Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — FY2022 Earnings Presentation
44 slides from Innovent Biologics's earnings presentation, Mar 28, 2023
Slide 1: Innovent Biologics 2022 Annual Results
Innovent Biologics 2022 Annual Results March, 2023
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 and Speakers
Agenda and Speakers 1 Business Review and Outlook Dr. Michael Yu Founder, Chairman and CEO 2 R&D Achievements and Updates Dr. Yongjun Liu President 3 Financials and Summary Mr. Ronnie Ede CFO 4 Q&A All Confidential Copyright© 2023 Innovent 3
Slide 4: Business Review & Outlook
Business Review & Outlook Dr. Michael Yu Founder, Chairman and CEO 4
Slide 5: 2022 Review: We Strengthened the Foundation for Sustainable Growth amid a Challenging 2022
2022 Review: We Strengthened the Foundation for Sustainable Growth amid a Challenging 2022 and Macro Headwinds Expanding and diversifying commercial Improving efficiency of commercial 01 portfolio 02 operation • Two new oncology products approved (CYRAMZA®, Retsevmo®) • Established a more agile and
Slide 6: R&D: Five More Late-stage Assets; Developing a More Diversified Pipeline
R&D: Five More Late-stage Assets including Potential Blockbuster in Metabolism; Developing a More Diversified Pipeline +5 +4 +5 +5 New clinical +8 stage assets Regulatory NDA Pivotal/Phase 3 Preliminary Approvals Acceptances New Assets Positive PoC Delivered innovative • Pemazyre®(Pemigatinib) • IBI
Slide 7: Commercial: Product Revenue Growth Impacted by One-off Factors
Commercial: Product Revenue Growth Impacted by One-off Factors while Diversified Portfolio and Improved Efficiency Achieved RMB mn RMB mn 5,000 3,000 100% 4,500 2,620 2,591 90% 4,139 4,001 2,500 80% 4,000 68.5% 65.5% 70% 3,500 2,000 62.6% 60% Retsevmo® 3,000 56.6% CYRAMZA® 56.9% 50% 2,368 Olverembat
Slide 8: Collaboration: Three Strategic MNC Collaborations
Collaboration: Three Strategic MNC Collaborations Further Validate the Intrinsic Value of Our Integrated Platform Collaboration for the development and Innovent receives: Collaboration for the development 2 commercialization of two potentially • Sole commercialization rights to import, and commercia
Slide 9: 2023 Outlook: Continuous Focus on Strategic Goals of Sustainable Growth and Global Innovation
2023 Outlook: Continuous Focus on Strategic Goals of Sustainable Growth and Global Innovation Further portfolio expansion, solid growth, and efficiency improvement Commercialization Increase contribution from new products Build presence for upcoming high potential non-oncology products Improve
Slide 10: Near-term Portfolio Growth Potential
Near-term Portfolio Growth Potential: Anticipate Solid Revenue Growth in 2023 TYVYT® visible growth driver Increasing contribution from new products Two new 1L indications included in NRDL with no price More diversified commercial portfolio cut Products entering less competitive landscapes to
Slide 11: Strong Long-term Growth Potential: ~RMB 20bn Upside Potential
Strong Long-term Growth Potential: Diversified Commercial Portfolio With High Potential Assets and Improving Operational Efficiency Fully-fledged Commercial Ecosystem + Validated Track Record + Rich and De-risked Portfolio + Sustainable Business Model = More products into visibility: ~RMB 20bn GLP-1
Slide 12: Oncology: Established a Leading Position and Brand Franchise
Oncology: Established a Leading Position and Brand Franchise Expansive Oncology Pipeline with Robust Supporting Commercial Structure Robust Oncology Pipeline Well-positioned with Industry Leading Footprint and Comprehensive Coverage More ADC, IO Bispecific, T/NK Engager… Targeted therapy CLDN18.2 AD
Slide 13: CVM & Endocrinology: New Franchise with High Potential Innovative Assets
CVM & Endocrinology: New Franchise with High Potential Innovative Assets Substantial Patient Base in Need of Next-Generation Drugs Hypercholesterolemia Diabetes Hyperuricemia Obesity TAO NASH Heart failure No SoC* Renal disease 200m 140m 180m 160m AD …… adults affected only 50% receiving treatment ~
Slide 14: Autoimmune: Strategic Vision to Fulfill Unmet Medical Needs
Autoimmune: Strategic Vision to Fulfill Unmet Medical Needs Switching from Traditional to Innovative Targeted Therapies in Various Autoimmune Diseases High Potential Therapeutic Area Driven By: Patient Friendly Solutions: Deeper understanding of the mechanisms of action Longer dosing interval to imp
Slide 15: Firmly Invest in Global Innovation
