Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
31 slides from Nxera Pharma's conference presentation, Jan 15, 2025
Slide 1: Leading the next era of medicine. From Japan, for Japan, and the world.
NON-CONFIDENTIAL Leading the next era of medicine. From Japan, for Japan, and the world. 43rd Annual J.P. Morgan Healthcare Conference 15 January 2025
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: Chris Cargill, President & CEO
Chris Cargill President & CEO Nxera Pharma (TSE:4565) 3
Slide 4: Nxera is a commercial stage, emerging biopharma from Japan
Nxera is a commercial stage, emerging biopharma from Japan Founding 2015 2024 Founded with the purpose …and evolved with the …now accelerating the to bring the best biotech NxWaveTM GPCR structure- development and delivery of innovations to Japan… based drug discovery life-changing medicines. platfo
Slide 5: By the numbers – a snapshot of our business
By the numbers – a snapshot of our business OVERVIEW THERAPEUTIC FOCUS JPY29bn JPY36bn 400+ NEUROLOGY/ NEUROPSYCH METABOLIC DISEASES IMMUNOLOGY/ GI Annual Cash on Hand Employees in $120bn+ $150bn+ $300bn+ Revenues to Invest 5 locations MARKET SIZE MARKET SIZE MARKET SIZE PRODUCTS AND PROGRAMS RESEAR
Slide 6: Not a traditional Japanese pharma. We think and innovate globally
Not a traditional Japanese pharma. We think and innovate globally, and specialize locally Global centers of excellence Bilingual local leadership ~200 team CEO Research Finance Operations members Finance Development Commercial Compliance / Medical / Operations Research & Early Clinical • Proprietary
Slide 7: Not a traditional Japanese pharma. Committed to speed and operational excellence
Not a traditional Japanese pharma. Committed to speed and operational excellence Core Values Innovation Focus Speed Operational excellence Japan + APAC commercial business Global discovery business Focusing on Japan’s most World- diseases Highly effective & NxWaveTM Innovating leading that matter ex
Slide 8: Let’s talk about our products and clinical pipeline
Let’s talk about our products and clinical pipeline Nxera’s Commercialized Products Partnered Products (Discovered by Nxera/with NxWave tech) 1 Neurological disorders – diseases of ageing 3 Neurological disorders – psychiatric / cognition PIVLAZ® – Muscarinic agonists – prevention of cerebral vasosp
Slide 9: Commercialized Products in Japan
Commercialized Products in Japan
Slide 10: PIVLAZ (clazosentan, an endothelin A antagonist)
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® Sales (NHI-based) Annual PIVLAZ® sales and its growth NHI sales Market share (patient ba
Slide 11: QUVIVIQ (daridorexant, dual orexin antagonist)
2 QUVIVIQTM (daridorexant, dual orexin antagonist) PMDA approved September 2024, launched with partner Shionogi December 2024 Unmet needs in insomnia About QUVIVIQTM Dual Orexin Alleviates excessive wakefulness through Nocturnal awakenings Receptor Antagonist strong inhibition of orexin receptors Re
Slide 12: QUVIVIQ: DORA is rapidly establishing its position in insomnia treatment
2 QUVIVIQTM (daridorexant, dual orexin antagonist “DORA”) DORA is rapidly establishing its position in the treatment paradigm for insomnia Lemborexant (Dayvigo) Zolpidem Others (JPY Bn) Suvorexant (Belsomra) Eszopiclone 80 DORA share (patient base) 22%** ✓ DORAs are rapidly penetrating 19% the insom
Slide 13: Partnered Products
Partnered Products
Slide 14: Following recent approval of BMS’ COBENFY, muscarinic agonism became a new mode of action
3 Following recent approval of BMS’ COBENFY , muscarinic agonism became the first new mode of action to treat schizophrenia patients in decades First clinical evidence for benefit of Positive KarXT Phase2 clinical Cerevel M4 PAM Phase1b Positive KarXT Phase3 clinical COBENFY FDA approved xanomeline
Slide 15: Neurocrine is advancing the world’s most comprehensive portfolio of muscarinic agonists
3Neurocrine 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 molecule programs across key receptors • Comprehensive approach to maximising the pote
