Q2 FY2020(Fiscal Year Ending March 31, 2021)
Financial Results Presentation
Eisai Co., Ltd.November 5, 2020
Safe Harbor Statement
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.
The Company cannot guarantee the actual outcomes and results for any forward-looking statements.
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 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).
1
1H FY2020 Consolidated Statement of Income (IFRS)Achieved increase in both revenue and operating profit
exceeding business plan despite the impact of COVID-19
April-September 2019 April-September 2020Results % Results % YoY
Revenue 299.3 100.0 317.0 100.0 106Cost of sales 83.2 27.8 79.7 25.1 96
Gross profit 216.1 72.2 237.3 74.9 110R&D expenses 68.0 22.7 67.5 21.3 99R&D expenses including partners’ reimbursement 104.3 34.9 97.3 30.7 93
SG&A expenses 120.5 40.3 133.9 42.2 111Other income & expenses 4.4 1.5 -1.8 -0.6 -
Operating profit 32.0 10.7 34.1 10.7 106Profit for the period 27.4 9.1 26.1 8.2 95Profit for the period (Attributable to owners of the parent)
27.0 9.0 25.8 8.1 96
ROE (%) 8.7 7.6
End of March 2020 End of September 2020Net DER* -0.29 -0.25Ratio of equity attributable to owners of the parent (%) 63.8 64.8
2
(Billions of yen, %)
1H FY2020 average exchange rates: 1 USD: 106.91 yen (-1.6% YoY), 1 EUR: 121.29 yen (-0.1% YoY), 1 GBP: 135.37 yen (-1.0% YoY), 1 RMB: 15.26 yen (-2.7% YoY)* Net DER = (Interest bearing debt (corporate bonds and loans) – cash and cash equivalents – time deposits exceeding 3 months – parent company holding investment securities) / equity attributable to owners of the parent company
299.3317.0
250
260
270
280
290
300
310
320
April-September2019
Revenue
Japanbusiness
Americasbusiness
Chinabusiness
EMEAbusiness
Asia and LatinAmericabusiness
Others April-September2020
Revenue
Breakdown of Revenue MigrationAchieved increase in revenue from Lenvima’s growth in all regions
-6.2 +9.6 +1.3 -1.3
+13.5
+0.8
+/- in global brands• Lenvima 18.0• Fycompa 1.3• Halaven -2.0
<Factor for increase> Increase of products
designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use*1
<Factors for decrease> Revision of drug prices Impact of COVID-19
<Factor for increase> Increase in Lenvima
and Fycompa<Factors for decrease> Impact of
discontinued sales of BELVIQ
Impact of COVID-19
<Factor for increase> Increase in
Lenvima, Fycompa, and Halaven
<Factor for increase> Transfer of rights for
tazemetostat*2 11.5
<Factor for increase> Increase in
Lenvima/Kisplyx and Fycompa
<Factor for decrease> Impact of COVID-19
<Factors for decrease> Termination of sales
contract of Humira
* Figures shown in breakdown are approximate. *1: Lenvima, Fycompa, Dayvigo, Equfina, Careram, and Lunesta *2: Rights to receive royalties outside of Japan
(Billions of yen) +17.8B yenYoY
3
32.0 34.1
0
100
200
300
400
500
April-September
2019Operating
profit
Globalbrands
Launchcost of
Dayvigo
R&Dcost of
Lenvima
Increase ofshared profitof Lenvima
paid by Eisai
ADrelatedcosts
Others April-September
2020Operating
profit
68.0 67.5
36.3 29.8
104.3
April-September
2019
April-September
2020
Reimbursementfrom partnersR&D expenses
97.3
Breakdown of Operating Profit MigrationAchieved increase in operating profit regardless of
proactive investment for growth opportunity
4
-7.3
+18.3
-7.4
-8.9
-2.5
+9.7
(Billions of yen)
<Factor for increase> Transfer of rights for tazemetostat*3 11.5<Factor for decrease> Gain on transfer of shares of Elmed Eisai Co., Ltd. (Q1 FY2019) 4.4
(Reference) R&D expenses including partners’ reimbursement
(Billions of yen)
* Figures shown in breakdown are approximate. *1: Operating profit from Lenvima, Halaven, and Fycompa *2: Shared profit associated with strategic partnership with Merck & Co., Inc., Kenilworth, N.J., U.S.A.*3: Rights to receive royalties outside of Japan
+2.1B yenYoY
10
*1
*2
20
30
40
50
Initiatives Toward Development of Treatments and Vaccines for COVID-19
Natural products screening• Provided 2,650 natural compounds
library to support building pandemic library led by Bill & Melinda Gates Foundation
• Identify several compounds with anti-SARS-CoV-2 activity
E6020• Provided API*4 as an adjuvant to vaccine
candidates developed by VBI Vaccines Inc.*5• Strong immunogenicity was confirmed in
non-clinical study• Discussion is underway to proceed to clinical
study
1. Potential suppression of cytokine storm/becoming severe with immunoregulatory activity
2. Development of treatment agents 3. Collaboration for the development of vaccines
REMAP-COVID*3
Initiated patient enrollment for international clinical
study (Phase III study) in October 2020
Adopted by AMED*1
Industry-academia-government project for non-clinical study
(pharmacometrics and biomarker
discovery)
EritoranSelective TLR (toll-like receptor) 4 antagonist
Inhibits the activation of TLR4, which is the most upstream of various cytokine gene expression signaling that causes the cytokine-storm*2
5
All projects are investigational *1: The Japan Agency for Medical Research and Development *2: Nature 497:498-502, 2013, In collaboration with Prof. Vogel at the University of Maryland *3: A substudy of REMAP-CAP (A Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) that tests multiple interventions for the treatment of patients hospitalized with COVID-19 *4: Active pharmaceutical ingredient *5: A commercial-stage biopharmaceutical company developing next-generation vaccines to address unmet needs in infectious diseases and immuno-oncology. Headquarters are located in Cambridge, M.A., U.S. and the research facility in Ottawa, Canada.
E6011Anti-FKN (fractalkine) monoclonal antibody
CD16 positive monocyte, which highly expresses FKN receptor, is associated with formation and exacerbation of angiopathy
Clinical Stage Pipeline Based on AD Continuum and ATN+
6
A Amyloidaggregates
Implement drug creation based on hypothesis of novel pathophysiologyConduct clinical research making full use of biomarkers
aducanumab*1
(Anti-Aβ antibody)
lecanemab*1, *2 (Anti-Aβ protofibrils antibody)
All projects are investigational. *1: Co-development with Biogen *2: Generic name for BAN2401, an investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic *3: Co-research with University College London (UCL), UK *4: microtubule binding region
Preclinical ADA3 A45
Early ADMCI due to AD Mild AD Moderate AD Severe AD
AD
T
(S)
Tauopathy
Synucleinopathy
NSynaptic
dysfunctionNeurodegeneration
E2027(PDE9 inhibitor) Phase II/III study ongoing
Dementia with Lewy bodies (approx. 20% of all dementia)
E2511 (Synapse regenerant)Phase I study initiated
E2814*3 (Anti-MTBR*4 tau antibody)Phase I study ongoing
7
aducanumab*
Under review by both FDA (US) and EMA (EU) with plans to file with PMDA (Japan)
FDA accepted Biologics License Application (BLA) and granted Priority Review with a PDUFA action date on March 7, 2021, and may act early on this BLA under an expedited review
Advisory Committee meeting scheduled on November 6, 2020 to discuss data submitted (EMERGE, ENGAGE, PRIME) that are intended to establish the effectiveness of aducanumab and to provide an overview of the safety profile
Marketing Authorization Application (MAA) submitted to and accepted by EMA
Formal regulatory meeting held with PMDA and planning to file New Drug Application (NDA)
Initiating regulatory discussions in additional key markets of significant potential
* Investigational. Co-development with Biogen
Phase III study Clarity AD (early AD)
8
Anti-Aβ Protofibrils Antibody lecanemab*1 (BAN2401)
Study resumed at majority of sites that were affected by COVID-19 Utilizing home infusion and telemedicine to secure safety of enrolled patients Aim for completion of patient enrollment in 2020.
Final readout of Primary endpoint is targeted for Q2 FY2022
Phase III study AHEAD 3-45 (preclinical AD)Initiated study as an industry-government-academia partnership with the ACTC*2
Achieved the first infusion in the U.S. in September 2020 Aim to enroll 1,165 subjects in the U.S.
Plan to initiate the study in over 100 sites including Japan, Singapore, Australia, and Europe
Aim to enroll a total of 1,400 subjectsSeek potential of broader contribution with lecanemab
in preclinical AD to early AD*1: Generic name for BAN2401, an investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. Co-development with Biogen *2: The Alzheimer’s Clinical Trials Consortium, funded by the National Institute on Aging at the US National Institutes of Health (NIH), provides the infrastructure for academic clinical trials in Alzheimer’s Disease and related dementias. The ACTC was established in December 2017 and includes 35 primary clinical sites across the United States.
Novel Anti-MTBR Tau AntibodyCharacteristics of E2814*1
Phase I study ongoing
Confirmed the increase of MTBR tau, which E2814 specifically targets in AD brainAccelerate development with the right target
E2814 is designed to target MTBR specifically and capture MTBR fragments at extracellular space to prevent
spreading of tau seeds
E2814
E2814
MTB
R
Tau peptides in brain*2
Investigational. *1: Co-research with University College London (UCL) *2: Poster presentation at AAIC 2019 *3: Tau fragment *4: Progressive supranuclear palsy
Neurofibrillary tangles (NFT), composed of fibers of aggregated tau protein, are known as one of the pathological features of AD
The propagation of pathology is thought to be mediated by tau species containing the MTBR of tau. The increase of fragments, including MTBR, is specifically seen in the brain and cerebrospinal fluid (CSF) in patients with AD
244 369MTBR
Anti-MTBR tau antibody
E2814
Anti-central tau antibody
Conformation recognized anti-tau antibodyAnti-N terminal
tau antibody
Tau protein
MTBR taupropagation species
E2814× MTBR tau
propagation species
9
Presynaptic cell
Synaptic cleft Postsynaptic cell
Microtubule Binding Region (MTBR)
*4
*3
10
In-house Developed Novel Synapse Regenerant E2511
Initiated Phase I study
Aim to develop new concept of “synapse regeneration” by restoring damaged cholinergic neurons to functional neuron with E2511
Cholinergic neurons are significantly vulnerable and their dysfunction is correlated to cognitive decline in AD continuumWhile significant decrease of expression
of TrkA* (decrease of number of synapses at axon tip) is confirmed, significant decrease of neuronal cell body is not confirmed (damaged neuron) in the stage of MCI due to ADE2511 binds to TrkA on the cell
membrane and potentially enhances restoring damaged neuron. It remodels the synapse by turning on the survival and signal of synapse regeneration of cholinergic neurons and potentially suppresses brain atrophy caused byneurodegeneration
Investigational. * tropomyosin receptor kinase A
Synaptic dysfunction
Brain atrophy by neurodegeneration
Damaged neural restoring by E2511
Synaptic degeneration
