Wuxi Chemistry Wuxi Chemistry – Leading a New Era of CRDMO
WuXi Chemistry WuXi Chemistry – leading a new era of CRDMO
3 Established Global Brands
IDSU CSU STA (International Discovery Service Unit) (Chemistry Service Unit) (CDMO/CMO subsidiary of WXAT)
Unique CRDMO Model Captures Entire Value Chain CRO CDMO CMO
Target Hit Lead Commercial Preclinical Phase I Phase II Phase III Submission& to Hit to Lead to PCC ManufacturingLaunch
Global Platform, Global Talents
17,967 15 1,831 employees global sites clients worldwide 2021 H1 Rich CRDMO pipeline drives sustainable high growth
“R” 274,212 Individually synthesized compounds 2020.7 – 2021.6
1,113 Preclinical & Phase I
“D” 220 Phase II
48 Phase III
“M” 32 Commercial
Delivered in 2020.7-2021.6 A dominant leader in China chemistry-based CRDMO market
2020 Chemistry Based Revenue (¥ Million RMB)
9,531
WuXi Chemistry Competitor 1 Competitor 2 Competitor 3 Competitor 4
Source: companies annual reports and investor analysis report 15 sites across the globe continue to expand
China
Shanghai Waigaoqiao Shanghai Zhangjiang Tianjin Wuhan, Hubei Chengdu, Sichuan Qidong, Jiangsu R D M R R R R R
Shanghai Jinshan Changzhou, Jiangsu Changshu, Jiangsu Taixing, Jiangsu Wuxi city, Jiangsu D M D M M M D M
R Research 7 United States Switzerland
D Development 5
M Manufacturing San Francisco, CA San Diego, CA Middletown, DE Couvet, Neuchâtel 9 R D M M M The largest chemistry services workforce in the world
Research Development Manufacturing 10,190 3,741 4,036
2,549 process chemists & analytical scientists
1,192 formulation scientists & analytical scientists
9,510 chemists 3,592 API manufacturing 680 analytical scientists 444 DP manufacturing
17,967 WuXi Chemistry Employees WuXi Chemistry leadership team
Minzhang Chen, Ph.D. Tao Guo, Ph.D. Jingchao Dong, Ph.D. Xiaoyong Fu, Ph.D. Jinling Chen, Ph.D. Yu Lu
Co-CEO, WuXi AppTec SVP, IDSU SVP, CSU CTO, API SVP, DP CBO & New Modality
20+ years 20+ years 20+ years 20+ years 20+ years 20+ years of experience of experience of experience of experience of experience of experience Healthy CRDMO client base drives long term growth
CR“D”MO C“R”DMO CRD“M”O
1340 269 203 19 “R” only clients “R” + “D” clients “D” only clients “D” + “M” clients
1,831 WuXi Chemistry CRDMO clients in 2021 H1 WuXi Chemistry C“R”DMO WuXi Chemistry C“R”DMO capability overview
Discovery Medicinal Custom Library Catalog Non-GMP Process Chemistry Synthesis Synthesis Business Manufacture Chemistry
Technology Platform Specialty Chemistry Integrated Discovery
PROTAC®, AI for Retrosynthesis, Carbohydrate, Nucleoside/tides, Medchem Design, Computer-Aided Quantum Mechanics for Synthesis, Macrocyclic, Boron, Deuteration, Drug Design, Project Management, Flow Chemistry, Electrochem, Lipids, Polymer, Fluorescent Bio- Compound Management Photoredox, Catalyst Screening, probe and Labeling, Steroids, Fluorine, Automation Late Stage Functionalization Strong, loyal and expanding “R” client base
BROAD CLIENT BASE DEEP ENGAGEMENT LONG HISTORY COLLABORATION
1,609 global clients 516 have FTE collaboration 458 clients with >5 years’ collaboration including:
20 of global top 20 27 clients with 50+ FTE team • 75 clients with >10 years’ pharmaceutical companies including: collaboration
• 13 clients with 100+ FTE team WuXi Chemistry CR“D”MO WuXi Chemistry CR “D”MO capability overview
DISCOVERY PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL
Process R&D, API and Advanced Intermediates Manufacturing API
Pre-formulation Study , Formulation & Process Development, Drug Drug Product Manufacturing, Packaging and Labeling product
Analytical Development, Quality Control and Stability Studies Analytical
Regulatory Global Regulatory CMC Filing Support CMC Our pipeline outgrew global clinical stage small molecule new drug candidate pipeline by 2+ times
