Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Investor Presentation (October 2025)
59 slides from Nxera Pharma's investor presentation, October 2025
Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation October 2025 | Nxera Pharma Co., Ltd. (TSE: 4565)
Slide 2: Disclaimer
The material that follows is a presentation of general background information about Nxera Pharma Co., Ltd and its subsidiaries (collectively, the “Company”) as of the date of this Disclaimer presentation. This material has been prepared solely for informational purposes and is not to be construed as
Slide 3: Agenda
Agenda 01 Business Overview 02 Strategic Roadmap 03 Our Pipeline 04 Japan/APAC Business 05 Our NxWave Platform 06 Financial Results 07 Appendix 3
Slide 4: Business Overview
Business Overview 01
Slide 5: We are Nxera Pharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX We are Nxera Pharma A technology-powered biopharma in pursuit of new specialty medicines to improve the lives of patients OVERVIEW PRODUCTS AND PROGRAMS PRODUCT FOCUS & SCIENCE Sales Market Size Of Product Focus $200m Annual Re
Slide 6: Not a traditional Japanese pharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Not a traditional Japanese pharma. We think and innovate globally, and specialize locally Global Drug Discovery Center Japan Operations Team ~200 team CEO Finance Chief of Staff Legal members Finance Operation Compliance Resear
Slide 7: Strategic Roadmap
Strategic Roadmap 02
Slide 8: Our History
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our History Strategic steps taken to build Nxera over the last two decades 2000s 2015 2023 2024 Launched a public company Out-licensed several programs to Elevated our status in the Tokyo dedicated to bringing innovation to glo
Slide 9: Building a fully integrated biopharma from Japan
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Building a fully integrated biopharma from Japan Accelerating growth to achieve our mission by leveraging business platform in Japan and UK Drug discovery / Clinical Commercialization Preclinical Early-stage Late-stage Our sour
Slide 10: Priority objectives for FY2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Priority objectives for FY2025 01 JPY 17 billion+ Net product sales (PIVLAZ® plus QUVIVIQ®) Commercial 02 Acquire/in-license at least one late-stage medicine for Japan/APAC (ex-China) Commercial Execute at least one new major p
Slide 11: Wave1 and Wave2 programs across fast growing disease areas
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Partner’s Wave 1 and Wave 2 programs are positioned across fast growing disease areas of healthcare MARKET SIZE (2030) WAVE1 (Potential Launch by 2030) WAVE2 (Potential Launch by 2035) Neurology P2 mGlu5 NAM* P2 Ox2 agonist P3
Slide 12: Our 2030 vision: high growth, highly profitable Japanese biopharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our 2030 vision is to build a high growth, highly profitable Japanese biopharma JPY Bn Royalties from WAVE1 + WAVE2 create step-change WAVE2 WAVE2 Royalty Royalty Potential royalty from next generation Only 1-2 launches from se
Slide 13: Our Pipeline
Our Pipeline Programs by Design 03
Slide 14: Major pipeline Overview (incl. projections)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (incl. projections) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral vasospasm •
Slide 15: Major pipeline Overview (incl. key partner highlights)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (incl. key partner highlights） Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral
Slide 16: Major pipeline Overview (By business categories)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview (By business categories) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A IN-HOUSE Advanced solid tumors Fabry disease Cerebral vasosp
Slide 17: Looking ahead to potential catalysts in 2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Looking ahead to potential catalysts in 2025* ✓ : Progress in 2025 PROGRAM PARTNER TIMING EVENT ✓ Cenerimod Feb. 2025 Assignment of JAPAC rights (excl. China) ✓ TMP-301 (mGlu5 NAM) Mar. 2025 Phase 2 study start in alcohol use d
Slide 18: Key strategy for each business category
