FY 2021 Financial Results
Ended March 2022

May 12 , 2022
KYORIN Holdings, Inc.

Representative Director, President and Chief Executive Officer

Yutaka Ogihara

Outline of Consolidated Financial Results
Trends of mainstay products

Consolidated Financial Forecast
Status of R&D Pipeline
Initiatives toward realizationof the long-term vision “HOPE 100”
Medium-Term Business Plan “HOPE 100-Stage3-”(Fiscal Year 2020～2023）

Renovation the group structure2Outline of Consolidated Financial Results3

Breakdown of Gain and Loss
（Units: ¥billion）

FY2020Net Sales

Vs forecast (announced

Year-on-year

FY2021

on May 11, 2021)

ChangeChange (%)

Change

102.9

105.5

n/a

n/a

+2.9

New ethical drugs,
etc. (Japan)

69.7

69.7

n/a

n/a

+1.1

New ethical drugs(Overseas)

1.0

1.0

n/a

n/a

+0.2

Generic drugs

32.2

34.8

n/a

n/a

+1.7

Cost of sales

51.3

56.1

n/a

n/a

-

SG&A
(R&D)

45.8

44.4
(8.9)

n/a

(-0.8)

n/a(-8.3)-(-0.3)

Operatingprofit

5.8

5.0

-0.8

-13.5

+1.7

Ordinary
profit

6.4

5.6

-0.8

-13.6

+1.8

Profit attributable to owners ofparent

6.1

3.9

-2.2

-35.9

+1.2

(9.7)

* From the beginning of March 2022, “Accounting Standards for Revenue Recognition” (ASBJ Statement No.29, Mar 31, 2020) etc. have been applied and the revenue recognition standards forthe current year is different from the previous year. Therefore the amount of increase / decrease compared to the current year or change rate of year on year are not shown. There is no impact
on operating loss, ordinary income and net income.

4

Highlights of Business Performance (1/3)(Units: ¥billion)
120.0

102.9

105.5

New ethical drugs, etc. (Japan): sales remained flat
【Reason of increase】

100.0

32.2

34.8

80.0

1.0

1.0

60.0

●New drugs (Dezalex, Beova, Lasvic) grew
●Increase in sales of long-listed products (Pentasa, Mucodyne etc.)【Reason of decrease】●Decrease in sales of out-licensing product and income of
lump-sum payment for out licensing products

New ethical drugs (Overseas): sales remained flat
40.0

●Upfront of payment for Lascufloxacin (out-licensing to

69.7

69.7

Chinese company)

Generic drugs: sales increased

20.0●Sales increase in Kipres AG etc.
●New generic drugs in FY 2021 contributed to sales

0.0
FY 2020

FY 20215

Highlights of Business Performance (2/3)

Net sales increased
100.0
Cost of
51.3

60.0

Cost of
sales
ratio
49.8%

Sales

56.1

Sales

Cost of
sales
ratio
53.2%

105.5 R&D

102.9 R&D
9.7

SG&A
45.8

40.0
SG&A
(exclude R&D)

20.0

36.1

SG&A
(exclude R&D)

SG&A
44.4

35.5

Operatingincome5.8
FY 2020Gross profit decreased

8.9

Operatingincome0.0【Reason of decrease】●Sales of new drugs increased【Reasons of increase】●Impact of NHI drug price revision(KYORIN Pharmaceutical : 6%range）●Sales of generic drugs increased

sales

sales
80.0

Cost of sales ratio increased

Cost of

5.0
FY 2021

SG&A cost decreased●Cost of R&D cost decreased

Upfront payment for AKP-009 in FY2020●SG&A (excluding R&D) decreased
Upfront payment for Lyfnua
Cost reduction, Applied to accounting standards forrevenue recognition

Operating income decreased

6

Highlights of Business Performance (3/3)（Units: ¥billion）

FY2020

FY2021

102.9

105.5

New ethical drugs,
etc. (Japan)

69.7

New ethical drugs(Overseas)
Generic drugs

vs forecast

Year-on-year
Change (%)

Change

n/a

n/a

+2.9

69.7

n/a

n/a

+1.1

1.0

1.0

n/a

n/a

+0.2

32.2

34.8

n/a

n/a

+1.7

Cost of sales

51.3

56.1

n/a

n/a

-

SG&A
(R&D)

