Slides
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44th Annual J.P. Morgan Healthcare Conference January 14, 2026
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Introduction Corporate Overview • Life Cycle Management of OPDIVO • Impact of Deciphera Acquisition • Valuable Products from Deciphera • Acceleration of Pipeline Development Key for Future Growth Outlook for the Future Toichi Takino, Ph.D. Representative Director, President and Chief Operating Officer 1
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Information about pharmaceutical products (including products currently in development) included in this document is not intended to constitute an advertisement of medical advice. Forecasts and other forward-looking statements included in this document are based on information currently available and certain assumptions that the Company deems reasonable. Actual performance and other results may differ significantly due to various factors. Such factors include, but are not limited to: 2 Forward-looking statements: Current assumptions: Risks and uncertainties: No guarantee of outcomes: Official guidance: Product/market risks: Economic/industry risks: No obligation to update: This presentation contains forward-looking statements regarding the Company’s future plans, strategies, and performance. These statements are based on current expectations, assumptions, and information available to management at this time. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. Forecasts, targets, and projections are not guarantees of future performance or achievement of stated goals. Official financial guidance should be referred to in accordance with relevant regulatory requirements and disclosures. Risks include, but are not limited to, product development challenges, regulatory approvals, market acceptance, and competition. Additional risks may arise from changes in economic conditions, currency fluctuations, and healthcare policy reforms. The Company undertakes no obligation to update or revise any forward-looking statements as a result of new information or future events. Forward-Looking Statements
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Corporate Overview
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ONO’s History of Over 300 Years 1717 Established in Doshomachi, Osaka, Japan 2014 World’s first launch anti-PD-1 antibody “OPDIVO” For patients worldwide : Toward becoming “Global Specialty Pharma” 1968 World’s first company to achieve the total chemical synthesis of prostaglandin 2024 Acquired Deciphera (US) Started direct sales in the US and Europe 4
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Focus Area As of October 30, 2025Innovation Focus and Open Innovation NeurologyOncology Immunology & Inflammation 5 Partners South Korea
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Revenue Growth over the Past 15 Years 0 100 200 300 400 500 600 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 （JPY bn） (Fiscal Year) Acquisition of Deciphera (June 2024) Anti PD-1 antibody OPDIVO launch FY2025 Revenue 490 JPY bn (Forecast) 6
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売上高 • Loss of Exclusivity － US : 2028 － EU : 2030 － JP : 2031 • New Formulation － OPDIVO Qvantig (sc) • Combination Therapies － Opdualag － ONO-4578 • Indication expansion • QINLOCK (Launched) • ROMVIMZA (Approved) － US (Feb 2025) － EU (Sep 2025) • Tirabrutinib / ONO-4059 ★ • Sapablursen / ONO-0530 (Phase 2) P • ONO-4578 (Phase 2) P • ONO-2808 (Phase 2) P ★ Preparation for filing P Recent clinical update Revenue FY2025 490 JPY bn (Forecast) R&D: 150 JPY bn (30.6%) Core OP: 114 JPY bn (23.3%) Life Cycle Management of OPDIVO Driving Global Growth with Deciphera Acceleration of Pipeline Development ONO Today 7 Royalties and Others 33% ONO (Japan) Including OPDIVO 120 JPY bn 55% ONO (KR, TW) 3% (US, International) Deciphera 9%
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Key for Future Growth Life Cycle Management of OPDIVO Impact of Deciphera Acquisition Valuable Products from Deciphera Acceleration of Pipeline Development
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Life Cycle Management of OPDIVO : Strategic LCM Initiatives in Progress Approved IndicationsOPDIVO Sales in JP (JPY bn) Ongoing LCM Activities GC NSCLCESC RCC UC Others % in JP Sales (As of October 2025) Melanoma 2014 NSCLC 2015 RCC 2016 Hodgkin’s lymphoma 2016 Head and Neck Cancer 2017 Gastric Cancer 2017 Malignant Pleural Mesothelioma 2018 Colorectal Cancer (MSI-High) 2020 Esophageal Cancer 2020 Cancer of Unkown Primary 2021 Urothelial Cancer/Bladder Cancer 2022 Malignant Mesothelioma (Excluding Pleura) 2023 Epithelial Skin Malignancies 2024 Hepatocellular Carcinoma 2025 2.5 21.2 103.9 90.1 90.6 87.3 98.8 112.4 142.3 145.5 120.3 120.0 '14 '16 '18 '20 '22 '24 Price Revision 9 EU LOE JP LOEUS LOE US Launch EU Launch iv sc* 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035- (Forecast) sc* : OPDIVO Qvantig Orphan Orphan : Pharmaceuticals designated and approved for rare diseasesare granted 10 years as a re-examination period.
