Post on 28-May-2018
transcript
FY2016
(Fiscal Year Ended March 31, 2017)
Financial Results Presentation
May 10, 2017
Eisai Co., Ltd.
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
FY2016
Plan ‘EWAY 2025’ inaugurated
Business portfolios clarified
2
Fields where innovation to be focused
Neurology Business Group Dementia field
Oncology Business Group Cancer microenvironment field
Cancer informatics field*
EA Pharma Inflammatory bowel disease field
Field specialization objectives
1. Productivity of pipeline and business is improved through
Early Decisions made by an organization where Discovery,
Clinical and Commercial functions are integrated.
2. Scientific Acumen, an important organizational culture,
is developed through an integrated business structure
including Discovery.
* A field of drug development aiming at precision medicine with potential for shorter development timeline and smaller-scaled clinical studies utilizing strength in human
biology informatics, an library for small molecules including natural products, and research to find biomarkers for aberrant splicing in relevant to cancer with competitive
advantage and gene mutation
(billions of yen, %)
3
FY2016 Consolidated Statement of Income (IFRS)
Achieved increase in profit and secured financial integrity
FY2016 average exchange rates:
USD 1: 108.38 yen (-9.8% YoY), EUR 1: 118.78 yen (-10.4% YoY), GBP 1: 141.59 yen (-21.9% YoY), RMB 1: 16.10 yen (-14.6% YoY)
*1: The result excluding the effects of foreign exchange fluctuations (Calculated converting FY2016 cumulative result into yen by YoY average exchange rates)
*2: Net Debt Equity Ratio= (Interest-bearing debt (corporate bonds and loans)- Cash and cash equivalents - Time deposits exceeding 3 months)/
Equity attributable to owners of the parent
FY2015 FY2016
Results % Results % YoYYoY
Based on local currency*1
Revenue 547.9 100.0 539.1 100.0 98 104
Cost of sales 194.5 35.5 195.9 36.3 101 104
Gross profit 353.5 64.5 343.2 63.7 97 104
R&D expenses 122.3 22.3 112.5 20.9 92 99
SG&A expenses 192.8 35.2 179.7 33.3 93 100
Other income & expenses 13.6 2.5 8.0 1.5 59 60
Operating profit 51.9 9.5 59.1 11.0 114 116
Profit for the year 55.0 10.0 42.2 7.8 77 79
Profit for the year(Attributable to owners of the parent)
54.9 10.0 39.4 7.3 72 74
ROE (%) 9.4 6.8
End of March 2016 End of March 2017
Net DER*2 0.01 (0.05)
Free cash flow 81.1 82.0
4
Growth in Main Business
1. Revival of Japan Business
2. Growth in All Regions
3. Momentum of Global 4 Brands
Revival of Japan Business
Provide evidence-based solutions for issues that patients and local communities are facing, based on clinical
questions we found out at 91 towns/cities*5
where Eisai has partnership agreements for collaboration in dementia
Continuously launch tools to provide solutions
Interprofessional collaboration service Hikari One Team SP (Service commenced in July 2016, launched by NTT IT),
administration support device “e-OKUSURI-SAN” (January 2017), olfactory test “UPSIT” (April 2017) and tracking tool to
support elderly people going out “Me-MAMORIO” (under development)
*1: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use: Halaven, Lenvima, Fycompa, Humira,
Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue) *2: Revenue of 13 branded drugs/revenue of prescription medicines excluding EA Pharma products
*3: Co-development with Mochida Pharmaceutical Co., Ltd *4: Co-development with Kissei Pharmaceutical Co., Ltd. *5: As of April 26, 2017
58%
51%
Outperformed the Japan market growth in Q4 FY2016
Ratio of branded drugs*1 to revenue*2 achieved over 50%
Growth of Halaven, LENVIMA, Fycompa, Humira and Lunesta contributed
hhc solutions business: Support to establish a social systemwhich enables dementia patients to live safely and with peace of mind in their community
Japan business
revenue forecast
*6
5
EA Pharma: Steady progress of development pipeline mainly in inflammatory bowel disease field AJG533 (elobixibat)*3 Chronic constipation treatment: Submitted in February 2017
AJG511 (budesonide)*4 Ulcerative colitis treatment: Submitted in October 2016
Pariet Maintenance therapy for proton pump inhibitor resistant reflux esophagitis: Submitted in October 2016
AJM300 (carotegrast methyl)*4 Ulcerative colitis treatment: Phase III study ongoing E6007 Ulcerative colitis treatment: Phase II study ongoing
E6011 Anti-fractalkine antibody: Phase II study ongoing for primary biliary cholangitis
Phase I/II study ongoing for Crohn’s disease E6130 Inflammatory bowel disease treatment: Phase I study ongoing
43%
51%
58%
2015年度
実績
2016年度
実績
2017年度
見通し
売上収益
新薬創出等加算品目等
対売上収益比率
FY2015
Results
FY2016
Results
Revenue
Eisai Japan
Ratio of branded
drugs to revenue*2
284.9Byen
293.0BYen
(101%
YoY)
291.1Byen
Halaven: Achieved re-education of physicians about Halaven’s efficacy in patients with HER2-negative hormone-positive recurrent metastatic breast cancer
LENVIMA: Contributed to over 2,000 thyroid cancer patients in total since its launch in May 2015
Fycompa: Contributed to over 4,000 epilepsy patients in total since its launch in May 2016
Aim for further growth by leveraging administration restriction lift anticipated in June 2017
Humira: Achieved success in joint promotion with approx. 440 sales reps of EA Pharma for inflammatorybowel disease field, such as ulcerative colitis and Crohn’s disease
Approved for double-dose treatment in patients with moderate or severe Crohn’s disease in June 2016
Lunesta: Established position as a proper insomnia treatment for elderly people with its lower risk of falls and bone fractures
Eisai Japan
(102%
YoY)
FY2017
Forecast
Aiming to outperform the market in FY2017
All projects are investigational
6
*1: The impact of foreign exchange fluctuations are excluded for the figures in the brackets (calculated FY2016 YTD performance based on the average exchange rate of FY2015)*2: The influence of risks relating to the patent infringement litigation for antiemetic agent Aloxi in the United States announced on May 3, 2017 has not been included. *3: Methycobal, Aricept, Stronger Neo-Minophagen C/Glycyron and Pariet *4: Europe, Middle East, Africa, Russia and Oceania *5: Gemeinsame Bundesausschuss
(German Federal Joint Committee) *6: National Institute for Health and Care Excellence *7: Aricept, Pariet and Methycobal
Growth in All Regions
Aim to achieve double-digit growth in 4 overseas regions
◆Growth of LENVIMA (190% YoY), Halaven (101% YoY) and
Fycompa (152% YoY)
◆Fycompa: FDA confirmed receipt of submission of
monotherapy for partial-onset seizures (investigational)in December 2016
◆BELVIQ: Launched once daily formulation in October 2016
Americas
<FY2016 achievement*1>
<FY2017 forecast>
◆Growth of global brands
LENVIMA 156% YoY, Halaven 111% YoY
Fycompa 181% YoY , BELVIQ 135% YoY
China
AsiaEMEA*4
Revenue: 132.0B yen (113% YoY)*2
Revenue: 38.0B yen (109% YoY)Revenue: 44.5B yen (118% YoY)
◆Achieved double-digit growth in Methycobal, Aricept and Pariet
Methycobal (112% YoY), Aricept (130% YoY), Pariet (141% YoY)
◆Penetration in Low Tier Market: Coverage expanded to approx. 150
cities
◆Achieved 9 product launches of high-quality generics by
Eisai (Liaoning) Pharmaceutical Co., Ltd.
Revenue: 54.0B yen (110% YoY)<FY2017 forecast>
◆Continuous growth of 4 major products*3 centered around Methycobal
◆Accelerated growth in Low Tier Market
◆Approval anticipated for additional indication of severe AD for Aricept
◆Accelerated contribution to patients with Parkinson‘s disease with
Comtan and Stalevo
◆Growth of Halaven (116% YoY) and Fycompa (424% YoY) in
addition to 3 major products*7
◆Expansion of LENVIMA launch (Thailand, Taiwan and Singapore)
◆Steady growth in South Korea (114% YoY) and Taiwan
(115% YoY) where Universal Healthcare Coverages (UHC) are
established
◆Halaven was provided to 1,020 patients (162% YoY) through
the patient assistance program (PAP) in India and other countries
where UHC has yet to be established
<FY2017 forecast>◆Growth of global brands (LENVIMA, Halaven and Fycompa)
◆Growth in Indochina (Vietnam, Myanmar, Cambodia and Laos)
◆ Growth of LENVIMA (336% YoY) and Fycompa (133% YoY)
◆ LENVIMA: G-BA*5 confirmed the additional benefit of Kisplyx inthe treatment of advanced renal cell carcinoma (RCC)
◆ Halaven: NICE*6, UK recommendation for treatment of advancedbreast cancer (3rd line)The first breast cancer treatment to be recommended by NICE since 2007
<FY2017 forecast>
◆Growth of global brands
LENVIMA 181% YoY, Halaven 123% YoY, Fycompa 153% YoY
Revenue: 49.3B yen (117% YoY)Revenue: 117.2B yen (106% YoY)
Revenue: 34.7B yen (113% YoY)Revenue: 37.8B yen (104% YoY)
< FY2016 achievement*1>
<FY2016 achievement*1><FY2016 achievement
*1>
7
Growth of Global 4 Brands
0
20
40
60
80
100
120
FY2015 Results FY2016 Results FY2017 Forecast
40.2 37.3 43.0
11.5 21.5
33.0 7.6
10.3
20.5
4.4
3.7
5.0 BELVIQ
Fycompa
LENVIMA
Halaven
(billions of yen)
72.8B yen
114% YoY(Local currency base*: 126% YoY)
101.5B yen
139% YoY(Local currency base*: 135% YoY)
Percentage of global 4
brands in total revenue11.6% 13.5% 17.6%
63.6B yen
140% YoY(Local currency base*: 135% YoY)
* The impact of foreign exchange fluctuations are excluded
8
*1 : Indications vary in each country or territory. Unresectable or recurrent breast cancer in Japan, 3rd-line+ therapy for locally advanced or metastatic breast cancer in the US, and 2nd-line+ therapy for locally advanced or metastatic breast cancer in EU.*2: Approved indication in U.S. and EU: advanced liposarcoma. Approved indication in Japan: soft tissue sarcoma
*3: The impact of foreign exchange fluctuations are excluded. *4: Renal cell carcinoma. *5: The RCC indication in the US and EU: in combination with everolimus in advanced RCC following one prior anti-angiogenic (VEGF) therapy *6: Investigational
Establish strong position and increase awareness in breast cancer chemotherapy market through Halaven’s MOA
National Comprehensive Cancer Network (NCCN) recommended Halaven in Category 1 in December 2016
Approx. 780 patients with soft tissue sarcoma treated with Halaven in Japan since its launch
Halaven revenue
FY2016 results FY2017 forecast
Asia
Japan
EMEA
Americas
37.3B yen93% YoY
(Local currency base*3:
102% YoY)
43.0B yen115% YoY
(Local currency base*3:
112% YoY)
Soft tissue
sarcoma
Breast cancer
The only chemotherapy confirmed to prolong overall survival (OS) as monotherapy in multiple
large-scaled clinical studies in metastatic breast cancer*1
and advanced soft tissue sarcoma*2
Momentum of Global Brands
Aiming at expansion of contribution to patients with thyroid cancer and RCC*4
and early development of combination therapies
LENVIMA revenue
2nd line combination therapy with everolimus*5
Approved in US in May 2016 and in EU in August 2016National Comprehensive Cancer Network (NCCN) recommended LENVIMA in Category 1 in the guideline in September 2016
1st line*4,6
: Initiated Phase III study of combination therapies; “lenvatinib+pembrolizumab” and “lenvatinib+everolimus” in September 2016Aim to obtain topline results in FY2019
FY2016 results FY2017 forecast
AsiaJapanEMEAAmericas
Aim for further growth as realized 1st line therapycapable of fast, superior clinical effects over long term
RCC*4
Thyroid cancer
Phase Ib/II studies ongoing for patients with RCC, endometrial cancer, melanoma, head and neck squamous-cell carcinoma (HNSCC), urothelial cancer, and non–small cell lung cancer
Patient enrollment following additional endometrial cancer cohort currently on target
Aim for potential launch after FY2020
Combination
therapies with
pembrolizumab*6
21.5B yen187% YoY
(Local currency base*3:
205% YoY)
33.0B yen154% YoY
(Local currency base*3:
148% YoY)
Steady progress in development of monotherapy*1
for partial-onset seizuresUS: PDUFA action date: July 26, 2017
Europe: Received positive opinion from CHMP*2 in February 2017 in regards to
include additional data on monotherapy in SmPC*3
Japan: Initiated Phase III study in April 2017
(Historical control open study*5 with 80 patients planned)
Initiatives aimed at indication expansion
Pediatric indication*1: Phase III study ongoing and Lennox-Gastaut syndrome
*1: Phase III study ongoing
Fycompa administration restriction lift in JapanLeverage upcoming June 2017 administration restriction lift and utilize accumulated real-world
evidence with the aim of rapidly expanding Eisai’s contribution to patients
FY2016 results FY2017 forecast
FY2016 results FY2017 forecast
Asia
Japan
EMEA
Americas
9
Momentum of Global Brands
Leverage acquisition of worldwide commercialization and supply rights to achieve a return to growth for BELVIQ
Agreement reached with Arena in December 2016 to revise commercialization
and supply agreement
Acquired all global development and commercialization rights
Increase revenue outside the Americas through partners*6
Expand utilization of once-daily formulation for further growth in US
Fycompa revenue
BELVIQ revenue
Leverage planned milestone events to maximize growth
*1: Investigational *2: Committee for Medicinal Products for Human Use *3: Submission of the Type-II variation for conversion to monotherapy described in Section 5.1 of
SmPC *4: Excluding impact of foreign exchange fluctuations *5: Single-arm, open trial to evaluate efficacy comparing to the past efficacy data as a reference
*6: South Korea
10.3B yen137% YoY
(Local currency base*4:
152% YoY)
20.5B yen199% YoY
(Local currency base*4:
193% YoY)
3.7B yen84% YoY
(Local currency base*4:
93% YoY)
5.0B yen135% YoY
(Local currency base*4:
129% YoY)
11
Anti-tau antibodyAD/dementia
New mechanism of
action
Lemborexant*1
ISWRD*2 associated with
AD/dementia
Orexin receptor
antagonist
E2027Behavioral/cognitive
disorder due to Lewy body disease/dementia
PDE9 inhibitor
Aducanumab*3
Early ADAnti-amyloid-beta
antibody
Elenbecestat*4,5
Early AD BACE inhibitor
E6011AD/dementia
Anti-fractalkine
antibody
EphA4Synapse
modulator
E2082Epilepsy
Next generationAMPA receptor
antagonist
E2730Epilepsy
New mechanism of action
All projects are investigational *1: Co-development with Purdue Pharma *2: Irregular sleep-wake rhythm disorder *3: Under development by Biogen. Eisai has an option to
jointly develop and commercialize *4: Co-development with Biogen. *5: Generic name for E2609. The generic name is pending final approval at this time.
New Paradigm for Medicine Creation
in Dementia Field
Three pillars
A-beta Tau Reactive glial cell
Intracerebral clearance enhancer
by reinforcing protective
mechanism
Brain homeostasis improving agent
targeting astrocyte
Neural stem cell activation
agent
Sleepdisorder
Behavioraldisorder
Cognitivedisorder
Ideation Stage
Transformation of
symptoms over time
Progress of aggressive
factors accumulation
Brain maintenance
system
Genetic background Protective
mechanismEnvironmental factor
BAN2401*4
Early AD Anti-amyloid-beta
protofibrils antibody
12
*1: Generic name for E2609. The generic name is pending final approval at this time. *2: Investigational. Co-development with Biogen
*3: Names for Phase III studies (AD1 refers to Study 301 and AD2 to Study 302) *4: Clinical Trial Authorization *5: Sources: (1) Jonsson, T. et al. (2012) “A mutation in APP
protects against Alzheimer’s disease and age-related cognitive decline. Nature 488; 96-99 (2) Maloney, J.A. et al. (2014) “Molecular mechanisms of Alzheimer disease
protection by the A673T allele of amyloid precursor protein.” J Biol Chem 289; 30990-31000
Medicine creation targeting the accumulation of aggressive factors
Accelerated Development of Elenbecestat*1,*2
Phase III studies (MISSION AD1 and MISSION AD2)*3 ongoing
US: Initiated in October (AD1) and December (AD2) 2016
Japan: Initiated in March 2017
EU: Plan to initiate in Q1 FY2017
China: CTA*4 filed in April 2017
Topline results of MISSION AD1 and MISSION AD2
anticipated in FY2020
Elenbecestat(BACE inhibitor)
Target A-beta positive early AD patients (MMSE≧24)
Select CDR-SB as a sensitive tool for early AD patients
Selected optimal single dose of 50 mg based on the evidence
of human biology*5 and PK/PD data of Phase I and II studies
Clinical study design with keys to seek higher probability of success
Right patient target
Optimal endpoint
Optimal dose setting
Plan to implement clinical studies at over 60 sites in Japan
Clinical studies with Eisai’s advisory board members’ support
Contribution of medical experience in dementia field
in Japan
13
Medicine creation targeting the accumulation of aggressive factors
Accelerated Development of Anti-A-beta Antibodies
*1: Investigational. *2: Co-developed with Biogen *3: Interim analyses anticipated at 3, 6, and 9 months after 800th patient randomized, respectively. Interim analysis criteria
for early success based on Bayesian adaptive design; the probability of at least one dose having ≥25% difference in ADCOMS from placebo is >= 95% after 12 months
treatment *4: Independent Monitoring Committee *5: Alzheimer’s Disease Composite Score (ADCOMS) Bayesian Analysis *6: Secondary endpoints (3 items), namely,
ADCOMS at month 18; total hippocampal volume utilizing vMRI at months 6, 12, and 18; and amyloid level in brain utilizing amyloid PET imaging at months 12 and 18
*7: Under development by Biogen. Eisai has option to jointly develop and commercialize
Phase III studies (ENGAGE, EMERGE) ongoingAducanumab*1,*7
(Anti-A-beta antibody)
April 2017: Conducted interim analysis*3 six months after 800 patients randomized
IMC*4 recommended continuation of the study
Q3 FY2017(12 months after 856 patients randomized): Topline results for primary endpoint*5 anticipated
FY2018(18 months after 856 patients randomized): Results of full data analysis (secondary endpoints*6)
anticipated
Large-scaled Phase II study with 856 patients underwayBAN2401*1,*2
(Anti-A-beta protofibrils antibody)
Target A-beta positive early AD patients (MMSE≧22)
Select in-house developed evaluation index, ADCOMS as an endpoint
to seek higher sensitivity to early AD patients
Adoption of Bayesian adaptive design, which potentially enables Eisai
to find out the optimal dose and administration from 6 different dose/
administration arms, including a placebo arm
Right patient target
Optimal endpoint
Optimal dose setting
Clinical study design with keys to seek higher probability of success
With the assistance of regulatory agencies, explore how to leverage ongoing Phase II study
in future pivotal program provided the Phase II study achieves positive outcome
14
Medicine creation targeting transformation of symptoms over time
Accelerated Development of Lemborexant*1
ISWRD*3 associated with AD/dementia
Insomnia Aim for best-in-class insomnia agent suitable for elderly patients
Obtained favorable data for lemborexant versus zopiclone*2 and placebo
Lemborexant*1
Orexin receptor
antagonist
Phase II study targeting AD patients ongoing Topline results anticipated in FY2017
Study 106 (Driving study)The study to evaluate drug effect on the ability on driving.
