Nxera Pharma Co., Ltd. · TSE:4565

Nxera Pharma — FY2025 Earnings Presentation

37 slides from Nxera Pharma's earnings presentation, Feb 13, 2026

  1. Slide 1: FY2025 Financial Results

    NON-CONFIDENTIAL FY2025 Financial Results 12-month period ended December 31, 2025 13 February 2026 | Nxera Pharma Co., Ltd. (TSE: 4565)

  2. 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

  3. Slide 3: Agenda

    Agenda 01 Financial Results 02 Operational Highlights 03 Japan /APAC Commercial Business 04 R&D Progress 05 FY2026 Objectives and beyond 06 Appendix 3

  4. Slide 4: Financial Results

    Financial Results Hironoshin Nomura, CFO 01

  5. Slide 5: Key financial results

    Key financial results While the commercial business grew, milestones decreased year-on-year, resulting in a core operating loss (JPY million) Progress in 2025 28,835 29,615 30,000 2,293 2,329 ◼ Multiple milestone receipts 1,392 from Neurocrine, Centessa, 25,000 Lilly, AbbVie, etc. 7,879 Platform ◼ D

  6. Slide 6: Breakdown of 2025 results

    Breakdown of 2025 results Strong profitability growth in the commercial business; accelerated clinical-trial investment in the platform business Consolidated Consolidated (JPY million) Platform*1 + Commercial*2 = P&L (Core) +Non-core costs = P&L (IFRS) (YoY) (YoY) (YoY) (YoY) Revenue 10,207 -31% 19,

  7. Slide 7: Analysis of changes in R&D expenses

    Analysis of changes in R&D expenses Clinical Development and Increased Investment Focus on Obesity as Key Drivers of Growth Other R&D FX Impact (JPY million) Commercial 362 Obesity 110 222 1,398 Clinical 14,466 558 11,816 FY2024 FY2025 7 5

  8. Slide 8: Operational Highlights

    Operational Highlights Chris Cargill, President and CEO 02

  9. Slide 9: Recap of FY2025 Priority Objectives

    Recap of FY2025 JPY 17 billion+ Net product sales Priority Objectives 01 (PIVLAZ® plus QUVIVIQ®) Commercial  JPY17.8Bn Acquire/in-license at least one late-stage Vamorolone 02 medicine for Japan/APAC (ex-China) Commercial  In-licensing(Jan) Execute at least one new major partnership, EP4 Antagonis

  10. Slide 10: Both sides of the business continue to advance rapidly

    Both sides of the business continue to advance rapidly Drug Discovery Platform Commercial Clinical Asset Products Active Programs Changes in 2025 2025 Sales Changes in 2025 (Actual : JPY) (Actual : JPY) Phase 3 2* +2 PIVLAZ® 13.5Bn +7% Phase 2 5 +2 QUVIVIQ® 4.3 Bn +224% Phase 1 5 -3 (moved to Ph2) L

  11. Slide 11: Commercial Business

    Commercial Business Commercial Two marketed products continue to grow, with a new product launch in early 2026 to support the next phase Vamorolone Sales Market Share North America (Catalyst) Europe (Santhera) (JPY million) +5% (JPY million) 547 (mUSD) +7% +30% 16,000 +14% 120% 13,800-14,200 +47%* 1

  12. Slide 12: Platform Business

    Platform Business Platform Partner-led development progressing well; strong phase 1 readouts for in-house programs GPR52 ago | EP4 ago EP4 antag Muscarinic Agonist Portfolio Orexin Agonist Portfolio Licensing activities in progress Under development in-house Program Target Disease Phase Program Targ

  13. Slide 13: Major Pipeline Overview

    Major Pipeline Overview Discovery – Preclinical Phase1 Phase2 Phase3 Filed Commercial Vamorolone PIVLAZ® Duchenne Muscular Dystrophy Cerebral vasospasm Commercial Lucerastat QUVIVIQTM Fabry disease Insomnia Develop programs in-house up to a IN-HOUSE Best-in-class, EP4 ag. NXE’744 EP4 ant. NXE’732 ce

