Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Q1 2025 Earnings Presentation
40 slides from Kyowa Kirin's earnings presentation, 2025
Slide 1: Results Presentation Fiscal 2025 First Quarter
Results Presentation Fiscal 2025 First Quarter
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
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 Q1 Results
Summary of Q1 Results ( Billion Yen / Rounded ) 2024Q1 2025Q1 FY2025 Progress Changes Results Results Plans to goal Revenue 105.6 104.7 -0.8 (-1%) 478.0 22% [Overseas Ratio] [68%] [73%] [73%] * Gross Profit 80.0 80.1 +0.2 (+0%) 352.0 23% [Gross Profit Margin] [76%] [77%] [74%] SG&A 40.2 42.0 +1.9 (+
Slide 6: YoY Analysis -Revenue-
YoY Analysis -Revenue- -0.8 billion JPY ⚫ Japan -4.4 (-3.2 B excl. forex impact) Although Phozevel, Duvroq and Crysvita increased, revenue in Japan region decreased by 14% due mainly to the termination of the sales partnership agreement for Dobovet (-1.8), negative impact by annual NHI price-cut and
Slide 7: Revenue of Major Items
Revenue of Major Items ( Billion Yen / Rounded ) 2024Q1 2025Q1 FY2025 Progress Item Changes Reasons Results Results Plans to goal Crysvita 37.8 42.4 +4.6 (+12%) 210.2 20% JP 2.5 2.8 +0.3 (+13%) 13.1 21% 22.8 24.1 +1.3 (+6%) Market penetration NA EMEA 11.9 14.8 +2.9 (+24%) 197.1 20% Other 0.6 0.8 +0.
Slide 8: YoY Analysis -Core OP-
YoY Analysis -Core OP- ⚫ Gross Profit -1.9 (excl. forex impact +2.1) Decreased in conjunction with the 3.2B (excl. FX impact) down in revenue. -8.8 billion JPY (-9.2 B excl. forex impact) ⚫ SG&A -0.9 (excl. forex impact -1.0) While there was a decrease due to the restructuring of the APAC business,
Slide 9: YoY Analysis -Profit-
YoY Analysis -Profit- Profit (Jan-Mar) -8.5 billion yen Core Operating Profit -8.8 Profit Before Tax -10.2 ⚫ Finance/Other -1.5 • Gain on disposal of fixed assets -2.4 (2.4 → 0) • Foreign exchange gains and losses -0.6 (0.5 → -0.1) • Business restructuring expenses +1.4 (-2.3 → -0.9) © Kyowa Kirin C
Slide 10: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 10
Slide 11: 2025 Key Actions & Q1 Topics
2025 Key Actions & Q1 Topics 2025 Key Actions Q1 Topics ⚫ Strengthen evidence-based marketing activities. ⚫ Global; Sales rev. YoY +12%, annual plan progress rate 20% (typical for Q1 level). ⚫ North America: ⚫ North America: Sales rev. YoY, in Yen +6%, in local currency +1% Strengthening promotional
Slide 12: 2025 Key Actions & Q1 Topics
2025 Key Actions & Q1 Topics 2025 Key Actions Q1 Topics ⚫ Global : ⚫ Global; Sales rev. YoY +13%, annual plan progress rate 22% (typical for Q1 level). • Evidence-based promotion activities will continue to expand, addressing both cases ⚫ NA : Sales rev. YoY, in Yen +10%, in local currency +5% with
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 New information highlighted in orange As of May. 1st , 2025 Products Diseases under development Events Status/Schedule ROCKET HORIZON (P3) Detailed data March 2025 Moderate to severe atopic dermatitis ROCKET IGNITE, SHUTTLE and VOYAGER (P3) Topline data roc
Slide 15: Rocatinlimab targeting pathogenic T-cells via OX40 receptor
By directly targeting pathogenic T-cells via the OX40 receptor, rocatinlimab is a novel approach for the management of Moderate-to-Severe AD10 OX40R–Targeted Therapies9 Rocatinlimab, potentially directly targets Skin pathogenic T-cells via OX40 receptor is a novel upstream treatment approach which r
Slide 16: T-cell Rebalance
T-cell Rebalance – Aiming for broad and sustained therapeutic effects by addressing a root cause of inflammatory diseases Novel OX40-mediated mechanism targeting pathogenic T-cells improves T cell imbalance, root cause of inflammatory diseases, aiming for T cell rebalancing. Potential action on memo
Slide 17: ROCKET HORIZON: EASI-75 and vIGA-AD 0/1 Responses at Week 24
ROCKET HORIZON: EASI-75 and vIGA-ADTM 0/1 Responses at Week 24 Primary analysis set (patients with any rescue use classified as non-responders) All Data as observed (patient population analyzed based on observed data regardless of rescue therapy use) EASI-75 at Week 24 vIGA-AD 0/1 at Week 24 ROCA (N
Slide 18: ROCKET HORIZON: EASI 75-89 and EASI 90-100
