Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Q3 2025 Earnings Presentation

48 slides from Kyowa Kirin's earnings presentation, Oct 30, 2025

  1. Slide 1: Results Presentation Fiscal 2025 Third Quarter

    Results Presentation Fiscal 2025 Third Quarter

  2. Slide 2: Agenda

    Agenda Financial Review Managing Executive Officer, Chief Financial Officer (CFO) Motohiko Kawaguchi Commercial Update Managing Executive Officer, Chief Strategy Officer (CSO) Yasuo Fujii R&D Update Director Executive Vice President, Chief Medical Officer (CMO) Takeyoshi Yamashita, Ph.D. News Flow i

  3. Slide 3: Forward-looking statements

    This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present time and upon reasona

  4. Slide 4: Financial Review

    Financial Review © Kyowa Kirin Co., Ltd. 4

  5. Slide 5: Summary of Q3 Results

    Summary of Q3 Results ( Billion JPY / Rounded ) 2024 2025 FY2025 Progress Jan-Sep Jan-Sep Changes Plans to goal Revenue 362.8 349.5 -13.3 (-4%) 478.0 73% [Overseas Ratio] [72%] [73%] [73%] Gross Profit 268.8 259.4 -9.4 (-3%) 352.0 74% [Gross Profit Margin] [74%] [74%] [74%] SG&A 123.6 121.5 -2.1 (-2

  6. Slide 6: YoY Analysis -Revenue-

    YoY Analysis -Revenue- -13.3 billion JPY ⚫ Japan -8.3 (-9.5 B excl. forex impact) Although Phozevel, Duvroq and Crysvita increased, revenue in the Japan region decreased by 9% due mainly to the termination of the sales partnership agreement for Dobovet (-5.8B), and negative impact by annual NHI pric

  7. Slide 7: Revenue of Major Items

    Revenue of Major Items ( Billion JPY / Rounded ) 2024 2025 FY2025 Progress Item Changes Reasons Jan-Sep Jan-Sep Plans to goal Crysvita 134.9 146.7 +11.9 (+9%) 210.2 70% JP 8.2 9.7 +1.5 (+18%) 13.1 74% NA 87.2 92.0 +4.8 (+5%) Market penetration EMEA 37.1 42.4 +5.3 (+14%) 197.1 70% Other 2.3 2.6 +0.3

  8. Slide 8: YoY Analysis -Core OP-

    YoY Analysis -Core OP- ⚫ Gross Profit -6.1 (excl. forex impact -3.3) -12.4 billion JPY Decreased in conjunction with the down in revenue. (-10.2 B excl. forex impact) ⚫ SG&A +1.5 (excl. forex impact +0.6) SG&A decreased due to the restructuring of the APAC business, although increased the Jan-Sep 20

  9. Slide 9: YoY Analysis -Profit-

    YoY Analysis -Profit- Profit (Jan-Sep) -23.3 billion JPY Jan-Sep 2024 55.9 Gross Profit -9.4 Core Operating SG&A/R&D Profit -0.5 -12.4 Equity Method Profit Before Tax -2.5 -23.6 Finance/Other ⚫ Finance/Other -11.2 -11.2 • Gain on Equity transfer for KKCN (China affiliate) -7.8 (7.8 → 0) • Gain on n

  10. Slide 10: Commercial Update

    Commercial Update © Kyowa Kirin Co., Ltd. 10

  11. Slide 11: 2025 Key Actions & Q3 Topics

    2025 Key Actions & Q3 Topics 2025 Key Actions Topics up to Q3 (YTD) ⚫ Strengthen evidence-based marketing activities. ⚫ Global; YTD Sales rev. YoY +9%, annual plan progress rate 70% ⚫ North America: ⚫ North America: YTD Sales rev. YoY, in Yen +5%, in local currency +8% Strengthening promotional acti

  12. Slide 12: 2025 Key Actions & Q3 Topics

    2025 Key Actions & Q3 Topics 2025 Key Actions ⚫ Global : Topics up to Q3 (YTD) • Evidence-based promotion activities will continue to expand, addressing both cases ⚫ Global; YTD Sales rev. YoY +16%, annual plan progress rate 74% (typical for Q3 level). with predominantly blood involvement and early-