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key strategy for each business category Maximize the value of each business and demonstrate synergies by conducting integrated development in future NxWaveTM platform driven Acquire or in-license for Japan ◼ Collaborate with ex
Slide 19: Japan/APAC Business
Japan/APAC Business Deliver innovation to patients in Japan/APAC 04
Slide 20: Japan will serve as our base to expand across APAC markets
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Japan will serve as our base to expand across APAC markets Commercial Japan is an attractive, established market with strong volumes Japan is the second Tailwinds from near- High quality clinical APAC is the second largest phar
Slide 21: PIVLAZ (clazosentan, an endothelin A antagonist)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX PIVLAZ® (clazosentan, an endothelin A antagonist) Commercial Our first commercially available product for the prevention of cerebral vasospasm in patients with Aneurysmal Subarachnoid Haemorrhage (aSAH) Quarterly PIVLAZ® Net Sa
Slide 22: QUVIVIQ (daridorexant, dual orexin antagonist)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQ® (daridorexant, dual orexin antagonist “DORA”) Commercial DORA is rapidly establishing its position in the treatment paradigm for insomnia (Bn JPY) Lemborexant (Dayvigo) Zolpidem Others Suvorexant (Belsomra) Eszopiclone
Slide 23: QUVIVIQ Business structure
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQ® Business structure Commercial Royalty profits initiated and supply margin expected in a few years Sales structure Profit structure for Nxera Product net sales Royalty + Product supply sales Product Product Supply Suppl
Slide 24: Full year product sales guidance
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year product sales guidance Commercial Target 13.0 - 14.0 Bn JPY (PIVLAZ®) from net sales, and 4.0 - 5.0 Bn JPY (QUVIVIQ®) from royalty and supply Target sales in FY2025 13.0 – 14.0 Bn JPY 4.0 – 5.0 Bn JPY +7% +220% (NHI S
Slide 25: Our NxWave Platform
Our NxWave Platform Cutting-edge Science 05
Slide 26: NxWave platform enables faster, cheaper and more precise drug discovery
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave platform enables faster, cheaper and more precise drug discovery Platform World-leading science and platform enables efficient drug discovery against difficult targets Conventional drug discovery Our drug discovery Appro
Slide 27: NxWave: Proprietary structure-based drug design
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave : Proprietary structure-based drug design delivering proven pipeline impact Platform Target ID and NxStaR NxHit NxDesign Translational Med. Validation Identifying the Stabilising the Identifying the Selecting the Testing
Slide 28: Number of structures solved and deposited in PDB
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Number of structures solved and deposited in PDB, resolution by technology Platform The number of structures solved using Cryo-EM is increasing, X-ray crystallography has extremely high resolution Number of structures solved by
Slide 29: Our platform enables precise design of GPCR models
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our platform enables precise design of GPCR models Platform Only by performing detailed structural analysis can we design great drugs. Imprecise GPCR model: Standard Medicine Precise GPCR model: Optimized Medicine Poorly unders
Slide 30: Our track record of major licensing transactions
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our track record of major licensing transactions speaks for itself… Platform Income from licensing provides a great source of non-dilutive financing to support our growth Balance of potential milestone income from Top 15 pharma
Slide 31: Hundreds of millions of dollars received, billions in potential
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX … hundreds of millions of dollars received, billions of dollars in potential to come Platform New collaboration and exclusive option to license agreement executed with Boehringer Ingelheim Upfront and Initial Potential Total Pa
Slide 32: Muscarinic program development
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Muscarinic program development. Platform Ph3 ongoing for our product NBI'568, which aims to be best-in-class, owing to its predecessor Cobenfy First clinical evidence for benefit of Positive KarXT Phase2 clinical Cerevel M4 PAM
Slide 33: Topline Results for Phase 2 Trial of M4 Agonist
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Topline Results for Phase 2 Trial of M4 Agonist Platform Efficacy confirmed at 20 mg. Statistically significant difference in both PANSS and CGI-S compared to placebo. “The effects with the 20-milligram dose, both PANSS and CGI
Slide 34: Comparison of Study Sites and Duration with Known Muscarinic Programs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Comparison of Study Sites and Duration with Known Muscarinic Programs Platform Mentioned in a presentation Phase 3 of NBI-568 will be one to one randomization and around 20 sites per study Neurocrine/Nxera Neurocrine/Nxera BMS/
Slide 35: Placebo effect
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Data comparison of placebo effects (Total PANSS) Platform Large number of study sites in a clinical trial of muscarinic program may be linked to a higher placebo response. 20 Emraclidine (Empower-3) 15 Emracridine (Empower-2) K
Slide 36: Safety: Adverse Events Risk
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Safety: Adverse Events Risk Platform The gastrointestinal and cardiovascular adverse events were higher than placebo in Cobenfy, but not with NBI-568 Safety Dietary Number of Gastrointestinal Cardiovascular Restriction doses Ot
Slide 37: Neurocrine's portfolio of muscarinic orthosteric agonists
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Neurocrine is advancing the world’s most comprehensive portfolio of Platform muscarinic orthosteric agonists – discovered by Nxera using NxWave Compound Target Indication Phase1 Phase2 Phase3 s NBI’568 M4 agonist Schizophrenia
Slide 38: Centessa building a leading portfolio of OX2R agonists
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Centessa are building a leading portfolio of OX2R agonists in sleep/neuro disorders Platform ORX750, ORX142, and ORX489 positioned as potential first/best-in-class across NT1, NT2, IH, and neuro disorders Multi-asset pipeline d
Slide 39: Data on OX2 agonist competitors
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Data on OX2 agonist competitors Platform ORX750 reported favorable safety and efficacy results in Phase 1b trials TAK-861 ALKS2680 ORX750 *MWT (mins) % Side Effects *MWT (mins) % Side Effects *MWT (mins) % Side Effects 40 100 4
Slide 40: New pipeline for obesity and chronic weight management
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Nxera launched broad new pipeline for obesity and chronic weight management Platform 7 programs underway with in-house development in the obesity area Aligned with the Oral Therapeutics Shift Highlights ORAL SMALL • Benefits of
Slide 41: GPR52 agonist for schizophrenia
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX GPR52 agonist for schizophrenia Platform A novel first-in-class mechanism to treat positive, negative & cognitive domains of schizophrenia Disease Rationale Progress • GPR52 is expressed on D2 dopamine neurons in striatum where
Slide 42: EP4 antagonism for advanced solid tumours
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX EP4 antagonism for advanced solid tumours Platform Under development in combination with an immune checkpoint inhibitor (CPI). Disease Rationale Progress • Prostaglandin E2 (PGE2) is secreted by tumour and surrounding • Ph1 stu
Slide 43: EP4 agonist for inflammatory bowel disease (IBD)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX EP4 agonist for inflammatory bowel disease (IBD) Platform A first-in-class GI-targeted agent to promote mucosal healing in IBD Disease Rationale Progress • IBD is an immunological disorder in which current standard-of-care agen
Slide 44: Financial Results
Financial Results 06
Slide 45: Key financial indicators
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key financial indicators Despite growth in the sales business, core operating income posted a loss due to a YoY decline in milestone. Major factors Latest result ◼ USD10m received from Viatris for assignment of rights for Upfro
