Our strategy and targeted investments extend across the entire
value chain
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION
RESEARCH & DEVELOPMENT
14
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION
RESEARCH & DEVELOPMENT
15
BioLife, part of Takeda’s Plasma-Derived Therapies Business Unit,
is an industry leader in the sourcing of high-quality plasma
Broad global footprint Recognized expertise
140+ collection centers across Trained medical staff at each center
four countries Dedicated quality, regulatory and
Plasma sourced externally from eight medical employees
countries Recognized safety and quality
Three dedicated screening labs expertise, industry-leading standards
Fully compliant with requirements from:
16 Source: Takeda internal data. / MRB. The plasma protein market in the United States by company, 2018. / Bain & Co. Plasma donor survey 2015. / Takeda. Plasma-Derived Therapeutics. Pathogen Safety Monograph.
Our BioLife centers offer an exceptional donor experience
Efficiency & convenience central to our
approach
• Repeat donors spend just ~1 hour at the center
• Appointment-based process with digital scheduling
Staff committed to the well-being of our donors
Modern, high quality facilities, with
free Wi-Fi and supervised children's playroom
in certain centers
Facilities designed for donor comfort
and regulatory compliance
17
We are accelerating the rate of plasma collection and incrementally
increasing overall volume through third parties and acquisition
We are building momentum….
Increased plasma volumes by approximately 20% in 2018
Expanded European presence from 7 to 30 collection centers within past 12 months
Completed 5 acquisitions in the past 12 months in US, Austria, Hungary and Czechia We are accelerating
Plan on opening a total of 19 additional new collection centers in fiscal year 2019 growth with the goal of
increasing plasma supply by
>65%
Leveraging third party supply through long-term contracts
Participating in contract agreements with governments
We will continue to focus on operational excellence over the next 5 years
Open collection sites faster
Increase speed to peak collection volumes
Create efficiency via new models and approaches
18 Source: Takeda internal data.
We are further enhancing and digitalizing facilities and services
to meet growing needs for the future
Improving the donor experience and
Attracting new donors in the community improving cost-per-liter through
omnichannel engagement
Reaching new donors
Increasing community engagement
Mobile Website
App
Donor
Scheduling Information
Payment
19
FOR INTERNAL USE ONLY
19
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION
RESEARCH & DEVELOPMENT
20
We have a world-leading plasma-derived therapies manufacturing
network in which we continue to significantly invest
Covington, GA 8 STRATEGIC LOCATIONS
Sanquin, NL Vienna, Austria
plus four strategic partners, allowing
Round Lake, IL
Narita, Japan independent yet inter-related
Lessines, Belgium
manufacturing operations
Pisa, Italy
Halozyme, CA
Los Angeles, CA
INNOVATION MINDSET
Rieti, Italy
digitalization and constant drive for
Baxter BioPharma, IN excellence to accelerate supply to patients
Kamada, Israel
CONTINUED CAPACITY EXPANSION
to increase production of our portfolio to
meet market growth while driving
efficiencies
CONTINUALLY INVESTING
in state-of-the-art facilities that meet
the highest quality standards
Takeda Mfg.
21
External Mfg.
The global network builds on the strengths of each location while
leveraging operational excellence across the sites
Mass Capture, Fractionation
Los Angeles, USA Rieti, Italy Vienna, Austria Sanquin, NL Covington, USA
Downstream Processing
Lessines, Belgium Covington, USA Round Lake, USA Pisa, Italy Vienna, Austria
22
We're increasing production capacity by accelerating investment, while
further enhancing our quality standards
Investing in manufacturing capacity
Continually investing in technologies and processes to maximize yield
Higher yield, lower cost fractionation techniques
We plan to increase our
Analytics, automation and digitization to optimize network
manufacturing capacity within
Optimizing plasma efficiency through the value chain our existing network by
>65%
Downstream optimization within broader Takeda manufacturing
network
Capacity Expansion: 2018 – 2023 (projected) over the next 5 years
>65%
2018 2023
23
Takeda has world-class safety capabilities and an unsurpassed
reputation in both plasma donation and pathogen safety
Donation safety standards
Strict donation Donation Strong Plasma screening,
criteria and frequency inspection inventory hold and look
screening at management record back procedure
each visit system
Every plasma donation screened for HIV, hepatitis A, B & C, parvo B19
Pathogen safety standards
BioSafety Level 3+ Lab Process sciences Virology Publication /
Purpose-built, state-of- Qualified models of all Classical & presentation
the-art biocontainment bioprocessing steps molecular virology Strong track
laboratory expertise and record
capability
Dedicated virology expertise and capabilities
40+ highly >50% with specialized >200 years post-
trained staff education graduate experience
24
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION
RESEARCH & DEVELOPMENT
25
Our broad and differentiated portfolio of plasma-derived therapies
treats rare and complex diseases worldwide
ATIII
26 For illustrative purposes only, geographies and products do not correspond
Our two SCIG brands complement each other and address
different patient needs
• Similar efficacy to IVIG and IV-like
• Well tolerated
administration features
• Limited volumes (up to 60ml per
• High volumes (up to 600ml per site) and
site) through frequent infusions
monthly infusions (every 3-4 weeks)
• Ease of use/preparation
• Improved Bioavailability vs cSCIG
Key Features • 2 or 4 infusion sites/needles
• 1 or 2 infusion sites/needles
• PID, SID*
• PID and SID* • CIDP (regulatory approval decision
expected in 2023)
Indications
• Fast, regular infusions • Less frequency, high volume
• Daily to biweekly • Monthly to biweekly
For patients • Home setting • Home or hospital setting
who prefer
Source: Borte, et al., Clin Exp Immunol. 2017 Jan;187(1):146-159. (doi: 10.1111/cei.12866) / Suez, et al., J Clin Immunol. 2016 Oct;36(7):700-12. (doi: 10.1007/s10875-016-0327-9) /
CUVITRU SmPC. / Wasserman RL, et.al, J Allergy Clin Immunol. 2012 Oct;130(4):951-7. (doi: 10.1016/j.jaci.2012.06.021) / HyQvia SmPC. / Wasserman RL, et al., J Clin Immunol. 2016
Aug;36(6):571-582. (doi: 10.1007/s10875-016-0298-x) / Clinical trials.gov with published study completion Dec 31 2021
*SID not approved in the US. Only select SIDs are approved for the above-mentioned products: chronic lymphocytic leukemia, multiple myeloma and hematopoietic stem cell
27 transplantation.
Currently, global supply is not keeping up with demand for
IG therapies
STRONG & CONTINUED IG DEMAND
The Global Polyvalent IG Market (IVIG/SCIG) IG is increasingly recognized for its diverse
from 2000 to 2016, with Projected Global Demand Through 2024
therapeutic value, and is expected to grow in
Millions of grams
approved indications for a range of diseases
300
Actual
250 Estimate
MARKED BY SCIG GROWTH RATE
200 SCIG market continues to drive IG growth
at CAGR of 20%
150
100
15%
30%
50
$12B $20B
0 (2025)
(2019)
2000 2003 2005 2008 2010 2012 2014 2016 2018 2020 2022 2024
Source: The Marketing Research Bureau, Inc. (Orange, CT) 85% 70%
IVIG SCIG
Source: 2016 WW MRB Report, 2017 US MRB Report / Berman. Plasma Fractionation: The Challenge of Keeping Pace with Global IG Demand / Chapel H, et al. Front Immunol 2014 Dec 15;5:627. / Jones G, et al. Front Immunol. 2018 Jul 2;9:1308. / PPTA. The PPTA vision on the
28 plasma protein therapies sector for the next decade in Europe. 10 April 2014
Takeda’s commitment during times of supply-demand imbalance is
to focus on sustainable patient care
Consider the global Support for those Focus on existing Partner to explore
community with highest need to patients first and and implement
gain treatment responsibly pursue policies and practices
new opportunities that enable
sustainable supply
29
Our goal is to continue to bring personalized, innovative, lifelong
care to as many people as possible throughout the patient journey
Diagnosis Access
Partnership with large hospital Sustainable pricing
systems in the US to leverage Dedicated access support
electronic medical records
Patient assistance programs
Co-chairing the Global Commission
to End the Diagnostic Odyssey for Broad portfolio of products
Children with Rare Disease
Awareness campaigns
Diagnostic test kits
Personalized Care & Support
Enhanced patient services
Nurse training to support new patients
Devices and delivery systems
30
We anticipate significant growth opportunities across our portfolio
Global plasma
Takeda revenue market size
Example Takeda products (OY, 2018) (OY, 2018)
Immunoglobulin ~2,870 ~12,500
Last
Liter
Albumin ~580 ~5,000
Hemophilia ~890 ~2,800
products
First
Liter
Other products ~660 ~3,700
Antithrombin III
*2018 revenue is a pro-forma which adds Legacy Shire’s 9 month (April – December 2018) revenue previously reported under US GAAP and conformed to IFRS without material
differences and converted to JPY using FY2018 actual rate for the period. 2018 revenue also includes product sales of Nihon Pharmaceutical products, Takeda’s consolidated subsidiary.
Total ~5,000* ~24,000
31
Source: MRB; EvaluatePharma; Takeda internal data
And we are embarking on a trajectory to improve overall Plasma-
Derived Therapies business performance
Key Growth & Margin Drivers for PDT Key Financial Aspiration for PDT*
• Focused sustainable, value-based commercial Annual revenues
strategies, including tenders (CAGR)
Mid to high
single digit
• Process efficiencies across the network
• Capacity increase across collections and
manufacturing
CAPEX
(% of Revenue)
• R&D investments across portfolio
Mid single digit
* The “Key Financial Aspirations” listed above represent Takeda’s goals in the long-term for the PDT business as of the date hereof and are based on certain assumptions. Actual Amounts/results may differ materially and are subject to a number of risks and
32 uncertainties. See “Note Regarding Forward Looking Statements” on Page 1 of this presentation.
Key takeaways
1 2 3
At Takeda, plasma is a Our goal is to Our broad and
long-term strategic accelerate growth in differentiated portfolio
focus, led by a capacity by >65% over brings personalized,
dedicated business the next 5 years to innovative, lifelong
unit investing to grow bring additional and care and underlines our
across the value chain improved therapies to credentials for
and leveraging Takeda more people around reimagining the
capabilities the world industry
33
A New Dedicated Focus on Innovative, Sustainable
Solutions for Plasma-Derived Therapies
Christopher Morabito, M.D.
Head of R&D, Plasma-Derived Therapies
PDT R&D’s credentials and infrastructure are well-established
Partobulin
Albumin (Austria, Health
Ministry Approval)
1941 1952 1968 1968 1986 1994 1998 1999 2001 2002 2005 2006 2008 2010 2013 2016
Tetabulin Antithrombin III
(Canada, Health
Ministry Endobulin S/D
Approval)
Partobulin S/D
Pathogen Pharmaceutical
Pilot Labs
Safety Science
Global Center of Strong team Within Vienna, Los
Excellence for connected across Angeles, Georgia and
Pathogen Safety the value chain Lessines sites
35
Our independence brings focus on plasma and is bolstered by
access to broader R&D capabilities and resources
Focused entirely on plasma-derived therapies
Lean and agile team
PDT Based in Cambridge, MA and Vienna, Austria
R&D Separate R&D prioritization
Dedicated budget
Global
R&D
Common Takeda values, patient-focused vision
Common governance
Shared resources (e.g. Medical Affairs, Safety, Quality)
These links strengthen Takeda R&D’s modality mix, now the broadest among the Top 10 global biopharmaceutical companies
36
The PDT R&D Leadership Team is well-integrated and brings
deep and diverse functional expertise
Christopher Morabito MD
R&D Head
Boston, MA
Catherine Parham MD Rory Bukofzer Leman Yel MD Chris Tremblay Bagirath Gangadharan PhD Andreas Liebminger PhD Sascha Haverfield DPhil
Program Leadership Program Leadership Clinical Medicine R&D Operations Translational Research Pharmaceutical Sciences Regulatory Affairs &
Boston, MA Boston, MA Boston, MA Boston, MA Vienna, Austria & Devices Development Operations
Vienna, Austria/Boston, MA Boston, MA
Geoffrey Pot PhD Gabriele Ricci William Standaert Cara Laurello Ambreen Landa Pritesh Patel Julia Ellwanger
Global Manufacturing Digital Technologies Legal Ethics and Compliance Human Resources Finance Communications
External Supply & Plasma Boston, MA Zurich, Switzerland Boston, MA Boston, MA Boston, MA Bannockburn, IL