  13. Slide 13: R&D Update

    R&D Update © Kyowa Kirin Co., Ltd. 13

  14. Slide 14: News Flow of Development Pipeline Products

    News Flow of Development Pipeline Products As of October 30th , 2025 New information highlighted in orange Products Diseases under development Events Status/Schedule Moderate to severe atopic dermatitis ROCKET ASCEND (P3) Interim data September 2025 rocatinlimab Prurigo Nodularis P3 Enrollment Compl

  15. Slide 15: R&D Update – ziftomenib

    R&D Update – ziftomenib © Kyowa Kirin Co., Ltd. 15

  16. Slide 16: Product Overview and Advancement in Development

    Product Overview and Advancement in Development Profile of the product ◼ Oral Small Molecule Menin Inhibitor ◼ Target disease：Acute Myeloid Leukemia (AML) with NPM1 mutations or KMT2A rearrangements • In the United States, about 22,000 new AML diagnoses occur annually1 • Approximately 50% of AML cas

  17. Slide 17: R&D Update – rocatinlimab

    R&D Update – rocatinlimab © Kyowa Kirin Co., Ltd. 17

  18. Slide 18: Atopic Dermatitis is a chronic, heterogeneous inflammatory skin disease

    Atopic Dermatitis (AD) is a chronic, heterogeneous inflammatory skin disease that imposes a substantial burden on patients and caregivers Impact of Moderate-to-Severe AD: Skin Symptoms Excessively dry, itchy, and painful skin Repeated scratching can lead to thickened, hardened skin and increased inf

  19. Slide 19: Current treatment options often fail to provide sufficient symptom improvement

    Current treatment options often fail to provide sufficient depth 1-3 and durability of symptom improvement ◼ Due to the heterogeneous pathogenesis of AD, no one therapy shows consistent efficacy across diverse patient populations. ◼ Only 10–15% of eligible patients are currently receiving biologic t

  20. Slide 20: Rocatinlimab targets pathogenic T cells via the OX40 receptor

    By directly targeting pathogenic T cells via the OX40 receptor, rocatinlimab represents a potentially novel upstream approach for the management of Moderate-to-Severe AD10 OX40R–Targeted Therapies9 Rocatinlimab, potentially directly targets pathogenic T-cells Skin via OX40 receptor. It represents a

  21. Slide 21: Robust ROCKET Phase 3 Program

    Robust ROCKET Phase 3 Program Evaluating the Long-Term Efficacy and Safety of Rocatinlimab in Diverse AD Populations • Eight global studies enrolling adults and adolescents with moderate-to-severe AD • 3,300+ patients enrolled; all 8 studies have completed enrollment 1. ClinicalTrials.gov. https://c

  22. Slide 22: Study Design of ROCKET IGNITE and SHUTTLE

    Study Design of ROCKET IGNITE and SHUTTLE Monotherapy* Study: Rocatinlimab Q4W in Adults with msAD *Use of ANY rescue therapy including low/medium TCS/TCI was considered a non-responder in the primary analysis Combination** Therapy Study: Rocatinlimab Q4W + TCS/TCI in Adults with msAD **All subjects

  23. Slide 23: Rocatinlimab showed greater EASI-75 and vIGA-AD 0/1 response vs. placebo

    Rocatinlimab showed significantly greater improvement in EASI-75 and vIGA-AD 0/1 response rate at Week 24 vs. placebo EADV Congress 2025, Sept. 17-20, Paris © Kyowa Kirin Co., Ltd. Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health a

  24. Slide 24: Rocatinlimab Demonstrates Deepening of Response Over Time

    Rocatinlimab Demonstrates Deepening of Response (EASI 90-100) Over Time Rocatinlimab shows Monotherapy Study continuous improvement over time in both monotherapy and combination therapy, with EASI-90 responders increasing through Week 24 without plateau Combination Therapy Study EADV Congress 2025,

  25. Slide 25: ROCKET ASCEND: Week 32 interim safety summary

    ROCKET ASCEND : Week 32 interim safety summary for rocatinlimab Long-term safety monitoring will continue until Week 104 study completion. ◼ Long-term Safety Evaluation ̵ ASCEND study (~2,600 patients) evaluating long-term safety as primary endpoint ̵ Includes patients from prior ROCKET trials (IGNI

