Slide 1: Third Quarter 2022 Financial Results
Third Quarter 2022 Financial Results November 3rd, 2022 © 2022 M oderna, Inc. All rights reserved.
Slide 2: Forward-looking statements and disclaimer
Forward-looking statements and disclaimer This presentation contains forward-looking statements within the meaning of the Priv ate Securities Litigation Reform Act of 1995, as amended, including statements regarding: anticipated sales, including the timing of sales, under adv ance purchase agreement
Slide 3: 3Q22 earnings call agenda
3Q22 earnings call agenda 1 Business Review – Stéphane Bancel, CEO 2 R&D/Clinical Programs – Stephen Hoge, M.D., President 3 Commercial Market – Arpa Garay, CCO 4 Financials – Jamey Mock, CFO 5 Looking Forward – Stéphane Bancel, CEO 3 © 2022 M oderna, Inc. All rights reserved.
Slide 4: Financial highlights 3Q22
Financial highlights 3Q22 Third quarter 2022 GAAP financial results • Revenue: $3.4 billion • Net income: $1.0 billion • Cash and investments: $17 billion 2022 outlook • Revenue from advance purchase agreements for anticipated delivery in 2022 expected to be $18 to $19 billion, following delay of ce
Slide 5: Pipeline highlights and advances
Pipeline highlights and advances COVID booster vaccines • Received authorizations for Spikevax bivalent original/Omicron BA.1 (mRNA-1273.214) in countries around the world, including the EU, UK and Japan • Received authorizations for Spikevax bivalent original/Omicron BA.4/5 (mRNA-1273.222) in count
Slide 6: Programs in development
Moderna as of November 2022 Commercial Phase 3 Phase 2 48 development Pipeline Moderna COVI D-19 Vaccine/Spikev ax®, mRNA- COVI D boosters, Flu, RSV, CMV PCV, Zika, VEGF-A, next generation COVI D booster programs 1273.222 and mRNA-1273.214 Respiratory vaccines Latent vaccines mRNA therapeutics Progr
Slide 7: 3Q22 earnings call agenda
3Q22 earnings call agenda 1 Business Review – Stéphane Bancel, CEO 2 R&D/Clinical Programs – Stephen Hoge, M.D., President 3 Commercial Market – Arpa Garay, CCO 4 Financials – Jamey Mock, CFO 5 Looking Forward – Stéphane Bancel, CEO 7 © 2022 M oderna, Inc. All rights reserved.
Slide 8: Moderna has launched two vaccine boosters to meet different market needs
Moderna has launched two vaccine boosters to meet different market needs across the largest markets • Induced significantly higher titers than mRNA-1273 against the BA.1 mRNA-1273.214 and BA.4/5 strains in a clinical trial conducted before the fall booster season (25 µg of mRNA-1273 and 25 µg of Omi
Slide 9: Respiratory vaccines: Combination vaccine (COVID + flu + RSV) Phase 1 started
Respiratory vaccines: Combination vaccine (COVID + flu + RSV) Phase 1 started • COVID-19 variant boosters and next generation booster (mRNA-1283) in development • Flu (mRNA-1010) Phase 3 studies ongoing; Flu (mRNA-1020/-30) Phase 1/2 trial fully enrolled • Older adults RSV (mRNA-1345) Phase 3, known
Slide 10: Phase 3 Flu and RSV vaccines continue enrolling
Phase 3 Flu and RSV vaccines continue enrolling Flu vaccine RSV vaccine (mRNA-1010) (mRNA-1345) • Southern hemisphere immunogenicity • Pivotal Phase 3 efficacy study in older study in adults (18+) is fully enrolled adults (60+) has enrolled >35,500 (6,000 participants) participants – Readout expecte
Slide 11: Latent & public health vaccines: CMV vaccine ongoing in Phase 3 study
Latent & public health vaccines: CMV vaccine ongoing in Phase 3 study • CMV vaccine pivotal Phase 3 study, known as CMVictory, is ongoing • EBV vaccine (to prevent infectious mononucleosis) Phase 1 is ongoing; EBV vaccine (to prevent EBV sequelae) in preclinical • HIV vaccines Phase 1 trials are ong
Slide 12: mRNA therapeutics: Checkpoint vaccine started Phase 1
mRNA therapeutics: Checkpoint vaccine started Phase 1 Immuno-oncology • PCV Phase 1 ongoing; Phase 2 fully enrolled, data expected in 4Q 2022 • KRAS Phase 1 ongoing; evaluating next steps for the program • Triplet ongoing in Phase 1 • IL-12 after portfolio review AstraZeneca returns program; evaluat
Slide 13: Encouraging early clinical signs in rare disease modality
Encouraging early clinical signs in rare disease modality As presented during September R&D Day 13 © 2022 M oderna, Inc. All rights reserved. Moderna R&D Day 2022 presentation link
Slide 14: PCV (mRNA-4157) Phase 2 trial results expected in 4Q22
PCV (mRNA-4157) Phase 2 trial results expected in 4Q22 Primary endpoint is recurrence free survival compared to pembrolizumab Patients with resected melanoma at high risk of recurrence • Randomized, placebo controlled, PCV + Enrollment and randomization 2:1 pembrolizumab (KEYTRUDA®) vs. pembrolizuma
Slide 15: 3Q22 earnings call agenda
3Q22 earnings call agenda 1 Business Review – Stéphane Bancel, CEO 2 R&D/Clinical Programs – Stephen Hoge, M.D., President 3 Commercial Market – Arpa Garay, CCO 4 Financials – Jamey Mock, CFO 5 Looking Forward – Stéphane Bancel, CEO 15 © 2022 M oderna, Inc. All rights reserved.
Slide 16: Q3 2022 Sales of $3.1B, Year to Date Sales of $13.6B
Q3 2022 Sales of $3.1B, Year to Date Sales of $13.6B Product Sales YoY Comparison In USD Billions Q3 2022 Product Sales: $3.1 billion 13.6 ▪ United States: $1.0 billion 10.7 3.4 ▪ Europe: $1.0 billion 4.6 ▪ RoW: $1.1 billion 4.8 1.2 10.2 3.1 YTD September 30, 2022, Product Sales: $13.6 billion 1.0 6
Slide 17: Key topics for COVID booster commercial outlook
Key topics for COVID booster commercial outlook 1 2 3 4 The medical burden Annual COVID Important factors to Current 2023 signed for endemic COVID booster volumes consider as we contracts is expected to be could approximate transition to a greater than the flu vaccine volumes commercial market Outlo
Slide 18: Since October 2021, the substantial medical burden for COVID has been greater than flu's
Since October 2021, the substantial medical burden for COVID has been greater than flu’s historical burden Flu vs. COVID medical burden comparison in United States ~3x 2,368,000 Flu: Range cov ers the last 10 flu seasons Flu low-end (2011/12) before pandemic-related disruptions Flu high-end (2017/18
Slide 19: As COVID transitions to endemic, annual COVID booster volumes could approximate flu vaccine volumes
As COVID transitions to endemic, annual COVID booster volumes could approximate flu vaccine volumes over time Scenarios global COVID booster market Key variables that will impact the ($USD billions) COVID volume in 2023 Global average price per dose • Medical need $20 $30 $40 • Viral evolution 400 $
Slide 20: Transitioning to a commercial market in the U.S.
Transitioning to a commercial market in the U.S. Important factors to consider as COVID vaccine market in U.S. shifts to a commercial market in 2023 • More fragmented customer base • Less predictability in orders • Seasonality of deliveries • Moderna assuming full distribution costs • Transitioning
Slide 21: COVID sales contracts in 2023
COVID sales contracts in 2023 Advance Purchase Deferrals from Expected new contracts Agreements ’22 contracts • U.S. transitioning to commercial • United Kingdom • Japan • Potential for additional EU contract • Canada • European Union • Japan fall contract • Switzerland • Switzerland • Australia (in
Slide 22: COVID vaccine endemic outlook summary
COVID vaccine endemic outlook summary The medical burden of endemic COVID is expected to be larger than flu As COVID transitions to endemic, annual COVID booster volumes could approximate flu vaccine volumes over time In 2023 as we transition to a commercial market in the US, important factors (such
Slide 23: Advancing respiratory vaccine franchise
Advancing respiratory vaccine franchise Preclinical Phase 1 Phase 2 Phase 3 Licensed mRNA-1273 SARS-CoV-2 Respiratory Earliest Infectious mRNA-1010 Seasonal Flu (HA) 2023 Diseases Earliest mRNA-1345 RSV (older adults) 2023 • COVID boosters: Launched Omicron-targeting bivalent candidates • Flu: Immun
Slide 24: 3Q22 earnings call agenda
3Q22 earnings call agenda 1 Business Review – Stéphane Bancel, CEO 2 R&D/Clinical Programs – Stephen Hoge, M.D., President 3 Commercial Market – Arpa Garay, CCO 4 Financials – Jamey Mock, CFO 5 Looking Forward – Stéphane Bancel, CEO 24 © 2022 M oderna, Inc. All rights reserved.
