Slide 1: Fourth Quarter & Full Year 2021 Financial Results
DNA mRNA Protein Fourth Quarter & Full Year 2021 Financial Results February 24, 2022
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 vaccines against COVID-19, including efforts to develop
Slide 3: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Spikevax® COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO 4Q21 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 3
Slide 4: Fiscal year 2021 GAAP financial highlights
Fiscal year 2021 GAAP financial highlights Fiscal year 2021 GAAP financial results: • Revenue: $18.5B • Net income: $12.2B • Diluted EPS: $28.29 • Cash and investments: $17.6B (as of 12/31/21) Share buyback: • Previous program of $1B announced in August 2021 has been fully utilized1 • Average dilute
Slide 5: Development pipeline advances and expands
Development pipeline advances and expands • Received full U.S. FDA approval for COVID-19 Vaccine Spikevax® to prevent COVID-19 in individuals 18+ years of age • COVID-19 Vaccine for adolescents ages 12 to 17: Approved in key markets globally; studying heterologous boost (50 µg) • COVID-19 Vaccine fo
Slide 6: Programs in development
Moderna as of February 2022 Commercial Phase 3 Phase 2 44 development programs Pipeline Moderna COVID-19 CMV, RSV Flu, COVID-19 boosters, Vaccine/Spikevax® Zika, PCV, VEGF-A Respiratory vaccines Latent vaccines mRNA therapeutics Programs in development • CMV in Phase 3 • COVID-19 variant boosters (O
Slide 7: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Spikevax® COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO 4Q21 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 7
Slide 8: Real-world evidence continues to demonstrate strong effectiveness of mRNA-1273/Spikevax
After two doses, independent, real-world evidence continues to demonstrate the strong effectiveness of mRNA-1273/Spikevax® Risk ratios 1.27 1.39 1.70 1.38 1.11 (95% CI) (1.15 to 1.42) (1.21 to 1.70) (1.42 to 2.24) (1.01 to 2.42) (0.69 to 1.91) Dickerman et al, New England Journal of Medicine (Jan 20
Slide 9: Spikevax booster is highly effective against hospitalization
Spikevax® booster is highly effective against hospitalization regardless of primary series, but waning is expected Booster effectiveness against hospitalization After BNT162b2 primary series After ChAdOx1-S primary series Vaccine effectiveness (%) Vaccine effectiveness (%) Hospitalization Hospitaliz
Slide 10: Neutralization of ancestral virus and Omicron wanes by 6 months
Neutralization of the ancestral virus, and Omicron, wanes by 6- months, particularly accelerated for Omicron • Omicron PsVNT remains detectable for all tested recipients 6 months post-boost • Omicron PsVNT declines significantly by 6 months post- boost; approaching dose 2 levels • Antigen matched wi
Slide 11: We predict antibody titers will continue to wane
We predict antibody titers will continue to wane, underpinning the need for a fall 2022 booster to provide protection Booster (6 months PD2) 10000 Dotted line = projection Post dose 2 assuming constant rate of decay D614G Omicron T½ = 128 d 1000 PsVNT (ID50) GMT T½ = 60 d Six months after booster do
Slide 12: Transitioning into an endemic phase
Transitioning into an endemic phase ILLUSTRATIVE Stage Focus for vaccines Pandemic Endemic • Heavy focus on protecting high-risk Pandemic populations Initial waves 2020 • Mostly ancestral virus vaccine Morbidity 2021-2022 2023+ Variant • Focus on suppressing transmission of (variant waves) (seasonal
Slide 13: Endemic coronaviruses cause significant annual disease
Endemic coronaviruses cause significant annual disease Incidence of Community-onset Respiratory Viruses Estimated impact of endemic HCoV in 65+ across Associated with Hospitalization per 100,000 Persons OECD markets NYC, 10/2018 – 9/2019 240 Endemic HCoV 535 Over 1 million outpatient visits 145 RSV
Slide 14: Key takeaways
Key takeaways Importance of • After the primary series (two doses), mRNA-1273/Spikevax® has Vaccination been demonstrated to be highly effective in real-world settings • Real-world evidence shows a 50-µg booster dose of mRNA- Current mRNA-1273 1273/ Spikevax® provides protection against hospitalizat
Slide 15: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Spikevax® COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO 4Q21 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 15
Slide 16: COVID-19 booster development for endemic phase
COVID-19 booster development for endemic phase • Neutralizing titers (NT) will wane, similar to endemic HCoV • Decline in NT will increase risk of breakthrough hospitalization for Strategic rationale those at higher risk (e.g., older adults, immune compromised) for seasonal booster • Emergence of ne
Slide 17: Strategy to develop Omicron-containing booster for Fall '22
Strategy to develop Omicron-containing booster for Fall ’22 Moderna is evaluating 3 booster strategies for adults aged 18+ • Bivalent booster (prototype + Omicron; mRNA-1273.214) • Omicron-specific booster (mRNA-1273.529) • mRNA-1273 (prototype booster) U.S. Phase 2 (P205) U.K. Phase 3 (P305) ▪ ~750
Slide 18: Bivalent booster may improve durability against VOC
Emerging data suggests bivalent booster may improve durability against VOC while preserving activity against ancestral virus mRNA-1273 - 50 µg Bivalent 211 (1273/Beta) - 50 µg (n=54) (n=73) GMT 146 1887 936 122 2206 1161 Ancestral (D614G) PsVNT ID50 • Six months after .211 bivalent booster, neutrali
Slide 19: Bivalent booster may improve durability against VOC
Emerging data suggests bivalent booster may improve durability against VOC while preserving activity against ancestral virus Booster (dose 3) Ancestral: Bivalent .211 booster (prototype / VOC: Bivalent shows potentially improved mRNA-1273 Beta) retains activity against D614G virus durability against
Slide 20: Summary: COVID-19 booster development for Fall '22
Summary: COVID-19 booster development for Fall ‘22 • Moderna believes a seasonal (fall) booster will be necessary to prevent breakthrough disease, including hospitalizations in vulnerable populations as SARS-CoV-2 becomes endemic • Continued viral evolution may put pressure on pre-existing immunity
Slide 21: Primary series and booster in adolescent and pediatric populations
Other COVID-19 vaccine updates: Primary series and booster in adolescent and pediatric populations Indication Regulatory update • Received regulatory approvals for Spikevax® (100 µg primary series dose) in Europe, U.K., Australia, Canada and other countries Adolescents • In the U.S., plan to submit
Slide 22: Moderna's respiratory vaccines
Moderna’s respiratory vaccines Pipeline Highlights COVID-19 variant boosters (Omicron, Wild-type/Omicron, and Delta) and next generation in development Flu Phase 2 fully enrolled, data expected in early 2022; Phase 3 expected to start in 2022 Combination Flu + COVID in preclinical, expected to start
Slide 23: Moderna's latent & public health vaccines
Moderna’s latent & public health vaccines Pipeline Highlights 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) is in preclinical Announcing HSV and VZV development candidates
Slide 24: New development program: Vaccine against HSV-2 (mRNA-1608)
New development program: Vaccine against HSV-2 (mRNA-1608) mRNA vaccine containing HSV-2 antigens induces strong HSV-2 (Herpes) disease overview immune response in preclinical animal studies • Herpes simplex virus type 2 (HSV-2) primarily HSV-2 infects the genitals Neutralization • HSV-2 establishes
Slide 25: New development program: Vaccine against herpes zoster/shingles (mRNA-1468)
New development program: Vaccine against herpes zoster/shingles (mRNA-1468) mRNA vaccine generated similar anti-gE titers compared to an adjuvanted subunit gE vaccine (proxy for ShingrixTM)2 in NHP Herpes Zoster (shingles) disease overview Anti-VZV gE binding • Herpes zoster is caused by reactivatio
Slide 26: Moderna's therapeutics
Moderna’s therapeutics Pipeline Highlights Immuno-oncology • PCV Phase 1 ongoing; Phase 2 fully enrolled, data expected in 4Q 2022 • KRAS regained rights from Merck; evaluating next steps for the program • Checkpoint vaccine announced as new development program • Triplet, IL-12 ongoing in Phase 1 Ca
Slide 27: New development program: Checkpoint vaccine (mRNA-4359)
New development program: Checkpoint vaccine to promote anti-checkpoint T-cell responses (mRNA-4359) ▪ Program objective: Stimulate effector T cells that target and kill suppressive immune and cancer cells that T cell T cell express high levels of target checkpoint antigens: Encoded IDO/PD-L1 concate
Slide 28: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Spikevax® COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO 4Q21 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 28
Slide 29: Product sales of $6.9 billion in Q4 and $17.7 billion for full year 2021
Product sales of $6.9 billion in the fourth quarter and $17.7 billion for the full year 2021 Product Sales by Quarter 2021 Product Sales Full Year 2021 In USD Billions In USD Billions 6.9 4.8 Q4 2021 Product Sales: $6.9B 4.2 17.7 6.1 ▪ $6.1B Rest of World 2.1 3.6 1.7 0.4 ▪ $0.7B US 1.4 2.1 1.2 0.7 Q
Slide 30: Fourth quarter 2021 financial results
Fourth quarter 2021 financial results QoQ Change In $ millions, except per share amounts (unaudited) Q4 2021 Q3 2021 Q4 2020 (Q4'21 vs. Q3'21) Product sales1 $ 6,935 $ 4,810 $ 200 $ 2,125 44 % Grant revenue 262 140 341 122 87 % Collaboration revenue 14 19 30 (5) (26) % Total revenue 7,211 4,969 571
Slide 31: Full year 2021 financial results
Full year 2021 financial results In $ millions, except per share amounts FY 2021 FY 2020 YoY (unaudited) Change Product sales1 $ 17,675 $ 200 $ 17,475 NM Grant revenue2 735 529 206 39 % Collaboration revenue 61 74 (13) (18) % Total revenue 18,471 803 17,668 2,200 % Cost of sales 2,617 8 2,609 NM Res
Slide 32: Cash/investments and cash deposits
Cash/ investments and cash deposits Cash / Investments In USD Billions Cash, Cash equivalents and Investments 17.6 15.3 ▪ Cash, Cash equivalents and Investments as 12.2 of December 31, 2021 at $17.6B, up from 8.2 $15.3B as of September 30, 2021 5.2 12/31/2020 3/31/2021 6/30/2021 9/30/2021 12/31/2021
Slide 33: Moderna's capital allocation priorities
Moderna’s capital allocation priorities R&D Expense (in $B) Capital Expenditure (in $B) Reinvest in the business & ~2.5-3 accelerate investment in R&D, 2.0 1 manufacturing infrastructure and 1.4 ~0.6-0.8 0.5 0.4 company buildout <0.1 0.1 2019 2020 2021 2022E 2019 2020 2021 2022E Seek attractive exte
Slide 34: 2022 financial framework
2022 financial framework ▪ For expected delivery in FY 2022: Advance Purchase Agreements (APAs) currently signed for product sales of Sales ~$19 billion and ~$3B of signed options (probabilized) ▪ We expect sales to be larger in the second half of 2022 than in the first half as SARS-CoV-2 becomes en
Slide 35: Today's Agenda
Today’s Agenda 1 Business Review – Stéphane Bancel, CEO 2 Spikevax® COVID-19 Vaccine Update – Paul Burton, M.D., Ph.D., CMO 4Q21 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 35
Slide 36: Executing on Moderna's product strategy
