Explanation of Strategy

Business Conditions

Strengths and Strategies
As a leading company in the Ob/Gyn area, ASKA Pharmaceutical is using its strengths in the fields ofendocrinology and hormones to implement a range of strategies aimed at helping solve women’s health issues.

ASKA PharmaceuticalStrengths• Leading company in the Ob/Gyn area
• Leading company in the thyroid area
• Specializing in endocrine and hormone areas for over 100 years

Creating new value as aleading company infemale healthcare

Strategies• Provide 21 pharmaceutical products that accommodate women’s lifestyles• Achieve penetration of agents for uterine fibroids, endometriosis, and dysmenorrhea• Contribute to solving women’s health issues through a variety of initiatives, including dissemination of
information on women’s health• Contribute to raising awareness and treatment of thyroid-related diseases• Maintain a stable supply of basic pharmaceutical products• Conduct R&D with a focus on hormone-related areas, launch new products, ensure quality and stable supply,and promote dissemination of information on proper use• Concentrate management resources on the three priority areas of internal medicine, Ob/Gyn, and urology, anddevelop the pharmaceutical business with a focus on new drugs
Founded in 1920, ASKA Pharmaceutical began its businessIn light of this trend, in April 2023 we established thewith the unique idea of developing hormone preparations

Femtech Business Promotion Unit, which is tasked with supportingfrom animal organs. Today, we concentrate management

women’s health more broadly, beyond pharmaceuticals.

resources on the three priority areas of internal medicine,

As women enter the workforce and their lifestyles change,

Ob/Gyn, and urology, and develop the pharmaceutical

we feel that now more than ever there is a need to address

business with a focus on new drugs.

women’s specific health issues.

Our strengths lie in the trust and experience we haveto various needs, we will create innovative new drugs byrelated areas, launching new products, ensuring quality andaccelerating open innovation through collaboration between

stable supply, and promoting dissemination of informationindustry, government, and academia in Japan and overseas.

on proper use.

We will continue making efforts to raise awareness in various

In the Ob/Gyn area, in particular, we approach various

ways such as using the knowledge we have cultivated overissues according to women’s life stages. We support women’s

the years to disseminate information. In doing so, we will

health and lives with a wide variety of pharmaceuticals forcreate opportunities for women to make choices that lead todysmenorrhea, contraception, uterine fibroids andhealthy and fulfilling lives.

endometriosis, infertility, perinatal period disorders andWhile strengthening the core of our pharmaceuticalmenopause-related diseases, among other indications.

business with a focus on new drugs, we aim to go beyond

In the thyroid area, our domestic market share ofsolely providing pharmaceuticals. We will take an integrated

pharmaceuticals for hypothyroidism and hyperthyroidism

approach covering prevention, testing, diagnostics, treatment,each exceeds 90%. We are fulfilling our mission of providing

and prognosis to become a total healthcare company whilea stable supply of these products, which are indispensable intransforming into a competitive specialty pharma company.

medical settings.

pregnancy, childbirth, and menopause. There is increasing

to disseminate information

Main Products• Internal Medicine• Ob/Gyn

Sohta Yamaguchi• Urology

Hepatic encephalopathy
agent
RIFXIMA

Hypothyroidism
agent
THYRADIN

Uterine fibroids andendometriosis agent
RELUMINA(rifaximin)(levothyroxine)(relugolix)

Dysmenorrhea agent
DroEthi “ASKA”(drospirenone/ethinylestradiol)

Endometriosis, uterine
fibroids, and prostatecancer agent
LEUPRORELIN “ASKA”(leuprorelin)

Antihypertensive agent
CANDESARTAN “ASKA”

In the healthcare field, there has been growing public interest
address health issues specific to women, such as menstruation,

government, and academia in Japan and overseas• Make efforts to raise awareness in various ways such as using the knowledge we have cultivated over the years

As a leading company in female healthcare that responds

accumulated by conducting R&D with a focus on hormone-in Femtech, which is defined as the use of technology to• Create innovative new drugs by accelerating open innovation through collaboration between industry,(candesartan)

Dysmenorrhea
Infertility agent Emergency
agent
LUTEUM
contraceptive
FREWELL “ASKA”(progesterone)
NORLEVO(norethisterone/ethinylestradiol)(levonorgestrel)

President, Representative Director
ASKA Pharmaceutical

momentum toward creating an environment where everyone
can work and live comfortably.

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Explanation of Strategy

Business Conditions

Performance in FY2022
The pharmaceutical business, which focuses on the three priority

rose to ¥5,397 million (up 11.2% year on year). In the urology

areas of internal medicine, Ob/Gyn, and urology, remained

field, sales of LEUPRORELIN, an endometriosis, uterine fibroids,

strong overall despite the impact of NHI drug price revisions. Net

and prostate cancer agent, decreased to ¥4,999 million (downsales increased to ¥53,579 million (up 5.5% year on year). By

3.6% year on year). As a specialty pharma company focusing

product, in the Ob/Gyn area, sales of RELUMINA (relugolix), aon the three areas of internal medicine, Ob/Gyn, and urology,

uterine fibroids and endometriosis agent, increased to ¥8,839

we will continue to actively expand our development pipeline

million (up 20.5% year on year), a significant increase following

by further promoting drug discovery and alliances.

the previous year, and sales of FREWELL (norethisterone/
ethinylestradiol, a dysmenorrhea agent), grew to ¥3,489 million

Net Sales in the Pharmaceutical Business(up 0.8% year on year) despite a price reduction of over 10%(Millions of yen)

due to the NHI drug price revision in April 2022. Sales of DroEthi

60,000(launched in June 2022), a dysmenorrhea agent for which we

50,000acquired manufacturing and marketing approval as the only

40,000company, totaled ¥3,671 million. In addition, in the area of

30,000internal medicine, sales of our key product THYRADIN, aInternal medicine
Urology

47,85150,31450,79153,5798.6%

41,75738.4%

20,000hypothyroidism agent, increased to ¥7,733 million (up 3.1%
year on year). Sales of RIFXIMA, a hepatic encephalopathy agent

Ob/Gyn53.0%

10,0000

We launched RELUMINA in 2019 as the first oral GnRH antagonist agent for the treatmentof uterine fibroids in 20 years. Since then, the switch from the standard injectable formulationof comparable drugs with similar efficacy is progressing steadily. In December 2021, it
received approval for an additional indication as an endometriosis agent. We are working
to promote the penetration of RELUMINA as a treatment for endometriosis as well as foruterine fibroid treatment with the aim of providing a new option in pharmaceuticals forendometriosis. In FY2022, sales increased significantly to ¥8,839 million (up 20.5% year
on year). By accelerating the penetration of RELUMINA for the treatment of uterine
fibroids and endometriosis, we plan to significantly increase sales to ¥10,128 million (up14.6% year on year) in FY2023. In this way, we expect to achieve our target of over ¥10billion for the final year of the current medium-term management plan ahead of schedule.
Note: Amounts are rounded down to the nearest million yen.

3 Dysmenorrhea Treatments
Achieved No.1 share in the LEP market by selling DroEthi as thecompany with sole sales rights

We have established a specialty area system, which we

co-promotion activities. In addition, with the revision of

introduced to conduct information provision activities focusing

guidelines, RIFXIMA has established its status as a standard

on the Ob/Gyn area and RIFXIMA. Under this system, we willagent for hepatic encephalopathy. As a result, we will further

The dysmenorrhea market is rapidly expanding due to factors such as women’s
advancement in the workforce and increased health literacy. In this area, we have three
products in our lineup: FREWELL (authorized generic) and Jemina (a co-promotion with
Nobelpharma), and DroEthi (a generic drug) launched in June 2022 for which we havethe sole sales rights. As such we provide a range of options for people suffering fromdysmenorrhea. The combined market share of the three LEP* formulations (pharmaceuticals)
is 42.7%, and we expect this to continue to grow in line with market expansion. In
addition to provision of pharmaceutical products, we also operate Health Lab Mint+ for
Women’s health as an initiative to support women’s health. We continue striving tocontribute to women’s health through dissemination of a variety of information.

