q2 fy2019 (fiscal year ending march 31, 2020) …demography of dementia 5 0 50 100 150 20.4 22.6...
TRANSCRIPT
Q2 FY2019(Fiscal Year Ending March 31, 2020)
Financial Results Presentation
Eisai Co., Ltd.October 30, 2019
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.
1
1H FY2019 Consolidated Statement of Income (IFRS)Achieved target revenue, operating profit
and profit for the period
April-September 2018 April-September 2019Results % Results % YoY
Revenue 310.1 100.0 299.3 100.0 96Cost of Sales 92.0 29.7 83.2 27.8 90
Gross profit 218.1 70.3 216.1 72.2 99R&D expenses 65.0 21.0 68.0 22.7 105
Partner’s share of R&D expenses 89.3 28.8 104.3 34.9 117SG&A expenses 104.8 33.8 120.5 40.3 115Other income & expenses 0.0 0.0 4.4 1.5 -
Operating profit 48.4 15.6 32.0 10.7 66Profit for the period 36.3 11.7 27.4 9.1 75Profit for the period(Attributable to owners of the parent) 32.7 10.5 27.0 9.0 83
ROE (%) 10.7 8.7End of March 2019 End of September 2019
Net DER*1 -0.32 -0.24Ratio of equity attributable to owners of the parent (%) 58.6 60.41H FY2019 average exchange rates: 1 USD: 108.62 yen (-1.5% YoY), 1 EUR: 121.41 yen (-6.5% YoY), 1 GBP: 136.73 yen (-6.9% YoY), 1 RMB: 15.68 yen (-6.3% YoY)*1: Net DER=(“Interest-bearing debt” (“Bonds and borrowings”) – “Cash and cash equivalents” – “Time deposits exceeding three months, etc.” – “Investment securities
held by the parent company”) / “Equity attributable to owners of the parent”2
(Billions of yen, %)
310.1 299.3
2,400
2,600
2,800
3,000
3,200
3,400
2018年
4-9月
売上収益
グローバル
ブランドの
拡大
日本事業 中国・アジア レンビマ
肝細胞がん
承認
マイルストン
エルメッド
エーザイ
譲渡
その他増減 2019年
4-9月
売上収益
Breakdown of Revenue MigrationExpansion of Lenvima offset the difference of milestone payment
receipt, business transfer and return of marketing rights
+26.8(億円)
-10.9 B yenYoY
+4.4
*1
<Factors for decrease> Return of marketing rights for Lipacreon (Q1 FY2018) Transfer of rights for Prialt (Q1 FY2018)
-12.2
<Amount increased>Lenvima 23.5Fycompa 2.1BELVIQ 1.1Halaven 0.1
+2.3
-9.9
*2
-22.2
3
(Billions of yen)
340
320
300
280
260
240
* Figures shown in breakdown are approximate*1: Revenue from Lenvima, Halaven, Fycompa, and BELVIQ, excluding revenue from Japan business*2: Excluding the revenue from Elmed Eisai Co., Ltd. and return of marketing rights for Lipacreon in Q1 FY2018*3: Revenue from China and Asia/Latin America region, excluding revenue from global brands *4: Hepatocellular carcinoma
April-September 2018
Revenue
April-September 2019
Revenue
Global brands*1 Japan business*2
China and Asia business*3
Transfer of shares of
Elmed Eisai Co., Ltd.
OthersMilestone payments associated with HCC*4 indication
approvals of Lenvima
48.432.0
0
200
400
600
800
2018年
4-9月
営業利益
グローバル
ブランドの
拡大
日本事業 中国・アジア レンビマ
肝細胞がん
承認
マイルストン
利益折半
費用の増加
研究開発費の
増加
その他 2019年
4-9月
営業利益
+2.6 -22.2
*3
4
(Billions of yen)
-16.4B yenYoY
-14.9
65.0 68.0
24.336.3
2018年度
4-9月
2019年度
4-9月
Partners' share of R&D costsR&D expenses
(Reference) R&D expenses including partners’ share of cost
(Billions of yen)
<Factors for increase> Gain on transfer of shares of Elmed Eisai Co., Ltd. (FY2019 Q1) 4.4<Factors for decrease> Return of marketing rights for Lipacreon (Q1 FY2018) Transfer of rights for Prialt (Q1 FY2018)
89.3
104.3
+4.1
-3.0
2018年4-9月営業利益
グローバルブランドの拡大
日本事業 中国・アジア
レンビマ肝細胞がん承認
マイルストン
利益折半費用の増加
研究開発費の増加
その他 2019年4-9月営業利益*1
*2*3
-6.9
Breakdown of Operating Profit MigrationAlong with the growth of Lenvima and business in China, proactively invested in R&D through partnership model
80
40
60
20
April-September 2018
Operating Profit
April-September
2019
Global brands*1
Japan business*2
China and Asia
business*3
OthersMilestone payments associated with HCC*4
indication approvals of
Lenvima
April-September
2018
April-September 2019
Operating Profit
Increase of shared profit
paid by Eisai*5
Increase in R&D
expenses
* Figures shown in breakdown are approximate*1: Operating profit from Lenvima, Halaven, Fycompa, and BELVIQ, excluding profit from Japan business*2: Excluding the profit from Elmed Eisai Co., Ltd. and return of marketing rights for Lipacreon in Q1 FY2018*3: Operating profit from business in China and Asia/Latin America region, excluding profit from global brands*4: Hepatocellular carcinoma *5: Shared profit associated with strategic partnership with Merck & Co., Inc., Kenilworth, N.J., U.S.A.
*1: World Alzheimer Report 2018 *2: High income countries are defined as those with a GNI (Gross National Income) per capita of $12,736 or more, Middle income countries are defined as those with a GNI per capita of more than $1,046 but less than $12,736 and Low income countries are defined as those with a GNI per capita of $1,045 or less(World Alzheimer Report 2015) *3: World Alzheimer Report 2015 *4: 2017 Aging society white paper (Cabinet Office) *5: New Orange Plan (January 2015) estimated by Ministry of Health, Labour and Welfare
Estimated number of people with dementiain each region*3
Africa Europe AsiaAmericas2018 2030 2050
82million
152million
High incomecountries*2
(32%)
Middle incomecountries*2
(65%)
Low incomecountries*2
(3%)
Future estimation of number of people with dementia in Japan*4
2012 2015 2020 2025 2030 2040 2050
Number of people with dementia 4.62 million 5.25 million 6.31 million 7.30 million 8.30 million 9.53 million 10.16 million
The numbers of people with dementia in the world were estimated at 50 million in 2018*1 and 152 million in 2050.Higher proportion of dementia in middle income countries are reported and it is growing rapidly, mainly in Asia.
