cmic co., ltd. corporate corporate...

55
www.cmic.co.jp/e/ CMIC CO., LTD. CMIC CO., LTD. Corporate Corporate Presentation Presentation February, 20 February, 20 10 10 Kazuo NAKAMURA Kazuo NAKAMURA Chairman and CEO Chairman and CEO This presentation contains future financial projections. While such projections were prepared in good faith by our management, no assurance can be made regarding future events. Therefore, such projections cannot be considered a reliable predictor of future operating results, and this information should not be relied on as such. In the view of our management, the information was prepared on a reasonable basis, reflects the best currently available estimates and judgments, and presents, to the best of our management‘s knowledge and belief, the expected course of action and our expected future financial performance. However, this information is not fact and should not be relied upon as being necessarily indicative of future results, and you are cautioned not to place undue reliance on this information. The estimates and assumptions underlying the projections involve judgments with respect to, among other things, future economic, competitive, regulatory and financial market conditions and future business decisions that may not be realized and are inherently subject to significant business, economic, competitive and regulatory uncertainties, all of which are difficult to predict and many of which are beyond our control. Accordingly, there can be no assurance that the projected results would be realized or that actual results would not differ materially from those presented in the financial information. We do not intend to update or otherwise revise the prospective financial information to reflect circumstances existing since its preparation or to reflect the occurrence of unanticipated events, even in the event that any or all of the underlying assumptions are shown to be in error. Furthermore, we do not intend to update or revise the prospective financial information to reflect changes in general economic or industry conditions.

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Page 1: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

www.cmic.co.jp/e/

CMIC CO., LTD.CMIC CO., LTD. CorporateCorporate PresentationPresentation

February, 20February, 201010

Kazuo NAKAMURAKazuo NAKAMURA

Chairman and CEOChairman and CEO

This presentation contains future financial projections. While such projections were prepared in good faith by our management, no assurance can be made regarding future events. Therefore, such projections cannot be considered a reliable predictor of future operating results, and this information should not be relied on as such. In the view of our management, the information was prepared on a reasonable basis, reflects the best currently available estimates and judgments, and presents, to the best of our management‘s knowledge and belief, the expected course of action and our expected future financial performance. However, this information is not fact and should not be relied upon as being necessarily indicative of future results, and you are cautioned not to place undue reliance on this information.The estimates and assumptions underlying the projections involve judgments with respect to, among other things, future economic, competitive, regulatory and financial market conditions and future business decisions that may not be realized and are inherently subject tosignificant business, economic, competitive and regulatory uncertainties, all of which are difficult to predict and many of which are beyond our control. Accordingly, there can be no assurance that the projected results would be realized or that actual results would not differ materiallyfrom those presented in the financial information.We do not intend to update or otherwise revise the prospective financial information to reflect circumstances existing since its preparation or to reflect the occurrence of unanticipated events, even in the event that any or all of the

underlying assumptions are shown to be in error. Furthermore, we do not intend to update or revise the prospective financial information to

reflect changes in general economic or industry conditions.

Page 2: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

2

Contents

Business EnvironmentOur Business

Performance

CRO (Contract Research Organization) SMO (Site Management Organization)

CMO (Contract Manufacturing Organization) CSO (Contract Sales Organization)

IPD (Intellectual Property Development)

Page 3: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

3

Business Environment

Page 4: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

4

人口

1万

人あ

たり

の発

症率

0

5

10

15

20

25

30

35

40

1950 55 60 65 70 75 80 85 90 95 2000 05 10 15 20 25 30 35 40 45 2050

65歳以上人口の割合

日本

イギリス

イタリア

フランス

ドイツ

カナダ

アメリカ

韓国

中国

(高齢化率、総人口に占める65歳以上人口の割合、%)

(出所)人口統計資料集2008(国立社会保障・人口問題研究所)、World population prospects, 2008Revision(UN)

(暦年)

(推計)

日本

アメリカ

カナダ

フランス イタリア

ドイツ

05年

アメリカ 12.4%

イギリス 16.1%

ドイツ 18.9%

フランス 16.5%

イタリア 19.6%

韓国 9.3%

中国 7.6%

日本 20.2%韓国

イギリス

中国

65歳以上人口の割合65歳以上人口の割合

JapanJapan

GermanyGermany

ItalyItalyFranceFrance

UKUK

USAUSA

CanadaCanada

KoreaKorea ChinaChina

Accelerating Aging Society

Proportion of the global population of 65 and over

% of

population

65 and over

Source: Latest demographic statistics 2008/ Institute of Population Problems, Ministry of Health and Welfare, World population prospects,2008 Revision(UN)

CY

Estimate

Page 5: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

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Global Pharma Market

59.764.7

67.763.7

65.7

47.5

55.9

73.6

88.5

66.2

0.0

100.0

200.0

300.0

400.0

500.0

600.0

700.0

800.0

2003 2004 2005 2006 2007

South America

AAA

Japan

Europe

US

(billion $)

Source: JPMA DATA BOOK 2009AAA: Asia, Africa and Oceania excluding Japan

499.0559.9 604.5

648.9714.8

• Market has grown and is expected to grow in the near future• Asian market, including Japan, is the most promising area

Page 6: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

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Sales and R&D Expenditures Japanese Pharma(billion yen)

Source:Japan Pharmaceutical Manufacturers Association (JPMA) DATA BOOK 2009

0

100

200

300

400

500

600

2003 2004 2005 2006 2007

40

60

80

100

120

Average Sales per company (Major 10 Japanese pharma)

Average R&D expenditures per company (Major 10 Japanese pharma)

Both Sales and R&D Investment of Japanese Top 10 Pharma have been increasing

(billion yen)

Page 7: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

7

Our Business

Page 8: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

8

CMIC Group

• Established in 1985, Tokyo– Net Sales: 28.7billion yen (Sep 2009) or US$320 million – No. of Employees: 2759 (Sep 2009)– No. of Domestic Offices: 18– No. of Overseas Offices: Korea, China, Taiwan, Singapore, US, Brazil

• Services– CRO (Contract Research Organization)– SMO (Site Management Organization)– CMO (Contract Manufacturing Organization)– CSO (Contract Sales Organization)– IPD (Intellectual Property Development)

New Business Model :

Pharmaceutical Value CreatorNew Business Model :

Pharmaceutical Value Creator

Page 9: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

9

History Highlights I

• 1992 Kazuo Nakamura, CEO, started the operation of CMIC as the 1st Japanese CRO

• 1994 Monitoring Business started• 1996 CMIC established a joint venture as the 1st Korean CRO• 1996 SMO business started• 1997 CMIC North America (Toronto) branch established• 1998 CMIC Europe (Manchester) branch established• 1998 CMIC Korea Co., Ltd. established• 2000 CSO business started• 2001 CMIC China established• 2002 Listed on the JASDAQ market • 2003 Healthcare Information Service business started

(CMIC and NTT DATA established a joint venture)

Page 10: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

10

History Highlights Ⅱ

• 2004 IPD business started (L-FABP diagnostic for predicting the progression of renal diseases)

• 2005 CMO business started• 2005 Listed on the Tokyo Stock Exchange 1st section• 2005 CMIC and Fuji Film established Fujifilm CMIC Healthcare • 2006 CMIC BRASIL PESQUISAS CLÍNICAS LTDA. established • 2006 CMIC Asia-Pacific, Pte. Ltd. established• 2007 CMIC-VPS Corporation acquired (NJ U.S.A)• 2008 Obtain Orphan Drug Development and Marketing Rights

in Japan (Human hemin)• 2009 Sign License Agreement on L-FABP diagnostic with ROCHE • 2010 April

Ownership transfer of Shizuoka Plant from DAIICHI SANKYOPROPHARMA Co., Ltd.

Page 11: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

11

Domestic Offices

Kagoshima

Kumamoto

Fukuoka

Osaka

Okayama

Nagoya

Shizuoka

Toyama

Hokkaido

Tokyo

Takamatsu

Hiroshima

Kanazawa

Sendai

Kobe

MatsuyamaOita

Nagasaki

Number of branches/offices: 18

Page 12: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

12

CMICCMIC--VPSVPS

ShanghaiShanghaiTaiwanTaiwan

CMIC AsiaCMIC Asia--PacificPacific

CMIC (Beijing)

CMIC KoreaCMIC Korea

CMIC CMO KoreaCMIC CMO Korea

CMIC Brazil

Beijing and Shanghai, ChinaBeijing and Shanghai, ChinaSeoul, KoreaSeoul, Korea

New Jersey, USNew Jersey, USPorto Porto AlegreAlegre, Brazil, Brazil

SingaporeSingaporeTaipei, TaiwanTaipei, Taiwan

8 offices in 6 CountriesOverseas Offices

Page 13: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

13

CMIC’s Unique Business Model - Pharmaceutical Value Creator -

Basic Basic researchresearch

Preclinical Preclinical trialtrial

Clinical trialClinical trialPhasePhase II

Clinical trialClinical trialPhasePhase IIII

Clinical trialClinical trialPhasePhase IIIIII

Application Application for approvalfor approval

ManufacManufac--turingturing MarketingMarketing

Pharmaceutical CompanyPharmaceutical Company

CROPreclinical trial

CSOCSOContract Sales Organization

CROCRO Contract Research OrganizationContract Research Organization・

IND data monitoring・

Data management, statistics analysis・

Application documents preparation SMOSMO Site Management OrganizationSite Management Organization・

Site Management Office and IRB administration・

SOP preparation・

Clinical Research Coordinator

CMOCMO Contract Manufacturing Organization, Manufacturing of Investigational Drug

IPDIPDIntellectual Property

Development

Page 14: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

14

CMIC Group Business ModelCMIC Group

HVCHVC Healthcare Value CreatorHealthcare Value Creator

for Patients, Hospitalsfor Patients, Hospitals

PVCPVC Pharmaceutical Value CreatorPharmaceutical Value Creator

for for PharmaPharma CompaniesCompanies

CROCROContract Research Contract Research

OrganizationOrganization

CMOCMOContract Manufacturing Contract Manufacturing

OrganizationOrganization

CSOCSOContract Sales Contract Sales OrganizationOrganization

HealthcareHealthcareInformation ServiceInformation Service

SMOSMOSite Management Site Management

OrganizationOrganization

IPDIPDIntellectualIntellectual

Property Property DevelopmentDevelopment

Page 15: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

15

程度

700

390

199

2660

?

700

1400

0

200

400

600

800

1000

1200

1400

1600

Japanese Market

Global Market

Source preclinical: Mitsubishi Research CRO・SMO:JCROA, JSMOACMO:Yano Research Institute CSO: MIC Research , Mitsubishi Research

Basic research

Basic Basic researchresearch Preclinical trialPreclinical trialPreclinical trial Clinical trialClinical trialClinical trial ManufacturingManufacturingManufacturing MarketingMarketingMarketingApplication

for approval Application Application for approvalfor approval

Preclinical CRO (including drug discovery)

CRO、SMO CMO CSO

Market size of service industries for pharmaceutical industry

(billion yen)

Page 16: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

16

Pharmaceutical Value Creator -

CMIC’s unique business model -

PVC is our unique business model providing comprehensive services for pharmaceutical value chain PVC includes CRO, SMO, CMO and CSO

The largest CRO and SMO in Japan

Track Record in Multinational Clinical TrialsCMIC provides services for one of the largest global pharma as its preferred vendor

Intellectual Property Development CMIC accumulates IP and knowhow of applying it to healthcare and other pharmaceutical businesses for future use

Promoting eClinical Trials ( Data digitization)

CMIC’s Competitive Edge

Page 17: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

17

CRO (Contract Research Organization)

Page 18: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

18

156 241389

501614 710

831955 1025 1130

514500

403

286221

85

8

31

482

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

Dec.2000 Dec.2001 Dec.2002 Dec.2003 Dec.2004 Dec.2005 Dec.2006 Dec.2007 Dec.2008 Dec.2009

