Upload
trinhdien
View
213
Download
1
Embed Size (px)
Citation preview
June 29, 2016
140th Ordinary General Meeting of ShareholdersReports on the Business Report, Consolidated Financial Statements and Unconsolidated Financial Statements for the 139th Fiscal Year
Christophe WeberPresident & Chief Executive Officer
140th Ordinary General Meeting of Shareholders | June 29, 20161
Important Notice
Forward-Looking Statements
This presentation contains forward-looking statements regarding Takeda’s future business, financial position and results of operations, including estimates, forecasts, targets and plans. These forward-looking statements may be identified by the use of forward-looking words such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “endeavor,” “estimate,” “expect,” “forecast,” “initiative,” “intend,” “may,” “outlook,” “plan,” “potential,” “probability,” “pro-forma,” “project,” “risk,” “seek,” “should,” “strive,” “target,” “will” or similar words, or expressions of the negative thereof, or by discussions of strategy, plans or intentions.
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 or failure of product development programs; decisions of regulatory authorities and the timing thereof; changes in exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product 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 suchforward-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.
Any forward looking statements herein speak only as of the date of this document, and Takeda and its management undertake no obligation to update or revise any forward-looking statements or other information contained in this presentation, whether asa result of new information, future events or otherwise.
Medical Information
This presentation contains information about products that may not be available 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 drug including the ones under development.
140th Ordinary General Meeting of Shareholders | June 29, 2016
Business Environment Surrounding Takeda
2 140th Ordinary General Meeting of Shareholders | June 29, 2016
Number of FDA Drug Approvals is Increasing Driven by New Scientific Insight
Novel approvals in the U.S.A.*
x245
41
27
39
30
212524
1822
20152006
* Approved by CDER (Center for Drug Evaluation and Research) and CBER (Center for Biological Evaluation and Research) in the U.S.A.
From website: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htm
3 140th Ordinary General Meeting of Shareholders | June 29, 2016
Truly Differentiated Medicines are Increasingly Sourced from Biotechs and Academia
27%
54%
73%
46%
20152007
Source: EvaluatePharma®
Origination of Global Top 100 Productsby Worldwide Sales
Pharma
Biotech, Non-profit,Academia
Pharma
Biotech,Non-profit,Academia
4 140th Ordinary General Meeting of Shareholders | June 29, 2016
Takeda's Strategic Roadmap: Focus on Execution
5 140th Ordinary General Meeting of Shareholders | June 29, 2016
6
Takeda Strategic RoadmapOn the Road to Sustained Growth
- Takeda-ismPatient → Trust → Reputation → Business
- Patient and customer centricity- Agile global organization- Fostering talent
- Focused world class R&DNew approaches to innovation
- Sustaining sales growthGI, Oncology, CNS and Emerging Markets
- Sustaining profit growthCost discipline
VALUES
PEOPLE
R&D
BUSINESSPERFORMANCE
Strategy
140th Ordinary General Meeting of Shareholders | June 29, 2016
7
VALUES Corporate Philosophy
140th Ordinary General Meeting of Shareholders | June 29, 2016
Takeda-ism will guide us to reach our Vision
We take action and make decisions by focusing on our four priorities, in order of:
Putting the patientat the center1 2 3 4Building trust
with societyReinforcing ourreputation
Developing thebusiness
We serve the needs of our patients, wherever they are. We earn the trust of society and customers through Takeda-ism. We are recognized as best in class because of agility and innovation, qualities that help us build a steady pipeline and deliver growth, year on year.
Our mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine
8
Actively Engaged in CSR to Promote a Sustainable SocietyVALUES
Our Key CSR & Access to Medicine Activitiesfor Patients & People
■ Global Measles Vaccination Program for 5 million Children
■ Maternal and Child Health Programs in 7 Asian countries
- Selected by global employees voting- Aligned with the UN Sustainable Development Goals
Improving Access to Medicines
Partnering Global
Programs
Employee Volunteer
Participation
Supporting Disaster Reliefin Tohoku & Kumamoto
Initiatives in FY2016
140th Ordinary General Meeting of Shareholders | June 29, 2016
9
Global, Diverse and ExperiencedTakeda's Executive Team (TET)
Christophe WeberPresident & CEO
PresidentJapan PharmaBU
Masato Iwasaki
PresidentGlobal Oncology BU
Christophe Bianchi
PresidentUS BU
Ramona Sequeira
Corporate Communications and Public Affairs Officer
Haruhiko Hirate
Global General Counsel
Yoshihiro Nakagawa
Global Human Resources Officer
David Osborne
PresidentEmerging MarketsBU
Giles Platford
PresidentEUCAN BU
Marc Princen
PresidentGlobal Vaccine BU
Rajeev Venkayya
Corporate Strategy Officer
Shinji Honda
Chief Financial Officer
Global Quality Officer
Gerard Greco
Chief Medical and Scientific Officer
Andrew Plump
Global Manufacturing and Supply Officer
Thomas Wozniewski
James Kehoe
PEOPLE
140th Ordinary General Meeting of Shareholders | June 29, 2016
140th Ordinary General Meeting of Shareholders | June 29, 2016
FY2015 Annual Results
10 140th Ordinary General Meeting of Shareholders | June 29, 2016
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
2014Jun.
