Kaken Pharmaceutical Co., Ltd.TSE: 4521

Reference Data of Financial Statements for the 2Q of Fiscal 2024

· Issued by Kaken Pharmaceutical Co., Ltd.

Consolidated Financial Results for the Second Quarter of Fiscal 2024

(Reference Data of Consolidated Financial Results)

November 8, 2024

KAKEN PHARMACEUTICAL CO., LTD.

Corporate Communications

Tel: +81-(0)3-5977-5002

1. Summary of Consolidated Financial Statements for the Second Quarter of Fiscal 2024

(amounts are rounded down to the nearest million Yen)

FY2023

FY2023

FY2024

Change

Revised Plan

Change

2Q

2Q

Yen

%

FY2024

Yen

%

Net sales

36,171

72,044

51,372

15,201

142.0%

88,500

16,455

122.8%

Operating profit

5,512

9,513

19,579

14,066

355.2%

20,800

11,286

218.6%

Ratio to net sales

15.2%

13.2%

38.1%

23.5%

Ordinary profit

5,722

9,951

19,823

14,100

346.4%

21,200

11,248

213.0%

Ratio to net sales

15.8%

13.8%

38.6%

24.0%

Profit

4,068

8,025

14,286

10,217

351.2%

14,200

6,174

176.9%

Ratio to net sales

11.2%

11.1%

27.8%

16.0%

Per share profit (Yen)

108.18

212.67

377.23

374.93

Comprehensive income

5,814

11,684

13,469

7,655

231.7%

Capital expenditures

722

2,304

2,315

1,593

320.6%

3,000

695

130.2%

R&D expenses

5,738

12,543

5,973

235

104.1%

15,700

3,156

125.2%

Depreciation and amortization

1,291

2,596

1,265

(25)

98.0%

2,600

3

100.1%

Number of employees

1,155

1,135

1,143

(12)

2. Consolidated Net Sales by Segment

(amounts are rounded down to the nearest million Yen)

FY2023

FY2023

FY2024

Change

2Q

2Q

Yen

%

Pharmaceuticals,

34,958

69,613

50,150

15,192

143.5%

medical devices & crop

protection products

Real estate business

1,212

2,430

1,222

9

100.8%

Total

36,171

72,044

51,372

15,201

142.0%

1

KAKEN PHARMACEUTICAL CO., LTD.

2

3. Summary of Consolidated Balance Sheet

(amounts are rounded down to the nearest million Yen)

As of

As of

As of

Y o Y

Sept. 30,

Ratio

Mar. 31,

Ratio

Sept. 30,

Ratio

Increase

2023

2024

2024

(Decrease)

Total assets

171,651

100.0%

171,623

100.0%

187,123

100.0%

15,472

Current assets

112,745

65.7%

106,974

62.3%

122,681

65.6%

9,936

Non-current assets

58,906

34.3%

64,648

37.7%

64,442

34.4%

5,536

Total liabilities

30,922

18.0%

27,868

16.2%

32,718

17.5%

1,795

Current liabilities

22,160

12.9%

19,024

11.1%

23,683

12.7%

1,522

Non-current liabilities

8,762

5.1%

8,843

5.2%

9,034

4.8%

272

Total net assets

140,728

82.0%

143,755

83.8%

154,405

82.5%

13,676

Capital stock

23,853

13.9%

23,853

13.9%

23,853

12.7%

0

Capital surplus

11,462

6.7%

11,462

6.7%

11,500

6.1%

38

Retained earnings

127,390

74.2%

128,506

74.9%

139,949

74.8%

12,558

Treasury stock

(28,612)

▲ 16.7%

(28,613)

▲ 16.7%

(28,629)

▲ 15.3%

(16)

Net unrealized holding

6,472

3.8%

7,184

4.2%

6,408

3.4%

(63)

gain on securitiess

Remeasurements of

162

0.1%

1,363

0.8%

1,322

0.7%

1,159

defined benefit plans

4. Summary of Consolidated Statements of Cash Flows

(amounts are rounded down to the nearest million Yen)

FY2023

FY2024

Y o Y

FY2023

Increase

2Q

2Q

(Decrease)

Net cash provided by (used in) operating activities

(245)

2,577

23,932

24,177

Net cash provided by (used in) investing activities

(1,141)

(5,854)

(2,432)

(1,290)

Net cash provided by (used in) financing activities

(2,813)

(5,658)

(2,839)

(25)

Cash and cash equivalents at end of year

70,060

65,325

83,987

13,926

KAKEN PHARMACEUTICAL CO., LTD.

