Moderna, Inc. · NASDAQ:MRNA
Moderna — Investor Day (September 2019)
90 slides from Moderna's investor day presentation, Sep 12, 2019
Slide 1: R&D Day September 12, 2019
Encoded mRNA(s) Ribosome Protein chain(s) Encoded mRNA(s) Nucleus Endoplasmic Reticulum Cytosol hMPV+PIV3 OX40L IL12 IL36γ Relaxin Mitochondrion Fabry PA PKU Systemic intracellular therapeutics Intratumoral immuno- oncology Localized regenerative therapeutics Systemic secreted therapeutics Lysosome
Slide 2: Welcome and Introduction
Welcome and Introduction Stéphane Bancel Chief Executive Officer
Slide 3: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning: the potential approval and commercial launch of Moderna’s development candidates, including CMV vaccine (
Slide 4: mRNA as a potential new class of medicines
Large product opportunity Higher probability of technical success Accelerated research and development timelines Greater capital efficiency over time vs. recombinant technology mRNA as a potential new class of medicines
Slide 5: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Increasing biology risk Varying technology risk
Slide 6: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Increasing biology risk Varying technology risk De-risk technology with first program in a modality Diversify biology risk by working on multiple programs in parallel within a modality Stage risk, build on learnings over time Our appr
Slide 7: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Increasing biology risk Localized regenerative therapeutics Intratumoral immuno-oncology Cancer vaccines Systemic secreted therapeutics Systemic intracellular therapeutics Prophylactic vaccines Varying technology risk De-risk technolo
Slide 8: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Chikungunya Antibody Increasing biology risk VEGF-A (no LNP) Localized regenerative therapeutics Intratumoral immuno-oncology OX40L OX40L+ IL23+IL36g (Triplet) Cancer vaccines Personalized cancer vaccine Systemic secreted therapeutics
Slide 9: Two important positive clinical milestones in two modalities
Two important positive clinical milestones in two modalities announced today Cytomegalovirus (CMV) vaccine (mRNA-1647) Positive interim phase 1 data Successfully immunized seronegatives and boosted seropositives Generally well tolerated Phase 2 to start in the near term Preparations underway for the
Slide 10: Body of clinical data from Moderna's platform to date
Body of clinical data from Moderna’s platform to date Chikungunya Antibody Increasing biology risk VEGF-A (no LNP) Localized regenerative therapeutics Intratumoral immuno-oncology OX40L OX40L+ IL23+IL36g (Triplet) Cancer vaccines Personalized cancer vaccine Systemic secreted therapeutics Fabry Syste
Slide 11: Moderna's development pipeline at IPO
KRAS+Sting Vaccine hMPV+PIV3 vaccine Zika Vaccine mRNA-1893 CMV vaccine IL12 PCV OX40L+IL23+IL36g (Triplet) Chikungunya antibody Open IND Moderna’s development pipeline at IPO Pre-Clinical Development *Data in some cases are interim; positive data means the data warrant continued advancement within
Slide 12: Moderna's development pipeline today
PCV KRAS Vaccine hMPV+PIV3 vaccine Zika vaccine CMV vaccine RSV (1172) vaccine IL12 PCV PCV hMPV+PIV3 vaccine OX40L+IL23+IL36g (Triplet) Chikungunya antibody Open IND Moderna’s development pipeline today (9 months since IPO) Pre-Clinical Development *Data in some cases are interim; positive data mea
Slide 13: Moderna in September 2019
Moderna in September 2019 Programs in Development 4 Vaccines for major unmet needs CMV preparing Phase 2 hMPV+PIV3 – positive interim Ph 1 data RSV and Zika in Ph 1 5 Immuno-Oncology PCV in Ph 2 OX40L preparing for Ph 2 cohort Triplet, IL2, KRAS in Ph 1 5 Rare Disease First systemic therapeutic: Chi
Slide 14: R&D Day 2019 agenda
R&D Day 2019 agenda Sign-in, Coffee, Breakfast 7:30–8:30 AM 60 min Introduction Stéphane Bancel 8:30–8:40 AM 10 min CMV Tal Zaks, MD, PhD Sallie Permar, MD, PhD, Duke University School of Medicine Tal Zaks, MD, PhD Juan Andres Mark Schleiss, MD, University of Minnesota Laura Riley, MD, Weill Cornell
Slide 15: Prophylactic vaccines
Prophylactic vaccines Tal Zaks, MD, PhD Chief Medical Officer
Slide 16: Progress by modality
