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CSL Ltd. — Investor Presentation 2023
Mar 27, 2023
17854_rns_2023-03-27_a2f94775-394a-41ac-ac5f-a65cb330573c.pdf
Investor Presentation
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28 March 2023
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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 Mead
Company Secretary
For further information, please contact:
| Investors: | Media: |
|---|---|
| Bernard Ronchi | Bernadette Murdoch |
| Investor Relations | Communications |
| CSL Limited | CSL Limited |
| P: +61 3 9389 3470 | P: +61 449 950 745 |
| E: [email protected] | E: [email protected] |
Investor Tour, CSL Behring/Vifor European Operations March 2023
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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 not purport to be complete. It should be read in conjunction with CSL's other periodic corporate reports and continuous disclosure announcements filed with the Australian Securities Exchange ( ASX ), available at www.asx.com.au This presentation is for information purposes only and is not a prospectus or product disclosure statement, financial product or investment advice or a recommendation to acquire CSL shares or other securities.
Legal Notice
No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of CSL or its directors, employees or agents, nor any other person, accepts liability for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability from fault or negligence on the part of CSL or its directors, employees, contractors or agents.
This presentation contains forward-looking statements in relation to CSL, including statements regarding CSL's intent, belief, goals, objectives, initiatives, commitments or current expectations with respect to CSL's business and operations, market conditions, results of operations and financial conditions, products in research, risk management practices, climate change and other environmental and energy transition scenarios. Forward-looking statements can generally be identified by the use of words such as "forecast", "estimate", "plan", "will", "anticipate", "may", "believe", "should", "expect", “project,” "intend", "outlook", "target", "assume" and "guidance" and other similar expressions.
The forward-looking statements are based on CSL's good faith assumptions as to the financial, market, risk, regulatory and other relevant environments that will exist and affect CSL's business and operations in the future. CSL does not give any assurance that the assumptions will prove to be correct. The forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors, many of which are beyond the control of CSL, that could cause the actual results, performances or achievements of CSL to be materially different to future results, performances or achievements expressed or implied by the statements . 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 or divestitures; research collaborations; litigation or government investigations, advances in environmental protection processes, uncertainty and disruption caused by the COVID-19 pandemic and CSL’s ability to protect its patents and other intellectual property.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as at the date of the presentation. Except as required by applicable laws or regulations, CSL does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in assumptions on which any such statement is based.
TRADEMARKS
Except where otherwise noted, brand names designated by a ™or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.
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CSL is expanding our capabilities by building an integrated, worldclass network of internal sites as well as contract manufacturers, with focus on Reliability, Quality, Cost, Innovation and Safety
Key CMO Partners Abbvie Fresenius Kabi Alphasigma Thermo Fisher Corden UniQure
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CSL Behring Manufacturing Sites
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Bern, Switzerland (1,800+ employees)
Products: Immunoglobulins (IG), Albumin anti-D-hyperimmune, potential CSL112
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Broadmeadows, Australia (1,300+ employees)
Products: IG, Albumin, potential CSL112 and Coagulation factor toll manufacturing services for Australia, New Zealand, Hong Kong, Malaysia, Singapore and Taiwan
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Marburg, Germany (2,900+ employees)
Products: Albumin, IG & Albumin paste, Coagulation factors and Hyperimmunes
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Kankakee, US (1,500+ employees)
Products: Albumin, IG intermediate paste, Coagulation factors, alpha1-proteinase inhibitor, PCC & C1 intermediates
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Wuhan, China (240+ employees)
Products: Albumin & Immunoglobulins for the Chinese market.
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Lengnau, Switzerland (Operated by Thermo Fisher) Products: Idelvion and other recombinant products Scheduled to begin manufacturing in FY24
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Donor to Patient
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Collection Testing Logistics Manufacturing
IMED Exchange Key Products
Fraction V Paste
Fractionation IV Paste (CSL 112) Privigen
Precipitate C Paste Alburex
I+II+III Paste / II+III Paste
Hizentra
Precipitate A
Indianapolis, IN Bern II+II+III Paste Bern …
I+III Paste
CSL Plasma Center Knoxville, TN Specialty Products
Rhophylac
Cryoprecipitate Human Albumin,
HAEGARDA, Beriplex,
DEAE Eluat; QAE-AS Precipitate
Cryoprecipitate; Albumin Paste Beriplast, AFSTYLA,
Dallas, TX
Marburg
Voncento Marburg Idelvion, …
Semi-finished
Kybernin
Goettingen, DE Water for injection vials Zemaira
Schwalmstadt, DE Alburex
Kankakee …
Kankakee
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Fraction V Paste
Precipitate A Privigen
I+II+III Paste Alburex
WFI vials Toll
II/III Paste …
Broadmeadows Broadmeadows
| Confidential – Internal Use Only
Cryoprecipitate
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CSL Behring Operating Model
Value Stream Value Stream Value Stream Value Stream Bulk and Base Frac Fill Finish Packaging recombinant Quality Engineering & Maintenance Site Logistics and support Planning
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Tier Meeting Cascade & Reliability Room
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 on reliable supply to patients.
Tier Meetings ensure a daily cascade of critical issues within the site involving all operational functions. Supply "smoke signals" are elevated to the weekly Reliability Room ensure appropriate resolution and/or contingency planning.
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Tier 4 Reliability
Room
weekly
Tier 3
Bern BMW Marburg Kankakee
daily
Tier 2
VS
VS Basefrac VS BULK VS FILL QC
Packaging
daily
Tier 1
Shop floor Shop floor Shop floor Shop floor Laboratories
daily
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People
Safety
Quality
Reliability
Innovation
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Operational Highlights
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Manufacturing
-
Broadmeadows and Marburg new base fractionation facilities licensed and operational
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Continued investment in short and long term yield/capacity initiatives:
-
Albumin in Broadmeadows
-
IgG in Bern
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Plasma Collections 1H23
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Strong increase in plasma collected +36% with levels now 10% above pre-pandemic
-
Mexico border re-opened with collections recovering strongly
-
• 7 new centers in US and 1 in Germany
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Continued adoption of technology
-
CSL Plasma donor app – downloads >2.5m
-
− Online health questionnaire
-
RIKA program commenced
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Network Asset Financial & Risk Capacity Management Resource Management Optimization
Our focus on Network Strategy ensures both a resilient and reliable Supply Chain
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Network Resiliency
Ensuring safe, reliable product supply for our patients across a complex, global supply chain.
Fractionation
Plasma
-
Optimizing annual center expansions to align with IG demand & yield forecasts.
-
Adding right-time capacity and balancing risk
-
Optimizing supply chain.
-
Balancing new builds vs. center efficiency vs. donor marketing & remuneration
Fill / Finish
Bulk
-
Balancing CSL investment across sites and broadening knowledge of key products to across the network
-
Leveraging relationships with key partners to find the right expertise, optimize production flexibility & ROIC
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Reducing Supply Chain Lead Times
-
Timing new capacity to ensure supply & maximize ROIC
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CSL has continued to execute against our growth strategy
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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 U.S. and utilization of non-injectable plasma for qualification, delivering an approval faster than conventional timelines.
