Wuxi Biologics (Cayman) Inc. · HKEX:2269
Wuxi Biologics (Cayman) — Investor Day (2023)
52 slides from Wuxi Biologics (Cayman)'s investor day presentation, 2023
Slide 1: Global Premier CRDMO: Enabling Global Partners and Delivering Sustainable High Growth
Global Premier CRDMO: Enabling Global Partners and Delivering Sustainable High Growth 2023 Investor Day Fengxian Shanghai Stock Code: 2269.HK
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on our beliefs as well as assumptions made by and information currently available to our management. Although we believe
Slide 3: Contents
CONTENTS Success of Follow the Molecule Digital and AI will drive the 01 Strategy 04 future of WuXi Biologics Transferring the secret of Company Update 02 success to Ireland 05 Disposables as powerful as 03 stainless technologies 06 Summary 3
Slide 4: Success of Follow the Molecule Strategy
Success of Follow the Molecule Strategy 01
Slide 5: Pompe Disease Overview
Pompe Disease Overview Pompe disease is a rare genetic disorder that causes progressive weakness to the heart and skeletal muscles. Two types which are Late-onset 5,000 – 10,000 patients globally. Caused by mutations in a gene Respiratory failure and heart failure Pompe disease (LOPD) and Infantile-
Slide 6: How Drug Discovery Became a Personal Journey (1998-2010)?
How Drug Discovery Became a Personal Journey (1998-2010)? John Crowley The Story was taken into the movie “Extraordinary Executive Chairman of Measures” in 2010 Amicus 6
Slide 7: Sequel of Extraordinary Measures (2011-2023)
Sequel of “Extraordinary Measures” (2011-2023): Finding a Next-generation Biologics – More Precise and Potent 12,000+ 70 Employees 450 Employees 5,666 Employees Employees 2011 2012 2013 2015 2019 2023 Idea Cell First In Line Animal Human Pivotal POC Trials • EU Approval in Q2 • FDA inspection comple
Slide 8: AT-GAA: Global Regulatory Status
AT-GAA: Global Regulatory Status Anticipate regulatory approvals and launch into the three largest Pompe markets in Q3 2023 8
Slide 9: Global Dual Sourcing Strategy to Enable the Client
Global Dual Sourcing Strategy to Enable the Client Dundalk, Ireland Germany MFG6.1 Leverkusen Wuxi MFG6.2 DP7 MFG2P China DP1 Every batch can provide a full year supply for approx. 1% of global population! 9
Slide 10: D to M Conversion 100% Since 2018
D to M Conversion 100% Since 2018: 80% programs 100% sourced from WuXi, remaining 20% ~90% sourced Concentrated Fed-batch process; China NDA Approved in US & EU; Continuously reporting approval as breakthrough in Aug 2021 positive data in new indication DNA IND NDA DNA IND BLA China NDA approval in
Slide 11: Commercial Manufacturing will Drive Strong Growth from 2021 and Beyond
Commercial Manufacturing will Drive Strong Growth from 2021 and Beyond 2020 CMO Prediction 1H2022 CMO Prediction 2023 CMO Prediction 32~38 28~34 26~29 22~27 21~26 21~23 17~22 17~20 17 13~17 11~14 11~13 9 9 9 1 2 2 2 1 1 • CMO projects are expected to increase by implementing “Follow & Win the Molecu
Slide 12: CRDMO: Three Growth Curves Drive Sustainable Long-term Growth
CRDMO: Three Growth Curves Drive Sustainable Long-term Growth Three Long-Term Growth Curves R+D+M D+M D 2019 2017 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 12
Slide 13: Transferring the Success to Ireland
Transferring the Success to Ireland 02
Slide 14: Project Execution: Fastest Project Built to GMP in Ireland
Project Execution: Fastest Project Built to GMP in Ireland Despite COVID • 65.5 Acre greenfield site • Construction started in early 2019 and completed 26 months later • 467,520sq.ft. of floor space across 18 distinct areas/buildings, 313,058sq.ft. GEP, 154,150sq.ft. GMP • 500,000 tons of earth move
Slide 15: Project Successes
Project Successes • Over the course of the project nearly 75 archaeologists were empowered to dig and preserve the historical artifacts spread across the construction site • Project was completed with a remarkable safety record of a 0.35 recordable injury rate with the final 13 months of constructio
Slide 16: ISPE Facility of the Year for 2023
ISPE Facility of the Year for 2023 • ISPE’s (International Society for Professional Engineers) Facility of the Year Awards is an annual program that recognizes state-of-the-art projects unitizing new technologies to improve the quality of products, to reduce the cost of producing high-quality medici
Slide 17: Ireland will Deliver High Revenue & Profitability
Ireland will Deliver High Revenue & Profitability Signed Commercial MFG Scale (FB) Est. Batches/Yr. Contracts Pharma A Perfusion 1K 30+ Pharma B Fed Batch 12K 10+ Pharma C Fed Batch 16K 6+ Pharma D Fed Batch 8K 20+ Pharma E Fed Batch 12K 15+ Pharma F Fed Batch 12K 13+ Pharma G Fed Batch 12K 20+ Sign
Slide 18: Disposables achieved multiple ton scale with similar COGS
Disposables achieved multiple ton scale with 03 similar COGS
Slide 19: Disposable Manufacturing Technology Proven Effective in Commercial Manufacturing
TECHNOLOGY: Disposable Manufacturing Technology Proven Effective in Commercial Manufacturing VS • Global leader and pioneer in using disposable manufacturing technology • 4,000kg+ neutralizing mAbs delivered 12,000/16000L scale • COGS reduced to <US$80/g at 12,000L scale, comparable COGS with simila
Slide 20: Disposable Bioreactors CAN Deliver Lower COGS than Stainless Steel
Disposable Bioreactors CAN Deliver Lower COGS than Stainless Steel Scale of Disposable Scale of Stainless Manufacturing Experience at Cost Difference Bioreactors Steel Bioreactors WuXi Biologics 2,000L 12,000L Disposable ~30% more expensive MFG1 500+ batches 6 x 2,000L 12,000L Disposable ~10% cheape
Slide 21: Disruptive Single-Use Technology Pioneered by WuXi Bio
Disruptive Single-Use Technology Pioneered by WuXi Bio ~44% Market Share in New Capacity, 65-70% in R&D Biotech Companies Use more Single-Use The Advantages of Single-Use Bioreactor Bioreactors for Capacity Expansion Less water resource consumed No detergent, more environmental- friendly Save projec
Slide 22: Embracing ESG-friendly Disposable Technology to Protect Environment
Embracing ESG-friendly Disposable Technology to Protect Environment • Launched one of the world’s largest cGMP biologics manufacturing facilities using disposable bioreactors in Wuxi • Significantly reduced the impact on environment 70% water saving 33% energy saving 0 waste water generation • Other
Slide 23: Digital & AI drives Continued Success of WuXi Biologics
Digital & AI drives Continued Success 04 of WuXi Biologics
Slide 24: WuXi Biologics Aspires to Become a Digital 4.0 Enterprise
WuXi Biologics Aspires to Become a Digital 4.0 Enterprise 4.0 Predictive & Adaptive 3.0 Connected 2.0 Digital Silos 1.0 Pre-Digital Featuring manual handling and Partially paperless and automated. Being fully paperless and automated, e.g., use of Minimal human input and intervention with 24/7 automa
Slide 25: Illustrative Future State of WuXi Biologics Digitalization
Illustrative Future State of WuXi Biologics Digitalization III. Digitally-enabled II. Digital Enterprise Innovation I. Digital Business 4.0 Key digital initiatives Talent Data Client Data Building Digital Talent People Analytics Development Platform Employee WuXi Digital Performance and Digital Lean
Slide 26: AI Integrated Antibody Discovery (2021)
AI Integrated Antibody Discovery (2021) Proprietary AI Tools Routinely Solve Various Challenges in Lead Identification Binder Binder Wet-lab Immunization NGS Training Selection Generation Validation MVYLQMNSLRAEDTA MLYLQMNSLKSEDTA Pre-trained on ~108 MLYLQMNSLKSEDTA … … NGS sequences Binder features
Slide 27: AI Empowered Antibody Generation
AI Empowered Antibody Generation Developing AI Models that Can Generate Epitope-specific Antibodies AI Empowered Antigen Design De novo Antibody Generation Aimed epitope, covey special Structure diffusion biological signal Scaffold hallucination Wild type Ag AI generated Ag Abs bind to ELISA Binding
Slide 28: AI Guided Antibody Optimization
AI Guided Antibody Optimization Sequence Optimization is Guided by AI Model Trained with Developability Data In-house wet lab developability data Sophisticated AI model detects flaws in antibody sequences causing developability issues and proposes Antibody Sequences engineering strategies. …QQLISYP.
Slide 29: AI Codon Optimization for Cell Line Development (2020)
AI Codon Optimization for Cell Line Development (2020) Key Tool that Enabled Record Speed for COVID-19 mAb Development • WuXi Codon • Average titer: 5.9g/L for mAbs • 80% projects >5g/L • HT NGS of plasmids and clones • No sequence variants • Accelerated biosafety testing • IND timeline vs tradition
Slide 30: WuXiBrain Enables Developability's Unique Strength
WuXiBrain Enables Developability’s Unique Strength Developability issues can occur throughout the entire drug development process… Developability Criteria: Specificity… Solubility… Expression… Yield… Purity… Stability… Target 目标靶点 Efficacy/ Antibody Cell Line Downstream Screening Construction Develo
Slide 31: Bioreactor Dry-lab
Bioreactor Dry-lab All biologics drug development require large amount of experiments using bioreactors, which consumes time, Scenario FTE, and material. AI model can recommend optimized experiment designs to expedite drug development bioprocess 1) Optimized Experiment Design ▪ Bioreactor experiment
Slide 32: Bioreactor Dry-lab + Smart Automated Lab Results
Bioreactor Dry-lab + Smart Automated Lab Results 2020: Forecast experiment protocol 2022: Automatically adjust feed 2023: Suggest Exp. Protocol for for users schedule Yield+CQA pH vs.Time Feed vs.Time Feed vs.Time 8 8 8 6 6 6 4 4 4 2 2 2 0 0 0 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14
Slide 33: Auto Feeding-AI Analyzed Process
Auto Feeding-AI Analyzed Process 33
Slide 34: Automated A to Z in Biologics Development
Automated A to Z in Biologics Development 5 Automated Systems Launched in Research & Development Labs HTP Gene Synthesis Smart Platform Smart Cell Line Development System HTP pDNA Maxiprep Platform Smart Lab of Bioreactors uHTP Smart Protein Production System 34
Slide 35: Smart Lab Enables Faster, Better, Cheaper and Smarter Development
Smart Lab Enables Faster, Better, Cheaper and Smarter Development 32 BRs 5 17 Projects* Benefits Running in parallel Individual module Applied Successfully * Includes 1 PC project 50% Labor cost reduce 7×24 h “Dark Lab” ⊕ Bioreactor success rate LDMS ㊀ EHS/5S issues 35
Slide 36: Digitalized Plant Framework and Smart Applications
Digitalized Plant Framework and Smart Applications PAS For Manufacturing Cycle PI Data Infrastructure Wuxi Intelligent Apps Seed Expansion Gasket Care Collect Manage Deliver Smart Maintenance (valve, pump, agitator) Smart Operation and Diagnostics PAS Smart Alerting System Equipment Monitor(QTMS) Ce
Slide 37: Digital Twin First Implementation in MFG5 (2021)
Digital Twin First Implementation in MFG5 (2021) Engineering Process Control Operator Training Process Environment Design System (OTS) Optimization Connect with expert with no Virtual process upgrade and Design、build and test with Train operator with test before a GMP change is geographic constraint
Slide 38: Smart Reminder for Manufacture Operation & Quality Management
Smart Reminder for Manufacture Operation & Quality Management Gowning Check Reminder Remind people wearing hair caps correctly, safety glasses, masks, gloves, shoe covers, clothes 10 + More Upcoming Speed Reminder People Health & Mood Speed rate detection, moving speed > 5m/S is defined as running R
Slide 39: WuXi Proprietary LDMS Built Up the Electronic Records and Data Foundation
WuXi Proprietary LDMS Built Up the Electronic Records and Data Foundation 100% ~700 224720* Paper Less Projects Experiments Record * Since 2021 Library Display Sequence Gene synthesis Drug Discovery Experiment Management Gene Sequence Gene Sequence Scale- Cell Protein Expression Cell Line Plate QC d
Slide 40: Smart Writing Enables Automated Reports for Efficiency
Smart Writing Enables Automated Reports for Efficiency Client Satisfactory 10 2900 IND Reports PD Reports 500 200 Quality Reports MFG Reports Benefits Save 1/3 FTE Time Reports Data Source Auto Contents Smart Smart Review & Template AI Contents Draft Selection Generation Formatting Translation Appro
Slide 41: Business Update
Business Update 05
Slide 42: R in CRDMO
R in CRDMO Enable our Clients to Develop First-in-Class & Best-in-Class Biological Drugs Arcus Biosciences Expands Strategic Relationship WuXi Biologics and GSK Enter into with WuXi Biologics to Develop a Best-in-Class License Agreement on Multiple Novel anti-CD39 Antibody for the Treatment of Cance
Slide 43: Soft Growth in Pre-clinical balanced with Strong Growth in Phase III & CMO
Soft Growth in Pre-clinical balanced with Strong Growth in Phase III & CMO Drive 2X industry growth • Biotech funding slowdown especially in WuXiBody® OMT Platform ADC Platform SDArBodY® China resulted in softer growth in pre- clinical stage. Only observed 6Q into the cycle still highlighted our lea
Slide 44: Rich Pipeline across All Biologics Modalities: ADC and BsAb
Rich Pipeline across All Biologics Modalities: ADC and BsAb WuXiBody® SDArBodYTM OMT Platform ADC Platform Total Integrated 613 mAb Multiple-Platform Discovery Engines 285 “R” BsAb* 102 281 Preclinical 36 ADC 102 192 Phase I 11 Fusion Protein 70 “D” 75 Phase II 5 One of the largest Other Protein 34
Slide 45: QUALITY: Global Regulatory Inspections
QUALITY: Global Regulatory Inspections Number of Regulatory Inspections:30 Number of License Approvals: 42 Q1, 3 WBP23XX Q1, 1 Q2, 1 30 WBP23XX WBP1XX WBP21XX Others NMPA EMA FDA FDA 2023 42 26 5 6 5 EMA 27 Q2, 1 Others NMPA EMA FDA 2022 37 NMPA 23 5 5 4 FDA, 7 Others(ANVISA,HAS,PMDA etc.) Others NM
Slide 46: ESG Highlights
ESG Highlights 1. 53% of employee are women; 47% of managerial positions and 30% of executive management are female 2. 100% renewable energy combined with disposable manufacturing technologies make Irish manufacturing site “greenest” biologics manufacturing globally 3. Committed to Science Based Tar
Slide 47: WBS: Continuous Improvement CEO Kaizen
WBS: Continuous Improvement CEO Kaizen 70million 15million 4batches 30% 70% Risk-based material Inventory control management process AS/QC cost saving MFG5 capacity XDP1 capacity QC CoA approval lead strategy optimization optimization to Cost saving on on testing increase by buffer increase by reduc
Slide 48: Summary
Summary 06
Slide 49: Evolution of Biologics Service Companies: WuXi Biologics Leading the Industry as CRDMO
Evolution of Biologics Service Companies: WuXi Biologics Leading the Industry as CRDMO CMO: Contract • Business rationale: mostly 2nd supplier for large pharmas to Manufacturing ensure robust supply chain 1990s – 2000s • Core expertise: large-scale manufacturing CDMO: Contract • Business Rationale:
Slide 50: Eight Keys for Future Success: Sustainable High Growth
Eight Keys for Future Success: Sustainable High Growth Technology Execution Quality People Speed Strategy Flexibility Vision BETTER FASTER CHEAPER 50
Slide 51: Global Premier CRDMO
Global Premier CRDMO Enable Global Partners and Deliver Sustainable High Growth Despite Recent Challenges 2X industry growth achievable due to success of both Follow and Win the Molecule strategies. 1 1H witnessed slower growth of follow the molecule, however win the molecule for phase III and block
Slide 52: WuXi Bio Vision
WuXi Bio Vision “Every drug can be made and every disease can be treated” by building an open-access platform with the most comprehensive capabilities and technologies in the global biologics industry 52 52