Takeda is a global values-based biopharmaceutical company committed to developing innovative treatments to improve patient health. The presentation discusses Takeda's acquisition of Shire which expanded its therapeutic areas and pipeline. It also outlines Takeda's R&D strategy which focuses on developing new treatments in oncology, gastroenterology, neuroscience, and rare diseases. Additionally, the presentation notes Takeda is exploring innovative approaches beyond traditional medicines, such as cell, gene, and RNA therapies, to serve more patients.
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Innovative Approaches in Pharma Sector
1. Innovative approaches to serve for patients
in pharma sector
16 December 2019
Cluster Head, General Manager, The Middle East
Taka Horii,
Takeda Pharmaceutical Company Limited
2. Important Notice
NOT FOR RELEASE, PRESENTATION, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT
LAWS OR REGULATIONS OF SUCH JURISDICTION.
This presentation has been prepared by Takeda Pharmaceutical Company Limited (“Takeda”) solely for information and for use in connection with the possible recommended offer for Shire plc (“Shire”) by Takeda (the “Offer”)
and does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate Takeda, Shire or the business prospects of the Offer. 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 during the presentation. This presentation (including any oral briefing and any question-
and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise
dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares are being offered to the public by means of this presentation. This presentation is being given (together with any further information
which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to
comply with these restrictions may constitute a violation of applicable securities laws.
None of Takeda, its shareholders, subsidiaries, affiliates, or its or their respective directors, officers, partners, employees, representatives and advisers (the “Relevant Parties”) makes any representation or warranty, express or
implied, as to the accuracy or completeness of the information contained in this presentation, or otherwise made available, nor as to the reasonableness of any assumption contained herein or therein, and any liability therefor
(including in respect of direct, indirect, consequential loss or damage) is expressly disclaimed. Nothing contained herein or therein is, or shall be relied upon as, a promise or representation, whether as to the past or the future and
no reliance, in whole or in part, should be placed on the fairness, accuracy, completeness and correctness of the information contained herein or therein. Further, nothing in this presentation should be construed as constituting
legal, business, tax or financial advice. None of the Relevant Parties undertakes any obligation to provide the recipient with access to any additional information or to update or correct any inaccuracies in or omissions from this
presentation.
Unless specified otherwise, no statement in this presentation (including any statement of estimated synergies) is intended as a profit forecast or estimate for any period and no statement in this presentation should be interpreted
to mean that earnings or earnings per share for Takeda or Shire for the current or future financial years would necessarily match or exceed the historical published earnings per share for Takeda or Shire.
Statements of estimated cost savings and synergies relate to future actions and circumstances which, by their nature, involve risks, uncertainties and contingencies. As a result, the cost savings and synergies referred to may not
be achieved later or sooner than estimated, or those achieved could be materially different from those estimated. For the purposes of Rule 28 of the City Code on Takeovers and Mergers, quantified financial benefits statements
contained in this presentation are the responsibility of Takeda and the Takeda directors. Neither these statements nor any other statement in this presentation should be construed as a profit forecast or interpreted to mean that
the combined group’s earnings in the first full year following implementation of the Offer, or in any subsequent period, would necessarily match or be greater than or be less than those of Takeda or Shire for the relevant preceding
financial period or any other period. The bases of belief, principal assumptions and sources of information in respect of any quantified financial benefits statement are set out in the announcement published on May 8 2018 in
connection with the Offer.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this presentation, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in
general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular
company or companies. Similar references are made to “Shire” with similar logical application.
Forward-Looking Statements
This presentation and any materials distributed in connection with this presentation may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations,
including estimates, forecasts, targets and plans for Takeda and, following completion of the Offer, if made, the combined group (“Combined Group”). Without limitation, forward looking statements often include the words such
as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or words or terms of similar substance or the negative thereof. Any
forward-looking statements in this document are based on the current assumptions and beliefs of Takeda in light of the information currently available to it. Such forward-looking statements do not represent any guarantee by
Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s business, including general
economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory
authorities and the timing there of; changes in exchange rates; claims or concerns regarding the safety or efficacy of marketed products or products candidates; and post-merger integration with acquired companies, any of which
may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking
statements. Neither Takeda nor its management gives any assurances that the expectations expressed in these forward-looking statements will turn out to be correct, and actual results, performance or achievements could
materially differ from expectations. Persons receiving this presentation should not place undue reliance on forward looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained
in this presentation or any other forward-looking statements it may make. Past performance is not an indicator of future results and the results of Takeda in this presentation may not be indicative of, and are not an estimate,
forecast or projection of Takeda’s, Shire’s, or the Combined Group’s future results.
