Hutchmed (china) Limited · HKEX:13

Hutchmed (china) — Hutchison China MediTech (Chi-Med) — Investor Presentation (January 2020)

117 slides from Hutchmed (china)'s investor presentation, January 2020

  1. Slide 1: Corporate Presentation

    Corporate Presentation January 2020 AIM/Nasdaq: HCM

  2. Slide 2: Safe harbor statement & disclaimer

    Safe harbor statement & disclaimer The performance and results of operations of the Chi-Med Group contained within this presentation are historical in nature, and past performance is no guarantee of future results. This presentation contains forward-looking statements within the meaning of the “safe

  3. Slide 3: Agenda

    Agenda 1 Company Overview P4 2 Operating Highlights P12 3 Financial Highlights, Cash & Guidance P44 4 Summary P47 5 Appendix P52 3

  4. Slide 4: Company Overview

    1 Company Overview

  5. Slide 5: Building a global science-focused biopharma company from an established base in China

    Building a global science-focused biopharma company from an established base in China… Global Innovation  5 clinical drug candidates in US/EU development  Building global clinical development footprint  World-class ~500-person scientific team China Oncology  Major market potential driven by regu

  6. Slide 6: Proven innovation & commercial operations

    Proven innovation & commercial operations Industry / Chi-Med Management Team (years) Integrated Innovation Organization [1] Mr. CHRISTIAN HOGG, BSc, MBA US Office 30 / 19 Analytical 3% Medicinal Chief Executive Officer Chem. 11% Chem. 8% Dr. WEIGUO SU, PhD Pharmacology 4% 29 / 14 Process EVP, Chief

  7. Slide 7: Portfolio summary

    Portfolio summary Multiple waves of innovation – progressing rapidly Dose Finding / Proof-of-Concept Registration Intent Marketed Safety Run-In Fruquintinib + Tyvyt (PD-1) Savolitinib Savo + Tagrisso (SAVANNAH) Elunate (Fruquintinib capsules) Solid Tumors [1] MET Exon 14 deletion NSCLC 2L/3L Tagriss

  8. Slide 8: Potential 2020 upcoming events

    Potential 2020 upcoming events 2019 H1-20 H2-20 Savo + Imfinzi® Savo Savo + Imfinzi® Savo + Tagrisso® Savo NSCLC + RCC + GC Papillary RCC (CALYPSO) 2L gastric (VIKTORY) Papillary RCC (CALYPSO) NSCLC (SAVANNAH) Anticipate further Ph. II Interim Data Ph. II Data Ph. II Data Update Ph.II Interim* Ph.II

  9. Slide 9: Global clinical drug portfolio (1/2)

    Global clinical drug portfolio (1/2) Savolitinib (c-MET) Fruquintinib (VEGFR1/2/3) Potential First-in-class small molecule selective MET inhibitor Potential Best-in-class small molecule selective VEGFR 1/2/3 inhibitor Indications: MET-driven NSCLC; RCC; Gastric; Prostate cancer Indications: Colorect

  10. Slide 10: Global clinical drug portfolio (2/2)

    Global clinical drug portfolio (2/2) Surufatinib (VEGFR, FGFR1, CSF-1R) HMPL-523 (Syk) HMPL-689 (PI3Kδ) Potential First-in-class small molecule Potential Best-in-class small molecule Unique small molecule VEGFR 1/2/3, FGFR1 & CSF-1R inhibitor selective Syk inhibitor selective PI3Kδ inhibitor Neuroen

  11. Slide 11: Important milestones in Chi-Med's evolution

    Important milestones in Chi-Med’s evolution Innovation Discovery China Registr. & China Launches & Start-up & M&A Platform Global Early Dev. Expanding Global Registration 2000 - 2005 2006 - 2010 2011 - 2016 2017 - 2018 2019 2017 NSCLC PoC data WCLC Savo + Tagrisso® Global license deal savo. + Tagris

  12. Slide 12: Recent Operating Highlights

    2 Recent Operating Highlights

  13. Slide 13: Recent Operating Highlights

    Recent Operating Highlights Savolitinib  Reached enrollment goal on Phase II registration study – MET Exon 14 deletion NSCLC;  AstraZeneca collaboration leading global position in EGFR-TKI resistant NSCLC;  Emerging signal for savolitinib/Imfinzi® (PD-L1) combo – renal cell carcinoma. Surufatinib

  14. Slide 14: Other Recent Operating Highlights

    Other Recent Operating Highlights B-cell malignancies / non-Hodgkin’s lymphoma  HMPL-523 (Syk) – >150 patients dosed in China/Australia Phase I/Ib; to guide registration strategy in late 2019;  HMPL-689 (PI3Kδ) – Phase II dose selected in China & expansion underway;  US/EU Phase I 1st patient dos

  15. Slide 15: AstraZeneca and Chi-Med: Savolitinib

    AstraZeneca and Chi-Med Harnessing the power of Chinese Innovation  Savolitinib 2a

  16. Slide 16: Savolitinib: Biggest opportunity is MET+ NSCLC

    Savolitinib Biggest opportunity is MET+ NSCLC Primary NSCLC Resistance-driven EGFRm+ NSCLC All Iressa/Tarceva patients relapse Median PFS 9-10 months. 1.8 million NSCLC patients per year MET+ MET+ ~6% Other ~10% Other EGFRm (T790M-) MET+ / ~30% T790M+ MET+ SCLC/ ~6% ~30% Unknown Unknown Unknown 1st

