Results Presentation Fiscal 2023 Third Quarter

Agenda

Financial Review

Managing Executive Officer, CFO Head of Finance Motohiko Kawaguchi

Commercial Update

Executive Officer, Head of Global Product Strategy Tomohiro Sudo

R&D Update

Executive Officer, Head of R&D Yoshifumi Torii, Ph.D.

News Flow in 2023

Managing Executive Officer, CSO Head of Strategy Yasuo Fujii

Q&A

Managing Executive Officer, CFO Head of Finance Motohiko Kawaguchi

Managing Executive Officer, CSO Head of Strategy Yasuo Fujii

Executive Officer, Head of R&D Yoshifumi Torii, Ph.D.

Executive Officer, Head of Global Product Strategy Tomohiro Sudo

© Kyowa Kirin Co., Ltd.

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This document contains certain forward-looking statements relating to such items as the company's

(including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present time and upon reasonable assumptions made by the company in making its forecasts, but the actual results in practice may differ substantially due to uncertain factors.

These uncertain factors include, but are not limited to, potential risks of the business activities in the pharmaceutical industry in Japan and overseas, intellectual property risks, risk of side effects, regulatory risks, product defect risks, risks of changes to the prices for raw materials, risks of changes to market prices, as well as risks of changes to foreign exchange rates and financial markets.

This document is used only for the purpose of providing the information to investors. Though it may contain the information concerning pharmaceutical products (including products under development), it is not for the purpose of promotion, advertising, or medical advice.

© Kyowa Kirin Co., Ltd.

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Financial Review

© Kyowa Kirin Co., Ltd.

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Summary of Q3 Results

( Billion Yen / Rounded )

2022Q3

2023Q3

Changes

2023

Progresses

Results

Results

Revised Plans

Revenue

283.8

306.1

+22.3 (+8%)

426.0

72%

[Overseas Ratio]

[61%]

[64%]

[64%]

Gross Profit

219.6

229.1

+9.4 (+4%)

326.0

70%

[Gross Profit Margin]

[77%]

[75%]

[77%]

SG&A

117.3

119.3

+2.0 (+2%)

162.0

74%

[SG&A Ratio]

[41%]

[39%]

[38%]

R&D

44.1

51.2

+7.0 (+16%)

79.0

65%

[R&D Ratio]

[16%]

[17%]

[19%]

Gain/Loss on

2.6

2.3

-0.4 (-14%)

3.0

76%

Equity Method

Core Operating Profit

60.9

60.9

+0.0 (+0%)

88.0

69%

[Core OP Margin]

[21%]

[20%]

[21%]

Profit

49.2

53.6

4.3 (+9%)

76.0→70.0

77%

© Kyowa Kirin Co., Ltd.

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YoY Analysis -Revenue-

+22.3 billion yen

(incl. forex effect +13.9)

  • Japan -2.3

Although Duvroq, Romiplate, and Crysvita increased, revenue in Japan region decreased by 2% due mainly to negative impact by annual NHI price-cut and shrink in Nesp-AG affected by competitive products.

  • North America +17.0 (incl. forex effect +7.6)

Revenue in North America region increased by 22% with the growth of Crysvita(+22%), Poteligeo(+20%), and Nourianz(+23%).

  • EMEA -2.3 (incl. forex effect +3.6)

Revenue in EMEA region decreased by JPY2.3B due to the shift from product sales to sales royalties/license fees for 13 established medicines portfolio, such as Abstral, by entered into the Joint Venture Collaboration with Grünenthal on Aug 1, despite the continued growth of Crysvita(+15%), and Poteligeo(+37%).

  • APAC +3.5 (incl. forex effect +1.0)

APAC revenue increased by 15% with the growth of Crysvita, and Nesp, while Gran was down due to the Chinese national tender system.

  • Other +6.3 (incl. forex effect +1.8)

23% growth in the other revenue was due to the royalties of growing Fasenra (Benralizumab).

© Kyowa Kirin Co., Ltd.

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Revenue of Major Items (Japan)

( Billion Yen / Rounded )

Item

2022Q3

2023Q3

Changes

Reasons

2023

Progresses

Results

Results

Plans

Nesp + Nesp-AG1

15.7

12.7

-3.1(-20%)

16.6

76%

Nesp

2.5

2.3

-0.2(-8%)

NHI price-cut &

2.8

82%

Biosimilars' penetration

Nesp-AG

13.2

10.3

-2.9(-22%)

13.8

75%

Duvroq

4.4

6.9

+2.4 (+54%)

Market penetration (Launched in Aug 2020)

7.8

88%

Orkedia

7.5

7.6

+0.1 (+1%)

11.2

68%

G-Lasta

22.7

23.2

+0.5(+2%)

33.5

69%

Poteligeo

1.5

1.4

-0.0(-1%)

2.0

73%

Rituximab BS

7.6

6.7

-0.9(-12%)

NHI price-cut

8.7

77%

Romiplate

7.5

8.7

+1.2 (+16%)

Market penetration

11.2

77%

(New indication in Jun 2019)

Allelock

4.8

4.1

-0.6(-13%)

NHI price-cut

4.7

88%

Nouriast

5.9

5.5

-0.3(-6%)

7.5

73%

Haruropi

2.8

3.2

+0.4 (+15%)

Market penetration (Launched in Dec 2019)

4.7

68%

Crysvita

6.4

7.4

+1.0 (+16%)

Market penetration (Launched in Dec 2019)

11.1

67%

1 AG stands for Authorized Generic. Official product name is Darbepoetin Alfa [KKF]. Kyowa Kirin Frontier is a marketing authorization holder; Kyowa Kirin is a distributor.

© Kyowa Kirin Co., Ltd.

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Revenue of Major Items (ex-Japan)

Item

2022Q3

2023Q3

Changes

Results

Results

Crysvita

78.7

95.7

+17.0 (+22%)

North America

57.4

70.2

+12.8 (+22%)

EMEA

21.2

24.5

+3.2 (+15%)

APAC

0.1

1.1

+0.9 (+709%)

Poteligeo

16.1

19.9

+3.8 (+24%)

North America

12.6

15.1

+2.5 (+20%)

EMEA

3.5

4.8

+1.3 (+37%)

APAC

-

0.0

+0.0 ( - %)

Nourianz

4.5

5.5

+1.0

(+23%)

Nesp

5.9

7.0

+1.2

(+20%)

Gran

6.4

5.2

-1.2

(-19%)

Neulasta

4.4

4.5

+0.1 (+2%)

Tech-licensing

23.3

29.3

+6.0

(+26%)

Benralizumab Royalty1

15.4

19.1

+3.8 (+25%)

Reasons

[North America] Market penetration

[EMEA] Geographical expansion

  • Additional indication (Adult/TIO) [APAC] Geographical expansion

[North America] Market penetration

[EMEA] Geographical expansion

& Market penetration

Market penetration

Listed on Chinese tender list

Growth of Fasenra

( Billion Yen / Rounded )

2023 Progresses Plans

138.069%

27.572%

19.478%

8.061%

0.23%

7.573%

8.089%

8.263%

5.779%

39.075%

1 Sales royalties of Fasenra which has been marketed by AstraZeneca, including our own estimation.

© Kyowa Kirin Co., Ltd.

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YoY Analysis -Core OP-

+0.0 billion yen

(incl. forex effect +4.2)

  • Gross Profit +9.4 (incl. forex effect +12.0)

Increased in conjunction with JPY22.3B rise in revenue. COGs have increased due to the North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (77% →75%)

  • SG&A -2.0 (incl. forex effect -6.2)

Although decreased in Crysvita profit sharing expenses due to the North America Crysvita-related scheme change after Apr 27, 2023, increased in HR exp, etc by the Crysvita commercial operation. In addition to that, increased due to FX impact.

[HR exp -7.1 / Sales promotion +9.1 (incl. Crysvita profit sharing expenses +11.3) ]

  • R&D -7.0 (incl. forex effect -1.8)

Increased in clinical study costs of KHK4083 which is undergoing joint global Phase III clinical study.

  • Gain/Loss on Equity Method -0.4

While revenue of Hulio (FKB327/Adalimumab biosimilar) increased, FKB's profit declined due to decrease in tax-accounting effect.

FKB; Fujifilm Kyowa Kirin Biologics Co., Ltd.

© Kyowa Kirin Co., Ltd.

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YoY Analysis -Profit-

Profit (Jan-Sep) +4.3 billion yen

• EMEA established medicines portfolio:

Gain on sales of 51% shares plus gain on valuation of remaining 49% shares +14.8

• Impairment losses -6.2

[FY22: irofotase alfa IPR&D -3.2]

[FY23: RTA 402 IPR&D -8.3, Expiration of research collaboration with Ardelyx -1.1]

• Provision for loss on contracts -2.4 (closing costs: RTA 402 -1.5,ME-401-0.8)

• Business restructuring expenses -2.6(-1.1→ -3.6)

Core Operating Profit +0.0

Profit Before Tax +3.9

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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 06:49:51 UTC.