Medical information
This presentation contains information about products that may not be available and in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing
contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
3. 2
Self-introduction: Takafumi (Taka) Horii
Career at Takeda
• VP, Area Head, Near East Middle East Africa(NEMEA) , Dubai
• President & General Manager, Takeda Taiwan, Taipei
– Standing Director at IRPMA, Market Access Committee Chair
– Director, Pharmaceutical & Medical Device Committee, Japan
Chamber of Commerce & Industry, Taipei
• VP, Head of Strategy, Emerging Markets, Singapore/Swiss
• Head of Strategic Project & Planning, North Asia, Tokyo
• Head of Strategic Planning, Takeda China, Shanghai
• Manager, International Operations (Asia), Tokyo
• Manager, Corporate Strategy & Planning, HQ, Tokyo
Education Background
• BA of Law, Doshisha University, Kyoto Japan
• MBA, Darden Graduate School of Business at University of Virginia, U.S.A.
• Executive Development Program, Tsinghua University in China,
• Global Executive MBA at INSEAD, France
Current Role
• General Manager,
Middle East Cluster,
Growth & Emerging Market
• Executive Committee,
PhRMA
Middle East and Africa
• | Takeda Company Overview | 28/10/2019
4. 3
Agenda
Takeda pharmaceutical
Global pharma industry trend
Takeda’s Innovative
approaches to serve for
patients
Acquisition of Shire
R&D strategy
Beyond medicines
5. 4 | Title | DD/MM/YY
Takeda is a patient-focused, values-
based, R&D-driven global
biopharmaceutical company
committed to bringing Better Health
and a Brighter Future to people
worldwide.
Our passion and pursuit of potentially
life-changing treatments for patients
are deeply rooted in our distinguished
238-year history in Japan.
6. Takeda is a global, values-based,
R&D-driven biopharmaceutical leader
headquartered in Japan, committed
to bringing Better Health and a
Brighter Future to patients by
translating science into highly-
innovative medicines.
PUTTING
PATIENTS FIRST
FOR OVER TWO
CENTURIES
WHO WE ARE
YEARS
7. 6
SERVING THE NEEDS OF OUR PATIENTS
Our values serve as our guiding compass. Takeda-ism
grounds us as we deliver on our role to serve the
public by ensuring integrity in our every action for
and on behalf of patients.
OUR VALUES
OUR PRIORITIES
We make decisions and take action by focusing on our four priorities, in this order:
Put the patient
at the center
Build trust
with society
Reinforce
our reputation
Develop
the business1 2 3 4
Learn about our history
| Takeda Company Overview | 28/10/2019
8. R&D
Our R&D efforts are focused on four
therapeutic areas: Oncology,
Gastroenterology (GI), Rare Diseases and
Neuroscience. We also make targeted
R&D investments in Plasma-Derived
Therapies and Vaccines.
