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Generating Innovation with Japan: Toronto HealthTech Taiho Pharmaceuticals Robert Tam, Director, Market Access February 20, 2020

Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Page 1: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

Generating Innovation with Japan:

Toronto HealthTech

Taiho Pharmaceuticals

Robert Tam, Director, Market Access

February 20, 2020

Page 2: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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1

Taiho Corporate Philosophy

Page 3: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Taiho at a Glance

● Established June, 1963

● Head office Tokyo

● President & Representative Director Masayuki Kobayashi

● Employees 2,380

● Net sales ¥124.9B (US$1.12B)

● R&D expenditures 27.3% of sales2018 Fiscal year (2018 Jan- 2018 Dec) results;

1USD = 111.43JPY

Employees

n=2,380

Discovery

Clinical・MA

CMC

Production

Drug Sales

CHC

QA

OthersOncology

73.9%Urology 1.1%

Other Drugs 1.8%

Others(Bulk, Royalty)

3.7%

OTC 10.1%

(as of January 2019)

Net Sales

¥ 124.9 B

Dermatology / Allergy

9.4%

Page 4: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Offices and Facilities

Tsukuba ・ Target identification・ Lead optimization

Tokushima・ Pre-clinical studies・ CMC development

Saitama (API)U.S. InspectionEuropean authorities Inspection

Kitajima (Products)U.S. InspectionEuropean authorities InspectionOSDrC Tec

Drug Discovery Drug Development Manufacturing Sales & Marketing

● Head Office/Tokyo

・ Headquarter functions・ Clinical development・ QA・ Medical affairs・ Marketing

● Branch Offices: 15

Pharmaceutical value chain

Tokushima (Products)U.S. InspectionEuropean authorities Inspection

Inuyama (API)

Okayama (OTC)

● Research Institute: 2 ● Plants: 5

・ Ethical drug: 15・ Consumer: 7

Page 5: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Taiho Subsidiary Companies

Taiho Pharma Singapore Pte., Ltd.

Sales

Taiho Pharmaceuticalof Beijing Co., Ltd.Promotion/Clinical

Taiho Pharma Europe, Ltd.Clinical

Taiho Oncology, Inc.Sales/Clinical

Taiho Pharma Canada, Inc.Sales

Taiho Ventures LLC.Venture Capital

Okayama -TaihoPharmaceutical Co., Ltd.

Research / Clinical /Production / Sales

Taiho Pharmaceutical Co., Ltd.

Global Headquarters

Taiho Innovations LLC.Venture Capital

Page 6: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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● 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

Taiho is a wholly owned subsidiary of Otsuka HD.Otsuka HD also holds a 100% share of 6 other companies.

● Structure of Group Capital

1st section of the Tokyo Stock Exchange.

(as of December 31, 2018)

Otsuka

Chemical

・Functional chemicals

・Fine chemicals

Otsuka

Pharmaceutical

・Pharmaceutical Business

・NutraceuticalBusiness

Otsuka

Pharmaceutical Factory

・Pharmaceutical Business

・Nutraceutical Business

Taiho

Pharmaceutical

・Pharmaceutical

Business

・Nutraceutical

Business

Otsuka

Warehouse

・Distribution

Otsuka

Medical Devices

・Medical devices

Otsuka

Foods

・ConsumerProducts

Business

Nutraceuticals = nutrition + pharmaceuticals

(as of December 31, 2018 )

Otsuka Holdings Co., Ltd.(Otsuka HD)

Overview of Otsuka Group

Page 7: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

6…

North America

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Our Business Focus

Gastrointestinal Diseases(Gastrointestinal tract and related organs)

- Cancer & Supportive care

- Unmet medical needs

Products: Lonsurf, Abraxane, Aloxi, TS-1, Uzel

Dermatology and Otolaryngology(Skin, Nose, Ear, and related organs)

- Allergy

- Psoriasis & Dermatitis

Products: Bilanoa, Tremfya, Methaderm, IPD

Pulmonary Diseases(Lung, Bronchi, and related organs)

- Cancer & Supportive care

- Inflammatory Diseases

Products: Abraxane, Aloxi, TS-1, Keytruda

Other Diseases(Mammary gland, Bladder and other organs)

- Cancer & Supportive care

- Urination Dysfunctions- Rare Cancers & diseases

Products: Abraxane, Aloxi, TS-1, Zolinza, Yondelis

Page 9: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Product Portfolio - Oncology Pipeline -

