Moderna, Inc. · NASDAQ:MRNA
Moderna — 39th Annual J.P. Morgan Healthcare Conference (January 2021)
37 slides from Moderna's conference presentation, Jan 11, 2021
Slide 1: 39th Annual J.P. Morgan Healthcare Conference
DNA mRNA Protein Storage Software Applications 39th Annual J.P. Morgan Healthcare Conference Stéphane Bancel January 11th, 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 approach to research and development and timelines for individual prod
Slide 3: Moderna COVID-19 Vaccine: Indication & Safety Information
Moderna COVID-19 Vaccine: Indication & Safety Information Authorized Use in the United States: The Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent coronavirus disease 2019 (C
Slide 4: How could a team of 1,000 people go from a novel virus sequence to a COVID-19 vaccine
How could a team of 1,000 people go from a novel virus sequence to a COVID-19 vaccine with 94% efficacy and an EUA in 11 months? Slide 4
Slide 5: Software uses a binary system
Software uses a binary system Binary System Slide 5
Slide 6: Life uses a quaternary system
Life uses a quaternary system Binary System Quaternary System Adenine (A) Uracil (U) Cytosine (C) Guanine (G) Slide 6
Slide 7: Life uses a quaternary system; mRNA is an information molecule
Life uses a quaternary system Binary System Quaternary System Adenine (A) Uracil (U) Cytosine (C) Guanine (G) mRNA is an information molecule Slide 7
Slide 8: mRNA is now a new class of medicines
mRNA is now a new class of medicines 1. Large product opportunity 2. Higher probability of technical success 3. Accelerated research and development timelines 4. Greater capital efficiency over time vs. recombinant technology Slide 8
Slide 9: Moderna's vision for mRNA science
Moderna’s vision for mRNA science mRNA is an Invest in science to invent novel ways to deliver mRNA into various cell 1 information molecule 2 types – each will be a new application, which we call a modality Medicine 2 Medicine 2 Medicine 2 Medicine 2 Medicine 2 Medicine 2 Medicine 2 Medicine 2 Medi
Slide 10: Moderna in January 2021
Moderna in January 2021 10 years and more than $3 billion in investments later 1 COMMERCIAL COVID-19 vaccine Prophylactic vaccines Modality 7 Slide 10 1. Total operating expenses as of 09/30/20
Slide 11: Moderna in January 2021
Moderna in January 2021 10 years and more than $3 billion in investments later 1 COMMERCIAL DEVELOPMENT Core Modalities Exploratory Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secreted Can
Slide 12: Moderna in January 2021
Moderna in January 2021 10 years and more than $3 billion in investments later 1 COMMERCIAL DEVELOPMENT RESEARCH Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophyl
Slide 13: Core modality – prophylactic vaccines
Core modality – prophylactic vaccines COMMERCIAL DEVELOPMENT RESEARCH Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secreted Cancer Intratumoral
Slide 14: Infectious disease vaccines
Infectious disease vaccines 2020 mRNA is the best platform High probability of Many viruses with Pandemic to make vaccines success no vaccine yet S CIE NCE | S P EED | RE S OURCES • It will change how the • Ability to make complex • In clinical trials, we have • High unmet medical need world thinks
Slide 15: Infectious diseases remain a high unmet need
Infectious diseases remain a high unmet need 80+ new viruses discovered in the last 40 years Only 4% have a Select viruses: • Yellow fever (1901) vaccine commercially • Rubella (1941) available in the US • Dengue (1943) • PIV3 (1950s) • Chikungunya (1952) • Zika (1952) Worldwide vaccine • VZV (1954)
Slide 16: Moderna's COVID-19 vaccine (mRNA-1273) is authorized in over 30 countries
Moderna’s COVID-19 vaccine (mRNA-1273) is authorized in over 30 countries Vaccines against respiratory viruses 2021 Revenue • Advance Purchase Agreements (APAs) for FY 2021 already signed for $11.7 COVI D-19 billion with customer deposits of $2.81 billion for future supply of product v accine • More
Slide 17: hMPV/PIV3 vaccine (mRNA-1653) is the first mRNA vaccine in children
hMPV/PIV3 vaccine (mRNA-1653) is the first mRNA vaccine in children Vaccines against respiratory viruses • Revenue: Advance Purchase Agreements (APAs) for FY 2021 already signed for COVI D-19 $11.7 billion, including customer deposits of $2.81 billion for future supply of product v accine • Supply i
Slide 18: RSV vaccine (mRNA-1345) is expanding to elderly population
RSV vaccine (mRNA-1345) is expanding to elderly population Vaccines against respiratory viruses • Revenue: Advance Purchase Agreements (APAs) for FY 2021 already signed for COVI D-19 $11.7 billion, including customer deposits of $2.81 billion for future supply of product v accine • Supply in FY 2021
Slide 19: Moderna announces three new development candidates against influenza
Moderna announces three new development candidates against influenza (mRNA-1010, mRNA-1020 & mRNA-1030) Vaccines against respiratory viruses • Revenue: Advance Purchase Agreements (APAs) for FY 2021 already signed for COVI D-19 $11.7 billion, including customer deposits of $2.81 billion for future s
Slide 20: CMV vaccine (mRNA-1647) Phase 3 to start in 2021
CMV vaccine (mRNA-1647) Phase 3 to start in 2021 Vaccines requiring complex antigens and against highly prevalent infections • Potential first-in-class vaccine (no vaccine on the market) CMV • Phase 3 planned to start in 2021 v accine • Projected $2-5 billion annual peak sales Slide 20
Slide 21: EBV vaccine (mRNA-1189) is a multi-antigen vaccine
EBV vaccine (mRNA-1189) is a multi-antigen vaccine to prevent IM and EBV infection Vaccines requiring complex antigens and against highly prevalent infections • Potential first-in-class vaccine (no vaccine on the market) CMV • Phase 3 planned to start in 2021 v accine • Projected $2-5 billion annual
Slide 22: Zika vaccine (mRNA-1893) Phase 2 to start in 2021
Zika vaccine (mRNA-1893) Phase 2 to start in 2021 Public health vaccines • Potential first-in-class vaccine (no vaccine on the market) Zika • Partnered with BARDA v accine • Successful Phase 1 • Phase 2 to start in 2021 BARDA: Biomedical Advanced Research and Development Authority IAVI: Internationa
Slide 23: Moderna announces two new HIV vaccine development candidates
Moderna announces two new HIV vaccine development candidates (mRNA-1644 & mRNA-1547) Public health vaccines • Potential first-in-class vaccine (no vaccine on the market) Zika • Partnered with BARDA v accine • Successful Phase 1 • Phase 2 to start in 2021 • Potential first-in-class vaccine HI V v acc
Slide 24: Moderna announces a new development candidate against Nipah virus
Moderna announces a new development candidate against Nipah virus (mRNA-1215) Public health vaccines • Potential first-in-class vaccine (no vaccine on the market) Zika • Partnered with BARDA v accine • Successful Phase 1 • Phase 2 to start in 2021 • Potential first-in-class vaccine HI V v accine • P
Slide 25: Infectious disease vaccine modality
Infectious disease vaccine modality Four first-in-class vaccines against respiratory viruses – One commercial vaccine: FY 2021 existing APAs of $11.7 billion and more being negotiated for 2021 and 2022 deliveries – One potential best-in-class vaccine candidate in development for influenza Two first-
Slide 26: Core modality – systemic secreted & cell surface therapeutics
Core modality – systemic secreted & cell surface therapeutics COMMERCIAL DEVELOPMENT RESEARCH Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secr
Slide 27: Moderna can repeat dose safely with systemic secreted & cell surface therapeutics
Moderna can repeat dose safely with systemic secreted & cell surface therapeutics Pharmacology • Consistent CHKV-IgG exposure (Emax) was seen after the first dose between Cohort 3 (0.3 mg/kg single dose) and Cohort 7 (0.3 mg/kg qWx2) • Administration of the second 0.3 mg/kg dose in the 0.3 mg/kg qWx
Slide 28: Systemic secreted & cell surface therapeutics
Systemic secreted & cell surface therapeutics Development Candidates PD-L1 • First indication intended to be autoimmune hepatitis, a compelling unmet need • IL-2 based therapeutics are being clinically evaluated for a IL-2 wide range of autoimmune conditions • First intended subcutaneous administrat
Slide 29: Four exploratory modalities
Four exploratory modalities COMMERCIAL DEVELOPMENT RESEARCH Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secreted Cancer Intratumoral Localized
Slide 30: Looking to generate clinical proof-of-concept data from sentinel programs
Looking to generate clinical proof-of-concept data from sentinel programs in the exploratory modalities Across these modalities we have six programs with ongoing clinical trials and Exploratory Modalities 4 programs in preclinical development Examples: • PCV ̶ Randomized Phase 2 in combination with
Slide 31: Inventing new modalities
Inventing new modalities COMMERCIAL DEVELOPMENT RESEARCH Core Modalities Exploratory Modalities Future Modalities Biology risk Personalized cancer VEGF-A OX40L (no LNP) PA vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secreted Cancer Intratumoral Localized Sy
Slide 32: Anticipated clinical next steps, catalysts and proof-of-concept data
Anticipated clinical next steps, catalysts and proof-of-concept data • COVID-19 – Additional data from Phase 3 study, Phase 2/3 adolescent data readout • CMV – Phase 3 start • hMPV/PIV3 – Phase 1b seropositiv e age de-escalation study data Core modalities • Zika – Phase 2 start Prophylactic • RSV –
Slide 33: Moderna in January 2021
Moderna in January 2021 Phase 3 Phase 2 12 positive Phase 1 readouts Pipeline Commercial COVID-19 vaccine preparation PCV, OX40L, VEGF 8 ID vaccines PCV, OX40L, VEGF, anti-Chikungunya antibody (repeat dose) CMV vaccine Infectious Disease Vaccines mRNA Therapeutics Programs in development 9 Vaccines
Slide 34: Events in 2021: Vaccines Day, Science Day, R&D Day
Vaccines Day April 14th Science Day Save the Date May 27th Events in 2021 R&D Day September 9th Slide 34
Slide 35: 2021 will be the most important inflection year in Moderna's history
2021 will be the most important inflection year in Moderna’s history mRNA is an information molecule Moderna is a platform company making mRNA medicines and vaccines Moderna is a commercial company, already generating positive cash flows Each day we ask ourselves: how do we increase our impact by 10
Slide 36: Thank You!
“Se We've been at this for Le Weel, Our mRNA platform iS amodern approach to medicine. Thank You! But it’s just the beginning. moderna
Slide 37: Development pipeline January 2021
Development pipeline January 2021 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 Commercial Ph2 prep Ph3 prep COVID-19 EBV Flu RSV Zika Zika CMV CMV (pediatric) COVID-19 Prophylactic Core modalities vaccines Nipah HIV H7N9 hMPV/PIV3 Chikungunya Systemic secreted Relaxin PD-L1 antibody & cell s
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