EX-99.2 3 bgneinvestordeckhkannrev.htm EXHIBIT 99.2 bgneinvestordeckhkannrev
2018 Annual Results Review and Investor Presentation February 27-28, 2019


 
Disclosures ▪ Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Examples of such forward-looking statements include those regarding investigational drug candidates and clinical trials and the status and related results thereto, as well as those regarding continuing and further development and commercialization efforts and transactions with third parties. Such statements, based as they are on the current analysis and expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BeiGene’s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical industries, changes in the global and regional regulatory environments in the jurisdictions in which BeiGene does business, market volatility, fluctuations in costs and changes to the competitive environment. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. In the case of forward-looking statements regarding investigational drug candidates and continuing further development efforts, specific risks which could cause actual results to differ materially from BeiGene’s current analysis and expectations include: failure to demonstrate the safety, tolerability and efficacy of our drug candidates, final and quality controlled verification of data and the related analyses, the expense and uncertainty of obtaining regulatory approval, including from the FDA, NMPA (formerly CFDA/CDA) and EMA, the possibility of having to conduct additional clinical trials and BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services. Further, even if regulatory approval is obtained, pharmaceutical products are generally subject to stringent on-going governmental regulation, challenges in gaining market acceptance and competition. These statements1 are also subject to a number of material risks and uncertainties that are described in BeiGene’s filings with the Securities and Exchange Commission (SEC). The reader should not place undue reliance on any forward- looking statements included in this presentation or in the accompanying oral presentation. These statements speak only as of the date made, and BeiGene is under no obligation and disavows any obligation to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. ▪ Clinical data in this presentation relating to BeiGene’s investigational drug candidates is from early phase, single-arm trials. When such data are presented in relation to other investigational or marketed drug products, the presentation and discussion are not based on head-to-head trials between BeiGene’s investigational drug candidates and other products. BeiGene is still conducting clinical trials and, as additional patients are enrolled and evaluated, data on BeiGene’s investigational drug candidates may change. ▪ This presentation and the accompanying oral presentation contains data and information obtained from third-party studies and internal company analysis of such data and information. BeiGene has not independently verified the data and information obtained from these sources. Forward-looking information obtained from these sources is subject to the same qualifications noted above. 2


 
Agenda • Welcome and Introduction – John Oyler, Founder, CEO and Chairman • Commercial Operations Highlights – Dr. Xiaobin Wu, General Manager of China and President of BeiGene • Clinical Programs Updates – Dr. Eric Hedrick, Chief Advisor • Financial Results – Dr. Howard Liang, CFO and Chief Strategy Officer • Q&A 3


 
John V. Oyler 4


 
2018 • Established leadership in China-inclusive global development Highlights to leverage the historic opportunity that China represents and 2019 • Broad clinical programs advancing with compelling data Outlook readouts and significant trial and regulatory progress • Expanded the BeiGene team to over 2,200 people and made key hires in Dr. Xiaobin Wu, our China GM, and Dr. Yong Ben, our CMO of Immuno-oncology • Significantly expanded commercial capabilities and demonstrated success with existing portfolio • Strengthened our manufacturing team with key additions and continued buildout of our Guangzhou facility • Well positioned for 2019, a potentially transformational year for BeiGene with key launches, data readouts and potential filings 5


 
2018 Business Highlights and Accomplishments Assets Compelling Data Readouts Significant Trial and Regulatory Progress ✓ 1 ✓ 5 MCL China CLL/SLL China ✓ • 84% ORR • 80% ORR China NDAs R/R MCL and R/R CLL/SLL announced acceptance 8/26 and 10/24 • 59% CR • 2% CR ✓ Priority review status granted to NDA in R/R MCL 11/15 and R/R CLL/SLL 1/14/19 ✓ WM global Ph12 ✓ Fast Track WM; Breakthrough Therapy MCL • 82% MRR BTK • 41% VGPR ✓ First global Ph3 trial (H2H vs. ibrutinib in WM) completed enrollment 7/22 ✓ Pooled safety data from 476 patients3 ✓ Initiated second Ph.3 trial in CLL (vs. ibrutinib); global pivotal Ph2 trial in MZL; all • Low rate of A-fib (2%, only 1 Gr3) 3 pivotal trials in China completed enrollment • Low rate of severe hemorrhage (2%) ✓ cHL China pivotal4 ✓ China NDA cHL announced acceptance 8/31; priority review granted 11/15 PD-1 • 86% ORR ✓ 7 late-stage trials initiated, total of 11 ongoing* • 61% CR ✓ Initiated China Ph3 in OC PARP ✓ Initiated global Ph3 in GC Capabilities COMMERCIAL CLINICAL ✓ Product revenues grew 2.5x from 4Q17 to 4Q18 ✓ 800+ clinical development team ✓ Launched VIDAZA and REVLIMID in NDMM in China ✓ Running 21 pivotal or potentially registrational trials ✓ Vidaza added to NRDL, expanded reimbursement for ABRAXANE ✓ 2000+ subjects enrolled across all clinical programs during 20186 into Jiangsu and Hunan (PRDL) and Shandong (CII) ✓ Over 50 ongoing or planned clinical trials 1. ASH 2018 Song et al.; 2. Tam et al. IWWM 2018; 3. Tam et al. EHA 2018 [Abstract PF445]; 4. ASH 2018 Song et al., Safety data below; 5. Pivotal trial, BeiGene press release 10/24/18; 6 6. as of Dec 31, 2018; *Tislelizumab global Ph3 in 1L GC and 1L ESCC, 2L ESCC, Ph2 in HCC, Ph2 in NK/T lymphoma, and 2 China Ph3’s in NSCLC initiated (squamous, non- squamous). Other ongoing include 2 global Ph3 in NSCLC and HCC, 2 China pivotal in cHL and urothelial carcinoma. PRDL = Provincial Reimbursement Drug List, CII = Critical Illness Insurance