5. Summary of Non-consolidated Financial Statements for the Second Quarter of Fiscal 2024

(amounts are rounded down to the nearest million Yen)

FY2023

FY2023

FY2024

Change

Revised Plan

Change

2Q

2Q

Yen

%

FY2024

Yen

%

Net sales

36,147

71,955

51,327

15,180

142.0%

88,400

16,444

122.9%

Operating profit

5,725

9,784

19,626

13,900

342.8%

20,900

11,115

213.6%

Ratio to net sales

15.8%

13.6%

38.2%

23.6%

Ordinary profit

5,932

10,220

19,870

13,938

335.0%

21,300

11,079

208.4%

Ratio to net sales

16.4%

14.2%

38.7%

24.1%

Profit

4,293

8,483

14,333

10,040

333.8%

15,300

6,816

180.4%

Ratio to net sales

11.9%

11.8%

27.9%

17.3%

Capital expenditures

721

2,304

2,315

1,593

320.7%

3,000

695

130.2%

R&D expenses

5,622

12,427

5,973

350

106.2%

15,700

3,272

126.3%

Depreciation and amortization

1,291

2,596

1,265

(25)

98.0%

2,600

3

100.1%

Export volume

2,665

6,353

16,506

13,840

619.3%

Pharmaceuticals

1,625

3,260

15,599

13,974

959.8%

Crop protection products

1,040

3,092

906

(133)

87.2%

Number of employees

1,146

1,124

1,133

(13)

6. Non-consolidated Net Sales by Segment

(amounts are rounded down to the nearest million Yen)

FY2023

FY2023

FY2024

Change

Revised Plan

Change

2Q

2Q

Yen

%

FY2024

Yen

%

Pharmaceuticals & medical

32,991

63,458

48,232

15,241

146.2%

79,620

16,161

125.5%

devices

Crop protection products

1,943

6,066

1,872

(70)

96.4%

6,340

273

104.5%

Real estate business

1,212

2,430

1,222

9

100.8%

2,440

9

100.4%

Total

36,147

71,955

51,327

15,180

142.0%

88,400

16,444

122.9%

3

KAKEN PHARMACEUTICAL CO., LTD.

7. Sales of Main Pharmaceuticals and Medical Devices (Non-consolidated)

(amounts are rounded down to the nearest million Yen)

FY2023

FY2023

FY2024

Change

Plan

Change

2Q

2Q

(%)

FY2024

(%)

Onychomycosis treatment

9,199

17,116

9,172

99.7%

17,200

100.5%

Clenafin

Anti-osteoarthritis agent

8,929

18,040

9,804

109.8%

19,000

105.3%

Artz

Post-operative anti-adhesive

3,544

6,995

3,567

100.7%

6,800

97.2%

Seprafilm

Wound-healing agent

1,321

2,626

1,249

94.5%

2,600

99.0%

Fiblast

Primary axillary

hyperhidrosis treatment

1,387

1,812

1,360

98.1%

2,200

121.4%

Ecclock

Periodontal regenerative agent

442

898

463

104.7%

900

100.2%

Regroth

Lumbar disc herniation treatment

188

382

205

108.9%

400

104.7%

Hernicore

Generic products (total)

4,024

7,992

4,279

106.3%

8,100

101.4%

4

KAKEN PHARMACEUTICAL CO., LTD.

8. Projects under Development

As of November 8, 2024

Development

Planned

Development

Remarks

Code

Indication

Stage (*)

KAR

Head lice

P III

In-licensed from Arbor Pharmaceuticals, LLC.

Product name in the US: Sklice®

KP-001

Refractory vascular

P III

-

malformations

KC-8025 (Seladelpar)

Primary biliary

P III

In-licensed from CymaBay Therapeutics, Inc.

cholangitis

Acquired by Gilead Sciences in February 2024.

KP-483

Solid tumors

P I

Product discovered in-house

(Immuno-oncology)

KP-910

Peripheral neuropathic

P I

Product discovered in-house

pain

Tildacerfont

Congenital adrenal

P I

In-licensed from Spruce Biosciences, Inc.

hyperplasia

KP-001 (USA)

Refractory vascular

P I

Consulting with FDA on PIII plan

malformations

  1. The development stage includes the clinical trial preparation period.

9. Status of out-licensed products overseas

As of November 8, 2024

Generic name

Planned indication

Development stage

Out-licensed to (developing country)

(domestic sales name)

Efinaconazole

Onychomycosis

Authorization application

Almirall S.A. (Europe (Germany and Italy))

(Clenafin)

Efinaconazole

Onychomycosis

P III

AIM (China)

(Clenafin)

Sofpironium bromide

Primary axillary

Authorization application

Dong-Wha Pharm Co., Ltd. (Korea)

(Ecclock)

hyperhidrosis

10. Status of projects under development with a commercial option agreement in Japan

As of November 8, 2024

Development Code

Planned indication

Development stage

Remarks

NM26

Atopic dermatitis

P I

Clinical trial underway after IP transfer to J&J

※Although NM26 was removed from the list of projects under development as a result of the IP transfer, Kaken has the option to negotiate a commercial agreement for all indications for which J&J receives regulatory approval in Japan

11. Status of development products for which license agreements have been concluded (medical devices)

As of November 8, 2024

Application Name

Intended use

Development stage

Remarks

or effect

Silk-Elastin Wound

Manufacturing and marketing approval is under

Wound treatment

Authorization application

review after submission by the licensor, Sanyo

Healing Sheet

Chemical Industries, Ltd.

5

KAKEN PHARMACEUTICAL CO., LTD.