Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — Investor Presentation (March 2021)
42 slides from Innovent Biologics's investor presentation, March 2021
Slide 1: Innovent Investor Presentation
Innovent Investor Presentation March 2021 To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people
Slide 2: Disclaimer
Disclaimer This presentation includes forward-looking statements. All statements contained in this presentation other than statements of historical facts, including statements regarding future results of operations and financial position of Innovent Biologics (“Innovent” “we,” “us” or “our”), our bu
Slide 3: Agenda
Agenda 1 Business Updates 2 Pipeline Review 3 Core Strategy 4 Financial Review 5 Outlook Confidential Copyright© 2021 Innovent Biologics 3
Slide 4: Business Update
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Slide 5: Innovent: Established Leadership in China with Unique Position to Become a Global Premier Biopharmaceutical Company
Innovent: Established Leadership in China with Unique Position to Become a Global Premier Biopharmaceutical Company Leading Core strategy of global Fully-integrated, 1 2 3 biopharmaceutical innovation multi-function company in China platform CMC nag Discovery (manufacturing & quality) nag Commercial
Slide 6: Strong Execution and Major Accomplishments in 2020 and YTD 2021
Strong Execution and Major Accomplishments in 2020 and YTD 2021 3.84bn 1→4 4 6 4 5 7 4 6 Overseas Assets under Commercial NDA NDA Pivotal trial Late-stage New molecules out-licensing global portfolio approvals accepted data release assets into IND deals development • 2020 total revenue: • TYVYT® • T
Slide 7: Anticipated Milestones in 2021 (to Early 2022)
Anticipated Milestones in 2021 (to Early 2022) 5 5 9 7 Multiple Multiple Capacity Pivotal trial Commercial Potential NDA Potential NDA Prioritized Early data Capacity data release portfolio approvals acceptance clinical assets readout expansion / readout • TYVYT® • TYVYT® • TYVYT® • TYVYT® • Phase 3
Slide 8: Leverage Unique Commercialization Capability to Capture Rapid Growth in China Market
Leverage Unique Commercialization Capability to Capture Rapid Growth in China Market Diversified portfolio Commercialization team • Expanded experienced sales and marketing team to ~1,600 employees • 4 commercialized products • 23 assets in pipeline covering Oncology, Autoimmune, Ophthalmology, Meta
Slide 9: TYVYT as Leading PD-1 brand in China Market with Unveiled Huge Potentials in Global Markets
TYVYT® as Leading PD-1 brand in China Market with Unveiled Huge Potentials in Global Markets Strong sales growth since launch First-mover Advantage Comprehensive Out-license Partnership RMB mn Development Strategy with Eli Lilly 2,500 RMB 2,290mn Maintain strong Backbone role for Best positioned to
Slide 10: State-of-the-art Manufacturing Facilities Designed to, Built with, and Operating at International Standards
State-of-the-art Manufacturing Facilities Designed to, Built with, and Operating at International Standards M1b Facility Total capacity in the future: 60,000 L 36,000L 24,000L Manufacturing facilities (a total of 24,000L bioreactors) received cGMP certification from the NMPA for manufacturing TYVY
Slide 11: Comprehensive Global Partnership Enhances Our Overall Development from R&D to Commercialization
Comprehensive Global Partnership Enhances Our Overall Development from R&D to Commercialization Continued solid collaborations with global As integrated platform with validated capabilities, pharmaceutical and biotech companies Striving to be the best choice for our partners • R&D: 1000+ in-house R&
Slide 12: Executives with a Proven Track Record of Success
Executives with a Proven Track Record of Success Visionary Founder, CEO and Chairman Supported by Experienced Management Team Founder, CEO & Chairman 24 years of industry experience Ph.D. in Genetics, Chinese Academy of Sciences 1997 - 2001: Vice President of R&D, Calydon Inventor of Oncorine®
Slide 13: Pipeline Review
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Slide 14: Robust Pipeline Across Novel Therapeutics
Robust Pipeline Across Novel Therapeutics 4 commercialized assets, 5 assets in pivotal trials and 14 assets in clinical stage Status Pivotal Phase 2 / Products Target (s) Therapeutic Area Commercial Rights Pre-clinical IND Approved Phase 1 Phase 2 NDA Launched Phase 3 TYVYT® (sintilimab injection) P
Slide 15: Oncology Pipeline Summary
Oncology Pipeline Summary: 18 Assets in Pipeline under Development (3 products launched, 15 assets in clinical trials) Oncology Pipeline IBI-308 (PD-1) IBI-188 (CD47) IBI-318 (PD-1/PD-L1) IBI-319 (PD-1/4-1BB) IBI-301 (CD20) IBI-315(PD-1/HER2) IBI-321 (PD-1/TIGIT) IBI-101 (OX40) Roche partnership IBI
Slide 16: Non-oncology Pipeline Summary
Non-oncology Pipeline Summary: 5 Assets in Pipeline under Development (1 product launched, 4 assets in clinical trials) Non-oncology Pipeline IBI-302 IBI-362 (GLP1/GCGR) (VEGF/Complement) IBI-303 (TNF-α) IBI-306 (PCSK9) IBI-112 (IL-23 p19) Confidential Copyright© 2021 Innovent Biologics 16
Slide 17: Clinical Development Programs for Sintilimab
Clinical Development Programs for Sintilimab 2 indications approved, 3 sNDAs accepted, over 20 clinical trials ongoing globally STATUS PHASE 1 INDICATION MONO-/COMBO-THERAPY (OTHER COMPONENTS) 1A 1B PHASE 2 PHASE 3 NDA FILED NDA APPROVED China r/r Classical Hodgkin’s Lymphoma Mono 1L Non-squamous NS
Slide 18: ORIENT-11 (1L nsqNSCLC): Sintilimab Combination Achieved Significant Improvement in both PFS and OS
ORIENT-11 (1L nsqNSCLC): Sintilimab Combination Achieved Significant Improvement in both PFS and OS PFS (by IRRC) Sintilimab in combination with chemo demonstrated larger decrease of Events HR (95% CI) P progression and death hazard as 1L therapy for non-squamous NSCLC Sint+chemo 42.1% 0.482 PL+chem
Slide 19: ORIENT-32 (1L HCC): Global First PD-1 Combination Study that Met Primary Endpoints
ORIENT-32 (1L HCC): Global First PD-1 Combination Study that Met Primary Endpoints OS PFS (by IRRC) Sintilimab in combination with BYVASDA® (bevacizumab biosimilar): the global first PD-1 combo study that met primary endpoints with significant improvement in both OS and PFS for 1L HCC Proffered Pape
Slide 20: IBI-310 (CTLA-4) Development Plan Overview
IBI-310 (CTLA-4) Development Plan Overview Phase 1a/1b Safety Data (N=27) IBI-310 + Sintilimab Development Program Overview Part B+C (1b): • Melanoma Part A (1a): IBI-310 Melanoma subtypes IBI-310 + sintilimab - Phase 3 trial in adjuvant setting N=10 N=17 (First patient dosed in China in Apr 2020) M
Slide 21: IBI-375 (FGFR1/2/3) Development Plan Overview
IBI-375 (FGFR1/2/3) Development Plan Overview Enzyme Inhibitory Activity of IBI-375 IBI-375 (pemigatinib) Development Program Overview IBI-375 • mCCA Desired target activity - Submitted NDA application and accepted in Taiwan market for IBI-375 for 2L mCCA in 1H 2020 Off-target activity - Completed p
Slide 22: IBI-376 (PI3Kδ) Development Plan Overview
IBI-376 (PI3Kδ) Development Plan Overview IBI-376 demonstrated a high rate of rapid and durable response in r/r FL and r/r MZL IBI-376 (parsaclisib) Development Program Overview Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular • r/r F
Slide 23: IBI-306 (PCSK9) Development Plan Overview
IBI-306 (PCSK9) Development Plan Overview Data of SAD and MAD was disclosed in ESC, Aug 2020 IBI-306 Development Program Overview The point estimate and 95% confidence interval for the difference in percent reduction from baseline in LDL-C at 12 weeks • HeFH for each dose group compared with placebo
Slide 24: IBI-188 (Letaplimab): Potential Best-in-Class anti-CD47 Monoclonal Antibody
IBI-188 (Letaplimab): Potential Best-in-Class anti-CD47 Monoclonal Antibody IBI-188 Differentiated Advantages Clinical Highlights • Optimized affinity for balanced toxicity and efficacy Phase 1a data published on SITC 2020: • Stronger efficacy than hu5F9 and comparable tolerability in NHPs - Well to
Slide 25: IBI-322 (PD-L1/CD47): A First-in-Class Anti-PD-L1/CD47 Bispecific Antibody
IBI-322 (PD-L1/CD47): A First-in-Class Anti-PD-L1/CD47 Bispecific Antibody IBI-322 Differentiated Advantages Clinical Highlights • Manageable safety profiles with reduced CD47 binding on • Modified Fibonacci method was used in the dose escalation RBC to mitigate anemia AE and decreased RBC phagocyto
Slide 26: LAG-3 Cluster: IBI-110 and IBI-323
LAG-3 Cluster: IBI-110 (LAG-3 mAb) and IBI-323 (PD-L1/LAG-3 Bispecific Antibody) IBI-110 Clinical Highlights IBI-323 Preclinical Highlights Promising preliminary results in Phase 1a and 1b • Dual blockade of LAG-3 and PD-L1. Blocking LAG-3 can also inhibit the - Well tolerated. No DLT observed negat
Slide 27: TIGIT Cluster: IBI-939 and IBI-321
TIGIT Cluster: IBI-939 (TIGIT mAb) and IBI-321 (PD-1/TIGIT Bispecific Antibody) IBI-939 Preclinical Highlights IBI-321 Preclinical Highlights • IBI-939 is fully human antibody with high TIGIT binding affinity and • Combining PD-1 and TIGIT inhibition to release PD-1/PD-L1 as well as strong ligand bl
Slide 28: IBI-302 (VEGF/Complement): First-in-Class Bispecific Fusion Protein
IBI-302 (VEGF/Complement): First-in-Class Bispecific Fusion Protein Blocking VEGF/Complement Proteins IBI-302 Differentiated Advantages Clinical Highlights • High affinity blocker of VEGF family and complement proteins that • Phase 1 data published at 2020 AAO: good safety and tolerability with simu
Slide 29: IBI-362 (GLP-1/GCGR): A Weekly GLP-1/GCGR Dual Agonist
IBI-362 (GLP-1/GCGR): A Weekly GLP-1/GCGR Dual Agonist IBI-362 Differentiated Advantages Clinical Highlights • Weekly injectable OXM analog via optimized ratio of activation of • Promising data of IBI-362 in both weight loss and glucose GLP-1 and Glucagon receptor vs. binding GLP-1 only control • Du
Slide 30: Core Strategy
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Slide 31: Innovation and Globalization are Our Key Strategies
Innovation and Globalization are Our Key Strategies Innovation Globalization Develop Develop and sell A premier global potentially Innovent biopharmaceutical global first-in- products globally company class products Build on robust pipeline Collaboration with leading global By 2030, more comme
Slide 32: Global R&D Platform Led by Dr. Yong Jun Liu
Global R&D Platform Led by Dr. Yong Jun Liu, A World-class, Accomplished Executive Innovent R&D • Chairman of the Department of Immunology; Founding Director of the Center for Cancer Immunology Research (n=1,000+) of MD Anderson Cancer Center Led by Dr. Yong Jun Liu • Global Head of Research of Sano
Slide 33: Innovent Academy and Key Drug Discovery Strategies
Innovent Academy and Key Drug Discovery Strategies Innovent Academy Objective: To develop and launch First-in-Class product globally as Innovent’s powerful discovery engine Key Therapeutic Focus: Oncology, metabolic diseases, immunology, and ophthalmology Position: Global leading drug discover
Slide 34: Innovation and Globalization are Our Key Strategies
Innovation and Globalization are Our Key Strategies Expand in global markets Accelerate global development of pipeline portfolio FDA IND approvals for 7 pipelines Anticipate BLA filing with the U.S. FDA for IBI-305 (bevacizumab injection): PT Etana to file TYVYT® in NSCLC in 2021: NDA in Indon
Slide 35: Financial Overview
Section 4 Financial Overview
Slide 36: Income Statement
Income Statement Year Ended 31 December RMB'million 2020 2019 Revenue Revenue 3,843.8 1,047.5 In 2020, we generated total revenue of RMB3,843.8 million, including RMB2,367.5 million driven by product Cost of sales (387.8) (124.9) sales; coupled with RMB1,476.3 million from License fee and service
Slide 37: Balance Sheet
Balance Sheet Year Ended 31 December RMB'million 2020 2019 Cash balance Bank balances and cash 7,763.8 4,232.6 As of December 31, 2020, our total cash Other financial assets-current 357.3 462.5 increased to RMB8,121.1 million Trade receivables 475.4 247.9 - (equivalent to US$1.2 billion) Contract
Slide 38: Continuously Strong Support from Globally Renowned Investors
Continuously Strong Support from Globally Renowned Investors Total fundraising since inception: US$ 2.6bn+ Total follow-on offering: ~US$ 1.6bn The largest IPO fund raise at the time for pre-revenue biopharmaceutical company The first and only HK biotech 18A with successful 4 rounds follow-on Pre-IP
Slide 39: Outlook
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Slide 40: Key Takeaways
Key Takeaways CMC (Manufacturing & Quality) Clinical Development Discovery Commercialization • Growing into a global biopharmaceutical company with fully-integrated capabilities (discovery, development, manufacturing, commercialization) and clear strategy of global innovation • Robust pipeline of 23
Slide 41: Summary: A Long Term Vision
Summary: A Long Term Vision 2030 2025 • More commercialized • Expanded 03 products, including first- commercialized products in-class products 2020 in China launched globally • 4 commercialized • Multiple products • To be a premier global 02 products approved in the biopharmaceutical international m
Slide 42: Confidential
Confidential Copyright© 2021 Innovent Biologics 42
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