Endpoint is measured with the standard deviation of lateral position (SDLP)
Sleep disorder Behavioral disorder Cognitive disorder
Two Phase III studies ongoing・Study 304: Controlled study with active comparator (zolpidem)
Topline results anticipated in FY2017・Study 303: 6-month, long-term placebo-controlled study
Aim for first-in-class treatment agent for ISWRD in patients with AD/dementia
*1: Investigational. Co-development with Purdue Pharma *2: Control drug *3: Irregular sleep–wake rhythm disorder
15
Potential to Delay the Onset of Dementia through Suppressing
Behavioral Disorder Symptoms
Novel findings and Eisai’s approach
toward clinical relevance between epilepsy and dementia
*1: Lancet Neurology (2017)16, 311-322, Keith A. Vossel, et al *2: Neuroscience 286 (2015) 251-263, H.A. BORN *3: Investigational
Neuronal hyperexcitability potentially occurs in early AD patients, similar to epilepsy
and potentially accelerates decline of cognitive function when epileptic seizure
occurred in AD patients*1
A-beta (an aggressive factor for the onset of AD) or APP (precursor of A-beta)
induces electrical imbalances in the brain, which potentially induces epilepsy and
seizures*2
Hypothesis
APP and A-beta ⇒ Neuronal hyperexcitability ⇒ epileptic seizure and the onset of AD
Initiated Phase I study
in February 2017
Epilepsy and other
neurological disordersE2730*3
New mechanism
of action
E2082*3
Next generation AMPA
receptor antagonistIND submission
planned in FY2017
Epilepsy and other
neurological disorders
Sleep disorder Behavioral disorder Cognitive disorder
Currently published research papers suggested epilepsy and the physiology associated with epilepsy is clinically relevant to AD
16
Progress in oncology field
1.
Hepatocellular carcinoma
(HCC)* potential
2. Steady progress of
pipeline
* Investigational and not approved
17
Annual number of new patients diagnosed
with liver cancer worldwide:
780,000*2
Highest in Asia, including China and Japan,
representing approx. 80%*2
HCC represents the highest incidence in all liver
cancer, accounting for approx. 85% to 90% in
primary liver cancer*2
Median OS of patients with progressive HCC:
Less than 12 months
Unmet Medical Needs Remain in Treatment for HCC*1
Lung cancerLiver cancerStomach cancerColorectal cancerBreast cancerEsophageal cancerPancreas cancerOther
Mortality*2
*1: Hepatocellular carcinoma. Investigational and not approved.
*2: Source: GLOBOCAN2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. http://globocan.iarc.fr/
*3: Internal estimates based on Decision resources and other data
*4: Japan, US and EU 5 (UK, France, Germany, Italy and Spain) *5: Brazil, China(city areas), India (city areas), Mexico, Russia, South Korea and Turkey
19.4%
9.1%
8.8%
8.5%6.4%4.9%
4.0%
39.0%
Liver cancer ranking among other cancer-
related deaths:
2nd highest overall
80,000
90,000
100,000
110,000
2015 2020 2025 2030
Developed countries
Number of diagnosed patients are
increasing worldwide
Etiology: hepatitis B virus, hepatitis C
virus and cirrhosis due to alcohol abuse
Current research shows increasing
trend of non-B non-C
hepatocellular carcinoma*2
(number of
patients)
Transition of number of patients diagnosed
for hepatocellular carcinoma*3
270,000
300,000
330,000
2015 2020 2025 2030
Emerging countries(number of
patients)*4 *5
Approx.
90,000
Approx.
110,000
Approx.
290,000
Approx.
320,000
HCC 1st line monotherapy
18
Achieved primary endpoint in Phase III study
*1: Hepatocellular carcinoma. Investigational and not approved.
*2: The American Society of Clinical Oncology. The 2017 ASCO Annual Meeting will be held on June 2 to June 6 at Chicago, US.
Oral presentation is scheduled on June 4.
“Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts)with unresectable hepatocellular carcinoma (uHCC)”
Aim to establish as the standard treatment for HCC*1
Five most common adverse events observed in the lenvatinib arm: hypertension, diarrhea, decreased appetite,
weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib
Met the statistical criteria for non-inferiority of OS
compared to sorafenib, and showed statistically significant and clinically
meaningful improvement for PFS, TTP and ORR
The HCC results will be shared via an oral presentation at ASCO*2
Submission plan Japan in June 2017 US and Europe in July 2017 China in 2H FY2017
19
H3B-6545First-in-class, estrogen
receptor 1 (ESR1) covalent
antagonist
H3B-8800Splicing modulator with
chemical structure combined
with natural derived products
Phase I study ongoing
H3B-6527
FGFR4 inhibitor
Phase I study ongoing
Medicine Creation at H3 Biomedicine
Accelerate development in cancer informatics area
Aberrant splicing
Driver gene mutation
Driver gene mutation
Drug resistance mutation
All projects are investigational *1: Internal estimates *2: J Clin Oncol. 1984 Oct;2(10):1102-9. *3: Curr Oncol Rep. 2017 May;19(5):35
*4: Presented at American Association for Cancer Research (AACR) Abstract number: DDT01-04
Frequency of spliceosome gene
mutation is approx. 50% to 60%*1
in chronic myelomonocytic
leukemia (CMML), : Aim for new
treatment option for patients with
hematological malignancies
Overexpression of driver gene
FGF19 (FGFR4 ligand) in approx.
35%*1
of hepatocellular carcinoma
(HCC) patients: Aim for new
treatment option for patients with
HCC with activated FGFR4
pathway
Approx. 70% of breast cancer is
estrogen receptor (ER) positive*2
ER mutation is found in 25 to 40%
of endocrine resistant metastatic
breast cancer*3
Shows activity in not only
wild-type ESR1, but also mutant
ESR1, which is potentially associated
with endocrine therapy resistance*4
Potential to contribute to patients
with ER positive breast cancer
Aim to launch by FY2020 Aim to launch by FY2020Plan to initiate Phase I
study in FY2017Aim to launch shortly after FY2020
Novel ADC with potential against overexpressed folate receptor alpha cancer types.
