First Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2023
1. Overview of Consolidated Financial Results
2. Highlights of Business Performance
3. Consolidated Financial Results
4. Main Product Sales Update
5. Financial Results and Forcast
6. Development pipeline

August 2, 2022
KYORIN Holdings, Inc.

P.2
P.3
P.4
P.5
P.6
P.7～8

■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 and outlooks
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 factorsthat 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.

1Overview of Consolidated Financial Results for Fiscal 2022（¥ in millions）

1Q (Apr-Jun)

Change（％）

Interim term
FY2022（Forecast）

Change（％）

Full term
FY2022(Forecast）

Change（％）－0.3

49,600+1.0

112,000＋6.1

700-

5,500＋9.8

FY2019FY2020

FY2021

FY2022

1Q (Apr-Jun)

1Q (Apr-Jun)

1Q (Apr-Jun)

Net sales

25,74924,68924,695

24,619Operating profit

1,575

2,014－756

489

ーOrdinary profit

1,827

2,265－491

779

ー1,000 +249.8

6,000＋7.7

Profit attributable toowner of parent

1,280

1,609－462

1,183

ー

700 +475.2

4,500＋14.4

First Quarter Consolidated Financial Results for the Fiscal Year Ending March 31, 2023
[Net sales] Sales of new ethical drugs decreased from year on year due to the impact of NIH drug price revision (KYORIN pharmaceutical: 8% range), thoughmain products such as “Desalex” and “Beova” etc. increased. On the other hand, sales of generic drugs increased, resulting in net sales of 24,619
million yen.
[Profit] Despite gross profit remain flat, a decline in SG&A expenses (include of R&D expenses) due to the absence of upfront payment in FY2021 lead tooperating profit of 489 million yen. Gain on insurance related to storage products damaged from a fire at Nishinihon delivery center was posted in value
to extraordinary income of 879 million yen, and profit attributable to owner parent for this quarter was 1,183 million yen.

Consolidated Financial Results for the Fiscal Year Ending March 31, 2023 (forecast)
The forecast for the first half and full year announced on May 11, 2022 remain unchanged at this moment.
(Progress compared with the forecast for the first half; Net sales 49.6%, Operating profit 70.0%)
There is no change to the dividend forecast announced on May 11, 2022 (Annual dividend of 52 yen per share).

2

Highlights of Business Performance（¥ in billions）

Net sales decreased

25.0(－¥0.1 bln)

⚫ Decrease in sales of new ethical drugs etc. (Japan)- Main product (Beova, Desalex) grew

20.0

Cost ofSales

Cost ofSales

13.7

13.6

⚫ Increase in sales of generic drugs

Cost of sales ratio decreased (－0.2 point)<Reasons of decrease>⚫ Increase in sales of new drugs,

Cost ofSales
Ratio

15.0
Net Sales

55.4%

Net Sales

24.7<Reasons of increase>

55.2%⚫ Impact of NHI drug price revisions

2.1（excluding R&D）
R&D）
（excluding9.6
9.6(Kyorin Pharmaceutical: 8% range)

2.3
SG&A
SG&A

11.8

（excluding R&D）

-0.8
FY2021 1Q

Gross profit remained flat
SG&A

10.5

8.3
0.5
0.5

FY2022 1Q

SG&A cost decreased (－¥1.3 bln)
⚫ R&D cost increase (+¥0.2 bln)
- Upfront payment⚫ SG&A (excluding R&D) decreased

Operating
ProfitOperating
Profit0.0⚫ Increase in sales of generic drugs

R&D

SG&A
SG&A

5.0

⚫ Decrease of loss on retirement of inventories

24.6
R&D

10.0

Cost reduction of Beova

Cost ofSales
Ratio- Decrease in license fees
(Absence of upfront payment in FY2021)

Operating profit increased ( +¥1.3 bln)3

Consolidated Financial Results（Year on Year）■Net sales●New ethical drugs, etc. (Japan)（¥ in billions）

FY2021
1Q (AprJun)