45.8

44.4
(8.9)

n/a

(-0.8)

n/a(-8.3)-(-0.3)

Operatingprofit

5.8

5.0

-0.8

-13.5

+1.7

Ordinary
profit

6.4

5.6

-0.8

-13.6

+1.8

Profit attributable to owners ofparent

6.1

3.9

-2.2

-35.9

+1.2

Net Sales(9.7)

Change(announced on May 11, 2021)【Difference from original Forecast (Announce on May 11, 2021)】
Net sales : Sales of long-listing products and generic drugs increased due to effect by short supply triggered by quality violation stemming from several generic companies.
Operating profit: Gross profit increased owing to better than expected sales of new ethical drugs etc. (Japan) and generic drugs. On the other hand, operating
profit exceed forecast owing to being in line for SG&A expenses (including R&D expenses) . R&D ¥8.9 bln (Forecast ¥ 9.2bin)
7

FY2021 Main Product Sales Update（Units: ¥billion）

FY2020
Flutiform(announced on May 22, 2021)

ChangeChange (%)

Change

12.6

-0.7

-5.5

-1.3

5.7

7.1

+1.4

+24.0

-0.1

7.3

8.6

+1.3

+17.8

0

0.9

1.8

+0.9

+111.3

-1.0

12.8

14.0

+1.2

+9.4

+2.3

Kipres

8.3

8.4

+0.1

+1.4

+1.5

Mucodyne

3.3

3.5

+0.2

+5.6

+0.6

Nasonex

2.8

2.4

-0.4

-14.2

+0.6

Uritos (KYORIN)

2.3

1.3

-1.0

-44.7

+0.3

Milton

2.1

2.1

0

-3.9

-0.1

2.0

2.1

+0.1

+2.5

0

10.8

12.2

+1.4

+12.7

+3.0

Mometasone Nasal 50mg “KYORIN”

3.8

3.6

-0.2

-5.3

+0.1

Imidafenacin tablets & OD“KYORIN”

0.7

0.8

+0.1

+3.1

+0.1

Desalex(Antiallergic Agent)

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

Pentasa(Ulcerative colitis and Crohn’s disease treatment)(Leukotriene Receptor Antagonist)（Mucoregulant）（Spray type allergic rhinitis remedy）(Overactive bladder))(Disinfectant)

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

Genericdrugs

vs Forecast

Year-on-year

13.3(Combination drug for asthma treatment)New
ethicaldrugs, etc.
(Japan)FY2021

Spray type allergic rhinitis remedy）(Overactive bladder)Impact of a Fire at Nishinihon Delivery Center

Occurrence Status
Date and time of Fire: November 29, 2021 at 8:50 am
Place: Hitachi Transport System West Japan Co., Ltd. (Konohana-ku,Osaka Japan)
Damages and Impact on Product Supply
Due to the inventory storage status of KYORIN Pharmaceutical and KYORIN Rimedio products,
there was no significant impact on product supply*Products to Nishinihon area were shipping from Higashinihon delivery center (Kazo-shi SAITAMA)
Consideration for establishment of new Nishinihon delivery center is ongoing
Impact on Operating Results
The impact of this event on operating results in FY2021 is negligible.
Negotiation for compensation payment is ongoing.

9Trends of Mainstay Products and Generic Drugs

10

Flutiform（Anti-asthmatic）（Units: ¥billion）

Market Sales

ICS/LABA market

Flutiform share（Units: %）

140.0

20

15.5

120.0
100.0

11.4

12.2

15.9
15

13.2

115.1

120.3

Sales

14
12
10

80.0
60.0

（Units: ¥billion）

10

123.2
101.3

40.0

8
6

90.4
5

20.0

13.1

14.6

13.3

12.6

21/3

22/3

12.0

4
2

0.0

0
18/3

19/3

20/3

21/3

22/3

0

19/3

ICS/LABA market: Shrink 10.8%

20/3

23/3
(Forecast)

Copyright © 2022IQVIA. JPM Calculated based on Mar 2018 MAT-Mar 2022 MAT Reprinted with permission

Status in FY 2021
*1¥101.3 bln (Mar 2021 MAT）⇒ ¥90.4 bln (Mar 2022 MAT)
● Impact of NHI drug price revision and expansion of triple therapy● Launch generic drug of competitor