Neuro-degeneration
Damaged neuronFunctional neuron
Synapse regeneration by E2511
Cholinergic neurons
TrkAAxon
Neuronal cell body
MCI due to AD
2.3 3.16.9 7.05.8 7.57.1
9.1
28.4
41.9
April-September2019
April-September2020
Americas
China
EMEA
Japan
Asia/Latin America
Revenue of Lenvima(billions of yen)
11
50.5B yen
68.5B yen136% YoY
LenvimaProgress to expand contribution to patients in all regions
to achieve FY2020 annual target of 158 billion yen
• Expanded access to medicine in uHCC indication by introducing new patient assistance program (PAP)
• Expanded contribution to patients through initiatives to share the uHCC treatment experience in Japan to China by virtual conferences of China Japan Liver Cancer Alliance and others
China 9.1B yen (128% YoY)
• Expanded contribution to patients with uHCC after the 4th edition of medial treatment manual for hepatic cancer published by the Japan Society of Hepatology, recommended Lenvima for the treatment of BCLC-B*2
Japan 7.0B yen (101% YoY)
• Stable growth in EC indication in Russia and others and uHCC indication including Portugal after obtaining approvals
EMEA 7.5B yen (128% YoY)
• Maintained the top market share in unresectable hepatocellular carcinoma*1 (uHCC)• Achieved steady growth in endometrial carcinoma (EC) indication after the approval for
combination therapy with KEYTRUDA®
• Strengthen commercial activity in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A.focusing on uHCC monotherapy and EC from Q3 FY2020
Americas 41.9B yen (148% YoY)
• Established Lenvima’s position as a first line treatment for uHCC in Asian countries by APPLE Consensus Guideline*3, and by distributing KOL’s treatment algorithm through live/on-demand broadcasting
• Expanded contribution to patients with combination therapy with KEYTRUDA® in EC indication in South Korea, Taiwan, the Philippines, Malaysia, and Singapore
Asia/Latin America 3.1B yen (131% YoY)
Aim to achieve annual target of 158B yen by expanding number of approved countries for EC indication and contributing to patients with BCLC-B in uHCC
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. *1: Source: IPSOS *2: Barcelona Clinic Liver Cancer stage B. Intermediate stage of HCC *3: 10 clinical questions and consensus statement were defined among experts from Japan, China, South Korea, Taiwan, Hong Kong and Singapore, aiming at suggesting science-based optimal treatment option for patients with intermediate stage HCC at the 10th
Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE) held in August 2019
12
Accelerate Growth of Lenvima in the U.S.
Endometrial carcinoma*1 (EC)• Continuously increased the number of prescriptions despite the impact of COVID-19
• Plan to increase commercial activity of Lenvima in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (Merck)
• Aim to expand market share as the first novel treatment in 50 years
Unresectable Hepatocellular carcinoma*2 (uHCC)Aim to further expand market share in uHCC by increasing the number of calls based on Full-Time Equivalent (FTE) increase by Merck for monotherapy and leveraging RWD*3 on the treatment of BCLC-B*4
Differentiated thyroid cancer*7 (DTC)Aim to utilize digital tools to further expand market share by increasing the number of prescriptions from unvisited facilities/non-prescribers
Renal cell carcinoma*5 (RCC)• Sustained growth following EC in 1H, with EAU*6 guideline which recommended oral formulation anti-cancer agent
• Aim to continuously grow by leveraging the position as an oral formulation anti-cancer agent
Seeking further contribution to patients in the U.S., the largest market, by overcoming the impact of COVID-19 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. *1: In combination with KEYTRUDA® for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation *2:First-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) *3: Real world data *4: Barcelona Clinic Liver Cancer stage B. Intermediate-stage HCC *5: Combination therapy with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. *6: European Association of Urology EAU guidance: https://uroweb.org/guideline/renal-cell-carcinoma/#1 Edn. Presented at the EAU Annual Congress Amsterdam 2020. ISBN 978-94-92671-07-3. *7: Treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC *8: Internal estimates of revenue of Lenvima in Americas region
28.4
41.9
0
10
20
30
40
19年度上期 20年度上期
Transition of revenue ratioby indication*8
子宮内膜がん
腎細胞がん
肝細胞がん
甲状腺がん
(Billions of yen)
123% YoY
107% YoY
105% YoY
20,311%YoY
1H FY2019 1H FY2020
EC
RCC
uHCC
DTC
Aim to recover the level before COVID-19
Number of customer contacts(including virtual) by Eisai and Merck
Number of customer contacts(including virtual) in the U.S. by Eisai and Merck
Melanoma 2L (LEAP-004 study): Presented favorable clinical result at ESMO 2020Basket trial*6 (LEAP-005 study): Presented favorable clinical result at ESMO 2020
Studies targeting refractory cancer types with high unmet needs
NSCLC*2 1L in combination with chemotherapy (LEAP-006 study):Presented favorable results observed in safety run-in part at ESMO 2020
NSCLC 1L PD-L1 positive (LEAP-007 study)NSCLC 2L (LEAP-008 study)HCC*3 1L (LEAP-002 study): Completed patient enrollmentHCC 1L in combination with TACE (LEAP-012 study)Bladder cancer 1L (LEAP-011 study)RCC*4 1L (Study 307): Topline result anticipated in FY2020EC*5 2L (Study 309): Completed patient enrollmentEC 1L (LEAP-001 study)Head and neck cancer 1L (LEAP-010 study)Melanoma 1L (LEAP-003 study)
Clinical studies for NSCLC, HCC and RCC to contribute 500B yen level target in FY2025 are steadily ongoing
13
Lenvima and KEYTRUDA® (LEAP Studies)Aim to contribute to patients with 11 ongoing randomized controlled studies targeting cancer types with high needs
Randomized controlled studies (Phase III studies)
254
100
67
48
45
42
34
Lung cancer
Hepatic cancer
Bladder cancer
Kidney cancer
Endometrialcarcinoma
Oral cancer(Head and neck
cancer)
Melanoma
Estimated number of newly diagnosed patients in 2025*1
(10,000 people)
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 forLenvima are under joint development with Merck & Co., Inc., Kenilworth, N.J., U.S.A. 1L: First line 2L: Second line *1: Cancer tomorrow (Global) https://gco.iarc.fr/tomorrow/home *2: Non-small cell lung cancer *3: Hepatocellular carcinoma *4: Renal cell carcinoma *5: Endometrial carcinoma *6: Triple-negative breast cancer, gastric cancer, ovarian cancer, colorectal cancer, glioblastoma, biliary tract cancer
14
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. 1L: First line 2L: Second line *1: Investigational *2: ESMO Virtual Congress 2020 abstract number: 1313P. The most common TRAEs were hypertension, hyponatremia, and pneumonia *3: RECIST v1.1. A set of assessment criteria used to evaluate effects on solid cancers (based on changes in tumor diameter). *4: Cancer tomorrow https://gco.iarc.fr/tomorrow/home
Steady progress to potentially contribute to patients with NSCLC,of which over 2 million new global patients are diagnosed every year*4 globally
Cha
nges
in tu
mor
siz
e fro
m b
asel
ine
(%)
Response rate*3: 69%
Study to compare approved regimen with approved regimen in combination with
LenvimaLenvima + approved regimen
(KEYTRUDA® + platinum agent + pemetrexed)
Presented at ESMO 2020*2
Two more Phase III studies targeting NSCLC
Open-label safety run-in part(Single arm, 13 subjects)
Comparative control part(Randomized, double-blind approx. 700 subjects)
LEAP-007 study (1L, PD-L1 positive)LEAP-008 study (2L)
Lenvima + approved regimen (KEYTRUDA®)
Phase III study in patients with previously untreated metastatic nonsquamous NSCLC(LEAP-006 study)
Combination Therapy with KEYTRUDA®
Non-small cell lung cancer*1 (NSCLC)Favorable results were observed in patients who were untreated with systemic therapy
15
Interim analysis of Phase II study (LEAP-005 study) in patients who are standard therapy-resistant or whose status became exacerbated after treatments*2
Combination Therapy with KEYTRUDA®
Basket trial*1
Clinical efficacy was observed in multiple solid tumors
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. *1: Investigational *2: ESMO Virtual Congress 2020 abstract number: LBA41. The most common TRAEs of any grade occurring in at least 20% of the overall study population were hypertension (39.0%), fatigue (29.4%), diarrhea (26.7%), decreased appetite (25.1%), hypothyroidism (27.8%) and nausea (21.9%). *3: A set of assessment criteria used to evaluate effects on solid cancers (based on changes in tumor diameter). *4: Response Assessmentt in Neuro-Oncology *5: Colorectal caner that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) *6: Triple negative breast cancer *7: Objective response rate *8: Disease control rate
Based on these initial results, enrollment for the study will be expanded
RECIST v1.1*3
/RANO*4
Independent imaging review
based on blinded independent central
review (BICR)
3L Non-MSI-Hcolorectal cancer*5
N=32
4LOvarian cancer
N=31
3LGastric cancer
N=31
2LBiliary tract
cancerN=31
2LGlioblastoma
N=31
2L/3L TNBC*5
N=31
ORR*7 21.9% 32.3% 9.7% 9.7% 16.1% 29.0%
DCR*8 46.9% 74.2% 48.4% 67.7% 58.1% 58.1%
32.3% to 9.7% ORR were observed in cases that were standard therapy-resistant or tumor types with high unmet needs, which exacerbated after treatments
Showed potential of combination therapy
Eisai JapanPresident
RWD*3
Marketing Dept.
Healthcare ProfessionalEngagementTransformation (HX)
Alzheimer’s Disease Franchise
ConsumerExperienceTransformation (CX)
hAC*4
Value
Field Force Support Dept.
DigitalSolution Dept.
DigitalMarketing Dept.
Network
ADFPromotion HQ
Brand
16 *1: Digital Transformation *2: Customer Relationship Management *3: Real World Data *4: hhc Area Coordinator
• Plan and promote AD branding strategies• Plan and promote strategies to train key
opinion leaders
• Analyze and utilize medical data using RWD
• Key account management
• Introduce, plan and promote digital solutions
• Plan and promote disease area apps to support realization of P3 model(Participation, Prediction, and Prevention)
• Plan and implement digital marketing strategies
• Develop disease progression prediction algorithm through maintenance and analysis of clinical trial data and cohort data. Realize “visualization” of treatment effect.
• Maintain digital infrastructures
• Develop and implement system including apps and security
Marketing Dept.
Eisai JapanDeputy President
Tech Squad
CX HQ
ChiefDigital Officer
Planning &Partnership Dept..
HX HQ
• Disseminate diagnosis by amyloid PET and cerebrospinal fluid (CSF)
• Establish early diagnosis method for AD• Plan and implement outcome related to
DMT and pricing strategies• Introduce Patient Assistance Program to
improve access
• Grasp actual status of diagnosis and treatment for MCI and dementia
- CSF testing implementation status and operating status of institutions that possess PET
‐Grasp number of beds for intravenous drip required for administration and so on
- Grasp system to follow up on safety• Establish medical cooperation system related to
MCI and dementia
• Educate importance of measuring brain performance and encourage doctor consultation using NouKNOWTM at 167 dementia cooperation agreement partners
• Deliver dementia related products such as Aricept to geriatric health services facilities
• Plan and implement functional improvement of NouKNOWTM, Easiit and other products
• Disseminate and expand NouKNOWTM, Easiit and others through collaboration with partners from different industries
Cross-functional organizationto promote education on brain
performance and value maximization of a product to promote implementation of
cognitive function checks and preventive activities
Structural Reform in JAPANAiming at DX*1
Conversion Science
NouKNOWTM・・・
• Support CRM*2 design and implementation• Track key performance index of sales
reps’ activities
• Plan and implement expanding Easiit membership measures
• Plan education to raise awareness of brain performance
DAILY LIVING DOMAIN MEDICAL DOMAIN*2
LINK
Brain performance app
Measure brain performanceMake a habit of practicing preventive action
17
DietSleep
NouKNOWTM*5
Blood testresults
Cognigram*6Progression
stage of dementia
MRI/PETimages
INPUTINPUT
OUTPUTVisualization of health data about brain and
bodyUseful info to improve
brain performancePrediction of
dementia onset*2Visualization of
treatment effectsSide effect detection,
imaging diagnosis assistance
Medical infodashboard
Clinical trial results for dementia treatmentsHigh-quality data from external cohorts*2
AI algorithm
*1: A project in Japan *2: The concept includes ideas under consideration. *3: Personal health records including personal health and medical information, such as the results of medical examinations and medication history *4: Brain performance *5: Non-medical device to self-check BP *6: Cognitive function test tool marketed in the U.S., Europe, Australia, and New Zealand for medical diagnosis *7: 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
BP*4 check
PHR*3 data collection
Cooperate with related service providersProvide personalized services based on PHR
OUTPUT
Foster ties and trust between the people in need and physicians
Standardize advanced medical care by supporting the best treatment
Medical info data
Eliminate chasm*7 by creating links among awareness of disease, early access to consultation, and behavior modification through
Create an optimal environment forconsultation, diagnosis, and treatmentEfficient consultations and diagnoses
Available for iOS since July 2020, for Android since August 2020
Data linkage to app since Sep 2020
Walk
Progress of Ecosystem Platform xxxx
BUSINESSALLIANCE
Services designed for healthcare professionals
based on data from app
*1
1. Under COVID-19, the number of sleeping pill prescriptions*1
by psychiatric and psychosomatic physicians exceeded the number of prescriptions across all diagnosis and treatment departments by 10%
2. Became No. 1*2 in terms of volume of details thanks to digital-centric launch, and No. 1*3 most impressive product among physicians
3. Created an environment where Dayvigo is used by over 70% of psychiatric and psychosomatic family physicians
Dayvigo
18
Expanding Contributions to Patientsin Japan During COVID-19 Pandemic
Inhibited progression of joint damage inpatients who had inadequate response to methotrexate (MTX)
Demonstrated consistent safety profilethroughout global Phase III FINCH studies(FINCH 1, FINCH 2, and FINCH 3)
Jyseleca*4, *5
有効性Efficacy
Safety
Next-generation JAK inhibitor with good balance of efficacy and safety
Demonstrates true value of RA Franchise*6
Contributes to achieving “Fear Free” lives*7
As a new treatment option Dayvigo has further accelerated patient contribution
Seeking potential to relieve anxiety in patients with insomnia in the New Normal era
Demonstrated to have high JAK1 selectivity and good tolerability and less progression of structural
damage in joints
Significant improvements to sleep latency, quality of sleep, and residual next-morning effect are widely
recognized
*1: Copyright © 2020 IQVIA. Own compilation based on IQVIA Rx (April-August 2019, April-August 2020). All rights reserved. *2: s.maX Co., Ltd. (June-September 2020). *3: Copyright© INTAGE Healthcare Inc. All Rights Reserved. Share of Channels (July). *4: Indication in Japan: Rheumatoid arthritis with inadequate response to existing treatment (including prevention of structural damage to joints). *5: Under the terms of the marketing agreement, Gilead Sciences K.K. will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in rheumatoid arthritis. The companies will jointly commercialize the medicine to make it available to physicians and patients across Japan. *6: Rheumatoid Arthritis Franchise: Humira, Careram, Jyseleca, and other in-house-developed drugs for rheumatic diseases. *7: Fear-free refers to living a normal life; as the patient did before the disease.
Structural Reform in the U.S.Aiming at Further Growth
19
Aiming to make significant contribution with new structure consisting of four pillars of AD, insomnia, epilepsy and oncology
Executive Vice PresidentPurpose
AD Insomnia Epilepsy OncologyEstablish AD
Commercial to maximize partnership
Maximize Contribution to Patients in China (1)Fulfill Patient Needs from Innovative New Drugs to Low-Tier Markets
Expand contribution to patients through long-term products
Expansion of global brands
Expand Benxi Plant as 2nd production base in China to manufacture 4 high-quality generic drugs
20
Lenvima128% YoY
Strong collaborationwith MSD*1
FycompaLaunched inJan. 2020
Filed additional applications for
monotherapy and pediatric indications
HalavenLaunched inJan. 2020
Expandedaccess through
introduction of PAP*2
1H FY2019 results
1H FY2020 results
103% YoY
Expansion of global brands
16%
22%
Continuously expand patient contributions in any
healthcare environment
*1: Name used by Merck & Co., Inc., Kenilworth, N.J., U.S.A. to conduct business outside of the U.S. and Canada. *2: Patient Assistance Program Initiated in October 2020.*3: Internal estimates based on the size of the mecobalamin market *4: Small and medium-sized cities and hospitals in inland and rural areas
Expand contributions to patients in low-tier market*4 with high-quality generic drugs
Lenvima
Halaven
Fycompa
Others
• Successful bid for Methycobal through government’s centralized procurement system
• Promote business in response to China market changes and other factors, in hopes of expanding patient contribution by Methycobal to 34 million*3
Loxoprofen produced at Eisai’s Benxi Plant passed China authorities’ generic-quality consistency evaluation (GQCE)
Partner with Chinese digital business leader to build ecosystem in China.Aim to realize societal innovations in business in China
Joint venture company established by JD Healthof the JD (Jing Dong) Group and Eisai China
21
Maximize Contribution to Patients in China (2)Build an ecosystem in China through new partnership
with Jing Dong Group
Eisai China’s Strengths
Eisai China’s Role• Promote participation to platform for medical/care staffs
• Development of content for early screening tools, disease understanding, etc.
