Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Sosei Group — FY2023 Earnings Presentation
34 slides from Nxera Pharma's earnings presentation, Feb 13, 2024
Slide 1: FY2023 Financial Results
NON-CONFIDENTIAL FY2023 Financial Results 12-month period ended December 31, 2023 13 February 2024 | 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 Financial Results 2 Operational Highlights 3 Sales in Japan and APAC 4 R&D Progress 5 Objectives for FY2024 and Beyond 2030 Vision 3
Slide 4: FY2023 Financial Results
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 1 FY2023 Financial Results Hironoshin Nomura, CFO 4
Slide 5: Financial summary for FY2023
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Financial summary for FY2023 2023 results incorporate transformational acquisition of Idorsia’s Japan/APAC business. Revenue of ¥12,766m ($91m) vs. ¥15,569m ($119m) in the prior year. 1 Revenue lower due to lack of new business develop
Slide 6: Key financial indicators
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Key financial indicators Product sales of PIVLAZ® made a significant contribution to total Revenue FY23 actual Explanation (JPY million) ◼ No new out-licensing transactions signed in FY2023 vs. two 20,000 Upfront1 new deals / upfront f
Slide 7: Breakdown of FY2023 result
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Breakdown of FY2023 result Impact of Non-cash/Non-recurring costs on full-year result is more significant in 2023 due to M&A Sosei Heptares* ＋ IPJ/IPK* Consolidated Non-recurring Consolidated (JPY million) (12 months) (7/20-12/31:c.5.4
Slide 8: Full year product sales guidance
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Full year product sales guidance PIVLAZ® sales are projected to reach JPY 16+ billion* (c. 114+ million USD) in 2024 Actual Sales of PIVLAZ® (NHI base) Target Sales in FY2024 c. JPY 7.5 Bn c. JPY 13.4 Bn JPY 16.0 + Bn 4,537 Sales growt
Slide 9: Full year cost guidance
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Full year cost guidance Incremental investment designed to deliver greater returns over the medium to long term Latest Guidance R&D expenses (IFRS basis) (JPY million) ¥12,000 to ¥14,000m 15,000 14,000 ~ Inclusion of ◼ Inclusion of IPJ
Slide 10: Operational Highlights
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 2 Operational Highlights Chris Cargill, CEO 10
Slide 11: Significant progress in 2023 across in-house and partnered programs
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Significant progress in 2023 across in-house and partnered programs Pre-Discovery / Discovery Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial P PDaridorexant P PIVLAZ® P IN-HOUSE APAC* APAC* APAC* EP4 ag. GPR52 ag. HTL’149 Cenerim
Slide 12: 2023 in review – a transformative year
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 2023 in review – a transformative year CORPORATE IN-HOUSE PARTNERED MILESTONES PROGRAMS PROGRAMS ✓ Up-listed to Tokyo Stock ✓ PIVLAZ® receives Marketing ✓ Neurocrine initiated Ph.1 Exchange Prime Segment Approval in South Korea studies
Slide 13: Performance against FY2023 objectives
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Performance against FY2023 objectives Majority achieved. New high value partnership discussions are ongoing FY2023 OBJECTIVES FY2023 ACHIEVEMENT 1 WORLD-LEADING Invest to enhance GPCR SBDD platform ✓ DRUG DISCOVERY 1 capability 2 MAJOR
Slide 14: Exposed to the fastest growing areas of medicine
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Exposed to the fastest growing areas of medicine Muscarinic agonism in neuropsychiatry, plus current and next-gen targets for metabolic diseases Neuropsychiatry: latest news Metabolic disease: latest news • 22 December 2023: Bristol My
Slide 15: Development and Sales in Japan and APAC
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 3 Development and Sales in Japan and APAC Dr. Satoshi Tanaka, President of IPJ 15
Slide 16: PIVLAZ: Our first commercially available medicine
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix PIVLAZ® Our first commercially available medicine protecting Japanese lives every day Cum. patients to have received PIVLAZ® 10,377 JP GUIDELINES INCLUSION FOR MANAGEMENT OF STROKE1 • Aug '23: Authorized and recommended by the Japanese
Slide 17: Daridorexant J-NDA filed; expected launch in late 2024
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Daridorexant J-NDA filed; expected launch in late 2024 Daridorexant will contribute significantly to Japanese society Impact of Insomnia on Japanese Society Q4 2024 POTENTIAL LAUNCH IN JAPAN 15 TRILLION YEN (3% GDP) • Oct-23: J-NDA sub
Slide 18: R&D Progress
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 4 R&D Progress Dr. Matt Barnes, President of Heptares and Head of UK R&D 18
Slide 19: Clinical partnered programs
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix P Clinical milestone in 2023 Clinical partnered programs Significant progress through 2023 Schizophrenia Neuropsychiatry Metabolic Inflammatory bowel disease NBI-1117568 M4 Ag Phase 2 P NBI-1117569 M4 Ag Phase 1 P PF-06954522 GLP-1 Ag
Slide 20: Rapidly advancing in-house programs into the clinic
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix P Clinical milestone in 2023 Rapidly advancing in-house programs into the clinic Immunosuppression Schizophrenia Inflammatory bowel Inflammatory bowel In solid tumors and psychosis disease disease P EP4 Ant Phase 1/2a P GPR52 Ag Phase
Slide 21: GPR52 Agonist – A Novel Approach to Treat Schizophrenia
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix GPR52 Agonist – A Novel Approach to Treat Schizophrenia First-in Class mechanism Disease Rationale Results so far • GPR52 is expressed on D2 dopamine neurons in striatum • In June 2023 we were the first company to initiate a Phase1 stu
Slide 22: Platform & Discovery Growth
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix P Strategic milestone in 2023 Platform & Discovery Growth 2023 Highlights Platform Growth Target Identification/Validation Discovery P P P Non-GPCR Drug Targets Jun. ’23 AI Drug Design Oct. ’23 FIC GPCR progression Oct. ’23 • Membrane
Slide 23: Objectives for FY2024 and Beyond 2030 Vision
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 5 Objectives for FY2024 and Beyond 2030 Vision Chris Cargill, CEO 23
Slide 24: Objectives for FY2024
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Objectives for FY2024 Positioning for long-term growth potential 1 JPY 16 billion + NHI sales for PIVLAZ® 2 JNDA approval for daridorexant in Japan 3 Acquire/in-license at least one late-stage medicine for the Japan/APAC (ex-China) reg
Slide 25: Several potential catalysts over the next 12 months
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Several potential catalysts over the next 12 months (excluding new business development transactions) PROGRAM PARTNER TIMING EVENT Cenerimod 1H 2024 Exclusive opt-in decision Lucerastat 1H 2024 Exclusive opt-in decision EP4 Ag 1H 2024
Slide 26: Beyond 2030 vision
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Beyond 2030 vision Next-generation pharma company and top 15 in Japan by market capitalization Focused on innovative specialty medicines Tech-powered systems for decision-making speed and scalability Development and commercialization p
Slide 27: Appendix
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Appendix 27
Slide 28: ~¥8bn ($54m) investment from new OPF1 fund of JIC VGI
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix ~¥8bn ($54m) investment from new OPF1 fund of JIC VGI JIC Venture Growth Investments is an affiliate of govt-backed Japan Investment Corporation (JIC) JIC VGI OPPORTUNITY FUND NO.1 (OPF1) INVESTMENT IN SOSEI GROUP CORPORATION • One of
Slide 29: Exclusive Opt-in Rights And ROFN/ROFR
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 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 er
Slide 30: Introduction of 'Core Operating Profit'
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix Introduction of ‘Core Operating Profit’ Core Operating Profit – the financial indicator closer to the reality of our business Operating Profit Operating Profit “Core” “IFRS” ◼ Core Operating Profit is a new key + Material Non-cash Cost
Slide 31: Partnered pipeline
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 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
Slide 32: Partnered pipeline (cont'd)
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 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 di
Slide 33: In-house pipeline
1. Financial 2. Operation 3. JP/APAC 4. R&D 5. Strategy Appendix 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 a
Slide 34: Locations
Locations SOSEI GROUP PMO Hanzomon 11F Midtown East, F17, 410 Teheran-Ro Steinmetz Building Burleigh on the Strand Spaces Grosspeter Tower 2-1 Kojimachi, 9-7-2 Akasaka Minato- GangHam-Gu Granta Park, 355-359 Strand Chiyoda-ku ku Grosspeteranlage 29 Seoul 06192 Cambridge CB21 6DG London WC2R 0HS Toky