First Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2022
1. Overview of Consolidated Financial Results
2. Highlights of Business Performance
3. Main Product Sales Update
4. Financial Results and Forecast
5. Development Pipeline

August 3, 2021

KYORIN Holdings, Inc.
These forecast performance figures are based on information currently available to theCompany and may include uncertain factors or risk that affect our future performance.
Accordingly, actual business results may materially differ from the forecasted figures due
to various factors in the future.

Overview of First Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2022
Units:millions of yen

Firstquarter
Jun / 2018

Firstquarter
Jun / 2019

Firstquarter
Jun / 2020

Firstquarter
Jun / 2021

YoYchange(%)

Interim term
Sep / 2021
(forecast)

Net sales

25,131

25,74924,68924,695n/aOperating income

1,320

1,575

2,014－756

Ordinary income

1,596

1,827

2,265

Net income

1,077

1,280

1,609

YoYchange(%)

Year ending
Mar / 2022
(forecast)

YoY change(%)

47,300n/a

102,600

n/a―－800―

3,300－43.0％

－491―

－600―

3,800－41.1％

－462―

－300―

2,700

－56.0％First Quarter Consolidated Financial Results for the Fiscal Year Ending March 31, 2022
[Net sales] Due to the impact of NHI drug price revisions and the expansion of the new coronavirus infection etc., the respiratory andotolaryngology markets, which are our priority areas, remained sluggish. Although sales of main products “Desalex” and “Lasvic” increased,sales of New ethical drugs, etc. (Japan) decreased due to a decrease in long-listed products and royalty income and service income. On theother hand, Generic drugs increased, and overall sales were 24,695 million yen.
[Profit] Gross profit decreased due to an increase in the cost ratio caused by drug price revisions. In addition, due to the recording of an
upfront payment for the introduction of a drug for treating chronic cough, SG&A expenses increased, resulting in an operating loss of 756
million yen.

Consolidated Financial Results for the Fiscal Year Ending March 31, 2022(forecast)
The forecast for the first half and full year announced on May 11, 2021 remain unchanged at this moment.
(Net sales progress compared with the forecast for the first half : 52,2%)
There is no change to the dividend forecast announced on May 11, 2021 (Annual dividend of 52 yen per share).
* From the beginning of the first quarter, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar 31,2020) etc. have been applied, andthe revenue recognition standards for the previous first quarter is different from the current first quarter, the amount of increase / decrease compared to thecurrent first quarter and the YoY change rate (%) are not shown. The impact of the application of the "Accounting Standard for Revenue Recognition" was sales
decreased by 256 million yen and SG&A expenses decreased by 256 million yen, and there is no impact on operating loss, ordinary loss, and net loss.

1Highlights of Business Performance（Units : ¥ billion）

25■Net Sales remains flat

20

Net Sales

24.7

10

47.0%

55.4%

Cost ofSales

Cost ofSales

11.6

15

➢Sales of New ethical drugs, etc.(Japan)
decreased

Cost of
Sales Ratio

Cost of
Sales Ratio

Net Sales・Sales of main products grew

➢Sales of Generic drugs increased■Gross Profit decreased
1Q FY2021: 11.0 ¥ billion(1Q FY2020 : 13.1 ¥ billion)

13.7

24.7

R&D

2.0

➢Cost of Sales Ratio increased
R&D

2.1
SG&A
(excluding R&D)

9.0

SG&A

11.1

SG&A
(excluding R&D）

9.6

5

SG&A

11.8

Operating
Income2.00

Operating
Income－0.8

Jun / 2020

・Impact of NHI drug price revisions(Kyorin Pharmaceutical : 6％ level)
・Sales of Generic drugs increased
・Loss on retirement of inventories, etc.
increased■SG&A expenses increased
・Cost of R&D remains flat
・Upfront payment for the introduction ofGefapixant citrate
・Labor expenses decrease

Jun / 20212

Consolidated Financial Results
for the first Quarter ending March 31, 2022(¥ billion)