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Key CSL Behring Capital Projects CSL conducts annual Long-Term Demand & Capacity Forecasts to ensure optimal timing for CapEx projects
Fractionation
Technology
-
Rika Device Rollout
-
Marburg & Broadmeadows Production Ramp In Progress
-
New Quality Management System (Veeva)
-
CSL112 paste – Broadmeadows, AU
-
Base Frac – planning
Bulk & Finish
Other
-
Zemaira Fill – TFS, US
-
Asset retirement & replacement
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Albumin Bulk & Fill – BMW, AU
-
CSL112 Bulk & Fill – Bern, CH
-
IG Bulk – planning
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•
Optimizing Spend
•
Maximizing ROIC
•
Balancing Risk
•
Leveraging CMOs
•
Ensuring Growth
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Annual CapEx Investment
Network Strategy & Portfolio Management continue to
focus on optimization of CapEx spend
$Billion USD
•
1.40 Optimizing Spend
1.37
1.29
1.10 •
1.08
Maximizing ROIC
1.00
0.28
0.86 (25%)
•
Balancing Risk
0.57
0.41 0.82 •
Leveraging CMOs
(75%)
•
Ensuring Growth
FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23
(Forecast)
Actuals Compliance & Efficiency Grow
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*CSL CapEx Investment, Excluding Vifor
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Enterprise Wide Quality Framework
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➢ 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 visiting our locations globally
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Quality Facts and Figures FY22
-
➢ 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
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➢ 378 inspections of CSL Plasma centers
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➢ CSL performed 676 Quality Audits of our suppliers to assure continued consistent high-quality materials from our partners
-
➢ 15 Corporate GXP Internal Audits have been completed across the CSL Group since the commencement of the program 2 years ago
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Quality Culture & Continuous Improvement
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
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Our 2030 Strategy in 4 Words: 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, trusted R&D platforms, and
5. Transforming – our digital intellect and technologies
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Biopharma in the Heart of the Capital 2023
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2
| External Use
02
Welcome to Bern!
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Our Pioneering on the Bern Site
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| Confidential – Internal Use Only
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Functions in Bern
Commercial Enabling E2E Operations R&D Operations Functions Fractionation Commercial Operations CSL Behring Biologics Finance Bulk Intercontinental Research Center I&T Filling & Visual (sitem-insel) HR Commercial Operations Inspection Legal Switzerland Plasma Product Packaging Communications Development Maintenance & Utilities Global Regulatory Engineering Affairs Environment, Health & Safety (EHS) Quality & Quality Controll
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Our People
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Diverse Workforce
-
1800 employees:
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39% women / 61% men
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65 nationalities
-
8.7 years of average tenure
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43 years of average age
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Talents & Culture
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Early career concept
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40 apprentices, trainees and internships
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Gender equality
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Equal pay certification
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Bern Leading Sustainable Technology to Reduce Environmental Impact
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• Since 2016, we have savings of about 6,000 MWh of energy and about 1,000 tons of CO . This 2 corresponds to 9% energy and 11% CO 2 savings compared to 2015.
• We have been using electricity exclusively from hydropower for several years.
Project idea to bring CO2 down to net 0
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04
Products Bern
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Product Portfolio CSL Behring – Northern Hemisphere
Critical Care
Immunology
Albumin Solutions Polyvalent Immunoglobulins Human Albumin Behring[®] Privigen[®] Alburex[®] , AlbuRx[®] , Albumex[®, ] Hizentra[®] Albuminar[®] Carimune[® ] NF Inhibitors Sandoglobulin[®] Berinert[®] P, Haegarda[®] Intragam[®] Kybernin[®] P Evogam[®] Other Trauma Therapies Hyperimmunes Beriplex[®] P/N, Coaplex, Kcentra[®] Rhophylac[®] , Rhesogam RiaSTAP[®, ] Haemocomplettan[®] P CytoGam[®] Thrombotrol[®] Beriglobin[®] P Prothrombinex[®] Berirab[®] P Hepatitis B IG P Behring[®] Tetagam[®] P
Wound Healing
Coagulation
Plasma-derived factor II Human Thrombin a.s. Recombinant factor VIII Afstyla[®] Recombinant factor IX Idelvion[® ] Factor VIII:C/von Willebrand factor Haemate[®] P, Humate[®] P, Biostate[®] Plasma-derived factor VIII Beriate[®] P, Monoclate[®] P, Biostate[® ] Plasma-derived factors X Factor X P Behring[®]
Beriplast[®] P Combi-Set
Fibrogammin[®] , Corifact®, Cluvot[®] Fibrinogen a.s.
