EMITS

Eisai Medicine Innovation Technology Solutions
Aiming to strongly promote innovation under the concept of"One Kawashima" to increase value for patients,
utilizing EMITS as a base for disseminating advanced pharmaceuticaltechnology that embodies new modalities
June 5, 2024
Eisai co., Ltd.
Akiko Nakahama
Chief Portfolio Officer, Japan / Asia Filing and Registration,

Chief Quality Officer, and Japan Regulatory Affairs

Eisai at a Glance

1 Eisai is a human health care (hhc) company
The hhc concept, established in 1992, governs the way we do business – the research we do, the products
we develop, the way we train our employees and the allocation of our financial resources. For this in Eisai
we spend 1% of our working hours to know the reality of patients that can help satisfy unmet medical
needs and contribute to the health and wellbeing of people worldwide

2 In 2021, Eisai celebrated the80th anniversary
Toyoji Naito, Eisai’s founder,
established Nihon Eisai Co., Ltd. in 1941, focusing
on in-house R&D to create new medicines.

3 A global R&D-based company focusing on

4 More than 40 Subsidiaries
Over 11,000 Global Employees
Over 10,000 employees is working across ourglobal network of R&D facilities, manufacturing
sites and marketing subsidiaries with operations in
Asia, Europe, the Middle East and the U.S.

Neurology & Oncology
FINANCIAL
FY2023 Revenue

5(year ending 3/31/2024)

741.8 Billion JPY
1938

1941

1967

11 |

Eisai Global Network
More than 40 subsidiaries worldwide●

EMEA (EU, Middle East, Russia and Oceania)
Eisai Europe Ltd. (UK)●

Eisai China Holdings Ltd. (China)

Employees: 1,305

Eisai Ltd. (UK)
Research: 85
Eisai Manufacturing Ltd.(UK)
MRs: 370
Eisai GmbH (Germany)
Eisai GesmbH (Austria)
Eisai S.A.S. (France)
Eisai B.V. (The Netherlands)
Eisai Farmacéutica S.A. (Spain)
Eisai S.r.l. (Italy)
Eisai Pharma AG (Switzerland)
Eisai AB (Sweden)
Eisai SA/NV (Belgium & Luxembourg)
Limited Liability Company Eisai (Russia)
Eisai Farmacêutica,Unipessoal Lda. (Portugal)
Eisai Australia Pty. Ltd. (Australia)
Eisai Israel Ltd. (Israel)
Eisai New Zealand Ltd. (New Zealand)

China

Eisai China Inc. (Beijing, Shanghai, China)
Eisai (Liaoning) Pharmaceutical Co., Ltd. (China)
Eisai (Suzhou) Trading Co., Ltd. (China)
Eisai (Hong Kong) Co., Ltd.

Eisai Co., Ltd (Global Headquarters, Tokyo, Japan)● JapanEisai Japan in Eisai Co., Ltd (Tokyo, Japan)
EA Pharma Co., Ltd. (Japan)
Sunplanet Co., Ltd.
Arteryex Inc.
Theoria Technologies Co., Ltd.

●

Asia and Latin America

Employees: 11,067
Research: 1,835
MRs: 4,055

Employees: 4,311
Research: 1,110
MRs: 1,030

Employees: 1,920
Research: 550
MRs: 640●

Americas (North America)
Eisai Inc. (U.S.)
Eisai Corporation of North America (U.S.)
Eisai Innovation Inc. (U.S.)
Eisai Limited (Canada)(Primarily South Korea, Taiwan, India, ASEAN, Africa, Latin America)
ALA Regional Headquarters in Eisai Co., Ltd (Tokyo, Japan)

