Innovent Biologics, Inc. · HKEX:1801
Innovent Biologics — H1 2020 Earnings Presentation
43 slides from Innovent Biologics's earnings presentation, August 2020
Slide 1: 2020 Interim Results Presentation
2020 Interim Results Presentation August 2020 To develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people Confidential Copyright© 2020 Innovent Biologics 0
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: Our Mission, Vision and Development Strategy
Our Mission, Vision and Development Strategy COMPANY MISSION COMPANY VISION COMPANY STRATEGY To develop and commercialize high To be a premier biopharmaceutical • Robust and high quality pipeline quality biopharmaceuticals that are company in the world affordable to ordinary people • Global standard
Slide 4: Our History
Our History Tyvyt® (sintilimab injection) listed in the NRDL Granted priority review status for the NDAs of three Strategic partnership with Eli Lilly Strategic alliance with Hanmi biosimilars (IBI-301, IBI-303 and IBI-305) by the NMPA Innovent was Strategic alliance Passed audit on GM
Slide 5: Major Accomplishments since 2020
Major Accomplishments since 2020 COMMERCIALIZATION GLOBAL COLLABORATIONS SIX COLLABORATIOND WITH WORLD-CLASS PATERNERS, INCLUDING LILLY AND ROCHE STRONG SALES GROWTH MOMENTUM AND ENLARGED PRODUCT PORTFOLIO Expanded Strategic Collaboration with Lilly on Tyvyt® Continued Strong Sales Growth of Tyvyt ®
Slide 6: Agenda
Agenda 1 COMMERCIALIZATION 2 Research & Development 3 Manufacturing Facilities 4 Global Partnerships 5 Organization & Fundraise 6 Financial Review 7 Outlook Copyright© 2020 Innovent Biologics 5
Slide 7: Commercialization Summary of Tyvyt in 1H 2020
Commercialization Summary of Tyvyt® (Sintilimab Injection) in 1H 2020 Strong Revenue Growth Momentum Key Achievements in 1H 2020 Strong Revenue Growth Momentum Rmb mn • Revenue of Rmb920.9mn in 1H 2020, representing 1000 177.7% growth year-over-year 920.9 900 • Fully leveraged the unique advantage a
Slide 8: Launched Second Commercial Product BYVASDA
Launched Second Commercial Product BYVASDA®(Bevacizumab Biosimilar) BYVASDA ® (Bevacizumab biosimilar): • NMPA marketing approval date: Jun 19, 2020 • Indications: advanced non-small cell lung cancer and metastatic colorectal cancer Copyright© 2020 Innovent Biologics 7
Slide 9: Accelerated the Penetration of Immunotherapy with Guideline, Government Office, Public-welfare Program
Accelerated the Penetration of Immunotherapy with Guideline, Co-working with Government Office, and Public-welfare Program Listed in CSCO and IASLC Guidelines APS benefited 20,000+ patients • Tyvyt® was featured in CSCO and IASLC Guideline of Lymphoma • Patient assistant program has benefited 20,000
Slide 10: Established Broad and Deep Commercial Footprint throughout China
Established Broad and Deep Commercial Footprint throughout China 30 ~300 ~3,500 ~900 ~1,000 Provinces Coverage Cities Coverage Target Hospital DTP/Pharmacies Commercial Team Size Copyright© 2020 Innovent Biologics 9
Slide 11: Built a Competitive and Professional Commercial Force
Built a Competitive and Professional Commercial Force AUTO-IMMUNE BU & COO SALES SOUTH CHINA SALES NORTH CHINA MARKETING CHANNEL MANAGEMENT MIN LIU KEWIN XU DONGSHENG LIU SPARKLER MAO LI CHEN Chief Commercial Officer, General Manager of Innovent Shanghai Branch • East 1 • North • Medical Marketing •
