November 1, 2023

Kyowa Kirin Co., Ltd.

Appendix to the Consolidated Financial Summary (IFRS)

Fiscal 2023 Third Quarter

(January 1, 2023 - September 30, 2023)

  • These materials were made as a supplement to the Kessan Tanshin (Consolidated Financial Summary, IFRS), disclosed at the Tokyo Stock Exchange on November 1, 2023 for the first nine months of Fiscal 2023, from January 1, 2023 to September 30, 2023.
  • This document is an English translation of the Japanese-language original.
  • The statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.
  • Figures presented in these materials have been rounded to the nearest tenth
  • Figures inside parenthesis presented in these materials indicate negative values.
  • Change amount in these materials presents change amount compared to the same period of the previous fiscal year.

Index

Page

  1. Consolidated Financial Results

1.

Trends in consolidated profit

1

2.

Revenue by regional control function

2

3.

Revenue by location of customer

2

4.

Capital expenditures and intangible assets investment,

2

depreciation and amortization

5.

Number of employees by regional control function

2

II. Consolidated Statement of Cash Flows

2

Ⅲ. Revenue from Main Products

3

Ⅳ. R&D Pipeline

6

The average exchange rates for each period were as follows:

Unit: Yen

FY 2022 results

FY 2023 results

FY 2023

forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

USD

114

120

126

130

132

134

137

130

GBP

154

158

160

161

161

164

170

160

EUR

129

133

135

137

141

144

148

135

Contact

Kyowa Kirin Co., Ltd.

Corporate Communications Department

Tel +81 3 5205 7206

. Consolidated Financial Results

1. Trends in consolidated profit

The "" symbol indicates financial KPIs (numerical guidance) that were set as targets in the FY2021-2025 Medium Term Business Plan.

Unit: Billions of yen

FY2021-2025

FY 2022 results

FY 2023 results

FY 2023 forecasts

Change

Rate of

Medium Term

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Progress

Business Plan

amount

change

Financial KPIs

Revenue

87.8

185.3

283.8

398.4

93.5

199.2

306.1

22.3

8%

426.0

72%

CAGR (compared to FY 2020)

-

-

-

11.9%

-

-

-

-

-

10.2%

-

10% or higher

Cost of sales

(22.2)

(43.4)

(64.1)

(86.9)

(18.9)

(47.0)

(77.0)

(12.8)

20%

(100.0)

77%

Gross profit

65.6

141.9

219.6

311.5

74.6

152.2

229.1

9.4

4%

326.0

70%

Gross profit to revenue ratio

74.7%

76.6%

77.4%

78.2%

79.7%

76.4%

74.8%

-

-

76.5%

-

Selling, general and administrative

(36.1)

(76.4)

(117.3)

(166.2)

(41.8)

(82.4)

(119.3)

(2.0)

2%

(162.0)

74%

expenses

Research and development expenses

(13.6)

(27.9)

(44.1)

(62.9)

(16.6)

(33.7)

(51.2)

(7.0)

16%

(79.0)

65%

R&D expense ratio

15.5%

15.1%

15.6%

15.8%

17.8%

16.9%

16.7%

-

-

18.5%

-

Target of 18-20%

Share of profit (loss) of investments

1.4

2.4

2.6

4.3

0.8

1.4

2.3

(0.4)

(14)%

3.0

76%

accounted for using equity method

Core operating profit

17.3

39.9

60.9

86.7

17.0

37.5

60.9

0.0

0%

88.0

69%

Core operating profit ratio

19.8%

21.5%

21.4%

21.8%

18.2%

18.8%

19.9%

-

-

20.7%

-

25% or higher

Other income

0.4

0.6

1.0

1.7

0.2

0.5

16.6

15.6

-

Other expenses

(0.2)

(1.2)

(5.1)

(23.1)

(2.6)

(14.2)

(16.6)

(11.6)

228%

Finance income (costs)

1.2

4.2

3.6

2.2

1.0

2.2

3.5

(0.0)

(2)%

Profit before tax

18.7

43.5

60.4

67.6

15.6

26.0

64.3

3.9

7%

86.0

75%

Income tax expense

(2.7)

(8.5)

(11.2)

(14.0)

(2.8)

(4.4)

(10.8)

0.4

(4)%

(16.0)