GlobalEmployees: 1,948
Research: 40
MRs: 1,200

Eisai Korea Inc.
Eisai Taiwan Inc.
Eisai (Singapore) Pte. Ltd.
Eisai Asia Regional Service Pte. Ltd. (Singapore)
Eisai Clinical Research Singapore Pte. Ltd. (Singapore)
HI-Eisai Pharmaceutical Inc. (Philippines)
PT Eisai Indonesia (Indonesia)
Eisai (Thailand) Marketing Co., Ltd.
Eisai (Malaysia) Sdn. Bhd.
Eisai Vietnam Co., Ltd. (Vietnam)
Eisai Pharmaceuticals India, Pvt. Ltd. (India)
Eisai Laboratórios Ltda. (Brazil)
Eisai Laboratorios, S. de R.L. de C.V. (Mexico)
Eisai Pharmaceuticals Africa (Pty) Ltd (South Africa)

Employees: 1,583
Research: 50
MRs: 815

2

Eisai Global R&D and Production Sites
14 Drug Discovery, R&D and ClinicalResearch Sites and 10 Production Sites
●

EMEA

●

China

European Knowledge Centre (Hatfield, U.K.)

Eisai China Inc.

▲ Drug discovery and clinical research▲ Formulation and packaging

Suzhou Factory▲ Clinical research▲ Formulation and packaging

Benxi Plant▲ API production (only herbal medicine), formulation and packaging

Eisai Co., Ltd.
●
European
Knowledge Centre(Hatfield, UK)Japan

Kawashima Industrial Park
▲ Drug development research▲ Formulation and packaging

Kashima Business Office●

Asia

Tsukuba ResearchLaboratory(Tsukuba, Japan)

Knowledge Centre, India▲ Drug development research▲ API production, formulation and packaging▲ Clinical research

Bogor Factory (Indonesia)▲ Formulation and packaging▲ Drug development research▲ API(active pharmaceutical ingredients) production

Tsukuba Research Laboratories▲ Drug discovery and development research

Fukushima Business Office (EA Pharma Co., Ltd.)▲ Formulation and packaging

Eisai Clinical Research Singapore Pte. Ltd. Knowledge Centre,

Kobe Research Laboratories

India(Vizag, India)▲ Drug discovery and development research

Koishikawa Knowledge Center

Genetics Guided Dementia
Discovery (G2D2)(Cambridge, U.S.)

Exton Site
(Exton, U.S.)●

Americas
Eisai Inc.
▲ Clinical research

Baltimore Plant▲ Formulation and packaging (only wafers)

Eisai Center for Genetics Guided Dementia
Discovery (G2D2)▲ Drug discovery research

Exton Site
▲ Drug discovery (Epochal Precision Anti-Cancer
Therapeutics; EPAT)▲ Drug development research▲ API production▲ Clinical research

Kobe ResearchLaboratory(Kobe, Japan)

EA Pharma Co., Ltd. Research Institute▲ Drug discovery and development research

EA Pharma Co., Ltd.
▲ Clinical research▲ Drug Discovery, R&D Function▲ Production Sites

33|

EMITS(Eisai Medicine Innovation Technology Solutions)
The concept and key features of EMITS

Mechanical balcony

Comprehensive manufacturing

3F
functions are
Research
Meeting/
Research Researchgathered in 3F
Plate innovation lounge

Design lab and Alliance lab

2F
Development
Plate

ISS/Machine
room
Development
Flexible lab considering
variability•

An integrated research building comprising all steps from formulation research to
manufacturing with installation of facilities that enable the in-house manufacturing ofinvestigational injection drug, as global formulation and modality research basis•

A base for disseminating advanced and cutting-edge formulation technology which
realize new modalities- Correspond to expanding modalities such as antibodies, antibody drug
conjugates (ADCs), and nucleic acid drugs, in addition to conventional small
molecule compounds

Meeting/individual booth

1F
Manufacturing
Plate

The world's first compact filling system

Manufacture Aggregation of GMP functions
and warehouse facilities
QC/Warehouse Manufacturing
segregated for hazards and general use
QC to correspond various modalities' evaluation- Strengthen development function for injection
formulation and drug delivery system (DDS)
including liposomal and lipid nanoparticle
formulation, and support development of various
modalities

