Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — H1 2024 Earnings Presentation
40 slides from Nxera Pharma's earnings presentation, Aug 9, 2024
Slide 1: H1 FY2024 Financial Results
EXTERNAL NON-CONFIDENTIAL H1 FY2024 Financial Results Six-month period ended June 30, 2024 9th August, 2024 | 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 FY2024 Objectives 06 Appendix 3
Slide 4: Financial Results
Financial Results Hironoshin Nomura, CFO 01
Slide 5: Financial summary for 1H FY2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Financial summary for 1H FY2024 Another period of successful business execution with a new collaboration and development milestone events Revenue of ¥12,720m ($84m) vs. ¥2,146m ($16m) in the prior comparative period.
Slide 6: Key financial indicators
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Key financial indicators Quarterly revenues are substantially higher than prior comparative quarters due to the inclusion of PIVLAZ® product sales, revenue from the new Boehringer Ingelheim deal and several developme
Slide 7: Full year cost guidance
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Full year cost guidance Incremental investment designed to deliver greater returns over the medium to long term LATEST (JPY million) GUIDANCE R&D expenses (IFRS basis) ¥12,000 to ¥14,000m 15,000 14,000 ~ 12,000 ◼ Inc
Slide 8: Operational Highlights
Operational Highlights Chris Cargill, President and CEO 02
Slide 9: Objectives for 2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Objectives for 2024 Executing on our objectives to fuel long-term growth 1 2 3 4 5 Execute new major Investment in post- JPY 16 billion+ JNDA approval for Acquire/in-license partnership(s), and merger integration NHI
Slide 10: Pipeline progress
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Pipeline progress Accelerating the development of life-changing medicines, by investing in science and technology TARGET ID PRE-DISCOVERY DISCOVERY PHASE 1 PHASE 2 Expansion of R&D $10M milestone payment Two NME1 pro
Slide 11: Exposed to the fastest growing areas of medicine
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Exposed to the fastest growing areas of medicine Advancing with world-leaders in neuropsychiatry, metabolic disease, and sleep disorders Neuropsychiatry Metabolic disease Sleep disorders • Oral, selective muscarinic
Slide 12: Pipeline snapshot
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Pipeline snapshot A comprehensive clinical development pipeline Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial ✓ ✓ GPR35 ag. NXE’477 EP4 ant. NXE’732 APAC* APAC* APAC* EP4 ag. NXE’744 Cenerimod Dari
Slide 13: Japan/APAC Commercial Business
Japan/APAC Commercial Business Dr. Satoshi Tanaka, President of NPJ 03
Slide 14: Our product: PIVLAZ
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Our product: PIVLAZ® PIVLAZ® sales projected to reach JPY 16+BN* in 2024 Cum. patients to have received PIVLAZ® 14,036 • Becoming the new standard of care in preventing cerebral vasospasm following Subarachnoid Hemor
Slide 15: In-house pipeline: Daridorexant
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX In-house pipeline: Daridorexant On-track for JNDA approval in H2 2024 About daridorexant DORA: rapidly establishing its position in insomnia treatment Lemborexant (Dayvigo) Zolpidem Others • Dual orexin receptor anta
Slide 16: Accelerating our Japan/APAC business
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Accelerating our Japan/APAC business Maximizing our Japan APAC business potential by utilizing external partners / alliances Sales / Marketing In-licensing activity • Announced an exclusive supply and distribution •
Slide 17: R&D Progress
R&D Progress Dr. Matt Barnes, President of Nxera Pharma UK and Head of UK R&D 04
Slide 18: Clinical Partnered Programs and In-house Clinical Programs
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Clinical Partnered Programs 9 Clinical Programs in Neuroscience, Autoimmune and Metabolic Diseases P M4 Agonist M4 Agonist GLP-1 Agonist mGlu5 NAM Schizophrenia - Phase 2 Neuropsychiatry - Phase 1 Metabolic - Phase 1
Slide 19: GPR52 Agonist for Schizophrenia
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX GPR52 Agonist for Schizophrenia A Novel First-In-Class Mechanism to Treat Positive, Negative & Cognitive Domains of Schizophrenia Disease Rationale Results So Far • GPR52 is expressed on D2 dopamine neurons in striat
Slide 20: EP4 Antagonism for Advanced Solid Tumours
