Slide 1: Business Updates and Third Quarter 2020 Financial Results
DNA mRNA Protein Business Updates and Third Quarter 2020 Financial Results October 29, 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 statements regarding: the timing of the first interim analysis and safety data for mRNA-1273, the disclosu
Slide 3: Key business updates
Key business updates • COVE Phase 3 study: Fully enrolled with 30,000 participants including 37% from diverse communities • Moderna is committed to ensuring quality & transparency: COVE weekly reporting, recruitment from diverse communities, biopharma pledge and posting of Phase 3 protocol • First i
Slide 4: Evolution of net cash (used in) provided by operating activities
Evolution of net cash (used in) provided by operating activities (unaudited) Net cash (used in) provided by operating activities in USD million Upfront and milestone Merck payments AstraZeneca AstraZeneca Vertex Vertex $30M $79M $305M 2020 (by quarter) Deposits for supply contracts ~$1.2B $893 depos
Slide 5: Moderna in October 2020
Moderna in October 2020 Phase 3 Phase 2 Phase 1 12 Pipeline COVI D-19 v accine CMV v accine 7 programs Positiv e Phase 1 readouts: 8 v accines, PCV, (30,000 fully enrolled) PCV, OX40L OX40L, VEGF, anti-Chikungunya antibody VEGF Programs in development 6 5 4 2 Vaccines for major unmet needs Immuno-On
Slide 6: 3Q20 earnings call agenda
3Q20 earnings call agenda 1 Clinical programs update 2 Financial update 3 Conclusion Slide 6
Slide 7: Clinical program updates in core modalities
Clinical program updates in core modalities Modality Program Program Update COVID-19 • Phase 2 fully enrolled; Phase 3 COVE study fully enrolled (30,000 participants) on vaccine October 22nd CMV • Positive interim Phase 2 data announced during R&D Day (September 17 th); pivotal vaccine Phase 3 trial
Slide 8: Clinical program updates in exploratory modalities
Clinical program updates in exploratory modalities Modality Program Program Update • Randomized Phase 2 in combination with KEYTRUDA ® vs. KEYTRUDA ® alone, partnered with Merck, is ongoing Cancer PCV vaccines • Phase 1 cohorts A (resected solid tumors) and B (metastatic/locally advanced solid tumor
Slide 9: Development pipeline October 2020
Development pipeline October 2020 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 Commercial Phase 2 Phase 3 Launch EBV Pediatric RSV Zika preparations CMV preparations COVID-19 preparation Prophylactic Zika CMV COVID-19 Core modalities vaccines H7N9 hMPV/PIV3 Chikungunya Relaxin PD-L1 Systemic
Slide 10: COVID-19 vaccine (mRNA-1273) poised to deliver safety & efficacy readouts
COVID-19 vaccine (mRNA-1273) poised to deliver safety & efficacy readouts Preclinical and clinical data show consistent and robust immune responses Nonhuman primate data publication showed mRNA-1273 led to a robust immune response and protection against SARS-CoV-2 infection1 • Two-dose vaccination s
Slide 11: 100 µg mRNA-1273 well-tolerated across age groups (Phase 1)
100 µg mRNA-1273 well-tolerated across age groups (Phase 1) Grade 1 (mild) Grade 2 (moderate) Grade 3 (severe) Phase 1: No Vaccine-Related SAEs Have Been Reported Solicited Local and Systemic Symptoms Followed for 7 Days Post-vaccination Majority of symptoms resolved within 2 days, some persisted as
Slide 12: Distribution of antibody titers in pseudovirus neutralization assay
Distribution of antibody titers in pseudovirus neutralization assay comparable across age groups (Phase 1) Pseudovirus neutralization assay titers (ID50)- 100 μg at Day 1 and Day 29 18 – 55 years 56 – 70 years 71+ years D57 GMT: 267 D57 GMT: 324 D57 GMT: 242 95% CI: 186, 385 95% CI: 212, 496 95% CI:
Slide 13: Pivotal Phase 3 efficacy, safety and immunogenicity study
Pivotal Phase 3 efficacy, safety and immunogenicity study Fully enrolled (N=30,000) on October 22nd Phase 3 trial overview (NCT04470427) Protocol Title A Phase 3, Randomized, Stratified, Observ er-Blind, Placebo-Controlled Study to Ev aluate the Efficacy, Safety, and I mmunogenicity of mRNA-1273 SAR
Slide 14: COVE study successfully recruited diverse and representative participants
COVE study successfully recruited diverse and representative participants Race and ethnicity distribution Age breakdown* Gender distribution All Others Asian 4% 3% 12,000 Male Black/AA Female 10% 10,000 8,000 6,000 39% 47% 53% Hispanic 20% 4,000 29% 25% /Latinx 63% White 2,000 5% 0 18 to 24 25 to 44
