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マスター タイトルの書式設定 © Copyright CMIC Group CMIC HOLDINGS Co., Ltd. May 15, 2019 Overview of Financial Results for FY2019 2 nd Quarter/1H

New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Page 1: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

マスター タイトルの書式設定

© Copyright CMIC Group

CMIC HOLDINGS Co., Ltd.

May 15, 2019

Overview of Financial Results for FY2019 2nd Quarter/1H

Page 2: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

マスター タイトルの書式設定 FY2019 2nd Quarter/1H

Financial highlights (October 1, 2018-March 31, 2019)

CMIC HOLDINGS Co., Ltd.

Wataru Mochizuki, CFO

Page 3: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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3 © Copyright CMIC Group

Business segments and group companies Blue indicates overseas. *indicates affiliated company

Segment Products and services CMIC Group companies (as of end of Mar. 2019)

CRO

Business

Services related to pharmaceutical development support and analytical chemistry services for pharmaceutical companies, and BPO and personnel services for the pharmaceutical and healthcare industry

CMIC HOLDINGS Co., Ltd. CMIC Co., Ltd. CMIC ShiftZero K.K. CMIC Korea Co., Ltd. CMIC ASIA-PACIFIC, PTE. LTD. CMIC ASIA PACIFIC (MALAYSIA) SDN. BHD. CMIC Asia-Pacific (Hong Kong) Limited CMIC ASIA-PACIFIC (PHILIPPINES), INC. CMIC (Beijing) Pharmaceutical Services Co., Ltd. CMIC (Beijing) Co., Ltd. CMIC DATA SCIENCE VIETNAM COMPANY LIMITED CMIC Pharma Science Co., Ltd. CMIC, INC. CMIC (Suzhou) Pharmaceutical Technology Co., Ltd. CMIC Career Co., Ltd.

CDMO

Business

Services related to drug formulation development and manufacturing support, from formulation design to investigational new drug manufacturing to commercial production of ethical drugs and nonprescription drugs for pharmaceutical companies

CMIC CMO Co., Ltd. CMIC CMO Korea Co., Ltd. CMIC CMO USA Corporation CMIC JSR Biologics Co., Ltd.*

CSO

Business

Services provided to pharma companies related to sales & marketing support

CMIC Ashfield Co., Ltd. McCann MDS Inc.*

Healthcare Business

Support services primarily for medical institutions and treating, maintaining, and promoting the health of patients and general consumers, such as SMO services and healthcare information services

Site Support Institute Co., Ltd. CMIC Healthcare Co., Ltd. CMIC VIETNAM COMPANY LIMITED

IPM

Business

Provision of new business solution to pharmaceutical companies that combines the system to support all value chains and manufacturing authorization and other licenses (intellectual properties) held by CMIC Group

CMIC HOLDINGS Co., Ltd. CMIC CMO Co., Ltd. OrphanPacific, Inc.

Page 4: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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4 © Copyright CMIC Group

Main initiatives of the current term

Push forward “Project Phoenix ‐Initiatives to achieve sustainable growth‐” and start “2019-2021 Mid-term Plan"

Focus activities In addition to the PVC model, we will accelerate the IPM solution business that combines the marketing

authorization licenses Strengthening Area Competitiveness and promoting Globalization Creation of healthcare business

CRO Business Enhanced Post-marketing surveillance (PMS) and Clinical research support business using medical database Promoted readiness for evolving fields including biologics and regenerative medicine

CDMO Business Launched a new parenteral drug manufacturing facility with capabilities to manufacture high-potency drugs and started producing

clinical-trial materials Concluded a stock transfer agreement on the assignment of Nishine Plant from Astellas Pharma Tech (scheduled for June 1 2019) Formed business alliances with U.S.-based corporations that possess 3DP technology platform and sophisticated flexible dosing tablet

technology

CSO Business Opened “MA academy”, the first private sector institution to train Medical Affairs (MA) personnel, and expanded services in the

Medical Affairs arena

Healthcare Business BELL24・Cell Product became the CMIC Group's wholly-owned subsidiary (as of April 2019) to enhance our SMO business presence in

Hokkaido Concluded a formal agreement with Sony Corporation for the transfer of “harmo”, the electronic prescription record service

(scheduled for June 1 2019) Started services for self-collect HPV test “SelCheck Cervical Cancer”

IPM Business Supported foreign pharmaceutical companies entering the Japanese market through provision of the IPM platform

Page 5: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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5 © Copyright CMIC Group

2018/1H 2019/1H

Amount Composition

ratio Amount Composition

ratio

YoY change

Percent change

(¥ millions) (%) (¥ millions) (%) (¥ millions) (%)

Sales 33,640 100.0 36,633 100.0 2,992 8.9

Operating income 2,471 7.3 2,879 7.9 407 16.5

Ordinary income 2,225 6.6 2,661 7.3 435 19.6

Profit attributable to

owners of parent 489 1.5 1,536 4.2 1,047 214.1

Earnings per share ¥26.14 ¥82.72

Consolidated income statement (overview)

Page 6: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Breakdown of Non-operating income and expenses /Extraordinary income and losses/Income taxes

(¥ millions) 2018/1H 2019/1H

Non-operating income 39 50

Interest income 3 2

Rent income 8 11

Refunded consumption taxes 8 10

Insurance income - 15

Other 19 11

Non-operating expenses 285 268

Interest expenses 57 56

Share of loss of entities accounted

for using equity method 59 108

Foreign exchange losses 131 77

Other 36 25

2018/1H 2019/1H

Extraordinary income - 6

Gain on sales of non-current

assets - 6

Extraordinary losses 287 174

Impairment loss - 124

Loss on sales of non-current assets 0 -

Loss on retirement of

non-current assets 28 50

Loss on valuation of

investment securities 4 -

Loss on revision of pay

regulations 252 -

Income taxes 1,450 1,142

Current 1,038 1,035

Deferred 412 107

Page 7: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Sales & Operating income by segment

2018/1H Amount (¥ millions)

2019/1H Amount (¥ millions)

Change (¥ millions)

Percent change (%)

CRO Business Sales 18,553 19,947 1,393 7.5

Operating income 3,929 4,306 376 9.6

CDMO Business

Sales 6,786 7,724 937 13.8

Operating income (525) (147) 377 -

CSO Business Sales 3,486 3,701 214 6.2

Operating income 153 (33) (187) -

Healthcare Business

Sales 3,607 3,597 (10) (0.3)

Operating income 465 416 (48) (10.5)

IPM Business Sales 1,420 1,881 460 32.4

Operating income (111) (108) 3 -

Adjustments Sales (215) (219) (3) -

Operating income (1,440) (1,553) (113) -

Consolidated Sales 33,640 36,633 2,992 8.9

Operating income 2,471 2,879 407 16.5

Page 8: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Orders received / Backlog

・ New orders dropped as a rebound from the acquisition of large-scale projects from the same period of the previous year, and the number of inquiries remains high. New orders for Healthcare significantly exceeded that of the same period of the previous year. ・ Accounts for only the backlog of firm CDMO business orders. There is customer demand for scheduled orders but these are different from firm orders so we have not included these in the backlog. ・Order status is not included for IPM Business because its business conditions are different from those of contract business.

2018/1H 2019/1H

Orders received

Backlog Orders

received Percent Change

Backlog Percent change

(¥ millions) (¥ millions) (¥ millions) (%) (¥ millions) (%)

CRO Business 25,564 62,065 18,934 (25.9) 54,960 (11.4)

CDMO Business 7,290 4,186 8,274 13.5 4,409 5.3

CSO Business 5,234 4,843 5,302 1.3 4,863 0.4

Healthcare Business

3,027 8,582 4,542 50.0 10,601 23.5

Total 41,117 79,677 37,053 (9.9) 74,836 (6.1)

8

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Trend in consolidated Sales & Operating income

16,508 18,553 19,947

6,643

6,786 7,724

3,452

3,486

3,701 4,023

3,607

3,597

1,240

1,420

1,881

31,743 33,640

36,633

0

20,000

40,000

2017/1H 2018/1H 2019/1H

CRO business CDMO business CSO business

Healthcare business IPM business

1,902

2,471

2,879

6.0%

7.3% 7.9%

0%

10%

0

2,000

2017/1H 2018/1H 2019/1H

Operating income Operating margin

*(215) *(125)

*(219)

[ Sales ] [ Operating income ] (¥ millions) (¥ millions)

*Adjustment

Page 10: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Contract Research Organization (CRO) Business

Supported overseas companies entering the Japanese market, non-healthcare companies entering the healthcare sphere, and promoted measures to address sophisticating development needs including biopharmaceuticals and regenerative medicine. Sales and operating income exceeded those from the same period of the previous year thanks to robust growth in new and existing contracts.