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Impact of Deciphera Acquisition
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1 Product + 1 Late-Stage Program* Further beyond OPDIVO : Driving Growth with Deciphera Acquisition completed in June 2024 and P/L consolidation started in July 2024 *As of June 2024 Pipeline Enrichment US / EU Platform for Clinical Development, Registration and Commercialization Kinase-Focused Discovery with Early-Stage Program Geographical Expansion Strengthening Drug Discovery 11
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• Tirabrutinib (ONO-4059) • Sapablursen (ONO-0530 ) • ONO-2808 • ONO-4578 Successful Integration with Deciphera Leverage Development Capabilities to Advance Existing Pipeline Headquarters Osaka Waltham, Massachusetts Geographic Expansion with Complementary Coverage Deciphera ONO 12 • QINLOCK Sales Growth • ROMVIMZA Launch Reinforcement of Pipeline • Sapablursen (ONO-0530) Global In-Licensed • Early-Stage Pipeline (DCC-3009 etc.)
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Valuable Products from Deciphera
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(Ripretinib) QINLOCK is the only approved drug for 4th line GIST in the US, Europe and others KIT Inhibitor / Small molecule (Oral) 2023 : $163M (23.6 JPY bn, $=145 JPY) 2024 : 25.5 JPY bn 2025 : 36.0 JPY bn (Forecast) Gastrointestinal Stromal Tumor (GIST) 1 ONO market survey in 2024 2 Tyrosine kinase inhibitors Approved in more than 40 Countries Product Positioning Potential to Optimize 2L Therapy Based on Mutations 1st Line 4th Line3rd Line2nd Line Imatinib Sunitinib Regorafenib QINLOCK® Established 4L SOC Across All Mutations The most common sarcoma of the gastrointestinal tract and present in the stomach or small intestine The total number of annual cases in the US and Europe is 4,000 - 5,000 for each 1 The majority of advanced GIST patients will eventually develop resistance, and require lifelong TKI2 therapy • GIST 4th line : Approved (US 2020, EU 2021) • GIST 2nd line KIT Exon 11+17/18 : Phase 3 INSIGHT trial has completed enrollment 14 Characteristic Mechanism of Action Indication Sales
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(Vimseltinib) ROMVIMZA has the potential to be best-in-class CSF1R inhibitor for TGCT in the US and Europe CSF1R Inhibitor / Small molecule (Oral) • TGCT : Approved (US and EU 2025) • cGVHD1 : Phase 2 2025 : 8 JPY bn (Forecast) 1 chronic Graft-Versus-Host Disease 2 Deciphera’s Corporate Presentation (Feb 2024) 3 Tyrosine kinase inhibitors By Oncologist without TKI Approx. 700/year By Surgeons Approx. 1,300/year By Oncologist with TKI 3 Approx. 700/year Step 1 Step 2 Step 3 Market Opportunity in US Product Positioning RecurrenceSurgery ROMVIMZANot amenable to surgery Diagnosis Systemic Treatment High disease burden with multiple symptoms including severe pain, limited function, swelling and stiffness The total number of all cases in the US and Europe is approx.15K for each2 Repeated surgeries and multiple recurrences can turn TGCT into a chronic, lifelong condition Tenosynovial Giant Cell Tumor (TGCT) 15 Characteristic Mechanism of Action Indication Sales 3 TGCT Patients : Approx.15,000/year2 (epidemiological estimate) 1 2