Progress by modality Intratumoral immuno-oncology Prophylactic vaccines Cancer vaccines Localized regenerative therapeutics Systemic intracellular therapeutics Systemic secreted therapeutics
Slide 17: Prophylactic vaccines pipeline
Modality ID # Program Preclinical dev elopment Phase 1 Phase 2 Phase 3 and commercial Moderna rights Prophylactic vaccines – Commercial programs Prophylactic vaccines- Global health programs mRNA-1172/ RSV vaccine Merck V172 Merck to pay milestones and royalties mRNA-1777RSV vaccine mRNA-1653hMPV+PI
Slide 18: mRNA platform advantages for infectious disease vaccines
Our mRNA platform has significant advantages for the development of infectious disease vaccines mRNA mimics natural infection to activate the immune system and achieve a potentially potent response Multiple mRNAs in one vaccine for more compelling product profiles Faster discovery, ability to respon
Slide 19: Positive readouts from six prophylactic vaccines
Immunogenicity at sufficient levels to warrant further study Clinical safety and tolerability Dose dependent pharmacology NHP protein expression Antigen complexity Positive readouts from six prophylactic vaccines Phase 1 safety and immunogenicity data (H10N8, H7N9, RSV, Chikungunya virus, hMPV+PIV3,
Slide 20: Prophylactic vaccines pipeline
Modality ID # Program Preclinical dev elopment Phase 1 Phase 2 Phase 3 and commercial Moderna rights Prophylactic vaccines – Commercial programs Prophylactic vaccines- Global health programs mRNA-1172/ RSV vaccine Merck V172 Merck to pay milestones and royalties mRNA-1777RSV vaccine mRNA-1653hMPV+PI
Slide 21: CMV vaccine (mRNA-1647): Review of interim phase 1 data
Cytomegalovirus (CMV) vaccine (mRNA-1647): Review of interim phase 1 data Tal Zaks, MD, PhD Chief Medical Officer
Slide 22: Congenital CMV vaccine mRNAs encode Pentamer and gB
Congenital CMV vaccine includes 6 mRNAs 5 encode the Pentamer, 6th encodes gB antigen Fibroblasts Epithelial cells
Slide 23: CMV vaccine Phase 1 trial design
CMV vaccine (mRNA-1647) Phase 1 trial design Key Objective: To assess the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 Primary endpoint: Safety Secondary endpoints: Neutralizing antibodies against CMV infection of epithelial cells and fibroblasts Binding antibodie
Slide 24: Immunogenicity in CMV-seronegative participants
CMV Vaccine (mRNA-1647) Phase 1 Interim Analysis Immunogenicity in CMV-seronegative participants, per-protocol set GMT = geometric mean titer; CMV-seropositive benchmark values derived from baseline values of all CMV-seropositive participants Seronegative subjects successfully immunized to generate
Slide 25: Immunogenicity in CMV-seropositive participants
CMV Vaccine (mRNA-1647) Phase 1 Interim Analysis Immunogenicity in CMV-seropositive participants, per-protocol set GMT = geometric mean titer; GMR = geometric mean ratio, defined here as the average of the ratio between Baseline/post 2nd vaccination for each participant Seropositive subjects effecti
Slide 26: Adverse events by CMV serostatus
CMV Serostatus at Baseline CMV-seronegative CMV-seropositive Placebo n=13 30 μg n=15 90 μg n=16 180 μg n=15 Placebo n=13 30 μg n=12 90 μg n=11 180 μg n=11 Pain - 11 (73%) - 13 (81%) 2 (13) 12 (80%) 2 (13) - 9 (75%) 1 (8) 8 (73%) - 10 (91%) 3 (27) Redness - - - 3 (21) - - - - 2 (18) 1 (9) Swelling -
Slide 27: Durable immunogenicity followed to one year
CMV vaccine (mRNA-1647) Phase 1 Interim Analysis Durable immunogenicity demonstrated in initial cohort followed to one year
Slide 28: Phase 2 dose-confirmation trial
A phase 2, randomized, observer-blind, placebo-controlled, dose-confirmation trial to evaluate the safety and immunogenicity of Cytomegalovirus vaccine mRNA-1647 in healthy adults Evaluate intended phase 3 formulation (same LNP) at 3 dose levels (50µg, 100µg, 150µg) N = 252 adult females and males 1
Slide 29: Phase 3 pivotal trial preparations underway
CMV vaccine (mRNA-1647) Phase 3 pivotal trial preparations are underway Solicited and received Type C meeting feedback from FDA Primary endpoint: prevention of primary CMV infection in a population that includes women of child bearing age (WOCBA) We believe we can achieve this objective with a trial
Slide 30: CMV vaccine supply plans
CMV vaccine supply plans for late stage development and commercialization Juan Andres Chief Technical Development, Manufacturing, Quality Officer
Slide 31: Internal Manufacturing Site, Norwood MA
Moderna’s Internal Manufacturing Site, Norwood MA Pre-clinical, clinical & personalized cancer vaccine production Built and operationalized in 22 months 1st clinical batch manufactured in Aug ’18, 70 batches manufactured to date
Slide 32: Slide 32
Slide 33: Internalizing manufacturing for quality, speed and scale
Internalizing manufacturing to enable focus on quality, speed and scale Norwood now provides the scalability we need for our growing pipeline Plasmid mRNA Lipid Nano-particle (LNP) Form, Fill, Finish (FFF) Quality Control 2011-2013 No GMP needs in this horizon CMO 2014-2015 Sourced entirely by CMOs
Slide 34: Norwood manufacturing competitive advantage for CMV vaccine
Manufacturing in Norwood brings a competitive advantage to CMV vaccine (mRNA-1647) Cost at economical scale (anticipated 90+ % Gross Margin for mRNA-1647 in US) Enables fast scale up mRNA technology : Platform allows similar manufacturing process across all products Process improvements implemented
Slide 35: CMV vials produced; Norwood capacity
CMV vials already produced for phase 2 trial Same lyophilized image intended for phase 3 Norwood site can produce mRNA and LNP for phase 3 Norwood site can support commercial launch (FFF to be done at CMO) Potential for >10+ million doses/year from Norwood
Slide 36: CMV commercial opportunity
CMV commercial opportunity Stéphane Bancel Chief Executive Officer
Slide 37: Development plan for CMV vaccine
Preparing for the pivotal phase 3 trial Near-term initiation of the dose-confirmation phase 2 (supply and clinical operations preparation is already advanced) Rapid phase 2 with 252 healthy subjects and a three-month interim analysis (IA) endpoint Phase 3 to demonstrate prevention of CMV infection i
Slide 38: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine CMV is a blockbuster commercial opportunity
Slide 39: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity CMV is a blockbuster commercial opportunity Women of child bearing age (WOCBA) ~ 8 million (USA+EU only) Adolescents HPV vaccine precedent Infants Early vaccination Rubella precedent (ubiquitous MMR vaccine)
Slide 40: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 40-70 million vaccinations per year CMV is a blockbuster commercial opportunity
Slide 41: CMV vaccine infant cohort opportunity size
2030 Birth Cohort Opportunity Size 2040 Birth Cohort Opportunity Size Accessible male & female birth cohort exceeding 20 million around the anticipated time of potential launch 2050 Birth Cohort Opportunity Size Further market maturation grows the addressable cohort to more than 70 million by 2050 1
Slide 42: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 70 million vaccinations per year Focused sales effort: OBGYN and Pediatricians CMV is a blockbuster commercial opportunity
Slide 43: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 70 million vaccinations per year Focused sales effort: OBGYN and Pediatricians Opportunity to leverage social media during Phase 3 for pre-launch activities to educate a mo
Slide 44: Raising CMV awareness to accelerate recruitment and uptake
We aim to raise CMV awareness in the medical community and the public to accelerate trial recruitment and launch uptake Source: ClearView Partner with national and regional CMV advocacy groups 1 Educate OB/GYNs, pediatricians, and PCPs about congenital CMV infection 2 Distribute educational material
Slide 45: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 70 million vaccinations per year Focused sales effort: OBGYN and Pediatricians Opportunity to leverage social media during Phase 3 for pre-launch activities to educate a mo
Slide 46: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 70 million vaccinations per year Focused sales effort: OBGYN and Pediatricians Opportunity to leverage social media during Phase 3 for pre-launch activities to educate a mo
Slide 47: CMV is a blockbuster commercial opportunity
Large unmet medical need with no approved vaccine Indication expansion opportunity Total addressable market could be as high as 70 million vaccinations per year Focused sales effort: OBGYN and Pediatricians Opportunity to leverage social media during Phase 3 for pre-launch activities to educate a mo
Slide 48: Q&A
moderna: | _ Q8A
Slide 49: R&D Day 2019 agenda
R&D Day 2019 agenda Sign-in, Coffee, Breakfast 7:30–8:30 AM 60 min Introduction Stéphane Bancel 8:30–8:40 AM 10 min CMV Tal Zaks, MD, PhD Sallie Permar, MD, PhD, Duke University School of Medicine Tal Zaks, MD, PhD Juan Andres Mark Schleiss, MD, University of Minnesota Laura Riley, MD, Weill Cornell
Slide 50: Cancer vaccines and Intratumoral immuno-oncology
Cancer vaccines and Intratumoral immuno-oncology Tal Zaks, MD, PhD Chief Medical Officer
Slide 51: Modalities
Modalities Intratumoral immuno-oncology Prophylactic vaccines Cancer vaccines Localized regenerative therapeutics Systemic intracellular therapeutics Systemic secreted therapeutics
Slide 52: Cancer vaccines programs
mRNA-4157 Phase 1 ongoing, dose expansion cohorts recruiting. Protocol for randomized Phase 2 filed with FDA. NCI-4650 Phase 1 ongoing (investigator-initiated, single-arm trial sponsored by the NCI). KRAS vaccine mRNA-5671 CRC, NSCLC,50-50 global profit pancreatic cancersharing with Merck Note: NCI-
Slide 53: mRNA advantages in immuno-oncology
Natural cellular processing (antigen presentation, membrane proteins) Combinations (neoantigens, immuno-stimulatory agents) Single process and single, multi-product facility enables rapid production and economies of scale Transient, localized immuno-stimulatory effect at the tumor site mRNA sequence
Slide 54: mRNA opportunity in immuno-oncology
mRNA opportunity in immuno-oncology Combining with PD1/PDL1 inhibitors to improve the benefit to patients Powerful antitumor responses can be achieved by activating antigen specific T cells Checkpoint inhibitors available to unleash tumor-reactive T cells and provide significant benefit to a subset
Slide 55: mRNA vaccines elicit T cell activation
Moderna’s mRNA vaccines elicit T cell activation for curative intent cancer therapy
Slide 56: Personalized cancer vaccine (mRNA-4157)
Personalized cancer vaccine (mRNA-4157) Designed to target an individual patient’s unique tumor mutations Partnered with Merck (Keytruda combo) Interim Phase 1 data presented at ASCO 2019 Dosed for up to 9 cycles Randomized Phase 2 trial in adjuvant melanoma started and major histocompatibility comp
Slide 57: mRNA-4157 Phase 1 data
Personalized Cancer Vaccines mRNA-4157: Phase 1 data Clinical & regulatory update Continuing to enroll patients in phase 1 safety, tolerability and immunogenicity trial monotherapy and in combination with pembrolizumab Part C&D: Continuing to enroll patients Interim safety, tolerability immunogenici
Slide 58: KRAS opportunity
KRAS opportunity: mutation is present in >20% of human cancers KRAS is a key regulator of cell proliferation and survival; mutations cause dysregulated cell proliferation One of the most frequently mutated oncogenes in human cancers Mutations found principally in pancreatic cancer, lung cancer, and
Slide 59: KRAS Vaccine mRNA-5671/Merck V941
KRAS Vaccine mRNA-5671/Merck V941: KRAS Overview: KRAS is a key regulator of cell proliferation and survival; mutations cause dysregulated cell proliferation One of the most frequently mutated oncogenes in human cancers; mutation is present in >20% of human cancers Mutations found principally in pan
Slide 60: KRAS vaccine Phase 1 study overview
KRAS vaccine (mRNA-5671)/Merck V941 Patients dosed in Phase 1 trial Phase 1 study overview A Phase 1, Open-Label, Multicenter Study to Assess the Safety and Tolerability of mRNA-5671/Merck V941 as a Monotherapy and in Combination With Pembrolizumab in Participants With KRAS Mutant Advanced or Metast
Slide 61: Intratumoral immuno-oncology programs
OX40L+IL23+IL36γ mRNA-2752(Triplet)Worldwide Solid tumors/lymphoma 50-50 U.S. profit MEDI1191IL12sharing; AZ to pay Solid tumorsroyalties on ex-U.S. sales Modality Program # Program Indication Preclinical development Phase 1 Phase 2 Phase 3 and commercial Moderna rights Intratumoral immuno- oncology
Slide 62: OX40L (mRNA-2416)
OX40L (mRNA-2416) OX40L Overview: OX40L is a potent co-stimulator, which promotes T-cell proliferation and enhanced survival in the presence of antigen mRNA-2416: mRNA-2416 encodes for OX40L, which is a membrane protein that we believe cannot be manufactured by recombinant technologies
Slide 63: OX40L interim analysis
Clinical: Interim analysis SITC 2018: mRNA-2416 is tolerable at all dose levels studied with no DLTs reported and the majority of AE’s being grade 1 or 2 A clear increase in OX40L protein expression from mRNA-2416 was observed in both tumor and stromal regions in three out of the five post-treatment
Slide 64: OX40L+IL23+IL36γ Triplet (mRNA-2752)
OX40L+IL23+IL36(Triplet) (mRNA-2752) OX40L+IL23+IL36(Triplet) Overview: OX40L powerful co-stimulatory protein that enhances T-cell expansion, function and memory formation IL23 and IL36 have established roles in mediating immune responses mRNA-2752: mRNA-2752 encodes for OX40L which is a membrane pr
Slide 65: Triplet Phase 1 ongoing
OX40L+IL23+IL36γ (Triplet) (mRNA-2752) Phase 1 ongoing; First patient dosed in combination durvalumab Key Objectives Evaluate safety and tolerability of mRNA-2752 administered alone and in combination with checkpoint inhibitors Define MTD and recommended dose for expansion for mRNA-2752 alone and in
Slide 66: IL12 (MEDI1191)
IL12 (MEDI1191) IL12 Overview: IL12 is a potent immune modulator associated with type 1 immune response and production of interferon gamma MEDI1191: Encodes for IL12, a secreted cytokine that acts locally in the tumor microenvironment (TME)
Slide 67: IL12 Phase 1 study
Clinical: Phase 1, open-label, multicenter, dose escalation and expansion study of MEDI1191 administered intratumorally as monotherapy and in combination with durvalumab in subjects with advanced solid tumors Key objectives to evaluate safety and tolerability in monotherapy and combination arms and
Slide 68: Systemic Therapeutics - Secreted and Intracellular
Systemic Therapeutics - Secreted and Intracellular Tal Zaks, MD, PhD Chief Medical Officer
Slide 69: Progress by modality
Progress by modality Intratumoral immuno-oncology Prophylactic vaccines Cancer vaccines Localized regenerative therapeutics Systemic intracellular therapeutics Systemic secreted therapeutics
Slide 70: Systemic secreted therapeutics
Systemic secreted therapeutics 50-50 U.S. profit AZD7970Relaxinsharing; AZ to pay Heart failureroyalties on ex-U.S. sales mRNA-3630 -GAL Worldw ide Fabry disease Modality ID # Program Indication Preclinical dev elopment Phase 1 Phase 2 Phase 3 and commercial Moderna rights Systemic secreted therapeu
Slide 71: Systemic secreted therapeutics
Systemic secreted therapeutics 50-50 U.S. profit AZD7970Relaxinsharing; AZ to pay Heart failureroyalties on ex-U.S. sales mRNA-3630 -GAL Worldw ide Fabry disease Modality ID # Program Indication Preclinical dev elopment Phase 1 Phase 2 Phase 3 and commercial Moderna rights Systemic secreted therapeu
Slide 72: Antibody against Chikungunya virus (mRNA-1944)
Antibody against Chikungunya virus (mRNA-1944) mRNA-1944 contains two mRNAs that encode for the heavy and light chains of CHKV-24 antibody, which may confer passive immunity Expected protective level in mice2
Slide 73: Preclinical evidence of functional antibody
Species: Mouse Antibody against Chikungunya virus (mRNA-1944) Preclinical evidence that mRNA-1944 encodes for functional antibody against Chikungunya virus Expected protective level Therapeutic level for autoimmune and oncology drugs Expression of antibody against Chikungunya virus with repeat dosin
Slide 74: mRNA-1944 trial design
Key Objectives Safety: Evaluate safety and tolerability of escalating doses of mRNA-1944 administered via intravenous infusion Translation of protein: Evaluate pharmacology of mRNA-1944 Activity: Determine ability of antibody to neutralize viral infection Antibody against Chikungunya virus (mRNA-194
Slide 75: Protective antibody levels expected to endure
Antibody against Chikungunya virus (mRNA-1944) Protective antibody levels of >1µg/mL expected to endure at least 16 weeks at the middle dose of 0.3 mg/kg Pharmacology Administration of mRNA-1944 resulted in dose-related increase in levels of CHKV-24 Half life (t1/2) of antibody was 62 days Middle an
Slide 76: Functional antibody neutralization