13,330 14,976 15,844

2,147

2,560 3,092

1,146

1,216 1,309

16,508

18,553 19,947

0

10,000

20,000

2017/1H 2018/1H 2019/1H

Clinical Non-clinical Others

2,913

3,929 4,306

17.6%

21.2% 21.6%

0%

10%

20%

30%

0

2,000

4,000

2017/1H 2018/1H 2019/1H

Operating income Operating margin

*(198) *(114)

*(299)

[ Sales ] [ Operating income ] (¥ millions) (¥ millions)

*Adjustment

10

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Contract Development Manufacturing Organization (CDMO) Business

Launched a new parenteral drug manufacturing facility in Ashikaga and started producing clinical-trial materials. Concluded a stock transfer agreement on the assignment of Nishine Plant from Astellas Pharma Tech to improve the oral solid dose manufacturing capabilities. Sales exceeded that of the same period last year mainly due to increase of contract production sales in Japan and the United States. While operating loss was recorded due to commercial production start-up expenses and increased depreciation cost for the new parenteral drug manufacturing facility in Ashikaga, the loss amount has decreased following the increase of contract manufacturing volume.

5,324 5,831 6,363

1,028 519

1,014 291 434

346 6,643 6,786

7,724

0

5,000

10,000

2017/1H 2018/1H 2019/1H

CCJ (Japan) CCU (U.S.) CCK (Korea)

[ Sales ] [Operating income ] (¥ millions) (¥ millions)

11

(169)

(525)

(147)

-10%

0%

10%

(600)

(400)

(200)

02017/1H 2018/1H 2019/1H

Page 12: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Contract Sales Organization (CSO) Business

3,452 3,486 3,701

0

2,000

4,000

2017/1H 2018/1H 2019/1H

CMAS

247

153

(33)

7.2%

4.4%

-5%

0%

5%

10%

15%

(100)

0

100

200

300

2017/1H 2018/1H

Operating income Operting margin

2019/1H

[ Sales ] [Operating income ] (¥ millions) (¥ millions)

Enhanced the sales activities for Medical Affairs-related operations. Sales exceeded that of the same period of the previous year thanks to the steady execution of both new and existing projects, but operating loss was recorded due to the costs generated to meet the increasing demand of MR dispatch and take on large-scale projects including hiring and training costs. 12

Page 13: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Healthcare Business

BELL24-Cell Product became the wholly-owned subsidiary to further enhance our presence in Hokkaido. Enhanced patient services by offering "SelCheck" (self-screening) and transferring "harmo", the electronic prescription record service from Sony Corporation. While sales remain unchanged from the previous year, operating income are below that of the same period of the previous year due to the impact of discontinuation or temporary interruption of contract studies in SMO business operations.

3,710 3,272 3,076

293

310 511

1

2

4,023

3,607 3,597

0

2,000

4,000

2017/1H 2018/1H 2019/1H

SSI CHC Others

616

465 416

15.3%

12.9% 11.6%

0%

10%

20%

0

200

400

600

2017/1H 2018/1H 2019/1H

Operating income Operating margin

[ Sales ] [Operating income ] (¥ millions) (¥ millions)

*Adjustment

13

*9

* 18

*22

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Innovative Pharma Model( IPM ) Business

(145)

(111) (108)

-10%

0%

10%

(200)

(100)

0

100

Operating income

1,098 1,341

1,834

53

68

34

88

9

13

1,240

1,420

1,881

0

1,000

2,000

2017/1H 2018/1H 2019/1H

OP L-FABP Others

[ Sales ] [Operating income ] (¥ millions) (¥ millions)

Marketed orphan drugs, including products developed in-house. Expanded the market and strengthened promotions of the kidney disease biomarker “human L-type fatty acid-binding protein (L-FABP) kit”. Sales exceeded that of the same period of the previous year due to sales increase of orphan drugs. Continued to expand our business scale through provision of new solutions towards positive turnaround of sales. 14

2018/1H 2019/1H 2017/1H

Page 15: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Balance sheet (assets)

39,861 41,801 40,830

2,363 2,754 2,954

5,443 5,812 5,710

12,989 13,655 14,460

4,947

14,009 14,939 65,605

78,034 78,894

0

50,000

2017/9 2018/9 2019/3

Cash equivalents

Trade receivables

Inventory

Other current assets

Fixed assetsTotal assets +859

■ Cash equivalents

+929

■ Trade receivables

+804

■ Inventory (102)

Other current assets

+199

■ Fixed assets (971)

(¥ millions)

*Deferred assets in the past BSs are reclassified according to "Partial Amendments to Accounting Standard for Tax Effect Accounting"

Page 16: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Balance sheet (liabilities and net assets)

23,608

33,536 33,892

18,899

19,277 20,706 9,193

9,577 9,288 12,870

14,916 14,186

1,034

726 819

65,605

78,034 78,894

0

50,000

2017/9 2018/9 2019/3

Accounts payable

Other current liabilities

Other fixed liabilities

Interest-bearing debt

Net assets■ Accounts

payable +93

■ Other current liabilities

(729)

■ Other fixed liabilities

(289)

Interest-bearing debt

+1,429

■ Net assets +356

(¥ millions)

Page 17: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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2018/1H 2019/1H Increase

(decrease)

Cash flows from operating activities

1,986 1,744 (242)

Cash flows from investing activities

(4,266) (1,687) 2,579

Cash flows from financing activities

2,853 931 (1,921)

Effect of exchange rate change on cash and cash equivalents

(40) (28) 11

Net increase(decrease) in cash and cash equivalents

533 960 427

Cash and cash equivalents at beginning of period

4,928 13,976 9,048

Increase in cash and cash equivalents from newly consolidated subsidiary

19 - (19)

Cash and cash equivalents at end of period

5,481 14,937 9,456

Cash Flows

[Key factor]

(Cash flow from operating activities)

• Increase in funds due to increase in net income before tax and depreciation

• Decrease in funds due to increase in accounts receivable, and income taxes paid

(Cash flow from investing activities)

• Outflow from purchase of property, plant and equipment

(Cash flow from financing activities)

• Expenditure due to the decrease of the net change of the commercial paper and repayment of long-term loans

• Decrease in funds due to cash dividends paid

(¥ millions)

Page 18: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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Forecast for FY ending Sep. 2019

2018/9 Actual

(¥ millions)

2019/9 Forecast

(¥ millions)

Change (%)

Sales 69,869 74,400 6.5

Operating income 4,321 4,630 7.1

Ordinary income 4,061 4,170 2.7

Profit attributable to owners of parent

1,487 2,000 34.4

Earnings per share

¥79.71 ¥107.69

3,897 4,321

4,630

6.0% 6.2%

6.2%

0%

5%

10%

0

2,000

4,000

6,000

2017/9 2018/9 2019/9E

Operating income Operating margin

(¥ millions)

Page 19: New Overview of Financial Results for FY2019 2nd Quarter/1H · 2019. 5. 17. · *indicates affiliated company Segment Products and services CMIC Group companies (as of end of Mar

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CMIC HOLDINGS Co., Ltd.

Keiko Oishi, President & COO

FY 2019 2Q

Activity Highlights

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3 key focuses of the new mid-term management plan from fiscal year 2019 to 2021

In addition to the PVC model, we will accelerate the IPM solution business that combines the marketing authorization licenses

Creation of healthcare business

Strengthening area competitiveness and promoting globalization

1

2

3

Increased number of PVC/IPM projects

Succeeded CDMO Astellas Pharma Tech Nishine Plant (June 2019) to enhance formulation capabilities

Established the MA Academy

Acquired an SMO based in Hokkaido

Established a subsidiary company in Australia

Succeeded Sony's “harmo“ electronic prescription record service

Launched “SelCheck Cervical Cancer”, a self-collect HPV test

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Acceleration of PVC model and IPM solution 1

Comprehensively support the value chain of pharmaceutical companies

Re-

Evaluatio

n

Ap

pro

val ap

plicatio

n

Gain

ing A

pp

roval

Dru

g laun

ch

IPM Platform-type pharmaceutical business

HC Business to enhance individual health value

Industrial research

Drug Discovery

Non-clinical studies

Clinical Studies

Man

ufact

urin

g Provision medical information

Sales

PMS Safety Reporting

CRO CRO SMO

CDMO

CRO

CDMO CDMO CSO

CRO IPM IPM

IPM IPM IPM

Clin

ical trial n

otificatio

n

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Responding to new development needs

Increased expertise and productivity for CRO

Utilization of RWD for rare and other diseases

Proactive readiness for new development activities including treatment apps and virtual clinical trials

Increased support for regenerative medicine and other therapies (Academia and VB support)

Talent development

Increase in the number of global trials and the decrease in the number of subjects for Japan local studies

Utilization of the Real World Data (RWD)

Improved productivity of both routine and non-routine operations using RPA and AI

Development trends

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Readiness for advanced therapies (biopharmaceuticals and regenerative medicine)

Bioresearch Center (Yamanashi)

CMIC, INC. US Lab

► Analytical services for Nucleic acid drugs

●Enhanced analytical support at CMIC, Inc.

(our laboratory in the United States)

●Top class contracting record for nucleic acid drugs

among analytical laboratories in the U.S.

► Participating in Megakaryon

consortium

●Established the edge as a pioneer in non-

clinical analysis of iPS cell-derived products

► Development consulting

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Succession of CDMO Astellas Pharma Tech Nishine Plant

Purpose and expected outcome

シミックのPVCモデル DBJの Overview of Astellas Pharma Tech Nishine Plant

1 Location Obuke 2-154-13, Hachimantai-city, Iwate

2 Area Site area: 345,563㎡,Building area: 14,337㎡

3 Commencement of operations

1986

4 Employees Approx. 190 employees (as of the end of September 2018)

5 Dosage forms Tablets and capsule

Ensuring stable supply

Flexible production of solid oral dosage forms

Enhanced technical capabilities

To build advanced drug manufacturing platform and enhance PVC model Scheduled to be transferred in June 2019

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To be transferred in June 2019

High alcohol containing drugs

CMIC Group Manufacturing Sites

Solid dosage forms Semi-solid dosage forms Injections/Solid dosage forms

Shizuoka/Nishine Toyama Ashikaga

Establishing readiness for manufacturing biopharmaceutical and other drugs Preparing for full commercial production of the parenteral drug manufacturing building in Ashikaga (FY20-FY21) Considering the launch of manufacturing process study service by CMIC JSR Biologics

High potency drugs

Korea

Semi-solid dosage forms

Solid dosage forms

USA Overseas

Building a efficient drug manufacturing system

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Improving formulation capabilities

© Copyright CMIC

to lead Aprecia’s Business Development in Japan

to introduce a new flexible dosing tablet technology in Japan

Accu-Break Tablets Exclusive alliance with Accu-Break Pharmaceuticals, Inc. (USA)

Business alliance with Apprecia (USA), the world leader in three-dimensionally-printed pharmaceutical products

The top layer contains API

The second layer is inert

Scored image

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MA (Medical Affairs) Academy

Enhancing the Medical Affairs Area

Opened “MA academy”, the first private sector institution to train Medical Affairs personnel

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To enhance our SMO business presence in Hokkaido

SSIーCP (former BELL24・Cell Product) Overview

1 Address 5-1-1 Odori Nishi-4, Chou-ku, Sapporo, Hokkaido

2 Employees Approx. 50

3 Offices Hokkaido (Sapporo, Asahikawa, Hakodate, Obihiro), Osaka, Matsuyama

4 Partner sites 240 medical institutions: 90 University hospitals/Hospitals, 150 Clinics

5 Clients Approx. 60

►Improve our positioning in Hokkaido (Market share in Hokkaido: 30%)

Enhance specific disease areas

(Increase the hospital network for Oncology, CV, CNS, Respiratory, Renal, Dermatology)

BELL24・Cell Product became the CMIC Group‘s wholly-owned subsidiary (April 2019)

Purpose and expected outcome

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►OrphanPacific, Inc. was established in May 2012 to provide orphan drugs that utilize the functions of CMIC Group and MEDIPAL Group

►Portfolio expansion (additional indications/formulation changes) of existing products

►Contributions to the stable supply of essential drugs, introduction of new orphan drugs, and providing support to foreign companies entering the Japanese market

IPM platform expansion

[2 orphan drugs developed internally] [5 drugs transferred from other companies]

Buphenyl® Normosang® Astomin® Somazon®

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Promoting Globalization 2

Established a subsidiary company in Australia

Supports Japanese companies that wish to enter the US market

CMIC, Inc. provides services in Japan and the U.S. simultaneously by cooperation with CMIC Pharma Science

Japan study data analysis utilizing overseas base (Vietnam)

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Healthcare business creation 3

Succeeded Sony‘s “harmo”* electronic prescription record service ・To enhance patient support program *Number of users: approx. 300,000 (as of March 2019),

with over 10,000 pharmacies nationwide

Concluded a technical support contract with Sony ・To adopt latest technologies and launch health tech business

Started services for self-collect HPV test “SelCheck Cervical Cancer”

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© Copyright CMIC Group

CMIC HOLDINGS Co., Ltd.

Kazuo Nakamura, CEO

Healthcare Revolution

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マスター タイトルの書式設定 “Japanese paradox”

and their longevity

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JPN

JPN

Japan’s Mean Life Expectancy:

From the bottom to the top

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G7 Countries Median Life Expectancy(2050)

"A universal pattern of mortality decline in the G7 countries." Tuljapurkar S1, Li N, Boe C.: Nature. 2000 Jun 15;405(6788):789-92.

Nature

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Japan reached the highest mean life expectancy in the World …

Medical budget and social security in the danger of bankrupt

National Health Insurance Costs in red

The taxes pay the negative balance

It will be impossible to continue paying for all the medical costs with the National Health Insurance System in the future

Now, what we do?

Japan’s Public Medical Budget

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Japanese Pharmaceutical Market

97,232

89,586 88,820

94,980

113,432

106,516

116,137 118,567

132,948 132,948

106,578 107,132

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

(JPY billion )

Source: Pharmaceutical and medical device industry Survey (Ministry of Health, Labor and Welfare)

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Japanese Pharmaceutical Market Trend

Revenue Forecast ($B), 2017–2022

67.5 69.6 69.5 68.7 65.7 67.2 66.0

61.8 60.5 59.3 58.2 57.0 55.9

2010 2011 2012 2013 2014 2015 2016 2017f 2018f 2019f 2020f 2021f 2022f

Pharmaceutical Market, Japan, Revenue ($B), 2010–2016

Source: GlobalData, Country Focus Report: ‘Healthcare Regulatory, and Reimbursement Landscape Japan’ (published April 2019)

Drug price revision in 2016

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Healthcare spending growth in the U.S. has exceeded GDP growth for decades

U.S. healthcare spending

0

2000

4000

6000

8000

10000

12000

14000

19

60

19

63

19

66

19

69

19

72

19

75

19

78

19

81

19

84

19

87

19

90

19

93

19

96

19

99

20

02

20

05

20

08

20

11

20

14

20

17

Total National Health Expenditures (Index, 1960 = 100)

Total GDP (Index, 1960 = 100)

Source: CMS.gov, St. Louis Fed

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U.S. Pharmaceutical Market Trend

Revenue Forecast ($B), 2017–2022

283.7 287.2 287.9 294.7 329.4

357.8 362.6 377.3 392.8

409.4 427.0

444.5 464.1

2010 2011 2012 2013 2014 2015 2016 2017f 2018f 2019f 2020f 2021f 2022f

Pharmaceutical Market, US, Revenue ($B), 2010–2016

Source: GlobalData, Country Focus Report: ‘Healthcare Regulatory, and Reimbursement Landscape US’ (published October 2018)

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Emerging company clinical stage pipeline (2008-2017)

Source : BIO Industry Analysis, Emerging Therapeutic Company Investment and Deal Trends

45.6% 40.9%

32.1%

21.3%

24.9% 33.2%

33.4% 44.4%

29.4% 26.0% 34.5% 34.3%

0%

20%

40%

60%

80%

100%

Phase I Phase II Phase III NDA

Small Co. Unpartnered Small Co. Partnered Large Companies

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Current options outside of hospitals

Providing care outside of hospitals

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Providing care outside of hospitals

Venue When to go Who works there Cost

Minute Clinic

• Routine problems such as bronchitis or minor sprains

• Preventive care such as vaccinations or diabetes screening

• Nurse practitioners • Pharmacists

• Low • Usually less than

$100 out of pocket • Insurance copay

Urgent Care Center

• More serious problems such as stitches, suspected fractures, or minor asthma attacks

• X-ray and lab services such as blood tests

• Physicians • Nurse practitioners • Radiologists

• Pharmacists

• Moderate • Usually less than

$200 out of pocket • Insurance copay

Retail clinics and urgent care centers provide many services at attractive price points

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Virtual Clinical Trial

Source Office of Pharmaceutical Industry Research News No.55 http://www.jpma.or.jp/opir/news/news-55.pdf

To execute virtual clinical trials, various systems need to be in place including home care for trial subjects and delivery of study drugs to home, in addition to the introduction of the mechanism based on IT technologies such as wearable devices and communication devices.

[Reason why Virtual Clinical Trial is not widely accepted in Japan]

Conventional clinical trial

(Example)

Explanation Consent Enrollment Home Complete

Explanation Consent Enrollment Visit Visit Visit Complete

On-line consultation ePRO, wearable devices Delivery of study drugs

Face-to-face consultation Physical and laboratory exams Dispensing and administrating drugs at medical institutions

Face-to-face

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Succession of Sony's “harmo” electronic prescription record service

Concluded a formal agreement for the transfer of “harmo”, the electronic prescription record service, with Sony Corporation

Users: Approx. 300,000 Nation-wide: over 10,000

(as of March 2019) pharmacies

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Utilizing data to solve Healthcare-related issues

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51 © Copyright CMIC Group CONFIDENTIAL

Health Promotion Activities

▸ Certified for two consecutive years as “Health and

Productivity Management Organization “

▸ Female health seminar, Yoga trial lesson

▸ Health promotion event “Let’s walk! Rainbow

bridge walking”

Diversity

▸ Nikkei “100 Best Companies Where Women Play Active Part” 2019

Ranked 28th in the overall ranking (4th in the industry)

CSR Activities

▸ Cosponsored “Rare Disease Day 2019”

▸ Travel clinic service for Japanese immigrants in the

south Brazil awarded the social contribution award

▸ AIDS Society (CMIC Award) (bestowed on

14 individuals to date)

Promotion of CREED

The 2019 Certified Health and Productivity Management Organization Recognition Program (White 500)

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Significant advancement in the Nikkei

“100 Best Companies Where Women Play Active Part” 2019 CMIC has advanced to 28th in the above ranking by Nikkei Woman, a women’s

career and lifestyle magazine published by Nikkei Business Publications.

CMIC is ranked 5th in the Promotion to Managerial Positions category

Promotion of CREED

(Source: Nikkei BP)

~ Women’s promotion to managerial positions is rated by whether the company has female executives, the male-female ratio in the managerial positions, as well as the number of women who have children in the managerial positions.

5th CMIC Holdings

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CMIC’S CREED

Our CREED

We are determined to bring innovation to healthcare so that

all people, regardless of age and gender, can live their

precious lives according to their will. This is our aspiration as

the CMIC Group.

Whether in childhood, when brilliance has yet to blossom, or

in late adulthood, when potential has bloomed, we respect

every individualʼs drive to live fully in the moment. We shall

sincerely address each and every life. We shall overlook no

one.

To achieve this, we shall continually challenge ourselves to

strive for a better future. We shall transform ourselves, seek

new vantage points, turn our unwavering passion into values,

and continue to contribute to individuals and society.

With unchanging determination at heart, we change

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マスター タイトルの書式設定 Cautionary statement: This material includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management, and is subject to significant risks and uncertainties. Actual financial results may vary materially from the content of this material depending on a number of factors. While this material contains information on pharmaceuticals (including compounds under development), this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of their preparations, promote any kind of unapproved uses, nor provide medical advice of any kind.