Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — Investor Presentation (June 2021)
33 slides from Cstone Pharmaceuticals's investor presentation, June 2021
Slide 1: CStone Pharmaceuticals Company Presentation
CSTONE PHARMACEUTICALS (2616.HK) COMPANY PRESENTATION June 2021
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 with it
Slide 3: Table of Contents
Table of Contents 1 Opening Remarks 4 2 Our Achievements in 2020 9 3 2021 Outlook 29 3
Slide 4: Opening Remarks
Opening Remarks 4
Slide 5: To become a world-renowned biopharmaceutical company leading the way to conquering cancer
To become a world-renowned biopharmaceutical company that is leading the way to conquering cancer HKEx listed Full-fledged Biopharma 2616.HK 5 Years Since Company Inception $150M $262M $328M Series A Series B HK IPO Industry-leading (July 2016) (May 2018) (Feb 2019) management team $200M Pfizer stra
Slide 6: Well-balanced oncology portfolio of innovative assets
Well-balanced oncology portfolio of 14 innovative assets Focused on immuno-oncology and precision medicine Lead Indication(s) Dose Drug Candidate Rights Pre-clinical POC Pivotal NDA Partner and Line(s) of Therapies Escalation Pralsetinib 1L / 2L NSCLC, Commercial Mainland China NDA approved (RET) MT
Slide 7: Secured three approvals for our precision medicines
Secured three approvals for our precision medicines Bringing innovative drugs to market with speed and quality 普吉华® 泰吉华® 泰时维® Pralsetinib Avapritinib Avapritinib (RET inhibitor) (KIT/PDGFRA inhibitor) (KIT/PDGFRA inhibitor) 2L RET fusion-positive PDGFRA exon 18 PDGFRA D842V mutant NSCLC mutant GIST
Slide 8: Primary endpoint met for sugemalimab in stage III NSCLC
Primary endpoint met for sugemalimab in stage III NSCLC China NDA filing expected soon, ex-China regulatory discussions planned Strategic Significance Significant unmet need with high incidence • World’s first PD-(L)1 to successfully 2020 stage III NSCLC incidence improve PFS in stage III NSCLC not
Slide 9: Our Achievements in 2020
Our Achievements in 2020 9
Slide 10: 2020: A highly productive year
Overview 2 3 4 5 6 7 2020: A highly productive year Significant objectives achieved across all aspects of our business Filed multiple NDAs for key late-stage assets • Pralsetinib: 2L RET fusion-positive NSCLC (mainland China) • Avapritinib: PDGFRA exon 18 mutant GIST (mainland China / Taiwan) • Suge
Slide 11: Renowned commercial leadership team
1 Commercial 3 4 5 6 7 Renowned commercial leadership team Seasoned leaders with diverse range of experience at multinational biopharmas and innovative biotechs Shirley Zhao Greater China GM, Head of Commercial Operations Sophia Lee Yanchu Lu Zezhou Wang TW & HK Marketing Sales Strong track record w
Slide 12: Full-fledged commercial team established
1 Commercial 3 4 5 6 7 Full-fledged commercial team established Ready to ensure successful launches in 2021 4 Oncology therapeutic areas >300 Provide >400 comprehensive Hospital coverage FTE* coverage ~100 YE2019 YE2020 YE2021 City coverage Comprehensive coverage with a well-established commercial t
Slide 13: Major achievements to deliver on our commercial goals
1 Commercial 3 4 5 6 7 Major achievements to deliver on our commercial goals Focus on branding, patient identification, and market access Patient Market Branding identification access ▪ Product awareness: 94% ▪ Early access program: ▪ Channel capability: partnering Ayvakit recommendation rate to enr
Slide 14: Engagement with partners to maximize I/O asset value
1 Commercial 3 4 5 6 7 Engagement with partners to maximize I/O asset value >300 >2,600 >1,000 Cities with business Hospital Field force in operations coverage China 11 oncology products covering 5 major therapeutic areas Abundant experience in NRDL negotiation ▪ Joint working model: Regular working
Slide 15: Pralsetinib: first-in-class RET inhibitor in China
1 2 Products 4 5 6 7 Pralsetinib: first-in-class RET inhibitor in China CStone’s first approved therapy; multiple NDA filings expected in 2021 2L RET fusion-positive NSCLC 1L RET fusion-positive NSCLC 2L RET fusion-positive NSCLC Mainland China Mainland China Taiwan, China NDA filing planned in 2H 2
Slide 16: Avapritinib: first-in-class KIT/PDGFRA inhibitor in China
1 2 Products 4 5 6 7 Avapritinib: first-in-class KIT/PDGFRA inhibitor in China NDA approvals granted by NMPA and TFDA PDGFRA ex 18 GIST PDGFRA D842V GIST PDGFRA D842V GIST Mainland China Taiwan, China Hong Kong, China Approved Approved NDA accepted in May 2021 Advanced Systemic Mastocytosis Indolent
Slide 17: Ivosidenib: global first-in-class IDH1 inhibitor
1 2 Products 4 5 6 7 Ivosidenib: global first-in-class IDH1 inhibitor No immediate competitor in China; significant indication expansion potential IDH1m R/R AML IC-Ineligible 1L AML Mainland China Mainland China NDA filing and approval expected in 2H 2021 Registrational study ~35,000 newly diagnosed
Slide 18: Sugemalimab: best-in-class anti-PD-L1 mAb (1/2)