continue to provide high-quality information and pursue

promote the dissemination and penetration of the agent. In* Low-dose estrogen/progestin combination

efficient sales activities such as through webinars. We work to

addition, THYRADIN, which holds a domestic market share offurther enhance our presence in the Ob/Gyn area through theover 90%, is an indispensable pharmaceutical in the medical

provision of information on products that contribute to businesssetting. As a leading company in thyroid disease-related

performance, mainly RELUMINA and DroEthi (launched in June

medicines, we will maintain a stable supply system and continue2022), as well as Jemina and Riona for which we are conducting

to engage in activities to raise awareness of thyroid diseases.

for which we worked to establish clinical practice guidelines,

2018

2019

2020

2021

2022

(FY)

Note: Amounts are rounded down to the nearest million yen.

Major Initiatives
1 Specialty Areas

Ob/Gyn Pharmaceuticals by Life Stage
Early childhood

Puberty
Contraception

Sexual maturity
Drospirenone (LF111)ANGENORLEVO

Menopause

Old age

Menopause

HOLIN

Iron deficiency anemia Riona (Co-promotion*)
STD/Infection

Rapid SP Chlamydia (Co-promotion*)

RELUMINALEUPRORELIN

Adhesion barrier (TRM-270)
DroEthiPMS/PMDD drugs

Relugolix combination tablet (AKP-022)
Jemina (Co-promotion)
PLANOVAR

Imminent miscarriage/premature birth, labor induction, uterine contraction and hemostasis
Magsent

MAGNESOL

RITODRINEATONIN

Methylergometrine

Infertility* Mainly in the Ob/Gyn field

ASKA HD REPORT 2023

HMG injection

uFSH injection

LUTEUM

GONATROPINSEXOVID

Abnormal thyroid function can cause a variety of physical and mental symptoms. Thyroid
disease is a common disorder among women and said to be related to menstrual disorders
and infertility. Through a wide range of activities to raise disease awareness among medical
professionals and the general public, we are working to be able to identify patients in needof treatment at an early stage. In addition to activities to provide information, lengthening
the administration period by extending life expectancy has also contributed to sales growthof roughly 2-3% each year. We will work to ensure stable supply through daily production,
stocking, and business continuity planning (BCP) measures so that we can continue todeliver pharmaceuticals to patients even in the event of an emergency. In doing so, we will
fulfill our mission as a leading company in the thyroid area.

5 Hepatic Encephalopathy Treatment
Contribution to unmet medical needs through RIFXIMAFREWELL (AG)Now on sale
Under development

Reality of Treatment forEndometriosis
Patients diagnosed
with endometriosis(1,000,000 patients)
Patients receiving
hormone preparations(670,000 patients)
Patients receiving
GnRH preparations(63,000 patients)
Patients receiving RELUMINA(34,000 patients)
Source: Survey results by JMDC Inc. (March 2023)
Note: Estimation from electronic health insurance claims data

Product Share in the LEP
Formulation Market(FY2022)

ASKA
Pharmaceutical’sMarket Share

42.7%

Note: Estimated based on Encise data

4 Thyroid Disease Treatments
Domestic thyroid pharmaceutical market share of 95% with
THYRADIN, MERCAZOLE, etc.

Note: Amounts are rounded down to the nearest million yen.

