Takeda Pharmaceutical Co. Ltd. · TSE:4502
Takeda Pharmaceutical — Investor Day (October 2018)
113 slides from Takeda Pharmaceutical's investor day presentation, Oct 11, 2018
Slide 1: Takeda R&D Investor Day 2018
TAKEDA R&D INVESTOR DAY 2018 CAMBRIDGE, MASSACHUSETTS October 11, 2018
Slide 2: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 3: Delivering on Our R&D Vision
DELIVERING ON OUR R&D VISION CAMBRIDGE, MASSACHUSETTS ANDY PLUMP MD, PHD Chief Medical and Scientific Officer October 11, 2018
Slide 4: Important Notice
IMPORTANT NOTICE For the purposes of this notice, “presentation” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) during the presentation. This presentation (inclu
Slide 5: Outline for Today
• Overview of Takeda, our R&D transformation and progress to date • Deep dive by Therapeutic Area (Oncology, Gastroenterology, Neuroscience plus Vaccines) and how each is contributing to unlock innovation and deliver meaningful value • Recurring themes: - Focus - Robust research engine and capabilit
Slide 6: Doing More for Our Patients
HISTORY, VALUES R&D & PRIORITIES TRANSFORMATION DOING MORE FOR OUR PATIENTS WHAT WE’VE WHAT’S NEXT DELIVERED 6
Slide 7: History, Values & Priorities
HISTORY, VALUES & PRIORITIES Takeda-ism & Our Priorities 7
Slide 8: Putting Patients First for Over Two Centuries
WHO WE ARE PUTTING PATIENTS FIRST YEARS FOR OVER TWO CENTURIES Takeda is a patient-centric, innovation-driven global pharmaceutical company that builds on a distinguished 237-year history, aspiring to bring better health and a brighter future for people worldwide. 8
Slide 9: Takeda-ism & Our Priorities
VALUES TAKEDA-ISM TAKEDA-ISM & OUR PRIORITIES OUR PRIORITIES We make decisions and take actions by focusing on our four priorities in this order: 1 2 3 4 Established by our founding spirit and integral to every part of our business, Putting the patient Building trust with Reinforcing our Developing
Slide 10: R&D Legacy: The Case for Change Was Absolute
R&D LEGACY: THE CASE FOR CHANGE WAS ABSOLUTE PRODUCT LAUNCHES BY DISCOVERY SOURCE (FY2005 – 2015) Period of poor productivity following approval of Internal (4) Acquisition (8) Licensed (10) pioglitazone in 1999 DEXILANT NESINA ADCETRIS EDARBI / AZILVA1 COLCRYS2 AMITIZA - Fragmented R&D footprint -
Slide 11: What We Committed To
WHAT WE COMMITTED TO Reinventing R&D 11
Slide 12: Building an Agile R&D Organization Driven by Innovative Science
BUILDING AN AGILE R&D ORGANIZATION DRIVEN BY INNOVATIVE SCIENCE THERAPEUTIC AREA FOCUS Oncology, Gastroenterology, Neuroscience plus Vaccines PARTNERSHIPS & CAPABILITIES TRANSFORM OUR CULTURE R&D TRANSFORMATION KEY IMPERATIVES • Agile and lean • Dynamic and sustainable research and early development
Slide 13: What R&D Transformation Meant
WHAT R&D TRANSFORMATION MEANT… A STRATEGIC, TECHNICAL, SKILL-SET, STRUCTURAL, GEOGRAPHIC AND CULTURAL CHANGE THAT IMPACTED NEARLY ALL R&D EMPLOYEES.
Slide 14: Strong Leadership Driving Change
STRONG LEADERSHIP DRIVING CHANGE HIRED IN THE LAST 12 MONTHS ANDY PLUMP PHIL ROWLANDS CMSO Oncology TAU STEFAN WILDT GEORGIA KERESTY Pharmaceutical Medical Sciences & Sciences Development ASIT PARIKH EMILIANGELO Operations Gastroenterology RATTI TAU Neuroscience TAU COLLEEN TOSHIO BEAUREGARD FUJIMOT
Slide 15: What We've Delivered
WHAT WE’VE DELIVERED Our innovations are transforming our business and the lives of patients 15
Slide 16: Two Years into a Five-Year R&D Transformation Journey
TWO YEARS INTO A FIVE-YEAR R&D TRANSFORMATION JOURNEY Focused (3+1) A pipeline that’s delivering Culture: engaged and therapeutic area strategy - Fueled by a robust empowered teams and lean operating model research engine and a rich, global partner ecosystem 16
Slide 17: We've Focused Our Therapeutic Areas
WE’VE FOCUSED OUR THERAPEUTIC AREAS ALL IN: 3+1 ONCOLOGY GASTROENTEROLOGY VACCINES NEUROSCIENCE 17 RESEARCH, DIVERSE MODALITIES AND PARTNERSHIPS
Slide 18: We've Streamlined Our Global Footprint
WE’VE STREAMLINED OUR GLOBAL FOOTPRINT B O STON, M A S HO N A N , JA PA N SA N D I EGO, CA R&D Center Neuroscience Research, Specialized drug Oncology, GI Research T-CiRA, iPark discovery technologies, GI and Neuroscience 18
Slide 19: We've Redirected Resources to Highly Innovative Medicines
