Q3 FY 2021 Financial Results
Ended Dec 31, 2021

February 4 , 2022

KYORIN Holdings, Inc.
President Yutaka Ogihara➢ Outline of Consolidated Financial Results➢ Consolidated Financial Forecast➢ Status of R&D Pipeline➢ Renovation of the Group Structure1Outline of Consolidated Financial Results2

Segment Sales and Breakdown of Gain and Loss（Units: ¥billion）

Dec /20

Dec /21

ChangeChange(%)

Progress to Full
Term Forecast
(%)

75.0

77.7

n/an/a75.7

New ethical drugs, etc.
（Japan）

51.7

52.4

n/an/a76.3

New ethical drugs（Overseas）

0.8

0.5

n/an/a61.7

Generic drugs

22.5

24.9

n/an/a75.1

Cost of Sales

36.2

41.5

n/an/a－

SG&A
（R&D）

34.7
(7.6)

33.3
(6.6)

n/a(－1.1)

n/a(－13.6)－（71.4)

Operating Income

4.1

2.9

－1.2

－28.9

88.7

Ordinary Income

4.7

3.5

－1.2

－24.5

92.5

Net Income

4.5

2.5

－2.0

－44.9

92.0

Sales

* From the beginning of the current term, "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 comparedto the third quarter and the Year on Year change rate (%) are not shown. There is no impact on operating income, ordinary income, and net income.

33

Highlights of Business Performance : Net sales（Units: ¥billion）

80

75.0

77.7

70
60
50

22.5

24.9

0.8

0.5

40
30

51.7

New ethical drugs, etc.(Japan)
Increased・New drugs (Beova,Desalex,Lasvic) grew・Sales of long-listed products (Pentasa, Mucodyneetc.) increased

New ethical drugs（Overseas）

Decreased

Generic drugs

Increased

52.4

20

・Sales increase in 3 AG products (Kipres AG, etc.)
・New generic drugs(June & Dec) contributed tosales

100
Dec/2020

Dec/2021

44

Main Product Sales Update（Units：¥billion）

Dec /21

Dec /20
Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(β3 adrenergic receptor agonist overactive
bladder therapeutics )Lasvic(New quinolone synthetic antibacterialagent)New
ethicaldrugs,etc.
(Japan)Pentasa(Ulcerative colitis andCrohn’s disease treatment)

Uritos（Kyorin）(Overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipres(Leukotriene Receptor Antagonist)

Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta(Disinfectant)

ChangeChangeFY2021(%)（Forecast）

Progress toFull Term
Forecast(%)

10.2

9.8

－0.4

－4.6

13.9

70.0

3.1

4.3

＋1.2

＋38.3

7.2

59.8

5.5

6.5

＋1.0

＋16.8

8.6

74.7

0.6

1.4

＋0.8

＋149.6

2.8

49.5

9.8

10.9

+1.1

＋11.6

11.7

92.9

2.0

1.0

－1.0

－47.9

1.0

101.8

1.2

1.3

+0.1

＋3.6

1.8

68.9

5.9

6.1

+0.2

＋4.2

6.9

87.8

2.5
1.7
1.6

2.9
1.6
1.5

+0.4

＋12.5

2.9

96.4

－0.1

－5.6

2.2

70.7

－0.1

－2.2

2.1

70.6

..

(Leukotriene Receptor Antagonist)

7.3

8.5

+1.2

＋16.7

9.2

91.7

Mometasone Nasal 50mg
“KYORIN”（Spray type allergic

1.7

1.9＋0.2

＋11.6

3.5

53.4

0.5

0.6

+0.1

＋8.9

0.7

75.0

Montelukast tablets “KM”
Generic
drugs

rhinitis remedy）

Imidafenacin tablets & OD
“KYORIN”Overactive bladder)55

Highlights of Business Performance :Operating Income（Units：¥billion）

80.0

Net sales increased
70.0

60.0

50.0

40.0

Sales

75.0
30.0

20.0

Cost ofsales ratio

Cost ofsales ratio

48.2%

53.4%

Cost ofsales

Cost ofsales

36.2

Sales

R&D

77.7

7.6

SG&A
(exclude R&D)

