Hutchmed (china) Limited · HKEX:13
Hutchmed (china) — Hutchison China MediTech (Chi-Med) — Investor Presentation (July 2020)
109 slides from Hutchmed (china)'s investor presentation, Jul 30, 2020
Slide 1: Corporate Presentation
Corporate Presentation July 30, 2020 Nasdaq/AIM: HCM
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
Slide 3: Building a global science-focused biopharma from an established base in China
Building a global science-focused biopharma from an established base in China Realizing the global potential of Chi-Med’s novel oncology assets Building a fully integrated oncology business in China 3
Slide 4: Our strengths
Our strengths Fully integrated platform built over 20 years First global-focused novel drug discovery 9 innovative clinical stage NMEs – company in China – est. 2002 all discovered in-house by Chi-Med World-Class Highly ~550 integrated R&D Discovery & Differentiated 3 lead assets NDA filed/ staff fo
Slide 5: World class discovery engine
World class World class discovery engine Discovery & Development Capability Most prolific & validated in China biotech Focus on Global Quality Innovation Chi-Med’s Advanced Chemistry Approach Proven & Validated at all Levels Provides Superior Selectivity Profiles 53 15+ year track record in oncology
Slide 6: Deep global development infrastructure
World class Deep global development infrastructure Discovery & Development Capability Track record of breakthroughs Integrated development team of ~120 C&R & Elunate® (Fruquintinib) ~200 CMC staff located in Shanghai, Suzhou & 1st ever China-discovered & developed targeted oncology therapy to receiv
Slide 7: Maximizing the value of our lead assets
Highly Maximizing the value of our lead assets Differentiated NME Portfolio & Global Pipeline Potential 5 NDAs filed & 8 reg. studies by 2020/2021 Dose Finding / Proof-of-Concept Registration Intent NDA Filed / Marketed Safety Run-In MET Exon 14 skipping NSCLC MET Exon 14 skipping NSCLC NDA Filed Ma
Slide 8: Deep NME early pipeline
Highly Deep NME early pipeline Differentiated NME Portfolio & Global Pipeline Multiple further waves of innovation progressing Dose Finding/ IND preparation Proof-of Concept Registration Intent Safety Run-In Dose Escalation – Indolent NHL 6 Indolent NHL settings HMPL-523 Syk inhibitor Immune Thrombo
Slide 9: Differentiated portfolio
Highly Differentiated portfolio Differentiated NME Portfolio & Global Pipeline Designed for global registration – 12 discovered assets [2] [2] Product MOA Discovery [1] Indications Partner Rights In-house Colorectal, gastric, NSCLC, solid tumors HCM has WW rights ex-China; Marketed (Colorectal); Ph.
Slide 10: Significant China Commercial Platform
Significant China Commercial Platform Proven commercial capabilities & deep market access Deep pan- China Market Access Commercial Platform Established China Rx Commercial Platform Compliant & adaptable across many TAs ~19 yrs' experience operating in China’s complex Successfully marketed 3rd party
Slide 11: Seasoned executives – MNC veterans
Seasoned executives – MNC veterans Global standards – Reputation & transparency Seasoned MNC Mgmt Team – Strong Governance Management Team Selected Shareholders Christian Hogg Weiguo Su Johnny Cheng Junjie Zhou Chief Executive Chief Scientific Chief Financial General Officer Officer Officer Manager,
Slide 12: AstraZeneca and Chi-Med
AstraZeneca and Chi-Med Harnessing the power of Chinese Innovation 1 Savolitinib
Slide 13: Savolitinib opportunities
PAPILLARY RCC EXON14 MUTATION NSCLC ~8% RCC. No biomarker NDA under review. Priority Review. therapies approved. First in China. Global in planning. PD-L1 COMBINATION POST-EGFR TKI NSCLC Preliminary signal with Imfinzi®. ~30% Tagrisso®-resistant pts. Exploring further. (Tag. 2019 $3.2bn, #1 globally
Slide 14: Savolitinib – MET inhibitor
Savolitinib – MET inhibitor Current development status Strong position in NSCLC Renewed RCC strategy Other exploratory studies MET Exon 14m – NDA accepted in Savo monotherapy – ~60 pt. Gastric monotherapy – 50% May 2020 & priority review; SAVOIR data; Restart in PRCC; ORR; Global Ex.14 study
