Third Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2021
1. Overview of consolidated results
2. Highlights of Business Performance
3. Consolidated Financial Results
4. Main Product Sales Update
5. Development pipeline
6. Financial Summary and Forecasts

February 4, 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 Third Quarter Consolidated Financial Results
for the Fiscal Year Ending March 31, 2021（¥ million）

Dec/2017

Dec/2018

Dec/2019

Dec/2020

Y to Y change(%)

Mar/2021(forecast)

Y to Y change(%)

82,92382,01778,61474,955－4.7％

108,000-1.8％

Operating Income

7,805

6,794

5,271

4,114

－21.9％

7,800

＋4.0％

Ordinary Income

8,246

7,124

5,836

4,656

－20.2％

8,400

＋2.7％

Net Income

6,119

5,112

4,374

4,504

+3.0％

7,200＋17.1％

Net Sales

Third Quarter Consolidated Financial Results for the Fiscal Year Ending March 31, 2021
[Net Sales] Although the main products "Desalex" and "Beova” grew, the main product market shrank due to the impact of drug price revisions and[Profit]

patient’s suppressive behavior to medical consultation caused by the spread of new coronavirus infections. Also MR activity restraint led thedelay in market penetration of New drug groups, as the result New ethical drugs etc. (Japan) was lower than the previous year. On the otherhand, although Mometasone (AG) and Imidafenacin (AG) grew and sales of Generic drugs increased , New ethical drugs (overseas) fell
below the previous year's level, and overall sales decreased by 3,658 million yen year-on-year (4.7% in the same period of the previous year)
to 74,955 million yen.
Gross profit decreased by 2,314 million yen year-on-year due to a decrease in sales. On the other hand, selling, general andadministrative expenses decreased by 1,157 million yen (including R & D expenses increased by 18 million yen) from the same
period of the previous year due to cost reduction efforts and voluntary restriction on MR activities, etc., and operating income
was 4,114 million yen. Profit decreased by 1,156 million yen year-on-year (down 21.9%). Net income attributable to owners of
the parent was 4,504 million yen (up 3.0%) due to the recording of extraordinary income.

Consolidated Financial Results for the Fiscal Year Ending March 31, 2021 (forecast)
The forecasts for the full year announced on November 5, 2020 remain unchanged.
(Progress compared with the forecast for the fiscal year ending March 31, 2021: net sales: 69.4%; operating income: 52.8%)
There is no change to the dividend forecast announced on May 12, 2020 (annual dividend of 75 yen per share).

1Highlights of Business Performance( Units: ¥ billion )80

70

Net Sales

78.6

Net Sales

20

7.6

28.3

5.3
Dec / 2019

■Gross Profit decreased ¥2.3billion year on year

SG&A

35.8

5.3

➢SG&A expenses decreased ¥1.1billion year on year

36.2

・R & D expenses remained flat
・SG&A(excluding R&D) decreased ¥1.2billion

R&D■Operating Income decreased¥1.2billion year on year

7.6
SG&A
(excluding R&D)

27.1

OperatingIncome10075.0

R&D

SG&A

・NHI drug price revisions
・Generic drugs ratio increased

Cost of
Sales

37.5

(excluding R&D)

➢Cost of sales ratio increased 0.5%

48.2%

Cost ofSales

5030

Cost of
Sales Ratio

47.7%

6040

➢Net Sales decreased ¥3.6billion year on year

Cost of
Sales Ratio

SG&A

34.7
Operating
Income3.4

4.1

Dec / 20202

Consolidated Financial Results
for the Third Quarter ending March 31, 2021
（Year on Year）( unit : ¥ billion )(¥ billion)

Net Sales
New ethicaldrugs, etc.
（Japan）
New ethicaldrugs（Overseas）
Generic drugs

Dec/
2019

Dec/
2020

■Net Sales

Change

78.6

75.0

－3.6

55.4

51.7

－3.7

1.2

0.8

－0.4

22.0

22.5

＋0.5

●Sales of new ethical drugs in Japan(billion)
・ Flutiform・ Desalex
・ Beova・ Lasvic・ Pentasa
・ Uritos
・ Nasonex
・ Kipres・ Mucodyne

