3sbio, Inc. · HKEX:1530
3sbio — FY2019 Earnings Presentation
30 slides from 3sbio's earnings presentation, Mar 31, 2020
Slide 1: 2019 Annual Results Announcement
珍 CHERISH LIFE CARE FOR LIFE CREATE LIFE 爱 生 命 2019 Annual Results / 关 Announcement 注 生 存 / 创 造 生 活 March 31, 2020
Slide 2: Disclaimer
Disclaimer This document has been prepared by 3SBio Inc. (the "Company") solely for selected recipients for information purposes only. You must read the terms, conditions, limitations, notifications, restrictions, acknowledgments and representations in the following (collectively, the "Terms") befor
Slide 3: 2019 Highlights
2019 Highlights R&D Collaboration 302H (Cipterbin) Technical reviews, clinical trial site inspection and manufacturing site inspection have all been completed 301S (Pre-filled injection of Yisaipu) NDA was accepted Xenopax (Anti-CD20 antibody) Obtained the GMP Certificate and launched to market 609A
Slide 4: Industry Policy Reform Deepens, and Innovation Continues to be Encouraged
Industry Policy Reform Deepens, and Innovation Continues to be Encouraged • R&D and sale of innovative drugs will be encouraged continually • Higher generic drug quality and more regulated competition Continuing to speed up new drug application1 2019 NRDL update • In 2019, the total applications to
Slide 5: Major Progress in R&D in 2019
Major Progress in R&D in 2019 Product Target Situation Key Collaboration in R&D 302H (Inetetamab) HER2 • Technical reviews, clinical trial site inspection as well as manufacturing site inspection have all been completed 301S (Pre-filled aqueous TNFa • NDA was accepted injection of Yisaipu) Xenopax C
Slide 6: Robust and Innovative Product Pipeline
Robust and Innovative Product Pipeline 32 product candidates, including 22 National New Drugs Therapeutic Area Product Candidate Pre-Clinical Clinical Trial Application Phase I Phase II Phase III New Drug Registration Production Permit SSS06 Long-acting EPO RD001 Long-acting EPO SSS17 HIF inhibitor
Slide 7: Biologics Pipeline in Nephrology, Auto-immune and Other Diseases
Biologics Pipeline in Nephrology, Auto-immune and Other Diseases Production Product Target Indication Pre-Clinical CTA Phase I Phase II Phase III BLA/NDA Permit Rheumatoid arthritis, plaque psoriasis and 301S TNFa ankylosing spondylitis Rheumatoid arthritis, ankylosing spondylitis, SSS07 TNFa ulcera
Slide 8: Biologics Pipeline in Oncology
Biologics Pipeline in Oncology Production Product Target Indication Pre-Clinical CTA Phase I Phase II Phase III BLA/NDA Permit 302H HER2 Breast Cancer 304R CD20 NHL 602 EGFR Colorectal cancer (CRC) 609A PD1 NSCLC, Gastric and Liver cancer SB8 VEGF Multiple Cancer (615) 612 HER2 Breast and Gastric Ca
Slide 9: Growing Cancer Patient Population Globally and in China
Growing Cancer Patient Population Globally and in China Rising Mortality and Diagnosis Rates Estimated Number of New Cases in 2018 Cancer Deaths New Cancer Diagnoses China 4,285,033 US 2,129,118 19.3MM India 1,157,294 Japan 883,395 Germany 608,742 11.2MM Brazil 559,371 Russia 543,045 France 455,618
Slide 10: Well Positioned to Meet the Needs of Patients in Oncology
Well Positioned to Meet the Needs of Patients in Oncology Key Challenge for Healthcare Systems Globally China Oncology Market Forecast (2014-2023E) Size of bubble represents WW Sales (US$Bn) in 2018 US$Bn 49 20% 2014-2018 CAGR % Sales Growth: CAGR 2018-2024 +12.8% 43 Immunosuppressants 2019E-2023E C
Slide 11: Top 10 Oncology Drugs by Generic Name Globally and in China
Top 10 Oncology Drugs by Generic Name Globally and in China Top 10 Oncology Drugs Globally in 2019 Top 10 Oncology Drugs in China in 2019 Sales from Sample Hospitals Generic Name Market Size (US$Bn) Generic Name (RMB¥Bn) Pembrolizumab 11.3 Paclitaxel 3.1 Lenalidomide 9.4 Trastuzumab 1.9 Nivolumab 8.