Pulmonology
Zemaira[®]
Respreeza[®]
Seqirus
Afluria[®] Flucelvax[®] Tetra
Green: products manufactured in Bern
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Bern Products
Immunoglobulins
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Privigen[®] Hizentra[®]
25/50/100/200/400mL 5/10/20/50mL
3 years by +2 to +25 ° C 30 months by +2 to +25 ° C
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Hizentra® PFS
5/10/20mL
30 months by +2 to +25 ° C
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Rhophylac[®]
2mL
3 years by +2 to +8 ° C
Albumin
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Alburex® 5%
100/250/500mL
Alburex® 20%
50/100mL
Alburex[®] 25%
CSL112
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Promotes
cholesterol removal leading to plaque stabilization
Reduction of recurrent heart attacks and stroke
50/100mL
3 years by +2 to +30 ° C
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Current Products
Serving patients and people in 100+ countries
Future Product
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03
CSL Behring’s Presence & Innovation in Bern
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Facilites Site Bern
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Value Stream
Value Stream
Value Stream Bulk
Packaging
Fractionation Value Stream
Filling
Packaging (1 facility)
Fractionation (1 facility) Privigen / Hizentra (3 facilities) Filling (3 facilities)
Albumin (1 facility) Pasteurisation / Incubation
(1 facility with 5 past baths)
CSL112 (1 facility)
Visual Inspection (2 facilities)
Rhophylac (1 facility)
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Investments
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180
160
140
120
100
80
60
40
20
0
2000/01 2001/02 2002/03 2003/04 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
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Efficiency & Innovation
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Growth IgG
More
batches
Increase
batch size
Increase
yield
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IG Capacity
-
Project delivered, ahead of schedule, on budget
-
IgLAB Module V & VI IG capacity:
-
Max capacity utilization demonstrated (14 batches per week)
Bulk & Filling Capacity
-
Upgrade existing Phase 3 CSL112 bulk facility and install new filling line and lyophilises
-
Minimize capital investment at risk
-
Bern’s yearly production will supply approx. 80’000 patients per year
Automation
-
Our new manufacturing site for visual inspection, secondary packaging and storage of intermediate and finished products
-
Transition into fully automated final manufacturing from incubation to delivery
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CSL R&D in Switzerland
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Plasma Product Development Global Regulatory Affairs
GPS, CMC, BioProcess Sciences, BioAnalytical GRA CMC, GRA OpX, GRA GPS, GRA
Science, Breakthrough Launchpad, Primary Policy & Intelligence
Packaging & Medical Devices
Wankdorfstrasse
27%
Feusi
45%
Sitem-Insel
20%
8%
Research
Other R&D functions Biochemistry, Gene Therapy
Project Management, Research, Preclinical Innovation,
Pharmacology & Translational Translational Research, Research
Development, Clinical Safety, External Innovation
Global Licensing, IP
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Global Regulatory Affairs
300+ (500+)
GRA CMC, GRA OpX, GRA GPS, GRA
Policy & Intelligence R&D employees
3 (6)
sites
17 225
collaborations with scientific papers
academic institutions published with our
and hospitals in EU collaborators since
and CH 2015
32
nationalities
Biochemistry, Gene Therapy
Research, Preclinical Innovation,
Translational Research, Research 56
External Innovation languages
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R&D Cooperations
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Memberships & Community Commitments
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05
Thank you for your attention!
