November 10, 2023

Consolidated Financial Results for
the Second Quarter of the Year Ending
March 31, 2024 (FY2023)
Presentation for Investors
Securities code : 4886 (TSE)
ASKA Pharmaceutical Holdings Co., Ltd.

Forward Looking Statement
 The forward-looking statements contained in this presentation are based on the Company’s

assumptions and beliefs in the light of information currently available to it and involves known
and unknown risks and uncertainties.

 Accordingly, there is a possibility that actual results and development programs may differ

largely from these forecasts, due to a variety of factors.

 Thisreport contains information on Pharmaceuticals Products (including those underdevelopment), and the content of this report is not intended for medical promotion or medical
advice.

 This translation is provided solely as a reference material. In the case of any discrepancy

between the two versions, the original Japanese version shall prevail.

2

Financial Results Summary for 2Q FY2023

Atsushi Maruo,

Senior Managing Member of the Board of Directors, Representative Director

ASKA Pharmaceutical Holdings Co., Ltd.

FY2023 2Q (Consolidated) Highlight
Net sales

Cost of sales✓ 31.6 billion yen, up 4.9% YOY

The pharmaceuticals business remained strong, with record-high sales.

✓ 16.4 billion yen, improved 0.6 percentage points YOY

The product mix improved due to growth in Brand-name drugs such as RELUMINA, THYRADIN,
and RIFXIMA.

SG&A
expenses✓ 12.1 billion yen, up 0.4 percentage points YOY

Operatingprofit✓ 3.0 billion yen, up 6.1% YOY

Full-year
forecast✓ Revised upward, as announced on September 25, 2023

Impacted by an increase in business activity expenses due to the normalization of economic activities.

Despite increases in R&D, SG&A, and other expenses, the increased sales and gross profit boosted
profits.

Revised upward due to a record of sales of investment securities (extraordinary income).
44Consolidated Statements of Income(Millions of yen)

FY2022 Apr - Sep
ActualFY2023 Apr - Sep
ActualActual +/-Growth +/-Net sales

30,172

31,648

1,475

4.9%

Cost of sales

15,87016,461590

3.7%

Gross profit

14,301

15,186884

6.2%

Selling, general andadministrative expenses

11,422

12,130708

6.2%

Operating profit

2,879

3,055

176

6.1%

Ordinary profit

2,987

3,096

108

3.6%

Profit attributable toowners of parent

2,346

4,129

1,783

76.0%

* Put a current exchange rate and the reference: ( 1 US dollar = 150.07 yen, as of Nov 6th 2023)( 1 Euro = 160.82 yen, as of Nov 6th 2023)

5

Consolidated Net Sales by Business(Millions of yen)

FY2022
Apr - Sep
ActualFY2023Apr - Sep
ActualBreakdown

Actual +/-Growth +/-Pharmaceuticalbusiness

26,851

28,404

89.7%

1,553

5.8%

Animal healthbusiness

3,234

3,162

10.0%

-71

-2.2%

86

80

0.3%

-5

-6.6%

30,172

31,648100.0%

1,475

4.9%

Other businesses

Total

6

Sales of Main Products (ASKA Pharmaceutical Co., Ltd.)
Area

Category

Internal Medicine

FY2023

ActualYOY

Revised
Forecast

Reference
YOY

Notes

Previous
Forecast

5,477

4,952

-9.6%

9,438

-12.0%

9,268 quantity basis maintained.

Brand-name

THYRADIN

3,921

4,000

2.0%

7,823

1.2%

7,833 Progressed as expected

Brand-nameRIFXIMA

2,757

2,997

8.7%

5,671

5.1%

5,578 Sales grew as the guideline penetration increased

Brand-name

MERCAZOLE

761

776

1.9%

1,515

1.9%

1,513 Progressed as expected

AMLODIPINE

465

430

-7.4%

844

-6.2%

844 Progressed as expected

RELUMINA

4,524

5,186

14.6%

10,23415.8%

10,128 Continued penetration activities for endometriosis

Generic

DroEthi

1,279

2,909

127.4%

5,370

46.3%

4,165 Progressed significantly more than expected.

AG

FREWELL

1,765

1,663

-5.8%

3,329

-4.6%

3,407 expected

Brand-name

LUTEUM

569

876

53.8%

1,462

16.9%

1,363 external factors, etc.

