Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — H1 2023 Earnings Presentation
26 slides from Cstone Pharmaceuticals's earnings presentation, Aug 16, 2023
Slide 1: 2023 Interim Results Presentation
2023 Interim Results Presentation August 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 2023YTD 4
Slide 5: 2023YTD Achievements
2023YTD Achievements A full-fledged biopharma with strong growth momentum in 2023YTD Financial Research & Development as of June 30, 2023 as of Aug 15, 2023 2 NDA approvals 5 NDAs currently under review Total revenue in 1H 2023 R/R ENKTL 261.5 1L NSCLC 1L GC/GEJC RMB Mn (Flat YoY) Pralsetinib Sugema
Slide 6: Pipeline Updates
02 Pipeline Updates 6
Slide 7: Pioneering Revolutionary Treatments Addressing Critical Unmet Needs
Pioneering Revolutionary Treatments Addressing Critical Unmet Needs Commercial-stage Key Clinical Program Other Programs Programs Significant value driver Pralsetinib (RET) with leading position globally (Top 2 in position / Avapritinib CS1003 best-in-class potential) (PD-1; Global PhIII) (KIT/PDGFR
Slide 8: CS5001 (ROR1 ADC) (1/3)
Key Clinical Program (1/3) CS5001 (ROR1 ADC) (1/3) Top 2 in position globally with Ph1 study ongoing in US, Australia and China 4 key differentiators support best-in-class potential: An ADC target for both hematological malignancies 2 and solid tumors 3 4 • Largely absent in normal blood lymphocytes
Slide 9: CS5001 (ROR1 ADC) (2/3)
Key Clinical Program (2/3) CS5001 (ROR1 ADC) (2/3) Outstanding pre-clinical data in both solid and hematological cancers Data Highlights 1• 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 mo
Slide 10: CS5001 (ROR1 ADC) (3/3)
Key Clinical Program (3/3) CS5001 (ROR1 ADC) (3/3) Dose finding Ph1 study ongoing in US, Australia and China Development Progress March 2023 Translational study results presented at World ADC Conference April 2023 Global multi-regional Ph1 trial expanded to include China Registration planned for 202
Slide 11: Pralsetinib
Commercial-stage Programs (1/4) Pralsetinib FIC RET inhibitor supplemental NDA approval for 1L NSCLC in mainland China in 1H 2023 Development and Regulatory Progress NDA Approval 2021 2022 2023 ~70K 1L NSCLC Manufacturing Tech Transfer to annual newly diagnosed patients with 2L NSCLC China Underway
Slide 12: Avapritinib
Commercial-stage Programs (2/4) Avapritinib FIC KIT/PDGFRA inhibitor with potential to expand to indications beyond PDGFRA exon 18 GIST Development and Regulatory Progress ~45K PDGFRA GIST KIT 17/18 SM KIT D816 or N822 mutant r/r AML Advanced Non-advanced annual newly diagnosed patients with exon 18
Slide 13: Ivosidenib
Commercial-stage Programs (3/4) Ivosidenib FIC and the only IDH1 inhibitor approved in mainland China with potential for indication expansion Development and Regulatory Progress ~45K AML CCA annual newly diagnosed patients with R/R[1] 1L IDH1 mutation tumors in China[1] In regulatory Approved In reg
Slide 14: Sugemalimab
Commercial-stage Programs (4/4) Sugemalimab Expanding into global markets to maximize sugemalimab’s asset value, in active discussion with global partners 2021 2022 2023 2024… Stage IV NSCLC R/R ENKTL ESCC R/R ENKTL ESCC CN Stage III NSCLC GC/GEJC GC/GEJC Stage IV NSCLC Stage IV NSCLC UK Potential t
Slide 15: Nofazinlimab (PD-1)
Other Programs (1/2) Nofazinlimab (PD-1) Global registrational study of nofazinlimab + lenvatinib for 1L HCC, with topline readout expected in Q1 2024 Development Progress Front Runner Global phase III trial design approved by regulatory agencies including China NMPA, US FDA and EMA • Potentially th
Slide 16: New Research Strategy Yields 10+ Discovery Projects
Other Programs (2/2) New Research Strategy Yields 10+ Discovery Projects Solid progress on multiple projects, seeking partnership opportunities Multiple potential FIC/BIC discovery programs are at/near PCC CS2009 ADCs EX001 PD-1 x VEGF x another IO target CS5006 Cell Penetrating Therapeutic Platform
Slide 17: CStone's Innovative Portfolio Covers a Broad Range 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 (commercial) • Sugemalimab (commercial
Slide 18: Financial Highlights
03 Financial Highlights 18
Slide 19: 1H 2023 Financial Results
1H 2023 Financial Results Significantly lower operating loss on strong product sales +53% and stringent cost control Mn RMB 1H 2023 1H 2022 Change GROUP REVENUES 261.5 261.8 0% Total Group Revenues of RMB 261.5Mn • Sales of Pharmaceutical Products +53% to RMB 246.9Mn Sales of Pharmaceutical Products
Slide 20: Catalysts
04 Catalysts 20
Slide 21: Expected Catalysts for the Next 12 Months
Expected Catalysts for the Next 12 Months Assets Catalysts Date Sugemalimab (PD-L1) Marketed NDA approval for R/R ENKTL in mainland China By the end of 2023 MAA approval for 1L stage IV NSCLC in EU 1H 2024 MAA approval for 1L stage IV NSCLC in UK 1H 2024 NDA approval for 1L GC/GEJ in mainland China
Slide 22: Thanks
Thanks 22
Slide 23: Appendix
Appendix 23 [HEI
Slide 24: Well-balanced Oncology Portfolio of 14 Innovative Assets
Well-balanced Oncology Portfolio of 14 Innovative Assets Pre- Approval Drug candidate Rights Indication FIH POC Pivotal NDA Marketed Partner clinical CN TW HK US 2L NSCLC 1L NSCLC Pralsetinib (RET) 1L MTC / TC Multiple tumors PDGFRA exon 18 GIST Avapritinib (KIT/PDGFRA) SM1 R/R AML Ivosidenib (IDH1)
Slide 25: Industry Leading Management Team
Industry Leading Management Team Proven track record, oncology focus and complementary expertise Jason Yang MD, PhD Chief Executive Officer Archie Tse Josh Zhou Michael Choi Yinghua Zhang MD, PhD MD MBA Chief Scientific Officer Greater China GM Chief Business Officer SVP, Operations Qingmei Shi Jun
Slide 26: END
END 26
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