Moderna, Inc. · NASDAQ:MRNA
Moderna — FY2019 Earnings Presentation
39 slides from Moderna's earnings presentation, Feb 26, 2020
Slide 1: Business Updates: Fourth Quarter & Full Year 2019 Financial Results
Business Updates Fourth Quarter & Full Year 2019 Financial Results February 26, 2020 Slide 1
Slide 2: Forward-looking statements
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: initiating clinical trial sites outside of the U.S. for mRNA -3704; study star
Slide 3: mRNA as a potential new class of medicines
mRNA as a potential new class of medicines 1. Large product opportunity 2. Higher probability of technical success 3. Accelerated research and development timelines 4. Greater capital efficiency over time vs. recombinant technology Slide 3
Slide 4: Risk management is essential to building a new class of medicines
Risk management is essential to building a new class of medicines Personalized OX40L/ cancer IL-23/IL-36𝛾 CMV vaccine (triplet) vaccine VEGF-A (no LNP) Biology risk KRAS cancer OX40L Zika vaccine vaccine Fabry MMA PA H10/H7 Chikungunya influenza antibody vaccine Technology risk Modality Localized…
Slide 5: 2019 was an inflection year in Moderna's history
2019 was an inflection year in Moderna’s history Our modality strategy Personalized OX40L/ cancer IL-23/IL-36𝛾 CMV vaccine (triplet) vaccine VEGF-A (no LNP) Biology risk KRAS cancer OX40L Zika vaccine vaccine Fabry MMA PA H10/H7 Chikungunya influenza antibody vaccine Technology risk Modality…
Slide 6: 2019 was an inflection year in Moderna's history
2019 was an inflection year in Moderna’s history Our modality strategy Core Exploratory CMV vaccine Personalized OX40L/ cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk VEGF-A Zika (no LNP) vaccine Fabry KRAS cancer OX40L vaccine H10/H7 Chikungunya MMA PA influenza antibody vaccine Technology…
Slide 7: Expanding core modalities with additional development candidates
Expanding core modalities with additional development candidates Core Exploratory Personalized OX40L/ antibody cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk antibody VEGF-A (no LNP) antibody KRAS cancer OX40L antibody vaccine CMV Chikungunya vaccine antibody MMA PA Technology risk Localized…
Slide 8: Progression towards a new class of medicines
Progression towards a new class of medicines Impact Slide 8 Stage of development
Slide 9: Progression towards a new class of medicines
Progression towards a new class of medicines Goal: Enter the Impact clinic safely Develop mRNA science, delivery technology and manufacturing Scientific foundation First-in-human (Dec. 2015) Slide 9 Stage of development
Slide 10: Progression towards a new class of medicines
Progression towards a new class of medicines Goal: Validate Impact modalities through clinical data Develop mRNA Explore mRNA science, delivery technology across six technology and different modalities manufacturing Scientific Clinical foundation First-in-human data First Core (Dec. 2015) Modality (
Slide 11: Progression towards a new class of medicines
Progression towards a new class of medicines Goal: File multiple Impact BLA(s) and continue exploration Develop mRNA Explore mRNA Build Core modalities science, delivery technology across six technology and different modalities Investigate current and manufacturing create new Exploratory modalities
Slide 12: Progression towards a new class of medicines
Progression towards a new class of medicines Goal: Deliver a large Impact commercial portfolio of innovative medicines Develop mRNA Explore mRNA Build Core modalities Scale for commercial science, delivery technology across six technology and different modalities Investigate current and manufacturin
Slide 13: Core modality: Prophylactic vaccines
Core modality: Prophylactic vaccines Core Personalized OX40L/ antibody cancer IL-23/IL-36𝛾 vaccine (triplet) antibody VEGF-A (no LNP) antibody KRAS cancer OX40L antibody vaccine CMV Chikungunya vaccine antibody MMA PA Prophylactic Systemic vaccines secreted & cell surface therapeutics Slide 13
Slide 14: Moderna's vaccine franchise
Moderna’s vaccine franchise CMV Phase 2 trial enrolling briskly; announcing three new development candidates >1,000 healthy volunteers enrolled in nine Phase 1 vaccine trials (dose levels up to 400µg); Safety emerging safety & tolerability profile consistent with marketed adjuvanted vaccines1 In cli
Slide 15: Congenital cytomegalovirus (CMV) overview
Congenital cytomegalovirus (CMV) overview • CMV is a common infection and is the CMV infection sequelae leading cause of birth defects in the U.S. • Jaundice — 0.65% of U.S. newborns infected annually • Microcephaly (~25,000 U.S. newborns) Neonatal • Hearing loss period • Vision loss • Disease burde
Slide 16: CMV vaccine (mRNA-1647)
CMV vaccine (mRNA-1647) Immunogenicity from 7-month data confirms and builds on 3-month data • Safety1: — Generally well-tolerated — No vaccine-related serious adverse events • CMV-seronegative group at seven months (after third vaccination): — Epithelial cell assay titers >10-fold higher than CMV-s
Slide 17: Late stage clinical development for CMV vaccine (mRNA-1647)
Late stage clinical development for CMV vaccine (mRNA-1647) • 3 dose levels; randomized, observer-blind, placebo-controlled, multicenter • 252 seronegative & seropositive adults Phase 2 • Utilizes intended Phase 3 formulation; same lipid nanoparticle (LNP) used in Phase 1 dose confirmation • Phase 2
Slide 18: CMV is a blockbuster opportunity
CMV is a blockbuster opportunity • We estimate annual peak sales of $2-5 billion • Assuming GARDASIL2 like average selling price; GM estimated to be >90%3 (EBIT margins estimated at approximately 50%) • >$3billion market size expected globally1 • NEJM Phase 2 publication by Pass et al shows 50% vacc
Slide 19: Epstein-Barr virus (EBV) overview
Epstein-Barr virus (EBV) overview • EBV is a member of the herpesvirus family that includes CMV, is spread through bodily fluids (e.g., EBV infection sequelae saliva) and contracted primarily by young children and Infectious adolescents Mononucleosis Adolescents • Sore throat • Disease burden: EBV i
Slide 20: EBV vaccine (mRNA-1189) is designed to provide broad protection
EBV vaccine (mRNA-1189) is designed to provide broad protection Encodes for five glycoproteins to inhibit both mechanisms for viral entry • EBV has multiple surface (envelope) glycoproteins that mediate virus entry in different cell types1 — gp350 and gp42/gH/gL complex primarily mediate B cell infe
Slide 21: Pediatric respiratory syncytial virus (RSV) overview
Pediatric respiratory syncytial virus (RSV) overview • RSV is the leading cause of unaddressed severe lower respiratory tract disease and hospitalization in infants and young children worldwide • Disease burden: Major cause of hospitalization due to respiratory infection — Hospitalization rate in ch
Slide 22: Pediatric RSV vaccine (mRNA-1345)
Pediatric RSV vaccine (mRNA-1345) • mRNA-1345 encodes for a stabilized prefusion F glycoprotein • mRNA-1345 will use the same LNP as our hMPV/PIV3 (mRNA-1653) and CMV (mRNA-1647) vaccines • We believe that neutralizing antibodies elicited by mRNA-1345 will lead to the reduction of medically attended
Slide 23: mRNA vaccine (mRNA-1273) against SARS-CoV-2
mRNA vaccine (mRNA-1273) against SARS-CoV-2 • mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein of the novel coronavirus, which was selected by Moderna in collaboration with investigators at the National Institute of Allergy and Infecti
Slide 24: Chikungunya antibody data supports systemic secreted & cell surface therapeutics modality
Chikungunya antibody data supports systemic secreted & cell surface therapeutics modality Core Personalized OX40L/ antibody cancer IL-23/IL-36𝛾 vaccine (triplet) antibody VEGF-A (no LNP) antibody KRAS cancer OX40L antibody vaccine CMV Chikungunya vaccine antibody MMA PA Prophylactic Systemic…
Slide 25: IL-2 (mRNA-6231) – long acting tolerizing IL-2
IL-2 (mRNA-6231) – long acting tolerizing IL-2 mRNA-encoded IL-2 modified for the expansion of regulatory T cells • Modified IL-2 is longer acting and more selective for the high affinity IL-2 receptor which is expressed mainly by regulatory T cells • First intended subcutaneous administration of th
Slide 26: PD-L1 (mRNA-6981)
PD-L1 (mRNA-6981) mRNA-encoded PD-L1 to send a tolerizing signal to immune cells • We intend to influence myeloid cells to provide additional co-inhibitory signals in the context of immune synapses by augmenting endogenous expression of PD-L1 • We believe that this tolerizing signal to lymphocytes m
Slide 27: Exploratory modalities are a critical part of our strategy
Exploratory modalities are a critical part of our strategy to maximize applications of our mRNA medicines Exploratory Personalized OX40L/ cancer IL-23/IL-36𝛾 vaccine (triplet) Biology risk VEGF-A (no LNP) KRAS cancer OX40L vaccine MMA PA Technology risk Localized Systemic Intratumoral regenerative…
Slide 28: Sentinel clinical program updates
Sentinel clinical program updates Evaluation in patients Clinical trial updates PCV (mRNA-4157) – Randomized Phase 2 in combination with KEYTRUDA® vs. KEYTRUDA® alone, led by Merck, is ongoing Cancer vaccines KRAS (mRNA-5671) – Phase 1 as a monotherapy and in combination with KEYTRUDA®, led by Merck
Slide 29: Development pipeline
Development pipeline (as of February 26th, 2020) Preclinical (incl. Open IND) Phase 1 Phase 2 Phase 3 EBV SARS-CoV-2 Adult RSV Zika CMV Phase 3 preparations (mRNA1172) CMV Prophylactic vaccines Core modalities Pediatric RSV hMPV/PIV3 H7N9 (mRNA-1345) Chikungunya Relaxin PD-L1 Systemic Antibody secre
Slide 30: Anticipated clinical next steps and catalysts
Anticipated clinical next steps and catalysts • CMV – Phase 2 immunogenicity data at 3-month IA, Phase 3 start • hMPV/PIV3 – Phase 1b seropositive age de-escalation immunogenicity data readout • RSV – Phase 1 safety and immunogenicity data readout Prophylactic vaccines • Zika – Phase 1 safety and im
Slide 31: 2019 fourth quarter and full year financial results (Unaudited)
2019 fourth quarter and full year financial results (Unaudited) Balance Sheets December 31, December 31, 2019 2018 Cash, cash equivalents and investments 1 $ 1.26 billion $ 1.69 billion Statements of Cash Flows Year ended Year ended Dec. 31, 2019 Dec. 31, 2018 Net cash used in operating activities 2
Slide 32: 2019 selected cash flow information and 2020 guidance
2019 selected cash flow information and 2020 guidance 2019 Selected Cash Flow Information (unaudited) 3 months 6 months 9 months Year ended ended ended ended Statements of Cash Flows Mar. 31, 2019 Jun. 30, 2019 Sept. 30, 2019 Dec. 31, 2019 Net cash used in operating activities $ 144 mm $ 256 mm $ 36
Slide 33: We have up to $2 billion to invest and create value
We have up to $2 billion to invest and create value Cash Position (unaudited) February Financing Grants2 Net proceeds of approximately Total additional funding $550 million from our recent Approximately $1.26 billion available from grants is financing in February 2020, of cash and investments1 at ap
Slide 34: Moderna in February 2020
Moderna in February 2020 1 4 11 10 Pipeline Preparing for In or preparing Ph 1 trials Positive Ph 1 readouts: 6 vaccines, PCV, Ph 3 for Ph 2 ongoing OX40L, VEGF, anti-Chikungunya antibody Programs in development 7 5 5 2 Vaccines for major Immuno- Rare Autoimmune unmet needs Oncology disease disease
Slide 35: Moderna priorities for 2020
Moderna priorities for 2020 1 Execute on the development pipeline • Execution of CMV Phase 2 and preparation for CMV Phase 3 2 New development candidates in core modalities • Infectious disease vaccines • Systemic secreted and cell surface therapeutics 3 New development candidates in new modalities
Slide 36: Save the Date – Events in 2020
Save the Date – Events in 2020 Manufacturing and Digital Day March 4th in Norwood, MA (Moderna’s Manufacturing Facility) Vaccines Day April 14th in New York City Science Day June 2nd in New York City R&D Day September 17th in New York City Slide 36
Slide 37: Exciting new phase of growth for Moderna
Exciting new phase of growth for Moderna Impact Develop mRNA Explore mRNA Build Core modalities Scale for commercial science, delivery technology across six technology and different modalities Investigate current and manufacturing create new Exploratory modalities Scientific Clinical Accelerated Com
Slide 38: mRNA as a potential new class of medicines
mRNA as a potential new class of medicines 1. Large product opportunity 2. Higher probability of technical success 3. Accelerated research and development timelines 4. Greater capital efficiency over time vs. recombinant technology 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