Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Investor Presentation (November 2024)
49 slides from Nxera Pharma's investor presentation, November 2024
Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation November 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 Business Overview 02 Strategic Roadmap 03 Our Pipeline 04 Japan/APAC Business 05 Our NxWaveTM Platform 06 Financial Results 07 Appendix 3
Slide 4: Business Overview
Business Overview 01
Slide 5: Our Mission, Vision and Values
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Leading the Next Era of Medicine. From Japan, for Japan, and the world World-leading NxWave platform (UK), coupled with Japan’s most effective development and commercial organization Our Mission Our Vision Our Values To acceler
Slide 6: We are Nxera Pharma
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX We are Nxera Pharma A technology-powered biopharma in pursuit of new specialty medicines to improve the lives of patients Cutting-edge Science Programs by Design Real Human Outcomes WORLD-LEADERS IN GPCR 30+ ACTIVE PROGRAMS PRO
Slide 7: Global Corporate Structure
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Global Corporate Structure Over 350 team members employed across Japan, South Korea, UK and Switzerland Nxera Pharma (formerly “Sosei Group”) Group Operations | ~60 people Nxera Pharma UK (NPU) Nxera Pharma Japan (NPJ) Nxera Ph
Slide 8: Agile and decisive leadership team
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Agile and decisive leadership team BOARD OF DIRECTORS Shinichi Tamura Chris Cargill Tomohiro Toyama Rolf Soderstrom David Roblin Kuniaki Kaga Eiko Tomita Noriaki Nagai Miwa Seki Chairman CEO Legal Finance Clin Dev Clin Dev Reg
Slide 9: Strategic Roadmap
Strategic Roadmap 02
Slide 10: Our History
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our History Strategic steps taken to build Nxera over the last two decades 2000s 2015 2023 2024 Launched a public company Out-licensed several programs to Elevated our status in the Tokyo dedicated to bringing innovation to glo
Slide 11: To make our mission happen…
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX To make our mission happen… Accelerate the development of life-changing medicines 1 2 3 Acquire or in-license Invest in our Build a first-class multiple de-risked NxWaveTM platform technology medicines for Japan to seed program
Slide 12: …building a fully integrated biopharma from Japan
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX …building a fully integrated biopharma from Japan Accelerating growth to achieve our mission by leveraging business platform in Japan and UK 2000s 2015 2023 2024 JAPAN KOREA Clinical Trials Approved Discovery / Preclinical Phas
Slide 13: Priority objectives for FY2024
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Priority objectives SLIGHTLY BEHIND for FY2024 01 JPY 16 billion+ NHI sales for PIVLAZ® New target is JPY 15-16Bn 02 JNDA approval for daridorexant in Japan P Sep. 2024 Acquire/in-license at least one late-stage ON-TRACK 03 med
Slide 14: Our Pipeline
Our Pipeline Programs by Design 03
Slide 15: Major Pipeline Overview
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview 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
Slide 16: Major Pipeline Overview (with future projection)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview (with future projection) Discovery – Preclinical Phase 1 Phase 2 Phase 3 Filed Commercial 10+ PROGRAMS EP4 ant. NXE’732 2025 Cenerimod A PIVLAZ® A Advanced (current Ph1/2a study will Systemic lupus Cereb
Slide 17: Achievements and several potential catalysts in 2024
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Achievements and several potential catalysts in 2024 Potential catalysts of in-house and out-licensed programs (excluding new business development transactions) PROGRAM PARTNER TIMING EVENT P EP4 Ag Achieved (Mar. 2024) Ph.1 st
Slide 18: Major Pipeline Overview (with business categories)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Major Pipeline Overview (with business categories) 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 t
Slide 19: Key strategy for each business category
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key strategy for each business category Maximize the value of each business and demonstrate synergies by conducting integrated development in future NxWaveTM platform driven Acquire or in-license for Japan ◼ Collaborate with ex
Slide 20: Japan/APAC Business
Japan/APAC Business Deliver innovation to patients in Japan/APAC 04
Slide 21: Japan will serve as our base to expand across APAC markets
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Japan will serve as our base to expand across APAC markets Commercial Japan is an attractive, established market with strong volumes Japan is the second Tailwinds from near- High quality clinical APAC is the second largest phar
Slide 22: Our product: PIVLAZ
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our product: PIVLAZ® Commercial Our first commercially available medicine is penetrating the market and protecting lives every day. Quarterly PIVLAZ® Sales (NHI-based) Yearly PIVLAZ® sales and its growth 5,000 NHI sales Market
Slide 23: QUVIVIQ: A Novel Dual Orexin Receptor Antagonist
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQTM *: A Novel Dual Orexin Receptor Antagonist (DORA) Commercial DORA is rapidly establishing its position in insomnia treatment Lemborexant (Dayvigo) Zolpidem Others (JPY Bn) Suvorexant (Belsomra) Eszopiclone 80 DORA sha
Slide 24: QUVIVIQ Business scheme change
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX QUVIVIQTM Business scheme change Commercial SHIONOGI to Exclusively Handle Distribution and Sales Activities in Japan Old Scheme New Scheme (Sold by 3 companies / 2 channels) (Sold by 1 company / 1 channel) Originator Marketing
Slide 25: In-house pipeline: QUVIVIQ
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX In-house pipeline: QUVIVIQTM Commercial JNDA approval received in September 2024, and aim to be best-in-class drug Unmet needs in insomnia About QUVIVIQTM Dual Orexin Alleviates excessive wakefulness through Receptor Antagonist
Slide 26: Our NxWave Platform
Our NxWaveTM Platform Cutting-edge Science 05
Slide 27: NxWave platform is focussed on drugging GPCRs
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave platform is focussed on drugging GPCRs Platform GPCRs are the largest family of drug discovery targets – comprising 1/3 of all FDA approved drugs (Billion USD) Market share of GPCR-targeting drug NEUROLOGICAL DISORDERS 2
Slide 28: First-in-class opportunities
ADORA2A ADRA2A ADRB2 CHRM1 DRD1 DRD3 HTR2A HTR4 & OPRD1 OPRM1 P2RY12 ant. ago. (54*) PTGER2 GHRHR TSHR ADORA2B ADRB3 CHRM2 GLP1R HTR1B HTR1F MTNR1A PTGER3 PTGIR S1PR5 GCGR (31) ago. GIPR MC4R RXFP1 SCTR AVPR1A C5AR1 CCR5 CXCR4 DRD4 EDNRB GNRHR HCRTR2 HTR2B TACR1 (26) CALCRL ant. Marketed drugs only,
Slide 29: Our drug discovery
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX NxWave platform enables faster, cheaper and more precise drug discovery Platform World-leading science and platform enables efficient drug discovery against difficult targets Conventional drug discovery Our drug discovery Appro
Slide 30: Our platform enables precise design of GPCR models
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our platform enables precise design of GPCR models Platform Only by performing detailed structural analysis can we design great drugs. Imprecise GPCR model: Standard Medicine Precise GPCR model: Optimized Medicine Poorly unders
Slide 31: Our track record of major licensing transactions
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Our track record of major licensing transactions speaks for itself… Platform Income from licensing provides a great source of non-dilutive financing to support our growth Balance of potential milestone income from Top 15 pharma
Slide 32: Hundreds of millions of dollars received, billions in potential
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX … hundreds of millions of dollars received, billions of dollars in potential to come Platform New collaboration and exclusive option to license agreement recently executed with Boehringer Ingelheim Upfront and Initial Potential
Slide 33: M4 ago. (NBI'568) demonstrated positive phase 2 data
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX M4 ago. (NBI’568) demonstrated competitive positive phase 2 data Platform Once-daily 20 mg dose showed efficacy, and good safety / tolerability profile for schizophrenia patients. ➢ PANSS total score change -18.2 ➢ PANSS total
Slide 34: Financial Results
Financial Results 06
Slide 35: Key financial indicators
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Key financial indicators Full impact of NPJ/NPK product sales and cost base reflected in FY2024 3Q result Explanation for 1Q-3Q 2024 (JPY million) 25,000 21,983 Upfront1 ◼ New option-to-license deal signed with Boehringer. (Mar
Slide 36: Breakdown of 3Q 2024 result
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Breakdown of 3Q 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 Consolidated Non-recurring Consolidated (JPY million) NPC / NPU*1 ＋ N
Slide 37: Full year cost guidance
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Full year cost guidance Incremental investment designed to deliver greater returns over the medium to long term (JPY million) LATEST GUIDANCE 15,000 R&D expenses (IFRS) 13,000 ~ Old New 10,000 11,000 ¥12,000 ~ ¥14,000m - ¥1,000
Slide 38: Cost expenses guidance gap vs. beginning of FY24
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX Cost expenses guidance gap vs. beginning of FY24 We expect downward trend in SG&A expenses to continue through optimization in 2025 R&D expenses (IFRS) guidance SG&A expenses (IFRS) guidance (JPY million) (JPY million) * 13,000
Slide 39: PIVLAZ sales guidance update
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS APPENDIX PIVLAZ® sales guidance update Updated sales guidance due to SAH occurrence decrease and cancellation of inventory adjustment plan Sales guidance of PIVLAZ® Background of sales guidance update Updated sales guidance though PIVLA
Slide 40: Appendix
Appendix 07
Slide 41: Exclusive Opt-in Rights And ROFN/ROFR
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 lu
Slide 42: Core Operating Profit - Definition
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 ◼ Financial resu
Slide 43: Estimation of potential market size
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 million $7
Slide 44: Partnered pipeline (1/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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® Breezhaler®
Slide 45: Partnered pipeline (2/2)
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 diseases (N
Slide 46: In-house pipeline
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 QUVIVIQTM Dual Orexin antagonist SME Insomnia NXE0048149 1
Slide 47: Glossary
OVERVIEW STRATEGIC ROADMAP PIPELINE JP/APAC PLATFORM FINANCIALS 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 drugged Nxera’
Slide 48: 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 48
Slide 49: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS