Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
March 6, 2020
Eisai Co., Ltd
Information Meeting
Safe Harbor Statement
Forecast or target figures in this material are not official earnings guidance but represent midterm strategies, goals,
and visions. Official earnings guidance should be referred to in the disclosure of the annual financial report
(Consolidated Financial Statement) in accordance with the rules set by Tokyo Stock Exchange.
Materials and information provided during this presentation may contain so-called “forward-looking statements.”
These statements are based on current expectations, forecasts and assumptions that are subject to risks and
uncertainties that could cause actual outcomes and results to differ materially from these statements.
Risks and uncertainties include general industry and market conditions, and general domestic and international
economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly
apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not
limited to, technological advances and patents attained by competitors; challenges inherent in new product
development, including completion of clinical trials; claims and concerns about product safety and efficacy;
regulatory agency examination periods and obtaining regulatory approvals; domestic and foreign healthcare
reforms; trends toward managed care and healthcare cost containment; and governmental laws and regulations
affecting domestic and foreign operations.
Furthermore, for products that are approved, there are manufacturing and marketing risks and uncertainties, which
include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials,
and failure to gain market acceptance.
The Company cannot guarantee the actual outcomes and results for any forward-looking statements.
The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a
result of new information, future events or otherwise.
The English-language presentation was translated from the original Japanese-language version. In the event of any
inconsistency between the statements in the two versions, the statements in the Japanese-language version shall
prevail.
The Company discloses its consolidated financial statements according to the International Financial Reporting
Standards (IFRS).
• Plan ‘EWAY 2025’ is the mid-term business
plan from FY2016 to FY2025
• We have positioned the period of FY2016 to
FY2019 as “EWAY CURRENT” and reviewed
• We have positioned the period of FY2020 to
FY2025 as “EWAY FUTURE” and analyzed
Plan ‘EWAY 2025’
Converting Knowledge into Business
We Make Medicines, We Make Solutions
through Eisai’s WAY
1
EWAY
CURRENT
(FY2016~FY2019)
2
EWAY 2025 Strategic Intents
“Therapeutic Areas of Focus”,
“Transformation of Business Portfolio”
and “ ‘Ricchi’ and Innovation”
Creation of Neurology and
Oncology Business Groups
Progress to Partnership Model
3
Progress of Partnership Model
With Biogen
*1: Investigational. Co-development with Biogen. *2: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between
Eisai and BioArctic. *3: Open-label extension *4: Phase III study for BAN2401 *5: AD prevention study in collaboration with Alzheimer’s Clinical Trials Consortium
(ACTC) and is comprised of A3 substudy and A45 substudy
Progress of co-development:
- Aducanumab*1
: under preparation for filing
- BAN2401*1,2
Study 201 : completed
Study 201-OLE*3
: ongoing
Clarity AD*4
: ongoing
AHEAD 3-45*5
: under preparation
- Elenbecestat*1
: discontinued
Multiple sclerosis business:
- Co-promotion in Japan
- Commercialization by Eisai in Asia excluding China
Close cooperation:
CEO level, Development, Regulatory, Medical, Manufacturing,
Commercial
(Strategic partnership originally established in March 2014
and expanded in October 2017)
4
Progress of Partnership Model
- All planned milestones are expected to be achieved based on
steady progress of collaboration regarding LENVIMA
FY2017
Upfront payment $300M
Approval of uHCC*2
indication in Japan $25M
FY2018
One-time payment for certain option rights $325M
Approval of uHCC indication in the US $125M
Approval of uHCC indication in EU $75M
Approval of uHCC indication in China $25M
Sales-based milestone payment ($500M) $50M
FY2019
One-time payment for certain option rights $200M
Sales-based milestone payment (CY $800M) $150M
Sales-based milestone payment ($750M) $150M
Sales-based milestone payment(Receipt
expected)
Total payments received $1,425M +
Received $450M as reimbursement for R&D expenses in FY2017
With Merck*1
(1) (Strategic partnership since March 2018)
*1: Merck & Co., Inc ., Kenilworth, N.J., U.S.A. *2: Unresectable hepatocellular carcinoma5
Progress of Partnership Model
KEYTRUDA®
is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are under joint
development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A.