Slide 46: Breakdown of Q2 YTD results
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Breakdown of Q2 YTD results Significant growth in commercial revenues Consolidated Consolidated (JPY million) Platform*1 ＋ Commercial*2 = P&L (Core) ＋ Non-core costs = P&L (IFRS) （YoY） （YoY） （YoY） （YoY） Revenue 8,162 -40% 13,68
Slide 47: Full year cost Guidance for FY2025 (Unchanged)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year cost Guidance for FY2025 (Unchanged) Small increase in R&D expenditure with progression of several programs into later stages of development, and in-licensing of one or more late-stage candidates. Lower to flat SG&A e
Slide 48: Appendix
Appendix 07
Slide 49: Partnered pipeline (1/2)
Partnered pipeline (1/2) Compound Target / Mechanism of Action Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt Partnered Seebri® Breezhaler® LAMA SME COPD Ultibro® Breezhaler® LAMA+LABA SME COPD Enerzair® Breezhaler® LAMA+LABA+ICS SME Asthma ORAVI® Antifungal agent miconazole SME Oropharyn
Slide 50: Partnered pipeline (2/2)
Partnered pipeline (2/2) Compound Target / Mechanism of Action Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt Co-development KY1051 CXCR4 mAb mAb Immuno-oncology (Not disclosed) AI-Augmented Drug Discovery SME Neurology diseases (Not disclosed) Multi targe SME/LME Immune / Neurology disea
Slide 51: In-house pipeline
In-house pipeline Compound Target / Mechanism Modality Indication Partner Disc. PCC Ph1 Ph2 Ph3 App Mkt In-house Programs PIVLAZ® ETA antagonist SME Cerebral vasospasm QUVIVIQ® Dual Orexin antagonist SME Insomnia NXE0048149 1 GPR52 agonist SME Neurology diseases NXE0039732 2 EP4 antagonist SME Immun
Slide 52: Clinical Trials
Clinical Trials Compound MoA Condition Phase Size Patient Start Completion* Last Update Link (main/latest) Link (others) NBI-1117568 M4 agonist Schizophrenia Ph2 210 Yes 2022-10-04 2024-07-10 2025-07-11 NCT05545111 - NBI-1117568 M4 agonist Schizophrenia Ph3 284 Yes 2025-05-08 2027-10 2025-10-24 NCT0
Slide 53: Estimation of potential market size
Estimation of potential market size Multi-billion USD annual peak sales potential for our post-pre-clinical pipeline Peak Sales Category Indication2 Number of Patients Candidates Market Size Individual Products Dementia ~55 million $7.3 billion (2010) $3.9 billion (2009/Aricept) M1 ag, M1/M4 ag Schi
Slide 54: Exclusive Opt-in Rights And ROFN/ROFR
Exclusive Opt-in Rights And ROFN/ROFR1 Option to develop up to five clinical programs for Japan and APAC (ex-China) from Idorsia Program Mechanism of Action Indication Stage Region Exclusive Lucerastat Glucosylceramide synthase inhibitor Fabry disease Phase 3 Opt-in Right Multiple sclerosis and ACT-
Slide 55: Core Operating Profit - Definition
Core Operating Profit - Definition Core Operating Profit/Loss – a financial indicator closer to the reality of our business Operating Profit Operating Profit “Core” “IFRS” ◼ Core Operating Profit/ Loss is a key ◼ Financial results recorded and financial indicator that highlights the + Material Non-c
Slide 56: Exchange Rate, Intangible Assets and Non-core Costs
Exchange Rate, Intangible Assets and Non-core Costs Average exchange rate during period Non-core costs (full year) (JPY mn) FY2025 FY2024 FY2023 FY2022 FY 2024 FY 2023 FY 2022 USD:JPY Actual - 151.43 140.53 131.30 Cost of sales adjustment 2,401 1,812 - Estimate 152 140 143 Amortization 2,371 1,495 7
Slide 57: Glossary
Glossary Basic Terminology/Technology GPCR G Protein-Coupled Receptor There are about 800 types of GPCRs in the human body. While 400 of them are known to be potential drug targets, about 300 of them are not yet drugged Nxera’ proprietary technology to stabilize a GPCR by engineering a small number
Slide 58: Locations
Locations Midtown East, F17, 410 Teheran- Steinmetz Building Office 26.01 9-7-2 Akasaka Ro Granta Park, Flexoffice Messteurm 26th Floor Minato-ku GangHam-Gu Cambridge Messeplatz 10 Tokyo 107-0052 Seoul 06192 CB21 6DG CH-4058 Basel Japan South Korea United Kingdom Switzerland 58
Slide 59: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS