Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — BeiGene — Investor Presentation (August 2019)
51 slides from Beone Medicines Ltd. Class A's investor presentation, Aug 8, 2019
Slide 1: Corporate Presentation August 8, 2019
Corporate Presentation August 8, 2019
Slide 2: Disclosures
• Certain statements contained in this presentation and in the accompanying oral presentation, other than Disclosures statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include those regardin
Slide 3: BeiGene At-A-Glance
BeiGene At-A-Glance Fully-integrated global biotech 2,700+ employees Key catalysts in 2019 / 20 company with internal 10 offices on 4 continents including expected product capabilities in research, clinical Trials in 34 countries and approvals and up to 10 development, commercialization regions Phas
Slide 4: Our Strategies
Our Strategies -- Building a Leading Global Innovative Biotech Company From China With the utmost commitment to patients, quality, and science Realize two large near-term commercial opportunities • Global opportunity for potentially best-in-class BTK inhibitor zanubrutinib • Opportunity for differen
Slide 5: Our Leadership Team
Our Leadership Team Attracting global talent to build a world-class team John V. Oyler Xiaodong Wang, Ph.D. Founder, CEO, and Chairman Founder and Chairman SAB BioDuro, Galenea, Telephia, NIBS: National Institute of Biological Sciences in Genta, McKinsey & Company Beijing, UT Southwestern Medical Ce
Slide 6: BeiGene Product Portfolio and Pipeline
BeiGene Product Portfolio and Pipeline Global Three marketed products in China, three late-stage assets, seven early-stage clinical assets China DOSE ESC. DOSE EXPANSION PIVOTAL COMMERCIAL ASSETS PROGRAMS FILED PH1a PH1b PH2* PH2** PH3 RIGHTS R/R MCL, R/R CLL/SLL (NDAs accepted) R/R WM zanubrutinib
Slide 7: Two Late-Stage Assets Represent Significant Commercial Opportunities
Two Late-Stage Assets Represent Significant Commercial Opportunities zanubrutinib tislelizumab Potentially Best-in-Class BTK Inhibitor PD-1 Inhibitor Targeting Asia-Prevalent Tumors ▪ 2018 Global: $4.2 Bn ▪ 2018 Global^: $15.5 Bn CLASS REVENUE & FORECAST** ▪ 2025E Global: $13.8 Bn ▪ 2025E Global^: $
Slide 8: Zanubrutinib Broad Clinical Development Program
Zanubrutinib Broad Clinical Development Program Eight ongoing potentially registration-enabling studies Filed, In NDA review Pivotal Phase 2 (n=86) in R/R MCL Phase 3 (n=500) in 1L MCL Phase 1 cohort (n=45) in MCL zanu monotherapy, PE: ORR R+zanu vs. R+chemo, PE: PFS zanu monotherapy, PE: Safety RP2
Slide 9: Tislelizumab Broad Late-stage Development Program
Tislelizumab Broad Late-stage Development Program Fifteen ongoing potentially registration-enabling studies Phase 3 (n=360) in 1L Stage IIIB or IV squamous NSCLC Filed, In NDA review Phase 3 (n=800) in 2L NSCLC tislelizumab+ paclitaxel and carboplatin combo or nab-paclitaxel and carboplatin tisleliz
Slide 10: Other Clinical-Stage Drug Candidates and Internal Combinations
Other Clinical-Stage Drug Candidates and Internal Combinations Global China ROBUST PIPELINE BEYOND BTK AND PD-1 DOSE ESC. DOSE EXPANSION INDICATIONS pamiparib • Late stage studies in ovarian cancer in China PH1a PH1b PH2* (PARP1&2 Inhibitor) • Combination studies with temozolomide HCC or GEJ tisleli
Slide 11: Leverage China to Pursue Global Excellence
Leverage China to Pursue Global Excellence BeiGene Is Becoming a Leader in China-Inclusive Global Clinical-Development • In-house research capability with a team of approximately 300; all three late-stage clinical assets were discovered by BeiGene scientists with potentially differentiating profiles
Slide 12: Building Oncology-Focused Commercial Footprint in China and U.S.
Building Oncology-Focused Commercial Footprint in China and Establishing a Presence in the U.S. Marketed product growth and commercial team expansion in China; Building a 100-200-person hematology commercial team in the U.S. A growing 600+ top innovative oncology commercial Marketed Brand Revenue te
Slide 13: Developing Strong Manufacturing Capabilities
Developing Strong Manufacturing Capabilities • Manufacturing collaborations with BIOLOGICS MULTI-FUNCTIONAL leading high-quality manufacturers MANUFACTURING in biologics and small molecules MANUFACTURING • BI collaboration established in FACILITY IN FACILITY IN 2013; cell line and CMC process SUZHOU
Slide 14: China Is Becoming an Important Clinical Science Center
China Is Becoming an Important Clinical Science Center, Representing a Historic Opportunity BeiGene is well-positioned within this ecosystem • NMPA reforms have removed delays, allowing China NMPA reforms expand to participate in early drug development and to China’s role in global contribute signif
Slide 15: Commercial Transformation in China Facilitates Access
Commercial Transformation in China Facilitates Access Expanding national reimbursement, at reasonable prices Median Monthly cost of oncology drugs included in NRDL through price negotiation monthly cost $4,000 ZELBORAF No generic NEXAVAR competition at $3,500 AVASTIN IMBRUVICA the time of NRDL inclu
Slide 16: China Enables a Model to Succeed in an Evolving Global Environment
China Enables a Model to Succeed in an Evolving Global Environment BeiGene is uniquely positioned to leverage the large commercial base Dramatic changes to biopharma industry occurring – China increasingly key focal point for future Being able to effectively operate in clinical development in China
Slide 17: Established Collaborations Leverage China Capabilities
Established Collaborations Leverage China Capabilities and Expand Portfolio ▪ Obtained Celgene’s commercial operations and ▪ Global collaboration for co- license to three marketed products in development, manufacturing and China commercialization of conditionally active anti-CTLA-4 antibody BA3071 ▪
Slide 18: Financial Summary
Financial Summary Selected Financials Three Months Ended Six Months Ended Amounts in thousands of U.S. dollars, except for shares, American June 30, 2019 June 30, 2018 June 30, 2019 June 30, 2018 Depositary Shares (ADSs), per share and per ADS data) (unaudited) (unaudited) (unaudited) (unaudited) To
Slide 19: Upcoming Milestones and Catalysts
Upcoming Milestones and Catalysts Zanubrutinib (BTK Inhibitor) Timing Approval ▪ Approval in China for MCL and CLL ▪ 1H20 Submission ▪ File sNDA for WM in China ▪ 2019 Submission ▪ NDA filing in the U.S. ▪ 2019 or early 2020 Data ▪ Top-line Phase 3 data of zanubrutinib vs. ibrutinib in WM, ASPEN ▪ 2
Slide 20: Review of Product Candidates
Review of Product Candidates
Slide 21: Overview of Zanubrutinib (BGB-3111)
• Optimized pharmacologic properties relative to ibrutinib: superior bioavailability and higher selectivity OVERVIEW Overview of • Development hypothesis: more complete target inhibition, deeper Zanubrutinib responses, and favorable safety profile (BGB-3111) • More than 1,4501 patients enrolled acro
Slide 22: Zanubrutinib Clinical Program
