Shionogi & Co., Ltd. TSE:4507

Shionogi : FY2024 Supplement

Published

Source: MarketScreener

Financial Results for FY2024 Supplement

May 12, 2025 SHIONOGI & CO., LTD.

1. Consolidated statement of profit or loss

(Billions of yen)

FY2023

FY2024

Change

Change (％)

Comment

FY2024

forecast

Progress (％)

FY2025

forecast

Change

Revenue

Cost of sales

435.1

(57.6)

438.3

(63.8)

3.2

6.2

0.7

10.8

Increasing/(decreasing) in Prescription drugs (52.4) billion

Overseas subsidiaries/Export 9.2billion Royalty income 44.3billion

460.0

(67.0)

95.3

95.3

530.0

(89.0)

91.7

25.2

Gross profit

377.5

374.4

(3.0)

(0.8)

393.0

95.3

441.0

66.6

SG&A expenses

(99.7)

(101.9)

2.2

2.2

(104.7)

97.3

(126.8)

24.9

R&D expenses

(102.6)

(108.6)

6.0

5.8

Investments in major development projects and foreign exchange effects

(116.0)

93.6

(131.0)

22.4

Amortization of intangible assets associated with products

(3.7)

(4.2)

0.4

12.1

(4.3)

97.2

(4.2)

0.0

Other income

6.2

0.5

(5.7)

(91.5)

Other expenses

(24.3)

(3.7)

(20.6)

(84.8)

FY2023：Impairment losses on in-process research and development assets and expenses relating to the implementation of a special early retirement program

(3.0)

105.8

(4.0)

0.8

Operating profit

153.3

156.6

3.3

2.1

165.0

94.9

175.0

18.4

Finance income

51.7

53.2

1.5

2.9

41.0

107.7

47.0

2.9

Finance costs

(6.7)

(9.0)

2.3

34.7

Profit before tax

198.3

200.8

2.5

1.2

206.0

97.5

222.0

21.2

Income tax expense

(37.7)

(31.2)

(6.5)

(17.2)

Profit

160.6

169.5

9.0

5.6

Profit attributable to Owners of parent

Non-controlling interests

162.0

(1.5)

170.4

(0.9)

8.4

(0.6)

5.2

(38.1)

171.0

99.7

180.0

9.6

Profit

160.6

169.5

9.0

5.6

*Revenue for FY2023 includes Lump-sum income for transfer of ADHD drug.

Reconciliation from operating profit to EBITDA

(Billions of yen)

FY2023

FY2024

Operating profit

153.3

156.6

Other income

Other expenses

(5.9)

23.0

(0.2)

2.0

Core operating profit *1

170.4

158.4

Depreciation and amortization

18.3

20.9

EBITDA *2

188.7

179.3

*1. Core operating profit: An adjusted profit in which non-recurring items (impairment, gain on sales of property, plant, and equipment, etc.) are deducted from operating profit.

2. Earnings Before Interest, Taxes, Depreciation and Amortization: Core operating profit added depreciation and amortization.

2. Revenue by segment

FY2024 actual

(Billions of yen)

FY2023

FY2024

Change

Change(％)

FY2024

forecast

Progress(％)

Prescription drugs

151.1

98.8

(52.4)

(34.6)

124.7

79.2

Infectious Disease Drugs

82.9

61.4

(21.6)

(26.0)

83.4

73.6

COVID-19 related products + Influenza Franchise

73.4

51.8

(21.6)

(29.5)

72.3

71.6

SYMPROIC

4.5

5.0

0.5

11.1

5.9

85.1

OXYCONTIN Franchise

4.2

4.3

0.1

2.4

5.0

85.0

ACTAIR

0.7

0.9

0.2

22.9

1.3

66.0

CYMBALTA

3.8

2.1

(1.7)

(44.7)

3.3

64.1

Others

55.0

25.2

(29.8)

(54.2)

25.8

97.4

QUVIVIQ

-

0.8

0.8

-

3.0

26.5

Overseas subsidiaries/Export

49.9

59.1

9.2

18.4

57.6

102.6

Shionogi Inc. (US)

17.9

23.4

5.5

30.6

22.6

103.4

Shionogi B.V. (EU)

13.6

16.8

3.3

24.0

16.7

100.7

Ping An-Shionogi / C&O

10.6

8.7

(1.9)

(18.3)

9.1

95.3

Others

7.8

10.2

2.4

30.3

9.2

111.0

Contract manufacturing

17.6

17.3

(0.4)

(2.0)

16.5

104.6

OTC and quasi-drugs

14.6

16.8

2.2

14.8

16.6

101.3

Royalty income

200.4

244.7

44.3

22.1

242.8

100.8

HIV Franchise

195.8

240.4

44.6

22.8

234.9

102.3

Others

4.6

4.3

(0.3)

(6.8)

7.9

54.0

Others

1.4

1.7

0.2

17.0

1.8

93.4

Total

435.1

438.3

3.2

0.7

460.0

95.3

*1. Sales of prescription drugs are shown on non-consolidated basis.

  1. Products included in Infectious Disease Drugs: Xocova, Xofluza, Rapiacta, Brightpoc Flu Neo, Finibax, Flumarin, Flomox, Shiomarin, Baktar, Flagyl,

    Isodine, Fetroja

  2. Others in prescription drugs for FY2023 include Lump-sum income for transfer of ADHD drug.

FY2025 forecast

(Billions of yen)

FY2024

FY2025

forecast

Change

Prescription drugs

98.8

183.0

84.2

Acute Respiratory Virus Infection Treatment

51.8

85.8

34.0

QUVIVIQ

0.8

9.3

8.5

SYMPROIC

5.0

8.1

3.1

OXYCONTIN Franchise

4.3

5.6

1.3

Others

36.9

74.2

37.3

Overseas subsidiaries/Export

59.1

54.9

(4.2)

Shionogi Inc. (US)

23.4

22.6

(0.8)

Shionogi B.V. (EU)

16.8

16.9

0.1

Shionogi China

8.7

7.0

(1.7)

Others

10.2

8.4

(1.8)

Contract manufacturing

17.3

13.2

(4.1)

OTC and quasi-drugs

16.8

18.5

1.7

Royalty income

244.7

257.9

13.2

HIV Franchise

240.4

244.8

4.4

Others

4.3

13.1

8.8

Others

1.7

2.5

0.8

Total

438.3

530.0

91.7

*1. Sales of prescription drugs are shown on non-consolidated basis.

2. Products included in Acute Respiratory Virus Infection Treatment: COVID-19 Treatment "Xocova", Influenza Franchise "Xofluza" and "Rapiacta"

3. Quarterly trend (Consolidated statement of profit or loss)

(Billions of yen)

FY2023

FY2024

1Q

2Q

3Q

4Q

1Q

Y on Y change (%)

2Q

Y on Y change (%)

3Q

Y on Y change (%)

4Q

Y on Y change (%)

Revenue

Cost of sales

109.3

(13.1)

121.2

(14.8)

106.3

(14.5)

98.3

(15.2)

97.6

(14.4)

(10.7)

10.1

116.4

(15.7)

(4.0)

6.3

119.6

(15.9)

12.6

9.5

104.7

(17.8)

6.5

17.0

Gross profit

96.2

106.5

91.8

83.1

83.1

(13.6)

100.7

(5.4)

103.7

13.0

86.9

4.6

SG&A expenses R&D expenses

Amortization of intangible assets associated with products

Other income Other expenses

(23.2)

(25.0)

(0.8)

0.1

(0.7)

(24.3)

(22.2)

(0.9)

0.1

(7.6)

(24.1)

(25.4)

(0.9)

0.2

(0.8)

(28.0)

(30.0)

(1.1)

5.8

(15.2)

(24.0)

(29.4)

(1.1)

0.1

(0.5)

3.7

17.7

28.9

(16.6)

(18.0)

(23.7)

(27.4)

(1.1)

0.4

(1.2)

(2.6)

23.4

21.6

330.4

(84.5)

(25.5)

(22.6)

(1.1)

0.0

(1.2)

5.4

(11.0)

22.0

(90.5)

46.6

(28.7)

(29.2)

(0.9)

0.0

(0.8)

2.5

(2.8)

(16.5)

(99.5)

(95.1)

Operating profit

46.6

51.5

40.6

14.6

28.1

(39.7)

47.8

(7.3)

53.4

31.3

27.4

87.9

Finance income

Finance costs

10.1

(1.0)

10.6

(2.2)

11.4

(3.1)

21.9

(2.7)

11.3

(2.8)

11.7

197.5

13.9

(4.4)

31.4

97.3

10.2

(1.5)

(10.5)

(52.3)

21.0

(3.5)

(4.2)

30.0

Profit before tax

55.7

59.9

48.9

33.8

36.5

(34.4)

57.3

(4.3)

62.0

26.9

44.9

32.8

Income tax expense

(13.5)

(11.9)

(12.6)

0.3

(6.2)

(53.9)

(4.7)

(60.2)

(11.6)

(8.4)

(8.7)

-

Profit

42.2

48.0

36.2

34.1

30.3

(28.2)

52.6

9.5

50.5

39.2

36.2

6.0

Profit attributable to Owners of parent

Non-controlling intersts

42.6

(0.3)

48.0

(0.0)

36.6

(0.4)

34.8

(0.7)

30.6

(0.3)

(28.0)

(5.0)

52.5

0.1

9.3

-

50.7

(0.2)

38.3

(47.2)

36.6

(0.4)

5.2

(35.3)

Profit

42.2

48.0

36.2

34.1

30.3

(28.2)

52.6

9.5

50.5

39.2

36.2

6.0

* Revenue for FY2023 includes Lump-sum income for transfer of ADHD drug.

4. Quarterly trend (Revenue by segment)

(Billions of yen)

FY2023

FY2024

1Q

2Q

3Q

4Q

1Q

Y on Y change (%)

2Q

Y on Y change (%)

3Q

Y on Y change (%)

4Q

Y on Y change (%)

Prescription drugs

45.9

50.4

31.2

23.6

15.4

(66.4)

32.3

(36.0)

31.2

0.2

19.8

(16.0)

Infectious Disease Drugs

9.3

39.8

20.0

13.9

6.1

(34.4)

23.1

(41.8)

20.8

4.0

11.3

(18.5)

COVID-19 related products + Influenza Franchise

7.1

37.3

17.6

11.4

3.9

(44.9)

21.0

(43.9)

18.5

4.8

8.5

(25.5)

SYMPROIC

1.0

1.1

1.2

1.2

1.1

6.0

1.3

19.4

1.5

19.9

1.2

(0.9)

OXYCONTIN Franchise

1.1

1.1

1.1

0.8

1.0

(6.7)

1.0

(4.4)

1.2

9.5

0.9

13.5

ACTAIR

0.1

0.2

0.2

0.2

0.2

43.9

0.2

24.9

0.3

19.0

0.2

9.2

CYMBALTA

1.1

1.0

1.0

0.7

0.8

(27.0)

0.7

(32.7)

0.4

(61.9)

0.3

(63.8)

Others

33.3

7.4

7.5

6.8

6.2

(81.3)

6.0

(19.2)

7.1

(6.6)

5.9

(12.7)

QUVIVIQ

-

-

-

-

-

-

-

-

0.5

-

0.3

-

Overseas subsidiaries/Export

12.0

10.9

13.6

13.4

15.0

24.9

13.4

22.0

15.0

10.8

15.7

17.2

Shionogi Inc. (US)