46%* increase of WuXi Chemistry clinical stage new drug pipeline 602 550 561 474 487 14% 413 444
2019Q4 2020Q1 2020Q2 2020Q3 2020Q4 2021Q1 2021Q2 2021 Q2 12%
20%* increase of global clinical stage new drug pipeline 4278 3918 4072 3579 3620 3743 3816 2019 Q4
2019Q4 2020Q1 2020Q2 2020Q3 2020Q4 2021Q1 2021Q2
* Growth rate from 2019Q4 to 2021Q2 Source: Clarivate Cortellis, July. 01, 2021 WuXi Chemistry CR “D”MO capability overview: API
process chemists & processes developed 2,549 analytical scientists 846 APIs & Intermediates in 2021 H1
Globally Leading API Enabling Technology Platform
Crystallization Biocatalysis Chemo Continuous Preparative & Particle Catalysis Processing HPLC and SFC Engineering (Flow Chemistry) WuXi Chemistry CR “D”MO capability overview: Drug Product
One-Stop Bioavailability Solid State Enhancing Platform Development 1,192 formulators and analytical scientists
Pre- Formulation 1,704 275 Formulation Spray Dried Dispersion Hot Melt Extrusion Development pre-formulation molecules formulations developed evaluated in 2021H1 in 2021H1
Broad Dosage Forms Advanced Delivery Technologies tablets | capsules | powder | pediatrics | modified release liquid capsules | granules | sublingual delivery Nano Suspension Liquid Capsules injectable | liquid in bottle Maximizing synergies from API to DP
API and DP client overlap API DP molecule conversion
132 125 115 152 179 156 103 110 88 124 137 161
2019 2020 2021 H1 2019 2020 2021H1 API only Both DP only
• Number of clients using both API and DP services increased by 74% from 2019
• API to DP molecule conversion increased by 73% from 2019 Accelerating new drug development for both early and late phases via integrated CMC offering
4-6 months saving for IND submission
3-9 months saving for NDA submission
TIME & COST SAVINGS streamlined process and seamless tech transfer
REDUCED RISK same high quality and EHS systems across all sites
IMPROVED EFFICIENCY simplified CMC vendor management with ONE partner
Data source: Expediting IND Submission, PharmTech, March 2021 The 3rd WiXi STA New Drug Development Strategy Summit, October 2019 WuXi Chemistry CRD“M”O An engine to support global launch of new drugs
Supported 23 new drugs approved between 2017-2020
6-8**
7 7 6 4 3
2017 2018 2019 2020 2021
*: only count first approval, all of those drugs are approved by FDA, EMA, NMPA or PMDA. ** 6-8 molecules in WuXi Chemistry pipelines are estimated to be approved in 2021 H2 Growing weight of CRD“M”O business in WuXi Chemistry
2015-2021 WuXi Chemistry Commercial Project Revenue 4000 (RMB ¥ Million) 25%
3500 20% 19% 18% 18% 20% 3000 2,751 15% 2500 14% 15%
2000 1,845
9% 10% 1500 1,325
1000 964 684 5% 500 471 271
0 0% 2015 2016 2017 2018 2019 2020 2021Est A proven track record of global standard quality system
7 successful US FDA inspections 30+ successful China NMPA inspections 2013, 2014, 2016, 2018 and 2019 2015-2020
2 successful EU EMA inspections 2 successful Japan PMDA inspections 2019 2019
3 successful SwissMedic inspections 200+ client audits 2018, 2019 & 2020 every year Our winning strategy: follow the molecule Case study u: Support ibrutinib API and intermediates from phase 1 to commercial through different partners
Cumulative API and Intermediate Delivery
105 countries launched 125+ MT delivered
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Nov 2013 FDA approval
acquired Initiated project at announced co-development Aug 2017 STA in phase I and worldwide license NMPA approval agreement Our winning strategy: follow the molecule Case study v : Won the business to cover the entire supply chain of niraparib over time
32 countries approved Out licensed in 2012
FDA approval acquired EMA approval
2008 2012 2014 2015 2016 2017 2018 2019 2020 2021
