H.u.group Holdings, Inc. · TSE:4544
H.u.group — Investor Day (December 2023)
36 slides from H.u.group's investor day presentation, Dec 1, 2023
Slide 1: IVD Business: Progress of R&D Activities and CDMO Business
IR Session 2023 IVD Business Progress of R&D Activities and CDMO Business (Neuro/Alzheimer and Ultrasensitive Detection Technology) December 1st, 2023
Slide 2: Agenda
Agenda H.U. Group Holdings, Inc., Executive Officer (IVD) (1) Progress of IVD Business Strategy Fujirebio Holdings, Inc., President and CEO (Overview) Goki Ishikawa Fujirebio Holdings, Inc., Board Member (Neuro Business) Fujirebio Europe NV, CEO (2) R&D Activities and CDMO Business Christiaan De Wil
Slide 3: Progress of IVD Business Strategy (Overview)
Progress of IVD Business Strategy (Overview) H.U. Group Holdings, Inc., Executive Officer (IVD) Fujirebio Holdings, Inc., President and CEO Goki Ishikawa 2
Slide 4: Progress of Strategy (Overview)
Progress of Strategy (Overview) CDMO agreements 15% Base Revenue for contract development spend on R&D activities and manufacturing • Focus on Immunoassay with IVD players having immunoassay Supply to Develop Global R&D Team、 analyzer installed base Global market New Contents 300+ members in JPN/EU/
Slide 5: ADx and Fluxus successfully integrated into the group
ADx and Fluxus successfully integrated into the group ADx creates tailor-made antibodies and assays in the Neuro field. Fluxus develops Ultrasensitive Detection Technology based platform. • No employees left the company because of acquisition. • R&D teams across entities are collaborating day-to-day
Slide 6: Our Approaches
Our Approaches Life Science / RUO market In Vitro Diagnostics Market Pharma and Research institutions etc. Medical institutions etc. LUMIPULSE Speed-up the expansion of Neuro Regulatory applications for selected markers markers line-up. (e.g. FDA) • Subsidiaries experienced in regulatory affairs (Cl
Slide 7: Progress of KPI: Accumulated # of Markers (Reagent)
Progress of KPI：Accumulated # of Markers (Reagent) Global Partners Regional Partners # of # of In development Development completed In development Development completed Markers Markers 60 54 60 49 50 47 50 45 45 42 40 26 40 30 31 26 30 25 30 17 45 20 20 28 10 18 10 19 17 17 17 0 0 2019 2020 2021 202
Slide 8: Growth scenario Post-COVID
Growth scenario Post-COVID Revenue growth in IVD business “Base business” will continue to grow steadily ■: Base business CAGR • “Base business” excluding COVID MSD has grown by +6.5%/year since FY2019 □: COVID • Aiming at continuous Mid-Single Digit growth CAGR +6.5% CDMO will lead our growth in mi
Slide 9: R&D Activities and CDMO Business in Neuro/Alzheimer field
R&D Activities and CDMO Business in Neuro/Alzheimer field Fujirebio Holdings, Inc., Board Member (Neuro Business) Fujirebio Europe NV, CEO Christiaan De Wilde ADx NeuroSciences, CEO Koen Dewaele 8
Slide 10: Presenters
Presenters Board Member, Fujirebio Holdings Inc. Fujirebio Europe NV, CEO ADx NeuroSciences, CEO Christiaan De Wilde Koen Dewaele • 15+yrs, J&J/Janssen Pharmaceuticals • 35+yrs, in In Vitro Diagnostic business • CFO, Janssen-Cilag Belux • 10+yrs, Innogenetics • CEO, Innogenetics/Fujirebio Europe (20
Slide 11: Alzheimer's Disease Pathology
Alzheimer’s Disease Pathology Source: Le Bastard et al., 2009 Micro CML-Neurology A. Amyloid plaques identified in the hippocampus with 4G8 immunohistochemistry (40x) B. Neurofibrillary tangles identified in the hippocampus with NFT200 immunohistochemistry (100x) A. Normal brain Macro B. Atrophic br
Slide 12: History of Alzheimer's Diagnosis
History of Alzheimer’s Diagnosis Innogenetics (Fujirebio Europe) ADx NeuroSciences Source: https://doi.org/10.1152/physrev.00015.2020 11
Slide 13: Biomarker changes during the disease process
Biomarker changes during the disease process Source: https://doi.org/10.3390/biomedicines10040850 12
Slide 14: Trends in Neurobiomarker Testing
Trends in Neurobiomarker Testing Early Detection From CSF to Blood Ultrasensitive 13
Slide 15: Effective therapies will need specific biomarkers
Effective therapies will need specific biomarkers Up to 20 years to clinical AD Disease progression Clinical AD Clinical Asymptomatic Prodromal Mild Moderate Severe Stage preclinical AD AD AD AD AD Progressive Brain Pathology Inflammation, protein abnormalities, neuronal loss, synapse loss Future Th
Slide 16: Specific biomarkers for neurodegeneration
Specific biomarkers for neurodegeneration Up to 20 years to clinical AD Disease progression Clinical AD Clinical Asymptomatic Prodromal Mild Moderate Severe Stage preclinical AD AD AD AD AD Progressive Brain Pathology Inflammation, protein abnormalities, neuronal loss, synapse loss Tau (total), BD T
Slide 17: Neuro – Fujirebio Assay Development Road Map
Neuro – Fujirebio Assay Development Road Map FY FY FY FY 2021 2022 2023 2024 RUO Launch RUO Launch RUO Launch • Plasma • CSF Neurofilament • Plasma Amyloid Beta 1-42 Light (NfL) pTau217 RUO • Plasma • Plasma Neurofilament Amyloid Beta 1-40 Light (NfL) • Plasma pTau181 • Plasma ApoE4 • Plasma Pan Apo
Slide 18: Publications - Broad International Scientific Coverage
Publications - Broad International Scientific Coverage > 25 Posters on international conferences > 15 Peer reviewed scientific articles > 10 Oral presentations on international conferences 17 Period Jul 2022- Nov 2023
Slide 19: LUMIPULSE Assay Performance, Sant Pau, Barcelona
LUMIPULSE Assay Performance Sant Pau, Barcelona, Spain (pTau 217, pTau181, Aβ1-42 and Aβ1-40) Study principle Study set-up • Plasma samples selection from the clinic 20 A-T- cognitively healthy 30 A+T+ prodromal AD (Mild Cognitive Impairment) 20 A-T- non-neurodegenerative MCI (MCI not linked to AD o
Slide 20: LUMIPULSE Assay Performance, Sant Pau, Barcelona
LUMIPULSE Assay Performance Sant Pau, Barcelona, Spain (pTau 217, pTau181, Aβ1-42 and Aβ1-40) Ability LMP assays to categorize samples correctly Clinical performance LMP assays by AUC by Area Under the Curve (AUC) (A+ vs A- samples) → Amyloid positive (A+) from Amyloid negative (A-) → Amyloid positi
Slide 21: Fujirebio's Value Story
Fujirebio’s Value Story Pharma Clinical Pre-Clinical FDA Drug Launch Process Phase I / II / III What’s • Novel • Exploratory • Biomarkers for necessary Drug Modifying biomarker trials Clinical use Therapy (DMT) Candidates • Novel biomarkers Fujirebio’s • New biomarker • Develop and supply reagents •
Slide 22: SUMMARY
SUMMARY • There is huge portfolio of neurodegenerative disease biomarkers • We will expand our biomarker portfolio from Amyloid Beta, pTau, NfL etc. • Fujirebio aims to develop novel biomarkers on a robust system, LUMIPULSE Since 2021, we are successful in developing and registering new markers • Fu
Slide 23: Ultrasensitive Detection Technology and CDMO Business
Ultrasensitive Detection Technology and CDMO Business Fujirebio Holdings, Inc., Board Member (R&D) Katsumi Aoyagi Ph.D. Fluxus Inc., CEO Peter Wagner Ph.D. 22
Slide 24: Presenters
Presenters Board Member, Fujirebio Holdings Inc. Managing Director, Fujirebio, Inc. Fluxus Inc., CEO Katsumi Aoyagi Ph.D. Peter Wagner Ph.D. • Ph.D.（Tohoku University） • 26+yrs experience in Life Science tools and IVD • CEO, Advanced Life Science Institute, Inc. (2017~) • Founder and CEO, Zyomyx Inc
Slide 25: Fluxus Ultrasensitive Detection Technology
Fluxus Ultrasensitive Detection Technology • Fluxus, located in Silicon Valley, California, co- developed Ultrasensitive Detection technologies with Fujirebio for the past 6 years. • Fluxus was acquired by Fujirebio HD in July 2022. • At IR Day 2022, Fluxus was announced with the promise of launchin
Slide 26: Fujirebio Ultrasensitive Analyzer powered by Fluxus Technology
Fujirebio Ultrasensitive Analyzer powered by Fluxus Technology • Fully Automated: Walk-away sample-to-answer processing • Ultrasensitive: Integrated UDM detection system for single-molecule counting • Efficient: Up to 48 assays per batch run, multiple formats in parallel • Flexible: Accommodates a w
Slide 27: Why Ultrasensitivity?
Why Ultrasensitivity? • Conventional immunoassay methods have reached their limits of sensitivity and dynamic range. • Market demand for ultrasensitive technologies is increasing - particularly in neurology infectious disease, and oncology testing. • Higher sensitivity enables: • New clinical utilit
Slide 28: Fluxus Technology – Key Components
Fluxus Technology – Key Components • Universal Detection Module (UDM) • Optofluidic Cartridges • High Performance Reagents & Assays • Data Analysis Algorithms • Ultrasensitive Analyzer (RUO) 27
Slide 29: Universal Detection Module (UDM)
Universal Detection Module (UDM) • Single molecule detection • Incorporates replaceable optofluidic UDM Cartridge • Sample injection with automated pipettor • Small footprint for integration into any system • Stackable to accommodate any throughput: 1x ~ 60 tests/hour 2x ~ 120 tests/hour 3x ~ 180 te
Slide 30: Assays Incorporate Fluxus and Fujirebio Components
Assays Incorporate Fluxus and Fujirebio Components Fujirebio Reagents • Industry leader in the identification and supply of novel antibodies Fluxus Reporter • Proprietary fluorescent dye- carrier construct • Conjugated to detection Single Test Cartridges antibody • Same concept as LUMIPULSE G1200 •
Slide 31: Easy Adaptation of Pre-Existing Assays
Easy Adaptation of Pre-Existing Assays Existing Immunoassay + Fluxus Reporter + UDM Single Molecule Detection 30
Slide 32: Typical Analytical Performance Data
Typical Analytical Performance Data Detection Sensitivity and Dynamic Range 1 nM 100 pM • Linearity: 100 aM ~ 1 nM 10 pM • Sensitivity: < 100 aM Measurement value Digital detection 1 pM 100 fM Analog detection • Dynamic range : > 7 Logs Potentially > 9 Logs 10 fM 1 fM < 100 aM - 100 nM 100 aM 100 aM
Slide 33: Performance Comparison Alpha-Version of New Analyzer vs LUMIPULSE
Performance Comparison Alpha-Version of New Analyzer vs LUMIPULSE Typical example: IL-6 Assay Detector performance using only measurement of diluted reporter conjugate (no immunoassay) Approx. 128- folds Approx. 125-folds >1,000 folds The new platform detector demonstrated the potential for more tha
Slide 34: Future Roadmap
Future Roadmap Launch RUO Analyzer and expand menu line-up (Neuro, Infectious diseases, Oncology etc.) Bring to IVD (Analyzer and selected markers) Licensing-out technology to be used for CDMO partner’s next-generation immunoassay platform + + 33
Slide 35: SUMMARY
SUMMARY • Fujirebio believes Ultrasensitive Detection will add huge clinical benefit for selected markers in immunoassay field. • Fluxus has been developing the Ultrasensitive Detection system since 2017, through partnership with Fujirebio, with the intent to include in Fujirebio’s future immunoassa
Slide 36: QUESTIONS?
QUESTIONS? 35