Interim Term Financial Results Ended
September 2021

November 9 , 2021
KYORIN Holdings, Inc.
President Yutaka Ogihara➢ Outline of Consolidated Financial Results• Trends of mainstay products, Generic products➢ Consolidated Financial Forecast➢ Status of R&D Pipeline➢ Initiative toward realization of
the long-term vision “HOPE100”
1Outline of Consolidated Financial Results2

Segment Sales and Breakdown of Gain and Loss

（Units: ¥billion）

Sep/20

Sep/21

ChangeChangeChange(forecast)(%)

Announced on
May 11,2021

47.7

49.1

n/a

n/a

+1.8

New ethical drugs, etc.
（Japan）

32.9

33.3

n/a

n/a

+1.4

New ethical drugs（Overseas）

0.5

0.3

n/a

n/a

－0.2

Generic drugs

14.4

15.5

n/a

n/a

+0.7

Cost of Sales

22.9

26.7

n/a

n/a

－

SG&A
（R&D）

23.3

22.4

(5.2)

(4.4)

n/a
(－0.8)－1.9(－16.1)－（－0.5)

Operating Income

1.5

－0.1

－1.6

－

+0.7

Ordinary Income

1.8

0.3

－1.5

－84.2

+0.9

Net Income

2.1

0.1

－2.0

－94.3

＋0.4

Sales

* From the beginning of the current term, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc. have been applied,
and the revenue recognition standards for the previous second quarter is different from the current second quarter, the amount of increase / decrease
compared to the second quarter and the Year on Year change rate (%) are not shown. There is no impact on operating loss, ordinary income, and net
income.

3

Highlights of Business Performance:①Net sales（Units: ¥billion）

50

40

47.7

49.1

14.4

15.5

0.5

0.3

New ethical drugs, etc.(Japan)
Increased・New drugs (Beova,Desalex,Lasvic) grew・Sales of long-listed products (Pentasa etc.)30

New ethical drugs（Overseas）

Decreased

Generic drugs

Increased

20

32.9

33.3

10

・Sales increase in 3 AG products (Kipres AG, etc.)
・New generic drugs in June contributed to sales0
Sep/2020

Sep/2021
4

Highlights of Business Performance :②Operating Income（Units：¥billion）

50.0

40.0

30.0
売上高

47.7
20.0

Cost ofsales ratio

Cost ofsales ratio

48.0
%

54.4
%

Cost ofsales

Cost of
sales

22.9

売上高

R&D

49.1

5.2
SG&A
(exclude R&D)

10.0

0.0

18.1

Cost of sales ratio increased＜Reasons of increase＞⚫ Impact of NHI drug price revision(Kyorin Pharmaceutical : 6％ range)⚫ Sales of Generic drugs increased⚫ Loss on retirement of inventories, etc.
increased＜Reason of decrease＞⚫
Product mix

26.7
R&D

SG&A
23.3
Operatingincome4.4
SG&A(exclude R&D)

18.1

SG&A Gross profit decreased
22.4 SG&A cost decreased
Operatingincome1.5
Sep/20Net sales increased

Sep/21-0.1⚫ Cost of R&D cost decreased
Upfront payment for AKP-009 in FY20
⚫ SG&A(excluding R&D) remained flat
Cost reduction
Upfront payment for Gefapixant citrate

Operating income decreased5Highlights of Business Performance:③Change (forecast)（Units：¥billion）

Sep/20

Sep/21

ChangeChange(%)

Change(forecast)
Announced on
May 11,2021

47.7

49.1

n/a

n/a

+1.8

New ethical drugs, etc.(Japan)

32.9

33.3

n/a

n/a

+1.4

New ethical drugs (Overseas)

0.5

0.3

n/a

n/a

－0.2

Generic drugs

14.4

15.5

n/a

n/a

+0.7

Cost of Sales

22.9

26.7

n/a

n/a

－

SG&A
（R&D）

23.3

22.4

(5.2)

(4.4)

n/a
(－0.8)－1.9(16.1)－（－0.5)

Operating Income

1.5

－0.1

－1.6

－

+0.7

Ordinary Income

1.8

0.3

－1.5

－84.2

+0.9

Net Income

2.1

0.1

－2.0

－94.3

＋0.4

Net Sales■Difference from Original Forecast(May 11, 2021)
Net Sales：Though New drug groups (Flutiform etc.) did not reach the forecast, Long-listed products (Pentasa,
Kipres etc.) and Generic drugs sales were strong.
Operating Income：Gross profit also exceeded forecast as sales of new ethical drugs, etc. (Japan) and Genericdrugs exceeded expectations. R & D expenses were lower than initially expected, but SG&A expenses (excludingR&D) exceeded expectations. As a result, SG & A expenses as a whole remained almost as expected, operating
income exceeded expectations.
6

Main Product Sales Update（Units：¥billion）

Sep/20
Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(β3 adrenergic receptor agonist overactive
bladder therapeutics )Lasvic tablets(New quinolone synthetic antibacterial agent)

Pentasa
New ethicaldrugs,etc.
(Japan)(Ulcerative colitis andCrohn’s disease treatment)

Uritos（Kyorin）(Overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipres(Leukotriene Receptor Antagonist)

Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta(Disinfectant)

Sep/21

ChangeChange(%)

Change(forecast)
Announced on May
11,2021

6.4

6.3

－0.1

－1.2

－0.3

1.8

2.6

＋0.8

＋42.9

－0.2

3.8

4.3

＋0.5

＋14.9

＋0.2

0.2
6.4
1.6
0.6

0.8
7.1
0.7
0.7

＋0.6

＋431.3

－0.3

+0.7

＋12.0

＋1.1

－0.9

－57.0

＋0.2

+0.1

＋11.6

＋0.2

3.5

3.6

+0.1

＋1.6

＋0.6

1.4
1.1
1.0

1.6
1.0
1.0

+0.2

＋10.8

＋0.4

－0.1

－5.9

－0.1

0

－0.8

0

..

(Leukotriene Receptor Antagonist)

4.5

5.1

+0.6

＋13.2

＋1.1

Mometasone Nasal 50mg
“KYORIN”（Spray type allergic

0.9

1.0

＋0.1

＋13.7

0

0.3

0.4

+0.1

＋18.1

0

Montelukast tablets “KM”
Generic
drugs

rhinitis remedy）

Imidafenacin tablets & OD
“KYORIN”Overactive bladder)7

Trends of mainstay products
and Generic drugs

8

■Main Product Flutiform（Anti-asthmatic）（Units：bln）

ICS/LABA market(Apr-Sep)

60（Unit：％）

40

11.0
55.2

11.9

56.7

20

15.8
15

12.6

51.1

6.5

4.0
2.0

0

0

Mar/20

11.9

7.0

7.9

6.9

7.6

6.4

6.3

Mar/21

Mar/22

6.0

45.7
5

Mar/19

13.9

10

20

Mar/18

13.3

13.1

10.0

8.0

60.8

14.6

14.0
12.0

2nd half
1st half

Flutiform

16.0

Share of
Flutiform

15.2

sales
（Units：bln）

Mar/21

5.4

6.1

6.7

Mar/18Mar/19Mar/20

6.6(forecast)

0.0

Mar/22(forecast)

Copyright © 2021 IQVIA. Calculated based on MIDAS 2017-2021 .(Apr-Sep) Reprinted with permission■ICS/LABA market： Shrink 10.6％¥51.1bln(FY20 first half) ⇒ ¥45.7bln(FY21 first half) ※1●NHI drug price revision●Generic for a competitive product●Impact from triple therapy(ICS/LABA/LAMA)◼Status in first half 2021
●Proactively developed web seminar and briefing●Competition with triple therapy◼Effort for FY 2021

■Share of Flutiform sales：expanded 0.6％
15.2%（FY20 first half ） ⇒ 15.8%(FY21 first half)※ 1［NHI price revision 125aerosolized 120 for inhalation ▲6.3%（Compared with Apr,2020）］※1 Copyright © 2021 IQVIA. Calculated based on MIDAS 2020 Apr- S ep, 2021 Apr - Sep Reprinted with permission

Establish the "First Choice for Asthma Treatment
Position● Appeal the utility of the aerosol formulations
To get understanding and permeate the significance ofadministration to patients with cough symptoms● Penetrate pediatric indications and increase market share● Provide information according to “Practical guideline for Asthma
management"