  26. Slide 26: ROCKET ASCEND: Interim Primary Analysis of Week 56 Efficacy Data

    ROCKET ASCEND: Interim Primary Analysis of Week 56 Efficacy Data (Week 32 of a 104-week study) Ignite & Horizon Responders (vIGA-AD 0/1 and/or EASI-75 at W24 without use of any rescue treatment) 150 mg Q4W Responders 300 mg Q4W Responders R R Rerandomized to Rerandomized to Rerandomized to Rerandomi

  27. Slide 27: Rocatinlimab: Pioneering a Novel Treatment Paradigm Through T-cell Rebalance

    Rocatinlimab: Pioneering a Novel Treatment Paradigm Through T-cell Rebalance • Targets a root cause of inflammation to potentially achieve deeper and longer-lasting improvement • Potential to expand to other inflammatory diseases with significant unmet need Moderate-to-Severe AD Ongoing Clinical Pro

  28. Slide 28: News Flow in 2025

    News Flow in 2025 © Kyowa Kirin Co., Ltd. 28

  29. Slide 29: Year-to-date Key News Flow

    Year-to-date Key News Flow As of October 30th, 2025 Category Date Headline R&D Jan 20 Received the 7th Prime Minister’s Award for the Japan Medical Research and Development Grand Prize, recognizing the accomplishment of developing mogalizumab featuring our proprietary Potelligent technology and achi

  30. Slide 30: Year-to-date Key News Flow

    Year-to-date Key News Flow As of October 30th, 2025 Category Date Headline R&D May 15 New England Journal of Medicine publicities long-term clinical outcomes from its HSC Gene Therapy Orchard presents six accepted abstracts at ASGCT 2025 detail the therapeutic potential of HSC gene therapy to addres

  31. Slide 31: Year-to-date Key News Flow

    Year-to-date Key News Flow As of October 30th, 2025 Category Date Headline R&D Sep 9 AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG- TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS R&D Sep 11 Kyowa Kirin Announces Late-Breaking Abstract

  32. Slide 32: Transition to Company with Audit and Supervisory Committee

    Transition to Company with Audit and Supervisory Committee ✓ Ensure sufficient decision-making agility to further enhance competitive advantage for sustainable growth. ✓ Clearly separate execution matters from Board discussions, focus the Board on medium- Purpose to long-term strategies, and ensure

  33. Slide 33: P/L Impact on EMEA established medicines portfolio

    P/L Impact on EMEA established medicines portfolio Before After 2024 2025 2026 Aug 2023 Aug 2023 unrealized 49% of the transfer value £ 66.4M(JPY13.1B) ￡30.6M (JPY 6.1B) ※includes the true-up of the Tostran until Oct 3 brands 1 brand transferred assets in 2024 Product sales IP transfer IP transfer E

  34. Slide 34: Appendix

    Appendix © Kyowa Kirin Co., Ltd. 34

  35. Slide 35: Story for Vision 2030

    Story for Vision 2030 Strategies for creating and delivering life-changing value Disease Science Value Global deployment of delivery on products developed by Focus disease areas: bone & mineral, intractable taking full advantage of our own hematological diseases/hemato oncology, and rare diseases th

  36. Slide 36: Special Voluntary Early Retirement Program

    Special Voluntary Early Retirement Program Purpose and overview of the program At the turning point for realization of Kyowa Kirin's vision for 2030, we aim to broaden the career development options of our employees and to provide maximum support for those who wish to move outside the company. ◎Prom

  37. Slide 37: Main Development Pipeline Products (P2-P3)

    Main Development Pipeline Products (P2-P3) As of October 30th , 2025 Total addressable Diseases under development*1 Planned Approval Year*2 Development status No. of Patients*4 market*3 Moderate to severe 2026/2027 P3 (Global) ★★★★★ 16M Atopic Dermatitis Rocatinlimab Prurigo nodularis TBD P3 (Global

  38. Slide 38: Main Development Pipeline Products (P1)

    Main Development Pipeline Products (P1) As of October 30th , 2025 Diseases under development*1 Development status Modality, technology KK4277 SLE, CLE P1 (JP, Asia) Antibody, POTELLIGENT® Advanced or metastatic solid P1 (JP: in progress, US: in KK2260 tumors preparation) Antibody, REGULGENTTM Advanc