67%

Ratio of income tax burden

14.3%

19.5%

18.5%

20.7%

18.1%

16.9%

16.8%

-

-

18.6%

-

Profit

16.0

35.0

49.2

53.6

12.8

21.6

53.6

4.3

9%

70.0

77%

Profit to revenue ratio

18.3%

18.9%

17.3%

13.4%

13.6%

10.9%

17.5%

-

-

16.4%

-

EPS (¥/share)

29.85

65.16

91.57

99.68

23.74

40.27

99.62

8.05

-

130.23

-

Core EPS (¥/share)*1

29.52

66.14

97.70

131.19

27.33

61.40

99.69

1.99

-

136.37

-

Annual dividend (¥/share)

51.00

54.00

-

Dividend payout ratio (%)*2

38.9

39.6

-

Target of 40%

ROE (%)

7.1

8.9

-

10% or higher

*1 Core EPS is calculated as an indicator showing recurring profitability by dividing core profit (determined by subtracting "other income," "other expenses" and the related "income tax expense" from "profit") by the average number of shares during the period.

*2 Dividend payout ratio is shown based on core EPS.

Unit: Billions of yen

FY 2022 results

FY 2023 results

Jan - Mar

Apr - Jun

Jul - Sep

Oct - Dec

Jan - Mar

Apr - Jun

Jul - Sep

Change

Rate of

amount

change

Revenue

87.8

97.5

98.5

114.6

93.5

105.7

106.8

8.3

8%

Cost of sales

(22.2)

(21.2)

(20.8)

(22.8)

(18.9)

(28.1)

(29.9)

(9.2)

44%

Gross profit

65.6

76.3

77.7

91.8

74.6

77.6

76.9

(0.8)

(1)%

Gross profit to revenue ratio

74.7%

78.2%

78.9%

80.1%

79.7%

73.4%

72.0%

-

-

Selling, general and administrative

(36.1)

(40.4)

(40.8)

(48.9)

(41.8)

(40.6)

(36.9)

3.9

(10)%

expenses

Research and development expenses

(13.6)

(14.3)

(16.2)

(18.8)

(16.6)

(17.0)

(17.5)

(1.3)

8%

R&D expense ratio

15.5%

14.7%

16.5%

16.4%

17.8%

16.1%

16.4%

-

-

Share of profit (loss) of investments

1.4

0.9

0.3

1.7

0.8

0.6

0.9

0.6

233%

accounted for using equity method

Core operating profit

17.3

22.6

21.0

25.8

17.0

20.5

23.4

2.5

12%

Core operating profit ratio

19.8%

23.1%

21.3%

22.5%

18.2%

19.4%

21.9%

-

-

Other income

0.4

0.2

0.5

0.7

0.2

0.3

16.1

15.6

-

Other expenses

(0.2)

(1.0)

(3.9)

(18.0)

(2.6)

(11.6)

(2.5)

1.4

(36)%

Finance income (costs)

1.2

3.1

(0.6)

(1.4)

1.0

1.3

1.3

1.9

-

Profit before tax

18.7

24.8

16.9

7.2

15.6

10.5

38.3

21.4

126%

Income tax expense

(2.7)

(5.8)

(2.7)

(2.8)

(2.8)

(1.6)

(6.4)

(3.7)

134%

Profit

16.0

19.0

14.2

4.4

12.8

8.9

31.9

17.7

125%

Profit to revenue ratio

18.3%

19.5%

14.4%

3.8%

13.6%

8.4%

29.9%

-

-

- 1 -

2. Revenue by regional control function

Unit: Billions of yen

FY 2022 results

FY 2023 results

FY 2023 forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change

Jan - Dec

Progress

amount

Japan

35.4

72.8

109.2

148.7

34.0

70.9

107.0

(2.3)

145.6

73%

North America

20.7

47.5

75.9

112.6

25.7

60.3

92.9

17.0

132.5

70%

EMEA

14.5

30.9

48.0

66.9

15.4

30.8

45.7

(2.3)

66.1

69%

APAC

7.2

14.8

22.5

30.1

7.4

16.0

26.0

3.5

34.5

75%

Others

9.8

19.3

28.1

40.1

11.0

21.2

34.5

6.3

47.4

73%

Total consolidated revenue

87.8

185.3

283.8

398.4

93.5

199.2

306.1

22.3

426.0

72%

  • Revenue by regional control function is classified based on consolidated revenue from products of regional control functions in the One Kyowa Kirin (OKK) matrix global management structure, which combines a regional organization based on four regions of Japan, North America, EMEA and APAC, a functional organization, and a product organization (product franchises).
  • EMEA consists of Europe, the Middle East, Africa, etc.
  • Others consists of revenue from technology out-licensing, original equipment manufacturing, etc.

3. Revenue by location of customer

Unit: Billions of yen

FY 2022 results

FY 2023 results

FY 2023 forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Percentage of

Jan - Mar

Jan - Jun

Jan - Sep

Percentage of

Jan - Dec

Percentage of

consolidated

consolidated

consolidated

revenue

revenue

revenue

Japan

36.9

75.8

111.3

154.6

39%

35.0

73.7

111.1

36%

153.3

36%

International

50.9

109.5

172.5

243.7

61%

58.5

125.6

194.9

64%

272.7

64%

Americas

28.2

62.2

99.8

143.9

36%

34.2

76.9

121.5

40%

169.2

40%

Of which, the U.S.

27.3

60.3

97.1

139.9

35%

32.8

74.4

117.7

38%

162.6

38%

Europe

13.5

28.8

44.9

62.3

16%

14.4

28.5

40.9

13%

61.9

15%

Asia

9.1

18.4

27.6

37.4

9%

9.7

19.8

31.9

10%

40.9

10%

Others

0.0

0.1

0.2

0.2

0%

0.2

0.4

0.7

0%

0.7

0%

Total consolidated revenue

87.8

185.3

283.8

398.4

100%

93.5

199.2

306.1

100%

426.0

100%

* Revenue by location of customer is classified by region or country based on location of customer.

4. Capital expenditures and intangible assets investment, depreciation and amortization

Unit: Billions of yen

FY 2022 results

FY 2023 results

FY 2023

forecasts

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Capital expenditures (property, plant and equipment)*

1.8

5.0

10.3

17.7

3.7

7.0

10.5

24.0

Intangible assets investment

1.0

3.1

4.9

13.3

2.3

4.7

13.6

15.0

Total

2.8

8.2

15.2

31.0

6.0

11.7

24.1

39.0

Depreciation (property, plant and equipment)

2.9

6.0

9.0

11.4

3.1

6.3

9.7

13.0

Amortization (intangible assets)

1.7

3.5

5.3

7.0

1.8

3.6

5.8

7.0

Total

4.6

9.5

14.3

18.5

4.8

9.9

15.5

20.0

  • Acquisitions of right-of-use assets are not included.

5. Number of employees by regional control function

FY 2022 results

FY 2023 results

As of March 31

As of June 30

As of September

As of December

As of March 31

As of June 30

As of September

Change

30

31

30

amount

Japan

4,035

4,114

4,146

4,135

4,154

4,236

4,207

61

North America

446

490

532

560

574

608

630

98

EMEA

781

768

747

729

743

714

587

(160)

APAC

536

540

555

558

571

578

568

13

Total

5,798

5,912

5,980

5,982

6,042

6,136

5,991

11

. Consolidated Statement of Cash Flows

Unit: Billions of yen

FY 2022 results

FY 2023 results

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change

amount

Cash flows from operating activities

8.8

22.5

35.5

48.7

29.4

60.3

84.3

48.7

Cash flows from investing activities

(4.6)

(6.8)

(13.4)

(17.2)

(9.1)

(14.0)

(12.5)

0.9

Cash flows from financing activities

(13.2)

(14.1)

(27.9)

(29.0)

(15.2)

(16.1)

(31.4)

(3.5)

Effect of exchange rate changes on cash and cash equivalents

0.4

3.3

3.5

1.7

0.5

2.6

2.7

(0.8)

Net increase (decrease) in cash and cash equivalents

(8.6)

4.8

(2.3)

4.1

5.7

32.9

43.1

45.4

Cash and cash equivalents at beginning of period

335.1

335.1

335.1

335.1

339.2

339.2

339.2

4.1

Cash and cash equivalents at end of period

326.5

339.9

332.8

339.2

344.8

372.1

382.3

49.5

- 2 -

. Revenue from Main Products

Unit: Billions of yen

FY 2022 results

FY 2023 results

FY 2023

forecasts

Product name

Jan - Mar

Jan - Jun

Jan - Sep

Jan - Dec

Jan - Mar

Jan - Jun

Jan - Sep

Change

Jan - Dec

Progress

amount

Nesp

0.8

1.6

2.5

3.4

0.8

1.5

2.3

(0.2)

