Slide 1: Business Updates and First Quarter 2020 Financial Results
DNA mRNA Protein Business Updates and First Quarter 2020 Financial Results May 7, 2020
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, but not limited to, statements concerning: the impact of the SARS-CoV-2 pandemic on the Company’s clinical
Slide 3: mRNA as a potential new class of medicines
mRNA as a potential 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 3
Slide 4: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Personalized OX40L/ cancer IL-23/IL-36𝛾 CM V vaccine (triplet) vaccine VEGF-A (no LNP) KRAS Biology risk cancer OX40L Zika vaccine vaccine PD-L1 M MA PA H10/H7 Chikungunya influenza antibody vaccine Technology risk Modality Localized
Slide 5: 2019 was an inflection year in Moderna's history
2019 was an inflection year in Moderna’s history Our modality strategy Personalized OX40L/ cancer IL-23/IL-36𝛾 CM V vaccine (triplet) vaccine VEGF-A (no LNP) KRAS Biology risk cancer OX40L Zika vaccine vaccine PD-L1 M MA PA H10/H7 Chikungunya influenza antibody vaccine Technology risk Modality…
Slide 6: 2019 was an inflection year in Moderna's history
2019 was an inflection year in Moderna’s history Our modality strategy Core Exploratory Personalized OX40L/ CM V cancer IL-23/IL-36𝛾 vaccine vaccine (triplet) Biology risk VEGF-A (no LNP) Zika KRAS vaccine PD-L1 cancer OX40L vaccine M MA PA H10/H7 Chikungunya influenza antibody vaccine Technology…
Slide 7: Expanding core modalities with additional development candidates
Expanding core modalities with additional development candidates Core Exploratory Personalized OX40L/ cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk VEGF-A (no LNP) KRAS cancer OX40L vaccine M MA PA CMV Chikungunya vaccine antibody Technology risk Systemic Localized Systemic Prophylactic…
Slide 8: Progression towards a new class of medicines
Progression towards a new class of medicines Strategic plan presented in February 2020 May 2020 Impact Develop mRNA science, Explore mRNA t echnology Build Core modalities Scale for commercial delivery t echnology and across six different manufacturing modalit ies Investigate current and creat e new
Slide 9: Major acceleration of Moderna's development
Major acceleration of Moderna’s development SARS-CoV-2 vaccine (mRNA-1273) Phase 2 – FDA clearance to proceed with Phase 2 study on Wednesday, May 6th Phase 3 – Finalizing protocol for Phase 3 study, expected to begin in early summer 2020 Potential biologic license application (BLA) approval for mRN
Slide 10: Progression towards a new class of medicines
Progression towards a new class of medicines May 2020 Build Core modalities Impact Investigate current and creat e new Exploratory modalit ies Develop mRNA science, Explore mRNA t echnology Scale for commercial delivery t echnology and across six different manufacturing modalit ies Scientific Accele
Slide 11: New leadership additions
New leadership additions Patrick Bergstedt Jacqueline Miller, M.D., FAAP Charbel Haber, M.P.H., Ph.D. SVP, Commercial Vaccines SVP, Infectious Disease Development SVP, Regulatory Affairs Joining from Merck & Co. Joining from GlaxoSmithKline Joining from Biogen Previously Head of Global Marketing & P
Slide 12: Core modality: Prophylactic vaccines
Core modality: Prophylactic vaccines Core Exploratory Personalized OX40L/ cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk VEGF-A (no LNP) KRAS cancer OX40L vaccine M MA PA CMV Chikungunya vaccine antibody Technology risk Systemic Localized Systemic Prophylactic secreted & cell Cancer…
Slide 13: mRNA as a potential new class of vaccines
mRNA as a potential new class of vaccines 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 13
Slide 14: Evidence that the platform is delivering in vaccines
Evidence that the platform is delivering in vaccines Higher probability of Accelerated research and Greater capital efficiency Large product opportunity technical success development timelines over time (vs. recombinant) Market opportunity Probability of success Time requirements Power of the platfo
Slide 15: Moderna's vaccine franchise
Moderna’s vaccine franchise FDA clearance to proceed with SARS-CoV-2 Phase 2 study >1,500 healthy volunteers enrolled in ten Phase 1 and one Phase 2 vaccine trials (dose levels up to 400µg); Safety emerging safety & tolerability profile consistent with marketed adjuvanted vaccines 1 We have observed
Slide 16: Accelerated research and development
Accelerated research and development SARS-CoV-2 vaccine (mRNA-1273) April 16, 2020 May 1, 2020 January 13, 2020 Aw ard from U.S. gov ernment Collaboration announced w ith Sequence for mRNA-1273 agency BARDA for up to Lonza Ltd to manufacture Early summer 2020 against the nov el $483 million to accel
Slide 17: SARS-CoV-2 vaccine (mRNA-1273)
