Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Investor Presentation (March 2025)
53 slides from Nxera Pharma's investor presentation, March 2025
Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation March 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: Our Mission, Vision, Values
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Leading the Next Era of Medicine. From Japan, for Japan, and the world World-leading NxWave platform (UK), coupled with Japan’s most effective development and commercial organization Our Mission Our Vision Our Values To acceler
Slide 6: 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 Cutting-edge Science Programs by Design Real Human Outcomes WORLD-LEADERS IN GPCR 30+ ACTIVE PROGRAMS PRO
Slide 7: Global Corporate Structure
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Global Corporate Structure Over 350 team members employed across Japan, South Korea, UK and Switzerland Nxera Pharma (formerly “Sosei Group”) Group Operations | ~60 people Nxera Pharma UK (NPU) Nxera Pharma Japan (NPJ) Nxera Ph
Slide 8: Agile and decisive leadership team
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Agile and decisive leadership team BOARD OF DIRECTORS Shinichi Tamura Chris Cargill Tomohiro Toyama Rolf Soderstrom David Roblin Kuniaki Kaga Eiko Tomita Noriaki Nagai Miwa Seki Chairman CEO Legal Finance Clin Dev Clin Dev Reg
Slide 9: Strategic Roadmap
Strategic Roadmap 02
Slide 10: 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 11: Acquire or in-license multiple de-risked medicines for Japan
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX To make our mission happen… Accelerate the development of life-changing medicines 1 2 3 Acquire or in-license Invest in our Build a first-class multiple de-risked NxWave platform technology medicines for Japan to seed programs
Slide 12: 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 2000s 2015 2023 2024 JAPAN KOREA Clinical Trials Approved Discovery / Preclinical Phas
Slide 13: 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®) 02 Acquire/in-license at least one late-stage medicine for Japan/APAC (ex-China) Execute at least one new major partnership, and initia
Slide 14: Wave1 and Wave2 programs across growing areas of healthcare
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our Wave 1 and Wave 2 programs are positioned across fast growing areas of healthcare MARKET SIZE (2030) WAVE1 (Potential Launch by 2030) WAVE2 (Potential Launch by 2035) Neurology P1 mGlu5 NAM P2 Ox2 agonist P2 M4 agonist PreC
Slide 15: 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 16: Our Pipeline
Our Pipeline Programs by Design 03
Slide 17: Major Pipeline Overview
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A Advanced Fabry disease Cerebral vasospasm IN-HOUSE solid tumours • Immunology EP4 ag.
Slide 18: Major Pipeline Overview
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A Advanced 1H 2025 Fabry disease Cerebral vasospasm IN-HOUSE solid tumours • Immunology
Slide 19: Looking ahead to potential catalysts in 2025
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Looking ahead to potential catalysts in 2025* PROGRAM PARTNER TIMING EVENT TMP-301 (mGlu5 NAM) H1 2025 Phase 2 study start in alcohol use disorder Cenerimod (S1P1) / Lucerastat H1 2025 Exclusive opt-in decision NXE’732 (EP4 ant
Slide 20: Major Pipeline Overview
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 Lucerastat A PIVLAZ® A Advanced Fabry disease Cerebral vasospasm IN-HOUSE solid tumours • Immunology EP4 ag.
Slide 21: 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 22: Delivering science with commercial potential
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Delivering science with commercial potential Nxera’s Commercialized Products Partnered Products (Discovered by Nxera/with NxWave tech) 1 Neurological disorders – diseases of ageing Neurological disorders – psychiatric / cogniti
Slide 23: Japan/APAC Business
Japan/APAC Business Deliver innovation to patients in Japan/APAC 04
Slide 24: Japan as 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 25: 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 26: QUVIVIQ (daridorexant, dual orexin antagonist)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 (Belso
Slide 27: QUVIVIQ Business scheme change
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQ Business scheme change Commercial SHIONOGI to Exclusively Handle Distribution and Sales Activities in Japan Old Scheme New Scheme (Sold by 3 companies / 2 channels) (Sold by 1 company / 1 channel) Originator Marketing *
Slide 28: In-house pipeline: QUVIVIQ
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX In-house pipeline: QUVIVIQ Commercial JNDA approval received in Sep. 2024 and launched in Dec. 2024. Aim to be the best-in-class drug Unmet needs in insomnia About QUVIVIQ Dual Orexin Alleviates excessive wakefulness through Re
Slide 29: 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 30: Our NxWave Platform
Our NxWave Platform Cutting-edge Science 05
Slide 31: 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 32: 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 33: NxWave platform enables faster, cheaper, 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 34: 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 35: 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 36: Hundreds of millions of dollars received, billions 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 37: M4 agonist (NBI'568) 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 38: Financial Results
Financial Results 06
Slide 39: 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) FY2024 result 40,000 Upfront1 New option-to-license
Slide 40: Breakdown of 2024 results
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Breakdown of 2024 results Impact of Non-cash/Non-recurring costs was more significant in 2024 due to the inclusion of the Idorsia businesses Consolidated Non-recurring Consolidated (JPY million) NPC / NPU*1 ＋ NPJ / NPK*2 = P&L
Slide 41: 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 42: Appendix
Appendix 07
Slide 43: Exclusive Opt-in Rights And ROFN/ROFR
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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
Slide 44: Core Operating Profit - Definition
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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 resu
Slide 45: Estimation of potential market size
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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 mil
Slide 46: Partnered pipeline (1/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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®
Slide 47: Partnered pipeline (2/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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 Neurol
Slide 48: In-house pipeline
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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 GP
Slide 49: Clinical Trials
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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-111756
Slide 50: Exchange Rate, Intangible Assets and Non-core Costs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX 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
Slide 51: 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 52: 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 52
Slide 53: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS