Moderna, Inc. · NASDAQ:MRNA
Moderna — Q1 2022 Earnings Presentation
42 slides from Moderna's earnings presentation, May 4, 2022
Slide 1: First Quarter 2022 Financial Results
DNA mRNA Protein First Quarter 2022 Financial Results May 4th, 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: anticipated sales under advanced purchase agreements in 2022 and the associated doll
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 1Q22 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: Financial highlights
Financial highlights First quarter 2022 GAAP financial results • Revenue: $6.1B • Net income: $3.7B • Diluted EPS: $8.58 • Cash and investments: $19.3B (as of 03/31/22) • Reduced outstanding shares again in 1Q22 2022 outlook • Reiterating ~$21B in signed advanced purchase agreements Slide 4
Slide 5: Spikevax's market share has increased across key markets
Jan 23, 2022 Spikevax’s® market share has increased – and stayed consistent – across key markets • Booster market in OECD countries continues to be an mRNA vaccine market Spikevax® Booster/Third Dose Cumulative Market Share +45% +49% 57% 56% +9% +16% +10% 54% +33% 52% 45% 43% 44% 43% +23% +30% 44% 3
Slide 6: Phase 3 pipeline could lead to three respiratory commercial launches
Our Phase 3 pipeline could lead to three respiratory commercial launches over the next two to three years; will share proof-of-concept readouts in therapeutics in 2022 Vaccines in Phase 3: • Omicron-containing biv alent COVID booster ongoing in Phase 2/3 studies; mRNA-1273.214 biv alent booster v ac
Slide 7: Programs in development
Moderna as of May 2022 Commercial Phase 3 Phase 2 46 development Pipeline Moderna COVI D-19 Vaccine/Spikev ax® COVI D boosters, RSV, CMV Flu, Zika, PCV, VEGF-A programs Respiratory vaccines Latent vaccines mRNA therapeutics Programs in development • CMV in Phase 3 • COVID variant boosters (variant-s
Slide 8: 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 1Q22 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 8
Slide 9: SARS-CoV-2 continues to evolve rapidly
SARS-CoV-2 continues to evolve rapidly Omicron subvariants • Omicron subvariant BA.2 is now the dominant strain in the US, with BA.2.12.1 increasing rapidly, showing enhanced transmissibility • Omicron subvariants BA.4 and BA.5 are of concern and spreading in other countries Slide 9 https://covid.cd
Slide 10: UK data show boosters protect against Omicron BA.2 but waning continues
Data from the UK show that boosters against the wild-type virus protect against Omicron variant BA.2 but waning continues Vaccine effectiveness against symptomatic disease after 2 doses or a booster dose across vaccine types Primary series: BNT162b2, ChAdOx1, mRNA-1273 Booster dose: BNT162b2 or mRNA
Slide 11: A fourth dose increased vaccine effectiveness in high-risk population
A fourth dose of Moderna’s COVID-19 Vaccine increased vaccine effectiveness against infection, symptomatic infection and severe outcomes in high-risk population Effectiveness of a fourth dose of mRNA COVID-19 • An Ontario study observed waning vaccine against Omicron outcomes of a third dose for ind
Slide 12: People at high-risk who would benefit from annual boosting
People at high-risk who would benefit from annual boosting Health, age-related and environmental/occupation risk factors • Age over 50 • Age 18+ with other health risk factors, including: – Chronic kidney disease, chronic obstructive pulmonary disease, cardiac disease, and diabetes mellitus – Receiv
Slide 13: Summary
Summary • SARS-CoV-2 continues to evolve rapidly with multiple new variants and recombinants circulating globally • Real world data demonstrate the effectiveness of a booster shot (third dose) of mRNA- 1273 against evolving variants of concern • A fourth dose of mRNA-1273 shows good marginal effecti
Slide 14: 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 1Q22 Earnings 3 Clinical Program Review – Stephen Hoge, M.D., President Call 4 Financials – David Meline, CFO 5 Looking Forward – Stéphane Bancel, CEO Slide 14
Slide 15: COVID booster development for endemic phase
COVID 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 new v
Slide 16: Objective of lead bivalent candidate (.214)
The objective of our lead bivalent candidate (.214) is to demonstrate superior immunogenicity against variants of concern • Three bivalents have been evaluated to date (containing an equal mass ratio) Primary focus has been on the bivalent – mRNA-1273.211 (9 mutations, based on wild-type and Beta) a
Slide 17: Overview of bivalent candidates in clinical development
Overview of bivalent candidates in clinical development All subjects received mRNA-1273 primary series (100 µg) Trial Booster Dose Subjects(n) Phase mRNA- 50 µg 171 2 1273 • mRNA-1273 has been authorized/ P201 approved for a third or fourth booster • Data for the first bivalent (.211) has .211 50 µg
Slide 18: Safety and reactogenicity similar between .211 and 1273 boosters
Safety and reactogenicity are similar between .211 and 1273 boosters Solicited reactogenicity (through day 7) Safety summary • The reactogenicity profile was similar between the two booster vaccines (.211 n=298, 1273 n=167) • The frequency and types of unsolicited adverse events were also comparable
Slide 19: Neutralizing antibody responses after .211 booster vs 1273
Neutralizing antibody responses against ancestral SARS-CoV-2, Beta, Delta and Omicron after booster dose of .211 were higher than after booster dose of 1273 Spike-pseudotyped lentivirus neutralization assay ID50 Chalkias, Spyros et al. https://www.researchsquare.com/article/rs-1555201/v1 Slide 19
Slide 20: Superiority met for .211 booster versus 1273 at Day 29
In comparing .211 booster to 1273 at Day 29, superiority was met for ancestral SARS-CoV-2 and all variants of concern • The clinical endpoint to demonstrate superiority was based on the neutralizing antibody geometric mean titer ratio (GMR); superiority was considered met if the lower bound of 95% C
Slide 21: Conclusion and next steps
Conclusion and next steps • The safety and reactogenicity profile of the 50 µg mRNA-1273.211 booster dose was comparable to the 50 µg mRNA-1273 booster vaccine • We believe that the superiority shown by .211 confirms the potential of bivalent platform • We continue to believe that bivalent booster w
Slide 22: Primary series and booster update in adolescent and pediatric populations
Primary series and booster update in adolescent and pediatric populations Spikevax®/Moderna COVID-19 Vaccine in ages <18 • In adolescents aged 12-17 years: ̶ Primary series (2 dose, 100 µg) authorized/approv ed in more than 40 countries ̶ Submitted EUA for boosters globally ̶ Submitted longer term s
Slide 23: Respiratory vaccines: Flu vaccine expected to start Phase 3 in 2Q22
Moderna’s respiratory vaccines: Flu vaccine (mRNA-1010) expected to start Phase 3 in 2Q22 Pipeline Highlights COVID-19 variant boosters and next generation mRNA-1283 in development Flu (mRNA-1010) Phase 2 positive data announced in March; expected to start Phase 3 safety & immunogenicity trial in 2Q
Slide 24: Three pivotal Phase 3 trials started by end of 2Q22
By the end of 2Q22, we will have started three pivotal, Phase 3 trials within approximately one year of an IND being opened IND Ph 3 Efficacy opened st arted readout COVI D- 19 5 months v accine March ‘20 July ‘20 Nov ‘20 • mRNA vaccine technology is Older adult s Ph 3 Seasonal efficacy de-risked; p
Slide 25: 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) in preclinical HIV vaccines Phase 1 trials are ongoing HSV and V
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 Phase 1 ongoing; evaluating next steps for the program • Triplet, IL-12 ongoing in Phase 1 • Checkpoint vaccine in preclinical Cardiovascular • VEGF moving to Pha
Slide 27: Propionic acidemia (PA) ongoing in Phase 1/2 study
Propionic acidemia (PA) ongoing in Phase 1/2 study mRNA-3927 Phase 1/2 study Propionic Acidemia (PA) is a rare metabolic disorder • PA is characterized by a deficiency of propionyl-CoA carboxylase (PCC), an enzyme involved in the • Adaptive trial design; enrolling participants >1 years breakdown (ca
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 1Q22 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: First quarter 2022 Product Sales of $5.9 billion
First quarter 2022 Product Sales of $5.9 billion Product Sales by Quarter 2021 – 2022 In USD Billions $6.9 US $0.7 Rest of World $5.9 Q1 2022 Product Sales: $5.9B $0.9 ▪ $5.0B Rest of World $4.8 $4.2 ▪ $0.9B US $1.2 $2.1 $6.2 $5.0 $1.7 $3.6 $1.4 $2.1 $0.4 Q1’21 Q2’21 Q3’21 Q4’21 Q1’22 Slide 29
Slide 30: First quarter 2022 GAAP financial results
First quarter 2022 GAAP financial results QoQ Change In $ millions, except per share amounts (unaudited) Q1 2022 Q1 2021 (Q1'22 vs. Q1'21) Product sales $ 5,925 $ 1,733 $ 4,192 242 % Grant rev enue 126 194 (68) (35) % Collaboration rev enue 15 10 5 50 % Total revenue 6,066 1,937 4,129 213 % Cost of
Slide 31: Cash/investments and cash deposits
Cash/ investments and cash deposits Cash / Investments In USD Billions Cash, Cash equivalents and Investments ▪ Cash, Cash equiv alents and I nv estments as $17.6 $19.3 of March 31, 2022 at $19.3B, up from $17.6B as of December 31, 2021 $8.2 $5.2 12/31/2020 3/31/2021 12/31/2021 3/31/2022 Balance of
Slide 32: 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, 1 $2.0 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 attra
Slide 33: Impact of share repurchase program on share count
Impact of share repurchase program on share count (in shares M) -5 405 403 400 ▪ Quarter ending basic shares declined 5M from Basic Shares the end of Q3 2021 to Q1 2022, due to 7M of share Quart er End repurchase activity, partially offset by 2M of employee equity compensation Q3/2021 Q4/2021 Q1/202
Slide 34: 2022 financial framework
2022 financial framework ▪ For expected delivery in FY 2022: Advance Purchase Agreements (APAs) currently signed for product sales of ~$21 billion Sales ▪ We continue to expect sales to be larger in the second half of 2022 than in the first half as SARS-CoV-2 becomes endemic Cost of sales ▪ We conti
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 1Q22 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: New additions to executive committee
New additions to executive committee Jorge Gomez Arpa Garay Chief Financial Officer Chief Commercial Officer Previously CFO of Dentsply Sirona and Previously Chief Marketing Officer for Cardinal Health Merck’s Human Healt h business Slide 36
Slide 37: Moderna's 2022 priorities
Moderna’s 2022 priorities 1 Execute on $21B signed APAs and prepare for Fall booster 2 • Execute on four Phase 3 vaccine programs, which could lead to three respiratory commercial launches over the next two to three years 3 • Advance therapeutic programs and share proof-of-concept readouts for our P
Slide 38: Science Day, R&D Day, ESG Day events in 2022
Science Day May 17th R&D Day Save the Date September 8th Events in 2022 ESG Day November 10th Slide 38
Slide 39: Our mission
Our mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients. Slide 39
Slide 40: 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-1273.351 Beta variant Worldw ide mRNA-1273.617 Delta variant Worldw ide mRNA-1273.211 Beta variant + w ild-type Worldw ide
Slide 41: 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 42: 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 Systemic Autoimmune disorders mRNA-6231 Worldwide secreted & cell Relaxin surface Heart failure mRNA-0184 Worldwide therapeutics PD-L1 Autoimmune hepatitis mRNA-