2.8

82%

Darbepoetin Alfa Injection Syringe [KKF]

4.4

8.8

13.2

17.6

3.5

6.9

10.3

(2.9)

13.8

75%

Duvroq

1.1

2.7

4.4

6.6

1.8

4.2

6.9

2.4

7.8

88%

Regpara

0.5

1.1

1.7

2.2

0.4

0.8

1.2

(0.4)

2.1

60%

Orkedia

2.2

4.9

7.5

10.3

2.2

5.0

7.6

0.1

11.2

68%

Rocaltrol

0.7

1.5

2.3

3.1

0.7

1.4

2.1

(0.2)

2.4

86%

Onglyza

1.2

2.6

3.8

5.2

1.1

2.2

3.2

(0.6)

4.3

74%

Coniel

0.6

1.1

1.6

2.0

0.4

0.7

1.1

(0.5)

1.4

76%

G-Lasta

7.1

14.8

22.7

31.1

7.0

15.0

23.2

0.5

33.5

69%

Japan

Fentos

0.8

1.8

2.7

3.7

0.7

1.6

2.5

(0.2)

3.3

76%

Poteligeo

0.5

1.0

1.5

2.0

0.4

0.9

1.4

(0.0)

2.0

73%

Rituximab BS [KHK]

2.5

5.0

7.6

10.3

2.2

4.4

6.7

(0.9)

8.7

77%

Romiplate

2.2

4.8

7.5

10.4

2.7

5.7

8.7

1.2

11.2

77%

Allelock

2.4

3.8

4.8

6.0

1.9

3.1

4.1

(0.6)

4.7

88%

Patanol

1.8

2.2

2.4

2.8

1.4

1.5

1.7

(0.7)

1.9

90%

Dovobet

1.7

3.8

5.6

7.8

1.8

3.9

5.7

0.1

7.6

75%

Lumicef

0.7

1.5

2.2

3.0

0.6

1.3

2.1

(0.1)

3.5

59%

Nouriast

1.8

3.9

5.9

8.0

1.7

3.7

5.5

(0.3)

7.5

73%

HARUROPI

0.8

1.8

2.8

4.0

0.9

2.1

3.2

0.4

4.7

68%

Depakene

0.8

1.7

2.5

3.3

0.6

1.4

2.1

(0.4)

3.0

69%

Crysvita

2.0

4.1

6.4

8.9

2.3

4.8

7.4

1.0

11.1

67%

Crysvita

22.2

49.4

78.7

118.2

27.1

61.9

95.7

17.0

138.0

69%

Poteligeo

4.2

10.3

16.1

22.3

5.8

12.5

19.9

3.8

27.5

72%

Nourianz

1.1

2.6

4.5

6.5

1.7

3.5

5.5

1.0

7.5

73%

International

Abstral

1.4

3.6

5.4

6.9

1.1

2.6

2.9

(2.4)

2.0

149%

Pecfent

1.0

1.7

3.0

3.7

0.9

1.7

2.1

(0.9)

1.2

169%

Moventig

0.7

1.5

2.2

3.1

0.8

1.6

1.9

(0.4)

1.2

155%

Adcal-D3

0.7

1.5

2.2

3.0

0.7

1.5

1.7

(0.5)

1.2

134%

Nesp

1.9

3.9

5.9

7.6

2.2

4.4

7.0

1.2

8.0

89%

Regpara

1.0

2.0

2.9

3.9

0.9

1.9

3.1

0.1

3.9

79%

Neulasta/Peglasta

1.7

3.0

4.4

5.6

1.3

2.8

4.5

0.1

5.7

79%

Gran

2.1

3.8

6.4

8.2

1.4

3.2

5.2

(1.2)

8.2

63%

Technology out-licensing

7.8

15.7

23.8

33.8

9.2

18.4

30.1

6.3

40.2

75%

Of which, Benralizumab royalty

4.7

9.3

15.4

21.6

5.7

11.6

19.1

3.8

  • Revenue from products is classified into Japan or international (other than Japan) based on consolidated revenue of regional control functions.
  • Revenue listed as "Technology out-licensing" represents the upfront income, milestone revenue and running royalty income that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc.
  • The revenue for Abstral, Pecfent, Moventig and Adcal-D3 does not include the royalties revenue from the joint venture with Grünenthal in August 2023 and thereafter.
  • Benralizumab royalty only refers to the royalty on sales of Fasenra by AstraZeneca (including the Company's own estimates).