  14. Slide 14: Japan/APAC Commercial Business

    Japan/APAC Commercial Business Toshihiro Maeda, Chief Operating Officer (COO) and President of Nxera Pharma Japan 03

  15. Slide 15: PIVLAZ® (clazosentan, an endothelin A antagonist)

    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) PIVLAZ® sales growth 2025 PIVLAZ® highlights (million JPY) Net Sales Market Share(patient base) ✓

  16. Slide 16: QUVIVIQ® (daridorexant, dual orexin antagonist)

    QUVIVIQ® (daridorexant, dual orexin antagonist “DORA”) Commercial DORA is rapidly establishing its position in the treatment paradigm for insomnia Domestic Market Size for DORA QUVIVIQ® Annual Sales and Growth Rate (Bn JPY) 90 45% Daridorexant (Quviviq) 83Bn Suvorexant (Belsomra) 5.0 – 6.0 Bn JPY 79

  17. Slide 17: QUVIVIQ® Business structure

    QUVIVIQ® Business structure Commercial Royalty profits initiated and supply margin expected in a few years Sales structure Profit structure for Nxera Supply chain optimization Product net sales Comprehensive strategy to optimize the end-to-end supply Royalty + chain Product supply sales Achievements

  18. Slide 18: Announced: In-licensing of vamorolone (AGAMREE®) for DMD

    Announced: In-licensing of vamorolone (AGAMREE®) for DMD Commercial There is no established therapy for DMD other than corticosteroids in Japan Vamorolone (AGAMREE®) Duchenne Muscular Dystrophy (DMD) • First-in-class drug candidate that binds • DMD is a rare and life-threatening neuromuscular disord

  19. Slide 19: Vamorolone (AGAMREE®) addresses the need for a tolerable steroid

    Vamorolone (AGAMREE®) addresses the need for a tolerable steroid Commercial Compared with conventional corticosteroid therapy, the risk of treatment-related adverse events is reduced • Vamorolone confronts the limitations of standard Consensus sales forecast of vamorolone in other countries corticos

  20. Slide 20: Synergy with Pivlaz

    Synergy with Pivlaz Commercial DMD treatment is concentrated in a limited number of centers and there is approximately 70% commercial overlap with PIVLAZ, creating significant sales synergies Proportion of prescription volume by hospital Pivlaz® target University Hospital/Special Core hospital for L

  21. Slide 21: R&D Progress

    R&D Progress Dr. Patrik Foerch, Chief Scientific Officer (CSO) and President of Nxera Pharma UK 04

  22. Slide 22: Renewed R&D focus where the science is strongest and the opportunity is greatest

    Renewed R&D focus where the science is strongest and the opportunity is greatest Platform IN-HOUSE PORTFOLIO - R&D FOCUS AND PROGRAM PRIORITISATION Discovery Phase 2 ready Phase 2 NXE’149 NXE’744 NXE’732 Discovery candidates GPR52 agonist EP4 agonist EP4 antagonist Obesity, metabolic & endocrine Sch

  23. Slide 23: NXE'744: EP4 agonist for IBD – target engagement & Phase ready

    NXE’744: EP4 agonist for IBD* – target engagement & Phase 2 ready Platform A first-in-class GI-targeted agent to promote mucosal healing in IBD EP4 AGONIST OFFERS A DIFFERENTIATED MOA TO CURRENT SOC: • All elements of the first-in-human study have now Modulation of barrier homeostasis and inflammato

  24. Slide 24: NXE'149: GPR52 agonist for schizophrenia – Phase ready

    NXE’149: GPR52 agonist for schizophrenia – Phase 2 ready Platform A novel first-in-class mechanism to treat positive, negative & cognitive domains of schizophrenia Phase 1 highlights: Phase 2 enablement: ✓ Safe and well tolerated • 3 month GLP toxicology in 2 species ✓ Human PK showed low variabilit

  25. Slide 25: NXE'732: EP4 antagonist is our novel immunotherapy for solid tumors

    NXE’732: EP4 antagonist is our novel immunotherapy for solid tumors Platform Phase 2a expansion in process in combination with atezolizumab Disease Rationale Phase 1 trial results • When EP4 is activated, it • The emerging data for NXE-732 points to a potential best-in-class profile dampens immune r

  26. Slide 26: Leveraging our GPCR expertise in areas of highest unmet medical need

    We can make a huge impact by leveraging our GPCR expertise in the areas of highest unmet Platform medical need: next-generation small molecules for obesity, metabolic and endocrine disorders Unparalleled GPCR SBDD capabilities • Launched broad new pipeline, advancing next-gen BIC therapies for obesi

  27. Slide 27: Neurocrine is advancing the world's most comprehensive portfolio of muscarinic agonists

    Neurocrine is advancing the world’s most comprehensive portfolio of Platform muscarinic agonists to treat neuropsychiatric disorders Stage of Program Mechanism Disease State Development Schizophrenia Phase 3 Direclidine M4 Agonist Bipolar Mania Phase 2 Dual M1/M4 Schizophrenia / LAI NBI-’570 Phase 2

  28. Slide 28: Centessa is advancing ORX750, a potential best-in-class Orexin Receptor 2 agonist

    Centessa is advancing ORX750, a potential best-in-class Orexin Receptor Platform 2 agonist for treatment of NT1, NT2 and IH Potential BIC for NT1, NT2 and IH Phase 2a study update Endpoints Maintenance of >20 min change at 1.5mg vs baseline (with half of participants Wakefulness Test >30 min). NT1 (

  29. Slide 29: FY2026 Objectives and beyond

    FY2026 Objectives and beyond Chris Cargill, President and CEO 05

  30. Slide 30: Priority objectives for FY2026

    Priority objectives JPY 19.5 billion+ Net product sales for FY2026 01 (PIVLAZ® plus QUVIVIQ®) Commercial Get one or more late-stage assets 02 for Japan and APAC (excl. China) Commercial 03 Sign one or more high-value partnership deals Platform 04 Initiate at least one partner-sponsored phase 2 trial

  31. Slide 31: Historical financial and 2026 guidance

    Historical financial and 2026 guidance (Without significant upfront from BD activity) Target profitability for both Core Operating Profit and Operating Profit in FY26 (JPY million) FY26 Strategy 35,000 33,800~ 1,800 ◼ Multiple milestones to be 28,835 29,615 received from Neurocrine, 30,000 2,329 Cen

  32. Slide 32: Breakdown of 2026 guidance

    Breakdown of 2026 guidance (Without significant upfront from BD activity) Commercial business profitability has grown significantly. Platform business has reached breakeven on a core basis Consolidated Consolidated (JPY million) Platform*1 + Commercial*2 = P&L (Core) +Non-core costs = P&L (IFRS) (Yo

  33. Slide 33: Looking ahead to potential catalysts in 2026

    Looking ahead to potential catalysts in 2026* PROGRAM PARTNER TIMING EVENT ORX750 (OX2 agonist) Q1 2026 Phase 2a data across NT1, NT2, and IH ORX750 (OX2 agonist) Q1 2026 Registrational program start in NT1/NT2/IH ORX142 (OX2 agonist) Q1 2026 Phase 2 study start ORX489 (OX2 agonist) Q1 2026 Phase 1

  34. Slide 34: Our 2030 vision is to build a high growth, highly profitable Japanese biopharma

    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 seven pipelines. WAVE1 drives significant upside WAVE1 WAVE1 Royalty Royalt

  35. Slide 35: Questions?

    ~ Questions? Nxera:™

  36. Slide 36: Thank you

    Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS

  37. Slide 37: Locations

    Locations Midtown East, F17, 410 Teheran- Steinmetz Building Spaces Grosspeter 9-7-2 Akasaka Ro Granta Park, Tower, Minato-ku GangHam-Gu Grosspeteranlage Cambridge 29, Tokyo 107-0052 Seoul 06192 CB21 6DG 4052 Basel Japan South Korea United Kingdom Switzerland 37

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