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Fujifilm’s Initiatives in Regenerative Medicine Shigetaka Komori Chairman and CEO FUJIFILM Holdings Corporation March 30, 2015

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Page 1: Fujifilm’s Initiatives in Regenerative · PDF fileFujifilm’s Initiatives in Regenerative Medicine ... Drug Discovery Research (R) ... New Drug Development Process Thus FarNew Drug

Fujifilm’s Initiatives in Regenerative Medicine

Shigetaka KomoriChairman and CEO

FUJIFILM Holdings CorporationMarch 30, 2015

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Expand business with focus on six core business areas

Graphic ArtsSystems

Graphic ArtsSystems Priority Priority

Business Business FieldsFields

Priority Business: HealthcarePriority Business: Healthcare

1

Healthcare

Optical DevicesOptical Devices

Highly FunctionalMaterials

Highly FunctionalMaterials

DocumentSolutionsDocumentSolutions

DigitalImagingDigital

Imaging

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2

Diagnostics Treatment

Endoscopes

Low Molecular Drugs

Business E

xpansion

Business E

xpansionBiopharmaceuticals

Comprehensive Healthcare CompanyComprehensive Healthcare Company

Fujifilm Diosynth BiotechnologiesKalon

Regenerative Medicine

Autologous cultured

epidermis

Autologous cultured cartilage

Perseus Proteomics

X-Ray Imaging (FCR/DR/Film)

Radio DiagnosticMedicines

Influenza DetectionUltrasound

Prevention

��������

FunctionalCosmetics

Supplements

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Regenerative medicine field

Biopharmaceuticals field

Low-molecular drugs field

Fields

Therapeutic InitiativesTherapeutic Initiatives

2006

2006

2006

2008

2009

2009

2010

2010

2010

2014

2014

2011

2010

2013

2013

Fujifilm Fine Chemicals Co., Ltd. became a wholly owned subsidiary

Investment in Perseus Proteomics Inc.Became a Fujifilm subsidiary

Aquired FUJIFILM RI Pharma Co., Ltd.

Acquired Toyama Chemical Co.

Entry into the Pharma IndustryPharmaceutical Research Laboratories established

Pharmaceutical Products Division Established

Acquired Fujifilm Diosynth Biotechnologies

Invested in Japan Tissue Engineering Co., Ltd.Became consolidated

subsidiary

FUJIFILM Pharma Co., Ltd. established

Established Fujifilm Kyowa Kirin Biologics

Established Regenerative Medicine Business Development office

Established Regenerative MedicineLaboratories

Acquired Kalon*1

*1 : Now FUJIFILM Diosynth Biotechnologies, LLC in Texas

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Significance of Efforts in Regenerative MedicineSignificance of Efforts in Regenerative Medicine

Drug DiscoveryDrug Discovery

Legal ReformLegal ReformLegal Reform Technical Advancements

Technical Technical AdvancementsAdvancements

Regenerative MedicineRegenerative Medicine

Unmet Medical NeedsUnmet Medical NeedsAge-related

macular degeneration

Severe heartfailure Strokes

iPS Cell

Spinal CordInjuries

Diabetes ����

4

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iPS cellsiPS cells

FujifilmFujifilm’’s Rs Regenerative Medicineegenerative Medicine InitiativesInitiatives

Regenerative MedicineRegenerative Medicine

Related fieldsRelated fields

Autologous cultured epidermis

Autologous cultured cartilage

Utilizing somatic cells and stem cells

Utilizing somatic cells and stem cells iPS���

• Isolator• Incubator• Automated Culture

Apparatus• Cell sorters, etc.

• Contract Cell Culture

• Cell Banking• Cell Transport• Contract Quality

Control

Devices ConsumablesConsumables Services Drug discoveryDrug discovery

Using iPS cellsUsing iPS cells

Scaffolding material (RCP)

RCP : Recombinant peptide

3D cell structure technology3D cell structure technology

Heart

Kidneys

Brain

PancreasLiver

Early commercialization

Early commercialization

Technology application

Technology application

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Acquisition of U.S.-based Cellular Dynamics International, Inc.,

a leading developer and manufacturer of iPS cells

Towards a new stage in the regenerative medicine business

6

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Acquisition of Cellular Dynamics International, Inc. (USA), a leading developer

and manufacturer of iPS cells

Yuzo TodaDirector, Senior Vice President

FUJIFILM Corporation

March 30, 2015

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Cellular Dynamics International, Inc.Cellular Dynamics International, Inc. SummarySummary

Name: Cellular Dynamics International, Inc. (“CDI”)

Founded: 2004

Founded by world-renowned researcher, Dr. James Thomson of University of Wisconsin-Madison, the first in the world to generate ES cells.

IPO: July 30, 2013, listed on NASDAQ

Location: Madison, Wisconsin, USA

Chairman and CEO: Robert J. Palay

Core product: Human iPSC derived cells from a single genetic background, e.g. cardiomyocytes, neurons, hepatocytes, etc.(iCell® products),

Human iPSC’s and iPSC derived cells from custom genetic backgrounds (MyCell® products)

Sales: $ U.S.16.7 million (FY 2014/12)

Number of employees: 155 (as of Dec. 31, 2014)

8

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Identify/ConfirmTarget MoleculesIdentify/Confirm

Target MoleculesPhase III(Verify)

Phase III(Verify)

Phase I(Clinical pharmacology)

Phase I(Clinical pharmacology)

Phase II(Search/ Verify)

Phase II(Search/ Verify)

Drug Discovery Research (R)Drug Discovery Research (R)Drug Discovery Research (R) Clinical Developments �D�Clinical Developments Clinical Developments ��DD��

Pharmacology/DynamicToxicity/GLP Safety

EffectivenessSafety

PharmocokineticSafety

EffectiveDosage and

Administration

Human TrialsHuman Trials��PatientsPatients��

Human TrialsHuman Trials��PatientsPatients��

Human TrialsHuman Trials��Healthy SubjectsHealthy Subjects��

Animal Cell TestingAnimal Cell Testing//Animal TestingAnimal Testing

Build evaluation system. Evaluate

target.

Human Cell TestingHuman Cell TestingAnimal TestingAnimal Testing Animal TestingAnimal Testing

Pharmaceutical

Laws, R

egulations

Search/ Optimize Leads

Search/ Optimize Leads

Narrow down development products,

Preclinical

Narrow down development products,

Preclinical

Screeningin vitro/in vivo

Drug Discovery Innovation through Human iPS CellsDrug Discovery Innovation through Human iPS Cells

Disease-specific human iPSC derived cellsDisease-specific human iPSC derived cells

Normal human iPSC derived cellsNormal human iPSC derived cells

New Drug Development Process Thus FarNew Drug Development Process Thus FarNew Drug Development Process Thus Far

New Drug Development Process of the FutureNew Drug Development Process of the Future

MyCell®Products

iCell®Products

ReplacementReplacement hERG TestinghERG Testing Human QT Human QT Extension TestingExtension Testing

Effective Patient Effective Patient ScreeningScreening

�� Shorter period for Shorter period for new drug development.new drug development.

�� Reduction in new drugReduction in new drugdevelopment costs.development costs.

�� Improved probability of Improved probability of new drug development.new drug development.

InnovationInnovation

9

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� Ready made iCell�: 12 types (incl. prototypes) such as cardiomyocytes, neurons, endothelial cells, dopaminergic neurons, hepatocytes

� Custom made MyCell�: reprogramming, genetic engineering, and cell differentiation

� Ready made iCell�: 12 types (incl. prototypes) such as cardiomyocytes, neurons, endothelial cells, dopaminergic neurons, hepatocytes

� Custom made MyCell�: reprogramming, genetic engineering, and cell differentiation

� Currently contracted to establish and bank iPS cells from over 3000 people via CIRM (USA)*1

� 2 cGMP HLA superdonor iPSC lines established� Currently contracted to establish and bank iPS cells from over 3000 people via CIRM (USA)*1

� 2 cGMP HLA superdonor iPSC lines established

� 12 types of iPS cell-derived differentiated cells can be used to treat over 50 diseases� Providing US NEI*2 with retinal pigmented cells for preclinical studies in the treatment

of age-related macular degeneration

� 12 types of iPS cell-derived differentiated cells can be used to treat over 50 diseases� Providing US NEI*2 with retinal pigmented cells for preclinical studies in the treatment

of age-related macular degeneration

Strengths and Features of CDIStrengths and Features of CDI

� Patent portfolio includes over 800 entities (includes licences and pending patents)� Awarded US patent covering automated production of iPSC’c�� Patent portfolio includes over 800 entities (includes licences aPatent portfolio includes over 800 entities (includes licences and pending patents)nd pending patents)� Awarded US patent covering automated production of iPSC’c

