Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — H1 2024 Earnings Presentation
45 slides from Innovent Biologics's earnings presentation, August 2024
Slide 1: Innovent Biologics 2024 Interim Results
Innovent Biologics 2024 Interim Results August, 2024 TO EMPOWER PATIENTS WORLDWIDE WITH AFFORDABLE, HIGH-QUALITY BIOPHARMACEUTICALS
Slide 2: Agenda and Speakers
Agenda and Speakers Business Review and Outlook 01 Dr. Michael Yu Founder, Chairman and CEO R&D Progress Updates 02 Dr. Hui Zhou SVP, oncology clinical development Dr. Lei Qian VP, general biomedicine clinical development 03 Financials and Summary Ms. Rachel You CFO Q&A 04 All Management Team Confid
Slide 3: Business Review & Outlook
Business Review & Outlook Dr. Michael Yu Founder, Chairman and CEO 3
Slide 4: Poised for sustainable growth and aimed at global innovation
Poised for sustainable growth and aimed at global innovation Our growth strategy delivering on track 2030+ 2027 Global innovation 2023 Be a global biopharma company ~20 launched products 2011 10 launched products RMB20bn annual sales in 2027 RMB 6.2bn total sales, +36% yoy Innovent inception Founded
Slide 5: Strong performance and strategic innovation delivered in 1H 2024
Strong performance and strategic innovation delivered in 1H 2024 Strong Growth RMB 3,952.3m +46.3% RMB 3,811.4m +55.1% yoy growth yoy growth Momentum Total revenue Product revenue Improved 84.1% 48.6% 5.2% 160.8m RMB10,112.3m Financial +1.8pp yoy -5.9pp yoy -4.9pp yoy USD 1.4+bn -39.9% yoy Performan
Slide 6: Product portfolio achieved robust revenue growth in 1H 2024
Product portfolio achieved robust revenue growth in 1H 2024 Product revenue +55.1% yoy in 1H; new product launches in 2H Product revenue (RMBm) • Robust demand for innovative medicines driven by our comprehensive portfolio, broad NRDL coverage and patient access +55.1% 3,811.4 • Increasing diversifi
Slide 7: Substantial R&D milestones unlocking growth potential
Substantial R&D milestones unlocking growth potential Oncology CVM Immunology Ophthalmology Dupert® (KRAS G12C) Mazdutide (GLP-1R/GCGR) Picankibart (IL-23p19) Teprotumumab (IGF-1R) Key Late-Stage Assets • Approval for KRAS G12Cm NSCLC • NDA in obesity/overweight • Ph3 readouts in PsO • NDA and Ph3 r
Slide 8: Strengthen CVM franchise and prepare for upcoming launches
Strengthen CVM franchise and prepare for upcoming launches To be an innovative leader in the CVM area Accelerating new launches will unlock significant opportunities Innovative medicines offering Building up capability and preparing for new launches Function build up and team Marketing, pricing, dis
Slide 9: Strong growth trajectory targeting RMB20bn in 2027 sales
Strong growth trajectory targeting RMB20bn in 2027 sales and continued innovation beyond Clear momentum toward achieving this aim RMB 20bn Next wave innovation Global market potential Beyond 2027 VEGF/C XOI CTLA-4 IL-23p19 ROS1 IGF-1R Dupert® (KRAS G12C ) GLP-1R/GCGR FUCASO® (BCMA CAR-T) SINTBILO® (
Slide 10: Encouraging progress in the next wave oncology innovation of IO+ADC
Encouraging progress in the next wave oncology innovation of “IO+ADC” Significant R&D advancements IBI343 (CLDN18.2 ADC) IBI363 (PD-1/IL-2α-bias) IBI389 (CLDN18.2/CD3) IBI310 (CTLA-4)+ TYVYT® Postive PoC readouts in 3L GC Encouraging Phase 1 results in Encouraging Phase 1 results in New Phase 3 in E
Slide 11: Investing in disruptive innovation and global development to drive long-term business growth