ROCKET HORIZON: EASI 75-89 and EASI 90-100 at Week 24 All Data as observed (patient population analyzed based on observed data regardless of rescue therapy use) ROCA (N = 543) PBO (N = 183) EASI 90-100 EASI 75-89 EASI 90-100 EASI 75-89 50 47 50 44 Percent Responders (%) Percent Responders (%) 40 39
Slide 19: ROCKET HORIZON: Longitudinal change of T cell number
ROCKET HORIZON: Longitudinal change of T cell number after rocatinlimab treatment CD4+ T Cells OX40+CD4+ T Cells 2 2 1 1 0 0 (cells/µL mean ± 95% CI) (cells/µL mean ± 95% CI) -2 Fold Change From Baseline Fold Change From Baseline -2 -4 -4 -6 -6 -8 -8 -10 -10 -12 -12 -14 ROCA -14 ROCA -16 PBO -16 PBO
Slide 20: Topline Data: ROCKET IGNITE, SHUTTLE, VOYAGER
Topline Data: ROCKET IGNITE, SHUTTLE, VOYAGER https://ir.kyowakirin.com/en/news/news-3032964777820161808/main/00/link/e20250308.pdf Primary Endpoint* rocatinlimab Higher Dose (Week 24) rocatinlimab Lower Dose (Week 24) % Difference from placebo (p-value) % Difference from placebo (p-value) EASI-75 4
Slide 21: ROCKET Program: Summary of Phase 3 studies
ROCKET Program: Summary of previous Phase 3 studies HORIZON Study Detailed Results @ 2025 AAD Late-breaking Abstract ◼ Achieved co-primary endpoints and key secondary endpoints with monotherapy 300 mg once every 4 weeks dosing (with a loading dose at week 2) ◼ The proportion of patients achieving EA
Slide 22: 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 23: 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 20,800 new AML diagnoses occur annually1 • Approximately 50% of AML cases are considered menin-dep
Slide 24: Study Design of KOMET-017
Study Design of KOMET-017 Based on the promising results in 1st line therapy from P1 combination study (KOMET-007), a P3 1st line combination study will begin in H2 2025 https://ir.kuraoncology.com/static-files/86a05da2-640f-4533-bbf4-6b12688a3b82 Aim to deliver new therapeutic option for a broad ra
Slide 25: News Flow in 2025
News Flow in 2025 © Kyowa Kirin Co., Ltd. 25
Slide 26: Year-to-date Key News Flow
Year-to-date Key News Flow As of Feb. 6th, 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 achievin
Slide 27: Appendix
Appendix © Kyowa Kirin Co., Ltd. 27
Slide 28: 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 29: Main Development Pipeline Products (P2-P3)
Main Development Pipeline Products (P2-P3) As of May. 1st , 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 30: Main Development Pipeline Products (P1)
Main Development Pipeline Products (P1) As of May. 1st , 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 o
Slide 31: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of May. 1st , 2025 Development Product Target Disease Status 2025 2026 2027 + IGNITE Q2 Topline data HORIZON Detailed data presentation in 1H SHUTTLE Q2 Topline data ASTRO Moderate to severe H2 ‘25 Topline data Atopic Dermatitis P3 ORBIT rocatinlim
Slide 32: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of May. 1st , 2025 Products Target Development Status 2025 2026 2027 ＋ AML P21 (NPM1-m) Topline Data reported ALL KOMET-001 P1a2 (KMT2A-r) Ongoing 2L+ Mono P1a2 (non NPM1-m / Ongoing KMT2A-r AML) KOMET-007 1L, 2L+ ziftomenib Combinations with cytar
Slide 33: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of May. 1st , 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 In progress KK8123 XL
Slide 34: FOREX Information
FOREX Information Average FOREX Rates (yen) 2024Q1 2025Q1 Changes 2025 Plans USD 147 154 +7 145 GBP 187 193 +6 190 EUR 160 161 +1 160 2025Q1 FOREX Impacts (billion yen) Revenue Core OP USD +2.1 +0.4 GBP +0.1 -0.1 EUR +0.2 +0.1 FY2025 FOREX Sensitivities (vs FY25 Plan, billion yen) Changes Revenue Co
Slide 35: 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 36: 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 37: 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 ⁃ Supply price: 35% of net sales through 2022, 30% thereafter (No impact on the sales royalties stated below) • After 5 years (April 27, 2023-), Kyowa
Slide 38: 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 39: 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 40: 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