Slide 15: Savolitinib
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
Slide 16: Savolitinib – MET Exon 14 skipping NSCLC
Savolitinib – MET Exon 14 skipping NSCLC China NDA accepted in May 2020; data at AACR19 & ASCO20 1. MET Exon14 skipping NSCLC NDA filed 2019 2020 Topline May 28, ‘20 – NDA accepted May 29, ’20 – Mar ’19 – Jun-Jul ’19 – • Prior CDE[1] discussion 2020 ASCO Virtual results Oral AACR Pres. Study fully •
Slide 17: Savolitinib – MET Exon 14 skipping NSCLC
Savolitinib – MET Exon 14 skipping NSCLC [1] China NDA accepted in May 2020; global dev. in planning 1. Encouraging single agent anti-tumor activity [2] 3. Savo study had 36% pts with PSC, a more aggressive Efficacy Evaluable Full Analysis NSCLC sub-type, vs. 1-5% in VISION/GEOMETRY (N=61) (N=70) 36
Slide 18: + savo in EGFR TKI refractory NSCLC
+ 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 prior third-ge
Slide 19: TATTON B & D data – ORR
TATTON B & D data – ORR + 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 50 50 baseline in target les
Slide 20: SAVANNAH – global registration-intent study
+ 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 T790M+ SA
Slide 21: 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
Slide 22: Savolitinib in PRCC
Savolitinib in PRCC Phase II study’s encouraging efficacy led to SAVOIR Phase III [1] 1. Phase 80 II: Savolitinib clear ORR benefit in MET+ pts. 3. Phase II: Disease Control Rate (“DCR”) – advantage in MET+ with DCR 73.2% vs. MET- 28.2%.^ 60 Objective Response Rate: Tumor responses in the overall tr
Slide 23: Savolitinib in PRCC – SAVOIR data
Savolitinib in PRCC SAVOIR 60 pt. data – actively evaluating progressing clinical work 2017 2018 2019 SAVOIR Study initiation Enrollment stopped Data cut-off (DCO) Planned number of pts = 180 60 pts enrolled 23 pts remained on therapy timeline (90 savolitinib / 90 sunitinib) (33 savolitinib / 27 sun
Slide 24: Exploring Savolitinib + PD-L1 inhibitor
Exploring Savolitinib + PD-L1 inhibitor CALYPSO Savo/Imfinzi® combo tolerable, w/ durable efficacy 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 (%
Slide 25: Savo + Imfinzi in PRCC (CALYPSO)
Savo + Imfinzi® in PRCC (CALYPSO) Continue to accumulate clinical data & explore developments CALYPSO: Encouraging response independent of CALYPSO: MET +ve results to be confirmed based on biomarkers assessed so far genetic alterations (40% ORR based on IHC ≥3) 40% tumor size from baseline (%) 33% B
Slide 26: Surufatinib mechanism of action
Angiogenesis Tumor-associated Mechanism of Action macrophages Anti-angiogenesis: cut off blood flow to tumor ` (VEGFR/FGFR). Immunotherapy: inhibit expression of tumor- associated macrophages T-cells which cloak cancer cells from T-cell attack (CSF-1R). 2 Surufatinib
Slide 27: Surufatinib opportunities
BILIARY TRACT CANCER NET REGISTRATION (GLOBAL) NET LAUNCH (CHINA)* Poor prognosis patients. Fast Track Designation in U.S. & NDA under review; Target launch NDA filing plan end 2020; Dialogue in EU. Q4-20; Commercial team in place. PD-1 COMBINATIONS PD-1 COMBINATIONS Multiple PD-1s approach; Multipl
Slide 28: Surufatinib – dual VEGFR & CSF-1R inhibitor
Surufatinib – dual VEGFR & CSF-1R inhibitor Current development status China NET Global NET Biliary Tract Cancer PD-1 combos • Non-pancreatic NET NDA • U.S. NDA in late 2020 [1]; • Ph.II/III underway with • Tuoyi® (Junshi) Ph.II (in 8 accepted; Priority review; • Fast Track Designations for interim
Slide 29: 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 –
Slide 30: G1/2 Advanced non-pancreatic NET
G1/2 Advanced non-pancreatic NET Major unmet need – important surufatinib efficacy NET growth U.S. better diagnosis SANET-ep [2] (n=198) Incidence per 100 000 for Neuroendocrine Tumors Incidence per 100 000 for All Malignant Neoplasms Surufatinib: 9.2 months (95% CI 7.4, 11.1) 1.0 Placebo: 3.8 month
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 Octreotide Lanreotide 177Lu-Dotatate Surufatinib Site est. % Streptozocin Sunitinib Everolimus LAR autogel (not yet approved) Progressed in past Progressed in past Progressed in past Disease status Treat