Slide 16: NBI-568 is positioned for a Phase 3 start in schizophrenia in H1 2025
3 NBI-568 is positioned for a Phase 3 start in schizophrenia in H1 2025 First compound discovered using Nxera’s NxWave technology to progress into Phase 3 Clinically Effective Good Tolerability Efficacy at 20mg dose comparable Across all doses tested supporting to all competitors good future complia
Slide 17: Centessa advancing orexin agonists; Pfizer advancing PFE’522
4 Centessa advancing Orexin 2 5 Pfizer advancing PFE’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 – discovered using NxWave – discovered by Pfizer using NxWave Significant commercia
Slide 18: Emerging wholly-owned pipeline
Emerging wholly-owned pipeline
Slide 19: Fuelling the Wave 1 and Wave 2 launches with novel programs
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) Target Indication Schizophrenia Advanced solid tumors IBD Global Patient 24 million
Slide 20: Leveraging and expanding the world’s most comprehensive platform for GPCRs – NxWave
Leveraging and expanding the world’s most comprehensive platform for GPCRs – NxWave NxWaveTM Platform Small Molecules Excellent efficacy and safety Antibodies Structure-Based Oral route of Drug Design administration Peptides Affordable pricing and cost Our core strength is in small molecules. Expand
Slide 21: The Big Picture
The Big Picture
Slide 22: Broad and balanced pipeline with two recently launched products
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 Systemic lupus Cerebral vasospasm IN-HOUSE solid tumours erythematosus EP4 ag. NXE’744
Slide 23: Our Wave 1 and Wave 2 programs are positioned across fast growing areas of healthcare
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 PreC Ox2 agonists P1 M4 pref. agonist P1 GPR52 agonist (2030) Substance Use Narcolep
Slide 24: 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 Upside Potential royalty from next Only 1-2 launches from seven generation pipelines. WAVE1 drives significant upside WAVE1 WAVE1 Royalty Royalty
Slide 25: Looking ahead to potential catalysts in 2025
Looking ahead to potential catalysts in 2025* PROGRAM PARTNER TIMING EVENT TMP-301 (mGlu5 NAM) Q1 2025 Phase 2 study start in alcohol use disorder Cenerimod (S1P1) / Lucerastat Q1 2025 Exclusive opt-in decision NXE’732 (EP4 antagonist) Q1 2025 Phase 2 study start in Advancing Solid Tumors NBI’568 (M
Slide 26: Now is the time to invest in one of Japan’s most transformative emerging biopharmas
Now is the time to invest in one of Japan’s most transformative emerging biopharmas Year IPO / Value of # Non-clinical # Clinical Modality Founded Listing Business Programs Programs NASDAQ SME, 2019 $600M 3+ 1 (2024) Biologics NASDAQ 2019 $890M SME 3+ 1 (2024) NASDAQ 2019 $1,493M SME 4 2 (2023) SME,
Slide 27: Questions?
~ Questions? Nxera:™
Slide 28: Thank you
Thank you 28 BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS
Slide 29: Japan is our home, and the best lynchpin market for broader APAC growth
Japan is our home, and the best lynchpin market for broader APAC growth Well understood healthcare challenges Excellent place to do business ▪ Ageing population ▪ Stable, growing market → 1 in 3 Japanese citizens will be 65+ this year → In an increasingly unstable world, Japan is an → Age-related /
Slide 30: Nxera is the partner of choice to develop your medicines in Japan, Korea and APAC
Nxera is the partner of choice to develop your medicines in Japan, Korea and APAC Diseases that matter to us in Japan & APAC Active in-licensing discussions targeting 20+ assets Commercial considerations Nxera Pharma capabilities 50+ proposals evaluated Universe of Disease Areas 472 DAs 20+ product
Slide 31: Lead program, NBI’568 demonstrated positive phase 2 data in H2 2024
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 score change vs. Placebo -7.5 (p = 0.011) Met primary and Clinically meaningful and
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