OUR
COMITTMENT
TO DELIVER
INNOVATION
SEE OUR COMPLETE PIPELINE on TAKEDA.COM
ONCOLOGY
GASTRO-
ENTEROLOGY
NEUROSCIENCERARE DISEASES
PLASMA-DERIVED
THERAPIES
VACCINES
Takeda has a unique highly focused R&D engine
9. 8
Board
| Title | DD/MM/YY
Highly diversified, well experienced Takeda Executive Team (TET)
11. 10
Middle East cluster at glance
# of
markets
17
Countries
Population
5 year CAGR
610
Million
1.9%
Real GDP
5 year CAGR
3
Trillion
2.2%
Healthcare
spending
5 year CAGR
155
Billion
2.7%
Real GDP per
Capita
Pharma
Market size
5 year CAGR
27.7
Billion
6.1%
Healthcare
spending
% of GDP
Key Markets
# of Employees Approx. 300
Therapeutic area
Gastroenterology, Oncology,
Immunology, Haematology and
Genetic Disease
New Launches 50+
PSA/PSP
Program
7
Partners 40+ distributors
Top Brands
8.9
Thousands
5.3%
| In USD $
TAKEDA MIDDLE EAST CLUSTER
12. 11
Agenda
Takeda pharmaceutical
Global pharma industry trend
Takeda’s Innovative
approaches to serve for
patients
Acquisition of Shire
R&D strategy
Beyond medicines
13. Global Market Projection –
Expect to accelerate the growth in the next five years driven not by larger MNCs but by small start-ups
1,487,450
73,930 31,070
59,346
267,777
Top20-50
1,055,327
(71%)
Top102019 Top10-20 Others 2025
1,055,327
5.9%
925,483
1,063,219
2013 2018
2.8%
2013-2018 Actual from EP
2019-2025 Forecasting from EP
Source: EvaluatePharma : Historic performance data (as of May 2019), 1USD=110.68 JPY
(unit: Oku-yen)
CAGR
432,123
17.1%
13.7%62.0%
Top10
Others
7.2%
Top10-20
Top20-50
Share of growth
12
14. NOTE: EvaluatePharma TA classifications used; see Appendix A for key indications within each TA.
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE
]
Genito-Urinary
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
[CELLRANGE]
0%
2%
4%
6%
8%
10%
12%
14%
16%
-10% -5% 0% 5% 10%
2024
Rx+OTC
SalesPast growth (2012-2018) CAGR
Futuregrowth(2018-2024)CAGR
Industry CAGR
2012-18 +2.2%
IndustryCAGR
2018-24+5.8%
• Four therapy areas to overperform the industry growth rate: Oncology, Blood, Immunomodulators and
Dermatology
• Focused TA by Takeda is consistent with positive growth TA (e.g. Blood- Takhzyro, Advate/Adynovate)
• As a TA, Oncology grows from 13% of the total market in 2017 to 19% in 2024; Keytruda to become biggest selling
product globally in 2024 with sales >$17B
Focused TA by Takeda
Not focused TA by Takeda
Market size and growth by therapy areas
Positive growth to 2024 across all therapy areas; oncology is the largest therapeutic area and the biggest contributor for the entire market
growth
13
15. Revenue by technology
Innovation across modalities with emergence of new technologies
Revenue by technology*1:
Conventional vs biotechnology
486,449
485,126
530,798
693,756
143,261
199,999
311,679
500.000
100.000
1.000.000
600.000
0
300.000
200.000
400.000
700.000
800.000
900.000
1.100.000
1.200.000
2010 2015 2020
441,248
2024
Conventional
Biotechnology
Revenue by technology:
subcategories of biotechnology
46,537
83,884
169,994
233,153
76,649
94,912
103,659
300.000
0
50.000
200.000
350.000
100.000
150.000
250.000
400.000
450.000
2010 2015 2020
113,885
2024
441,248
Other biotechnology product
Transgenic product
Gene therapy
Cell therapy
DNA & RNA therapeutics
Bioengineered vaccine
Recombinant product
Monoclonal antibody
*2
*1 Exclude Other Unclassified Rx & OTC Sales
*2 Small molecule chemistry, In vivo diagnostics, Chiral chemistry, Plant extract, Protein extract, Vaccine, Miscellaneous
NOTE: EvaluatePharma Technology classifications used; see Appendix for definition of each technology
(oku-yen)
Source: EvaluatePharma : Historic performance data (as of May 2019), 1USD=110.68 JPY
14
16. Next Generation Therapeutics
Cell, gene, and DNA/RNA therapeutics can become the next pillar of medicines
(oku-yen)
Revenue growth of cell, gene
and DNA/RNA therapeutics
Source: EvaluatePharma : Historic performance data (as of May 2019), 1USD=110.68 JPY
Revenue growth of monoclonal
antibody
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
200,000
220,000
240,000
2005 20152000 2010 2020 2024
+20.9%
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
20192018 2020 20232021 2022 2024
+57.7%
Gene therapy
DNA & RNA therapeutics
Cell therapy
• Current consensus forecasts predict a market >45,000 oku-yen by 2024 for cell, gene and DNA/RNA based
medicines
• Given the uncertainties around addressable patient populations, affordability, and adoption for these medicines
will be tested in the real world as products enter the market
CAGR
CAGR
NOTE: EvaluatePharma Technology classifications used; see Appendix B for definition of each technology
15
17. Digital related technology examples
Source: KPMG report “Pharma outlook 2030: From evolution to revolution”
Patient empowerment
• Health coaching app Noom launched by Noom, Inc. in 2010 helps people
living with pre-diabetes with weight loss and health management
• In Rwanda, the digital healthcare platform Babylon developed by Babylon
Health in Sep 2016 provides patients with access to doctors through an
online consultation app
Nanotechnology
• Novartis partnered with Proteus, which developed a sensory enabled smart
pill, that once swallowed, can gather information that can be used to
diagnose patients
Bionics
• A smart contact lens, co-developed by Verily Life Science (a subsidiary of
Alphabet), and Novartis, measures glucose levels in the wearer’s tears and
can transmit data to a wireless device
• US-based artificial heart manufacturer SynCardia has approvals in US,
Canada and Europe to use a completely artificial heart as a bridge to
transplant for patients with end-stage biventricular heart failure
17
18. 18
Agenda
Takeda pharmaceutical
Global pharma industry trend
Takeda’s Innovative
approaches to serve for
patients
Acquisition of Shire
R&D strategy
Beyond medicines
19. 1919
2019: A WATERSHED YEAR FOR TAKEDA
• 18 assets added to the clinical pipeline*
• Creation of a Rare Diseases Therapeutic Area
• Access to world-class Gene Therapy
capabilities
• VARSITY study demonstrated head-to-head
superiority of Entyvio vs Humira and published
in New England Journal of Medicine
• TAKHZYRO indication expansions in bradykinin
mediated angioedema
• Expecting >15 approvals in China over the next
5 years
• 17 NMEs in Phase 2 and Phase 3
• Potentially curative novel mechanisms (e.g.
TAK-101, Orexin2R-ag, CAR-NK)
• Momentum in Cell Therapies, including new
partnership with MD Anderson
* Including approved products with ongoing R&D investment
INTEGRATION OF SHIRE EXPANSION OF OUR GLOBAL BRANDS UNPRECEDENTED NMEs
20. 2020
PATIENT-DRIVEN AND SCIENCE-FIRST IN 3 CORE AREAS
INNOVATIVE BIOPHARMA
ONCOLOGY GASTROENTEROLOGYNEUROSCIENCERARE DISEASES
PLASMA DERIVED THERAPIES
Complementing our
rare disease focus
VACCINES BUSINESS UNIT
Differentiated
Dengue vaccine
21. 2121
WE ARE DOING MORE FOR OUR PATIENTS
1.BIC/FIC Best-In-Class/First-In-Class (incl. relugolix). Three NMEs in pivotal studies in 2018
2. 31 Orphan Drug Designations in at least one indication for assets in Phase 1 through LCM in 2019 versus 15 in 2018
R&D EMPLOYEES
GLOBALLY
PIPELINE WITH
ORPHAN DRUG
DESIGNATION2
NEW MOLECULAR
ENTITY CLINICAL
STAGE ASSETS
~40
ACTIVE PARTNERSHIPS
200+
POTENTIAL BIC/FIC NMEs IN
PIVOTAL STUDIES1
8 ~4,500
~70% ~50%DIVERSIFIED
MODALITIES
IN RESEARCH
22. 22
WE ARE POSITIONED TO DELIVER NEAR-TERM & SUSTAINED GROWTH
ONCOLOGY
TAK-252
Solid tumors
TAK-981
Multiple cancers
TAK-164
GI malignancies
TARGET
APPROVAL FY25 AND BEYOND
CLINICAL-STAGE NMEs PLATFORMS
NEUROSCIENCE TAK-653
TRD
TAK-418
Kabuki Syndrome
TAK-831
CIAS NS
TAK-341
Parkinson’s
Disease
WVE-120102
