Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Q2 2025 Earnings Presentation
51 slides from Nxera Pharma's earnings presentation, Aug 8, 2025
Slide 1: Q2 FY2025 Financial Results
NON-CONFIDENTIAL Q2 FY2025 Financial Results 8 August 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 Operational Highlights 02 Financial Results 03 Japan /APAC Commercial Business 04 R&D Progress 05 FY2025 Objectives and Beyond 06 Appendix 3
Slide 4: Operational Highlights
Operational Highlights Chris Cargill, President and CEO 01
Slide 5: Priority objectives for FY2025
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 6: Advancing as a global biopharma with strong foundations
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Advancing as a global biopharma with strong foundations CORPORATE MILESTONES UK R&D JAPAN/APAC BUSINESS ✓ Enriched the management ✓ TMP-301 entered Ph2 study ✓ PIVLAZⓇ established strong structure with appointments o
Slide 7: Major pipeline Overview (incl. projections)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 2H 2025 IN-HOUSE Advanced solid tumors Fabry disease C
Slide 8: Nxera launched broad new pipeline for obesity and chronic weight management
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Nxera launched broad new pipeline for obesity and chronic weight management 7 programs underway with in-house development in the obesity area Aligned with the Oral Therapeutics Shift Highlights ORAL SMALL • Benefits
Slide 9: Financial Results
Financial Results Hironoshin Nomura, CFO 02
Slide 10: Key financial indicators
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Key financial indicators H1 Revenue up 19% driven by Product Sales and Milestones (due to progress of partnered programs). Major factors (JPY million) Latest result ◼ USD10m received from Viatris for assignment of ri
Slide 11: Breakdown of Q2 YTD results
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Breakdown of Q2 YTD results Business is progressing well, with significant growth in commercial revenues Consolidated Consolidated (JPY million) Platform*1 ＋ Commercial*2 = P&L (Core) ＋ Non-core costs = P&L (IFRS) （Y
Slide 12: Full year cost Guidance for FY2025 (Unchanged)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 13: Japan/APAC Commercial Business
Japan/APAC Commercial Business Hironoshin Nomura, CFO 03
Slide 14: PIVLAZ® (clazosentan)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 PIV
Slide 15: QUVIVIQ® (daridorexant)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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)
Slide 16: QUVIVIQ® Business structure
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 S
Slide 17: Full year product sales guidance
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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% +
Slide 18: R&D Progress
R&D Progress CSO and President of Nxera Pharma UK Matt Barnes 04
Slide 19: Key Events 1H 2025
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Key Events 1H 2025 Platform Accelerating the development of life-changing medicines, by investing in science and technology DISCOVERY PHASE 1 PHASE 2 PHASE 3 Launch of 7 new $4.8M milestone payment NXE-149 is a first
Slide 20: NxWave: Proprietary structure-based drug design
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 21: Total Number of Reported Active Programs
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Significant opportunity to expand beyond peptides leveraging our proprietary NxWaveTM Platform Anchored by differentiated positions on a novel GLP-1R agonist with an additional 6 innovative programs Opportunity for s
Slide 22: Preclinical metabolic assets
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Preclinical metabolic assets: A strategic focus for investment and pipeline expansion Platform Recent transactions highlight the demand for oral metabolic therapeutics with differentiation potential GLP-1 small molec
Slide 23: Neurocrine is advancing a broad muscarinic agonist pipeline
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Neurocrine is advancing a broad muscranic agonist pipeline Platform Five Clinical-Stage Programs Spanning M1, M4, and Dual M1/M4 Mechanisms with Readouts Expected in 2025 Compounds Target Indication Phase1 Phase2 Pha
Slide 24: NBI-568 Phase 3 underway
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX NBI-568 Phase 3 underway – a new modality for schizophrenia treatment Platform Advancing the first and only selective M4 orthosteric agonist into phase 3 NBI’568 Short-Term Study Design Differentiation points Large o
Slide 25: Topline Results for Phase 2 Trial of NBI'568
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Topline Results for Phase 2 Trial of NBI’568 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
Slide 26: Safety: Adverse Events Risk
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 Restricti
Slide 27: Centessa are building a leading portfolio of OX2R agonists
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 28: Data on OX2 agonist competitors
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 Effec
Slide 29: TMP-301, an mGlu5 NAM being developed by TemperoBio
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX TMP-301, an mGlu5 NAM being developed by TemperoBio Platform Two clinical trials in alcoholism and cocaine disorder are ongoing in patients Pipeline Highlights • Tempero Bio Secures $70 Million Series B Financing to
Slide 30: Internal assets progressing through early clinical development
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Internal assets progressing through early clinical development Platform OPTION TO DISCOVERED DISCOVERED BY DISCOVERED BY LICENSE WITH BY Compound & Stage NXE-149 (Ph 1b) NXE-732 (Ph 1) NXE-744 (Ph 1b) Target Indicati
Slide 31: GPR52 agonist for schizophrenia
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 str
Slide 32: EP4 antagonism for advanced solid tumours
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX EP4 antagonism for advanced solid tumours Platform Alone or in combination with Checkpoint Inhibitors (CPIs) Disease Rationale Progress • Prostaglandin E2 (PGE2) is secreted by tumour and surrounding • Ph1 study enro
Slide 33: EP4 agonist for inflammatory bowel disease (IBD)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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-o
Slide 34: FY2025 Objectives and beyond
FY2025 Objectives and beyond Chris Cargill, President and CEO 05
Slide 35: Priority objectives for FY2025
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 36: Wave 1 and Wave 2 programs across growing disease areas
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 a
Slide 37: Our 2030 vision is to build a high growth, highly profitable Japanese biopharma
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 pipelines. Onl
Slide 38: Looking ahead to potential catalysts in 2025
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 al
Slide 39: Questions?
~ Questions? Nxera:™
Slide 40: Appendix
Appendix 06
Slide 41: Partnered pipeline (1/2)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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® B
Slide 42: Partnered pipeline (2/2)
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 43: In-house pipeline
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 NXE
Slide 44: Clinical Trials
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 -
Slide 45: Estimation of potential market size
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 Demen
Slide 46: Exclusive Opt-in Rights And ROFN/ROFR
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 Glucosylcerami
Slide 47: Core Operating Profit - Definition
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 ◼ Fin
Slide 48: Exchange Rate, Intangible Assets and Non-core Costs
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 Co
Slide 49: Glossary
OPERATIONAL HIGHLIGHTS FINANCIAL JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 drug
Slide 50: 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 50
Slide 51: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS