Moderna, Inc. · NASDAQ:MRNA
Moderna — Technical Presentation (May 2019)
24 slides from Moderna's technical presentation, May 7, 2019
Slide 1: Norwood May 2019
Norwood May 2019 DNA mRNA Protein Exhibit 99.2
Slide 2: 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: mRNA as a potential new class of medicines; the scope of the mRNA opportunity; Moderna’s ability to scale
Slide 3: Moderna Mission & Role of Norwood
Moderna Mission & Role of Norwood Stéphane Bancel DNA mRNA Protein
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: Moderna's Mission
Moderna’s Mission Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Slide 6: Norwood Vision: To enable Moderna scale up for the next years
Norwood Vision: To enable Moderna scale up for the next 20 years Fully integrated site: Raw materials + API + Formulation + Fill vials + Finish + Ship to clinical sites + QC Highly flexible Highly scalable: Up to 100 GMP batches of mRNA planned per year Fully digital site Environmentally friendly Fo
Slide 7: GMP manufacturing strategy: Phase appropriate
GMP manufacturing strategy: Phase appropriate Norwood now provides the scalability we need for our growing pipeline 2011 - 2013 2014 - 2015 2016 - 2018 2H 2018+ Plasmid: No GMP needs • Outsourced • Outsourced • Norwood mRNA: • • Moderna, Cambridge • Outsourced • Norwood Form: • • Moderna, Cambridge
Slide 8: Norwood: businesses in plant
Norwood: 3 businesses in 1 plant Core business: GMP manufacturing to supply our clinical pipeline Preclinical Production for Research Engine (was in Cambridge, moved to NW to reduce real estate cost) Personalized Cancer Vaccine (PCV)
Slide 9: Manufacturing Capability
Manufacturing Capability Juan Andres DNA mRNA Protein
Slide 10: 5’ Region Region
5’ Region 3 Region —— —————— Coding Region (Open Reading Frame, or ORF) =a moderna
Slide 11: What we do… Create Technical Development
What we do… Create Technical Development
Slide 12: Technical development enabled scale
Technical development enabled scale 2015 < 20 employees Scale for mRNA content in final Drug Product (DP) ~2.5g ~2 GLP toxicology/consistency batches (DP) completed >150 in 2019, 30% PhDs Scale for mRNA content in final Drug Product (DP) ~10g with line of sight to 100g within next 12 month >60 GLP t
Slide 13: Technical development enabled scale
Technical development enabled scale 2015 < 20 employees Scale for mRNA content in final Drug Product (DP) ~2.5g ~2 GLP toxicology/consistency batches (DP) completed >150 in 2019, 30% PhDs Scale for mRNA content in final Drug Product (DP) ~10g with line of sight to 100g within next 12 month >60 GLP t
Slide 14: What we do… Make Internal & External GMP Manufacturing
What we do… Make Internal & External GMP Manufacturing Pre-Clinical
Slide 15: We make bold choices: Norwood
We make bold choices: Norwood
Slide 16: Manufacturing asset as competitive advantage to industrialization of a platform
Manufacturing asset as competitive advantage to effective industrialization of a platform technology Cost at economical scale – progressing as planned Enables fast scale up Competitive Advantage of mRNA technology Critical mass in production volume Less future capital investment Process improvements
Slide 17: Pre-clinical automation enabled speed of research
Pre-clinical automation enabled speed of research 2014 Manual mRNA production process Time from order to mRNA delivery ~120 days Located in Cambridge Fully automated mRNA production process Time from order to mRNA delivery ~30-45 days Located in Moderna Manufacturing Site, Norwood Current
Slide 18: Pre-clinical automation enabled speed of research
Pre-clinical automation enabled speed of research 2014 Manual mRNA production process Time from order to mRNA delivery ~120 days Located in Cambridge Fully automated mRNA production process Time from order to mRNA delivery ~30-45 days Located in Moderna Manufacturing Site, Norwood Current
Slide 19: Built internal GMP Production Capability early in the lifecycle
Built internal GMP Production Capability early in the lifecycle 2015 No internal GMP Production, DS and DP outsourced to CMOs 2 GMP clinical trial mRNA vaccine batches (DS+DP) completed Internal GMP DS and DP production since April 2016 Advanced from 10g output in 2016 to 45g DS output in 2018 ~50 G
Slide 20: Built internal GMP Production Capability early in the lifecycle
Built internal GMP Production Capability early in the lifecycle 2015 No internal GMP Production, DS and DP outsourced to CMOs 2 GMP clinical trial mRNA vaccine batches (DS+DP) completed Internal GMP DS and DP production since April 2016 Advanced from 10g output in 2016 to 45g DS output in 2018 ~50 G
Slide 21: Norwood equipped to support Phase III & initial launch
Norwood equipped to support Phase III & initial launch Norwood equipped to become Phase III and initial launch site and support demand for upside scenarios for some processes/products Optionality enabled with US based CMO that has a longstanding experience with commercial Drug Product Production Add
Slide 22: As we scale and streamline the process…
As we scale and streamline the process… Scale progression 2015/2016 2017/2018 2020/2022 When commercial & at scale 2.5g 10g 100g >500g
Slide 23: …Cost is rapidly improving.
…Cost is rapidly improving. 2015/2016 2017/2018/2019 2020/2022 Scale progression Direct Drug Substance Cost ($/mg) 45-55% When commercial & at scale 2015/2016 to 2017/2018/2019 drug substance costs reductions are based upon illustrative examples for different development candidates
Slide 24: Manufacturing is becoming a competitive advantage
Manufacturing is becoming a competitive advantage Critical mass of platform approach enables accelerated learning and rapid adoption of technical advances End to End integration of different technologies (Plasmid; Drug Substance; Drug Product) at Norwood creates Flexibility = â cost á speed Top CMC