  17. Slide 17: Savolitinib – MET Exon 14 deletion NSCLC

    Savolitinib – MET Exon 14 deletion NSCLC [1] Potential China NDA submission in 2020 [2] 4. Encouraging MET Exon14d NSCLC Brain MRI …8 weeks later …32 weeks later study China data at AACR 2019 [3] before treatment… on savolitinib… on savolitinib… 41 pts; 31 pts efficacy evaluable. Promising antitumor

  18. Slide 18: Tagrisso + savo in EGFR TKI refractory NSCLC

    Tagrisso® + savo in EGFR TKI refractory NSCLC TATTON B & D data – efficacy TATTON Part B TATTON Part D osimertinib 80 mg osimertinib 80 mg + savolitinib 600 mg [1] + savolitinib 300 mg Part B1 (n=69) Part B2 (n=51) Part B3 (n=18) Part D (n=36) Prior third-generation No prior third-generation No prio

  19. Slide 19: TATTON B & D data – ORR

    TATTON B & D data – ORR Tagrisso® + savolitinib in EGFR TKI refractory NSCLC 100 100 Part B2 – savolitinib 600 mg [1] Part D – savolitinib 300 mg 75 75 No prior third-generation EGFR-TKI, T790M negative No prior third-generation EGFR-TKI, T790M negative Best percentage change from baseline in target

  20. Slide 20: TATTON B & D data – PFS

    TATTON B & D data – PFS Tagrisso® + savolitinib in EGFR TKI refractory NSCLC 1.0 Median (range) duration Median PFS, of follow-up in censored 0.9 months [95% CI] patients, months 0.8 Part B1 0.7 Prior third-generation EGFR-TKI; 5.4 [4.1, 8.0] 2.6 [0.0–27.3] progression-free survival 0.6 (600 mg [1]

  21. Slide 21: TATTON B & D data – AEs & tolerability

    Tagrisso® + savo in EGFR TKI refractory NSCLC TATTON B & D data – AEs & tolerability Event, n (%) All Part B (n=138) Part D (n=42) osimertinib 80 mg osimertinib 80 mg + savolitinib 600 mg [1] + savolitinib 300 mg [1] Any AE 135 (98) 39 (93) Any AE possibly related to savolitinib 115 (83) 25 (60) AE

  22. Slide 22: TATTON B & D data – AEs & SAEs

    TATTON B & D data – AEs & SAEs Most common AEs[1] independent of causality & SAEs (≥3%)[2] All Part B (n=138) Part D (n=42) All Part B (n=138) Part D (n=42) AE*, n (%) AE*, n (%) All grades Grade ≥3 All grades Grade ≥3 All grades Grade ≥3 All grades Grade ≥3 Nausea 67 (49%) 4 (3%) 13 (31%) 0 Rash 26

  23. Slide 23: SAVANNAH – global registration intent study

    Tagrisso® + savo in EGFR TKI refractory NSCLC SAVANNAH – global registration intent study Addressing resistance with combinations SAVANNAH (NCT03778229) 1st Line Metastatic 2nd Line+ Metastatic  Phase II single-arm study:  Global – N. & S. America, Eur., & Asia. AURA3  Primary endpoint ORR. IPASS

  24. Slide 24: Savolitinib in papillary RCC

    Savolitinib in papillary RCC Important data planned at ASCO 1. Could MET + PD-L1 inhibition be synergistic? 3. PD-1/PD-L1s important in non-ccRCC but need to see mature mPFS/mOS & further biomarker analysis [1] Synergistic benefit TT + IO Savo mono. Survival (%) MET+ All lines: (n=44) Additive benef

  25. Slide 25: Surufatinib: angio-immuno kinase inhibitor

    Tumor-associated macrophages Mechanism of Action ` Anti-angiogenesis: cut off blood flow to tumor (VEGFR/FGFR). Immunotherapy: inhibit T-cells expression of tumor- associated macrophages which cloak cancer cells from T-cell attack (CSF-1R). Angiogenesis  Surufatinib: angio-immuno kinase inhibitor 2

  26. Slide 26: Surufatinib

    Surufatinib Potentially our first un-partnered oncology drug launch Two Phase III neuroendocrine tumor (“NET”) registration studies...  25 China sites. SANET-ep Surufatinib Non-pancreatic NET  Met all efficacy endpoints  1° endpoint: median PFS. (Actual N=198) R 2:1 Placebo  Well tolerated  2°

  27. Slide 27: Surufatinib – China NET

    Surufatinib – China NET Non-Pancreatic NET estimated to represent ~80% of China NET Epidemiology – China NET & BTC patient populations Potential Annual Estimated NRDL Pricing First suru Incidence Prevalence mPFS References monotherapy China NET 100% 67,600 ~300,000 indication Non- (Est. China ratio[

  28. Slide 28: Surufatinib – China NET

    Surufatinib – China NET NET potential ~$100-120m/yr. – under treated/diagnosed Competitive landscape – China NET treatments [1] Brand Indication/s Launched 2017 2018 Q1-2019 SUTENT® Pancr. NET 2007 Sales (US$ million) 27 24 7 (sunitinib – VEGFR) (& GIST/RCC) NRDL Pfizer List Price (US$/month) 4,455

  29. Slide 29: Surufatinib: Overview of NET

    Surufatinib Overview of NET – ~170,000 patients in the U.S. [1][2][3]  What are neuroendocrine tumors (“NET”)? NET growth – better diagnosis  ~2% of all malignancies. Incidence per 100 000 for All Malignant Neoplasms Incidence per 100 000 for Neuroendocrine Tumors  Tumor begins in the specialized

  30. Slide 30: High-level NET landscape

    High-level NET landscape Long-term disease – rapid deterioration in later stages [1][2][3] Grade 1 (G1) NET G1/2 – Advanced NET G3 – NET/NEC Localized / Regional Regional / Distant Distant ~8-35% NET patients – Somatostatin Analogue ~60% NET patients – first No approved Functional NET – Treatment –

  31. Slide 31: G1/2 Advanced NET

    G1/2 Advanced NET [1] (Ki-67 Index 0-20) Global opportunity in lung/other NETs & China wide-open Site Site 177177 est.est. % % Octreotide Octreotide Lanreotide Lanreotide Lu-Dotatate Lu-Dotatate Streptozocin Streptozocin Sunitinib Sunitinib Everolimus Everolimus Surufatinib Surufatinib Progressed Pr

  32. Slide 32: SANET-ep vs. RADIANT-4 – cannot compare

    SANET-ep vs. RADIANT-4 – cannot compare SANET-ep broader range of tumor origins & later-stage patients Asia/China SANET-ep U.S. RADIANT-4 Extra- (n=198) Extra- (n=302) SANET-ep Enrolled more pts with poor prognosis. Pancreatic (surufatinib vs Pancreatic (everolimus vs placebo) placebo) Survival Rate

  33. Slide 33: G1/2 Advanced extra-pancreatic NET

    G1/2 Advanced extra-pancreatic NET Investigator assessed median PFS SANET-ep [1] (n=198) RADIANT-4 [2] (n=302) Surufatinib: 9.2 months (95% CI 7.4, 11.1) Everolimus: 14.0 months (95% CI, 11.24-17.71) 1.0 Placebo: 3.8 months (95% CI 3.7, 5.7) 1.0 Placebo: 5.5 months (95% CI, 3.71-7.39) HR[3] = 0.334

  34. Slide 34: Very different mechanism of action

    Very different mechanism of action Everolimus inhibits mTOR and blocks the effects Surufatinib inhibits VEGFR1/2/3 and FGFR1 blocking caused by the loss of certain genes thereby vascular cell growth and angiogenesis; as well as reducing cell growth, proliferation, CSF-1R which limits the production

  35. Slide 35: Surufatinib efficacy post everolimus failure

    Surufatinib efficacy post everolimus failure U.S. Phase Ib (n=15) – pNET duration of treatment PR Confirmed PR (n=2) 12 3.1 uPR Unconfirmed PR (n=2) 2 4.8 Treatment ongoing (n=9) 3 3.7 PR X Rx stop – AE (n=2) X Rx stop – PD (n=4) 18 4.1 X 7 5.4 surufatinib 4 6.4 X uPR everolimus 2 6.4 PR Other Tx 6

  36. Slide 36: Surufatinib: Life cycle indications & other ongoing trials

    Surufatinib Life cycle indications & other ongoing trials Phase IIb/III study in 2L BTC  First patient dosed in March 2019;  Nearly all planned sites now activated;  Interim analysis mid-2020, based on first 80 patients;  Total enrollment ~300 patients. PD-1 collaborations  With Junshi (Tuoyi®)

  37. Slide 37: Elunate (fruquintinib capsules)

     2c Elunate® (fruquintinib capsules)

  38. Slide 38: NRDL – highly competitive price

    NRDL – highly competitive price Epidemiology Launch pricing [3] National Reimbursed Drug List (NRDL) China Annual Incidence Launch pricing (OOP [4]) 2019 NRDL released by China’s National Healthcare 380,000 patients [1] ~US$ 3,260 per cycle Security Administration (“NHSA”) (RMB 21,966 per cycle) ● A

  39. Slide 39: H1 2019 performance

    H1 2019 performance Elunate® Performance Sales (millions) [1] Total Cycles (OOP&PAP) [2] Chi-Med Revenue (US$ million) 12 8,000 H2-2018 H1-2019 10 $11.4 Manufacturing [3] $3.3m $3.0m (RMB 77.1) 6,000 ~6,850 Royalty 0.3 1.7 8 Total HCM Revenue 3.6 4.7 6 4,000 4 2,000 2 $1.7 ~680 (RMB 12.0) 0 0 H2-201

  40. Slide 40: China VEGFR landscape

    China VEGFR landscape Competitive landscape – small molecule VEGFR TKIs Brand Indication/s Launch 2011 2012 2013 2014 2015 2016 2017 2018 Q1-2019 STIVARGA® 3L CRC /2L GIST May 2017 Sales (US$ million) [1] 5 21 20 (regorafenib) 2L HCC Mar 2018 NRDL List Price (US$/mo.) 4,368 2,352 Bayer AG Oct-18 NEX

  41. Slide 41: Elunate Efficacy advantage

    Elunate® Efficacy advantage FRESCO [1] CONCUR CONCUR CORRECT Third-Line Metastatic Colorectal cancer Chinese Patients (Mainland China, Mainland China, Hong Kong, Mainland China Global Hong Kong, Taiwan) [2] Taiwan, Vietnam, South Korea Treatment arms Elunate® Placebo Stivarga® Placebo Stivarga® Plac

