/20
Slide 27: Moderna's capital allocation priorities
2Q 2023 Update| Financial Review Moderna’s capital allocation priorities R&D investment ($B) Reinvest in the business and ~4.5 • Phase 3 trials: COVID boosters, Flu, accelerate investment in R&D, RSV, CMV, Next-gen COVID-19, INT 3.3 2.0 • Individualized Neoantigen Therapy manufacturing infrastructur
Slide 28: 2023 updated financial framework
2Q 2023 Update| Financial Review 2023 updated financial framework • Expecting 2023 COVID-19 sales of $6-8 billion, dependent on U.S. vaccination rates Sales • 2H23 sales timing subject to regulatory approvals; currently expecting sales split of ~30% in Q3; 70% in Q4 Cost of sales • Now expect FY 202
Slide 29: 2Q23 earnings call agenda
2Q23 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 29 © 2023 Moderna, Inc. All rights reserved.
Slide 30: Commercial outlook
2Q 2023 Update| Conclusion Commercial outlook COVID-19 sales RSV Individualized Neoantigen Therapy Commercial contracts Anticipate RSV Comprehensive plan to in place across U.S. commercial launch expand manufacturing customer segments in 2024 scale while reducing needle-to-needle time frames Expecti
Slide 31: Preparing to launch new products in 2024 through 2026
Moderna is preparing to launch a number of new products in 2Q 2023 Update| Conclusion 2024 through 2026 • RSV • Next-gen Up to 5 • Seasonal Flu COVID-19 respiratory • Combination vaccines • Next-gen Flu vaccines Our mRNA Our first latent virus vaccine • CMV platform is poised to deliver Our first on
Slide 32: Save the Date: R&D Day and ESG Day
R&D Day September 13th Save the Date ESG Day Events in 2023 December 7th © 2023 Moderna, Inc. All rights reserved.
Slide 33: Our Mission
Our Mission Deliver the greatest possible impact to people through mRNA medicines. © 2023 Moderna, inc. Confidential. All rights reserved.
Slide 34: Thank you
Thank you Q&A © 2023 Moderna, inc. Confidential. All rights reserved.
Slide 35: 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® Worldwide COVID-19 vaccine mRNA-1283 Next generation (2-5 °C) Worldwide mRNA-1010 Worldwide Adults mRNA-1020 Worldwide Flu vaccine mRNA-1030 Worldwi
Slide 36: 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 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 Systemic Relaxin mRNA-0184 Worldwide secreted & cell Heart failure surface PD-L1 Worldwide Autoimmune hepatitis mRNA-6981 therapeutics Individualized neoantigen 50-50
Slide 38: Anticipated pipeline milestones in 2023
2Q 2023 Update| Conclusion Anticipated pipeline milestones in 2023 COVID-19 vaccines sBLA approval/authorization of new XBB.1.5 vaccine; ACIP Fall booster recommendations Flu vaccines mRNA-1010 P303 update in 3Q RSV vaccine Complete FDA rolling submission in 3Q with priority review voucher (PRV) CMV