WE’VE REDIRECTED RESOURCES TO HIGHLY INNOVATIVE MEDICINES FOCUS AND PRIORITIZATION FOCUS ON EXECUTION • Reduced Drug Discovery Units Established a research KPI in FY18 to from 6 to 3 achieve industry leading cycle-times for candidate selection • Changed research from “pipe” to “funnel” along stage-g
Slide 20: Research & Early Clinical Engine: Key Capabilities
RESEARCH & EARLY CLINICAL ENGINE: KEY CAPABILITIES THE RIGHT TARGET THE RIGHT MODALITY FLAWLESS EXECUTION • Leveraging human- • Patient -> Biology -> Modality • Human early POC is a key derived data • Embrace innovative platforms performance indicator • Potential for game-changing • Expand internal
Slide 21: Select Partnerships by Strategic Focus Area
SELECT PARTNERSHIPS STRATEGIC FOCUS AREA DISCOVERY/ PRECLINICAL PHASE 1 PH2, PH3, FILED, LCM Hematologic Malignancies Molecular Templates, Adimab, Heidelberg, HaemaLogiX, HiFiBio Nektar Seattle Genetics Lung Cancer Crescendo Biologics, Shattuck Labs ONCOLOGY Discovery and development of next generat
Slide 22: With Our Partners, We're at the Forefront of Innovation
WITH OUR PARTNERS, WE’RE AT THE FOREFRONT OF INNOVATION Diversity of modalities in the research pipeline* 9 programs in Lead 41 programs in Lead Generation Optimization 11 Candidates Small Molecules 22% Biologics 34% Oligonucleotides Cell Therapies Other Modalities 64% 33% 39% 22% 18% 12% Over 60% o
Slide 23: Investing in the Transformative Potential of Cell Therapies
INVESTING IN THE TRANSFORMATIVE POTENTIAL OF CELL THERAPIES RESEARCH APPROVED* “We’re at a key point when it comes to cell and gene therapy…for a long time, they were largely theoretical constructs. Now they Key Academic are a therapeutic Collaborations in CAR-T reality.” SCOTT GOTTLIEB, M.D. Allian
Slide 24: Comprehensive, Differentiated Partnership Model
WE’VE BUILT A COMPREHENSIVE, DIFFERENTIATED PARTNERSHIP MODEL CENTER FOR EXTERNAL INNOVATION (CEI) • Integrated into the innovation system; access to promising, potentially revolutionary platforms prior to validation • Close alignment of interests/incentives with many engagement mechanisms including
Slide 25: We Executed 56 Partnerships in FY17
WE EXECUTED 56 PARTNERSHIPS IN FY17 THERAPEUTIC AREA FOCUSED NOVEL PLATFORMS, NEW CAPABILITIES ONCOLOGY External Value Creation Companies Created GASTROENTEROLOGY New Capabilities Rare Disease Initiatives Strategic Academic Alliances Leland Stanford Jr. NEUROSCIENCE University Takeda Ventures Slide
Slide 26: Our Approach to External Innovation Is Global
AND OUR APPROACH TO EXTERNAL INNOVATION IS GLOBAL Shonan (Japan) Boston (Massachusetts) San Diego (California) 37 99 7 31 10 Number of ongoing partnerships by region 26
Slide 27: Dynamic and Re-invigorated Pipeline
…RESULTING IN A DYNAMIC AND RE-INVIGORATED PIPELINE PHASE 1 PHASE 2 PHASE 3/FILED Approved* TAK-573 XMT-1522 NINLARO ® ADCETRIS® TAK-788 sapanisertib pevonedistat 30 pipeline assets Proteasome inhibitor Seattle Genetics Teva Mersana Therapeutics EGFR/HER2 inhibitor mTORC 1/2 inhibitor NAE inhibitor
Slide 28: We'll Continue to Focus on Core Therapeutic Areas
WE’LL CONTINUE TO FOCUS ON CORE THERAPEUTIC AREAS ALL IN: 4+2 ONCOLOGY GASTROENTEROLOGY VACCINES NEUROSCIENCE RARE DISEASES PLASMA DERIVED THERAPIES 28
Slide 29: Potential to Deliver More Value in the Future
WITH THE POTENTIAL TO DELIVER MORE VALUE IN THE FUTURE PHASE 1 PHASE 2 PHASE 3/FILED APPROVED* TAK-573 NINLARO® ADCETRIS® ICLUSIG® Teva XMT-1522 Mersana Therapeutics sapanisertib TAK-659 SYK inhibitor relugolix Myovant pevonedistat Proteasome inhibitor MM R/R (EM), R/R Amyloidosis, Seattle Genetics
Slide 30: Evolving Our Culture and the Way We Work
CENTRAL TO EVERYTHING, WE’VE EVOLVED OUR CULTURE AND THE WAY WE WORK SELECT INITIATIVES METRICS R&D Voluntary Turnover Co-location 0.9% vs. 3.4% Pharma industry benchmark* Engagement Patient-centric activities 84% 74% in 2017 and touchpoints vs. ** ** Alignment Transparency and engagement around Key
Slide 31: R&D Alignment Around Big Important Value Inflections
R&D ALIGNMENT AROUND BIG IMPORTANT VALUE INFLECTIONS (BIVIs) FOR R&D FY18 Trintellix: Alunbrig: Ninlaro: Approval of processing a) ALTA-1L interim a) Interim analysis speed (important analysis b) Submission for both newly aspect of cognitive b) EU approval for 2nd line diagnosed multiple myeloma and