Brand-name

ANGE

420

367

-12.6%

713-9.0%

799 Decreased due to shift to other companies' products

Brand-name

MAGSENT * 2

309

355

14.9%

711

13.4%

750 The NHI price increase reflected in its figure

2,619

2,321

-11.4%

4,494-10.1%

Generic

Obstetrics and Gynecology

ActualFY2023Apr - Sep

CANDESARTAN * 1

AGUrology

Products(generic name)

FY2022
Apr - Sep

(Millions of yen)

Brand-nameGeneric(candesartan)(levothyroxine)(rifaximin)(thiamazole)(amlodipine)(relugolix)(drospirenone/ethinylestradiol)(norethisterone/ethinylestradiol)(progesterone)(levonorgestrel/ethinylestradiol)(magnesium sulfate)

LEUPRORELIN * 3(leuprorelin)* 1 Including compounding agents* 3 1.88mg formulation is for gynecological indications only but combined with 3.75mg formulation* 2 Total value of magnesium sulfate preparation

The NHI drug price decreased, but sales on a

Increased sales volume but less than initially
Sales grew due to lifting of shipping restrictions,Continued switch to other products from the initial

4,828 forecast

77

Sales of Major Business Field (ASKA Animal Health Co., Ltd.)(Millions of yen)

Business field

FY2022 Apr - Sep
ActualFY2023 Apr - Sep
ActualFY2023YOY

Forecast

YOY

Feed additives andmaterials, Mixed feed

2,062

1,873

-9.1

3,484

-16.1%

Veterinary
pharmaceuticals

1,081

1,189

10.0

2,415

1.9%

Key factors
 Market conditions for feed additives remained uncertain, although there were trends toward a bottoming out of the market.
 Sales of veterinary drugs remained steady, centering on TRILOSTANE TABLETS " ASKA," launched last year, andhormone agents.

8

Consolidated Balance Sheet
End of FY2022(Millions of yen)

End of 2Q FY2023(Millions of yen)

Current liabilities

Current liabilities

20,036

17,650Non-current liabilities

Current assets

14,95453,759（+2,386）
Current assets

59,644（+5,884）

Property, plant andequipment

10,796

Intangible assets

Net assets

54,533

4,465

Investments
and other assets

18,1171
2
Total
assets 87,138

Property, plant andequipment
10,649（-147）
Intangible assets
3,615（-849）
Investments
and other assets
18,011（-105）

Non-current liabilities

13,262（-1,691）

Assets(Millions of yen)

Cash and deposits+2,941

Accounts receivable - trade+2,126Inventories+899

Intangible assets-849

Liabilities/Net assets

Net assets

58,621（+4,087）2
Total 1assets 92,120（+4,782）

Notes and accounts payable – trade,
Electronically recorded obligations operating+1,587

Income taxes payable+730

Retirement benefit liability+145

Short/long-term borrowings-2,298Retained earnings+3,903

Analysis of key factors
Assets:Liabilities/
Net assets:

Increase in cash and deposits, accounts receivable - trade, inventories decrease in intangible assets due to amortization of distributorship
Increase in notes and accounts payable – trade, electronically recorded obligations – operating, income taxes payable, and retirement
benefit liability, Decrease in short/long-term borrowings, Increase in retained earnings

9Analysis of Operating Profit (YOY)(Millions of yen)

2,879

148

641
215

2Q FY2022
ActualIncrease in
R&D expenses

Increase in promotion
expenses, travel expenses,
and transportation costs etc.

3,055

884

Increase ingross profit

Decrease inother expenses

2Q FY2023
Actual

Key factors

 R&D expenses increased due to progress in clinical trials and aggressive discovery research Promotion expenses etc. increased as economic activities normalized Increase in profit due to increased gross profit with higher net sales
10Consolidated FY2023 Performance Forecast(Millions of yen)

FY2022
ActualFY2023

Previous Forecast

Revised on September 25, 2023

FY2023

Revised Forecast

YOY
Actual +/-YOY
Growth +/-Net sales

60,46162,00062,000

1,538

2.5％

Operating profit

5,108

5,400

5,400

291

5.7％

Ordinary profit

5,232

5,500

5,500

267

5.1％

Profit attributable toowners of parent

4,238

4,400

6,200

1,961

46.3％

Analysis of Major factors

 Profit attributable to owners of parent was revised upward because an extraordinary income isexpected to be recorded due to the sale of investment securities.