 
Developing Strong Manufacturing Capabilities Multi-Functional Manufacturing Experienced High-Quality Biologics Manufacturing Facility in Facility in Suzhou Manufacturing Partners Guangzhou (under construction) • Aligned with the design criteria of US, EU and • Manufacturing collaborations with leading • Joint venture with Guangzhou Development China high-quality manufacturers in biologics District • Total area of 9,000m² and small molecules • Investment of $300+ million -- mostly from • Commercial-scale small molecule drug • BI collaboration established 2013; cell external funding but BeiGene retains majority products facility, ~100M pills annual capacity line and CMC process for tislelizumab equity ownership developed by BI • Pilot-scale biologic facility at 500L scale • 100,000 square meter manufacturing site; • Commercial scale 2,000L at BI’s Shanghai 24,000-liter commercial-scale biologics expandable facility manufacturing facility • First phase of the manufacturing plant planned to be completed in 2019 William Novotny, Advisor, Zhengming Du, Ph.D. Jonathan Liu, Ph.D. Michael Garvey Technical Operations Head of Chemistry SVP, Bio-Manufacturing VP, Head of • BMS, VP and Global Lead Manufacturing & Control • J&J, Head of China Guangzhou Biologics (CMC) Manufacturing 7 in Supply Chain Pharmaceutical • Merck, AVP in Global • Roche China, Head of Development and • Samsung Biologics, Supply Chain Management Process and Synthesis, Manufacturing VP of Manufacturing and Product Operations Deputy Head of CMC Sciences 7


 
Our Strategy Building a Leading Global Biotech Company From China with the Utmost Commitment to Patients Globally, Through Quality, and Science Realize two large near-term commercial opportunities: BTK and PD-1 Strengthen and deepen key strategic capabilities including global clinical development, commercial footprint, and manufacturing … … to capture opportunities created by regulatory reforms in China NMPA (reimbursement and clinical) and continue to expand our portfolio Pursue a different, truly global model by leveraging our strengths in China and clinically 8


 
Leveraging China Strengths to Pursue Global Clinical Excellence BeiGene Is Becoming a Leader in China-Global Clinical Development • Leader in global China-inclusive clinical development (initiated 6 of the first wave); • Clinical team of over 800, with over 50% in China and remainder in US, EU, AU • Largest oncology-focused clinical development team in China • 21 pivotal trials or potentially registration-enabling trials ongoing • 50+ ongoing or planned clinical trials in China and globally with 4,000+ patients and healthy subjects enrolled Countries with BeiGene clinical trial sites • Regulatory interactions and monitoring from 20+ countries 9


 
Establishing Collaborations to Leverage Unique Clinical Capabilities to Expand Our Portfolio ▪ In-licensed ZW25 and ZW49 in Asia ▪ In-licensed sitravatinib in Asia (ex-JP) and AU/NZ; global research and (ex-JP) and AU/NZ license agreement for AzymetricTM and ▪ Leverage China capabilities to expedite EFECTTM platforms Agreement: Jan. 2018 and expand global development Agreement: Nov. 2018 ▪ sitravatinib program ZW25 HER2-targeted Leverage China capabilities to expand (multi-kinase inhibitor including ▪ Encouraging results -- 16 PRs and CRs bispecific antibody and pipeline in areas of high interest (breast and TAM receptors (TYRO3, Axl, ZW49 bispecific antibody (9 confirmed) in 56 patients -- reported gastric cancers) MER), split receptors (VEGFR2, drug conjugate (ADC); ▪ KIT) and RET) by Mirati in an ongoing Ph2 trial in AzymetricTM and EFECTTM Complements existing portfolio; broadens combination with nivolumab in NSCLC platforms biologic pipeline patients who have progressed on ▪ Access to bispecific antibody discovery checkpoint inhibitor therapy1 platform ▪ Global clinical collaboration to ▪ Global clinical collaboration to evaluate in RAS-mutant advanced solid evaluate safety and efficacy in B-cell tumors in combination with BeiGene’s malignancies in combination with Agreement: Sept. 2018 RAF dimer inhibitor lifirafenib. zanubrutinib. ▪ MEK inhibitor PD-0325901 Leverage China capabilities to expedite ▪ MEI will amend its ongoing Phase 1b trial (MEK inhibitor synergistic with and expand global development Agreement: Oct. 2018 to include evaluation of ME-401 and RAF inhibition in RAS-mutant program ME 401 zanubrutinib combination therapy in solid tumors) ▪ Phase 1b clinical study is expected in (oral phosphatidylinositol 3- patients with B-cell malignancies 1Q19 kinase , PI3K, delta inhibitor) 10 1. ESMO 2018 Ticiana et al.


 
China Enables a Model to Succeed in an Evolving Global Environment Dramatic changes to biopharma industry occurring – China increasingly key focal point for future Changes enable an alternative model, for which BeiGene was specifically built Expand global access to medicines to 3- 4B people (~3x historic pharma model) Pursue different, truly global model without sacrificing quality, innovation, or science 11


 
Xiaobin Wu, Ph.D. 12


 
China’s Overall Pharmaceutical Market Is Still Dominated by Generics 2017 China Western Medicine Top 10 brands in China vs. the U.S.* Market China 3Q2018 MAT $Mn U.S. 3Q2018 MAT $Mn LIPITOR 788 HUMIRA 18,119 Local MNC patented JIA LUO NING 760 EMBREL 7,773 patented 0.4% PLAVIX LANTUS 12.8% 732 7,696 PULMICORT 703 ELIQUIS 6,187 SULPERAZON 603 NOVORAPID 5,703 OPO** 22.4% XUE SHUAN TONG 517 HUMALOG 5,451 Generics 65.8% DAN HONG 465 JANUVIA 5,419 EN BI PU 461 LYRICA 5,244 DANSHEN… 407 REMICADE 5,161 LI PU SU 375 XARELTO 4,806 13 Source: IQVIA data (hospital channel) and McKinsey Report. *IQVIA 3Q2018 MAT USD / RMB=6.7812 :1. OPO: Off Patent Originator; MNC: Multi-national Corporations


 
Market Growth Is Shifting Towards Therapeutics Value Share by Category Growth Trend by Category Nov. 2018 YTD Nov. 2018 YTD 11.0% IV 5.1% Auxiliary Medicine 15.8% 3.1% Therapeutics 58.5% TCM 20.6% -3.8% -5.6% -7.4% Total Market IV TCM Auxiliary Therapeutics Drugs Source: IQVIA. TCM: Traditional Chinese Medicine; IV: Intravenous-used Solution; Therapeutics: all other products excluding IV, 14 TCM and Auxiliary Drugs.


 
Oncology Is the Fastest Growing and One of the Largest Therapeutic Areas in China China Key Therapeutic Areas Value Growth Dynamics, 2012 - 2017 - Billion USD, based on ex-factory price, include hospital (bed size over 100) and retail channels 20 China Market Avg. CAGR – 9.1% 16 Oncology 17) % 17) 12 - Antithrombotic 8 Diabetes 4 Vasotherapeutics Hypertension China Market Avg. Growth – 4.2% 0 Antibiotics Ulcerants term Growth (16 Growth term TCM - -4 Intra Solution Cardiac Short -8 Immuno CNS -12 2 3 4 5 6 7 8 9 10 11 12 13 Long-term Growth (12-17) % Source: IQVIA Midas database; IQVIA analysis. 15 Bubble size represents therapeutic area value.


 
BeiGene’s 2018 Commercial Organization Growth Commercial Team Sub Groups A growing 600+ top innovative oncology commercial team targeting to cover 800 – 1,000 Sales 1 hospitals in China Marketing 1000 KA 900 800 Market Access 700 Others 600 500 Commercial Team Background 400 MNC 300 200 Local 100 Pharma/Biotech 0 Gov / Hospital 4Q2017 1Q2018 2Q2018 3Q2018 4Q2018 MNC over 80% Others 16 1. As of December 31, 2018


 
Strong Core Product Growth Under BeiGene Mn RMB Mn RMB Mn RMB 150 150 15 14% Growth QoQ 42% Growth QoQ 81% Growth QoQ 120 120 12 90 90 9 60 60 6 30 30 3 0 0 0 4Q17 1Q18 2Q18 3Q18 4Q18 4Q17 1Q18 2Q18 3Q18 4Q18 4Q17 1Q18 2Q18 3Q18 4Q18 *REVLIMID® approved as a combination therapy with dexamethasone; ABRAXANE® is included in PRDL of Fujian, Hubei, Ningxia, Jiangsu, Hunan; CII of 17 Zhejiang and Shandong as of December 25, 2018. VIDAZA® is approved in MDS, CMML and AML and first commercial availability and inclusion on NRDL in 2018. NRDL = National Reimbursement Drug List, PRDL = Provincial Reimbursement Drug List, CII = Critical Illness Insurance.


 
Existing Portfolio Provides Market Presence for Launch of Internally Developed Assets th 2018 BeiGene The 15 Congress of Oncology Forum China Society of Hematology (Launched Revlimid Patient Assistance 2018 Annual Meeting of Program) 2018 BeiGene China Society of Clinical Hematology Forum 2018 BeiGene 2nd Oncology Hematology Forum March May September October December 18 2018 2018 2018 2018 2018


 
Preparing to Launch Zanubrutinib and Tislelizumab Vision Establish as the Gold Standard Treatment for Approved Indications DRIVE INTERNAL STRENGTHS AND EXTERNAL ENGAGEMENTS • Trials designed to show differentiated • Expand and accelerate market competitive clinical data access • Broad indications under development • Hospital and key accounts coverage • Global ongoing trials in large • Government engagement with indications to support potentially broad central and regional authorities label • Medical affairs, KOL engagement • Focus on quality manufacturing in and patient education small molecule and biologics CONTINUE TO BUILD MARKETED PRODUCTS LEVERAGE EXISTING INFRASTRUCTURE • Gov. • Medical • Market • Sales and Affairs Affairs Access Marketing 19


 
Building Commercial Presence Outside of China • U.S. – Preparing for potential launch of zanubrutinib, planned filing in 2019 or early 2020 – Hired senior management for key commercial functions – Planning to build a hematology salesforce • EU – Evaluating commercialization strategy including potential collaborations • New Markets – Planning to pursue a true global model for growth by leveraging China Countries with BeiGene commercial teams Countries with BeiGene clinical trial sites 20


 
Eric Hedrick, M.D. 21


 
22 In-Licensed Internally-Developed ThreeMarketed Products in China, ThreeLate BeiGene Product Portfolio and Pipeline with Mirati Therapeutics, with Mirati Therapeutics, Inc; APACstudy. with Zymeworks Collaboration 3. s in tislelizumab commercialize and the has right develop to 1. Celgene with dexamethasone.therapy a as combination approved * Some indications will not require non a require not will Someindications ABRAXANE zanubrutinib tislelizumab sitravatinib REVLIMID avadomide BGB BGB pamiparib lifirafenib (RAF (RAF Dimer) VIDAZA ASSETS ZW25 (PD (PARP) (TIM (PD (BTK) - - - A425 A333 - L1) - 1) 3) PROGRAM ® ® ® (TARGET) PROGRAMS(MECHANISMS) (albumin monotherapy chemo combo tislelizumab tislelizumab combo monotherapy monotherapy RT/TMZ combo TMZ combo monotherapy zanubrutinib combo monotherapy pamiparib pamiparib combo GAZYVA (bispecific HER2 antibody ) antibody HER2 (bispecific (multi (IMiD) (CC tislelizumab combo monotherapy (hypomethylating agent) (hypomethylating - 122, CELMoD) 122, - kinase inhibitor)kinase - bound paclitaxel) bound ® combo combo - pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. trials. **Conf Ph2 or Ph3 clinical pivotal to beginning prior trial clinical Ph2 pivotal (Chemo) and and (Chemo) (RT/Chemo) (CD20) (PARP) (PD (PD (BTK) - - 1) 1) DOSE ESC. Planned Planned (in Ph2 ex Planned Planned (in Ph1b ex PH1a . DOSE EXPANSION PH1b - - China China by Celgene) Stage Assets,and Six Early - China China by Zymeworks PH2* ) PH2** PIVOTAL irmatory clinical trials post approval are required for accelerated approvals. ***REVLIMID approvals. for accelerated are required post trials approval clinical irmatory PH3 oli d d U.S., the in tumors rest EU, the and Japan Marketed Marketed Marketed - FILED StageClinical Assets • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • LEADINDICATIONS 1L GC, GC, 1L ESCC1L Sq1L 1L NSCLC,Non Solid tumorsSolid NHL AMLMDS, 20 with Breast cancer (Ph3) R/R MMNDMM(marketed), R/R NHL (marketed), tumorsSolid B B Glioblastoma tumorsSolid platinum 1L platinum 2L cancer ovarian gBRCA+3L tumorsSolid B R/R NK/T HCC 2L/3L ESCC 2L 1L HCC, NSCLC,2L Ph2) UC(pivotal 2L+ accepted) (NDAR/R HL R/R MZL WM, 1L R/R CLL/SLL CLL/SLL, R/R WM R/R MCL, Solid tumorsSolid Solid tumorsSolid R/R FL HER2+ gastric, cancers other gastric, breast and HER2+ - - - Raf Raf malignancies cell - - or K or K or - cell cell lymphoma R/R CLL/SLL - - - - RAS/N RAS/N sensitive cancer maintenance gastric sensitive cancer maintenance ovarian sensitive - - - - 30% bone marrow blasts, blasts, marrowCMMoLbone 30% RAS RAS of - world world of outside Asia. - Sq NSCLCSq - - (NDAs accepted) mutated solid tumors solid mutated tumors solid mutated 2 .Collaboration .Collaboration ® Global Global (heme malignancies) Asia ex Asia Asia ex Asia ex Asia tumors) COMMERCIAL AU,NZ AU,NZ - Japan (solid Japan (solid China China China China Global Global Global Global Global Global China Global RIGHTS - - Japan, Japan, Japan, ¹ 3 2


 
Zanubrutinib Clinical Program Broad Clinical Development Plan Global China COMMERCIAL DOSE ESC. DOSE EXPANSION PIVOTAL PROGRAM (TARGET) FILED RIGHTS PH1a PH1b PH21 PH22 PH3 Relapsed / Refractory (R/R) chronic lymphocytic leukemia / small lymphocytic leukemia (CLL/SLL) (NDA Accepted) R/R mantle cell lymphoma (MCL) (NDA accepted) Waldenstrom’s macroglobulinemia (WM): zanubrutinib vs. ibrutinib Treatment-naïve CLL/SLL: zanubrutinib vs. BR zanubrutinib (BGB-3111, BTK) Worldwide R/R CLL/SLL: zanubrutinib vs. ibrutinib R/R marginal zone lymphoma (MZL) WM R/R diffuse large B-cell lymphoma B-cell malignancies R/R follicular lymphoma: zanubrutinib + GAZYVA® vs. GAZYVA® zanubrutinib + GAZYVA® (BTK + CD20) Worldwide B-cell malignancies tislelizumab + zanubrutinib (PD-1 + BTK) Worldwide Hematological tumors ▪ More than 1,300 patients3 treated with zanubrutinib across the program, including combination trials 1. Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. 2. Confirmatory clinical trials post approval are 23 required for accelerated approvals. 3. as of December 31, 2018