  42. Slide 42: Toxicity limitations of Stivarga

    Toxicity limitations of Stivarga® BIOCHEMICAL ACTIVITY IC50 (nmol/L) IC50 (nmol/L) FRESCO Study CONCUR Study On-Target Kinases: 3rd-Line Metastatic Colorectal cancer Mainland China [1] (Mainland China, HK, Taiwan) [2] VEGFR1 VEGFR2 33 35 13 4.2 Treatment arms Elunate® Placebo Stivarga® Placebo VEGFR

  43. Slide 43: Life cycle indications

    Life cycle indications Phase III in 2L gastric cancer (FRUTIGA)  Second interim analysis by IDMC expected mid 2020;  On track to complete enrollment H2 2020. PD-1 collaborations  With Innovent (Tyvyt®): dose/regimen finding ongoing;  With Genor (genolimzumab): dose escalation ongoing; Phase II i

  44. Slide 44: H1 2019 Financial Results, Cash & Guidance

    3 H1 2019 Financial Results, Cash & Guidance

  45. Slide 45: H1 2019 Financial results

    H1 2019 Financial results R&D expense accelerated to $74.5m in first 6 months at CER [2] 2018 H1-18 H1-19 Growth (Non-GAAP) GROUP REVENUES 214.1 102.2 102.2 - +5% Global Unconsolidated JV Revenues 491.5 271.7 276.9 +2% +8% Innovation SEGMENT NET INCOME/(LOSS) [1] INNOVATION PLATFORM (102.4) (52.9) (

  46. Slide 46: Cash position & 2019 Guidance

    Cash position & 2019 Guidance $384 million in available cash resources [1] Cash Position (at end June 2019) (US$ millions) 2019 Guidance  $237 million cash / Research & (130) – (170) cash equiv. / Short Global Development Expenses term inv. [2] Innovation Adj. (non-GAAP) Group (90) – (120)  $147 m

  47. Slide 47: Summary

    4 Summary

  48. Slide 48: What is next from discovery?

    What is next from discovery? Differentiated assets against multiple targets Priming & activations Anti-angiogenesis  aOX40  VEGFR (fruquintinib)  VEGFR/FGFR (surufatinib)  4-1BB  FGFR (HMPL-453) Antigen release Negative regulators  Treg (HMPL-689)  MET (savolitinib)  CSF-1R (surufatinib)  E

  49. Slide 49: 2020 Summary

    2020 Summary Potential for break-out year  Chi-Med’s first unpartnered oncology drug launch Suru Launch  Oncology commercial team ~300-350 reps by mid-2020  Submit 1st NDA (Exon14 NSCLC)  SAVOIR PRCC Savo Breakout data & strategy  SAVANNAH (w/Tagrisso®) interim  NRDL Jan 2020 – broad China acc

  50. Slide 50: Thank you

    CHI- HUTCHISON CHINA MEDITECH Thank you

  51. Slide 51: Appendix

    Appendix A1 Strategies Global Innovation P53 China Oncology Opportunities P60 Existing China Business P66 A2 Product Candidate Details P72 A3 Further Corporate Information P108 51

  52. Slide 52: Strategies – Global Innovation

     Strategies – Global Innovation A1a Pushing the envelope on our most valuable assets

  53. Slide 53: One of China's largest & most established discovery platforms in oncology

    One of China’s largest & most established discovery platforms in oncology Global step-change innovation  Aiming for multiple potential first-in-class assets Kinase selectivity – enable combos  Limit off-target toxicity & address TKI resistance Discovery of broad range of assets against novel targe

  54. Slide 54: Attack cancer from multiple angles at same time

    Attack cancer from multiple angles at same time Immune Desert Excluded Infiltrate Insufficient T cell response Inadequate T cell homing  Chemotherapies  Anti-angiogenics  Vaccines  Stromal targets  CAR-T (pro-inflammatory  Chemokines strategies)  Vaccines  TCB’s Antigen Release Inflamed Aber

  55. Slide 55: Our advanced medicinal chemistry provides superior selectivity & safety profiles

    Our advanced medicinal chemistry provides superior selectivity & safety profiles… C-MET (Wild-type & mutants) VEGFR 1/2/3 PAK3 Savolitinib ~1,000 times ~250 times more selective to c-MET more selective to than next kinase (PAK3) [5] VEGFR3 than next non- VEGFR kinase (Ret) [6] Screening at >90% inhi

  56. Slide 56: Superior safety allows for combinations

    Superior safety allows for combinations TKI + TKI combos to address acquired resistance RESULTS:CANDIDATE RESULTS: CANDIDATEACQUIRED ACQUIREDRESISTANCE RESISTANCEMECHANISMS MECHANISMSWITH WITH OSIMERTINIB (n=91)* R OSIMERTINIB (n=91)* • No • Noevidence ofacquired evidence of acquired EGFR EGFR T790M

  57. Slide 57: 5 assets in global development

    5 assets in global development …US/EU clinical & regulatory team fully operational Program Treatment Indication Target patient Study name Sites Dose finding / safety run-in Proof-of-concept Registration ® ® Savolitinib + Tagrisso NSCLC 2L/3L EGFRm; Tagrisso ref.; MET+ SAVANNAH Global Oxnard/Ahn – DF