11Capital Expenditures, Depreciation and R&D expenses
Capital Expenditures

Depreciation

R&D expenses(Millions of yen)

(Tangible/intangible total)(Millions of yen)

(Tangible and software transfer basis)(Millions of yen)

(Forecast)

3,598
2,885
(Forecast)

657

1,256

3,127 (Forecast)
2,663

1,550

370

FY2021 FY2022 FY2023

4,227

4,581

1,376
FY2021 FY2022 FY2023

2,410
FY2021 FY2022 FY2023

Key factors
Capital expenditures: Expected to exceed the previous year due to planned partial renovation of Iwaki factory, etc.
Expected to be lower than the previous year due to a decrease in depreciation expenses for production facilities and mission-critical systems
Depreciation:
Expected to exceed the previous year due to aggressive discovery researches and progress in clinical trials.
R&D expenses:

12About Action to Implement
Management That Is Conscious of
Cost of Capital and Share Price

13

Business Environment and the Company’s Direction

Business Environment under Headwinds
The business environment remains challenging due to policies to curb
healthcare costs, such as annual NHI drug price revisions, drug quality/
supply issues, increasing difficulty in drug discovery, changing
international circumstances, including the Russian-Ukrainian crisis,
global supply chain disruptions, and rising costs associated with soaring
energy, raw materials, wages, and other costs.
Despite facing an uncertain future and challenges ahead,
we aim for growth by capitalizing on external changes.
14

PBR and ROE
PBR

PBR (multiple)

1.40

1.21

1.20
1.00
0.80
0.60
0.40

0.87
1.5

0.95

1.05

7.8

3.4
1.9

ROE

ROE（％）

8.8

1.14
5.8

8.2

6.3
4.1
0.76

0.72
1.5

0.97

0.73

0.65

FY2013 FY2014 FY2015 FY2016 FY2017 FY2018 FY2019 FY2020 FY2021 FY2022

10.0
9.0
8.0
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0

In the light of PBR being below 1x, we assessed the current situation and discussed
improvement policies and detailed initiatives at the board meeting several times.
* PBRs for FY2013-FY2022 are calculated based on the year-end share price.
PBRs and ROEs up to FY2020 are those of ASKA Pharmaceutical Co., Ltd.
PBRs and ROEs after FY2021 are those of ASKA Pharmaceutical Holdings Co., Ltd.

15

Assessment of Current Status and Policy for Improvement
Assessment of Current Status
 The Company's ROE has increased to the 8% level for three consecutive fiscal years of profit growth andhas exceed the 8% target for FY2025, the final year of the Medium-Term Management Plan.
 On the other hand, PBR has been below 1x since FY2018. We assess that the feasibility of the growthstrategy was not fully understood, the external communication was not sufficient, and the Company did notdisclose specific cash allocation. This was due to the Company's lack of clear direction for growth strategy
and shareholder returns.

Policy for Improvement
To improve market valuation, we will continue to strengthen IR activities to communicate our growth strategy byholding financial results briefings and pipeline briefings. Moreover, we will consider optimal cash allocation andtake action to implement management that is conscious of the cost of capital and our share price to enhance
the feasibility of the growth strategy and meet the expectations of our shareholders. We will continue to reducecross-shareholdings as a percentage of net assets to less than 20% by the end of March 2024.

16

Details of Initiatives 1) Growth Strategy
Toward Total Healthcare Company

Implementation of
Growth Strategy
 Pharmaceutical businessLeading Company
in Ob/Gyn field
Overseas
New Businesses
Development
such as Femtech

Female healthcare

Endocrine hormone
Endogenous
hormone microanalysis(Non-invasive testing)Groupstrengths

Animal health

Further strengthening ourposition as a leading company
in the Ob/Gyn field Establish new businesses
In the peripheral area ofpharmaceutical, such as
Femtech, as a total healthcarecompany Overseas development

With a focus on the growing
Southeast Asian market

17

Details of Initiatives 1) Growth Strategy
Cash allocation for future growth

FY2020-2022

FY2023-2025

Source of funds(Historical breakdown)

Growth investment
Strengthen managementbase
6.7 billion

OperatingCF
Debt repayment
12.7 billion
OthersSale of
Increase in cash on hand
tangible
10.2 billion
assets10.3 billion*Dividend + Share buyback

Reference
March 2023

Pharmaceuticalbusiness

Operating CF*
20 billion

4.5 billion

Shareholder return*
1.6 billion

Cash Equivalents 17.5 billion
Interest-bearing debt 12.6 billion

Investment direction

Cash from sale ofcross-shareholdings
3 billion

Growthinvestment

New field

Objectives

Distribution

Expand pipeline by strengthening R&D and BD
Femtech, CVC, Digital Health
Testing, Animal Health (CA)Overseasdevelopment

