Second Quarter Business Resultsfor Fiscal 2022

November 7, 2022

TSUMURA & CO.

agenda01

Second Quarter Business Results for FY 2022

02

R&D Direction and Recent Progress2

Second Quarter Business Resultsfor Fiscal 2022

November 7, 2022
President and Representative Director, CEO

Terukazu Katoagenda01

Second Quarter Business Results for FY 2022

02

Initiatives and Progress for
Domestic Business and China Business03

FY 2022 Earnings Forecast

4

2Q Business Results for FY 2022
[Million yen]

2Q FY 2022
Revised Plan
（3/8/2022）

2Q FY 2022
results

Achievement
rate

YoY
AmountChange68,90070,107101.8％+6,690+10.5%

Domestic business－

62,922－－－China business

－

7,184

－

－

－

Operating profit

10,70011,677109.1%（6）（0.1）%

Domestic business－

11,765－－－China business

－

△87

－

－

－

Sales

Ordinary profit
Profitattributable to owners ofparentPL translation rate (CNY)14,00015,965 114.0%+2,556+19.1%

9,600

11,889 123.8%+1,923+19.3%

18.98

－

+2.32

－

Ratio to total sales

Prescription
Kampo Products
85.8%
External sales by
consolidated subsidiaries
10.9%
OTC Kampo etc 2.9%
Other prescription
pharmaceuticals 0.4%

5

Key Points in Performance

Achieved revised plan for sales and profits at each level
Net sales

70,107

million yen

Achievement
rate＋101.8％YoY＋10.5％◼ Sales of the 129 prescription Kampo products: 60,191 million yen, grew 6.8％ year-on-year◼ Sales of OTC Kampo formulations and other healthcare products: 2,003 million yen, rose 20.0％ year-on-year◼ China business sales: 7,184 million yen

Operating profit
Operating profit
margin11,677
16.7

million yen

Achievement
rate＋109.1％

YoY(0.1％)％

vs. revised
plan＋1.2ptYoY(1.7pt)◼ Cost-to-sales ratio: 50.3％, down 0.1pt vs. revised plan but up 1.9pt year-on-year; YoY comparison: Mainly impact of a climb
in energy expenses and a growth in external sales in China◼ SG&A ratio: 33.0％, down 1.1pt vs. revised plan and down 0.1pt year-on-year; YoY comparison: Rise in sales mainly
absorbed the one-off rise in expense in tandem with operations at the Tianjin Plant

Ordinary profit

15,965

million yen

Achievement
rate＋114.0％

YoY＋19.1％◼ Foreign exchange gain primarily related to loans to overseas subsidiaries: 3,950 million yen, up 2,765 million yen; foreignexchange impact (acceleration in the devaluation of the yen)

Profit attributable to owners ofparent11,889million yen

Achievement
rate＋123.8％YoY＋19.3％
6

Factors Triggering Changes in Operating Profit (YoY)（ Million yen ）（ Million yen ）Breakdown of change in net sales: +2,999＋2,201＋797

Domestic
Overseas+2,999（960）（1,646）

Breakdown of change in cost-to-sales: (960)
Crude drug procurement cost
(Domestic: decline in unrealized profit)（400）

Raw material expense (Domestic: Soaring expense formaterials other than raw material crude drugs)

Processing expense, etc.
Outside sales in China (Overseas: Growth at China business
which has a high cost-to-sales ratio)

11,677(641)

Breakdown of change in SG&A expense: (1,646)
Depreciation(Mainly increase in tandem with operations at Tianjin Plant)

Profit impact Profit impact Profit impact Profit impact
2Q FY 2021
2Q FY 2022
from changes
due todue toOperating profit due to changes
Operating profit
in SG&A
exchangechanges inin salesexpensesrate
cost-to-sales

(170)
(274)

(Domestic: Mainly soaring energy prices)

11,684

+126

(449)

Advertising

(129)

R&D

(103)

Sales promotions(73)

Salary allowance＋14

Other (Mainly rise in volume of activities, system introduction)(905)