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Most TEAEs were grade 1/2, and grade 3/4 TEAEs were similar between randomized Vimseltinib and crossover groups Vimseltinib MOTION Phase 3 Trial 2-Year Data Week 25 ≥2 years on studyb Vimseltinib n = 83 Placebo n = 40 Vimseltinib n = 83 Crossover n = 35 RECIST v1.1 ORR, n (%) (95% CI) 33 (40%)a (29 to 51) 0 (0 to 9) 40 (48%) (37 to 59) 19 (54%) (37 to 71) Complete response 4 (5%) 0 19 (23%) 4 (11%) Partial response 29 (35%) 0 21 (25%) 15 (43%) DOR, median (range), months NRb (2.5+ to 30.9+) N/A NR (0.03+ to 30.9+) NR (0.03+ to 25.4+) TVSc ORR, n (%) (95% CI) 56 (67%)a (56 to 77) 0 (0 to 9) 67 (81%) (71 to 89) 25 (71%) (54 to 85) Complete response 4 (5%) 0 20 (24%) 4 (11%) Partial response 52 (63%) 0 47 (57%) 21 (60%) DOR, median (range), months NR b (2.5+ to 33.1+) N/A NR (2.4+ to 33.1+) NR (1.9+ to 25.4+) +denotes response was ongoing at the last assessment. a Data cutoff: August 22, 2023. b Data cutoff: February 22, 2025. C TVS response corresponds to ≥50% reduction in estimated tumor volume.1 1 Peterfy C, et al. Future Oncol. 2022;18(12):1449-59. At 2 years, Vimseltinib demonstrated a durable antitumor efficacy consistent with the results at week 25 Presented at ESMO Congress 2025 (Oct 2025) Efficacy Safety 16 ORR: objective response rate CI: confidence interval DOR: duration of response NR: not reached RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1 N/A: not applicable TVS: Tumor Volume Score
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Acceleration of Pipeline Development
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Our Pipeline ※Flag: Indicates countries with approval/application or rights Phase 1 - Phase 2 Tirabrutinib / ONO-4059 PCNSL・P2 Non- Oncology ONO-2020 Alzheimer’s Disease etc・P2 ONO-2808 Multiple System Atrophy・P2 ONO-4685 T-cell lymphoma・P1 Inlexisertib / DCC-3116 Advanced malignancies・P1/2 QINLOCK GIST4L・Approved in >40 counries ROMVIMZA TGCT・Launch DCC-3009 GIST・P1/2 ROMVIMZA cGVHD・P2 Oncology (Excluding OPDIVO) ONO-4685 Autoimmune disease・P1 ONO-4578 Gastric cancer, Colorectal cancer・P2 ONO-8250 HER2-expressing solid tumor・P1 Tirabrutinib / ONO-4059 Pemphigus・P3 QINLOCK GIST2L, KIT Exon 11+17/18・P3 ONO-4482 Melanoma・P1/2 ONO-7427 Solid tumor ・P1/2 Sapablursen / ONO-0530 Polycythemia Vera・P2 DecipheraONO BRAFTOVI BRAF-mutant thyroid cancer・ Approved MEKTOVI BRAF-mutant thyroid cancer・ Approved BRAFTOVI 1L BRAF-mutant colorectal cancer combination with cetuximab and FOLFOX・Filed Cenobamate/ONO-2017 Epilepsy・Filed Gel-One ® / ONO-5532 Osteoarthritis of the Knee & Hip・P3 ONO-1110 Postherpetic Neuralgia etc・P2 ONO-4578 Hormone receptor-pos., HER2-neg. Breast cancer, NSCLC ・P1 ONO-7913 Pancreatic cancer, Colorectal cancer・P1 ONO-7428 Solid tumor・P1 ONO-4915 Autoimmune disease ・P1 New in-licensed DCC-2812 RCC, UC, CRPC・P1 Povetacicept / ONO-8531 IgA Nephropathy, pMN・P3 Tirabrutinib / ONO-4059 PCNSL, WM ・Approved Pivotal Filing・Approval GIST: Gastrointestinal Stromal Tumor TGCT: Tenosynovial Giant Cell Tumor NSCLC: Non Small Cell Lung Cancer As of October 30, 2025 18 PCNSL: Primary Central Nervous System Lymphoma WM: Waldenström’s Macroglobulinemia cGVHD: chronic Graft Versus Host Disease RCC: Renal Cell Carcinoma UC: Urothelial Cancer CRPC: Castration-Resistant Prostate Cancer
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In-licensedExpected Launch* Top line data GIST: Gastrointestinal Stromal Tumor TGCT: Tenosynovial Giant Cell Tumor UC: Urothelial Cancer PV: Polycythemia Vera ADC: Antibody-Drug Conjugate CRC: Colorectal Cancer HCC: Hepatocellular Carcinoma GC: Gastric Cancer FY2024 FY2025 FY2026 MSA: Multiple System Atrophy PCNSL: Primary Central Nervous System Lymphoma AD: Alzheimer’s Disease IgAN: IgA Nephropathy pMN: primary Membranous Nephropathy OA: Osteoarthritis PHN: Postherpetic Neuralgia QINLOCK GIST4L ROMVIMZA TGCT OPDIVO UC Sapablursen / ONO-0530 Licensed from Ionis PV LCB97(ADC) Licensed from LigaChem Solid tumor ROMVIMZA TGCT OPDIVO MSI-High CRC HCC Povetacicept / ONO-8531 Licensed from Vertex IgAN pMN Gel-One / ONO-5532 Licensed from Seikagaku OA ONO-4578 GC・P2 Sapablursen / ONO-0530 Licensed from Ionis PV ・P2 ONO-2808 MSA・P2 Tirabrutinib / ONO-4059 PCNSL Cenobamate / ONO-2017 Epilepsy ONO-2020 AD・P2 Agitation in AD・P2 ONO-1110 PHN・P2 Fibromyalgia・P2 Interstitial Cystitis・P2 Depression・P2 Anxiety・P2 ※Flag: Indicates countries with approval/application or rights As of October 30, 2025 19 Pipeline Progress (FY2024-2026) Launched *Subject to successful regulatory submission and approval
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Tirabrutinib (ONO-4059) Tirabrutinib is the first drug approved in Japan (VELEXBRU) for the treatment of PCNSL. There are currently no approved treatments for PCNSL in the US BTK(Bruton's tyrosine kinase) inhibitor / Small molecule (oral) Duration of Response by IRCIn most cases, constitutive activation of B-cell receptor signaling is considered a major mechanism underlying disease onset and tumor growth The estimated patients in Japan is approx. 1.5K per year The incidence rate is approx. 5 cases per million per year in the US Rare and highly malignant type of lymphoma Primary Central Nervous System Lymphoma (PCNSL) PROSPECT : Primary Endpoint: ORR by IRC Preparation for filing - Orphan drug designation (2023) P3 : PCNSL (confirmatory trial, US) P3 : Pemphigus (JP) 32 25 16 12 9 5 4 3 0Patients at risk 0 3 6 9 12 15 18 21 24 Duration of Response (months) 0.0 0.2 0.4 0.6 0.8 1.0 Tirabrutinib Probability of Patients Continuing Response • Median DOR by IRC = 9.3 months (95% CI: 4.6, 14.6) • Median time to response by IRC = 1.0 months (range, 0.9-3.7) Presented at ASCO 2025 Annual Meeting (May 2025) ORR by IRC n (%) 95% CI ORR (CR+CRu+PR) 32 (67%) 52, 80 CRR (CR+CRu) 21 (44%) 29, 59 BOR CR 13 (27%) 15, 42 CRu 8 (17%) 7, 30 PR 11 (23%) 12, 37 SD 9 (19%) 9, 33 PD 6 (13%) 5, 25 NE 1 (2%) 0, 11 20 Characteristic Mechanism of Action Status * ORR: overall response rate IRC: response determined per IPCG criteria CI: confidence interval CRR: complete response rate SD: stable disease. PD: progressive disease NE: not evaluable BOR: best overall response CR: complete response CRu: unconfirmed complete response PR: partial response *This image is of the product currently available in Japan
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Sapablursen (ONO-0530) Sapablursen (ONO-0530) increases hepcidin production by suppressing the TMPRSS6 gene expression, thereby reducing red blood cells (RBC) in PV patients RNA-targeted medicine designed to inhibit TMPRSS6 expression / subcutaneous injection once a month PV patients have a JAK2 gene mutation that leads to overproduction of RBC PV is a rare and potentially life-threatening hematologic disease The incidence rate of approx. 