FY2022
1Q (AprJun)

ChangeNet sales

24.7

24.6

－0.1

New ethical drugs,etc. (Japan)

16.8

16.4

－0.4

New ethical drugs(Overseas)

0.2

0.1

－0.1

21.6（1Q）

・Flutiform
3.2
・Desalex
1.3・Beova
2.1・Lasvic
0.4・Lyfnua
・Pentasa
3.6・Kipres
1.8・Mucodyne
0.8・Nasonex
0.4・Uritos
0.4●New ethical drugs (Overseas)¥24.6 bln（－0.1）¥16.4 bln（－0.4）

22.6（1Q）

⇒⇒
⇒
⇒⇒
⇒
⇒
⇒
⇒
⇒

2.9
1.6
2.7
0.4
0.1
3.4
1.5
0.8
0.4
0.2
¥1.0 bln（－0.3）（+0.3）（+0.6）（0）（+0.1）（－0.2）（－0.3）（0）（0）（－0.2）（－0.1）¥8.1 bln（＋0.4）¥0.5 bln（＋1.3）

Decrease in sales of Gatifloxacin●Generic drugs
Sales increase in AG products (Kipres AG, etc.)

Generic drugs

Operating profit

7.7－0.8

8.1

0.5+0.4+1.3■Operating profit●Cost of Sales ratio : 55.2％（1Q FY2021: 55.4％）[Reasons of decrease] Increase of sales for new drugs, Cost reduction of Beova,
Decrease of loss on retirement of inventories[Reasons of increase] NHI drug price revisions, Increase in sales of generic drugs●R&D : ¥2.3 bln（1Q FY2021: ¥2.1 bln）
Upfront payment

Ordinary profit
Profit attributableto owner of parent－0.5－0.5

0.8
1.2+1.3+1.7●SG&A (excluding R&D expenses) : ¥8.3 bln（1Q FY2021: ¥9.6 bln）
Decrease in license fee (Absence of upfront payment in FY2021),
Decrease in labor costs■ Profit attributable to owner of parent¥ 1.2 bln（＋1.7）●Extraordinary income: ¥ 0.9 bln
Gain on insurance related to storage products damaged from a fireat Nishinihon delivery center

4

Main Product Sales Update
1Q (Apr-Jun)(¥ in billions）

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova (Kyorin)(β3 adrenergic receptor agonist overactive bladder therapeutics )LasvicNew ethical drugs, etc. (Japan)(New quinolone synthetic antibacterial agent)

Lyfnua(selective P2X3 receptor antagonist for the treatment of chroniccough)Pentasa(Ulcerative colitis and Crohn’s disease treatment)

Kipres(Leukotriene Receptor Antagonist)

Mucodyne(Mucoregulant)

Nasonex(Spray type allergic rhinitis remedy)

Uritos (Kyorin)(Therapeutic agent for overactive bladder)

Milton(Disinfectant)

Rubysta(Disinfectant)Generic drugs

Montelukast tablets “KM”
(Leukotriene Receptor Antagonist)

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

Imidafenacin tablets & OD
“KYORIN”(Therapeutic agent for overactive bladder)

Progressto interim

FY2021

FY2022（Actual）（Actual）

3.2

2.9

－0.3

－10.8

50.2

1.3

1.6

+0.3

+24.2

2.1

2.7＋0.6

0.4

0.4

－

Progress
to fullterm (%)

Full term

FY2021

FY2022

FY2021

FY2022（Actual）（Forecast)（Actual）（Forecast)