Entrance, reception room

Further enhancing the technical capabilities and knowledge of our formulation research function,
and aiming a base for disseminating innovation, technology, and solutions relating to formulations
4

Eisai R&D: Deep Human Biology Learning (DHBL)

The targeting of neurodegenerative diseases such as Alzheimer's disease
and refractory cancers remains unchanged
Chief Scientific Officer (CSCO)

Chief Portfolio
Officer (CPOO)

Portfolio and project management
Budget & site management
Collaboration and incubation (C&I)
Academia-industry alliance (A&I)

DHBL office

IT strategy
HR strategy & operation

1.Human Biology Integration (HBI) foundation
Integrate and comprehensively analyze our own clinical data and cohort data to develop drug discovery hypothesis based on
Human Biology
Establishment of DHBL drug
discovery hypothesis based on
genome information linked tothe underlying cause of
disease and pathophysiologicalinformation(five drug discovery areas)Protein Integrity& Homeostasis(PIH) domain
Target disturbance inprotein integrity &homeostasis

Cell Lineage &Differentiation(CLD) domain

Microenvironment
Dynamics(MD) domain

Target a specificity of cellular Target a microenvironment
origins of cancer andto break cancer
promote neuro-regeneration immunotherapy resistance

InflammAging &Senescence(IAS) domain
Target a cell aging
and lipid abnormality

Microbes & Host Defense(MHD) domain
Discover conqueringsolutions for Neglected
Tropical Diseases andPandemics

2. Discovery Concept Validation (DCV) function
Develop advanced human model system and modality screening method to validate hypothesis of potential therapeutic discovery
Verification of DHBL drug
discovery hypotheses andselection of optimal modalities
in preclinical models by
maximizing chemistry
capabilities

Prove DHBL drug
discovery hypothesis
in humans by clinical study
using advanced statisticalanalysis method

3. Discovery Evidence Generation (DEG) function

Clinical data,biomarker dataand cohort dataobtained fromhigh-quality inhouse clinicalresearch

Determine the optimal modality that is enable to maximize target engagement to select the best drug candidates for clinical investigation

4. Pharmaceutical Profiling & Development (PPD) function
Conduct process research for the selected modality and evaluate preclinical safety and pharmacokinetics to predict safety andpharmacokinetics in human
5. Clinical Evidence Generation (CEG) fulfillment
Validate drug discovery hypotheses in clinic to secure regulatory approvals and obtain a variety of human biology data thatcan be leveraged for next-generation drug discovery

Eisai’s proprietary knowledge of Human Biology
Drug discovery based on genome information obtained from high-quality clinical samples

5Eisai Q3 FY2023 Financial
Next-generation AD Pipeline:
Disclosure Meeting Material
Next Therapeutic Drug Related to Underlying Pathology

Anti-MTBR*1 Tau Antibody E2814*2

Leading the global research of AD with a comprehensive AD pipeline covering the ATN*3 framework◼ Hypothesis: Capture MTBR-tau propagating species in the extracellular space andinhibit its propagation, leading to potential treatment by inhibiting spread ofneurofibrillary tangles◼ POM*4: MTBR-tau243*5, a biomarker specific to tau neurofibrillary tangles in AD, wasreduced by E2814 administration in DIAD*6 patients*7 (Study 103)
◼ Clinical development (ongoing)• Tau NexGen*8: Phase II/III: Lecanemab + E2814 combination regimen
Anti-MTBR Tau Antibody E2814• Target population: Preclinical AD – Moderate AD• DIAD: Phase Ib/II (Study 103): Target engagement confirmed using MTBR-tau243• Target Population: Mild – Moderate AD◼ Based on the pathophysiology caused by MTBR tau, considering opportunities toexpand the target population not only to DIAD but also to Sporadic AD• Pursuing higher clinical efficacy through combination therapy with anti-Aβ antibodies and expanding
to a wider range of populations aiming to establish a next-generation standard treatment for AD• Development of new biomarkers for Aβ and tau may enable early treatment initiation and contributeto the establishment of standard treatment
Above projects are investigational, except for lecanemab for early AD, which is approved in the U.S., Japan and China. *1: Microtubule binding region *2: Discovered as part of research collaboration between Eisai and University
College London *3: Amyloid, Tau, and Neurodegeneration *4: Proof of Mechanism *5: Horie et al., Nature Medicine 2023 *6: Dominantly inherited Alzheimer disease. Gene mutation was confirmed in either PSEN1, PSEN2, or
APP *7: Zhou et al., AAIC2023 *8: Study name is Tau Next Generation. Study in DIAD conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU)

6

Advanced Technology and Strategy in
Formulation Research:
Challenging to Develop Next-Generation Drugs
at EMITS
June 5, 2024
Eisai co., Ltd.

Koji Ukai
DHBL, Pharmaceutical Profiling & Development(PPD) Function,
PST Unit, Formulation Research Department

Roles of the Formulation Research Department<Variety of operations>
A wide range of work related to formulation, from discovery
research to commercial production

What is formulation research?

Development research

Active pharmaceutical ingredient(API) itself can be◼
◼
◼
◼

API supply/
Clinical Trial Material manufacturing

Synthesis for drug discovery
Lead compound optimization

Process chemistry research

New drugcandidate

Biological evaluation
In vitro/in vivo
Pharmacokinetics/
pharmacodynamics
Physical properties
General pharmacology
SafetyBiomarker

Development of nextgeneration products,
manufacturing and analysis
technologies

Clinicalintroduction

Safety research
Pharmacokinetics/
Pharmacodynamics
Drug development
research for efficacy
general pharmacology
Biomarker research

Regulatory
Submission

Review

Screening

Drug use results
surveyClinical researchPhase 3 studies

Physical properties analysis andresearchIdea
targetDrug fosteringand evolution(After launch)

Formulation researchPhase 2 studies

Formulation research isresolving various difficulties
and design the “medicine“from “API"

Drug discovery
researchPhase 1 studies◼
◼
◼

Difficult to administer a fixed dose in
a convenient manner
Not suitable for carrying or transportation
Chemical and physical stability can bepoor in some cases
in-vivo absorption can be low in somecases
Administion only be possible at a hospital
Bitter in taste
and so on ・・・・・・・

Commercial production andtechnology transfer

Non-clinical research

Post-marketingclinical study
Approval

Life cycle
management
Drug- druginteraction studies
Compatibility
study
Establish safety
database<Variety of alliance>
Collaborate with departments and external CMOs and CROs

8

Oral formulation

E2020

E2007

E2006

Aricept Tablets

Fycompa Tablets

Dayvigo Tablets

E2020

E2007

Aricept
Dry syrup

Fycompa
Fine granules

E2020
Aricept 23 mg Tablets
Extended-release

E3810
Pariet Tablets
Improved stability,
enteric coating

Releasecontrol

E2020

E3810

Aricept OD Tablets
Molded tablet

Pariet Pediatric Granules
Improved stability,
particulate coating

E2020

Conventional
formulation
technology

E7080
Lenvima Capsules
Additives new application

Solubility improvement
High-potent compound
manufacturing

E7438

E7090*1

Tazverik Tablets

Continuous manufacturing:
real-time quality monitoring

Continuous manufacturing

Specialtechnology

Aricept Jelly
Masking bitterness

Injectable formulation

Formulation Technology

Formulation Research and Development for Market Launch

Manufacturing process innovation
E2007

E0302

Fycompa IV

High-dose mecobalamin
Photostability improved
formulation
Manufacturing processes,
packaging technology

Solubility improvement
technology

Solubility improvement

BAN2401

2000

2010

BAN2401

Lecanemab

Lecanemab

Antibody
IV infusion

Subcutaneous
auto injector

Bio-evaluation technology

Dosing device technology

Eisai’s uniquemanufacturing
processiSEMT*2

MORAb-202*3
BB-1701*4
Freeze-drying scaleup predictions

E2814*5
EMITS
Advanced aseptic
manufacturing technology,
Advanced Bioassessment

2020*1 FGFR1,2,3 inhibitor *2 iSEMT: in situ solidification in Eisai molded tablets A manufacturing method developed by Eisai which enables delivering investigational drug for early phase clinical trials with extremely low volume of drug
substance and short manufacturing periods *3 Co-development with Bristol Myers Squibb. Generic name is farletuzumab ecteribulin *4 Entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltdwith option rights for a strategic collaboration *5 Anti-MTBR tau antibody, Discovered as part of the research collaboration between Eisai and University College London

9

EMITS:
Hub for pharmaceutical innovation, technology and solutions
Visions for the future
Fast and low-budget drug development for
supporting a variety of modalities

Eisai Medicine Innovation Technology Solutions

Concept•

Communication•

・Fostering a sense of unity under the concept of “One Kawashima”(R&D and Manufacturing) (All areas)• Developing formulation technology for next-generation drug
pipelines through inter-departmental communication•

Innovativion
・ Unique compact filling system (1F)・ Introduction of the latest centralized management system of
manufacturing data and utilization of AI
・ Rapid environmental microbial monitoring system
・ Develop cutting-edge formulation technologies such as liposomesand LNP*1 as new modalities

Flexibility・ Introduction of the “Activity Based Working (ABW)”*2 concept (3F)・ Flexible laboratory (2F)

Safety and security
・Biometric authentication system (1F)・ITV*3 monitoring system (1F)

Launch EMITS GMP area for injectables with the aim ofpursue innovation in manufacturing technology and rapid
supply of investigational drugs
Improve quality and speed of formulation process researchby introducing latest centralized management system of
manufacturing data and utilizing AI
Advance microbial control and sterility assurance throughintroduction of rapid microbial testing methods

Patient-centered product development•

Develop products based on people’s anxieties and take on
the necessary technological developments despite howchallenging they are.

Strengthening collaboration both internally andexternally, including socialization•••

Create a space where employees can socialize and gain
understanding of patients, and then can immediately put into
practices of manufacturing
Realize a work space that stimulates collaboration bothinternally and externally and generates multifaceted ideas
through diverse working styles
Improve productivity through efficient layout and ABW*1: LNP: Lipid Nanoparticles *2: ABW: Work style that allows employees to freely choose where they work depending on their mood and the type of work they do *3: ITV: Industrial Television

10

EMITS:

Fast and Low-budget New Drug Development (Manufacturing Technology)
Operation of EMITS GMP area for injectables, aiming for early supply of investigational drugs for various modalities

In-house sterile
manufacturing site

Concept

Concrete
proposalEstablish a system for the rapid and flexible
supply of high-quality investigational drugs,
including injectables
1. Secure a large preparation area that can
manufacture investigational drugs based on
new modalities• Saving space by introduction of uniquecompact filling machine• Actively introducing new technologies andequipment suitable for small-lot, multi-variety
manufacturing of investigational drugs

2. Centralizing data management and enhancing
DI*1 through Manufacturing Data Management
System (MDMS)

1) Large preparation area

2) Manufacturing data management system
fun-SOP(Electronic
manufacturing records)

MDMS

Facilityequipment

TabletStandard PC

Automatic
email contact

Data science
Analysis PC

Remote monitoring
Work
from
home

Cloud

Data (primary) centralized management
DI function granted

Server in EMITS

Data (secondary) Centralized management
DI function granted

Environmental
equipment

OfficeControlroom

Manufacturing equipment
Other manufacturing
equipment

External system

Manufacture of E2814 as the first investigational drug for EMITS*1 Data integrity