Slide 15: COVE study enrolled participants with risk factors for severe COVID-19
COVE study successfully enrolled participants with risk factors for severe COVID-19 disease Risk stratification Comorbidities of at risk participants (all ages) ➢ 8,000+ participants who are living with chronic conditions Slide 15 I nterim data snapshot - October 21, 2020 - subject to change
Slide 16: A vaccine for everyone…find yourself in the COVE study
A vaccine for everyone…find yourself in the COVE study Hispanic 6,000+ participants Educators and Students 9% participants African American 3,000+ participants Over 65 Years of Age 25% of participants Male 53% of participants Ages 25-44 29% of participants Healthcare Workers 22% of participants Livi
Slide 17: Overview of primary efficacy endpoint
Overview of primary efficacy endpoint Boundary Crossing Probabilities by Interim Boundaries Using O’Brien-Fleming Spending Function Effect Size Approximate # VE: Efficacy of cases bound >95% probability Interim 53 ~0.74 analysis #1 ~50% probability Interim 106 ~0.57 analysis #2 151 ~0.50
Slide 18: Commitment to transparency of Phase 3 interim analyses
Commitment to transparency of Phase 3 interim analyses Three potential outcomes from the interim analyses • Study meets statistical hurdle (>74% at first interim and >57% at second interim) and we will trigger the analyses required to determine whether to proceed with regulatory submissions while th
Slide 19: Distribution to any immunization locations using existing infrastructure
Distribution to any immunization locations using existing infrastructure Storage Conditions* Freezer: -20°C/-4°F for 6 Flexible and adaptable months supply chain + Uses standard existing vaccination infrastructure Fridge: 2-8°C/~36-46°F for up to 7 days No dilution required + Currently anticipate Sh
Slide 20: 3Q20 earnings call agenda
3Q20 earnings call agenda 1 Clinical programs update 2 Financial update 3 Conclusion Slide 20
Slide 21: Third quarter 2020 financial results (Unaudited)
Third quarter 2020 financial results (Unaudited) Balance Sheet Data September 30, June 30, 2020 2020 Cash, cash equivalents and investments 1 $ 3.97 billion $ 3.07 billion Cash Flow Data 9 months ended 9 months ended September 30, 2020 September 30, 2019 Net cash provided by (used in) operating acti
Slide 22: Selected cash flow information
Selected cash flow information 3 months 6 months 9 months Year 3 months 6 months 9 months ended ended ended ended ended ended ended Statements of Cash Flows March 31, 2019 June 30, 2019 Sept. 30, 2019 Dec. 31, 2019 March 31, 2020 June 30, 2020 Sept. 30, 2020 (unaudited) (unaudited) (unaudited) (audi
Slide 23: Publicly announced supply agreements
Publicly announced supply agreements On track to supply between 500 million and 1 billion doses in 2021 3Q20 deferred revenues: $1.1 billion Deals signed Pricing of deals signed • United States (100 million doses with option • Smaller volume agreements executed at for additional 400 million doses) $
Slide 24: 2020 Financial Update
2020 Financial Update 2020 Financial Update: +$0.1 to +$0.3 billion of net cash provided by operating activities and used for purchases of property and equipment, including ~$1.2B of customer deposits received as of Sept. 30 Net cash provided by operating activities and for purchases of property and
Slide 25: Key accounting issues related to mRNA-1273
Key accounting issues related to mRNA-1273 Accounting Practice Current Practice Approval Event Future Practice (through approval event) (Example – EUA) (post approval event) • Commercial Expensed as R&D in the period Commence capitalization of inventory Inventory incurred associated with probable sa
Slide 26: 3Q20 earnings call agenda
3Q20 earnings call agenda 1 Clinical programs update 2 Financial update 3 Conclusion Slide 26
Slide 27: 2021 should be a major inflection point in Moderna's history
2021 should be a major inflection point in Moderna’s history We entered this crisis strong (YE 2019) We expect to exit this crisis stronger (YE 2021)* • Cash: Large cash balance expected…$4B Sep 2020 + • Cash and investments of $1.26B CF to be generated in 2021* • Diverse clinical portfolio of vacci
Slide 28: 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 28
Slide 29: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 29