Slide 1: Business Updates and Second Quarter 2020 Financial Results
DNA mRNA Protein Business Updates and Second Quarter 2020 Financial Results August 5, 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 interim results from the Phase 2 study of mRNA-1647; the timing and de
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: 2Q20 accomplishments
2Q20 accomplishments • Vaccine against COVID-19 (mRNA-1273) • Phase 2 start, Phase 3 investments made at risk • Lonza partnership signed and technology transfer started • Raised $1.3B from equity offering to enable manufacturing for mRNA-1273 • Initially awarded up to $483M from BARDA for mRNA-1273
Slide 5: 2Q20 earnings call agenda
2Q20 earnings call agenda 1 Clinical programs update 2 mRNA-1273 value discussion 3 Financial update Slide 5
Slide 6: 2Q20 earnings call agenda
2Q20 earnings call agenda 1 Clinical programs update 2 mRNA-1273 value discussion 3 Financial update Slide 6
Slide 7: Moderna's vaccine franchise
Moderna’s vaccine franchise Prophylactic Vaccines Clinical Trial Updates • Positive interim Phase 1 data published in The New England Journal of Medicine COVID-19 vaccine • Phase 2 fully enrolled, trial is ongoing (mRNA-1273) • Phase 3 trial started July 27th CMV vaccine • Phase 2 interim data expec
Slide 8: Moderna's vaccine franchise
Moderna’s vaccine franchise Prophylactic Vaccines Clinical Trial Updates • Positive interim Phase 1 data published in The New England Journal of Medicine COVID-19 vaccine • Phase 2 fully enrolled, trial is ongoing (mRNA-1273) Phase •New 3 trial data started Julytoday: available 27th CMV vaccine Phas
Slide 9: Most common systemic ARs
CMV vaccine (mRNA-1647) Phase 1 interim analysis Solicited adverse reactions (AR) post 3rd vaccination, solicited safety set Local ARs Most common systemic ARs Values represent n (%) participants reporting each AR, red tex t=grade 3 ARs ▪ One asymptomatic Grade 4 elevation in partial thromboplastin
Slide 10: CMV vaccine (mRNA-1647) Phase 1 interim analysis
CMV vaccine (mRNA-1647) Phase 1 interim analysis Immunogenicity in CMV-seronegative participants, per-protocol set • In CMV-seronegative subjects, neutralizing antibody titers against epithelial cell infection at the 90 μg and 180 μg doses were 3.6- and 3.9-fold higher than the CMV-seropositive benc
Slide 11: CMV vaccine (mRNA-1647) Phase 1 interim analysis
CMV vaccine (mRNA-1647) Phase 1 interim analysis Neutralizing antibodies against epithelial cell infection by serostatus Slide 11
Slide 12: Late stage development for CMV vaccine (mRNA-1647)
Late stage development for CMV vaccine (mRNA-1647) Phase 2 • 3 dose levels; randomized, observer-blind, placebo-controlled, multicenter dose • 252 seronegative & seropositive adults fully enrolled in Phase 2 confirmation • Utilizes intended Phase 3 formulation; same lipid nanoparticle (LNP) used in
Slide 13: Zika vaccine (mRNA-1893) Phase 1 interim analysis
Zika vaccine (mRNA-1893) Phase 1 interim analysis Safety profile (10, 30, 100 and 250 µg cohorts) Solicited ARs post-Dose 1 (solicited safety set) Solicited ARs post-Dose 2 (solicited safety set) • Both the 100 and 250 Placebo 10µg 30µg 100µg 250µg Placebo 10µg 30µg 100µg 250µg µg dose levels were N
Slide 14: Zika vaccine (mRNA-1893) Phase 1 interim analysis
Zika vaccine (mRNA-1893) Phase 1 interim analysis Immunogenicity in baseline seronegative participants Immunogenicity in Flavivirus Baseline Seronegative Participants (Per-Protocol Set) PRNT 50 • All dose levels induce a strong neutralizing ZIKV - Placebo 10µg 30µg 100µg 250µg specific antibody resp
Slide 15: Zika vaccine (mRNA-1893) Phase 1 interim analysis
Zika vaccine (mRNA-1893) Phase 1 interim analysis Immunogenicity in baseline seropositive participants • All dose levels induce a strong neutralizing ZIKV - specific antibody response in both flavivirus infection naive participants and in participants with pre-existing flavivirus antibodies (such as
Slide 16: mRNA-1273 vaccine against COVID-19
mRNA-1273 vaccine against COVID-19 Data generated to date • Phase 1 clinical data – Neutralizing antibody titers were observed in 100% of evaluated participants • In the live SARS-CoV-2 (PRNT80) neutralization assay, the Day 43 geometric mean titer levels at the Phase 3 selected dose of 100 µg were
Slide 17: Other clinical program updates
Other clinical program updates Modality Program Clinical Trial Update Systemic • Phase 1 additional cohorts are fully enrolled and all participants dosed secreted & cell Antibody against • One cohort with steroid premedication at the 0.6mg/kg dose surface Chikungunya virus therapeutics • One cohort
Slide 18: Development pipeline