The total number of people with dementia is estimated at approximately over 10 million in Japan:6.31 million*4 with dementia and 4 million*5 with mild cognitive impairment (MCI).
Transition of number of people with dementia worldwide*1(million)
50million
Demography of Dementia
5
0
50
100
150
20.4
22.6
19.0
10.4
19.4
43.1
69.2
58.0
37.9
0% 50% 100%
604.0(Approx. 66 trillion yen)
817.9(Approx. 90 trillion yen)
0
500
2010 2015
High income countries
Low income countries
Medicalcost
Social care cost
Family care cost
• Huge burden on care cost, including social cost for care and family burden for care, compared to medical cost
• Cost for dementia is estimated at approximately 90 trillion yen in 2015, and will increase up to approximately 220 trillion yen in 2030
*1: High income countries are defined as those with a GNI (Gross National Income) per capita of $12,736 or more, Middle income countries are defined as those with a GNI per capita of more than $1,046 but less than $12,736 and Low income countries are defined as those with a GNI per capita of $1,045 or less. Source: World Alzheimer Report 2015 *2: Alzheimer’s Association (2015). Changing the Trajectory of Alzheimer’s Disease: How a treatment by 2025 saves lives and dollars *3: Tama University, Center for Rule-making Strategies, July 2018
Cost estimation of dementia worldwide*1
(Billion USD)
Middle income countries
Estimated reduction in medical and care cost through five years
delay of dementia onset(1) US*2
(2) Japan*3
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 (approximately 40 trillion yen) the total costs of care, including Medicare, Medicaid, co-pay and others) per year in 2050
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 approximately 1.9 trillion yen (1 trillion yen in medical cost and 900 billion yen in care cost) in fiscal 2025
Cost Estimation of Dementia
6
Aducanumab*
Despite studies were announced as discontinued following a futility analysis, new analysis of larger dataset of aducanumab
(EMERGE/ENGAGE) represents the first time a Phase III program has demonstrated that clearance of aggregated amyloid beta can reduce
the clinical decline of Alzheimer’s disease.
The new analysis of larger dataset showed EMERGE to be statistically significant on the pre-specified primary endpoint and Biogen believes
data from a subset of ENGAGE support findings from EMERGE.
Safety and tolerability profile was consistent with prior studies of aducanumab.
Based on discussions with the FDA, Biogen plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue
with regulatory authorities in international markets including Europe and Japan.
7EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. * Investigational. Co-development with Biogen.
8
New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and
secondary endpoints in EMERGE
Aducanumab*1
EMERGE
Cognitive function and activities of daily living (Pre-specified ITT*2 analysis)
Reduction of brain amyloid
% Reduction vs. Placebo*3
p-valueLow dose(N*4=543)
High dose(N*4=547)
CDR-SB -14%0.117
- 23%0.010
MMSE 3%0.690
-15%0.062
ADAS-Cog13 -14%0.167
- 27%0.010
ADCS-ADL-MCI
-16%0.156
- 40%0.001
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: Intent to treat, a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped *3: Difference in change from baseline vs. placebo at Week 78. Negative percentage means less decline in the treated arm. *4: Numbers of all randomized and dosed subjects that were included in the analysis. Placebo = 548 (ITT) and 313 (OTC)
Aducanumab*1
ENGAGE
9
ENGAGE consistent with EMERGE in subset of patients with sufficient exposure to 10mg/kg aducanumab
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab *1: Investigational. Co-development with Biogen
≥ 10 uninterrupted 10 mg/kg dosing intervals at steady-statePlacebo
Amyloid PET CDR-SBEMERGE EMERGEENGAGE ENGAGE
10
Phosphorylation of tau in CSF
EMERGE ENGAGE
Placebon=22
Lowdosen=28
Highdosen=15
Placebon=17
Lowdosen=21
Highdosen=18
EMERGE ENGAGE
CSF total Tau
Adju
sted
mea
n ch
ange
from
bas
elin
e (S
E)U
nit:
pg/m
l
Adju
sted
mea
n ch
ange
from
bas
elin
e (S
E)U
nit:
pg/m
l
Placebon=23
Lowdosen=29
Highdosen=14
Placebon=17
Lowdosen=21
Highdosen=16
P=0.0001P=0.0106 P=0.0075P=0.0016n.s. n.s. n.s. n.s.5
0
-5
-10
-15
-20
-25
0-20-40-60-80
-100-120-140-160-180-200-220
Aducanumab*1 (EMERGE/ENGAGE)Results of cerebrospinal fluid (CSF) biomarkers of tau
pathology and neurodegeneration in AD supported clinical outcomes
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab * 1: Investigational. Co-development with Biogen.
CSF biomarkers of tau pathology and neurodegeneration in AD are reduced in aducanumab-treated subjects
Aducanumab*1
Timeline, events and outline of available datasets
Protocol amendments to enable more patients to reach high dose aducanumab (10mg/kg)
August 2015ENGAGE initiated
August 2015ENGAGE initiated
September 2015EMERGEinitiated
September 2015EMERGEinitiated
Protocol amendment in July 2016: Patients dose suspended due to ARIA*2
to resume aducanumab treatment at the originally assigned dose
Protocol amendment in March 2017:ApoE4 carriers to titrate to 10 mg/kg
Period for patient enrollment for futility analysis ~ June 2017
Period for patient enrollment for the new analysis ~ July 2018 December 2018:
Futility analysisdata cutoff date
March 2019:Larger Dataset
analysis data cutoff date
1,748
3,285
Dataset Subject Population EMERGEn(%)
ENGAGEn(%)
Futility Opportunity to Complete (OTC)*3 803 (49%) 945 (57%)
Larger DatasetOpportunity to Complete (OTC)*4 982 (60%) 1,084 (66%)
Intent to Treat (ITT) *5, 6 1,638 (100%) 1,647 (100%)
Larger dataset
11
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: ARIA = amyloid-related imaging abnormality *3: Subjects who have had the opportunity to complete week 78 visit by December 26, 2018 *4: Subjects who have had the opportunity to complete week 78 visit by March 20, 2019 *5: All subjects’ data (data after March 20, 2019, are censored for efficacy analyses) *6: Intent to treat: a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped
Number of subject for new analysis
Futility(Subjects who have
had the opportunity to complete week 78 visit
by December 26, 2018.)