JD’s StrengthsCommunity
Medical Care Nursing Care
Malls
Promote disease understanding
Self-checks
Online clinicsHealthcare
consultations
Introduce nursing homes
Dissemination of nursing care information
Merchandise patient/family-focused products
Pharmaceuticals are available to purchase
• 330 million active users in China• Possesses a strong e-commerce
business base and internet medical service know-how, as well as a logistics infrastructure that covers 99% of China
JD Health’s Role• Extensive existing user base, rapid user growth through high awareness
• Establish online hospitals and e-commerce and provide logistics infrastructure
In particular, developing services for people with
dementia and their families in China
• Strong network of medical professionals, including dementia specialists
• Highly knowledgeable and specialized professionals in healthcare business with over 25 years’ experience in China
Jingyi Weixiang (Shanghai) Health Industry Development
Limited CompanyBuild a one-stop online
service platform
22
Consolidated Financial Forecast for FY2020 (IFRS)Proactive investment in growth opportunities for EWAY FUTURE
with leveraging expansion of Lenvima(Billions of yen, %)
FY2019 average exchange rates: 1 USD: 108.73 yen, 1 EUR: 120.81 yen, 1 GBP: 138.24 yen, 1 RMB: 15.60 yenFY2020 average exchange rates (forecast rates): 1 USD: 105 yen, 1 EUR: 117 yen, 1 GBP: 130 yen, 1 RMB: 14.6 yen*1: Reflecting a reversal of provisions in accounting on income taxes in the U.S. and a decrease in income taxes at the Company following a repayment of paid-in capital from
a U.S. subsidiary to the Company in order to resolve the Group's cash imbalance between Japan and the U.S.
FY2019 FY2020Results % Forecast % YoY
Revenue 695.6 100.0 719.0 100.0 103(Reference) Revenue of other business 118.4 17.0 102.0 14.2 86Cost of sales 175.7 25.3 171.5 23.9 98
Gross profit 519.9 74.7 547.5 76.1 105R&D expenses 140.1 20.1 165.5 23.0 118SG&A expenses 256.3 36.8 294.5 41.0 115Other income & expenses 2.0 0.3 0.5 0.1 25
Operating profit 125.5 18.0 88.0 12.2 70Profit for the year*1 122.5 17.6 67.5 9.4 55Profit for the year(Attributable to owners of the parent)
121.8 17.5 67.0 9.3 55
EPS (yen) 425.01 233.00ROE (%) 18.6 9.7DOE (%) 7.0 6.7Dividend per share (yen) 160 160
Reference Data
23
April-September 2019 April-September 2020
Results % Results % YoY
Japan 125.8 42.0 119.6 37.7 95
Americas*1 57.9 19.3 67.5 21.3 117
China 44.7 14.9 46.0 14.5 103
EMEA*2 26.1 8.7 26.9 8.5 103
Asia and Latin America*3 24.0 8.0 22.8 7.2 95
OTC and others (Japan) 13.1 4.4 13.3 4.2 101Pharmaceutical business
total 291.6 97.5 296.1 93.4 102
Other business*4 7.6 2.5 21.0 6.6 275
Consolidated revenue 299.3 100.0 317.0 100.0 106
Revenue by Reporting Segment
24
(Billions of yen, %)
*1: North America *2: Europe, Middle East, Africa, Russia and Oceania *3: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *4: Income mainly from license and the pharmaceutical ingredient business of the parent company
Profit by Reporting Segment
April-September 2019 April-September 2020
Results % % of revenue Results % % of
revenue YoY
Japan 50.3 38.9 40.0 47.1 32.6 39.4 94Americas*1 30.6 23.7 52.9 31.0 21.5 46.0 101
China 21.5 16.7 48.2 24.2 16.7 52.6 112EMEA*2 11.7 9.1 45.0 13.1 9.1 48.6 112
Asia and Latin America*3 9.0 7.0 37.4 9.3 6.4 40.8 103OTC and others (Japan) 3.4 2.7 26.1 3.3 2.3 24.8 96Pharmaceutical business
total 126.6 98.0 43.4 128.0 88.6 43.2 101
Other business*4 2.6 2.0 33.7 16.5 11.4 78.8 644Reporting segment total 129.2 100.0 43.2 144.6 100.0 45.6 112
R&D expenses and group headquarters’ management costs and
other expenses*5(97.2) - - (110.5) - - -
Consolidated operating profit 32.0 - 10.7 34.1 - 10.7 106
25
*1: North America *2: Europe, Middle East, Africa, Russia and Oceania *3: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *4: Income mainly from license and the pharmaceutical ingredient business of the parent company *5: Including the amount of profits and expenses shared with partners under strategic collaborations, the amount of shared profit for Lenvima paid by Eisai to Merck & Co., Inc., Kenilworth, N.J., U.S.A. (22.8B yen in 1H FY2019 and 30.1B yen in 1H FY2020), and gain on sales of shares of subsidiary company