Foreign exchange impact(400 million yen)7

Financial Condition/Cash Flow Position（ Million yen ）Equity ratio

68.3％

63.8%

（4.5）pt

FY 2021

FY 2022
2Q

Current assets
Non-current assets

Total liabilities
Current liabilities

Work in process
Raw materials andsupplies

+44

1,004

31,756
1,879
29,877
20,192

Change

+96

（80）

675

Of which,
Exchange rate

8,012

7,470

（109）

408

（475）

238

8,596

6,823

Financing activities

Merchandise andfinished goods

92,751 100,764
10,247
10,138
13,614
13,13968,88977,485+269

Investing activities

Inventories

5,931

Cash and cash equivalents at
beginning of period(March 2022)

46,017

Operating activities

Non-current liabilities（ Hundred million yen ）Cash and cash
equivalents at end of
period402,930
275,438
127,492
124,628
47,75476,873
278,30251,948

Total net assets

350,981229,420
121,561
92,87145,875
46,996258,109

Total assets

ChangeBond issuance: 30 billion yen (Sep. 8, 2022)

Impact of exchange ratetranslations(March 2022)

FY 20222Q

FY 20218

Bond Issuance
Procure funds through bond issuance to use to fund growth investments
and for the redemption of outstanding bonds
No. 1 unsecured bondNo. 2 unsecured bondNo. 3 unsecured bondNo. 4 unsecured bond

(7-year bond)(10-year bond)(7-year bond)(10-year bond)Totalissuance

15.0 billion yen

15.0 billion yen

15.0 billion yen

15.0 billion yen

Issuancedate

June 2017

June 2017

September 2022

September 2022

Maturity

May 2024

June 2027

September 2029

September 2032

Use of funds procured from the issuance of the No. 3 andNo. 4 unsecured bonds

Redemption foroutstanding bonds
Portion of funds will be forthe redemption of the No. 1
unsecured bond

Growth investment
CAPEX & DX investment
Improve productivity via capacity boost, automation andDX (digital transformation): roughly 115.0 billion yen

9agenda01

Second Quarter Business Results for FY 2022

02

Initiatives and Progress for
Domestic Business and China Business03

FY 2022 Earnings Forecast

10Comparison with the Prescription Pharmaceutical Market
On a NHI drug price basis, grew 9.6% year-on-year
Gap with the market expanded 0.9pt, versus 1Q(YoY/drug price basis)

All sales channels
Tsumura

7.9%

9.6%
7.7%
6.6%

Gap withmarket＋5.0pt7.1%

5.4%

Prescription
pharmaceutical
2.5%
market

4.2%

1Q

2Q

FY2021

3.6%

Gap withmarket＋4.1pt

4.6%

2.9%
1.3%

3Q

4Q

1Q

2Q

FY2022
Copyright © 2022 IQVIA. Proprietary calculation by Tsumura based on “JPM Apr. 2022 – Sep. 2022”
Reproduction prohibited

11

Sales of Drug-fostering Program Formulations/Growing
Formulations（ Million yen ）Net sales
Product No./formulation nameRanking

FY 2021 2Q

FY 2022 2Q

Ratio to total sales

YoY

100 Daikenchuto

4,790

4,927

+137

+2.9%

2

54 Yokukansan

3,720

3,775

+55

+1.5%

4

43 Rikkunshito

3,557

3,698

+141

+4.0%

8

107 Goshajinkigan

1,736

1,755

+18

+1.1%

23

14 Hangeshashinto

678

708

+30

+4.4%

Total sales for drug-fostering program formulations

14,482

14,865

+382

+2.6%

Drug-fostering program
formulations

1

41 Hochuekkito

3,741

4,060

+319

+8.5%

5

17 Goreisan

2,680

3,198

+517

+19.3%

7

24 Kamishoyosan

2,415

2,583

+168

+7.0%

16

108 Ninjin’yoeito

961

1,034

+73

+7.6%

17

137 Kamikihito

849

1,013

+164

+19.3%

Total sales for growing formulations

10,647

11,890+1,242+11.7%

Total sales for 119 formulations other than drugfostering program and growing formulations

31,24733,435+2,188+7.0%

Total sales for 129 prescription Kampo
products

56,37760,191+3,814+6.8%

Growing formulations

2

Drug-fostering
programformulations

25%
129
prescription
119 formulations
other than drugfostering programand growing
formulations

Growing
formulations

20%

55%

12

Results owing to Transformation in Information Provision Activities
Increase the number of doctors newly prescribing Kampo formulations and the number ofdoctors boosting the number of Kampo prescriptions they write by improving the recognition of
Kampo information
450000Detailing impact cases*1 (Monthly average number of cases)