  58. Slide 58: Global Innovation: Main targets for 2020-2021

    Global Innovation Main targets for 2020-2021  Aim for Savolitinib / Tagrisso® combo NDA submission  Build out US/EU development operation  US/EU C&R operation set up in Florham Park, NJ  Accelerate development of 4 un-partnered global assets  Fruq (ex-China) & suru registration studies & explor

  59. Slide 59: Strategies – China Oncology

     Strategies – China Oncology A1b Next-gen oncology drugs to meet major needs in China

  60. Slide 60: China oncology – ~24% of world's cancer patients

    China oncology – ~24% of world’s cancer patients[1] Industry’s attention turning to unmet medical need in China oncology  Regulatory reforms in China – addressing low SoC [2]  Major investment inflow Chi-Med is a first mover  Elunate® launch in 3L mCRC; First ever in China [3]  Deep pipeline – 8

  61. Slide 61: China now world's 2nd largest pharma market

    China now world’s 2nd largest pharma market …investment, approvals & access all accelerating rapidly Per Capita Healthcare Spending PRC Pharmaceutical Market Size Medical Insurance Coverage [1] (US$ billions) 7% CAGR Million people (2018-2023E) 317 Urban employees with 8% CAGR 328 USA 287 307 Full a

  62. Slide 62: Cancer is a major unmet need in China

    Cancer is a major unmet need in China …investments in launches/access starting to have an impact Cancer Incidence in China (2018) Novel drugs post NRDL inclusion China 4,285 U.S. 1,735 (Bar Chart US$ millions) India 1,157 Japan 883 Germany 609 Price per cycle: US$4,505 -66% US$1,538 (RMB10,364) Braz

  63. Slide 63: Assets in China development

    8 assets in China development …fruq launched – savo/suru NDAs & Syk/PI3Kδ PoC ahead Program Treatment Indication Target patient Study name Sites Dose find / safety run-in Proof-of-concept Registration Enrolled Savolitinib NSCLC MET Exon 14 deletion China Lu Shun – SH Chest Hosp. n >70 Savolitinib Sa

  64. Slide 64: China Oncology: Main targets for 2019-2021

    China Oncology Main targets for 2019-2021  Establish Elunate® as the best-in-class VEGFR TKI in China market  Work with Lilly to maximize penetration & sales performance;  Aggressively expand PD-1 combination collaborations & broader LCI program  Launch our un-partnered oncology drugs  Target s

  65. Slide 65: Strategies – Existing China Business

     Strategies – Existing China Business A1c Cash generation & China commercial know-how / infrastructure

  66. Slide 66: Existing China business

    Existing China business Chi-Med spent 17 years building China commercial presence  Valuable know-how in operating within the complex medical system in China  Clear operating synergies with our novel oncology assets  China operations/JVs have generated >$210 million dividends since inception China

  67. Slide 67: Chi-Med's Commercial Platform in China

    Chi-Med’s Commercial Platform in China Integrated platform built from ground up 2 National House- Major Commercial Leadership JVs with 3 Major Hold Name Brands & Production Scale Market Shares China Pharmas >2,400 Rx & ~900 OTC sales Market leader in the sub- people in over 330 [1] cities & categori

  68. Slide 68: Established Rx Commercial Platform in Mainland China

    Established Rx Commercial Platform in Mainland China… Chi-Med management run all day-to-day operations  National Coverage: Over 330 cities & towns. NORTH ~24,400 hospitals. ~88,400 doctors. >2,400 Rx Pop’n: 320m (23%) CV Medical Reps: 585 (25%)  Medical reps. covering Sales People 585 HSP Sales st

  69. Slide 69: Chi-Med's Commercial Platform in China

    Chi-Med’s Commercial Platform in China Proven track record, ~$300 million in net income since inception Revenues (Non-GAAP) [1][2] Net Income/(Loss) attrib. to Chi-Med (US$ millions) (US$ millions) 70 664 Total NI [3] NI to Chi- 2007-2018 Med CAGR 639 Prescription Drugs 342 171 +38% 582 Consumer Hea

  70. Slide 70: Existing China Business: Plans for 2019-2021

    Existing China Business Plans for 2019-2021  Continue organic growth  Focus on proprietary prescription drug products  Build out synergies with China Oncology Organization  Strategically evaluate potential for M&A  Focus on cash generation 70

  71. Slide 71: Product Candidate Details

     Product Candidate Details A2 Further details on each drug candidate

  72. Slide 72: Savolitinib (AZD6094)

     Savolitinib (AZD6094) A2a Potential first-in-class selective MET inhibitor

  73. Slide 73: Savolitinib (AZD6094)

    Savolitinib (AZD6094) Potential first-in-class selective MET inhibitor 1. Strong potential to become first selective MET 2. MET is aberrant in many tumor settings. [7] MET New Cases (2018) inhibitor approved in certain indications. Over-  Clear clinical efficacy observed in non-small cell lung Indi

  74. Slide 74: Savolitinib – MET Exon deletion NSCLC

    Savolitinib – MET Exon 14 deletion NSCLC China’s lead MET inhibitor 1. Competitive landscape outside China: Treatment Line N BICR [1] ORR 95% CI Capmatinib ASCO 2019 #9004 2/3L 69 40.6% (28/69) 28.9%, 53.1% selective MET (Novartis/ Incyte) ASCO 2019 #9004 1L 28 67.9% (19/28) 47.6%, 84.1% Tepotinib s