Executing on Moderna’s product strategy Bring to market a pan-respiratory annual booster vaccine (which we will continuously customize) 1 Waiting for Flu Phase 2 data to pick dose for Phase 3 AND to pick dose for mRNA-1073 (COVID+Flu) for Phase 1 Bring to market first-in-class vaccines for latent vi
Slide 37: Material change in commercial momentum in 2021
Material change in commercial momentum in 2021 as we built the organization Early 2021 Early 2022 • At the time of EUA, Phase 3 showed • Multiple, independent RWE studies mRNA-1273 vaccine efficacy (VE) of confirm the strong effectiveness of approximately 95%; at ~6 months mRNA- Spikevax® 1273 VE of
Slide 38: Spikevax's market share has increased across key markets
Jan 23, 2022 Spikevax’s® market share has increased across key markets • Booster market in OECD countries is an mRNA vaccine market • Booster approvals, supply and real-world evidence have been the key factors Spikevax® Booster/Third Dose Market Share +51% +46% +18% 54% 57% +9% +34% 45% 43% +32% +22
Slide 39: Spikevax commercial outlook in 2022
Spikevax® commercial outlook in 2022 Spikevax® 2022 commercial outlook 3Q21 Earnings J.P. Morgan 4Q21 Earnings • Signed APAs: ~$19B Call Conference Call (Nov. 4th, 2021) (Jan. 10th, 2022) (Feb. 24th, 2022) • Options (probability weighted): ~$3B • Discussions ongoing with countries around Signed ~$17
Slide 40: Expanding Moderna commercial network in 2022
We are expanding Moderna commercial network in 2022: 10 new commercial subsidiaries planned this year Operating commercial 2022 new commercial Distributor partnerships as subsidiary as of Dec 2021 subsidiaries of Feb 2022 Commercial expansion Europe • Poland • Sweden • Netherlands • Denmark • Belgiu
Slide 41: Commercial outlook in 2023 and subscription model
Commercial outlook in 2023 and driving to a service/subscription model for our pan-respiratory franchise 10-year agreements with strategic countries Spikevax® 2023 commercial outlook • Strategic supply agreements with • Firm orders for delivery in 2023 from: governments ̶ United Kingdom • Announced
Slide 42: Moderna's capital allocation priorities
Moderna’s capital allocation priorities R&D Expense (in $B) Capital Expenditure (in $B) Reinvest in the business & ~2.5-3 accelerate investment in R&D, 2.0 1 manufacturing infrastructure and 1.4 ~0.6-0.8 0.5 0.4 company buildout <0.1 0.1 2019 2020 2021 2022E 2019 2020 2021 2022E Seek attractive exte
Slide 43: Progress on important expansions announced in 2021
We will make progress on important expansions announced in 2021 In 2021, ~25% of doses were shipped to low- and middle-income countries Investing in Moderna Science Center and launched AI Academy Pledge to achieve net-zero carbon emissions globally by 2030 Announced Moderna Charitable Foundation and
Slide 44: Events in 2022
Vaccines Day March 24th Science Day May 17th Save the Date Events in 2022 R&D Day September 8th ESG Day November 10th Slide 44
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: Moderna's Respiratory Vaccines (Pipeline 1/3)
Moderna’s Respiratory Vaccines (Pipeline 1/3) Preclinical Moderna Modality Program ID # Phase 1 Phase 2 Phase 3 Commercial development rights mRNA-1273/Spikevax® Worldwide mRNA-1273.351 Beta variant Worldwide mRNA-1273.617 Delta variant Worldwide mRNA-1273.211 Beta variant + wild-type Worldwide COVI
Slide 47: 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 Worldwide EBV vaccine (to prevent mRNA-1189 Worldwide infectious mononucleosis) Latent vaccines EBV vaccine (to prevent EBV m
Slide 48: 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 IL-2 mRNA-6231 Worldwide Systemic Autoimmune disorders secreted & cell Relaxin mRNA-0184 Worldwide surface Heart failure therapeutics PD-L1 mRNA-6981 Worldwide Autoim