Slide 32: What's Next
WHAT’S NEXT Looking Ahead 32
Slide 33: What We Still Need to Deliver
WHAT WE STILL NEED TO DELIVER Maximize the value of our current portfolio Progress our research and early pipeline Implement improvements to our clinical trial operating model Develop enhanced capabilities to support rare disease portfolio growth 33
Slide 34: Promising Pivotal Programs
PROMISING PIVOTAL PROGRAMS NEAR-TERM PIVOTAL RESULTS NEXT PIVOTAL INITIATION Pevonedistat NAE inhibitor TAK-003 Dengue vaccine TAK-788 EGFR/HER2 inhibitor Phase 1b study of pevonedistat Antibody-mediated immune response Antitumor activity in all patients treated with azacytidine1 in dengue naïve pop
Slide 35: China Is an Important Part of Our Global Growth Strategy
CHINA IS AN IMPORTANT PART OF OUR GLOBAL GROWTH STRATEGY 6 NEW PRODUCTS, 14 NEW INDICATIONS ANTICIPATED BY 2020 RR MM Approved (EE H) (UC, CD) (NDMM; Maint. MM NSCT & PSCT; (RR HL, sALCL) Amyloidosis) Selected for NDA filing with global data package* (EE M, GU, DU) (RR MM) (Hypertension) (Type2 DM)
Slide 36: Sustained Value Creation
SUSTAINED VALUE CREATION FY 2018 FY 2019 FY 2020 O N O O ALUNBRIG, 1L ALK+ O NINLARO, ND MM O NINLARO, MM maint. non- ALUNBRIG, 2L ALK+ NINLARO MM maint. post- N TRINTELLIX, TESD (US) N N N N NSCLC post crizotinib (EU) S SCT (US, EU, JP, CN) NSCLC (US, EU) (US, JP, CN) SCT (US, EU, JP, CN) C C C C C
Slide 37: Conclusion
CONCLUSION: 1 Distinct R&D strategy based on TA 2 Delivering an innovative and compelling pipeline 3 With the successful execution of R&D focus, sustainable with near-term, data- transformation research and driven inflections across complete, we’re now partnership engine each therapeutic area ready
Slide 38: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 39: Takeda Oncology
TAKEDA ONCOLOGY WE ASPIRE TO CURE CANCER PHILIP ROWLANDS, PHD Head, Oncology Therapeutic Area
Slide 40: Orientation to Our Oncology R&D Overview
ORIENTATION TO OUR ONCOLOGY R&D OVERVIEW Focused Oncology • Building on foundational expertise in hematologic R&D Strategy malignancies and a growing portfolio in lung cancer • Pursuing novel I/O targets and next-generation platforms Novel Discovery Strategy with world class external partners in Imm
Slide 41: Orientation to Our Oncology R&D Overview
ORIENTATION TO OUR ONCOLOGY R&D OVERVIEW Focused Oncology • Building on foundational expertise in hematologic R&D Strategy malignancies and a growing portfolio in lung cancer • Pursuing novel I/O targets and next-generation platforms Novel Discovery Strategy with world class external partners in Imm
Slide 42: We Aspire to Cure Cancer
WE ASPIRE TO CURE CANCER HEMATOLOGIC MALIGNANCIES OUR MISSION We endeavor to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation, LUNG CANCER and passion for improving the lives of patients. IMMUNO-ONCOLOGY (I/O) 42
Slide 43: Building on Takeda Oncology Foundation in Hematologic Malignancies
BUILDING ON THE TAKEDA ONCOLOGY FOUNDATION IN HEMATOLOGIC MALIGNANCIES Next Generation I/O TAK-573 TAK-981 GROWING LEADERSHIP POSITION IN MDS AML HEMATOLOGIC Phase 3 Phase 3 MALIGNANCIES pevonedistat alisertib Lymphoma Chronic Myeloid Leukemia Improving Patient Outcomes in Multiple Myeloma 43
Slide 44: Recent Progress and Next Steps
RECENT PROGRESS AND NEXT STEPS Approved in 59 countries for Ideal Maintenance Therapies in Multiple Myeloma: Current Relapsed/Refractory Multiple Myeloma Easy to administer Minimal toxicity Maintain response Status First Phase 3 maintenance readout (post-transplant) 1 0 Continuous Therapy 0 Activ
Slide 45: Advance CD38 Biology for Refractory Multiple Myeloma
ADVANCE CD38 BIOLOGY FOR REFRACTORY MULTIPLE MYELOMA Engineered Toxin Bodies Binds to Binds to CD38 CD38 Engineered SLT A A-Subunit Human IgG4 Fc IgG1lambda antibody Attenuated IFNa2b VL VH CD38 with 2 point mutations Targeting Domain TAK-079 TAK-573 TAK-169 • A fully human, anti-CD38 cytolytic IgG1
Slide 46: TAK-079: Improving Upon First Generation Anti-CD38 mAb
TAK-079: IMPROVING UPON FIRST GENERATION ANTI-CD38 mAb FOR REFRACTORY MULTIPLE MYELOMA PATIENTS A potent anti-CD38 mAb administered as a low volume subcutaneous (SC) injection Plasmablast depletion* NK cell depletion* Change from baseline level Study No. TAK-079_101 Study No. TAK-079_101 Time (Days)
Slide 47: Bringing Novel Therapies to MDS and AML
BRINGING NOVEL THERAPIES TO MDS AND AML PEVONEDISTAT IN HR-MDS ALISERTIB IN AML Overall 1 in 3 MDS No new survival AML: Current Transplant patients will therapies Unmet Need progress to 1-1.5 years in the last 5 year survival remains only in the relapse ~30% curative option AML decade setting Clinic
Slide 48: Dual Strategy in Lung Cancer
DUAL STRATEGY IN LUNG CANCER: TARGETING DRIVER MUTATIONS AND NEXT-GENERATION I/O Molecularly-Targeted Precision Therapy CURRENT PORTFOLIO EMERGING ASSETS Sapanisertib (TAK-228) Next-generation TAK-788 kinase inhibitors NEXT GENERATION TARGETS AND PLATFORM Tumor Mutational Burden 48
Slide 49: ALUNBRIG ALTA 1L: Potential Best-in-Class Profile in ALK+ NSCLC
ALUNBRIG ALTA 1L— POTENTIAL BEST-IN-CLASS PROFILE IN ALK+ NSCLC Clear superiority to crizotinib and early separation in PFS curve Primary endpoint (PFS) Primary endpoint hazard ratio ratio hazard compelling is 0.49 relative to competition Risk/benefit profile consistent with the expectations of a be
Slide 50: TAK-788: Addressing Unmet Need in EGFR Exon20 Mutations
TAK-788: ADDRESSING UNMET NEED IN EGFR EXON20 MUTATIONS RESPONSE TO CURRENT EGFR TKIs ANTITUMOR ACTIVITY IN ALL PATIENTS TREATED WITH in EXON 20 INSERTIONS TAK-788 AT A TOTAL DAILY DOSE OF ≥80−160 mga Percent Survival HR = 12.3 p <0.0001 Time (Months) Median PFS EGFR Ex20 insertion (N=9) 2 months Cl
Slide 51: Orientation to Our Oncology R&D Overview
ORIENTATION TO OUR ONCOLOGY R&D OVERVIEW Focused Oncology • Building on foundational expertise in hematologic R&D Strategy malignancies and a growing portfolio in lung cancer • Pursuing novel I/O targets and next-generation platforms Novel Discovery Strategy with world class external partners in Imm
Slide 52: World Class Partners Fueling the I/O Pipeline
WORLD CLASS PARTNERS FUELING THE I/O PIPELINE Re-directed immunity Memorial Sloan Kettering 2018 Cancer Center HaemaLogix Key Academic Collaborations in CAR-T Noile-Immune Biotech 2017 Shattuck Labs Heidelberg Pharma Targeted Tumor payloads micro-environment Gamma Delta Therapeutics Maverick Therape
Slide 53: TAK-573: Novel Immuno-Cytokine Approach to Multiple Myeloma
TAK-573: BRINGING A NOVEL IMMUNO-CYTOKINE APPROACH TO MULTIPLE MYELOMA Targeted delivery of attenuated interferon α to CD38 - a known target in multiple myeloma NCI-H929 Myeloma Model Binds to CD38 Human IgG4 Fc TAK-573 Attenuated IFNα2b with 2 point mutations Highly compelling pre-clinical data wit
Slide 54: Takeda Oncology Aims to Become a Leader in Cell Therapies
TAKEDA ONCOLOGY AIMS TO BECOME A LEADER IN CELL THERAPIES TRANSFORMATIVE POTENTIAL UTILIZING NEXT GENERATION CELL THERAPY PLATFORMS Cell therapy engine FY2019: Differentiated CAR-Ts in Phase I for Takeda R&D FY2020+: Other Hematologic Malignancy and (Takeda-CiRA) Joint Solid Tumor CAR-Ts Program Fra
Slide 55: Orientation to Our Oncology R&D Overview
ORIENTATION TO OUR ONCOLOGY R&D OVERVIEW Focused Oncology • Building on foundational expertise in hematologic R&D Strategy malignancies and a growing portfolio in lung cancer • Pursuing novel I/O targets and next-generation platforms Novel Discovery Strategy with world class external partners in Imm
Slide 56: Innovative Pipeline Enhanced with External Partnerships
AN INNOVATIVE PIPELINE ENHANCED WITH EXTERNAL PARTNERSHIPS Discovery/preclinical* Phase 1 Phase 2 Phase 3 Approved** NINLARO ICLUSIG TAK-659 Pevonedistat Amyloidosis, ND MM, 2nd-Line Chronic Lymphoma HR-MDS/AML R/R MM dara combo, Phase CML, SYK, FLT-3 NEDD 8 R/R MM Ninlaro/dex,, Ph+ ALL Small Molecu
Slide 57: Expected Key Oncology Portfolio Inflection and Milestones
EXPECTED KEY ONCOLOGY PORTFOLIO INFLECTION AND MILESTONES Dates in fiscal year (FY) starting April 1st ALUNBRIG JP APPROVAL NINLARO non-transplant maintenance US APPROVAL NINLARO newly diagnosed US/EU APPROVAL Pevonedistat US APPROVAL NINLARO Niraparib JP APPROVAL ALUNBRIG EU APPROVAL (2L) ALUNBRIG
Slide 58: Conclusion
CONCLUSION 1 Focused on delivering the next approvals for 2 Expanding transformative treatment options in our 3 Harnessing the power of external innovation with NINLARO, ALUNBRIG, focus areas of a diverse set of world- and pevonedistat hematologic malignancies class partnerships, and lung cancer wit
