St Pharm Co., Ltd. · KRX:237690
St Pharm — Investor Presentation (February 2023)
24 slides from St Pharm's investor presentation, February 2023
Slide 1: ST PHARM IR Book Feb. 2023
IR Book | Feb. 2023 ST PHARM Technology Driven Gene therapy CDMO From Oligonucleotide to xRNA
Slide 2: Introduction
PART 01 Introduction
Slide 3: History & Supply Record
Introduction HISTORY & SUPPLY RECORD ▪ ST PHARM HISTORY ▪ SUPPLY RECORD 1983 Foundation of Samchully Pharm 1988 Supplied Thymidine (dT) to GSK and BMS 2010 Joined Dong-A Socio Group and the corporate name changed to World-largest supplier of Thymidine (dT) ST PHARM (Science and Technology) 2015 Comp
Slide 4: Approval history
Introduction Approval history International FDA Inspection PMDA FDA (2006) PMDA PAI WHO EDQM & WHO (2007) MFDS FDA (2009) EDQM MFDS MFDS US-FDA(PAI) MFDS (2010) PMDA MFDS MFDS Pre-Approval ANVISA (2011) TGA (PAI) FDA Inspection HPRA PMDA Korean GMP WHO 1992 ~ 1998 2000 ~ 2005 2006 ~ 2011 2013 2014 2
Slide 5: ST PHARM Global Family
Introduction ST PHARM GLOBAL FAMILY Gene therapy CDMO business from oligonucleotide to xRNA Seamless Development from Manufacturing to Non-clinical animal safety service ANAPATH SERVICES BASEL, SWITZERLAND (HISTOPATHOLOGY SERVICE) STP AMERICA RESEARCH DELAWARE, USA ST PHARM VERNAGEN ANAPATH RESEARCH
Slide 6: CDMO Business Overview
Business CDMO Business Overview ▪ ST PHARM CDMO strategy 2018. Polynucleotide 2008. Oligonucleotide • mRNA 1983. Nucleoside/tide • Antisense (ASO) • circRNA • siRNA / miRNA • Monomer (PNS / PA) • Aptamer • Zidovudine (AIDS) • Decoys • samRNA • Others • Sofosbuvir (HCV) 6
Slide 7: Market Overview
PART 02 Market Overview
Slide 8: RNA-based Therapeutics' concept
Market RNA-based Therapeutics’ concept ▪ Overview ▪ Central Dogma RNA-based therapeutics, fundamentally controlling gene expression (disease- Mechanism of RNA based drug (ASO) relevant gene), 3rd generation therapy DNA mRNA DISEASE PROTEINS ▪ RNA based drugs - mechanism: interfere or control the exp
Slide 9: RNA-based Therapeutics' market
Market RNA-based Therapeutics’ market ▪ Geron, Imetelstat, new Oligonucleotides drug in blood cancer MDS(myelodysplastic syndrome), Forecasting sales 1.2B/year 2023 plans on target for regulatory submission in US and EU, commercial launch in 1H. 24 MF(myelofibrosis) in Phase 3, AML(acute myeloid leu
Slide 10: RNA-based Therapeutics' market
Market RNA-based Therapeutics’ market ▪ Dawn of RNA-based Therapeutics - ‘18 development of Gal-NaC has enabled an expansion to chronic liver-related diseases, Big phama’s investment on RNA pipeline hikes - Starting ‘24, blockbuster RNA drugs will be commercialized, such as Leqvio (Inclisiran) - Dem
Slide 11: RNA-based Therapeutics' market (mRNA)
Market RNA-based Therapeutics’ market (mRNA) ▪ Overview ▪ mRNA Platform - widespread use of mRNA vaccines for COVID 19. 1) 5’ Cap ping - Market grows from $46.7 billion in 2021 to $101.3 billion by 2026 (CAGR 16.8%) mRNA ▪ mRNA therapeutics - Safety/ Specificity (binding to target disease) UTR CODIN
Slide 12: RNA-based Therapeutics' market
Market RNA-based Therapeutics’ market [출처 : Biomedtracker] 12
Slide 13: RNA-based Therapeutics (mRNA concept)