Larger DatasetAll subjects’ data (data after March 20, 2019,
are censored for efficacy analyses)
AducanumabEffect of protocol amendments
In the new analysis of larger dataset, data from 3,285 subjects were used, with more patients having greater exposure to high dose aducanumab
Differences in exposure to high dose aducanumab largely explain the different results between the futility analysis and the new analysis of this larger dataset, as well as the different results between the two studies
As a result, the proportion of high dose exposure in ENGAGE was less compared to EMERGE where high dose opportunity were increased by the protocol amendment
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. * 1: Investigational. Co-development with Biogen *2: Intent to treat, a method of analysis, which includes all patients for the analysis, such as patients who discontinued or dropped 12
13
BAN2401*1
Study 201
*1: Investigational. Co-development with Biogen. Licensed in from BioArctic. *2: Estimation based on baseline value as 1.10 threshold of composite SUVR for negative conversion *3: Alzheimer’s Disease Composite Score *4: Aβ-Tau-Neurodegeneration *5: First time as a large scale late-stage clinical study
0 12 18
*
*
Months
Amyloid PET
10 mg/kg biweekly*P<0.0001
Adju
sted
Mea
n C
hang
e Fr
om B
asel
ine
(±SE
)
*
*
(p<0.034)
ADCOMS*3
(p<0.027)
(p<0.033)
0 6 12 18
p-tau Neurogranin
NfLAd
just
edM
ean
Cha
nge
From
Bas
elin
e (±
SE)
10 mg/kg biweekly
Months
A-be
ta re
duct
ion
0
-2
-4
-6
-8
-10
-12
-14Placebo10 mg/kg monthly
Cog
nitiv
e de
clin
e
Placebo10 mg/kg monthly
+0.01
-12Combined 10mg/kg
Placebo
Med
ian
chan
ge fr
om b
asel
ine
(pg/
ml)
10mg/kg bi-weekly and 10mg/kg monthly groups were combined to increase the sample size in CSF sub group
Placebo Combined 10mg/kg
Med
ian
chan
ge fr
om b
asel
ine
(pg/
ml)
+13.5
-58
Placebo Combined 10mg/kg
+156
+75
48% median observed difference vs placebo
0.05
0.00
-0.05
-0.10
-0.15
-0.20
-0.25
-0.30
-0.35
0.00
0.05
0.10
0.15
0.20
Med
ian
chan
ge fr
om b
asel
ine
(pg/
ml)
Med
ian
chan
ge fr
om b
asel
ine
(pg/
ml)
10
0
-10
-20
-30
-40
-50
-60
16014012010080604020
0
30% slowing in cognitive decline compared with
placebo arm
Disease modifying effect was observed by both clinical functionand multiple ATN*4 biomarkers in the brain for the first time*5
Removed brain amyloid to amyloid negative level*2
BAN2401*1
Progress of Clarity AD and preparation for Phase III studies for preclinical AD
Final readout of Primary endpoint targeted in Q1 FY2022
Phase III study (Clarity AD) is ongoingPopulation: 1,566 patients with early ADThe study is ongoing in Japan, US, EU and AsiaSubmitted Clinical Trial Application (CTA) in 1H FY2019. Review is
underway and Quality Site*2 selection is ongoing to initiate the study in FY2019 in China
*1: 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 sites which have expertise in AD field, accumulated experience for clinical studies for AD, and capability to enroll right patients. *3: The ACTC, 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 *4: Target of the study is clinically normal individuals (no cognitive impairment) with intermediate levels of brain amyloid, and are at increased risk for further amyloid accumulation *5: Target of the study is clinically normal individuals (no cognitive impairment) who have elevated levels of brain amyloid and are at increased risk of cognitive decline due to AD14
AD prevention study planned in partnership with Alzheimer’s Clinical Trials Consortium (ACTC)*3
Pursuing optimal study design in consultation with ACTCInitiated consultation with regulatory authorities.
Plan to initiate Phase III studies (A3*4, A45*5) in 2020.
Establishment of Dementia FranchiseOrigin of two compounds
Aducanumab*1 is a human monoclonal antibody derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline
BAN2401*1,2 is a humanized monoclonal antibody comprised of Aβ protofibrils as an antigen, with Arctic mutation based on the research of cases on Swedish familial AD with Arctic mutation, which concluded that abnormal accumulation of Aβ protofibrils may be a cause of AD onset
15EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *1: Investigational. Co-development with Biogen. *2: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic.
16(Mean±SD)
Elenbecestat(N=1054)
Placebo(N=1076)
Mean Age 71.9 72.0CDR-SB 2.63±1.263 2.62±1.197ADAS-cog11 12.599±5.2691 12.433±4.9088
MMSE 25.761±2.5491 25.764±2.5980ADCOMS 0.343±0.1494 0.340±0.1403
Demographic and Baseline Characteristics
Safety related Eg. adverse events, details of severe adverse event cases, ARIA*3
Clinical endpoints related CDR-SB, ADAS-Cog, MMSE, ADCOMS
DSMB*2 reviewed safety data including clinical endpoints
2,130 subjects (data up to 24 months including approx. 1,700 subjects who were treated for 6 months and approx. 900 subjects were treated for 12 months) were reviewed by DSMB.Patient background between placebo arm and elenbecestat arm were equal and in-depth analysis is being conducted based on these data
*1: Investigational. Co-development with Biogen *2: Data Safety Monitoring Board *3: Amyloid-related imaging abnormalities
Elenbecestat*1
Discontinuation of Phase III program (MISSION AD)
Even though the increase in adverse events, such as weight loss, mental symptoms, and skin symptoms was observed, frequency was low. These adverse events are consistent with the results of clinical trials for BACE inhibitor in the past.
Impact on cognitive function were analyzed with clinical endpoints. When 80% of lower confidence limit exceeded the mean value of placebo in CDR-SB index, it was evaluated as decline.
All case analysis suggested decline in CDR-SB index at 24 months, but did not show decline as defined by any clinical evaluation index at any other time, and the average was the placebo endpoints. In addition, the mean values were distributed near mean value of placebo.
Comprehensive review was conducted, including the success rate based on conditional power*2. As a result, DSMB recommended discontinuation of the study due to an unfavorable risk-benefit ratio.
Administration was immediately stopped, and a follow up of the enrolled subjects is underway. Data at the point of discontinuation and after certain period of time are gathered and final analysis will be conducted. Analyzed data will be presented at clinical conference in the future.