Zanubrutinib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) FILED PH1a PH1b PH2* PH2** PH3 R/R CLL/SLL (NDA Accepted) R/R MCL (NDA accepted) WM: zanubrutinib vs. ibrutinib, ASPEN TN CLL/SLL: zanubrutinib vs. BR, SEQUOIA zanubrutinib R/R CLL/SLL: zanubrutinib vs
Slide 23: Zanubrutinib – Pharmacokinetics Profile
Zanubrutinib – Pharmacokinetics Profile zanubrutinib ibrutinib acalabrutinib Data from separate Ph1/2 trials^ 700 700 700 Ph3 Dose: Approved Doses: Ph3 Dose: • 160mg BID • 420mg QD for CLL/WM • 100mg BID 600 600 600 • 560mg QD for MCL/MZL 500 500 500 400 400 400 300 300 300 200 200 Adapted from 200
Slide 24: Zanubrutinib Efficacy in WM
Zanubrutinib Efficacy in WM Favorable response depth and durability Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in zanubrutinib WM Overall TN RR Evaluable for 73 24 49 efficacy, n 95% CI Median Follow-up 23.9 mo 12.3 mo 24.8 mo Mod. 6th IWWM Response Criteria (IgM decre
Slide 25: Ibrutinib Efficacy in WM
Ibrutinib Efficacy in WM Overall Response Rate (ORR) Progression Free Survival (PFS) Best Response in WM ibrutinib Enrolled, n 63 100 free Median Time-on-Treatment 19.1 months - 90 80 Modified 3rd IWWM 70 Response Criteria (IgM only) 60 50 Median Prior Lines of Tx 2 (1-9) 40 Survival (%) 30 20 ORR,
Slide 26: Zanubrutinib MYD88WT Data from Phase 1 and Phase 3 Cohort
Zanubrutinib MYD88WT Data from Phase 3 Cohort 2 and Phase 1 Suggest Activity in Difficult-to-Treat WM Patients Best response, Phase 3 cohort 21 Phase 12 n (%) (n=26) (n=8) EHA 2019 ORR 21 (80.8) 7(87.5) MRR 14 (53.8) 5(62.5) CR / VGPR 6 (23.1)a,b 2(25.0) PR 8 (30.8) 3(37.5) MR 7 (26.9) 2(25.0) SD 4
Slide 27: Zanubrutinib Efficacy in CLL/SLL
Zanubrutinib Efficacy in CLL/SLL Frequent and durable responses Overall Response Rate (ORR) Progression Free Survival (PFS) zanubrutinib TN CLL R/R CLL Total CLL n 16 50 66 free Median follow- - 7.6 14.0 10.5 up (mo) Best Response ORR 16 (100%) 46 (92%) 62 (94%) CR 1 (6%) 1 (2%) 2 (3%) Survival (%)
Slide 28: Ibrutinib Efficacy in CLL/SLL
Ibrutinib Efficacy in CLL/SLL Overall Response Rate (Relapsed / Refractory) Progression Free Survival (Relapsed / Refractory) n 85 free - Median FU (mo) 20.9 Best Response ORR 75 (88%) CR 2 (2%) PR 58 (68%) Survival PR-L 15 (18%) SD NR PD NR Probability Progression of Probability Overall Response Ra
Slide 29: Ibrutinib Discontinuation for toxicity or progression in CLL/SLL
Ibrutinib Discontinuation for toxicity or progression in CLL/SLL Treatment-Naïve (n=80) Relapsed/Refractory (n=536) Total (n=616) Median Follow-Up 14.5 months Total Treatment Discontinuation 19 (24%) 231 (43%) 250 (41%) Toxicity/Tolerability 12 (15%) 117 (22%) 129 (21%) CLL/SLL Progression 3 (4%) 49
Slide 30: Zanubrutinib Discontinuation for toxicity or progression in CLL/SLL
Zanubrutinib Discontinuation for toxicity or progression in CLL/SLL is uncommon Treatment-Naïve (n=18) Relapsed/Refractory (n=51) Total (n=69) Median Follow-Up 10.3 months Total Treatment D/C 0 (0%) 2 (4%) 2 (3%) Toxicity/Tolerability 0 (0%) 1 (2%) 1 (1%) CLL/SLL Progression 0 (0%) 0 (0%) 0 (0%) Tra
Slide 31: Zanubrutinib Safety and Tolerability Summary
Zanubrutinib Safety and tolerability summary; Over 600-patient experience Adverse Events of Interest for BTK Inhibitors in Patients Treated with Zanubrutinib Zanubrutinib Zanubrutinib AE of Interest (All Causes)1 (Including Patients AE of Interest (All Causes)2 (Single Agent Only) Enrolled in Combo
