Wuxi Apptec Co., Ltd. Class A · SSE:603259
Wuxi Apptec Co., Ltd. Class A — Investor Day (July 2022)
38 slides from Wuxi Apptec Co., Ltd. Class A's investor day presentation, Jul 28, 2022
Slide 1: WuXi Chemistry: A Global Leading CRDMO
2 0 2 2 W u X i A p p Te c I n v e s t o r D a y WuXi Chemistry: A Global Leading CRDMO Minzhang Chen, Ph.D. Co-CEO 1
Slide 2: 3 Business Growth Engines; Global Platform, Global Talents
CRO CDMO CMO Target Hit Lead Commercial Preclinical Phase I Phase II Phase III Manufacturing to Hit to Lead to PCC 3 Business Growth Engines Small Molecule Chemistry Drug Product New Modalities Medicinal Chemistry｜Custom Synthesis｜ Pre-formulation｜Formulation Development｜ Oligonucleotides｜Peptides｜M
Slide 3: CRDMO business model drives sustainable high growth
CRDMO business model drives sustainable high growth 3
Slide 4: CRDMO compounds across development stages
“R” 28%↑[2] 349,704 compounds 5,485 compounds “R+” 99[1] 1,627 Preclinical & Phase I 39[1] “D” 42%↑[2] 288 Phase II 8[1] 52 Phase III 8[1] [1] number of molecules were moved to next stage and kept “M” 34%↑ [2] 43 Commercial in WuXi Chemistry within past 12 months [2] increase rate vs. the number of
Slide 5: Number of Compound Delivered by WuXi Chemistry C"R"DMO
Number of Compound Delivered by WuXi Chemistry C“R”DMO +28% +38% 355,189 278,105 201,516 2019.07-2020.06 2020.07-2021.06 2021.07-2022.06 5
Slide 6: WuXi Chemistry Clinical Stage New Drug Pipeline
WuXi Chemistry Clinical Stage New Drug Pipeline 670 744 550 602 413 474 2019 H2 2020 H1 2020 H2 2021 H1 2021 H2 2022 H1 Market ↑ 2% in 6 quarters ↑ 2% in 4 quarters Share 12% 14% 16% Global Clinical Stage New Drug Pipeline 4,278 4,401 4,722 3,579 3,743 3,918 2019 H2 2020 H1 2020 H2 2021 H1 2021 H2 2
Slide 7: Supported 33 New Drugs Approved between 2017-2021
Supported 33 New Drugs Approved between 2017-2021 10 4-6** 7 7 6 3 2 2017 2018 2019 2020 2021 2022 *: only count first approval, all of those drugs are approved by FDA, EMA, NMPA or PMDA. ** 4-6 molecules in WuXi Chemistry pipelines are expected to be approved in 2022 H2 7
Slide 8: 2021 vs. 2020 Chemistry Based Revenue
2021 vs. 2020 Chemistry Based Revenue (¥ Million RMB) +47% 14,087 9,583 2020 2021 2020 2021 2020 2021 2020 2021 2020 2021 WuXi Chemistry Competitor 1 Competitor 2 Competitor 3 Competitor 4 Total revenue of 4 competitors in 2021 is 13,129 ￥Million RMB, 40% increase vs. 2020 8 Source: companies annual
Slide 9: Global sites across China, United States, Switzerland, Singapore
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 United States Switzerland Singapore San Francisco, CA San Diego, CA Middletown
Slide 10: WuXi Chemistry Employees
Research Development Manufacturing 12,978 4,354 6,805 2,835 process chemists & analytical scientists 1,208 formulation scientists & analytical scientists 311 new modality process chemists & analytical scientists 12,153 chemists 5,693 API manufacturing 825 analytical scientists 1,112 DP manufacturing
Slide 11: WuXi Chemistry CRDMO clients in 2022 H1
CR“DM”O C“R”DMO 1,222 421 371 “R” clients “R” + “D” clients “D” + “M” clients 2,014 WuXi Chemistry CRDMO clients in 2022 H1 11 Note: active client with revenue contribution or PO awarded
Slide 12: Revenue from Global Top Pharmaceutical Companies
Revenue from Global Top 20 Pharmaceutical Companies (RMB ￥100 Million) 152.9 H2 60.5 47.0 28.2 33.8 H1 24.4 72.1 2017 2018 2019 2020 2021 2022E 2017 2018 2019 2020 2021 2022E 20 of global top 20 pharmaceutical companies use “R” & “D” services. 10 of global top 20 pharmaceutical companies use “R” & “
Slide 13: Revenue from Biotech Clients