1Q
FY20201Q
FY2021■Net Sales

Change●New Ethical drugs, etc. （Japan）
20.6（1Q）

Net Sales

24.7

24.7

n/a

New ethical drugs,etc.（Japan）

17.0

16.8

n/a

New ethical drugs（Overseas）

0.2

0.2

n/a

Generic drugs

7.5

7.7

n/a

・Flutiform
・Desalex
・Beova・Lasvic
・Pentasa・Uritos・Nasonex
・Kipres・Mucodyne

3.1
0.9
1.9
0.1
3.2
1.2
0.3
1.8
0.7

¥ 24.7blnYear on Year（n/a）¥ 16.8bln（n/a）

21.6（1Q）

⇒⇒⇒⇒
⇒⇒⇒
⇒
⇒

3.2
1.3
2.1
0.4
3.6
0.4
0.4
1.8
0.8

（ ＋0.1）（ ＋0.4）（ ＋0.2）（ ＋0.3）（ ＋0.4）（ －0.8）（ ＋0.1）（0）（ ＋0.1）●New Ethical drugs business（Overseas）¥ 0.2bln（n/a）●Generic drugs¥ 7.7bln（n/a）

Increase of Montelukast AG, Mometasone AG and products released in June

Operating
Income2.0-0.8-2.8

Ordinary
Income2.3-0.5-2.8

Net Income

1.6-0.5-2.1* From the beginning of the first quarter, "Accounting Standards forRevenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc. havebeen applied, and the revenue recognition standards for the previous
first quarter is different from the current first quarter, the amount of
increase / decrease compared to the first quarter and the Year on Yearchange rate (%) are not shown. There is no impact on operating loss,ordinary loss, and net loss.

■Operating Income¥ー0.8bln（ー2.8）● Cost of Sales Ratio : 1Q FY2021: 55.4% (1Q FY2020: 47.0%)[Decrease] Sales increase in New drugs group[Increase] Impact of NHI price revision, increase of sales for Generic drugs
Increase of loss on retirement of inventories● R&D
・1Q FY2021: ¥2.1bln (1Q FY2020: ¥2.0bln)● SG&A Ratio(excluding R&D expenses)
1Q FY2021: ¥9.6bln (1Q FY2020: ¥9.0bln)
・Decrease in labor costs, increase in patents royalty(Upfront payment for the introduction of Gefapixant)■Net Income¥ ー0.5bln（ー2.1）
3

Main Product Sales Update(Units: ¥ billion)

Interim term

ProductFlutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova（Kyorin）(β3 adrenergic receptor agonist overactive bladder therapeutics)

Lasvic tablets(Oral new quinolone synthetic antibacterial agent)New
ethicaldrugs,etc.
(Japan)Pentasa(Ulcerative colitis and Crohn’s disease treatment)

Uritos（Kyorin）(Therapeutic agent for overactive bladder)

Nasonex(Spray type allergic rhinitis remedy)

Kipres(Leukotriene Receptor Antagonist)

Mycodyne(Mucoregulant)

Milton(Disinfectant)

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

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

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

Full termFirst quarter（April 1 to June 30）

Sep/2020

Sep/2021(forecast)

Mar/2021

Mar/2022(forecast)Jun/2020

Jun/2021

YoY change(%)

Progress toInterim term
forecast(%)

Progress toFull term
forecast(%)

6.4

6.6

13.3

13.9

3.1

3.2

＋1.8%

48.5%

22.9%

1.8

2.8

5.7

7.2

0.9

1.3

＋44.5％

47.0％

18.1％

3.8

4.1

7.3

8.6

1.9

2.1

＋12.1％

50.6％

24.4％

0.2

1.1

0.9

2.8

0.1

0.4

＋814.9％

36.1％

14.6％

6.4

6.0

12.8

11.7

3.2

3.6

＋11.5%

59.6%

30.5%

1.6

0.5

2.3

1.0

1.2

0.4

－70.2%

72.7%

35.8%

0.6

0.5

2.8

1.8

0.3

0.4

＋10.6％

67.7％

20.5％

3.5

3.0

8.3

6.9

1.8

1.8

＋1.6%

58.4%

26.0%

1.4

1.2

3.3

2.9

0.7

0.8

＋13.2%

66.6%

28.1%

1.1

1.1

2.1

2.2

0.5

0.5

－1.3%

45.9%

22.3%

1.0

1.0

2.0

2.1

0.6

0.5

－12.4％

48.3％

22.8％

4.5

4.0

10.8

9.2

2.3

2.6＋8.9％

63.1％

27.6％

0.9

1.0

3.8

3.5

0.4

0.5

＋13.2％

48.5％

13.9％

0.3

0.4

0.7

0.7

0.2

0.2

+10.3％

49.0％

24.9％

4

Consolidated Financial Results and Forecast
for the first Quarter ending March 31, 2022
Interim term
(Units: ¥million)

