Supplementary Materials for

Consolidated Financial Results for

the 1st Quarter of Fiscal Year 2021. 12 (IFRS)

Chugai Pharmaceutical co., ltd.

Notes: 1. Portions of this report that refer to performance forecasts or any other future events are believed to be reasonable under information available at the time of the forecasts. Actual results may materially differ from these forecasts due to potential risks and uncertainties.

  1. Amounts shown in this report are rounded to the nearest 0.1 billion yen. Variance and % are calculated based on the amounts shown.
  2. Exchange rates used for each period are as follows.

QTR

(Yen)

Actual*

Actual*

FY2020

FY2021

1-3

4-6

7-9

10-12

1-3

4-6

7-9

10-12

QTR

QTR

QTR

QTR

QTR

QTR

QTR

QTR

CHF

112.61

111.54

115.39

115.52

117.08

EUR

120.19

118.35

124.06

124.51

127.65

USD

109.02

107.53

106.16

104.50

105.83

SGD

78.72

76.15

77.23

77.58

79.47

*Market average exchange rate

YTD

Actual*

Actual*

Actual*

Assumption

FY2019

FY2020

FY2021

FY2021

1-12

1-3

1-6

1-9

1-12

1-3

1-6

1-9

1-12

1-12

Full-year

YTD

YTD

YTD

Full-year

YTD

YTD

YTD

Full-year

Full-year

CHF

109.72

112.61

112.07

113.14

113.72

117.08

116.00

EUR

122.08

120.19

119.27

120.80

121.69

127.65

126.00

USD

109.05

109.02

108.28

107.57

106.80

105.83

105.00

SGD

79.94

78.72

77.42

77.36

77.41

79.47

78.00

*Market average exchange rate

Period-end

Actual

Actual

Actual

FY2019

FY2020

FY2021

31 Dec.

31 Mar.

30 Jun.

30 Sep.

31 Dec.

31 Mar.

30 Jun.

30 Sep.

31 Dec.

CHF

112.31

112.49

113.07

114.92

117.10

117.14

EUR

121.93

119.13

120.93

124.08

126.89

129.30

USD

108.88

107.83

107.57

105.66

103.19

110.37

SGD

80.72

75.73

77.18

77.19

77.98

81.87

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

1

Reconciliation of IFRS results to Core results

(Billions of yen)

FY2020

FY2021

1-3

1-3

IFRS results

Intangible

Others

Core results

IFRS results

Intangible

Others

Core results

assets

assets

Revenues

179.4

-

-

179.4

168.8

-

-

168.8

Sales

144.5

-

-

144.5

130.3

-

-

130.3

Royalties and other operating income

34.9

-

-

34.9

38.6

-

-

38.6

Cost of sales

(61.3)

0.3

-

(61.0)

(55.3)

0.3

-

(55.0)

Gross profit

118.2

0.3

-

118.5

113.5

0.3

-

113.8

Operatingexpenses

(45.7)

0.2

1.2

(44.4)

(49.5)

0.0

1.1

(48.5)

Marketing and distribution

(15.8)

-

0.3

(15.5)

(15.9)

-

0.0

(15.8)

Research and development

(26.1)

0.2

0.9

(25.0)

(29.7)

0.0

1.0

(28.7)

General and administration

(3.9)

-

-

(3.9)

(3.9)

-

0.0

(3.9)

Operating profit

72.4

0.5

1.2

74.1

64.0

0.3

1.1

65.4

Financing costs

(0.0)

-

-

(0.0)

(0.0)

-

-

(0.0)

Other financial income (expense)

(0.6)

-

-

(0.6)

0.3

-

-

0.3

Other expense

(0.5)

-

-

(0.5)

-

-

-

-

Profitbefore taxes

71.2

0.5

1.2

72.9

64.2

0.3

1.1

65.6

Income taxes

(19.7)

(0.1)

(0.3)

(20.2)

(16.8)

(0.1)

(0.3)

(17.2)

Net income

51.5

0.3

0.8

52.7

47.4

0.2

0.8

48.4

Attributable to

Chugai shareholders

51.5

0.3

0.8

52.7

47.4

0.2

0.8

48.4

Non-controlling interests

-

-

-

-

-

-

-

-

Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its transition to IFRS. Core results are the results after adjusting non-recurring items recognized by Chugai to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the status of recurring profits both internally and externally, and as the basis for payment-by-results.

The table above shows the reconciliation of IFRS results into Core results. The detail is as below.

Intangible assets

Amortization (0.4 billion yen in 2020 and 0.3 billion yen in 2021)

Impairment (0.1 billion yen in 2020 and none in 2021)

Others

Restructuring expenses (1.2 billion yen in 2020 and 1.1 billion yen in 2021)

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

2

IFRS results (QTR)

3

4

5

6

(Billions of yen)

Actual

Actual

FY2020

FY2021

1-3

4-6

7-9

10-12

1-3

Change

4-6

Change

7-9

Change

10-12

Change

QTR

QTR

QTR

QTR

QTR

(%)

QTR

(%)

QTR

(%)

QTR

(%)

Revenues

179.4

188.7

208.4

210.4

168.8

(5.9)

Sales

144.5

161.1

159.1

168.5

130.3

(9.8)

Domestic

101.9

102.7

98.6

105.9

94.9

(6.9)

Overseas

42.6

58.4

60.6

62.6

35.4

(16.9)

Royalties and other operating income

34.9

27.6

49.3

41.9

38.6

+10.6

Royalty and profit-sharing income

26.4

27.1

35.6

40.5

36.6

+38.6

Other operating income

8.5

0.5

13.6

1.4

2.0

(76.5)

Cost of sales

(61.3)

(70.6)

(69.4)

(72.3)

(55.3)

(9.8)

(% of Sales)

42.4

43.8

43.6

42.9

42.4

-

Gross profit

118.2

118.1

139.0

138.2

113.5

(4.0)

(% of Revenues)

65.9

62.6

66.7

65.7

67.2

-

Operating expenses

(45.7)

(49.9)

(52.4)

(64.2)

(49.5)

+8.3

(% of Revenues)

25.5

26.4

25.1

30.5

29.3

-

Marketing and distribution

(15.8)

(17.0)

(17.0)

(22.8)

(15.9)

+0.6

(% of Revenues)

8.8

9.0

8.2

10.8

9.4

-

Research and development

(26.1)

(28.8)

(30.1)

(32.8)

(29.7)

+13.8

(% of Revenues)

14.5

15.3

14.4

15.6

17.6

-

General and administration

(3.9)

(4.1)

(5.2)

(8.6)

(3.9)

0.0

(% of Revenues)

2.2

2.2

2.5

4.1

2.3

-

Operating profit

72.4

68.2

86.7

73.9

64.0

(11.6)

(% of Revenues)

40.4

36.1

41.6

35.1

37.9

-

Financing costs

(0.0)

(0.0)

(0.0)

(0.0)

(0.0)

0.0

Other financial income (expense)

(0.6)

0.5

(0.8)

(0.5)

0.3

-

Other expense

(0.5)

(0.3)

(0.3)

(0.4)

-

-

Profit before taxes

71.2

68.4

85.6

73.1

64.2

(9.8)

(% of Revenues)

39.7

36.2

41.1

34.7

38.0

-

Income taxes

(19.7)

(17.6)

(25.4)

(20.7)

(16.8)

(14.7)

Net income

51.5

50.8

60.1

52.3

47.4

(8.0)

(% of Revenues)

28.7

26.9

28.8

24.9

28.1

-

Attributable to

Chugai shareholders

51.5

50.8

60.1

52.3

47.4

(8.0)

Non-controlling interests

-

-

-

-

-

-

Earnings per share

Basic (yen)

31.37

30.89

36.58

31.82

28.84

(8.1)

Diluted (yen)

31.33

30.85

36.55

31.80

28.82

(8.0)

Other financial income (expense) includes net amount of FX related gains/losses.

Effective July 1, 2020, Chugai Pharmaceutical Co., Ltd. ("Chugai") implemented a three-for-one stock split of its common stock. "Earnings per share (Basic)" and "Earnings per share (Diluted)" presents the amount after the stock split.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

3

IFRS results (YTD)

2

3

(Billions of yen)

Actual

Actual

Actual

FY2019

FY2020

FY2021

1-12

1-3

1-6

1-9

1-12

1-3

Change

1-6

Change

1-9

Change

1-12

Change

YTD

YTD

YTD

YTD

YTD

YTD

(%)

YTD

(%)

YTD

(%)

YTD

(%)

Revenues

686.2

179.4

368.1

576.5

786.9

168.8

(5.9)

Sales

588.9

144.5

305.7

464.8

633.3

130.3

(9.8)

Domestic

437.6

101.9

204.6

303.2

409.1

94.9

(6.9)

Overseas

151.3

42.6

101.0

161.6

224.2

35.4

(16.9)

Royalties and other operating income

97.3

34.9

62.5

111.7

153.6

38.6

+10.6

Royalty and profit-sharing income

76.5

26.4

53.5

89.1

129.6

36.6

+38.6

Other operating income

20.8

8.5

9.0

22.6

24.1

2.0

(76.5)

Cost of sales

(266.1)

(61.3)

(131.8)

(201.2)

(273.5)

(55.3)

(9.8)

(% of Sales)

45.2

42.4

43.1

43.3

43.2

42.4

-

Gross profit

420.1

118.2

236.3

375.3

513.5

113.5

(4.0)

(% of Revenues)

61.2

65.9

64.2

65.1

65.3

67.2

-

Operating expenses

(209.5)

(45.7)

(95.7)

(148.0)

(212.3)

(49.5)

+8.3

(% of Revenues)

30.5

25.5

26.0

25.7

27.0

29.3

-

Marketing and distribution

(77.2)

(15.8)

(32.8)

(49.8)

(72.6)

(15.9)

+0.6

(% of Revenues)

11.3

8.8

8.9

8.6

9.2

9.4

-

Research and development

(107.9)

(26.1)

(54.9)

(85.0)

(117.9)

(29.7)

+13.8

(% of Revenues)

15.7

14.5

14.9

14.7

15.0

17.6

-

General and administration

(24.4)

(3.9)

(8.0)

(13.2)

(21.8)

(3.9)

0.0

(% of Revenues)

3.6

2.2

2.2

2.3

2.8

2.3

-

Operating profit

210.6

72.4

140.6

227.3

301.2

64.0

(11.6)

(% of Revenues)

30.7

40.4

38.2

39.4

38.3

37.9

-

Financing costs

(0.1)

(0.0)

(0.0)

(0.0)

(0.1)

(0.0)

0.0

Other financial income (expense)

0.5

(0.6)

(0.2)

(1.0)

(1.5)

0.3

-

Other expense

(3.1)

(0.5)

(0.9)

(1.1)

(1.5)

-

-

Profit before taxes

207.9

71.2

139.6

225.1

298.2

64.2

(9.8)

(% of Revenues)

30.3

39.7

37.9

39.0

37.9

38.0

-

Income taxes

(50.3)

(19.7)

(37.3)

(62.7)

(83.5)

(16.8)

(14.7)

Net income

157.6

51.5

102.3

162.4

214.7

47.4

(8.0)

(% of Revenues)

23.0

28.7

27.8

28.2

27.3

28.1

-

Attributable to

Chugai shareholders

157.6

51.5

102.3

162.4

214.7

47.4

(8.0)

Non-controlling interests

-

-

-

-

-

-

-

Earnings per share

Basic (yen)

95.95

31.37

62.26

98.84

130.66

28.84

(8.1)

Diluted (yen)

95.81

31.33

62.18

98.74

130.53

28.82

(8.0)

Other financial income (expense) includes net amount of FX related gains/losses.

Effective July 1, 2020, Chugai Pharmaceutical Co., Ltd. ("Chugai") implemented a three-for-one stock split of its common stock. "Earnings per share (Basic)" and "Earnings per share (Diluted)" presents the amount after the stock split.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

4

Core results (QTR)

3

4

5

6

(Billions of yen)

Actual

Actual

FY2020

FY2021

1-3

4-6

7-9

10-12

1-3

Change

4-6

Change

7-9

Change

10-12

Change

QTR

QTR

QTR

QTR

QTR

(%)

QTR

(%)

QTR

(%)

QTR

(%)

Revenues

179.4

188.7

208.4

210.4

168.8

(5.9)

Sales

144.5

161.1

159.1

168.5

130.3

(9.8)

Domestic

101.9

102.7

98.6

105.9

94.9

(6.9)

Overseas

42.6

58.4

60.6

62.6

35.4

(16.9)

Royalties and other operating income

34.9

27.6

49.3

41.9

38.6

+10.6

Royalty and profit-sharing income

26.4

27.1

35.6

40.5

36.6

+38.6

Other operating income

8.5

0.5

13.6

1.4

2.0

(76.5)

Cost of sales

(61.0)

(70.3)

(69.1)

(72.0)

(55.0)

(9.8)

(% of Sales)

42.2

43.6

43.4

42.7

42.2

-

Gross profit

118.5

118.4

139.3

138.5

113.8

(4.0)

(% of Revenues)

66.1

62.7

66.8

65.8

67.4

-

Operating expenses

(44.4)

(48.8)

(51.2)

(62.4)

(48.5)

+9.2

(% of Revenues)

24.7

25.9

24.6

29.7

28.7

-

Marketing and distribution

(15.5)

(16.8)

(16.7)

(22.5)

(15.8)

+1.9

(% of Revenues)

8.6

8.9

8.0

10.7

9.4

-

Research and development

(25.0)

(27.9)

(29.3)

(31.3)

(28.7)

+14.8

(% of Revenues)

13.9

14.8

14.1

14.9

17.0

-

General and administration

(3.9)

(4.1)

(5.2)

(8.6)

(3.9)

0.0

(% of Revenues)

2.2

2.2

2.5

4.1

2.3

-

Operating profit

74.1

69.7

88.2

76.1

65.4

(11.7)

(% of Revenues)

41.3

36.9

42.3

36.2

38.7

-

Financing costs

(0.0)

(0.0)

(0.0)

(0.0)

(0.0)

0.0

Other financial income (expense)

(0.6)

0.5

(0.8)

(0.5)

0.3

-

Other expense

(0.5)

(0.3)

(0.3)

(0.4)

-

-

Profit before taxes

72.9

69.8

87.0

75.2

65.6

(10.0)

(% of Revenues)

40.6

37.0

41.7

35.7

38.9

-

Income taxes

(20.2)

(18.0)

(25.9)

(21.4)

(17.2)

(14.9)

Net income

52.7

51.8

61.2

53.8

48.4

(8.2)

(% of Revenues)

29.4

27.5

29.4

25.6

28.7

-

Attributable to

Chugai shareholders

52.7

51.8

61.2

53.8

48.4

(8.2)

Non-controlling interests

-

-

-

-

-

-

Core earnings per share (diluted) (yen)

32.04

31.47

37.17

32.71

29.42

(8.2)

Please see page 1 "Reconciliation of IFRS results to Core results" for the detail of the adjustments.

Core earnings per share (diluted) (yen) : Net income attributable to Chugai shareholders / Weighted average number of shares in issue used to calculate diluted earnings per share. Other financial income (expense) includes net amount of FX related gains/losses.

Effective July 1, 2020, Chugai Pharmaceutical Co., Ltd. ("Chugai") implemented a three-for-one stock split of its common stock. Core EPS presents the amount after the stock split.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

5

Core results (YTD)

6

6

6

6

6

(Billions of yen)

Forecast

Actual

Actual

Actual

(Feb 4th

announced)

FY2019

FY2020

FY2021

FY2021

1-12

1-3

1-6

1-9

1-12

1-3

Change

1-6

Change

1-9

Change

1-12

Change

1-12

Change

YTD

YTD

YTD

YTD

YTD

YTD

(%)

YTD

(%)

YTD

(%)

YTD

(%)

YTD

(%)

Revenues

686.2

179.4

368.1

576.5

786.9

168.8

(5.9)

800.0

+1.7

Sales

588.9

144.5

305.7

464.8

633.3

130.3

(9.8)

631.0

(0.4)

Domestic

437.6

101.9

204.6

303.2

409.1

94.9

(6.9)

393.7

(3.8)

Overseas

151.3

42.6

101.0

161.6

224.2

35.4

(16.9)

237.3

+5.8

Royalties and other operating income

97.3

34.9

62.5

111.7

153.6

38.6

+10.6

169.0

+10.0

Royalty and profit-sharing income

76.5

26.4

53.5

89.1

129.6

36.6

+38.6

163.0

+25.8

Other operating income

20.8

8.5

9.0

22.6

24.1

2.0

(76.5)

6.0

(75.1)

Cost of sales

(265.1)

(61.0)

(131.2)

(200.3)

(272.3)

(55.0)

(9.8)

(252.5)

(7.3)

(% of Sales)

45.0

42.2

42.9

43.1

43.0

42.2

-

40.0

-

Gross profit

421.1

118.5

236.9

376.2

514.7

113.8

(4.0)

547.5

+6.4

(% of Revenues)

61.4

66.1

64.4

65.3

65.4

67.4

-

68.4

-

Operating expenses

(196.2)

(44.4)

(93.2)

(144.3)

(206.7)

(48.5)

+9.2

(227.5)

+10.1

(% of Revenues)

28.6

24.7

25.3

25.0

26.3

28.7

-

28.4

-

Marketing and distribution

(73.5)

(15.5)

(32.3)

(49.0)

(71.5)

(15.8)

+1.9

(% of Revenues)

10.7

8.6

8.8

8.5

9.1

9.4

-

Research and development

(102.1)

(25.0)

(52.9)

(82.2)

(113.5)

(28.7)

+14.8

(131.5)

+15.9

(% of Revenues)

14.9

13.9

14.4

14.3

14.4

17.0

-

16.4

-

General and administration

(20.6)

(3.9)

(8.0)

(13.1)

(21.7)

(3.9)

0.0

(% of Revenues)

3.0

2.2

2.2

2.3

2.8

2.3

-

Operating profit

224.9

74.1

143.7

231.9

307.9

65.4

(11.7)

320.0

+3.9

(% of Revenues)

32.8

41.3

39.0

40.2

39.1

38.7

-

40.0

-

Financing costs

(0.1)

(0.0)

(0.0)

(0.0)

(0.1)

(0.0)

0.0

Other financial income (expense)

0.5

(0.6)

(0.2)

(1.0)

(1.5)

0.3

-

Other expense

(3.1)

(0.5)

(0.9)

(1.1)

(1.5)

-

-

Profit before taxes

222.2

72.9

142.7

229.7

304.9

65.6

(10.0)

(% of Revenues)

32.4

40.6

38.8

39.8

38.7

38.9

-

Income taxes

(54.6)

(20.2)

(38.2)

(64.1)

(85.5)

(17.2)

(14.9)

Net income

167.6

52.7

104.5

165.6

219.4

48.4

(8.2)

232.0

+5.7

(% of Revenues)

24.4

29.4

28.4

28.7

27.9

28.7

-

29.0

-

Attributable to

Chugai shareholders

167.6

52.7

104.5

165.6

219.4

48.4

(8.2)

Non-controlling interests

-

-

-

-

-

-

-

Weighted average number of shares in

issue used to calculate diluted earnings per

1,645

1,645

1,645

1,645

1,645

1,645

0.0

share (Millions of shares)

Core earnings per share (diluted) (yen)

101.93

32.04

63.51

100.68

133.39

29.42

(8.2)

141.00

+5.7

Core payout ratio (%)

45.8

41.2

42.6

-

Dividend per share (Full year) (yen)

140

-

60

-

Dividend per share (Year end) (yen)

92

30

30

-

Dividend per share (Half year) (yen)

48

75

30

-

Please see page 1 "Reconciliation of IFRS results to Core results" for the detail of the adjustments.

Core earnings per share (diluted) (yen) : Net income attributable to Chugai shareholders / Weighted average number of shares in issue used to calculate diluted earnings per share. Other financial income (expense) includes net amount of FX related gains/losses.

Effective July 1, 2020, Chugai Pharmaceutical Co., Ltd. ("Chugai") implemented a three-for-one stock split of its common stock. Core EPS presents the amount after the stock split. Weighted average number of shares in issue used to calculate diluted earnings per share presents the amount after the stock split.

The dividend for the fiscal year ended December 31, 2019 and the second quarter of the fiscal year 2020 presents the amount prior to the stock split.

The annual dividend per share for the fiscal year ended December 31, 2020 is not stated because the amounts cannot be simply combined due to the implementation of the stock split. The annual dividend per share is ¥165 when calculated based on the assumption of no stock split, and ¥55 when calculated with the stock split taken into account.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

6

Statements of revenues (QTR)

Actual

Actual

FY2020

FY2021

1-3

4-6

7-9

10-12

1-3

Change

4-6

Change

7-9

Change

10-12

Change

QTR

QTR

QTR

QTR

QTR

(%)

QTR

(%)

QTR

(%)

QTR

(%)

Sales

144.5

161.1

159.1

168.5

130.3

(9.8)

Domestic

101.9

102.7

98.6

105.9

94.9

(6.9)

Oncology

55.3

58.1

56.0

62.9

57.9

+4.7

Avastin

20.4

20.4

19.7

21.1

18.8

(7.8)

Tecentriq

7.8

8.8

8.9

12.0

14.1

+80.8

Perjeta

8.3

8.4

8.1

8.7

7.4

(10.8)

Alecensa

5.6

6.6

6.4

7.3

6.0

+7.1

Kadcyla

2.1

2.5

2.6

3.1

3.2

+52.4

Herceptin

4.5

4.1

3.7

3.6

2.6

(42.2)

Gazyva

1.0

1.0

1.1

1.3

1.0

0.0

Rituxan

1.9

1.8

1.8

1.8

1.2

(36.8)

Xeloda

1.1

0.9

0.8

0.8

0.6

(45.5)

Rozlytrek

0.0

0.1

0.1

0.2

0.1

-

Foundation Medicine

0.6

0.6

0.8

0.9

1.0

+66.7

Other products

2.0

2.8

2.1

2.1

1.8

(10.0)

Primary

46.6

44.6

42.6

43.0

36.9

(20.8)

Hemlibra

7.9

8.2

8.4

9.5

8.8

+11.4

Actemra

9.5

9.7

9.4

10.7

9.2

(3.2)

Edirol

8.8

9.5

5.9

3.6

2.9

(67.0)

Mircera

4.2

4.3

4.5

4.6

3.4

(19.0)

Bonviva

2.1

2.1

2.3

2.4

2.0

(4.8)

CellCept

2.2

2.3

2.2

2.4

2.0

(9.1)

Oxarol

1.4

1.6

1.6

1.7

1.4

0.0

Enspryng

-

-

0.3

1.0

1.4

-

Tamiflu(Ordinary use)

0.6

0.0

0.0

0.2

(0.1)

-

Tamiflu(Govt. stockpiles etc.)

2.6

-

0.3

0.7

1.2

(53.8)

Other products

7.2

7.0

7.7

6.0

4.7

(34.7)

Overseas

42.6

58.4

60.6

62.6

35.4

(16.9)

Hemlibra

8.6

7.9

5.1

4.5

8.5

(1.2)

To Roche

8.2

7.5

4.7

4.2

8.0

(2.4)

Actemra

24.1

36.5

37.0

36.8

17.4

(27.8)

To Roche

23.5

35.9

36.5

36.0

16.9

(28.1)

Alecensa

6.2

10.7

13.9

13.6

6.0

(3.2)

To Roche

5.9

10.3

13.6

13.2

5.6

(5.1)

Enspryng

0.1

0.3

1.1

4.0

-

-

To Roche

0.1

0.3

1.1

4.0

-

-

Neutrogin

2.5

2.0

2.3

2.3

2.2

(12.0)

Other products

1.1

1.1

1.1

1.4

1.2

+9.1

Royalties and other operating income

34.9

27.6

49.3

41.9

38.6

+10.6

Royalty and profit-sharing income

26.4

27.1

35.6

40.5

36.6

+38.6

Other operating income

8.5

0.5

13.6

1.4

2.0

(76.5)

Revenues

179.4

188.7

208.4

210.4

168.8

(5.9)

Domestic

109.5

102.7

100.6

106.2

95.3

(13.0)

Overseas

69.9

86.0

107.8

104.3

73.6

+5.3

From the 1st Quarter of FY2021, sales for Foundation Medicine is included "Oncology", instead of "Others" until FY2020.

Also sales for products included "Bone and Joint", "Renal Diseases", "Others" until FY2020, are included "Primary" from the 1st Quarter of FY2021.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

7

Statements of revenues (YTD)

(Billions of yen)

Actual

Actual

Forecast

Actual

(Feb 4th

announced)

FY2019

FY2020

FY2021

FY2021

1-12

1-3

1-6

1-9

1-12

1-3

Change

1-6

Change

1-9

Change

1-12

Change

1-12

Change

YTD

YTD

YTD

YTD

YTD

YTD

(%)

YTD

(%)

YTD

(%)

YTD

(%)

YTD

(%)

Sales

588.9

144.5

305.7

464.8

633.3

130.3

(9.8)

631.0

(0.4)

Domestic

437.6

101.9

204.6

303.2

409.1

94.9

(6.9)

393.7

(3.8)

Oncology

240.9

55.3

113.4

169.4

232.3

57.9

+4.7

226.7

(2.4)

Avastin

95.6

20.4

40.7

60.4

81.5

18.8

(7.8)

60.5

(25.8)

Tecentriq

20.6

7.8

16.6

25.5

37.5

14.1

+80.8

49.2

+31.2

Perjeta

30.7

8.3

16.7

24.8

33.5

7.4

(10.8)

31.8

(5.1)

Alecensa

23.0

5.6

12.3

18.7

26.0

6.0

+7.1

27.0

+3.8

Kadcyla

9.0

2.1

4.6

7.1

10.2

3.2

+52.4

13.3

+30.4

Herceptin

26.7

4.5

8.6

12.3

15.9

2.6

(42.2)

10.9

(31.4)

Gazyva

3.6

1.0

2.1

3.2

4.6

1.0

0.0

5.7

+23.9

Rituxan

11.9

1.9

3.7

5.5

7.2

1.2

(36.8)

5.2

(27.8)

Xeloda

8.0

1.1

2.0

2.8

3.6

0.6

(45.5)

2.7

(25.0)

Rozlytrek

0.0

0.0

0.1

0.2

0.4

0.1

-

0.9

+125.0

Foundation Medicine

0.4

0.6

1.2

2.0

2.8

1.0

+66.7

7.2

+157.1

Other products

11.3

2.0

4.9

6.9

9.1

1.8

(10.0)

12.3

+35.2

Primary

196.6

46.6

91.2

133.8

176.8

36.9

(20.8)

167.0

(5.5)

Hemlibra

25.2

7.9

16.1

24.6

34.1

8.8

+11.4

51.7

+51.6

Actemra

41.8

9.5

19.1

28.6

39.3

9.2

(3.2)

38.5

(2.0)

Edirol

36.7

8.8

18.3

24.2

27.8

2.9

(67.0)

17.3

(37.8)

Mircera

22.2

4.2

8.5

12.9

17.5

3.4

(19.0)

11.7

(33.1)

Bonviva

9.7

2.1

4.2

6.5

8.9

2.0

(4.8)

8.5

(4.5)

CellCept

9.3

2.2

4.5

6.7

9.1

2.0

(9.1)

8.3

(8.8)

Oxarol

6.9

1.4

3.1

4.7

6.4

1.4

0.0

5.5

(14.1)

Enspryng

-

-

-

0.3

1.3

1.4

-

4.0

+207.7

Tamiflu(Ordinary use)

7.4

0.6

0.7

0.7

0.8

(0.1)

-

0.8

0.0

Tamiflu(Govt. stockpiles etc.)

3.2

2.6

2.6

3.0

3.7

1.2

(53.8)

1.2

(67.6)

Other products

34.3

7.2

14.2

21.9

27.9

4.7

(34.7)

19.6

(29.7)

Overseas

151.3

42.6

101.0

161.6

224.2

35.4

(16.9)

237.3

+5.8

Hemlibra

3.6

8.6

16.4

21.5

26.1

8.5

(1.2)

89.7

+243.7

To Roche

3.3

8.2

15.7

20.4

24.6

8.0

(2.4)

88.0

+257.7

Actemra

88.3

24.1

60.6

97.6

134.4

17.4

(27.8)

85.3

(36.5)

To Roche

86.5

23.5

59.4

96.0

132.0

16.9

(28.1)

83.0

(37.1)

Alecensa

45.3

6.2

16.8

30.7

44.3

6.0

(3.2)

44.2

(0.2)

To Roche

44.6

5.9

16.2

29.8

43.0

5.6

(5.1)

42.5

(1.2)

Enspryng

-

0.1

0.4

1.6

5.6

-

-

3.9

(30.4)

To Roche

-

0.1

0.4

1.6

5.6

-

-

3.9

(30.4)

Neutrogin

9.9

2.5

4.5

6.8

9.0

2.2

(12.0)

8.7

(3.3)

Other products

4.2

1.1

2.2

3.4

4.8

1.2

+9.1

5.4

+12.5

Royalties and other operating income

97.3

34.9

62.5

111.7

153.6

38.6

+10.6

169.0

+10.0

Royalty and profit-sharing income

76.5

26.4

53.5

89.1

129.6

36.6

+38.6

163.0

+25.8

Other operating income

20.8

8.5

9.0

22.6

24.1

2.0

(76.5)

6.0

(75.1)

Revenues

686.2

179.4

368.1

576.5

786.9

168.8

(5.9)

800.0

+1.7

Domestic

444.0

109.5

212.2

312.8

419.0

95.3

(13.0)

394.2

(5.9)

Overseas

242.2

69.9

155.9

263.7

368.0

73.6

+5.3

405.8

+10.3

From the 1st Quarter of FY2021, sales for Foundation Medicine is included "Oncology", instead of "Others" until FY2020.

Also sales for products included "Bone and Joint", "Renal Diseases", "Others" until FY2020, are included "Primary" from the 1st Quarter of FY2021.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

8

Financial position

(Billions of yen)

Actual

Actual

Actual

FY2019

FY2020

FY2021

Dec. 31

Mar. 31

Jun. 30

Sep. 30

Dec. 31

Mar. 31

vs. Mar. 31, 2020

vs. Dec. 31, 2020

Jun. 30

vs. Jun. 30, 2020

vs. Dec. 31, 2020

Sep. 30

vs. Sep. 30, 2020

vs. Dec. 31, 2020

Dec. 31

vs. Dec. 31, 2020

Trade accounts receivable

139.6

150.1

169.2

172.6

195.6

138.4

(11.7)

(57.2)

Inventories

168.1

174.4

172.0

179.6

183.9

184.7

10.3

0.8

Trade accounts payable

(47.7)

(51.3)

(44.7)

(45.2)

(58.3)

(42.1)

9.2

16.2

Other net working capital

(22.9)

(21.5)

8.5

(18.4)

(21.2)

0.3

21.8

21.5

Net working capital

237.2

251.6

305.0

288.5

300.0

281.3

29.7

(18.7)

Property, plant and equipment

255.6

277.4

275.3

288.3

289.2

291.4

14.0

2.2

Right-of-use assets

9.7

8.4

7.7

9.0

8.3

7.4

(1.0)

(0.9)

Intangible assets

23.5

23.8

24.0

23.8

23.9

26.0

2.2

2.1

Other long-term assets - net

21.0

24.9

24.4

24.1

24.6

25.5

0.6

0.9

Long-term net operating assets

309.8

334.5

331.3

345.1

346.0

350.3

15.8

4.3

Net operating assets

547.0

586.1

636.3

633.6

646.0

631.6

45.5

(14.4)

Debt

-

-

-

-

-

-

-

-

Marketable securities

129.1

134.0

94.1

136.1

166.3

181.3

47.3

15.0

Cash and cash equivalents

203.9

138.7

196.6

182.7

212.3

162.0

23.3

(50.3)

Net cash

333.1

272.7

290.7

318.8

378.6

343.4

70.7

(35.2)

Other non-operating assets - net

(26.1)

(4.7)

(21.1)

(27.2)

(44.6)

7.7

12.4

52.3

Net non-operating assets

307.0

268.0

269.6

291.7

334.0

351.0

83.0

17.0

Total net assets

854.0

854.1

905.9

925.3

980.0

982.6

128.5

2.6

Total net assets

Total assets

1,058.9

1,045.6

1,072.1

1,136.1

1,235.5

1,144.6

99.0

(90.9)

Total liabilities

(204.9)

(191.5)

(166.2)

(210.8)

(255.5)

(162.0)

29.5

93.5

Attributable to

Chugai shareholders

854.0

854.1

905.9

925.3

980.0

982.6

128.5

2.6

Non-controlling interests

-

-

-

-

-

-

-

-

Trade accounts receivable: trade receivable and notes receivable

Trade accounts payable: trade payable and notes payable

Other net working capital: accrued receivable (other receivable), accrued payable (other payable), accrued expenses (other current liabilities) etc.

Other long-termassets-net:long-term prepaid expenses, long-term provisions etc.

Other non-operatingassets-net: deferred income tax assets, current income tax liabilities etc.

Net operating assets (NOA) and Net assets:

The consolidated balance sheet has been prepared in accordance with International Accounting Standards (IAS) No. 1, "Presentation of Financial Statements." On the other hand, Net operating assets (NOA) and Net assets are a reconfiguration of the consolidated balance sheet as internal indicators and are identical to the indicators disclosed by Roche. Furthermore, no items from Net operating assets (NOA) and Net assets of IFRS have been excluded, as the Core results concept only applies to the income statement.

Net operating assets (NOA):

Net operating assets allow for an assessment of the Group's operating performance of the business independently from financing and tax activities. Net operating assets are calculated as net working capital, long-term net operating assets that includes property, plant and equipment, right-of-use assets, intangible assets etc. minus provisions.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

9

Cash flows

(Billions of yen)

Actual

Actual

Actual

FY2019

FY2020

FY2021

1-12

1-3

1-6

1-9

1-12

1-3

1-6

1-9

1-12

YTD

YTD

YTD

YTD

YTD

YTD

YTD

YTD

YTD

Operating profit - IFRS basis

210.6

72.4

140.6

227.3

301.2

64.0

Depreciation and impairment of property, plant and equipment

19.0

5.2

10.5

16.1

22.3

5.3

Depreciation and impairment of right-of-use assets

6.0

1.5

2.8

4.2

5.5

1.3

Amortization and impairment of intangible assets

5.3

0.9

1.6

2.3

3.6

0.7

Other cash adjustment on operating profit

4.3

1.1

2.0

3.1

2.9

0.9

Operating profit, net of operating cash adjustments

245.2

81.0

157.6

253.0

335.5

72.2

(Increase) decrease in trade accounts receivable

11.1

(10.5)

(29.5)

(32.9)

(55.9)

57.4

(Increase) decrease in inventories

(9.0)

(6.8)

3.6

6.4

3.3

(1.0)

Increase (decrease) in trade accounts payable

11.8

3.7

(3.0)

(2.5)

10.5

(16.5)

Change in other net working capital etc.

(7.7)

(21.2)

(32.4)

(27.1)

(22.3)

0.3

Total (increase) decrease in net working capital etc.

6.2

(34.8)

(61.4)

(56.1)

(64.4)

40.2

Investment in property, plant and equipment

(53.0)

(11.1)

(40.6)

(47.3)

(57.0)

(28.9)

Lease liabilities paid

(8.9)

(2.1)

(4.2)

(6.3)

(8.4)

(2.2)

Investment in intangible assets

(8.2)

(1.2)

(2.3)

(3.1)

(4.3)

(2.9)

Operating free cash flows

181.4

31.8

49.0

140.3

201.2

78.3

as % of revenues

26.4%

17.7%

13.3%

24.3%

25.6%

46.4%

Treasury activities (interest income/expenses, foreign exchange gains/losses etc.)

(0.9)

0.6

2.2

3.7

2.5

(2.5)

Settlement for transfer pricing taxation

(3.1)

(0.5)

(0.9)

(1.1)

(1.5)

-

Tax paid

(34.8)

(41.0)

(41.9)

(66.4)

(66.8)

(63.3)

Free cash flows

142.6

(9.1)

8.4

76.4

135.4

12.4

Dividends paid

(56.4)

(50.1)

(50.4)

(91.2)

(91.4)

(49.0)

Transaction in own equity instruments

0.7

0.3

0.3

0.4

0.4

0.2

Purchase of non-controlling interests

(2.3)

-

-

-

-

-

Net effect of currency translation on net cash

(0.8)

(1.4)

(0.8)

0.2

1.2

1.2

Net change in net cash

83.9

(60.4)

(42.4)

(14.3)

45.5

(35.2)

Other cash adjustment on operating profit: adjustments for all non-cash income and expense items other than amortization expenses and impairment included in operating profit (such as loss on inventory differences, reserve for doubtful accounts, stock option expenses, loss on asset retirement, and increase/decrease in reserves) as well as all non-operating income and expense cash flows relating to net operating assets (NOA) including proceeds from the sales of assets and reserve payments.

Operating free cash flow (Operating FCF): pretax cash flow after adjusting changes in working capital and operating investments in assets (tangible and intangible) to "operating profit, net of operating cash adjustments," which shows the company's cash generation ability from operating activities.

Free cash flow (FCF): the ability to generate net cash from a management perspective after deducting tax, dividends, and other payments from operating FCF.

Net change in net cash: dividends paid, increases and decreases in marketable securities and interest-bearing debt、changes in equity are included.

The concepts of operating profit, operating FCF and Net operating assets (NOA) presented in the previous page are mutually consistent. Free cash flow (FCF):

The consolidated statement of cash flows has been prepared in accordance with International Accounting Standard (IAS) No. 7, "Statement of Cash Flows." FCF is a reconfiguration of the consolidated statement of cash flows as internal indicators and is identical to the indicators disclosed by Roche. Furthermore, no items from FCF have been excluded, as the Core results concept only applies to the income statement.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for Consolidated Financial Results for the 1st quarter of FY2021(IFRS)

10

Key Performance indicators

Actual

Actual

Actual

Forecast

(Feb 4th

announced)

2019

2020

2021

2021

1-12

1-3

1-6

1-9

1-12

1-3

1-6

1-9

1-12

1-12

Units

As of Dec. 31

As of Mar. 31

As of Jun. 30

As of Sep. 30

As of Dec. 31

As of Mar. 31

As of Jun. 30

As of Sep. 30

As of Dec. 31

As of Dec. 31

Total indicator

Core return on invested capital (Core ROIC)

%

31.9

9.5

17.8

28.4

37.3

7.5

Return on invested capital (ROIC)

%

30.1

9.3

17.5

27.9

36.5

7.4

Ratio of profit to total assets (ROA)

%

15.8

4.9

9.6

14.8

18.7

4.0

Ratio of equity attributable to

%

80.6

81.7

84.5

81.4

79.3

85.8

Chugai shareholders

Ratio of equity attributable to

%

521.2

654.7

883.9

682.2

732.2

644.8

Chugai shareholders (stock price base)

Price book value ratio(PBR)

times

6.5

8.0

10.5

8.4

9.2

7.5

Ratio of net income to equity attributable to

%

19.6

6.0

11.6

18.3

23.4

4.8

Chugai shareholders (ROE)

Margin indicator

ROS

%

32.8

41.3

39.0

40.2

39.1

38.7

40.0

COS ratio(vs. Prod. sales)

%

45.0

42.2

42.9

43.1

43.0

42.2

40.0

M&D cost ratio

%

10.7

8.6

8.8

8.5

9.1

9.4

R&D cost ratio

%

14.9

13.9

14.4

14.3

14.4

17.0

16.4

G&A cost ratio

%

3.0

2.2

2.2

2.3

2.8

2.3

Turn over indicator

Total asset turnorver

%

68.9

17.1

34.5

52.5

68.6

14.2

Working capital turnover

%

128.7

31.7

62.2

97.7

131.9

26.4

Inventory turnover

Months

7.6

8.5

7.8

8.0

8.1

10.0

Receivables turnover

Months

2.8

3.1

3.3

3.3

3.7

3.2

Payables turnover

Months

2.2

2.5

2.0

2.0

2.6

2.3

Fixed asset turnover

%

250.0

60.0

123.6

189.1

257.9

52.2

PP&E turnover

%

287.3

67.3

138.7

212.0

288.9

58.2

intangible assets turnover

%

2,968.0

757.7

1,548.1

2,436.2

3,319.0

676.6

Dividend / per stock indicator

Dividends per share (Half year)

Yen

48

75

30

Dividends per share (Year end)

Yen

92

30

30

Dividends per share (Full year)

Yen

140

-

60

Core earnings per share (diluted)

Yen

101.93

32.04

63.51

100.68

133.39

29.42

141.00

Core payout ratio (%)

%

45.8

41.2

42.6

Equity per share attributable

Yen

519.91

519.90

551.13

562.88

596.16

597.67

to Chugai shareholders (BPS)

Ratio of dividends to equity attributable to

%

9.5

9.9

Chugai shareholders (DOE)

Cashflow indicator

Cash conversion cycle(CCC)

Months

8.3

9.1

9.1

9.4

9.2

10.9

Net cash turnover period

Months

5.8

4.6

4.7

5.0

5.8

6.1

Number of employees

7,394

7,400

7,536

7,559

7,555

7,490

Investment on property, plant and equipment

Billions of yen

54.0

27.3

38.7

67.9

75.2

7.4

79.5

Depreciation

Billions of yen

17.8

5.2

10.5

16.1

22.0

5.3

21.0

Investment on intangible assets

Billions of yen

6.1

1.1

2.1

2.5

3.9

2.9

Amortization

Billions of yen

2.6

0.7

1.5

2.2

2.9

0.7

Core ROIC:Core net operting profit after taxes / Net operating assets (Core ROIC is calculated by using Core Income taxes)

ROIC: Net operating profit after taxes / Net operating assets (Net operating profit after taxes = Operating profit - income taxes)

ROA: Net income / total assets, ROE: Net income attributable for Chugai shareholders / Equity attributable to Chugai shareholders

Total asset turnorver: Revenues / Total asset, CCC:[Trade accounts receivable/Sales+(Inventories - Trade accounts payable)/Cost of sales]* passed months Net cash turnover period:Net cash/Revenue* passed months

Core ROIC, ROIC, ROA, ROE, total asset turnover, working capital turnover, fixed asset turnover, PP&E turnover, and intangible assets turnover are not annualized The Adjusted figures are used for calculating average NOA for Core ROIC and ROIC

Effective July 1, 2020, Chugai Pharmaceutical Co., Ltd. ("Chugai") implemented a three-for-one stock split of its common stock.

The dividend for the fiscal year ended December 31, 2019 and the second quarter of the fiscal year 2020 presents the amount prior to the stock split.

The annual dividend per share for the fiscal year ended December 31, 2020 is not stated because the amounts cannot be simply combined due to the implementation of the stock split. The annual dividend per share is ¥165 when calculated based on the assumption of no stock split, and ¥55 when calculated with the stock split taken into account.

Core EPS and BPS presents the amount after the stock split.

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 11

Development pipeline (as of April 22, 2021)

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

Oncology

RG7596

Roche/Seattle Genetics

Relapsed or refractory diffuse large B-cell

Approved

polatuzumab vedotin

Anti-CD79bantibody-drug conjugate

Polivy

lymphoma (DLBCL)

(21/03)

Polivy

Injection

DLBCL

Phase III

#

RG7446

Roche

Non-small cell lung cancer (NSCLC)

Phase III

atezolizumab

Engineered anti-PD-L1 monoclonal antibody

Tecentriq

(adjuvant)

Tecentriq

#

Injection

NSCLC (neoadjuvant)

Phase III

#

NSCLC (stage III)

Phase III

#

(in combination with

RG6058)

Urothelial carcinoma

Phase III

#

Renal cell carcinoma (adjuvant)

Phase III

#

Roche

Renal cell carcinoma (2nd Line)

Phase III

Tecentriq

#

(in combination with

(Takeda)

cabozantinib)

Roche

Early breast cancer

Phase III

Tecentriq

#

Ovarian cancer

Phase III

#

(in combination with

RG435)

Hepatocellular carcinoma (HCC) (adjuvant)

Phase III

#

(in combination with

RG435)

HCC (intermediate stage)

Phase III

#

(in combination with

RG435)

Head and neck carcinoma (adjuvant)

Phase III

#

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 12

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

Esophageal cancer

Phase III

#

(in combination with

RG6058)

Pancreatic adenocarcinoma

Phase I

#

Morpheus platform

(in combination with

RG1569 or RG6058)

RG435

Roche

HCC (adjuvant)

Phase III

bevacizumab

Anti-VEGF (Vascular Endothelial Growth

Avastin

#

(in combination with

Avastin

Factor) humanized monoclonal antibody

RG7446)

Injection

HCC (intermediate stage)

Phase III

#

(in combination with

RG7446)

Small cell lung cancer (SCLC)

Phase III

#

(in combination with

RG7446)

RG7440

Roche/Array BioPharma

Breast cancer

Phase III

ipatasertib

AKT inhibitor

Oral

Prostate cancer

Phase III

RG6264

Roche

Breast cancer

Phase III

trastuzumab/pertuzumab

Anti-HER2 humanized monoclonal antibody/

Phesgo

(Fixed-dose combination, subcutaneous

HER2 dimerization inhibitory humanized

injection)

Injection

monoclonal antibody

AF802 / RG7853

In-house

NSCLC (adjuvant)

Phase III

alectinib

ALK inhibitor

Alecensa

#

Alecensa

(Roche)

Oral

RG6058

Roche

SCLC

Phase III

tiragolumab

Anti-TIGIT human monoclonal antibody

(in combination with

RG7446)

Injection

NSCLC

Phase III

(in combination with

RG7446)

NSCLC (stage III)

Phase III

(in combination with

RG7446)

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 13

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

Esophageal cancer

Phase III

(in combination with

RG7446)

RG6171

Roche

Breast cancer

Phase III

giredestrant

SERD (Selective Estrogen Receptor Degrader)

Oral

OBP-301

Oncolys BioPharma

Esophageal cancer

Phase II

Oncolytic type 5 adenovirus

Injection

HCC

Phase I

(in combination with

RG7446 and RG435)

GC33

In-house

HCC

Phase I

codrituzumab

Anti-Glypican-3

humanized

monoclonal

antibody

Injection

ERY974

In-house

Solid tumors

Phase I

Anti-Glypican-3/CD3 bispecific antibody

Injection

RG7421

Roche/Exelixis

Solid tumors

Phase I

cobimetinib

MEK inhibitor

Cotellic

Oral

RG7802

Roche

Solid tumors

Phase I

cibisatamab

Anti-CEA/CD3 bispecific antibody

Injection

RG7828

Roche

Hematologic tumors

Phase I

mosunetuzumab

Anti-CD20/CD3 bispecific antibody

Injection

RG6026

Roche

Hematologic tumors

Phase I

glofitamab

Anti-CD20/CD3 bispecific antibody

Injection

AMY109

In-house

Solid tumors

Phase I

Injection

STA551

In-house

Solid tumors

Phase I

Anti-CD137 agonistic Switch antibody

Injection

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 14

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

SPYK04

In-house

Solid tumors

Phase I

Oral

RG6194

Roche

Solid tumors

Phase I

Anti-HER2/CD3 bispecific antibody

Injection

Bone and Joint Diseases

ED-71

In-house

Osteoporosis

Approved

eldecalcitol

Activated vitamin D3 agent

(20/12)

Edirol

China

Oral

NRD101

In-house

Knee osteoarthritis / Shoulder periarthritis

Phase III

purified

sodium

Sodium hyaluronate

(China)

hyaluronate

Suvenyl

Injection

Renal Diseases

EOS789

In-house

Hyperphosphatemia

Phase I

NaPi-IIb,PiT-1,PiT-2 inhibitor

Oral

Autoimmune Diseases

RG7880

Roche

Inflammatory bowel disease

Phase I

efmarodocokin alfa

Human IL-22 fusion protein

Injection

Neurology

SA237 / RG6168

In-house

Neuromyelitis optica spectrum disorder

Filed

satralizumab

pH-dependent binding humanized anti-IL-6

Enspryng

(NMOSD)

(19/08)

Enspryng

receptor monoclonal antibody

(Roche)

EU

Injection

RG7916

Roche/PTC Therapeutics

Spinal muscular atrophy (SMA)

Filed

risdiplam

SMN2 splicing modifier

Evrysdi

(20/10)

Oral

RG1450

Roche/MorphoSys

Alzheimer's disease

Phase III

gantenerumab

Anti-amyloid-beta human monoclonal antibody

Injection

RG6042

Roche/Ionis

Huntington's disease

Phase III

tominersen

Antisense oligonucleotide targeting HTT mRNA

Pharmaceuticals

Injection

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 15

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

RG7906

Roche

Schizophrenia

Phase II

ralmitaront

Partial TAAR1 agonist

Oral

RG7935

Roche/Prothena

Parkinson's disease

Phase I

prasinezumab

Anti-α-synuclein monoclonal antibody

Injection

GYM329 / RG6237

In-house

Neuromuscular disease

Phase I

Anti-latent myostatin sweeping antibody

(Roche)

Injection

RG6100

Roche/AC Immune

Alzheimer's disease

Phase I

semorinemab

Anti-tau humanized monoclonal antibody

injection

Other diseases

MRA / RG1569

In-house

COVID-19 pneumonia

Phase III*

tocilizumab

Humanized anti-humanIL-6 receptor

Actemra/RoActemra (EU)

#

(Japan)

Actemra

monoclonal

Injection

antibody

RG7716

Roche

Diabetic macular edema

Phase III

faricimab

Anti-VEGF/Ang2 bispecific antibody

Neovascular age related macular

Phase III

Injection

degeneration (nAMD)

Retinal vein occlusion

Phase III

ACE910 / RG6013

In-house

Acquired hemophilia A

Phase III

emicizumab

Anti-coagulation factor IXa/X humanized

Hemlibra

#

(Japan)

Hemlibra

bispecific monoclonal antibody

Injection

SKY59 / RG6107

In-house

Paroxysmal nocturnal hemoglobinuria

Phase III

crovalimab

Anti-C5 recycling antibody

(PNH)

(Roche)

Injection

NXT007

In-house

Hemophilia A

Phase l/II

Anti-coagulation factor IXa/X bispecific

antibody

Injection

PCO371

In-house

Hypoparathyroidism

Phase I

PTH1 receptor agonist

Oral

AMY109

In-house

Endometriosis

Phase l

Injection

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 16

Origin

Indication

Stage

Generic name

Development code

Overseas name

Product name

Mode of Action

# Additional indication

(Date)

(Collaborator)

Dosage form

RG6413/RG6412

Roche/Regeneron

COVID-19

Phase l

casirivimab/imdevimab

SARS-CoV-2 Neutralizing antibody

Pharmaceuticals

cocktail

Injection

In principle, completion of first dose is regarded as the start of clinical studies in each phase. * Roche is conducting global Phase III studies of Actemra/RoActemra against COVID-19 pneumonia separately.

Changes from the last announcement on February 4, 2021

Oncology

- RG7596

Filed (Relapsed or refractory diffuse large B-cell lymphoma) → Approved

- RG7446

Phase III (HCC (intermediate stage) / in combination with RG435: development started)

- RG435

Phase III (HCC (intermediate stage) / in combination with RG7446: development started)

Other diseases

- RG7716

Phase III (Retinal vein occlusion: development started)

- RG6413/RG6412

Phase I (COVID-19: development started)

R&D Activities

For the changes during the FY2021 (January 1 - March 31), please refer to page 4 of "CONSOLIDATED FINANCIAL STATEMENTS (IFRS) (Non-Audited) (for the first quarter of the fiscal year 2021)."

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 17

Major Chugai originated developments licensed out to 3rd party excluding Roche

Development code

Generic name

Licensee

Indication

Stage

Product name

Mode of Action

in Chugai

(granted right )

Dosage form

CIM331

Atopic dermatitis

Filled

nemolizumab

Maruho

Anti-IL-31 receptor A humanized

(20/Q3)

(rights for development and marketing in the

monoclonal antibody

Japan

Injection

skin disease area for the Japanese market)

Phase III

Galderma

(global)

(exclusive global license for the

development and marketing excluding

Japan and Taiwan)

Prurigo nodularis

Phase III

Galderma

(global)

(exclusive global license for the

development and marketing excluding

Japan and Taiwan)

Phase II/III

Maruho

(Japan)

(rights for development and marketing in

the skin disease area for the Japanese

market)

OWL833

Type 2 diabetes

Phase I

Eli Lilly and Company

Oral non-peptidicGLP-1 receptor

(worldwide development and

agonist

Oral

commercialization rights)

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 18

Major clinical trials in oncology field

Treatment

Expected Indication

Study design

Study name

Stage

Planned filing year

NSCLC [1st line]

PD-L1 positive: Tecentriq ± RG6058

SKYSCRAPER-01

Phase III

2023

NSCLC [stage III]

Tecentriq + RG6058 vs. durvalumab

SKYSCRAPER-03

Phase III

2024 and beyond

NSCLC [2nd line]

Tecentriq + cabozantinib vs. docetaxel

CONTACT-01

Phase III

2023

NSCLC (neoadjuvant)

Chemo ± Tecentriq

IMpower030

Phase III

2023

NSCLC (adjuvant)

Tecentriq vs. best supportive care

IMpower010

Phase III

2021

SCLC

Tecentriq + chemo ± Avastin

BEAT-SC

Phase III

2023

Tecentriq + chemo ± RG6058

SKYSCRAPER-02

Phase III

2022

Urothelial carcinoma (UC)

Tecentriq ± chemo vs. chemo

IMvigor130

Phase III

2022

RG7446

Renal cell carcinoma (adjuvant)

Tecentriq

IMmotion010

Phase III

2022

Renal cell carcinoma [2nd line]

cabozantinib ± Tecentriq

CONTACT-03

Phase III

2023d

(Tecentriq)

Early breast cancer

TNBC (adjuvant): paclitaxel ± Tecentriq

IMpassion030

Phase III

2024 and beyond

TNBC (neoadjuvant): nab-paclitaxel ± Tecentriq

IMpassion031

Phase III

Ovarian cancer

carboplatin + paclitaxel + Avastin ± Tecentriq

IMagyn050

Phase III

2022

HCC (adjuvant)

Tecentriq + Avastin vs. active surveillance

IMbrave050

Phase III

2022

HCC (intermediate stage)

Tecentriq + Avastin + TACE vs. TACE

TALENTACE

Phase III

2024 and beyond

Head and neck carcinoma (adjuvant)

Tecentriq

IMvoke010

Phase III

2022

Esophageal cancer

Tecentriq + RG6058 vs. Tecentriq vs. placebo

SKYSCRAPER-07

Phase III

2024 and beyond

Pancreatic adenocarcinoma [1st line]

Tecentriq + Actemra vs. gemcitabine + nab-paclitaxel

Morpheus-PC

Phase I

Tecentriq + RG6058 vs. gemcitabine + nab-paclitaxel

RG7440

Prostate cancer

castration-resistant: abiraterone ± RG7440

IPATential150

Phase III

2022

(ipatasertib)

Breast cancer

fulvestrant + palbociclib ± RG7440

IPATunity150

Phase Ib/III

2024 and beyond

RG7596

DLBCL

Rituxan + Chemo ± RG7596

POLARIX

Phase III

2021

(polatuzumab vedotin)

RG6264

Breast cancer

RG6264 (SC) + chemo vs. Herceptin (IV) + Perjeta (IV) + chemo

FeDeriCa

Phase III

2021

AF802 (Alecensa)

NSCLC (adjuvant)

ALK fusion-positive: Alecensa vs. chemo

ALINA

Phase III

2023

RG6171 / SERD

Breast cancer

HR positive: RG6171 + palbocicilib ± Letrozole

-

Phase III

2024 and beyond

OBP-301

Esophageal cancer

OBP-301 + radiotherapy

-

Phase II*

2024 and beyond

TNBC: triple negative breast cancer, HR: hormone receptor, TACE: transarterial chemoembolization, *: domestic

Chugai Pharmaceutical Co., Ltd. (4519) Supplementary Materials for the 1st quarter of FY2021 (IFRS) 19

FoudationOne CDx Cancer Genomic Profile: companion diagnostic indications (as of April 22, 2021)

Alterations

Cancer type

Relevant drugs

Activated EGFR gene alterations

NSCLC

afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate

EGFR exon 20 T790M alterations

osimertinib mesylate

ALK fusion genes

alectinib hydrochloride, crizotinib, ceritinib

ROS1 fusion genes

entrectinib

MET exon 14 skipping alterations

capmatinib hydrochloride hydrate

BRAF V600E and V600K alterations

Malignant melanoma

dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib

ERBB2 copy number alterations (HER2 gene

Breast cancer

trastuzumab (genetical recombination)

amplification positive)

KRAS/NRAS wild-type

Colorectal cancer

cetuximab (genetical recombination), panitumumab (genetical recombination)

Microsatellite Instability-High

nivolumab (genetical recombination)

Microsatellite Instability-High

Solid tumors

pembrolizumab (genetical recombination)

NTRK1/2/3 fusion gene

entrectinib, larotrectinib sulfate

BRCA1/2 alterations

Ovarian cancer

olaparib

BRCA1/2 alterations

Prostate cancer

olaparib

FGFR2 fusion genes

Biliary Tract Cancer

pemigatinib

* Underlined are the companion diagnostic features and relevant drugs currently

under application for regulatory approval

FoudationOne Liquid CDx Cancer Genomic Profile: companion diagnostic indications (as of April 22 2021)

Alterations

Cancer type

Relevant drugs

Activated EGFR gene alterations

NSCLC

afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate

EGFR exon 20 T790M alterations

osimertinib mesylate

ALK fusion genes

alectinib hydrochloride, crizotinib, ceritinib

ROS1 fusion genes

entrectinib

NTRK1/2/3 fusion gene

Solid tumors

entrectinib

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Chugai Pharmaceutical Co. Ltd. published this content on 22 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 April 2021 08:03:04 UTC.