Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — FY2024 Earnings Presentation
62 slides from Kyowa Kirin's earnings presentation, February 2025
Slide 1: Results Presentation Fiscal 2024
Results Presentation Fiscal 2024
Slide 2: Agenda
Agenda 2021-2025 Medium Term Business Plan - FY2024 Review, FY2025 Plans - Capital Allocation, Shareholders Return Commercial Update R&D Update News Flow Q&A President and Chief Executive Officer (CEO) Masashi Miyamoto, Ph.D. Senior Managing Executive officer and Chief Medical Officer (CMO) Takeyosh
Slide 3: Forward-looking statements disclaimer
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: 2021-2025 Medium Term Business Plan - FY2024 Review
2021-2025 Medium Term Business Plan - FY2024 Review - © Kyowa Kirin Co., Ltd. 4
Slide 5: Qualitative Review for FY2024
Qualitative Review for FY2024 Provide pharmaceuticals for unmet medical needs Address patient-centric healthcare needs ◼ Formulated the Strategy for Achieving the Vision 2030 'Story for Vision 2030' ◼ Improvement of Access to medicine ◼ Maximize the value of global strategic products ✓ Continued dis
Slide 6: Quantitative Summary of FY24 Results
Quantitative Summary of FY24 Results ( Billion Yen / Rounded ) FY2023 FY2024 2024 Changes Achieved Results Results Revised Plans Revenue 442.2 495.6 +53.3 (+12%) 492.0 101% [Overseas Ratio] [65%] [72%] [71%] Gross Profit 331.0 362.9 +31.9 (+10%) 364.0 100% [Gross Profit Margin] [75%] [73%] [74%] SG&
Slide 7: FY23 vs FY24 -Revenue-
FY23 vs FY24 -Revenue- ⚫ Japan -12.3 Although Phozevel, Duvroq and Crysvita increased, revenue in Japan region decreased by 8% +53.3 billion yen due mainly to negative impact by annual NHI price-cut and shrink in G-Lasta affected by competitive products. (incl. forex effect +24.4) ⚫ North America +3
Slide 8: FY23 vs FY24 -Revenue of Major Items in Japan-
FY23 vs FY24 -Revenue of Major Items in Japan- ( Billion Yen / Rounded ) FY2023 FY2024 2024 Item Changes Reasons Achieved Results Results Rev. Plans Crysvita 10.5 11.7 +1.2(+12%) Market penetration (Launched in Dec 2019) 12.9 91% Poteligeo 1.9 1.8 -0.1 (-5%) 1.9 95% Nesp + Nesp-AG1 17.1 14.2 -2.9 (-
Slide 9: FY23 vs FY24 -Revenue of Major Items outside Japan-
FY23 vs FY24 -Revenue of Major Items outside Japan- ( Billion Yen / Rounded ) FY2023 FY2024 2024 Item Changes Reasons Achieved Results Results Rev. Plans Crysvita 142.0 184.8 +42.8 (+30%) 187.8 98% North America 105.2 130.0 +24.8 (+24%) Market penetration EMEA 35.1 51.5 +16.4 (+47%) APAC 1.6 3.3 +1.
Slide 10: FY23 vs FY24 -Core OP-
FY23 vs FY24 -Core OP- -1.4 billion yen ⚫ Gross Profit +31.9 (incl. forex effect +21.3) Increased in conjunction with the 53.3 rise in revenue. COGs have increased due to the (incl. forex effect +8.6) North America Crysvita Sales royalty after Apr 27, 2023. Hence, gross profit % declined YoY. (75% →
Slide 11: FY23 vs FY24 -Profit-
FY23 vs FY24 -Profit- Profit (Jan-Dec) -21.3 billion yen ⚫ Finance/Other -12.4 • EMEA established medicines portfolio: Core Operating Gain on sales of 51% shares plus gain on valuation of remaining 49% shares -14.8 Profit (14.8 → 0) -1.4 • Business restructuring expenses -6.7 (-6.2 → -12.9) FY24: AP
Slide 12: 2021-2025 Medium Term Business Plan - FY2025 Plans
2021-2025 Medium Term Business Plan - FY2025 Plans - © Kyowa Kirin Co., Ltd. 12
Slide 13: Qualitative Plans for FY2025
Qualitative Plans for FY2025 Provide pharmaceuticals for unmet medical needs Address patient-centric healthcare needs ◼ Value creation and provision in disease areas that the company focuses on ◼ Improvement of Access to medicine and Provide value that goes ✓ Application for approval of ziftomenib f
Slide 14: Quantitative Summary of FY25 Plans
Quantitative Summary of FY25 Plans ( Billion Yen / Rounded ) FY2023 FY2024 FY2025 Changes Results Results Plans Revenue 442.2 495.6 478.0 -17.6 (-4%) [Overseas Ratio] [65%] [72%] [70%] Gross Profit 331.0 362.9 352.0 -10.9 (-3%) [Gross Profit Margin] [75%] [73%] [74%] SG&A 163.1 167.5 166.0 -1.5 (-1%
Slide 15: FY25 -Revenue of Major Items-
FY25 -Revenue of Major Items- ( Billion Yen / Rounded ) FY2023 FY2024 FY2025 Item Changes Reasons Results Results Plans Crysvita 152.4 196.6 210.2 +13.7 (+7%) JP 10.5 11.7 13.1 +1.3 (+11%) NA 105.2 130.0 Market penetration EMEA 35.1 51.5 197.1 +12.3 (+7%) APAC 1.6 3.3 Poteligeo 30.3 39.9 45.4 +5.5 (
Slide 16: FY24 vs FY25 -Core OP-
FY24 vs FY25 -Core OP- ⚫ Gross Profit -10.9 -15.4 billion yen While Crysvita and Poteligeo are driving revenue growth primarily in North America, the total revenue is expected to decline by 17.6 (Japan -12.9, North America +16.6, EMEA - (incl. forex effect -4.4) 11.2, Other -10.0 (incl. the impact o
Slide 17: FY24 vs FY25 -Profit-
FY24 vs FY25 -Profit- Profit (Jan-Dec) -2.9 billion yen Core Operating Profit -15.4 ⚫ Finance/Other +6.0 • Derivative valuation losses +6.0 Profit Before Tax -9.5 ⚫ Income Taxes +6.6 • Tax burden ratio 28.3% → 23.0% © Kyowa Kirin Co., Ltd. 17
Slide 18: 2021-2025 Medium Term Business Plan - Revision of Financial KPI
2021-2025 Medium Term Business Plan - Revision of Financial KPI - ◼ Although 2023 achieved record profits and “10% of ROE”, 2024 and 2025 (plan) are expected to miss financial KPIs due to increased R&D investment. ◼ Due to the restructuring of our business model to adapt to environmental changes, th
Slide 19: Capital Allocation, Shareholders Return
Capital Allocation, Shareholders Return © Kyowa Kirin Co., Ltd. 19
Slide 20: FY2024 Capital Allocation
FY2024 Capital Allocation - Investment and Shareholder Returns for Sustainable Growth - ✓ Strategic investments, such as the acquisition of Orchard Therapeutics, ziftomenib, and significantly increased R&D spending, along with aggressive shareholder returns including share buyback, support sustainab
Slide 21: Shareholders Return
Shareholders Return ✓ FY24 dividend is 58 yen, and FY25 to be 60 yen (plan) ✓ Plans 9-year consecutive rises since FY17 ✓ FY21-25 weighted average payout ratio is 42.6% (plan) (Mid-term guidance for payout ratio “Targeting sustained dividend hikes with 40%”) Dividend (yen) Payout Return on Year Inte
Slide 22: Share buyback and cancellation of treasury shares
Share buyback and cancellation of treasury shares ✓ To improve capital efficiency and shareholder returns, the company implemented its largest-ever share buyback and cancellation of 40.0 billion (14 million shares, 2.7%) from February to October 2024. ✓ Total return ratio for FY2024 is 109.6% ( Bill
Slide 23: Commercial Update
Commercial Update © Kyowa Kirin Co., Ltd. 23
Slide 24: Crysvita: 2024 Review & 2025 Key Actions
2024 Review & 2025 Key Actions 2024 Review 2025 Key Actions ⚫ NA: Sales revenue increased by 24% year-on-year YTD due to: ⚫ Strengthen evidence-based marketing activities. The number of new patients has remained at a high level throughout the year, ⚫ North America: mainly among adults. Strengthening
Slide 25: Poteligeo: 2024 Review & 2025 Key Actions
2024 Review & 2025 Key Actions 2024 Review 2025 Key Actions ⚫ NA : Sales revenue increased by 38% year-on-year YTD due to: ⚫ Global : • Continue to expand evidence-based promotional activities to focus not only on cases • Evidence-based promotion activities will continue to expand, addressing both c
Slide 26: R&D Update
R&D Update © Kyowa Kirin Co., Ltd. 26
Slide 27: News Flow of Development Pipeline Products
News Flow of Development Pipeline Products As of Feb. 6th, 2025 Products Diseases under development Events Status/Schedule ROCKET HORIZON (P3) Detailed data 1H 2025 Moderate to severe atopic dermatitis ROCKET SHUTTLE (P3) Topline data rocatinlimab Q2 2025 ROCKET IGNITE (P3) Topline data KHK4083/AMG
Slide 28: Atopic Dermatitis burden on patients and caregivers
Atopic Dermatitis (AD) is a chronic and heterogeneous inflammatory skin disease that imparts a significant burden on patients and caregivers ◼ AD causes excessively dry, itchy skin that can be painful ◼ Repeated scratching can cause the skin to thicken, harden or become vulnerable to infection Pain
Slide 29: T-cell Imbalance – a root cause of inflammatory diseases
T-cell Imbalance – a root cause of inflammatory diseases • Atopic dermatitis is thought to be caused in part by T-cell imbalance due to the increase and enhanced activation of pathogenic T cells • T-cell imbalance is one of the root causes of various inflammatory diseases 29 © Kyowa Kirin Co., Ltd.