2 cases per 100K population1 Total of 75K patients on treatment in the US2 Controlling hematocrit levels (less than 45%) is a key therapeutic goal to reduce thrombotic events3 Polycythemia Vera (PV) IMPRSSION : Phase 2a, Multicenter, Randomized, Open-Label Trial of Sapablursen in Patients With Phlebotomy-Dependent PV Screening Treatment period Treatment extension period Post-treatment follow-up 7 weeks 37 weeks 36 weeks 13 weeks Week17-37 Primary endpoint window Cohort A (n = 32): Sapablursen 120→80 mg Q4W SC Cohort B (n = 17): Sapablursen 40 mg Q4W SC Safety Met Primary Endpoint: Reduction in Phlebotomy Rate Advancing to Phase 3 Fast track designation (2024) Orphan drug designation (2024) Breakthrough therapy designation (2025) Presented at 67th ASH Annual Meeting (Dec 2025) 21 Characteristic Mechanism of Action Status 1 Blood Cancer Journal (2020) 10:22 2 Nat Rev Dis Primers. 2025 Apr 17;11(1):26 3 Marchioli R. N Engl J Med. 2013 3; 368: 22. Baseline hematocrit was defined as the last non-missing assessment prior to the first dose of study drug. Values are from the central lab data. SEM, standard error of the mean. Hematocrit Cohort A : 0.15±0.07 (~7.8/yr) 0.05±0.09 (~2.6/yr) Cohort B : 0.17±0.07 (~8.9/yr) 0.07±0.07 (~3.6/yr) Administration of Sapablursen Resulted in a Dose- and Time-Dependent Increase in Hepcidin With a Corresponding Reduction in Hematocrit
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ONO-2808 yearsPossible MSAPremotor MSA Probable MSA Possibility of Death 0 3 6 9 Movement disorder Autonomic dysfunction Assisted walking Wheelchair mobility Bedridden Death Progressive neurodegenerative disease characterized by cerebellar atrophy Estimated patients in US 1, 2 : 15-50K, Japan 3 : 10K Currently only symptomatic treatments with limited efficacy are available Multiple System Atrophy (MSA) 1 National Institutes of Health: https://www.ninds.nih.gov/health- information/disorders/multiple-system-atrophy, 2 Kaplan S, et al. Parkinsonism Relat Disord. 2023;117:105920. 3 https://www.nanbyou.or.jp/entry/59 Placebo-controlled, double-blind, randomized, parallel-group study Primary Endpoint : Safety, Tolerability Secondary Endpoint : PK, conc. in CFS Exploratory Endpoint: UMSARS (Historical Review, Motor Examination) ONO-2808 is expected to reduce the accumulation of aberrant α-synuclein in oligodendrocytes or neurons, contributing to the protection of the myelin sheath Sphingosine 1-phosphate receptor 5 (S1P5) agonist / Small molecule (oral) P2 (US, JP) Characteristic Mechanism of Action Status High dose (n=20) Medium dose (n=20) Low dose (n=20) Placebo (n=20) Phase 2 : ONO-2808-03 Design • 30 to 80 years of age diagnosed with MSA • With an anticipated survival of at least 3 years • Defined as a maximum of 5 years since the onset of symptoms Patients (Target criteria) 22 Total Treatment Period : 80 weeks 24 weeks Transition Period 8 weeks Open-Label Treatment Period 48 weeks PK: pharmacokinetics CFS: cerebrospinal fluid
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ONO-4578 is expected to have an antitumor activity by abolishing the immunosuppressive mechanism mediated by the binding of PGE2 to the EP4 receptor Prostaglandin receptor (EP4) antagonist / Small molecule (oral) P2 : Gastric cancer 1L* (JP, KR, TW) : Colorectal cancer 1L * (JP, US, EU, etc) P1 : Non-small cell lung cancer * (JP), Hormone receptor-pos., HER2-neg. breast cancer (JP) *with OPDIVO 23 Characteristic Mechanism of Action Status Both the M1/M2 macrophage ratio and the T cell signature score increased Phase 1 T-cell Gene Signature and M1/M2 Macrophage Gene Signature in Tumor Biopsies Phase2 : ONO-4578-08 Design (Gastric Cancer) • Untreated, unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) • HER2-negative • ECOG PS 0-1 • Neoadjuvant or adjuvant chemotherapy allowed if completed ≧180 days prior to recurrence R 2:1 Stratification factors • PD-L1 CPS • PS • Peritoneal metastasis • ONO-4578 40mg QD PO • Nivolumab 360mg, Q3W • Chemotherapy, Q3W （ SOX or CapeOX ） • Placebo QD PO • Nivolumab 360mg, Q3W • Chemotherapy, Q3W （ SOX or CapeOX ） Follow up / Outcome survey SOX: S-1 40mg/m2 orally twice daily (days 1-14) and oxaliplatin 130mg/m2 IV (day1), Q3W CapeOX: capecitabine 1000mg/m2 orally twice daily (day1-14) and oxaliplatin 130mg/m2 IV (day1), Q3W n=210 n=140 n=70 Met Primary Endpoint : PFS Secondary Endpoint : OS, ORR, DOR, Safety etc. Continue until • Disease Progression • Unacceptable toxicity • Withdrawal consent ESMO 2023: Poster #1546 ONO-4578 OS: overall survival ORR: overall response rate DOR: duration of response treated untreated treated untreated pre post pre post pre post pre post
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Launch Projections (-FY2031) Japan US & EU GIST: Gastrointestinal Stromal Tumor TGCT: Tenosynovial Giant Cell Tumor CRC: Colorectal Cancer HCC: Hepatocellular Carcinoma UC: Urothelial Cancer GC: Gastric Cancer PV: Polycythemia Vera MSA: Multiple System Atrophy IgAN: IgA Nephropathy OA: Osteoarthritis cGVHD: chronic Graft Versus Host Disease PCNSL: Primary Central Nervous System Lymphoma FY2025 FY2026 FY2027FY2024 FY2028-2031 PCNSL Tirabrutinib (ONO-4059) GIST 4L QINLOCK TGCT ROMVIMZA KIT Exon 11+17/18 GIST 2L QINLOCK HCC 1L OPDIVO/YERVOY MSI-H/dMMR CRC 1L OPDIVO/YERVOY CRC 1L BRAFTOVI HCC Adjuvant OPDIVO T-cell Lymphoma/Autoimmune Disease ONO-4685 PV Sapablursen (ONO-0530) GC ONO-4578 MSA ONO-2808 cGVHD ROMVIMZA IgAN Povetacicept (ONO-8531) OA Gel-One (ONO-5532) Solid Tumor Nivolumab sc (ONO-4538HSC) Epilepsy Cenobamate (ONO-2017) 24 UC, Neoadjuvant, Adjuvant OPDIVO
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Outlook for the Future
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Prospect for the Next 10 Years Growth Driver ※Diagram does not represent actual sales of each product Nivolumab sc formulation Povetacicept Cenobamate, Gel-One ® etc. Global QINLOCK (GIST) ROMVIMZA (TGCT) Tirabrutinib (PCNSL) Sapablursen (Polycythemia Vera) ONO-4578 (Gastric Cancer) ONO-2808 (MSA) etc. Japan 2025 2030 2035 Japan sales (OPDIVO) Global sales Royalties Japan sales (other than OPDIVO) 26 GIST: Gastrointestinal Stromal Tumor TGCT: Tenosynovial Giant Cell Tumor MSA: Multiple System Atrophy PCNSL: Primary Central Nervous System Lymphoma
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Capital Allocation (FY2022-2026) Shareholder return Result of FY2022-2024Assumption for FY2025-2026 • Progressive dividends, target payout ratio of 40% • Annual dividend 80 JPY/share (FY2026 forecast) • Flexible buyback • M&A • Pipeline acquisition • Geographical expansion • Venture investment R&D Strategic Investments Strategic investments ≈ 250 JPY bn Capacity to invest to further increase corporate value Progressive dividends & flexible share buyback ≈ 350 JPY bn ≈ 300 JPY bn ≈ 100 JPY bn Including M&A ≈ 500 JPY bn ≈ 160 JPY bn Shareholder Return • Cumulative annual expenses for 2 years R&D ≈ 600 JPY bn Update (as of May 2025) Planned as of Apr 2022 27
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Dedicated to the Fight against Disease and Pain ONO’s Philosophy
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Dedicated to the Fight against Disease and Pain For further information, please contact: Ono Pharmaceutical Co., Ltd. Investor Relations Email: public_relations@ono-pharma.com