Nxera Pharma Co., Ltd. · TSE:4565

Nxera Pharma — Investor Presentation (May 2025)

52 slides from Nxera Pharma's investor presentation, May 2025

Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation May 2025 | Nxera Pharma Co., Ltd. (TSE: 4565)
Slide 2: Disclaimer
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 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. We think and innovate globally, and specialize locally
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 Research Finance Chief of Staff members Finance Development Operation /
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: Partner's Wave and Wave 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 M
Slide 12: Our 2030 vision is to build a 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 1H 2025 IN-HOUSE Advanced solid tumors Fabry disease Cerebral vas
Slide 15: Major pipeline Overview (Key Partner Highlights)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major pipeline Overview（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 vasospa
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 ✓ TMP-301 (mGlu5 NAM) Mar. 2025 Phase 2 study start in alcohol use disorder ✓ NBI’
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 QUVIVIQTM (daridorexant, dual orexin antagonist “DORA”) Commercial DORA is rapidly establishing its position in the treatment paradigm for insomnia (Bn JPY) Lemborexant (Dayvigo) Zolpidem Others 100 Suvorexant (Belsomra) Eszopi
Slide 23: 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) as net sales, and 4.0 - 5.0 Bn JPY (QUVIVIQ) as royalty and supply Target sales in FY2025 13.0 – 14.0 Bn JPY +7% 4.0 – 5.0 Bn JPY +220% (NHI Sales:1
Slide 24: Our NxWave Platform
Our NxWave Platform Cutting-edge Science 05
Slide 25: NxWave platform is focussed on drugging GPCRs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave platform is focussed on drugging GPCRs Platform GPCRs are the largest family of drug discovery targets – comprising 1/3 of all FDA approved drugs (Billion USD) Market share of GPCR-targeting drug NEUROLOGICAL DISORDERS 2
Slide 26: GPCR: Large unmet needs and FIC opportunities
ADORA2A ADRA2A ADRB2 CHRM1 DRD1 DRD3 HTR2A HTR4 & OPRD1 OPRM1 P2RY12 ant. ago. (54*) PTGER2 GHRHR TSHR ADORA2B ADRB3 CHRM2 GLP1R HTR1B HTR1F MTNR1A PTGER3 PTGIR S1PR5 GCGR (31) ago. GIPR MC4R RXFP1 SCTR AVPR1A C5AR1 CCR5 CXCR4 DRD4 EDNRB GNRHR HCRTR2 HTR2B TACR1 (26) CALCRL ant. Marketed drugs only,
Slide 27: 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 28: 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 29: Our track record of major licensing transactions speaks for itself
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 30: Hundreds of millions of dollars received, billions in potential to come
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 31: M4 agonist (NBI'568) demonstrated competitive positive phase 2 data
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX M4 ago. (NBI’568) demonstrated competitive positive phase 2 data Platform Once-daily 20 mg dose showed efficacy, and good safety / tolerability profile for schizophrenia patients.  PANSS total score change -18.2  PANSS total
Slide 32: Financial Results
Financial Results 06
Slide 33: Key financial indicators
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key financial indicators NPJ/NPK product sales and cost base fully included in FY2024. Milestones increased due to progress of partnered programs Major factors (JPY million) Latest result 8,000 6,644  USD10m from Viatris for a
Slide 34: Breakdown of Q1 results
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Breakdown of Q1 results Business is progressing smoothly. Significant improvement in revenue from commercial Consolidated Consolidated (JPY million) Platform*1 ＋ Commercial*2 = P&L (Core) ＋ Non-core costs = P&L (IFRS) （YoY）（Yo
Slide 35: Full year cost guidance for FY2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year cost guidance for FY2025 Slight increase in R&D expenses with progression of programs into later stages of development and in-licensing of one or more late-stage candidates. Lower to flat SG&A expenses through streaml
Slide 36: Appendix
Appendix 07
Slide 37: Partnered pipeline (1/2)
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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
Slide 38: Partnered pipeline (2/2)
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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) M
Slide 39: In-house pipeline
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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 dise
Slide 40: Clinical Trials
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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 2024-09-27 NCT05545111 - NBI-1117569 M4 preferring agonist Neurol
Slide 41: Estimation of potential market size
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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
Slide 42: Exclusive Opt-in Rights And ROFN/ROFR
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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
Slide 43: Topline Results for Phase 2 Trial of M4 Agonist
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER Topline Results for Phase 2 Trial of M4 Agonist 20mg dose demonstrated statistically significant efficacy at Week 3, 4, 5 and 6 vs. placebo “The effects with the 20-milligram dose, you see statistical significance between Week 3, 4, 5, and six, meaning that
Slide 44: Comparison of Study Sites and Duration with Known Muscarinic Programs
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER Comparison of Study Sites and Duration with Known Muscarinic Programs Mentioned in a presentation Phase 3 program of NBI-1117568 will be one to one randomization and around 20 sites per study Neurocrine/Nxera Neurocrine/Nxera BMS/Karuna AbbVie/Cerevel Compo
Slide 45: Safety: Adverse Events Risk
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER Safety: Adverse Events Risk The gastrointestinal and cardiovascular adverse events were similar to placebo in NBI-568, but higher than placebo in KarXT Gastrointestinal Cardiovascular Others Similar to None or similar Somnolence NBI-568 placebo to placebo D
Slide 46: Number of Structures Solved and Deposited in PDB
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER Number of Structures Solved and Deposited in PDB The number of structures solved using Cryo-EM is increasing. 16,000 15,309 14,451 14,255 13,985 14,000 12,569 12,000 11,470 11,155 11,059 10,802 10,000 9,338 9,554 9,244 8,751 7,925 8,000 7,743 7,134 7,288 6,
Slide 47: Resolution by technology
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER Resolution by technology X-ray crystallography has extremely high resolution, greatly exceeding that of electron crystallography. X-ray crystallography Cryo-EM 100% 100% > 4.5Å > 4.5Å 90% 90% 4.0 - 4.5Å 4.0 - 4.5Å 80% 80% 3.5 - 4.0Å 3.5 - 4.0Å 70% 70% 26% 2
Slide 48: Core Operating Profit - Definition
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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 ind
Slide 49: Exchange Rate, Intangible Assets and Non-core Costs
PIPELINE/MARKET MUSCARINE TECHNOLOGY OTHER 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 - Esti
Slide 50: Glossary
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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’
Slide 51: 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 51
Slide 52: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS

Nxera Pharma — Investor Presentation (May 2025) on 6ix

Nxera Pharma — Investor Presentation (May 2025)

Slide 1: Corporate Presentation

Slide 2: Disclaimer

Slide 3: Agenda

Slide 4: Business Overview

Slide 5: We are Nxera Pharma

Slide 6: Not a traditional Japanese pharma. We think and innovate globally, and specialize locally

Slide 7: Strategic Roadmap

Slide 8: Our History

Slide 9: Building a fully integrated biopharma from Japan

Slide 10: Priority objectives for FY2025

Slide 11: Partner's Wave and Wave programs across fast growing disease areas

Slide 12: Our 2030 vision is to build a high growth, highly profitable Japanese biopharma

Slide 13: Our Pipeline

Slide 14: Major pipeline Overview (incl. projections)

Slide 15: Major pipeline Overview (Key Partner Highlights)

Slide 16: Major pipeline Overview (By business categories)

Slide 17: Looking ahead to potential catalysts in 2025

Slide 18: Key strategy for each business category

Slide 19: Japan/APAC Business

Slide 20: Japan will serve as our base to expand across APAC markets

Slide 21: PIVLAZ (clazosentan, an endothelin A antagonist)

Slide 22: QUVIVIQ (daridorexant, dual orexin antagonist)

Slide 23: Full year product sales guidance

Slide 24: Our NxWave Platform

Slide 25: NxWave platform is focussed on drugging GPCRs

Slide 26: GPCR: Large unmet needs and FIC opportunities

Slide 27: NxWave platform enables faster, cheaper and more precise drug discovery

Slide 28: Our platform enables precise design of GPCR models

Slide 29: Our track record of major licensing transactions speaks for itself

Slide 30: Hundreds of millions of dollars received, billions in potential to come

Slide 31: M4 agonist (NBI'568) demonstrated competitive positive phase 2 data

Slide 32: Financial Results

Slide 33: Key financial indicators

Slide 34: Breakdown of Q1 results

Slide 35: Full year cost guidance for FY2025

Slide 36: Appendix

Slide 37: Partnered pipeline (1/2)

Slide 38: Partnered pipeline (2/2)

Slide 39: In-house pipeline

Slide 40: Clinical Trials

Slide 41: Estimation of potential market size

Slide 42: Exclusive Opt-in Rights And ROFN/ROFR

Slide 43: Topline Results for Phase 2 Trial of M4 Agonist

Slide 44: Comparison of Study Sites and Duration with Known Muscarinic Programs

Slide 45: Safety: Adverse Events Risk

Slide 46: Number of Structures Solved and Deposited in PDB

Slide 47: Resolution by technology

Slide 48: Core Operating Profit - Definition

Slide 49: Exchange Rate, Intangible Assets and Non-core Costs

Slide 50: Glossary

Slide 51: Locations

Slide 52: Thank you