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Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program February 2nd, 2026 Chairman and Chief Executive Officer (CEO) Masashi Miyamoto, Ph.D. President and Chief Operating Officer (COO) Abdul Mullick, Ph.D. Managing Executive Officer, Chief Financial Officer (CFO) Motohiko Kawaguchi Managing Executive Officer, Chief Strategy Officer (CSO) Yasuo Fujii, MBA
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© Kyowa Kirin Co., Ltd. Kyowa Kirin will continue to advance rocatinlimab development to create Life-changing value that makes people smile 1 ◼ Existing license and collaboration agreement will be terminated following Amgen’s strategic portfolio prioritization, and Kyowa Kirin will regain control of the global rocatinlimab program ◼ Kyowa Kirin affirms commitment to developing rocatinlimab as a Life-changing differentiated asset with significant market potential ◼ Regulatory submissions are planned for the first half of 2026 ◼ Amgen will provide transitional long-term manufacturing and supply of rocatinlimab to Kyowa Kirin ◼ All eight Phase 3 studies (ROCKET Program) successfully met their primary and key secondary endpoints. Of note, rocatinlimab demonstrated a significant improvement in the co-primary endpoint required for US regulatory submission, the revised Investigator’s Global Assessment (rIGA) score of 0 or 1 (defined as achieving a vIGA-AD score of 0 [clear skin] or 1 [almost clear skin] with presence of only barely perceptible erythema) at week 24 Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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2© Kyowa Kirin Co., Ltd. Novel upstream mechanism directly targeting pathogenic T cell: Inhibits and reduces OX40R+ T-cells that produce cytokines, one of the root causes of chronic inflammation Cytokines Antigen Presenting Cell Activated T-cell IL-4, IL-13, IL-31, TNFα, IL- 17, IL-5, IL-2, IL-22, IFNγ OX40 (Receptor) OX40 Ligand T-cell Rebalancing Approach Rocatinlimab is a T-cell Rebalancing Therapy which directly targets a root cause of AD, activated pathogenic Effector and Memory T-cells Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. OX40 (Receptor) OX40 (Receptor)
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3© Kyowa Kirin Co., Ltd. At present, more than 10 assets related to OX40/OX40L are in clinical stage globally Antigen Presenting Cell (APC) Activated T-cell Amlitelimab1,2 APG9905 Rocatinlimab1,2 IMG-0073 STAR-03104 Rocatinlimab acts directly on pathogenic T cells by targeting OX40 receptor1,2 OX40 (Receptor) Amlitelimab is an anti-OX40L therapy that blocks the OX40 pathway by binding to OX40L on APCs1,2 Note: AD, atopic dermatitis; APC, antigen-presenting cell; OX40R, OX40 receptor; OX40L, OX40 ligand. 1. Croft, et al. Am J Clin Dermatol 2024;25:447–461; 2. Le AM, et al. Pharmaceutics 2022;14:2753; 3. Shen Y, et al. Br J Dermatol 2024;191(Suppl 2); 4. Biris N, et al. Presented at EAACI 2024. Poster D1.343; 5. Wong M et al. RAD 2025., Kyowa Kirin internal search OX40 Ligand … … Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. OX40 signalling leads to the activation of downstream pathways that drive effector and memory T-cell differentiation, proliferation and survival1,2
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4© Kyowa Kirin Co., Ltd. 4 Activity of rocatinlimab confirmed 1st IND for rocatinlimab Global Ph3 mono-therapy data Published in the Lancet Antagonist OX40 mAb discovery project initiated based on proposal from Dr. Croft at La Jolla Institute (LJI) Kyowa Kirin has absolute conviction in rocatinlimab’s science and excited to advance Rocatinlimab program to the next chapter rocatinlimab precursor discovered 2003 2003 2007 2016 2021 Partnership with Amgen Initiation of Ph3 AD ROCEKT Program 2023 2025 Global Ph2b data Published in the Lancet 2010 Pre-clinical studies initiated Rocatinlimab was discovered and advanced by Kyowa Kirin scientists, drawing on our deep expertise in immunology and antibody engineering Kyowa Kirin regain control of the global program 2026 Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. Moderate-to-Severe Atopic Dermatitis (msAD) is a chronic, heterogeneous inflammatory skin disease that imposes a substantial burden on patients and caregivers 5 1. Lio P, et al. J Drugs Dermatol. 2023;22:119-131. 2. Eichenfield LF, et al. SKIN J Cutaneous Med. 2024;8(6):s462. 3. Hongbo Y, et al. J Invest Dermatol. 2005;125:659-664. Impact of Moderate-to-Severe AD: Skin Symptoms Excessively dry, itchy, and painful skin Repeated scratching can lead to thickened, hardened skin and increased infection risk Sleep Disruption Chronic symptoms negatively impacts sleep in up to 80% of children and 90% of adults Mental Health Adults are twice as likely to experience depression and anxiety Daily Life Reduced productivity, limited social interactions and an overall decrease in Quality of Life Despite existing therapies, many patients with moderate-to-severe AD continue to experience inadequate disease control1,2,3 Many patients strive to find relief, and hope for new treatment options Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. There remains an urgent need for new therapies with novel mechanisms of action to expand treatment options for patients with moderate-to-severe AD Current treatment options often fail to provide sufficient depth and durability of symptom improvement1-3 6 1. Lio P, et al. J Drugs Dermatol. 2023;22:119-131. 2. Eichenfield LF, et al. SKIN J Cutaneous Med. 2024;8(6):s462. 3. Hongbo Y, et al. J Invest Dermatol. 2005;125:659-664. 4. IQVIA analysis: Closing in: Novel oral immunotherapies are taking on the biologics [LINK], 5. Kyowa Kirin/Amgen internal data on file ◼ 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 treatment4, indicating considerable opportunity for growth in the msAD market. ◼ More than 50% of patients receiving systemic therapies discontinue treatment within a year5. ◼ Treatment goals have evolved from ”short-term symptom control” to “long-term disease control”, and ultimately toward “disease modification”. Strictly Confidential Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. 7 ◼ There remain significant unmet medical needs in AD. Few patients are able to continue existing advanced treatments over the long term. Patients are eagerly waiting for innovative new options. ◼ I welcome new drug candidates with novel mechanism of actions that have the potential to deliver unique value that other therapies are not able to provide. For patients with Atopic Dermatitis, Unmet Medical Needs (UMN) still exist Professor Kenji Kabashima Department of Dermatology, Kyoto University Graduate School of Medicine COI Disclosure Kenji Kabashima Department of Dermatology, Kyoto University Graduate School of Medicine Professor The following conflicts of interest (COI) should be disclosed in relation to this material. • Receives consulting fees from Kyowa Kirin Co., Ltd. Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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8 8© Kyowa Kirin Co., Ltd. Strong Growth Expected in the msAD Markets Driven by increasing penetration of biologics and the introduction of novel therapies Over 15% Atopic Dermatitis Market Outlook Atopic Dermatitis Market Overview SOURCE: National Eczema Association; Asthma and Allergy Foundation of America; US Census Data; WHO, CDC, analyst research.FDA labels; corporate presentations; Clinicaltrials.gov; Allergy& Asthma Network; Datamonitor; Chan et al., J Am Acad Dermatol (2025); Hanifin et al., Dermatitis (2007); Silverberg et al., J Allergy Clin Immunol (2013); Datamonitor; Therapeutic Categories Outlook, TD Cowen (2024), Gorritz et al., J Derm Treat (2022); Heratizadeh et al., J Eur Acad Dermatol Venereol (2024); Lio et al., J Drugs Dermatol (2023); Fuxench et al., J Inv Dermatol(2019); Boytsov et al., J Derm Treat (2022); * Advanced Therapy, ** Based on L.E.K. epidemiology assessment AT*-treated # of Patients in U.S** 15- 20% Dupixent Nemluvio Ebglyss Adbry 400-450K Cibinqo Rinvoq 6 therapies launched to date ~75% anticipated increase in AT treated population from 6 to 10+ products launched based on similarities with psoriasis market 800-850K>23 million Estimated U.S. AD patient 12y+ population Biologic penetration in the U.S. Projected sales growth 2026 2030 and