*1: Merck & Co., Inc. ., Kenilworth, N.J., U.S.A *2: Advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient who have
disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
With Merck*1
(2) (Strategic partnership since March 2018)
Close cooperation:
CEO level, Development, Regulatory, Medical,
Manufacturing, Commercial
- Developed co-commercialization arrangement
in 18 countries across the globe
- Launched endometrial carcinoma*2
,
the first approved indication of KEYTRUDA®+
LENVIMA combination in 2019
Initiated pivotal studies in 7 cancer types/11
indications and basket trial (LEAP Studies)
6
- HCC*1
1L PIII, PIb*2
- RCC*3
1L PIII
- EC*4
2L PIII
- Melanoma 2L PII
- EC 1L PIII
- Melanoma 1L PIII
- NSCLC*5
(Combo with Chemo*6
) 1L PIII
- NSCLC (PD-L1+) 1L PIII
- NSCLC 2L PIII
- Head&Neck 2L
- Head&Neck 1L PIII
- Urothelial 1L PIII
- HCC (Combo with TACE*7
)
Breakthrough Therapy Designation
Breakthrough Therapy Designation
Breakthrough Therapy Designation
LEAP Study Overview
- Basket Trial (PII) -
Gastric Cancer*8
Colorectal Cancer
Biliary Tract Cancer
Ovarian Cancer
TNBC*9
Glioblastoma
KEYTRUDA®
is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. 1L: First line 2L: Second line *1: Hepatocellular carcinoma *2: Study 116 for combination of KEYTRUDA® + Lenvima European Society for Medical Oncology (ESMO) 2019 Abstract #: 747P. Confirmed tumor shrinkage and manageable safety profile *3: Renal cell carcinoma *4: Endometrial cancer *5: Non-small cell lung cancer *6: Chemotherapy *7: Transcatheter Arterial ChemoEmbolization *8: American Society of Clinical Oncology Gastrointestinal (ASCO-GI) 2020 Abstract #: 374. Confirmed tumor shrinkage and manageable safety profile *9: Triple-negative breast cancer *10: Based on the information disclosed at Clinicaltrials.gov
Large-scale clinical studies for combination therapy planning
approx. 8,200*10 patients with cancer, are steadily ongoing.
Aim to establish KEYTRUDA®
+ LENVIMA combination as backbone therapy.
7
With Nichi-Iko (Strategic partnership since March 2018)
Progress of Partnership Model
* Active pharmaceutical ingredient
Completed transfer of Elmed Eisai (April 2019)
Established comprehensive strategic
partnership for generic business in China
(September 2019)
Initiated supply of API* developed and
manufactured at Eisai Vizag Plant in India to
Nichi-Iko
Proceeded with Integrated Product Package
between Eisai and Nichi-Iko
8
Revenue by region FY2015 results FY2019 forecast CAGR (15-19)
Japan* 284.9 272.0 -1.2%
US 122.2 135.0 2.5%
China 49.3 70.0 9.2%
EMEA 41.3 51.0 5.4%
Asia and Latin America 34.0 49.0 9.6%
Revenue by focused area FY2015 results FY2019 forecast CAGR (15-19)
Neurology Business 179.7 - -0.7%
Oncology Business 118.4 - 9.5%
Consolidated P/L FY2015 results FY2019 forecast CAGR (15-19)
Revenue 547.9 680.0 5.5%
COGS rate (%) 35.5% 25.0% -
R&D 122.3 148.0 4.9%(excluding alliance effects) 134.2 188.0 8.8%
Operating profit 51.9 110.0 20.6%
EPS (1 JPY) 192.2 354.6 16.5%
ROE 9.4% 15.6% -
(Billions of yen)
Realized huge R&D investment based on the partnership modelGrowth of in-house products reduced COGS rate and increased profitability
Asia and Latin America Region and China Region made remarkable progressOncology Business drove growth
Plan to achieve FY2025 ROE target of 15% or over, ahead of schedulePlan to achieve FY2020 operating profit target of 102 billion yen ahead of schedule
* Revenue from OTC and others (Japan) is included. Transfer of Generic business (Elmed Eisai) was completed in April 2019.
