Slide 1: Business Updates Second Quarter 2021 Financial Results
DNA mRNA Protein Business Updates Second Quarter 2021 Financial Results August 5, 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 development of the Moderna COVID-19 Vaccine (mRNA-1273); its efforts t
Slide 3: Moderna COVID-19 Vaccine: Authorized Use & Important Safety Information
Moderna COVID-19 Vaccine: Authorized Use & Important Safety Information Authorized Use in the United States: Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respira
Slide 4: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Commercial Review – Corinne Le Goff, Pharm.D., CCO 2Q21 Earnings 3 Financials – David Meline, CFO Call Clinical Program Review – Jacqueline Miller, M.D., SVP 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stépha
Slide 5: Second quarter 2021 highlights – Strong pipeline momentum
Second quarter 2021 highlights – Strong pipeline momentum • Moderna COVID-19 Vaccine/SpikevaxTM: Final blinded analysis of Phase 3 COVE study shows 93% efficacy; Efficacy remains durable through six months after second dose ̶ Initiated the rolling submission process for a BLA in the U.S. and expect
Slide 6: Second quarter 2021 highlights – Strong commercial momentum
Second quarter 2021 highlights – Strong commercial momentum • Advance Purchase Agreements (APAs) for Moderna COVID-19 Vaccine/SpikevaxTM: ̶ FY 2021: APAs signed for product sales of ~$20 billion versus $19.2 billion announced on Q1 earning call ̶ FY 2022: APAs already signed for $12 billion and an a
Slide 7: Moderna COVID-19 Vaccine supply update
Moderna COVID-19 Vaccine supply update Global manufacturing supply Global manufacturing supply forecast to be between 2 2021 forecast to be between 800 2022 billion doses (if primarily 100 μg Supply million to 1 billion doses Supply doses) and 3 billion doses (if primarily 50 μg doses) Additional li
Slide 8: New additions to the Executive Committee
New additions to the Executive Committee Shannon Thyme Klinger Paul Burton, M.D., Ph.D., Kate Cronin Chief Legal Officer and F.A.C.C, M.R.C.S Chief Brand Officer Corporate Secretary Chief Medical Officer Previously Global CEO of Ogilvy Previously Chief Legal Officer Previously Chief Global Health, p
Slide 9: Programs in development
Moderna as of August 2021 Commercial Phase 2/3 Phase 2 13 positive Phase 1 readouts Pipeline COVID-19 vaccine preparation COVID-19 boosters, Zika, PCV, VEGF 9 ID vaccine programs PCV, OX40L, VEGF, anti-Chikungunya antibody (repeat dose) CMV, RSV and Flu vaccine Infectious Disease Vaccines mRNA Thera
Slide 10: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Commercial Review – Corinne Le Goff, Pharm.D., CCO 2Q21 Earnings 3 Financials – David Meline, CFO Call Clinical Program Review – Jacqueline Miller, M.D., SVP 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stépha
Slide 11: Moderna COVID-19 vaccine APAs signed for 2021 delivery
Moderna COVID-19 vaccine APAs signed for 2021 delivery Contracted product sales of ~$20 billion in 2021 North and South America Int’l Organizations Signed APAs for 2021 United States (~400M doses) COVAX/UNICEF (34M doses) Canada1 (34M doses) Working with U.S government to Colombia (10M dos
Slide 12: Moderna COVID-19 vaccine APAs signed for 2022 and 2023 delivery
Moderna COVID-19 vaccine APAs signed for 2022 and 2023 delivery Contracted product sales of ~$12 billion and options of ~$8 billion in 2022 North and South America Int’l Organizations Signed APAs for 2022 and 2023 United States (90M doses) COVAX/UNICEF (117M (incl. options) Argentina (20M dose
Slide 13: Q2'21 Commercial Update
Q2’21 Commercial Update $4.2B in Product Sales, 199M doses delivered Product Sales In USD Billions 4.2 ▪ Q2’21 Product Sales of $4.2B 2.1 Rest of World ▪ $2.1B US 1.7 ▪ $2.1B Rest of World, including EU, Canada, Japan, 0.4 2.1 US Switzerland, United Kingdom, Singapore, Qatar, 1.4 Philippines, Taiwan
Slide 14: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Commercial Review – Corinne Le Goff, Pharm.D., CCO 2Q21 Earnings 3 Financials – David Meline, CFO Call Jacqueline Miller, M.D., SVP 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 14
Slide 15: Second quarter 2021 financial results
Second quarter 2021 financial results In $ millions, except per share amounts (unaudited) Q2 2021 Q1 2021 Q2 2020 QoQ Change QoQ Change (Q2'21 vs. Q1'21) (Q2'21 vs. Q1'21) Product sales1 $ 4,197 $ 1,733 $ — $ 2,464 142 % Grant revenue2 139 194 38 (55) (28)% Collaboration revenue 18 10 29 8 80 % Tota
Slide 16: Year-to-date 2021 financial results
Year-to-date 2021 financial results 2021 YTD 2020 YTD YoY YoY In $ millions, except per share amounts (unaudited) ended 6/30/21 ended 6/30/20 Change Change Product sales1 $ 5,930 $ — $ 5,930 100 % Grant revenue2 333 42 291 693 % Collaboration revenue 28 33 (5) (15)% Total revenue 6,291 75 6,216 8,28
Slide 17: Cash and selected cash flow information
Cash and selected cash flow information June 30, 2021 March 31, 2021 December 31, Balance Sheet Data (unaudited) (unaudited) 2020 Cash, cash equivalents and investments1 $12.2 billion $8.2 billion $5.2 billion 2021 YTD 2020 YTD Statements of Cash Flows Data ended 6/30/21 Q2 2021 Q1 2021 ended 6/30/2
Slide 18: Q2 Financial considerations – Cost of Sales
Q2 Financial considerations – Cost of Sales Cost of Sales (CoS) – Q1 2021 Cost of Sales (CoS) – Q2 2021 In USD Millions In USD Millions 750 ▪ Cost of sales reported in ▪ Cost of sales reported in Q2 is Q1: $193M or 11% of not materially impacted by product sales zero cost inventory ▪ In Q1 $184M of
Slide 19: Q2 Financial considerations – Cash/Investments
Q2 Financial considerations – Cash/ Investments Cash / Investments In USD Billions Cash, Cash equivalents and Investments 12.2 ▪ Cash, Cash equivalents and Investments as 8.2 of June 30, 2021 at $12.2B, up from $8.2B as of March 31, 2021 5.2 ▪ Net balance of Cash deposits for future 12/31/2020 3/31/
Slide 20: Moderna's capital allocation priorities
Moderna’s capital allocation priorities ▪ Advance and accelerate our existing pipeline of 23 development programs ▪ Expand our pipeline, particularly within core modalities Reinvest in the base business & ▪ Invest in our technology platform and in potential new modalities - such as 1 accelerate inve
Slide 21: 2021 and 2022 updated financial framework
2021 and 2022 updated financial framework ▪ For expected delivery in FY 2021: Advance Purchase Agreements (APAs) already signed for product sales of ~$20 billion 2021 ▪ FY dose capacity for 2021: minimum of 800M up to 1 billion doses (at 100μg / dose) APAs and Dose ▪ For expected delivery in FY 2022
Slide 22: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Commercial Review – Corinne Le Goff, Pharm.D., CCO 2Q21 Earnings 3 Financials – David Meline, CFO Call 4 Jacqueline Miller, M.D., SVP Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 22
Slide 23: Clinical program review topics for today
Clinical program review topics for today Jacqueline Miller, Update on primary vaccination data for mRNA-1273 1 M.D., SVP • Phase 3 final analysis • Emerging real-world evidence of effectiveness Stephen Hoge, M.D., COVID-19 booster strategy 2 President Summary of emerging data from 3 booster (Dose 3)
Slide 24: Final analysis of Phase 3 COVE Study demonstrates vaccine efficacy of 93%
Final analysis of Phase 3 COVE Study demonstrates vaccine efficacy of 93% ▪ COVE Study vaccine efficacy (95% CI) by primary and secondary endpoints at final analysis1: ̶ Against COVID-19: 93.2% (91.0-94.8)* ̶ Against severe COVID-19: 98.2% (92.8-99.6)* ̶ Against death caused by COVID-19: 100% (NE-10