Market RNA-based Therapeutics (mRNA concept) ▪ mRNA manufacturing process DRUG SUBSTANCE DRUG PRODUCT DNA pDNA IVT Synthesis New 5’ Cap Analog Formulation (DDS) Fill & Finish • pDNA linearization R • LNP • Final step • Novel cap analog (SmartCap ) To protect the encapsulated to stabilize mRNA mRNA f
Slide 14: Business Overview
PART 03 Business Overview
Slide 15: Oligonucleotide CDMO
Business Oligonucleotide CDMO ▪ ST PHARM’s Core Strength (Oligonucleotide CDMO) ▪ ST PHARM’s Oligo CDMO projects Stage - Global top-3 positioned service Clients Indication Phase1 Phase2 Phase3 Commercial - The only integrated In-House production capability in the global market Company A Hyperlipidem
Slide 16: Oligonucleotide CDMO Capacity
Business Oligonucleotide CDMO ▪ Capacity (Oligonucleotide) ST PHARM plans to invest in total $126 million USD to build a 2nd oligonucleotide manufacturing plant. [1 mole ≒ 167kg~500kg] Current 2022, 3Q 2024, 3Q 2026, 1Q Oligo production st st st nd nd st 1 Plant 1 Plant (1 & 2 expansion) 2 Plant (1
Slide 17: mRNA CDMO Business Strategy
Business mRNA CDMO ▪ mRNA Business Strategy mRNA LNP Manufacturing 5’ Cap mRNA Modification Novel RNA Platform API Manufacturing LNP Development Mass Production (Microfluidics) • SMARTCAP® • Owned Patent • circRNA, saRNA • Ionizable lipid • SMARTLNP® • In-house facility(GMP) (Co-development) • Colla
Slide 18: mRNA CDMO: SmartCap and STLNP
Business mRNA CDMO - SmartCap® - STLNP® /SmartLNP® SMARTCAP ® STPHARM LNP Strategies - Stabilizing synthetic technology of mRNA 1. In-Licensing LNP - Patented in Korea / USA (on going) - Proven, unsurpassed technology (applied to Covid19 vaccine) - Diverse cap analogues (over 30 types) 2. ST Pharm L
Slide 19: mRNA CDMO production scale
Business mRNA CDMO “ From milligram to kilogram scale production” 1. R&D / Small scale production mRNA plant ,1F (Banwol) Completion: 2020.08 Capacity : gram / month (for pre-clinical) 2. Mid-scale production (GMP) mRNA plant ,1F (Banwol) mRNA Plant Completion: 2021.05 Capacity: mg to multi-gram /mo
Slide 20: mRNA platform: SmartCap
Business mRNA platform ▪ SmartCap® Cap 5’-UTR ORF 3’-UTR AAAAAn Own novel capping analogues with 30 types(competitor 3 types) Poly(A) Tail Oct. ’20, registered patent in Korea, processing the global patent(expecting 1H. 23) Data announcement at global conference in Nov. ’22 Enzyme substitute ▶ 12 mo
Slide 21: mRNA platform: LNP
Business mRNA platform ▪ LNP platform - Genevant LNP In-licensing LNP - Only available to COVID-19 mRNA vaccine - Own developed LNP STLNP® - for mRNA CDMO(neoantigen, autoantigen vaccine etc.) - Next generation LNP SmartLNP® - 2 types candidates in pre-clinical stage(co-develop with EWHA university)
Slide 22: mRNA platform (US affiliates)
Business mRNA platform (US affiliates) ▪ Vernagen(Atlanta, USA) ▪ Levatio(San-Diego, USA) mRNA based vaccine for infectious disease Gene/Cell therapeutics with mRNA, circRNA, CAR-NKT Indication partnership 2021 2022 2023 2024 Shingles virus Emory university, US circRNA Platform Engineering RSV(respi
Slide 23: CRO
Business CRO In 2019, Acquired Global CRO company in Europe (Client-dependent CMO ⇒ Client-leading CDMO) After completion of restructuring in 2020, achieved of turnaround. ▪ AnaPath Research (Barcelona, Spain) ▪ AnaPath Service (Basel, Switzerland) - Established in 1986 (Envigo, Spain) - CSO : Klaus
Slide 24: Thank You
Thank You ST PHARM Technology-Driven Gene therapy CDMO From Oligonucleotide to mRNA