9

■Main Product Desalex（Antiallergic Agent）（Units：bln）

Antihistamine market（Unit：％）(Apr-Sep)

880

Share of
Desalex

Sales（Units：bln）

Desalex

2nd half
1st half

8

7.2

5.9
60

6

5.2

4.9

4.1
40

20

74.9

4

68.4

66.1

58.7

4.0
2

2

0.0
0

0

Mar/19Mar/20Mar/21

Mar/220

Supply suspended:

3.7

4

55.9

1.4

Mar/18

5.7

6

3.9

0.9

2.6

2.8

2.6

0.9
Mar/18

4.6

about 10 months

Mar/190

Mar/201.8
21-Mar2.6

2.8(forecast)

2021/3/22(forecast)

Copyright © 2020 IQVIA. Calculated based on MIDAS 2017-2021 (Apr–Sep) Reprinted with permission■Antihistamine market ：shrink 4.7%
¥58.7bln(FY20 first half))⇒ ¥55.9bln(FY21 first half) ※1●Market shrinking due to NHI drug price revision andlaunch of Generic drugs etc.

■Share of Desalex sales
4.1%(FY20 first half)⇒ 5.9% (FY21 first half)※1●Dec. 18 single month：6.3%※2(Before supply suspension)◼Status in first half 2021
●Amount of pollen dispersed in spring was lower than usual●Accelerated effort for skin disease in internal
medicine and expanded adoption in medical institutions◼Effort for FY2021● Aim to be No. 1 prescription in otolaryngology● Focus on acquiring prescriptions in internal medicine●Sep.21 single month：6.2%※1[NHI price revision ▲8.3% （compared with Ap,2020）]※1 Copyright © 2021 IQVIA. Calculated based on MIDAS 2020.4-9,2021.4-9 Reprinted with permission※2 Copyright © 2021 IQVIA. Calculated based on MIDAS 2018.12, 2021.9 Reprinted with permission

10

■Main Product Beova/Uritos（OAB）（Units：bln）

50

OAB market

Sales（Unit：％） （Units：bln）

Share of
Beova

(Apr-Sep)
8.9

9.2

10

8

30

6

44.3

46.6

48.5

Beova

10

40

44.8

2nd half
1st half

47.3

20

8.6
8

7.3
4.3

6

4.3
4

3.5

4

1.8
10

2

3.7

2

0.7

0

0

Mar/18Mar/19Mar/20Mar/21

Mar/22

Copyright © 2021 IQVIA. Calculated based on MIDAS 2017-2021(Apr-Sep) Reprinted with permission◼Status in first half 2021

0
Mar/18
8●Share of Uritos sales

Mar/19Mar/20■Effort for FY2021※. At each OEM manufacturer, they are working to expand facilities
and launch new manufacturing sites. Shipment adjustments are expected tobe lifted during FY2022※1 Copyright © 2021 IQVIA. Calculated based on MIDAS 2020.4-9,2021.4-9 Reprinted with permission

22-Mar

2nd half
1st half

5.8

6

3.6

3.1
2.8

4

2.3
2

3.6

3.5

3.0

0.7
1.6

● Aim to contribute to urology together with Zymso *1● After clearing shipping adjustment ※, aim for the top share soon

21-Mar

4.1(forecast)

Uritos7.2

4.1%(FY20 first half)⇒1.7%(FY21 first half)※1［NIH price revision Beova▲3.8％,Uritos▲6.6％（compared with Apr.2020)］

4.3

6.6

●Share of Beova sales
8.9%(FY20 first half)⇒9.2%(FY21 first half)※1

0.6

Sales
（Units：bln）

OAB market：expand 2.5％
¥48.5bln(FY20 first half)⇒¥47.3bln（FY21 first half）※1・β3 adrenergic receptor agonist market expanded

0.7

3.8

0
Mar/18Mar/19Mar/20Mar/21

1.0
0.3
0.7
Mar/22(forecast)

0.5(forecast)

11

■Main Product Lasvic（New quinolone synthetic antibacterial agent)（Units：bln） Oral antimicrobial market(Apr-Sep)

