Orgenesis Inc. · OTC:ORGS
Orgenesis — Investor Presentation (October 2018)
28 slides from Orgenesis's investor presentation, Oct 29, 2018
Slide 1: Leading the Revolution in Regenerative Cellular Therapy
( =} orgenesis” Leading the Revolution in Regenerative Cellular Therapy NASDAQ: ORGS October 2018
Slide 2: Forward Looking Statements
Forward Looking Statements This Presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking reflect management's current expectations and assumptions, as of the date of this Presentation, and involve certain risks and u
Slide 3: Investment Highlights
Investment Highlights v Regenerative medicine industry growth estimated from $26.7bn USD in 2018 to $150bn USD in 2025* © Anticipated global manufacturing shortage as the cell therapy industry scales up v New point-of-care (POCare) model; establishing a global network of leading healthcare facilitie
Slide 4: Orgenesis' vision
Orgenesis’ vision Provide the pathway for Advanced Therapy Medicinal Products (ATMP) from research to patients worldwide
Slide 5: Orgenesis - Overview
Orgenesis - Overview Multi-pronged strategy - vertically integrated service and research company within the Regenerative Medicine Industry, focusing on cell therapy development and manufacturing Manufacturing & development services Development of own proprietary cell therapies for world’s leading bi
Slide 6: Regenerative Medicine Industry - Expansion
Regenerative Medicine Industry - Expansion Early stage development candidates represent near-term opportunity in rapidly growing cell therapy market Estimated Global Regenerative Medicine Market Global Regenerative Medicine Clinical Trials 1 Global market volume [USD br] Gene Therapy 160 Global annu
Slide 7: In-house Versus Contract Manufacturing
In-house Versus Contract Manufacturing Estimated cell therapy manufacturers by type = Contract Manufacturing CAGR bias 44.9% 967 CAGR 41.95%, 182 CAGR 40.8% ret a 225 2 1716 1 104 a 6 i és 764 me i 2017 2018 2019 2020 2021 2022 2023 2024 2028 2028 2027 In-house Manufacturing @ orgenesis” ‘Source: Ro
Slide 8: Cell Therapy Manufacturing Market
Cell Therapy Manufacturing Market Manufacturing market is estimated at $86m in 2017 and forecasted to reach $4bn by 2027 Estimated cell therapy manufacturing market, by region $m CAGR US meEU = Asia RoW 300 46.15% 46.26% 305 230 40.73% 1296) 1024 fer) 40.66% 988 49 6) mm 4B ioe 78 95 Ome 2:7 i 2017
Slide 9: Masthercell Global - Representative Customers
Masthercell Global - Representative Customers ine MM Adzotimmune Each customer represents a potential significant : revenue/growth opportunity upon regulatory = apioval “— v Manufacturing cos/CDMO revenues range per patient: Estimated $10,000 - $50,000 sae IN ¥ Cell manufacturing profits may equal o
Slide 10: Masthercell Global MaSTherCell
Masthercell Global MaSTherCell Monufochaira Syreiges or Thetapeuts Oo Our Masthercell subsidiary is a global leader in the CDMO market: among the best known and most highly trusted CDMOs worldwide Market recognition & positioning of Orgenesis CDMO Masthercell /ey results Great Point Partners, a lead
Slide 11: Advanced Therapy Medicinal Products (ATMPs)
Advanced Therapy Medicinal Products (ATMPs) Innovative medicines leveraging cell and gene-based approaches to treat diseases ATMPs } t 1 STMPs GTMPs TEPs Combined ATMPs | | |___Friecicaaeve |_f component Somatic Cell Therapy | GeneticallyModified Tissue Engineered Combined Advanced Medicinal Product
Slide 12: How Do We Categorize These Therapies? Treatment / Drug
How Do We Categorize These Therapies? Treatment / Drug B orgenesis
Slide 13: Regenerative Medicine Industry Challenges and Orgenesis' Solution
Regenerative Medicine Industry Challenges and Orgenesis’ Solution POCare R&D Collaboration Challenges 1 Manufacturing technology lacking behind No defined commercial pathway No industrial and distribution infrastructure Disconnect between hospitals and industry Orgenesis’ solution * Apply industrial
Slide 14: Hospital based collaboration model POCare
Hospital based collaboration model POCare Decentralized model for ATMP development and supply Goal: Leverage IP, technical and manufacturing expertise to allow a closed system manufacturing approach for our development stage products. How: Setting up a network of leading healthcare facilities with i
Slide 15: Basis for Hospital R&D Collaborations
Basis for Hospital R&D Collaborations Unique mix of competencies and proprietary technology Four Pillars of Point of Care Model Unique Know-How + QC assays development + Industrial processes + Operational excellence + Process development and ‘optimization + Quality management system + Regulatory exp
Slide 16: Core activities and capabilities of Orgenesis
Core activities and capabilities of Orgenesis Therapy development @O ot + Industry 4.0 solutions 7 i ” Blockchain Core R&D and e Advisory board + Increasing productivity (3) technology + Strong support from ondiredieimn cots + Proprietary data solutions capabilities Intemational KOLs + Empowering cl
Slide 17: Orgenesis Closed Production Systems
Orgenesis Closed Production Systems witoe seraed presented in aiterent presentatin > Production costs Level of automation p. 18‘ generation closed systems (expected Q1 2020) The core product will be a closed POCare production system for different types of cells: ¥ [immune system cells — NK /T/ CarT
Slide 18: Transforming Immuno-Oncology Treatment Costs
Transforming Immuno-Oncology Treatment Costs High costs of product of ~$300k are considered the main obstacle for cell therapies - An efficient POCare system could potentially lower cost to ~$30k Costs of conventional manufacturing vs. automated POCare production Rationale + With new and state of th
Slide 19: Proprietary Platform for Autologous Trans-differentiation
Proprietary Platform for Autologous Trans-differentiation Process by which an adult cell is converted into another type of cell with distinct phenotype and function Pancreatic Transcription Factors * Utilizes the patient's own cells ©@ orgenesis Pancreatic Hormones Producing Cells Advantages of Tran
Slide 20: Therapeutic Pipeline: Autologous Insulin Producing (AIP) cells
Therapeutic Pipeline: Autologous Insulin Producing ("AIP") cells + The first indication for the Company's unique cell-based therapy, was development of Autologous Insulin Producing ("AIP") cells * Potential “practical cure” for insulin dependent diabetes * Transforms the patient's own liver cell int
Slide 21: First Indication for AIP: Pancreatectomy (Orphan Drug Indication)
First Indication for AIP: Pancreatectomy (Orphan Drug Indication) + The first indication for AIP cells is for the treatment of severe diabetes following Total Pancreatectomy (TP), an orphan drug indication + Patients with Diabetes of the Exocrine Pancreas (DEP) have an underlying disease of the panc
Slide 22: In-Licensing Technologies
In-Licensing Technologies Advanced hematopoietic chimeras (AHC) Human Postnatal Hemogenic Endothelial (Hu-PHEC) technology + Acell replacement product candidate that is being designed to generate cancer-free, patient-matched blood stem cells after transplantation into the patient. + New type of huma
Slide 23: Establishing Global Network
Establishing Global Network Growing global network throughout North America, Europe, Asia and Middle East North America @ orgenesis”
Slide 24: Financial Results
Financial Results Fiscal Q3 2018 financial highlights include: o Revenue increased 143% to $6.2M o Gross profit increased 316% to $2.9M o Gross margin increased to 46.4% versus 27.1% o CDMO segment recorded an operating profit of $2.1M o Ended quarter with $16.7M of cash and approximately $32.5M of
Slide 25: Senior Management Team
Senior Management Team Vered Caplan - President, Chief Executive Officer and Director. Vered Caplan has been the CEO since August 14, 2074, prior to which she was Interim President and CEO since December 23, 2013. Since 2008, Ms. Caplan has been Chief Executive Officer of Kamedis Ltd,, a company foc
Slide 26: Senior Management Team (cont.)
Senior Management Team (cont.) Dr. Ohad Karnieli (PhD, MBA) ~ General Manager Dr Kamiel is the founder of Atvio Biotech, a specialty cell and gene therapy automation and process development fim, part of the MaSTherCell global network. Dr, Kamieli earned his PhD in Biotechnology focusing on Cell & Ge
Slide 27: Investment Summary
Investment Summary v Regenerative medicine industry growth estimated from $26.7bn USD in 2018 to $150bn USD in 2025 © Anticipated global manufacturing shortage as the cell therapy industry scales up v New point-of-care (POCare) model; establishing a global network of leading healthcare facilities to
Slide 28: Orgenesis Inc
Orgenesis Inc Contact Us Vered Capian, CEO E-mail investor Relations: David Waldman Crescendo Communications, LLC Email: Tel: 212-671-1021 NASDAQ: ORGS ( = orgenesis”