Development pipeline August 2020 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 H7N9 Adult RSV COVID-19 COVID-19 COVID-19 EBV (mRNA1172) Prophylactic Core modalities vaccines Pediatric RSV Adult RSV Phase 2 Phase 3 (mRNA-1345) hMPV/PIV3 Zika preparations CMV preparations (mRNA1777) Zika CMV Ch
Slide 19: Anticipated clinical next steps and catalysts
Anticipated clinical next steps and catalysts • COVID-19 – Phase 1 older adults and elderly data, Phase 2 data, Phase 3 interim analysis • 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 Prophylac
Slide 20: 2Q20 earnings call agenda
2Q20 earnings call agenda 1 Clinical programs update 2 mRNA-1273 value discussion 3 Financial update Slide 20
Slide 21: COVID-19 has profound and wide-ranging health impacts
COVID-19 has profound and wide-ranging health impacts • SARS-CoV-2 virus: novel coronavirus first identified in humans in COVID-19 sequelae identified to date5,6 December 2019 and cause of COVID-19 Pneumonia • Disease burden: Acute Respiratory Distress - Global: 18,364,694 confirmed cases and 695,84
Slide 22: Approach to assigning value to a COVID-19 pandemic vaccine
Approach to assigning value to a COVID-19 pandemic vaccine Using Health Economic Assessment Framework Populations ICER (QALY $50K) All High-risk • Healthcare value typically includes formal healthcare Short-term adults (age 65+) (age 18+) (medical) costs Current Epidemiology • Incremental cost effec
Slide 23: Approach to assigning value to a COVID-19 pandemic vaccine
Approach to assigning value to a COVID-19 pandemic vaccine Not included in ICER analysis Populations ICER (QALY $50K) All High-risk • Long-term medical Short-term adults (age 65+) sequelae (age 18+) Current Epidemiology trajectory ~$300 ~$650 per course • Social disruption Increased ~$350 ~$725 tran
Slide 24: Approach to delivering value during the COVID-19 pandemic
Approach to delivering value during the COVID-19 pandemic Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients Slide 24
Slide 25: Approach to delivering value during the COVID-19 pandemic
Approach to delivering value during the COVID-19 pandemic Our responsibility in this moment Do everything we can do to Our mission develop a safe and effective vaccine To deliver on the promise of mRNA Invest in manufacturing ahead of science to create a new generation approval to ensure supply of t
Slide 26: Approach to delivering value during the COVID-19 pandemic
Approach to delivering value during the COVID-19 pandemic Pandemic: Price below value Endemic: Traditional dynamics • Pre-approval supply mostly • Price in-line with other to governments innovative vaccines • To date, smaller volume • Market forces, including agreements executed at vaccine efficacy
Slide 27: 2Q20 earnings call agenda
2Q20 earnings call agenda 1 Clinical programs update 2 mRNA-1273 value discussion 3 Financial update Slide 27
Slide 28: Second quarter 2020 financial results (Unaudited)
Second quarter 2020 financial results (Unaudited) Balance Sheets June 30, March 31, 2020 2020 Cash, cash equivalents and investments 1 $ 3.07 billion $ 1.72 billion Statements of Cash Flows 6 months ended 6 months ended June 30, 2020 June 30, 2019 Net cash used in operating activities 2 $ 130 mm $ 2
Slide 29: Selected cash flow information
Selected cash flow information 3 months 6 months 9 months Year 3 months 6 months ended ended ended ended ended ended Mar. 31, 2019 June 30, 2019 Sept. 30, 2019 Dec. 31, 2019 Mar. 31, 2020 June 30, 2020 Statements of Cash Flows (unaudited) (unaudited) (unaudited) (audited) (unaudited) (unaudited) Net
Slide 30: 2020 Guidance
2020 Guidance 2020 Financial Guidance: $0.65 to $0.85 billion of net cash used in operating activ ities and for purchases of property and equipment, including ~$0.4B of customer deposits r eceiv ed as of July 31st ▪ Moderna updates financial guidance to include substantial at-risk investments to ena
Slide 31: Accounting considerations in relation to commercialization of mRNA-1273
Accounting considerations in relation to commercialization of mRNA-1273 • We expense costs related to the production of inventory as research and development Pre-launch expense in the period incurred, until regulatory approval and subsequent inventory commercialization is deemed “probable” and we al
Slide 32: 2Q20 earnings call – closing remarks
2Q20 earnings call – closing remarks Slide 32
Slide 33: Moderna in August 2020
Moderna in August 2020 Phase 3 Phase 2 Phase 1 12 Pipeline COVI D-19 v accine CMV v accine 8 programs Positiv e Phase 1 readouts: 8 v accines, PCV, PCV OX40L, VEGF, anti-Chikungunya antibody VEGF Programs in development 7 5 4 2 Vaccines for major unmet needs Immuno-Oncology Rare disease Autoimmune d
Slide 34: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 34