Slide 32: Zanubrutinib Responses Across Additional B-Cell Malignancies
Zanubrutinib Responses Across Additional B-Cell Malignancies MZL MCL MCL FL FL DLBCL China CSCO Source ASH 20171 ICML 20193 pivotal data ASH 20171 ASH 20171 20184 ASH20182 n 9 48 85 17 26 26 Follow-up 7.0 mo 16.7 mo 35.9 wk 7.8 mo 9.5 mo 4.2 mo (med) Prior Lines 2 (1-8) 1 (1-4) 2 (1-4) 2 (1-8) 3 (1-
Slide 33: Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma
Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma Data from separate trials Zanubrutinib + FL Zanubrutinib Ibrutinib Obinutuzumab Idelalisib Obinutuzumab Source ICML 20191 ASH 20172 ASH 20163 JCO 20134 NEJM 20145 n 36 17 110 34 72 prior alkylator and CD20, prior alkylator and CD20, m
Slide 34: Ongoing Global Phase 3 Study ASPEN
Ongoing Global Phase 3 Studies ASPEN Zanubrutinib vs. Ibrutinib in WM Cohort 1: R/R or TN* WM with MYD88L265P mutation Arm A *TN must be unsuitable for standard chemoimmunotherapy Zanubrutinib 160 mg BID until PD MYD88MUT WM patients R (N=201, 164 R/R) 1:1 Arm B Ibrutinib 420mg QD until PD Primary e
Slide 35: Ongoing Global Phase 3 Studies SEQUOIA and ALPINE
Ongoing Global Phase 3 Studies SEQUOIA and ALPINE Zanubrutinib vs. BR in 1L CLL/SLL Phase 3 Zanubrutinib Vs Ibrutinib in R/R CLL/SLL Cohort 1: Non–17p del TN CLL Arm A Must be not suitable for FCR Zanubrutinib Relapsed/Refractory CLL/SLL 160 mg BID until PD Arm A Previously (received ≥ 1 prior treat
Slide 36: Ongoing Pivotal Study Zanubrutinib + Obinutuzumab in R/R FL
Ongoing Pivotal Study Phase 2 Zanubrutinib + Obinutuzumab vs Obinutuzumab in R/R FL Relapsed/Refractory FL (received ≥2 prior treatments*) Arm A Zanubrutinib 160 QD + Obinutuzumab X 6 cycles then q 8 wks until PD Grade 1, 2, or 3a FL (n = 140) patients R 2:1 (N=210) Arm B Obinutuzumab X 6 cycles the
Slide 37: Zanubrutinib Potentially Addresses Areas of Need
Zanubrutinib Potentially Addresses Areas of Need for Patients Treated with BTK Inhibitors Efficacy • Complete and sustained target inhibition may result in better response quality • We are testing this hypothesis in Phase 3 head-to-head trials against ibrutinib in WM and CLL Tolerability • In “real-
Slide 38: Overview of Tislelizumab (BGB-A317)
• Tislelizumab is a PD-1 checkpoint inhibitor with distinct molecular structure and an engineered Fc region; believed to minimize potentially negative interactions with other immune cells1 Overview of • Pivotal data in lead indication: 87% ORR (63% CR) in R/R cHL • Broad development in Asia-prevalen
Slide 39: Tislelizumab Clinical Program
Tislelizumab Clinical Program Broad development for Asia-prevalent cancers Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) TUMOR FILED PH1a PH1b PH2* PH2** PH3 R/R cHL (NDA accepted) Heme R/R NK/T-cell lymphoma 2L+ UC (NDA accepted) Bladder 1L UC 2L NSCLC 1L non-squamous NSCLC L
Slide 40: Tislelizumab's Lack of FcγR Binding
Tislelizumab’s Lack of FcγR Binding Is Designed to Prevent Macrophage-Mediated T-Cell Clearance We believe the different FcγR design may have meaningful differences in the clinic Antibody-Dependent Cellular Phagocytosis Tislelizumab Differential Preclinical Efficacy in in vivo Mouse Tumor Model Base
Slide 41: Tislelizumab China cHL Pivotal Trial Data
Tislelizumab China cHL Pivotal Trial Data Deep and frequent responses observed in both transplant-ineligible patients and patients who failed transplant Baseline Characteristics Total (N=70) Age (years), median (range) 32.5 (18, 69) Age group <65 / 65-74 years, n (%) 66 (94.3) / 4 (5.7) 40 (57.1) /
Slide 42: Summary of Tislelizumab Adverse Events
Summary of Tislelizumab Adverse Events cHL pivotal trial Summary of Treatment-Emergent TEAEs in ≥10% of Patients and Grade ≥3 TEAEs in ≥2 Adverse Events Patients Regardless of Causality Event, n (%) N=70 Pyrexia Grade ≥3 TEAE 21 (30) Hypothyroidism Serious TEAE 12* (17.1) Weight increased TEAE leadi
Slide 43: Tislelizumab China UC Pivotal Trial Data
Tislelizumab China UC Pivotal Trial Data Activity in previously treated patients UC Enrolled Patients/evaluable N=113/104 Median Follow-up 8 months ORR 23.1% CR 7.7% PR 15.4% • IRC assessed • Frequency and severity of adverse events were generally consistent with the previously reported Phase 1/2 sa
Slide 44: Tislelizumab Response Data in Disease-Specific Cohorts
Tislelizumab Response Data in Disease-Specific Cohorts Gastric Esophageal Head & Neck Ovarian Hepatocellular Urothelial MSI-H / Tumor Type NSCLC NPC Cancer Cancer SCC Cancer Carcinoma Cancer dMMR ESMO-IO Source ESMO-IO 20181 ESMO-IO 20181 ESMO 20172 ESMO 20173 ESMO-IO 20181 ESMO-IO 20181 CSCO 20185
Slide 45: Tislelizumab Phase 1 Common AEs
Tislelizumab Phase 1 Common AEs in ≥ 10% of Patients Phase 1a Phase 1b Total System Organ Class Preferred Term N=116 N=335 N=451 n (%) n (%) n (%) Patients with at least one TEAE 114 (25.3) 322 (71.4) 436 (96.7) Fatigue 47 (10.4) 78 (17.3) 125 (27.7) Nausea 41 (9.1) 68 (15.1) 109 (24.2) Decreased ap
Slide 46: Tislelizumab Chemotherapy Combination Data in Lung Cancers
Tislelizumab Chemotherapy Combination Data in Lung Cancers Non-Sq Sq Sq SCLC Tislelizumab + Tislelizumab + Tislelizumab + Tislelizumab + Total Responses pemetrexed + paclitaxel + gemcitabine + etoposide + (N=54) platinum (n=16) platinum (n=15) platinum (n=6) platinum (n=17) BOR, n (%) CR 0 0 0 0 0 P
Slide 47: Overview of Pamiparib (BGB-290)
• Highly selective PARP1 and PARP2 inhibitor with potential brain OVERVIEW Overview of penetration and strong PARP trapping activity in preclinical studies Pamiparib • Ph1/2 data demonstrated pamiparib was generally well-tolerated with (BGB-290) CLINICAL promising anti-tumor activity in ovarian canc
Slide 48: Pamiparib Clinical Program
Pamiparib Clinical Program Global China DOSE ESCALATION DOSE EXPANSION PIVOTAL PROGRAM (TARGET) PH1a PH1b PH2* PH2** PH3 3L gBRCA+ OC 2L plat-sensitive OC maintenance pamiparib (BGB-290, PARP) 1L plat-sensitive GC maintenance Solid tumors + TMZ (Chemo) Solid tumors + RT/TMZ (RT/Chemo) Solid tumors +
Slide 49: Pamiparib Monotherapy Phase 1/2 Data
Pamiparib100 Monotherapy Phase 1/2 Data 80 Promising activity and generally well-tolerated 60 Best Change from Baseline in Target Lesions in Epithelial 40 Summary of Adverse Events from Across the Ph1/2 Trial 100 Ovarian Cancer and Other Associated Tumors BRCA+ 2080 Ph1 Ph1 Total BRCA-WT BRCA Unknow
Slide 50: Tislelizumab/Pamiparib Combination Escalation Data
Tislelizumab/Pamiparib Combination Escalation Data Generally well-tolerated with preliminary anti-tumor activity in multiple tumor types • Ovarian or fallopian tube cancer patients (n=29) had best responses of CR (1), PR (2 confirmed, 5 unconfirmed), and SD (7). Breast cancer patients (n=2) had 1 co
Slide 51: Thank you
Thank you 51