Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Sosei Group — Investor Day (November 2023)
37 slides from Nxera Pharma's investor day presentation, Nov 10, 2023
Slide 1: R&D Day
NON-CONFIDENTIAL R&D Day Innovative R&D and Late-stage Development Progress 10 November 2023 | Sosei Group Corporation (TSE: 4565)
Slide 2: Disclaimer
Disclaimer The material that follows is a presentation of general background information about Sosei Group Corporation 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
Slide 3: Agenda
Agenda 1 Business update 2 Development and Sales in Japan and APAC 3 Progress in UK R&D 4 Supplementary Explanation for Q3FY2023 Results 3
Slide 4: Business update
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results 1 Business update Chris Cargill, CEO 4
Slide 5: Our mission
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Our mission CUTTING-EDGE MEDICINES REAL HUMAN SCIENCE BY DESIGN OUTCOMES BUILDING THE NEXT-GENERATION PHARMA COMPANY FOR JAPAN 5
Slide 6: Cutting-edge science
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Cutting-edge science World leaders in structure-based drug design, strong focus on GPCR targets GPCRs MOST SUCCESSFUL TARGETS IN MODERN MEDICINE FIRST TO SOLVE GLP-1R
Slide 7: Cutting-edge science enables medicines by design
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Cutting-edge science enables medicines by design Exposed to the fastest growing area in healthcare GLP-1 BEYOND GLP-1 NEXT-GENERATION BROAD INCRETIN/ UPSTREAM TARGETS
Slide 8: Cutting-edge science enables medicines by design
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Cutting-edge science enables medicines by design Exposed to the fastest growing area in healthcare DIABETES AND OBESITY ARE JUST THE BEGINNING. EMERGING RESEARCH SUGG
Slide 9: Medicines by design
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Medicines by design Advancing through early clinical development IN-HOUSE PROGRAMS PARTNERED PROGRAMS P Neurology GPR52 ag M4 ag Schizophrenia CCR6 ant IBD Phase 1 Ph
Slide 10: Real human outcomes
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Real human outcomes First commercially available medicine (PIVLAZ®) protecting lives in Japan every day Patients that have received PIVLAZ® since launch “The mechanis
Slide 11: Real human outcomes
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Real human outcomes Daridorexant to contribute significantly to Japanese health (Q4 2024 potential launch) 15 TRILLION YEN (3% GDP) 604,000 10% ECONOMIC LOSS LOST WOR
Slide 12: Our mission, in progress
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Our mission, in progress CUTTING- ✓ World-leader in SBDD, using AI/ML tools, accelerating new drug discovery EDGE SCIENCE ✓ Exposure to fastest growing area of health
Slide 13: Development and Sales in Japan and APAC
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results 2 Development and Sales in Japan and APAC Dr. Satoshi Tanaka, President of IPJ/IPK 13
Slide 14: Insomnia: potential in Japan of drugs targeting the Orexin system
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Insomnia: potential in Japan of drugs targeting the Orexin system Market size of orexin system is expected to grow rapidly Number of Patients (Million) Orexin CAGR 17
Slide 15: NDA submission of daridorexant
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results NDA submission of daridorexant NDA submission on 31 Oct 2023 based on the excellent results of Japanese Phase 3 studies Japanese Phase 3 study design Double blind stu
Slide 16: Cenerimod (S1P1 receptor modulator)
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Cenerimod (S1P1 receptor modulator) S1P1 receptor modulator proven to be effective for treating multiple immune-related diseases S1P1 receptor Cenerimod • Sphingosine
Slide 17: Sales trend and target of PIVLAZ
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Sales trend and target of PIVLAZ® (NHI based sales) Sales Target in 2023 : JPY 13,266 million Actual sales Target sales JPY million +43% 4,396 +41% 3,326 3,477 3,071
Slide 18: PIVLAZ included in Japanese Guidelines for the management of STROKE
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results PIVLAZ® included in Japanese Guidelines for the management of STROKE PIVLAZ® demonstrated the true endpoints of SAH with higher level of evidence Japanese Guidelines
Slide 19: Leverage commercial capability by using external resource
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Leverage commercial capability by using external resource Creating commercial synergies to optimize sales and distribution ＄ Service fee for sales personnel External
Slide 20: Progress in UK R&D
