Third Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2022
1. Overview of Consolidated Financial Results

P.1

2. Highlights of Business Performance

P.2

3. Consolidated Financial Results

P.3

4. Main Product Sales Update

P.4

5. Consolidated Financial Results and Forecast

P.5

6. Development pipeline

P.6-7

February 4, 2022

KYORIN Holdings, Inc.

■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 outlooksbased 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 Third Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2022
Units:
millions of yen

Dec / 2018

Dec / 2019

Dec / 2020

Dec / 2021

％ Y/YMarch / 2022
（Forecast）％ Y/Y

Net sales

82,01778,61474,95577,717n/a

102,600

Operating income

6,794

5,271

4,114

2,926

－28.9

3,300

－43.0

Ordinary income

7,124

5,836

4,656

3,515

－24.5

3,800

－41.1

Net income

5,112

4,374

4,504

2,483

－44.9

2,700

－56.0

n/a

Third Quarter Consolidated Financial Results for the Fiscal Year Ending March 31, 2022
[Net sales] Although the respiratory and otolaryngology markets, which are our priority areas, remained sluggish due to the impact of
NHI drug price revisions and the spread of the new coronavirus infection etc., sales of New ethical drugs increased byefficient promotion, and sales of main long-listed products increased due to product supply insecurity for quality problem
of some generics drug companies, then sales of New ethical drugs, etc. (Japan) were higher than the previous year. In
addition, Generic drugs increased, and overall sales were 77,717 million yen.
[Profit]Despite an increase of sales, gross profit decreased to 36,240 million yen (38,798 million yen in same period a year ago)
due to an increase in the cost ratio. Although an upfront payment for a drug for treating chronic cough was posted, SG&A
expenses (including R & D expenses) was 33,313 million yen, down from year on year (34,684 million yen in same perioda year ago) due to cost reduction, etc.. As a result, Operating income was 2,926 million yen, Ordinary income was 3,515
million yen, Net income was 2,483 million yen.

Consolidated Financial Forecast for the Fiscal Year Ending March 31, 2022The forecast for the full year announced on May 11, 2021 remain unchanged at this moment.
(Progress compared with the forecast for the fiscal year ending March 31, 2022: net sales: 75.7%; operating income: 88.7%)
There is no change to the dividend plan announced on May 11, 2021 (Annual dividend of 52 yen per share).
*From the beginning of the current term for the fiscal year ending March 31, 2022, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar 31,2020)
etc. have been applied, and the revenue recognition standards for the previous Third quarter is different from the current Third quarter, the amount of increase / decrease
compared to the current Third quarter and the YoY change rate (%) are not shown. There is no impact on operating income, ordinary income, and net income, from theapplication of the "Accounting Standard for Revenue Recognition".

2

Highlights of Business Performance(Units : ¥ billion)

Net sales increased

80

Cost of sales ratio increased
7060
50
4030

Sales

75.0

Cost ofsales

Cost ofsales<Reason of decrease>

36.2

41.5

<Reasons of increase>

Cost ofsales ratio

Cost ofsales ratio

20Sales

77.7

R&D

7.6
SG&A

27.1

10

 Loss on retirement of inventories, etc. increased

Gross profit decreased

R&D

6.6
SG&A

34.7

4.1

Dec / 2020

 Sales of Generic drugs increased

53.4%

SG&A

(excluding R&D)

26.7

Operatingincome0 Impact of NHI drug price revisions(Kyorin Pharmaceutical : 6% range)

48.2%(excluding R&D)

 Sales of New drugs increased

SG&A cost decreased
SG&A

33.3

Upfront payment for AKP-009 in FY2020
 SG&A (excluding R&D) decreased
Upfront payment for Lyfnua Tablets 45mg

Operatingincome
2.9

 Cost of R&D decreased

2.9

Cost reduction

Operating income decreased

Dec / 2021
3Third Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2022
（Year on Year）■Net sales(Units : ¥ billion)

Dec / 2020

Dec / 2021

Change●New ethical drugs, etc. (Japan)
21.3（3Q）

Net Sales

75.0

77.7

n/a

New ethical drugs,etc. (Japan)

51.7

52.4

n/a

New ethical drugs(Overseas)

