Slide 1: Business Updates First Quarter 2021 Financial Results
DNA mRNA Protein Business Updates First Quarter 2021 Financial Results May 6, 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); the number o
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: The Moderna COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authoriza
Slide 4: 1Q21 earnings call agenda
1Q21 earnings call agenda Stéphane Bancel Business Review Chief Executive Officer Corinne Le Goff, Pharm.D., M.B.A. Commercial Review Chief Commercial Officer David Meline Financials Chief Financial Officer Stephen Hoge, M.D. Clinical Program Review President Stéphane Bancel Conclusion/Q&A Chief Exe
Slide 5: 102 million doses shipped in 1Q 2021
Moderna’s COVID-19 vaccine is protecting people in 37 countries already 102 million doses of Moderna COVID-19 vaccine shipped in 1Q 2021 Slide 5
Slide 6: First quarter 2021 highlights
First quarter 2021 highlights • Q1 financials summary ̶ Revenue: $1.9B ($1.7B of COVID-19 vaccine sales) ̶ Net income: $1.2B - First GAAP profitable quarter in company’s history ̶ Cash and investments: $8.2B • 2021 vaccine supply: Increased 2021 supply forecast to between 800 million and 1 billion d
Slide 7: Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines
Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines in 2022 and beyond Science Market Pipeline • Variants of concern continue to emerge • Epidemiologists expect a surge in cases in the southern hemisphere during April 2021-October 2021 • Expect booster shots wil
Slide 8: Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines
Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines in 2022 and beyond Science Market Pipeline • Variants of concern continue to • We believe mRNA vaccines are emerge best-in-class • Epidemiologists expect a surge in • Through numerous discussions we cases in th
Slide 9: Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines
Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines in 2022 and beyond Science Market Pipeline • Variants of concern continue to • We believe mRNA vaccines are • COVID-19 annual booster emerge best-in-class vaccines late 2021, 2022, 2023… • Epidemiologists expec
Slide 10: Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines
Additional manufacturing investments to respond to global need for mRNA COVID-19 vaccines in 2022 and beyond 2021 Supply 2022 Supply • Investments allow for a doubling of drug substance • Raised 2021 manufacturing production capacity and an increase in formulation, fill supply forecast to between an
Slide 11: Best-in-class vaccine storage and distribution requirements
Best-in-class vaccine storage and distribution requirements among authorized mRNA vaccines Shipping is in standard freezers (-20°C) and 100 doses in carton to pallet(s) (237,600 doses/pallet) Storage is up to 6 months in a standard freezer and 4 weeks at refrigerated temperatures (2-8°C) Only author
Slide 12: Progress in developing therapies for rare diseases and other indications
We are proud of our progress in developing therapies for rare diseases and other therapeutic indications First patient dosed in Propionic Acidemia (mRNA-3927) Phase Systemic Intracellular Therapeutics 1/2 Paramount Study • Infectious diseases We have now • Oncology entered the clinic • Cardiovascula
Slide 13: Programs in development
Moderna as of May 2021 Phase 3 Phase 2 13 positive Phase 1 readouts Pipeline Commercial COVI D-19 v accine preparation PCV, OX40L, VEGF 9 I D v accine programs PCV, OX40L, VEGF, anti-Chikungunya antibody (repeat dose) CMV v accine Infectious Disease Vaccines mRNA Therapeutics Programs in development
Slide 14: 1Q21 earnings call agenda
1Q21 earnings call agenda Stéphane Bancel Business Review Chief Executive Officer Corinne Le Goff, Pharm.D., M.B.A. Commercial Review Chief Commercial Officer David Meline Financials Chief Financial Officer Stephen Hoge, M.D. Clinical Program Review President Stéphane Bancel Conclusion/Q&A Chief Exe
Slide 15: Access to our COVID-19 vaccine with recently signed agreements for 2022 and beyond
Our commitment to provide access to our COVID-19 vaccine continues with our recently signed agreements for 2022 and beyond Recently signed deals for 2021, 2022 and beyond Signed APAs for 2021 Signed APAs for 2021 and 2022 (incl. options) COVAX (34 million doses in 2021 with option for up to additi
Slide 16: Q1'21 Commercial Update