Investing in disruptive innovation and global development to drive long-term business growth IBI3003 (GPRC5D/BCMA/CD3) The next wave innovation of Oncology IBI3001(EGFR/B7H3 ADC) IBI343 (CLDN18.2 ADC) IBI343 (CLDN18.2 ADC) “IO+ADC” *2L PDAC *3L GC IBI354(HER2 ADC) IBI129 (B7H3 ADC) IBI363 (PD-1/IL-2
Slide 12: Conclusion: expected strong pipeline momentum through early 2025
Conclusion: expected strong pipeline momentum through early 2025 Oncology General Biomedicine Approval Submission Under review Submission Regulatory Taletrectinib TYVYT® IBI310 Teprotumumab Mazdutide Mazdutide Picankibart (ROS1) (PD-1) (CTLA-4)+TYVYT® (IGF-1R) (GLP-1R/GCGR) (GLP-1R/GCGR) (IL-23p19)
Slide 13: Major R&D update - Oncology
Major R&D update - Oncology Dr. Hui Zhou Senior Vice President, Oncology Development 13
Slide 14: Oncology: leverage IO + ADC strategy to transform cancer treatment
Oncology: leverage “IO + ADC” strategy to transform cancer treatment Immuno-oncology ADC Next wave • Deep biological understanding of • Differentiated linker-payloads including TOPO1i platform • World-class antibody-based global • Synergy with antibody platform technology platform innovation and IO
Slide 15: Full lifecycle management of TYVYT as current IO backbone
Full lifecycle management of TYVYT®as current IO backbone to maximize clinical value cHL TYVYT ® approved for 7 indications First PD-1 inhibitor to enter the NRDL and currently 1L non-squamous NSCLC included with the most first-line indications coverage 1L squamous NSCLC China leading PD-1 bra
Slide 16: IBI363 (PD-1/IL-2α-bias): First-in-class immuno-cytokine
IBI363 (PD-1/IL-2α-bias): First-in-class immuno-cytokine based on breakthrough findings shows initial next-generation IO potential First-in-class α-biased IL-2 and anti-PD-1 immuno-cytokine • Efficacy：IL-2Rα-bias selectively activate PD-1+CD25+ TST cells through autocrine IL-2–CD25 signaling • Safet
Slide 17: IBI363: positive Phase 1 results across tumor types; continue PoC studies
IBI363 (PD-1/IL-2α-bias): positive Phase 1 results across tumor types; continue PoC studies Safety and Efficacy Highlights of Phase 1 Study Continue exploration in PoC studies ESMO Virtual Plenary Oral Presentation (13 June 2024) IO-failed: NSCLC & melanoma All dose levels (n=347) 3mg/kg Q3W (n=38)
Slide 18: IBI343 (CLDN18.2 ADC): Positive PoC readouts in gastric cancer
IBI343 (CLDN18.2 ADC): novel site-specific TOPO1i CLDN18.2 ADC; Positive PoC readouts in gastric cancer Superior safety & efficacy PoC results achieved in GC ≥G3 nausea ≥G3 vomitting 22.0% Superior GI AE Safety 15.0% 10.0% 9.0% 4.0% 6.0% 1.3% 1.9% IBI343 CMG901 SYSA1801 Zolbetuximab (CLDN18.2 ADC) (
Slide 19: IBI343: First ADC reporting encouraging efficacy in PDAC
IBI343 (CLDN18.2 ADC): First ADC reporting encouraging efficacy in PDAC; follow up underway Preliminary outstanding efficacy signal in PDAC Phase 1 Phase 1 Publications at ASCO 2024 2L PDAC: 6mg/kg in CLDN18.2 1+2+3+ ≥ 60%（n=10) ORR 40.0%, DCR 90.0% First ADC with encouraging signal in PDAC • Fc-sil
Slide 20: IBI389 (CLDN18.2/CD3): bispecific T-cell engager efficacy in PDAC and GC
IBI389 (CLDN18.2/CD3): Global first-in-class CLDN18.2 bispecific T-cell engager reporting encouraging efficacy in PDAC and GC Preliminary outstanding efficacy signal in GC and PDAC Phase 1 Publications at ASCO 2024 GC: ≥10 μg /kg in CLDN18.2 2+3+≥ 10% (n=26) Encouraging signal including low and ORR
Slide 21: Summary: oncology clinical data release plan in 2H 2024
Summary: oncology clinical data release plan in 2H 2024 2024H1 AACR ASCO ESMO Plen. ESMO GI Published IBI3001 IBI343 IBI363 IBI343 EGFR/B7H3 ADC CLDN18.2 ADC PD-1/IL-2α-bias CLDN18.2 ADC Preclinical results Ph1 & Ph1b in PDAC Ph1 & Ph1b in GC Ph1 in melanoma, NSCLC, IBI3007 IBI389 CRC TROP2 ISAC CLD
Slide 22: Major R&D update – General Biomedicine
Major R&D update – General Biomedicine Dr. Lei Qian Vice President, General Biomedicine Development 22
Slide 23: CVM: Build a strong franchise centered on mazdutide lifecycle management
CVM: Build a strong franchise centered on mazdutide lifecycle management and metabolism-related diseases “Develop pipeline of blockbusters and next-gen innovation to serve significant unmet needs” OSA SINTBILO® (PCSK9) Approved - Hyperlipidemia Oral delivery MASH Teprotumumab (IGF-1R) Weight NDA - T
Slide 24: CVM: Build a strong franchise centered on mazdutide
CVM: Build a strong franchise centered on mazdutide lifecycle management and metabolism-related diseases 200mn SINTBILO® (PCSK9) First domestic PCSK9 drug Significant L-DLC and Lp(a) lowering Hyperlipidemia Adults affected* Long dose interval 140mn CVM cornerstone asset T2D Adults affected * CVM Maz
Slide 25: Mazdutide: next-generation GLP-1R/GCGR dual agonist for weight management
Mazdutide: next-generation GLP-1R/GCGR dual agonist for weight management Mazdutide Next-generation GLP-1R/GCGR dual agonist for weight management 500M NDA Under NMPA’s review for weight management since 2024.02 GLROY-1 Phase 3 in adults with obese/overweight met endpoints Adults in China living wit
Slide 26: Mazdutide: a new therapy for T2D
Mazdutide: a new therapy for T2D with dual benefits in glycemic control and weight reduction Mazdutide Bring dual benefits of glycemic control and weight loss for T2D 160m NDA Under NMPA’s review for T2D since 2024.08 T2D adults in China DREAMS-1 & 2 Phase 3 studies in T2D succeeded; publications on
Slide 27: Mazdutide: develop our CVM cornerstone asset as a pipeline in a product
Mazdutide: develop our CVM cornerstone asset as a pipeline in a product Mazdutide development programs overview New indications in plan Indications Trial Ph3 NDA Approval Weight Management Adolescent • 10mn obese adolescents in China and still growing rapidly obesity • No approved drug for preventio
Slide 28: IBI3016 (AGT siRNA): novel siRNA treatment in Phase 1 for hypertension
IBI3016 (AGT siRNA) : novel siRNA treatment in Phase 1 for hypertension AGT as upstream target for hypertension IBI3016 (AGT siRNA) advantages over SoC antihypertensives Potential to overcome the RAAS escape with oral RAAS blockage and address issues of uncontrolled hypertension and poor compliance
Slide 29: Autoimmune: positive Ph3 readouts for best-in-class IL-23p19
Autoimmune: positive Ph3 readouts for best-in-class IL-23p19; advance early-stage programs for global unmet needs Approved Product Late Stage Asset Early Stage Assets Preclinical Projects IBI356 (OX40L) ~10 undisclosed pre-clinical projects SULINNO® (TNF-α) Picankibart (IL-23p19) IBI355 (CD40L) to a
Slide 30: Ophthalmology: potential first IGF-1R drug for TED in China
Ophthalmology: potential first IGF-1R drug for TED in China; first-in-class VEGF/C bispecific in Phase 3 for nAMD NDA Stage Asset Late Stage Asset Early Stage Assets Preclinical Projects Teprotumumab (IGF-1R) IBI302 (VEGF/C) IBI324 (VEGF-A/ANG-2) Multiple next generation FIC bispecifics for retinopa
Slide 31: Summary: general biomedicine clinical data release plan in 2H 2024
Summary: general biomedicine clinical data release plan in 2H 2024 Teprotumumab Mazdutide Teprotumumab Mazdutide IBI311 (IGF-1R) GLP-1/GCGR IBI311 (IGF-1R) GLP-1/GCGR APAO Ph1 in TED ADA GLORY-1 Topline RESTORE-1(topline readout) Topline DREAMS-2 (topline readout) Teprotumumab Mazdutide Picankibart
Slide 32: Financials and Summary
Financials and Summary Ms. Rachel You CFO 32
Slide 33: Statement of profit or loss
Statement of profit or loss Total Revenue & Gross Profit Non-IFRS measure* Six months ended 30 June • For the six months ended 30 June 2024, total revenue increased by 46.3% RMB'million 2024H1 % 2023H1 % to RMB3,952.3 million. Gross profit margin increased by 1.8 percentage Revenue from contracts wi
Slide 34: Statement of financial position
Statement of financial position RMB’ million At June 30 2024 At December 31 2023 Non-current Assets Property, plant and equipment 4,989.4 4,289.7 Right-of-use assets 431.4 366.7 Equity instruments at fair value through 205.8 218.3 other comprehensive income Intangible assets 987.4 1,270.3 Prepayment
Slide 35: Summary: successful 1H laid a solid foundation, and we will continue to deliver value
Summary: successful 1H laid a solid foundation, and we will continue to deliver value Achievement Highlights in 2024 Vision: a global premier biopharmaceutical company Robust Revenue Growth Strong revenue performance and solidified For second decade of development operation under sustainable busines
Slide 36: Company Overview
Company Overview Innovent
Slide 37: With established integrated platform, Innovent continues the journey toward becoming a global biopharmaceutical company
With established integrated platform, Innovent continues the journey toward becoming a global biopharmaceutical company 11 25 140KL 30+ 6000 Commercial Clinical stage Capacity in Global Experienced products candidates operation partnerships talents Strategy for the 2nd decade of the company’s develo
Slide 38: Robust pipeline across novel therapeutics – oncology
Robust pipeline across novel therapeutics – oncology 9 approved, 1 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 39: Robust pipeline across novel therapeutics – general biomedicine
Robust pipeline across novel therapeutics – general biomedicine 2 approved, 2 under NDA review, 2 in Ph3 stage and ~10 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 40: 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) Affordability Health Insurance Commercial City 5.7 bn Solutions Team Coverage Patient ~3000 300+ 4.1 bn 4.0 bn 3.8 bn Benefits 2.
Slide 41: Global R&D structure with expanding footprint
Global R&D structure with expanding footprint 1,500 R&D employees ⚫ Innovent Academy ~300 ⚫ Focus areas: Immunology, ⚫ 80+ preclinical projects scientists in China and U.S. cancer biology, antibody ⚫ Delivery of 10 novel molecules into IND- engineering, PK/PD, Toxicology enabling stage in 2023 Suzho
Slide 42: State-of-the-art manufacturing facilities designed to international standards
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 ⚫ A total of 140,000L manufacturing ⚫ Full CMC capability across process ⚫ Advanced CMC development facilities in opera
Slide 43: From product development to commercial launch, Innovent is the preferred partner
From product development to commercial launch, Innovent is the preferred partner Pioneering MNC Building Platforms for Unlocking Value of Best -in- Regional Partnerships the Future class Assets Partnering ● Strategic partnership ● Partnering to Build Capabilities ● Untapping Portfolio Potentials ● A
Slide 44: 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 45: Confidential
Confidential Copyright© 2023 Innovent 45