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CSL Research - Investor Site Tour @ Bio21 Institute 30 April 2018

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CSL Research - Investor Site Tour @ Bio21 Institute 30 April 2018 CSL Research - Investor Site Tour @ Bio21 Institute 30 April 2018 CSL Research • Bio21 / Parkville, Marburg, Bern • Protein, gene & cell based therapies Specialty Breakthrough Immunoglobulins Haemophilia Transplantation Products Medicines • ~200 staff • Molecular Biology, Protein Biochemistry, Cell Biology & Physiology, Bioinformatics, Research & Clinical Analytics, Pharm/Tox Plasma Protein Science & Discovery 2 | Driven by Our Promise™ Global Hub for Research & Translational Medicine • New laboratories being constructed on the Bio21 site, 3628m2 • CSL space from 1470m2 to 3500m2 • Capacity to increase from 75 FTE’s to 165 (relocation from PKV) • University of Melbourne to fund construction • CSL to fund fit-out of CSL space • Construction commenced Q3 2016 with fit-out completed Q3 2018 3 | Driven by Our Promise™ Melbourne / Parkville Biomedical Precinct • a CSL competitive advantage Bio21 CSL 4 | Driven by Our Promise™ Melbourne / Parkville Biomedical Precinct • a CSL competitive advantage Melb. University Royal Melb. Florey Inst. Medical School Hospital Neuroscience Doherty Inst. Immunol. Microbiol Aust. Genomics Research Facility Victorian Comprehensive Cancer Centre Peter Mac WEHI Bio21 Cancer Inst. Women’s Hospital Royal Children's Murdoch Research Hospital Institute 5 | Driven by Our Promise™ WEHI / CSL Bioinformatics Alliance WEHI - world leaders in bioinformatic software development • By research specialty - differential expression - regulation of gene expression - cancer genome analysis - statistical genetics - molecular epidemiology • By technology - DNA-seq, RNA-seq (population and single cell), ChIP-seq, Microarray • By disease area - cancer, auto-immune diseases, neurological disorders, malaria • By people - 9 computational labs - ~ 90 computational researchers (including post-docs, RAs and students) - underpinned by strong, ongoing investment in IT support and infrastructure 6 | Driven by Our Promise™ CSL Research New development Research & Clinical opportunities to SG2 Bioanalytics Develop SG1 Add value to existing opportunities, CSL product portfolio: monitor threats new indications Early Clinical Development Pharmacology / toxicology package supporting SG3 7 | Driven by Our Promise™ MRCF BTF • Partnership with Brandon Capital • Medical Research Commercialisation Fund Network • $200M MRCF3 and $230M MRCF BTF • Four super funds, CSL and the Aus Govt (BTF only) The new fund is a partnership between the Federal government and the private sector. 8 | Driven by Our Promise™ Australian R&D Pipeline Model CSL Global Hub for Research & Translational Medicine Aus Strategic Partnerships CSL Research CSL Development CSLCommercial Portfolio Pipeline Centenary Fellowship Program MRI Aus Network NPOs MRCF3 BTF • $200m fund • $230m • Early stage assets • Ph 1 – 2b studies New Australian Biotech Companies The new fund is a partnership between the Federal government and the private sector. 9 Early Development Pipeline Examples PI A Ph II G-CSF Antagonist Ph III Reg Launch/Post Registration PI B Ph II (CSL324) Ph III Reg Launch/Post Registration PI C Ph II PI Ph II Ph III Clinical Reg Launch/Post Registration FXIIa Antagonist Ph III LT Safety (CSL312) Ph I Ph II Ph III Reg Launch/Post Registration VEGF-B Antagonist Ph I Ph II Ph III Reg Launch/Post Reg (CSL346) Ph I Ph II Ph III Reg Launch/Post Reg Anti-Beta Common Ph II (CSL311) Ph III Reg Launch/Post Reg Ph II rD’D3-FP Tox Ph I POC Ph I/III Reg Launch/Post Registration (CSL 626) 10 Ph II cITP Ph III cITP Reg Launch/Post Registration CSL730/M230 rFC Ph I Ph II Neuro Ph III Launch/Post Registration Ph II TBD Reg 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 | Driven by Our Promise™ CSL312 Targeting Factor XIIa for HAE and other indications 11 | Driven by Our Promise™ Hereditary Angiodema • Hereditary angioedema (HAE) is a disorder that results in recurrent attacks of severe swelling • All body sites are associated with impairment and patients are impacted during and between attacks • Most severe are laryngeal attacks which can require emergency interventions to protect the airway Berinert – intravenous, on-demand HAEGARDA – subcutaneous, prophylactic (2x/week) CSL312 – subcutaneous, prophylactic (1x/2 weeks, 1x/month?) 12 | Driven by Our Promise™ CSL312 – targeting FXII Clot occluding FXII activation ECMO system HAE attack Damaged / negatively charged surface CSL312 FXII FXIIa Heparin C1-INH PK → KAL FXI FXIa Hereditary Angioedema C1 INH FIX etc. HK → BK→ BR2 Thrombosis Hemostasis Vasodilation Heparin induced bleeding | Driven by Our Promise™ CSL312 – targeting FXII for HAE Percutaneous anaphylaxis, a mouse model of HAE • anti-FXIIa mAb inhibits edema * ** *** 120 *** Ctrl CSL312 – Fully human mAb 100 targeting Factor XIIa S 80 B P f 60 o % 40 20 ANTI- 0 FXIIa 0.5 0.5 0.2 0.1 0.05 mg BM4 3F7 14 | Driven by Our Promise™ CSL312 – targeting FXII for HAE • CSL312 inhibits Factor XIIa activity in human plasma Healthy Donors (n=10) HAE Type I (n=2 pts) ) ) 3 4 5 5 0 0 4 4 HAE #1 + Dex D D 3 O O ( ( HAE #2 + Dex 2 y y t t i i v v i i t t 2 c c a a a a I I I I 1 X X 1 r r HAE #1 - Dex o o t t c c HAE #2 - Dex a a F F 0 0 0 5 4 4 2 7 .1 .3 0 0 0 5 4 4 2 7 .1 .3 0 0 0 1 .0 .1 .3 1 3 1 3 0 1 .0 .1 .3 1 3 1 3 .0 .0 0 0 0 .0 .0 0 0 0 0 0 0 0 VR115 (ug/mL) VR115 (ug/mL) 15 | Driven by Our Promise™ CSL312 – targeting FXII for HAE A Phase I FIH Single Ascending Dose Study Cohort IV5 10 mg/kg Cohort IV4 3 mg/kg Cohort IV3 Cohort SC3 1 mg/kg 10 mg/kg Cohort IV2 0.3 mg/kg Cohort SC2 Cohort IV1 3 mg/kg 0.1 mg/kg Cohort SC1 1 mg/kg SRC safety review • Randomised, double blind, placebo controlled • 48 healthy male subjects • 4 active subjects and 2 placebo subjects per cohort • Successfully completed, Phase II planning in progress 16 | Driven by Our Promise™ CSL312 – targeting FXII for ECMO Clot occluding ECMO system RCH ECMO Collaboration • Translational science collaboration (Prof. Monagle) Part 1. Evaluation of plasma from healthy children. Part 2. Evaluation of plasma from children on ECMO Part 3. Evaluation of plasma from children on CPB Heparin FXII and the kallikrein-kinin system in infants on ECMO, bradykinin production, FXII antigen levels, FXII activity and CSL312 inhibitory potential Heparin induced bleeding 17 | Driven by Our Promise™ CSL Gene Therapy Strategy for Calimmune Technology 18 | Driven by Our Promise™ Calimmune GT Technologies Expertise/Know-how In vivo Selection Tool Cell Processing Lenti Manufacturing VECTOR DESIGN SELECT+TM PROPRIETARY METHODS CYTEGRITYTM Genetic cassette to Novel SOPs to achieve Ability to design and render stem cells Only large-scale, stable high cell yields and make efficient protected against purine vector production system standardization of cell therapeutic vectors analogues to drive in-vivo used clinically product selection 19 | Driven by Our Promise™ Select+ Reduces conditioning, increases engraftment and enables out-patient treatment Hypoxanthine- guanine phosphoribosyltran sferase (HPRT) knockout to confer resistance to 6- Thioguanine (6TG) EX VIVO IN VIVO Stem Cell Gene Therapy Select+ Treatment setting 14-21 Day Hospitalisation Outpatient Scalability Limited Scalable Conditioning Higher toxic dose Reduced intensity Engraftment Inconsistent Ability to drive engraftment Reproductive Impact Causes sterility and infertility None at anticipated dose Post-infusion Selection No Yes, including re-dosing 20 | Driven by Our Promise™ Copyright © 2016 Calimmune, Inc. Sickle Cell Disease (SCD) • SCD results from a single point mutation in the b-globin gene • Hb tetramers (HbS) polymerise and deform the RBC shape (“sickle shape”) • Sickle RBCs obstruct blood flow causing vaso-oclusive crisis and pain • Can be overcome by expression of fetal g-globin Epidemiology and Health care costs of SCD 4.4 million incidence, most common in sub- Saharan Africa but SCD has a global footprint Estimated 100,000 people in US have SCD ~1500/yr born in US (mandatory screening) >$1.8b US medical costs annually >$1m lifetime cost to patient in US 21 | Driven by Our Promise™ Gene Therapy for Sickle Cell Disease CSL’s approach using CAL-H Post Infusion Mild 6-TG Myeloablation (+ selection) Cell Apheresis Infusion SCD patient CSL200 HSCs CAL-H CELL MANUFACTUING (IN VITRO) 22 | Driven by Our Promise™ Opportunities for Select+ Haemophilia SCD ADA-SCID Haematology b-Thalasemia WAS Fanconi Anemia CGD Diamond Black Severe Congenital Fan Anemia Neutropenia Muscular Immunology Neurology Dystrophies Lysosomal Storage Diseases ALS Friedrich’s Ataxia Spinal Muscular Haematopoietic Atrophy Stem Cell Transplant Transplant 23 | Driven by Our Promise™ CSL Behring Operations Investor Tour 30-April 2018 Val Romberg, EVP Manufacturing Operations and Planning Legal Notice Forward looking statements The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL Limited and its related bodies corporate (CSL) financial results and estimates, business prospects and products in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Factors that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestments; research collaborations; litigation or government investigations, and CSL’s ability to protect its patents and other intellectual property.
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