Status of EWAY CURRENT
9
EWAY
FUTURE
(~FY2025)
10
Region
Population (million)
US EU ALL*1 Japan China Asia*2 ROW*3
Region
Total*4Total% of
regionTotal
% of
regionTotal
% of
regionTotal
% of
regionTotal
% of
regionTotal
% of
region
2020 Total*5 331.0 6% 437.4 8% 126.5 2% 1,440.0 27% 2,081.4 38% 1,009.8 19% 5,426.0
above 65(%)*5(17%)
55.0 10%
(19%)
82.7 14%
(28%)
35.9 6%
(12%)
172.3 30%
(7%)
151.9 27%
(7%)
74.6 13%
(11%)
572.4
AD All 5.9 12.6% 10.7 21.9% 5.6 11.3% 11.6 23.2% 10.3 20.6% 5.1 10.4% 49.1
MCI due to AD*6 2.4 3.8 1.9 4.3 3.8 1.9 18.0
Mild AD 2.2 4.4 2.3 4.7 4.2 2.1 19.9
Early AD 4.6 8.2 4.3 9.0 7.9 3.9 37.9
2025 Total*5 340.4 6% 437.8 8% 124.0 2% 1,458.6 26% 2,175.7 39% 1,075.4 19% 5,611.9
above 65(%)*5(19%)
63.5 9%
(21%)
91.6 14%
(30%)
36.7 5%
(14%)
204.7 30%
(9%)
186.5 28%
(8%)
89.6 13%
(12%)
672.6
AD All 6.7 12.4% 11.8 20.8% 6.3 11.0% 14.0 24.0% 12.3 21.2% 6.2 10.8% 57.2
MCI due to AD*6 2.6 4.1 2.2 5.1 4.5 2.2 20.7
Mild AD 2.6 4.9 2.6 5.7 5.0 2.5 23.4
Early AD 5.2 9.0 4.9 10.8 9.5 4.8 44.1
The early AD population is estimated as approx. 38 million globally and
is expected to be 44 million in 2025.
AD population is estimated to be the largest in China followed by EU ALL and Asia.
The number of people living with AD will increase in all regions through 2025.
The ratio of people aged 65 and over is estimated to be the highest in Japan. *1: EU ALL: France, Germany, Italy, Spain, United Kingdom, Austria, Greece, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland, Belgium, Czech Republic,
Denmark, Finland and Russia *2: Asia: Hong Kong, Indonesia, India, South Korea, Australia, New Zealand, Malaysia, Philippines, Singapore, Taiwan, Thailand and
Vietnam *3: Rest of World: Brazil, Mexico, Argentina, Canada, Chile, Columbia, Venezuela, Egypt, Nigeria, Saudi Arabia, South Africa and Turkey *4 Region Total: US,
EU ALL, Japan, China, Asia and ROW *5: Source: United Nations World Population Prospects 2019, Medium fertility variant *6: Source: Symptomatic Pre-AD based on
Decision Resources 2019
Alzheimer’s Disease (AD) Demography
11
Daily living domain
Preventive behaviors are
not performed as common practice
Convenient diagnostic tools
for early AD are not widely used
Preventive action(diet, exercise, sleep, etc.)Understanding of
disease Cognitive check-ups
Promote understanding of disease through disease
awareness activities• Promote proper understanding
of dementia and MCI from
disease awareness activities
on various media, owned
media such as sodan.e65.net*2
and through influencers
Promote disease prevention by *3 and make it a
common practice • Preparing a brain performance
App for family members to manage health against dementia
• Promote disease prevention by recording, presenting and measuring brain performance and make it a common practice
Little awareness or
perception of disease
Chasm ChasmCognitive function
check-up are not performed
Chasm Chasm
Eliminate Chasms of Disease Understanding,
Preventive Actions, Cognitive Function Check-up and
Consultation with Physicians
Chasm : A hurdle, which has to be overcome to promote understanding of disease, making it possible to make a habit of
checking cognitive function in daily living
Medical
domain
(millions of people)(millions of people)
Dementia MCIUnderstand
the purpose
Individualized Implement Common
practiceImplement
People
40-79 year-old male
and female*1
Medical institutions
Consult with
general
ppractice
Cognitive
function
check-up
65.91 51.60 43.96 36.71 13.24 14.03 12.98 4.87 1.384.81
0.72
*1: Internal estimates based on the survey of 1,648 people aged 40-79*2: sodan.e-65.net: Website for disease awareness and provision of information for patients with dementia and their family run by Eisai (available only in Japanese) *3: Named easiit for Eisai Dementia Ecosystem Platform. Under review for trademark registration *4: Under review for trademark registration
12
Common
practice
• Named ‘NOUKNOW’ for Cogstate Brief Battery (non-medical use). Measure brain performance by simple card tests on PCs or tablets, enabling to make a habit of checking cognitive function in daily living (it only takes 15 minutes for testing),which may lead to disease preventive action by understanding brain performance over time.
• Cognigram (medical use) has been approved as a medical device and is used by medical professionals for diagnosing MCI and dementia. In Japan, the development as a medical device for diagnosis of MCI and dementia is under consideration.
