Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — BeiGene — FY2018 Earnings Presentation
39 slides from Beone Medicines Ltd. Class A's earnings presentation, Feb 27, 2019
Slide 1: 2018 Annual Results Review and Investor Presentation
2018 Annual Results Review and Investor Presentation February 27-28, 2019
Slide 2: Disclosures
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 regardin
Slide 3: Agenda
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 Strateg
Slide 4: John V. Oyler
John V. Oyler 4
Slide 5: 2018 Highlights and 2019 Outlook
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 ov
Slide 6: 2018 Business Highlights and Accomplishments
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
Slide 7: Developing Strong Manufacturing Capabilities
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 leadi
Slide 8: Our Strategy
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, c
Slide 9: Leveraging China Strengths to Pursue Global Clinical Excellence
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 •
Slide 10: Establishing Collaborations to Expand Our Portfolio
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
Slide 11: China Enables a Model to Succeed in an Evolving Global Environment
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 his
Slide 12: Xiaobin Wu, Ph.D.
Xiaobin Wu, Ph.D. 12
Slide 13: China's Pharmaceutical Market Is Still Dominated by Generics
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
Slide 14: Market Growth Is Shifting Towards Therapeutics
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 Chin
Slide 15: Oncology Is the Fastest Growing Therapeutic Area in China
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) 1
Slide 16: BeiGene's 2018 Commercial Organization Growth
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 Ph
Slide 17: Strong Core Product Growth Under BeiGene
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; A
Slide 18: Existing Portfolio Provides Market Presence for Launches
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 BeiGe
Slide 19: Preparing to Launch Zanubrutinib and Tislelizumab
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 un
Slide 20: Building Commercial Presence Outside of China
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 potent
Slide 21: Eric Hedrick, M.D.
Eric Hedrick, M.D. 21
Slide 22: BeiGene Product Portfolio and Pipeline
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 dexam
Slide 23: Zanubrutinib Clinical Program
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
Slide 24: Zanubrutinib vs. Ibrutinib in WM
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 endpoi
Slide 25: Zanubrutinib vs. BR in 1L CLL/SLL and vs. Ibrutinib in R/R CLL/SLL
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
Slide 26: Zanubrutinib vs. BR in 1L CLL/SLL and vs. Ibrutinib in R/R CLL/SLL
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
Slide 27: Zanubrutinib + Obinutuzumab vs 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 28: Zanubrutinib Potentially Addresses Areas of Need for BTK Inhibitor Patients
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 “r
Slide 29: Tislelizumab Clinical Program
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 hepatoc
Slide 30: Tislelizumab Broad Late-stage Development Program
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 follo
Slide 31: Tislelizumab Broad Late-stage Development Program
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 follo
Slide 32: Pamiparib Clinical Program
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 tumorstumo
Slide 33: Other Clinical-Stage Drug Candidates and Internal Combinations
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 f
Slide 34: Howard Liang, PhD
Howard Liang, PhD 34
Slide 35: Financial Summary
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 Guangzh
Slide 36: Financial Summary, continued
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 Cel
Slide 37: Product Revenue Growth
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 2Q
Slide 38: 2019 Milestones and Catalysts
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 fr
Slide 39: Q&A
Q&A 39