Antibody against Chikungunya virus (mRNA-1944) mRNA-1944 driven protein expression results in functional antibody (CHKV-24) Neutralizing antibody titers observed at all dose levels, indicating functional antibody production by mRNA-1944 All placebo subjects below the lower limit of detection 100% of
Slide 77: Summary of related adverse events
Antibody against Chikungunya virus (mRNA-1944) Summary of related adverse events Cohort Grade 1 Grade 2 Grade 3 Placebo (N=6) None None None mRNA-1944 0.1 mg/kg (N=6) Feeling of warmth, transient (1) None None mRNA-1944 0.3 mg/kg (N=6) None None None mRNA-1944 0.6 mg/kg (N=4) Subject 1 Sinus tachyca
Slide 78: Translation from preclinical species to humans
Antibody against Chikungunya virus (mRNA-1944) Translation from preclinical species to humans Solid line = Median predicted Shaded area = 90% prediction interval Symbols = Individual participant observations CHKV-24 IgG concentration (µg/mL)
Slide 79: Conclusions for mRNA-1944
Conclusions: mRNA-1944 achieved the target level of functional protein translation at a well tolerated dose Administration of mRNA-1944 resulted in dose-dependent increases in levels of antibody against Chikungunya (CHKV-24) Neutralizing antibodies were observed at all dose levels, indicating functi
Slide 80: mRNA-1944 enables Moderna's systemic therapeutics
MRNA-1944 enables Moderna's systemic therapeutics For the first time, the systemic administration of an mRNA containing LNP has been demonstrated to produce a fully functional complex protein in humans Dose dependent pharmacology has been fully predicted from preclinical species with no loss of pote
Slide 81: Progress in systemic intracellular therapeutics
Phase 1/2 Recruiting patients IND Open Natural history study initiated Successful IND-enabling GLP toxicology studies Pre-clinical activity and dose dependent pharmacology in animal models Sites open for MMA phase 1/2 trial and actively recruiting patients MMA (mRNA-3704) utilizes the same LNP formu
Slide 82: Conclusion
Conclusion Stéphane Bancel Chief Executive Officer
Slide 83: Two important positive clinical milestones in two modalities
Two important positive clinical milestones in two modalities announced today Cytomegalovirus (CMV) vaccine (mRNA-1647) Positive interim phase 1 data Successfully immunized seronegatives and boosted seropositives Generally well tolerated Phase 2 to start in the near term Preparations underway for the
Slide 84: Clinical data validating quality and relevance of our science
Moderna continues to mature and clinical data are validating the quality and relevance of our science 4 programs in or preparing for phase 2 10 positive phase 1 studies (6 vaccines, PCV, OX40, VEGF and Chikungunya antibody) 12 programs in phase 1 Vaccine modality: Six vaccines with positive phase 1
Slide 85: Innovative vaccines are a great business
We believe innovative vaccines are a great business Me too vaccines (i.e., Tetanus, …) Innovative vaccines (i.e., Prevnar, HPV…) Public health vaccines (i.e., Yellow Fever…) Moderna will not fund, but might partner Moderna will fund or partner Moderna will partner with governments and foundations to
Slide 86: Vaccines with strong, recurring revenues
Several vaccines have realized this value-add with strong, recurring revenues Source: EvaluatePharma Top selling vaccines, by 2024 projected sales Vaccine Indication Company Launch Year 2018 WW Sales 2024E WW Sales Prevnar 13* Pneumococcus Pfizer 2000 (PCV7) $5.8 bn $6.7 bn GARDASIL** HPV Merck 2006
Slide 87: Our strategy for the mid-term
Build a strong vaccine business based on innovative vaccines like CMV, RSV, hMPV+PIV3, Zika… Execute the clinical research plans on 5 I/O programs to potentially improve on PD1/PDL1 mono therapy Build a rare disease business, with an initial focus on metabolic diseases Expand into new therapeutic ar
Slide 88: Moderna's vision is intact
Large product opportunity Higher probability of technical success Accelerated research and development timelines Greater capital efficiency over time vs. recombinant technology Moderna’s vision is intact: more than ever, we believe mRNA could be a potential new class of medicines
Slide 89: Our Mission
Our Mission To deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Slide 90: Thank you
moderna’ _ Thank you