400000e-Promotion
350000300000Level prior to
COVID-19

250000E-mail magazine being
sent to Medical Site members
・Rise in Web lecture participants
・Increase in video viewership200000

Number of doctors newly prescribing
Kampo formulations*2

150000MR
activities

100000approx. 6,000 doctors*4
Number of doctors boosting the numberof Kampo prescriptions they write*3

50000
0

2019年度FY20192020年度FY20202021年度FY20212022年度2Q
2Q
FY2022

Source: INTAGE Healthcare Inc. “Impact Track”*1: Number of detailing impact cases: Number of cases of information recognition from various channels, including MR activities
and the Internet(MR activities: Detailing via MR, online interviews, in-hospital presentations, etc.; e-Promotions: Online information provision
activities other than those via MR.)approx. 20,000 doctors*4
Tsumura survey*2: Confirmed number of doctors going from writing no Kampo prescriptions
to writing prescriptions*3: Confirmed number of doctors increasing the number of Kampo
prescriptions they write*4: Increase as of September 30, 2022 starting from April 1, 202213

Impact of Intense Heat (Heat Stroke/Summer Fatigue Formulation: Seishoekkito)<Medical Site: Video library (Kampo lesson)>Seishoekkito sales

Kampo formulation/use by disease/symptoms “Heatstroke/summer fatigue”

250(Million yen)Kampo Lesson
Heat stroke/summer fatigue
Supervised by: Dr. Shuji Ono, director of the Ono Clinic

2022
200

150

Commentary on “heat stroke/summer fatigue,”conditions unique to the summer months

100

2021

Kampo lesson: Heat stroke/summer fatigue
Use depending on timing

50

GoreisanSeishoekkito Hochuekkito

0

4月
Apr

5月
May

6月
Jun

7月
Jul

8月
Aug

9月
Sep

Bar graph: Japan Meteorological Agency data
Line graph: Tsumura actual sales (invoice price) data

Heat stroke
symptoms start toshow

Exhaustion due toheat stroke, andcontinual dry mouthand sweat

Heat sensation, sweating
and dry mouth symptoms
dissipate but
gastrointestinal
symptoms

14

COVID-19 Impact (1)Growth in common cold-related formulation
adjustments for acetaminophen formulations

sales

due

Number of new COVID-19 patients & total sales for 4 common cold-related formulations

500
450

shipment

Number of newly infectedindividuals

Acetaminophen formulation (10,000 people)
700
shipment adjustments

600yen)(Million

550

toKakkonto
Maoto
Maobushisaishinto
Shosaikotokakikyosekko

600

500
400

400
300

350

200

300
250

100

200

0

BA.2

BA.5
Bar graph: Ministry of Health, Labour and Welfare open data; Number of newindividuals testing positive (by day)
15
Line graph: Actual sales (Invoice price: Tsumura data)

COVID-19 Impact (2)Growth in sales of formulations related to Long-COVID symptoms due to anincrease in the number of people infected with the omicron strain
Differences in Omicron and Delta strain symptoms
39%

デルタ株
Delta
strain34%

オミクロン株
Omicronstrain30%

Number of COVID-19 patients and sales of formulations related to Long-COVID symptoms
Number of
newly-infected
700
individuals

900yen)(Million(10,000 people)

800

Hochuekkito (fatigue)

600

700
500

600

26%
23%

22%

400

500
400

300

Bakumondoto (cough)

300
10%

11%

200

200
100

100

Tokyo iDC After-Effect Task Force
Based on analyzed data from consultations with the COVID
After-effect consultation desk at Tokyo metropolitan andpublic hospitals

Delta strain

2022年9月
Sep
2022

2022年8月
Aug
2022

2022年7月
l 2022Ju

2022年6月
Jun
2022

2022年5月
May
2022

2022年4月
Apr
2022

2022年3月
Mar
2022

2022年2月
Feb
2022

2022年1月
Jan
2022

2021年12月
Dec
2021

2021年11月
Nov
2021

Oct
2021
2021年10月

Sep
2021
2021年9月

Aug
2021
2021年8月

l 2021
Ju
2021年7月

Taste
Olfactory
嗅覚障害 味覚障害
impairment impairment

Jun
2021
2021年6月

Fatigue
倦怠感

May
2021
2021年5月

Cough
咳

0

Apr
2021
2021年4月

0Omicron strain
Bar graph: Ministry of Health, Labour and Welfare open data; Number of newindividuals testing positive (by day)
16
Line graph: Actual sales (Invoice price: Tsumura data)Impact on Shipments of Intense Heat and COVID-19
April

May

June

July

AugustSeptember

Response

BCP
response
Intense heat
Shanghai lockdown Domestic plants
Substitute production

COVID-19
Seventh wave•

Boost production capacity for seasonal
formulations, common cold-related
formulations•

Change production plans to boost capacity➡ Limited shipments for some
Kampo formulations

Forecast
・Ongoing demand for common cold-related Kampo formulations owing toincrease in Long-COVID patients・Increase in demand for common cold-related Kampo formulations owing toseasonal influenza trends and the re-expansion of COVID-19
17

China Business Sales
Crude drug platform: Achieved the 1H plan owing to an expansion inraw material crude drug sales
about 7.1
57.4％
growth※billionRaw material crude drugs

about 4.5
billionDrug pieces (chopped crude drugs)

2Q FY2021

2Q FY2022“Yakushokudogen”
products※local currency basis：38.2％ growth18

agenda01

Second Quarter Business Results for FY 2022

02

Initiatives and Progress for
Domestic Business and China Business03

FY 2022 Earnings Forecast

19

FY 2022 Earnings Forecast【Million yen】

FY 2021
Results

FY 2022
Forecast

YoY
AmountChange129,546

138,500＋8,953＋6.9%

Domestic business－

124,300－－

China business－

14,200－－22,37620,800(1,576)(7.0)％

Domestic business－

21,200－－China business

－

(400)

－

－

25,904

21,200(4,704)(18.2)%

18,83615,000(3,836)(20.4)％

64 yen64 yenEPS

246.2 yen

196.1 yen

ROE

8.2 %

6.0 ％

Net sales

Operating Profit

Ordinary Profit
Profit attributableto owners of parent

Dividends （per share）(Note) Foreign exchange impact (non-operating profit) is
not factored into the earnings forecast as it isdifficult to make reasonable calculations given
trends in the foreign exchange market.
20

Shareholder Returns
Policy◼ We aim to improve our corporate value by continually expanding domestic businessand through growth investments in the China business, and by building foundations.
Accordingly, we plan to implement stable dividends, taking into account factors such as
medium/long-term profit levels and cash flow conditions.
45.0%

100

32.1%

35.9% 35.7%

31.9% 33.5%

35.6%

32.6%

31.9%

40.0%

35.0%

80

26.0％

25.0%

30.0%

60

40

25.0%

32

32

32

32

32

32

32

32

32

32

20.0%

15.0%

20

From Oct. to Mar.
From Apr. to Sept.

10.0%

32

32

32

32

32

32

32

32

32

0

32

Dividends payout ratio
5.0%

0.0%

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022forecast
2022

Note: The FY 2022 year-end dividend and payout ratio (forecast) are an estimate based on the assumption that the dividend resolution isapproved at the 87th Ordinary General Meeting of Shareholders.

21Second Quarter Business Resultsfor Fiscal 2022
—R&D Direction and Recent Progress, etc.—
November 7, 2022
Executive Officer, Head of Kampo Research & Development Division / International
Pharmaceutical Research & Development Division

Akihito Konda

“Further” Build Foundation for Standard Treatments—Expand Existing Research and Dig Deep—【Geriatric Health】
・Conduct research related to frailty based on more detailed types, including from social,physical and mental aspects
・Conduct research pertaining to behavioral and psychological symptoms of dementia(BPSD), including mild cognitive impairment, and Stages I, II, III, etc.
・Implement the full-fledged building of evidence in the circulatory domain, including
congestive heart failure and cardio-renal related diseases【Cancer】
・Conduct research related to support for cancer survivorship(Provide employment support assistance from social, physical and mental viewpoints)【Women’s Health】“Implement research that is close-knit with the life stages of women”
23Agenda01

Women’s Health Initiatives at Tsumura (Origin of Founding)& Confirmation of Changes in the External Environment

02“Further” Build Foundation for Standard Treatments
Research Results Thus Far & Research Pipeline

03

Propose New Treatment Methods (Tackling Personalized Medicine)
Tackle Presymptomatic Diseases*Points to consider
This presentations contains a plethora of information related to matters such as pharmaceuticals. This information is not for the purpose of solicitation or advertising.
24Tsumura has Been a Company that is Close-knit to Women’s Health
Since its Foundation

Jusha Tsumura (founder of Tsumura Juntendo, the predecessor to modern-day Tsumura) improved a drug for
women’s disorders that was passed down through the Fujimura family, his mother’s family
Tsumura Juntendo launched the drug, Chujoto in 1893 in Nihonbashi, Tokyo

We aim to assist in preconception and conception care that is closeknit to the health of women throughout their lives!
*Preconception care: Women and couples face their lives and health while considering a future pregnancy
25Transformation in the Promotion of Women’s Activities
2015•Act on the Promotion of Female Participation and Career Advancement

Work conditions for Japanese females
1990s: M-curve in the employment rate; rate drops for women in theirlate 20s and 30s and rises once again from those 40 and older

in the Workplace established

2000s: M-curve in the employment rate become gradual2021•Act on Childcare Leave, Caregiver Leave, and Other Measures for the
Welfare of Workers Caring for Children or Other Family Members•Infertility prevention and support package

In and after 2020: L-curve for the regular employment rate peaked for
women in their late 20s; Declines after pregnancy ➡ Need to improvethe continued employment rate
Femtech market forecast to reach about JPY2 trillion/year by 2025

•Femtech nominated for the “new word & buzzword of the year award”•“Femtech promotion” included in the basic policy 2021
2022

•Infertility treatment covered by insurance•Basic policy 2022 established•Declaration on the Promotion of Sexual and Reproductive Health andRights: Japan Society of Obstetrics and Gynecology

Expert consultation/support

Simple test kit

Consult on anxieties
and concerns

Easily know physicalconditions

Health management/tracking

Medical support

Aim for daily
healthmanagement

Alleviate out-patient andexam burden

Other
Aim to try more superior
solutions◆Measures against population decline◆Women’s employment assistance policy◆Femtech gains momentum

Source: Prepared by Tsumura, having modified https://www.femtech-projects.jp/ (“Femtech:
Creating a new “matter of course” for a society where it is comfortable for women to work”(METI))*Femtech ＝ Female + Technology
Femtech is a coined word that combines “Female” and “Technology.” Products andservices that solve women’s health issues with technology.
26

Agenda01

Women’s Health Initiatives at Tsumura (Origin of Founding) &Confirmation of Changes in the External Environment

02“Further” Build Foundation for Standard Treatments
Research Results Thus Far & Research Pipeline

03

Propose New Treatment Methods (Tackling Personalized Medicine)
Tackle Presymptomatic Diseases*Points to consider
This presentations contains a plethora of information related to matters such as pharmaceuticals. This information is not for the purpose of solicitation or advertising.
27

Kampo Research Pipeline—Research Strategy by Life Stage in Women’s Health—High↑
Estrogensecretion
volume↓Low

Average age of
first
menstruation
among
Japanese
women is 12
years and twomonthsAverage age ofJapanese women when
they start menopause:
50.5 years old

Average age of Japanesewomen when they give birth totheir first child: 30.7 year old

80% of women over 60
years old suffer fromdysuria

Preconceptions (care prior to pregnancy)

Menstrual troubles, including premenstrual syndrome (PMS)
TJ-23 Tokishakuyakusan: menstrual irregularity/difficulty, infertility,
miscarriage, etc.
TJ-24 Kamishoyosan: menstrual irregularity/difficulty, chi-no-michi-sho, etc.
TJ-106 Unkeito: menstrual irregularity/difficulty, neurosis, chills, etc.

Various symptoms related to endometriosis

Commonconditions/diseases

TJ-23 Tokishakuyakusan

Infertility/various
pregnancy disorders
TJ-23 Tokishakuyakusan
TJ-106 Unkeito

Menopause
TJ-24 Kamishoyosan
TJ-25 Keishibukuryoganryo

Ovulation factor (ovulation disorder)
Tubal factor (blockage, constriction, adhesion）
Uterine factor (uterine fibroid, endometriosis)
Cervical factor (cervical mucus disorder）
Immunity factor (antisperm antibodies）

TJ-41 Hochuekkito
Poor appetite, boost endurance,etc.

TJ-67 Nyoshinsan pre/postnatal neurosis, etc.
TJ-108 Ninjin'yoeito Anemia, fatigue, etc.

10

20

30

Co-existing
pharmaceuticals
Infancy

Puberty40

TJ-40 Choreito
Urination pain, constanturge to urinate, etc.

Frailty

Postpartum depression

Age

Female lower urinary tract
symptoms

50

60

70

80（歳）

Symptomatic therapy: LEP, etc.

Symptomatictherapy: HRT, etc.

Symptomatic therapy: β3,
Anticholinergic agent

Sexual maturation

Climacteric period

Elderly years
28Actual Trends in Kampo Treatments for Various Diseases during Pregnancy
Research Report based on Real World Data (Medical Big Data)“Benefit of Kampo medicine on birthrates among women with a history ofrecurrent pregnancy loss (including habitual abortion, etc.)
Goal: Examine efficacy of Kampo medicine for overall childbirth rate among patients with a history ofrecurrent pregnancy loss (habitual abortion)
Target: Extract women diagnosed with recurrent pregnancy loss from January 2005 to August 2018
(5,517 women)
Analysis of childbirth rate after 2 years, after 4 years (Kampo usage rate: 29.9%; percentage
using Tokishakuyakusan: 60%, other Kampo 40%)
Kampo medicine(1,651)

Non-Kampo medicine(3,302)Childbirth rate after 2 years

15.7 %

11.2 %

Childbirth rate after 4 years

22.6 %

17.8 %
Childbirth rate comparison during tracking period: P = 0.0003
log-rank test

Reviews of medical big data have indicated that Kampo formulations, including Tokishakuyakusan,
possibly contribute to an improvement in birthrates among women with a history of recurrent pregnancy
loss
Prepared by Tsumura based on International of Journal of Gynecology & Obstetrics153(3) 489-495 (2021) data29

Expand Standard Kampo Treatments (Build Evidence: Publish）

How Tokishakuyakusan works for the rat infertility model
1. Adhesion

2. Infiltration: Infertility modelPregnancy

3. Endometrial cell differentiation

Tokishakuyakusan

Fertilized
egg
Fertilized
egg

Endometrium
Implantation
factor（LIF）

Endometrial celldifferentiation

Implantation
Successful
pregnancy

Endometrial gland
Prepared by Tsumura based on J Ethnopharmacol. 2021, 265:113288 data30

Changes in the Performance of Working Females and Related Labor Loss
In comparison with healthy conditions, work performance for around half of females drops
to below 50% due to premenstrual syndrome or catamenial symptoms
Performance ratio for less than half of working females is 45%
1

Low

6

０点points

5

Performancepoints３点

310

1点points
2点points

1

14

9

points
４点
points５点
points６点
points７点

16

21

points８点
points９点
points
１０点

14

High
Assuming the score for working in a healthy condition is 10 points, self-assessment
when experiencing premenstrual syndrome or catamenial symptoms (n=2000)
Source: Figures modified by Tsumura based on data from Survey on Health Promotion and Working Women2018, Health and Global Policy Institute (HGPI)
https://hgpi.org/wp-content/uploads/1b0a5e05061baa3441756a25b2a4786c.pdf (revised)31

Expand Standard Kampo Treatments (Build Evidence: Publish）
Efficacy of Tokishakuyakusan on lesions and pain in the endometriosis-like model★In 2018-2019, number of downloads is in the top 10% of papers selected

Suppress endometriosis-like lesions

Alleviate pain
10

1mm

1mm

Tokishakuyakusan
Endometriosis-like model Control
Lesion exacerbation factor(Interleukin 33)

Degree of pain relief

Endometriosis-like lesions

Pain response due
to heat stimulation〈Pain measurement test〉
＊

＊

8
6
4
2
0
Pre-operative
Tokishakuyakusan
Comparison
mouse

Average + standard deviation,* p<0.05, Student’ t-test (Restricted)

Tokishakuyakusan: Mechanism of Action〇 Action on lesion exacerbation factor
Inhibit interleukin 33 mRNA

Pathological findings

Epithelial cyst Interleukin 33〇 Action on the source of pain
Inhibit cyclooxygenase 2 mRNA
Prepared by Tsumura based on Am J Reprod Immunol. 2019 Nov;82(5):e13182 data32

Kampo Research Pipeline—Research Strategy by Life Stage in Women’s Health—High↑
Estrogensecretion
volume↓Low

Average age of
first
menstruation
among
Japanese
women is 12
years and twomonthsAverage age ofJapanese women when
they start menopause:
50.5 years old

Average age of Japanesewomen when they give birth totheir first child: 30.7 year old

80% of women over 60
years old suffer fromdysuria

Preconceptions (care prior to pregnancy)

Menstrual troubles, including PMS
TJ-23 Tokishakuyakusan: menstrual irregularity/difficulty, infertility,
miscarriage, etc.
TJ-24 Kamishoyosan: menstrual irregularity/difficulty, chi-no-michi-sho, etc.
TJ-106 Unkeito: menstrual irregularity/difficulty, neurosis, chills, etc.

Various symptoms related to endometriosis

Commonconditions/diseases

TJ-23 Tokishakuyakusan

Infertility/various
pregnancy disorders
TJ-23 Tokishakuyakusan
TJ-106 Unkeito

Menopause
TJ-24 Kamishoyosan
TJ-25 Keishibukuryoganryo

Ovulation factor (ovulation disorder)
Tubal factor (blockage, constriction, adhesion）
Uterine factor (uterine fibroid, endometriosis)
Cervical factor (cervical mucus disorder）
Immunity factor (antisperm antibodies）

TJ-41 Hochuekkito
Poor appetite, boost endurance,etc.

TJ-67 Nyoshinsan pre/postnatal neurosis, etc.
TJ-108 Ninjin'yoeito Anemia, fatigue, etc.

10

20

30

Co-existing
pharmaceuticals
Infancy

Puberty40

TJ-40 Choreito
Urination pain, constanturge to urinate, etc.

Frailty

Postpartum depression

Age

Female lower urinary tract
symptoms

50

60

70

80（歳）

Symptomatic therapy: LEP, etc.

Symptomatictherapy: HRT, etc.

Symptomatic therapy: β3,
Anticholinergic agent

Sexual maturation

Climacteric period

Elderly years
33Agenda01

Women’s Health Initiatives at Tsumura (Origin of Founding) &Confirmation of Changes in the External Environment

02“Further” Build Foundation for Standard Treatments
Research Results Thus Far & Research Pipeline

03

Propose New Treatment Methods (Tackling Personalized Medicine)
Tackle Presymptomatic Diseases*Points to consider
This presentations contains a plethora of information related to matters such as pharmaceuticals. This information is not for the purpose of solicitation or advertising.
34

Research for a Kampo Diagnosis Support System(Focus on Women’s Health)Top 10 commonly experience
disorders (Multiple choice)※1

Overall (n=1,000)
1st

Fatigue/sluggishness

2nd Chill
3rd

Frustration

4th

Damaged skin (acne, eczema, etc.), blemishes

5thHeadaches

6th

Anxiety

7th PMS※2※2

8th

Lower back pain

9th

Difficulty falling asleep, wake up feeling poorly,
light sleeper, insomnia
10th Menstrual cramps, irregular menstruation,
abdominal pains pre/post menstruation*1: Fact-finding survey on concealing pain (March 3, 2021,
implemented by Tsumura)https://www.tsumura.co.jp/newsroom/topics/2021/03031750.html*2: Poor physical condition due to menstrual cycle (frustration, fatigue,headache, etc.)35

Direction in R&D of Kampo Diagnosis Support System (Women’s Health Examples)
1st Medium-Term Management Plan

2nd Medium-Term Management Plan

3rd Medium-Term Management Plan

(2022～2024)(2025～2027)(2028～2031)

Research phase

Development phase

Social implementation

Develop a questionnaire system(Truth-fake/chills & fever/qi, blood, fluid)

Multi-faceted research,
pivoting around chills, etc. topersonalize medicine

Validation testingfor formulation
selection

Research to clarify genetic
background, mechanism ofchills and correlation

Automatic Kampo medical exam

Expand medical treatment data /improve forecast precision

ChillsRelated to genes

Physical symptoms*Genetic testing＋blood flow /intestinal bacterial flora
36Kampo is a “Long Tail Drug”
Calculating the tail portion,
comes to a considerable number…

Niche products

Sales volume

Popular products

Profile for specifically detected ingredients in plasma
after administration of Kampo medicines

Tail portion〈Reference〉
Business model for lineup of omni-directional products

Estimated
ingredients

Unidentified
ingredients

Prepared by Tsumura based on NPJ Syst Biol Appl. 2017, 3, 32 data
37

“A Chill Can Lead to All Kinds of Diseases”: Treating a Chill as a
“Presymptomatic Disease,” Pursue Clues to a Solution in KAMPOmics
TJ-23 Tokishakuyakusan 3D HPLC Pattern

Western medicine

Kampo medicine

Single ingredientMultiple ingredients

IngredientA

Ingredient A, C, E･･･
Metabolite/Conjugate a, b, B*, c ,C*, e ･･･

Kampo

Organism

ActionMetabolism

Receptor

Receptor, etc.

Enzyme

RNA

Lipid

DNA

･･･

Multiple
ingredients
Intestinal
Multiple ingredientsbacterial flora

System biology

Biologicalnetwork

Symptoms
Variation

Pharmacokinetics of ingredients, Function of intestinal bacteria, Function of biological metabolite,
Diverse biological response,Metabolism of ingredients

KAMPOmicsⓇ

38

Inquires about these materials
Corporate Communications Dept.
Investor Relations Groupinvestor_madoguchi@mail.tsumura.co.jp
Cautionary items regarding forecasts⚫ The materials and information provided in this presentation contain so-called forward-looking
statements. Readers should be aware that the realization of these statements can be affected by avariety of risks and uncertainties and that actual results could differ significantly.

⚫ Changes in Japan or other foreign countries related to healthcare insurance systems or regulations
set by medical treatment authorities on drug prices or other aspects of healthcare or in interest andforeign exchange rates could negatively impact the Company’s performance or financial position.
⚫ In the unlikely event that sales of the Company’s core products currently on the market be halted orshould sales substantially decline due to a defect, unforeseen side effect or some other factor, there
could be a major impact on the Company’s performance or financial position.

39

Appendix

Comparison with the Prescription Pharmaceutical Market
TsumuraPrescription pharmaceutical market(YoY/drug price basis)

12%
10%

9.6%
7.9%

8%
6%
Overall

4%

7.7%
4.2%

2.5%

7.1%

6.6%

5.4%

4.6%

3.6%

2.9%

1.3%

2%
0%
-2%
1Q
FY2021

General clinics (GP)

2Q

3Q

11.1%
9.1%

6%
0.7%

8.7%

2.3%

7.5%

1.9%

7.8%

2.4%

8%
6%

6.3%

5.2%

2Q

6.4%
4.7%

4.1%

5.1%
3.9%

4%

2%

1.4%

1%

3.1%

3.4%

2.7%

3.7%

0%
1Q

-4%

1Q
FY2022

Hospital market (HP)

16%
11%

4Q

FY2021

2Q

3Q

4Q

1Q

2Q

-2%

1.1%

3.2%

1.1%
1Q

2Q

3Q

4Q

1Q

2Q

FY2021
FY2022-4%
Copyright © 2022 IQVIA. Proprietary calculation by Tsumura based on “JPM Apr. 2022 – Sep. 2022”

FY2022

Reproduction prohibited

41

COVID-19 impact（shipment volume basis：growth rate）

Increase reflecting changes inliving environment•••

Increase owing to omicron strain

Anxiety/insomnia (6 formulations)Dizziness (2 formulations)
Loss of appetite, fatigue (2 formulations)•

Common cold, influenza and hay fever (13 formulations)
140% Cold-related formulations

Increase owing to theuse of masks•

Skin irritation, acne (4 formulations)

110%

120%

Formulations owing to
impact of environmental
change118%

129 prescriptions

108%
105%

FY20202Q

FY2021
2Q

FY20222Q

42

Number of Doctors that Write 10 or More Kampo Prescriptions
The number of doctors that write 10 or more Kampo prescriptions increasedaround 10,000 doctors, a ratio of 29%
Number of doctors that write 10 or more Kampo prescriptions

Clinicians: 320,000

50％
approx. 84,000
doctors

26％

Rise ofapprox.
10,000
doctors

approx. 94,000
doctors

50%
-plus

29％
*Tsumura survey

End-FY202
2021年度末

2Q FY2022
2022年度2Q

End-FY2024
2024年度末First medium-term management plan
43