*1: Co-development with Biogen *2: The rate whether pre-specified hypothesis (Suppress disease progression) would be proven or not in planned final analysis17
Elenbecestat*1
Discontinuation of Phase III program (MISSION AD)
Aβ Theory, Our Update
Dimer Oligomer Protofibrils Amyloid plaqueFibrilMonomer
Aβ aggregation
AβAPP
BACE
γ-secretase
AβExtracellular
Intracellular
Neurofilament LNeurogranin P-tauTotal tau
4. It is important to examine biomarkers associated with downstream of Aβ-Tau-neurodegeneration (ATN)
aggregateaggregate
dissociatedissociate
1. 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) of aducanumab*2)
2. BACE inhibitor may be associated with several substrates other than amyloid precursor protein (APP) as well as bring 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.
18
5. Of Aβ aggregates, the toxicity of protofibrils may be the most important. Therefore, BAN2401, which has high-selectivity to protofibrils, has high expectations.
Tau
Microtubule
EMERGE and ENGAGE were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. *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
Phosphorylationof tau
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.
4Rs for Potential Successful Drug Development
Right Hypothesis
Right Population
Right Dosage
Right Endpoint
19
NeurologyObtained 2 approvals; 2 projects are under review;
1 project is under preparation for submission; and 1 project is ongoing for Phase III
Fycompa (AMPA receptor antagonist)Partial onset seizures*1
Approved in Chinabased on Priority Review
Equfina*2(MAO-B inhibitor)
Parkinson’s disease approved in JapanApproved indication: improvement of wearing-off phenomenon*3 in patients with Parkinson’s disease under treatment with a drug containing levodopa
Plan to launch in November 2019
Immunodementia Project*9 AD
EphA4 Project*8 (Synapse modulator) ADE2511 (Synapse regenerant) AD
E2814*7 (Anti-tau antibody) AD
BAN2401*4,5 (Anti-Aβ protofibrils antibody)Early AD Clarity AD ongoing Under preparation for preclinical AD
E2027 (PDE9 inhibitor)Dementia with Lewy bodies Phase II/III ongoing
All projects are investigational except for Fycompa in China and Equfina in Japan *1: Approved for the treatment of partial onset seizures in epilepsy patients 12 years of age and older *2: Meiji Seika Pharma Co., Ltd. holds the manufacturing and marketing approval for Equfina, and Eisai exclusively sells it in Japan. *3: As the disease progresses, levodopa’s duration of effect decreases, and there are cases where patients may experience wearing-off phenomena, a return of Parkinson’s disease symptoms before the next dose. *4: Co-development with Biogen *5: Antibody for Alzheimer’s disease produced as the result of a strategic research alliance between Eisai and BioArctic. *6: Irregular Sleep-Wake Rhythm Disorder *7: First clinical candidate from drug discovery collaboration between Eisai and University College London (UCL), UK *8: Research at KAN Research Institute *9: Research at G2D2 (Eisai Center for Genetics Guided Dementia Discovery)
Lemborexant(Dual orexin receptor antagonist)
Lemborexant (Dual orexin receptor antagonist)ISWRD*6 associated with AD/dementia
20
Fycompa (AMPA receptor antagonist)
Aducanumab*4(Anti-Aβ antibody) Plan to submit in early 2020AD Under preparation for submission in the U.S.
Insomnia Under review in the U.S. and Japan
Monotherapy for partial onset seizuresUnder review in Japan
Plan to launch in FY2019
Approved
Under review
Phase III(Including projects under preparation)
Phase II
Phase IUnder preparation
Preclinical
Approved in Sep. 2019
Under preparation
for submission
Approved in Sep. 2019
2.0 2.33.7 5.84.3
6.9
7.114.4
28.4
2018年度4-9月 2019年度4-9月
Americas
China
Japan
EMEA
Asia/Latin America
• Over 80% of patients with uHCC were treated with Lenvima as a first-choice treatment*4
LenvimaPursuing Over 1 Billion USD Revenue in FY2019
to Reach Blockbuster StatusUpward revision of revenue forecast to 119.0B yen*1
• Lenvima expanded contribution to patients with uHCC in China, where the largest number of patients with uHCC are reported
• Treatment provided to approximately 10,000 patients since launch in November 2018*3
• Discussions on-going with the authorities to potentially add Lenvima to China’s National Reimbursement Drug List in 2019 that would expand patient access for Lenvima in uHCC
China 7.1B yen
Japan 6.9B yen (159% YoY)
• Unresectable hepatocellular carcinoma (uHCC) indication drove rapid growth in the U.S.
• Aim to expand contribution to patients by additional indication of endometrial carcinoma in combination with KEYTRUDA®*2, approved on September 17, 2019
Americas 28.4B yen (197% YoY)Revenue of Lenvima (Billions of yen)
50.5B yen207% YoY
*1: Previously disclosed forecast of Lenvima in FY2019 was 116.0B yen *2: 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. Approved 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 in the U.S. *3: Internal estimates *4: Source: Internal estimates based on MDV analyzer of Medical Data Vision Co., Ltd.
24.5B yen
21
• Contribution to patients steadily expanded in Russia, Australia, and Germany after being listed as eligible for reimbursement
EMEA 5.8B yen (156% YoY)
April-September2018
April-September2019
22
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: Combination therapy of Lenvima and KEYTRUDA®. Approved 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 in the U.S. *2: Makker V. et al. Gynecol Oncol Res Pract. 2017 19 *3: Source: American Cancer Society. These estimates include both endometrial cancers and uterine sarcomas. Up to 10% of uterine body cancers are sarcomas, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates. *4: Decision resources *5: Nagle C.M. et al. J Gynecol Oncol 2018 e39 *6: Microsatellite instability high/deficient mismatch repair pathway *7: This program aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible. *8: This is an accelerated approval reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible
Endometrial carcinoma: Unmet medical need remains Approximately 60,000 new cases are diagnosed and approx. 12,000 deaths occur*3
in the U.S. Number of patients with endometrial carcinoma 2nd line is estimated to be 14,000*4
Patients (2nd line advanced endometrial carcinoma patients whosetumor is not MSI-H or dMMR+*6) eligible for approved indication
is estimated to be approx. 10,000 annually in the U.S.