1 2 Products 4 5 6 7 Sugemalimab: best-in-class anti-PD-L1 mAb (1/2) First NDA approval expected in 2021 and multiple NDA filings in 2021 / 2022 ■ Outstanding efficacy: • The first PD-L1 in combo with chemo to demonstrate clinical efficacy in both sq and nsq NSCLC patients, reducing the risk of canc
Slide 19: Sugemalimab: best-in-class anti-PD-L1 mAb (2/2)
1 2 Products 4 5 6 7 Sugemalimab: best-in-class anti-PD-L1 mAb (2/2) Outstanding efficacy and safety profile in 1L Stage IV NSCLC Reduction of the Risk of Disease Progression or Death (%) 60 50 PD-1 52 PD-L1 48 50 46 48 44 40 39 40 36 36 29 PD-(L)1 for 1L 30 treatment of 20 Stage IV NSCLC 10 (sq & n
Slide 20: CS1003 (PD-1): Another I/O backbone in registration study
1 2 Products 4 5 6 7 CS1003 (PD-1): Another I/O backbone in registration study Global Ph3 in HCC supported by compelling PoC data ■ Humanized IgG4 anti-PD-1 mAb Asset ■ Recognizes both human & murine PD-1 with unique advantage to evaluate efficacy in overview syngeneic mouse models, esp. for testing
Slide 21: Strategic and multi-dimensional collaboration with Pfizer
1 2 3 BD 5 6 7 Strategic and multi-dimensional collaboration with Pfizer Equity investment: $200mm (at ~HK$13.37 / share) 1 2 3 China commercialization of Co-development of Joint in-licensing of global sugemalimab Pfizer’s assets innovative drugs In addition to the equity investment ▪ Two post proof
Slide 22: Global out-licensing deal with top-notch biotech EQRx
1 2 3 BD 5 6 7 Global out-licensing deal with top-notch biotech EQRx CStone to out-license ex-China rights to EQRx for two key late-stage assets, sugemalimab (PD-L1) and CS1003 (PD-1) ▪ EQRx will lead clinical development and commercialization of these two assets outside of Greater China ▪ CStone to
Slide 23: Pipeline 2.0: CStone-driven innovation model
1 2 3 4 Pipeline 2.0 6 7 Pipeline 2.0: CStone-driven innovation model Primarily focus on global FIC/BIC/FW assets in emerging therapeutic categories I/O (Combo) & Precision Medicine 1 FIC/BIC/FW Examples Idea Generation CStone-Driven Project Design • 2 ADCs, incl. CS5001 Innovation 2 Global rights •
Slide 24: Advancing Pipeline 2.0 development
1 2 3 4 Pipeline 2.0 6 7 Advancing Pipeline 2.0 development Multiple first-in-class / best-in-class molecules ▪ We have secured the global rights to multiple innovative molecules with first-in-class / best-in-class potential ▪ Modular and multi-functional ADCs and multi-specific molecules advance ou
Slide 25: CS5001: Potential first-wave/best-in-class ROR1 ADC
1 2 3 4 Pipeline 2.0 6 7 CS5001: Potential first-wave/best-in-class ROR1 ADC Broad tumor coverage with potentially improved efficacy and reduced toxicity CStone acquired global development & commercialization rights (ex-Korea) Asset Highlights ▪ A potential global first-wave / best-in-class drug wit
Slide 26: CS2006 (PD-L1x4-1BBxHSA): potential BIC 4-1BB agonist
1 2 3 4 Pipeline 2.0 6 7 CS2006 (PD-L1x4-1BBxHSA): potential BIC 4-1BB agonist and next generation PD-(L)1 inhibitor Asset Highlights ▪ A potential best-in-class drug with special design to reduce unwanted toxic effects and improve therapeutic index Next − Unique monovalent 4-1BB binding conditional
Slide 27: State-of-the-art manufacturing facility in construction
1 2 3 4 5 Manufacturing 7 State-of-the-art manufacturing facility in construction Pilot operation expected in 2021 ◼ Manufacturing facility built in collaboration with Sungent (state-owned controlled by Suzhou Industrial Park) ◼ Integrated capabilities for R&D, pilot plant, and full commercial scale
Slide 28: Financial summary for 2020
1 2 3 4 5 6 Financials Financial summary for 2020 • RMB3,383 million of cash, cash equivalents and time deposits as Cash Balance of December 31, 2020 vs. RMB2,726 million as of December 31, 2019 • Equity investment from Pfizer1: RMB1,356 million Sources of Cash • License fee income from EQRx2: RMB1,
Slide 29: 2021 Outlook
2021 Outlook 29
Slide 30: Maintaining significant clinical development momentum
Maintaining significant clinical development momentum 30 clinical trials expected in 2021, including 15 registrational trials ▪ We expect 5 NDA approvals and 5+ NDA submissions in 2021 ▪ Additional assets potentially entering registrational trials, including assets co-developed with Pfizer, CS1002 (
Slide 31: Completing transition to full-fledged biopharma
Completing transition to full-fledged biopharma A full agenda for 2021 to build on last year’s significant achievements Imminent and robust commercialization activity Expect 5 NDA approvals in total, an industry-leading amount 3 approvals for pralsetinib and avapritinib received; 2 others pending Ex
Slide 32: A defined commercialization roadmap beyond 2021
A defined commercialization roadmap beyond 2021 Snapshot of launch roadmap for our current pipeline with expansion potential from the development of new assets Near-term (2021) Mid-term (2022~2025) Longer-term (2026~) Expect 10+ potentially approved products Across 20+ indications1 Avapritinib Prals
Slide 33: Thank you!
dG] 204 ba S tansceunicats Thank you!
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