2014Sep.
2014Dec.
2015Mar.
2015Jun.
2015Sep.
2015Dec.
2016Mar.
2016May
Emerging markets
Europe and Canada
U.S.
900
800
700
600
500
400
300
200
100
02014Jun.
2014Sep.
2014Dec.
2015Mar.
2015Jun.
2015Sep.
2015Dec.
2016Mar.
2016May
11
GI: ENTYVIO®
On Track to Exceed $2bn MAT Sales within FY2018
MAT*Revenue(oku-yen)
140th Ordinary General Meeting of Shareholders | June 29, 2016
Approx. 47,000 patients treated
>580,000 vials manufactured
Approved in 50 countries
Emerging Markets
Europe &Canada
U.S.
Constant Currency
BUSINESSPERFORMANCE
* MAT: Moving Annual Total
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
2015Dec.
2016Jan.
2016Feb.
2016Mar.
2016Apr.
2016May.
U.S.
12
Oncology: NINLARO®
Encouraging Uptake in the US since Dec 2015 Launch
IISR: Investigator Initiated Sponsored Research
140th Ordinary General Meeting of Shareholders | June 29, 2016
Revenue(oku-yen)
Cumulative Sales @ Constant Currency
70
60
50
40
30
20
10
02015Dec.
2016May
2016Feb.
2016Jan.
2016Mar.
2016Apr.
2,500 patients treated in US,94% market coverage achieved
Appealing and requesting a re-examination in EU
5 pivotal Ph-3;80 IISR studies approved and
ongoing
BUSINESSPERFORMANCE
13
Growth Drivers Continue to Boost Our Top line Growth
GI*
Oncology***
Emerging Markets*
+9.5%
+23.6%
+1.0%
+4.8%
FY14(oku-yen)
Growth Drivers Total**
52%Growth Drivers Total**
Takeda Total
Underlying revenue growth
FY15
CNS
2,977
3,364
3,314
569
2,409
3,330
3,163
415 +37.3%
(oku-yen)
* Sales of pantoprazole in Emerging Markets (EM) is included in EM, but not in GI (Gastrointestinal),as it is a key driver in EM. Sales of pantoprazole in other regions is not included in this slide.
** Total GI/Oncology/CNS/EM, eliminated duplications (e.g. ADCETRIS in EM and in Oncology)*** Underlying growth of Oncology excl. VELCADE royalties is +4.4%
Performance by Growth Driver
140th Ordinary General Meeting of Shareholders | June 29, 2016
BUSINESSPERFORMANCE
14
Robust Growth Driven by the U.S.and Emerging Markets
140th Ordinary General Meeting of Shareholders | June 29, 2016
FY15 Regional Revenue* vs. FY14
BUSINESSPERFORMANCE
+4.8%[+7.0%]
-0.3%[+3.0%]
* % in parenthesis represents growth of product sales, excluding royalty and other income.
+5.5%[+5.4%]
Underlying revenue growth
EmergingMarkets
+12.4%[+14.3%]
U.S.
Europe andCanada
-3.3%[-2.8%]
JapanPharma
Japan Consumer Health and Others
140th Ordinary General Meeting of Shareholders | June 29, 201615
FY2015 Management Guidance Delivered; ROE is Improving
Fiscal Year
15.1
10.9
11.8
6.1
14.4
6.34.5
- 6.3
(%)
0
Historical Takeda's ROE
1.43.9
ExcludingActos settlement
BUSINESSPERFORMANCE
2007 2008 2009 2010 2011 2012 2013 2014 2015
FY2016 and Future Outlook
16 140th Ordinary General Meeting of Shareholders | June 29, 2016
17 140th Ordinary General Meeting of Shareholders | June 29, 2016
Our Long-term Aspiration
• We serve the needs of our patients, wherever they are.
• We earn the trust of society and customers through Takeda-ism.
• We are recognized as best in class because of agility and innovation, qualities that help us build a steady pipeline and deliver growth, year on year.