Current standard first line treatment:Combination therapy with two chemotherapy agents, includingplatinum agent
Combination with KEYTRUDA®
Endometrial Carcinoma*1
First new treatment option in approximately 50 years since FDA approved megestrol acetate in 1971*2
75%NoMSI-H/dMMR
MSI-H/dMMR ratiofor endometrial cancer*5
Aim to provide new treatment option for patients with refractory endometrial cancer
Approved under new FDA-Initiated Program “Orbis”*7, this was the first to receive simultaneous review decisions in the U.S., Australia and Canada, 3 months after being submitted on June 17, 2019*8
25%MSI-H/dMMR
23
Complete responseobserved in 8 cases
++++++ + +
+
+ + + + + + ++++ ++++ + + + + + + ++++ ++++ + + ++○ ○ ○○ ○○
Combination with KEYTRUDA®
Advanced Endometrial Carcinoma*1
Final results on the data that led to the accelerated approval were presented at ESMO*2
Histopathological type■Endometrioid adenocarcinoma ■Clear cell adenocarcinoma■Serous adenocarcinoma ■Others
PD-L1 status +: positive, ○: unknown
Confirmed complete responses in patients with refractory serous adenocarcinoma and clear cell adenocarcinoma.Deep and durable tumor shrinkage was observed
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: Approved 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 in the U.S *2: European Society for Medical Oncology *3: ESMO Congress 2019. Abstract No. 994O. The most common treatment-related TEAEs (any grade) were hypertension, diarrhea, decreased appetite, fatigue, hypothyroidism. *4: Response Evaluation Criteria In Solid Tumors *5: Microsatellite instability high/deficient mismatch repair pathway*5: Objective Response Rate *7: January 10, 2019 *8: Complete Response *9: Duration Of Response *10: Progression-Free Survival *11: Overall Survival*12: Not Evaluable
RECIST v1.1*4 Independent imaging review ORR*6 DOR*9
(median)PFS*10
(median)OS*11
(median)Time of data cutoff*7 CR*8
94 patients who are not MSI-H/dMMR*5 38.3% 10.6% NE*12 5.4 months 16.4 months
Maximum tumor shrinkage
>0% 72/84 (85.7%)
>50% 26/84 (31.0%)
>75% 13/84 (15.5%)
Interim analysis of Study 111 in 108 patients with metastatic endometrial carcinoma who had progressed following prior systemic therapy*3
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(%)
*1: Approved for monotherapy for the treatment of unresectable hepatocellular carcinoma *2: Barcelona Clinic Liver Cancer stage B. Intermediate stage of HCC*3: Objective Response Rate *4: Kudo M. et al. Lancet 2018: 1163-1173 *5: Real World Data *6: Kudo M. et al. Cancers 2019 11 1084 *7: Transcatheter Arterial ChemoEmbolization *8: The International Liver Congress 2019 “Assessing Response in Advanced Liver Cancer – Does Response Matter?” *9: Albumin - bilirubin grade *10: Radiofrequency ablation *11: Sato N. et al. Anticancer Res. 2019 5695-5701 *12: 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 in Hokkaido, Japan24
Lenvima monotherapy for Hepatocellular Carcinoma*1
Contribution to patients with BCLC-B*2 uHCC with conversion
Unresectable/ TACE refractory and HCC
Potential tumor shrinkage
with Lenvima
Selective TACE, resection, RFA*10 liver transplant
TumorPotential conversion to curative treatment
Pursuing paradigm shift in treatment aiming for radical treatment of uHCC by offering a potentially clinically meaningful treatment worldwide
Patient contribution has been expanded with Lenvima’s potential in conversion based on the evidence*11 that
showed prolonged survival time with Lenvima administration for patients with uHCC in BCLC-B
Experts in Asia, including Japan, presented APPLE expert consensus*12, which recommended that Lenvima should be the first treatment option for patients with
HCC in BCLC-B and TACErefractory
ORR*3: 40.6%REFLECT trial*4
ORR: 38-60%RWD*5 in Japan
ORR: 73.3%*6
BCLC-B, TACE*7-Naive
ORR: 80.9%*8
BCLC-B, ALBI grade 1*9, TACE-Naive
FY2017
FY2018
FY2019
FY2019
Combination with KEYTRUDA®
Unresectable Hepatocellular CarcinomaTumor response was observed including complete responses
25
Lenvima + KEYTRUDA®
combination therapyORR
(including unconfirmed responses)
ORR PFS(median)
OS(median) DCR*11
mRECIST*9 by Independent imaging review 52% 46% 9.7 months 20.4 months 85%RECIST v1.1*10 by Independent imaging review 40% 33% 9.5 months 20.4 months 85%
(Ref.) Tecentriq + Avastin combination therapy*12
RECIST v1.1 by Independent imaging reviewORR
(including unconfirmed responses)
ORR PFS(median)
OS(median) DCR
Phase I Arm A (104 subjects) ー 36% 7.3 months 17.1 months 71%
Phase I Arm F (60 subjects) ー 20% 5.6 months Unsettled 67%
Complete responseobserved in 5 cases
HBV 14HCV 20Alcohol 13
■ Part 1 dose-limiting toxicities (n=6)■ Part 2 dose-escalating (n=54)
High efficacy was demonstrated in combination therapy of Lenvima and KEYTRUDA®:OS*2: 20.4 months, PFS*3: 9.7 monthsORR*4,5: 52%*6 and 40%*7
Tumor response was observed in patient population of which 70% were BCLC*8-C
Interim analysis of Phase Ib study (Study 116) in 67 patients with unresectable hepatocellular carcinoma*1
Breakthrough Therapy designation granted by the U.S. FDA in July 2019KEYTRUDA® 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. All projects are investigational. *1: European Society for Medical Oncology (ESMO) 2019 Congress. Abstract No.747P. The most common AEs (any grade) were diarrhea, decreased appetite, hypertension, fatigue and aspartate aminotransferase increased. *2: Overall survival *3: Progression-free survival *4: Objective response rate *5: Including unconfirmed responses *6: Based on mRECIST *7: Based on RECIST v1.1. *8: Barcelona Clinic Liver Cancer *9: modified Response Evaluation Criteria In Solid Tumors *10: Response Evaluation Criteria In Solid Tumors *11: Disease control rate *12: ESMO Congress 2019 Abstract No. LBA39. Roche announced on October 21, 2019 that Phase III IMbrave150 study evaluating Tecentriq in combination with Avastin met both of its co-primary endpoints demonstrating statistically significant and clinically meaningful improvements in OS and PFS compared with standard-of-care sorafenib.
