Takeda Pharmaceutical Co. Ltd. · TSE:4502
Takeda Pharmaceutical — Investor Day (March 2023)
31 slides from Takeda Pharmaceutical's investor day presentation, Mar 15, 2023
Slide 1: QDENGA: Transforming Dengue Prevention
QDENGA: TRANSFORMING DENGUE PREVENTION Ramona Sequeira President, Global Portfolio Division Derek Wallace Vice President, Head of Dengue Global Program Guest Speaker: Eng Eong Ooi Professor, Programme in Emerging Infectious Diseases, Duke-NUS Medical School March 15, 2023 EST / March 16, 2023 JST Th
Slide 2: 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”) regarding this presentation. This presentation (i
Slide 3: Today's Speakers
TODAY’S SPEAKERS Presenting Joined by Special Guest Ramona Sequeira Derek Wallace President, Vice President, Global Portfolio Division Head of Dengue Global Program Q&A Eng Eong Ooi Professor, Programme in Emerging Infectious Diseases, Duke-NUS Medical School Gary Dubin Renata Campos President, Pres
Slide 4: Dengue – Top Threat to Global Public Health
DENGUE – TOP 10 THREAT TO GLOBAL PUBLIC HEALTH Ramona Sequeira – President, Global Portfolio Division
Slide 5: Dengue is listed by the WHO as one of ten threats to global health
DENGUE IS LISTED BY THE WORLD HEALTH ORGANIZATION AS ONE OF TEN THREATS TO GLOBAL HEALTH1 Growing >125 390M prevalence >3.9 Billion Endemic in over 390M estimated infections and Global incidence rates have people are at risk of dengue infection globally2 125 countries; 70% of the 500,000 hospitaliz
Slide 6: QDENGA Strategic Launch Imperatives
QDENGA STRATEGIC LAUNCH IMPERATIVES Create awareness of the health and Build confidence with regulators, economic risks associated with dengue recommending bodies, HCPs and for consumers living or traveling to consumers by leveraging strong endemic regions clinical profile Ensure launch preparedness
Slide 7: Today's Agenda
TODAY’S AGENDA Dengue Burden and Control – Eng Eong Ooi BMBS, PhD, FRCPath Professor Programme in Emerging Infectious Diseases, Duke NUS Medical School. Singapore QDENGA Program and Clinical Results – Derek Wallace QDENGA Commercial Outlook – Ramona Sequeira Q&A – Ramona Sequeira, Derek Wallace, Gar
Slide 8: Dengue burden and control
Dengue burden and control Why the world needs a vaccine Eng Eong Ooi BMBS, PhD, FRCPath Professor Programme in Emerging Infectious Diseases
Slide 9: The Global Burden of Dengue
THE GLOBAL BURDEN OF DENGUE • More than 4 billion people are at risk and Geographical distribution of dengue cases reported worldwide, 2021 4 estimated 390 million infections per year1 • 30 times increase in disease over the past 50 years2 Driven by • Urbanization • Global warming • Increased global
Slide 10: Dengue Symptoms and Presentation Varies
DENGUE SYMPTOMS AND PRESENTION VARIES Most dengue infections are asymptomatic or Severe dengue is present in 5% of cases2,3. lead to mild illness with flu-like symptoms1 High plasma viral load and NS1 levels have been associated with plasma leakage, a hallmark of severe dengue4 CDC image 1. World He
Slide 11: Risk of Severe Dengue Peaks Within a Narrow Range of Pre-Infection Antibody Levels
RISK OF SEVERE DENGUE PEAKS WITHIN A NARROW RANGE OF PRE-INFECTION ANTIBODY LEVELS1 1. Salje et al, Nature 2018 11
Slide 12: Dengue Types 1 and 2 Cause Majority of Outbreaks
DENGUE TYPES 1 AND 2 CAUSE MAJORITY OF OUTBREAKS Four strains of the dengue virus (DENV) 1-4 are spread by the Aedes aegypti and Aedes albopictus mosquitos worldwide In recent years, DENV-1 and DENV-2 have emerged as the most prominent strains associated with known outbreaks1 - According to empirica
Slide 13: Dengue outbreaks occur every few years
Dengue outbreaks occur every few years1 Hospitals can become overwhelmed with the spike in cases2 1. Clin Epidemiol. 2013; 5: 299–309. Published online 2013 Aug 20. doi: 10.2147/CLEP.S34440 2. PLOS. Neglected Tropical Disease. Societal impact of dengue outbreaks: Stakeholder perceptions and related
Slide 14: Without Vaccination, Dengue Control Lacks Sustainability
WITHOUT VACCINATION, DENGUE CONTROL LACKS SUSTAINABILITY Dengue and Aedes population density in Singapore – 1966 to 20221 Current efforts for dengue control are directed at reducing infection rate through vector control methods In the medium to long term, this could cause lower population immunity a
Slide 15: Developing Safe and Effective Vaccine for a Broad Population
DEVELOPING SAFE AND EFFECTIVE VACCINE FOR A BROAD POPULATION Derek Wallace, MBBS – Head of Dengue Global Program
Slide 16: Dengue Virus Infections Have a Distinct Pathophysiology
DENGUE VIRUS INFECTIONS HAVE A DISTINCT PATHOPHYSIOLOGY Severe disease, although rare, is unpredictable and typically affects children1,2 Severe dengue infections are characterized by vascular leakage associated with a high risk of hospitalization and mortality2 • Dengue virus non-structural (NS) pr
Slide 17: QDENGA: Engineered to Elicit a Broad and Lasting Immune Response
QDENGA: ENGINEERED TO ELICIT A BROAD AND LASTING IMMUNE RESPONSE AGAINST ALL DENGUE SEROTYPES Tetravalent QDENGA To contain the structural Built on a dengue virus serotype 2 backbone containing 1 genes of serotypes 1 to 4 2 dengue virus non-structural genes, including NS-1 protein was engineered: QD
Slide 18: Phase 3 TIDES Trial Designed to Assess Safety and Efficacy of TAK-003
PHASE 3 TIDES TRIAL DESIGNED TO ASSESS THE SAFETY AND EFFICACY OF TAK-003 IN BROAD POPULATION Trial design met WHO Broad Population recommendations for a second- generation dengue vaccine – 3-5 20,000 8 4/4 Both children & endemic Includes all Sero-positive & years of follow-up prior to licensure ad
Slide 19: Sustained Protection Against All Dengue Serotypes & Lower Risk of Hospitalization
SUSTAINED PROTECTION AGAINST ALL DENGUE SEROTYPES & LOWER RISK OF HOSPITALIZATION REGARDLESS OF PREVIOUS EXPOSURE Strong efficacy across all endpoints Reduction in symptomatic VCD & hospitalizations Durable Reduction in Hospitalizations regardless of previous exposure @ 4.5 yrs (exploratory endpoint
Slide 20: Significant Regulatory Momentum: QDENGA Approved with Broad Label
SIGNIFICANT REGULATORY MOMENTUM: QDENGA APPROVED WITH BROAD LABEL REGARDLESS OF SEROSTATUS 2023 Approved in Brazil December 2022 for ages 4 – 603 November 2022 Approved in EU2 for ages 4 and up October 2022 US FDA accepts filing August 2022 EU-M4all application receives Positive Approved in CHMP opi
Slide 21: QDENGA Commercial Outlook
QDENGA COMMERCIAL OUTLOOK Ramona Sequeira – President, Global Portfolio Division
Slide 22: QDENGA Strategic Launch Imperatives
QDENGA STRATEGIC LAUNCH IMPERATIVES Create awareness of the health and Build confidence with regulators, economic risks associated with dengue recommending bodies, HCPs and for consumers living or traveling to consumers by leveraging strong endemic regions clinical profile Ensure launch preparedness
Slide 23: Country-Level Activation of Strategic Imperatives
COUNTRY-LEVEL ACTIVATION OF STRATEGIC IMPERATIVES INITIATED AHEAD OF EXPECTED APPROVALS Driving Establishing Building a consumer trust in dengue dengue travel awareness prevention business of dengue risk in BRAZIL in NON-ENDEMIC and prevalence COUNTRIES in THAILAND 70M+ people in country 200M+ peopl
Slide 24: Establish Rapid and Broad Access – Brazil
ESTABLISH RAPID AND BROAD ACCESS AT AN INDIVIDUAL- AND POPULATION-LEVEL - BRAZIL Initiation of National Immunization programs (NIP) # of people vaccinated Steps to broaden access happen in parallel, volume increases with Engaging at a state and municipal level to each step as we work towards impleme
Slide 25: Variable Pricing Approach for Individual Countries & Market Segments
VARIABLE PRICING APPROACH TO MEET THE NEEDS OF INDIVIDUAL COUNTRIES & MARKET SEGMENTS We aim to make QDENGA available to all who are eligible for vaccination in the countries where approved PRIVATE ENDEMIC PUBLIC ENDEMIC TRAVEL • Pricing at or below the average price for • Aim to price lower than av
Slide 26: Launch Ready: Established Manufacturing & Supply Chain
LAUNCH READY: ESTABLISHED MANUFACTURING & SUPPLY CHAIN AND LEVERAGING BROAD GLOBAL FOOTPRINT Manufacturing capacity in place Well-established distribution Proven track record In Growth & for launch and investing to network Emerging Markets (GEM) expand for growth • Early investments to • Cold chain
Slide 27: Global Expansion Through the End of the Decade
GLOBAL EXPANSION THROUGH THE END OF THE DECADE Target launches in >20 countries by 2025, representing 55% of eligible at-risk population Leveraging EU-M4all review process to potentially accelerate approvals in participating endemic markets Indonesia, Malaysia, Thailand, Colombia, Brazil, China, Ind
Slide 28: Steady Revenue Growth Through the End of the Decade
STEADY REVENUE GROWTH THROUGH THE END OF THE DECADE Strong Clinical Profile - 4.5-yr data demonstrating durable reduction in hospitalization and no important safety signals consistent with 1° & 2 ° endpoints $1.6 - 2.0B Momentum with regulators – Brazil, Indonesia & EU approvals with broad labels, r
Slide 29: Summary of QDENGA Commercial Outlook
SUMMARY OF QDENGA COMMERCIAL OUTLOOK Near-term: Mid-term: Long-term: Drive Early Adoption Accelerate Volume Growth Durable Sales Post Peak • Launch into key endemic and travel • Initiation of national vaccination • Continued global expansion into the markets – leveraging strong clinical programs wil
Slide 30: QDENGA – Addressing the Urgent Need for a Safe and Effective Dengue Vaccine
QDENGA – ADDRESSING THE URGENT NEED FOR A SAFE AND EFFECTIVE DENGUE VACCINE Significant, Growing Global Burden • >3.9 billion people at risk of infection1 • Growing prevalence – increasing 30-fold over the last 50yrs2 • Significant economic burden of disease both at the government, healthcare system
Slide 31: Thank You
THANK YOU © 2023 Takeda Pharmaceutical Company Limited. All rights reserved.
Takeda Pharmaceutical Company — Investor Day (March 2023) on 6ix