20.3（3Q）
10.8
0.8
2.2
0.6
10.3
4.6
3.8
8.6
4.5

●Sales of new ethical drugs in Overseas

⇒⇒⇒⇒⇒
⇒
⇒
⇒
⇒

¥75.0bln（－3.6）¥51.7bln（－3.7）

21.3（3Q）
10.2
3.1
5.5
0.6
9.8
2.0
1.2
5.92.5(－0.6)(+2.3)(＋3.3)(0)(－0.5)(－2.6)(－2.6)(－2.7)(－2.0)¥0.8bln（－0.4）¥22.5bln（＋0.5）

Decreased the sales of Gatifloxacin●Sales of Generic drugs
OperatingIncome

5.3

4.1

－1.2

Ordinary
Income

5.8

4.7

－1.1

Net Income

4.4

Sales increase by Nazonex AG, and Uritos AG(launched in June),supplement products
in 2020 contributed■Operating Income¥4.1bln（－1.2）◆Operating Income margin decreased 1.2 percentage points to 5.5%

4.5＋0.1※ The classification of reporting segment ("Prescription drugs business"and "Healthcare business") was consolidated to a single segment from thefirst quarter consolidated financial results for the fiscal year ending March31, 2021
Along with this, the classification of sales was changed to combine theexisting “New ethical drugs (Japan)” and “healthcare business” to "Newethical drugs, etc. (Japan)".
There is no change in "New ethical drugs (overseas)" and "Generic drugs".

●Cost of Sales Ratio : 47.7%⇒48.2% Increased 0.5 percentage points[Increase] NHI drug price revisions, Increase of sales of Generic products etc.
[Decrease]Product mix, Efforts to reduce costs(Raw material costs, etc.)●R&D Ratio : 9.6%⇒10.1% increased 0.5 percentage points＊¥7.6bln⇒¥7.6bln●SG&A Ratio （excluding R&D） : 35.9%⇒36.1% （＋0.2%）＊Decrease of ¥1.2bln (¥28.3bln⇒¥27.1bln) Decrease of selling and general expenses■Net Income¥4.5bln（+0.1）

Debt exemption gain due to the partial exemption of repayment obligation for long-term
debt from JST, and gain on sale of fixed assets were recorded as extraordinary profit.

3

Main Product Sales Update（Units: ¥billion）

Dec/2019

Dec/2020

Mar/2020(Actual）

Mar/2021（forecast）

－5.2%

14.6

14.5

Change（%）

Change

6.4

10.8

10.2

0

1.8

0.8

3.1

＋2.3 ＋294.3%

2.6

7.5

0.6

3.8

2.2

5.5

＋3.3 ＋151.2%

4.3

7.3

－0.2

0.6

0.6

0＋1.7%

1.1

1.7

6.8

6.4

10.3

9.8

－0.5

－5.3%

13.3

12.5

3.0

1.6

4.6

2.0

－2.6

－56.9%

5.8

2.2

2.7

0.6

3.8

1.2

－2.6

－67.6%

6.0

2.4

2.4

1.7

3.8

2.7

－1.1

－27.6%

5.3

3.8

3.01.8

4.8

3.1

－1.7

－35.3%

6.5

4.3

2.8

1.4

4.5

2.5

－2.0

－44.1%

5.8

3.3

1.1

1.1

1.7

1.7

0＋2.1%

2.4

2.3(Disinfectant)

0.6

1.0

1.0

1.6

＋0.6

＋54.6%

1.5

2.1

Montelukast tablets “KM”

5.4

4.5

8.3

7.3

－1.0

－11.9%

11.5

10.2

Mometasone Nasal 50mg
“KYORIN”

0.4

0.9

1.1

1.7

＋0.6

＋57.6％

2.8

3.5

Imidafenacin tablets & OD
“KYORIN”

－0.3

－

0.5

＋0.5

—

－0.8

(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(β3 adrenergic receptor agonist overactive bladdertherapeutics )Lasvic tablets(Oral new quinolone synthetic antibacterial agent)

Pentasa(Ulcerative colitis andCrohn’s disease treatment)

Uritos（Kyorin）(Therapeutic agent for overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipresfor adult(Leukotriene Receptor Antagonist)for children
Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta

Genericdrugs

Sep/
2020

6.7

FlutiformNew
ethicaldrugs, etc.
(Japan)