60◆
Share ofLasvic（Unit：％）

5

Sales（Units：bln）

2nd half
1st half

Lasvic

3

2.8

4

2

40

2.0

3

60.2

50.4

48.7

2.7
2

20
1.4
30.7

1

0

Mar/19Mar/20Mar/21

1.1

31 .3

0
Mar/180.9

1

Mar/22

0

0.7

0.8

0.2
Mar/20Mar/21

1.1(forecast)

Mar/22(forecast)

Copyright © 2021 IQVIA. Calculated based on MIDAS 2017-2021(Apr-Sep) Reprinted with permission■Oral antimicrobial market：expand 1.7％
¥30.7bln (FY 20 first half) ⇒ ¥31.3bln (FY 21 first half)※1●Prevent infection (washing hands, gargling, wearing masks,etc.) has continued to reduce the number of infectious
diseases, and the market remained flat

■Share of Lasvic sales
1.4% (FY 20 first half) ⇒2.7%(FY 21 first half)※1［NHI price revision ▲2.2％ （compared with Apr.2020）］※1 Copyright © 2020 IQVIA. Calculated based on MIDAS 2020.4-9,2021.4-9 Reprinted with permission◼Status in first half 2021

●Actively provide solution (Prevention, Diagnosis, Medication)in
the infection field●Continue cognitive activities for diseases and AMR through web
seminar◼Effort for FY2021●Appeal that both dosage forms can cover respiratory infections●Increase in-hospital and outpatient treatment options
Tablets: Aim to maximize product penetration
Injection: Aim for early adoption and widespread use

12

■Status of Generic Drugs
Sales（Units：bln）

35.0
30.0

27.7

29.3

31.0

14.7

32.2

33.1

◼Status in first half 2021

25.0
20.0

2nd half
1st half

Generic Drugs Sales

15.7

16.8

17.8

14.2

14.4

17.6

Action for an authorized generic drug(AG)●Montelukast AG, Mometasone AG, Imidafenacin
AG maintain the market share of more than 50% in the
GE market

15.0
10.0
5.0

13.0

13.6

14.8

15.5

(forecast)

GE drugs released in Jun 21( 3 ingredients 5 items )Eszopiclone 1mg/2mg/3mg, Epinastine hydrochloride
ophthalmic Solution 0.05%, Tadalafil 20mg OD

0.0
Mar/18Mar/19Mar/20Mar/21

Mar/22(forecast)

Sales（Units：bln）

AG Sales（3 Products）

18.0
16.0
14.0

12.0

14.3
11.7

◼Effort for FY2021

15.4

Promotion of AG strategy

13.4●Aim to achieve a market share of more than 50% foreach AG product in GE market

11.9

10.0
8.0

2nd half
1st half

8.5

9.7

6.7

6.6

5.0

5.3

5.8

5.7

Mar/18Mar/19Mar/20Mar/21

6.9

GE drugs to be released in Dec 21(2 ingredients 4 items)
Levetiracetam 250mg/500mg/DS50%, Olopatadine
Ophthalmic Solution 0.1%

6.0
4.0
2.0

5.4

6.5

(forecast)

0.0
Mar/22(forecast)13

Consolidated Financial
Forecast

14

Consolidated Financial Forecast in FY2021（Units：¥billion）

Net
sales

FY2021

FY2020Y/Y（forecast）

ChangeChange(%)

102.9

102.6

n/a

n/a

New ethical drugs,etc.(Japan)

69.7

68.6

n/a

n/a

New ethical drugs(Overseas)

1.0

0.8

n/a

n/a

32.2

33.1

n/a

n/a

Cost of Sales

51.3

ー

ー

ー

SG&A

45.8

ー

ー

ー

(R&D)

(9.7)

（9.2）

（ー0.5）(ー5.2)

Operating Income

5.8

3.3

ー2.5

ー43.0

Ordinary Income
Net Income

6.4
6.1

3.8
2.7

－2.6
ー3.4

ー41.1
ー56.0

Generic drugs※The results forecasts for the full year announced on May 11, 2021 remain unchanged

Net Sales: Although sales of main products (Desalex, Lasvic, etc.) will grow, sales of new ethical drugs (Japan) are expected todecrease due to NHI drug price revisions (Kyorin Pharmaceutical 6% range). Meanwhile, GE's sales are expected to increase
Operating Income: Gross profit decrease due to a decrease in sales. Despite efforts to reduce SG & A expenses(including R&D expenses), profits are expected to decline due to investment costs to expand the development pipeline
Cost of sales ratio: Increase about 3.5 points, SG&A expenses ratio (excluding R&D expenses): Decrease about 1 point,
R&D: Decrease ¥0.5 bln (¥9.7 bln ⇒¥9.2 bln)
* From the beginning of the current term, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc. have been applied, and therevenue recognition standards for the previous second quarter is different from the current second quarter, the amount of increase / decrease compared to the second
quarter and the Year on Year change rate (%) are not shown. There is no impact on operating loss, ordinary income, and net income.

15

Forecast of Mainstay Products Sales（Units：¥billion）

ChangeChange(%)

13.9

＋0.6

＋4.8

5.7

7.2

＋1.5

＋27.2

7.3

8.6

＋1.3

＋18.3

0.9

2.8

＋1.9

＋229.0

12.8

11.7

－1.1

－7.8

2.3

1.0

－1.3

－56.3

2.8

1.8

－1.0

－33.7

8.3

6.9

－1.4

－16.1

3.3

2.9

－0.4

－9.6

2.1

2.2

＋0.1

＋5.6

2.0

2.1

＋0.1

＋8.3

10.8

9.2

－1.6

－14.2

Mometasone Nasal 50mg “KYORIN”

3.8

3.5

－0.3

－6.4

Imidafenacin tablets & OD
“KYORIN”(Overactive bladder)

0.7

0.7

0

＋5.9

(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(Kyorin)(β3 adrenergic receptor agonist overactive bladdertherapeutics )Lasvic(New quinolone synthetic antibacterial agent)

Pentasa(Ulcerative colitis andCrohn’s disease treatment)

Uritos（Kyorin）(Overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipres(Leukotriene Receptor Antagonist)

Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta(Disinfectant)Montelukast tablets “KM”
(Leukotriene Receptor Antagonist)

Generic
drugs(Forecast)

13.3

Flutiform

New ethicaldrugs,etc.
(Japan)YoY

FY2021

FY2020(Actual)（Spray type allergic rhinitis remedy）※The results forecasts for the full year announced on May 11, 2021 remain unchanged

16

Shareholder Returns
Capital Policy
・While maintaining the sound financial base, we aim to improve the capitalefficiency through growth investment and returns to shareholders
・We will maintain stable dividends taking DOE (Dividend on Equity ratio) into
account

Revision of Dividend Level
In consideration of dramatic changes in the business environment, risingdemand for growth investments such as expansion of development pipelines,
investment in facilities, we lowered the level of DOE while maintaining the capital
policyDividend

Dividend per
Share

FY2019FY2020

FY2021（Plan）

¥75

¥75

¥52

（Interim ¥30）

（Interim ¥30）

（Interim ¥20）

※ There is no change in the dividend plan (¥52/year) announced on May 11, 2021.

◆ The interim dividend of ¥20 was resolved by the Board of Directors on November 8, 2021 17

Application for New Market Segment “Prime
Market” on the Tokyo Stock Exchange
KYORIN Holdings,Inc. (Head Office: Chiyoda-ku Tokyo Japan, hereafter“KYORIN”) received on July 9, 2021 the results of the initial assessmentof its compliance with the listing standards of the new market segments
to be introduced on April 4, 2022 from the Tokyo Stock Exchange(hereafter the “TSE”), and confirmed its compliance with the listing
standards for the “Prime Market”.
Based on these results, at the Board of Directors Meeting held on
November 8, 2021, KYORIN resolved to select the new market segment“Prime Market” as its listing market (Press release on November 8, 2021)
Hence, KYORIN will follow the prescribed procedures related to theapplication for the selection of the new market segment, in accordancewith the schedule set by the TSE.

18

Status of R&D Pipeline19Drug R&D Pipeline: Progress
Plan in FY2020
development code

PhⅠ

PhⅡ

PhⅢ

application

Approval/
LaunchKRP-R120
Respiratory

Infections

Gefapixant
citrateKRP-A218

MSD (Feb)(Apr)

KRP-116D

Launched (Apr)Urology

AKP-009

ASKA inprogress※ Gefapixant citrate: Concluded Distribution Agreement in Japan with MSD（Apr 2021）【 Licensed Compound / Program 】
Compound/CodeLicenseeStage

FeaturesBMS

PhⅠ

・FPR-2 agonists that mainly inhibit the migration of neutrophils and exhibit
anti-inflammatory action.
・Therapy area : Non-disclosure

KRP-203

Priothera

PhⅠ・Sphingosine-1-Phosphate Receptor Agonist
・ Target：AML patients undergoing HSCT・Assignment of intellectual properties and drug substances(Sep.2020)

Compound for
Sensorineural
Hearing Loss

OtonomyNon-clinical・「OTO-6XX」 (Otonomy’s Development Code)・License Agreement (Aug.2020)

FPR2 agonist
program20

Drug R&D Pipeline: Progress
Progress in FY2021

Respiratory

Infections

development code

PhⅠ

KRP-R120

Completed

PhⅡ

PhⅢ

Gefapixant
citrateKRP-A218

application

Approval/
LaunchMSD (Feb)(Apr)

KRP-116D

Launched (Apr)Urology

AKP-009

ASKA
interrupted※※ASKA started an additional PhⅠ study to confirm the maximum effect at a higher dose

【 Licensed Compound / Program 】
Compound/CodeLicenseeStage

FeaturesBMS

PhⅠ

・FPR-2 agonists that mainly inhibit the migration of neutrophils and exhibit
anti-inflammatory action.
・Therapy area : Non-disclosure

KRP-203

Priothera

PhⅠ・Sphingosine-1-Phosphate Receptor Agonist
・ Target：AML patients undergoing HSCT・Assignment of intellectual properties and drug substances(Sep.2020)

Compound for
Sensorineural
Hearing Loss

OtonomyNon-clinical・「OTO-6XX」 (Otonomy’s Development Code)・License Agreement (Aug.2020)

FPR2 agonist
program21

Initiative toward realization of
the long-term vision “HOPE 100”22

Overview of Medium-Term Business Plan
“HOPE 100-Stage 3-”
Statement : Realize growth trend by pursuing Kyorin’s originality
・Shift to business based on the proposal of solutions andaccelerate the growth of new drug groups.
・ Enhance pipeline to support medium-term growthBusiness Strategy

・ Strengthen drug discovery capability to realize the creation of
innovative new drugs.
・ Improve cost competitiveness・ Expand overseas revenue

Organization Strategy

Performance Targets

・ Aim to be the No. 1 company for career fulfillment

・Growth potential and profitability
・Capital policy and shareholder returns

23

Shift to business based on the proposal of solutions

Solution Provision Activities in Infection Domain
Response to changing environment（MR activities/Medical care provision system）
Rebuild sales structure and enhance details

Shift to business based on
proposal of solutions”Lasvic tablets 75mg ”“Lasvic IV Drip Infusion Kit 150mg”
・Contribute to respiratory and ENT
infection along with tablets“KRP-A218”(Rhinovirus)PhⅠ
・Expand pipeline in infection medicines

Treatment

治療
LasvicTablets/Injection
ソリューション
Baccidal Tablets
etc.

Contribution to
infection control
in medical
institutions

GeneSoC®
PCR pretreatment kit
launched（Jul)Aim to launch IVD
GeneSoC mini will be launched(Notified as a medical device
in Oct)Doctors/Pharmacists/Nurses

ICT/AST*
Prevention
MiltonRubystaetc.

Diagnosis
GeneSoC®
Reagent for COVID19,Reagent for RUO・GeneSoC* ICT: Infection Control Team
AST: Antimicrobial Stewardship Team

Infection-related product sales ¥5.8 bln(FY20) ⇒ ¥8.3 bln(FY21:forecast)Kyorin’s unique contribution to health care workers in the infection fields

24Shift to business based on the proposal of solutions

Effort in diagnosis business“Genetic Analyzer GeneSoC® mini
GeneSoC® mini

Launch: End of Nov

GeneSoC®

AspectDiameter 10.5cm/Height 15.5cm

Width 62cm/Depth 29cm//Height 15.4cm

Notification

General medical device

Laboratory equipment

Principle

RT-PCR

RT-PCR

Specimen/Test

1

1～4

Detecting time

5～15 min5～15 minPrice（with Tax）

¥1,152,800¥3,278,000（Body+1 Unit）

Weight0.65㎏（Body）

4㎏（Body）＋1㎏（Unit）

Characteristics of GeneSoC® mini : Lightweight・Compact/Rapid/Low price
Promote the use as a POCT * compatible device and develop reagentsas IVD (in-vitro diagnostic drug) aiming to contribute to the properuse of antimicrobial drugs※POCT : Point of Care Testing (Examine beside the subjects and promptly make use of the results in medical treatment) 23

Enhance pipeline to support medium-term growthInterstitial cystitis “Zymso Intravesical Solution 50%”

Launched : Apr 2021

▶As a new treatment, Zymso contributes to patient treatment and better QOL
Indication : Improvement of symptoms of interstitial cystitis(Hunner type) (chronic pelvic pain, pressure anddiscomfort associated with the bladder, lower
urinary tract symptoms such as increased
urgency or pollakiuria)

Characteristics: ⚫ First therapeutic agent for interstitial cystitis⚫ Exhibits anti-inflammatory effect,shows sedative
and analgesic effects on inflammation in the
bladder“Gefapixant Citrate” a Treatment for Chronic Cough▶MSD’s drug application (Feb), KYORIN’s Exclusive distribution rights (Apr)
Refractory chronic cough (RCC) or unexplained chronic cough (UCC)
Targettreatment: (Reported that the prevalence of chronic cough in Japan is about 2% among Japanese
16 years and older) Fujimura, Allergology International. 2012; 61: 573-581

Characteristics: Currently, there is no therapeutic drug with the indication or effect of
RCC and UCC, and Gefapixant is expected as a new treatment option
26

Enhance pipeline to support medium-term growth

Pulmonary sarcoidosis treatment“KRP-R120”

aTyr社 ATYR1923 Ph 1b/2a Study

Trial Design
Design• Randomized (2:1), double-blind, placebo-controlled, multiple
ascending dose• 24 week study: 6monthly IV dose of ATYR1923 being tested at
1.0, 3.0, 5.0 mg/kg• Forced steroid taper to 5.0 mg by week 8; amendment to allow
taper to 0 mg at week 16 in responders

Population• 37 histologically confirmed pulmonary sarcoidosis patients

Endpoints【Primary Endpoint】• Safety and tolerability of multiple ascending IV ATYR1923 doses【Secondary Endpoint】• Steroid-sparing effect• Immunogenicity• Pharmacokinetics(PK)• Exploratory : Lung function (FVC and other PFTs); sarcoidosis symptomscores and quality of life scales; inflammatory and sarcoidosis biomarkers;
FDG-PET/CT imaging

Reference : ATYR Pharma Conference Call and Webcast(Sep 13, 2021)

Enhance pipeline to support medium-term growth

Pulmonary sarcoidosis treatment“KRP-R120”
Primary Endpoint⚫ The trial met its endpoint : Safe and well-tolerated
Secondary Endpoint⚫ 58% overall steroid reduction from baseline and 22% relative reduction insteroid utilization post taper in the 5.0mg/kg treatment group⚫ 33% of patients able to taper completely off steroids in the 5.0mg/kg
treatment group⚫ 3.3% absolute improvement in lung function as measured by FVC%
predicted at week 24 in the 5.0mg/kg treatment group⚫ Dose-dependent clinically meaningful improvement in all sarcoidosis
symptom measures in the 5.0mg/kg treatment group⚫ Dose-dependent improvement on inflammatory biomarkers including IL-6,
MCP-1, IFN-γ, IP-10 and TNFα as well as sarcoidosis markers ACE, IL-2Ra
and SAA with tightest control in the 5.0mg/kg treatment group
Reference : ATYR Pharma Conference Call and Webcast(Sep 13, 2021)

Kyorin is initiating investigation to proceed to the next stage ofdevelopment such as MRCT together with aTyr

Enhance pipeline to support medium-term growth

Treatment agent for BPH “AKP-009”
Development Outline⚫ PhⅡa study（Randomized, double-blind, parallel-group comparative study
with placebo as a control）⚫ Target treatment ： Benign Prostatic Hyperplasia patients⚫ Number : About 100⚫ Frequency of administration : Once a day⚫ Primary endpoint : Safety & efficacy(Rate of change from baseline in prostate volume
at 12 weeks of administration)

Development Result
No statistically significant dose correlation was found, and no significant
difference was found for each active group compared to the placebo group

Next Step
Based on the results of the PhⅡa study, it is necessary to conduct clinicalstudy at a higher dose in order to confirm the maximum effect, and Aska
Pharmaceutical started an additional PhⅠ study in September.
29

Strengthen drug discovery capability torealize the creation of innovative new drugs
Cooperation

Watarase Research Center

ActivX(USA)Open innovation

Open innovation

Academia, Venture

Pharmaceutical companies inJapan and overseas

Selection and Concentration

Kyoto University
Joint researchcourse (Apr 20)

Priority study area
Kinase / Fibrogenesis study

Drug discovery
Outside thecompany
Theme(Diversity)

Multi-tiered efforts

Novel drug discovery target

Worldwide (world-class drug discovery)
30

Strengthen drug discovery capability to realize the creation of innovative new drugs“KPR-A218” a Treatment for Rhinovirus infection
Development background
Discovered from Kinase research by Watarase Drug Discovery Center andActivX in the United States

Development status
Started PhⅠ in Apr 2021 in England

Target Treatment
Rhinovirus infection at risk of aggravation
Rhinovirus is known as the causative virus of the common cold, but the risk ofdeveloping a lower respiratory tract infection is becoming recognized as a medical
issue in immunocompromised patients.

Mode of Action
An antiviral drug that targets host molecules and suppresses viral growthin the body

● Expected to be widely effective against many rhinovirus
serotypes (types of surface antigens)● Less generate resistant virus by mutant strain
31

Strengthen drug discovery capability to realize the creation of innovative new drugs“Discovery for Lung Diseases” course
at Graduate School of Kyoto University (Phase 2)
Purpose of Joint Research
A joint research course "Discovery for Lung Disease" was established in 2017 at theGraduate School of Medicine, Kyoto University. The joint research was extended forthree years in 2020, aiming to create innovative therapeutic drugs originating inJapan, by integrating the pathological research and basic research capabilities of
the Kyoto University Graduate School with the drug discovery capabilities of Kyorin
Pharmaceutical, and identifying various factors that are deeply involved in thepathophysiology of respiratory disease, and proceed with the search for new
targets through validation research on the potential as drug discovery targets▶Research on the pathophysiology of organ fibrosis processes such as pulmonary fibrosis
based on both technologies (continued from phase 1)▶ Promote patient stratification research with a view to clinical application in collaboration
with the Department of Respiratory Medicine, Kyoto University, for candidate compounds
for new drug discovery targets (Phase 2)
Outline of Joint Research
Place :
Name:
Faculty:

Graduate school of Medicine, Kyoto University
Discovery for Lung Disease Course
Associate Professor Shimpei Gotoh (Ex assistant professor, iPS group leader,Department of Respiratory Medicine, Graduate School of Kyoto University)
Assistant Professor Masayasu Toyomoto (Ex assistant professor, Department of
Anatomy and Developmental biology, Graduate School of Kyoto University)

Terms :
April 1, 2021 – March 31, 2023
Contributions : About ¥200 Million / 3 years

32Shift to business based on the proposal of solutions and accelerate the growth of new drug groups

Accelerate growth of new drug groups◼ Maximize the spread of Flutiform and Desalex◼ Establish Lasvic’s position as a quinolone for respiratory
and otolaryngological infections◼ Accelerate growth of Beova (FY2022)◼ Preparation for Gefapixant citrate

New Growth【Image diagram】
COVID-19
Annual NHI drug
price revision
Gefapixant citrate

Zymso
LasvicInjection Launched

Beova

Clear shipping
adjustment

DesalexFlutiform
FY201933
FY2020

FY2021

FY2022

FY2023

Disclaimer

This material contains performance forecasts, goals and plans, and other forwardlooking statements related to the Group.
These statements are based on the judgment of the Group’s assumptions andoutlooks based on the information and forecasts available at the time of
preparation of this material, and contain known or unknown risks anduncertainties. Therefore, due to various factors that may occur, the actual
performance, progress / success / failure of the development and other insights
may differ significantly from the description. It also contains information about
medicines (including those under development), but the description is not for the
purpose of advertising or medical advice.

35