Establish business in Southeast Asia

M&A

Acquisition of competencies necessary for growth

15 billion＋X

Renewal and expansion of production facilities
Strengthen management base

Digital transformation

3-4 billion

Investment in human capitalFundraising (+X)

Shareholder return*Assumed operating profit + depreciation+Research and development expenses (except tangible assets)

Dividends, share buybacks

3-4 billion

Maintain Equity ratio of over 50%

18

Details of Initiatives 2) Strengthen Shareholder Returns
 Revised Shareholder Return Policy
 We plan to increase the annual dividend
payment to 40 yen per share, considering
the solid performance and theextraordinary income from sale ofinvestment securities in FY2023.
 Starting from FY2024, we will maintainstable profit distribution by indicating a
consolidated dividend payout ratio of
30% as performance-linked profit
distribution, with a minimum annual
dividend per share of 30 yen.

 Consideration of Share Repurchase We will consider flexible measures,
taking into account growth investment,
dividend level, cash on hand and shareprice level, and other factors.

Dividends per share (Yen)Dividend payout ratio (%)

40

45

74.0%

40

80%

70%

35

60%
30

55.7%

50%

25

20

15

14

14

14

10

5

0

13.3%

16.5%

14

17

14

16*

16

20

40%

30%

20%

22.7%
14.6%
5.3%

10.7% 9.1%

18.1% 10%0%

FY2015 FY2016 FY2017 FY2018 FY2019 FY2020 FY2021 FY2022 FY2023 FY2023

Previous Revised*The interim dividend for FY2021 was paid from other capital surplus and is excluded from the dividend payout ratio.

19

Details of Initiatives 3) Strengthen IR Activities
 Strengthen financial results briefings for individual/institutional investors Continue constructive dialogue with shareholders and investors (IR meetings)
 Create new opportunities for dialogue, such as small meetings and pipeline briefings
 Report to the Board of Directors on opinions obtained at IR meetings, etc., as appropriate,and conduct reviews
 Enhance information disclosure by expanding our website information and availability in
EnglishIR meetings with analysts
and institutional investors:
78 times; total of 98
participants
Financial results briefing
for institutional investors(Webcasts in May and November)IR seminars for individual investors(Held in February and August 2023)

IR meetings(Actual in FY2022)

20

FY2023 Interim Report
Takashi Yamaguchi,

President, Member of the Board of Directors, Representative Director

ASKA Pharmaceutical Holdings Co., Ltd.
21

About Action to Implement Management That Is Conscious of
Cost of Capital and Share Price
Details of initiatives to swiftly achieve a PBR of above 1x
1. Growth strategy (implementation of growth strategy, optimal cash allocation)
2. Strengthen shareholder returns（dividend payout ratio of 30% from FY2024）
3. Strengthen IR activities(Creation of dialogue opportunities, expansion of information disclosures)
In addition to the above three initiatives, actively promote governance and ESG
management, etc., to implement management that is conscious of cost of capitaland share price.

Adapt to different environmental changes and utilize
them to promote corporate growth22

ASKA Pharmaceutical Holdings Co., Ltd.
FY2023 Interim Report

23

The Goals of the Medium-Term Management Plan 2025

"Become a Total Healthcare Company witha Strong Foundation asa Specialty Pharma Company”
The Medium-Term Management Plan 2025 Numerical Targets

Net sales: 70 billion yen, Operating profit rate: 8%, ROE: 8%
Based on below foundation, The Medium-Term Management Plan 2025 was
designed with four visions and seven strategies.

Specialty

Ability to create

Social contribution24

Interim Summary: 3rd Year of the Medium-Term Management Plan 2025
The Medium-Term Management Plan 2025 Numerical Targets
Net sales: 70 billion yen, Operating profit rate: 8%, ROE: 8%
3rd year of the Plan

2Q FY2023 Actual
Net sales: 31.6 billion yen
Operating profit rate: 9.7 %FY2023 Target: Net sales 62.0 billion yen
Steady Progress Toward Achievement of the Medium-Term Management Plan

25

The Accomplishments of Operating Companies
ASKA Pharmaceutical■ Co-founded a Corporate Venture Capital Fund “ASKA Innovation Fund”■ Newly established the Femtech Business Promotion Unit
■ Filed an Application for Partial Change of Manufacturing and Marketing Approval for L-105(rifaximin for pediatric patients)■ Initiated the domestic phase I/II clinical trial of relugolix combination tablet (AKP-022)■ Signed an agreement with SUSMED for joint development and marketing of therapeutic apps
in Ob/Gyn field.