beyond Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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9© Kyowa Kirin Co., Ltd. Rocatinlimab delivers progressive increases in the proportion of patients achieving deep responses through Week 52 0 10 20 30 40 50 60 70 80 90 100 2 4 8 12 16 20 24 28 32 36 40 44 48 52 0 10 20 30 40 50 60 70 80 90 100 2 4 8 12 16 20 24 28 32 36 40 44 48 52 EASI-90vIGA-0/1 Study week AD = atopic dermatitis; AU = aphthous ulcers; vIGA-AD = Validated Investigator's Global Assessment for Atopic Dermatitis; EASI = Eczema Area and Severity Index; TEAE = Treatment-Emergent Adverse Event Study week ROCKET-ORBIT Topline: 52-week Open Label Adolescent Trial* ■ Safety results are consistentwith those observed in the ROCKET 24-week and 56-week adult trials. ■ The most frequent TEAE in ROCKET- ORBIT were headache, pyrexia, apthous ulcer, upper respiratory tract infection, and nasopharyngitis. ■ Low discontinuation rate due to adverse events. Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. 57.4 60.2 Percentage of patients *Data on file
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© Kyowa Kirin Co., Ltd. 10 Robust Manufacturing Capabilities Established • Combines Amgen's world-class manufacturing capability with Kyowa Kirin’s global supply infrastructure to ensure stable and reliable product supply Kyowa Kirin has established operations in Japan, U.S., and Europe with proven track records • Japan: Strong track record in dermatology • U.S. and Europe: Excellent core teams across Sales, Marketing, Market Access, Medical, Patient Support; proven success with Crysvita and Poteligeo A Robust Launch Readiness Upon Regulatory Approval U.S. Dermatology Launch Preparation • Multi-year preparation for co-promotion with Amgen • Core functional teams already in place • Continued investment to ensure readiness for potential approval and launch Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. This transition will allow Kyowa Kirin to bring Rocatinlimab with the highest priority and urgency to patients around the world 11 Item Original Agreement After Original Agreement Termination Market Authorization Holder Amgen Kyowa Kirin Manufacturing Amgen Amgen will provide transitional long-term manufacturing and supply of rocatinlimab to Kyowa Kirin Development Led by Amgen Led by Kyowa Kirin with certain transition services from Amgen Commercialization Japan: Kyowa Kirin US: Amgen (Kyowa Kirin co-promotion) Europe/Asia: Amgen (Kyowa Kirin retains co- promotion rights) Japan & US: Kyowa Kirin Europe/Asia: Kyowa Kirin explores all options Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. Impact on P&L: Short-term cost increase, but substantially beneficial over the mid to long term Item Original Agreement After Original Agreement Termination Revenue Kyowa Kirin receives double-digit % royalty Kyowa Kirin records sales revenue COGS — Amgen supplies products at an agreed-upon price SG&A Expenses Shared equally by both companies 100% borne by Kyowa Kirin R&D Expenses Shared equally by both companies 100% borne by Kyowa Kirin Service fee payment to Amgen for transition support (FY2026-2027) 12 Future Prospects Peak Sales Potential Over ¥200 billion Profit Contribution Timing 2028 Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.
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© Kyowa Kirin Co., Ltd. Rocatinlimab: Pioneering a Novel Treatment Paradigm Through T-cell Rebalance ◼ Directly targets a root cause of inflammation and chronicity to potentially achieve deeper and durable improvement ◼ Potential to expand to other inflammatory diseases with significant unmet need Kyowa Kirin is fully committed to bringing rocatinlimab to patients worldwide with the highest priority and urgency This is a catalyst for accelerated growth and the gateway to our next chapter Moderate-to-Severe Atopic Dermatitis P3 Study (ROCKET program) ongoing Prurigo Nodularis P3 Study Enrollment Complete Moderate-to-Severe Asthma P2 Study Enrollment Complete Patients 16 million Existing Market Size JPY 1 trillion~ Patients 1 million Existing Market Size JPY 0.5-1 trillion Patients 13.5 million Existing Market Size JPY 1 trillion~ Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.