Slide 32: U.S. NDA rolling submission to start by YE20
U.S. NDA rolling submission to start by YE20 Surufatinib efficacy is highly applicable to U.S. population setting Suru Efficacy Post Everolimus or Sunitinib Failure Similar PK profile between Chinese & US PR Confirmed PR (n=3) patients: 8 12 10 33 X 24 2 15 X uPR Unconfirmed PR (n=1) China Ph I/II
Slide 33: Promising PD-1 combo in difficult G3 NET/NEC pts
Promising PD-1 combo in difficult G3 NET/NEC pts Phase II proceeding at 250mg RP2D 100% >160% PD AACR 2020 – Phase 1 dose-finding study RP2D 250mg surufatinib + toripalimab. 80% (N=11): ORR = 64%, 60% PD DCR = 100%. 40% Anti-tumor signal, particularly in NEC & NET. Percent change from baseline
Slide 34: Elunate (fruquintinib capsules)
3 Elunate® (fruquintinib capsules)
Slide 35: Fruquintinib – VEGFR 1/2/3 inhibitor
– VEGFR 1/2/3 inhibitor CRC REGISTRATION (GLOBAL) CRC BROADEN ACCESS (CHINA) Regulatory interactions complete in U.S./EU NRDL inclusion Jan 2020; & Japan. U.S. FTD. Ph.III start mid-2020 Chi-Med to commercialize in China from Q4 ‘20 PD-1 COMBINATIONS CHEMO COMBINATIONS High selectivity enhances tole
Slide 36: Fruquintinib – VEGFR1/2/3 inhibitor
– VEGFR1/2/3 inhibitor Current development status Elunate® CRC China CRC GLOBAL FRUTIGA Gastric Ph.III PD-1 combos • NRDL inclusion from • U.S. Ph.Ib/II completed; • 2nd Interim analysis in • Tyvyt® (Innovent) Ph.II (in January 1, 2020. • FRESCO-2 Ph.III initiated June 2020 complete; 5 solid tumor i
Slide 37: NRDL – 2020 accessible pricing
NRDL – 2020 accessible pricing Epidemiology National Reimbursement Drug List (NRDL) China Annual Incidence Effective Jan 1, 2020: 380,000 patients [1] ● 8 newly listed oncology drugs, including Elunate® ● NRDL reimburses 50-70% of patient costs under urban scheme Surgery ~15% Urban Med. Insur. 1st-l
Slide 38: H1 2020 performance
H1 2020 performance Elunate® Performance Sales (millions) [1] Total Cycles (OOP&PAP) [2] 2020 Lilly Amendment 16 20,000 18,000 ● Starting October 1, 2020, Chi-Med will 14 ~18,800 $14.0 16,000 take on all medical detailing, 12 (RMB 98.9) 14,000 +174% promotion & local/regional marketing 10 $11.4 12,0
Slide 39: China VEGFR landscape
China VEGFR landscape Competitive landscape – small molecule VEGFR TKIs Brand Indication/s Launch 2011 2012 2013 2014 2015 2016 2017 2018 2019 STIVARGA® 3L CRC /2L GIST May 2017 Sales (US$ million) [1] 5 21 81 (regorafenib) 2L HCC Mar 2018 NRDL List Price (US$/mo.) 4,368 2,352 Bayer AG Oct-18 NEXAVA
Slide 40: 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
Slide 41: 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
Slide 42: Commercialization & Next Wave of Innovation
4 Commercialization & Next Wave of Innovation
Slide 43: >320 person dedicated oncology commercial team
>320 person dedicated oncology commercial team Building on >15 yrs Rx commercial knowhow in mainland China To cover ~1,300 hospitals across China Full suru launch team in place by mid-2020 Establishing dedicated oncology commercial team to All key senior roles are already in-place; cover ~95% of
Slide 44: Next wave of innovation
Next wave of innovation Development strategies and current status HMPL-523 & HMPL-689 HMPL-523 & HMPL-689 HMPL-453 HMPL-306 • China Ph.Ib dose • Over 20 Ph.I sites in U.S. • Ph.II initiated in • 9th in-house discovered expansions underway; & Europe enrolling; advanced malignant asset (IDH1/2) Ph.I;
Slide 45: HMPL-523 (Syk) & HMPL-689 (PI3Kδ)
HMPL-523 (Syk) & HMPL-689 (PI3Kδ) Exciting targets emerging – our next wave of innovation The B-cell signaling is critical in hematological cancer with HMPL-523 (Syk inhibitor) three breakthrough therapies recently approved. Large Phase Ib expansion in Australia & China 2019 sales: Imbruvica® $5.7
Slide 46: HMPL-306 – Phase I in China underway
HMPL-306 – Phase I in China underway Designed as potential best-in-class IDH 1/2 inhibitor 1. The IDH family converts isocitrate to α-KG via 2. Unmet medical need and potential indications – oxidative decarboxylation, an important process for IDH1/2 mutations are frequent genetic alterations in norm
Slide 47: What is next from discovery?