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX EP4 Antagonism for Advanced Solid Tumours Alone or in Combination with Checkpoint Inhibitors (CPIs) Disease Rationale Results So Far • Prostaglandin E2 (PGE2) is secreted by tumour and surrounding tissue and • Select
Slide 21: EP4 Agonist for Inflammatory Bowel Disease (IBD)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX EP4 Agonist for Inflammatory Bowel Disease (IBD) A First-In-Class GI Targeted Agent to Promote Mucosal Healing in IBD Disease Rationale Results So Far • IBD is an immunological disorder in which current standard-of-c
Slide 22: FY2024 Objectives
FY2024 Objectives Chris Cargill, CEO 05
Slide 23: Priority objectives for FY2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Priority objectives for FY2024 01 JPY 16 billion+ NHI sales for PIVLAZ® ON-TRACK 02 JNDA approval for daridorexant in Japan ON-TRACK Acquire/in-license at least one late-stage ON-TRACK 03 medicine for Japan/APAC (ex-
Slide 24: Several potential catalysts remain for 2024
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Several potential catalysts remain for 2024 (excluding new business development transactions) PROGRAM PARTNER TIMING EVENT P EP4 Ag Achieved (Mar. 2024) Ph.1 start P GPR35 Ag Achieved (Mar. 2024) Program reversion P
Slide 25: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS
Slide 26: Appendix
Appendix 06
Slide 27: Breakdown of 1H 2024 result
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Breakdown of 1H 2024 result Impact of Non-cash/Non-recurring costs on full-year result is more significant in 2024 due to the inclusion of Idorsia businesses Legacy Business＋ Consolidated Non-recurring Consolidated (
Slide 28: Japan will serve as our base to expand across APAC markets
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Japan will serve as our base to expand across APAC markets APAC is one of the most rapidly growing markets in the world Established market with strong volumes Japan Second largest pharma Universal health care system
Slide 29: Utilizing Japan's high quality clinical data in development and marketing
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Utilizing Japan's high quality clinical data in development and marketing Expanding into APAC by leveraging clinical innovations based on Japan's high-quality data Quality Clinical Development Quality Regulatory Envi
Slide 30: PIVLAZ: Positive top-line results from Japan registration program
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX PIVLAZ® Positive top-line results from Japan specific registration program RESULTS OF TWO PIVOTAL PHASE 3 STUDIES IN JAPAN1 COILING STUDY CLIPPING STUDY • PIVLAZ® (clazosentan) demonstrated significant reduction of E
Slide 31: Daridorexant – Global And Japan-Specific Program
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Daridorexant – Global And Japan-Specific Program Positive Japanese Phase 3 study; in-line with US study as published in The Lancet1 RESULTS OF GLOBAL AND JAPANESE PIVOTAL TRIALS1 TWO PRIMARY ENDPOINTS FULLY MET IN GL
Slide 32: Cenerimod and Lucerastat
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Cenerimod and Lucerastat Exclusive opt-in rights for two potentially exciting product opportunities Cenerimod Lucerastat Indication Systemic Lupus Erythematosus (SLE) Indication Fabry Disease MoA Selective S1P1 recep
Slide 33: Exclusive Opt-in Rights And ROFN/ROFR
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES 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
Slide 34: Core Operating Profit - Definition
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 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 35: Estimation of potential market size
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES APPENDIX Estimation of potential market size Multi-billion USD annual peak sales potential for our post-pre-clinical pipeline Number of Category Indication2 Our Candidates Patients Market Size Individual Products Dementia ~55
Slide 36: Partnered pipeline (1/2)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 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 37: Partnered pipeline (2/2)
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 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) PAR-2 Peptide Inflammatory
Slide 38: In-house pipeline
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 OBJECTIVES 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 Insom
Slide 39: Glossary
FINANCIAL OPERATIONAL HIGHLIGHTS JAPAN/APAC R&D PROGRESS FY2024 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 40: 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 40