First quarter （April 1 to June 30）

Full term

Progressto interim
term forecast(%)

Progress tofull term
forecast(%)

Mar/2021

Mar/2022(forecast)Jun/2020

Jun/2021

ChangeYoYchange(%)

47,300102,904

102,600

24,68924,695

n/a

n/a

52.2％

24.1％

32,85731,90069,73568,60017,01016,820

n/a

n/a

52.7％

24.5％

527

500

996

800

220

200

n/a

n/a

40.0％

25.0％

Generic drugs

14,35114,80032,172

33,100

7,458

7,674

n/an/a

51.9％

23.2％

Operatingincome1,502－800

5,786

3,300

2,014－756－2,771－－－

Ordinary
income1,813－600

6,447

3,800

2,265－491－2,756－－－

Net income

2,118－300

6,130

2,700

1,609

－462

－2,071－－－

Sep/2020

Sep/2021(forecast)

Sales

47,735

New ethical drugs,etc. (Japan)
New ethical drugs(Overseas)

From the beginning of the first quarter, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc. have been applied, andthe first quarter results, second quarter forecast, and the full-year forecast are based on the "Accounting Standard for Revenue Recognition".

5Development pipeline
Main R&D Activities -1 (as of August 3 2021)
Ph III ~ Application submitted
StageJapan

Overseas

Compound /CodeIndication

OriginFeatures

Launch(Apr 2021)―ZymsoIntravesicalSolution 50%/KRP-116DInterstitial cystitis―

Evaluation committee on unapproved or off-labeled drugs with highmedical needs “Dimethyl sulfoxid”

Application(Feb 2021)
MSD―

Gefapixantcitrate(INN)

Chronic coughing(planned)

Merck

Selective P2X3 receptor antagonist expected as the treatment ofrefractory chronic cough (RCC) or unexplained chronic cough(UCC)

Comments

Distributionagreement inJapan withMSD（Apr2021）

POC Project (Ph I ~ Ph II)
Stage
Code

ProposedIndication

OriginFeatures

Japan

Overseas

PhⅠ(Jul 2020)

PhⅠb/Ⅱa(aTyrpharma,USA)KRP-R120Interstitial lungdisease : ILD(pulmonarysarcoidosis)

aTyrpharma

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

PhⅠ(Apri 2021,England)

KRP-A218

Rhinovirus
infection at risk ofpotentially severe

In-house

It is antiviral drug that suppresses viral growth by targeting hostmolecules

Comments6

Development pipeline
Main R&D Activities -2 (as of August 3 2021)
Licensing development (License-in)Stage

CodeOverseasJapan
PhⅡ(Dec 2019)
ASKA
Pharmaceutical―AKP-009

ProposedIndication
Benign Prostatic
Hyperplasia

OriginFeatures

ASKA
Novel androgen receptor modulator
Pharmaceut mode of action with the potential toicalexhibit prostatic shrinkage and to
improve urinary function as a novel
therapeutic agent for Benign
Prostatic Hyperplasia

Comments
ASKA Pharmaceutical granted KYORIN
Pharmaceutical the joint development
and commercialization rights for AKP009 in Japan (Sep 2020)

Licensing development (License-out)Stage

Compound /CodeLicensee

Therapyarea / Action

OriginFeaturesComments

PhⅠ

FPR-2 agonist
programBMS

Nondisclosure

In-house

FPR-2 agonists that mainly inhibit
the migration of neutrophils andexhibit anti-inflammatory action.

PhⅠ

KRP-203

Priothera－In-house

Sphingosine-1-Phosphate Receptor Transfer of intellectual property(patentsAgonist
and data required for the development
and sale) and APIs (Sep 2020)

OtonomySensorineural In-house
Hearing Loss

Nonclinical Compound for

SensorineuralHearing Loss

Candidate compound forsensorineural hearing loss

License agreement with BMS (Dec2015)

Grant a global exclusive license todevelop, manufacture andcommercialize the therapeutic agent for
the treatment of otic disorders such as
hearing loss (Aug 2020)
Kyorin Pharmaceutical reserves acommercialization right of thetherapeutic agent in Japan
Otonomy’s Code: OTO-6XX7