Slide 59: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 60: Takeda Gastroenterology
TAKEDA GASTROENTEROLOGY A GLOBAL LEADER IN GASTROENTEROLOGY ASIT PARIKH MD, PHD Head, Gastrointestinal Therapeutic Area
Slide 61: We Are a Leading GI Company
WE ARE A LEADING GI COMPANY GASTROENTEROLOGY OUR VISION Restore Life to Living for patients suffering with GI and liver diseases OUR MISSION Deliver innovative, life-changing therapeutics for patients with GI and liver diseases 61
Slide 62: Strategy Expands Portfolio Across Core Disease Areas
OUR STRATEGY EXPANDS THE PORTFOLIO ACROSS CORE DISEASE AREAS SUPPORTED BY PLATFORM TECHNOLOGIES IBD Celiac disease • Build upon success of Entyvio with new formulations • Advance approaches for the prevention • Expand treatment options with Alofisel of immune responses to gluten Motility disorders L
Slide 63: Executing on Strategy Through a Rich, Diversified Pipeline
WE ARE EXECUTING ON OUR STRATEGY THROUGH A RICH, DIVERSIFIED PIPELINE FUELED BY STRONG EXTERNAL PARTNERSHIPS Discovery/preclinical* Phase 1 Phase 2 Phase 3 Approval** Multiple targets in IBD ENTYVIO SC ENTYVIO Needle-free UC/CD, JP, China Multiple targets SC UC/CD Small molecule GvHD prophylaxis IBD
Slide 64: Building on the Success of Entyvio
WE ARE BUILDING ON THE SUCCESS OF ENTYVIO TO ADDRESS CONTINUED UNMET NEED IN IBD PATIENTS 1 Geographic expansion 2 First and only biologic specifically targeting gut inflammation New formulations 3 Expanded patient populations 4 New evidence generation First-in-class mesenchymal stem cell therapy fo
Slide 65: Continuously Improving the Value of Entyvio for Patients
WE ARE CONTINUOUSLY IMPROVING THE VALUE OF ENTYVIO FOR PATIENTS GEOGRAPHIC EXPANDED PATIENT NEW FORMULATIONS EXPANSION POPULATIONS • Japan NDA approval for UC ENTYVIO SUBCUTANEOUS • GvHD prophylaxis Ph3 first patient expected • Potential China approval in FY2020* • Positive topline results from VISI
Slide 66: Entyvio Continues to Deliver Against Unmet Need
ENTYVIO CONTINUES TO DELIVER AGAINST UNMET NEED FOR PATIENTS NEW EVIDENCE GENERATION MUCOSAL HEALING IN CROHN’S DISEASE – PREVIOUSLY A GAP FOR ENTYVIO OTHER DATA Complete mucosal healing (absence of ulceration) • Head-to-head vs. adalimumab readout 30% 24% All expected in H1 FY2019 Anti-TNFα naïve •
Slide 67: Alofisel: First Approved Stem Cell Therapy for Fistulizing Crohn's
ALOFISEL: FIRST AND ONLY APPROVED (EU) MESENCHYMAL STEM CELL THERAPY FOR FISTULIZING CROHN’S DISEASE ADDRESSES THE HIGHEST UNMET NEED CX601 MEANINGFULLY IMPROVES STANDARD OF IN IBD, PERIANAL CROHN’S CARE IN ACHIEVING REMISSION (52 WK)* 56.30% 59.20% • ~5% of Crohn’s patients experience perianal fist
Slide 68: TAK-906: Distinctive Mechanism for Gastroparesis
TAK-906: DISTINCTIVE MECHANISM OF ACTION (ORAL D2/D3 RECEPTOR ANTAGONIST) THAT FILLS A LARGE UNMET NEED IN GASTROPARESIS CURRENT THERAPIES DO NOT MEET THE TAK-906: PHASE 2A STUDY DEMONSTRATES TARGET SIGNIFICANT UNMET NEED IN GASTROPARESIS ENGAGEMENT AND ENABLES DOSE SELECTION 200 Prolactin concentra
Slide 69: Kuma062: Highly Potent Oral Glutenase for Celiac Disease
KUMA062: A HIGHLY POTENT ORAL GLUTENASE THAT COULD CHANGE THE STANDARD OF CARE IN CELIAC DISEASE CELIAC DISEASE GLUTEN RECOVERY FROM RAT STOMACHS 30MINS AFTER DIGESTION OF A HIGH-GLUTEN BREAD SLURRY • Affects ~1% of the population1, rising prevalence 100 • Triggered by exposure to omnipresent gluten
Slide 70: Commitment to Liver Diseases Through Early Research Partnerships
WE HAVE STRENGTHENED OUR COMMITMENT TO ADDRESSING LIVER DISEASES THROUGH EARLY RESEARCH PARTNERSHIPS TARGETING LIVER FIBROSIS PREVENTION AND REVERSAL THROUGH NEW PLATFORMS, NEW PROJECTS AND BUSINESS DEVELOPMENT FOCUSED ON PERI-IND OPPORTUNITIES Human cell system for new Liver-targeted delivery of Ta
Slide 71: Expected Key GI Portfolio Inflections and Milestones
EXPECTED KEY GI PORTFOLIO INFLECTIONS AND MILESTONES Dates in fiscal year (FY) starting April 1st ENTYVIO (SC UC and SC CD) ENTYVIO EU FILING (IV CD) ENTYVIO ENTYVIO Alofisel JAPAN LAUNCH ENTYVIO (SC CD) (SC UC) (Perianal Crohn’s) (SC UC) US FILING US FILING TIMP-GLIA US Ph3 FSI JAPAN FILING Entyvio
Slide 72: Conclusion
CONCLUSION 1 Maximizing the potential of ENTYVIO 2 Progressing several early to mid-stage assets 3 Continuing to capture opportunities early and delivering including TAK-906 for through industry-leading ALOFISEL to global gastroparesis and scientific talent, markets KUMA062 for celiac sophisticated
Slide 73: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 74: Takeda Neuroscience
TAKEDA NEUROSCIENCE BRINGING INNOVATIVE MEDICINES TO PATIENTS FOR WHOM THERE ARE NO TREATMENTS AVAILABLE EMILIANGELO RATTI, PHD Head, Neuroscience Therapeutic Area
Slide 75: Challenge to Alleviate Immense Patient Need in Neuroscience
WE HAVE TAKEN ON THE CHALLENGE TO ALLEVIATE THE IMMENSE PATIENT NEED IN NEUROSCIENCE MISSION FOCUS To bring innovative medicines to patients • Treatment Resistant Depression • Alzheimer’s Disease suffering from neurologic and psychiatric • Schizophrenia Negative Symptoms & CIAS • Parkinson’s Disease
Slide 76: Executed on the Roadmap Described in 2016
WE HAVE EXECUTED ON THE ROADMAP DESCRIBED IN 2016 FROM 2016 R&D DAY KEY COMPONENTS OF ROADMAP • Differentiate TRINTELLIX • Advance early pipeline towards POC • Further expand in neurology and rare CNS diseases through partnerships 76
Slide 77: Building an Innovative Pipeline Enhanced with External Partnerships
BUILDING AN INNOVATIVE PIPELINE ENHANCED WITH EXTERNAL PARTNERSHIPS Discovery/Preclinical1 Phase 1* Phase 2 Phase 3 Approved** TRINTELLIX TAK-653 Processing Speed sNDA AMPA PAM Depression Treatment Resistant Depression Approved 2018 TESD sNDA (US) Submitted Small Molecule MDD (JP) Submitted TAK-041
Slide 78: Built Our Portfolio Through Three Main Levers
WE HAVE BUILT OUR PORTFOLIO THROUGH THREE MAIN LEVERS EXECUTED ON OPPORTUNITIES ADVANCED EARLY STAGE PIPELINE EXPANDED IN NEURODEGENERATION AND WITH LATE-STAGE ASSETS TOWARDS POC RARE DISEASE WITH WORLD CLASS PARTNERS • Successful differentiation of TRINTELLIX • TAK-925 Narcolepsy • Denali Therapeut
Slide 79: TRINTELLIX Shows Benefits in Processing Speed and Sexual Dysfunction
TRINTELLIX SHOWS BENEFITS IN PROCESSING SPEED, AN IMPORTANT ASPECT OF COGNITION, AND TREATMENT EMERGENT SEXUAL DYSFUNCTION FOR PATIENTS WITH MDD COGNITIVE FUNCTION (PROCESSING SPEED) TREATMENT EMERGENT SEXUAL DYSFUNCTION Digit Symbol Substitution Test (DSST) after 8 weeks of Changes in Sexual Functi
Slide 80: Built Our Portfolio Through Three Main Levers
WE HAVE BUILT OUR PORTFOLIO THROUGH THREE MAIN LEVERS EXECUTED ON OPPORTUNITIES ADVANCED EARLY STAGE PIPELINE EXPANDED IN NEURODEGENERATION AND WITH LATE-STAGE ASSETS TOWARDS POC RARE DISEASE WITH WORLD CLASS PARTNERS • Successful differentiation of TRINTELLIX • TAK-925 Narcolepsy • Denali Therapeut
Slide 81: Narcolepsy Type 1 Patients Suffer Debilitating Symptoms
DESPITE CURRENT TREATMENTS, PATIENTS WITH NARCOLEPSY TYPE 1 (NT1) SUFFER FROM A RANGE OF DEBILITATING SYMPTOMS NARCOLEPSY TYPE 1 “We take our current • Affects ~100K patients in US (~400K in G-7), with typical meds to survive. disease onset from 7-25 years old1 • Symptoms characterized by: We want n
Slide 82: Narcolepsy Type 1 Is Caused by Loss of Orexin Producing Neurons
NARCOLEPSY TYPE 1 IS CAUSED BY LOSS OF OREXIN PRODUCING NEURONS OREXIN mRNA LABELLING OF POSTMORTEM HYPOTHALAMIC SECTIONS1 LEADING Healthy Control Narcolepsy Type 1 patient RESEARCH TO SUPPORT THE OREXIN HYPOTHESIS An orexin 2 receptor agonist may mimic the • Orexin mRNA transcripts are detected in
Slide 83: TAK-925 Selective OX2R Agonist Reduces Narcolepsy-Like Symptoms
TAK-925 IS A SELECTIVE OX2R AGONIST SHOWING REDUCTION IN NARCOLEPSY-LIKE SYMPTOMS IN A MOUSE MODEL TAK-925 FULLY RESTORED TAK-925 ELIMINATED SLEEP / TAK-925 ABOLISHED WAKEFULNESS WAKE TRANSITIONS CATAPLEXY-LIKE EPISODES Wakefulness time of NT1 mouse model Hypnogram of sleep/wake transitions Cataplex
Slide 84: Built Our Portfolio Through Three Main Levers
WE HAVE BUILT OUR PORTFOLIO THROUGH THREE MAIN LEVERS EXECUTED ON OPPORTUNITIES ADVANCED EARLY STAGE PIPELINE EXPANDED IN NEURODEGENERATION AND WITH LATE-STAGE ASSETS TOWARDS POC RARE DISEASE WITH WORLD CLASS PARTNERS • Successful differentiation of TRINTELLIX • TAK-925 Narcolepsy • Denali Therapeut
Slide 85: Neurodegenerative Diseases Addressed with Alternative Modalities
MANY NEURODEGENERATIVE DISEASES CAN BE ADDRESSED WITH ALTERNATIVE MODALITIES TARGETED TO PATHOGENIC PROTEINS Antisense oligonucleotides can reduce Monoclonal antibodies can clear ASOs and mAbs could be combined intracellular expression of toxic proteins pathogenic extracellular proteins for greater
Slide 86: Denali Partnership Reinforces Alzheimer's Portfolio
PARTNERSHIP WITH DENALI HAS REINFORCED OUR ALZHEIMER’S DISEASE PORTFOLIO WITH HIGHLY BRAIN PENETRANT MONOCLONAL ANTIBODIES Antibody Transport Vehicles (ATVs) enable up to > 20X higher brain penetration of monoclonal antibodies than the same antibody without ATV1 Collaboration agreement to co- develo
Slide 87: Wave Life Sciences Partnership for Rare CNS Diseases
PARTNERSHIP WITH WAVE LIFE SCIENCES ENABLES TARGETED THERAPIES TO RARE CNS DISEASES WITH STEREOPURE ANTISENSE OLIGONUCLEOTIDES SYNTHESIS OF STEREOPURE OLIGONUCLEOTIDES: STEREOPURE APPROACH ENABLES ALLELE-SPECIFIC A SIGNIFICANT IMPROVEMENT IN THE FIELD TARGETING OF DISEASE GENES Racemic mixture up to
Slide 88: Expected Key Neuroscience Portfolio Inflections and Milestones
EXPECTED KEY NEUROSCIENCE PORTFOLIO INFLECTIONS AND MILESTONES Dates in fiscal year (FY) starting April 1st TRINTELLIX PDUFA Treatment Emergent Sexual TAK-831 Friedreich’s TAK-925 preliminary NT1 Dysfunction sNDA Ataxia Phase II efficacy data TAK-831 Schizophrenia Phase II 2H FY 2018 1H FY 2019 2H F
Slide 89: Conclusion
CONCLUSION 1 Successful differentiation of 2 Progressed TAK-925, the first OX2R agonist, as 3 Expanded in neurodegeneration and TRINTELLIX in potential transformative CNS rare disease with processing speed, an therapy for Narcolepsy world-class partners important aspect of Type 1 (exemplified by Wav
Slide 90: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 91: Takeda Vaccines
TAKEDA VACCINES INNOVATION FOR GLOBAL IMPACT RAJEEV VENKAYYA, MD President, Global Vaccine Business Unit
Slide 92: Our Mission
OUR MISSION Develop and deliver innovative vaccines that tackle the toughest problems in public health and improve the lives of people around the world 92
Slide 93: Global Vaccine Business Built on Foundation in Japan
WE HAVE BUILT A GLOBAL VACCINE BUSINESS UPON A STRONG FOUNDATION IN JAPAN Global pivotal Phase 3 PARTNERSHIPS clinical trial of dengue Polio vaccine ACQUISITIONS vaccine candidate initiated: candidate Japan vaccine business Global vaccine business Dengue vaccine 20,100 participants in 8 candidate Bi
Slide 94: The Vaccine Market Is an Attractive Place for Investment
THE VACCINE MARKET IS AN ATTRACTIVE PLACE FOR INVESTMENT Vaccine sales growth projected at 7.1% between Durability in sales with limited impact 2017 and 2024, reaching $44.6 billions in 20241 of patent expiry Blockbuster potential in newly launched vaccines Threat of emerging and existing infectious
Slide 95: Our Strategy
OUR STRATEGY Develop vaccines with global BUILD A GLOBAL TACKLE Target the greatest opportunity relevance and business potential PIPELINE UNMET NEED in infectious diseases LEVERAGE PARTNERSHIPS Partner to de-risk and drive vaccine development 95
Slide 96: Our Pipeline
OUR PIPELINE Discovery/preclinical Phase 1 Phase 2 Phase 3 Japan Marketed Vaccines EGG-BASED DENGUE VACCINE SEASONAL FLU (TAK-003) H5N1 FLU DENKA & KM BIOLOGICS (BLB-750) NOROVIRUS VACCINE MEASLES VARICELLA^ (TAK-214) RUBELLA+ BIKEN BARDA JAPANESE SABIN INACTIVATED MUMPS ENCEPHALITIS ZIKA VACCINE PO
Slide 97: Dengue Threatens Half of the World's Population
DENGUE THREATENS HALF OF THE WORLD’S POPULATION In 2015, >85 M Endemic in more than Causes an estimated Causes more than 120 countries1 390 M infections1 20K deaths each year2 US, Canada, and Japan travelers to endemic countries3 Without safe and effective dengue vaccine >3.9 BILLION people around t
Slide 98: Dengue Vaccine Should Protect Against All Four Strains
A SAFE AND EFFECTIVE DENGUE VACCINE SHOULD BE DESIGNED TO PROTECT AGAINST ALL FOUR STRAINS OF THE VIRUS • Dengue is a mosquito-borne disease that can be caused by each of the four strains of the dengue virus (DENV) 1-4 • In people previously exposed to dengue, a subsequent infection with a different
Slide 99: TAK-003 Modeled on the Complete Dengue Virus
TAK-003 IS MODELED ON THE COMPLETE DENGUE VIRUS AND ACTIVATES MULTIPLE ARMS OF THE IMMUNE SYSTEM • Live attenuated dengue vaccine based on the complete DENV-2 genome • Vaccine virus stimulates robust immune response without causing illness • Components of immune response that are activated include:
Slide 100: TAK-003 Triggers Antibody and Cell-Mediated Immune Responses
TAK-003 TRIGGERS BOTH ANTIBODY AND CELL-MEDIATED IMMUNE RESPONSES 100% % of Subjects with a Dengue- Percentage of participants specific T-cell Response 80% Participants responding to: 60% 3 or 4 serotypes 40% All 4 serotypes 20% 0% 28 91 180 540 Days Antibody-mediated immune response in dengue naïve
Slide 101: TAK-003 Triggers NS1 Antibodies That Prevent Vascular Leakage
TAK-003 TRIGGERS NS1 ANTIBODIES THAT PREVENT VASCULAR LEAKAGE IN THE LABORATORY1 Endothelial Permeability • Severe dengue is characterized by vascular leakage (Relative TEER) in the lungs and abdomen • This vascular leakage is thought to be mediated by the dengue virus non-structural protein 1 (NS1)
Slide 102: TAK-003 Generally Safe and Reduced Dengue Incidence in Phase 2
TAK-003 WAS GENERALLY SAFE AND REDUCED THE INCIDENCE OF DENGUE IN CHILDREN IN A RECENT PHASE 2 STUDY INCIDENCE OF SYMPTOMATIC DENGUE WAS SIGNIFICANTLY LOWER IN VACCINE RECIPIENTS OVER 18 MONTHS1 STUDY FEATURES • 1,800 participants received either TAK-003 (1 dose; 2 Dengue Incidence doses at 0, 3 mon
Slide 103: Phase 3 Pivotal Trial Designed to Answer Key Questions
OUR PHASE 3 PIVOTAL TRIAL IS DESIGNED TO ANSWER THE MOST IMPORTANT QUESTIONS ABOUT SAFETY AND EFFICACY OF OUR DENGUE VACCINE CANDIDATE STUDY DESIGN PRIMARY ENDPOINT SECONDARY ANALYSIS: ENDPOINT ANALYSIS: • 20,100 participants, aged 4 – 16 years old OVERALL VACCINE VACCINE EFFICACY IN - Age range ens
Slide 104: Most Advanced Norovirus Vaccine Candidate (TAK-214)
TAKEDA HAS THE MOST ADVANCED NOROVIRUS VACCINE CANDIDATE (TAK-214) AND RECENTLY COMPLETED PHASE 2B STUDY CHALLENGE • Leading cause of acute gastroenteritis – 600M infections per year • No vaccine available OUR PATH • Most advanced vaccine in development • Completed Phase 2b study • Phase 3 preparati
Slide 105: Partnered with U.S. Government on First Zika Vaccine (TAK-426)
TAKEDA HAS PARTNERED WITH THE U.S. GOVERNMENT TO DEVELOP THE FIRST ZIKA VACCINE (TAK-426) CHALLENGE • Devastating impact on newborns • Potential for recurrent outbreaks • No vaccine available OUR PATH • Largest Zika investment by U.S. government • Proven platform • Fast track designation OUR GOAL •
Slide 106: Conclusion
CONCLUSION 1 STRONG FOUNDATION AND TOP TALENT • Over 70 years of 2 BEST-IN-CLASS AND FIRST-IN-CLASS POTENTIAL • Dengue vaccine 3 A PARTNER OF CHOICE FOR VACCINES • U.S. Government vaccine manufacturing (TAK-003) in Phase 3 • Japan Government experience • Norovirus vaccine • Bill & Melinda Gates • To
Slide 107: If you want to save and improve lives around the world
“If you want to save and improve lives around the world, vaccines are a fantastic investment.” - Bill Gates
Slide 108: R&D Day Agenda – Cambridge, October 11, 2018
R&D DAY AGENDA – CAMBRIDGE, OCTOBER 11, 2018 Time Agenda 12:00 – 12:30 Registration and Lunch 12:30 – 13:10 R&D Transformation, Progress To Date, Future Outlook Andy Plump 13:10 – 13:45 Oncology Phil Rowlands 13:45 – 14:05 Gastroenterology Asit Parikh 14:05 – 14:20 Break 14:20 – 14:40 Neuroscience E
Slide 109: Looking Ahead
LOOKING AHEAD Shire 109
Slide 110: Recommended Offer for Shire – Transaction Update
RECOMMENDED OFFER FOR SHIRE – TRANSACTION UPDATE • $7.5 billion term loan agreed with leading global financial institutions • Regulatory review process commenced PROGRESS - U.S. Federal Trade Commission (FTC) clearance received TO DATE - Chinese State Administration for Market Regulation (SAMR) clea
Slide 111: Pending Acquisition of Shire Will Accelerate Takeda R&D
PENDING ACQUISITION AND INTEGRATION OF SHIRE WILL ACCELERATE TAKEDA R&D • Increase cash flow and strengthen R&D functions • Continue our TA focus, partnership model • Extend and elevate our rare disease expertise • Deliver consistent, breakthrough innovation • Reinforce patient-centric, science driv
Slide 112: Q&A Panel Cambridge
Q&A PANEL CAMBRIDGE ANDY PLUMP PHIL ROWLANDS ASIT PARIKH CMSO Oncology TAU Gastroenterology TAU EMILIANGELO RATTI RAJEEV VENKAYYA CHRIS MORABITO Neuroscience TAU Vaccine Business Unit R&D Shire Integration 112
Slide 113: Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company — Investor Day (October 2018) on 6ix