Slide 25: Third quarter 2022 financial results
Third quarter 2022 financial results Change In $ millions, except per share amounts (unaudited) Q3 2022 Q3 2021 (Q3 22 vs. Q3 21) Product sales $ 3,120 $ 4,810 $ (1,690) (35)% Grant rev enue 144 140 4 3 % Collaboration rev enue 100 19 81 426 % Total revenue 3,364 4,969 (1,605) (32)% Cost of sales 1,
Slide 26: Year-to-date 2022 financial results
Year-to-date 2022 financial results 2022 YTD 2021 YTD Change In $ millions, except per share amounts (unaudited) ended 9/30/22 ended 9/30/21 (YTD '22 vs. YTD '21) Product sales $ 13,576 $ 10,740 $ 2,836 26 % Grant rev enue 453 473 (20) (4) % Collaboration rev enue 150 47 103 219 % Total revenue 14,1
Slide 27: Cash/ Investments and Cash Deposits (unaudited)
Cash/ Investments and Cash Deposits (unaudited) Cash / Investments In USD Billions Cash, Cash equivalents and Investments ▪ Cash, Cash equivalents and Investments as of September 30, 2022, at $17.0 billion, dow n 17.6 19.3 18.1 17.0 from $18.1 billion as of June 30, 2022 12/31/2021 3/31/2022 6/30/20
Slide 28: Moderna's capital allocation priorities
Moderna’s capital allocation priorities R&D Expense (in $B) Reinvest in the business & ~2.5-3 accelerate investment in R&D, 2.0 1 1.4 ▪ Phase 3 trials: Flu, RSV, and CMV manufacturing infrastructure and 0.5 ▪ 48 development programs company buildout 2019 2020 2021 2022E ▪ Disciplined approach to eva
Slide 29: 2022 updated financial framework
2022 updated financial framework ▪ Advance purchase agreements (APAs) for expected delivery in 2022 of $18-19 billion, reflecting deferrals Sales of $2-3 billion into 2023 ▪ We now expect full year 2022 reported cost of sales in the 26 – 28 percentage range, upper end in the Cost of sales event of f
Slide 30: 3Q22 earnings call agenda
3Q22 earnings call agenda 1 Business Review – Stéphane Bancel, CEO 2 R&D/Clinical Programs – Stephen Hoge, M.D., President 3 Commercial Market – Arpa Garay, CCO 4 Financials – Jamey Mock, CFO 5 Looking Forward – Stéphane Bancel, CEO 30 © 2022 M oderna, Inc. All rights reserved.
Slide 31: Next 12 months priorities
Next 12 months priorities 1 2 3 Execute 2022 sales and Execute on late-stage Prepare for multiple prepare 2023 private market clinical pipeline commercial launches sales • 4Q22 PCV data • Preparations underway • Phase 3 vaccine trials: for multiple vaccine Flu, RSV and CMV launches between 2023- 202
Slide 32: Save the Date: ESG Day on November 10, 2022
Save the Date ESG Day on November 10, 2022 https://moderna-esg-day.open-exchange.net/registration 32 © 2022 M oderna, Inc. All rights reserved.
Slide 33: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. 33 © 2022 M oderna, Inc. All rights reserved.
Slide 34: Moderna's Respiratory Vaccines (Pipeline 1/3)
Moderna’s Respiratory Vaccines (Pipeline 1/3) Preclinical Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial Moderna rights development mRNA-1273/Spikevax ® Worldw ide mRNA-1273.214 Omicron (BA.1) variant + w ild-type Worldw ide mRNA-1273.222 Omicron (BA.4/5) variant + w ild-type Worldw ide mR
Slide 35: Moderna's Latent & Public Health Vaccines (Pipeline 2/3)
Moderna’s Latent & Public Health Vaccines (Pipeline 2/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights CMV vaccine mRNA-1647 W orldwide EBV vaccine (to prevent mRNA-1189 W orldwide infectious mononucleosis) Latent vaccines EBV vaccine (to prevent EBV
Slide 36: Moderna's Therapeutics (Pipeline 3/3)
Moderna’s Therapeutics (Pipeline 3/3) Preclinical Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial Moderna rights development Systemic Relaxin mRNA-0184 Worldwide secreted & cell Heart failure surface PD-L1 Autoimmune hepatitis mRNA-6981 Worldwide therapeutics Personalized cancer vaccine 50-