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Taiho Pharmaceutical Generating Innovation with Japan: BC 2021 - HealthTech Taiho Pharmaceutical Robert Tam, Director, Market Access March 9, 2021 Corporate Philosophy Company Profile Taiho Pharmaceutical, co. ltd ● Established June, 1963 ● Head Quarter Tokyo ● President & Representative Director Masayuki Kobayashi ● Employees 2,315 ● NET Sales ¥138.9B (US$1.3B) Others 8% Others Discovery CHC 9% Oncology 68% Clinical･MA Dermatology 5% CHC CMC Net Sales Employees Allergy n=2,315 10% ¥ 138.9 B Production Drug Sales (as of January 2019) QA 2 Offices and Facilities ● Head Office/Tokyo ● Branch Offices: 15 ・ Headquarter functions ・ Ethical drug: 15 ・ Clinical development ・ Consumer: 7 ・ QA ・ Medical affairs ・ Marketing Pharmaceutical value chain Drug Discovery Drug Development Manufacturing Sales & Marketing ● Research Institute: 2 ● Plants: 4 Tsukuba Saitama (API) Tokushima (Products) ・ Target identification U.S. Inspection U.S. Inspection European authorities Inspection ・ Lead optimization European authorities Inspection Tokushima Kitajima (Products) Inuyama (API) ・ Pre-clinical studies U.S. Inspection European authorities Inspection ・ CMC development OSDrC Tec 3 3 Taiho Subsidiary Companies Taiho Pharmaceutical Co., Ltd. Global Headquarters Taiho Pharmaceutical Taiho Oncology Europe, GmbH of Beijing Co., Ltd. Taiho Pharma Canada, Inc. Development, Sales Promotion/Clinical Sales Taiho Ventures LLC. Venture Capital Taiho Innovations LLC. Taiho Oncology, Inc. Venture Capital Sales/Clinical Okayama -Taiho Taiho Pharma Pharmaceutical Co., Ltd. Singapore Pte., Ltd. Research / Clinical / Sales Production / Sales 4 4 Overview of Otsuka Group ● Otsuka Group Profile 189 companies (162 subsidiaries and 26 affiliates , plus 1 company (Otsuka Holdings itself)) About 47,000 employees Global network: JP, Asia, MEA, Oceania, EU, NA, LA （as of December 31, 2018） ● Structure of Group Capital Otsuka Holdings Co., Ltd. （Otsuka HD） 1st section of the Tokyo Stock Exchange. Otsuka Otsuka Taiho Otsuka Otsuka Otsuka Otsuka Pharmaceutical Pharmaceutical Factory Pharmaceutical Warehouse Chemical Foods Medical Devices ･Pharmaceutical ･Pharmaceutical ･Pharmaceutical ･Distribution ･Functional ･Consumer ･Medical devices Business Business Business chemicals Products ･Nutraceutical ･Nutraceutical Business ･Nutraceutical ･Fine chemicals Business Business Business Nutraceuticals = nutrition + pharmaceuticals Taiho is a wholly owned subsidiary of Otsuka HD. （as of December 31, 2018 ） Otsuka HD also holds a 100% share of 6 other companies. 5 5 North America Holdings … 6 Our Business Focus Gastrointestinal Diseases Dermatology and Otolaryngology (Gastrointestinal tract and related organs) (Skin, Nose, Ear, and related organs) - Cancer & Supportive care - Allergy - Unmet medical needs - Psoriasis & Dermatitis Products: Lonsurf, Abraxane, Aloxi, TS-1, Uzel Products: Bilanoa, Tremfya, Methaderm, IPD Pulmonary Diseases Other Diseases (Lung, Bronchi, and related organs) (Mammary gland, Bladder and other organs) - Cancer & Supportive care - Cancer & Supportive care - Inflammatory Diseases - Urination Dysfunctions Products: Abraxane, Aloxi, TS-1, Keytruda - Rare Cancers & diseases Products: Abraxane, Aloxi, TS-1, Zolinza, Yondelis 7 7 Taiho Businesses ● Oncology Products Lonsurf TS-1 Abraxane Aloxi UFT UZEL Zolinza Yondelis E-fen & others Anti-cancer agent Anti-cancer agent Anti-cancer agent Supportive Care ● Allergy & Dermatology Products and Others Bilanoa IPD Methaderm Zosyn Protecagin Tremfya BUP4 & others Co-promotion with Janssen Allergy Allergy Dermatology Antibiotic ● OTC Products HarnCare PITAS Series Solmack Series Tiovita & others 8 8 Business Development… 9 Pipeline (Major Products) Products MOA Indication Preclinic Ph 1 Ph 2 Ph 3 Development Partnering Status al Locations TAS-115 VEGR/PDGFR inhibitor Osteosarcoma JP TAS-116 HSP90 inhibitor GIST JP TAS-120 FGFR inhibitor Cholangiocarcinoma JP,US,EU Futibatinib Chemotherapy-induced Nausea & NK1RA JP In-licensed from Helsinn Pro-NETU Vomiting Taiho Territory: JPN *US studies are TAS-117 Allosteric Akt inhibitor Solid Tumor conducted by Arcus JP *US studies are Oncology Oncology AB122 conducted by Arcus In-licensed from Arcus Anti-PD1 mAb NSCLC, CRC, Pancreas, TNBC US* Taiho Territory: JPN & Asia (ex China) Zimberelimab In-licensed from Arcus AB928 Etruma- A2R Antagonist NSCLC, CRC, Pancreas, TNBC US* Taiho Territory: JPN & Asia (ex China) denant *US studies are conducted by Cullinan TAS3681 AR Antagonist Prostate Cancer US, EU TAS6417 Out-licensed to Cullinan Pearl EGFR inhibitor NSCLC US*, JP Taiho Territory: JPN CLN081 TAS0953 RET inhibitor Solid Tumor - Out-licensed to Helsinn HM06 RAS and Collaboration with Astex and MSD RAS and SHP2 inhibitors Solid Tumor - MSD exercised the option of SHP2 SHP2 inhibitor Oncology - Prostaglandin D2 synthase Duchenne Muscular Dystrophy JP TAS-205 inhibitor Non TAS-115 VEGR/PDGFR inhibitor Idiopathic pulmonary fibrosis JP 10 TAC-302 Neuroprotective Agent Overactive Bladder JP In-licensed from Meiji-Seika Pharma TAS-303 Major Collaborations * Domestic Oncology General 2016-2019 2004 MSD Helsinn KEYTRUDA* Aloxi (co-promotion) 2012 FAES FARMA 2005 2017 Celgene Bilanoa* JANSSEN (formerly Abraxis) Abraxane Tremfya* (co-promotion) In-license 2019 Acquisition ASTEX 2017 ARCUS Otsuka MIRATI 2003 2005 Teva 2009 PharmaMar Yondelis (option agreement) (formerly MethylGene) (formerly Cima) Mocetinostat E-fen (OVF) 2011 MSD Zolinza* 2018 AB928* 1995 2005 2010 2015 1995 2000 2011 2015 2015 2016 2017 2019 2020 Out-license Zosyn Zosyn TS-1 Bilanoa Lonsurf Lonsurf Lonsurf TAS6417 KRAS programs Pfizer Taisho Toyama* NORDIC (co-marketing) SERVIER JEIL TTY CULLINAN MSD (formerly Wyeth) MEIJI SEIKA PHAMA PEARL 11 11 Key BD Transactions in past 5 years In-license LTI-01 (single-chain urokinase plasminogen activator): Lung Therapeutics, 2020 Zimberelimab/AB122 (anti-PD-1 antibody): Arcus Biosciences, 2020 Etrumadenant/AB928 (A2R Antagonist): Arcus Biosciences, 2018 Tremfya (anti-IL-23 antibody, co-promotion): Janssen, 2017 Keytruda (anti-PD1 antibody, co-promotion): MSD, 2016-2019 Out-license RAS and SHP2 Programs (Research Collaboration): ASTEX and MSD, 2020 TAS-119/VIC-1911 (Aurora A inhibitor): VITRAC Therapeutics, 2019 TAS6417/CLN-081 (EGFR inhibitor): Cullinan Pearl, 2019 TAS0953/HM06 (RET inhibitor): Helsinn, 2017 12 Taiho Ventures Fact Sheet Seeking investments in early stage preclinical oncology as well as platform technology companies for our core therapeutic areas. We will review the wide variety of modalities (both biologics and small molecules) and opportunities mainly in North America and Europe. We will also consider the option-type of investments and spin-outs, in addition to pure equity investments. Inception 2016 Business Investment into Global Biotech Ventures Office Menlo Park, CA Investment Pool $300M Report Line Global Chief Corporate Officer Goal of Investment Strategic Benefits > Financial Returns Strategic Benefits: Invest in promising biotech ventures with potential alliance opportunities in the near future Access to new biology candidates beyond Internal R&D Option Investment including establishing Build to Buy opportunities Create spin-out companies using Taiho pipeline programs 13 Taiho Ventures Investment Criteria Investment Sectors: Drug Discovery (1st-in-class or New biology based approach) Innovative Platform Technologies for Drug Discovery Spin-out Opportunities from Taiho Pipelines Medical Device/Diagnostics/Digital Health (opportunistic) Therapeutic areas: Oncology Non-oncology (Immunology/Allergy/Bone/Muscle/Orphan) Modality: Small molecules Biologics/Oncolytic virus Gene/Cell Therapy Stage: Research to Pre-IND IND to PoC (opportunistic) Region: Mainly NA, EU and Japan 14 Taiho Ventures Interest in Oncology and Portfolio Examples of Potential Investment Arena: ❑ Immune checkpoint pathway ❑ CAR-T/TCR-T ❑ 2nd generation of T-cell engager ❑ Post PD-1 therapy (tumor microenvironment) ❑ Cytokine ❑ Microbiome ❑ Next generation oncolytic virus ❑ Intracellular undruggable targets ❑ Protein degrader ❑ DNA damage response ❑ Chromatin remodeling ❑ RNA epigenetics/modulator/splicing/editing ❑ Cancer resistance ❑ AI based drug discovery ❑ Senescence ❑ Autophagy 15 Actively seeking new science in oncology! Research Collaboration with X-Chem Initiated by Taiho Ventures 16 Innovative R&D Collaboration with Arcus Biosciences (a Taiho Ventures portfolio) Innovative deal structure: Term Sheet negotiated by Taiho Ventures Opted in AB928 (A2aR and A2bR dual antagonist) in 2018 17 Spin-out activities using Taiho molecules 18 CONFIDENTIAL Otsuka Investment in BC’s Aurinia 19 Thank You ! Please visit our web sites: ⇒www.taiho.co.jp/en/ ⇒www.taihooncology.com →www.taihopharma.ca/ Robert Tam [email protected] 20 20.
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