Slide 1: FY2024 Financial Results
NON-CONFIDENTIAL FY2024 Financial Results 12-month period ended December 31, 2024 14 February 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 Financial Results 02 Operational Highlights 03 Japan /APAC Commercial Business 04 R&D Progress 05 FY2025 Objectives and beyond 06 Appendix 3
Slide 4: Financial Results
Financial Results Hironoshin Nomura, CFO 01
Slide 5: Financial summary for FY2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Financial summary for FY2024 Revenue grew significantly due to M&A and partner milestones. Most non-recurring core costs ceased in 2024. Revenue of JPY28,835m (+126% | JPY12,766m in the prior year) Revenue - PIVLAZ®
Slide 6: Key financial indicators
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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
Slide 7: Breakdown of 2024 results
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 / N
Slide 8: Full year cost guidance for FY2025
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 thro
Slide 9: Operational Highlights
Operational Highlights Chris Cargill, President and CEO 02
Slide 10: Recap of FY2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Recap of FY2024 Priority Objectives 01 JPY 15-16 billion NHI sales for PIVLAZ® JPY 15.2Bn 02 JNDA approval for daridorexant in Japan Sep. 2024 Acquire/in-license at least one late-stage 03 Ongoing discussions med
Slide 11: Advancing as a global biopharma with strong foundations
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Advancing as a global biopharma with strong foundations CORPORATE MILESTONES UK R&D JAPAN/APAC BUSINESS ✓ Rebranding from Sosei Heptares ✓ New option-to-license deal with ✓ PIVLAZⓇ established strong to Nxera Pharma
Slide 12: Broad and balanced pipeline with two recently launched products
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Broad and balanced pipeline with two recently launched products driving top-line growth Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial EP4 ant. NXE’732 Cenerimod A PIVLAZ® A 10+ PROGRAMS Advanced Sy
Slide 13: Delivering science with commercial potential
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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 – psychiatri
Slide 14: Japan/APAC Commercial Business
Japan/APAC Commercial Business President of Nxera Pharma Japan and Chief Medical Officer 03
Slide 15: PIVLAZ (clazosentan, an endothelin A antagonist)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX 1 PIVLAZ® (clazosentan, an endothelin A antagonist) Our first commercially available product for the prevention of cerebral vasospasm in patients with Aneurysmal Subarachnoid Haemorrhage (aSAH) Quarterly PIVLAZ® Net
Slide 16: QUVIVIQ (daridorexant, dual orexin antagonist)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX 2 QUVIVIQTM (daridorexant, dual orexin antagonist “DORA”) DORA is rapidly establishing its position in the treatment paradigm for insomnia (Bn JPY) Lemborexant (Dayvigo) Zolpidem Others 100 Suvorexant (Belsomra) Eszo
Slide 17: QUVIVIQ: APAC expansion
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX 2 QUVIVIQTM: APAC expansion Making progress in developing the APAC market to maximize the product value Market potential Expected Partner Partnering structure (# of insomnia patient) launch Japan > 20 million Launche
Slide 18: Full year product sales guidance
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Full year product sales guidance 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 19: R&D Progress
R&D Progress Dr. Matt Barnes, President of Nxera Pharma UK and Head of UK R&D 04
Slide 20: Key Events 2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX To be presented today Key Events 2024 Accelerating the development of life-changing medicines, by investing in science and technology PRE - DISCOVERY DISCOVERY PHASE 1 PHASE 2 Expansion of R&D Two NME1 programs Phase
Slide 21: Neurocrine advancing muscarinic orthosteric agonists discovered by Nxera
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Neurocrine is advancing the world’s most comprehensive portfolio of muscarinic orthosteric agonists – discovered by Nxera using NxWave Highlights • NxWave platform enabled full suite of Structurally- enabled small mo
Slide 22: Centessa and Pfizer advancing NxWave-discovered programs
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Centessa advancing Orexin 2 Pfizer advancing PF’522, agonists - ORX750 in Phase 2 as an improved once-daily, small molecule GLP-1 treatment for Narcolepsy Type 1 and beyond agonist in Phase 1 for T2D and obesity – di