4.0

4.1

5.0

4.8

6.0

48.6

5.2

27.4

6.3

26.6

5.9

22.5

Shionogi B.V. (EU)

3.0

3.1

4.0

3.5

4.0

34.2

4.3

37.1

4.6

17.3

3.9

11.0

Ping An-Shionogi / C&O

3.1

2.2

3.0

2.3

2.3

(25.8)

1.9

(11.6)

2.1

(32.0)

2.4

3.7

Others

1.9

1.6

1.6

2.8

2.7

42.9

1.9

23.9

2.1

27.4

3.5

27.1

Contract manufacturing

4.0

3.9

3.8

5.9

3.6

(10.4)

4.2

6.3

2.9

(22.9)

6.6

11.7

OTC and quasi-drugs

2.3

4.8

3.5

4.1

2.4

6.6

5.7

19.1

4.5

30.0

4.1

1.2

Royalty income

44.8

50.8

53.5

51.3

61.0

36.1

60.5

19.2

65.3

22.0

57.9

13.0

HIV Franchise

44.3

50.2

51.6

49.7

59.8

35.1

59.8

19.1

63.9

23.9

56.9

14.5

Others

0.6

0.5

1.9

1.6

1.2

109.6

0.7

27.3

1.4

(28.9)

1.0

(35.1)

Others

0.3

0.3

0.7

0.1

0.2

(44.1)

0.4

0.8

0.6

(16.8)

0.6

706.9

Total

109.3

121.2

106.3

98.3

97.6

(10.7)

116.4

(4.0)

119.6

12.6

104.7

6.5

*1. Sales of prescription drugs are shown on non-consolidated basis.

  1. Products included in Infectious Disease Drugs: Xocova, Xofluza, Rapiacta, Brightpoc Flu Neo, Finibax, Flumarin, Flomox, Shiomarin, Baktar, Flagyl,

    Isodine, Fetroja

  2. Others in prescription drugs for FY2023 include Lump-sum income for transfer of ADHD drug.

5. Consolidated statement of financial position

(Billions of yen)

As of Mar. 31 2024

As of Mar. 31 2025

Y on Y change

Comment

Assets

Non-current assets

Property, plant and equipment

114.6

115.4

0.8

Goodwill

15.3

15.7

0.5

Intangible assets

117.6

143.7

26.0

Increase due to acquisition of in-process research and development assets

Right-of-use assets

9.4

19.4

10.0

Increase in right-of-use assets relating to the new Head Office

Investment property

27.8

27.7

(0.0)

Other financial assets

292.3

299.8

7.5

Deferred tax assets

13.5

13.2

(0.3)

Other non-current assets

42.2

41.9

(0.3)

Total non-current assets

632.7

676.8

44.1

Current assets

Inventories

64.9

65.5

0.6

Trade receivables

122.8

120.6

(2.3)

Other financial assets

215.8

270.0

54.3

Increase in time deposits over 3 months

Other current assets

22.6

27.7

5.0

Cash and cash equivalents

358.1

374.8

16.7

Total current assets

784.2

858.5

74.3

Total assets

1,416.9

1,535.3

118.4

Equity and liabilities

Equity

Share capital

21.3

21.3

-

Capital surplus

14.2

17.8

3.6

Treasury shares

(137.9)

(65.9)

(72.0)

Cancellation of treasury shares

Retained earnings

1,065.9

1,115.7

49.8

Other components of equity

271.8

272.9

1.1

Equity attributable to owners

of parent

1,235.3

1,361.9

126.6

Non-controlling interests

17.2

0.6

(16.7)

Total equity

1,252.6

1,362.5

109.9

Liabilities

Non-current liabilities

Lease liabilities

8.8

18.4

9.7

Increase in lease liabilities relating to the new Head Office

Other financial liabilities

7.6

8.3

0.6

Retirement benefit liability

8.0

8.0

0.0

Deferred tax liabilities

4.4

4.4

0.0

Other non-current liabilities

1.7

4.4

2.7

Total non-current liabilities

30.4

43.5

13.0

Current liabilities

Lease liabilities

2.9

3.5

0.6

Trade payables

14.8

13.6

(1.2)