Three keys in MOA, with unique payload derived from natural products; internalized in the cell, can
cleave the linker enzymatically in the cell, and does not form
aggregates
20
Eisai’s First Antibody-Drug Conjugate (ADC) Project
Collaboration of Eisai’s strength in chemistry
and Morphotek’s antibody technology
MORAb-202*1ADC: Combination of in-house developed antibody, farletuzumab, which is currently in clinical development stage and eribulin, a compound developed
with advanced organic synthesis technology
Bind 4 eribulin
Plan to initiate Phase I study in FY2017
(target cancer types, including metastatic triple-negative breast cancer
in expansion cohort in consideration)
*1: Investigational *2: The agent to bind antibody through linker
LinkerAntibody Payload*2
eribulinfarletuzumab
• Unique mode of action of natural derived products targeting cancer micro environment
• Does not form aggregates due to its high water solubility
cleaved byenzyme in the cell
Farletuzumab is
internalized
in the cellMORAb-202
Linker
Non-clinical data showed
potentially favorable data in
efficacy and safety with
approx. 1/5 the extrapolated
clinical dosage
21*1: Neglected tropical diseases *2: diethylcarbamazine
*3: Cambodia, Cook Islands, Niue, Vanuatu, Marshall Islands, Sri Lanka, Maldives and Togo. Eisai manufactured DEC tablets were provided in Sri Lanka only
January 2012
Continuously providing DEC*2 tablets to eliminate lymphatic filariasis (LF)
1 billion tablets have been shipped to 27 LF endemic countries
LF has been eliminated in 8 countries*3 so far
Initiatives to Improve Access to Medicines
Eisai’s continued commitment to eliminating NTDs*1
Eisai is the only Japanese company that joined the “London Declaration,” the largest
public-private partnership in the healthcare field, with the aim of eliminating 10 NTDs
Agreement to provide 2.2 billion high quality DEC tablets (medicine for LF) manufactured at
Eisai’s Vizag plant in India by 2020 at “Price Zero” (free of charge) to overcome supply
shortages worldwide
Eisai to provide high quality DEC tablets
continuously and in a stable manner
beyond 2020, until the goal to eliminate the
disease in endemic countries is achieved
Announced continued support
at the event marking “London
declaration’s fifth anniversary”
Long-term investment aiming at emerging middle-income class
as the results of elimination of NTDs and expansion of working population
April 2017
Integration of ESG*1
and Financial Integrity
*1: Environment, Social and Governance *2: CDP requests information on the risks and opportunities of climate from the world’s largest companies on behalf of 827 institutional investor
signatories with a combined US$100 trillion in assets (as of 2016). *3: Dow Jones Sustainability Asia Pacific Index. Selected 4 consecutive years *4: FTSE4Good Index Series. Selected 15
consecutive years. *5: Net DER: Net Debt Equity Ratio=(interest-bearing debts[Bonds and borrowings]-Cash and cash equivalents-Time deposits exceeding three months)/Equity attributable to
owners of the parent *6: Dividend per share subject to resolution of Board of Directors *7: Dividend on Equity 22
ESG Financial Integrity
Aim for sustainable enhancement of shareholder value
S
G
Joined the “London Declaration”, the largest public-private partnership in the healthcare field with the aim of
eliminating 10 NTDs, as the only Japanese company
Corporate Governance
Strong Balance Sheet
Ample Cash Flow
Net cash: 27.3B yen
Net DER*5: -0.05
Ratio of equity attributable to owners
of the parent: 57%
Secured 82.0B yen in free cash flow,
exceeding annual dividend payment*6
of 42.9B yen
Balancing strategic investment
and stable dividend
Strategic investmentExpansion of global brands
Acceleration of investment
in AD assets utilizing an
escrow account
M&A and partnership
Stable dividend policy
Dividend:
maintain 150 yen
DOE*7 8% level
E
Recognized A- by CDP*2 Climate Change 2016Earned top-rating along with other companies
among healthcare sector in Japan
Listed for DJSI*3 and FTSE*4,
global socially responsible investment indexes
7 out of 11 board of directors are outside directors Clear separation of the function between the supervision of
management and the execution of businessThe Chair of the Board is an outside director and the CEO is the only director serving concurrently as a corporate officer
The Chairs of all committees (nomination, compensation, and audit) shall be appointed by the outside directors
Initiatives to improve Access to Medicine
Ranked 11th (among global companies) and 1st (among Japanese companies) in Access to Medicine Index
(ATM Index) 2016
FY2016 FY2017
Results % Forecast % YoY
Revenue 539.1 100.0 575.5 100.0 107
Cost of sales 195.9 36.3 206.0 35.8 105
Gross profit 343.2 63.7 369.5 64.2 108
R&D expenses 112.5 20.9 134.0 23.3 119
SG&A expenses 179.7 33.3 177.5 30.8 99
Other income & expenses 8.0 1.5 2.0 0.3 25
Operating profit 59.1 11.0 60.0 10.4 102
Profit for the year 42.2 7.8 41.3 7.2 98
Profit for the year(attributable to owners of the parent) 39.4 7.3 39.8 6.9 101
EPS (yen) 137.6 139.2 101
ROE (%) 6.8 6.8
DOE (%) 7.4 7.4
Dividends (yen) 150 150
Forecast for FY2017 (IFRS)
Sustain growth in main business while preparing for the future
FY2016 average exchange rates: USD 1: 108.38 yen, EUR 1: 118.78 yen, GBP 1: 141.59 yen, RMB 1: 16.10 yen
FY2017 average exchange rates (forecast): USD 1: 113 yen, EUR 1: 120 yen, GBP 1: 141 yen, RMB 1: 16.30 yen
The influence of risks relating to the patent infringement litigation for antiemetic agent Aloxi in the United States announced on May 3, 2017 has not been included.