Revenue from Biotech Clients* (RMB ￥100 Million) 150.00 137.3 H2 100.00 50.00 80.4 H1 37.9 48.8 57.6 20.3 24.8 0.00 2017 2018 2019 2020 2021 2022E 2017 2018 2019 2020 2021 2022E Note: * Biotech clients means clients excluding global top 20 pharmaceutical companies. 13
Slide 14: Inspection Highlights (2021H2 - 2022H1)
Inspection Highlights （2021H2 - 2022H1） 1st 1st 1st 4 Drug product Drug product Drug product Inspections passed in one US FDA inspection EMA inspection MFDS inspection single month 9 successful US FDA inspections 4 successful Japan PMDA inspections 2013 - 2021 2019 - 2022 4 successful EU EMA inspect
Slide 15: Speed, Capability, Capacity, Quality
9,180 22 4 compounds clinical stage drug candidates commercial drugs SPEED CAPABILITY CAPACITY QUALITY In-parallel activities via “One-stop” enabling Large manufacturing A proven track record close collaboration of “R” technology platforms to capacity and robust of global standard “D” and “M” sub te
Slide 16: Strong growth across all three CRDMO business lines
Strong growth across all three CRDMO business lines • Small molecule chemistry • Drug product • New modalities (oligonucleotide + peptide) 16
Slide 17: Small Molecule Chemistry CRDMO Platform Revenue
Small Molecule Chemistry CRDMO Platform Revenue (RMB ¥ 100 Million) 254.1 +108% H2 +43% 121.9 H1 85.3 114.7 2020 2021 2022E 17
Slide 18: 17 plants, 2,000+ m3 Total Reactor Volume
Shanghai Jinshan Changzhou, Jiangsu Taixing, Jiangsu Changshu, Jiangsu San Diego, CA China China China China USA 17 plants | 2,000+ m3 Total Reactor Volume (TRV) 18 TRV: Total Reactor Volume
Slide 19: Changzhou and Taixing capacity expansion
Changzhou, China Taixing, China Taixing, Jiangsu Changzhou, Jiangsu Changzhou Taixing Phase III expansion to be completed in 2022, adding Phase I (2023-2025) Phase II (2025-) ~1000 m3 TRV 4 Plants 1 Plant 7 Plants In planning H1 2022 H2 2022 ~1000 m3 TRV 19 TRV: Total Reactor Volume
Slide 20: Singapore R&D center and manufacturing facility
R&D center Singapore • Automated chemistry lab • Green Chemistry Center of Excellence • Start operation in 2025 Manufacturing facility ~50 acre, total 7 plants Phase I scope: • 2 plants for small molecule API, 350+ m³TRV • 1 plant for oligonucleotides, peptides and complex chemical conjugates • Star
Slide 21: Drug Product CRDMO Revenue
Drug Product CRDMO Revenue (RMB ¥ 100 Million) 15.7 16.0 14.0 +36% 12.0 H2 10.0 +51% 8.0 6.0 11.5 4.0 7.6 H1 2.0 5.5 0.0 2020 2021 2022E 21
Slide 22: IND Enabling Preformulation Package and Solid State Development
IND Enabling Preformulation Package (IEPP) Solid State Development (SSD) • Fast: IND formulation ready in 8-12 weeks • Large and experienced team (90+ scientists) • Most Comprehensive • Most Comprehensive • All enabling technology screening included • Support both API and DP development at any stage
Slide 23: DP PPQ and Commercial Projects; 3 DP sites approved
Number of DP PPQ Projects Number of DP Commercial Projects 1-2* 18 12 5 4 2021 2022 2021 2022E ** 1-2 drug product projects are expected to be approved in 2022 H2 3 DP sites approved by major regulatory agencies Shanghai Waigaoqiao, China Wuxi city, China Couvet, Switzerland 23
Slide 24: Spray Dried Dispersion, Continuous Manufacturing, High Potency Drug Product
Spray Dried Dispersion (SDD) Continuous Manufacturing High Potency Oral Drug Product • Doubled capacity in past 12 months • 1st continuous manufacturing line in • Target to open in Q3 2022 • 69% molecule number used SDD China for oral solid drug to be opened • Tablets and capsules with primary in Q
Slide 25: Injectable capacity and Lipid Nano Particle platform
