Slide 1: CSL European Investor Site Tour Presentations
For personal use only For immediate release 28 March 2023 CSL European Investor Site Tour Presentations The presentation materials to be used for an Investor Site Tour being conducted by CSL (ASX:CSL; USOTC:CSLLY) in Europe this week are attached for the information of investors. Authorised By Fiona
Slide 2: Investor Tour, CSL Behring/Vifor European Operations
For personal use only Investor Tour, CSL Behring/Vifor European Operations March 2023
Slide 3: Important Notice and Disclaimer
For personal use only IMPORTANT NOTICE AND DISCLAIMER This presentation contains summary information about CSL Limited (ACN 051 588 348) and its related bodies corporate (together, CSL) and CSL's activities as at the date of this presentation. It is information given in summary form only and does no
Slide 4: Building an integrated, world-class manufacturing network
CSL is expanding our capabilities by building an integrated, world- class network of internal sites as well as contract manufacturers, with focus on Reliability, Quality, Cost, Innovation and Safety For personal use only Key CMO Partners Abbvie Fresenius Kabi Alphasigma Thermo Fisher Corden UniQure
Slide 5: CSL Behring Manufacturing Sites
CSL Behring Manufacturing Sites For personal use only Bern, Switzerland (1,800+ employees) Kankakee, US (1,500+ employees) Products: Immunoglobulins (IG), Albumin anti-D-hyperimmune, Products: Albumin, IG intermediate paste, Coagulation factors, potential CSL112 alpha1-proteinase inhibitor, PCC & C1
Slide 6: Donor to Patient
Donor to Patient Collection Testing Logistics Manufacturing For personal use only IMED Exchange Key Products Fraction V Paste Fractionation IV Paste (CSL 112) Privigen Precipitate C Paste Alburex I+II+III Paste / II+III Paste Precipitate A Hizentra Indianapolis, IN Bern … II+II+III Paste Bern I+III
Slide 7: CSL Behring Operating Model
CSL Behring Operating Model For personal use only Value Stream Value Stream Value Stream Value Stream Bulk and Base Frac Fill Finish Packaging recombinant Quality Engineering & Maintenance Site Logistics and support Planning 6
Slide 8: Tier Meeting Cascade & Reliability Room
Tier Meeting Cascade & Reliability Room For personal use only We are driving transparency, action and accountability across the CSL Behring business unit through our tier escalation process. The regular Tier Meetings are focused on operational performance review and escalations with a strong focus o
Slide 9: Operational Highlights
For personal use only Operational Highlights Manufacturing • Broadmeadows and Marburg new base fractionation facilities licensed and operational • Continued investment in short and long term yield/capacity initiatives: − Albumin in Broadmeadows − IgG in Bern Plasma Collections 1H23 • Strong increase
Slide 10: Network Strategy
For personal use only Network Asset Financial & Risk Capacity Management Resource Management Optimization Our focus on Network Strategy ensures both a resilient and reliable Supply Chain 9
Slide 11: Network Resiliency
Network Resiliency Ensuring safe, reliable product supply for our patients For personal use only across a complex, global supply chain. Plasma Fractionation • Optimizing annual center • Adding right-time capacity and expansions to align with IG balancing risk demand & yield forecasts. • Optimizing s
Slide 12: CSL has continued to execute against our growth strategy
CSL has continued to execute against our growth strategy For personal use only Marburg Broadmeadows Bern Fractionation Capacity Fractionation Capacity Immunoglobulin Capacity Superb execution by the project teams enabled approval of Marburg and Broadmeadows fractionation projects via a CBE-30 in the
Slide 13: Key CSL Behring Capital Projects
Key CSL Behring Capital Projects CSL conducts annual Long-Term Demand & Capacity For personal use only Forecasts to ensure optimal timing for CapEx projects Technology Fractionation • Rika Device Rollout • Marburg & Broadmeadows • Optimizing Spend • New Quality Management Production Ramp In Progress
Slide 14: Annual CapEx Investment
Annual CapEx Investment* Network Strategy & Portfolio Management continue to For personal use only focus on optimization of CapEx spend $Billion USD 1.40 1.37 • Optimizing Spend 1.29 1.08 1.10 • Maximizing ROIC 1.00 0.28 0.86 (25%) • Balancing Risk 0.57 0.41 0.82 (75%) • Leveraging CMOs • Ensuring G
Slide 15: Enterprise Wide Quality Framework
Enterprise Wide Quality Framework For personal use only ➢ A standardized, and compliant Quality Management System (QMS) for all CSL Limited businesses ➢ Provides CSL standards across the CSL network aligned with regulatory requirements ➢ Provides consistency towards regulators and authorities visiti
Slide 16: Quality Facts and Figures FY22
Quality Facts and Figures FY22 For personal use only ➢ CSL was subject to 406 good manufacturing practice (GMP) regulatory agency inspections around the world with no impact to our licenses ➢ 28 inspections of our manufacturing facilities ➢ 378 inspections of CSL Plasma centers ➢ CSL performed 676 Q
Slide 17: Quality Culture & Continuous Improvement
Quality Culture & Continuous Improvement For personal use only Investments in Quality: State of the art automation in manufacturing & laboratories Equipment and facilities to meet new sterile product regulations Modernized training assets for our plasma centers 16
Slide 18: Our 2030 Strategy in Words
Our 2030 Strategy in 4 Words: For personal use only Driving Sustainable, Profitable Growth 1. Focusing – in therapeutic areas where we excel 2. Innovating – across our organization 3. Delivering – reliable supplies of our products as efficiently as possible 4. Growing – our pipeline with sustainable
Slide 19: Biopharma in the Heart of the Capital
For personal use only Biopharma in the Heart of the Capital 2023
Slide 20: For personal use only
For personal use only 2 | External Use
Slide 21: Welcome to Bern!
For personal use only 3 02 Welcome to Bern!
Slide 22: Our Pioneering on the Bern Site
Our Pioneering on the Bern Site For personal use only 4 | Confidential – Internal Use Only
Slide 23: Functions in Bern
Functions in Bern For personal use only Commercial R&D Enabling E2E Operations Operations Functions Fractionation Commercial Operations CSL Behring Biologics Finance Bulk Intercontinental Research Center I&T Filling & Visual (sitem-insel) HR Inspection Commercial Operations Legal Packaging Switzerla
Slide 24: Our People
Our People For personal use only Diverse Workforce Talents & Culture • 1800 employees: • Early career concept • 39% women / 61% men • 40 apprentices, trainees and internships • 65 nationalities • Gender equality • 8.7 years of average tenure • Equal pay certification • 43 years of average age 6
Slide 25: Bern Leading Sustainable Technology to Reduce Environmental Impact
Bern Leading Sustainable Technology to Reduce Environmental Impact For personal use only • Since 2016, we have savings of about 6,000 MWh of energy and about 1,000 tons of CO2. This corresponds to 9% energy and 11% CO2 savings compared to 2015. • We have been using electricity exclusively from hydro
Slide 26: Products Bern
For personal use only 8 04 Products Bern
Slide 27: Product Portfolio CSL Behring – Northern Hemisphere
Product Portfolio CSL Behring – Northern Hemisphere For personal use only Critical Care Immunology Coagulation Albumin Solutions Polyvalent Immunoglobulins Plasma-derived factor II Human Albumin Behring® Privigen® Human Thrombin a.s. Alburex®, AlbuRx®, Albumex ®, Hizentra® Recombinant factor VIII Al
Slide 28: Bern Products
Bern Products For personal use only Immunoglobulins Albumin CSL112 Privigen® Hizentra® Hizentra® PFS Rhophylac® Alburex® 5% Promotes cholesterol removal 25/50/100/200/400mL 5/10/20/50mL 5/10/20mL 2mL 100/250/500mL leading to plaque stabilization 3 years by +2 to +25°C 30 months by +2 to +25°C 30 mon
Slide 29: CSL Behring's Presence & Innovation in Bern
03 For personal use only CSL Behring’s Presence & Innovation in Bern 11
Slide 30: Facilities Site Bern
Facilites Site Bern For personal use only Value Stream Value Stream Value Stream Bulk Packaging Fractionation Value Stream Filling Fractionation (1 facility) Privigen / Hizentra (3 facilities) Filling (3 facilities) Packaging (1 facility) Albumin (1 facility) Pasteurisation / Incubation (1 facility
Slide 31: Investments
For personal use only 13 140 40 120 160 180 60 80 0 20 100 2000/01 2001/02 2002/03 2003/04 Investments 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 2017/18 2018/19 2019/20 2020/21 2021/22
Slide 32: Efficiency & Innovation
Efficiency & Innovation For personal use only IG Capacity Growth IgG • Project delivered, ahead of schedule, on budget • IgLAB Module V & VI IG capacity: More batches • Max capacity utilization demonstrated (14 batches per week) Bulk & Filling Capacity Increase • Upgrade existing Phase 3 CSL112 bulk
Slide 33: CSL R&D in Switzerland
CSL R&D in Switzerland For personal use only Plasma Product Development Global Regulatory Affairs GPS, CMC, BioProcess Sciences, BioAnalytical GRA CMC, GRA OpX, GRA GPS, GRA 300+ (500+) Science, Breakthrough Launchpad, Primary Policy & Intelligence R&D employees Packaging & Medical Devices Wankdorfs
Slide 34: R&D Cooperations
For personal use only 16 R&D Cooperations
Slide 35: Memberships & Community Commitments
Memberships & Community Commitments For personal use only 17
Slide 36: Thank you for your attention!