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Welcome to Marburg Investor Tour 28 March 2023
Michael Schröder, Site Head Marburg The picture shows Kathrin Schön, one of our HAE patients
CSL Behring Marburg Operations Site Overview
Focus on Reliable Supply
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Marburg at a Glance
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Behringwerke Campus Main Plant
H69 Filling/Packaging H68 Base Fractionation/ Bulk Plasma H67 Recombinant BDI
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Behringwerke Campus Görzhausen
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M483/M486/M484 Warehouses (operated by Pharmaserv) M305 Filling/Bulk Plasma M300 Bulk Plasma & Recombinants M240 QC Labs/Support M245 New Base Fractionation
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Our Technical Capabilities
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Plasma
Recombinant Flu
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Focus on Inframarginals
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Beriate ®
Plasma
Humate ® P
Haemate ® P
RiaSTAP ®
Haemocomplettan ®P
Cryodepleted plasma
Beriplast ®
Beriplex ® Kcentra
Berinert ® HEAGARDA ®
8 % Precipitation
(Fraction I)
Fibrogammin ®
factor XIII
Beriplast ®
Kybernin ®
Corifact ®
25% Precipitation
(Fraction II + III)
Immunoglobuline (incl.
hyperimmunes)
40% Precipitation
(Fraction V)
Albumin
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Product Portfolio of CSL Behring – Northern Hemisphere
| Albumin solutions Human Albumin Behring® Alburex ®, AlbuRx®, Albumex ®, Albuminar ® Inhibitors Berinert® P, Haegarda®,Berinert SC® Kybernin® P Other trauma therapies Beriplex® P/N, Coaplex, Kcentra® RiaSTAP ® Haemocomplettan® P Thrombotrol® Prothrombinex® Critical Care Wound Healing |
Polyvalent immunoglobulins Privigen® Hizentra® Carimune®NF Sandoglobulin® Intragam® Evogam ® Hyperimmunes Rhophylac® ,Rhesogam CytoGam® Beriglobin® P Berirab® P Hepatitis B IG P Behring® Tetagam® P Immunology |
Coagulation |
|---|---|---|
| Plasma-derived factor II Human Thrombin active substance Recombinant factor VIII Afstyla® Recombinant factor IX Idelvion® Factor VIII:C/von Willebrand factor Haemate® P, Humate® P,Biostate® Plasma-derived factor VIII Beriate® P,Biostate® Plasma-derived factors X Factor X P Behring® Gene therapy Hemgenix® |
Wound Healing
Beriplast[® ] P Combi-Set Fibrogammin[®] , Corifact[®, ] Cluvot[®] Fibrinogen active substance
Pulmonology Zemaira[®] Respreeza[®]
Seqirus Afluria[®] Flucelvax[®] Tetra
Green: products manufactured in Marburg Red: products filled and/or finished in Marburg
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Take a look inside our manufacturing
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| Confidential – Internal Use Only
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Focus on our People
-
Lean and agile culture and working environment
-
Embedded in the community
-
Well-established relations with universities
-
Focus on future talent
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Add Green to CSL's Red
"Phoenix" – New Base Fractionation Facility
M600 – R&D Cube
-
Investment: USD ~ 170M
-
Investment: USD 470M
-
Highest energy standards (ice storage combined with heat pump)
-
Sustainable and energyefficient planning
-
Highest KfW-credit in history (EUR 250M)
-
500 R&D employees under one roof
-
Fractionation capacity increased by 4
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Marburg's St. Elizabeth's Church lights up for "Rare Disease Day" 28 February 2023
Elena is impacted by iron deficiency
Maximizing the Iron Opportunity CSL Vifor
Hervé Gisserot General Manager CSL Vifor
Our Future is Built on the Framework of Our Rich Iron Heritage
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Ferinject/Injectafer
Vifor Fresenius achieves block-
Medical Care Renal buster status
Pharma (VFMCRP) 2019
established
Galenica acquires
2010
Vifor Ltd.
Foundation for
1977
Galenica Ltd. formed
1927
2022
CSL Limited
2017
acquires
Vifor Pharma becomes Vifor Pharma
2007
independent, stock-
Ferinject receives listed company
1944 first regulatory
approvals
Vifor Ltd.