  75. Slide 75: Savolitinib – EGFR-TKI resistant NSCLC

    Savolitinib – EGFR-TKI resistant NSCLC Very strong preclinical rationale for combination w/ EGFR-TKIs 1. 2nd Line NSCLC is a fast and attractive indication 2. Potential in EGFR-TKI resistant NSCLC: for savolitinib to go after. Also important unmet  Must shut down both EGFRm & MET signaling pathways

  76. Slide 76: Savolitinib – 2L NSCLC combo

    Savolitinib – 2L NSCLC[1] combo w/ Encouraging in MET+ / T790M-, next step under discussion Savo / Iressa® combo in 1st gen. EGFRm-TKI refractory ...Iressa® combo – ~6mo. Duration of patients[2]...outstanding response in MET+ / T790M- Response in MET+ / T790M- patients MET+ / T790M+ MET+ (T790M-) ME

  77. Slide 77: Savolitinib – 2L/3L NSCLC – resistant

    Savolitinib – 2L/3L NSCLC[1] – resistant MET+ driven resistance in ~30% of patients Tagrisso® resistant tissue & ctDNA analysis [2] Other EGFR # Prior Prior 3rd gen Pt TISSUE (NGS, FISH) PLASMA ctDNA (NGS) MET+ mutation Therapies TKI Unknown ~30% 1 L858R 1 MET amp, T790 WT MET amp, T790M ND 3rd Line

  78. Slide 78: Safety & tolerability

    Safety & tolerability Tagrisso® & savo both highly selective/tolerable monotherapies Efficacy Discontinuations as % Enrolled US FDA Median PFS Due to Withdrawn Approval Treatment Disease setting n ORR (mo.) AE / Other Total [5] Monotherapy – Tagrisso® / savolitinib 30-Mar-17 Tagrisso® (osimertinib)

  79. Slide 79: PRCC – unmet medical need

    PRCC – unmet medical need Lower response rates to treatments 1. Limited treatment options for non-ccRCC 2. RCC est. ~$13.0 bn. 3. Unmet medical need: market by 2030 [1] Several approved therapies in ccRCC [3] Immunotherapy setting new treatment paradigm FIRST LINE – clear-cell RCC [4] ORR mPFS mOS M

  80. Slide 80: Savolitinib – PRCC Phase II

    Savolitinib – PRCC Phase II Clear efficacy & durable response in MET+ PRCC patients 1. Savolitinib clear ORR benefit in MET+ patients. 3. Disease Control Rate (“DCR”) – big advantage in MET+ 80 with DCR 73.2% vs. MET- 28.2%.^ Best Tumor measurement changes from baseline (%) 60 Objective Response Rat

  81. Slide 81: Savolitinib – MET+ gastric cancer

    Savolitinib – MET+ gastric cancer A major problem in east Asia – Japan, South Korea & China 1. Gastric (stomach) cancer is the 3. VIKTORY trial savolitinib arm – male, 34; surgery ruled-out; failed 4-cycles XELOX. 5th most common cancer globally – 782,700 deaths/year Baseline … after 1,034 New cases

  82. Slide 82: Savo potential in gastric cancer

    Savo potential in gastric cancer VIKTORY Phase II trial highly promising in MET+ gastric cancer VIKTORY: Highest response rate in savolitinib monotherapy arm Biomarker guided treatment may prolong overall survival Tumor sequenced (N=715)  Eligible for 2nd line treatment (N=460) 1.00 p < 0.0001  Bi

  83. Slide 83: Elunate (fruquintinib capsules)

     Elunate® (fruquintinib capsules) A2b Highly selective anti-angiogenesis inhibitor

  84. Slide 84: Fruquintinib – 24hr full target coverage

    Fruquintinib – 24hr full target coverage The most selective VEGFR inhibitor in clinical trials globally [1] VEGF Production Blood vessel growth 1. Only inhibits VEGFR – limits off-target toxicity & Tumor allows for full & sustained target inhibition. Tumor growth 600 VEGF 500 Day=14, 6mg QD Plasma C

  85. Slide 85: Fruquintinib – 3L/4L colorectal cancer

    Fruquintinib – 3L/4L colorectal cancer Develop in US/EU for rego/TAS-102 ref./intol. patients[1] [1] ASCO = American Society of Clinical Oncology Annual Meeting. 85

  86. Slide 86: Many Firsts for China biotech

    Many “Firsts” for China biotech 2017 2018 Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Oral Presentation Presentation of further analyses JAMA Publication SHFDA Review Granted FRESCO Priority Positive NIFDC Review PAI Specs review & validation; Sample Reado

  87. Slide 87: Launched – Nov. 25, 2018

    Launched – Nov. 25, 2018 First ever oncology drug discovered & launched in China [1] [1] unconditional/Full approval 87

  88. Slide 88: FALUCA – Third-line NSCLC Monotherapy

    FALUCA – Third-line NSCLC Monotherapy Presented at WCLC 2019 FALUCA Phase III (enrolled Dec. 2015 Efficacy Endpoints (Intent-to-Treat) [2] Good safety; most Grade ≥3 TEAEs target-related & clinically manageable. to Feb. 2018) Fruq. Placebo Patient (%) Fruq (N=354) Pbo (N=173) p-value TEAE ≥ Grade 3

  89. Slide 89: Fruquintinib – 1L NSCLC combo

    Fruquintinib – 1L NSCLC combo w/ Two small molecule TKIs allow for better management of tox. 1. Promising efficacy in first line – 72% ORR (36/50). [1,2,3] 3. Combination of highly selective TKIs vs. mAbs: daily dose +20% PR, n (%) 36 (72.0%) flexibility improves tolerability. This enables maintaine

  90. Slide 90: Fruquintinib – Gastric combo with paclitaxel

    Fruquintinib – Gastric combo with paclitaxel Phase III initiated Oct 2017 – Interim analysis early 2019 1. Dose proportional increase of fruquintinib AUC at steady 3. Encouragingly low level of dose reduction/interruption. state. Over 30% increase in paclitaxel drug exposure (mean Actual mean admini

  91. Slide 91: Immunotherapy combinations: ideal TKI combo partners

    Immunotherapy combinations… assets potentially ideal TKI combo partners for immunotherapy ® 1L Clear Cell Renal Cell Carcinoma [1] Inlyta Fruquintinib Surufatinib Selective angio-immuno Objective Response Rate 59% Selectivity Relatively selective Highly selective kinase inhibitor Complete Response S

  92. Slide 92: Fruquintinib & surufatinib both unique VEGFR TKIs

    Fruquintinib & surufatinib both unique VEGFR TKIs …potentially ideal VEGFR combo partners for immunotherapy st nd TKI 1 Generation 2 Generation Next Generation Selective angio-immuno Selectivity Multiple targets Relatively selective Highly selective kinase inhibitor ® ® ® ® ® ® [1] Inhibitors Sutent

  93. Slide 93: Lilly amendment – Dec 2018

    Lilly amendment – Dec 2018 Secures long-term commercial potential  Chi-Med will pay full cost of any future development in China. In return, Chi-Med gains:  Freedom to operate in selecting & pursuing any future indications in China;  Materially higher milestones & royalties upon launch in new LCI

  94. Slide 94: Surufatinib

     Surufatinib A2c Highly active TKI with unique angio-immuno activity

  95. Slide 95: Surufatinib – China data

    Surufatinib – China data [1] [2] Broad spectrum NET efficacy incl. Sutent®/Afinitor® failure ptnts. Phase III: Non-Pancreatic NET Phase III: Safety – Well tolerated – Adverse Events manageable. MEDIAN PFS Suru Pbo Suru Pbo Adverse Events Grade ≥3 N=129 N=68 Surufatinib: 9.2 months (95% CI 7.4, 11.1)

  96. Slide 96: ~170,000 NET patients in U.S.

    ~170,000 NET patients in U.S. [1][2] U.S. NET treatment landscape – highly fragmented Somatostatin Based Therapies Kinase Inhibitor Therapies Sandostatin® LAR Somatuline Depot® Lutathera® Afinitor® Sutent® Surufatinib (octreotide) (lanreotide) (177Lu-Dotatate) (everolimus) (sunitinib) (China NDA acc

  97. Slide 97: Surufatinib – China NET – Phase II

    Surufatinib – China NET – Phase II (ENETS 2017 [1]) Tumor devascularization & central necrosis Duodenum NET G2 w/ multiple liver & retroperitoneal Baseline Week 52 lymph node metastases Patient 1 Baseline Week 56 w/ multiple liver metastases Rectum NET G2 Patient 2 [1] ENETS = European Neuroendocrin

  98. Slide 98: HMPL-523 (Syk) & HMPL-689 (PI3Kδ)

     HMPL-523 (Syk) & HMPL-689 (PI3Kδ) A2d Potential first-in-class (Syk) & best-in-class (PI3Kδ) assets

  99. Slide 99: HMPL-523 – hematological malignancies

    HMPL-523 – hematological malignancies Syk exciting target emerging – Lymphoma PoC ongoing 1. The B-cell signaling is critical in hematological cancer with three 2. Entospletinib – 65% Nodal Response Rate CLL & SLL [4] [5]. breakthrough therapies recently approved. Best Change in SPD from Baseline (%

  100. Slide 100: HMPL-523 (Syk) in hematological cancer

    HMPL-523 (Syk) in hematological cancer Australia & China – large Ph.Ib expansion. US/EU Ph.I imminent  Extensive Ph.I dose escalation Australia & China Phase I/Ib studies study now complete in Australia  & China (total n=60); RP2D [1] determined & large Ph. Ib Stage I: dose escalation • Australia:

  101. Slide 101: HMPL-689 – Phase I Australia & China ongoing

    HMPL-689 – Phase I Australia & China ongoing Designed to be a best-in-class inhibitor of PI3Kδ 1. PI3Kδ now a proven target. 2. PI3Kδ inhibitors being developed in a very broad range of indications.  PI3Kδ activation associated with allergy, Compound Indication Status Issue inflammation & oncology.