Firmly Invest in Global Innovation: Efficient Resource Allocation to Early Stage Pipeline and Globalization Strategy Globalization as Long-term Core Strategy: Position Innovent to Enter Next Stage of Becoming a Competitive in-house R&D platform with 1500+ professionals Premier Biopharma Globally P
Slide 16: Anticipated Development Milestones in 2023 to early 2024
Anticipated Development Milestones in 2023 to early 2024 5 Regulatory Actions 4 Regulatory Acceptance 8 New Phase 3 9 Key PoC Readouts 5 Early Stage Ongoing 7 First-in-Human Assets / Pivotal Trials TYVYT® IBI376 (PI3Kδ) IBI362(GLP-1R/GCGR) IBI110 (LAG3) IBI363 (PD-1/IL-2) T2DM 1L sqNSCLC PD-1 resist
Slide 17: Major R&D update
Major R&D update Dr. Yongjun Liu President 17
Slide 18: R&D Update: Expand Oncology Boundary with Novel Modalities, Roll Out Non-oncology Assets
R&D Update: Expand Oncology Boundary with Novel Modalities, Roll Out Non-oncology Best-in-class Assets Robust R&D Pipeline Oncology Non-oncology Expand Boundary with Novel Modalities Innovative Late-stage Assets to Roll Out Approved 8 Products TKI and Cell Therapy CVM • IBI306 (PCSK-9): NDA • IBI326
Slide 19: ADC Strategy: Established Fully Integrated Technology Platform
ADC Strategy: Established Fully Integrated Technology Platform Next-Generation ADC with Improved Efficacy and Therapeutic Windows World-class antibody engineering • Innovent discovered αTAA* mAbs Antibody • Ab with high internalization efficiency • TAA with differentiated tumor expression Balanced d
Slide 20: IBI343: Potential Best-in-Class CLDN18.2 ADC
IBI343: Potential Best-in-Class CLDN18.2 ADC Differentiated Design for Potential Wide Therapeutic Window and High Potency Differentiated Design Potential Best-in-Class Profiles • World leading ADC technology collaborated with Synaffix • Fully human, high internalization αCLDN18.2 mAb Asn297 • Silenc
Slide 21: IBI343: Preclinical Highlights & Clinical Progress
IBI343: Potential Best-in-Class CLDN18.2 ADC Preclinical Highlights & Clinical Progress Strong Bystander Killing Better In-vivo Efficacy than MMAE and Dxd Clinical Progress Heterogeneous TAA expression • Phase 1 MRCT ongoing in Australia and China since 2022, exploring in CLDN18.2+ solid cancers suc
Slide 22: IBI939 (TIGIT): Encouraging Efficacy Signal in 1L PD-L1 TPS>=50% NSCLC
IBI939 (TIGIT) : Encouraging Efficacy Signal in 1L PD-L1 TPS>=50% NSCLC Trend of PFS Improvement vs. PD-1 Monotherapy Presentation #86P @ ESMO IMMUNO-ONCOLOGY CONGRESS 2022 STUDY DESIGN More PoC Ph1b data readout (eg. ASCO) PROGRESSION-FREE SURVIVAL CHANGES IN TARGET LESION SIZE FROM BASELINE IN ARM
Slide 23: IBI110 (LAG3): Phase 1b Study for 1L sqNSCLC
IBI110 (LAG3) : Phase 1b Study for 1L sqNSCLC PFS On-going Potentially Improve the Efficacy of Sintilimab in the 1st Line of Major Cancer Indications Presentation #77P @ ESMO IMMUNO-ONCOLOGY CONGRESS 2022 STUDY DESIGN SWIMMING POOL OF OVERALL RESPONSE More PoC Ph1b data readout (eg. ASCO) SAFETY ANA
Slide 24: IBI363 (PD-1/IL-2): Highly Potent Bispecific Fc Fusion Protein
IBI363 (PD-1/IL-2) : Highly Potent Bispecific Fc Fusion Protein Mechanistically Enhance IO Treatment, including PD-1/PD-L1 Resistant and Cold Tumors NOVEL MOLECULAR DESIGN STRATEGY CLINICAL PHASE 1 STUDY DESIGN ● IL-2Rɑ activity maintained for max efficacy & selectivity, while reduce ● Phase 1 ongoi
Slide 25: IBI362 (mazdutide): GLP-1R/GCGR Dual Agonist in Phase 3
IBI362 (mazdutide) : GLP-1R/GCGR Dual Agonist in Phase 3 Potentially the Best Therapy to Treat Obesity and Diabetes Obesity Ph1b: Weight change at week 12 for IBI362 Obesity Ph2: Weight change at week 24 for IBI362 (6mg), (9mg), indirect Comparison with Semaglutide and indirect Comparison with Semag
Slide 26: IBI362 (mazdutide): Diabetes Phase 2 vs Dulaglutide
IBI362 (mazdutide) : GLP-1R/GCGR Dual Agonist in Phase 3 Potentially the Best Therapy to Treat Obesity and Diabetes Diabetes Ph2: Comparison at week 20 between IBI362 (6mg) and dulaglutide in HbA1c reduction and weight loss Week 20 HbA1c reduction(%) from baseline Week 20 proportion of participants
Slide 27: IBI362 (mazdutide): Huge Market Potential
IBI362 (mazdutide) : GLP-1R/GCGR Dual Agonist in Phase 3 Bolster Huge Market Potential with Robust Data and Comprehensive Metabolic Benefits Obesity: ~160m people with BMI>28 Substantial Commercial Opportunity T2DM: ~140m patient while GLP-1 usage within single digit Obesity: No prescription GLP-1 d
Slide 28: IBI128 (Tigulixostat)
IBI128 (Tigulixostat) Potentially Best-in-class Phase 3 XOI for Gout Patients with Hyperuricemia Role of Xanthine Oxidase in the Production of Uric Acid Clear Unmet Needs and BIC Profile • Huge population with gout/hyperuricemia (15M/177M) patients in China. Allopurinol / Febuxostat / IBI128 Tigulix
Slide 29: IBI112 (IL-23p19): Potentially Best-in-class IL-23
IBI112 (IL-23p19) : Potentially Best-in-class IL-23 Extended Half-life, Long-dosing Interval and Long-term Efficacy Longest Dose Interval Compared with Launched Products • Bio engineer innovation: Fc YTE Mutation to prolong half life • 12weeks dosing interval: less dose frequency improved QOL signif
Slide 30: IBI302 (efdamrofusp alfa): First-in-Class VEGF/Complement Fusion Protein
IBI302 (efdamrofusp alfa) : First-in-Class VEGF/Complement Fusion Protein Potential Effect in Anti-macular Atrophy and Longer Durability Ph2 primary endpoint met: BCVA gains with IBI302 Q8W Less macular atrophy on OCT in IBI302 group at week 36 & were noninferior to 2mg Aflibercept Q8W at week 36 &
Slide 31: Financials and Summary
Financials and Summary Mr. Ronnie Ede CFO 31
Slide 32: Income Statement (IFRS measure)
Income Statement (IFRS measure) IFRS measure Year ended 31 December Revenue For the year ended 31 December 2022, we generated total revenue of RMB'million 2022 % 2021 % RMB 4,556.4 million, including RMB4,139.1 million driven by product Revenue 4,556.4 100.0% 4,269.7 100.0% sales; coupled with RMB
Slide 33: Balance Sheet
Balance Sheet IFRS-measure RMB'million 2022/12/31 2021/12/31 Cash balance Bank balances and cash 9,162.8 8,377.1 Other financial assets 3.2 644.8 As at 31 December 2022, our total cash was RMB 9,166.0 Trade receivables 575.3 968.4 million (equivalent to approximately US$1.3 billion） Prepayments an
Slide 34: Key Takeaways
Key Takeaways We have set clear strategic goals of sustainable development and global innovation, and will continue to make progress in commercial operations and key R&D programs: Anticipate solid revenue growth and continuous improvement in operational efficiency Firmly invest in innovation and
Slide 35: Company Overview
Company Overview 35
Slide 36: With Established Integrated Platform, Innovent Continues to Improve our Business Model
With Established Integrated Platform, Innovent Continues to Improve our Business Model to Achieve Sustainable Growth • In the past decade, Innovent has transformed from a biotech start-up to a leading biopharma company in China with an established integrated platform. 8 28 60,000L 28 6,000 Commercia
Slide 37: Robust Pipeline Across Novel Therapeutics – Oncology
Robust Pipeline Across Novel Therapeutics – Oncology 7 approved, 2 NDAs, 3 in pivotal trials and over 10 assets in clinical stage Status Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area Rights Pre-clinical IND Phase 1 Phase 1b/2 NDA Launched Phase 3 TYVYT® (sintilimab injection） PD-1
Slide 38: Robust Pipeline Across Novel Therapeutics – Non-oncology
Robust Pipeline Across Novel Therapeutics – Non-oncology 1 approved, 1 NDA, 2 in pivotal stage, 6 assets in clinical stage Pivotal Phase 2 / Products Target (s) Modality Therapeutic Area Rights Pre-clinical IND Phase 1 Phase 1b/2 NDA Launched Phase 3 SULINNO® (adalimumab) TNF-α Monoclonal antibody A
Slide 39: Global R&D Structure with Expanding Footprint
Global R&D Structure with Expanding Footprint Innovent R&D • Chairman of the Department of Immunology; Founding Director of the Center for Cancer Immunology Research Led by Dr. Yongjun Liu of MD Anderson Cancer Center President, Innovent • Global Head of Research of Sanofi 1,500 R&D employees Innove
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 Annual Product Revenue Affordability Commercial City (RMB) Solutions Team Coverage 4.1 bn Patient ~3000 300+ 4.0 bn +60% Benefits 2.4 bn Hospital DTP Coverag
Slide 41: 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 • Full CMC capability across process • Advanced CMC development capability Total capacity: 60,000 L development, manufacturing, quality, including perfusion, ADC and high concentration DP plat
Slide 42: Innovent is Your Preferred Partner in China
Innovent is Your Preferred Partner in China “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 Most Comprehensive partnership with Lilly Establishing a world-cl
Slide 43: 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 2022 commercialized first-in-class products in China blockbusters launched globally • Multiple products • 8 commercialized appro
Slide 44: INNOVENT
INNOVENT