(Billions of yen, %)
Revenue of Major Products
April-September 2019 April-September 2020Results % Results % YoY
Lenvima 50.5 100.0 68.5 100.0 136 [138]Japan 6.9 13.7 7.0 10.1 101 [101]Americas 28.4 56.1 41.9 61.2 148 [150]China 7.1 14.1 9.1 13.3 128 [131]EMEA 5.8 11.5 7.5 10.9 128 [131]Asia and Latin America 2.3 4.6 3.1 4.5 131 [133]
Halaven 20.6 100.0 18.6 100.0 90 [92]Japan 5.0 24.3 4.3 23.0 85 [85]Americas 7.5 36.4 6.3 33.8 84 [85]China - - 0.6 3.4 - -EMEA 7.1 34.5 6.1 32.7 86 [88]Asia and Latin America 1.0 4.7 1.3 7.1 135 [138]
Fycompa 11.8 100.0 13.1 100.0 111 [112]Japan 1.9 16.4 2.6 19.7 133 [133]Americas 6.0 50.6 6.2 46.9 103 [104]China - - 0.2 1.6 - -EMEA 3.4 28.5 3.5 27.0 105 [106]Asia and Latin America 0.5 4.5 0.6 4.7 116 [117]
26
(Billions of yen, %)
[ ] based on local currency
Performance of Japan Pharmaceutical Business
April-September 2019 April-September 2020Results % Results % YoY
Revenue (Prescription medicines) 125.8 100.0 119.6 100.0 95Humira 25.3 20.1 25.6 21.4 101Lyrica*1 13.9 11.1 13.3 11.1 96Lenvima 6.9 5.5 7.0 5.8 101Lunesta 6.3 5.0 6.9 5.8 109Methycobal 7.4 5.9 6.3 5.3 85Aricept 7.4 5.9 5.2 4.3 69Halaven 5.0 4.0 4.3 3.6 85Pariet*2,3 5.8 4.6 4.2 3.5 73Careram 3.2 2.6 3.8 3.2 118Treakisym 4.1 3.3 3.6 3.0 86Elental*2 3.3 2.6 3.3 2.8 101Fycompa 1.9 1.5 2.6 2.2 133Goofice 1.5 1.2 2.3 1.9 150
Segment profit 50.3 40.0 47.1 39.4 94
27
*1: Alliance revenue *2: EA Pharma product *3: Includes sales of triple formulation Helicobacter pylori eradication packs, Rabecure Pack 400/800 and Rabefine Pack
(Billions of yen, %)
Performance of Americas Pharmaceutical Business
April-September 2019 April-September 2020
Results % Results % YoY
Revenue 57.9 100.0 67.5 100.0 117 [118]
Lenvima 28.4 49.0 41.9 62.2 148 [150]
Banzel 11.5 19.9 10.3 15.2 89 [91]
Halaven 7.5 13.0 6.3 9.3 84 [85]
Fycompa 6.0 10.3 6.2 9.1 103 [104]
AcipHex 2.0 3.5 1.5 2.3 76 [77]
Segment profit 30.6 52.9 31.0 46.0 101 [103]
28
(Billions of yen, %)
[ ] based on local currency
Performance of China Pharmaceutical Business
April-September 2019 April-September 2020
Results % Results % YoY
Revenue 44.7 100.0 46.0 100.0 103 [106]
Methycobal 12.5 27.9 12.0 26.0 96 [99]
Lenvima 7.1 15.9 9.1 19.8 128 [131]Stronger Neo-Minophagen C and Glycyron Tablets 5.4 12.0 5.4 11.7 100 [103]
Aricept 5.9 13.2 3.4 7.3 57 [59]
Pariet 3.5 7.8 3.1 6.8 90 [93]
Halaven - - 0.6 1.4 - -
Fycompa - - 0.2 0.5 - -
Segment profit 21.5 48.2 24.2 52.6 112 [116]
29
(Billions of yen, %)
[ ] based on local currency
Performance of EMEA Pharmaceutical Business
April-September 2019 April-September 2020
Results % Results % YoY
Revenue 26.1 100.0 26.9 100.0 103 [105]
Lenvima / Kisplyx 5.8 22.3 7.5 27.7 128 [131]
Halaven 7.1 27.3 6.1 22.6 86 [88]
Fycompa 3.4 12.9 3.5 13.2 105 [106]
Zebinix 3.1 12.0 3.3 12.4 107 [107]
Zonegran 2.0 7.7 1.8 6.7 90 [91]
Inovelon 1.2 4.6 1.2 4.5 102 [102]
Segment profit 11.7 45.0 13.1 48.6 112 [113]
30
(Billions of yen, %)
[ ] based on local currency
April-September 2019 April-September 2020
Results % Results % YoY
Revenue 24.0 100.0 22.8 100.0 95 [97]
Aricept 5.5 22.8 5.3 23.5 97 [100]
Humira 5.4 22.6 4.1 18.2 76 [79]
Lenvima 2.3 9.8 3.1 13.5 131 [133]
Pariet 2.1 8.8 2.2 9.6 104 [107]
Methycobal 1.5 6.1 1.5 6.6 103 [106]
Halaven 1.0 4.1 1.3 5.8 135 [138]
Fycompa 0.5 2.2 0.6 2.7 116 [117]
Segment profit 9.0 37.4 9.3 40.8 103 [104]
Performance of Asia and Latin America Pharmaceutical Business
31
(Billions of yen, %)
[ ] based on local currency
Performance of OTC and Others in Japan
April-September 2019 April-September 2020
Results % Results % YoY
Revenue 13.1 100.0 13.3 100.0 101
Chocola BB Group* 8.5 65.0 6.7 50.5 79
Segment profit 3.4 26.1 3.3 24.8 96
32
* Vitamin B preparation, “Chocola BB Plus” and others
(Billions of yen, %)
Overview of Anti-A-beta AntibodyClinical Trial Designs
Drug(Sponsor)
Study name(Stage)
Target population(Estimated enrollment) Dose Inclusion criteria
(partial)Efficacy measurement
(Primary endpoints)
BAN2401*1
(lecanemab)(Eisai, Biogen)
Clarity AD (Phase III)
Early AD(1566)
10mg/kg biweeklyplacebo
MCI due to AD, mild AD (NIA-AA), CDR: 0.5, CDR memory box ≧0.5,