23.8

6.3

5.6

12.6

12.0

55.2

20.3

2.6

2.9

7.1

8.0

+28.1

42.1

19.1

4.3

6.4

8.6

14.1

0+7.6

34.414.7

0.8

1.3

1.8

3.0

0.1

+0.1

－23.2

9.0

－

0.2

－0.5

3.6

3.4

－0.2

－6.7

52.5

26.7

7.1

6.3

14.0

12.5

1.8

1.5

－0.3

－17.8

52.0

21.7

3.6

2.8

8.4

6.8

0.8

0.8

0－5.6

55.0

26.4

1.6

1.4

3.5

2.9

0.4

0.4

0－3.3

70.1

20.0

0.7

0.5

2.4

1.8

0.4

0.2

－0.2

－44.4

52.1

26.4

0.7

0.3

1.3

0.7

0.5

0.5

0－0.2

47.7

24.4

1.0

1.0

2.1

2.0

0.5

0.5

0－4.0

44.0

23.2

1.0

1.0

2.1

2.0

2.6

2.8+0.2+8.6

59.5

25.8

5.1

4.6

12.2

10.7

0.5

0.6+0.1

+26.1

61.9

17.3

1.0

1.0

3.6

3.6

0.2

0.2

0－8.1

62.3

31.9

0.4

0.2

0.8

0.5

ChangeChangeInterim term

（％）

(%)

5

Financial Result and Forcast

1Q (Apr-Jun)（¥ in millions)

FY2021

FY2022（Actual）（Actual）

ChangeInterim term

Change（％）

Progress tointerimterm
forecast（％）

Progress tofull term
forecast（％）

Full term

FY2021

FY2022

FY2021

FY2022（Actual）(Forecast)（Actual）(Forecast)

Net sales

24,695

24,619

－75

－0.3

49.6

22.0

49,10249,600105,534

112,000

New ethical drugs, etc.
(Japan)16,82016,373

－447

－2.7

49.0

22.0

33,27933,40069,72574,500

200

142

－57

－28.9

47.5

20.4

342

300

1,033

700

Generic drugs

7,674

8,103

+429

+5.6

51.3

22.1

15,48115,80034,77536,700Operating profit

－756

489

+1,246

ー

70.0

8.9

－68

700

5,007

5,500

Ordinary profit

－491

779

+1,271

ー

78.0

13.0

285

1,000

5,569

6,000

Profit attributable toowner of parent－4621,183+1,645ー

169.0

26.3

121700

3,932

4,500

New ethical drugs(Overseas)6

Development pipeline
Main R&D Activities -1 (as of August 2, 2022)
POC Project (Ph I ～ Ph II)
StageJapan
Ph 1(Jul2020)

Code

Proposed Indication

OriginFeaturesPh 1b / 2a
KRP-R120(aTyr pharma,USA)Interstitial lung disease:
ILD(pulmonary sarcoidosis)

aTyrpharma

It is a fusion protein drug having the action tosuppress, by binding to neuropilin-2 (NRP2)
receptor, the excessive activation of immune
cells, and is a potential first-in-class therapyto treat inflammatory diseases such as
pulmonary sarcoidosis

Ph 1(Apr 2021,England)

Rhinovirus infection atrisk of potentially severe

In-house

It is antiviral drug that suppresses viral
growth by targeting host molecules

NoteOverseas

KRP-A218

7

Development pipeline
Main R&D Activities -2 (as of August 2, 2022)
Licensing development (License-in)StageJapan

Overseas―Ph 2(Dec 2019)
ASKA
Pharmaceutical

Code

AKP-009

Proposed
Indication

OriginFeatures

NoteBenign
ASKA
Novel androgen receptor
Prostatic
Pharmaceuti modulator mode of action withHyperplasia calthe potential to exhibit prostatic
shrinkage and to improve urinary
function as a novel therapeutic
agent for Benign Prostatic
Hyperplasia-ASKA Pharmaceutical granted
KYORIN Pharmaceutical the joint
development andcommercialization rights for AKP009 in Japan (Sep 2020)-Additional Ph1 study at a higher
dose has been completed (ASKA)

Licensing development (License-out)
StagePh 2

Compound /CodeKRP-203

LicenseePriothera

Therapyarea / Action―Origin
In-house

Features
Sphingosine-1-Phosphate
Receptor Agonist

NoteTransfer of intellectualproperty(patents and data required
for the development and sale) andAPIs (Sep 2020)8