05 For personal use only Thank you for your attention! 18
Slide 37: Welcome to Marburg
For personal use only Welcome to Marburg Investor Tour 28 March 2023 Michael Schröder, Site Head Marburg The picture shows Kathrin Schön, one of our HAE patients
Slide 38: CSL Behring Marburg Operations Site Overview
For personal use only CSL Behring Marburg Operations Site Overview
Slide 39: Focus on Reliable Supply
Focus on Reliable Supply For personal use only 3
Slide 40: Marburg at a Glance
For personal use only 4 Marburg at a Glance
Slide 41: Behringwerke Campus
Behringwerke Campus H69 Filling/Packaging For personal use only Main Plant H68 Base Fractionation/ Bulk Plasma H67 Recombinant BDI 5
Slide 42: Behringwerke Campus
Behringwerke Campus M483/M486/M484 Warehouses For personal use only (operated by Pharmaserv) Görzhausen M305 Filling/Bulk Plasma M300 Bulk Plasma & Recombinants M240 QC Labs/Support M245 New Base Fractionation 6
Slide 43: Our Technical Capabilities
Our Technical Capabilities For personal use only Plasma Recombinant Flu 7
Slide 44: Focus on Inframarginals
Focus on Inframarginals For personal use only Beriate ® Plasma Humate ® P Haemate ® P RiaSTAP ® Cryodepleted plasma Haemocomplettan ®P Beriplast ® Beriplex ® Kcentra Berinert ® HEAGARDA ® 8% Precipitation (Fraction I) Fibrogammin ® factor XIII Beriplast ® Kybernin ® Corifact ® 25% Precipitation (Fra
Slide 45: Product Portfolio of CSL Behring – Northern Hemisphere
Product Portfolio of CSL Behring – Northern Hemisphere For personal use only Critical Care Immunology Coagulation Albumin solutions Polyvalent immunoglobulins Plasma-derived factor II Human Albumin Behring® Privigen® Human Thrombin active substance Alburex ®, AlbuRx®, Albumex ®, Hizentra® Recombinan
Slide 46: Take a look inside our manufacturing
Take a look inside our manufacturing For personal use only 10 | Confidential – Internal Use Only
Slide 47: Focus on our People
Focus on our People For personal use only • Lean and agile culture and working environment • Embedded in the community • Well-established relations with universities • Focus on future talent 11
Slide 48: Add Green to CSL's Red
Add Green to CSL's Red For personal use only "Phoenix" – New Base M600 – R&D Cube Fractionation Facility • Investment: USD ~ 170M • Investment: USD 470M • Highest energy standards • Sustainable and energy- (ice storage combined with efficient planning heat pump) • Highest KfW-credit in history • 500
Slide 49: Marburg's St. Elizabeth's Church lights up for Rare Disease Day
For personal use only Marburg's St. Elizabeth's Church lights up for "Rare Disease Day" 28 February 2023
Slide 50: Maximizing the Iron Opportunity
For personal use only Elena is impacted by iron deficiency Maximizing the Iron Opportunity CSL Vifor Hervé Gisserot General Manager CSL Vifor
Slide 51: Our Future is Built on the Framework of Our Rich Iron Heritage
Our Future is Built on the Framework of Our Rich Iron Heritage For personal use only Ferinject/Injectafer Vifor Fresenius achieves block- Medical Care Renal buster status Pharma (VFMCRP) 2019 established Galenica acquires Vifor Ltd. 2010 Foundation for Galenica Ltd. formed 1977 1927 2022 CSL Limited
Slide 52: We are a Global Leader in Iron Replacement and Nephrology Therapies
We are a Global Leader in Iron Replacement and Nephrology Therapies For personal use only Iron Replacement Nephrology Further expansion in anemia; Launching the next generation growth through HF, PBM and of therapies addressing kidney geographic expansion disease progression Dialysis Non-Dialysis In
Slide 53: Iron Replacement: CSL Vifor's Largest Franchise
Iron Replacement: 1H23 revenue by CSL Vifor’s Largest Franchise For personal use only therapy group1 In $m Therapy Group Sales1 $m 6%, 4%, Ferinject/Injectafer Iron 315 Non Dialysis, Other, $55 $30 Mircera Dialysis 258 Velphoro Dialysis 77 48%, Iron, Venofer Iron 74 $427 42%, Dialysis, Veltassa Non
Slide 54: What is Iron Deficiency?