Amyloid positive, MMSE≧22,WMS-IV LMII: 1 SD below age-adjusted mean
CDR-SB(18 months)
BAN2401*1
(lecanemab)(Eisai, Biogen, ACTC,
NIA)
AHEAD 3-45(Phase III) Preclinical AD (1400) 5mg/kg + 10mg/kg,
placeboCDR: 0, MMSE≧27, WMS-R LM II≧6
A3: Intermediate levels of brain amyloid pathologyA45: Elevated brain amyloid pathology
A3: Amyloid PET SUVr (216 weeks)
A45: PACC5 (216 weeks)
aducanumab(Biogen, Eisai)
ENGAGE (Phase III) Early AD (1605) Low doseHigh doseplacebo
MCI due to AD or mild AD CDR-Global Score: 0.5,
MMSE≧24, Amyloid positiveCDR-SB
(78 weeks)EMERGE (Phase III) Early AD (1605)
gantenerumab(Roche)
Marguerite RoAD(Phase III) Mild AD (389)
gantenerumab,placebo
Clinical diagnosis of probable mild AD(NINCDS/ADRDA), Amyloid-beta positive in CSF
ADAS-Cog13 (104 weeks),ADCS-ADL (104 weeks)
Graduate I (Phase III) Early AD (1016) Probable AD dementia or prodromal AD (NIA-AA), Amyloid positive, MMSE≧22, CDR-GS: 0.5 or 1.0
CDR-SB (116 weeks)Graduate II (Phase III) Early AD (1016)
crenezumab(Roche, Genentech)
Phase II Preclinical AD (252) crenezumab, placebo PSEN1 E280A mutation carrier kindred,
MMSE≧24 (for ≧ 9 years of education) or MMSE≧26 (for ≦ 9 years of education), not meet the criteria for
dementia due to AD, MCI due to AD
API ADAD Composite Cognitive Test Total Score
(260 weeks)
Phase II Preclinical AD (150)crenezumab,
placebo, PET ligand ([18F]GTP1 )
Tau distribution measured by SUVR by [18F]GTP1 tau
PET scan (416 weeks)solanezumab
(Eli Lilly)A4
(Phase III)Preclinical AD*2
(1150)solanezumab
placeboMMSE≧25, CDR: 0, Logical Memory II score 6-18,
Amyloid positivePACC
(240, 366 weeks)
gantenerumab,solanezumab
(Washington University School of Medicine)
DIAN-TU*3
(Phase II/III)Preclinical AD*4
(490)gatenerumab solanezumab
Placebo
Have an AD-causing mutation or are unaware of their genetic status and have a 50% chance of having ADAD mutation, Cognitively normal or with mild cognitive impairment or mild dementia, CDR: 0-1
DIAN-TU cognitive composite score (52, 104,
156, and 208 weeks)
LY3002813/donanemab
(Eli Lilly)
TRAILBLAZER-ALZ (Phase II)
Prodromal to mild AD (266)
donanemab,Placebo
MMSE: 20-28, meet 18F flortaucipir PET scan criteria and 18F florbetapir PET scan (central read) criteria
Integrated Alzheimer‘s Disease Rating Scale (iADRS) (18 months)
TRAILBLAZER-ALZ 2 (Phase II) Early AD (500) donanemab,
placeboMMSE: 20-28, meet 18F flortaucipir and 18F
florbetapir PET scan (central read) criteria CDR-SB (76 weeks)
33
Study designs for Phase II and beyond in this chart was created by Eisai based on the information on ClinicalTrials.gov as of October 23, 2020. OLE studies not included. All projects are investigational. *1: Investigational antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *2: Target population for this trial is older individuals who may be at risk for memory loss *3: Washington University School of Medicine announced that in topline results of DIAN-TU, both gatenerumab and solanezumab did not meet primary endpoint did on February 10, 2020 in the press release *4: Target population for this trial is individuals at risk for or with a type of early onset Alzheimer's disease caused by a genetic mutation
Achievement of Milestones with Merck & Co., Inc., Kenilworth, N.J., U.S.A.
FY2019 700 million USD (76.2 billion yen)
125 million USD(13.1 billion JPY*)
+ recognition of multiple sales-based milestones and regulatory milestone payments
FY2020 forecastQ3 results
34
Q4 results550 million USD(59.8 billion JPY)
Multiple sales-based milestones and regulatory milestone payments are expected
One-time option payment associated with certain option rights
125 million USD(13.1 billion JPY*)
150 million USD(16.4 billion JPY)
Sales-based milestone payment recognized when revenue of 800 million USD from January to December
2019 was achieved150 million USD(16.4 billion yen)
One-time option payment associated with certain
option rights200 million USD(21.6 billion yen)
Sales-based milestone payment recognized when revenue of 750 million USD in FY2019
was achieved150 million USD(16.4 billion yen)
Sales-based milestone payment recognized when revenue of
1 billion USD in FY2019 was achieved
200 million USD(21.8 billion yen)
* Calculation based on 1USD=105 yen