Share of Flutiform sales ：Expanded 0.4%
15.5%（Mar 2021 MAT）⇒ 15.9%(Mar 2022 MAT) *1

Medium to long-term market outlook
Shrinking market due to NHI drug price revision and launch generic drug

●Appeal the utility of aerosol formulations●Penetrate pediatric indications and increase market share●Information activity accreting to “Practical guideline for Asthma management”

Effort for FY 2021
Rate for NHI drug price revision on Apr 2022 : ▲6.19%● Appeal the utility of aerosol formulations. Aerosol formulation suitable for patientswith weak inspiration● Penetrate pediatric indications and increase market share● Increase market share (quantity basis)*1 Copyright © 2022 IQVIA. JPM Calculated based on Mar 2021 MAT, Mar 2022 MAT Reprinted with permission
11Desalex (Antiallergic Agent)
Antihistamine market（Units: ¥billion）

New drugs

15long-listed drugs and generics Approx.

200.0

95.7

160.0

78.2
2.9

66.4
3.0

125.6

85.2

71.0
1.7

140.0

6

120.0
98.6

5

8

180.0
156.2
137.0

100.0

100.0
83.7
6.6

5.7
2

40.0
38.3

41.9

20.0

0

0.0
19/3

20/3

21/3

Supplysuspended :about 10 months

4

80.0
60.0

4.9

0
18/3

Sales

Desalex share

178.2
162.1

10

（Units: ¥billion）

22/3

3.7

19/3

¥137.0 bln(Mar 2021 MAT) ⇒ ¥125.6 bln(Mar 2022 MAT)*1●Shrinking market due to NHI drug price revision and launch generic drug●Market (>age 12) ¥ 110.0bln (our forecast)

Share of Desalex sales
4.9% (Mar 2021 MAT）⇒ 6.6%(Mar 2022 MAT)* 1●Dec 2018 single month：6.3%（Before supply suspension)⇒ Mar 2022 single month: 8.6%* 2

8.0

2.6
20/3

21/3

22/3

23/3
(Forecast)

Copyright © 2022IQVIA. JPM Calculated based on Mar 2018 MAT-Mar 2022 MAT Reprinted with permission

Antihistamine Market: Shrink 8.3%

7.1

Status in FY 2021
●Prescription in otolaryngology: No.2
●Focus on acquiring prescriptions in internal medicine

Effort for FY 2022
Rate for NHI drug price revision on Apr 2022 :▲9.62%●Aim to be first line treatment as effective and usability drug
Usability: less sleepiness, no-limitation for drive, administration with or without meals● Aim to be No.1 prescription in otolaryngology

Medium to long-term market outlook
Shrinking market due to NHI drug price revision and launch generic drug
*1: Copyright © 2022 IQVIA. JPM Calculated based on Mar 2021 MAT, Mar 2022 MAT Reprinted with permission*2: Copyright © 2022 IQVIA. JPM Calculated based on Dec 2018 single month, Mar 2022 single month Reprinted with permission

12

Beova (OAB)
OAB market

anticholinergic agent（Units: ¥billion）

100

91.0

Sales

β3 receptor antagonist others
Beova(KYORIN) share

91.3

96.3

97.7

93.0

(%)

20

（Units: ¥billion）

14
12

80

47.8
60

56.9

40.2

30.3

53.0

40

48.5
34.1

38.3

57.5

10
62.7

5.0

18/3

19/3

20/3

21/3

22/3

14.1
6
4

5

0.6
0

10
8

10.2
8.6

20

15

0

7.3
4.3

2
0

8.6

0.7
19/3

20/3

21/3

22/3

23/3
(Forecast)

Copyright © 2022IQVIA. JPM Calculated based on Mar 2018 MAT-Mar 2022 MAT Reprinted with permission

OAB market: Shrink 4.8%

¥97.7bln (Mar 2021 MAT）⇒ ¥93.0bln (Mar 2022 MAT）*● Impact of NHI drug price revision and launch for generic drug (anticholinergic agent)● Market expansion β3 adrenergic receptor agonist market of 9.0％
Share of Beova (KYORIN) sales: Expand 1.6%

8.6% (Mar 2021 MAT）⇒ 10.2% (Mar 2022 MAT)** Copyright © 2022 IQVIA. JPM Calculated based on Mar 2021 MAT, Mar 2022 MAT Reprinted with permission