Pre-clinical Phase 1 Phase 2 Phase 3

TAS-118Antimetabolite (TS-1/Leukovorin)

GastricJPN, Asia

TAS-115c-MET/VEGFR inhibitorProstateJPN

TAS-114dUTPase/DPD inhibitorNSCLCJPN, US, CAN, EU

TAS-116HSP90 inhibitorGISTJPN, US, CAN, EU

TAS-120FGFR inhibitorIntrahepatic Bile DuctJPN, US, CAN, EU

Pro-NETUNK1RAChemotherapy-induced Nausea & Vomiting

JPN In-licensed from Helsinn

ET-743DNA minor groove binderOvarianJPNIn-licensed from PharmaMar

TAS-117Allosteric Akt inhibitorSolid TumorJPN

TAS4464NAE inhibitorSolid Tumor & Hematological Cancer

JPN, US, EU

TAS3681Novel AR antagonistProstateUS, EU

TAS0728Her2 inhibitorSolid TumorUS, EU

TAS0313Peptide VaccineSolid TumorJPN

TAS6417/CLN-081

EGFR inhibitorNSCLCGlobalOut-licensed to Cullinan Pearl

RET inhibitorRET inhibitor

Co-development with Helsinn

AB928A2AR/A2BR Antagonist

In-licensed from Arcus

Molecular targeting Supportive careCytotoxic

・・・

And other projects

KRAS programsKRAS inhibitors

Research Collaboration and License Agreement with MSD

Page 10: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Major Collaborations

2016-2019MSD

KEYTRUDA*(co-promotion)

2005 Teva(formerly Cima)

E-fen (OVF)

2009 PharmaMar Yondelis2017 ARCUS(option agreement)

2017JANSSEN

Tremfya*(co-promotion)

2012FAES FARMA

Bilanoa*

2004Helsinn

Aloxi

MIRATI 2003(formerly MethylGene)

Mocetinostat

2005Celgene(formerly Abraxis)

Abraxane

2015 Bilanoa

(co-marketing)MEIJI SEIKA PHAMA

2011TS-1

NORDIC

2015LonsurfSERVIER

2016LonsurfJEIL

2017LonsurfTTY

1995ZosynPfizer(formerly Wyeth)

2000ZosynTaisho Toyama*

1995 2005 2010 2015

In-license

Out-license

OncologyGeneral

* Domestic

2011 MSD Zolinza* 2018 AB928*

2019TAS6417CULLINAN PEARL

2020KRAS programsMSD

2019 Acquisition ASTEXOtsuka

Page 11: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Major Collaborations

2016-2019MSD

KEYTRUDA*(co-promotion)

2005 Teva(formerly Cima)

E-fen (OVF)

2009 PharmaMar Yondelis2017 ARCUS(option agreement)

2017JANSSEN

Tremfya*(co-promotion)

2012FAES FARMA

Bilanoa*

2004Helsinn

Aloxi

MIRATI 2003(formerly MethylGene)

Mocetinostat

2005Celgene(formerly Abraxis)

Abraxane

2015 Bilanoa

(co-marketing)MEIJI SEIKA PHAMA

2011TS-1

NORDIC

2015LonsurfSERVIER

2016LonsurfJEIL

2017LonsurfTTY

1995ZosynPfizer(formerly Wyeth)

2000ZosynTaisho Toyama*

1995 2005 2010 2015

In-license

Out-license

OncologyGeneral

* Domestic

2011 MSD Zolinza* 2018 AB928*

2019TAS6417CULLINANPEARL

2020KRAS programsMSD

2019 Acquisition ASTEXOtsuka

Page 12: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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New Business Development…

Page 13: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Taiho Ventures Fact Sheet

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

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.

Page 14: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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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

Taiho Ventures Investment Criteria

Page 15: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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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

Taiho Ventures Interest in Oncology

and Portfolio

Actively seeking new science in oncology!

Page 16: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Taiho Ventures Portfolio

Page 17: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Research Collaboration with X-Chem

Initiated by Taiho Ventures

Page 18: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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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

Page 19: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Spin-out activities using Taiho

molecules

CONFIDENTIAL

Page 20: Generating Innovation with Japan: Toronto HealthTech€¦ · Otsuka Holdings Co., Ltd. (Otsuka HD ... Product Portfolio -Oncology Pipeline ... (co-promotion) 2012 FAES FARMA Bilanoa*

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Please visit our web sites:

⇒www.taiho.co.jp/en/

⇒www.taihooncology.com

→www.taihopharma.ca/

Thank You !