11

EMITS:
Fast and Low-budget New Drug Development (Analysis)“Deep understanding of molecular characteristics” and "rapid and high-precision analysis" to accommodate new modalities•

Analysis•••Become more complex molecular structures, such as those of antibody drugs and
DDS (Drug Delivery System) preparations
Require molecular characterization, including elucidation of molecular reaction anddegradation factors
Require analytical technologies consisting of advanced and diverse techniques
and rapid, highly accurate analysis
Essential to build a development system that integrates data science to handle theincreasing amount of data

Science
Generation of diverse quality data for in-depth characterization
Technology: Collecting all kinds of events as data
Automation: Achieving high-quality, high-speed operations

Digital Analysis
Integration and rapid analysis of huge amounts of quality data••

Full automation ofcritical quality tests

Acquisition of various advanced
analytical techniques

Faster and more appropriate decision-making through predictions basedon data analysis
Determining high-level quality standards and predicting shelf life basedon accurate evaluation of quality variation

Automatic identification of fineparticles in injection formulations
by machine learning

Achieving High quality and rapid formulation development

12

EMITS:
Fast and Low-budget for New Drug Development (Analytical Technology)
Enabling swift and flexible supply of clinical trial material for injection based on advanced aseptic management strategy

Microbial
management
Issues•••Parenteral injections are "sterile" drug products that canbe administered directly into the body
"Sterile" refers to the absence of viable microorganisms,
which is difficult to prove directly because the test method
is destructive
The probability that the product is sterile should bejustified based on the reasonable verification

EMITS GMP area for injection drugs: The control strategies forsterile environment based on scientific considerations••

Visualize and expedite sterility management using the latest
technology
Preventive action for the quality issues and remanufacturingrisks by using the advanced analytical technologies

Test case

Bacteria count(In manufacturing
water and theenvironment)

Introduction of
measurement technology

MALDI TOF MS*1
(Detection of microbial
counts and identification)

Effects of introduction
Identification of bacteria species inenvironment and manufacturing water• Clarifying the contamination route andsource of specific bacteria• Effective disinfectants are selectedbased on scientific considerations• Rapid identification achieved in 10
minutes

Endotoxin

Endosafe*2(Rapid endotoxin detection
assay)

Quality check of API before the next
process⇒ Quick visualization and certain
prevention of contamination

Microbial
measurements(Manufacturing
equipment)

Ensure touch*3(Rapid microbial detection
assay)

Rapid sanitary evaluation of
manufacturing equipment⇒ Visualization of microbial contamination,measurement without culture
Response time: 10 sec.

Microbial
measurements(time of filling)

Biotrak*4(Rapid microbial detection
assay)

Risk of microbial contamination whenfilling injections⇒ Understanding in real-time

Microbial managements in EMITS are the gate keeper for stable supply of investigational new drugs,
and to lead the further acceleration for new drug development*1: MALDI TOF MS: Microbial protein chamber analyzer *2: Endosafe: Simple Kit-type bacterial toxin analyzer *3: Ensure touch: Bioenergetic substance analyzer *4: Biotrak: Laser light-emitting bacterial fluorescence detector

13

EMITS:
Supporting Diverse and Emerging Modalities in the Injection GMP Area
mRNA-LNP*1

Establishment and infrastructure development of a platform
for in vivo protein drug production technology