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rate
(%)
PD-L1 status + : positive,○: unknown
++++++○○○○○○++○+○○+○○
26
irRECIST*3
Investigator review
ORR*4 DOR*5 PFS*6
(median)DCR*7
33 patients with RCC 64% 9.1
months11.3
months 100%
(Reference) RECIST v1.1*8
by Independent imaging review ORR PFS(median)
1st Line nivolumab/Ipilimumab*9 42.0% 11.6months
1st Line KEYTRUDA®/axitinib*10 59.3% 15.1months
1st Line avelumab/axitinib*11 51.4% 13.8monthsDisease control and favorable clinical
endpoints were observed in all patients
Breakthrough Therapy designation granted by the U.S. FDA in December 2017
Tum
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rate
(%)
PD-L1 (+): 36%PD-L1 (-): 30%Unconfirmed: 33%
Interim analysis for Phase Ib/II (Study 111) in 33 patients with RCC who had demonstrated disease progression after prior anti-PD-1/PD-L1 antibody treatment*2
Combination with KEYTRUDA®
Renal Cell Carcinoma (RCC)*1
Antitumor activity demonstrated in patients who had prior immune checkpoint inhibitor treatment
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. *1: Metastatic Clear Cell (mcc) Renal Cell Carcinoma (RCC). *2: European Society for Medical Oncology (ESMO) 2019 Congress. Abstract No. 1187PD. The most common AEs (any grade) were fatigue, diarrhea, dysphonia, stomatitis and nausea. *3:immune-related Response Evaluation Criteria In Solid Tumors *4: Objective Response Rate *5: Duration Of Response *6: Progression-Free Survival *7: Disease Control Rate *8: Response Evaluation Criteria In Solid Tumors *9: Motzer R.J. et al. N Engl. J. Med. 2018: 1277-1290 *10: Rini B.I. et al. N Engl. J. Med. 2019 : 1116-1127 *11: Motzer R.J. et al. N Engl. J. Med. 2019: 1103-1115
Combination of Lenvima and KEYTRUDA®
• Endometrial carcinoma 2L• Endometrial carcinoma 1L (LEAP-001)• Hepatocellular carcinoma 1L (LEAP-002)• NSCLC 1L*1 (LEAP-006)• NSCLC 1L*2 (LEAP-007)• NSCLC 2L (LEAP-008)• Urothelial carcinoma 1L (LEAP-011)• Melanoma 1L (LEAP-003)
• Endometrial carcinoma, renal cell carcinoma, melanoma, head and neck cancer, urothelial cancer, non-small cell lung cancer (Phase I/II, Study 111)
• Melanoma 2L (LEAP-004)• Basket trial*3 (LEAP-005)• Hepatocellular carcinoma (Study 116)
OncologyObtained 3 Breakthrough Therapy designations; 1 SAKIGAKE designation
and eribulin derived compounds are under development
27
Breakthrough therapy designation from U.S. FDA
LenvimaMonotherapy
Thyroid cancer in China(Study 308)
Approved
Phase I(including under
preparation)
PhaseII
Phase III
H3B-6545ERα inhibitor
Breast cancer (Phase I/II)
E7389-LF*4Liposomal formulation
Combination with nivolumabSolid tumors (Phase Ib/II)
H3B-6527FGFR4 inhibitor
Hepatocellular carcinoma
E7090FGFR1,2,3 inhibitorBiliary tract cancer and
others
E7386*5
CBP/β-catenin inhibitorSolid tumors
E7766*8
STING agonistSolid tumors
H3B-8800SF3B1 modulator
Hematological malignancies
LenvimaCombination with nivolumabHepatocellular carcinoma
(Study 117)
MORAb-202ADC*7
Folate receptor α (FRA)positive solid tumors
SAKIGAKE designation from Japan’s Ministry of Health, Labour and Welfare All projects are investigational except for combination therapy of Lenvima and KEYTRUDA® for the treatment of 2nd line endometrial carcinoma. KEYTRUDA® is a registeredtrademark 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: Non-squamous cell carcinoma, combination with chemotherapy *2: PD-L1 positive *3: Triple-negative breast cancer, gastric cancer, ovarian cancer, colorectal cancer, glioblastoma, biliary tract cancer *4: Under development in collaboration with Ono Pharmaceutical Co., Ltd. *5: Under development in collaboration with PRISM BioLab *6: Compound co-created with Harvard University *7: Antibody-drug conjugate *8: Under preparation for Phase I study
LenvimaCombination with KEYTRUDA®
or everolimusRenal cell carcinoma 1L
(Study 307)
E7130*6Next-generation drug improving
tumor microenvironmentSolid tumors
Upward Revision of FY2019 Consolidated Earnings Forecast (IFRS)Achieving FY2020’s profit*1 target a year ahead
by rapid expansion of Lenvima
FY2018 FY2019Results % Forecast % YoY
Revenue 642.8 100.0 680.0 100.0 106(Ref.) Other Business Revenue 79.1 12.3 103.0 15.1 130
Cost of Sales 184.5 28.7 170.0 25.0 92R&D expenses 458.3 71.3 510.0 75.0 111Partner’s share of R&D expenses 144.8 22.5 148.0 21.8 102
SG&A expenses 228.2 35.5 256.0 37.6 112Other income & expenses 0.9 0.1 4.0 0.6 462
Operating profit 86.2 13.4 110.0 16.2 128Profit for the period 66.5 10.3 82.0 12.1 123Profit for the period(Attributable to owners of the parent) 63.4 9.9 81.6 12.0 129
EPS (yen) 221.3 284.8ROE (%) 10.4 13.2DOE (%) 7.0 7.4Dividend (yen) 150 160
28
Previous disclosure
680.0103.0180.0500.0
154.5
245.02.5
103.072.5
72.0
251.311.27.1
160
(Billions of yen, %)
FY2018 average exchange rates: 1 USD: 110.90 yen, 1 EUR: 128.40 yen, 1 GBP: 145.67 yen, 1 RMB: 16.53 yen1H FY2019 average exchange rates: 1 USD: 108.62 yen, 1 EUR: 121.41 yen, 1 GBP: 136.73 yen, 1 RMB: 15.68 yen2H FY2019 expected average exchange rates: 1 USD: 105 yen, 1 EUR: 117 yen, 1 GBP: 130 yen, 1 RMB: 14.6 yen*1: FY2020 targets, which are interim targets of mid-term business plan “EWAY 2025”:102.0B yen level operating profit, 74.0B yen level profit and over 10% ROE
29
Reference Data
April-September 2018 April-September 2019
Results % Results % YoY
Japan*1 145.4 46.9 125.8 42.0 87
Americas*2 42.8 13.8 57.9 19.3 135
China 31.8 10.3 44.7 14.9 140
EMEA*3 25.4 8.2 26.1 8.7 103
Asia and Latin America*4 24.7 8.0 24.0 8.0 98
OTC and others (Japan) 12.3 4.0 13.1 4.4 107Pharmaceutical business
total 282.4 91.1 291.6 97.5 103
Other business*5 27.7 8.9 7.6 2.5 27
Consolidated revenue 310.1 100.0 299.3 100.0 96
Revenue by Reporting Segment
(Billions of yen, %)
30
Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments.*1: Revenue from generics were included in 1H FY2018 *2: North America *3: Europe, Middle East, Africa, Russia and Oceania *4: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *5: Income mainly from license and the pharmaceutical ingredient business of the parent company, including recognition of payments from Merck & Co., Inc., Kenilworth, N.J., U.S.A. under the strategic collaboration for anticancer agent Lenvima, which were 22.2B yen in 1H FY2018, none in 1H FY2019.