Innovation
Lessines, Belgium
37 Flag = country of origin
We are driving a culture of innovation through two R&D engines
Research/Early Development Late Development
Translational
Integrated
Pharmaceutical
Care Solutions
Sciences
Translational Research
Pharm Sci and Devices
Early Development Innovation Engine Late Development Innovation Engine
Generate new and improved therapeutics by: Improve health outcomes by:
Investigational new drug candidates Diagnostic efficiencies
Mechanisms of action Expanded data and devices to support effectiveness
Responder populations Point of Care services and drug delivery services
New process development Data-driven guidelines for acute and chronic management
38
PDT R&D Strategy
Maximize the therapeutic
Realize full potential of in-line First and Last Liter products
value of plasma-derived
Expanded indications and benefit-risk datasets
therapies for patients with
Device-driven solutions for diagnosis, management,
rare and complex diseases and long-term follow-up
through innovation across Global expansion
the product life cycle New formulations
Optimize efficiencies of plasma-derived therapy production
Pharmaceutical science support for manufacturing
Identify and develop new plasma-derived therapies
New targeted therapies for diverse therapeutic areas
39
We are prioritizing near-term late development…
RESEARCH / NON-CLINICAL DEVELOPMENT LATE DEVELOPMENT
CUVITRU HYQVIA HYQVIA
Halozyme Halozyme
Wearable Device US - Pediatric PID EU - Pediatric PID
HYQVIA HYQVIA - HyHub
Halozyme
IMMUNOLOGY
Flextronics
Chronic inflammatory demyelinating
Delivery Device
polyneuropathy (CIDP)
HYQVIA CINRYZE
Geographic expansion Geographic expansion
CUVITRU GLASSIA
Kamada
Immunogenicity/ bronchioalveolar
Geographic expansion
lavage
HEMATOLOGY
FEIBA
Volume reduction
40
… while enabling discovery of next generation therapeutics
RESEARCH / NON-CLINICAL DEVELOPMENT LATE DEVELOPMENT
TAK 881
CUVITRU HYQVIA HYQVIA
Facilitated 20% SC IgG Halozyme Halozyme
Wearable Device Halozyme US - Pediatric PID EU - Pediatric PID
Primary Immunodeficiency (PID)
TAK 880 Alpha-1 Antitrypsin HYQVIA HYQVIA - HyHub
Low IgA-IgG (IV) (A1AT)
Halozyme
IMMUNOLOGY
Flextronics
Chronic inflammatory demyelinating
Next generation formulations Delivery Device
Primary Immunodeficiency polyneuropathy (CIDP)
Hyper-Immune IG HYQVIA CINRYZE
Infectious disease Geographic expansion Geographic expansion
CINRYZE CUVITRU GLASSIA
Kamada
Immunogenicity/ bronchioalveolar
Ex-HAE indications TBD Geographic expansion
lavage
GLASSIA CUVITRU
Kamada
A1ATD-emphysema* Japan - PID (FPI Q4 2019)
HEMATOLOGY
PROTHROMPLEX TOTAL Butyryl Cholinesterase PROTHROMPLEX TOTAL FEIBA
Device and formulation Organophosphate poisoning US - Drug-induced bleeding** Volume reduction
CEPROTIN
Geographic expansion
41 *Subject to regulatory approval
**Pending FDA Pre-IND consultation and future acceptance of an IND Programs and projects added since Day 1
Over the next 3 years, we plan to allocate resources to
research and early development
Estimated % of
PDT R&D spend for
FY2023
Distribution of PDT
R&D spend for FY2019
60% ~70% of resources will
be allocated to improving
in-line products and
production efficiencies
95%
10%
Optimizing value of in-line products
30%
Plasma production efficiencies
5% 0%
New plasma-derived therapies
42