SARS-CoV-2 vaccine (mRNA-1273) Phase 1 trial (run by the National Institutes of Health) Key objective: To assess the safety, reactogenicity and immunogenicity of Day 1 Day 29 mRNA-1273 SARS-CoV-2 Phase 1 dosing regimen Study design: Phase 1, open-label dose ranging clinical trial in males and non- p
Slide 18: Late stage development for SARS-CoV-2 vaccine (mRNA-1273)
Late stage development for SARS-CoV-2 vaccine (mRNA-1273) • Expected to begin in 2Q20 • Study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of Planned mRNA-1273 given 28 days apart Phase 2 study • Subject to receive placebo, 50 μg or a 250 μg dose at both vaccinatio
Slide 19: Moderna and Lonza collaboration
Moderna and Lonza collaboration Goal to enable manufacturing of up to one billion doses per year 1 Plan to establish manufacturing suites at Lonza Lonza’s facilities in the U.S. Lonza NH Sw itze rland (New Hampshire) and Mode rna Switzerland Te chnology Ce nte r Technology transfer expected to begin
Slide 20: Late stage development for CMV vaccine (mRNA-1647)
Late stage development for CMV vaccine (mRNA-1647) • 3 dose levels; randomized, observer-blind, placebo-controlled, multicenter • 252 seronegative & seropositive adults Phase 2 • Utilizes intended Phase 3 formulation; same lipid nanoparticle (LNP) used in Phase 1 dose • Phase 2 study fully enrolled;
Slide 21: Zika vaccine (mRNA-1893) Phase 1 interim analysis
Zika vaccine (mRNA-1893) Phase 1 interim analysis 10 and 30 µg dose levels interim analysis summary Immunogenicity in Flavivirus Baseline Seronegative Participants (Per-Protocol Set) • Safety: Both 10 and 30 µg dose levels were generally well tolerated PRNT50 • No grade 3 adverse reactions (ARs) wer
Slide 22: Exploratory modalities are a critical part of our strategy
Exploratory modalities are a critical part of our strategy to maximize applications of our mRNA medicines Core Exploratory Personalized OX40L/ cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk VEGF-A (no LNP) KRAS cancer OX40L vaccine M MA PA CMV Chikungunya vaccine antibody Technology risk…
Slide 23: Anticipated clinical next steps and catalysts
Anticipated clinical next steps and catalysts • SARS-CoV-2 – Phase 1 safety and immunogenicity data readout for first 3 cohorts, Phase 2 start • CMV – Phase 2 immunogenicity data at 3-month I A, Phase 3 start • hMPV/PIV3 – Phase 1b seropositiv e age de-escalation study resumption Core modalities Pro
Slide 24: Vertex Agreement
Vertex Agreement Extended collaboration to August 2021 Goal: Aimed at discovery and development of potential mRNA medicines for the treatment of cystic fibrosis, or CF, by enabling cells in the lungs of people with CF to produce functional CFTR proteins July 2016 July 2019 March 2020 Entered into a
Slide 25: First quarter 2020 financial results (Unaudited)
First quarter 2020 financial results (Unaudited) Balance Sheets March 31, December 31, 2020 2019 Cash, cash equivalents and investments 1 $ 1.72 billion $ 1.26 billion Statements of Cash Flows 3 months ended 3 months ended Mar. 31, 2020 Mar. 31, 2019 Net cash used in operating activities 2 $ 106 mm
Slide 26: Selected cash flow information and 2020 guidance
Selected cash flow information and 2020 guidance Selected Cash Flow Information 3 months 6 months 9 months Year 3 months ended ended ended ended ended Mar. 31, 2019 Jun. 30, 2019 Sept. 30, 2019 Dec. 31, 2019 Mar. 31, 2020 Statements of Cash Flows (unaudited) (unaudited) (unaudited) (audited) (unaudi
Slide 27: We have up to $2.4 billion to invest and create value
We have up to $2.4 billion to invest and create value Cash Position (unaudited) Novel Coronavirus Award Additional Grants2 (unaudited) Award from U.S. government Total additional funding agency BARDA for up to available from grants is Approximately $1.72 billion $483 million to accelerate of cash an
Slide 28: Development pipeline
Development pipeline May 2020 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 SARS-CoV-2 Phase 3 H7N9 Adult RSV SARS-CoV-2 EBV (mRNA1172) (open IND) preparations Prophylactic SARS-CoV-2 Core modalities vaccines Pediatric RSV Phase 2 Phase 3 (mRNA-1345) hMPV/PIV3 Zika preparations CMV preparatio
Slide 29: Moderna in May 2020
Moderna in May 2020 2 6 12 11 Pipeline Preparing for I n or preparing Ph 1 trials ongoing Positiv e Ph 1 readouts: Ph 3 for Ph 2 7 v accines, PCV, OX40L, VEGF, anti-Chikungunya antibody 7 5 4 2 Development Vaccines for major unmet needs Immuno-Oncology Rare disease Autoimmune Programs in • SARS-CoV-
Slide 30: Progression towards a new class of medicines
Progression towards a new class of medicines May 2020 Build Core modalities Impact Investigate current and creat e new Exploratory modalit ies Develop mRNA science, Explore mRNA t echnology Scale for commercial delivery t echnology and across six different manufacturing modalit ies Scientific Accele
Slide 31: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 31