Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q2 2025 Earnings Presentation
44 slides from Kyowa Kirin's earnings presentation, 2025
Slide 1: Results Presentation Fiscal 2025 Second Quarter
Results Presentation Fiscal 2025 Second Quarter
Slide 2: Agenda
Agenda Financial Review Commercial Update R&D Update News Flow in 2025 Q&A Chairman and Chief Executive Officer (CEO) Masashi Miyamoto, Ph.D. President and Chief Operating Officer (COO) Abdul Mullick, Ph.D. Director Executive Vice President, Chief Medical Officer (CMO) Takeyoshi Yamashita, Ph.D. Man
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
Slide 4: Financial Review
Financial Review © Kyowa Kirin Co., Ltd. 4
Slide 5: Summary of Q2 Results
Summary of Q2 Results ( Billion Yen / Rounded ) 2024 2025 FY2025 Progress Changes Jan-Jun Jan-Jun Plans to goal Revenue 233.0 230.7 -2.3 (-1%) 478.0 48% [Overseas Ratio] [71%] [73%] [73%] * Gross Profit 173.5 168.8 -4.7 (-3%) 352.0 48% [Gross Profit Margin] [74%] [73%] [74%] SG&A 83.2 82.8 -0.4 (-0%
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- -2.3 billion JPY ⚫ Japan -6.9 (-0.7 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 (-3.9B), and negative impact by annual NHI price
Slide 7: Revenue of Major Items
Revenue of Major Items ( Billion Yen / Rounded ) 2024 2025 FY2025 Progress Item Changes Reasons Jan-Jun Jan-Jun Plans to goal Crysvita 90.9 99.8 +8.9 (+10%) 210.2 47% JP 5.4 6.1 +0.7 (+13%) 13.1 47% 58.7 64.0 +5.3 (+9%) Market penetration NA EMEA 25.4 28.0 +2.5 (+10%) 197.1 48% Other 1.3 1.7 +0.4 (+
Slide 8: YoY Analysis -Core OP-
YoY Analysis -Core OP- ⚫ Gross Profit -3.4 (excl. forex impact -1.3) -9.1 billion JPY Decreased in conjunction with the down in revenue and a one-off increase in CoGs resulting the gross profit margin fell by one percentage point YoY. (-7.8 B excl. forex impact) ⚫ SG&A +0.5 (excl. forex impact -0.1)
Slide 9: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Jun) -21.5 billion yen Core Operating Profit -9.1 Profit Before Tax -24.5 ⚫ Finance/Other -15.4 • Business restructuring expenses -7.8B (-2.7 → -10.5) FY25: JP Special Voluntary Early Retirement Program -9.4B • Foreign exchange gains and losses -4.0B (2.7 → -1.3) •
Slide 10: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 10
Slide 11: 2025 Key Actions & Q2 Topics
2025 Key Actions & Q2 Topics 2025 Key Actions Topics up to Q2 (YTD) ⚫ Strengthen evidence-based marketing activities. ⚫ Global; YTD Sales rev. YoY +10%, annual plan progress rate 47% ⚫ North America: ⚫ North America: YTD Sales rev. YoY, in Yen +9%, in local currency +11% Strengthening promotional ac
Slide 12: 2025 Key Actions & Q2 Topics
2025 Key Actions & Q2 Topics 2025 Key Actions ⚫ Global : YTD Topics up to Q2 • Evidence-based promotion activities will continue to expand, addressing both cases ⚫ Global; YTD Sales rev. YoY +14%, annual plan progress rate 48% (typical for Q2 level). with predominantly blood involvement and early-st
Slide 13: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 13
Slide 14: News Flow of Development Pipeline Products
News Flow of Development Pipeline Products As of July 31st , 2025 New information highlighted in orange Products Diseases under development Events Status/Schedule Moderate to severe atopic dermatitis ROCKET ASCEND and ASTRO (P3) Topline data H2 2025 rocatinlimab Prurigo Nodularis P3 In progress KHK4
Slide 15: Updates of ziftomenib
Updates of ziftomenib Summary of the product ◼ Oral Small Molecule Menin Inhibitor ◼ Target disease：Acute Myeloid Leukemia (AML) with NPM1 mutations or KMT2A rearrangement • In the United States, about 22,000 new AML diagnoses occur annually1 • Approximately 50% of AML cases are considered menin-dep
Slide 16: Ziftomenib across the AML continuum
KURA AND KYOWA KIRIN ARE INVESTIGATING ZIFTOMENIB ACROSS THE AML CONTINUUM IN UP TO 50% OF PATIENTS https://ir.kuraoncology.com/static-files/3b737096-e139-4235-a5b8-a896d10b41be FRONTLINE RELAPSED / REFRACTORY FDA Filing 2025 EHA 2025 ASCO © Kyowa Kirin Co., Ltd. 16
Slide 17: KOMET-001: Response & Duration of Response
2025 ASCO KOMET-001: RESPONSE & DURATION OF RESPONSE: R/R NPM1-m AML https://ir.kuraoncology.com/static-files/efd05295-b2dc-4db9-94a9-6e6c778a596e Primary Phase 2 endpoint met (P value=0.0058)* vs. 12% historical control rate 1 For Phase 2 patients, after a median follow up of 4.1 months (range, 0.1
Slide 18: KOMET-001: Safety & Tolerability
2025 ASCO KOMET-001: SAFETY & TOLERABILITY OF ZIFTOMENIB IN R/R NPM1-m AML (SAFETY POPULATION) https://ir.kuraoncology.com/static-files/efd05295-b2dc-4db9-94a9-6e6c778a596e Ziftomenib-related AEs in ≥5% of All Patients Ziftomenib was well tolerated, with a safety profile consistent with previous stu
Slide 19: KOMET-001: Conclusions