Slide 12: Extensive Coverage of Key Targets and Next-Generation Biologic Therapies
Extensive Coverage of Key Targets and Next-Generation Biologic Therapies 4 R&D Centers and over 380 Experienced Scientists Shenyang-Biologics/Chemicals Shanghai - Biologics Shenzhen - Biologics Hangzhou - Chemicals Covered Key Oncology Targets Next Generation Biologic Therapies HER2 CD20 EGFR MCM 1
Slide 13: Integrated International Strategic Collaborations (con’d)
Integrated International Strategic Collaborations (con’d) Mature Products and Platforms Innovative Products and Platforms Exclusive license for the commercialization of Exclusive license to develop and commercialize GLP-1 products in China programmed therapeutic cells in Greater China Collaboration
Slide 14: 2020-2022 R&D Outlook
2020-2022 R&D Outlook Production Permit • 302H (H1 2020) New IND / Phase I • IND of 10-15 new mAbs and bispecific (2020-2021) • 301S (H1 2021) (2020-2022) antibodies (China and US) Initiation of • SB8 • TRK-820 Autoimmune Nephology Registration Clinical Generics BE Studies and Inflammation • TPIAO 1
Slide 15: Comprehensive Manufacturing Capabilities Adhere to Int’l Quality Standards
Comprehensive Manufacturing Capabilities Adhere to Int’l Quality Standards All 10 production lines for different dosage forms are Plant certified by 11 countries, including Ukraine, certified by GMP in 2010 Brazil and Mexico QA personnel represent 20%+ of all manufacturing QA personnel repre
Slide 16: Integrated Cell Expression Systems and Sufficient Production Capacity
Integrated Cell Expression Systems and Sufficient Production Capacity Expression System Prokaryotic Eukaryotic Present Production Capacity Cell Chemical Cell Annual capacity of 50 million injections, in accordance with EU standard Shenyang Commercialized manufacturing base with more than 38,000 lite
Slide 17: Core Products Maintained Dominant Market Share
Core Products Maintained Dominant Market Share 2015 2016 2017 2018 2019 Market Share (%)1 TPIAO 605 765 975 1,670 2,323 73.2 Yisaipu 2 842 925 1,013 1,111 1,144 60.9 EPIAO/SEPO 727 773 855 897 749 41.6 Mandi 24 65 94 127 250 66.3 * Note： 1 The Market shares of TPIAO, Yisaipu and EPO franchise comes
Slide 18: Indications and Products Newly Included in 2019 NRDL
Indications and Products Newly Included in 2019 NRDL A product with broad applications in the treatment of a variety of Fluticasone Propionate Cream (Shinuo) dermatological disorders was newly included in the 2019 NRDL The indication for severe plaque psoriasis in adult patients was newly rhTNFR-Fc
Slide 19: Strong Sales Capability and Country-Wide Sales Network
Strong Sales Capability and Country-Wide Sales Network Proven marketing team with nearly 30 years of market validation Reached all provinces, autonomous regions and special municipalities in China 3,372 sales and marketing employees, 660 distributors and 2,079 third-party promoters Covered over 2,00
Slide 20: Market-Leading Products with Significant Growth Potential
Market-Leading Products with Significant Growth Potential TPIAO • First-to-market and the only commercialized rhTPO product in the world • Extended new indications for the surgery patients with hepatic dysfunction at the risk of thrombocytopenia and pediatric ITP • Market is still under-penetrated w
Slide 21: Market-Leading Products with Significant Growth Potential (con’d)
Market-Leading Products with Significant Growth Potential (con’d) Yisaipu Anti-TNFα Leadership in China Contributes most to overall category growth The increment of Anti-TNFα in 2019 1 Market share of Anti-TNFα in 2019 1 (RMB mm) ✤ First-to-market TNFa inhibitor product ✤ The indication of the treat
Slide 22: Market-Leading Products with Significant Growth Potential (con’d)
Market-Leading Products with Significant Growth Potential (con’d) Yisaipu Price is under pressure, but growth potential is Comparison of Etanercept and Adalimumab still significant Etanercept Adalimumab Sales of TNFa and Yisaipu1 fusion protein 1.62 per 100 person-years All products (Yisaipu, Qiangk
Slide 23: Market-Leading Products with Significant Growth Potential (con’d)
Market-Leading Products with Significant Growth Potential (con’d) EPIAO and SEPO • Still the only rhEPO product approved by the NMPA for all three indications • Consistently been the dominant market leader in Mainland China rhEPO market since 2002 Reasons for negative • The tendering prices in many
Slide 24: Market-Leading Products with Significant Growth Potential (con’d)
Market-Leading Products with Significant Growth Potential (con’d) Mandi RMB mm 2017-2019 CAGR 65% ✤ Used in the treatment of androgenetic alopecia 250 ✤ The only topical drug recommended by the guideline for diagnosis and 127 94 treatment of androgenetic alopecia ✤ Sales grew strongly in the past th
Slide 25: Consistent Strong Growth
Consistent Strong Growth Unit: RMB mm Revenue Gross Profit CAGR 5,318 CAGR 4,393 34% 4,584 32% 3,707 3,734 3,058 2,797 2,395 1,673 1,431 2015 2016 2017 2018 2019 2015 2016 2017 2018 2019 Normalized EBITDA Normalized Net Profit Attributable to Owners of the Parent 1,392 CAGR 2,005 CAGR 29% 1781.8 23%
Slide 26: Strong Management and Operational Capabilities
Strong Management and Operational Capabilities Unit: RMB mm Net Cash flows from operating activities R&D Expense 1,887 527 CAGR CAGR 43% 47% 363 1,150 1,004 1,074 243 257 455 111 2015 2016 2017 2018 2019 2015 2016 2017 2018 2019 Sales and Marketing Expense Financial Expense 1,951 148 141 138 1,691 1
Slide 27: Impacts from COVID-19
Impacts from COVID-19 Impacts Risks and Challenge for Company Responses • Work resumption was delayed • Minimal impact on manufacturing and • Close follow-up and careful analysis • Transportation was affected R&D of the risks posed by the outbreak • Flow of goods and people were • Impacted sales and
Slide 28: Outlook
Outlook Operation ✤ Operating indicators and revenue of key products will continue to grow steadily New Products ✤ Launch of new products (Cipterbin, Pre-filled injection of Yisaipu) ✤ Increase the investment in R&D, continue to accelerate clinical trials R&D and IND of pipeline products ✤ Continue
Slide 29: Company Strategy
Company Strategy Vision China-based Global Leader in Biologics Position Innovative Biologics & Core Product Portfolio Focused Therapeutics Oncology Autoimmune Nephrology Metabolic Dermatology Platforms R&D Manufacturing Sales and Marketing Collaboration 29
Slide 30: THANKS
THANKS 珍 爱 生 命 · 关 注 生 存 · 创 造 生 活 CHERISH LIFE CARE FOR LIFE CREATE LIFE