Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — FY2022 Earnings Presentation
33 slides from Cstone Pharmaceuticals's earnings presentation, Mar 16, 2023
Slide 1: CStone 2022 Annual Results Presentation
CStone 2022 Annual Results Presentation March 16th, 2023 Stock Code: 2616. HK
Slide 2: Presentation Disclaimer
Presentation Disclaimer • By attending the meeting where this presentation is made, or by reading the presentation materials, you agree to be bound by the following: • The information in this presentation has been prepared by representatives of CStone Pharmaceuticals (the "Company" and, together wit
Slide 3: A fully integrated biopharma with end-to-end capabilities
A fully integrated biopharma with end-to-end capabilities 5.5 years from inception to the first commercial launch RESEARCH DEVELOPMENT COMMERCIAL Clinical insight driven Efficient, high-quality and Full capability of in-house modular R&D model innovative clinical dev. engine commercialization 4 comm
Slide 4: Business Achievements
01 Business Achievements 2022 & 2023 YTD 4
Slide 5: 2022 & 2023YTD Achievements
2022 & 2023YTD Achievements A full-fledged biopharma with strong growth momentum in 2022 & 2023YTD Financial Commercialization as of Dec 31, 2022 as of Dec 31, 2022 4 142% Commercialized products Commercial revenue [3] growth Greatly improved coverage RMB Mn 481.4 Mn, RMB 394.1 800+ hospitals Pralse
Slide 6: Pipeline updates
02 Pipeline updates 6
Slide 7: CStone's innovative portfolio covers a broad of indications
CStone’s innovative portfolio covers a broad of indications with rapidly 5,000K+ growing commercial value Global annual incidence[3] 2,000K+ Global annual incidence[2] ~200K China annual incidence[1] Precision Medicine Immuno-oncology Pipeline 2.0 • Pralsetinib • Sugemalimab • CS5001 FIC RET inhibit
Slide 8: Pralsetinib
Precision Medicine (1/3) Pralsetinib FIC RET inhibitor rapidly expanding into new indications and territories Development and Regulatory Progress NDA Approval 2021 2022 2023 2024… ~70K 1L NSCLC Exp. annual newly diagnosed patients with 2L NSCLC RET-altered tumors in China[1] 1L MTC/TC • ORR: 83.3%[4
Slide 9: Avapritinib
Precision Medicine (2/3) Avapritinib FIC KIT/PDGFRA inhibitor with potential to expand to indications beyond GIST Development and Regulatory Progress ~45K PDGFRA GIST KIT 17/18 SM KIT D816V mutant r/r AML Advanced Non-advanced annual newly diagnosed patients with exon 18 mutant (2-4L) PDGFRA exon 18
Slide 10: Ivosidenib
Precision Medicine (3/3) Ivosidenib FIC and the only IDH1 inhibitor approved in mainland China with potential for indication expansions Development Progress ~45K AML CCA annual newly diagnosed patients with R/R[1] 1L IDH1 mutation tumors in China[1] In regulatory Approved In regulatory discussion wi
Slide 11: Sugemalimab (1/3)
Immuno-Oncology (1/4) Sugemalimab (1/3) Significant clinical milestones achieved in the past 12 months, leading to the successful completion of all 5 pivotal trials Sugemalimab clinical development progress ~2021 2022 2023 SIII NSCLC IA - PFS FA - PFS Confirmed PFS benefit GEMSTONE-301 Achieve prima
Slide 12: Sugemalimab (2/3)
Immuno-Oncology (2/4) Sugemalimab (2/3) Expanding into global markets to maximize sugemalimab’s asset value 2021 2022 2023 2024… SIV NSCLC R/R ENKTL ESCC R/R ENKRL ESCC CN SIII NSCLC GC/GEJC GC/GEJC SIV NSCLC SIV NSCLC UK Potential total UK and EU market MAA acceptance by MHRA value of $10-15 billio
Slide 13: Sugemalimab (3/3) The Grand Slam Journey
Immuno-Oncology (3/4) Sugemalimab (3/3) ➢ 100% completion on all 5 registrational studies ➢ Commercial launch The Grand Slam Journey in 1L NSCLC ➢ Ex-China launch ➢ World’s 1st success of PDL1 in R/R ENKTL and GC GEMSTONE-304 (EC) positive TLR Two Lancet Oncology MAA acceptance by publications EMA (
Slide 14: Nofazinlimab (PD-1)
Immuno-Oncology (4/4) Nofazinlimab (PD-1) Global registrational study of nofazinlimab + lenvatinib for 1L HCC, with topline readout expected in Q4/23 or Q1/24 Development Progress Front Runner Global phase III trial design approved by regulatory agencies including China NMPA, US FDA and EMA • Potent
Slide 15: CS5001 (ROR1 ADC) (1/2)
Pipeline 2.0 (1/4) CS5001 (ROR1 ADC) (1/2) Potential global BIC asset with FIH study commenced in US, Australia and China Leading Position: One of the Top 3 Globally Dose finding study ongoing Translational study results Accelerated registration pathways Well tolerated safety and expected PK profile
Slide 16: CS5001 (ROR1 ADC) (2/2)
Pipeline 2.0 (2/4) CS5001 (ROR1 ADC) (2/2) Outstanding pre-clinical data in both solid and hematological cancers Data Highlights • Given as a single dose in MCL (mantle cell lymphoma) xenograft models, CS5001 showed superior efficacy than the benchmark MMAE-based ROR1 ADC at a higher and more freque
Slide 17: CS2006 (PD-L1 x 4-1BB x HSA)
Pipeline 2.0 (3/4) CS2006 (PD-L1 x 4-1BB x HSA) Potential BIC 4-1BB agonist and next generation PD-(L)1 inhibitor, initiated PoC study in 2H2022 Development Progress Next Generation PD-(L)1 Ph Ia Ph Ib Partner with • Global FIH dose escalation completed • PoC expansion cohorts in selected tumor type
Slide 18: New research strategy yields 10+ discovery projects
Pipeline 2.0 (4/4) New research strategy yields 10+ discovery projects Solid progress on multiple projects with the “plug-and-play” research model Multiple potential FIC/BIC discovery programs are at/near PCC CS2007 CS6001 EX001 PD-L1 x VEGF x another IO target Immuno-cytokine Cell Penetrating Thera
Slide 19: Financial Highlights
03 Financial Highlights 19
Slide 20: 2022 Financial Results
2022 Financial Results Significantly lower operating loss on strong revenue growth and stringent cost control Mn RMB 2022 2021 Change Total Group Revenues up 98% to RMB 481.4Mn GROUP REVENUES 481.4 243.7 +98% • Commercial Revenue up 142% to RMB 394.1Mn (2021: RMB 162.8Mn) • License Fee Income up 8%
Slide 21: Growth Strategy
04 Growth Strategy 21
Slide 22: Strategic Objectives
Strategic Objectives Drive rapid revenue growth to overall profitability Expend to overseas markets to realize the full value of pipeline Maximize shareholder value 22
Slide 23: Clinical-centric Business Model
Strategy (1/3) Clinical-centric Business Model China Commercialization by Internal Team / Partners Clinical Multiple Sourcing Strategy to Build RD Pipeline Development Engine Global Commercialization through Partnership To leverage our industry-leading Clinical Development Capability to bring Innova
Slide 24: Clinical development engine
Clinical development engine Industry-leading team led by veteran leaders with track record • A senior executive and physician scientist with 25+ years biomedical research and biopharma Jason Yang, MD, PhD R&D experience in oncology Chief Executive Officer • Led 60+ global and China trials, brought o
Slide 25: Clinical development excellence: Strategy, Design, Speed and Quality
Clinical development excellence: Strategy, Design, Speed and Quality 1 3 yrs 50+ PD-L1 trial to cover both sq and nsq PD-L1 ph I FIH to first NDA approval site audit conducted by global S-IV NSCLC in S-IV NSCLC partners with 0 critical finding 1 2.8 yrs 6 PD-L1 trial to cover both concurrent From li
Slide 26: Continue to forge partnerships to expand pipelines
Strategy (2/3) Continue to forge partnerships to expand pipelines and maximize commercial value globally CStone is well positioned as the Partner of Choice in both the East and West + ➢ Bringing in post-POC Assets to develop for ➢ Licensing out late-stage/commercial Assets to greater China markets,
Slide 27: Efficient internal salesforce deployment complemented by partners
Strategy (3/3) Efficient internal salesforce deployment complemented by partners Cost-effective coverage to achieve commercial breakeven and overall profitability Strategic coverage and industry-leading productivity by CStone’s internal commercial team >800 75~80% ~2.5 Mn RMB[2] Hospitals coverage P
Slide 28: 2023 Catalysts
05 2023 Catalysts 28
Slide 29: Expected Catalysts in 2023
Expected Catalysts in 2023 Assets Catalysts Date Pralsetinib (RET) Marketed NDA approval for 1L RET+ NSCLC in mainland China H1 2023 Avapritinib (KIT/PDGFRA) Marketed NDA approval for non-advanced SM in US May 2023 Ivosidenib (IDH1) Marketed MAA approval in EU 2023 Lorlatinib (ROS1) In pivotal trial
Slide 30: Thanks
Thanks 30
Slide 31: Appendix
Appendix 31. (BE)
Slide 32: Industry leading management team
Industry leading management team Proven track record, oncology focus and complementary expertise Jason Yang Archie Tse Josh Zhou Michael Choi MD, PhD MD, PhD MD MBA Chief Executive Officer Chief Scientific Officer Greater China GM Chief Business Officer Yinghua Zhang Qingmei Shi Jun Cheng Nicky Ni,
Slide 33: END
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CStone Pharmaceuticals — FY2022 Earnings Presentation on 6ix