- 3 -

. Revenue from Main Products

Product name

Nesp

Darbepoetin Alfa Injection Syringe [KKF]

Duvroq

Regpara

Orkedia

Rocaltrol

Onglyza

Coniel

G-Lasta

Japan

Fentos

Poteligeo

Rituximab BS [KHK]

Romiplate

Allelock

Patanol

Dovobet

Lumicef

Nouriast

HARUROPI

Depakene

Crysvita

Unit: Billions of yen

FY 2022 results

FY 2023 results

Jan - Mar

Apr - Jun

Jul - Sep

Oct - Dec

Jan - Mar

Apr - Jun

Jul - Sep

Change

amount

0.8

0.8

0.9

0.9

0.8

0.8

0.8

(0.1)

4.4

4.4

4.4

4.4

3.5

3.4

3.5

(0.9)

1.1

1.6

1.8

2.1

1.8

2.4

2.6

0.9

0.5

0.6

0.5

0.5

0.4

0.5

0.4

(0.1)

2.2

2.7

2.6

2.8

2.2

2.7

2.6

(0.0)

0.7

0.8

0.8

0.8

0.7

0.7

0.7

(0.1)

1.2

1.3

1.3

1.3

1.1

1.1

1.0

(0.2)

0.6

0.5

0.4

0.4

0.4

0.4

0.4

(0.1)

7.1

7.7

7.9

8.4

7.0

7.9

8.2

0.4

0.8

1.0

0.9

1.0

0.7

0.9

0.9

(0.1)

0.5

0.5

0.5

0.5

0.4

0.5

0.5

0.0

2.5

2.5

2.5

2.7

2.2

2.3

2.2

(0.3)

2.2

2.6

2.7

2.9

2.7

3.0

3.0

0.2

2.4

1.4

0.9

1.2

1.9

1.2

1.0

0.1

1.8

0.3

0.3

0.4

1.4

0.2

0.2

(0.1)

1.7

2.1

1.8

2.1

1.8

2.1

1.8

(0.0)

0.7

0.8

0.7

0.8

0.6

0.7

0.7

(0.0)

1.8

2.1

2.0

2.1

1.7

2.0

1.9

(0.1)

0.8

1.0

1.0

1.2

0.9

1.1

1.1

0.1

0.8

0.8

0.8

0.8

0.6

0.7

0.7

(0.1)

2.0

2.2

2.3

2.5

2.3

2.5

2.6

0.3

Crysvita

22.2

27.2

29.3

39.5

27.1

34.8

33.8

4.5

Poteligeo

4.2

6.1

5.8

6.2

5.8

6.6

7.5

1.7

Nourianz

1.1

1.4

1.9

2.0

1.7

1.9

2.0

0.1

International

Abstral

1.4

2.2

1.8

1.5

1.1

1.4

0.4

(1.4)

Pecfent

1.0

0.7

1.3

0.7

0.9

0.9

0.4

(1.0)

Moventig

0.7

0.8

0.8

0.8

0.8

0.8

0.3

(0.5)

Adcal-D3

0.7

0.8

0.7

0.8

0.7

0.8

0.2

(0.5)

Nesp

1.9

2.0

2.0

1.7

2.2

2.2

2.6

0.7

Regpara

1.0

1.0

0.9

1.0

0.9

1.0

1.2

0.2

Neulasta/Peglasta

1.7

1.3

1.4

1.3

1.3

1.5

1.7

0.3

Gran

2.1

1.8

2.5

1.8

1.4

1.8

2.0

(0.6)

Technology out-licensing

7.8

7.9

8.1

10.0

9.2

9.2

11.8

3.6

Of which, Benralizumab royalty

4.7

4.6

6.1

6.2

5.7

5.9

7.5

1.4

  • Revenue from products is classified into Japan or international (other than Japan) based on consolidated revenue of regional control functions.
  • Revenue listed as "Technology out-licensing" represents the upfront income, milestone revenue and running royalty income that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group's pipeline compounds or the use of technology, etc.
  • The revenue for Abstral, Pecfent, Moventig and Adcal-D3 does not include the royalties revenue from the joint venture with Grünenthal in August 2023 and thereafter.
  • Benralizumab royalty only refers to the royalty on sales of Fasenra by AstraZeneca (including the Company's own estimates).

- 4 -

. Revenue from Main Products

Revenue of three global strategic products

Unit: Billions of yen

FY 2022 results

FY 2023 results

FY 2023 forecasts

Product name

Jan - Mar Jan - Jun Jan - Sep Jan - Dec

Jan - Mar Jan - Jun Jan - Sep

Change

Jan - Dec Progress

amount

Crysvita

24.2

53.5

85.1

127.1

29.4

66.7

103.1

18.0

149.1

69%

Japan

2.0

4.1

6.4

8.9

2.3

4.8

7.4

1.0

11.1

67%

North America

15.8

35.9

57.4

87.0

18.8

46.0

70.2

12.8

[Millions of USD]

139

298

456

662

143

344

530

74

EMEA

6.3

13.5

21.2

31.0

8.0

15.3

24.5

3.2

138.0

69%

[Millions of GBP]

41

85

133

192

50

93

151

18

APAC

0.0

0.1

0.1

0.3

0.3

0.6

1.1

0.9

Poteligeo

4.7

11.3

17.5

24.2

6.3

13.4

21.3

3.8

29.5

72%

Japan

0.5

1.0

1.5

2.0

0.4

0.9

1.4

(0.0)

2.0

73%

North America

3.3

8.1

12.6

17.2

4.3

9.4

15.1

2.5

19.4

78%

[Millions of USD]

29

67

100

132

33

70

114

14

149

EMEA

0.9

2.1

3.5

5.1

1.5

3.1

4.8

1.3

8.0

61%

[Millions of GBP]

6

14

22

32

9

19

30

8

50

APAC

-

-

-

-

-

-

0.0

0.0

-

-

Nouriast/Nourianz

2.9

6.5

10.3

14.5

3.3

7.2

11.0

0.7

15.1

73%

Japan

1.8

3.9

5.9

8.0

1.7

3.7

5.5

(0.3)

7.5

73%

North America

1.1

2.6

4.5

6.5

1.7

3.5

5.5

1.0

7.5

73%

Total of three global

31.8

71.3

113.0

165.8

39.0

87.3

135.5

22.5

193.6

70%

strategic products

Unit: Billions of yen

Product name

FY 2022 results

FY 2023 results

Jan - Mar

Apr - Jun

Jul - Sep

Oct - Dec

Jan - Mar

Apr - Jun

Jul - Sep

Change

amount

Crysvita

24.2

29.4

31.6

42.0

29.4

37.3

36.4

4.8

Japan

2.0

2.2

2.3

2.5

2.3

2.5

2.6

0.3

North America

15.8

20.0

21.5

29.6

18.8

27.2

24.1

2.6

[Millions of USD]

139

159

158

206

143

202

186

28

EMEA

6.3

7.1

7.8

9.7

8.0

7.3

9.2

1.4

[Millions of GBP]

41

44

47

59

50

43

57

10

APAC

0.0

0.0

0.1

0.2

0.3

0.3

0.5

0.4

Poteligeo

4.7

6.6

6.3

6.7

6.3

7.1

8.0

1.7

Japan

0.5

0.5

0.5

0.5

0.4

0.5

0.5

0.0

North America

3.3

4.8

4.4

4.6

4.3

5.1

5.7

1.3

[Millions of USD]

29

38

33

32

33

37

44

11

EMEA

0.9

1.2

1.4

1.6

1.5

1.6

1.8

0.4

[Millions of GBP]

6

8

8

10

9

9

11

3

APAC

-

-

-

-

-

-

0.0

0.0

Nouriast/Nourianz

2.9

3.6

3.9

4.1

3.3

3.9

3.8

(0.0)

Japan

1.8

2.1

2.0

2.1

1.7

2.0

1.9

(0.1)

North America

1.1

1.4

1.9

2.0

1.7

1.9

2.0

0.1

Total of three global

31.8

39.5

41.7

52.8

39.0

48.3

48.2

6.5

strategic products

  • Revenue is classified based on consolidated revenue from regional control functions.
  • The revenue, generated in various currencies inside each corporate region, is converted and aggregated in USD for North America and in GBP for EMEA.

- 5 -

Ⅳ.R&D Pipeline

antibody

Nephrology

protein

small molecule

New Molecular Entity

Updated since Dec. 31, 2022

Updated since Jun. 30, 2023

As of Sep 30, 2023

Code Name

Generic Name

Formulation

KHK7580

Evocalcet

Oral

KW-3357

Antithrombin Gamma

Injection

KHK7791

Tenapanor Hydrochloride

Oral

KRN1493

Cinacalcet Hydrochloride

Oral

Oncology

Code Name

Generic Name

Formulation

KW-0761

Mogamulizumab

Injection

KRN125

Pegfilgrastim

Injection

Stage

Mechanism of Action

Indication

Area

Approve

Ph

Ph

Ph

Filed

d

CN

Calcimimetic

Secondary Hyperparathyroidism

KR

TW

Recombinant Human

Preeclampsia

JP

Antithrombin

NHE3 Inhibitor

Hyperphosphatemia in Patients

JP

on Dialysis

Calcimimetic

Primary Hyperparathyroidism

HK

Stage

Mechanism of Action

Indication

Area

Approve

Ph

Ph

Ph

Filed

d

KW

IL

Anti-CCR4 Humanized

Mycosis Fungoides and

Antibody

Sézary Syndrome

ME

RS

Long-Acting

Mobilization of Hematopoietic

Stem Cells into Peripheral Blood

Granulocyte Colony-

JP

Stimulating Factor

for Autologous Blood Stem Cell

Transplantation

[In-House or Licensed]

Remarks

[Mitsubishi Tanabe Pharma] product name in Japan: Orkedia

[In-House]

product name in Japan: Acoalan

[Ardelyx]

[NPS Pharmaceuticals]

product name in Japan: Regpara

[In-House or Licensed]

Remarks

[In-House]

POTELLIGENT

product name in Japan, US and Europe: Poteligeo

[Amgen K-A]

product name in Japan: G-Lasta

-6-

Ⅳ.R&D Pipeline

antibody

protein

small molecule

New Molecular Entity

Updated since Dec. 31, 2022

Immunology/Allergy

Updated since Jun. 30, 2023

Code Name

Stage

Generic Name

Mechanism of Action

Indication

Area

Approve

Formulation

Ph

Ph

Ph

Filed

d

Ankylosing Spondylitis

TH

KHK4827

Anti-IL-17 Receptor A

Non-radiographic Axial

TH

Brodalumab

Spondyloarthritis

Fully Human Antibody

Injection

Palmoplantar Pustulosis

JP

Systemic Sclerosis

JP

JP

NA

KHK4083/AMG 451

Europe

Anti-OX40 Fully Human

Middle East

Rocatinlimab

Atopic Dermatitis

Antibody

CN

Injection

Asia

Oceania

others

KK4277

Autoimmune Disease

JP

Injection

Asia

[In-House or Licensed]

Remarks

[Amgen K-A]

product name in Japan and Asia: Lumicef

[In-House]

POTELLIGENT

Fully human antibody production technology

Collaboration agreement with Amgen for the development of KHK4083/AMG 451 in all the countries except for Japan.

[SBI Biotech]

Other

Code Name

Stage

[In-House or Licensed]

Generic Name

Mechanism of Action

Indication

Area

Approve

Remarks

Formulation

Ph

Ph

Ph

Filed

d

OM

QA

UAE

Tumor Induced Osteomalacia

KW

BH

(TIO)

RS

KRN23

Anti-FGF23 Fully

ME

Burosumab

Human Antibody

Injection

MK

MO

X-linked Hypophosphatemia

MK

(XLH)

RS

ME

[In-House]

Fully human antibody production technology

Jointly Developed with Ultragenyx in US and Europe product name in Japan, US and Europe: Crysvita

AMG531

Thrombopoietin Receptor

Aplastic Anemia Previously

JP

[Amgen K-A]

Romiplostim

Agonist

Untreated with

Ph/

product name in Japan:

Injection

Immunosuppressive Therapy

Asia

Romiplate

Ph

KW-3357

Recombinant Human

Disseminated Intravascular

[In-House]

Antithrombin Gamma

Coagulation, Congenital

Europe

Antithrombin

product name in Japan: Acoalan

Injection

Antithrombin Deficiency

KHK4951

VEGF Receptor Tyrosine

Neovascular (wet) Age-Related

Tivozanib

JP

[In-House]

Kinase Inhibitor

Macular Degeneration

Ophthalmic

Note: Our main progress from September 30, 2023 is as follows.

We decided to discontinue the development of KW-3357 (product name in Japan: Acoalan) for treatment for preeclampsia in the nephrology field.

-7-

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Kyowa Hakko Kirin Co. Ltd. published this content on 01 November 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 November 2023 06:49:52 UTC.