60 projects, including 1st injectable production line launched in 1st Lipid Nano Particle GMP plant to be 16 integrated CMC Wuxi city in Q1 2022 opened in Wuxi city in Q3 2022 (API+DP) oligo and Injectable Production Capacity Lipid Nano Particle Platform peptide projects Expansion (units / year) • N
Slide 26: Drug product sites: Shanghai, Wuxi city, Couvet
Shanghai Waigaoqiao Wuxi city, Jiangsu Couvet, Neuchâtel China China Switzerland Oral Dosage Form Injectable Dosage Form Tablets | Capsules | Powder | Liquid Capsules | Granules | Liquid in Bottle Solution | Suspension | Emulsion | Lyophilized Powder | Liposome 26
Slide 27: Middletown, DE, USA campus
Phase 1 Summary Start operation in 2025 Scope: • Formulation R&D • Formulation development • Analytical • Clinical and Commercial Drug Product Production • Oral solid and injectable • Packaging, labeling and distribution 190-Acre Campus Middletown, DE, USA 27
Slide 28: New Modality CRDMO Chemistry Revenue
N New Modality CRDMO Chemistry Revenue (RMB ¥ 100 Million) 20.4 +176% H2 +147% H1 7.4 9.5 3.0 2020 2021 2022E 28
Slide 29: Oligo and Peptide R compound and D+M molecule numbers
Oligo and Peptide “R” Compound # Oligo and Peptide “D+M” Molecule # 18,964 142 +26% +63% 15,093 +65% 87 +129% 9,147 38 2020H1 2021H1 2022H1 2020H1 2021H1 2022H1 Supporting 4 Phase 3 and 1 commercial oligo and peptide drugs 29
Slide 30: Most comprehensive CRDMO one-stop capabilities
u Most comprehensive CRDMO “one-stop” capabilities v Readily available and fast growing large “R”, “D”, and “M” capacity w Staying ahead of the technology curve x Synergies with WuXi Chemistry small molecule chemistry and drug product platforms y Global standard quality system inspected by all major
Slide 31: Oligo and peptide manufacturing capacity
Changzhou, China Taixing, China Singapore (3 oligo & peptide plants) (1st oligo and peptide plant ready in 2023) (1st oligo and peptide plant ready in 2026) Oligo Manufacture Capacity Peptide Manufacturing Capacity 2022: one of the largest oligo CDMOs in the world 2022: one of the largest peptide CD
Slide 32: Integrated small molecule and peptide R&D
Project Kick-off Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Analytical Method Development, Validation and Continuous Support (36 weeks) Peptide Process Development 0.5 kg Non-GMP Peptide Production (10 weeks) (8 weeks) 1 kg GMP Peptide Production (10 weeks) non-
Slide 33: Integrated CMC approach enables IND filing
Project Kick-off Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 API Analytical Method Development, Validation and Continuous Support (28 weeks) PMO, Peptide and PPMO Process Development and Continuous Optimization (28 weeks) 1st non-GMP Peptide Batch (8 wee
Slide 34: Financials
Financials 34
Slide 35: 2015-2022 WuXi Chemistry R Revenue
2015-2022 WuXi Chemistry “R” Revenue (RMB ¥ 100 Million) 73.2 H2 54.3 H1 37.0 28.6 35.0 19.1 22.2 12.6 14.8 2015 2016 2017 2018 2019 2020 2021 2022E 35
Slide 36: 2015-2022 WuXi Chemistry D&M Revenue
2015-2022 WuXi Chemistry “D&M” Revenue (RMB ¥ 100 Million) 217.0 H2 H1 86.6 94.7 58.8 30.8 43.1 17.6 19.7 25.6 2015 2016 2017 2018 2019 2020 2021 2022E 36
Slide 37: 2015-2022 WuXi Chemistry Revenue
2015-2022 WuXi Chemistry Revenue 290.2 (RMB ¥ 100 Million) H2 140.9 H1 95.8 129.7 71.7 44.7 53.0 30.2 34.5 2015 2016 2017 2018 2019 2020 2021 2022E 37
Slide 38: WuXi Chemistry's unique CRDMO model is well positioned
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 02 long-term sustainable business growth 03 Invest aggressively to expand capabilities and capacities of ne