Status in FY2021● Contribute to urology together with Zymso● Enhancement facilities at each OEM manufacture and efforts for launch new

manufacturing sites towards removal shipping adjustment

Effort for FY 2022
Rate for NHI drug price revision on Apr 2022 : ▲4.57%● Removal of shipping adjustment scheduled in August● Aim to establish evaluation of Beova as first line treatment for OAB

13

Removal of Shipping Adjustment for Beova

Removal of shipping adjustment is scheduled in August 2022
Building of production system for stable supply
 Forecast for removal of shipping adjustment in August 2022 by enhancement

facilities at each OEM manufacture and efforts for launch second source (newmanufacturing sites) towards removal of shipping adjustment
 Aim to establish supply capacity more than three times of both sales of two

companies

Cost reduction and further efforts
 Successful achievement of the cost reduction for Beova in FY2021 by thescale-up process and launch of the second source Aim to further cost saving of Beova, as main product to support medium-term

growth14

Lasvic (New quinolone synthetic antibacterial agent)
Market Sales

Oral antimicrobial market

Sales (include injection drug)

Lasvic share

150.0

15

3

100.0

10

2

125.9
50.0

3.0
105.6

96.2
0.9

63.3
1.9

62.3
2.9

5

0
19/3

20/3

21/3

1.8
1.1

0.0
18/3

1

22/3

0.9

0
20/3

21/3

22/3

(Forecast)

Copyright © 2022IQVIA. JPM Calculated based on Mar 2018 MAT-Mar 2022 MAT Reprinted with permission

Oral antimicrobial market: Shrink 1.7%

¥63.3bln (Mar 2021 MAT）⇒ ¥62.3bln (Mar 2021 MAT）*●Promoting for appropriate use against AMR and reducing the number of patients
due to infection prevention measure under Covid-19
Share of Lasvic sales: Expand 1.0%
1.9% (Mar 2021 MAT）⇒ 2.9%(Mar 2022 MAT)*
Medium to long-term market outlook

23/3

Status in FY2021● Tablets: aim to maximize product penetration

Injection: aim for early adoption and widespread use Out-licensing to Chinese company (Nanjing Neiwa Faith Co., Ltd.)
Effort for FY2022

Rate for NHI drug price revision on Apr 2022 :▲3.18%
Aim to be first line treatment for old people/patients with disease

Expect to tend to be slightly shrink market of oral antimicrobial market in
respiratory and otology
15* Copyright © 2022IQVIA. JPM Calculated based on Mar 2021 MAT, Mar 2022 MAT Reprinted with permission

Status of Generic Drugs

Sale

Status in FY2021（Units: ¥billion）

40

32.2

35

29.3

2.8

30

25

31.0

11.9

11.5

0.7

34.8
0.8

3.6

3.8
10.8

●Montelukast AG, Mometasone AG,

36.7
0.5

3.6

IMIDAFENACIN AG
MOMETASONE AG

17.4

16.7

16.8

10

● Released in June 2021: 3 ingredients 5 items○ Eszopiclone tablets 1mg/2mg/3mg○ Epinastine Hydrochloride Ophthalmic

10.7

MONTELUKAST AG

solution 0.5%
○ Tadalafil Tablets 20mg AD

12.2●Released in December 2021: 2 ingredients 4items○ Levetiracetam Tablets 250mg/500mg/DS50%○ Olopatadine Ophthalmic Solution 0.1%

20

15Imidafenacin AG maintain the market shareof more than 50% in the GE market

Effort for FY2022

18.2

21.9

Other AG

●Expand sales of strategic products andsupplementary items●Contribution of launched items in FY2021
through the year
Released in June 2021: 1 ingredients 3 items

5

0
19/3

20/3

21/3

22/3

23/3
(Forecast)●Promotion of AG strategy

Aim to maintain market share of more than 50% forMontelukast AG, Mometason AG and Imidafenacin AG
in the GE market
16Consolidated Financial Forecast FY2022

17

Consolidated Financial Forecast FY2022(Unit: ¥billion)

FY2021

FY2022105.5
New ethical drugs,
etc. (Japan)

Year-on-year
ChangeChange (%)

112.0

+6.5

+6.1

69.7

74.5

+4.8

+6.8

New ethical drugs(Overseas)