Contributing to make a habit of implementing/checking cognitive functions, including functions in daily living and disease-related area
seamlessly with ‘NOUKNOW*4, which has same algorithm as Cognigram
A
N
T
CSF*2
Amyloid PET
Tau PET
CSF
CSF
CSF
CSF
MRI
(I)
FDG PET*8
Blood
Blood
*14
Amyloid
Simple confirmation of brain performance to diagnosis utilizing AT(I)N biomarker will eventually be possible.
Diagnosis and efficacy evaluation in AD continuum is based on biomarker panel.
CSF testing will be capable of evaluating AT(I)N biomarkers simultaneously with a high degree of sensitivity.
(Aβ42/40, Amyloid PET)
Neuroinflammation (sTREM2*4
, YKL40*5
, TSPO*6
PET)
Synaptic dysfunction (NfL*7
, Neurogranin)
Neurodegeneration (t-tau*9
, NfL, vMRI*10
)
Tauopathy (p-tau*3
, Tau PET)
Cognigram*13
AD Continuum (Continuous Disease Pathology)
and Biomarker Panel
Mild AD Severe ADPreclinical AD Moderate AD MCI due to ADPeople with no pathological
changes
Confirmation
of brain
performance
Gene ApoE genotype and polygenic risk score*11 based on the analysis of SNPs*12
Definition based on biomarker panel*1
*1: The figure above is created based on the lecture at the 39th Annual Meeting of the Japanese Neuroscience Society by Dr. Makoto Higuchi, National Institute of Quantum and Radiological Science and Technology (Radiological Science and Development Directorate) *2: Cerebrospinal fluid *3: Phosphorylated tau *4: Soluble triggering receptor expressed on myeloid cells 2 *5: Chitinase-3-like protein 1 *6: 18kDa translocator protein *7: Neurofilament light chain *8: Positron emission tomography (PET) using fluoro-deoxy-glucose (FDG) *9: Total tau *10: Volumetric MRI *11: Evaluation system for the risk of disease onset with mass information of genetic SNPs as a key index *12: Single-nucleotide polymorphisms *13: Cognigram (global brand name) is used by medical professionals for diagnosis of MCI and dementia. In Japan, the development as medical devise for diagnosis of MCI and dementia is under consideration. Cogstate Brief Battery is a simplified version of Cognigram. *14: NOUKNOW: Self-checking tool (non-medical device), which individuals can check their cognitive functions by themselves with quantified brain performance data through simple card games utilizing PC or tablet-type device. Under review for trade mark registration 13
PET
- Transition from “amyloid positivity testing” to
“more precise diagnosis of disease stages ”
(e.g. preclinical AD) by using amyloid PET
tracer and imaging process with higher
sensitivity and accuracy
- Usage as imaging biomarker panel is expected by using tau-PET tracers
CSF
BloodGenetic
Future Progress of AD Diagnosis
- Diagnosis granted as Breakthrough Devices
Program designation by FDA• Lumipulse® G β-Amyloid (1-42/1-40),
Fujirebio Diagnostics, Inc.
• Elecsys® β-Amyloid (1-42) CSF/p-tau CSF,
F. Hoffmann-La Roche Ltd.
- Precise diagnosis of disease stages and
evaluation of drug efficacy utilizing AT(I)N
biomarker panel (CSF) is expected to be
possible
- Risk diagnosis with polygenic risk score system
is expected based on SNPs*3 analysis,
including ApoE genes status
*1: MISSION AD: Phase III program for elenbecestat (elenbecestat is a compound under co-development with Biogen) *2: Cerebrospinal fluid
*3: Single nucleotide polymorphism
- Co-research with Sysmex on measurement of
Aβ1-42/Aβ1-40 with samples from MISSION AD*1
is ongoing
- Diagnosis granted as Breakthrough Devices
Program designation by FDA• APTUSTM,
-Aβ blood test, C2N Diagnostics LLC.
- p-tau in CSF*2 correlates to p-tau in blood
- Pursue low-invasive disease stage diagnosis and
evaluation of drug efficacy utilizing AT(I)N biomarker
panel
Aim for paradigm shift in diagnosis with the introduction of blood and genetic testing
14
認知症ケアにかかる費用(医療・介護サービス・家族が行うケア等)の減少
US• It is estimated that if a treatment method would be introduced that delays the onset of dementia by five
years in 2025, it would reduce by 367 billion USD (approx. 40 trillion yen) the total costs of care, including
Medicare, Medicaid, co-pay and others) per year in 2050*4
Report on potential medical/care cost reduction effect by delaying disease onset of dementia by 5 years
• Similarly, if a treatment method would be introduced that delays the onset of dementia by five years, it is
estimated that medical and nursing cost would be reduced by approx. 1.9 trillion yen (1 trillion yen in medical
cost and 900 billion yen) in care cost in fiscal 2025*5
Estimated cost for dementia (global total)*2
Value of AD DMT*1
Aim for potential decrease of dementia care cost, including medical/care cost and informal care cost
• Huge burden on care cost
(social care cost and informal
care cost), compared to medical cost
• Cost for dementia was approx. 90
trillion yen worldwide total in 2015,
and it will be estimated to increase to
approx. 220 trillion yen in 2030
2010 2015
High incomecountries
604 billion USD
(Approx. 66 trillion yen)
817.9 billion USD
(Approx. 90 trillion yen)
Middle incomecountries
Low incomecountries
20.4
22.6
19.0
10.4
19.4
43.1
69.2
58.0
37.9
0% 50% 100%
Medical cost
Social care cost
Informal care cost
Aducanumab demonstrated
40% reduction*3 in scale
related to activities of daily
living (ADCS-ADL-MCI) in
early AD patients
Reduction of care costs and
continuation of economic activities
through improvement of the
degree of independence in daily
living are expected
Japan
AD DMT is expected to contribute to not only delaying disease onset/slowing cognitive decline, but also to reducing social cost such as medical, nursing and informal care cost. AD DMT is also expected to reduce the burden caused by disease onset
by extending the time without symptoms of dementia. AD: Alzheimer’s Disease *1: Disease modifying treatment for Alzheimer’s Disease *2: Alzheimer‘s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars,
total cost of dementia care includes Medicare, Medicaid and self-pay (1USD=110JPY) *3: Topline results of aducanumab EMERGE Study presented at 13th Clinical Trials on Alzheimer’s Disease (CTAD2019)
*4: Alzheimer‘s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars *5: Tama University, Center for Rule-making Strategies, July 2018 15
Aβ Hypothesis, Our Understanding
2. Less decline of cognitive function and benefits on
activities of daily living by reducing Aβ aggregates
were demonstrated in large-scale studies (Phase II
study of BAN2401*1,2 and Phase III studies
(EMERGE/ENGAGE*3) of aducanumab*2)
1. BACE inhibitor may be associated with several substrates other than amyloid precursor protein (APP) as well as bringing various effects. Therefore, high-selectivity to APP is required. Potential indication is prevention to accumulation of Aβ aggregates, or maintenance therapy after Aβ aggregates are removed by antibodies.
*1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *2: Co-development with Biogen *3: EMERGE/ENGAGE is a Phase III program for aducanumab
Aβ
AP
P
BACEAssociation
Dissociation
Extracellular
Intracellular γ-secretase
Aβ Amyloid plaqueDimer Oligomer Protofibrils
Fibril
Monomer
Microtubule
Tau Phosphorylation
of tau
Neurofilamentlight chain
NeurograninP-tau, Total tau
Amyloid
Tauopathy
Neurodegeneration
5. Of Aβ aggregates, the neurotoxicity of soluble aggregates may be important. It is also suggested that there is a process which directly forms amyloid plaque from soluble aggregates.
4. It is important within AD continuum to examine
AT(I)N biomarker panel and tau-PET
3. Antibodies with selectivity have been shown to remove Aβ aggregates, compared to anti-Aβ monomer antibodies or BACE inhibitors.The speed of lowering brain Aβ monomer level, breaking the balance, and dissociating Aβ aggregates of BACE inhibitors are slow. Therefore, it is unable to remove Aβ aggregates rapidly and broadly.
16
Aducanumab*1
and BAN2401*1,2
Ongoing Studies and Studies under Preparation
Aducanumab
EMBARK Study
(Re-dosing study)
Re-dosing of aducanumab (open-label, 2,400 subjects for 100 weeks, 10mg/kg monthly dosing) for
patients who have enrolled OLE of PRIME*3, EMERGE/ENGAGE*4 and EVOLVE*5.
