Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Investor Presentation (October 2024)
47 slides from Nxera Pharma's investor presentation, October 2024
Slide 1: Corporate Presentation
EXTERNAL NON-CONFIDENTIAL Corporate Presentation October 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 Medicines and Pipeline 04 Our NxWaveTM Platform 05 Financial Results 06 Appendix 3
Slide 4: Business Overview
Business Overview 01
Slide 5: Our Mission, Our Vision, Our Values
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 accel
Slide 6: We are Nxera Pharma
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 P
Slide 7: Global Corporate Structure
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Global Corporate Structure Over 350 team members employed across Japan, South Korea, UK and Switzerland Nxera Pharma Co., Ltd. Group Operations | ~50 people Nxera Pharma UK Limited Nxera Pharma Japan Co., Ltd. Nxera Pharma Ko
Slide 8: Agile and decisive leadership team
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 Re
Slide 9: Strategic Roadmap
Strategic Roadmap 02
Slide 10: Our History
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 g
Slide 11: Building a fully integrated biopharma from Japan
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 Pha
Slide 12: Our mission is clear
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Our mission is clear 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 programs env
Slide 13: Japan will serve as our base to expand across APAC markets
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Japan will serve as our base to expand across APAC markets Japan is an attractive, established market with strong volumes Japan is the second Tailwinds from near- High quality clinical APAC is the second largest pharma term r
Slide 14: Priority objectives for FY2024
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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-China) Ex
Slide 15: Achievements and potential catalysts in 2024 and early 2025
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Achievements and several potential catalysts in 2024 and early 2025 Potential catalysts of in-house and out-licensed programs (excluding new business development transactions) PROGRAM PARTNER TIMING EVENT P EP4 Ag Achieved (M
Slide 16: Our Pipeline and Medicines
Our Pipeline and Medicines Programs by Design 03
Slide 17: Active Pipeline Overview
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Active Pipeline Overview 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 QUVIVICTM PIVLAZ® IN-HOUSE IBD Advanced IBD Systemic lup
Slide 18: Our product: PIVLAZ
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Our product: PIVLAZ® Our first commercially available medicine protecting Japanese lives every day JP GUIDELINES INCLUSION FOR MANAGEMENT OF STROKE1 Cum. patients to have received PIVLAZ® 14,036 • Aug '23: Authorized and reco
Slide 19: In-house pipeline: Daridorexant
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 antagonist (D
Slide 20: Our track record of major licensing transactions
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Our track record of major licensing transactions speaks for itself… Income from licensing provides a great source of non-dilutive financing to support our growth Balance of potential milestone income from Top 15 pharmaceutica
Slide 21: Hundreds of millions received, billions in potential milestones
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX … hundreds of millions of dollars received, billions of dollars in potential milestones to come New collaboration and exclusive option to license agreement recently executed with Boehringer Ingelheim Upfront and Initial Poten
Slide 22: Our NxWave Platform
Our NxWaveTM Platform Cutting-edge Science 04
Slide 23: NxWave platform is focussed on drugging GPCRs
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX NxWave platform is focussed on drugging GPCRs GPCRs are the largest family of drug discovery targets – comprising 1/3 of all FDA approved drugs ~400 GPCR targets in the body active in disease2 ~400 NEUROLOGICAL DISORDERS GPCR
Slide 24: NxWave enables faster, cheaper, more precise drug discovery
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX NxWave platform enables faster, cheaper and more precise drug discovery World-leading science and platform enables efficient drug discovery against difficult targets Conventional drug discovery Our drug discovery Approach Emp
Slide 25: Our platform enables design of precise GPCR models
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX Our platform enables to design precise GPCR models Only by performing detailed structural analysis can we design great drugs. Imprecise GPCR model: Standard Medicine Precise GPCR model: Optimized Medicine Poorly understood GP
Slide 26: NxWave more productive than conventional approaches
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS APPENDIX NxWave platform has proven to be more productive than conventional approaches Trends in the number of programs per stage (cumulative)* Number of programs* 2022 vs 2023 40 2022 2023 35 Lead optimization Drug discovery 20+ 20+
Slide 27: Exposed to the fastest growing areas of medicine
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 M4 • Opti
Slide 28: Financial Results
Pedncial Results Q ~~ ~~ Ss
Slide 29: Financial summary for 1H FY2024
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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. Revenue
Slide 30: Key financial indicators
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 development milest
Slide 31: Breakdown of 1H 2024 result
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 (JPY milli
Slide 32: Full year cost guidance
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 ◼ Inclusion of
Slide 33: Appendix
Appendix 06
Slide 34: Japan will serve as our base to expand across APAC markets
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 market (e
Slide 35: Utilizing Japan's high quality clinical data
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 Environment D
Slide 36: PIVLAZ Phase 3 results
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 Event rate
Slide 37: Daridorexant – Global And Japan-Specific Program
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 GLOBAL PHAS
Slide 38: Cenerimod and Lucerastat
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 receptor modul
Slide 39: Exclusive Opt-in Rights And ROFN/ROFR
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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
Slide 40: Core Operating Profit - Definition
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 re
Slide 41: Estimation of potential market size
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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
Slide 42: Partnered pipeline (1/2)
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 43: Partnered pipeline (2/2)
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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
Slide 44: In-house pipeline
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE PLATFORM FINANCIALS 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 QUVIVIQTM Dual Orexin antagonist SME Insomnia NXE’149
Slide 45: Glossary
OVERVIEW STRATEGIC ROADMAP PRODUCT & PIPELINE 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 46: 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 46
Slide 47: Thank you
Thank you BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS ● BREAKTHROUGHS IN PROGRESS