 
Ongoing Global Phase 3 Studies Zanubrutinib vs. Ibrutinib in WM L265P Cohort 1: R/R or TN* WM with MYD88 mutation Arm A Zanubrutinib *TN must be unsuitable for standard chemoimmunotherapy 160 mg BID until PD MYD88MUT WM (n = 75) patients R (N=150) 1:1 Arm B Ibrutinib 420mg QD until PD Primary endpoint: CR or VGPR (n = 75) Cohort 2: WM with wild type MYD88; present in ~10% of enrolled patients Arm C MYD88WT WM patients Zanubrutinib (N = 15-20) 160 mg BID until PD WM=Waldenstrom’s macroglobulinemia, BID=twice daily, CR=complete response, MUT=mutation, PD=progressive disease, QD=once daily, R=randomization, R/R=relapsed/refractory, 24 TN=treatment naïve, VGPR=very good partial response, WT=wild type. This study is registered at ClinicalTrials.gov (NCT03053440)


 
Ongoing Global Phase 3 Studies 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 (received ≥ 1 160 mg BID until PD Arm A Previously prior treatments) untreated R Zanubrutinib CLL patients 1:1 160mg BID (N=420) (n = 200) Arm B R/R CLL/SLL ≥ 1 prior Bendamustine Primary endpoint: PFS treatment R + Rituximab (BR) 1:1 × 6 cycles (N=400) Arm B Ibrutinib 420mg QD Cohort 2: 17p del TN CLL (n = 200) Previously untreated Arm C Primary Endpoint: ORR (non-inferiority and superiority) 17p del CLL patients Zanubrutinib (N=110) 160 mg BID until PD 1L=first-line treatment, BID=twice daily, CLL=chronic lymphocytic leukemia, del=deleted, FCR=fludarabine, cyclophosphamide, and rituximab, ORR=overall response rate, PD=progressive 25 disease, PFS=progression-free survival, QD=once daily, R=randomized, SLL=small lymphocytic lymphoma, TN=treatment naïve. These studies are registered at ClinicalTrials.gov (NCT03734016) and (NCT03336333).


 
Ongoing Global Phase 3 Studies 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 (received ≥ 1 160 mg BID until PD Arm A Previously prior treatments) untreated R Zanubrutinib CLL patients 1:1 160mg BID (N=420) (n = 200) Arm B R/R CLL/SLL ≥ 1 prior Bendamustine Primary endpoint: PFS treatment R + Rituximab (BR) 1:1 × 6 cycles (N=400) Arm B Ibrutinib 420mg QD Cohort 2: 17p del TN CLL (n = 200) Previously untreated Arm C Primary Endpoint: ORR (non-inferiority and superiority) 17p del CLL patients Zanubrutinib (N=110) 160 mg BID until PD Cohort 2 enrollment completed 1L=first-line treatment, BID=twice daily, CLL=chronic lymphocytic leukemia, del=deleted, FCR=fludarabine, cyclophosphamide, and rituximab, ORR=overall response rate, PD=progressive 26 disease, PFS=progression-free survival, QD=once daily, R=randomized, SLL=small lymphocytic lymphoma, TN=treatment naïve. These studies are registered at ClinicalTrials.gov (NCT03734016) and (NCT03336333).


 
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 then q 8 wks until PD (n = 70) Primary Endpoint: ORR 27 CLL/SLL=chronic lymphocytic leukemia/small lymphocytic lymphoma, FL=follicular lymphoma, ORR=overall response rate, PD=progressive disease, PFS=progression-free survival, QD=once daily, R=randomization. *Must have received prior treatment with rituximab and an alkylator; relapsed <12 months from end of last treatment OR refractory to last treatment. This study is registered at ClinicalTrials.gov (NCT03332017).


 
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-world” ibrutinib use in CLL, not only acute/ serious toxicities (atrial fibrillation, serious bleeding), but cumulative tolerability issues (myalgia, arthralgia, hypertension) are frequently treatment-limiting – Zanubrutinib to date has been associated with low rates of toxicity-related discontinuations and cumulative “off-target” toxicities • Drug-Drug Interactions – Based on drug interaction studies, co-administration with strong CYP3A inhibitors is permitted • Includes important agents in management of leukemia/ lymphoma patients, such as azole anti-fungals – Co-administration of proton pump inhibitor (PPIs) or other Acid-Reducing Agents (ARA) does not affect zanubrutinib exposure – Patients have been allowed to receive warfarin and aspirin on zanubrutinib trials 28


 
Tislelizumab Clinical Program Broad Development for Asia-Prevalent Cancers Global China COMMERCIAL DOSE ESC. DOSE EXPANSION PIVOTAL PROGRAM (TARGET) FILED RIGHTS1 PH1a PH1b PH2* PH2** PH3 Relapsed / Refractory (R/R) Hodgkin’s lymphoma (NDA accepted) 2L non-small cell lung cancer Worldwide 1L hepatocellular carcinoma (Heme 2L esophageal squamous cell carcinoma tislelizumab (BGB-A317, PD-1) Malignancies); 1L gastric cancer Asia ex-Japan (Solid Tumors) 1L esophageal squamous cell carcinoma Stage III non-small cell lung cancer 2L/3L hepatocellular carcinoma R/R NK/T-cell lymphomas 1L non-squamous non-small cell lung cancer 1L squamous non-small cell lung cancer 2L+ urothelial carcinoma MSI-H or dMMR solid tumors Solid tumors tislelizumab + pamiparib (PD-1 + PARP) Worldwide Solid tumors tislelizumab + zanubrutinib (PD-1 + BTK) Worldwide Hematological tumors ▪ More than 2,200 patients2 enrolled over 3 years across tislelizumab program, including combination trials ▪ Broad development global program in collaboration with Celgene with additional Ph3/potential registration-enabling trials planned in lung, gastric, liver, and esophageal cancers 29 *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials. **Confirmatory clinical trials post-approval are required for accelerated approvals. 1. Celgene has the right to develop and commercialize tislelizumab in solid tumors in the United States, European Union, Japan and the rest-of-world outside of Asia; BeiGene retains rights to internal combinations. 2. As of December 31, 2018