Clarity AD Study
Early AD Phase III study (Double blind placebo, 18 months)1,566 subjects (Placebo:10mg/kg biweekly=1:1) Primary endpoint: CDR-SB*6, Other endpoints: Cognitive function test, biomarker panelInitiated in FY2018 4Q, final readout of primary endpoint targeted in Q1 FY2022
Study 201 OLEBAN2401 open label dosing extension part (Open label study, approx. 200 subjects, 24 months, 10mg/kg biweekly), initiated in Q3 FY2018
AHEAD 3-45
Study
• Preclinical AD Phase III Study (Double blind placebo, dosing: 4 years, 10mg/kg monthly(maintenance dose))
• Includes 2 substudies (A3 and A45) targeting cognitively healthy subjects with different amyloid levels in the brain
• A3 substudy*7: 400 subjects (2 arms, 1:1), Primary endpoint: Aβ PET, Other endpoints: Biomarker panel*8, PACC5*9
• A45 substudy*10: 1,000 subjects (2 arms, 1:1), Primary endpoint: PACC5, Other endpoints:Biomarker panel*8
• Recruitment and enrollment of subjects under common screening protocol to be initiated in 1H FY2020 in partnership with Alzheimer’s Clinical Trial Consortium (ACTC)
Subcutaneous
Study
Subcutaneous administration route clinical study (under consideration)
BAN2401
All projects are investigational. *1: Co-development with Biogen *2: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic *3: Open label extension study of Phase Ib study *4: Phase III studies *5: Long-term repetitive administration safety study in participants with asymptomatic amyloid-related imaging abnormalities (ARIA) in mild cognitive impairment (MCI) or mild Alzheimer's disease dementia *6: Clinical Dementia Rating Sum of Boxes *7: The A3 substudy will include cognitively normal participants with intermediate levels of amyloid as determined by amyloid PET scan, who are at high risk for further amyloid build-up *8: Fluid and neuroimaging *9: Preclinical AD Cognitive Composite 5 *10: The A45 substudy will include participants with little to no cognitive impairment who have elevated levels of amyloid in the brain, who are at high risk for progression to early Alzheimer’s dementia17
Development Progress of
Aducanumab*1
• Actively engaging with the FDA as well as
regulators in Europe and Japan
• Working to complete a regulatory filing in the U.S.
as soon as possible
• Plan to initiate open-label re-dosing study
(EMBARK Study*) for aducanumab according to
successfully submitted protocol to FDA
• Implementing a thorough Go-to-market model,
establishing commercial teams, building out
medical teams, and preparing for market access
*Re-dosing aducanumab 10mg/kg monthly for patients who enrolled in Phase III
study (ENGAGE, EMERGE), PRIME OLE*2
Study, and EVOLVE Study*3
after titration
*1: Investigational. Co-development with Biogen *2: Phase Ib study *3: Long-term repetitive administration safety study in participants with asymptomatic amyloid-
related imaging abnormalities (ARIA) in mild cognitive impairment (MCI) or mild Alzheimer's disease dementia 18
Non-clinical Phase I Phase II Phase IIIUnder preparation
for submission
Series of AD-associated Pipeline
(Classification by biomarker panel)
Anti-Aβ protofibrils antibody
BAN2401*1,2
Anti-tau antibody
E2814*4
Synapse modulator
EphA4 Project*6
Synapse regenerant
E2511
Anti-Aβ antibody
Aducanumab*1
A
TImmuno-Dementia
*5
Project(I)
N
Dual orexin receptor antagonist
DAYVIGO
PDE9 inhibitor
E2027
Collaborative research with Keio University
EKID*9
Preclinical AD: AHEAD 3-45 Study*3
Plan to initiate in 2020
Phase I ongoing
Under preparation for Phase I
Under preparation for submission in the US
Early AD: Clarity AD Study ongoing
ISWRD*7 associated with
AD/dementia: Phase II finished*8
Dementia with Lewy bodies:
Phase II/III ongoing
Drug creation based on immune mechanisms in the brain through discovering target which modulates microglia by leveraging human genetics
Drug creation based on protective mechanism of brain ongoing utilizing reverse translation by leveraging multiomics analysis of clinical samples
Non-clinical research in ongoing aimed at maintenance of memory through synapse stabilization
Beyond
AT(I)N
pathology
All projects are investigational. AD: Alzheimer’s Disease*1: Co-development with Biogen *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic *3: A single AD prevention study in collaboration with Alzheimer’s Clinical Trials Consortium (ACTC). *4: Co-research with University College London (UCL), UK *5: Research at G2D2 (Eisai Center for Genetics Guided Dementia Discovery) *6: Research at KAN Research Institute *7: Irregular sleep-wake rhythm disorder *8: Core study of Phase II has finished *9: Project aiming to identify and verify novel drug discovery target candidates linked to the development of next-generation treatments and preventative medicines for dementia at Eisai-Keio Innovation Lab for Dementia (EKID) has been selected by Japan Agency for Medical Research and Development (AMED) for the Cyclic Innovation for Clinical Empowerment (CiCLE) program
19
1. Monotherapy Strategy
Targeting driver mutation