Slide 23: Fuelling the Wave 1 and Wave 2 launches with novel programs
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Fuelling the Wave 1 and Wave 2 launches with novel programs in neurology and immunology OPTION TO DISCOVERED DISCOVERED BY DISCOVERED BY LICENSE WITH BY Compound & Stage NXE-149 (Ph 1b) NXE-732 (Ph 1) NXE-744 (Ph 1)
Slide 24: GPR52 Agonist for Schizophrenia
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX GPR52 Agonist for Schizophrenia 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 whe
Slide 25: EP4 Antagonism for Advanced Solid Tumours
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX EP4 Antagonism for Advanced Solid Tumours Alone or in Combination with Checkpoint Inhibitors (CPIs) Disease Rationale Progress • Prostaglandin E2 (PGE2) is secreted by tumour and surrounding • Ph1 study will complete
Slide 26: EP4 Agonist for Inflammatory Bowel Disease
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX EP4 Agonist for Inflammatory Bowel Disease (IBD) 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 •
Slide 27: FY2025 Objectives and beyond
FY2025 Objectives and beyond Chris Cargill, President and CEO 05
Slide 28: Priority objectives for FY2025
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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,
Slide 29: Major Pipeline Overview (with future projection)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Major Pipeline Overview (with future projection) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial EP4 ant. NXE’732 Cenerimod A PIVLAZ® A 10+ PROGRAMS Advanced 1H 2025 Systemic lupus Cerebral vasospasm
Slide 30: Wave 1 and Wave 2 programs across fast growing areas of healthcare
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Our Wave 1 and Wave 2 programs are positioned across fast growing areas of healthcare WAVE1 (Potential Launch by 2030) WAVE2 (Potential Launch by 2035) MARKET SIZE Neurology P1 mGlu5 NAM P2 Ox2 agonist P2 M4 agonist
Slide 31: 2030 vision: high growth, highly profitable Japanese biopharma
FINANCIAL OPERATIONAL HIGHLIGHTS 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 Only 1-2 launc
Slide 32: Looking ahead to potential catalysts in 2025
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES 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’7
Slide 33: Questions?
~ Questions? Nxera:™
Slide 34: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS
Slide 35: Appendix
Appendix 07
Slide 36: Lead program NBI'568 demonstrated positive phase 2 data in H2 2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Lead program, NBI’568 demonstrated positive phase 2 data in H2 2024 Once-daily 20 mg dose showed efficacy and good safety/tolerability profile for schizophrenia patients ➢ PANSS total score change -18.2 ➢ PANSS total
Slide 37: Exclusive Opt-in Rights and ROFN/ROFR
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Exclusive Opt-in Rights And ROFN/ROFR1 Option to develop up to six clinical programs for Japan and APAC (ex-China) from Idorsia Program Mechanism of Action Indication Stage Region Cenerimod S1P1 receptor modulator Sy
Slide 38: Core Operating Profit - Definition
FINANCIAL OPERATIONAL HIGHLIGHTS 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 39: Estimation of potential market size
FINANCIAL OPERATIONAL HIGHLIGHTS 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 40: Partnered pipeline (1/2)
FINANCIAL OPERATIONAL HIGHLIGHTS 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 41: Partnered pipeline (2/2)
FINANCIAL OPERATIONAL HIGHLIGHTS 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 42: In-house pipeline
FINANCIAL OPERATIONAL HIGHLIGHTS 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 NXE0
Slide 43: Clinical Trials
FINANCIAL OPERATIONAL HIGHLIGHTS 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 44: Exchange Rate, Intangible Assets and Non-core Costs
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2025 OBJECTIVES APPENDIX Exchange Rate, Intangible Assets and Non-core Costs Average exchange rate during period (actual) Non-core costs (full year) (JPY mn) FY2024 FY2023 FY2022 FY 2024 FY 2023 FY 2022 USD:JPY 151.43 140.53 131.30 Cost of s
Slide 45: Glossary
FINANCIAL OPERATIONAL HIGHLIGHTS 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 46: 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 46