 
Tislelizumab Broad Late-stage Development Program Eleven ongoing potentially registration-enabling trials Global Trials (China and ROW) Potential registration- Phase 3 (n=840) in Stage III NSCLC Phase 3 (n=800) in 2L NSCLC enabling trials based on tislelizumab vs. docetaxel Tislelizumab + cCRT followed by tislelizumab vs. cCRT followed by regulatory feedback NSCLC tislelizumab vs cCRT alone Primary endpoint: OS Primary endpoint: PFS Under NMPA review Initiated in Nov. 2017 Open for enrollment Phase 3 (n=640) in 1L HCC Phase 2 (n=225) in 2L/3L HCC Other late-stage studies tislelizumab vs. sorafenib tislelizumab monotherapy HCC Primary endpoint: OS Primary endpoint: ORR by IRC Initiated in Jan. 2018 Initiated in Apr. 2018 Phase 3 (n=450) in 2L ESCC Phase 3 (n=480) in 1L advanced ESCC tislelizumab vs. single-agent chemo (paclitaxel, docetaxel, or irinotecan) tislelizumab or placebo + platinum- and fluoropyrimidine-based chemo ESCC Primary endpoint: OS Co-primary endpoints: PFS and OS Initiated in Jan. 2018 Initiated in Dec. 2018 Phase 3 (n=720) in 1L advanced GC R/R Phase 2 (n=90) in 1L R/R Mature T- and NK- Neoplasms tislelizumab monotherapy GC tislelizumab or placebo + platinum- and fluoropyrimidine-based chemo NK/T-cell Co-primary endpoints: PFS and OS lympho Primary endpoints: ORR Initiated in Dec. 2018 mas Initiated in Apr. 2018 China Trials Phase 3 (n=340) in 1L Stage IIIB or IV squamous NSCLC Phase 3 (n=320) in 1L Stage IIIB or IV non-squamous NSCLC Tislelizumab+ paclitaxel and carboplatin combo or nab-paclitaxel and Tislelizumab+ chemo (platinum-pemetrexed) vs. chemo NSCLC carboplatin combo vs. paclitaxel and carboplatin combo Primary endpoint: PFS Primary endpoint: PFS Initiated in Jul. 2018 Initiated in Aug. 2018 Pivotal phase 2 (n=110) in 2L UC Pivotal phase 2 (n=70) in R/R cHL tislelizumab monotherapy UC tislelizumab monotherapy Primary endpoint: ORR cHL Primary endpoint: ORR Initiated in Jul. 2017, enrollment completed in 3Q:18 Initiated in Apr. 2017, enrollment completed in MSI-H or Phase 2 (n=60) in MSI-H or dMMR solid tumors 4Q:17, NDA accepted in Aug 2018 dMMR tislelizumab monotherapy solid Primary endpoint: ORR 30 tumors Initiated in Sept. 2018 *Tislelizumab dosage 200mg every three weeks, Q3W. Global Ph3 trial in Stage III NSCLC is run by Celgene; global Ph2 in R/R/ NK/T-cell lymphoma and Ph2 trial in MSI-H or dMMR solid tumors in China are potentially registrational-enabling trials. OS: Overall survival; ORR: Overall response rate; PFS: Progression-free survival; cCRT: concurrent chemoradiotherapy; IRC: Independent Review Committee; ITT: Intent-to-treat


