corporate presentation cmic co.,...

CMIC Co., Ltd.CMIC Co., Ltd.

Corporate Presentation Corporate Presentation

2

Amgen, Takeda To Collaborate On Drug 　　　　 Candidates In Japan Feb. 4,2008

Amgen, Takeda To Collaborate On Drug 　　　　 Candidates In Japan Feb. 4,2008

Amgen and Takeda Pharmaceutical Co. Ltd. entered an agreement under which Takeda will develop and commercialize as many as 13 molecules from Amgen's pipeline for the Japanese market.

Fujifilm Holdings said it would take control of Toyama Chemical for up to 155 billion yen ($1.45 billion) to gain a foothold in the pharmaceuticals market.

Fujifilm to Bid for Toyama Chemical Feb. 13,2008Fujifilm to Bid for Toyama Chemical Feb. 13,2008

Impact on CMIC?

Current TopicsCurrent Topics

3

•Efficacy and safety test on animals•Tests on CMC(Chemistry, Manufacturing and Controls)

•NDA Process

Pre-ClinicalStudy

Pre-ClinicalStudy

ClinicalTrials

ClinicalTrials

22--33yearsyears

ApplicationApprovalLaunch


ClinicalTrials

ClinicalTrials



CoreResearch

33--55yearsyears

33--77yearsyears

11--22yearsyears

44--1010yearsyears

•New chemical compounds discovery•NEC/new biologics candidates selection/screening

CTN(Clinical Trial Notification)•Phase I Studies•Phase II Studies•Phase III Studies

•Broad-based follow-up study on safety

Pharmaceutical R&D and Approval ProcessPharmaceutical R&D and Approval Process

Post-MarketingSurveillance

(PMS)


(PMS)


(PMS)


(PMS)

4

Change of the clinical trial environment in Japan　 Acceleration of outsourcing to CROs

Importance of CRC (Clinical Research Coordinator)

Acceptance of international dataIncrease of the Bridging studies

Partial liberalization of the advertisement for ethical drugsInitiation of the Patient Recruitment Business　

Change of the clinical trial environment in JapanChange of the clinical trial environment in Japan　Acceleration of outsourcing to CROsImportance of CRC (Clinical Research Coordinator)

Acceptance of international dataAcceptance of international dataIncrease of the Bridging studies

Partial liberalization of the advertisement for ethical drugsPartial liberalization of the advertisement for ethical drugsInitiation of the Patient Recruitment Business　

to secure ethical,scientific and reliable clinical trials

（March 1997）　　Adoption of “ICH-GCP”,

the international standard for clinical trials

（March 1997）　　Adoption of “ICH-GCP”,

the international standard for clinical trials

Impact of Revision to The Pharmaceutical Affairs LawImpact of Revision to The Pharmaceutical Affairs Law

5

CRO market CRO market

CMIC as the first CRO in Japan

JCROA(Japan CRO Association) Founded in 1994　　　

Total Number of Members ：41 Companies

2006 Sales and Employees;

Total Sales JPN 123,478 million Total:# of employees:11,553

　　Outsourcing Rate 15～20％

Top 3 companies have a majority

CMIC as the first CRO in Japan

JCROA(Japan CRO Association) Founded in 1994　　　

Total Number of Members ：41 Companies

2006 Sales and Employees;

Total Sales JPN 123,478 million Total:# of employees:11,553

　　Outsourcing Rate 15～20％

Top 3 companies have a majority

Corporate ProfileCorporate Profile

7

Corporate ProfileCorporate Profile

　CMIC Co., Ltd.

　Founded in 1985

　CEO: Kazuo Nakamura

　Service: CRO (Contract Research Organization)

CMO (Contract Manufacturing Organization)

CSO (Contract Sales Organization)

　Consolidated results in FY 2007 (ended Sep 30, ‘07)　

Sales: 21,616 millions of yen ($202.02 millions)

Operating Income: 2,160 millions of yen ($20.19 millions)

Net Income: 1,198 millions of yen ($11.20 millions)

Number of Employees: 1,921

　CMIC Co., Ltd.

　Founded in 1985

　CEO: Kazuo Nakamura

　Service: CRO (Contract Research Organization)


CSO (Contract Sales Organization)

　Consolidated results in FY 2007 (ended Sep 30, ‘07)　

Sales: 21,616 millions of yen ($202.02 millions)

Operating Income: 2,160 millions of yen ($20.19 millions)

Net Income: 1,198 millions of yen ($11.20 millions)

Number of Employees: 1,921

(USD to JPY: 107 yen)

8

CMICCMIC　　HQHQ

KyushuKyushu　　BranchBranch

Institute of Applied Medicine, Inc.(Lab.Sapporo,Ishikari)(Lab.Sapporo,Ishikari)

CMIC SS CMO Co., Ltd.

Domestic basesDomestic bases

Kagoshima OfficeKagoshima Office

ChugokuChugoku　　BranchBranch

Takamatsu OfficeTakamatsu Office

HokurikuHokuriku　　BranchBranch

NagoyaNagoya　　BranchBranch

OsakaOsaka　　BranchBranch

TohokuTohoku　　BranchBranch

HokkaidoHokkaido　　BranchBranch

9

CMIC BRASILCMIC BRASIL　　

CMIC KoreaCMIC Korea　　CMIC(Beijing)CMIC(Beijing)　　

CMIC CMO KoreaCMIC CMO Korea

ShanghaiShanghai

CMIC AsiaCMIC Asia--PacificPacific

TaiwanTaiwan

Overseas basesOverseas bases

CMICCMIC--VPSVPS　　

10

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008E

5,000

10,000

15,000

20,000

25,000

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

02468101214161820

30,000

0 0

Ordinary Income

Ratio of ordinary　

Income

(％)Sales

In 2005Revised PAL:Pharmaceutical

Affairs Law

New GCP

SalesOrdinary IncomeRatio of Ordinary Income

Performance (Consolidated basis) Performance (Consolidated basis)

((millions of yen)millions of yen)


11

920

710614

501389

241156

831

403

286

221

85

8

31

0

200

400

600

800

1,000

1,200

1,400

1,600

Dec.2000 Dec.2001 Dec.2002 Dec.2003 Dec.2004 Dec.2005 Dec.2006 Dec.2007E 2008?

Affiliated companiesMember

156249

420586

835

1,500

996

1,234

＿＿＿＿＿＿＿

Source:Japan CRO Association

excluding pre-clinical (2000-2003)

Japan CRO Market (excluding CSO) Japan CRO Market (excluding CSO)

（Yen 100 millions）

69%

40%

Growth rate 60%

42%

Growth % is CRO+SMO combined 19%

24%

Market share:18%Market share:18%

12

2,259

1,921

10 12 19 58 105138 173

322

500

658

880

1,197

1,503

1,743

0

500

1000

1500

2000

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

ENumber of EmployeesNumber of Employees

（Number of employees）

Industry trend and business domainIndustry trend and business domain

14

DrugDiscovery

DrugDiscovery

Pharmaceuticalcompanyof JAPAN


Development& Approval

Development& Approval ManufacturingManufacturing MarketingMarketing Sales,

DistributionSales,

Distribution

DrugDiscovery

DrugDiscoveryBio-TechBio-Tech Development

& ApprovalDevelopment& Approval MarketingMarketing Sales,

DistributionSales,

DistributionManufacturingManufacturing

Sales-FocusedSales-Focused Sales, Distribution

Sales, Distribution

DrugDiscovery

DrugDiscovery


Development& Approval MarketingMarketingManufacturingManufacturing

ManufacturingManufacturingDisease- Specialized Disease-

SpecializedDrug

DiscoveryDrug

DiscoveryDevelopment& Approval Marketing

Sales, Distribution

CMIC GroupCMIC Group

Our Business　- Pharmaceutical Value Creator -Our Business　- Pharmaceutical Value Creator -

15

DrugDiscovery

DrugDiscovery




Development& Approval ManufacturingManufacturing MarketingMarketing Sales,

DistributionSales,

Distribution

DrugDiscovery

DrugDiscoveryBio-TechBio-Tech Development

& ApprovalDevelopment& Approval MarketingMarketing Sales,

DistributionSales,

DistributionManufacturingManufacturing

Sales-FocusedSales-Focused Sales, Distribution

Sales, Distribution

DrugDiscovery

DrugDiscovery


Development& Approval MarketingMarketingManufacturingManufacturing

ManufacturingManufacturingDisease- Specialized Disease-

SpecializedDrug

DiscoveryDrug

DiscoveryDevelopment& Approval Marketing

Sales, Distribution

Manufacturing

ManufacturingManufacturing



Marketing

Marketing

MarketingMarketing

MarketingMarketing

Sales, Distribution

Sales, Distribution

Sales, Distribution

Sales, Distribution

Sales, Distribution







CMIC GroupCMIC Group

Our Business　- Pharmaceutical Value Creator -Our Business　- Pharmaceutical Value Creator -

DrugDiscovery

DrugDiscovery

DrugDiscovery

DrugDiscovery

16

CMIC Co., Ltd.CMIC-CP Co., Ltd.

CMIC-CRC Co., Ltd.

Institute of Applied Medicine, Inc.

CMIC Korea Co., Ltd.

CMIC (Beijing) Co., Ltd.

CMIC BRASIL PESQUISAS CLÍNICAS LTDA.

CMIC Asia-Pacific,Pte. Ltd.

CMIC SS CMO Co., Ltd.

CMIC CMO Korea Co., Ltd.

MDS Co., Ltd.

•Consulting•Monitoring•Data Management•STAT Analysis

CRO Company

•Quality Control•Medical Writing•Pharmacovigilance•Business Development

CRO

Specified worker dispatchingundertaking for pharmaceutical fields

SMO/CRC（Clinical Research Coordinator）

Stability and QualityDetermination of drug concentrationMicrobiology

CRO (As an Asian Basis)


SMO ・Clinical Research Center

Manufacturing Pharmaceutical Products

Manufacture, Import/Export and Sale of Pharmaceutical Products (Korea)

Designing and Producing Medical Communication Tool

Dispatched MR MR educational trainingResearching & ConsultingBusiness Development

CRO

Manufacturing Pharmaceutical Products（U.S.A.)

CMIC Group　– Pharmaceutical Value CreatorCMIC Group　– Pharmaceutical Value Creator

CMIC MPSS Co., Ltd.

CMIC-VPS Corporation


CMO CSO

17

Healthclick Co.,Ltd.Provision of disease Information through WEBSupporting clinic and patients linkSupporting patient recruitment

Outsourcing of various administrative functionsStaff agency for medical related

CMIC Group – Healthcare Value CreatorCMIC Group – Healthcare Value Creator

CMIC-BS Co.,Ltd.

FUJIFILM CMIC Healthcare Co., Ltd.supporting the development of Fujifilm’s life science business

Healthcare

((Equity method affiliate))

18

Sales by operating segmentsSales by operating segments

2006200617,55717,557

2007200721,61721,617

2008/2008/EE25,04425,044

((millions of yen)millions of yen) ((millions of yen)millions of yen) ((millions of yen)millions of yen)

CRO

CROCRO

CMO

CMO

CMO

CSO/ Others

CSO/ Others CSO/

Others

19

•Market assessment•Regulatory roadmap•Bridging, Orphan•Partnering•Japan Office setup•HR infrastructure

•Strategy consultation•Authorities meetings•Identifying doctors/sites•IB, Protocol, CRF, IC•DMF (Apr. 2005)•Licensing

•Patient recruitment•Site/CRC/SMO mgmt.•Monitoring•Data and statistics•Clinical Study Report•Contract CRA•Audit•Trials in Korea and China

•Application dossier (CTD)•Responses to authorities•Reimbursement price

•Marketing Plan•Promotion strategy•Contract MR•Pharmacovigilance

FeasibilityFeasibility ConsultationConsultationClinicalTrials

ClinicalTrials

NDANDA

Services - Strategic Partner -Services - Strategic Partner -

ApprovalLaunch

ApprovalLaunch

DMF: Drug Master FileCTD: Common Technical DocumentMR: Medical Representative

20

Grant of Rx drug and NonGrant of Rx drug and Non--Rx drug marketing business licenseRx drug marketing business license

New Business ModelNew Business Model

Japan KKJapan KK

Overseas pharmaceutical companies

found

Support

Approval,SalesDevelopmentDevelopmentCMIC Group

Another pharmaceutical

companyApproval,Sales

Overseas & domestic pharmaceutical companies,　

bio-venture

DevelopmentDevelopmentCMIC Group

Another pharmaceutical

company

Contractsales

Development, Development, Approval, Approval,


Overseas & domestic pharmaceutical companies, 　bio-venture

CMIC Group

Development,Manufacturing,SalesDevelopment,Manufacturing,Sales

Overseas & domestic pharmaceutical companies, 　bio-venture

Company X: Marketing ApprovalCMIC Group

CRO (Contract Research Organization)

CRO (Contract Research Organization)

22

PatientPatient

CROCRO

SMOSMO

Clinical siteClinical sitePharmaceuticalPharmaceuticalcompanycompany

Application of the clinical study

Site MonitoringAudit

Case report

Contract

・Clinical research coordinatorObtain Informed Consent

Care for patients etc.

explain Informed consent

Structure of clinical studyStructure of clinical study

IRBIRB

・Clinical Research Associate

・Investigator

Situation of　Clinical studySituation of　Clinical study

24

Clinical Research / MonitoringClinical Research / Monitoring

CNS(CentralNervous System)

Sensory Organs

Cardiovascular

Respiratory OrgansDigestive Organs

HormonesEpidermis

Blood and BodyFluidesMetabolism

AntineoplasticsAntiallergic Agents

Chemotherapeutics

BiologicalPreparations

Urology

Non TherapeuticPurpose

Other

Prior Preparation

Medical Device

We have 500 CRAs / Monitors, one of the largest number in Japan.

Total Number of Protocols; 170 (including Prior Preparation)

Based on year Oct,1997-Ｓｅｐ,2007 accomplishments.

25

6,7698,127

9,269

2,299

2,789

3,1712,231

2,027

2,010

498

903

991

1,203

1,437

1,538

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

2005/9 2006/9 2007/9

Pre-clinicalConsulting,OthersCRC

Data managementClinical monitoring

1,555 1,557

1,867

12.0%

11.0%

10.2%

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2,200

2005/9 2006/9 2007/9

5.0%

7.0%

9.0%

11.0%

13.0%

15.0%

Operating income

Ratio of operatingincome

+1,142

+382

-18

+88

+101

13,000

15,283

16,978

Sales & Operating IncomeSales & Operating Income CRO

((millions of yen)millions of yen) ((millions of yen)millions of yen)

26

Sales: MonitoringSales: Monitoring

5,9926,769

8,127

9,269

10,561

0

2,000

4,000

6,000

8,000

10,000

12,000

'04/9 '05/9 '06/9 '07/9 '08/9E

MonitoringMonitoring

Over 15% yearly sales growth

Largest monitors team in Japan

High-level monitors familiar with New GCP

Sophisticated education program

Phase II, III,IV

Unique nation-wide office network

Over 15% yearly sales growth

Largest monitors team in Japan

High-level monitors familiar with New GCP

Sophisticated education program

Phase II, III,IV

Unique nation-wide office network

Monitoring Monitoring of clinical trials to check the process, records and reporting to comply with new GCP

Monitoring Monitoring of clinical trials to check the process, records and reporting to comply with new GCP


27

1,968

2,298

2,789

3,1713,304

0

500

1,000

1,500

2,000

2,500

3,000

3,500

'04/9 '05/9 '06/9 '07/9 '08/9E

Data ManagementData Management

20 years of experience

Strong expertise in statistics and epidemiology

Pharmacovigilance Service

Application of IT, with accumulated knowledge

Support for doctor-leading clinical research, as independent business

20 years of experience

Strong expertise in statistics and epidemiology

Pharmacovigilance Service

Application of IT, with accumulated knowledge

Support for doctor-leading clinical research, as independent business

Sales: Data ManagementSales: Data Management((millions of yen)millions of yen)

Data Management Data verification and database construction of clinical trials, and statistical analysis

Data Management Data verification and database construction of clinical trials, and statistical analysis

28

CRCCRC

Started the first CRC service in Japan, since 1996

230 (approximately) Clinical Research Coordinators are available

Nation-wide NetworkHokkaido,Tohoku,Nagoya,Osaka,Hokuriku,Tokyo,Kyusyu,Chugoku,Shikoku

High expertise as CRCsQualified as NurseUnique training & Certification system

Started the first CRC service in Japan, since 1996

230 (approximately) Clinical Research Coordinators are available

Nation-wide NetworkHokkaido,Tohoku,Nagoya,Osaka,Hokuriku,Tokyo,Kyusyu,Chugoku,Shikoku

High expertise as CRCsQualified as NurseUnique training & Certification system

Sales: CRCSales: CRC

1,920

2,231

2,027 2,010

2,351

0

500

1,000

1,500

2,000

2,500

'04/9 '05/9 '06/9 '07/9 '08/9E

((millions of yen)millions of yen)CRC

Coordination of clinical trials with medical doctors, based on patient’s informed consent

CRC Coordination of clinical trials with medical doctors, based on patient’s informed consent

29

Consulting and Other ServicesConsulting and Other Services

520 498

903991

1,175

0

200

400

600

800

1,000

1,200

1,400

'04/9 '05/9 '06/9 '07/9 '08/9E

Wide Range ServicesICCCDevelopment strategy Product concept designInternational development projectSupport for approval applicationData review and documentation(including FDA, IND, NDA)Strategy and support for drug import, and legal affairs

High-level consulting ability, accumulated experiences and know-how

Close-relationship with authorities and clients

Wide Range ServicesICCCDevelopment strategy Product concept designInternational development projectSupport for approval applicationData review and documentation(including FDA, IND, NDA)Strategy and support for drug import, and legal affairs

High-level consulting ability, accumulated experiences and know-how

Close-relationship with authorities and clients

Sales: Consulting and Other servicesSales: Consulting and Other services((millions of yen)millions of yen)

Consulting services Consulting, from drug development to distribution (support for administrative approval, strategic advisory)

Consulting services Consulting, from drug development to distribution (support for administrative approval, strategic advisory)

30

Pre-ClinicalPre-Clinical

1,203

1,4371,538

2,175

0

500

1,000

1,500

2,000

2,500

'04/9 '05/9 '06/9 '07/9 '08/9E

Pre-clinical Works Stability tests,microorganism tests,drug concentration tests.

Pre-clinical Works Stability tests,microorganism tests,drug concentration tests.

Sales: PreSales: Pre--clinicalclinical((millions of yen)millions of yen)

business started ↓

Stability tests with medical drugs include long-term storage tests, acceleration tests, severe tests, light stability tests and relative comparison tests.

Stability tests with medical drugs include long-term storage tests, acceleration tests, severe tests, light stability tests and relative comparison tests.

32

Full Outsourcing to drug manufacture　　GMP　Shift manufacturing department into subsidiary

outsourcing to CMO

Strengthening product quality controlGQP　Increase in quality assurance business

Strengthening safety control　GVP　Strengthening of post-marketing surveillance　

Increase in number of clinical studies

Full Outsourcing to drug manufactureFull Outsourcing to drug manufacture　　GMP　Shift manufacturing department into subsidiary

outsourcing to CMO

Strengthening product quality controlStrengthening product quality controlGQP　Increase in quality assurance business

Strengthening safety controlStrengthening safety control　GVP　Strengthening of post-marketing surveillance　

Increase in number of clinical studies

Importance of product quality control and safety management

Strengthening

（April.2005）　　”Manufacturing Approval” ⇒　”Marketing Approval”（April.2005）　　”Manufacturing Approval” ⇒　”Marketing Approval”

Impact of Revision to The Pharmaceutical Affairs LawImpact of Revision to The Pharmaceutical Affairs Law

33

CMIC CMO Korea Co., Ltd. -Korea-CMIC CMO Korea Co., Ltd. -Korea-

In 2005,

CMIC acquired 90%

from SS pharmaceutical Co.,Ltd.

Employee：30 Ointment,Fluid medicine,internal solid medicineKey item：Ginseng sahmool tang etc.(14 item)

34

Employee：52　　 Ointment,Cream,Suppository,Cachet etc.　

Ethical drug account for approximately half of products.Number of item In 2006 ：61 Key item：OTC drugs 38／Ethical drugs 17／Quasi drugs 6　

CMIC SS CMO Co., Ltd.CMIC SS CMO Co., Ltd.

In Autumn 2006,Acquisition of plant in Toyama Japan

35

CMIC-VPS CorporationCMIC-VPS Corporation

Clinical manufacturingClinical manufacturing

In 2007,

CMIC acquired 86%

from Freund Corporation

Company name:CMIC-VPS CorporationLocation:Cranbury, NJ U.S.AFoundation:2001

36

Outline of CMIC-VPS CorporationOutline of CMIC-VPS Corporation

cGMP facility : Possession of the U.S. FDA approved factory

Manufacturing of Investigational Drugs : Facility being appropriate for small volume / large number investigational drug manufacturing and quality analysis