What is next from discovery? Differentiated assets against multiple targets Priming & activations Anti-angiogenesis VEGFR (fruquintinib) Multiple mAb VEGFR/FGFR (surufatinib) programs FGFR (HMPL-453) Antigen release Negative regulators Treg (HMPL-689) MET (savolitinib) CSF-1R (surufati
Slide 48: 1H 2020 Financial Results, Cash Position & Guidance
5 1H 2020 Financial Results, Cash Position & Guidance
Slide 49: H1 2020 Financial Results
H1 2020 Financial Results at CER [2] 2019 H1-19 H1-20 Growth (Non-GAAP) GROUP REVENUE 204.9 102.2 106.8 4% 9% Unconsolidated JV Revenue 487.5 276.9 274.8 -1% 4% Global SEGMENT NET INCOME/(LOSS) [1] Innovation INNOVATION PLATFORM [3] (133.2) (67.1) (73.6) -10% -14% COMMERCIAL PLATFORM 47.4 31.0 35.5
Slide 50: Cash position & 2020 Guidance
Cash position & 2020 Guidance $400 million in available cash resources (excl. PIPE) [1] Cash Position H1 2020 2020 Current Adj. vs. Previous (at end June 2020) (US$ millions) Actual [5] Guidance Guidance $281 million cash / Adj. (non-GAAP) cash equiv. / Short Innovation Platform (81.2) (180) – (21
Slide 51: Summary
6 Summary
Slide 52: Potential upcoming events
Potential upcoming events H1 2020 H2 2020 H1 2021 Savo + Imfinzi® Papillary RCC (CALYPSO) Savo Papillary RCC (SAVOIR) Savo + Tagrisso® NSCLC (SAVANNAH) Fruq / Suru PD-1 combos Savo NSCLC, RCC Anticipate further Savo + Tagrisso® NSCLC (SAVANNAH) Ph. II Data Update Term. RCT Data (ASCO) Ph. II I
Slide 53: 2020 Targets
2020 Targets Suru Launch • Chi-Med’s first unpartnered oncology drug launch • Submit 1st NDA (Exon14 NSCLC) • SAVOIR PRCC Savo Progress • SAVANNAH (w/Tagrisso®) enrolled registration • Endorsement of Ph. III studies on NSCLC strategy • Chi-Med to commercialize in China from Q4 2020 onwards ELUNATE®
Slide 54: Thank you
aM HUTCHISON CHINA MEDITECH fi Thank you
Slide 55: Appendix
Appendix A1 Strategies Realizing global potential of novel oncology assets Building a fully integrated China oncology business A2 Product Candidate Details A3 Further Corporate Information 55
Slide 56: Realizing global potential of novel oncology assets
A1a Realizing global potential of novel oncology assets 56
Slide 57: One of China's largest 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
Slide 58: 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
Slide 59: Superior safety allows for combinations
Superior safety allows for combinations TKI + TKI combos to address acquired resistance RESULTS: CANDIDATE ACQUIRED RESISTANCE MECHANISMS WITH R OSIMERTINIB (n=91)* • No evidence of acquired EGFR T790M • The most common resistance mechanisms were MET amplification and EGFR C797S mutation • Other mec
Slide 60: 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
Slide 61: 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; Colorectal cancer Indicatio
Slide 62: 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
Slide 63: 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
Slide 64: Building a fully integrated China oncology business
Building a fully integrated China oncology business A1b 64
Slide 65: China oncology – >25% of world's cancer patients
China oncology – >25% 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 – 9
Slide 66: 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
Slide 67: 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$1,538 (RMB10,364) Braz
Slide 68: Assets in China development
8 assets in China development …fruq launched – savo/suru NDAs & Syk/PI3Kδ PoC ahead Program Treatment Indication Target patient Study name Sites Dose find / safety run-in Proof-of-concept Registration NDA accepted Savolitinib Savolitinib NSCLC MET Exon 14 skipping China Lu Shun – SH Chest Hosp. May
Slide 69: Established Chi-Med Commercial Platform in China
Established Chi-Med Commercial Platform in China Focus on building out oncology commercial organization Focus on building out Major Commercial Leadership JVs with 3 Major Oncology commercial & Production Scale Market Shares China Pharmas Establishing oncology ~2,300 Rx & ~900 OTC sales Market leader
Slide 70: Building a China Specialty Pharma business
Building a China Specialty Pharma business Proven track record – major focus on oncology 2020 onwards Revenue (Non-GAAP) [1][2] Net Income/(Loss) attrib. to Chi-Med (US$ millions) (US$ millions) 70 NI to Chi- 2007-2019 Total NI [3] Med CAGR Prescription Drugs 422 217 +36% 668 676 639 Consumer Health
Slide 71: Product Candidate Details
Product Candidate Details A2 Further details on each drug candidate
Slide 72: Savolitinib
Savolitinib A2a Potential first-in-class selective MET inhibitor
Slide 73: Savolitinib – potential first-in-class selective MET inhibitor
Savolitinib 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 Indication Amp
Slide 74: Savolitinib – MET Exon 14 skipping NSCLC
Savolitinib – MET Exon 14 skipping NSCLC China’s lead selective MET inhibitor Competitive landscape outside China: MET mDoR [95% CI] Treatment Line aberration N BICR[1] ORR (%) (months) mPFS (months) Capmatinib ASCO 2019 #9004 1L (cohort 5b) Ex14 skipping 28 67.9 [47.6, 84.1] 11.14 [5.55, NE] 9.13 [
Slide 75: 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 progression-free survival Prior third-generation EGFR-TKI; 5.4 [4.1, 8.0] 2.6 [0.0–27.3] 0.6 (600 mg [1]
Slide 76: TATTON B & D data – AEs & tolerability
+ 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 grade ≥3 7
Slide 77: 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
Slide 78: 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
Slide 79: 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
Slide 80: Savolitinib potential in gastric cancer
Savolitinib 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 < 0.00
Slide 81: Surufatinib
Surufatinib A2b Highly active TKI with unique angio-immuno activity
Slide 82: 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
Slide 83: ~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
Slide 84: Surufatinib – China NET
Surufatinib – China NET NET potential ~$100-120m/yr.[1] – under treated/diagnosed Competitive landscape – China NET treatments [1] Brand Indication/s Launched 2017 2018 2019 SUTENT® Pancr. NET 2007 Sales (US$ million) 27 24 41 (sunitinib – VEGFR) (& GIST/RCC) NRDL Pfizer List Price (US$/month) 4,455
Slide 85: 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
Slide 86: 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
Slide 87: 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
Slide 88: Surufatinib – China NET
Surufatinib – China NET Two positive Ph. III studies unblinded a year ahead of schedule Epidemiology – China NET & BTC patient populations Annual Estimated NRDL Pricing First targeted Incidence Prevalence mPFS References therapy ever to address all NET China NET 100% 67,600 ~300,000 (Est. China rati
Slide 89: Elunate (fruquintinib capsules)
Elunate® (fruquintinib capsules) A2c Highly selective anti-angiogenesis inhibitor
Slide 90: Fruquintinib – 3L+ colorectal cancer
Fruquintinib – 3L+ colorectal cancer Launched in China, initiated global Ph.III registration study ASCO = American Society of Clinical Oncology Annual Meeting. 90
Slide 91: 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 kinase Selectivity Multiple targets Relatively selective Highly selective inhibitor ® ® ® ® ® ® Inhibitors Sutent Ne
Slide 92: FRUTIGA – Gastric combo with paclitaxel
FRUTIGA – Gastric combo with paclitaxel Phase III initiated Oct 2017 – 2nd interim analysis June 2020 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 administ
Slide 93: 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
Slide 94: FALUCA – Third-line NSCLC Monotherapy
FALUCA – Third-line NSCLC Monotherapy Presented at WCLC 2019 FALUCA Phase III (enrolled Dec 2015 to Efficacy Endpoints (Intent-to-Treat) [2] Good safety; most Grade ≥3 TEAEs target-related & clinically manageable. Feb 2018) Fruq. Placebo Patient (%) Fruq. (N=354) Pbo (N=173) p-value TEAE ≥ Grade 3 2
Slide 95: HMPL-523 (Syk) & HMPL-689 (PI3Kδ)
HMPL-523 (Syk) & HMPL-689 (PI3Kδ) A2d Potential first-in-class (Syk) & best-in-class (PI3Kδ) assets
Slide 96: HMPL-523 (Syk) in hematological cancer
HMPL-523 (Syk) in hematological cancer Phase I/Ib ongoing in Australia, China, US & EU 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: Relapsed/refra
Slide 97: HMPL-689 – Phase I/Ib ongoing in China, US & EU
HMPL-689 – Phase I/Ib ongoing in China, US & EU 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 & oncolo
Slide 98: HMPL-453 (FGFR)
HMPL-453 (FGFR) A2e Aim to establish proof-of-concept
Slide 99: HMPL-453 – Phase II in China initiated
HMPL-453 – Phase II in China initiated 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,
Slide 100: Further Corporate Information
Further Corporate Information A3
Slide 101: Chi-Med Group Structure
Chi-Med Group Structure - Main Entities / Offices Consolidated Hutchison China MediTech Group Level (Nasdaq/AIM: HCM) Non-Consolidated Commercial businesses Hutchison MediPharma Hutchison MediPharma Discovery, development and manufacturing of novel Innovative Medicines Commercialization Prescription
Slide 102: 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 $1.7 billion.[1] Given our share in the JVs, Chi-Med’s share of this value is approxi
Slide 103: Non-GAAP Financial Measures and Reconciliation (1/3)
Non-GAAP Financial Measures and Reconciliation (1/3) Reconciliation of GAAP revenue to Non-GAAP revenue and CER: Six M onths Ended Change A mount Change % $’Millions (except %) June 30, June 30, Exchange Exchange A ctual CER A ctual CER 2019 2020 ef f ect ef f ect Cons olidated revenue - Group 102.
Slide 104: Non-GAAP Financial Measures and Reconciliation (2/3)
Non-GAAP Financial Measures and Reconciliation (2/3) Reconciliation of Adjusted (non-GAAP) Innovation Platform segment Reconciliation of Adjusted (non-GAAP) Group net cash flows operating loss: excluding financing activities: H1 2020 H1 2020 Innovation Platform segment operating loss (73.4) Cash and
Slide 105: Non-GAAP Financial Measures and Reconciliation (3/3)
Non-GAAP Financial Measures and Reconciliation (3/3) Reconciliation of Non-GAAP revenue and Non-GAAP Net (loss)/income after tax [1] Prescription Drugs: includes our Consolidated subsidiaries (Hutchison Sinopharm and HMP) and Non-consolidated joint venture (SHPL); Consumer Health: includes our C
Slide 106: National Reimbursement Drug List Pricing (July 2017)
National Reimbursement Drug List Pricing (“NRDL”) July’17 update – 15 new drugs in oncology[1] added to NRDL Unit Pricing (US$) [3] Approximate Monthly Pricing (US$) [3] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage Avg. Tender Reimbursed Indication coverage Herceptin® Breast: 4mg/
Slide 107: National Reimbursement Drug List Pricing (Oct 2018)
National Reimbursement Drug List Pricing (“NRDL”) Oct’18 update – 17 new drugs in oncology added to NRDL Unit Pricing (US$) [2] Approximate Monthly Pricing (US$) [2] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage [1] Avg. Tender Reimbursed Indication coverage ® Focus V (anlotinib) S
Slide 108: National Reimbursement Drug List Pricing (Nov 2019)
National Reimbursement Drug List Pricing (“NRDL”) Nov’19 update – 8 new & 9 renewed drugs in oncology[1] Unit Pricing (US$) [3] Approximate Monthly Pricing (US$) [3] Brand (generic) Company Dosage Avg. Tender Reimbursed ∆% Dosage Avg. Tender Reimbursed Indication coverage ® Elunate Chi-Med 5mg $149
Slide 109: Thank you
aM HUTCHISON CHINA MEDITECH fi Thank you
Hutchison China MediTech (Chi-Med) — Investor Presentation (July 2020) on 6ix