Uterine fibroids, endometriosis, dysmenorrhea, menstrual disorders

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2 Endometriosis Treatment
Promoting the penetration of RELUMINA as a treatment
for endometriosis

Hepatic encephalopathy is a condition in which liver function is significantly reduced,
which can give rise to psychoneurological symptoms such as loss of consciousness. It is arare disease with fewer than 50,000 patients, and as such RIFXIMA is designated as anorphan drug. In addition, the Clinical Practice Guidelines for Cirrhosis strongly recommendRIFXIMA for treating hepatic encephalopathy. We are working to raise awareness of theseguidelines with the aim of promoting the penetration of RIFXIMA. In June 2023, we
additionally applied for dosage and administration approval for RIFXIMA as an agent for
the treatment of hepatic encephalopathy in children. We will continue to address unmet
medical needs so that we can contribute to society.

Sales of Thyroid-Related
Pharmaceuticals*
Financial results base (Millions of yen)

8,432

2019

8,768

2020

9,116

2021

9,375

2022

9,502

10,0002023

2025(Forecast)(Target)(FY)* THYRADIN, MERCAZOLE, PROPACIL

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Explanation of Strategy

Business Conditions

6 Development Pipeline
In clinical development, four clinical trials are currently inprogress. A Phase III trial is under way for LF111 (drospirenone),which is being developed for the indication of contraception. In
September 2021, we started a domestic Phase I/II clinical trial for
Relugolix (for which we have obtained exclusive development
and sales rights in Japan from Takeda Pharmaceutical Company
Limited) combination tablet (development code: AKP-022) for
the treatment of uterine fibroids. In addition, after the completionof a Phase IIa clinical trial of AKP-009 (ludaterone acetate), which
is being co-developed with Kyorin Pharmaceutical Co., Ltd.,
we conducted an additional Phase I clinical trial to confirm the
maximum efficacy. We are carrying out another Phase I clinical
trial to reconfirm the data based on the results. For TRM-270,
which we are developing jointly with Toray Industries, Inc.,
we are currently conducting a Phase III clinical trial. In addition,a Phase II/III clinical trial for L-105 (rifaximin), for which we are
seeking an additional dosage and administration approval for thetreatment of hepatic encephalopathy (pediatric), has been
completed and an application has been submitted to the

7 Overseas Business Development
regulatory authorities.
One theme we are pursuing in preparation for development
is transnasal testosterone (AKP-017), for which we aim to begin
clinical trials at an early date. In addition, we are pursuing several
themes in the non-clinical setting through the acquisition of drug
discovery seeds through open innovation in addition to our own
technologies.
In terms of out-licensing and in-licensing activities during
FY2022, in June 2022 ASKA Pharmaceutical signed a license
agreement with Hyundai Pharm. Co., Ltd. concerning thedevelopment and commercialization rights in South Korea forthe oral contraceptive drospirenone, which is currently underclinical trials in Japan.
In February 2023, we entered into a joint R&D agreementwith Epsilon Molecular Engineering, Inc. (EME) for new drug
creation of next-generation VHH antibodies in the Ob/Gyn area
using EME’s proprietary humanized VHH discovery platform“The Month.” We will continue to expand our development
pipeline by promoting drug discovery research activities.

The International Business Division is working to develop ouroverseas business, particularly in Southeast Asia, a region where
economic development is continuing. The new plant construction
project (in compliance with PIC/S GMP Guidelines) with ourstrategic partner Hataphar, a Vietnamese pharmaceutical company,
will be completed in August 2023. We are preparing to obtain
PIC/S GMP certification by using the expertise the Group has
accumulated through our domestic business. To achieve early
operation and profitability of the new plant, we will actively
carry out collaborative efforts between our two companies tofurther strengthen our framework for cooperation.
With regard to the marketing of our original health supplement
in Jordan, in the Middle East, which we have been working on
since 2021, we have submitted the export application to therelevant authorities in each country and are continuing activities
to obtain approval and start sales at an early date.
Going forward, we will continue to boldly take on thechallenge of expanding our overseas business to further improve
our presence in the Southeast Asia region for the growth anddevelopment of the Company.

Illustration of the new plant in Vietnam

R&D Status (As of August 2023)
Development code (generic name) / Indication

Research1 Non-clinical 1

Phase I

Phase II

Phase III

Application

Approval

LF111 (drospirenone)

Contraception(Option agreement)

PMS/PMDD 2 drugs under development at Renascience Inc.

