Kaken Pharmaceutical Co., Ltd. · TSE:4521

Kaken Pharmaceutical — FY2025 Earnings Presentation

53 slides from Kaken Pharmaceutical's earnings presentation, May 14, 2026

  1. Slide 1: Consolidated Financial Results for the Fiscal Year 2025

    Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translated document and the Japanese original, the original shall prevail. Consolidated Financial Results for the Fiscal Year 2025 (Year ended March 31, 2026)

  2. Slide 2: Cautionary Notes regarding Forward-looking Statement

    Cautionary Notes regarding Forward-looking Statement • The performance forecasts described in this material are rational based on the information currently available and have been determined by the Company as reasonable. • Considerable financial investment and a long development time are required be

  3. Slide 3: 1 Consolidated Financial Results for FY2025 2 Consolidated Financial Forecast for FY2026 3 Pipelines

    1 Consolidated Financial Results for FY2025 2 Consolidated Financial Forecast for FY2026 3 Pipelines 4 Actions to Implement Management that is Conscious of Cost of Capital and Stock Price (Updated) 2

  4. Slide 4: Consolidated Financial Results for FY2025

    1 Consolidated Financial Results for FY2025 3

  5. Slide 5: Consolidated Statements of Income

    Consolidated Statements of Income (amounts are rounded down to the nearest million yen) FY2024 FY2025 Growth actual actual (year-on-year) Net Sales 94,035 76,871 △17,163 △18.3 Cost of Sales 35,502 36,879 ＋1,376 ＋3.9 Gross Profit 58,532 39,991 △18,540 △31.7 Selling, General and Administrative Expense

  6. Slide 6: Net Sales Bridge

    Net Sales Bridge FY2024 FY2025 Change Change △ 17,163 YoY change △18.3 % actual actual (Yen) (％) Pharmaceuticals 91,553 74,328 △17,225 △18.8 (amounts are rounded down to the nearest million yen) 94,035 Pharmaceuticals and medical devices(domestic, overseas) 85,734 67,844 △17,889 △20.9 Upfront 17,900

  7. Slide 7: Operating Profit Bridge

    Operating Profit Bridge △ 21,934 YoY change ー % Analysis of Changes 21,034 (amounts are rounded down to the nearest million yen) Cost of sales YoY: +1,376 Increase due to increased net sales Upfront 17,900 (FYARRO, crop protection products) SG&A (excluding R&D) YoY: +1,534 Increase in stand-alone ex

  8. Slide 8: YoY Comparison of SG&A Expenses (FY2024 vs FY2025)

    YoY Comparison of SG&A Expenses (FY2024 vs FY2025) Aadi’s （million yen） 45,000 Stand-alone R&D Analysis of Changes SG&A expenses 40,000 Upfront (excluding R&D expenses) YoY: +1,534 payments 35,000 Upfront payments Increase in stand-alone expenses of Aadi. (other SG&A) Consolidated 30,000 R&D Incurre

  9. Slide 9: Domestic Pharmaceuticals & Medical Devices Sales by Products

    Domestic Pharmaceuticals & Medical Devices Sales by Products (amounts are rounded down to the nearest million yen) FY2024 FY2025 Change Change Main factors actual actual (Yen) （％） Clenafin​ Group Clenafin​ Group 16,866 13,245 △3,621 △21.5 Sales decreased due to the transition to authorized generic (

  10. Slide 10: Consolidated Balance Sheets

    Consolidated Balance Sheets (amounts are rounded down to the nearest million yen) As of Mar. As of Mar. YoY 31, 2025 31, 2026 change Total 193,377 178,217 △15,159 Assets Cash and cash equivalents: ¥50,705million （△¥19,380million） Current 111,393 94,051 △17,342 Assets Non-current 81,984 84,166 ＋2,182

  11. Slide 11: Consolidated Statements of Cash Flows

    Consolidated Statements of Cash Flows (amounts are rounded down to the nearest million yen) TOPICS *Negative figures indicate payments. As of Mar. As of Mar. YoY 31, 2025 31, 2026 change Cash flows from operating activities Profit before income taxes: ¥2,313million (△¥17,122million) Income taxes pai

  12. Slide 12: Consolidated Financial Forecast for FY2026

    2 Consolidated Financial Forecast for FY2026 11

  13. Slide 13: Financial Performance Forecast

    Financial Performance Forecast (amounts are rounded down to the nearest million yen) FY2025 FY2026 Change Change Main Focuses Plan (Yen) (%) Net Sales Growth: +13,028 Net Sales 76,871 89,900 13,028 ＋16.9 Includes milestone payments under the license agreement with Johnson & Johnson Domestic performa

  14. Slide 14: Domestic Sales Forecast: Pharma & Devices

    Domestic Sales Forecast: Pharma & Devices (amounts are rounded down to the nearest million yen) FY2026 Change Change Main Focuses FY2025 Plan (Yen) (％) Clenafin group Expect sales decline from the transition to its AG. Clenafin group 13,245 7,900 △5,345 △40.4 Plan to drive growth through market expa

  15. Slide 15: Clenafin AG Initiatives

    Clenafin AG Initiatives (Bottle/4ml formulation) 450,000 Launched AG（September） Early Launch of AG Became a Growth-Driven, Offensive Initiative 400,000 Strategic Significance of the Early Launch of AG 350,000 Preparation for the entry of other GE Earlier provision of more affordable treatment option

  16. Slide 16: Ecclock: Five Years Progress since the Launch

    Ecclock: Five Years Progress since the Launch Main Focuses Disease awareness Strengthen disease awareness Start a collaborative project Open disease awareness activities on sweating web site Launched Ecclock Launched twist bottle 5th Anniversary and won the Good Design Award Launched in Korea Produc

  17. Slide 17: Ecclock's Growth Through Expansion of the Market

    Ecclock’s Growth Through Expansion of the Market Primary Axillary Hyperhidrosis Topical Treatment Market （million yen） Launched of a New Dosage Form 6,000 (Twist Bottle) Initiatives for Future Growth 5,000 4,000 3,000 Launching a three-company joint disease awareness project to Launched encourage hy

  18. Slide 18: EKTERLY Tablet

    EKTERLY® Tablet The world’s first oral on-demand therapy for acute attacks of HAE Events in FY2025 1st X R&D Transformation Continuously launch innovative, world-class 2025 VISION drugs in our three priority fields of drug 4 License Agreement discovery Expand pipeline Rare Disease Priority Increase

  19. Slide 19: Consolidated Financial Performance

    Consolidated Financial Performance (Amount in Yen million) (Plan) Operating Profit 94,035 95,000 売上高 Sales 営業利益 純利益 89,900 Profit 76,034 76,871 72,984 72,044 75,000 55,000 35,000 21,034 17,064 7,998 9,513 7,900 15,000 2,144 9,549 5,440 8,025 13,945 6,500 △ 5,000 △899 FY2021 2022/3 FY2022 2023/3 FY20

  20. Slide 20: Pipelines

    ３ Pipelines 19

  21. Slide 21: Pipeline Status (In-house Discovered & In-licensed Projects)

    Pipeline Status (In-house Discovered & In-licensed Projects) Development Phase PⅠ PⅡ PⅢ Filed Announced the top line data KP-001 from the confirmatory trial (Refractory vascular malformations) KP-001 In-house (Refractory vascular malformations) discovered KP-483 (Solid tumors) KP-910 (Peripheral neu

  22. Slide 22: In-licensed Projects (Other Development Projects)

    In-licensed Projects (Other Development Projects) Development Phase PⅠ PⅡ PⅢ Filed March 2026 - Sebetralstat (Ekterly) Launch (Hereditary angioedema) Partner TWOCELLS COMPANY, LIMITED developed gMSC1 Preparing for PⅢ projects (Knee osteoarthritis with focal defect) December 2025: PIIb NM26 discontin

  23. Slide 23: Pipeline Progress Forecast

    Pipeline Progress Forecast PⅠ PⅡ PⅢ Filed ※ Based on our forecast as of May 2026 (Calendar year) 2024 2025 2026 2027 2028 2029 2030 2031 2032 KAR Head lice KP-001 Refractory vascular malformations KC-8025 Primary biliary cholangitis ESK-001 Plaque psoriasis Navenibart Hereditary angioedema KP-001 Re

  24. Slide 24: Envudeucitinib (ESK-001) in Moderate-to-Severe Plaque Psoriasis

    Envudeucitinib (ESK-001) in Moderate-to-Severe Plaque Psoriasis: 24-Week Results From the Randomized, Double-Blind, Active Comparator- and Placebo-Controlled, Phase 3 ONWARD1 and 2 Studies Andrew Blauvelt1, Howard Sofen2, April Armstrong3, Benjamin Ehst4-6, Jennifer Soung7, Maryam Shayesteh Alam8, D

  25. Slide 25: ONWARD1 and ONWARD2: Study Designs and Endpoints

    ONWARD1 and ONWARD2a : Study Designs and Endpoints Coprimary Endpoints (vs Placebo) • PASI 75 2:1:1 Randomization Envudeucitinib 40 mg BID (n = 459; 433) • sPGA-0/1 Rollover to Key Secondary Endpoints W16 ONWARD3 OR (vs Placebo or Apremilast) Placebo (n = 230; 211) (Transition to Study • PASI 75/90/

  26. Slide 26: Time course of PASI response rates

    Time course of PASI response rates At Week 24, approximately 65% and 40% of patients achieved PASI 90 and PASI 100, respectively ONWARD1 ONWARD2 Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg B