Merging University of Wisconsin-Madison's iPS cell technology with CDI's unique iPS cell culturing technology

Rich product line from iPS cell-derived differentiated cells

Pioneer in iPS cell banking

Applying iPS cells to Cell Therapy

*1 : California Institute for Regenerative Medicine *2 : National Eye Institute

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������������� ����������������������� ����������

�Functional cosmetics, Supplements, Pharmaceuticals, Regenerative medicine)

����������������

������������������������

���� ���� ���� ����

����

���

����������������

������������������������

���� ���� ���� ����

����

���

����������������

������������������������

���� ���� ���� ����

����

���

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������������������������

���� ���� ���� ����

����

���

FujifilmFujifilm’’ Core Technologies Core Technologies

Materials to Materials to capture lightcapture light

Highly Highly Functional Functional MaterialsMaterials

������������

EngineeringEngineering Revolutionary Revolutionary ValueValue

Materials to Materials to make colorsmake colors

Materials to Materials to create reaction fieldcreate reaction field

CouplerCoupler

ColorColor--fade fade inhibitorinhibitor

�����

����������������

�����

��������������������������������

�����

����������������

�����

����������������

Electron micrograph(Before development)

Optical micrograph(After development)

SensingSensing

MemoryMemory

DisplayDisplay

11

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Strengths and Strengths and Characteristics of Characteristics of Fujifilm GroupFujifilm Group

CellsCells

Three main pillars of Three main pillars of regenerative medicineregenerative medicine

Created first Created first regenerative medicine regenerative medicine productproducts in Japans in Japan

Autologous cultured epidermis

Autologous cultured cartilage

ScaffoldScaffold((extracellular matrix extracellular matrix ))

20072007 20122012

(intercellular signaling compound)Cytokines

Petaloid: meaning “petal-like”

Request Request itemitem

R&D, R&D, Clinical TrialsClinical Trials

ManufactureManufactureInspectionInspection

SalesSales UseUseGVPGQPGPSP

GCTPGQP

GLP, GCPApplication for Drug approval Post-marketing care

Feedback

Quality Management System supported by experience

Realization of nonRealization of non--animal derived animal derived scaffolding materialscaffolding material

1cm1cm

GranulesGranules SpongeSponge

Engineering TechnologyEngineering Technology

3D Cell Structure3D Cell Structure““CellsaicCellsaic””

Highly Functional Highly Functional Material TechnologyMaterial Technology

Yeast

RCP Gene Introduction

Lyophilized RCP

��������

High Added ValueHigh Added Value

Cultivate, Refine

Microscopic Petaloid Pieces

Combine Combine with Cellswith Cells

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Anticipated Technology SynergyAnticipated Technology Synergy

��

��

��

��

��

��

Extracellular matrixExtracellular matrix

Engineering TechnologyEngineering Technology

Reprograming/ differentiation

Reprograming/ differentiation

iPS cellsiPS cells

Quality managementQuality management

Somatic cell/Stem cellSomatic cell/Stem cell

FUJIFILM & CDI: Expand drug discovery supportFUJIFILM & CDI: Expand drug discovery support

J-TEC & CDI : Development of contract cell culturingJ-TEC & CDI : Development of contract cell culturing

FUJIFILM & CDI & J-TEC: Organ regeneration R&DFUJIFILM & CDI & J-TEC: Organ regeneration R&D

Combined with FUJIFILM’s extracellular matrix(Recombinant Peptide: RCP) enhanced performance materials can be used to create 3D structures, expanding drug discovery opportunities.

Together with quality management systems (GCTP/GQP, etc.) nurtured through J-TEC’s regenerative products, iPS cell banking and contract cell culturing for use in cell therapy.

Combine technology from these 3 companies and develop organ regenerative treatments enabling transplantation of a 3D cell structured organ mimic.� technologies developed during drug discovery support will flow back to regenerative medicine.

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SelfSelf--organizationorganizationStructuring /OrderingStructuring /Ordering

Simulated Bioorganism

StructuringLow moleculeLow moleculecompoundcompound

Single cellSingle cellSingle cell type Single cell type

tissuetissue::Heart (Heart (myocardiummyocardium), ),

Nerves,Nerves,Skin (epithelium), Skin (epithelium),

CartilageCartilage

Organs comprisingOrgans comprisingvarious cell types:various cell types:

LiverLiverPancreasPancreasKidneysKidneys

Low Molecule Drugs Organ Regeneration Therapy

Biopharmaceuticals Cell Therapy / Tissue Regeneration Therapy

BiopolymerBiopolymer

Insulin, AntibodyInsulin, Antibody

Use natural healing properties of bioorganismsUse natural healing properties of bioorganismsActs on a bioorganism

Candesartan(angiotensin�receptor antagonist)

MW: <1,000Size: � 3-4 nm

Size: 3-4 μm to 3-4cm

Cell

Size: � 3-4 cm

organInsulin Antibody

MW: order of 103 to 105

Size: 1 to 10 nmExtracellular matrix

Symptomatic Symptomatic TreatmentTreatment

Curative Curative TherapyTherapy

Fujifilm Group Fujifilm Group Goals in RGoals in Regenerative Medicineegenerative Medicine

Single Low Molecule �

Single Target

�Non-interactive� Single Polymer �Single/Multiple Targets

�Non-interactive�

Single Cell / Tissue � Body Tissue

Multiple Cells / Organ� Body Tissue

�Interactive�

�Interactive�First Wall Second Wall

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Overview of the AcquisitionOverview of the Acquisition

15

Method: Tender offer for common stock of CDI by a special purpose company formed as a wholly-owned subsidiary of Fujifilm’s U.S. holding company(If necessary, following the tender offer, exercise of top-up option to acquire new shares), followed by a short-form merger

Price: USD 16.5 per shareRepresents a 108% premium over the USD 7.94 closing price on March 27.

Total value Approximately 307 million USD (fully-diluted basis)

Offer period: Commences within 5 business days after March 30, 2015Ends 20 business days from commencement(subject to extension)

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CAUTIONARY STATEMENT ABOUT FORWARD-LOOKING STATEMENTSThis presentation contains certain statements which constitute “forward-looking statements”. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Many of these risks and uncertainties relate to factors that are beyond Fujifilm’s and CDI’s abilities to control or estimate precisely, such as future market conditions, the behaviors of other market participants, the effects of the transaction making it more difficult to maintain existing relationships with employees, customers or business partners, and other business effects, including the effects of industry, economic or political conditions, and therefore undue reliance should not be placed on such statements. Examples of forward-looking statements in this press release include, but are not limited to, statements regarding the proposed acquisition of CDI by Fujifilm, such as: the timing of the tender offer and the merger; results of the review of the transaction by regulatory agencies, and any conditions imposed in connection with consummation of the transaction; and satisfaction of various other conditions to the closing of the transaction. Actual results may differ materially from those in the forward-looking statements. For information regarding other related risks, please see the “Risk Factors” section of CDI’s filings with the Securities and Exchange Commission (the “SEC”), including its most recent filings on Form 10-K and Form 10-Q. CDI and Fujifilm assume no obligation to update these forward-looking statements, except as required pursuant to applicable law.

NOTE TO INVESTORS The tender offer to purchase shares of CDI common stock referenced in this press release has not yet commenced, and this press release is neither an offer to purchase, nor a solicitation of an offer to sell, any securities. The tender offer to purchase shares of CDI common stock will be made only pursuant to a Tender Offer Statement on Schedule TO containing an offer to purchase, forms ofletters of transmittal and other documents relating to the tender offer (the “Tender Offer Statement”), which Fujifilm will file with the SEC and mail to CDI stockholders. At the time the tender offer is commenced, CDI will file a Solicitation / Recommendation Statement on Schedule 14D-9 with respect to the tender offer (the “Recommendation Statement”). Investors and security holders of CDI are advised to read the Tender Offer Statement and Recommendation Statement carefully when they become available, before making any investment decision with respect to the tender offer because they will contain important information about the tender offer. Investors and security holders of CDI also are advised that they may obtain free copies of the Tender Offer Statement and otherdocuments filed by Fujifilm with the SEC (when these documents become available) and the Recommendation Statement and other documents filed by CDI (when these documents become available) on the SEC’s website at http://www.sec.gov. In addition, free copies of the Tender Offer Statement and related materials may be obtained (when these documents become available) from Fujifilm’s website at http://www.fujifilmholdings.com/en/investors/index.html; and free copies of the Recommendation Statement and related materials may be obtained (when these documents become available) from CDI’s website at www.cellulardynamics.com.