ASKA Animal Health■ L-histidine hydrochloride was designated as a new feed additive and is being prepared formarketing for aquaculture.

ASKA Pharma Medical■ Expansion of non-invasive testing business(launch of male hormone test kit and stress hormone test kit)

Each company achieved certain results that paved the way for the next steps.
26

ASKA Pharmaceutical Co., Ltd.
■Main initiatives

・Specialty Areas
・Development Pipeline
・Overseas Business Development

27

ASKA Pharmaceutical Co., Ltd.
■Main initiatives

・Specialty Areas
・Development Pipeline
・Overseas Business Development

28

Changes in the Environment Surrounding Women (Examples)
Changes in the politicalenvironment

Changes in the social
environment

Changes in the technologicalenvironment

 Establishment of the Headquarters
for Creating a Society in which All
Women Shine in the Cabinet
Secretariat, and formulation of the
Women's Version of the
Framework Policy

 Increase in the number of female
employees and promotion of
women to managerial positions
through promotion of women's
activities

 Development of pharmaceuticals
and advances in medical
technology related to diseases
specific to women, such astreatment of dysmenorrhea andinfertility

 Establishment of gynecologyspecific disease treatment andmanagement fee, and insurance
coverage of infertility treatment

 Increased awareness of healthliteracy through increased
attention to women's specifichealth issues and increased
exposure in the media and social
media, etc.

 Changes in access to medical care,including improved access tohealth information and expansionof online medical care due to thewidespread use of the Internet

Obstetrics and Gynecology(Ob/Gyn) market is expanding in response
to various changes in the environment surrounding women.
Ob/Gyn market in 2010: 49.5 billion yen*1 ➡ Ob/Gyn market in FY2026 (forecast): 100 billion yen*2*1 Fuji Keizai Corporation 2018-2019 Ethical Drugs Databook No.4 All rights reserved.
*2 Fuji Keizai Corporation, “Trend Analysis and Future Projections for Obstetrics and Gynecology Related Markets after 1 Year of Insurance Coverage in 2023," All rights reserved.

29

Contribute to Solving Health Issues for All Kinds of Women
Actively engage in activities as a leading company
in the field of obstetrics and gynecology*1
Health – Mibyou - Disease
Pharmaceuticals
Providing care for women's health during all stages of health, mibyou*1 and disease*1. Mibyou refers to a pre-symptomatic state.
*2. Mint+ disseminates information on women's health.

30

Our Ob/Gyn Pharmaceutical Products by Life Stage
Early
childhood

Puberty

Sexual maturity

Contraception

Drospirenone (LF111)

Iron deficiency
anemiaRiona (Co-Pro* )STD/infection
Uterine fibroids
Endometriosis
Dysmenorrhea
Menstrual disorder

ANGE

NORLEVORELUMINALEUPRORELIN

AKP-022

Jemina (Co-Pro)

FREWELL (AG)

DroEthiPMS/PMDD drugs

PLANOVAR

TRM-270

Menopause

Old age
HOLIN

Rapid SP Chlamydia (Co-pro*)

Imminent
miscarriage/
premature birth,labor induction

Infertility

Now on sale

Menopause

Under development

Magsent

MAGNESOL

RITODRINEATONINHMG
LUTEUMuFSH

Methylergometrine

SEXOVID

GONATROPIN* Mainly in the field of obstetrics and gynecology

Our Ob/Gyn drugs
under development
LF111
AKP-022
TRM-270
Expands the lineup andcontributes to women's
healthcare31Growth Driver - RELUMINA (relugolix)
RELUMINA sales trend

Growth rate of endometriosis-related figures in FY2022

Aims for further
growthFinancial results base (millions of yen)

*Calculated with April 2022 as 100%.
Source: Cross Fact, INTAGE Real World Inc.

140%

10,234

8,840

124%

7,344
5,709

5,186
119%

2,615

Apr

May

Jun

Jul

Aug

Endometriosis diagnosis

Sep

Oct

Nov

Dec

Jan

Feb

Mar

All pharmacological treatment

RELUMINA
2020年
FY20192021年
FY20202022年
2023年 FY2023
2024年
FY2021 FY2022
Target

2026年
FY2025

Promote market penetration of RELUMINA
in the treatment of endometriosis.
32

LEP*1 market continues to expand
LEP market trend(Thousands of sheets)■ ASKA products ■Competitors’ products
In-house analysis based on date of Encise Inc.
(unauthorized reproduction prohibited)

Our LEP*3 formulations

161

%*2

5,460

Current situation

3,350
ASKA’s share

50.5%
ASKA’s share

24.6%

FY2020 FY2020 FY2021 FY2021 FY2022 FY2022 FY2023
1st half 2nd half 1st half 2nd half 1st half 2nd half 1st half
*1 Low-dose Estrogen/Progestin combination*2 Calculated with the first half of 2020 as 100%
*3 Jemina tablets are co-promoted with Nobelpharma Co., Ltd.