Huntington’s
Disease
WVE-120101
Huntington’s
Disease
TAK-041
CIAS NS
Orexin2R-ag
Sleep Disorders
GENE
THERAPY
OTHER
PLATFORMS
RNA Modulation
Antibody Transport
Vehicle
TAK-754
HemA
RARE
DISEASES
Immunology
Hematology
Metabolic
TAK-573
R/R MM
Orphan potential in at least one indication
TAK-755
iTTP, SCD
TAK-0794
MG, ITP
GASTRO-
ENTEROLOGY
Kuma062
Celiac Disease
TAK-951
Nausea &
vomiting
TAK-101
Celiac Disease
TAK-018
Crohn’s Disease
(post-op and ileitis)
TAK-906
Gastroparesis
TAK-671
Acute
Pancreatitis
MICROBIOME
GENE
THERAPY
CELL
THERAPY
GENE
THERAPY
FY20 FY21 FY22 FY23 FY24
TAK-7883
2L NSCLC
TAK-9243
HR-MDS
TAK-007
Hematologic
malignancies
TAK-924
AML
TAK-609
Hunter CNS (IT)
TAK-620
CMV infect. in
transplant
TAK-611
MLD (IT)
TAK-607
Complications of
prematurity
TAK-755
cTTP
TAK-935
DEE
Orexin2R-ag
(TAK-925/994)
Narcolepsy T1
TAK-721
EoE
TAK-954
POGD
WAVE 11 WAVE 22
VACCINES TAK-003
Dengue Vaccine
TAK-214
Norovirus
Vaccine
TAK-426
Zika Vaccine
1. Projected timing of approvals depending on data read-outs; some of these Wave 1 target approval dates assume accelerated approval
2. Some Wave 2 assets could be accelerated into Wave 1 if they have breakthrough data
3. Projected approval date assumes filing on Phase 2 data
4. TAK-079 to be developed in Rare Diseases indications myasthenia gravis (MG) and immune thrombocytopenic purpura (ITP) (FPI projected in each indication in 2H FY19)
TAK-788
1L NSCLC
TARGETED
INNATE
IMMUNE
MODULATION
NEXT-GEN
CHECKPOINT
MODULATORS
CELL THERAPY
AND IMMUNE
ENGAGERS
Estimated dates as of November 14, 2019
TAK-531
Hunter CNS
TAK-021
EV71 vaccine
23. 23
Top 10 pharma companies by size of pipeline published in 2019
Source: Pharmaprojects – Informa UK Ltf 2019 published in Feb 2019
https://pharmaintelligence.informa.com/resources/product-content/pharma-rnd-annual-review-2019
24. 24
Agenda
Takeda pharmaceutical
Global pharma industry trend
Takeda’s Innovative
approaches to serve for
patients
Acquisition of Shire
R&D strategy
Beyond medicines
25. 25
Two MOUs signed with MOHAP of United Arab Emirates
|
Home Care Program “SAWA”
Supporting Patients with Rare diseases
• House-bound patients with primary
immunodeficiency will stay compliant with
treatment and be trained for self-administration of
subcutaneous immunoglobulin.
• Patients diagnosed with hemophilia usually need
intravenous infusions every two days. Enabling
home visits will reduce the burden of frequent
hospital visits and improve medicine adherence.
Patient Assistance Program “PAP”
Supporting Patients with Financial Access challenges
• A cost sharing initiative that aims to increase access to
specialty treatment for patients in the UAE, seeks to
support Hodgkin’s Lymphoma and Crohn’s Disease
patients with access to Takeda Pharmaceuticals’ key
innovations
• The financial eligibility will focus on patients who are
facing affordability barriers due to the absence of
comprehensive insurance schemes to support their
treatment
Serving the needs of our patients, wherever they are, being
recognized as best-in-class because of our agility and innovation,
qualities that help us build a steady pipeline and deliver growth,
year-on-year
26. 26
Beyond Medicine - Approach to serve for patients in Middle East
- Patient Assistant Program + Home Care program
|
Patient Assistance Program
Launched in Mar 2018
Patient Assistance Program
Launched in Mar 2018
40+ HCPs (Mar. 2016 – Feb. 2019)
have been engaged and introduced to the Adcetris and Entyvio Access programs enabling them to refer patients to the two programs
Home Care Program
Patients being helped in ME
Patient Assistance Program
Launched in Apr 2017
Patient Assistance Program
Launched in Oct 2017
Patient Assistance Program
Just launched
Patient Assistance Program
Launched in Feb 2018
Patient Assistance Program
Just launched