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CSL Ltd. — Investor Presentation 2024
Apr 10, 2024
17854_rns_2024-04-10_98ffa42e-8ee7-4ece-a562-72e9baada009.pdf
Investor Presentation
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For immediate release
11 April 2024
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CSL Australia Investor Site Tour Presentations
The presentation materials to be used for an Investor Site Tour being conducted by CSL (ASX:CSL; USOTC:CSLLY) in Melbourne today are attached for the information of investors.
Authorised By
Fiona Mead
Company Secretary
For further information, please contact:
Investors: Bernard Ronchi Director, Investor Relations CSL Limited P: +61 3 9389 3470 E: [email protected]
Stephen McKeon Director, Investor Relations CSL Limited P: 61 402 231 696 E: [email protected]
Media:
Bernadette Murdoch Communications CSL Limited P: +61 449 950 7451 E: [email protected]
Investor Tour CSL Behring & CSL Seqirus April 2024
1
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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Acknowledgement of Country
CSL acknowledges Traditional Owners of Country throughout Australia and recognises their continuing connection to lands, waters and communities. We pay our respects to all Aboriginal and Torres Strait Islander cultures; and to Elders past and present.
Artwork by Simone Thomson as featured in CSL’s Reflect Reconciliation Action Plan
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CSL Behring Broadmeadows Investor Tour
Mike Deem
Andrew Hodder
Manufacturing & Site Head CSL Behring Australia
Head Of Operations CSL Behring
April 2024
Visitor Safety Procedures
While you are in the facility you will be escorted by CSL Behring personnel
In the event of an emergency follow the instructions provided by your guide
Alert Tone – “BEEP-BEEP-BEEP”
-
Standby and await instructions of wardens
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Evacuate Tone – “WHOOP-WHOOPWHOOP”
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Evacuate as instructed by your wardens
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Site Safety Rules
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Who we are
CSL is a global biotechnology leader that develops and delivers innovative medicines that save lives, protects public health and helps people with life-threatening medical conditions live full lives.
Cheryl Blackwell Johnson Living with HAE
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Leading global biotech company
We are a global biotechnology leader that develops and delivers innovative medicines that save lives, protects public health and helps people with life-threatening medical conditions live full lives
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[Countries of operations ] 40[+] around the world
R&D Manufacturing Commercial Operations Testing Laboratory Distribution Warehousing Administration Regional Sales AND/OR Distribution
in annual US$ 9 Manufacturing sites across 6 countries 13.3bn revenue (FY23) Australia China Germany Switzerland UK
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US
Employees around the world[1]
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32,000[+]
R&D
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investment in the last 5 financial years
US$5.1bn
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2,000[+]
R&D employees[1]
340+
Plasma collection centres primarily in the US[1]
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1. As at 31 December 2023.
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CSL group operating structure
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Global Biotherapeutics Leader
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Global Influenza Vaccines Leader
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Global Specialty Pharma Leader
| Global Biotherapeutics Leader | Global Influenza Vaccines Leader | Global Specialty Pharma Leader | ||||
|---|---|---|---|---|---|---|
| • | One of the world’s largest collectors | • | One of the largest influenza vaccine | • | Global specialty pharmaceuticals | |
| of plasma and providers of plasma | companies in the world by revenue | business that is a leader in iron | ||||
| • | therapies Develops and delivers high-quality |
• | Formed in 2015 through the combination of bioCSL and Novartis |
therapies, dialysis, nephrology and rare diseases |
||
| medicines that treat rare and serious | influenza vaccines business | • | Specialises in strategic global | |||
| Overview | • • • |
diseases Manufactures, markets and develops plasma and recombinant therapies Early-stage research on plasma and non-plasma therapies (excluding influenza) Receives license and royalty income from commercialisation of IP |
• • |
In Australia and New Zealand, a leading provider of in-licensed vaccines and specialty pharmaceuticals Supplier to the Australian Government for a range of products, including antivenoms and Q fever vaccine |
• | partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare Joint company, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) with Fresenius Medical Care, a global leader in dialysis |
| • | Focuses on five key therapeutic | |||||
| areas1 | ||||||
| % of Revenue2 |
70% | 15% | 15% | |||
| • | Operations in over 40 countries | • | Operations in over 15 countries | • | Markets in over 100 countries | |
| Global Footprint |
• • |
Markets in over 100 countries 6 manufacturing sites in 5 countries |
• • |
3 manufacturing sites in 3 countries Research & production facilities and manufacturing plants across North |
• • |
Broad global network of affiliates and partners Certain final stage production |
| America, Europe and Australia | processes are outsourced to contract | |||||
| manufacturing organisations |
Source: Company filings.
- 9 1. Five key therapeutic areas are immunology, hematology, respiratory, cardiovascular & metabolic and transplant. 2. Based on FY23 revenue.
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CSL Behring: Driving sustainable, profitable growth
Working together from Donor to Patient
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PLASMA COLLECTION MANUFACTURING COMMERCIALISATION
2
1 3
Deploy Rika , Deliver Horizon 1 yield Outpace market
Nomogram A/I , improvements ; advance growth in Ig ,
digital transformation Horizon 2 and focus on Haemophilia B and
and operational OPEX reduction through HAE
excellence Operational Excellence
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CSL Behring – Global manufacturing presence
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Bern, Switzerland
Broadmeadows, Australia
Marburg, Germany
Kankakee, Illinois, US
Wuhan, China
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Core products: • Core products: immunoglobulins & immunoglobulins & albumin albumin
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Specialty products: coagulation factors, critical care
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Specialty products: anti-D-hyperimmune
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Core products: human albumin, coagulation factors, critical care
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Specialty products: hyperimmunes
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Core products: • Core products: albumin, albumin, fractionation for immunoglobulins intermediate pastes
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Specialty products: alpha1-proteinase inhibitor
• Toll plasma services for Australia, New Zealand, Hong Kong, Malaysia & Taiwan
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CapEx investments are providing capacity for growth
CSL expects CapEx investment needs to reduce as major projects are now coming online
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Annual CapEx Spend
New Capacity Online
30%
CSL Plasma Centers at Start of FY
Reduction in
IG Production CapEx Spend
COVID Dip
330
303
277
237
206
180
Marburg / Marburg
148 External Filling Fractionation
127
Broadmeadows Kankakee Bern Broadmeadows Broadmeadows
IG Bulk Fractionation Ig Bulk Albumin Bulk Fractionation
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24
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From donor to patient: Manufacturing plasma biotherapies
The process starts with plasma donors who play a vital role
Frozen plasma and plasma pastes are transported to site
Plasma and pastes are held in cold storage until needed
Separation of Reconstitution and whole plasma into filtration to manufacture component parts biotherapies
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FILLING
Formulation and filling of bulk product into vials
VISUAL INSPECTION Safety and quality checks of every vial
QUALITY CONTROL / TESTING
Testing of finished products and all manufacturing consumables
PACKING
Labelling, boxing and packing all products ready for distribution to patients
HOSPITALS & PATIENTS
Finished products are distributed to hospitals and direct to patients around the world
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WELCOME TO BROADMEADOWS
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CSL BEHRING BROADMEADOWS
Site opened 1994 Commercial facilities for 1,200+ employees production of PRIVIGEN®, Domestic AlbuRx® and plasma Hizentra® fractionation for Australia, New Recombinant Zealand, Hong manufacturing Kong, Taiwan, facility for clinical Malaysia trial production
Recombinant manufacturing facility for clinical trial production
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OUR WORKFORCE
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1,268 92% 89% EMPLOYEES FULL TIME HOURS PERMANENT EMPLOYEES 40 years 1 in 5 38% AVERAGE AGE EMPLOYEES ARE PEOPLE EMPLOYEES ARE FEMALE MANAGERS 10,368 years 1 in 10 29.5% OF COMBINED SERVICE EMPLOYEES ARE OVER 55 OF PEOPLE MANAGERS YEARS OLD ARE FEMALE 81% 8 years 90% EMPLOYEE ENGAGEMENT AVERAGE TENURE OF EMPLOYEES IN STEM INDEX SCORE
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Our Customers
GLOBAL COMMERCIAL SUPPLY
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Plasma supplied through CSL Plasma sourced in the USA
REGIONAL DOMESTIC SUPPLY
Contract Domestic Manufacturing supply agreements:
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National Blood Authority (Australia)
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NZ Blood (New Zealand)
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Future expansion will support Filling and Packing operations for CSL Seqirus Tullamarine site
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Taiwan Blood Services Foundation (Taiwan)
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Pusat Darah Negara (Malaysia)
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Hong Kong Red Cross Blood Transfusion Service
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CSL BEHRING BROADMEADOWS
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Haemophilia and Specialty Products Facility (Domestic/Contract)
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Turner Facility (PRIVIGEN®, Hizentra®)
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Facility A (AlbuRx®, Alburex®)
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Facility F (Base Fractionation)
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Biotech Manufacturing Facility (Recombinant)
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4
3
2
5
1
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Product Portfolio
CSL Behring Broadmeadows
Critical Care
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[®]
Wound Healing
Beriplast® P Combi-Set Fibrogammin®, Corifact®, Cluvot® Fibrinogen active substance
Pulmonology
Zemaira[®] Respreeza[®]
Immunology
Polyvalent immunoglobulins Privigen[®] , Privigen® AU Hizentra[®] Carimune® NF Sandoglobulin® Intragam® Evogam ® Hyperimmunes Rhophylac® , Rhesogam CytoGam® Beriglobin® P Berirab® P Hepatitis B IG P Behring® Tetagam® P
Domestic Hyperimmunes produced at Broadmeadows
Cytomegolavirus Immunoglobulin ~~-~~ VF Hepatitis B Immunoglobulin ~~-~~ VF ~~-~~ Rh(D) Immunoglobulin (Anti D) Tetanus Immunoglobulin ~~-~~ VF IM Tetanus Immunoglobulin ~~-~~ VF IV Zoster Immunoglobulin ~~-~~ VF Normal Immunoglobulin ~~-~~ VF
KEY Current portfolio Future filling capacity
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, Voncento[®] , Biostate[®]
Plasma-derived factor VIII Beriate[® ] P, Biostate[®] Plasma-derived factors X Factor X P Behring[®] Gene therapy - Hemgenix®
CSL Seqirus
Afluria[®]
Flucelvax[®] Tetra PNS (Antivenoms)
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MORE THAN A DECADE OF SUSTAINED GROWTH AND ALMOST A$2B IN CAPITAL INVESTMENT
2013 2014 2017 2022 Turner Biotechnology Facility A PRIVIGEN Manufacturing AlbuRx Facility Facility
FUTURE
Filling capacity expansion Ig yield Albumin Facility F Base capacity Fractionation expansion and Logistics Hub
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Sustainability Initiatives at Broadmeadows
CSL target: 40% reduction of Scope 1&2 emissions by 2030 against a baseline of average emissions across FY19-21
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Power Purchase Agreement for Australian renewable electricity will make a substantial contribution to achieving target
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Broadmeadows is the largest proportion of CSL’s electricity use and emissions in Australia
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Agreement starts in January 2025
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Energy efficiency projects focused on steam generated from natural gas to reduce Scope 1 emissions are being investigated
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Local sustainability initiatives
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On site ethanol recovery and recycling for reuse in manufacturing processes
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Evaluating waste reduction involving site audits and a workshop with waste service providers to set priority projects for action
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CSL BEHRING BROADMEADOWS FUTURE VISION
20 million+ vials in 2030
Our Vision
A world-class facility and network partner, reliably delivering for Our Patients.
Our Mission
We deliver live-saving therapies for Our Patients, collaborating globally to continuously improve production capacity. Our people are committed to delivering excellence, working with agility and innovating to strengthen our business today and deliver for our bright future.
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CSL Seqirus A Global Network
Driven by Our Promise to Protect Public Health
Chris Larkins
Jonah Smith
VP Program Lead – Project Banksia
April 2024
SVP, Global Operations
CSL Seqirus growth linked directly to differentiation strategy and core capabilities
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CSL Seqirus historic growth
Seasonal Influenza Revenue (US$'M)
1,500
23% CAGR
1,000
500
-
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23
Non-differentiated Differentiated
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Cornerstones for Success
Real World Differentiation
Evidence Strategy
Platform
Focus on Scaled
Innovation Manufacturing
Platforms
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CSL Seqirus’s focus within its 4 strategic pillars drives its near and long-term success
1. CONTINUED GROWTH IN INFLUENZA
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Opportunities in both new and existing markets to increase our global footprint
3. GROW BEYOND INFLUENZA
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Leverage core competence of respiratory vaccines
2. BROADEN OUR PANDEMIC BUSINESS
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Multi-pathogen pandemic capability
MANUFACTURING TECHNOLOGY
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Common technologies and yield investments to underpin our growth
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In influenza, Seqirus will grow the market through differentiation despite lower immunisation rates
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Historic Trend (US)
Expectations
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COVID-19
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2009
H1N1
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-
Influenza still has significant unmet need, particularly in paediatric and older adult populations
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Immunisation rates will return over time
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Annualisation of COVID-19 boosters will reduce vaccine fatigue
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CSL Seqirus growth will outpace the market through differentiation and advocacy efforts
Source: www.cdc.gov
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CSL Seqirus focused on continuous innovation to reduce the burden of influenza
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Multiple
Differentiators
Differentiated
aH5N1c
QIVc
Undifferentiated
aQIVc
aTIV
aQIV
TIVe
sa-mRNA
aH5N1
QIVe Development Status: Development Status:
• QIVc: 6-month+ age extension • aQIVc: Phase III
• aQIV: Advanced Real-World Evidence • sa-mRNA flu: Phase I
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Technologies will be complementary Cell will remain basis of rapid pandemic response for Flu
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CELL-BASED VACCINE
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MF59 ADJUVANT Squalene
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SELF-AMPLIFYING mRNA VACCINE
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sa-mRNA technology differentiates
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CSL Seqirus COVID-19 vaccine candidate
Differentiators of sa-mRNA Technology
Accelerating to market
Superior response to Omicron strain 1 as a booster in adults vs. approved booster (Phase III)
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Licensing and collaboration agreement with Arcturus Therapeutics Inc.
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• Finalising clinical programs
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• Studying emerging variants
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Regulatory submissions
2 Lower dose of mRNA
Global Launches Anticipated in 2024 - 2026
Duration of protection up 3 to 12 months
^ Links to online publications: https://www.medrxiv.org/content/10.1101/2023.07.13.23292597v1.full.pdf
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Japan EU UK US
(via Meiji Seika)
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https://ir.arcturusrx.com/news-releases/news-release-details/study-shows-novel-sa-mrnavaccines-offer-robust-broad-enduring
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CSL Seqirus – Global manufacturing presence
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Holly Springs NC, US
The world’s largest cellbased influenza vaccine manufacturing facility
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First and only site recognized by the U.S. Government with pandemic-ready designation.
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Recent expansion works include new formulation suites and expanded fill and finish capacity
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Liverpool, UK
The U.K.’s only injectable influenza vaccine manufacturing facility
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Includes proprietary adjuvant, MF59® manufacturing and highspeed fill and finish line
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Plays an important role in pandemic preparedness and response for the U.K. and other countries in Europe.
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Parkville, Australia
Australia’s first influenza vaccine manufacturer
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Manufacture of products of national significance, including antivenoms and the Q fever vaccine.
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Produces seasonal and pandemic vaccines for Australia and worldwide.
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Develops candidate vaccine viruses for the World Health Organisation
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sa-mRNA CTM, NC, US
New sa-mRNA clinical trial
- material (CTM) manufacturing facility located within Holly
Springs
-
Flu Vaccine Clinical Trial Material manufacturing will occur in CSL Seqirus’ Vaccine Pilot Plant (VPP) and SmallScale Filling (SSF) facility at Holly Springs
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SSF operationally setup for H5N1 and H2N3
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Waltham, MA, US
State-of-the-Art Vaccine Research and Development Facility
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Pre-clinical manufacturing
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The custom-built Biosafety level 3 laboratory (BSL-3)
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The site will serve as CSL's central hub for current and future vaccine design.