  102. Slide 102: Epitinib, Theliatinib & HMPL-453

     Epitinib (EGFR), Theliatinib (EGFRwt) & HMPL-453 (FGFR) A2e Aim to establish proof-of-concept

  103. Slide 103: Epitinib – 70% response in NSCLC w/ brain mets

    Epitinib – 70% response in NSCLC w/ brain mets[1] Unmet medical need. Investment case under review. 1. Phase Ib [1] – epitinib monotherapy in EGFRm+ NSCLC 2. Phase Ib [1] – solid/durable efficacy in brain in EGFRm+ patients – efficacy in lung in-line with Iressa®/Tarceva®. NSCLC patients with measur

  104. Slide 104: Epitinib – Safe & well tolerated

    Epitinib – Safe & well tolerated 3. Epitinib well tolerated by patients[1] w/advanced CASE STUDY – EGFR-TKI naïve patient solid tumors. Safety profile is consistent with that of  Male, 46, diagnosed with Stage IV NSCLC adenocarcinoma (Exon21)  Metastases in the approved EGFR-TKIs (e.g. Iressa®/ Ta

  105. Slide 105: Theliatinib

    Theliatinib Potent & highly selective TKI – strong affinity to EGFRwt kinase 1. Major unmet medical need for wild-type EGFR CASE STUDY – EGFR protein over expression activation tumors.  May 4, 2016: Man, 62, stage IV esophageal squamous cell cancer  EGFR TKIs are less effective in solid tumors wit

  106. Slide 106: HMPL-453 – Phase I in China ongoing

    HMPL-453 – Phase I in China ongoing Designed as best-in-class FGFR1/2/3 inhibitor 1. FGFR genetic alterations are oncogenic drivers. 2. FGFR – diverse & complicated genetic changes with  FGF/FGFR signaling normally involved in multiple tumor types harboring low incidence. embryonic development, tis

  107. Slide 107: Further Corporate Information

     Further Corporate Information A3

  108. Slide 108: Chi-Med Group Structure - Major Entities

    Chi-Med Group Structure - Major Entities Non-Consolidated Joint Ventures Chi-Med Group Level Revenues – H1 2019: $102.2m (H1 2018: $102.2m) Chi-Med Subsidiaries Net Loss Attributable to Chi-Med – H1 2019: -$45.4m (H1 2018: -$32.7m) Innovation Platform Commercial Platform Revenue – H1 2019: $12.0m (H

  109. Slide 109: FY2019 H1 Inter-group cash flow

    FY2019 H1 Inter-group cash flow $237.3m cash (Jun 30, 2019); $146.3m in undrawn bank facilities Capital Markets ESOP & Bank Loans (at Jun 30, 2019) Pharma Partners AIM (~$75m – May 2006) Treasury Drawn down: $0m AstraZeneca; Eli Lilly; Nestlé Nasdaq (~$96m – Mar 2016) Nasdaq (~$293m – Oct 2017) Shar

  110. Slide 110: Non-GAAP Financial Measures and Reconciliation (1/3)

    Non-GAAP Financial Measures and Reconciliation (1/3) Reconciliation of Adjusted Group net cash flows and Adjusted Group net Reconciliation of Adjusted Research and Development Expenses: cash flows excluding financing activities: Jun 30, 2019 Current 2019 Previous 2019 Guidance Guidance H1 2018 H1 20

  111. Slide 111: Non-GAAP Financial Measures and Reconciliation (2/3)

    Non-GAAP Financial Measures and Reconciliation (2/3) Reconciliation of GAAP growth to CER growth Six Months Ended Growth Amount Growth % $’Million (except %) June 30, June 30, Exchange Actual Exchange Actual at CER CER growth % 2019 2018 effects growth % effect % Consolidated sales 102.2 102.2 - 5.1

  112. Slide 112: Non-GAAP Financial Measures and Reconciliation (3/3)

    Non-GAAP Financial Measures and Reconciliation (3/3) Reconciliation of Non-GAAP Sales and Non-GAAP Net (loss)/income after tax [1]  Prescription Drugs: includes our Consolidated subsidiary (Hutchison Sinopharm) and Non-consolidated joint venture (SHPL);  Consumer Health: includes our Consolidated

  113. Slide 113: China Commercial Platform has substantial value

    China Commercial Platform has substantial value  Chi-Med’s Commercial Platform continues to perform well relative to our peer group.  The market value, based on China Pharma median PE multiples is approximately $1.8 billion.[1] Given our share in the JVs, Chi-Med’s share of this value is approxima

  114. Slide 114: National Reimbursement Drug List Pricing (NRDL)

    National Reimbursement Drug List Pricing (“NRDL”) July’17 update – 15 new drugs in oncology[1] added to NRDL Unit Pricing (US$) [3] Approximate Monthly Pricing (US$) [3] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage Avg. Tender Reimbursed Indication coverage Herceptin® Breast: 4mg/

  115. Slide 115: National Reimbursement Drug List Pricing (NRDL)

    National Reimbursement Drug List Pricing (“NRDL”) Oct’18 update – 17 new drugs in oncology added to NRDL Unit Pricing (US$) [2] Approximate Monthly Pricing (US$) [2] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage [1] Avg. Tender Reimbursed Indication coverage ® Focus V (anlotinib) S

  116. Slide 116: National Reimbursement Drug List Pricing (NRDL)

    National Reimbursement Drug List Pricing (“NRDL”) Nov’19 update – 8 new & 9 renewed drugs in oncology[1] Unit Pricing (US$) [3] Approximate Monthly Pricing (US$) [3] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage Avg. Tender Reimbursed Indication coverage ® Elunate Chi-Med 5mg $149

  117. Slide 117: Thank you

    CHI- HUTCHISON CHINA MEDITECH Thank you

Hutchison China MediTech (Chi-Med) — Investor Presentation (January 2020) on 6ix