Vision 2025
o No.1 GIo Top 10 Oncologyo Strong CNS and EM Presence
140th Ordinary General Meeting of Shareholders | June 29, 201618
VALUESR&D
Oncology
GI
CNS
Vaccines
Specialty CV
Other
Strengthening Our Pipeline is Key for Our Long-term Success
Phase 1 Phase 2 Phase 3 Life Cycle ManagementTAK-243UAE inhibitorSolid Tumors
TAK-580pan-RAF kinaseSolid Tumors
TAK-931CDC7 inhibitor Solid Tumors
TAK-202 CCR2 antagonist
Solid Tumors
TAK-659SYK inhibitor
Hematologic malignancies
ENTYVIO®
α4β7 mAbUC/CD (EM, JP), adalimumab H2H Subcutaneous formulation UC/CD
PSC, GvHD, IO Colitis
AMITIZA®
Chloride channel activatorPediatric constipation
New formulation
PevonedistatNAE inhibitor
HR MDS
TAK-117PI3Kα
NSCLC
TAK-228mTORC 1/2
RCC
alisertibAurora A kinase
SCLC
trebananib (JP) Anti-angiopoietin peptibody
Ovarian Cancer
NINLARO®
Proteasome inhibitor MM R/R (EU/EM), R/R AL Amyloidosis,
Front Line MM Maintenance MM post-SCT Maintenance MM w/o SCT
ADCETRIS®
CD30 ADC HL Post Transplant
FL HL, FL MTCL, Relapsed CTCL
DEXILANT®
PPIARD in adolescents
TAKECAB®
PCABARD (Asia)
PPI Partial Responder
TAK-828ROR t inverse agonist
Crohn’s Disease
TAK-041 GPR139 agonist
CIAS neg. symptoms
TAK-071M1PAM LBD-AD
TAK-0585-HT3 antagonist
CIAS
TAK-653AMPAR potentiator
TRD
TAK-831DAAO inhibitor
Schizophrenia, Ataxia
TAK-935CH24H inhibitor
Epilepsy
TAK-915PDE2Ai LBD-AD
TAK-063PDE10Ai
Schizophrenia
AD-4833 TOMM40Mitochondrial growth modulator
Delay of MCI
AZILECT®
MAOB inhibitor Parkinson’s (JP)
TRINTELLIXTM
Multimodal anti-depressantCognition data in label (CRL received)
MDD (JP), ADHD
TAK-003 Dengue
TAK-214 Norovirus
TAK-850 (JP) Influenza
TAK-021EV71
TAK-272 Direct renin inhibitor
Diabetic Nephropathy
AZILVA®
FDC w/ amlodipine & HCTZ (JP) ARB
Hypertension
NESINA®
FDC with Met (JP) DPP4i T2DM
AMG 403NGF Pain
TAK-079Anti-CD38 mAb
RA
TAK-020BTK inhibitor
RA
namilumabGM-CSF
Psoriasis & RA
ULORIC®
XAO inhibitor XR Formulation
Hyperuricemia
BENET ®
Bone resorption inhibitor
Additional formation (JP)
relugolix***(TAK-385)
LH-RH antagonist Prostate cancer
* XMT-1522 is still pre-clinical; IND expected in 2016 ** TAK-195 is still pre-clinical; Phase 1 start expected in Q4 FY2016*** Relugolix also in Phase 3 for uterine fibroids, Phase 2 for endometriosis. Takeda has granted Myovant an exclusive, worldwide license to relugolix, excluding Japan and certain
other Asian countries. See appendix for list of abbreviations
XMT-1522*anti-HER2 ADCSolid Tumors
TAK-195**sIPV
TD-8954 Selective 5-HT4 receptor agonistEnteral Feeding
Intolerance
18
19
Focusing Our Efforts in the Therapeutic Areas Where We Want to be at the Cutting Edge of Innovation
VALUESR&D
Oncology
Gastroenterology (GI)
Central Nervous System (CNS)
Specialty CV
Vaccines
Core focus
We are focusing our innovation in three core therapeutic areas where we have:• Track record of recent successes• Deep scientific expertise• High unmet patient need
We are committed to global public health through our Vaccines portfolio
Targeted approach to specific assets
140th Ordinary General Meeting of Shareholders | June 29, 2016
140th Ordinary General Meeting of Shareholders | June 29, 2016
External Partnership is KeyTakeda-CiRA Joint Program for iPS Cell Applications
20
VALUESR&D
Nature (May 26, 2016)
http://www.nature.com/advertorials/insideview/pdf/ivtakedamay2016.pdf
21 140th Ordinary General Meeting of Shareholders | June 29, 2016
FY2016 Management Guidance and Mid-Term Milestones
Underlying Mid-Term (3 year) Milestones (CAGR*)
Revenue: Mid-single digit
Core Earnings: Double digit
* CAGR: Compound Annual Growth Rate
FY2016 Management Guidance (Growth %)
Revenue: Mid-single digit
Core Earnings: Low- to mid-teen
Core EPS: Low- to mid-teen
Annual Dividend per Share180 yen for FY2016
Proposal for a New Governance StructureFrom "A Company with Board of Corporate Auditors" to "A Company with Audit and Supervisory Committee"
22
Y. Hasegawa President & CEO
C. Weber
Corporate Strategy Officer
S. Honda
JPBU PresidentM. Iwasaki
Chief Medical & Scientific Officer
A. Plump
Y. YamanakaInternal director
S. Kuniya K. Hatsukawa J. L. Butel
F. Sudo M. Sakane Y. FujimoriT. Shiga E. HigashiM. Orsinger
Internal directors
External directors
140th Ordinary General Meeting of Shareholders | June 29, 2016
Chairman
Audit & Supervisory Committee directors
23
Centuries of Takeda’s History and Outlook
1781 ~Founding –
Modernization
1944 ~Business
diversification
1993 ~Pharmaceutical Focus Overseas Expansion
2003 ~Globalization
Transforming into Global One Takeda
140th Ordinary General Meeting of Shareholders | June 29, 2016
Better Health, Brighter Future
Thank-you
140th Ordinary General Meeting of Shareholders | June 29, 201624