2025 ASCO KOMET-001: CONCLUSIONS https://ir.kuraoncology.com/static-files/efd05295-b2dc-4db9-94a9-6e6c778a596e ⚫ In the pivotal KOMET-001 phase 2 study, the primary endpoint was met ○ Ziftomenib achieved clinically meaningful, MRD negative responses in this heavily pretreated R/R NPM1 m AML populati
Slide 20: KOMET-007: Safety and Tolerability
2025 EHA KOMET-007: SAFETY AND TOLERABILITY OF ZIFTOMENIB IN COMBINATION WITH 7+3 in 1L AML (N=82) https://ir.kuraoncology.com/static-files/3b737096-e139-4235-a5b8-a896d10b41be Grade ≥3 TEAEs in ≥10% of All Patients Grade ≥3 Ziftomenib-related Adverse Events of Interest 29 Patients (35%) had Grade ≥
Slide 21: KOMET-007: Clinical Activity in 1L Patients
2025 EHA KOMET-007: CLINICAL ACTIVITY IN ALL RESPONSE-EVALUABLEa 1L PATIENTS (N=71) https://ir.kuraoncology.com/static-files/3b737096-e139-4235-a5b8-a896d10b41be a Patients who had ≥1 response assessment or who had died. b Among evaluable responders tested for MRD per local assay (NGS, RT-qPCR, FISH
Slide 22: KOMET-007: Conclusions
2025 EHA KOMET-007: CONCLUSIONS https://ir.kuraoncology.com/static-files/3b737096-e139-4235-a5b8-a896d10b41be ⚫ In the ongoing KOMET-007 study, ziftomenib 600 mg QD combined with 7+3 was well tolerated, with a safety profile consistent with previous reports ○ Low rates of ziftomenib-related cytopeni
Slide 23: Study Design of P3 studies for AML: KOMET-017
Study Design of P3 studies for AML: KOMET-017 https://ir.kuraoncology.com/static-files/3b737096-e139-4235-a5b8-a896d10b41be Aim to deliver new therapeutic options for a wide range of AML patients © Kyowa Kirin Co., Ltd. 23
Slide 24: Rocatinlimab targets pathogenic T-cells via OX40 receptor
By directly targeting pathogenic T-cells via the OX40 receptor, rocatinlimab offers a novel approach for the management of Moderate-to-Severe AD10 Novel approach targeting OX40R9 Rocatinlimab, potentially directly targets Skin pathogenic T-cells via OX40 receptor is a novel upstream treatment approa
Slide 25: Rocatinlimab – Phase 3 the ROCKET Program
Rocatinlimab – Phase 3 the ROCKET Program • Composed of eight global studies enrolling adult and adolescent moderate – severe AD patients • To date, over 3,300 patients have been enrolled with seven studies having completed enrollment • Studies were designed to examine long-term sustained efficacy a
Slide 26: ROCKET ASCEND Design – Adult Cohorts
Presented at the 2025 American Academy of Dermatology Association Annual Meeting March 7–11, Orlando, Florida, US Future Looking: ROCKET ASCEND Design – Adult Cohorts1,* Study Subjects ROCKET-ASCEND Cohort Key Questions (at 24 wks) (104 wks) • Long-term maintenance and/or additional efficacy on Adul
Slide 27: News Flow in 2025
News Flow in 2025 © Kyowa Kirin Co., Ltd. 27
Slide 28: Year-to-date Key News Flow
Year-to-date Key News Flow As of July. 31st, 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 achiev
Slide 29: Year-to-date Key News Flow
Year-to-date Key News Flow As of July. 31st, 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 address
Slide 30: 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
Slide 31: Appendix
Appendix © Kyowa Kirin Co., Ltd. 31
Slide 32: 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
Slide 33: Main Development Pipeline Products (P2-P3)
Main Development Pipeline Products (P2-P3) As of July 31st , 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) ★
Slide 34: Main Development Pipeline Products (P1)
Main Development Pipeline Products (P1) As of July 31st , 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 Advanced
Slide 35: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of July 31st , 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 Moderate to severe H2 ‘25 Topline data Atopic Dermatitis
Slide 36: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of July 31st , 2025 Products Target Development Status 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) Ongoing 2L+ Mono P1a2 (non NPM1-m / O
Slide 37: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of July 31st , 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 solid tumors P1 KK2845 R/R AML P1 KK8123 XLH P1 KK3910
Slide 38: FOREX Information
FOREX Information Average FOREX Rates (yen) 2024 2025 Jan-Jun Jan-Jun Changes 2025 Plans USD 151 150 -1 145 GBP 191 193 +2 190 EUR 163 162 -1 160 2025Q2 FOREX Impacts (billion yen) Revenue Core OP USD -1.3 -1.0 GBP +0.1 -0.1 EUR -0.1 -0.0 FY2025 FOREX Sensitivities (vs FY25 Plan, billion yen) Change
Slide 39: 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
Slide 40: 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 •
Slide 41: 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
Slide 42: 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
Slide 43: 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
Slide 44: 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