Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — FY2023 Earnings Presentation
44 slides from Innovent Biologics's earnings presentation, Mar 20, 2024
Slide 1: Innovent Biologics 2023 Annual Results
Innovent Biologics 2023 Annual Results March, 2024
Slide 2: Agenda & Speakers
Business Review and Outlook 01 Dr. Michael Yu Founder, Chairman and CEO Agenda R&D Updates & 02 Dr. Yongjun Liu President Speakers Financials and Summary 03 Ms. Rachel You CFO Q&A 04 All Management Team Confidential Copyright© 2024 Innovent 2
Slide 3: Business Review & Outlook
Business Review & Outlook Dr. Michael Yu Founder, Chairman and CEO 3
Slide 4: Set sustainable growth and global innovation as key strategic goals for our second decade
Set sustainable growth and global innovation as key strategic goals for our second decade of business operations A global premier biopharmaceutical company Our focus for the second decade Sustainable Growth A leading biopharmaceutical company in China In Innovent’s first 12 years ➢ Fortify long-term
Slide 5: 2023 marked a transformative year of strong performance and material innovation progress
2023 marked a transformative year of strong performance and material innovation progress Robust Revenue Growth Improved Financial Performance Material R&D milestones 6.2bn of 2023 total revenue ⚫ RMB ⚫ Total revenue IO + ADC Emerging General +36.2% yoy strong growth ⚫ Gross profit margin In Oncology
Slide 6: Robust revenue growth and improved financials under a sustainable business model
We achieved robust revenue growth and improved financials under a sustainable business model RMBm RMBm 45+% 65+% 6,206 Total revenue 2,000 6,000 36.2% 35+% 4,556 Product revenue ~10% 2022 4,500 38.4% 5,728 3,000 4,139 1,000 2023 1,500 Robust Revenue Growth 0 2022 2023 0 Q1 Q2 Q3 Q4 Total Revenue & P
Slide 7: Well-positioned for continued growth momentum in 2024
Well-positioned for continued growth momentum in 2024 2023 rapid revenue growth reflected… Continued growth momentum is anticipated in 2024… • Robust demand for our innovative portfolio • Continuous growth of exiting product portfolio ✓ TYVYT® (sintilimab injection) market leading position and NRDL
Slide 8: Systematically building commercialization capability in CVM field
Systematically building commercialization capability in CVM field Innovative medicines offering: • First wave of high-value products • Next wave of opportunities SINTBILO® Mazdutide IBI311 IBI128 IBI3016 Oral Novel Aging (PCSK9) (GLP-1R/GCGR) (IGF-1R) (XOI) (AGT) delivery modalities diseases CVM Sys
Slide 9: Reinforced portfolio potential in the mid-to-long term
Reinforced portfolio potential in the mid-to-long term XOI Ophthalmology PDE4 CVM VEGF/C Autoimmune Oncology GLP-1R/GCGR CTLA-4 RMB 20bn IL-23 p19 and more…… Annual domestic sales in 2027 IGF-1R KRAS G12C ROS1 5.7 bn 2023 SINTBILO® (PCSK9) FUCASO® (BCMA CAR-T) ~20 approved assets CYRAMZA®(VEGFR) BIC
Slide 10: Oncology and general biomedicines as key growth pillars of Innovent
Oncology and general biomedicines as key growth pillars of Innovent General Biomedicine Oncology CVM Autoimmune Ophthalmology Encouraging progress in Substantial R&D milestones Grow global BIC/FIC Commitment to the next wave innovation of key late stage pipeline to address elevate standard-of- of “I
Slide 11: Pipeline strategy for oncology: next wave innovation of IO+ADC
Pipeline strategy for oncology: encouraging progress in the next wave innovation of “IO+ADC” Focus on IO+ADC for the next wave of global innovation Material clinical advancements • 8 in existing portfolio: CLDN18.2 TYVYT® (PD-1), BYVASDA® (VEGF), HALPRYZA® (CD20), HER2 Pemazyre® (FGFR), olverembatin
Slide 12: Broaden global footprint for pipeline development
Broaden global footprint for pipeline development China and Ex-China PoC Exploration MRCT Phase 3 Preparation MRCT Phase 1 ~10 novel assets IBI363 IBI343 • ADCs of HER2, HER3, B7H3, TROP2 • Preliminary encouraging PoC observed • Positive PoC observed in Phase 1b • GPRC5D/BCMA/CD3 in melanoma, NSCLC,
Slide 13: Pipeline strategy for CVM: mazdutide as the anchor asset
Pipeline strategy for CVM: build a strong franchise with mazdutide as the anchor asset Develop pipeline of blockbusters and next-gen innovation Material clinical advancements • 1st commercialized product • SINTBILO® (PCSK9) approved and launched to market in 2023.08 • 1st NDA in obesity Oral deliver
Slide 14: Pipeline strategy for autoimmune
Pipeline strategy for autoimmune: leverage science in immunology and antibody engineering technology to fulfill unmet medical needs Switching from traditional to innovative targeted biologics Material clinical advancements IBI355 • Potentially best-in-class IL-23p19 for psoriasis (CD40L) • Picankiba
Slide 15: Pipeline strategy for ophthalmology
Pipeline strategy for ophthalmology: advance registrational study for first-in-class bispecific antibody Long-standing commitment to elevate standard-of-care Material clinical advancements Next-generation FIC • Global FIC VEGF/C in Ph3 for nAMD bispecific fusion • IBI302 (VEGF/C) demonstrated non-in
Slide 16: Anticipated development milestones by early 2025
Anticipated development milestones by early 2025 Regulatory Action Phase 3 / Pivotal Trials Major PoC Readouts Early Stage Ongoing & Phase 3 Readouts NDA Approval Ph3 ongoing PoC Ph1 & FIH 2L NSCLC & Melanoma; 10+ ADC & multi-specific oncology Taletrectinib (ROS1) Mazdutide 9mg Obesity IBI363 (PD-1/
Slide 17: Major R&D update
Major R&D update Dr. Yongjun Liu President 17
Slide 18: 2023 material R&D milestones achieved
2023 material R&D milestones achieved with a compelling set of late-stage programs; encouraging signals for early phase assets eying global innovation 4 Approval 10 Ph3/Pivotal New PoC & FIH • TVYVT® (PD-1): EGFRm NSCLC • IBI343 (CLDN18.2 ADC): 3L CLDN18.2+ GC PoC: • FUCASO®(BCMA CAR-T): R/R MM • IB
Slide 19: IBI343 (CLDN18.2 ADC): best-in-class CLDN18.2 ADC
IBI343 (CLDN18.2 ADC): best-in-class CLDN18.2 ADC, PoC achieved in gastric cancer Differentiated design from novel Superior safety and encouraging Milestone advancement site-specific TOPO1i platform efficacy profiles shown in PoC to watch in 2024 In ongoing Phase 1/1b clinical trial in 150+ Australi
Slide 20: IBI363 (PD-1/IL-2α-biased): first-in-class molecule
IBI363 (PD-1/IL-2α-biased): first-in-class molecule under development for IO resistant and cold tumors Milestone advancement First-in-class design Durable response observed to watch in 2024 based on breakthrough findings in IO-failed and cold tumors In ongoing Phase 1/1b clinical trial in 300+ Austr
Slide 21: Mazdutide: first GLP-1R/GCGR dual agonist under NDA review
Mazdutide: first GLP-1R/GCGR dual agonist under NDA review Five Phase 3 trials ongoing with GLORY-1 endpoints met Comprehensive metabolic benefits given differentiated in support of first NDA in chronic weight management MoA observed in multiple Ph2 data set and Ph3 GLORY-1 NDA Approval 1H Obesity G
Slide 22: Mazdutide: superior weight loss efficacy and favorable safety
Mazdutide: superior weight loss efficacy and favorable safety in 48-week treatment 48-week mean body weight reduction% SAE and AE-led drop-out in major GLP-1 class drugs (indirect comparison, placebo-adjusted) (indirect comparison) Chinese population oriented trials Chinese population oriented trial
Slide 23: Tigulixostat (IBI128): potentially best-in-class XOI
Tigulixostat (IBI128): potentially best-in-class Phase 3 XOI for gout patients with hyperuricemia Milestone advancement XOIs inhibit ‘XO’, an enzyme Global MRCT Ph3 ongoing to watch in 2024 that produces uric acid based on encouraging Ph2 data Primary Endpoint: Proportion of Subjects with sUA <5.0 m
Slide 24: Pincankibart (IBI112): potentially best-in-class IL-23p19 inhibitor
Pincankibart (IBI112) : potentially best-in-class IL-23p19 inhibitor with compelling efficacy and long dose interval Thoughtful upstream target selection and antibody bio-engineering Milestone advancement to watch in 2024 • Ph3 psoriasis data readout Plan to obtain and release the results from CLEAR
Slide 25: IBI311 (IGF-1R): unmet medical needs of thyroid eye disease
IBI311 (IGF-1R): eyes on unmet medical needs of thyroid eye disease (TED) IGF-1R/TSHR complex activation IBI311 eyes on unmet needs of Milestone advancement is the key step in TED provoking thyroid eye disease in China to watch in 2024 The estimated prevalence of clinically relevant TED ranges from
Slide 26: IBI311: favorable safety and efficacy in RESTORE-1 Phase 3
IBI311 (IGF-1R) : favorable safety and excellent efficacy demonstrated in RESTORE-1 Phase 3 trial Primary endpoint: the proptosis responder The percentage of subjects with a CAS2 of Case report: moderate-to-severe TED with fast rate in the study eye1 after 24-week treatment 0 or 1 after 24-week trea
Slide 27: IBI302 (efdamrofusp alfa): first-in-class VEGF/complement fusion protein
IBI302 (efdamrofusp alfa) : first-in-class VEGF/complement fusion protein VEGF/Complement inhibition IBI302 clearly differentiated from Milestone advancement have synergistic effect in nAMD anti-VEGF monotherapies to watch in 2024 VEGFR1 domain2 Two Phase 2 clinical studies conducted in • IBI302 8mg
Slide 28: IBI302: Key data from 8mg Ph2 in nAMD
IBI302 (efdamrofusp alfa) : Key data from 8mg IBI302 Ph2 in nAMD Significant CST improvement CST change CST change from from baseline atbaseline week 40through W40 value) (observed Non-inferior BCVA gain 50 Weeks 0 4 8 12 16 20 24 28 32 36 40 BCVA change from baseline at week 40 (observed value) -50
Slide 29: Summary: Data Release Plan in 2024
Summary: Data Release Plan in 2024 Oncology General Biomedicine Accepted Published IBI343 CLDN18.2 ADC Preclinical 2024 AACR IBI311 IGF-1R Ph1 2024 APAO IBI3001 EGFR/B7H3 ADC Preclinical 2024 AACR IBI311 IGF-1R Ph2 2024 ICE IBI334 EGFR/B7H3 bsAb Preclinical 2024 AACR IBI3007 TROP2 ISAC Preclinical 2
Slide 30: Financials and Summary
Financials and Summary Ms. Rachel You CFO 30
Slide 31: Statement of profit or loss
Statement of profit or loss Non-IFRS measure* Total Revenue & Gross Profit RMB in millions 2023 % 2022 % Change • For the year ended 31 December 2023, our total revenue increased by 36.2% to RMB6,206.1 million, gross profit margin increased by Revenue from contracts with customers 6,206.1 100.0% 4,5
Slide 32: Statement of financial position
Statement of financial position At 31 December At 31 December RMB in millions 2023 2022 Non-current Assets Property, plant and equipment 4,289.7 3,411.5 Right-of-use assets 366.7 414.7 Intangible assets 1,270.3 1,198.2 Equity instruments at FVTOCI 218.3 202.6 Prepayments for acquisition of long-term
Slide 33: Summary: 2023 marked a transformative year
Summary: 2023 marked a transformative year of strong performance and material innovation, reinforcing our commitment to long-term strategic goals Achievement Highlights in 2023 Vision: a global premier biopharmaceutical company Robust Revenue Growth For second decade of development Strong revenue pe
Slide 34: Company Overview
Company Overview Innovent
Slide 35: Integrated platform toward becoming a global biopharmaceutical company
With established integrated platform, Innovent continues the journey toward becoming a global biopharmaceutical company In the first 12 years, Innovent becomes a leading fully-integrated biopharmaceutical company in China 10 26 140,000L 30 6,000 Commercial products Clinical stage candidates Capacity
Slide 36: Robust pipeline across novel therapeutics – oncology
Robust pipeline across novel therapeutics – oncology 8 approved, 2 under NDA review, 2 in Ph3 stage and over 10 assets in clinical stage, covering monoclonal antibodies, multi-specific antibodies, cell therapy and small molecules Status Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area
Slide 37: Robust pipeline across novel therapeutics – general biomedicine
Robust pipeline across novel therapeutics – general biomedicine 2 approved, 1 under NDA review, 3 in Ph3 stage and 8 in clinical stage, covering major therapeutic areas including CVM, autoimmune and ophthalmology Status Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area Rights Pre-clini
Slide 38: Fully-fledged commercial ecosystem with validated track record
Fully-fledged commercial ecosystem with validated track record Fully-fledged commercial ecosystem + National coverage + Validated track record Total Product Revenue (RMB) Commercial City 5.7 bn Affordability Health Insurance Solutions Team Coverage Patient ~3000 300+ 4.1 bn 4.0 bn Benefits 2.4 bn Ho
Slide 39: Global R&D structure with expanding footprint
Global R&D structure with expanding footprint 1,500 R&D employees Innovent Academy Product Development BD & Global Alliance Project and Portfolio Management Management Discovery engine for global China & global clinical Partnership with regional and Process control and facilitation FIC/BIC products
Slide 40: State-of-the-art manufacturing facilities
State-of-the-art manufacturing facilities designed to, built with, and operating at international standards Suzhou Manufacturing Site Shanghai R&D Center Hanzhou Manufacturing Site M1b M1a • A total of 140,000L manufacturing facilities in operation, providing competitive advantage on the production
Slide 41: Innovent is your preferred partner
Innovent is your preferred partner “from product development to commercial launch” Building Platforms Unlocking Value of Regional Pioneering MNC for the Future Best-in-class Partnering In-house R&D Partnerships Biotech Assets Comprehensive partnership with Lilly Assisting local companies to Establis
Slide 42: Long-Term Vision
Long-Term Vision Developing core competiveness 2030 based on strategic vision, global 2025 talent and strong execution • More commercialized • Expanded products, including 2023 commercialized first-in-class products in China blockbusters launched globally • Multiple products • 10 commercialized • To
Slide 43: 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 44: Confidential
Confidential Copyright© 2024 Innovent 44