  39. Slide 39: Main Development Pipeline Products: Future plans

    Main Development Pipeline Products: Future plans Orange: In progress Grey: Not started / Completed As of October 30th , 2025 Development Product Target Disease Status 2025 2026 2027 + IGNITE Topline data Mar. 2025 HORIZON Detailed data presentation Mar. 2025 SHUTTLE Topline data Mar. 2025 ASTRO Mode

  40. Slide 40: Main Development Pipeline Products: Future plans

    Orange: In progress Main Development Pipeline Products: Future plans Grey: Not started / Completed As of October 30th , 2025 プロダクト名 標的疾患 開発段階 2025 2026 2027 ＋ Detailed data presentation June 2025 AML P21 (NPM1-m) US NDA (Priority Review, PDUFA date: November 30, 2025) ALL KOMET-001 P1a2 (KMT2A-r) On

  41. Slide 41: Main Development Pipeline Products: Future plans

    Main Development Pipeline Products: Future plans Orange: In progress Grey: Not started / Completed As of October 30th , 2025 Product Target Disease Phase 2025 2026 2027 + nAMD P2 KHK4951 tivozanib DME P2 KK4277 SLE, CLE P1 Advanced or metastatic KK2260 solid tumors P1 Advanced or metastatic KK2269 s

  42. Slide 42: FOREX Information

    FOREX Information Average FOREX Rates (JPY) 2024 2025 Jan-Sep Jan-Sep Changes 2025 Plans USD 151 149 -2 145 GBP 193 195 +2 190 EUR 164 165 +1 160 2025Q3 FOREX Impacts (billion JPY) Revenue Core OP USD -3.7 -1.9 GBP +0.1 -0.1 EUR +0.2 +0.1 FY2025 FOREX Sensitivities (vs FY25 Plan, billion JPY) Change

  43. Slide 43: Ziftomenib - Collaboration with Kura

    Ziftomenib ‐ Collaboration with Kura ‐ US ex- US • Kura leads development Development • Share global development cost • Kyowa Kirin leads development • Kura funds development costs (~2028) Commercialization • Kyowa Kirin commercializes and books sales • Kura books sales • 50/50 profit share Sales Ro

  44. Slide 44: KHK4083/AMG 451 - Collaboration with Amgen

    KHK4083/AMG 451 ‐ Collaboration with Amgen ‐ US Europe & Asia (ex. JP) JP • Amgen leads development • Amgen leads development Development • Kyowa Kirin leads development • Share development cost • Share development cost • Amgen commercializes and • Amgen commercializes and books sales books sales •

  45. Slide 45: Crysvita - Collaboration with Ultragenyx

    Crysvita ‐ Collaboration with Ultragenyx ‐ Economic Terms • Kyowa Kirin books sales • 50/50 profit share for 5 years from the U.S. launch US & Canada • After 5 years (April 27, 2023-), Kyowa Kirin pays tiered sales royalties in mid-high 20% range to Ultragenyx *Ultragenyx has sold 30% of its royalty

  46. Slide 46: Estimated Patient Numbers

    Estimated Patient Numbers Country/ Disease Incidence Prevalence1 Reference Region PTCL JP 2,000 Ministry of Health, Labour and Welfare: 2017 Patient survey (illness classification) JP 2,000 Ministry of Health, Labour and Welfare: 2017 Patient survey (illness classification) CTCL US 1,500 / y SEER Da

  47. Slide 47: List of Acronyms

    List of Acronyms AD Atopic Dermatitis AG Authorized Generic ALL Acute lymphoblastic leukemia AML Acute myeloid leukemia APAC Asia-Pacific BS Biosimilar CLE Cutaneous lupus erythematosus CTCL Cutaneous T cell lymphoma DME Diabetic Macular Edema EMEA Europe, the Middle East and Africa JP Japan LCM Lif

  48. Slide 48: Kyowa Kirin Co., Ltd. Corporate Communications Dept., IR&PR Group

    Kyowa Kirin Co., Ltd. Corporate Communications Dept., IR&PR Group +81-3-5205-7206 / ir@kyowakirin.com

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