Slide 25: Phase 3 COVE Study: Vaccine efficacy is durable through six months
Phase 3 COVE Study: Vaccine efficacy is durable through six months1 VE (%) First COVID-19 Occurrence2 (95% CI)3 ≥14 days after dose 2* 93.1% (90.9, 94.9) ≥14 days after dose 2 to <2 months after dose 2* 91.8% (86.9, 95.1) ≥ 2 months after dose 2 to <4 months after dose 2* 94.0% (91.2, 96.1) ≥4 month
Slide 26: Emerging real-world evidence confirms efficacy against variants of concern
Emerging real-world evidence confirms efficacy against variants of concern ▪ Emerging real-world evidence is consistent with the effectiveness seen with mRNA-1273 vaccination (e.g., Canada1, England2, and Qatar3) ▪ Emerging data also confirms effectiveness against variants of concern (VOCs), includi
Slide 27: Clinical program review topics for today
Clinical program review topics for today Jacqueline Miller, Update on primary vaccination data for mRNA-1273 1 M.D., SVP • Phase 3 final analysis • Emerging real-world evidence of effectiveness Stephen Hoge, M.D., COVID-19 booster strategy 2 President Summary of emerging data from 3 booster (Dose 3)
Slide 28: Updated COVID-19 perspective and strategy for boosters
Updated COVID-19 perspective and strategy for boosters Our emerging perspective Our booster strategy ▪ We believe that increased force of infection Advance a portfolio of booster resulting from Delta, non-pharmaceutical candidates in ongoing booster studies intervention (NPI) fatigue, and seasonal e
Slide 29: Clinical update: Comparison of booster candidates in P201
Clinical update: Comparison of booster candidates in P201 Validated clinical assays (NIH VRC) Exploratory analysis using research assays Wild-type (D614G) Neutralization mRNA-1273 booster mRNA-1273.351 booster mRNA-1273.211 booster 50µg, N=20 50µg, N=20 50µg, N=20 NAb Titer (ID50 , Log10) 2 weeks af
Slide 30: Performance of mRNA-1273 booster (>6 months) against VOC
Performance of mRNA-1273 booster (>6 months) against VOC Dose 3 booster of 50 μg of mRNA-1273 Pseudovirus neutralization titers Six months post second dose, neutralizing 1210 85 188 antibodies against wild-type (D614G) strain remained detectable Neutralizing antibodies against VOC started lower, and
Slide 31: Clinical update: Phase 2 results from prototype booster
Clinical update: Phase 2 results from prototype booster Earlier this year, our Phase 2 study of mRNA-1273 was amended to offer a 3rd dose of mRNA-1273 (50 µg) to all interested participants >6 months after dose 2 (n=344) Top-line results: (manuscript in preparation) ▪ Neutralizing antibody titers ha
Slide 32: Key takeaways on COVID booster (dose 3)
Key takeaways on COVID booster (dose 3) We believe a booster (dose 3) is likely to be necessary this fall, particularly in the face of Delta Clinical data appears to support 50 μg of mRNA-1273 for booster; no obvious advantage for Beta containing candidates We will wait for 100 μg data (coming weeks
Slide 33: Other vaccine programs in ongoing clinical trials
Other vaccine programs in ongoing clinical trials Quadrivalent seasonal flu vaccine in ongoing Phase 1/2 Prophylactic Vaccines Flu vaccine • mRNA-1010 is Moderna’s first seasonal influenza vaccine candidate to enter the clinic • mRNA-1010 is a quadrivalent seasonal influenza vaccine candidate target
Slide 34: Other vaccine programs in ongoing clinical trials
Other vaccine programs in ongoing clinical trials Quadrivalent seasonal flu vaccine in ongoing Phase 1/2 Prophylactic Vaccines Flu vaccine • mRNA-1010 is Moderna’s first seasonal influenza vaccine candidate to enter the clinic • Positive interim Phase 1 data announced at Vaccines Day on April 14th R