23
(billions of yen, %)
FY2015 FY2016
Results % Results % YoY
Japan*1 284.9 52.0 291.1 54.0 102
Americas*2 122.2 22.3 117.2 21.7 96
China 49.3 9.0 49.3 9.1 100
Asia*3 34.0 6.2 34.7 6.4 102
EMEA*4 41.3 7.5 37.8 7.0 92
Pharmaceutical business
total531.8 97.1 530.1 98.3 100
Others 16.2 2.9 9.0 1.7 55
Consolidated revenue 547.9 100.0 539.1 100.0 98
Revenue by Reporting Segment
25
(billions of yen, %)
*1: Prescription medicines, generics and OTC products *2: North, Central and South America *3: Mainly South Korea, Taiwan, Hong Kong,
India and ASEAN *4: Europe, Middle East, Africa, Russia and Oceania
Breakdown of Revenue Migration
Growth of global brands*1
and Japan business
547.9
4,500
5,000
5,500
6,000
FY2015Revenue
Growth of globalbrands
Pharmaceuticalbusiness in Japan
Others FY2016Revenue
539.1
+6.6 -8.8B yen
YoY
-21.6+6.2
26
Major factors for increase Establishment of
EA Pharma Co., Ltd.
Expansion of branded drugs*3
Major factors for decrease Japan drug price revisions
Transfer of EIDIA Co., Ltd.
*2
(billions of yen)
Major factors for decrease Transfer of Eisai Food & Chemical Co., Ltd.
Impact of foreign exchange fluctuations
* Figures shown in breakdown are approximate.
*1: LENVIMA, Halaven, Fycompa, BELVIQ *2: Excludes revenue from Japan pharmaceutical business
*3: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use: Halaven, Lenvima,
Fycompa, Humira, Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue)
450
500
550
600
FY2015 FY2016
Results %% of
revenueResults %
% of
revenueYoY
Japan*1 114.3 66.3 40.1 103.3 59.1 35.5 90
Americas*2 23.6 13.7 19.3 34.4 19.7 29.4 146
China 12.6 7.3 25.5 13.7 7.8 27.8 109
Asia*3 8.3 4.8 24.4 9.3 5.3 26.9 113
EMEA*4 10.2 5.9 24.8 12.5 7.2 33.1 122
Pharmaceutical business
total168.9 98.1 31.8 173.3 99.1 32.7 103
Others 3.3 1.9 20.5 1.5 0.9 17.0 46
Reporting segment total 172.3 100.0 31.4 174.8 100.0 32.4 101
R&D expenses and group
headquarters’ management
costs, etc.(135.4) (125.1)
Gain from a bargain
purchase*5 9.3
Gain on sale of
subsidiaries*6 15.0 0.1
Consolidated operating profit 51.9 9.5 59.1 11.0 114
27
Profit by Reporting Segment
(billions of yen, %)
From the fiscal year ending March 31, 2017, the method for calculating the segment profit of pharmaceutical business and other business has changed. Following the change, other income
and expenses that had been allocated to pharmaceutical business and other business in the consolidated statement of income until the previous fiscal year is now reported under Group
headquarters’ management costs and other expenses. *1: Prescription medicines, generics and OTC products *2: North, Central and South America *3: Mainly South Korea, Taiwan, Hong
Kong, India and ASEAN *4: Europe, Middle East, Africa, Russia, and Oceania *5: Recognition of bargain purchase gain in April 2016, following acquisition of EA Pharma Co., Ltd. shares
*6: Transferred shares of EIDIA Co., Ltd. in December 2015, Eisai Food & Chemical Co., Ltd. in February 2016, and Sannova Co., Ltd. in April 2016
59.1
0
200
400
600
FY2015Operating profit
Growth of globalbrands
Pharmaceuticalbusiness in Japan
Reduction in R&Dexpenses
Others FY2016Operating profit
51.9
28
Breakdown of Operating Profit Migration
Growth of global brands*1 and cost efficiency
contributed to profit increase
*Figures shown in breakdown are approximate.
*1: LENVIMA, Halaven, Fycompa, and BELVIQ *2: Operating profit from LENVIMA, Halaven, Fycompa and BELVIQ, excluding Japan pharmaceutical business
*3: Segment profit *4: 13 branded drugs including the products designated by MHLW as Premium to promote the development of new drugs and eliminate off-label use:
Halaven, Lenvima, Fycompa, Humira, Lunesta, Maxalt, Fostoin, Careram, Inovelon, NerBloc, Gliadel, Treakisym and Lyrica (alliance revenue)
+7.1B yen
YoY+9.8+9.9
*2
-11.0
*3
-1.6
(billion of yen)
60
40
20
Major factors for increase Establishment of EA Pharma Co.,
Ltd.
