Slide 1: Business Updates: Fourth Quarter & Full Year 2020 Financial Results
DNA mRNA Protein Business Updates Fourth Quarter & Full Year 2020 Financial Results February 25, 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 accounti
Slide 3: Moderna COVID-19 Vaccine: Indication & Safety Information
Moderna COVID-19 Vaccine: Indication & Safety Information Authorized Use in the United States: The Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent coronavirus disease 2019 (C
Slide 4: 4Q20 earnings call agenda
4Q20 earnings call agenda 1 2020: A historic year Business Review – Stéphane Bancel – CEO Financials – David Meline – CFO 2 2021: An inflection year Business Objectives – Stéphane Bancel – CEO Clinical Objectives – Stephen Hoge (President) & Tal Zaks (CMO) Slide 4
Slide 5: 2020 was a historic year
2020 was a historic year January July December Early-stage Late-stage development Commercial development company (with the start company company of our first Phase 3) 2019 2020 • First product authorized/First product • No approved products revenues • Negative cash flow from operations • Q3 and Q4 p
Slide 6: Received first Authorization in Moderna's history in 2020
Received first Authorization in Moderna’s history in 2020 Received Emergency Use Authorization • United States (US FDA) • Canada (Health Canada) Started rolling submissions in: • European Union (EMA) • United Kingdom (MHRA) • Israel (MOH) • Singapore (HSA) • Switzerland (Swissmedic) Slide 6
Slide 7: Moderna expanded its commercial network through new subsidiaries and partners in 2020
Moderna expanded its commercial network through new subsidiaries and partners in 2020 • Moderna USA • Moderna Canada • Europe ̶ Moderna France ̶ Moderna Germany ̶ Moderna Italy ̶ Moderna Spain ̶ Moderna UK ̶ Moderna Switzerland • Israel (Partner: Medison) • Japan (Partner: Takeda) Expanded commercia
Slide 8: Moderna as of February 2021: Programs in development
Moderna as of February 2021 Phase 3 Phase 2 12 positive Phase 1 readouts Pipeline Commercial COVID-19 vaccine preparation PCV, OX40L, VEGF 8 ID vaccines PCV, OX40L, VEGF, anti-Chikungunya antibody (repeat dose) CMV vaccine Infectious Disease Vaccines mRNA Therapeutics Programs in development 9 Vacci
Slide 9: 4Q20 earnings call agenda
4Q20 earnings call agenda 1 2020: A historic year Business Review – Stéphane Bancel – CEO Financials – David Meline – CFO 2 2021: An inflection year Business Objectives – Stéphane Bancel – CEO Clinical Objectives – Stephen Hoge (President) & Tal Zaks (CMO) Slide 9
Slide 10: Key accounting issues related to Moderna COVID-19 Vaccine
Key accounting issues related to Moderna COVID-19 Vaccine Chart presented during 3Q20 earnings call 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
Slide 11: Fourth quarter and full year 2020 financial results
Fourth quarter and full year 2020 financial results In $ Millions Statements of Operations 3 months ended 3 months ended Year ended Year ended December 31, 2020 December 31, 2019 December 31, 2020 December 31, 2019 (unaudited) (unaudited) (unaudited) (audited) Product sales 1 $ 200 - $ 200 - Grant r
Slide 12: Cash and selected cash flow information
Cash and selected cash flow information Balance Sheets September 30, 2020 December 31, 2020 Cash, cash equivalents and investments 1 $ 3.97 billion $ 5.25 billion 3 months 6 months 9 months Year 3 months 6 months 9 months Year ended ended ended ended ended ended ended ended Statements of Cash Flows
Slide 13: Considerations as we became a commercial company late in Q4
Considerations as we became a commercial company late in Q4 R&D and SG&A Expenses Cost of Sales (CoS) In USD Billions In USD Millions ~ 31% of product sales; 62 includes ramp up costs 0.8 -0.3 and royalties 0.5 55 8 Q4 2020 Certain R&D charges prior Q4 2020 Q4 Cost of Zero-cost Q4 Cost of R&D and SG
Slide 14: Moderna's COVID-19 Vaccine supply agreements
Moderna’s COVID-19 Vaccine supply agreements Deals signed1 Deals in negotiation • United States (300 million doses with option for • COVAX additional 200 million doses) • Additional doses in 2021 and 2022 for • European Union (310 million doses with option existing and new customers for additional 1
Slide 15: 2021 financial framework
2021 financial framework ▪ For expected delivery in 2021: Advance Purchase Agreements (APAs) already signed for product sales of ~$18.4 billion1 APAs and ▪ FY dose capacity for 2021: minimum of 700M up to 1 billion doses (at 100μg / dose) Dose Volume ▪ 2021 Q1 forecast for released doses: 100M - 125
Slide 16: 4Q20 earnings call agenda
4Q20 earnings call agenda 1 2020: A historic year Business Review – Stéphane Bancel – CEO Financials – David Meline – CFO 2 2021: An inflection year Business Objectives – Stéphane Bancel – CEO Clinical Objectives – Stephen Hoge (President) & Tal Zaks (CMO) Slide 16
Slide 17: Moderna's COVID-19 vaccine is now authorized in 37 countries
Moderna’s COVID-19 vaccine is now authorized in 37 countries Received Emergency Use Authorization/conditional approvals • United States (US FDA) • Canada (Health Canada) • European Union (EMA/EC) • United Kingdom (MHRA) • Israel (MOH) • Switzerland (Swissmedic) • Singapore (HSA) • Qatar (Ministry of
Slide 18: 2021 will be an inflection year for Moderna
2021 will be an inflection year for Moderna 2019 2020 2021 • No approved products • Authorized product • Authorized product • Negative cash flow • Positive Cash flow in two quarters • Cash flow positive • Unprofitable • Unprofitable • Profitable • Multiple capital raises needed to • Strong balance s
Slide 19: 2021 will be an inflection year for Moderna
2021 will be an inflection year for Moderna FY 2021 APAs FY 2021 Supply Commitment Goal to make the Moderna Signed ~$18.4 billion (as of Raising base case production COVID-19 vaccine available in 02/24/21) to 700 million to 1 billion doses as many countries as possible around the world Slide 19
Slide 20: 2022 manufacturing capacity
2022 manufacturing capacity New capex investments to create capacity of 1.4 billion doses (assuming 100 μg) 2022 Previous 1.2 B doses New Capex Capacity 0.2 B doses @ 100 μg Manufacturing facilities 1.4 B doses 1.4 B doses @ 100 μg 1.0 B doses @ 100 μg 0.8 B doses @ 100 μg 2022 Output OR OR Depends
Slide 21: We will continue to increase the scale of our commercial network in 2021
We will continue to increase the scale of our commercial network in 2021 Presence established Planned in 2021 Planned in 2021: • Moderna Japan • Moderna South Korea • Moderna Australia • Eastern Europe (distributor) • ASEAN (distributor) Slide 21
Slide 22: Hired Corinne Le Goff as our first Chief Commercial Officer
Hired Corinne Le Goff, Pharm.D as our first Chief Commercial Officer in January Chief Commercial Officer Joining from Amgen Previously SVP and President of the U.S. Business Organization Corinne Le Goff, Pharm.D. Slide 22
Slide 23: 4Q20 earnings call agenda
4Q20 earnings call agenda 1 2020: A historic year Business Review – Stéphane Bancel – CEO Financials – David Meline – CFO 2 2021: An inflection year Business Objectives – Stéphane Bancel – CEO Clinical Objectives – Stephen Hoge (President) & Tal Zaks (CMO) ̶ Overview of SARS-CoV-2 variant strategy ̶
Slide 24: Moderna's approach to SARS-CoV-2 variants of concern
Moderna’s approach to SARS-CoV-2 variants of concern (VOC) Initial data confirms that the Moderna COVID-19 Vaccine (mRNA-1273) provides neutralizing activity against variants of concern. Out of an abundance of caution, we have announced multiple strategies to increase protection against the variants
Slide 25: Moderna's COVID-19 Vaccines are ongoing in multiple trials
Moderna’s COVID-19 Vaccines are ongoing in multiple trials Prophylactic Vaccines Clinical Strategy – Proactive Approach COVID-19 • TeenCOVE: Phase 2/3 study in adolescents ages 12-17 years is fully enrolled vaccine Expansion • KidCOVE: Phase 2 study in pediatric population ages 6 months-11 years to
Slide 26: mRNA is well positioned to address evolution of SARS-CoV-2
mRNA is well positioned to address evolution of SARS-CoV-2 Key strengths • High efficacy of mRNA-1273 • Speed to update vaccine • Ability to combine multiple antigens • Manufacturing ̶ Fast scale-up ̶ Same raw material inputs ̶ Flexibility Already manufactured GMP batches of our variant booster cand
Slide 27: Four other vaccine programs are in clinical trials
Four other vaccine programs are in 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 begin in 202
Slide 28: Three new vaccine programs announced in January 2021
Three new vaccine programs announced in January 2021 Prophylactic Vaccines • Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, Flu causing respiratory illnesses and placing substantial burden on healthcare systems vaccine • Flu program will evaluate three ca
Slide 29: 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 30: Development pipeline, February 2021
Development pipeline February 2021 Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 Commercial Ph2 prep Ph3 prep COVID-19 EBV Flu RSV Zika Zika CMV CMV (pediatric) COVID-19 Prophylactic Core modalities vaccines Nipah HIV H7N9 hMPV/PIV3 Chikungunya Systemic secreted Relaxin PD-L1 antibody & cell
Slide 31: 4Q20 earnings call agenda: Conclusion
4Q20 earnings call agenda 3 Conclusion – Stéphane Bancel – CEO Slide 31
Slide 32: Clear strategic priorities for 2021
Clear strategic priorities for 2021 #1 Maximize the impact of Moderna COVID-19 Vaccine access: manufacturing output for 2021, additional manufacturing capacity for 2022 and commitment to take variants of concern to the clinic #2 Accelerate vaccine development to advance our pipeline and bring new va
Slide 33: 2021 will be an inflection year for Moderna
2021 will be an inflection year for Moderna 2019 2020 2021 • No approved products • Authorized product • Authorized product • Negative cash flow • Positive Cash flow in two quarters • Cash flow positive • Unprofitable • Unprofitable • Profitable • Multiple capital raises needed to • Strong balance s
Slide 34: 2021 will be an inflection year for Moderna
2021 will be an inflection year for Moderna mRNA is information molecule Team Moderna platform is unique Fully integrated manufacturing plant Year-end 2020 cash of $5.25 billion Made 100m doses of drug substance already Signed FY 2021 APAs of ~$18.4 B Shipped approximately 60 million doses globally
Slide 35: Events in 2021: Save the Date
Vaccines Day April 14th Science Day Save the Date May 27th Events in 2021 R&D Day September 9th Slide 35
Slide 36: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 36