1st starting 1st starting 1st starting 1st starting 1st starting material material material material material + + + + 2nd starting 2nd starting 2nd starting 2nd starting material material material material + + + intermediate intermediate intermediate + + API API + drug product
Increasing Business Scope Enabled Zejula® fast track NDA approval by FDA and EMA
Key Challenges: Key Criteria when Selecting CDMO: • Both strong in R&D and production • Complex process but fast timeline Why STA? • Late stage and launch experience • Tightened regulatory oversight • Quality and regulatory inspection track record • Virtual biotech company without CMC resources • Team size, technical capability and capacity
Resolved Regulatory Starting Material Completed process development and Result: push back from EMA (converted 2 non-GMP Process Performance Qualification in 8 steps to GMP steps in <4 months vs. 8-12 months if months (vs. 18 months quoted by another CDMO) switching to another CDMO)
Data Source: DCAT Sharp Sourcing 2018 - Launching Innovative Oncology Drugs Through External Collaboration Our winning strategy: follow the molecule Case study w : Supported Orelabrutinib approval by NMPA via integrated CMC offering
Supported Orelabrutinib Approval by NMPA (Dec.2020)
st 1 CDMO in China to support a new drug launch involving Spray Dried Dispersion (SDD) technology
st 1 CDMO in China to support a new drug launch with an integrated CMC platform across 4 sites
• Shanghai Waigaoqiao: API and DP R&D • Jinshan: API manufacturing • Changzhou: SDD manufacturing • Wuxi: Drug product manufacturing and packaging WuXi Chemistry CRD“M”O capacity overview: API
Changzhou, China
Current Capacity 2021H1 Delivered 15 1400 m3 (1,400,000 L) 6195 141 MT plants total reactor volume batches products Large and rapidly growing API manufacturing capacity
Changzhou, China Taixing, China
Expansion in Next 2 Years
15 new plants 2,486 m3 (2,486,000 L) 6 from Changzhou phase III and 9 from Taixing phase I additional total reactor volume WuXi Chemistry CRD“M”O capacity overview: Drug Product
Wuxi, China
Current Capacity 2021 H1 Delivered 2 sites 3.2 billion 1.4 billion 638 25 Shanghai tablets capsules Batches manufactured Ongoing Late phase and Waigaoqiao/Wuxi commercial projects Continue to strengthen drug product capability and capacity
Wuxi Phase II Wuxi Phase III
Expansion in Wuxi city
• Phase II: New R&D center with oral, injectable and analytical platforms opened in May 2021 • Phase II: Add additional capacity for both oral and injectable drug product manufacturing by Q1 2022 • Phase III: HP oral and injectable drug product manufacturing new technologies including continuous manufacturing in 2 years Key milestones in CRD“M”O global network expansion
Drug Product Manufacturing API & Drug Product Manufacturing Couvet, Switzerland (Deal closed in July 2021) Middletown, DE, USA (Announced in June 2021)
• Providing customer better flexibility with an enhanced supply worldwide • Gaining greater access to the global market
Global Brand Global Platform Global Talents WuXi Chemistry New Modality CRDMO Platform Follow the chemistry – expanding into new modalities
CRO CDMO CMO
Target Hit Lead Commercial Preclinical Phase I Phase II Phase III Submission& to Hit to Lead to PCC Manufacturing Launch
Oligo Peptide
Oligo Peptide Oligo GalNAc Peptide PEG
Oligo Toxin Peptide Toxin
Unique CRDMO New Modality Platform Captures Entire Value Chain Capable to offer both API and formulation services for oligonucleotide, peptide as well as their conjugates under one roof Capturing the next wave of oligonucleotide market growth via our unique CRDMO platform
134 global clients Broad Coverage Vertically Integrated 240 ASO, siRNA, Aptamer, From customized monomers and linkers to APIs scientists microRNA, PMO/PPMO etc.