Commercial Manufacturing : Starting from 2008

Efficient Operation : Facility efficiently operated with minimumoperators and support staff

cGMP facility : Possession of the U.S. FDA approved factory

Manufacturing of Investigational Drugs : Facility being appropriate for small volume / large number investigational drug manufacturing and quality analysis

Commercial Manufacturing : Starting from 2008

Efficient Operation : Facility efficiently operated with minimumoperators and support staff

37

456 484

1,926

0

500

1,000

1,500

2,000

2,500

2005/9 2006/9 2007/9

CMIC SS CMO

CMIC CMO Korea

43

127

5.3%

9.5%

0

30

60

90

120

150

2005/9 2006/9 2007/9

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

16.0%Operating income


CMO business started ↓

+28

456

2,410

Sales & Operating Income CMO

((millions of yen)millions of yen) ((millions of yen)millions of yen)

CSO (Contract Sales Organization)　

CSO (Contract Sales Organization)　

39

■ Marketing Communication and Sales Promotion Contract-MR（Medical Representative）:MR outsourcing servicesMedical Communication PlanningCreating Materiel for Promotion and Sales

■ MarketingMarketing ResearchConsultation

■ Training and EducationTraining and Educationfor MR

CSO:Contract Sales OrganizationCSO:Contract Sales Organization

8

25

1415

10

3

0

20,000

40,000

60,000

80,000

100,000

120,000

USA England France Germany Japan Canada

0

5

10

15

20

25

30

Number of C-MRs

Number of MRs

% of C-MR

≪Proportion of C-MRs to total MRs (2004)≫

Source : DMS

40

MDS　- Medical CommunicationMDS　- Medical CommunicationAcademic support for medical writing, translation and submission for publication

Advertisement, material planning and production for patient education

Planning and production of informational materials targeting physicians and healthcare workers

Planning and production of detailing tools for education and training of MRs

Planning and production of periodicals and PR brochures

Communication strategy planning, planning and development of product advertisement and product promotion materials

41

194334 378

477

1,1101,162

357

374

689

0

500

1,000

1,500

2,000

2,500

2005/9 2006/9 2007/9

Others

MDS

Dispatched MR,MReducat ional t rain ing

-168

-57

160

5.7%

-200

-150

-100

-50

0

50

100

150

200

2005/9 2006/9 2007/9

-10.0%

-8.0%

-6.0%

-4.0%

-2.0%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

Operating income


+44

+52

+315

1,027

1,818

2,229

Sales & Operating IncomeSales & Operating Income CSO/Others

((millions of yen)millions of yen)((millions of yen)millions of yen)

Medical and Healthcare Service

Medical and Healthcare Service

Healthclick Co., Ltd.

43

site views 11 million/month1.4 million Unique Users

Information support business to pharmaceutical companies, hospitals and patients

Healthclick　Support to pharmaceutical companies, hospitals and patients Healthclick　Support to pharmaceutical companies, hospitals and patients

Clinical Clinical StudyStudy

Patient recruitment

Patient follow-up

Health and nutrition consultation

Medical Call Center

Marketing Research

44

Sales & Operating Income (healthclick)Sales & Operating Income (healthclick)

146

821

-72

398

694

90

0

95

-200

0

200

400

600

800

1,000

2005/9 2006/9 2007/9 2008/9E

Sales

Operating income


IPD (Intellectual Property Development)

IPD (Intellectual Property Development)

46

Applied for Marketing Approval of L- FABP diagnostic for predicting the progression of renal diseases (Sep. 2006)

Development of　L-FABPDevelopment of　L-FABP

47

L-FABP project targets at Kidney diseasesL-FABP project targets at Kidney diseases

Number of patients with Number of patients with dialysis treatmentdialysis treatment

JapanJapan：：219,183219,183U.S.AU.S.A：：292,215292,215

A chronic kidney disease is the greatest risk factor of cardiovascular diseases. A chronic kidney disease is the greatest risk factor of cardiovascular diseases.

In 2003, Kidney disease conquest campaign began in the U.S.A.

American Heart Association(AHA)American Heart Association(AHA)statement Circulation 2003,Oct.28statement Circulation 2003,Oct.28

Number of patients with chronic renal diseases is increase on a global basis10.8% of population, about 20 million is suffering from early kidney disease in the U.S.A.In the year 2010, 650,000 will be in the late stage of renal failure（dialysis treatment or dysfunction of kidneys )The likelihood of the development of cardiovascular diseases for patients with chronic renal diseases is ten to thirty times, comparing to general population.

48

American Society of Nephrology in 2007American Society of Nephrology in 2007L-FABPL-FABP

SummarySummary

50

HHealthcareealthcare

VValuealue CCreatorreator・Patient oriented

healthcare services

・Disease management

CROConventional CRO Group of

skilled individualsWorking on

pharmaceuticaldevelopment

CROCROConventional CRO Group of

skilled individualsWorking on

pharmaceuticaldevelopment

Pharmaceutical

Value Creator

Contribution to growing pharma industry

PPharmaceuticalharmaceutical

VValuealue CCreatorreator

Contribution to growing pharma industry

　　　　　

Corporate Value ＝Sustainable Profit

CMIC’s VisionCMIC’s Vision

51

SummarySummaryPVC model

Consulting capability and wide-range coverage of CMIC groupTotal support for pharmaceutical companies, including ones foreign-owned and entered from other industries

Top leading CRO in Asia

Established competitive advantagesStrategy & regulatory consultingPharmacovigilance (Support to collect, evaluate and analyze drug safety information)

Aggressive challenges for new business frontiers

Global business strategy

High potentiality in the Japanese CRO market

Highly skilled management team

PVC modelConsulting capability and wide-range coverage of CMIC groupTotal support for pharmaceutical companies, including ones foreign-owned and entered from other industries

Top leading CRO in Asia

Established competitive advantagesStrategy & regulatory consultingPharmacovigilance (Support to collect, evaluate and analyze drug safety information)

Aggressive challenges for new business frontiers

Global business strategy

High potentiality in the Japanese CRO market

Highly skilled management team

Financial DataFinancial Data

53

Sales & Operating IncomeSales & Operating Income

13,00015,283

16,978

1,027

1,818

2,229

456

2,410

0

5,000

10,000

15,000

20,000

25,000

2005/9 2006/9 2007/9

CSO/Others

CMO

CRO

2,160

1,5531,394

8.8%

10.0%9.9%

0

500

1,000

1,500

2,000

2,500

2005/9 2006/9 2007/9

7.0%

8.0%

9.0%

10.0%

11.0%Operating Oncome


14,028

17,557

21,617

+1,954

+411

+1,696

((millions of yen)millions of yen)((millions of yen)millions of yen)

54

Amount % Amount %

Sales 17,557 100.0% 21,617 100.0% 23.1%

Gross operating Income 5,251 29.9% 6,356 29.4% 21.0%

Selling, general andadministrative expenses 3,698 21.1% 4,196 19.4% 13.5%

Operating income 1,553 8.8% 2,160 10.0% 39.1%

Ordinary income 1,613 9.2% 2,153 10.0% 33.5%

Net Income 1,004 5.7% 1,198 5.5% 19.3%

Growthrate

Sep.2007Sep.2006Amount % Amount %

Sales 17,557 100.0% 21,617 100.0% 23.1%

Gross operating Income 5,251 29.9% 6,356 29.4% 21.0%

Selling, general andadministrative expenses 3,698 21.1% 4,196 19.4% 13.5%

Operating income 1,553 8.8% 2,160 10.0% 39.1%

Ordinary income 1,613 9.2% 2,153 10.0% 33.5%

Net Income 1,004 5.7% 1,198 5.5% 19.3%

Growthrate

Sep.2007Sep.2006

Annual results of the FY ending Sep.2007 (Consolidated)Annual results of the FY ending Sep.2007 (Consolidated)


55

Business DomainsBusiness Domains

Monitoring(42.9%)

Data Management (14.7%)CRC

(9.3%)

Consulting and Others

(4.6%)

Consolidated sales ratio (Sep 2007)

Stable business structure based on the Three domains below:

CRO（Contract Research Organization)

Monitoring

Data Management

CRC (Clinical Research Coordinator)

Strategy & Regulatory Consulting, and Others

Ｐｒｅ-Clinical

CMO（Contract Manufacturing Organization）

CSO（Contract Sales Organization）

CRO（Contract Research Organization)

Monitoring

Data Management

CRC (Clinical Research Coordinator)

Strategy & Regulatory Consulting, and Others

Ｐｒｅ-Clinical

CMO（Contract Manufacturing Organization）

CSO（Contract Sales Organization）Total 21.6 billions of yen　(Oct 2006 - Sep 2007)

CSO/Others(10.3%)

Pre-clinical(7.1%)