Jemina, FREWELL✓Sales volume is increasing along with the growth of themarket.

DroEthi✓The significant increase has contributed to the gains inmarket share.

Contributes to dysmenorrhea treatment

33
33

Contribute to the Peripheral Pharmaceutical Fields with Femtech
Signed an agreement for joint development andmarketing of therapeutic applications in the fieldof obstetrics and gynecology

ASKA Pharmaceutical launches“Training Videos on Women's Health”* Japanese version only

Develop as therapeutic applications
Aim for insurance coverage

Improve health literacy in companies
Contribute to the realization of healthmanagement

Address women's health issues through new approaches in addition to traditional methods
34

RIFXIMA (rifaximin) Contributes to Unmet Medical Needs
RIFXIMA sales trend

Further growth
projected

Financial results base (millions of yen)

3,780

4,334

4,854

5,397 5,671

6,000

Clinical Practice Guidelines for Liver Cirrhosis 2020
Strength of recommendation:

Strongly recommended

Published in November 2020

Evidence level:A

Ongoing efforts to disseminate the guidelines
Clinical Practice Guidelines for Liver Cirrhosis（Renewal of Annual Review）* Published domestic long-term clinical data

2,997

＜ Effective penetration activities through face-to-face and web interviews ＞

Contribution to unmet medical needs
Pediatric indication for hepatic encephalopathy
Filed application in June
FY2019 FY2020 FY2021 FY2022 FY2023

FY2025

TargetTargetEstablishes itself as the standard treatment
for hepatic encephalopathy
35

A Leading Company for Thyroid Treatment
Sales trend of three thyroid products*

Sustainablegrowth projected

Financial results base (millions of yen)

8,432

8,768

9,116

9,3759,493

10,000Over 95% shareof the domestic market for the thyroid treatment

Thyroid
disease awareness efforts
甲状腺製品売上増加の背景✓Raise public awareness about thyroid testing✓寿命の延伸・Proposed thyroid testing to companies promoting
チラ-ヂンは生涯にわたり服用するケ-スが多い
healthmanagement✓甲状腺および疾患の認識向上
・Provided
thyroid information to health checkup
啓発活動により甲状腺疾患の認知が拡大
centers

4,855

Mission of ASKA Pharmaceutical
FY2019 FY2020 FY2021 FY2022 FY2023

FY2025

TargetTarget* THYRADIN, MERCAZOLE, PROPACIL

Promote disease awareness and contribute to treatment
Maintain stable supply as basic pharmaceuticals

36

ASKA Pharmaceutical Co., Ltd.
■ Main initiatives

・Specialty Areas
・Development Pipeline
・Overseas Business Development

37

Development Pipeline
R&D Status (as of November 2023)
Development code (generic name)Indication

Research*1

Changes from the previous financial results briefing
Non-clinical*1

Ph I

Ph II

Ph III

LF111 (drospirenone)
Contraception

Application

Approval

Ph IIIIII Ongoing
In prog(Option agreement)
Treatment for PMS/PMDD*2

Investigator-initiated Ph II Ongoing

AKP-022 (Relugolix combination tablet)
Uterine fibroids
Theme A / Ob/Gyn
Theme B / Ob/Gyn

Ph I/II OngoingTRM-270 (adhesion barrier)(Gastroenterology and Ob/Gyn)

Ph III ongoing

L-105 (rifaximin)
Hepatic encephalopathy (pediatrics)

Filed

Theme C / Internal Medicine

AKP-009 (ludaterone acetate)
Benign prostatic hyperplasia
AKP-017 (transnasal testosterone)
AKP-021 / mPGES-1 inhibitor agent

Ph IIa Completed*3
Preparing clinical trials*1 Details of research are not disclosed because it is non-clinical. *2 Premenstrual syndrome / premenstrual dysphoric disorder*3 After receiving the results of the additional Phase I study, we are again conducting a Phase I study to reconfirm the data.