1.0

0.7

-0.3

-32.2

Generic drugs

34.8

36.7

+1.9

+5.5

56.1

-

-

-

44.4

-

-

-

Net Sales

Cost of
sales
SG&A
(R&D)

(8.9)

(10.9)(+2.0)(+22.5)

Operatingprofit

5.0

5.5

+0.5

+9.8

Ordinary
profit

5.6

6.0

+0.4

+7.7

Profit attributable to ownersof parent

3.9

4.5

+0.6

+14.4

【Key factors for Increase/decrease (Year-on-Year)】Net sales : The sales of new ethical drugs (Japan)are expected to increase due to expansion of sales of new drugs by remove shipping adjustment in August 2022
and launch for Lyfnua etc. GE launched in FY2021 expected to contribute in sales increase.
Operating profit: Gross profit increased although impact on NIH drug price revisions. Operating profit are expected to increase according to decrease SG&A
expenses (excluding R&D expenses) but R&D expenses are increased.
Cost of sales ratio: Increase about 0.5 points SG&A expenses(excluding R&D expenses): decrease about 2 points R&D: Increase ¥2bln (¥8.9bln to ¥10.9 bln) 18

Forecast of Mainstay Products Sales
FY2021

ChangeChange (%)

12.6

12.0

-0.6

-4.6

7.1

8.0

+0.9

+13.6

8.6

14.1

+5.5

+64.4

1.8

3.0

+1.2

+65.8

-

0.5

+0.5

-

14.0

12.5

-1.5

-9.9

Kipres

8.4

6.8

-1.6

-18.5

Mucodyne

3.5

2.9

-0.6

-14.1

2.4

1.8

-0.6

-23.3

Uritos (KYORIN)

1.3

0.7

-0.6

-40.4

Milton

2.1

2.0

-0.1

+0.4

2.1

2.0

-0.1

-0.1

12.2

10.7

-1.5

-11.7

3.6

3.6

0

+0.1

0.8

0.5

-0.3

-26.3

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

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

Lyfnua(Selective P2X3 receptor antagonist/refractory chronic cough)New ethicaldrugs, etc.
(Japan)Pentasa(Ulcerative colitis and Crohn’s disease treatment)(Leukotriene Receptor Antagonist)（Mucoregulant）

Nasonex（Spray type allergic rhinitis remedy）(Overactive bladder))(Disinfectant)

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

Generic
drugs(Unit: ¥billion)

Year-on-year

FY2022(Forecast)

Mometasone Nasal 50mg “KYORIN”
Spray type allergic rhinitis remedy）

Imidafenacin tablets & OD“KYORIN”(Overactive bladder)19

Shareholders 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

Dividend

FY2019FY2020

FY2021

¥75

¥75

¥52

FY2022(Forecast)¥52

Dividend pershare (Yen)（Year-end ¥45）

(Year-end ¥45)

(Year-end ¥32)

(Year-end ¥32)

Consolidated
payout ratio

70.9%

71.1%

76.9%

67.2%

※The year-end dividend of 32 yen in the fiscal year ended March 2022 will be decided at in the Board Meeting scheduled in May 20

20

Status of R&D Pipeline21

Status of R&D Pipeline
Progress in FY2021

Development code

PhⅠ

KRP-R120

Completed

Respiratory

PhⅡ

PhⅢ

Application

Approval

LyfnuaInfections

Urology

Approval/Launch(MSD, Jan 2022)（Apr 2021）

KRP-A 218

Launched

Zymso(Apr 2021)

Competed

AKP-009(ASKA)※※ASKA started an additional Ph I study to confirm the maximum effect at a higher dose

[Licensed Compound / Program]Compound/CodeKRP-203
Compound for
Sensorineural Hearing
Loss

LicenseePriothera

OtonomyStage

Features

PhI● Sphingosine-1-Phosphate receptor Agonist● Target: AML patients undergoing HSCT● Assignment of IP and drug substances (Sep. 2020)

Non-clinical● "OTO-6XX“ (Otonomy’s development code)● License Agreement (Aug. 2020)※FPR2 agonist program was removed from the list since BMS (licensee) decided to discontinue the program for strategic reasons.

22

Status of R&D Pipeline in FY2022
Plan in FY2022

Development code

PhⅠ

KRP-R120

Completed

Respiratory

PhⅡ

PhⅢ

Application

Planning for initiating MRCT*
Launched

Lyfnua tablets
Infections

KRP-A 218

Urology

AKP-009

Approval/Launch(Apr 2022)（Apr 2021）
Lunched(Apr 2022)

Competed(ASKA)※※Additional Ph I study to confirm the maximum effect at a higher dose has been completed (ASKA)*MRCT: Multi-Regional Clinical Trials[Licensed Compound]
Compound/CodeKRP-203

LicenseePriotheraStage

Features

Ph I● Sphingosine-1-Phosphate receptor Agonist● Target: AML patients undergoing HSCT● Assignment of IP and drug substances (Sep. 2020)□Compound for sensorineural healing loss was removed from the list since Otonomy (licensee) decided to discontinue the program for strategic reasons23

Initiative toward Realization of the Long-term Vision “HOPE 100”24

Overview of Medium-Term Business Plan “HOPE 100-Stage 3-”

Statement

Realize growth trend by
pursuing Kyorin’s originality

Business
Strategy● Shift to business based on the proposal of solutions andaccelerate the growth of new drug groups● Enhance pipeline to support medium-term growth● Strengthen drug discovery capability to realize the creation of
innovative new drugs● Improve cost competitiveness● Expand overseas revenue

Organization
Strategy● Aim to be the No. 1 company for career fulfillment

Performance
Targets● Growth potential and profitability● Capital policy and shareholder returns

25

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

Solution Provision Activities in Infection Domain“Lasvic tablets“”Lasvic IV Drip Infusion Kit ”
・Contribute to respiratory and ENT infection along with tablets“KRP-A218”(Rhinovirus): PhⅠ
・Expand pipeline in infection medicines

Oral antiviral drug “LAGEVRIO” (2021.1-)

Contribution to treatment for Covid-19 by
Co-promotion with MSD.K.K.

Treatment

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

GeneSoC“PCR pre-treatmentkit””GeneSoc mini”(2021.11)“CSARS-CoV-2 N2 detectionkit” (2022.4)

Doctors/Pharmacists/Nurses
Contribution to
infection control in
medical institutions

Prevention

ICT/AST*

Diagnosis

GeneSoC
Reagent for COVID19,Reagent for RUO

MiltonRubysta etc.

Aim to development/sales of
new laboratory reagents and IVD
product in respiratory andsexually transmitted infections

・GeneSoC* ICT: Infection Control Team
AST: Antimicrobial Stewardship Team

Infection-related
product sales

F Y2 0 2 0¥5.8bln

F Y2 0 2 1¥7.2bln

F Y2 0 2 3¥8.9bln(Forecast）

Kyorin’s unique contribution to health care workers in the infection fields

26

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

Solution Provision Activities in Infection Domain

Expansion of product portfolios
AsthmaFlutiform/Kipres

Allergic rhinitis

Desalex/Kipres/Nasonex

COPD

EkliraInfection in
respiratory/otolaryngology

LasvicDisease inrespiratory/otolaryngology

Mucodyne

Refractory chronic coughLyfnuaPromotion of comprehensive information activities in
respiratory/otolaryngology

27

Lyfnua® Tablets 45mg (Gefapixant citrate) for treatment of refractory chronic coughProvide option for patients as only one drug for refractory chronic coughMay 2019 Memorandum of understanding onmarketing collaboration
Apr 2021 Exclusive distribution agreement in JapanApr 2022 List on the NHI drug price list

Details

Mode of action

P2X3 receptor antagonist

Primary endpoint

Mode-Based Geometric Mean Ratio of 24-hour
Coughs per Hour at Week 24/Baseline

Secondary endpoint

Model-Based Geometric Mean Ratio of Awake
Coughs Per Hour at Week 24/Baseline etc.