Enhance response to tumor immunity at the early
stage of cancer with less mutation
Target lineage dependency of cancer, driver mutation
and resistance to existing therapy
Target cancer microenvironment that is existing-
therapy- resistant and immunosuppressive
Induction of neoantigen*1
(Splicing modulator ADC*2)
Modulation of Wnt/β-catenin signaling pathway (E7386*3)
FGFR1-3(E7090*4)
ERα(H3B-6545)
FGF19/FGFR4(H3B-6527)
Tumor vessel remodeling, tumor stroma improvement and mesenchymal-epithelial transition
(MORAb-202, E7389-Liposomal formulation and E7130*5)
2. Combination Therapy StrategyEstablish combination therapy with KEYTRUDA® as a backbone therapy by utilizing immunomodulatory activity of LENVIMA
Wnt/β-catenin (E7386) + LENVIMA
KEYTRUDA®
+ LENVIMA (LEAP Study)
ERα (H3B-6545)+ standard therapy
FGFR1-3 (E7090)+ standard therapy
Eribulin liposomal formulation
+ nivolumab*6
STING agonist (E7766)+ immuno-oncology therapy
Enhance reactivity to tumor immunity and unlock resistance to
immuno-oncology therapy
Unlock resistance to existing standard therapy and realize
innovative combination effect
Aim at creation of precision medicine and cure of cancer by understanding individual cancer
evolution from “precancerous condition/ultra-early cancer” stage to “advanced cancer” stageAll projects are investigational. KEYTRUDA
®is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for Lenvima are
under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Under development in
collaboration with H3-Biomedicine, Eisai’s U.S.-based R&D subsidiary and Bristol-Myers Squibb *2: Antibody-drug conjugate *3: Under development in collaboration with PRISM BioLab
*4: SAKIGAKE designation granted from Japan’s Ministry of Health, Labour and Welfare *5: Compound co-created with Harvard University *6: Under development in collaboration with Ono
Pharmaceutical Co., Ltd.
Strategy in Cancer Continuum
Advanced cancerEarly cancerPrecancerous condition/
ultra-early cancer
Liquid biopsy Canceration/proliferation/
gene alteration associated with infiltration
Recurrence/metastasis/gene alteration
associated with treatment resistance
20
- Although ER positive breast cancer
accounts for approx. 70% in all breast
cancer, treatment resistant ERα gene
mutant cells are observed in approx. 30%
patients after a long-term administration of
aromatase inhibitors*3
- ERα gene mutant cells includes cells which
show resistance to SERM*4 and SERD*5
Next Flagship Candidates
Aim to reform endocrine therapy for estrogen
receptor (ER) positive breast cancer
Wnt
Wnt signal:
target
gene
nucleusCBP*2 β-catenin
×
β-catenin
cytoplasm Activation shown in
hepatocellular carcinoma,
colorectal cancer, gastric
cancer, endometrial
cancer and others cancer
types
Precancerous condition/
ultra-early cancerEarly cancer Advanced cancer
HCC Continuum
Genetic alteration of Wnt/β-catenin signal pathway
Regimen for ER positive breast cancerHormone therapy
Chemotherapy
E7386KEYTRUDA
®+LENVIMA H3B-6545
Existing hormone therapy-resistant ERα gene mutation
Modulation of Wnt/β-catenin signal pathway
E7386*1
Target β-catenin, one of “Cancer Big 4”, and
said to have great difficulty in drug creation Selective estrogen receptor (ER) α covalent
antagonist
H3B-6545
translation
Molecular target treatment
HALAVEN
All projects are investigational. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. Projects for LENVIMA are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. The LEAP studies are led and were submitted by Merck & Co., Inc., Kenilworth, N.J., U.S.A. *1: Under development in collaboration with PRISM BioLab *2: CREB-Binding Protein. One of transcriptional control factors *3: Jeselsohn R. et al. Curr Oncol Rep 2017 *4: Selective Estrogen Receptor Modulator *5: Selective Estrogen Receptor Degrader
E7386 blocks translation by inhibiting
protein-protein interaction of CBP-β-catenin, and
suppresses Wnt signal dependent canceration and
proliferation of cancer cells
H3B-6545 covalently inhibits downstream
signal and suppress proliferation of breast cancer cells
in both wild type and mutant type of ERα
21
Phase Ib Phase II
Origin of Eisai
Empathy Extracting
anxieties
Trying strategy Creating strategy to
satisfy anxieties
22
Spending Time with Patients
‘Empathy’ beyond language/generation
2. Socialization with people with
Lymphatic Filariasis
(Betun Malaka, Indonesia)
1. Relief supplies to cancer
patients at the time of hurricane
damage (Puerto Rico)
Empathy: Status of intersubjectivity of the feelings with other persons,
which may create mutual trust
4. Socialization in a
pediatric cancer ward
(Tokyo, Japan)
6. Socialization in a group home for the mentally handicapped
(Shizuoka prefecture, Japan)
7. Socialization with
people with epilepsy
(Kanagawa prefecture,
Japan)
5. Socialization with
people with Parkinson’s disease
(Tokyo, Japan)
3. Socialization with
elderly people with insomnia
(Kyoto prefecture, Japan)
23
AD Strategy
Spending time with people
living with dementia and
their family
Three anxieties
1.When will future risks surface?