Expansion of branded drugs*4
Major factors for decrease Japan drug price revisions
Transfer of EIDIA Co., Ltd.
Major factor for increase Gain from a bargain purchase
following acquisition of
EA Pharma Co., Ltd. shares +9.3
Major factor for decrease Transfer of shares of EIDIA Co., Ltd. -8.0
Transfer of shares of Eisai Food &
Chemical Co., Ltd. -7.0
Major factors for increase
Selection and focus in
priority pipeline
Cost efficiency through
co-development with partners
Impact of foreign exchange
fluctuations
FY2015 FY2016
Results % Results % YoY
Revenue 284.9 100.0 291.1 100.0 102
Prescription medicines 233.9 82.1 244.0 83.8 104
Humira 32.6 11.5 37.7 12.9 115
Aricept 40.5 14.2 29.5 10.1 73
Lyrica*1 24.7 8.7 24.3 8.3 98
Pariet*2, 3 30.4 10.7 21.2 7.3 70
Methycobal 20.8 7.3 18.2 6.2 87
Lunesta 6.0 2.1 8.0 2.8 134
Halaven 6.8 2.4 7.8 2.7 114
Warfarin 7.6 2.7 6.8 2.3 89
Livact*2 6.7 2.3
Elental*2 6.6 2.3
Actonel 6.4 2.3 5.6 1.9 88
Lenvima 1.5 0.5 2.7 0.9 175
Fycompa 0.5 0.2
Generics 28.5 10.0 28.0 9.6 98
Consumer Healthcare Business 18.1 6.3 19.0 6.5 105
Diagnostics 4.4 1.5
Segment profit 114.3 40.1 103.3 35.5 90
29
Performance of
Japan Pharmaceutical Business
(billions of yen, %)
*1: Alliance revenue *2: EA Pharma product
*3: Includes sales of triple formulation Helicobacter pylori eradication packs, Rabecure Pack 400/800 and Rabefine Pack
FY2015 FY2016
Results % Results % YoY
Revenue 122.2 100.0 117.2 100.0 96 [106]
Aloxi 54.7 44.7 48.1 41.0 88 [97]
Halaven 18.3 15.0 16.6 14.2 91 [101]
Lenvima 8.8 7.2 15.1 12.9 172 [190]
Banzel 13.2 10.8 13.8 11.8 105 [116]
AcipHex 8.3 6.8 7.2 6.1 86 [96]
Fycompa 3.8 3.1 5.3 4.5 137 [152]
BELVIQ 4.4 3.6 3.7 3.2 84 [93]
Segment profit 23.6 19.3 34.4 29.4 146 [162]
30
Performance of
Americas Pharmaceutical Business
(billions of yen, %)
[ ] based on local currency
FY2015 FY2016
Results % Results % YoY
Revenue 34.0 100.0 34.7 100.0 102 [113]
Aricept 10.0 29.3 9.8 28.1 98 [108]
Humira 9.0 26.4 9.6 27.7 107 [118]
Pariet 3.5 10.3 3.6 10.4 103 [114]
Methycobal 3.1 9.1 2.9 8.2 93 [104]
Halaven 1.9 5.6 2.0 5.8 104 [116]
Fycompa 0.1 0.3 0.4 1.0 384 [424]
Lenvima 0.0 0.0 0.3 0.9 3,217 [3,557]
Segment profit 8.3 24.4 9.3 26.9 113 [127]
FY2015 FY2016
Results % Results % YoY
Revenue 49.3 100.0 49.3 100.0 100 [117]
Methycobal 18.7 38.0 18.0 36.5 96 [112]Stronger Neo-Minophagen C and
Glycyron Tablets9.3 18.8 8.4 17.1 91 [106]
Aricept 5.6 11.3 6.2 12.5 111 [130]
Pariet 3.3 6.6 3.9 8.0 120 [141]
Segment profit 12.6 25.5 13.7 27.8 109 [141]
31
Performance of China and Asia*
Pharmaceutical Business
<China>
<Asia>
(billions of yen, %)
[ ] based on local currency
(billions of yen, %)
[ ] based on local currency* Mainly South Korea, Taiwan, Hong Kong, India, and ASEAN
FY2015 FY2016
Results % Results % YoY
Revenue 41.3 100.0 37.8 100.0 92 [104]
Halaven 13.2 31.9 10.9 28.9 83 [95]
Zonegran 7.6 18.5 5.2 13.7 68 [78]
Fycompa 3.6 8.8 4.2 11.2 117 [133]
Zebinix 3.8 9.3 3.6 9.5 94 [106]
Lenvima / Kisplyx 1.1 2.7 3.3 8.8 297 [336]
Inovelon 2.2 5.3 1.9 5.1 88 [101]
Segment profit 10.2 24.8 12.5 33.1 122 [131]
32
Performance of
EMEA* Pharmaceutical Business
* Europe, Middle East, Africa, Russia, and Oceania [ ] based on local currency
(billions of yen, %)