Slide 35: Advancing mRNA therapeutics: Seven programs with ongoing clinical trials
Advancing mRNA therapeutics Seven programs with ongoing clinical trials Modalities Cancer Intratumoral Localized regenerative Systemic secreted & cell Systemic intracellular vaccines immuno-oncology therapeutics surface therapeutics therapeutics Therapeutic Area Oncology Cardiovascular Autoimmune Ra
Slide 36: Moderna's Development pipeline August 2021
Moderna’s Development pipeline August 2021 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 Commercial Ph3 prep Ph3 prep Nipah EBV hMPV/PIV3 Flu Zika CMV COVID-19 CMV Flu Prophylactic Core modalities vaccines COVID-19 COVID-19 Ph3 prep HIV H7N9 RSV (mRNA-1283) (boosters) RSV Chikungunya Systemic
Slide 37: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Commercial Review – Corinne Le Goff, Pharm.D., CCO 2Q21 Earnings 3 Financials – David Meline, CFO Call 4 Clinical Program Review – Stephen Hoge, M.D., President 5 Looking Forward – Stéphane Bancel, CEO Slide 37
Slide 38: Maximizing our impact on patients with our mRNA platform
Maximizing our impact on patients with our mRNA platform Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized VEGF-A cancer Triplet PA (no LNP) vaccine PA COVID-19 Chikungunya vaccine antibody Technology risk Prophylactic Systemic secreted Cancer Intratumoral Localized
Slide 39: Expanding development programs within core modalities
Expanding development programs within core modalities Core Modalities Prophylactic Vaccines • Working on vision to develop a respiratory vaccine combining COVID-19 variant booster + seasonal flu booster + RSV booster: 1 single dose • First patient dosed in quadrivalent flu vaccine Phase 1/2 dose fin
Slide 40: mRNA therapeutics in the clinic across four exploratory modalities
mRNA therapeutics in the clinic across four exploratory modalities Exploratory Modalities Biology risk • Seven clinical programs within exploratory modalities are ongoing Personalized VEGF-A cancer Triplet PA (no LNP) vaccine PA • Each with the ability to establish proof of concept Technology risk C
Slide 41: Investing in science for new modalities, such as the Lung and HSPCs
Investing in science for new modalities, such as the Lung and HSPCs Future Modalities • Two ongoing collaborations with Vertex to address Cystic Fibrosis (~10% of CF patients are not addressable with a CFTR Modulator) I. Using mRNA for produce in patient’s body the correct CFTR protein II. Using mRN
Slide 42: Maximize the number of medicines by leveraging our mRNA platform
Moderna strategy is to maximize the number of medicines by leveraging our mRNA platform in 2 dimensions, at the same time Future Core Modalities Exploratory Modalities Modalities Biology risk Personalized VEGF-A cancer Triplet PA (no LNP) vaccine PA COVID-19 Chikungunya vaccine antibody Technology r
Slide 43: Moderna's capital allocation priorities
Moderna’s capital allocation priorities ▪ Advance and accelerate our existing pipeline of 23 development programs ▪ Expand our pipeline, particularly within core modalities Reinvest in the base business & ▪ Invest in our technology platform and in potential new modalities - such as 1 accelerate inve
Slide 44: Our Commitment to Corporate Social Responsibility
Our Commitment to Corporate Social Responsibility Announced Establishment of New Charitable Foundation • Initial up-front endowment of $50 million • Foundation to support charitable organizations and causes that promote public health, healthcare and educational opportunities, particularly in underse
Slide 45: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 45
Slide 46: R&D Day – Save the Date September 9th
R&D Day Save the Date September 9th Events in 2021 Slide 46