 
Tislelizumab Broad Late-stage Development Program Eleven ongoing potentially registration-enabling trials Global Trials (China and ROW) Potential registration- Phase 3 (n=840) in Stage III NSCLC Phase 3 (n=800) in 2L NSCLC enabling trials based on tislelizumab vs. docetaxel Tislelizumab + cCRT followed by tislelizumab vs. cCRT followed by regulatory feedback NSCLC tislelizumab vs cCRT alone Primary endpoint: OS Primary endpoint: PFS Under NMPA review Initiated in Nov. 2017 Open for enrollment Phase 3 (n=640) in 1L HCC Phase 2 (n=225) in 2L/3L HCC Other late-stage studies tislelizumab vs. sorafenib tislelizumab monotherapy HCC Primary endpoint: OS Primary endpoint: ORR by IRC Initiated in Jan. 2018 Initiated in Apr. 2018 Phase 3 (n=450) in 2L ESCC Phase 3 (n=480) in 1L advanced ESCC 2L/3L HCC tislelizumab vs. single-agent chemo (paclitaxel, docetaxel, or irinotecan) tislelizumab or placebo + platinum- and fluoropyrimidine-based chemo ESCC completed Primary endpoint: OS Co-primary endpoints: PFS and OS Initiated in Jan. 2018 Initiated in Dec. 2018 enrollment Phase 3 (n=720) in 1L advanced GC R/R Phase 2 (n=90) in 1L R/R Mature T- and NK- Neoplasms tislelizumab monotherapy GC tislelizumab or placebo + platinum- and fluoropyrimidine-based chemo NK/T-cell Co-primary endpoints: PFS and OS lympho Primary endpoints: ORR Initiated in Dec. 2018 mas Initiated in Apr. 2018 China Trials Phase 3 (n=340) in 1L Stage IIIB or IV squamous NSCLC Phase 3 (n=320) in 1L Stage IIIB or IV non-squamous NSCLC Tislelizumab+ paclitaxel and carboplatin combo or nab-paclitaxel and Tislelizumab+ chemo (platinum-pemetrexed) vs. chemo NSCLC carboplatin combo vs. paclitaxel and carboplatin combo Primary endpoint: PFS Primary endpoint: PFS Initiated in Jul. 2018 Initiated in Aug. 2018 Pivotal phase 2 (n=110) in 2L UC Pivotal phase 2 (n=70) in R/R cHL tislelizumab monotherapy UC tislelizumab monotherapy Primary endpoint: ORR cHL Primary endpoint: ORR Initiated in Jul. 2017, enrollment completed in 3Q:18 Initiated in Apr. 2017, enrollment completed in MSI-H or Phase 2 (n=60) in MSI-H or dMMR solid tumors 4Q:17, NDA accepted in Aug 2018 dMMR tislelizumab monotherapy solid Primary endpoint: ORR 31 tumors Initiated in Sept. 2018 *Tislelizumab dosage 200mg every three weeks, Q3W. Global Ph3 trial in Stage III NSCLC is run by Celgene; global Ph2 in R/R/ NK/T-cell lymphoma and Ph2 trial in MSI-H or dMMR solid tumors in China are potentially registrational-enabling trials. OS: Overall survival; ORR: Overall response rate; PFS: Progression-free survival; cCRT: concurrent chemoradiotherapy; IRC: Independent Review Committee; ITT: Intent-to-treat


 
Pamiparib Clinical Program Global China COMMERCIAL DOSE ESC. DOSE EXPANSION PIVOTAL PROGRAM (TARGET) RIGHTS PH1a PH1b PH2* PH2** PH3 3L gBRCA+ ovarian cancer pamiparib (BGB-290, PARP) Worldwide 2L plat-sensitive ovarian cancer maintenance 1L plat-sensitive gastric cancer maintenance Solid tumorstumor pamiparib + TMZ (PARP + Chemo) Worldwide Solid tumors pamiparib + RT/TMZ (PARP + RT/Chemo) Worldwide Glioblastoma ▪ Two ongoing global Ph1b/2 trials with chemotherapy: combination with radiation therapy and temozolomide (TMZ) in glioblastoma or combination with TMZ in advanced solid tumors ▪ Internal combination with tislelizumab: preliminary anti-tumor activity observed in multiple solid tumors *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials. **Confirmatory clinical trials post-approval are 32 required for accelerated approvals.


 
Other Clinical-Stage Drug Candidates and Internal Combinations PIVOTAL INDICATIONS DOSE ESC. DOSE EXPANSION Robust Pipeline Beyond BTK and PD-1 PH1a PH1b PH21 PH22 PH3 ▪ 1 Combination with tislelizumab initiated NSCLC, tislelizumab + sitravatinib** sitravatinib ▪ Multi-Kinase Inhibitor In-licensed from Mirati, rights in Asia ex-Japan, RCC, OC, AU, NZ HCC and GC Planned: lifirafenib + PD-0325901 (MEK ▪ Solid tumors Clinical activity observed in RAS-mutated cancers inhibitor, SpringWorks) including NSCLC and endometrial cancer lifirafenib ▪ Raf Dimer Inhibitor Global clinical trial collaboration with SpringWorks’ for combination with MEK inhibitor B-cell Planned: zanubrutinib + ME401 (PI3K delta malignancies inhibitor, MEI Pharma) ZW252 ▪ In-licensed from Zymeworks, rights in Asia ex- Japan, AU, NZ Bispecific HER2 ▪ Designed to provide dual HER2 signaling Antibody blockade by binding to epitopes for Herceptin and Solid tumors tislelizumab + BGB-A333 (PD-L1) Perjeta BGB-A333 ▪ Ph1 trial testing the monotherapy and the PD-L1 Antibody combination with tislelizumab Solid tumors tislelizumab + BGB-A425 (TIM-3) BGB-A425 ▪ Ph1 testing the combination with tislelizumab B-cell malignancies TIM-3 Antibody tislelizumab + zanubrutinib 3 ▪ Plan to test in NHL in China avadomide ▪ CELMoD (CC-122) In-licensed from Celgene, Rights in China Solid tumors tislelizumab + pamiparib 33 *1.Collaboration with Mirati Therapeutics, Inc. 2. Collaboration with Zymeworks, 3. Collaboration with Celgene. ** Clinical trials in Asia Pacific regions


 
Howard Liang, PhD 34


 
Financial Summary • Cash balance: $1,809M of cash and short-term investments at 12/31/18 vs. $2,101M at 9/30/2018, and $838M at 12/31/17 • Total cash decrease of $292M in 4Q:18 consists primarily of – Operating cash burn of $194M – Licensing payment of $60M to Zymeworks – CAPEX1 of $54M, for Guangzhou manufacturing facility construction and Beijing research facility purchase • Excluding proceeds from financing/equity issuance, outbound licensing and debt proceeds, cash burn totaled $736M2 in 2018 vs. $296M3 in 2017 and included – Cash used in operations of $548M in 2018 vs $237M in 2017 – Payments for in-licensing and business development of $70M vs. 0 in 2017 – CAPEX1 of $109M in 2018 vs $59M in 2017 – Repayment of loan for constructing Suzhou manufacturing facility of $9M in 2018 vs 0 in 2017 1 CAPEX includes purchases of property plant and equipment and payments to acquire long-lived assets; 2 Comprised of cash use from operations of $548M; payments for in-licensed BD of $70M and capital expenditures of $109M and cash payments for LT debt of $9M; 3 Comprised of cash provided from operations 35 of $13M, excluding $250M in license fees from Celgene, and capital expenditures of $59M.


 
Financial Summary, continued • Revenue: Total revenue of $198M in 2018 ($131M in product revenue and $67M in collaboration revenue --primarily R&D reimbursement from Celgene), compared to $238M in 2017 --$24M in product revenue and $214M in collaboration revenue (primarily upfront payment of the Celgene collaboration) – 4Q:18 product revenue was relatively flat compared to 3Q:18 (+1.5% in RMB; -1.8% in USD), impacted by seasonal pattern in 4Q. Year over year, 4Q:18 product revenue was ~2.5x of the prior year. • Expenses: • R&D expense was $679M in 2018 vs. $269M in 2017 – $257M in 4Q:18, sequential growth of $110M over 3Q:18 contributed by expenses related to business development activities, Zymeworks ($60M), and Merck KGaA ($19M) • SG&A expense was $195M in 2018 vs. $63M in 2017, and $72M in 4Q:18 vs. $49M in 3Q:18 – Increase primarily relates to the expansion of commercial organization in China to support the growth of the current portfolio and prepare for upcoming launches, establishment of commercial organization in the US and expanded global operations • Include $87M of stock-based compensation expense, compared to $43M in prior year • Net Loss of $674M for 2018, compared to $93M in 2017 – 2017 included benefit from recognition of upfront payment received from Celgene 36


 
Product revenue growth Marketed Brand Revenue Marketed Brands Composition in Total 2018 Since Transition to BeiGene (in USD and RMB) Product Revenue Over 150% Actual Growth YoY 3% ¥263Mn ¥267Mn ¥203Mn Abraxane ¥146Mn 42% Revlimid ¥103Mn 55% $31.4Mn $38.4Mn $37.8Mn Vidaza $15.6Mn $23.3Mn 4Q17 1Q18 2Q18 3Q18 4Q18 Patterns of slower sales in 4Q have been observed for oncology brands in China and for Abraxane and Revlimid historically *REVLIMID® approved as a combination therapy with dexamethasone; ABRAXANE® is included in PRDL of Fujian, Hubei, Ningxia, Jiangsu, Hunan; CII of Zhejiang and Shandong as of December 25, 2018. VIDAZA® is approved in MDS, CMML and AML and first commercial availability and inclusion on NRDL in 2018. NRDL = National Reimbursement Drug List, PRDL = Provincial Reimbursement Drug List, CII = Critical Illness Insurance.


 
2019 Milestones and Catalysts Zanubrutinib (BTK Inhibitor) Timing ▪ Approval in China for MCL and CLL ▪ 2019 ▪ China pivotal Phase 2 data and NDA filing for WM in China ▪ 2019 ▪ Phase 3 data of zanubrutinib vs. ibrutinib in WM ▪ 2H 2019 ▪ NDA filing in the U.S. ▪ 2019 or early 2020 ▪ Updated data from global Ph.1 in WM and MCL, pivotal data from China Ph.2 studies in CLL and MCL (12 month update), Ph.1 obinutuzumab combination data ▪ 1H:19 in CLL, Ph.3 data from the MYD88WT cohort of the WM trial ▪ Updated Ph.1 obinutuzumab combination data in NHL, updated CLL data from global Ph.1 trial ▪ 2H:19 Tislelizumab (PD-1 Antibody) ▪ Approval in China for cHL ▪ 2019 ▪ China pivotal Phase 2 data in UBC and NDA filing for UBC in China ▪ 1H:19 ▪ Global Phase 2 data in HCC and regulatory filing discussions ▪ 2019 ▪ Updated China pivotal Ph.2 data in cHL ▪ 1H:19 ▪ Chemotherapy combination data in gastric, esophageal and lung cancers from China Ph.2 trials, NPC, HCC cohort data from China Ph.1 ▪ 1H:19 ▪ Complete or close to completing enrollment in all four ongoing Phase 3 trials in lung and liver cancers ▪ 2019 Pamiparib (PARP inhibitor) ▪ China pivotal Phase 2 data in 3L+ ovarian cancer ▪ Late ‘19 or early ‘20 ▪ Ovarian expansion cohort data including (including QD cohort) from global Ph.1 trial presented at a medical conference ▪ 1H:19 ▪ Updated Ph.1 combination data with chemotherapy in solid tumors, and chemotherapy with or without radiation in GBM presented at medical conferences ▪ 2H:19 Early-stage Assets ▪ Advance at least one additional preclinical compound from internal pipeline into clinic ▪ 2019 In-licensed Products ▪ File at least one sNDA for REVLIMID® or ABRAXANE® in China ▪ 2019 Manufacturing ▪ Complete construction of Guangzhou manufacturing facility ▪ 2019 38


 
Q&A 39