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Looking Forward
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CSL Seqirus is well positioned to continue its success in influenza:
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Capacity development well advanced to support aQIVc launch
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Continuous innovation will enable CSL Seqirus to outpace market growth:
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aQIVc setting new standard of care
-
sa-mRNA
-
sa-mRNA technology will differentiate CSL Seqirus vaccine in COVID-19
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CSL SEQIRUS TULLAMARINE
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CSL Seqirus Tullamarine New World Class Flu Cell Culture facility in Australia to meet growing demand and pandemic protection
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Project is on target for schedule and budget, with first production in Q1 2026 Cell culture manufacturing Anti-venom production Best-in-class sustainability paired with innovative production capabilities
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Project Objectives
Australian Biosecurity contract:
-
10-year Biosecurity contract secured with Australian government, commencing in mid-2026
-
Secure onshore manufacturing capability for cell-based pandemic influenza response and secure supply of Products of National Significance (PNS).
Seasonal influenza vaccine supply:
- CSL Seqirus Long Range Plan indicates strong seasonal cell-based influenza demand into the future. Tullamarine FCC (Flu Cell Culture) facility (1 line) provides additional global FCC capacity to support that demand.
Pandemic Supply:
- Tullamarine FCC facility provides pandemic capacity to meet future growth in global sales of Pandemic Advance Purchase Agreements (outside of USA).
Critical FCC Milestones:
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3 x 5,000 L FCC bioreactors
Key Deliverables:
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Increase seasonal cell-based influenza capacity by 50% by NH 26/27 Season
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Increase pandemic cell-based influenza capacity by 50% by June 2026
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Secure site licensure and product registrations for Biosecurity contract by June 2026
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Commence production by Jan 2026, registration in Europe by March 2026
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Project Scope
New CSL Seqirus Tullamarine Site
-
Consolidated Drug Substance & Formulated Bulk Manufacture
- Flu Cell Culture (FCC) -
Products of National Significance (PNS)
- Supporting QC Laboratories
-
Supporting Utilities & Warehousing
- Site Administration
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FUTURE CSL SEQIRUS AUSTRALIAN OPERATIONS
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CSL Behring Broadmeadows Site
-
Pre-filled Syringe and Vial Fill/Finish
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Raw Materials, Chemistry & Microbiology Quality Control Testing
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Interim Warehousing to support Fill/Finish
Plus 3rd Party Logistics
- Finished Product Warehousing
Plus 3rd Party Logistics
- Raw Material Warehousing
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CSL Seqirus Woodend Site
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-
Venom & Plasma
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Production and QC Animal Testing
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A NETWORK OF SITES TO DELIVER
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New CSL Melbourne Site (Elizabeth Street, Melbourne)
- Virus Development (TD Laboratories)
35
Project Roadmap
Project Delivery (Engineering)
Validation, Licensure & Registration
-
Design
-
Construction
-
Automation
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Commissioning and Qualification
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Process Qualification, Engineering & Media Simulations
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• Process Performance Qualification (PPQ)
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Site Licensure & Product Registration
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Process C&Q
FCC Post-
Tech Transfer FCC
Engineering Runs Process Commercial
and Media Sims Improvement Manufacture
Qualification NH 26/27
window
PPQ
2022 2023 2024 2025 2026
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
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Construction Progress
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Admin & Labs
PNS
Warehouse
FCC
Utility Yard
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Tullamarine Construction Progress
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-
Project achieving milestones
-
Certificate of Occupancy received for Admin building
-
Mechanical & electrical installation complete
-
Full site hand-over to CSL Seqirus on track for April 2024
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FCC and PNS clean rooms practically complete
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On track for process validation in Q4 2024
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Utilities and Process commissioning underway.
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Digital Manufacturing
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Digital Training
Advanced Analytics
Live Viable Cell Density
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Sustainability Certification
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Rooftop Solar
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On site renewable energy generation
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Electrification of plant to reduce reliance on fossil fuels
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Heat recovery from heat decontaminated liquid waste
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Water recovery and reuse
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Ventilation setback operating modes
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Detailed Waste Management / Circular Economy plans to minimise Construction and Operations Waste
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Reuse of recycled materials in construction
CSL Seqirus Tullamarine on track for:
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✓ 5 star Green Star rating - all buildings
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✓ WELL Gold rating - Admin Labs building
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QUESTIONS & ANSWERS
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