CMO(11.1%)

CRO(78.6%)

56

Amount % Amount %

Clinical Monitoring 8,127 46.3% 9,269 42.9% 1,142 14.1%

Data Management 2,789 15.9% 3,171 14.7% 382 13.7%

CRC 2,027 11.5% 2,010 9.3% (18) -0.9%

Consulting,Others 903 5.1% 991 4.6% 88 9.8%

Pre-clinical 1,437 8.2% 1,538 7.1% 101 7.0%

CRO 15,283 87.0% 16,978 78.5% 1,696 11.1%

CMO 456 2.6% 2,410 11.1% 1,954 428.4%

CSO/Others 1,818 10.4% 2,229 10.3% 411 22.6%

Total 17,557 100.0% 21,617 100.0% 4,060 23.1%

Sep.2006 Increase/Decrease

Growthrate

Sep.2007Amount % Amount %

Clinical Monitoring 8,127 46.3% 9,269 42.9% 1,142 14.1%

Data Management 2,789 15.9% 3,171 14.7% 382 13.7%

CRC 2,027 11.5% 2,010 9.3% (18) -0.9%

Consulting,Others 903 5.1% 991 4.6% 88 9.8%

Pre-clinical 1,437 8.2% 1,538 7.1% 101 7.0%

CRO 15,283 87.0% 16,978 78.5% 1,696 11.1%

CMO 456 2.6% 2,410 11.1% 1,954 428.4%

CSO/Others 1,818 10.4% 2,229 10.3% 411 22.6%

Total 17,557 100.0% 21,617 100.0% 4,060 23.1%

Sep.2006 Increase/Decrease

Growthrate

Sep.2007

2007 Sales by operating segments2007 Sales by operating segments


57

Sep.2006 Sep.2007Increase

/Decrease

Currrent assets 10,028 10,946 918

Fixed assets 6,346 6,374 28

16,374 17,321 947

Currrent liabilities 3,489 3,796 307

Long-term liabilities 3,017 2,559 (458)

Shareholders' equity 9,868 10,967 1,098

Total assets

2007　Financial Highlight　–Balance sheet2007　Financial Highlight　–Balance sheet


58

Sep.2006Balance of

Orders Orders Sales Balance of Orders

CRO 15,726 16,763 16,978 15,510

CMO 285 2,334 2,410 210

CSO/others 783 1,809 2,229 363

Total 16,794 20,906 21,617 16,083

Sep.2007Sep.2006Balance of

Orders Orders Sales Balance of Orders

CRO 15,726 16,763 16,978 15,510

CMO 285 2,334 2,410 210

CSO/others 783 1,809 2,229 363

Total 16,794 20,906 21,617 16,083

Sep.2007

2007 Orders, Sales and Balance of Orders by operating segments2007 Orders, Sales and Balance of Orders by operating segments


59

Free cash flow Sep.2007

1,000 million yen

Ratio on sales Sep.2005 ～ Sep.2007

Operating Income 9.6% Ordinary Income 9.8% Net Income 5.3%

Sep.200514,000

million yen SalesGrowing at 25%per annual

financial strength

Sep.200617,500

million yen

Sep.200721,600 million yen

ROE(return on equity) Sep.2007

12.4％

Shareholders’ equity to total assets

Sep.2007

58.8%

60

Sep.2007 Sep.2008 Increase Growth rate

Sales 21,617 25,044 3,427 15.9%

Gross operating income 6,356 7,240 884 13.9%

Selling,general andadministrative expenses 4,196 4,855 659 15.7%

Operating income 2,160 2,384 224 10.4%

Ordinary income 2,153 2,417 264 12.3%

Net income 1,198 1,241 43 3.6%

Sep.2007 Sep.2008 Increase Growth rate

Sales 21,617 25,044 3,427 15.9%

Gross operating income 6,356 7,240 884 13.9%

Selling,general andadministrative expenses 4,196 4,855 659 15.7%

Operating income 2,160 2,384 224 10.4%

Ordinary income 2,153 2,417 264 12.3%

Net income 1,198 1,241 43 3.6%

Financial Forecast for the FY ending Sep.2008 (Consolidated)Financial Forecast for the FY ending Sep.2008 (Consolidated)


61

Thank you for your Thank you for your attention.attention.

[email protected]://www.cmic.co.jp/e/

corporate presentation cmic co.,...

Documents