  27. Slide 27: Time course of PASI 90 response rates

    Time course of PASI 90 response rates Envudeucitinib rapidly achieved PASI 90 and demonstrated significantly higher response rates compared with placebo and apremilast ONWARD1 ONWARD2 Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Envudeucitinib 40 mg BID (n = 43

  28. Slide 28: Time course of PASI 100 response rates

    Time course of PASI 100 response rates At Week 24, approximately 40% of patients achieved complete clearance of skin lesions, with steady improvement over time ONWARD1 ONWARD2 Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Envudeucitinib 40 mg BID (n = 433) Place

  29. Slide 29: Time course of scalp psoriasis improvement

    Time course of scalp psoriasis improvement More than 30% of patients treated with envudeucitinib achieved ss-PGA 0/1a as early as Week 4, and approximately 75% achieved ss-PGA 0/1a by Week 24 ONWARD2 Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223) Envudeucitinib 4

  30. Slide 30: Time course of pruritus reduction

    Time course of pruritus reduction The worst pruritus NRS decreased by ≥4 points by Week 12, with continued improvement thereafter ONWARD1 ONWARD2 Week Week 0 4 8 12 16 20 24 0 4 8 12 16 20 24 Worst Pruritus NRS, Δ Baseline, LSM (95% CI) Worst Pruritus NRS, Δ Baseline, LSM (95% CI) 0 0 -1 -0.8 -0.6 -

  31. Slide 31: Time course of PASI response, pruritus reduction, and QOL improvement

    Time course of PASI 90 response, pruritus reduction, and QOL improvement In the envudeucitinib group, improvements in pruritus and QOL were observed prior to achieving PASI 90 ONWARD1 ONWARD2 Envudeucitinib Envudeucitinib 80 40 mg BID 0 80 40 mg BID 0 Itch Δ Baselinea (95% CI) Itch Δ Baselinea (95%

  32. Slide 32: ONWARD1 and ONWARD2 Pooled Safety Through Weeks 24

    ONWARD1 and ONWARD2 Pooled Safety Through Weeks 24 Through Week 16 Through Week 24 Placebo to Overall Envudeucitinib Apremilast30 Envudeucitinib Envudeucitinib Envudeucitinib 40 Apremilast 30 40 mg BID Placebo mg BID 40 mg BID 40 mg BID mg BID mg BID n (%) n = 890 n =441 n = 438 only n = 890 n = 390

  33. Slide 33: Envudeucitinib summary of ONWARD1 and 2 results

    Envudeucitinib, a next-generation TYK2i, delivered early and progressively deepening skin clearance, with meaningful improvements in patient-reported outcomes in ONWARD1 and 2  All primary and secondary efficacy endpoints met, with approximately 65% and 40% of patients receiving envudeucitinib achi

  34. Slide 34: Actions to Implement Management that is Conscious of Cost of Capital and Stock Price

    4 Actions to Implement Management that is Conscious of Cost of Capital and Stock Price (Updated) 33

  35. Slide 35: VISION

    Reproduced from Long-term Business Plan 2031 - Vision and Strategies May 2022 materials 1. A company that contributes to longer healthy life expectancy by developing VISION and supplying innovative new drugs in a speedy manner. 2. A research-based pharmaceutical company with a global presence, prima

  36. Slide 36: What Kaken Aim for: Realize PBR of 1.0x or higher

    Reproduced from What Kaken Aim for May 2024 materials Kaken aim to increase mid- to long-term corporate value through execution of strategies to achieve VISION for Long-Term Business Plan 2031  Achieve ROE target of 10% through allocating cash as priority source for strategic investments and contin

  37. Slide 37: Target and Initiatives

    Reproduced from Target and Initiatives May 2024 materials  Target and Initiatives to achieve PBR of 1.0x or higher Target Initiatives A) Pursue 3Xs strategy to expand pipelines and increase net sales and profits ROE 10％ or higher B) Prioritize strategic investment based on cash flow allocation C) S

  38. Slide 38: Progress on Initiatives (Including Selected Updated)

    Progress on Initiatives (Including Selected Updated) Initiatives Major progress A) Pursue 3Xs strategy to expand pipelines and  Pipelines: 12 (As of May 13, 2026) increase net sales and profits In-licensing: Three (FY2025); cumulative total of 10 projects since the start of the Long-Term Business P

  39. Slide 39: Progress on Strategic Investment

    Progress on Strategic Investment  Spent approximately ¥97 billion in strategic investment for the past four years. ￥260 billion 【Breakdown of Strategic Investment for FY2025】 【Breakdown of cumulative investment】 R&D expenses (incl. CapEx and DX): ￥18 billion M&A, in-licensing:￥7 billion R&D:  Two

  40. Slide 40: Major Cash-Outflows and Cash and Cash Equivalents Balance Trend

    Major Cash-Outflows and Cash and Cash Equivalents Balance Trend Strategic investment and Cash & CE shareholder return （Unit: ¥100 million） （Unit: （億円） ¥100 million） 600 戦略投資 Strategic investment 800 Cash & CE 現預金等 株主還元 Shareholder return 746 742 750 500 700 Strategic investments: 131 700 R&D (incl.