Profit by Reporting Segment
April-September 2018 April-September 2019
Results % YoY Results % % of revenue YoY
Japan*1 57.3 43.5 39.4 50.3 38.9 40.0 88Americas*2 16.9 12.9 39.5 30.6 23.7 52.9 181
China 11.5 8.8 36.2 21.5 16.7 48.2 187EMEA*3 11.2 8.5 44.0 11.7 9.1 45.0 105
Asia and Latin America*4 8.5 6.5 34.4 9.0 7.0 37.4 106OTC and others (Japan) 2.7 2.1 22.3 3.4 2.7 26.1 125
Pharmaceutical business total 108.1 82.2 38.3 126.6 98.0 43.4 117Other business*5 23.4 17.8 84.5 2.6 2.0 33.7 11
Reporting segment total 131.5 100.0 42.4 129.2 100.0 43.2 98R&D expenses and group
headquarters’ management costs and other expenses*6
-83.2 -97.2
Consolidated operating profit 48.4 15.6 32.0 10.7 66
31
(Billions of yen, %)
Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments.*1: Profit from generics were included in 1H FY2018 *2: North America *3: Europe, Middle East, Africa, Russia and Oceania *4: Primarily South Korea, Taiwan, Hong Kong, India, ASEAN, Central and South America *5: Income mainly from license and the pharmaceutical ingredient business of the parent company, including recognition of payments from Merck & Co., Inc., Kenilworth, N.J., U.S.A. under the strategic collaboration for anticancer agent Lenvima, which were 22.2B yen in 1H FY2018,none in 1H FY2019. *6: Includes 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. (7.9B yen in 1H FY2018, 22.8B yen in 1H FY2019), and gain on sales of shares of subsidiary company
Revenue of Major Products
April-September 2018 April-September 2019
Results % Results % YoYLenvima 24.5 100.0 50.5 100.0 207 [212]Japan 4.3 17.8 6.9 13.7 159 [159]Americas 14.4 58.9 28.4 56.1 197 [200]China 7.1 14.1EMEA 3.7 15.2 5.8 11.5 156 [167]Asia and Latin America 2.0 8.1 2.3 4.6 118 [122]
32
Halaven 20.4 100.0 20.6 100.0 101 [104]Japan 4.9 24.1 5.0 24.3 102 [102]Americas 8.1 39.6 7.5 36.4 93 [94]EMEA 6.1 30.1 7.1 34.5 116 [123]Asia and Latin America 1.3 6.2 1.0 4.7 77 [79]
Fycompa 9.2 100.0 11.8 100.0 128 [132]Japan 1.4 15.2 1.9 16.4 139 [139]Americas 4.5 48.2 6.0 50.6 134 [137]EMEA 3.0 32.0 3.4 28.5 114 [122]Asia and Latin America 0.4 4.6 0.5 4.5 125 [131]
(Billions of yen, %)
[ ] based on local currency
April-September 2018 April-September 2019Results % Results % YoY
Revenue 145.4 100.0 125.8 100.0 87Prescription medicines 133.2 91.6 125.8 100.0 94
Humira 23.9 16.4 25.3 20.1 106Lyrica*1 13.8 9.5 13.9 11.1 101Aricept 9.8 6.7 7.4 5.9 76Methycobal 7.8 5.4 7.4 5.9 95Lenvima 4.3 3.0 6.9 5.5 159Lunesta 5.5 3.8 6.3 5.0 114Pariet*2,3 6.8 4.7 5.8 4.6 85Halaven 4.9 3.4 5.0 4.0 102Treakisym 3.7 2.5 4.1 3.3 113Elental*2 3.3 2.3 3.3 2.6 101Careram 2.0 1.4 3.2 2.6 159Fycompa 1.4 1.0 1.9 1.5 139
Generics 12.2 8.4 - - -Segment profit 57.3 39.4 50.3 40.0 88
33
Performance of Japan Pharmaceutical Business
(Billions of yen, %)
Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments. *1: Alliance revenue *2: EA Pharma product *3: Includes sales of triple formulation Helicobacter pylori eradication packs, Rabecure Pack 400/800 and Rabefine Pack
April-September 2018 April-September 2019
Results % Results % YoY
Revenue 42.8 100.0 57.9 100.0 135 [137]
Lenvima 14.4 33.7 28.4 49.0 197 [200]
Banzel 8.5 19.8 11.5 19.9 136 [138]
Halaven 8.1 18.9 7.5 13.0 93 [94]
Fycompa 4.5 10.4 6.0 10.3 134 [137]
BELVIQ 1.9 4.5 2.0 3.5 104 [106]
AcipHex 2.2 5.0 2.0 3.5 93 [95]
Segment profit 16.9 39.5 30.6 52.9 181 [184]
34
[ ] based on local currency
(Billions of yen, %)
Performance of Americas Pharmaceutical Business
April-September 2018 April-September 2019
Results % Results % YoY
Revenue 31.8 100.0 44.7 100.0 140 [150]
Methycobal 10.4 32.8 12.5 27.9 120 [128]
Lenvima 7.1 15.9
Aricept 4.9 15.3 5.9 13.2 121 [129]Stronger Neo-Minophagen C and Glycyron Tablets 5.1 16.2 5.4 12.0 104 [111]
Pariet 2.9 9.1 3.5 7.8 120 [128]
Segment profit 11.5 36.2 21.5 48.2 187 [204]
35
Performance of China Pharmaceutical Business
(Billions of yen, %)
[ ] based on local currency
April-September 2018 April-September 2019
Results % Results % YoY
Revenue 25.4 100.0 26.1 100.0 103 [109]
Halaven 6.1 24.2 7.1 27.3 116 [123]
Lenvima / Kisplyx 3.7 14.6 5.8 22.3 156 [167]
Fycompa 3.0 11.6 3.4 12.9 114 [122]
Zebinix 2.8 10.9 3.1 12.0 113 [121]
Zonegran 2.0 7.9 2.0 7.7 100 [107]
Inovelon 1.1 4.5 1.2 4.6 104 [111]
Segment profit 11.2 44.0 11.7 45.0 105 [111]
36
(Billions of yen, %)
[ ] based on local currency
Performance of EMEA Pharmaceutical Business
April-September 2018 April-September 2019
Results % Results % YoY
Revenue 24.7 100.0 24.0 100.0 98 [102]
Aricept 6.1 24.6 5.5 22.8 91 [96]
Humira 6.6 26.9 5.4 22.6 82 [88]
Lenvima 2.0 8.1 2.3 9.8 118 [122]
Pariet 1.9 7.8 2.1 8.8 109 [112]
Methycobal 1.8 7.4 1.5 6.1 80 [81]
Halaven 1.3 5.2 1.0 4.1 77 [79]
Fycompa 0.4 1.7 0.5 2.2 125 [131]
Segment profit 8.5 34.4 9.0 37.4 106 [111]
37
(Billions of yen, %)
[ ] based on local currency
Performance of Asia and Latin America Pharmaceutical Business
Performance of OTC and Others in Japan
Effective from this fiscal year, aiming for more flexible strategy execution, the Group separated OTC and others from Japan pharmaceutical business, to newly establish the OTC and others business. The financial results in the corresponding period of the previous fiscal year disclosed in the following reporting segments reflect this change of the reporting segments. *1: Vitamin B preparation, “Chocola BB Plus” and others.38