27.1

10.0

0.0

41.5
R&D

6.6
SG&A
34.7

SG&A
(exclude R&D)

Gross profit decreased
SG&A
33.3

26.7

OperatingincomeOperatingincome

4.1
Dec/20

Cost of sales ratio increased＜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⚫ Loss on retirement of inventories, etc.
increased

2.9

Dec/21

2.9

SG&A cost decreased⚫ Cost of R&D cost decreased
Upfront payment for AKP-009 in FY20
⚫ SG&A(excluding R&D) decreased
Upfront payment for Lyfnua Tablets
Cost reduction

Operating income decreased66

Consolidated FinancialForecast

7Consolidated Financial Forecast in FY2021（Units：¥billion）

Netsales

FY2021

FY2020Y/Y（Forecast）

ChangeChange(%)

102.9

102.6n/an/a

New ethical drugs,etc.(Japan)

69.7

68.6

n/an/aNew ethical drugs(Overseas)

1.0

0.8

n/an/a32.2

33.1

n/an/aCost of Sales

51.3

ーーー

SG&A

45.8

ーーー

(R&D)

(9.7)

（9.2）

（ー0.5）(ー5.2)

Operating Income

5.8

3.3

ー2.5

ー43.0

Ordinary Income
Net Income

6.4
6.1

3.8
2.7

－2.6
ー3.4

ー41.1
ー56.0

Generic drugs※The results forecasts for the full year and sales forecast for main products announced on May 11, 2021 remain unchanged* From the beginning of the current term, "Accounting Standards for Revenue Recognition" (ASBJ Statement No. 29, Mar.31,2020) etc. have been applied, and therevenue recognition standards for the previous year is different from the current year, the amount of increase / decrease compared to the current year and the Year on
Year change rate (%) is not shown. There is no impact on operating income, ordinary income, and net income.

8

Impact of fire at West Japan Distribution Center
Situation of Fire of West Japan Delivery Center of KYORIN Pharmaceutical
Date and time of Fire : AM8:50, November 29, 2021 (Extinguished PM5:00, December 4)
Place : Hitachi Transport System West Japan Co., Ltd. Maishima office (Osaka-City)

Damage situation and impact on business performance
Due to the inventory storage status of KYORIN Pharmaceutical and KYORIN Rimedio
products, there was no significant impact on product supply※Products to West Japan area are shipped from East Japan Delivery Center (Kazo-City, Saitama Pre.)

Impact on business performance
At this time, KYORIN believes that there will not be any impact on the consolidated
earnings forecast

Status of R&D Pipeline

10Drug R&D Pipeline: Progress
Progress in FY21

RespiratoryInfections※Change from the previous presentation（Nov.8,21）

Development code

PhⅠ

KRP-R120

CompletedPhⅡ

PhⅢ

Application※Ryfnua Tablets
45mg
KRP-A218

Approval/Launch

MSD approved(Jan,2022)(Apr,2021)
Launched(Apr,2021)

KRP-116D
Urology

AKP-009

ASKA
interrupted※※ASKA started an additional PhⅠ study to confirm the maximum effect at a higher dose

【 Licensed Compound / Program 】
Compound/CodeLicenseeStageFeatures

KRP-203

Priothera

PhⅠ・Sphingosine-1-Phosphate Receptor Agonist
・ Target：AML patients undergoing HSCT・Assignment of intellectual properties and drug substances(Sep.2020)

Compound for
Sensorineural
Hearing Loss

OtonomyNon-clinical・「OTO-6XX」 (Otonomy’s Development Code)・License Agreement (Aug.2020)※ BMS decided to discontinue development of FPR2 agonist program from their strategic viewpoint, it was deleted from the list

11

FPR2 agonist programOut-licensee
Bristol-Myers Squibb(BMS)

Progress⚫ Concluded a license agreement related to out-licensing (Dec, 2015)⚫ BMS announces that it is conducting a Ph1 study in the cardiovascular area (Jan, 2018)⚫ KYORIN and BMS have given presentations at American Chemical Society National Meetingand European Society of Cardiology Congress (Aug-Sep, 2019)

Though BMS has continued Ph1 study, they decided to discontinue the development offrom their development strategy viewpoint and return the development right etc. toKYORIN Pharmaceutical

KYORIN considers activities for searching for
a new out-licensee

LYFNUA® Tablets 45mg, selective P2X3 receptor antagonist for
the treatment of chronic cough (Generic name: gefapixant citrate)◼ Concluded an agreement for exclusive distribution rights in Japan (Apr, 2021)◼ MSD received manufacturing and marketing approval (Jan, 2022)

Indication
Refractory chronic coughDosage and Administration
Normally for adults, 45 mg of gefapixant is administered orally twice daily

Mode of Action
Reduce sensory nerve activation and, subsequently cough by inhibiting binding of extracellular
ATP to P2X3 receptors on found on sensory nerve fibers, predominantly C fibers in the airway

As the world's first selective P2X3 receptor antagonist indicatedfor refractory chronic cough,
KYORIN will penetrate the market soon after launch
13

LAGEVRIO® Capsules 200 mg, an oral antiviral drug(Generic name: molnupiravir)◼ MHLW granted a special approval for emergency to LAGEVRIO (Dec, 2021)◼ KYORIN and MSD concluded a co-promotion agreement (Jan, 2022)◼ Both companies started co-promotion (Jan 31, 2022)

Indication
SARS-CoV-2 infection

Dosage and Administration
Normally for patients over 18 years old , take molnupiravir 800 mg twice a day for five days

Characteristics〇 First oral antiviral drug in Japan indicated for SARS-CoV-2 infection〇 It is a ribonucleoside analog that inhibits the replication of SARS-CoV-2 causing COVID-19

KYORIN will prompt proper use of the drug
and contribute to the treatment of COVID-19
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Renovation of the Group Structure

15

Background of Renovation of the Group Structure
HOPE 100 Long term vision
Mid-term
Management Plan

Kyorin MIC-09
2005-2009

Corporate Image

Business Domain

Unique andintegrated
healthcare company
centered on drug
discovery operations

ExpandDiversification

Mar 2006
ManagementSystemPure Holding
Company Structure

Stage 1

Stage 2

Stage 3

2010-20152016-20192020-2023

Company that supports healthy lifestyles

Business selectionand concentration(ReduceDiversification)

Apr 2023
Business Holding
Company StructureOutline of the Group Structure Renovation
To become “a globally recognized company by creating
innovative new drugs”

Business
promotionfunctionManagement
efficiency

Business
HoldingCompanyStructure

Strongly promote new drug businesses
at the core and develop medicalrelated businesses
Increase management efficiency andproviding new value to patients andhealthcare professionals incollaboration with the new drug
business

Renovate the group structure in FY
2023, and aim for a further leap toward
the next 100 years

The Group chart
Merger scheme and date
Change Scheme

KYORIN Holdings will absorb KYORIN pharmaceuticaland change its trade name to KYORIN pharmaceutical
April 1, 2023

Expected Merger Date

[ Pure Holding Company Structure ]KYORIN
Holdings,Inc.
Absorption-type merger

KYORIN Rimedio
Co., Ltd.

KYORINKYORIN

PharmaceuticalPharmaceutical Group

Co.,Ltd.

Facilities Co., Ltd.

Kyorin Europe

ActivXGmbH

Biosciences, Inc.

[ Business Holding Company Structure ]KYORIN
Pharmaceutical
Co.,Ltd.※※Scheduled to change its name toKYORIN Pharmaceutical Co., Ltd. atthe same time as the merger

KYORIN Rimedio
Co., Ltd.

KYORIN Pharmaceutical
Group Facilities Co., Ltd.

Kyorin Europe
GmbH

ActivX Biosciences,Inc.

Disclaimer

This material contains performance forecasts, goals and plans, and other forwardlooking 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 anduncertainties. 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 under development), but the description is not for the
purpose of advertising or medical advice.

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