Other financial liabilities

31.1

18.1

(13.0)

Income taxes payable

20.8

22.4

1.6

Other current liabilities

64.3

71.9

7.6

Total current liabilities

133.9

129.4

(4.5)

Total liabilities

164.4

172.9

8.5

Total equity and liabilities

1,416.9

1,535.3

118.4

6. Management index

FY2023

FY2024

Apr.-Jun.

Apr.-Sep.

Apr.-Dec.

Apr.-Mar.

Apr.-Jun.

Apr.-Sep.

Apr.-Dec.

Apr.-Mar.

STS2030 Revision Growth

Revenue *1

Billions of yen

109.3

230.5

336.8

435.1

97.6

214.0

333.6

438.3

Overseas sales CAGR *2

％

-

-

-

17.4

-

-

-

17.9

EBITDA

Billions

of yen

51.3

114.2

160.2

188.7

33.1

86.7

146.4

179.3

STS2030 Revision Shareholder return

Basic earnings per share *3

yen

48.21

102.88

145.30

186.17

36.02

97.74

157.30

200.36

Diluted earnings per share *3

yen

48.19

102.85

145.25

186.11

36.01

97.70

157.25

200.29

Ratio of dividends to equity attributable to owners of parent (DOE)

％

-

-

-

4.0

-

-

-

4.0

Return on equity attributable to owners of parent (ROE)

％

3.7

7.8

11.1

13.9

2.4

6.6

10.4

13.1

Others

Ratio of profit before tax to total assets (ROA)

％

4.2

8.5

12.3

14.5

2.5

6.5

10.6

13.6

Ratio of operating profit to revenue

％

42.6

42.6

41.2

35.2

28.8

35.5

38.7

35.7

Ratio of equity attributable to owners of parent to total assets

％

85.8

85.8

87.7

87.2

87.9

88.7

88.7

88.7

Dividend payout ratio

％

-

-

-

28.6

-

-

-

30.6

*1. Revenue for FY2023 includes Lump-sum income for transfer of ADHD drug.

  1. Excluding royalty income, starting from FY2022

  2. The Company conducted a 3-for-1 stock split of shares of common stock, effective October 1, 2024. Basic earnings per share and Diluted earnings per share were calculated under the assumption that the stock split had been conducted at the beginning of FY2023.

7. Employees

FY2023

FY2024

As of

Jun. 30

SAs of ep. 30

As of

Dec. 31

As of

Mar. 31

As of

Jun. 30

As of

Sep. 30

As of

Dec. 31

As of

Mar. 31

Employees

Persons

5,719

5,325

4,957

4,959

5,001

4,990

4,944

4,955

* The decrease in FY2023 is mainly due to the fact that Shionogi Business Partner Co., Ltd. is no longer a consolidated subsidiary following the formation of a joint venture with Accenture Japan Ltd. in July 2023 and the implementation of a special early retirement program with a retirement date of October 31, 2023.

8. Capital investments and Depreciation and Amortization

(Billions of yen)

FY2023

FY2024

Change

Change(％)

FY2024

forecast

Progress(％)

FY2025

forecast

Change

Investments in equipments

Depreciation and Amortization

14.9

18.3

12.3

20.9

(2.6)

2.6

(17.5)

14.2

12.5

20.6

98.6

101.7

31.0

22.1

18.8

1.1

Property, plant andequipment

10.3

11.7

1.4

14.0

Intangible assets

5.9

6.2

0.3

5.1

Right-of-use assets

2.2

2.7

0.5

24.5

Investment property

0.0

0.4

0.3

-

9. Exchange rate

FY2023

FY2024

FY2025

forecast

CR

AR

CR

AR

AR

USD

151.33

144.59

149.53

152.62

147

GBP

191.13

181.72

193.76

194.73

187

EUR

163.24

156.76

162.05

163.88

153

10. Pipeline (as of May 12, 2025)

Areas

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

Infectious disease

Cefiderocol Tosilate Sulfate Hydrate

[US, Japan: Fetroja®] [EU:Fetcroja®]

Cell-wall synthesis inhibition (injection)

Gram-negative infection(pediatric)

Phase III

In-house

In-house

Gram-negative infection

Phase III

NDA submission: China (Aug. 2024)

MAA submission: Australia (Dec. 2024)

In-house

In-house

Baloxavir marboxil [USA:XofluzaTM] [Japan:Xofluza®]

Cap-dependent endonuclease inhibition (oral, granule)

Influenza virus infection(body weight <20kg)

NDA submission: Japan (Aug. 2018)

In-house

In-house/ Roche (Switzerland)

S-268019

[Japan:Covgoze®]

Vaccine (muscular injection)

Prevention of COVID-19 (Adolescent)

Phase II/III

In-house

In-house

Prevention of COVID-19 (Children)

Phase I/II/III

In-house

In-house

S-268023

Vaccine (muscular injection)

Prevention of COVID-19

Phase III

In-house

In-house

S-268024

Vaccine (muscular injection)

Prevention of COVID-19

Phase III

In-house

In-house

Ensitrelvir Fumaric Acid [Japan:Xocova®]

3CL protease inhibitor (oral)

Treatment of COVID-19 (12 years old and older)

Phase III

NDA submission: Taiwan (Jan. 2025)

NDA withdrawal: Singapore

In-house

Japan, global, Taiwan:

In-house South Korea:

In-house/Ildo ng Singapore: In-house/Jun iper

Treatment of COVID-19 (Children, 5 to 11 years)

Phase III

In-house

In-house

Post exposure prophylaxis of COVID-19

NDA submission: Japan (Mar. 2025)

In-house

In-house

Olorofim

Dihydroorotate dehydrogenase (DHODH) inhibition (oral)

Invasive aspergillosis

Phase III

F2G (UK)

In-house/ F2G

S-892216

3CL protease inhibitor (oral)

Treatment of COVID-19

Phase II

In-house

In-house

3CL protease inhibitor (long-acting injection)

Pre exposure prophylaxis of COVID-19

Phase I

In-house

In-house

S-337395

RNA dependent RNA polymerase inhibitor (oral)

Treatment of RSV infection

Phase II

In-house/ UBE

In-house/ UBE

S-743229

Cell-wall synthesis inhibition (oral)

Complicated urinary tract infections, including pyelonephritis

Phase I

In-house/ Qpex

In-house

S-649228

Cell-wall synthesis inhibition (injection)

Gram-negative infection

Phase I

In-house/ Qpex

In-house

QOL

Diseases

Naldemedine tosilate [Japan:Symproic®] [EU:Rizmoic®]

Peripheral opioid receptor antagonist (oral, powder)

Opioid-induced constipation (pediatric)

Phase I/II

In-house

In-house

Peripheral opioid receptor antagonist (oral)

Opioid-induced constipation

Phase III

In-house

In-house

Zuranolone

GABAA receptor positive allosteric modulator (oral)

Depression

NDA submission: Japan (Sep. 2024)

Sage (USA)

In-house/ Sage

SDT-001 [Japan:ENDEAVORRIDE®]

Treatment digital application based on cerebral mechanism

Treatment of ADHD (pediatric)

Approval: Japan (Feb. 2025)

Akili (USA)

In-house/ Akili

Zatolmilast

PDE4D negative allosteric modulator (oral)

Fragile X syndrome

Phase II/III

Tetra (USA)

In-house

Jordan syndrome

Phase II

Tetra (USA)

In-house

Alzheimer's disease

Phase II

Tetra (USA)

In-house

Resiniferatoxin

TRPV1 agonist

(Intra-articular injection)

Pain associated with osteoarthritis of knee

Phase III

Grünenthal (Germany)

Grünenthal

S-151128

Nav1.7 inhibitor (injection)

Chronic pain

Phase I

In-house

In-house

ADR-001

Human mesenchymal stem cells (injection)

Decompensated liver cirrhosis

Phase I/II

Rohto (Japan)

In-house/ Rohto

S-309309

Monoacylglycerol acyltransferase 2 inhibitor (oral)

Obesity

Phase II

In-house

In-house

S-588410

Cancer peptide vaccine (injection)

Esophageal cancer

Phase III

OncoTherapy Science, Inc. (Japan)

In-house

Cancer peptide vaccine (injection)

Bladder cancer

Phase II

OncoTherapy Science, Inc. (Japan)

In-house

S-488210

Cancer peptide vaccine (injection)

Head and neck squamous cell carcinoma

Phase I/II

OncoTherapy Science, Inc. (Japan)

In-house

S-588210

Cancer peptide vaccine (injection)

Solid tumor

Phase I

OncoTherapy Science, Inc. (Japan)

In-house

Areas

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

QOL

Diseases

S-222611

(Epertinib)

HER2/EGFR dual inhibitor (oral)

Malignant tumor

Phase I/II

In-house

In-house

SR-0379

Promote granulation formation (topical)

Cutaneous ulcer (Pressure ulcer, Diabetic ulcer)

Phase III

FunPep (Japan)

In-house/ FunPep

Redasemtide Trifluoroacetate

Mobilization of mesenchymal stem cells (MSCs) to peripheral blood (injection)

Stroke

Phase IIb

StemRIM (Japan)

In-house

Mobilization of mesenchymal stem cells (MSCs) to peripheral blood (injection)

Epidermolysis bullosa

Phase II

StemRIM (Japan)

In-house

S-531011

anti-CCR8 antibody (injection)

Solid tumor

Phase Ib/II

In-house

In-house

S-740792

New mechanism of action (oral)

Walking impairment associated with multiple sclerosis

Phase I

In-house

In-house

SASS-001

(S-600918 + Concomitant drug X)

P2X3 receptor inhibitor (oral) + Mechanism of Concomitant drug

Sleep apnea with a central component

Phase II

S-600918:

In-house

Shionogi-Apnimed Sleep Science, LLC (USA)

S-606001

Glycogen synthase 1 (GYS1) inhibitor (oral)

Pompe disease

Phase I

Maze (USA)

In-house

SDS-881

AI Programmed Medical Device for Conversational Cognitive Function Testing

Cognitive impairment in dementia

Phase III

FRONTEO

(Japan）

In-house

＜Out-Licensing Activity＞

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

Baloxavir marboxil [USA:XofluzaTM] [Japan:Xofluza®]

Cap-dependent endonuclease inhibition (oral)

Influenza virus infection (pediatric, < 1 year old)

NDA Submission: EU (Jun. 2024)

In-house

In-house/ Roche (Switzerland)

Influenza virus infection (transmission)

NDA submission: USA (Nov. 2024)

In-house

In-house/ Roche (Switzerland)

S-723595 (TLC-3595)

Acetyl-CoA carboxylase 2 inhibitor (oral)

Type 2 diabetes

Phase IIa

In-house

OrsoBio, Inc. (USA)

S-365598

Integrase inhibitor

(ultra long-acting injection)

HIV infection

Phase IIa

In-house

SHIONOGI-

ViiV Healthcare LLC

Since January 31, 2025

Change

Ensitrelvir Fumaric Acid(Prevention): Phase III→Japan: NDA submission

S-892216(oral): Phase I→ Phase II

SDT-001: Japan: NDA submission→ Approval

Add

S-268024: Phase III

S-892216(long-acting injection): Phase I

SDS-881： Phase III