Consolidated Financial Results
for the Third Quarter of Fiscal 2024
(Reference Data of Consolidated Financial Results)
February 6, 2025
Kaken Pharmaceutical Co., Ltd.
Corporate Communications
Tel: +81-(0)3-5977-5002
1. Summary of Consolidated Financial Statements for the Third Quarter of Fiscal 2024 | ||||||||
(amounts are rounded down to the nearest million Yen) | ||||||||
FY2023 | FY2024 | Change | Revised | Change | ||||
FY2023 | Plan | |||||||
3Q | 3Q | Yen | % | Yen | % | |||
FY2024 | ||||||||
Net sales | 54,685 | 72,044 | 75,990 | 21,304 | 139.0% | 88,500 | 16,455 | 122.8% |
Operating profit | 8,873 | 9,513 | 25,420 | 16,546 | 286.5% | 20,800 | 11,286 | 218.6% |
Ratio to net sales | 16.2% | 13.2% | 33.5% | 23.5% | ||||
Ordinary profit | 9,304 | 9,951 | 26,081 | 16,776 | 280.3% | 21,200 | 11,248 | 213.0% |
Ratio to net sales | 17.0% | 13.8% | 34.3% | 24.0% | ||||
Profit | 6,675 | 8,025 | 19,175 | 12,499 | 287.2% | 14,200 | 6,174 | 176.9% |
Ratio to net sales | 12.2% | 11.1% | 25.2% | 16.0% | ||||
Comprehensive income | 8,065 | 11,684 | 18,690 | 10,625 | 231.7% |
Capital expenditures | 880 | 2,304 | 2,736 | 1,856 | 310.9% | 3,000 | 695 | 130.2% | |
R&D expenses | 8,502 | 12,543 | 10,557 | 2,055 | 124.2% | 15,700 | 3,156 | 125.2% | |
Depreciation and amortization | 1,942 | 2,596 | 1,866 | (75) | 96.1% | 2,600 | 3 | 100.1% | |
2. Consolidated Net Sales by Segment | |||||||||
(amounts are rounded down to the nearest million Yen) | |||||||||
FY2023 | FY2024 | Change | |||||||
FY2023 | |||||||||
3Q | 3Q | Yen | % | ||||||
Pharmaceuticals, | |||||||||
medical devices & crop | 52,864 | 69,613 | 74,146 | 21,282 | 140.3% | ||||
protection products | |||||||||
Real estate business | 1,821 | 2,430 | 1,843 | 22 | 101.2% | ||||
Total | 54,685 | 72,044 | 75,990 | 21,304 | 139.0% | ||||
1 | KAKEN PHARMACEUTICAL CO., LTD. |
3. Sales of Main Pharmaceuticals and Medical Devices (Non-consolidated) | ||||||
(amounts are rounded down to the nearest million Yen) | ||||||
FY2023 | FY2023 | FY2024 | Change | Revised Plan | Change | |
3Q | 3Q | (%) | FY2024 | (%) | ||
Onychomycosis treatment | 13,821 | 17,116 | 13,551 | 98.0% | 17,200 | 100.5% |
Clenafin | ||||||
Anti-osteoarthritis agent | 13,845 | 18,040 | 14,731 | 106.4% | 19,000 | 105.3% |
Artz | ||||||
Post-operative anti-adhesive | 5,479 | 6,995 | 5,505 | 100.5% | 6,800 | 97.2% |
Seprafilm | ||||||
Wound-healing agent | 2,008 | 2,626 | 1,859 | 92.6% | 2,600 | 99.0% |
Fiblast | ||||||
Primary axillary hyperhidrosis | ||||||
treatment | 1,588 | 1,812 | 1,720 | 108.3% | 2,200 | 121.4% |
Ecclock | ||||||
Periodontal regenerative agent | 670 | 898 | 710 | 105.9% | 900 | 100.2% |
Regroth | ||||||
Lumbar disc herniation treatment | 291 | 382 | 317 | 108.8% | 400 | 104.6% |
Hernicore | ||||||
Generic products (total) | 6,200 | 7,992 | 6,684 | 107.8% | 8,100 | 101.3% |
2 | KAKEN PHARMACEUTICAL CO., LTD. |
4. Projects under Development
As of February 6, 2025 | |||
Development code | Planned indication | Development | Remarks |
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 | Primary biliary cholangitis | P III | In-licensed from CymaBay Therapeutics, Inc. |
(Seladelpar) | Acquired by Gilead Sciences in February 2024. | ||
KP-483 | Solid tumors | P I | Product discovered in-house |
(Immuno-oncology) | |||
KP-910 | Peripheral neuropathic pain | P I | Product discovered in-house |
Tildacerfont | Congenital adrenal | P I | In-licensed from Spruce Biosciences, Inc. |
hyperplasia | |||
KP-001 (USA) | Refractory vascular | P I | Consulting with FDA on P III plan |
malformations | |||
(*) The development stage includes the clinical trial preparation period.
Note: Kaken will advance KP-723, an oral STAT6 inhibitor in preclinical development, to the completion of Phase I clinical trials, which has entered into a licence agreement with J&J.
5. Status of out-licensed products overseas
As of February 6, 2025 | |||
Generic name | Planned indication | Development | Out-licensed to (developing country) |
(domestic sales name) | stage | ||
Efinaconazole | Onychomycosis | Authorization | Almirall S.A. (Europe (Germany and Italy)) |
(Clenafin) | application | ||
Efinaconazole | Onychomycosis | P III | AIM (China) |
(Clenafin) | |||
Sofpironium bromide | Primary axillary | Authorization | Dong-Wha Pharm Co., Ltd. (Korea) |
(Ecclock) | hyperhidrosis | application | |
6. Status of projects under development with a commercial option agreement in Japan | |||
As of February 6, 2025 | |||
Development code | Planned indication | Development | Remarks |
stage | |||
NM26 | Atopic dermatitis | P I | Clinical trial underway after IP transfer to J&J |
Note: 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
7. Status of development products for which license agreements have been concluded (medical devices)
As of February 6, 2025 | |||
Application name | Intended use | Development | Remarks |
or effect | stage | ||
Silk-Elastin Wound | Authorization | Marketing authorization is under review after | |
Wound treatment | submission by the licensor, Sanyo Chemical | ||
Healing Sheet | application | Industries, Ltd. | |
3 | KAKEN PHARMACEUTICAL CO., LTD. |