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results 3 Progress in UK R&D Dr. Matt Barnes, President of Heptares and Head of UK R&D 20
Slide 21: Partnered Programs (1)
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Partnered Programs (1) Neurocrine Biosciences Collaboration https://www.neurocrine.com//assets/2023/10/Final-NBIX-Q3-2023-Earnings-Presentation_10.31.23.pdf 21
Slide 22: Partnered Programs (2)
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Partnered Programs (2) Highlights Clinical & Pre-clinical Programs Oct. ’23 Sep. ’23 Jan. ’23 Oct. ’23 Clinical Program Clinical Program Clinical Program Pre-Clinical
Slide 23: Wholly-owned clinical & peri-clinical programs
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Wholly-owned clinical & peri-clinical programs Advancing priority programs into early clinical studies Immunosuppression Schizophrenia Inflammatory in solid tumors an
Slide 24: GPR52 agonist – a novel approach to treat schizophrenia
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results GPR52 agonist – a novel approach to treat schizophrenia Mechanism Preclinical results • HTL0041178 blocks psychostimulant-hyperlocomotion in rodents Striatum – GPR52
Slide 25: In House Portfolio – Future Programs
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results In House Portfolio – Future Programs Several internal targets 1 2 3 Inflammatory bowel disease Major Depressive Disorder Metabolic Disorders Stage Pre-clinical Discov
Slide 26: R&D Artificial Intelligence (AI)/Machine Learning (ML) Approaches
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results R&D Artificial Intelligence (AI)/Machine Learning (ML) Approaches Broad application of AI techniques across multiple functions StaR® Structure Molecule Design Transla
Slide 27: Future Innovation & Platform Growth
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Future Innovation & Platform Growth Investing in non-GPCR membrane drug targets and laboratory expansion Non-GPCRs Laboratory Expansion • Utilizing know-how to explor
Slide 28: Supplementary Explanation for Q3FY2023 Results
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results 4 Supplementary Explanation for Q3FY2023 Results Hironoshin Nomura, CFO 28
Slide 29: Breakdown of Q3 FY2023 result
2. Development and Sales in 4. Supplementary Explanation 1. Business update 3. Progress in UK R&D Japan and APAC for Q3FY2023 Results Breakdown of Q3 FY2023 result Because of M&A, Non-cash/Non-recurring cost impacted 3rd quarter results Sosei Heptares* ＋ IPJ/IPK* Consolidated Non-recurring Consolida
Slide 30: Appendix
Appendix 30
Slide 31: Exclusive Opt-in Rights And ROFN/ROFR
Exclusive Opt-in Rights And ROFN/ROFR1 Option to develop up to seven clinical programs for Japan and APAC (ex-China) from Idorsia Program Mechanism of Action Indication** Stage Region Cenerimod S1P1 receptor modulator Systemic lupus erythematosus Phase 3 Exclusive Opt-in Right Lucerastat Glucosylcer
Slide 32: Introduction of 'Core Operating Profit'
Introduction of ‘Core Operating Profit’ Core Operating Profit – the financial indicator closer to the reality of our business Operating Profit Operating Profit “IFRS” “Core” ◼ Financial results recorded and prepared in + Material Non-cash Costs ◼ Core Operating Profit is a new key accordance with In
Slide 33: Partnered pipeline
Partnered pipeline 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® Antifungal agent miconazole SME Oropharyngeal c
Slide 34: Partnered pipeline (cont'd)
Partnered pipeline (cont’d) 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) PAR-2 Peptide Inflammatory diseases (Not disclosed) Targeted Protein Degradation SME Gastrointestinal disord
Slide 35: In-house pipeline
In-house pipeline Compound Target / Mechanism Modality Indication Originator Disc. PCC Ph1 Ph2 Ph3 App Mkt In-house Programs PIVLAZ® ETA antagonist SME Cerebral vasospasm Daridorexant Dual Orexin antagonist SME Insomnia HTL’149 GPR52 agonist SME Neurology diseases HTL’732 EP4 antagonist SME Immuno-o
Slide 36: (For Reference) IPJ Standalone Operating Results
(For Reference) IPJ* Standalone Operating Results FY2022 FY2023 2Q (JPY million) Revenue 11,709 5,950 Product sales 6,254 4,812 Contract revenue (from related parties) 5,455 1,138 CoS 1,959 1,692 R&D 4,485 1,034 SG&A 4,475 2,876 Operating profit 790 348 Net income 468 158 * IPJ: Idorsia Pharmaceutic
Slide 37: Locations
Locations SOSEI GROUP PMO Hanzomon 11F Midtown East, F17, 410 Teheran-Ro Steinmetz Building North West House VISCHER AG 2-1 Kojimachi, 9-7-2 Akasaka Minato- GangHam-Gu Granta Park, 119 Marylebone Road Aeschenvorstadt 4 Chiyoda-ku ku Seoul 06192 Cambridge CB21 6DG London NW1 5PU 4051 Basel Tokyo 102-