38

Development Pipeline - Summary of Characteristics
 LF111
Progesterone only oral contraceptive. Under development with the expectationof reducing the risk of thrombosis.
 AKP-022
Combines estrogen and progesterone with relugolix. Under development withthe expectation that long-term administration for 6 months or longer will bepossible.
 TRM-270
Under development with the expectation that it will be an Adhesion Barrier
with good maneuverability, with a special focus on handling in laparoscopic
surgery and robot-assisted surgery.
39

ASKA Pharmaceutical Co., Ltd.
■ Main initiatives

・Specialty Areas
・Development Pipeline
・Overseas Business Development

40

Vietnam - Collaboration with Hataphar In 2021, ASKA acquired 24.9% of Hataphar’s shares
Hataphar became an affiliate company of ASKA
Seeking collaboration in Vietnam's growing
pharmaceutical market (CAGR 10%)

Factory construction support
Product technology transfer

Construction progress of a new plant(in compliance with PIC/S GMP)
 Initiated preparations for GMP acquisition for the start ofcommercial production
 Dispatch of new plant manager from ASKA in September Increased the number of seconded employees from 2 to 5

Reinforcement of support for plant operation

Deepening Collaboration

Aim to strengthen the alliance through further
financial incorporation
Expand market share in Vietnam
Aim to enter the Asian region

Aim to achieve further growth and increase corporate
value of both companies
41

ASKA Animal Health Co., Ltd.

42

ASKA Animal Health - FY2023 Target and Sales Composition Sales trend of ASKA Animal Health*Financial results base (millions of yen)

6,660

Maintain
6 billion yen
level

The Medium-Term
Management Plan's Target:
Over 6 billion yen

Companion animal-related
Others

1%

8%

5,630
4,502 4,742

33%

Sales
composition(FY2023 2Q)

Livestockpharmaceuticals

FY2019FY2020

FY2021

FY2022

FY2023

FY2025

TargetTarget58%
Feed additives
and Materials
Mixed feed

Promotes market penetration andthe development of pharmaceuticals
for companion animals
43

ASKA Animal Health - Circumstances and Initiatives
Key Initiatives for 2Q FY2023
Sales activities focused on products such as veterinary pharmaceuticals to improve profit
margins

 Focuses on TRILOSTAN TABLETS “ASKA,” a treatment for canine hyperadrenocorticism, launched in
November 2022

 Promotes market penetration of TRILOSTAN TABLETS “ASKA” by continuing to hold academic conference
exhibitions, webinars, etc.
 Prepares for the launch of L-histidine hydrochloride, a feed for aquaculture ( to be launched in November)

Outlook for Feed Additives
 Market conditions for feed additives remains uncertain, although there are trends toward a bottoming out of
the market.

Contributes to the creation of a society where humans and animals can coexist
44

ASKA Pharma Medical Co., Ltd.

45

ASKA Pharma Medical - Main Initiatives
Strength of ASKA Pharma Medical: Endogenous hormone microanalysis technologies

Main initiative: expansion of non-invasive testing business
Launched in April 2023
Target: male menopausal disorder

Launched in July 2023
Target: Stress

Under development
Test kits forcompanion animals
To be launched in FY2024

Hair hormone level measurement kit
Dihydrotestosterone

Hair/nail stress hormone level test kit
Cortisol

Contributes to the creation of a vibrant, healthy society
through the latest measurement technologies
46

ASKA Pharmaceutical Holdings - Group Strengths Sources of Growth
Specializing in endocrine R&D fora long timeOver

100 years

Developed and launchedvarious products
ASKA Animal Health
Product lineup

Feed additives
Industrial animal/
Companion animal
pharmaceuticals

Launched various products

ASKA Pharmaceutical

ASKA Pharmaceutical

A Leading Company
in Ob/Gyn field

A Leading Company
in Thyroid field

Top sales in Ob/Gyn field**In-house estimate: in 2nd half of FY2022

ASKA Pharma Medical
Measurement technologies

Endogenous hormone
microanalysis technologies
Expansion of non-invasive
testing businesses

Over 95% share of the domestic
market for the thyroid treatment
ASKA Pharmaceutical Holdings
Synergy Creation

Intensifying intergroup cooperation

Cooperation and collaborationin various fields

47

Become a Total Healthcare Company with a Strong Foundation as aSpecialty Pharma Company
Modality
axis
Regional axis

MedicaldevicePrevention

Overseas

Testing and
Diagnostics
Treatment

Prognosis

Broad health support

Medical life
cycle axis

48

ASKA Pharmaceutical Holdings Group

Corporate Message

For a Healthy Tomorrow and Future.

Appendix

50

Sales Ratio by Area and Sales Proportion of Brand-name Drugs
Sales Ratio by Area
(2Q FY2023)

Sales Proportion of Brand-name Drugs■Brand-name drugs■ Generic drugs
2Q FY2022

23.6%
7.6%

43.0%
47.7%

52.3％

46.8%

53.2％

25.9%

■Obstetrics and Gynecology

産婦人科
内科（消化器・甲状腺）■Internal medicine (Gastroenterology and thyroid)
泌尿器科
その他■Urology

2Q FY2023

Aims to increase the ratio of brand-name drugs(Numerical target in The Medium-Term Management Plan 2025: 70％)

■Others

The total may not add up to 100 because the figures are rounded to the second decimal place.

51

Net Sales/Operating Profit by Quarter(Millions of yen)

Net sales
15,947

13,714

14,221

13,689Operating Profit

14,256

15,702

2Q

1,188

3Q

FY20204Q

13,202

1,664

1,469

1,215
118

-167
1Q

14,903

2,162

2,020

1,830
898

15,26912,428

11,831

1,048

17,087

1Q

2Q

3Q

FY2021

4Q

67
1Q

2Q

3Q

4Q

FY2022

Both sales and profits tend to be low in 4Q due to restrained purchases and expenses incurred before NHI drug price revisions.

52

Increase in the Number of Menstrual Cycles due to Changes in Life Events
Women today experience their first menstruation earlier, tend to marry later, and experience fewer childbirths than women in past generations.
The increase in the number of menstrual cycles (MCs) experienced in women's lifetime is considered a factor for the increase in dysmenorrhea
and other menstrual problems.

Number of MCs experienced by
women today

450
Number of lifetime childbirths: Approx. 2

Menstrual periods of women today
Age: 10

20

30

40

Number of lifetime MCs: Approx.

Number of MCs experienced by
women in past generations
Number of lifetime MCs: Approx.

50

Number of lifetime childbirths: Approx.

5■Period before menarche ■Period with menstruation
Amenorrheic period due to pregnancy, childbirth or breast-feeding

Menstrual periods of women in past generations
Age: 10

20

30

40

■Period before menarche ■Period with menstruation
Amenorrheic period due to pregnancy, childbirth or breast-feeding

Modified from source: Short RV: Rroc. R. Soc. Lond B. Biol. Sci. 1976; 195, 3-24.

53

Number of Uterine Fibroids/Endometriosis/Dysmenorrhea Patients(Extended estimates from electronic receipt data, 12 months from January of each year to December of the following year)
2,500 ,000

209

228

(Million of patients)

225
179

2,000 ,000

196

146

1,500 ,000

80

1,000 ,000

93

100

2021

2022

500 ,0 00

0

2020

2021

2022

Uterine fibroids
Source: JMDC Claims Database

2020

Endometriosis

2020

2021

2022

Dysmenorrhea
54About Hataphar
Company(ハファ-社) name：Ha Tay Pharmaceutical Joint Stock Company
Founded：1965
Head office: Hanoi, Vietnam
Number of employees：Approx. 1000
Listed stock exchanges：Hanoi Securities Trading Center (2008)
Net sales in FY2022: 1,837 billion VND (11,223 million yen)
Operating profit in FY2022: 114 billion VND (855 million yen)
Net profit in FY2022: 98 billion VND (599 million yen)
Business: Manufacturing, sales and importation of pharmaceuticals, nonprescription and nutraceutical products- 3rd largest pharmaceutical company in Vietnam in terms of net sales in FY2022- Branch offices and others in major cities, with distribution and sales covering nationwide in Vietnam

VND/JPY:0.0061 October 17th 2023
55

ASKA Pharmaceutical Holdings’ Material Issues
Contribute toward the improvement of people's health and progressin society through the development of innovative products

Environmental-

Environmental protection and continuous
reduction of environmental impact

Governance-SocialCorporate governance
Secure compliance with laws andregulations, enforcement of compliance

Become a Total Healthcare Company with a Strong
Foundation as a Specialty Pharma Company-

Contribution to women’s healthContribution to animal health

Human resource development
Employee engagement
Creation of innovative products
Expanding access to healthcare
Stable supply of high-quality products
Promotion of proper use of products

Main SDGs ASKA contributes

ASKA scrutinized 17 material issues and consolidated those into 11 issues
56Inquiries

Corporate Planning Department
Tel: +81-3-5484-8366e-mail: kouhou@aska-pharma.co.jp

57