Number of Oligonucleotide new drug candidates in our pipeline
Chemistry Powerhouse Analytical Strength Solid phase synthesis 63 + Liquid phase synthesis Comprehensive analytical Complex oligo conjugates capability and know-how synthesis ensuring quality and speed 20 11
2019 2020 2021H1 Aggressively investing in oligonucleotide API production capacity to address the increasing market demand
Oligo API production capacity remains a global challenge as more and more high-volume oligo therapies are being developed.
2021 2023
1 Large scale Oligo plant 3 Large scale Oligo plants (2 in Changzhou and 1 in Taixing)
Largest Oligo API production Largest Oligo API production capacity in China The 1st and only multi kilo capacity in the world scale oligo production facility in China
Changzhou, China A unique peptide CRDMO platform with a long history working with global partners
174 224 2,500+
Peptide global clients Peptide scientists Unnatural amino acids
Chemistry Vertically Analytical Powerhouse Integrated Strength
Solid phase synthesis From unnatural amino Comprehensive + Liquid phase acids to peptide APIs analytical capability and synthesis know-how ensuring Complex peptide quality and speed conjugates synthesis Aggressively investing in peptide API production capacity and advancing peptide process technologies
1,000 L peptide synthesizer Changzhou · China 2021 2023
1 Large scale peptide plant 3 Large scale peptide plants (2 in Changzhou and 1 in Taixing)
1,000 L largest solid 2,000 L largest solid phase peptide synthesizer phase peptide synthesizer
Peptide Innovations
• Industry’s first fully contained peptide solid phase synthesis equipment train • Advancing multiple novel process technologies to make the traditional peptide manufacturing process greener Fast growing injectable platform to strengthen the integrated CMC offering for new modalities
22 Ongoing injectable projects including 8 integrated CMC oligo and peptide projects
Wuxi Site Fill-Finish Line
Dosage Forms Filling Capability
Injection, Solution Vial, prefilled syringe, cartridge Injection, Emulsion Injection, Sterile Powder Single-use mixing-filtration- (Lyophilized) filling system with sterile Injection, Liposome container closure system
Current Capacity Expansion 1 injectable line in Shanghai Waigaoqiao 4 injectable lines in Wuxi city between Q4 2021 to 2025 Financials Business far outgrew the industry average
Est1 2015-2021 WuXi Chemistry Revenue
H2 (RMB ¥100 Million) 95.3
71.7
53.0 H1 44.7 64.2 34.5 30.2
2015 2016 2017 2018 2019 2020 2021E Strong business growth achieved across all 4 markets
2021 H1 WuXi Chemistry revenue 64.2*, increased by 56% vs. 2020 H1
Europe +33% YOY
North America 12.2* +62% YOY 19% China 7.9* +62% YOY 40.5* 12% 63% 3.6* 6% Rest of World +61% YOY
*Unit: RMB 100 Million Yuan WuXi Chemistry CRDMO capability summary
CRO CDMO CMO
Target Hit Lead Commercial Preclinical Phase I Phase II Phase III to Hit to Lead to PCC Manufacturing
Most Comprehensive CRDMO Platform meeting any material requirement throughout the entire new drug development process
Capable at Any Scale
Milligram Gram 10 – 100 G Kilogram 10 – 100 KG Metric Ton
Cover All Categories for All Synthetic Molecular Modalities
Non-GMP API Small Molecule Peptide Conjugates GMP Drug Product Oligonucleotide HP API WuXi Chemistry key growth strategy
WuXi Chemistry’s unique CRDMO model is well positioned to capture the entire value chain for any synthetic molecules
01 Synergies from “R” to “D” to “M” and from API to DP are the key to drive long-term 02 sustainable business growth
Invest aggressively to expand capabilities and capacities of new modalities to capture the 03 fast growing market opportunities
04 Continue to penetrate long tail customers and grow top global clients
05
Continue to build and expand global “R” “D” and “M” network