Launch date

April 21, 2022

Sale in the first year

¥0.5 bln

Peak sales¥16 bln (Estimated patients 190,000 in 10th year）

Establish Promotion of better understanding for product characteristic torespiratory specialists
28

Selective P2X3 Receptor Antagonist/Refractory Chronic CoughStudy Results of Phase 3 Study of Gafapixant (COUGH-2 Trial)● Mode-Based Geometric Mean Ratio of 24-hour Coughs per Hour at Week 24/Baseline [Primary endpoint]
Geometric Mean 24-Hour
Cough Frequency

24-Hour Coughs Per Hour
100

Lyfnuatablet
45mg

80
60

0

Lyfnua tablet 45mg
Placebo（n=419）（n=409）（%） 0－14.64（n=409）40
20

Estimated Relative
Reduction(%) vsPlacebo*26.8±27.04Baseline（n=434）12.1±16.05

Week 24（n=352）

Lyfnua tablet 45mg

27.4
±24.44Baseline（n=332）14.8±15.25

Week 24（n=369）PlaceboBaseline

19.1［0.2-230.1］
10.2, 35.6

20.5［0.7-179.8］
11.3, 36.3

Week 24

7.2［0-132.3］
3.3, 14.7

10.7［0-93.9］
3.9, 19.5

Baseline

18.55

19.48

Week 24

6.83

8.34

Ratio of 24Hour Coughpre Hour at
Week
24/Baseline

Upper part: Midian [Minimum-Maximum value], Lower part: first quartile points, third quartile points

0.37（0.33-0.41）（－26.07,－1.43）
p=0.03150

0.43（0.39-0.48）

100( 95% Confidence Interval) ）Geometric Mean (95% Confidence Interval ）*Estimated relative reduction (%) vs placebo was estimated by 1OO*(exp(diff) -1), where diff was the difference provided by the analysis of the log transformed variable.

●Safety [*Primary endpoints]
Lyfnua tablet 45mg

Placebo

Overall Number of Participants Analyzed

440

432

Adverse Event *Number ofParticipants （％）

399(90.7)349(80.8)

Adverse Drug Reaction (ADR)

Number ofParticipants （％）

312(70.9)91(21.1)

Serious Adverse Event*

Number ofParticipants （％）

100(22.7)25(5.8)

Most Common ADR:
Dysgeusia 188（42.7%）
Hypogeusia 57 (13.0%）
29

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

Main Products’ Medium-term Growth

Aculeate new drugs group in Medium-team management plan”HOPE-100-Stage 3-”
Product Name●Market shrinks due to annual NHI Drug price revision

ICS/LABA Market ¥90bln

Flutiform

Market Environment/Strategy

Current Status (FY2021)
Flutiform

15.9％

Top Market Share 34％

and GE launch Impact■Aim to establish a first-choice position for asthma
treatment

ICS/LAB combination drugMarket share(quantity bais)
30%●Market remains flat due to decrease anticholinergic
agent though expanded by b3 receptor agonist■Removal of shipping adjustment scheduled in August■Aim for a significant increase in peak sales

Market share No.1

*1

Beova (KYORIN)

OAB
Market¥90bln10.2％
Top Beova
Market Share 46％*1

Desalex

Antihistamine¥130bln

Desalex

6.6％

Top Market Share

17％●Market shrinks due to annual NHI Drug pricerevision and GE launch Impact■No.1 prescription acquisition rate in the field of*1

Lasvic (Oral)

LyfnuaOral antibacterial
Market¥60blnLasvic

2.9%

Top Market Share6%

otolaryngology■Expand prescriptions in internal medicine●Market shrinks due to AMR and infection prevention■Aim to maximize product penetration (Expand thenumber of prescriptions)

Sales more than
¥10 bln
Top sales inantibacterial agent*1

Symptomatic patientsfor cough (adult)

11,000,000

Patients with chronic cough

2,500,000

Number of refractory chronic cough patients： 400K-500K

Vision■Provide option as only one drug forrefractory chronic cough■Establish Promotion of better understanding for
product characteristic

OAB market: Anticholinergic agent + b3 adrenergic receptor
Antibacterial agent market: Includes all systemic antibacterial agents and children in all markets

Sales more than
¥10 bln*1:Copyright © 2022IQVIA. JPM Calculated based on Mar 2022 MAT Reprinted with permission

30

Strengthen drug discovery capability to realize the creation of innovative new drugs

Watarase ResearchCenterCooperati on

Open innovation
Academia

Kyoto
University

VentureActivX(USA)Open innovation
Pharmaceutical companies
in Japan and overseas

Selection andConcentration

Priority study area
KinaseDrugdiscovery
with externalorganizations（Diversity）

Fibrogenesis

Multi-tiered efforts

Novel drug discover target

Collaboration with Lumen
Bioscience, Inc.
Spirulina genetic protein
engineering technology

Worldwide (world-class) Innovative Drug Discovery
31

Strengthen drug discovery capability to realize the creation of innovative new drugs

Progress of Research for Fibrosis

Enhancement of drug discovery targets by collaborations with academia
Progress in Department of Drug Discovery for Lung Diseases (Graduate school of
Medicine, Kyoto University) Success to establish novel in vitro pulmonary fibrosis model*
 Produce disease iPS cells and transgenic animal as new model for fibrosis Identify pharmacological targets for fibrosis
 Apply research capacity and technology: Collaboration with department of
respiratory medicine*Kyoto University https://www.kyoto-u.ac.jp/ja/research-news/2021-11-19
https://www.kyoto-u.ac.jp/ja/research-news/2021-11-15-0

Introduction of new modality and new technology
Collaboration with domestic/oversea companies for discovery in nucleic acid drug

Promote drug discovery for fibrosis in modalities

32

Improve cost competitiveness

Reform Cost Structure by Group Optimization

Construction of the Takaoka New Plant
Strengthen the supply capacity as the production of drugs increased【Outline of the Takaoka Plant】
Location

IC Park 8, Takaoka-City, Toyama

Site Area

42,457 m2

Building

Three floors, Building area about 7,262 m2,
Total floor area about 21,091 m2

Groundbreaking

August 2022

Completion

October 2023 (Scheduled)

Operation

April 2024 (Scheduled)

Investment

About 10 billion yen

前倒しで達成 Production function of 20年度
Inami which manufactures
GE are transferred to Takaoka
 Product capacity of approximately 2 billion tablets (More than twice of Inami Plant) Significantly reduce CO2 emissions, actively utilize LNG and renewable energy
Building production system supplies stably and at low cost33

Renovation the group structure34

Renovation the group structure
Improve business promotion function and management efficiency
Mid-term
Management Plan

Corporate
Image

Business
DomainManagement
SystemKYORIN-MIC-09
2005～2009

Unique and integrated healthcarecompany centered on drug discovery
operations
Expand Diversification

HOPE 100 Long term vision
Stage 1
2010～2015

Stage 2
2016～2019

Stage 32020～2023

Company that supports healthy lifestyles

Business selection
and concentration(Reduce Diversification)

Mar 2006
Pure Holding
Company Structure

April 1, 2023 (Scheduled)
FY 2022[Business Holding Company Structure]
New trade name:
KYORIN Pharmaceutical Co., Ltd.

●Board of Directors resolution of merger and execution of the merger agreement (May 11, 2022)●Change of trade name and Ordinary general meeting of shareholders for resolution of partial
amendment to the article of incorporation (June 24, 2022 Scheduled)Strongly promote the business with new drug business placed at the core of the group management

Globally Recognized Company by Creating Innovative New Drugs
35

Outline of Merger and Change of Trade Name
Date of merger

April 1, 2023 (Scheduled)Form of merger

Absorption-type merger with KYORIN Holdings, Inc. as the surviving company
and KYORIN Pharmaceutical being dissolved

Effective Date
to New Trade Name

April 1, 2023 (Scheduled)

Reason for change

Shift from a pure holding company structure to a business holding company structure,
and Change trade name in order to inherit the drug discovery and the pharmaceutical business of
KYORIN Pharmaceutical［ Pure Holding Company Structure ］［ Business Holding Company Structure ］
KYORIN
Pharmaceutical Co., Ltd*KYORIN
Holdings, Inc.

*Scheduled to change its name to KYORIN
Pharmaceutical Co., Ltd. at the same time as themerger

Absorption-type merger

KYORIN
RimedioCo., Ltd.

KYORIN
PharmaceuticalCo., Ltd

KyorinEuropeKYORIN

Pharmaceutical
Group Facilities
Co., Ltd.

KYORIN
PharmaceuticalCo., LtdKYORIN
Pharmaceutical
Group Facility
Co., Ltd.

KyorinEuropeActivX
Biosciences

ActivX
Biosciences36

Business strategy in FY 2022

Increase the “Speed”

37

Disclaimer

This material contains performance forecasts, goals and plans, and other forward-looking 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 and uncertainties. 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 underdevelopment), but the description is not for the purpose of advertising or medical advice.

38