1872
established,
Pharmacy founded by marketing hospital
Caspar Friedrich Haus- supply products
mann in St. Gallen,
Switzerland pioneering
iron products
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We are a Global Leader in Iron Replacement and Nephrology Therapies
Iron Replacement Further expansion in anemia; growth through HF, PBM and geographic expansion
Nephrology
Launching the next generation of therapies addressing kidney disease progression
Dialysis
Non-Dialysis
In Market
Pipeline
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Heart failure opportunity & geographic expansion
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4
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5
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(Ex-US)
SNF-472 Sparsentan [7]
vadadustat [6] INS-3001 vamifeport
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Note: HF = heart failure. PBM = patient blood management. | 1 Licensed from F. Hoffman-La Roche AG. | 2 Licensed from Pfizer Inc. | 3 Licensed from ChemoCentryx, Inc. | 4 Licensed from OPKO Health, Inc. | 5 Licensed from Cara Therapeutics, Inc. | 6 Licensed from Akebia Therapeutics, Inc., subject to certain conditions and limited to selling Vadadustat to certain providers within the US dialysis market. Status pending - Complete Response Letter received from FDA due to safety concerns. | 7 Licensed from Travere Therapeutics, Inc.
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| Iron Replacement: CSL Vifor’s Largest Franchise 1H23 revenue by therapy group1 In $m |
Iron Replacement: CSL Vifor’s Largest Franchise 1H23 revenue by therapy group1 In $m |
|---|---|
| Therapy Group Sales1 |
$m 48%, Iron, $427 42%, Dialysis, $377 6%, Non Dialysis, $55 4%, Other, $30 |
| Ferinject/Injectafer Iron 315 |
|
| Mircera Dialysis 258 |
|
| Velphoro Dialysis 77 |
|
| Venofer Iron 74 |
|
| Veltassa Non Dialysis 49 |
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| Maltofer Iron 36 |
|
1 ~5 months revenue contribution ( Acquired 9th August 2022)
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The number of ID[1] patients without IDA[2] is estimated to be more than twice as many as the number of IDA patients[3,4]
What is Iron Deficiency? Significant global prevalence
Iron ID Anaemia Deficiency ~1.2B people[5] >3B people
1. ID = Iron Deficiency; 2. IDA = Iron Deficiency Anaemia, occurs when ID is sufficiently severe to reduce erythropoiesis; 3. Iron deficiency (Blood. 2019;133(1):30 – 39) – Anaemia still affected one third of the population, with approximately half of the cases resulting from iron deficiency. The estimate is that 1.24 billion individuals experience iron deficiency anaemia. The global prevalence of iron deficiency without anaemia remains elusive, although the suggested figure is at least double that of iron deficiency anaemia; 4. These numbers are estimates, most studies either have a geographical focus or are done in specific subpopulations. 5. Blood. 2014 Jan 30;123(5):615-24.
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A market Leader in High Dose IV Iron Segment[1]
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1.2B CHF in-market sales in 2022
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28% market share of overall Iron market (Global In-Market Sales (MAT Q4 2022)
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47% market share in IV iron segment
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More than 22 million patient years of exposure
Significant untapped potential with Ferinject[®] /Injectafer[®]
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Majority of patients yet to be
diagnosed & treated (EU5 only)
-89%
-59%
-21%
5.3M -50%
-33%
2.2M
1.8M
0.9M
0.6M
Patients with ID/IDA Diagnosed ID/IDA Treated for ID/IDA Treated with IV Iron Treated with
Ferinject®
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1. IQVIA MIDAS Quarterly panel, GERS, Insight Health, DN, DLI.; Average 2022 exchange rates have been applied. ID = Iron Deficiency. IDA = Iron Deficiency Anaemia. 6
Priorities to accelerate Ferinject[®] /Injectafer[®] growth
Areas of focus
Strategic priorities
Focused targeting, amongst the many different patients suffering from ID and IDA
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Heart Chronic Kidney Patient Blood Failure (HF) Disease Management (PBM)
Maximise penetration ex-US
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Explore potential revenue synergies with CSL Behring on PBM
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Geographic expansion
Maximise penetration in the US
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Improve access
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Successfully launch HF indication with our partner American Regent (Daiichi Sankyo)
Explore other avenues for product differentiation
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ID = Iron Deficiency. IDA = Iron Deficiency Anaemia.