2.What should I do to avoid risks?
3.I don’t want to be a burden
on my family
Trying strategy that would
bring benefits to people
living with dementia
Designing dementia
ecosystem platform
as a strategy to
satisfy the hypothesis
24
AMED
and PMDA
解析
Named Eisai Platform as
Compliance with related rules and
regulations, such as Personal Information
Protection Law
Societal
People living with Dementia
and their families
People’s information
Cognitive function
in daily living
Information on
Prediction and
Prevention
- Information about
cognitive function checked
with “NOUKNOW”, sleep,
diet, and exercise
- For general public, establish
algorithm for prediction and
prevention and provide it as
easy-to-use apps
- For HCP, establish algorithm
to support disease
classification, prediction for
disease progression, and
prediction for treatment effect
for medical institutions
- Dataset of cognitive function data and
biomarker data obtained from clinical studies of
dementia treatments, including AD DMT*2
- Tracking cohort data of healthy status to MCI
stage
Support for sharing
patient life logs,
optimal diagnosis and
treatment intervention
mix, etc.
Support to create
optimal care
programs and
matching of users
Improvement of accuracy in diagnostic
measurement technology and
prediction of cognitive function
Medical
institution
Creating innovation by
creating and utilizing
high-quality data
Universities, Research
Organizations,
and Bio-venture
Expansion of
employment in over-the-
counter operations for
elderly people
Safety driving by
elderly people
(Connected Car)
Exercise program for
maintaining/improving
cognitive function
Diagnostic tool
Retail
business
Automobile
Manufacturer
Fitness club
Private
Insurance
Designing insurance
products including
information to prevent
dementia
Medico
Realization of Societal Innovation through Dementia Ecosystem*1: Trademark registration application under review. Under preparation for launch in Japan *2: Disease modifying treatment for AD
*1
Nursing
home
25
0
5000
10000
15000
20000
25000
FY2015 Forecast forFY2019
FY2025
EWAY FUTURE Aspiration
Overall CAGR
EWAY CURRENT*1
EWAY FUTURE*2,3
Revenue 5.5% 20%
Operating profit 20.6% 25%
Neurology Business*4 -0.7% 45%
Oncology Business*4 9.5% 25%
CURRENT
Region Balance
Aim for remarkable growth with expansion of LENVIMA and potential AD DMT*5
during EWAY FUTURE. Americas region is major driver for the whole company.
Tables shown above are estimated growth prediction, not an official forecast. Official forecast is disclosed in Consolidated Annual Financial Reports.
*1: During FY2015 to FY2019 (forecast) *2: During FY2019 (forecast) to FY2025 (numbers are approximate) *3: Round numbers *4: Revenue by focused area
*5: Disease Modifying Treatment for Alzheimer’s Disease
Revenue FY2019 FY2025*3
Japan 47% 25%
Americas 24% 50%
China 12% 10%
EMEA 9% 7%
Asia and Latin America 8% 8%
26
EWAY POINTS
Partnership Model has been and
will be the core of our business
through EWAY
Transforming Medico Innovation
to Societal Innovation is
the Task of EWAY FUTURE
27
“MEDICO SOCIETAL INNOVATOR, Eisai”
BASE
CAMP
CAMP III
2025
CAMP I
CAMP II
ATTACK
CAMP
Source: https://en.wikipedia.org/wiki/File:Everest_kalapatthar_crop.jpg
2016
28