Q1’21 Commercial Update $1.7B in Product Sales, 102M doses delivered Product Sales In USD Billions 1.7 0.4 Rest of World ▪ Q1’21 Product Sales of $1.73B ▪ $1.4B US ▪ $0.4B Rest of World, including EU, Canada, 1.4 US Switzerland, Israel, Singapore and Qatar 0.2 0.2 0.0 Q4’20 Q1’21 Millions of doses 1
Slide 17: 1Q21 earnings call agenda
1Q21 earnings call agenda Stéphane Bancel Business Review Chief Executive Officer Corinne Le Goff, Pharm.D., M.B.A. Commercial Review Chief Commercial Officer David Meline Financials Chief Financial Officer Stephen Hoge, M.D. Clinical Program Review President Stéphane Bancel Conclusion/Q&A Chief Exe
Slide 18: First quarter 2021 financial results
First quarter 2021 financial results In $ millions, except per share amounts (unaudited) Q1 2021 Q1 2020 Product sales1 $ 1,733 $ - Grant rev enue2 194 4 Collaboration rev enue 10 4 Total revenue 1,937 8 Cost of sales 193 - Research and dev elopment 401 115 Selling, general and administrativ e 77 24
Slide 19: Cash and selected cash flow information
Cash and selected cash flow information March 31, 2021 Balance Sheet Data December 31, 2020 (unaudited) Cash, cash equivalents and investments 1 $ 8.2 billion $ 5.2 billion Q1 2021 Q1 2020 Statements of Cash Flows Data (unaudited) (unaudited) Net cash provided by (used in) operating activities $ 2,9
Slide 20: Q1 Financial considerations – Product Sales
Q1 Financial considerations – Product Sales Product Sales – Q1 2021 In USD Billions Millions of doses 1.73 ▪ Total Product Sales in Q1: $1.73B ▪ US: $1.36B 0.38 102 1.36 ▪ Rest of World: $0.38B 88 14 ▪ Delivered doses in Q1: 102M ▪ US: 88M ▪ Rest of World: 14M US Rest of World Total US Rest of World
Slide 21: Q1 Financial considerations – Cost of Sales
Q1 Financial considerations – Cost of Sales Cost of Sales (CoS) – Q1 2021 In USD Millions 377 ▪ Cost of sales reported in Q1: $193M or 11% of product sales 184 ▪ In Q1 $184M of zero cost pre-launch inventory was sold. This inventory was 193 expensed as research and development prior to authorization
Slide 22: Q1 Financial considerations – Cash/ investments
Q1 Financial considerations – Cash/ investments Cash / Investments In USD Billions Cash, Cash equivalents and Investments 8.2 ▪ Cash, Cash equivalents and Investments as of March 31, 2021 5.2 4.0 at $8.2B, up from $5.2B end of December 2021 9/30/2020 12/31/2020 3/31/2021 ▪ Net balance of Cash deposi
Slide 23: Q1 Financial considerations – Tax rate
Q1 Financial considerations – Tax rate Tax Rate Considerations In USD Billions $2.3 ▪ Significant investments into our research, development and startup activities to develop the mRNA platform over the last decade resulted in Net-Operating loss carryforwards with a balance of $2.3B at year end 2020
Slide 24: 2021 updated financial framework
2021 updated financial framework ▪ For expected deliv ery in FY 2021: Adv ance Purchase Agreements (APAs) already signed for product sales of ~$19.2 billion APAs and ▪ FY dose capacity for 2021: minimum of 800M up to 1 billion doses (at 100μg / dose) Dose Volume ▪ 2021 Q1 deliv ered doses: 102M ▪ 20
Slide 25: 1Q21 earnings call agenda
1Q21 earnings call agenda Stéphane Bancel Business Review Chief Executive Officer Corinne Le Goff, Pharm.D., M.B.A. Commercial Review Chief Commercial Officer David Meline Financials Chief Financial Officer Stephen Hoge, M.D. Clinical Program Review President Stéphane Bancel Conclusion/Q&A Chief Exe
Slide 26: Our strategy for combating COVID-19
Our strategy for combating COVID-19 mRNA-1273: Moderna COVID-19 Vaccine I 50 μg of mRNA-1273 (data being shared today) Phase 2 trial mRNA-1273.351: Variant-specific booster candidate based on underway to II the B.1.351 (variant first identified in the Republic of South Africa) evaluate three • 20 μg
Slide 27: Solicited local and systemic adverse events within 7 days after booster
Solicited local and systemic adverse events within 7 days after vaccination with a booster dose of mRNA-1273 or mRNA-1273.351 Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA- 1273 or mRNA-1273.351 were generally comparable to those observed after the second
Slide 28: Neutralization of SARS-CoV-2 Pseudoviruses against wildtype and variants of concern
Neutralization of SARS-Cov-2 Pseudoviruses against wildtype and variants of concern Neutralization of SARS-CoV-2 Neutralization of SARS-CoV-2 Pseudoviruses in Serum Samples 1 Pseudoviruses 6-8 months post primary (1 week post second dose from the vaccination series with mRNA-1273 primary series of m
Slide 29: PsVN titers were boosted in all participants and against all tested variants
Two weeks after receiving either mRNA-1273 or mRNA-1273.351, PsVN titers were boosted in all participants and against all tested variants Initial observations Following boost, geometric mean titers (GMT) against the wild-type, B.1.351, and P.1 variants Booster Dose of 50 µg increased to levels simil
Slide 30: PsVN titers were boosted in all participants and against all tested variants
Two weeks after receiving either mRNA-1273 or mRNA-1273.351, PsVN titers were boosted in all participants and against all tested variants Primary series comparison, 1 week post dose 2 of mRNA-1273 Booster Dose of 50 µg of mRNA-1273 Booster Dose of 50 µg of mRNA-1273.351 Neutralization of recombinant
Slide 31: Other vaccine programs are in/preparing for clinical trials
Other vaccine programs are in/preparing for clinical trials CMV vaccine preparing for Phase 3 start in 2021 Prophylactic Vaccines CMV vaccine • CMV vaccine is on track to start the pivotal Phase 3 trial in 2021 (roughly ~8,000 participants) Zika vaccine • Preparing for Phase 2 trial; expected to beg
Slide 32: Clinical programs continue to enroll across modalities
Clinical programs continue to enroll across modalities Seven clinical proof of concept trials Modalities • VEGF (AstraZeneca): Phase 2 ongoing Localized regenerative therapeutics • PCV: Randomized Phase 2 in combination with KEYTRUDA ® vs. KEYTRUDA ® alone, partnered with Merck, is ongoing ̶ Phase 1
Slide 33: Moderna's Development pipeline
Moderna’s Development pipeline May 2021 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 Commercial Ph2 prep Ph3 prep EBV Flu RSV Zika Zika CMV CMV COVID-19 Prophylactic Core modalities vaccines COVID-19 Nipah HIV H7N9 COVID-19 hMPV/PIV3 (mRNA-1273-351/- (mRNA-1283) 211) Chikungunya Systemic sec
Slide 34: 1Q21 earnings call agenda
1Q21 earnings call agenda Stéphane Bancel Business Review Chief Executive Officer Corinne Le Goff, Pharm.D., M.B.A. Commercial Review Chief Commercial Officer David Meline Financials Chief Financial Officer Stephen Hoge, M.D. Clinical Program Review President Stéphane Bancel Conclusion/Q&A Chief Exe
Slide 35: 2021 and looking into 2022
2021 and looking into 2022 2021 APAs: ̶ Increased to $19.2B 2022 APAs: ̶ Some countries have already signed APAs for 2022: Israel, Switzerland ̶ COVAX facility for up to 466m doses in 2022 ̶ Discussions ongoing for 2022 APAs with all the countries that signed APAs for 2021 ̶ Discussions ongoing with
Slide 36: Looking at the next 5-10 years
Looking at the next 5-10 years • We believe we have the most innovative vaccine pipeline in the industry: COVID-19 variants, Flu, RSV, CMV, EBV, … • We now have therapeutics development candidates in the clinic in Oncology, Cardiology, and Rare Diseases ̶ Aim to start studies in Auto-immune diseases
Slide 37: Accelerating our investment in digital, automation and AI
Accelerating our investment in digital, automation and AI • R&D: Accelerate the pace of learning and innovation 2019-2021 digital investments and change the paradigm of clinical execution expected to be over $250 million • Manufacturing: Enable rapid and efficient scale up of internal and external m
Slide 38: We integrate automation, AI and digital technology into everything we do
We integrate automation, AI and digital technology into everything we do We are investing in harmonized and integrated data, intelligent Technical Development automation of repetitive tasks and integrated systems with More data Better algorithms one entry point Research Quality Select programs inclu
Slide 39: Expansion of Manufacturing Technology Center (MTC)
Expansion of Manufacturing Technology Center (MTC) MTC South (original manufacturing site) • ~200,000 square feet • Opened in July 2018 MTC South Slide 39
Slide 40: Expansion of Manufacturing Technology Center (MTC)
Expansion of Manufacturing Technology Center (MTC) MTC South (original manufacturing site) MTC East • ~200,000 square feet • Opened in July 2018 MTC MTC North North • ~225,000 square feet • Opened in May 2020 MTC East MTC • ~240,000 square feet South • Expected to open 4Q21 Approximately 650,000 squ
Slide 41: Our Commitment to Corporate Responsibility
Our Commitment to Corporate Responsibility Commitment to Belonging, Commitment to the Environment Community Outreach Inclusion & Diversity • Published expanded workforce • Aim to source U.S. facilities with • In our communities, we are giving diversity figures for the first time renewable energy and
Slide 42: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 42
Slide 43: Science Day and R&D Day: Save the Date
Science Day May 27th Save the Date Events in 2021 R&D Day September 9th Slide 43