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29 March 2023
CSL Vifor St. Gallen, Home of Iron
Hans-Martin Müller Head Manufacturing Iron & Strategic Projects
Employees are our most valuable asset, empowered to creating their own career journey with us
Head Count
Share of FTE’s
Time with CSL Vifor
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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 10
Share of women Share of educational Different nations Apprentices
•
10% Director + attainment at "tertiary
•
37% Manager level" (Universities & higher
vocational training)
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CSL Vifor’s rich heritage dates back to 1872 when the success story of iron began in St. Gallen
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Construction of new
Vifor joins CSL
building and plant
(August 2022)
for iron chloride
manufacturing 2022
2020
First Approval
First Approval 2013
1964
First Approval
1949
2023
Capacity Increase
2021
Ferinject/Maltofer
2018 Latest Capacity “Multicube building”
Increase Velphoro
2007 Latest Capacity
Increase Venofer
First Approval
1952
1872 Moving into the Site at
Rechenstrasse
Everything began in in St. Gallen
St. Gallen/Formation of
Hecht Pharmacy by
Caspar Friedrich
Hausmann
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10 Confidential – Internal Use Only
All iron products were discovered, developed and are produced in St. Gallen to this date
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The manufacturing site in St. Gallen focuses mostly on API production of its iron products
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API manufacturing in St.Gallen
FP Contract Manufacturing
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Complex manufacturing turns iron ore into the active pharmaceutical ingredients (API) of our iron therapies
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Iron Ore FeCl3 Synthesis Drying Finished Products
Iron – from Iron Precursor Manufacturing by
API Synthesis
Mine to SG Synthesis CDMO's
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Over 1,000 tons of iron based API’s are produced in St. Gallen per year
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Produced quantity of API
(tons of API)
1200
+ 58%
1000
800
600
400
200
0
2016 2017 2018 2019 2020 2021 2022
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FDA-Inspection History
| 2000 | PAI Venofer |
|---|---|
| 2007 | GMP Conformity Without deficiencies |
| 2010 | GMP Conformity Without deficiencies |
| 2012 | PAI Velphoro Without deficiencies |
| 2016 | GMP Conformity Without deficiencies |
| 2021 | GMP Conformity, (Mail Audit) Without deficiencies |
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Best Use of nearby sustainable Energy Sources
Participation in two River Power Plants since 2018
Future use of Communal District Heating
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Aim: Reduction of CO 2 Footprint by >80%
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Learn more about our iron expertise on today’s tour through the St. Gallen site
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1 The iron exhibition
2 From rock to iron dust 3 Take iron seriously 4 Nanomedicines 5 In the heart of the factory 6 The success story continues
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Behavioral Rules for the Tour
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.
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Our local experts will guide you through the iron experience today
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Group “Green” Group “Blue”
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Group “Yellow” Group “Red” Group “Purple”
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Hans-Martin Müller
Manuel Senn
Dominic Lampert
Markus Sonderegger
Philipp Bachmann
Head Manufacturing Iron & strategic projects
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With CSL Vifor for 23 years
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PhD in Organic Chemistry from the Federal Institute of Technology (ETH) Zurich, Switzerland
Site Head
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With CSL Vifor for 15 years
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Holds an BsC in Chemistry, focus on biochemistry, from the University of applied science in Winterthur, Switzerland
Head of Production
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With CSL Vifor for 13 years
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Holds a diploma in Industrial Engineering and Management from
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University of Mittweida, Germany
Head Quality Operations API, Manufacturing
Global Head Quality Management, TechOps
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With CSL Vifor for 12 • With CSL Vifor for 23 years years
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holds a Master in Biological Science from the University of Innsbruck, Austria
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holds a Master in Biochemistry from the Swiss Federal Institute of Technology in Zürich (ETH)
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