April-September 2018 April-September 2019
Results % Results % YoY
Revenue 12.3 100.0 13.1 100.0 107Chocola BB Group*1 8.0 64.9 8.5 65.0 107
Segment profit 2.7 22.3 3.4 26.1 125
(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
(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)
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 positive
CDR-SB (78 weeks)EMERGE (Phase III) Early AD (1605)
Gantenerumab(Roche)
SCarlet RoAD*2,3
(Phase III)Prodromal AD
(799)
105mg, 225mg,Up to 1200mg
Placebo
MMSE≧24, Prodromal AD who are not receiving memantine or cholinesterase inhibitors
CDR-SB (104 weeks)
Marguerite RoAD*3
(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 (760) Probable AD dementia or prodromal AD (NIA-AA), Amyloid positive, MMSE≧22, CDR-GS: 0.5 or 1.0
CDR-SB (104 weeks)Graduate II (Phase III) Early AD (760)
Crenezumab(Roche, Genentech)
CREAD 1*4 (Phase III) Prodromal to mild AD (813) Crenezumab
Placebo
MCI due to AD, Probable AD dementia (NIA-AA), MMSE≧22,
CDR-GS 0.5 or 1.0, A-beta positive
CDR-SB(105 weeks)
CREAD 2*4 (Phase III) Prodromal to mild AD (806)
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 (130, 260weeks)
Solanezumab(Eli Lilly)
A4(Phase III)
Preclinical AD*5
(1150)Solanezumab
PlaceboMMSE≧25, CDR: 0, Logical Memory II score 6-18,
Amyloid positivePACC
(240 weeks, 366 weeks)
Gantenerumab,Solanezumab
(Washington University School of Medicine)
DIAN-TU(Phase II/III)
Preclinical AD*6
(490)
Gatenerumab Solanezumab
Placebo
Have an Alzheimer's disease-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)
39
Study designs for Phase II and beyond in this chart was created by Eisai based on the information on ClinicalTrials.gov as of October 3, 2019. Studies shown here include those discontinued in the past 2 years. All projects are investigational. *1: Eisai licensed in from BioArctic *2: Roche announced discontinuation of SCarlet RoAD study on December 19, 2014 on their press release *3: FPI in OLE study was announced at Roche Nine Months 2016 Sales Conference Call on October 20, 2016 *4: Roche announced discontinuation of CREAD 1 and CREAD 2 study on January 30, 2019 on their press release *5: Target population for this trial is older individuals who may be at risk for memory loss *6: 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
All projects are investigational except for the Lenvima + KEYTRUDA® combo for EC. 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. * 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
Of the planned 13 studies for the combination therapy with KEYTRUDA®, 11 studies have been initiated, and the remaining 2 studies are planned to be initiated within FY2019
40
Endometrial carcinoma 2L*Approved in September 2019
Phase I/II Study 111
The first combination therapy with KEYTRUDA®
to receive simultaneous review decisions in the U.S., Australia and Canada
Progress of Development for Combination Therapy with KEYTRUDA®
Renal cell carcinoma 1LPhase III initiated in October 2016
Study 307
Endometrial carcinoma 1LPhase III initiated in April 2019
LEAP-001
Endometrial carcinoma 2LPhase III initiated in June 2018
Study 309
Basket trial in multiple cancer types:Triple-negative breast cancer
Gastric cancerOvarian cancer
Colorectal cancerGlioblastoma
Biliary tract cancersPhase II initiated in February
2019LEAP-005
NSCLC1LNon-squamous cell carcinoma
Combination with chemotherapyPhase III initiated in March 2019
LEAP-006
NSCLC 1LPD-L1 positive
Phase III initiated in March 2019LEAP-007
NSCLC 2LPhase III initiated in June 2019
LEAP-008
Head and neck cancer 1L
Head and neck cancer 2L
Urothelial carcinoma 1LPhase III initiated in May 2019
LEAP-011
Melanoma 1LPhase III initiated in March 2019
LEAP-003
Melanoma 2LPhase II initiated in January 2019
LEAP-004
Hepatocellular carcinoma 1LPhase III initiated in December
2018LEAP-002★
★ Breakthrough Therapy designation by the U.S. FDA
★
★
Receipt of Payments fromMerck & Co., Inc., Kenilworth, N.J., U.S.A.
FY2018 1H results
41
No receipt of milestone payments
Milestone payment associated with the
reimbursement approval in EU
25 million USD(2.8 billion yen)
Milestone payment associated with the approvals of
hepatocellular carcinoma indication in the U.S. 125 million USD(13.9 billion yen)
Milestone payment associated with the approvals of
hepatocellular carcinoma indication in EU
50 million USD(5.5 billion yen)
Milestone payment associated with the approvals of hepatocellular carcinoma indication in China
25 million USD(2.8 billion yen)
FY2018 2H results
One-time option payment associated with certain
option rights325 million USD(35.0 billion yen)
Sales-based milestone payment anticipated when annual
revenue of 500 million USD is achieved
50 million USD(5.5 billion yen)
Total 600 million USD (65.5 billion yen) in FY2018
* Calculation based on 1USD=105 yen
FY2019 1H results FY2019 2H forecast200 million USD (21.0
billion yen*) +recognition of milestone
payments and others
One-time option payment associated with certain
option rights200 million USD(21.0 billion yen*)
Recognition of multiple sales-based milestone
payments and regulatory milestone
payment are expected