New modality to replace protein and antibody drugs
Issue
The production of protein and antibody drugs requires cell culture andcell bank preparation, which requires a development period using large
facilities, etc.
Solution
LNP technology*2 enables to produce proteins and antibody drugs
from mRNA in vivo, with mass production and rapid supply.
(mRNA is a chemical synthesized product, but the active ingredient is
a protein/ antibody drug)

cell

Establishing a new drug discovery platform for
mRNA-based neutralizing antibody /protein drugs
1. Protein or Antibody
drugs

mRNA-LNP
Intravenous administration

2. Transformation ofamino acid sequence
to mRNA
Liver

3. Enclose to Livertargeted lipid nanoparticle ［mRNA-LNP］
4. Rapid production in vivo

Protein drugs

Antibody drugs

Chemically synthesizable
mRNA can be rapid supply* Particle formation process
Lipid nanoparticle formation
proceeds by self-association
based on ion concentration* External aqueous phasereplacement process (TFF)
Maturate gradually with pH change

LNP-mRNA Formulation

mRNA-LNP: GMP manufacturing possible as little as in 90 days
*1: LNP: Lipid Nanoparticles, *2: This research was supported by AMED under Grant NumberJP22fk0108524

14

Manufacturing Flow of E2814 Investigational Drug
Addition of drug
substance
Addition of raw material
solution
Final dilution(volume adjustment)

Preparation of
raw material solution

Sterile filtration

Preparation of
packaging materials

Filling and stoppering
Capping, external
washing, accumulation
15

Patient-Centered Product Development
Ultrahigh-dose mecobalamin*1(Under regulatory review in Japan)••

Anticipated indication:
amyotrophic lateral sclerosis (ALS)The active ingredient, mecobalamin, ishighly unstable to light

Subcutaneous formulation
with auto injector*1 for LEQEMBICharacteristics

25mg
formulation

Eisai’s original lightprotection packaging

Window forchecking insideat administration*Packaging for protecting the vial fromlight at administration• Antiepileptic drug (alternative when oral
administration is temporally not possible)*This photo is for illustration purposes• Highest protein concentration
formulation with low viscosity and highstability* Filling process with controlled illuminationlevels for quality-oriented manufacturing
management

Intravenous infusion for Fycompa• Tapered needle: Potentially relieve pain
• Plastic syringe: Potentially ensure safety
when administrating at home and a siteof care as it will not brake like glass
syringe• Silicone oil-free: Less likely to occur drug
aggregation based on no-using silicone
oil, which is used to make syringe
slippery• Administration time: Administration iscompleted within 15 seconds, making ithigh usability and safe for administration
by patients or caregiver at home

• Recognized the challenge of further
shortening the reconstitution time of thefreeze-dried formulations, through feedback
from healthcare professionals regarding
prototype formulations• By diluting the concentration prior to freezedrying, reconstitution time is reduced
without altering the volume of water needed
for reconstitution

Prototype*1: Investigational

Commercial product16

Safe Harbor Statement◼ Forecast or target figures in this material are not official earnings guidance but represent midterm strategies, goals, and visions. Official
earnings guidance should be referred to in the disclosure of the annual financial report (Consolidated Financial Statement) in accordancewith the rules set by Tokyo Stock Exchange.
◼ Materials and information provided during this presentation may contain so-called “forward-looking statements.” These statements are
based on current expectations, forecasts and assumptions that are subject to risks and uncertainties that could cause actual outcomes andresults to differ materially from these statements.
◼ Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions suchas interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forwardlooking statements. Product risks and uncertainties include, but are not limited to, technological advances and patents attained bycompetitors; challenges inherent in new product development, including completion of clinical trials; claims and concerns about productsafety and efficacy; regulatory agency examination periods and obtaining regulatory approvals; domestic and foreign healthcare reforms;
trends toward managed care and healthcare cost containment; and governmental laws and regulations affecting domestic and foreign
operations.
◼ Furthermore, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are notlimited to, inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance.
◼ The Company cannot guarantee the actual outcomes and results for any forward-looking statements.

◼ The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new
information, future events or otherwise.
◼ The English-language presentation was translated from the original Japanese-language version. In the event of any inconsistency between
the statements in the two versions, the statements in the Japanese-language version shall prevail.
◼ The Company discloses its consolidated financial statements according to the International Financial Reporting Standards (IFRS).
17