0.8

0.5

n/a

22.5

24.9

n/a

Generic drugs

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

10.2
3.1
5.5
0.6
9.8
2.0
1.2
5.9
2.5

¥ 77.7bln（ n/a ）

¥ 52.4bln（ n/a ）

22.3（3Q）

⇒⇒
⇒
⇒
⇒
⇒
⇒
⇒
⇒

9.8
4.3
6.5
1.4
10.9
1.0
1.3
6.1
2.9

（ －0.4）（ ＋1.2）（ ＋1.0）（ ＋0.8）（ ＋1.1）（ －1.0）（ ＋0.1）（ ＋0.2）（ ＋0.4）¥ 0.5bln（ n/a ）

¥ 24.9bln（ n/a ）

¥ 2.9bln（－1.2）●New ethical drugs (Overseas)

Operating
Income

4.1

2.9

－1.2

Ordinary Income

4.7

3.5－1.2Net Income

4.5

2.5

－2.0

*The impact of the application of the "Accounting Standard for Revenue
Recognition" was sales decreased by 816 million yen and SG&A expenses
decreased by 816 million yen, and there is no impact on operating income,ordinary income, and net income.

Sales of transfer of intellectual property and APIs in FY2020●Generic drugs

Sales increase in 3 AG products (Kipres AG, etc.)
New generic drugs in June and December contributed to sales■Operating income●Cost of Sales ratio : 53.4％（3Q FY2020: 48.2％）[Reason of decrease] Increase in sales of New drugs[Reason of increase] NHI drug price revisions, Increase in sales of Generic drugs
Increase in loss on retirement of inventories, etc.

●R&D : ¥ 6.6bln（3Q FY2020 : ¥ 7.6bln）
Upfront payment for AKP-009 in FY2020●SG&A (excluding R&D expenses) : ¥ 26.7bln（3Q FY2020：¥ 27.1bln）
Decrease in sales and labor costs, Increase in patents royalty（Upfront payment for Lyfnua Tablets 45mg）■ Net Income¥ 2.5bln（－2.0）

4Main Product Sales Update(Units : ¥billion)

Dec /2020Dec /2021

ChangeYoY
ChangeMar /2021（％）

Mar /2022
Forecast

Mar / 2022
Progress (%)

6.4

6.3

10.2

9.8

－0.4

－4.6

13.3

13.9

70.0

Desalex

1.8

2.6

3.1

4.3

＋1.2

＋38.3

5.7

7.2

59.8

Beova (Kyorin)

3.8

4.3

5.5

6.5

＋1.0

＋16.8

7.3

8.6

74.7

Lasvic

0.2

0.8

0.6

1.4

＋0.8

＋149.6

0.9

2.8

49.5

Pentasa

6.4

7.1

9.8

10.9

＋1.1

＋11.6

12.8

11.7

92.9

Uritos (Kyorin)

1.6

0.7

2.0

1.0

－1.0

－47.9

2.3

1.0

101.8Nasonex

0.6

0.7

1.2

1.3

＋0.1

＋3.6

2.8

1.8

68.9

Kipres

3.5

3.6

5.9

6.1

＋0.2

＋4.2

8.3

6.9

87.8

Mucodyne

1.4

1.6

2.5

2.9

＋0.4

＋12.5

3.3

2.9

96.4

Milton

1.1

1.0

1.7

1.6

－0.1

－5.6

2.1

2.2

70.7

Rubysta

1.0

1.0

1.6

1.5

－0.1

－2.2

2.0

2.1

70.6

Montelukast tablets “KM”

4.5

5.1

7.3

8.5

＋1.2

＋16.7

10.8

9.2

91.7

Mometasone Nasal 50μg “KYORIN”

0.9

1.0

1.7

1.9

＋0.2

＋11.6

3.8

3.553.4

Imidafenacin tablets & OD “KYORIN”

0.3

0.4

0.5

0.6

＋0.1

＋8.9

0.7

0.7

75.0

(Antiallergic Agent)(β3 adrenergic receptor agonist overactive bladder therapeutics )(New quinolone synthetic antibacterial agent)(Ulcerative colitis and Crohn’s disease treatment)(Therapeutic agent for overactive bladder)(Spray type allergic rhinitis remedy)(Leukotriene Receptor Antagonist)(Mucoregulant)(Disinfectant)(Disinfectant)(Leukotriene Receptor Antagonist)

Genericdrugs

Sep /2021Flutiform(Combination drug for asthma treatment)

Newethicaldrugs,etc.
(Japan)Sep /2020(Spray type allergic rhinitis remedy)(Therapeutic agent for overactive bladder)5

Consolidated Financial Results
for the Third Quarter and full year forecast

Sep / 2020

Sep / 2021

Dec / 2020

Dec / 2021

ChangeYoY
ChangeNet sales

47,735

49,102

74,95577,717n/an/aNew ethical drugs,etc. (Japan)

32,85733,27951,671

52,369n/an/aNew ethical drugs(Overseas)

527

342

755

493

n/a

Generic drugs

14,351

15,481

22,52824,855n/aOperating Income

1,502－68

4,114

Ordinary Income

1,813

285

Net Income

2,118

121

(Units : ¥ million)（％）

Mar / 2021

Mar / 2022
(Forecast)

Mar / 2022
(Progress)

102,904 102,600

75.7

69,73568,600

76.3

n/a

996

800

61.7

n/a

32,172

33,10075.1

2,926 －1,188

－28.9

5,786

3,300

88.7

4,656

3,515 －1,141

－24.5

6,447

3,800

92.5

4,504

2,483 －2,021

－44.9

6,130

2,700

92.0

From the beginning of the first quarter for the Fiscal Year Ending March 31, 2022, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc.
have been applied, and the Second quarter results, Third quarter results, and the full-year forecast are based on the "Accounting Standard for Revenue Recognition".

6Development pipeline
Main R&D Activities -1 (as of February 4, 2022)※Changes from the previous announcement (Nov 8, 2021)

Ph III ～ Application submitted
StageJapan

Overseas

Compound / CodeIndication

OriginFeatures

Comments

Launch(Apr 2021)―

Zymso IntravesicalSolution 50%/KRP-116D

Interstitial cystitis―

Evaluation committee on unapproved or offlabeled drugs with high medical needs “Dimethylsulfoxid”

Approval※(Jan 2022)
MSD―

Lyfnua Tablets 45mg /Gefapixant citrate(INN)

Chronic coughing(planned)

Merck

Selective P2X3 receptor antagonist expected asDistribution
the treatment of refractory chronic cough (RCC) or agreement in
unexplained chronic cough (UCC)
Japan withMSD（Apr2021）

POC Project (Ph I ～ Ph II)
Stage
Japan

CodeOverseas

Ph Ib / IIa
Ph I(Jul 2020) (aTyr pharma,USA)Ph I(Apr 2021,England)

ProposedIndication

OriginFeatures

KRP-R120Interstitial lungdisease : ILD(pulmonarysarcoidosis)

aTyr pharma 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 therapy to treat
inflammatory diseases such as pulmonary
sarcoidosis.

KRP-A218

Rhinovirus
infection at risk ofpotentially severe

In-house

Comments

It is antiviral drug that suppresses viral growth bytargeting host molecules7

Development pipeline
Main R&D Activities -2 (as of February 4, 2022)※Changes from the previous announcement (Nov 8, 2021)

Licensing development (License-in)StageOverseasJapanPh II (Dec 2019)
ASKA
Pharmaceutical―

CodeAKP-009

ProposedIndication

OriginFeatures

Benign Prostatic ASKA
Novel androgen receptor modulator
Hyperplasia
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 andcommercialization rights for AKP-009 in
Japan (Sep 2020)

Additional Ph I study at a higher dose started (Sep 2021)

Licensing development (License-out)
StagePh I

Compound /CodeKRP-203

LicenseePriothera

Nonclinical Compound for Otonomy

SensorineuralHearing Loss

Therapyarea / Action―OriginFeatures

In-house Sphingosine-1-Phosphate Receptor
AgonistSensorineural In-house Candidate compound forsensorineural hearing loss
Hearing Loss

※FPR-2 agonist program : Deleted from Main R&D Activities
BMS(Licensee) decided to discontinue development of FPR-2 agonist program for strategic reasonsComments
Transfer of intellectual property(patentsand data required for the development andsale) and APIs (Sep 2020)
Grant a global exclusive license to develop,
manufacture and commercialize thetherapeutic agent for the treatment of otic
disorders such as hearing loss (Aug 2020)
Kyorin Pharmaceutical reserves acommercialization right of the therapeutic
agent in Japan
Otonomy’s Code: OTO-6XX8