What is Iron Deficiency? Significant global prevalence For personal use only The number of ID1 patients Iron without IDA2 is estimated ID Anaemia Deficiency to be more than twice as ~1.2B people5 >3B people many as the number of IDA patients 3,4 1. ID = Iron Deficiency; 2. IDA = Iron Deficiency Anae
Slide 55: Significant untapped potential with Ferinject/Injectafer
Significant untapped potential with Ferinject®/Injectafer® For personal use only Majority of patients yet to be diagnosed & treated (EU5 only) -89% A market Leader in High Dose IV Iron Segment1 -59% >1.2B CHF in-market sales in 2022 • 28% market share of overall Iron -21% market (Global In-Market Sa
Slide 56: Priorities to accelerate Ferinject/Injectafer growth
Priorities to accelerate Ferinject®/Injectafer® growth For personal use only Areas of focus Strategic priorities Focused targeting, amongst the many different patients Maximise penetration ex-US suffering from ID and IDA • Explore potential revenue synergies with CSL Behring on PBM • Geographic expa
Slide 57: CSL Vifor St. Gallen, Home of Iron
For personal use only 29 March 2023 CSL Vifor St. Gallen, Home of Iron Hans-Martin Müller Head Manufacturing Iron & Strategic Projects
Slide 58: Employees are our most valuable asset
Employees are our most valuable asset, empowered to creating their own career journey with us For personal use only Head Count Share of FTE’s Time with CSL Vifor 30% 26% 23% 25% 20% 16% 15% 10% 11% 7% 10% 7% 5% 0% < 1 year 1-2 years 3-5 years 6-10 years 11-15 years 16-20 20+ years years 33% 62% 27 1
Slide 59: CSL Vifor's rich heritage dates back to 1872
CSL Vifor’s rich heritage dates back to 1872 when the success story of iron began in St. Gallen For personal use only Construction of new Vifor joins CSL building and plant (August 2022) for iron chloride manufacturing 2022 First Approval 2020 First Approval 2013 First Approval 1964 1949 2023 Capaci
Slide 60: All iron products were discovered, developed and are produced in St. Gallen
All iron products were discovered, developed and are produced in St. Gallen to this date For personal use only 11
Slide 61: The St. Gallen site focuses mostly on API production
The manufacturing site in St. Gallen focuses mostly on API production of its iron products For personal use only API manufacturing in St.Gallen FP Contract Manufacturing 12
Slide 62: Complex manufacturing turns iron ore into APIs
Complex manufacturing turns iron ore into the active pharmaceutical ingredients (API) of our iron therapies For personal use only Iron Ore FeCl3 Synthesis Drying Finished Products Iron – from Iron Precursor Manufacturing by API Synthesis Mine to SG Synthesis CDMO's 13
Slide 63: Over 1,000 tons of iron based APIs produced per year
Over 1,000 tons of iron based API’s are produced in St. Gallen per year For personal use only FDA-Inspection History Produced quantity of API (tons of API) 2000 PAI Venofer 1200 + 58% GMP Conformity 2007 1000 Without deficiencies 800 GMP Conformity 2010 Without deficiencies 600 PAI Velphoro 2012 Wit
Slide 64: Best Use of nearby sustainable Energy Sources
Best Use of nearby sustainable Energy Sources For personal use only Participation in two River Power Plants since 2018 Future use of Communal District Heating Aim: Reduction of CO2 Footprint by >80% 15
Slide 65: Learn more about our iron expertise on today's tour
Learn more about our iron expertise on today’s tour through the St. Gallen site For personal use only 1 The iron exhibition 5 8 4 2 From rock to iron dust 3 2 3 Take iron seriously 1 4 Nanomedicines 5 In the heart of the factory 6 The success story continues 16
Slide 66: Behavioral Rules for the Tour
Behavioral Rules for the Tour For personal use only Do not take photos on the site. Wear the specified personal protective equipment correctly during the tour. Do not touch any pipes, apparatus or surfaces. 17
Slide 67: Our local experts will guide you through the iron experience
Our local experts will guide you through the iron experience today For personal use only Group “Green” Group “Blue” Group “Yellow” Group “Red” Group “Purple” Hans-Martin Müller Manuel Senn Dominic Lampert Markus Sonderegger Philipp Bachmann Head Manufacturing Site Head Head of Production Head Qualit