Investigator-initiated Phase II ongoing

AKP-022 (Relugolix combination tablet)

Uterine fibroids

Phase I/II ongoing

Theme A

Ob/GynTheme B

Ob/GynTRM-270 (adhesion barrier)

Gastroenterology and Ob/Gyn

L-105 (rifaximin)

Hepatic encephalopathy (pediatric)

Theme CInternal medicine

AKP-009 (ludaterone acetate)

Benign prostatic hyperplasia

AKP-017 (transnasal testosterone)

Urology

AKP-021 (mPGES-1 inhibitor agent)

UrologyPhase III ongoing

Phase III ongoing
Filed

Phase IIa completed 3
Preparing development

The reference to a cervical dysplasia agent has been deleted because a decision not to exercise the option was made.
1. Details of research are not disclosed because it is non-clinical. 2. PMS: Premenstrual syndrome/PMDD: premenstrual dysphoric disorder
3. After receiving the results of the additional Phase I clinical trial, we are again conducting a Phase I clinical trial to reconfirm the data.

TOPICS

Establishment of the Femtech Business Promotion Unit

The term “Femtech,” blending the words “female” and“technology,” refers to products and services that use
technology to solve various health issues that women facein their various life stages.
There are many focus areas within Femtech, including
menstruation, pregnancy, infertility, childbirth, postpartum
care, childcare, gynecological diseases, among other issues
that women face, as well as items related to sexual wellness.
In Japan, although this domain has not yet been fully
established, it has been attracting particular attention inrecent years. In 2021, for example, the promotion of Femtech

was specified for the first time in government documents
such as the Honebuto no Houshin (“big-boned policies”).
According to a research report (issued by the Ministry of
Economy, Trade and Industry), into the effects (and related
challenges) that changes in the way we work and live will
have on the Japanese economy in the future, the economic
effect of Femtech that facilitates women’s participation in
the workforce will be approximately ¥2 trillion/year as of2025 (menstruation field: approx. ¥240.0 billion; pregnancy
and infertility field: approx. ¥300.0-500.0 billion; menopausal
field: approx. ¥1.3 trillion.)

For around a century since its establishment in 1920, ASKA

Drug Discovery and Alliance Activities

Pharmaceutical has been devoted to supporting women’s
health, mainly by providing sex hormone agents. The Femtech
Business Promotion Unit, which we newly established in April

Relugolix combination tablet (AKP-022), the successor product to RELUMINA as a treatment for uterine
fibroids and endometriosis started domestic clinical trials
In July 2023, we started a domestic Phase I/II clinical trial of
Relugolix combination tablet. By proposing the Relugolix
combination tablet as a successor to RELUMINA, we expect to beable to offer a new option as an agent for the treatment ofuterine fibroids (estimated number of patients in Japan: about 2
million). This formulation is a gonadotropin-releasing hormone(GnRH) receptor antagonist created by Takeda Pharmaceutical
Company Limited. Treatment with Relugolix single tablet

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ASKA HD REPORT 2023

(RELUMINA) is effective due to its estrogen-lowering effects.
However, since one side effect can be a decrease in bone mass,
dosing for more than 6 months is generally avoided. Relugolix
combination tablet contains estrogen to suppress the decrease ofbone mass and progestin to suppress the growth of theendometrium caused by estrogen. We are developing it with theaim of enabling long-term treatment for more than 6 months.

2023, will use the knowledge and network cultivated in the
Ob/Gyn field to offer options for solving women’s healthissues and concerns, which are becoming increasingly diverse
and apparent.
Through our efforts in Femtech, we aim to broadly support

Exhibited at the first Femtech Tokyo

women’s health, to help as many women as possible improve

Tomohito Nagao

their quality of life and play an active role in society, and to

Corporate Officer, Director of
Femtech Business Promotion Unit
ASKA Pharmaceuticallaunch new businesses in this area.

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