Slide 12: Agenda
Agenda 1 Commercialization 2 RESEARCH & DEVELOPMENT 3 Manufacturing Facilities 4 Global Partnerships 5 Organization & Fundraise 6 Financial Review 7 Outlook Copyright© 2020 Innovent Biologics 11
Slide 13: Robust Pipeline Across Novel Therapeutics
Robust Pipeline Across Novel Therapeutics Status Products Target (s) Therapeutic Area Commercial Rights Pre-clinical IND Phase1 Phase 2 Phase 3 NDA Launched sintilimab (IBI-308) PD-1 Oncology Worldwide NDA approved: Dec 24, 2018 Bevacizumab (IBI-305) VEGF-A Oncology Worldwide NDA approved: Jun 19, 2
Slide 14: Robust R&D Platforms and Oncology Product Candidates
Robust R&D Platforms and Oncology Product Candidates IBI-308 (PD-1) IBI-188 (CD47) IBI-318 (PD-1/ PD-L1) IBI-301 (CD20) IBI-101 (OX40) IBI-315（PD-1/HER2） IBI-305 (VEGF-A) IBI-110 (LAG-3) IBI-322 (PD-L1/ CD47) IBI-310 (CTLA-4) IBI-939 (TIGIT) IBI-323 (LAG-3/PD-L1) IBI-102 (GITR) IBI-319 (PD-1/unspeci
Slide 15: Clinical Development Programs for Sintilimab
Clinical Development Programs for Sintilimab 27 Studies with 12 Registratinal or Pivotal Trials Ongoing or Completed STATUS PHASE 1 NDA INDICATION MONO-/COMBO-THERAPY (OTHER COMPONENTS) 1A 1B PHASE 2 PHASE 3 NDA FILED APPROVED China r/r Classical Hodgkin’s Lymphoma Mono 1L Non-squamous NSCLC Combo (
Slide 16: Clinical Development Programs for Sintilimab
Clinical Development Programs for Sintilimab STATUS PHASE 1 INDICATION MONO-/COMBO-THERAPY (OTHER COMPONENTS) NDA 1A 1B PHASE 2 PHASE 3 NDA FILED APPROVED China 1L Squamous NSCLC Combo (gemcitabine and cisplatin) 2L Neuroendocrine Tumor Mono Solid Tumors/colorectal cancer Combo (Fruquintinib) Solid
Slide 17: Key Data of Tyvyt in 2020
Key Data of Tyvyt® (Sintilimab Injection) in 2020 Four Clinical Results 1L nsq NSCLC Expected major data at ASCO (2020.06) on WCLC (2020.08) release in 2H 2020 Phase 1b study in HCC of Tyvyt® in Phase 3 of 1L nsqNSCLC(EGFR and Biomarker data of 1L nsqNSCLC at virtual combination with Byvasda®
Slide 18: Entered Pivotal Trial for Four More Assets
Entered Pivotal Trial for Four More Assets Partner Target/TA Commercial Rights Trial Region Status IND Phase 2 Pre-clinical Phase 1 Phase 3 NDA Launched IBI-375 Filed Accepted (pivotal) Mainland China, HK, China 1H20 (FGFR) Taiwan, Macau Entered into Pivotal Phase 2 for 2L mCCA in mainland China 2H2
Slide 19: Trial Progress of Other Prioritized Assets
Trial Progress of Other Prioritized Assets Target/TA Commercial Rights Trial Region Status IND Pre-clinical Phase 1 Phase 2 Phase 3 NDA Launched Filed Accepted 1H20 Finalizing Phase 1a dosage escalation China Initiate Pivotal Phase 1b/2 in r/r AML 2H20E IBI-188 2H20E Initiate Pivotal Phase 1b/3 in M
Slide 20: Agenda
Agenda 1 Commercialization 2 Research & Development 3 MANUFACTURING FACILITIES 4 Global Partnerships 5 Organization & Fundraise 6 Financial Review 7 Outlook Copyright© 2020 Innovent Biologics 19
Slide 21: State-of-the-art Manufacturing Facilities Designed to, Built to, and Operating at International Standards
State-of-the-art Manufacturing Facilities Designed to, Built to, and Operating at-International Standards M1b Facility Total capacity in the future: 84,000 L 4 x 15,000L 6 x 1,000 L 6 x 3,000 L ® TYVYT® (sintilimab) On 29 December 2018, our manufacturing facilities received cGMP certification from t
Slide 22: Agenda