  41. Slide 41: Changes in the Pipeline Over Time

    Changes in the Pipeline Over Time Ove  After the announcement of the Long-Term Business Plan 2031, r projects had been in-licensed as of March 2026. ten :Rare diseases Tim Long-Term ESK-001 e Business Plan 2031 FYARRO Navenibart In-licensing and ART-648 Tildacerfont ND081 gMSC1 marketing (Discontin

  42. Slide 42: Reduction Policy on Cross-Shareholdings and Progress

    Reduction Policy on Cross-Shareholdings and Progress  As of March 31, 2026 approximately ¥3.3 billion of treasury stock has been disposed of against the target amount of approximately ¥6.0 billion (reduction ratio: approximately 56%), achieving more than half of the five-year target within two year

  43. Slide 43: Communication with Shareholders and Investors

    Communication with Shareholders and Investors  Conducted communication with shareholders and investors through investor meeting and individual meeting.  Feedback is also provided to the Board of Directors twice a year. Dialogue and meetings with institutional investors* Topics and themes in the me

  44. Slide 44: Progress Against Targets

    Progress Against Targets  Maintained PBR above 1.0x 30% Analysis 20% • ROE declined due to a ROE 10% 1.4% substantial decrease in net 0% sales. 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 • Net sales decreased as a result of the deferral of milestone from FY2025 to FY2026, the impact of 80 73

  45. Slide 45: Appendix

    Appendix Copyright © KAKEN PHARMACEUTICAL CO., LTD. All Rights Reserved 44

  46. Slide 46: Pipelines

    Pipelines In-house discovered and in-licensed projects As of May 13, 2026 (*) The development stage includes the preparatory period for clinical trials. Development Development パイプラインの状況 code Planned Indication Stage * In-house/In-licensed Remarks Arbor Pharmaceuticals, LLC ・Pre-submission KAR Head

  47. Slide 47: Other Development Programs

    Other Development Programs Other As of November 10, 2025 Development Development code Planned Indication Stage Remark ・Allogenic synovial mesenchymal stem cell-derived three-dimensional artificial tissue Knee osteoarthritis Preparing for gMSC1 ・Developed by the licensor, TWOCELLS Co., Ltd. with a fo

  48. Slide 48: Long-Term Business Plan 2031 — Review of Year 4 (FY2025)

    Long-Term Business Plan 2031 — Review of Year 4 (FY2025) Month Description Month Description Partnership and license agreement for the Announcement of the result of PⅢ trial of KP-001 in 4 commercialization of sebetralstat for Hereditary Japan Angioedema in Japan 11 Licensing and co-development agre

  49. Slide 49: Long-Term Business Plan 2031 — R&D Transformation Review

    Long-Term Business Plan 2031 — Review of Year 4 (FY2025) 1st X 2nd X 3 rd X R&D Overseas Expansion Management Base Transformation Transformation Transformation Address New Needs and 1 Improve Launch Probability 3 Overseas Expansion Improved hit rate of lead compounds through Promoting discovery of p

  50. Slide 50: Long-Term Business Plan 2031 — Expand Global Products

    Long-Term Business Plan 2031 — Review of Year 4 (FY2025) 1st X 2nd X 3 rd X R&D Overseas Expansion Management Base Transformation Transformation Transformation 3 Establish Global Manufacturing and 1 Expand Global Products Commercialization Structure Clenafin：Approved in Germany Considering expansion

  51. Slide 51: Long-Term Business Plan 2031 — Production Strategy

    Long-Term Business Plan 2031 — Review of Year 4 (FY2025) 1st X 2nd X 3 rd X R&D Overseas Expansion Management Base Transformation Transformation Transformation 1 Human Resource Strategy 3 Production Strategy Recruitment of highly skilled specialists and Preparations for domestic and international ac

  52. Slide 52: Long-Term Business Plan 2031 — Production Strategy and Agrochemicals

    Long-Term Business Plan 2031 — Review of Year 4 (FY2025) 1st X 2nd X 3 rd X R&D Overseas Expansion Management Base Transformation Transformation Transformation 1 Human Resource Strategy 3 Production Strategy Recruitment of highly skilled specialists and Preparations for domestic and international ac

  53. Slide 53: KAKEN helps improve the quality of life of patients

    KAKEN helps improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals. In this endeavor, we always strive to be “the best,” rather than pursuing the scale of business. We aspire to be, and to

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