Affiliated companiesJCROA members

156249

420586

835

1,437

996

1,234

69%

40%

Growth rate 60%

42%

19%

24%

16%

(¥ 100 mil)

Source:Japan CRO Association excluding pre-clinical (2000-2003)

Growth Rate: JCROA members + affiliated companies

CRO Market in Japan Total sales of CROs and their affiliated companies

1,5397%

1,6306%

Page 19: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

19

Clinical patientClinical patient

Clinical siteClinical sitePharmaceuticalPharmaceuticalcompanycompany

Application of clinical trial

Site monitoring /Auditing

Case report /Adverse event report

Contract

・Clinical Research CoordinatorObtain Informed ConsentTake care of clinical patients etc.

Inform To give consent

Structure of Clinical Trial(CRO&SMO)

IRBIRB・Investigator

CROCRO SMOSMO

Page 20: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

20

Largest No. of CRAs in Japan

• CRAs : over 700 • Protocols: 195

(Oct 1997 - Sep 2009)

Sensory Organs1%

Cardiovascular6%

Non TherapeuticPurpose

3%Diagnostic agents

1%

Medical Devices2% CNS

19%Other11%

Oncology3%

Infectious Disease7%

Metabolism16%

Hematology8%

Skin2%

Respiratory Organs2%

Gastro Intestinal3%

Endocrinology3%Urology

4%

Biologics5%

Antiallergic Agents3%

Therapeutic Areas

Page 21: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

21

SMO (Site Management Organization)

Page 22: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

22

Site Support Institute Co., Ltd. (SSI)

• Number of employees: 695CRC: 440 SMA: 98

• Protocol performances: 1,505Ongoing: 383

• Number of sites: 1,538University Hospitals: 47Hospitals: 593Clinics: 898

• Number of branches/offices: 18Kagoshima

Kumamoto

Fukuoka

Osaka

Okayama

Nagoya

Shizuoka

Toyama

Hokkaido

Tokyo

Takamatsu

Hiroshima

Kanazawa

Sendai

Kobe

Matsuyama

Oita

Nagasaki

The largest SMO in Japan

(As of Oct. 2009)

(As of Dec. 2009)

(As of Dec. 2009)

Page 23: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

23

Strategic Synergy – CMIC and SSI –

Strategic synergy between CMIC and SSI contributes to enhancing

the speed and quality of clinical trials

CMIC serves as a platform of clinical trial businesswith enhanced strategic advantages

Page 24: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

24

Strategic Synergy – CMIC and SSI – Advantages Over Competitors

0

50

100

150

200

250

300

2008/6 2008/7 2008/8 2008/9 2008/10 2008/11 2008/12

Total number of cases Planned number of cases

(Number of cases)

Achieved all the target patients two months earlier than planned

Early Achievement of All the Patient Enrolment- Perennial Allergic Rhinitis -

Page 25: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

25

0

5,000

10,000

15,000

20,000

25,000

2007/9 2008/9 2009/9

CMIC CRO・SMO Sales and Backlog

0

5,000

10,000

15,000

20,000

25,000

2007/9 2008/9 2009/9

BacklogSales

Steady growth in sales and backlog

↑↑55% % increaseincrease

↑↑4% 4% increaseincrease ↑↑19% 19%

increaseincrease

↑↑11% 11% increaseincrease

SMOCRO

(million yen) (million yen)

Page 26: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

26

Multinational Study

Page 27: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

27

0

5

10

15

20

25

30

35

1999 2000 2001 2002 2003 2004 2005 2006 2007

Multinational studies Asian studies

Multinational & Asian Studies - Rapid Increase in Number-

Data presented by Hidetoshi Syuto, Astellas Pharma Inc.

(Number of Global Studies)

Page 28: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

28

Pioneering CRO in the Asian market

Abundant experience in multinational studies

Speed of recruiting clinical patients for multinational studies

Selected as a preferred vendor by a global pharma

CMIC’s Advantages Multinational &Asian Studies

CMIC maintains the leading position in Multinational and Asian studies

Page 29: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

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Offices in Asia for Multinational & Asian Studies

CMIC Co., Ltd. Japan

No. of members : 60

CMIC Korea Co., Ltd.No. of members : 60

CMIC (Beijing) Co., Ltd. Beijing, ShanghaiR.O.C.No. of members : 20

CMIC Asia-Pacific Pte. Ltd. SingaporeTaipei TaiwanNo. of members : 10

Page 30: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

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CMO (Contract Manufacturing Organization)

Page 31: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

31

April 1994 Revised Pharmaceutical Affairs Law (PAL) allowed pharmaceutical companies to outsource drug manufacturing process partlyJuly 2005 Revised PAL allowed pharmaceutical companies without manufacturing facilities to outsource the whole process of drug manufacturingManufacturing Approval → Marketing Approval

CMO - Regulatory History

Revised regulations have accelerated drug manufacturing outsourcing services

Page 32: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

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Cost reduction effort ・With an imminent expiry of patents on major pharmaceutical products

(Year 2010 problem)

Increase in business efficiencyTrend to enter into a manufacturing business without production facilities

(fabless company)・Reduction in facility investment・Fixed cost → variable cost・Stable supply of quality products

High-mix low-volume production・Easy to increase / decrease production volume

New formulation development・Enhance the development capacity of new drug formulation

Reasons for Pharmaceutical Companies to Rely on CMO

Page 33: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

33

Why CMO in CMIC?

Market expansion expected Regulatory movement to accelerate outsourcing services in drug manufacturing process

Manufacturing Div. ⇒ Subsidiary Outsourcing ⇒ CMO

Establishment of PVC business model CMIC has advantages against competitive companies in that it has established a unique business model of PVC which provides comprehensive services for value chain of pharmaceutical companies

Manufacturing as a key businessManufacturing is a key business for Japanese companies to win a place in the global market

High quality / new formulation technologyCost?

Page 34: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

34

CSOCSOmarketing / marketing /

salessales

Strategic Synergy

Physical and Physical and chemical testchemical test

CROCROdrug developmentdrug development

Investigational drug Investigational drug managementmanagement

Documents for Documents for applicationapplication

Provide comprehensive services for Provide comprehensive services for Japanese pharmaceutical companiesJapanese pharmaceutical companiesto enter into global marketsto enter into global markets

Provide comprehensive services forProvide comprehensive services foroverseas pharmaceutical companies overseas pharmaceutical companies to enter into the Japanese marketto enter into the Japanese market

Safety InformationSafety Information

CMOCMOFormulation study Formulation study ~~ manufacturingmanufacturing

Investigational drug Investigational drug managementmanagement

PromotionPromotion

Page 35: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

35

One of the largest CMOs in Japan(Will have sales of about 13 billion yen)

Manufacturing high quality products

Capable of handling small lots of a large variety of products(Efficient production)

Upgrading formulation manufacturing technology(Technology transfer from drug manufacturers)

Enhancement of formulation development capabilities(Supporting new drug formulation design)

Synergies will be explored between CRO and CMO:(Make the most of every opportunity)

manufacturing of investigational drugs ~ clinical trials ~ manufacturing of commercial drugs

Medium Term Vision for the CMO Company

Page 36: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

36

CMO Business

Manufacturing services include : Ointment, Cream, Gel, Lotion, Suppository, Liquid, Tooth paste etc. Manufacturing services (packaging) include : Blister package (PTP) and Strip package (SP) for Tablets, Capsules etc.

Operation since:

Sep 2006 Number of

items:

71

CMIC SS CMO Co., Ltd.

CMIC CMO Korea Co., Ltd.Manufacturing services include : Liquid for internal use, Ointment, Cream, Gel

Operation since: Aug 2005 Number of items:

30 (including items for sales)

CMIC-VPS Corporation (USA)Manufacturing services include :Tablets(uncoated and film-coated tablets), Capsules, seamless-mini CapsulesOperation since:

Dec 2007

Number of items: 22(commercial production: 2,

drug development:

17, development of other products:

3)

Page 37: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

37

CMIC SS CMO has been showing Underlying upward trend in the number of items

0

2

4

6

8

10

12

14

16

2007/3 2008/3 2008/9 2009/9 2010/9(E)

50

55

60

65

70

75

80

85

Clients

items

CMIC SS CMO Growing Number of Items and Clients

Page 38: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

38

132

222

298

374

0

50

100

150

200

250

300

350

400

2008/3 2008/9 2009/3 2009/9

CMIC-VPS Corporation(NJ, US)

Investigational Drug and Drug Manufacturing Sales

CMIC VPS has been showing steady growth

(million yen)

Page 39: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

39

Manufacturing capacity:

Tablet formulations: 1.5 billion/year, Capsule formulations: 500 million capsules/year, Granule/powder formulations: 200 tons/year

Location :

1-588, Kanaya-azuma, Shimada, ShizuokaArea:

210,000㎡Commencement of operations:

1965

Overview of the Daiichi Sankyo Propharma Shizuoka Plant

Page 40: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

40

CMIC CMO - Drug Formulations -

Source :Japan Pharmaceutical Manufacturers Association Data Book 2009

(¥100 million)

Oral solution

Ointment / Cream Suppository

External Solution

Powders / Granule

Tablet

Pill

Capsule

Injection

Injectable

powder

Aerosols

Plaster

/ Cataplasm

Others

Page 41: CMIC CO., LTD. Corporate Corporate Presentationcmic-test.r-cms.jp/files/user/en/corporate/pr/pdf/ss...Japanese Pharma Source : Japan Pharmaceutical Manufacturers Association (JPMA)

41

CSO (Contract Sales Organization)

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42

MDS Co., Ltd.MDS Co., Ltd.Medical Communication with Academic Support

Academic ServiceAdvertising & Promotion

Promotion StrategyPromotion Materials

CMIC MPSS Co., Ltd.CMIC MPSS Co., Ltd.Contract MR (Medical Representative)MR TrainingMarket Assessment

Contract Sales Organization

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455816

1,447

1,146

0

500

1,000

1,500

2,000

2,500

2008/9 2009/9

MDSCMIC MPSS

1,901 1,962Internal

elimination

(1) MDS Good performance

MPSS High growth

Contract Sales OrganizationSales(million yen)

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IPD (Intellectual Property Development)

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Exclusive license in Japan Exclusive license in Japan including the right to sublicenseincluding the right to sublicense

Our Business Model - L-FABP – KIDNEY DISEASE DIAGNOSTIC AGENT

SublicenseHigh value-added service

Application for Application for clinical clinical

developmentdevelopment

PatentPatentPharmaceutical Pharmaceutical companycompany

Pharmaceutical CompanyOverseas Diagnostic Company

Clinical Laboratory Company

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L-FABP Patent for ROCHE

CMIC and ROCHE have entered into an agreementon L-FABP diagnostic test

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Our Business Model -Human Hemin‐

Pharmaceutical CompanyPharmaceutical CompanyCMIC CSOCMIC CSO

Exclusive license in Japan Exclusive license in Japan including the right to sublicenseincluding the right to sublicense

Orphan EuropeOrphan Europe((pharmaceutical companypharmaceutical company))

Application Application for clinical for clinical

developmentdevelopment

PatentPatent

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4848

Orphan Drug Development and Marketing Rights in Japan

Press release on December 17, 2008

Human Hemin (Orphan drug)Signed a license agreement with Orphan Europe of France for drug development in Japan

Indicated for acute porphyria

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Performance

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0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010E

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

02468101214161820(%)

CMIC Performance (Consolidated basis)Sales

Operating Income

Operating Income

Ratio

SalesOperating IncomeOperating Income Ratio

New GCP in 1997

Revised Japanese PharmaceuticalAffairs Law in 2005

(million yen) (million yen)

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50%

20%

7%

20%

3%

64%9%

7%

16%

4%

58%

10%

7%

22%

3%

Sep.2008 Sep.2009 Sep.2010

25,777 28,784 34,000

12% increase

18% increase

Sales by Operating Segments

OTHER

(million yen)

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From PVC to HVC

Annual Sales Target in 2015 Annual Sales Target in 2015 --¥¥1100 billion00 billion--

CROConventional CRO Group of

skilled individualsWorking on

pharmaceuticaldevelopment

CROCROConventional Conventional CRO Group ofCRO Group of

skilled individualsskilled individualsWorking on Working on

pharmaceuticalpharmaceuticaldevelopmentdevelopment

Pharmaceutical

Value Creator

Contribution to growing pharma industry

PPharmaceuticalharmaceutical

VValuealue CCreatorreator

Contribution to growingContribution to growing pharmapharma industryindustry

HHealthcareealthcare

VValuealue CCreatorreator・・Patient orientedPatient oriented

healthcare serviceshealthcare services

・・Disease managementDisease management

Corporate Value= Sustainable Profit

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Company Data

Trade Name CMIC Co., Ltd.

Established/Business initiated 1985(started as CRO in 1992)

Chairman and CEO Kazuo Nakamura

Fiscal year-end September

Business fields Parmaceutical and HealthcareCRO(Contract R&D)CMO(Contract Manufacturing)CSO(Contract Sales)SMO、Healthcare、IPD

Headquarters 7-10-4, Nishi-Gotanda, Shinagawa- ku, Tokyo

Contact Us E-mail:[email protected]:+81-3-5745-7070Fax:+81-3-5745-7077

Employees 2,759

Stock Listings First Section of the Tokyo Stock ExchangeCode Number:2309

Number of Stockholders 6,399

Issued Shares/Authorized Shares 894,957 / 2,300,000

The First and Largest Full Service CRO in Japan

Fiscal Year FY 2007 FY 2008 FY 2009 FY Sep2010 Est.

Net Sales 21,616 25,777 28,784 34,000

Operating Income 2,159 2,275 2,514 3,000

Ordinary Income 2,153 2,187 2,400 2,600

Net Income 1,198 829 1,059 1,200

Dividend※ 216 266 334 380

Dividend rate 13.7% 26.5% 27.7% 27.8%

※ CMIC’s Annual Dividend Payout Ratio target continues to set at 30%

Our position of Japanese association

【Frost & Sullivan】

2007 Best Practices Award for Competitive Strategy Leadership Award in the Japanese CRO Market.

【Japan Investor Relations Association】

JIRA IR Special Award

million yen (※yen)

Kazuo Nakamura

【Japan CRO Association】Chairman Kazuo Nakamura(CMIC)

【Japanese Association of SMO】Chairman Toshimasa Yasuda (CMIC Group)

Award

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(yen) (yen)

1,328.23

1,579.33

1,003.94

1,205.63

1,365.27

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2006/9 2007/9 2008/9 2009/9 2010/9E

216216

266334

38016.3% 13.7%

26.5%27.8%27.7%

0

50

100

150

200

250

300

350

400

450

500

2006/9 2007/9 2008/9 2009/9 2010/9E0%

5%

10%

15%

20%

25%

30%

35%Cash DividendsDividends Payout Ratio

【Earnings Per Share】 【

Cash dividends 】

CMICCMIC’’ss Annual Dividend Payout Ratio Annual Dividend Payout Ratio Continues to target 30% Continues to target 30%

FY2010 Forecasts –EPS/Cash Dividends –

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Stock Chart(CMIC:TSE2309) Weekly chart of stock price range and trading volume

0

5000

10000

15000

20000

25000

30000

2008

/10/

6

2008

/10/

27

2008

/11/

1720

08/1

2/8

2008

/12/

2920

09/1

/19

2009

/2/9

2009

/3/2

2009

/3/2

320

09/4

/13

2009

/5/7

2009

/5/2

520

09/6

/15

2009

/7/6

2009

/7/2

720

09/8

/17

2009

/9/7

2009

/9/2

8

2009

/10/

1920

09/1

1/9

2009

/11/

30

2009

/12/

2120

10/1

/12

2010

/2/1

0

2000

4000

6000

8000

10000

12000

14000

16000

Trading Volume

Stock Price

Stock Prices:yen Trading Volume