Agenda 1 Commercialization 2 Research & Development 3 Manufacturing Facilities 4 GLOBAL PARTNERSHIPS 5 Organization & Fundraise 6 Financial Review 7 Outlook Copyright© 2020 Innovent Biologics 21
Slide 23: Striving to Be the Partner of Choice
Striving to Be the Partner of Choice Strategic Partnerships with Renowned Global Partners Mar 20th, 2015 Dec 17th, 2018 June 9, 2020 • Innovent licensed out PD-1 mAb ex-China to Lilly • Innovent licensed in 3 clinical-stage molecules • Strategic Collaboration to Discover • Co-development of 3 mAbs i
Slide 24: Further Enhance R&D Capability by Strategic Collaboration with Roche
Further Enhance R&D Capability by Strategic Collaboration with Roche Access to Roche’s Bispecific Antibody and Universal CART Technologies Innovent: Will access certain Roche technologies in the discovery and development of specific 2:1 T-cell bispecific antibodies (TCB) as well as its universal C
Slide 25: Strategic Collaboration Expansion with Lilly on Tyvyt for Ex-China Market
Strategic Collaboration Expansion with Lilly on Tyvyt® for Ex-China Market >US$1Bn Total Deal Value • Lilly: will receive development and commercialization rights to Tyvyt® outside of China. • Innovent: will receive US$200Mn upfront payment, up to US$825Mn potential milestones and double digit royal
Slide 26: Accelerating Innovent's Global Footprint
Accelerating Innovent’s Global Footprint Jan 2020: Jan 2020: Jan-Feb 2020: 1H 2020: Jun 2018: Licensed out rights of Received IND approval Received orphan drug Completed Phase 1a Aug 2020: IBI-305 (bevacizumab from U.S. FDA for designations for Tyvyt® in study enrolment of IBI- Established U.S. bios
Slide 27: Keep Exploring Global Opportunities for Our Assets
Keep Exploring Global Opportunities for Our Assets IBI-308 IBI-188 IBI-305 IBI-322 IBI-939 (Sintilimab, PD-1) (CD47) (Bevacizumab) (PD-L1/CD47) (TIGIT) • Received IND approval • Completed Phase 1a • Licensed out rights of • Received IND approval • Planning for global from US FDA for global study enr
Slide 28: Comprehensive Globalization Plan from R&D to Commercial
Comprehensive Globalization Plan from R&D to Commercial 1 Innovation focused R&D • Robust in-house R&D platform • Strategic collaboration to further enrich R&D • Establishing global R&D presence 2 Anchor drug candidates with global potential • Potential FIC or BIC category in global market • Drugs w
Slide 29: Agenda
Agenda 1 Commercialization 2 Research & Development 3 Manufacturing Facilities 4 Global Partnerships 5 ORGANIZATION & FUNDRAISE 6 Financial Review 7 Outlook Copyright© 2020 Innovent Biologics 28
Slide 30: Expanded All-Rounded Talent Team
Expanded All-Rounded Talent Team 1,100+ employees Commercialization Fully fledged team in sales, medical affairs, strategy planning and operation functions Team R&D Team 750+ employees ~2,600 employees CMC Team 500+ employees General and Administrative Team ~200 employees Copyright© 2020 Innovent Bi
Slide 31: Executives with a Proven Track Record of Success
Executives with a Proven Track Record of Success Visionary Founder, Chairman and CEO Supported by Experienced Management Team Dr. MICHAEL YU Dr. QINWEI ZHOU RONNIE EDE MIN LIU VIVIAN ZHANG Founder, Chairman & CEO Chief Operating Officer Chief Financial Officer Chief Commercial Officer Chief People O
Slide 32: Senior Management Team with a Proven Track Record of Success
Senior Management Team with a Proven Track Record of Success Visionary Founder, CEO and Chairman Supported by Experienced Management Team Stephen Lau Dongming Wang Amy Que Junjian Liu SVP SVP VP COO Quality (QC & QA) Project Management Biologics Discovery US branch & Strategic Alliances Wei Xu Kaiso
Slide 33: Strong Support from Globally Renowned Investors
Strong Support from Globally Renowned Investors US$485M IPO & US$304M Over US$2.1B in aggregate Follow-On Offering (October 2019) Cornerstone The largest IPO fund raise at the time for pre- revenue biopharmaceutical company US$303M Follow-On Offering (February 2020) Over US$967M follow-on offering T
Slide 34: Included in Various Indices with Improved Capital Markets Recognition
Included in Various Indices with Improved Capital Markets Recognition Innovent 2019: 2020.06: 2020.08: Future Included in MSCI China Remove “B” marker Included in HSCI and a Potential to be and Hang Seng Hong from stock name series of Hang Seng included in the Stock Kong-Listed Biotech indices Conne
Slide 35: Agenda
Agenda 1 Commercialization 2 Research & Development 3 Manufacturing Facilities 4 Global Partnerships 5 Organization & Fundraise 6 FINANCIAL REVIEW 7 Outlook Copyright© 2020 Innovent Biologics 34
Slide 36: Income Statement
Income Statement IFRS Measure Six Months Ended 30 June Revenue RMB'million 2020 2019 Total revenue for the six months ended 30 June 2020 was RMB984 Revenue from contracts with customers 984.2 345.5 million, including RMB921 million attributable to sales of TYVYT® (sintilimab injection). Cost of sa
Slide 37: Income Statement
Income Statement Non-IFRS Measure Six Months Ended 30 June RMB'million 2020 2019 Revenue from contracts with customers 984.2 345.5 Cost of sales (168.8) (36.1) Gross profit（IFRS Measure） 815.4 309.4 Other income 107.4 56.0 Research and development expenses (766.2) (659.9) Administrative and other ex
Slide 38: Balance Sheet
Balance Sheet As of RMB'million 2020.06.30 2019.12.31 Cash balance Bank balances and cash 4,633.3 4,232.6 Other financial assets-current 1,561.1 462.5 As of June 30 2020, our total cash increased to Trade receivables 377.8 247.9 RMB6,194 million. Contract assets 2.3 2.2 As of July 30 2020, our t
Slide 39: Agenda
Agenda 1 Commercialization 2 Research & Development 3 Manufacturing Facilities 4 Global Partnerships 5 Organization & Fundraise 6 Financial Review 7 OUTLOOK Copyright© 2020 Innovent Biologics 38
Slide 40: Key Upcoming Milestones and Catalysts
Key Upcoming Milestones and Catalysts 2H 2020 to Early 2021 1 COMMERICAL SALES GROWTH • Continue to generate revenue growth of TYVYT® (Sintilimab injection) by leveraging the advantage of NRDL • Benefit from launch of BYVASDA®(bevacizumab biosimilar) 2 PRODUCT LAUNCHES • Expected Approval of IBI-303
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 • 3 commercialized • Multiple products • To be a premier global 02 products approved in the biopharmaceutical international m
Slide 42: Innovent: A Leading Platform Company
Innovent: A Leading Platform Company CMC (Manufacturing & Quality) Clinical Development Discovery Commercialization Fully-integrated, Multi-function Platform with World-class Discovery, Development, Manufacturing and Commercialization Capabilities Copyright© 2020 Innovent Biologics 41
Slide 43: Copyright© 2020 Innovent Biologics
Copyright© 2020 Innovent Biologics 42