Sep/
2019

－0.64

Development pipeline

Main R&D Activities -1 (as of February 4 2021)
Ph III ~ Application submitted
StageJapan

Overseas

Compound/CodeIndication

Origin※Changes from the previous announcement (Nov 5 2020)
FeaturesApproval※(Nov 2020)

LasvicIntravenousDrip Infusion
Kit 150mg/
KRPAM1977Y

New quinolone
antibacterialInjection

In-house

A novel quinolone injection developed specifically for thetreatment of lower respiratory tract infections
1. Highly distributed in the lung, showing strong antibacterial
activity against pathogenic bacteria of respiratory tract
infection
2. Effective against both aerobic and anaerobic bacteria, andable to administer once a day
3. Showed effectiveness against aspiration pneumonia,
pulmonary suppuration, and lung abscessApproval※(Jan 2021)

Zymso
IntravesicalSolution 50%/KRP-116DInterstitial
cystitis―

Evaluation committee on unapproved or off-labeled drugs withhigh medical needs “Dimethyl sulfoxid”

Comments

・MK-7264, a drug for chronic coughing: MSD is working on Phase III development.
Concluded a memorandum of understanding for sales collaboration (May 2019).

POC Project (Ph I ~ Ph II)
StageJapan

OverseasPhⅠ(Jul 2020)

PhⅠb/Ⅱa(aTyrpharma)

Compound/Code

Proposed
Indication

KRP-R120Interstitial lungdisease :ILD(pulmonarysarcoidosis)

OriginaTyrpharmaFeatures

Comments

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

6Main R&D Activities -2 (as of February 4 2021)
Licensing development (License-in)StageJapan
PhⅡ(Dec/2019)
ASKA
PharmaceuticalOverseas

Compound/
Code

Proposed
Indication

AKP-009Benign
Prostatic
Hyperplasia

OriginFeatures

ASKA
Pharmaceuti
calNovel androgen receptor modulator mode of action with thepotential to exhibit 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 within
Japan (09/2020)

Licensing development (License-out)
Stage/
Overseas

Compound/Code

Licensee /Collaborative
researchTherapy
area/Action

OriginFeatures

Comments

Nondisclosure

In-house

FPR-2 agonists that mainly inhibit themigration of neutrophils and exhibit antiinflammatory action.

License agreement with BMS(12/2015)

Priothera-In-house

Sphingosine-1-Phosphate Receptor Agonist

Transfer of intellectual property(patents anddata required for the development andsale) and APIs
(9/2020)

Otonomy-In-house

Candidate compound for sensorineural hearing
loss

Grant a global exclusive license to develop,
manufacture and commercialize thetherapeutic agent for the treatment of otic
disorders such as hearing loss(8/2020)
Kyorin Pharmaceutical reserves acommercialization right of the therapeutic
agent in Japan
Otonomy’s Code: OTO-6XX

PhⅠ

FPR-2 agonist
programBMS

PhⅠ

KRP-203

Nonclinical

Compound for
Sensorineural
Hearing Loss

7Consolidated Financial Results
for the Third Quarter ending March 31, 2021
（Units: ¥Million）

Sep/2019

Sep/2020

Dec/2019

Dec/2020

ChangeChange（%）

Mar/2020（Actual）

Mar/2021（forecast）

Net sales (total)

48,29947,73578,61474,955－3,658－4.7

109,983

108,000

New ethical drugs,etc.
（Japan）

33,74232,85755,351

51,671－3,679－6.6

77,53573,800

390

527

1,224

755

－468

－38.3

1,490

1,100

14,166

14,351

22,03822,528－489＋2.2

30,95733,000Operating Income

783

1,502

5,271

4,114

－1,156－21.9

7,503

7,800

Ordinary Income

1,076

1,813

5,836

4,656－1,180

－20.2

8,175

8,400

834

2,118

4,374

4,504

＋130＋3.0

6,149

7,200

New ethical drugs（Overseas）
Generic drugs

Net Income

The classification of reporting segment ("Prescription drugs business" and "Healthcare business") was consolidated to a single segment from the first quarter consolidated financial
results for the fiscal year ending March 31, 2021
Along with this, the classification of sales was changed to combine the existing “New ethical drugs (Japan)” and “healthcare business” to "New ethical drugs, etc. (Japan)".
There is no change in "New ethical drugs (overseas)" and "Generic drugs".

8