Slide 30: Pathogenic T-cell imbalance contributes to AD chronicity and heterogeneity
An imbalance in multiple pathogenic T-cell Types contributes to AD Chronicity and Heterogeneity1,2 Various types of pathogenic T cells Effector T-cells1 Initiate and maintain a broad range of inflammatory responses Excessive Pruritis5 Diverse lesion proliferation OX40* Morphology6,7 and activation m
Slide 31: T-cell Rebalance – Aiming for broad and sustained therapeutic effects
T-cell Rebalance – Aiming for broad and sustained therapeutic effects by addressing a root cause of inflammatory diseases • Directly targeting pathogenic T-cells via OX40 with rocatinlimab is a novel approach, and has potential to address T-cell imbalance, a root cause of inflammatory disease • Roca
Slide 32: 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 33: Rocatinlimab - Future Plans
Rocatinlimab - Future Plans Detailed data are planned to be presented in 1H 2025 *Interim data Topline data are to be disclosed in Q2 2025 Data readout is anticipated in 2H 2025 Current plan for regulatory submission is 2025/2026 © Kyowa Kirin Co., Ltd. 33
Slide 34: ROCKET ASCEND Study Design
ROCKET ASCEND Study Design Includes Adult Patients in Monotherapy Trials* Designed to evaluate the safety and efficacy beyond 24 weeks, including off-treatment durability of efficacy *The figure above illustrates, as an example, the trial content for patients transitioning from two trials, HORIZON a
Slide 35: Anti-OX40 antibody – Potential new treatment option
Anti-OX40* antibody – Potential new treatment option for multiple inflammatory diseases Future expansion into indications where "T-cell rebalancing" is expected to lead to reduced disease activity Moderate to Severe Atopic Dermatitis Moderate to Severe P3 ROCKET Program in progress Asthma P2 study i
Slide 36: Overview of ziftomenib
Overview of ziftomenib ◼ Selective Oral Small Molecule Menin Inhibitor ◼ Target Disease: Menin-dependent AML (NPM1 gene mutations and KMT2A gene rearrangements) ⚫ Up to 50% of AML cases are estimated to be menin-dependent (including NPM1 gene mutations and KMT2A gene rearrangements) ⚫ NPM1 gene muta
Slide 37: ASH2024 Presentation Overview - KOMET-007 P1a
ASH2024 Presentation Overview - KOMET-007 P1a (Dose escalation) ◼ Newly Diagnosed (1L) combination with 7+3 ⚫ Efficacy NPM1-m KMT2A-r ORR 100% 83% MRD negativity 76% 75% ⚫ Safety No dose-limiting toxicities, QTc prolongation, or severe myelosuppression observed Differentiation syndrome manageable at
Slide 38: Ziftomenib KOMET-001 Study Phase 2 Results
Ziftomenib KOMET-001 Study Phase 2 Results ◼ Target Disease: R/R NPM1-Mutated AML ◼ Results: Primary endpoints (CR1 and CRh2) were achieved, and safety and tolerability were consistent with previous reports. ◼ More detailed data presentation is scheduled at an upcoming medical conference in Q2 2025.
Slide 39: HSC-GT: Progress of OTL-203 development
HSC-GT : Progress of OTL-203 development Target Disease：MPS-IH - Disease snapshot • Multisystemic neurometabolic condition affecting cognition, growth and skeletal function • Diagnosed during first 2 years of life; life-expectancy up to 10 yrs. • Current standard of care: Allogeneic HSCT w/ or w/o E
Slide 40: News Flow in 2024
News Flow in 2024 © Kyowa Kirin Co., Ltd. 40
Slide 41: Year-to-date Key News Flow
Year-to-date Key News Flow As of Feb. 6th, 2025 Category Date Headline SP Jan 5 Out-licensed the exclusive and worldwide rights to Boehringer Ingelheim of developing first-in-class treatment for fibro-inflammatory diseases. SI Jan 24 Completion of share acquisition of Orchard Therapeutics plc, UK bi
Slide 42: Year-to-date Key News Flow
Year-to-date Key News Flow As of Feb. 6th, 2025 Category Date Headline ESG May 14 Announced the Publication of a Patient-focused Global Consensus Statement for Improving Diagnosis and Care in Cutaneous T-Cell Lymphoma ( Kyowa Kirin, Inc. ) LCM May 17 Approval for Partial Change of Approved Indicatio
Slide 43: Year-to-date Key News Flow
Year-to-date Key News Flow As of Feb. 6th, 2025 Category Date Headline MKT Sep 19 Presented new research on the real-world experiences of people living with XLH and the impact of Crysvita treatment at American Society for Bone and Mineral Research (ASBMR) 2024 annual meeting R&D Sep 25 Announced Top
Slide 44: 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 45: Appendix
Appendix © Kyowa Kirin Co., Ltd. 45
Slide 46: 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 47: Strategic Investment
Strategic Investment ～For successful creation and delivery of life-changing value Licensing-in and M&A investments to strengthen the portfolio 2021-2025 Cash Allocation* ● Priority will be given to the focus disease areas ➢ bone & mineral ➢ intractable hematological diseases/hemato oncology ➢ rare d
Slide 48: 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) Tostran until Oct 3 brands 1 brand Product sales IP transfer IP transfer Established portfolio Revenue 13 brands Sales Royalties & license fees Roya
Slide 49: P/L Impact on Restructuring of APAC business
P/L Impact on Restructuring of APAC business Country / region Until September 2024 October 2024 onwards Divest CN Sales to Partner (Established medicines portfolio) Partnering CN/HK/MO/ Revenue (Established medicines portfolio & Global MY/SG/TH Sales to market Sales to Partner products） /KR/TW In ad
Slide 50: Accounting treatment of share acquisition of Orchard Therapeutics
Accounting treatment of share acquisition of Orchard Therapeutics (Finalized) ✓ Completed the share acquisition on January 24, 2024, and started consolidation from the February 2024 ✓ Recognized intangible assets of $208M (JPY 30.8B) and goodwill of $230M (JPY 34.1B) ✓ Intangible assets will be amor
Slide 51: Main Development Pipeline Products (P2-P3)
Main Development Pipeline Products (P2-P3) As of Feb. 6th, 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 52: Main Development Pipeline Products (P1)
Main Development Pipeline Products (P1) As of Feb. 6th, 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 or
Slide 53: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of Feb. 6th, 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 2H Topline data Atopic Dermatitis P3 ORBIT rocatinlimab (K
Slide 54: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of Feb. 6th, 2025 Products Target Development Status 2025 2026 2027 ＋ AML P21 (NPM1-r) 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 cytara
Slide 55: Main Development Pipeline Products: Future plans
Main Development Pipeline Products: Future plans As of Feb. 6th, 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 XLH
Slide 56: FOREX Information
FOREX Information Average FOREX Rates (yen) FY2023 FY2024 Changes FY2025 Plans USD 140 151 +11 145 GBP 174 193 +19 190 EUR 151 164 +13 160 FY24 FOREX Impacts (vs FY23, billion yen) Revenue Core OP USD +14.8 +4.9 GBP +2.5 -0.0 EUR +4.1 +2.2 FY25 FOREX Sensitivities (vs FY25 Plan, billion yen) Changes
Slide 57: 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 58: 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 59: 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 60: Estimated Patient Numbers
Estimated Patient Numbers Country/ Disease Incidence Prevalence* 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 61: List of Acronyms
List of Acronyms AD Atopic Dermatitis AG Authorized Generic APAC Asia-Pacific AML Acute myeloid leukemia BS Biosimilar DME Diabetic Macular Edema EMEA Europe, the Middle East and Africa JP Japan LCM Lifecycle Management MDS Myelodysplastic syndromes MLD Metachromatic Leukodystrophy MPS-IH Mucopolysa
Slide 62: 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