3 November 2022

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CSL Highlights Progress Across Strong R&D Pipeline

CSL Limited (ASX:CSL; USOTC:CSLLY) – CSL will today hold its annual Research and Development Investor Briefing.

Please find attached the presentation materials, including a news release outlining highlights across the portfolio.

The briefing for investors and analysts will be held at 9:00am Australian Eastern Daylight Time.

The briefing will be webcast on the Company website at www.csl.com in the ‘Investors’ section. An archived copy of the webcast will be uploaded to the site later in the day.

Authorised by Fiona Mead , Company Secretary

For further information, please contact:

Investors: Bernard Ronchi Stephen McKeon Investor Relations Investor Relations Phone: +613 9389 3470 Phone: +61 402 231 696 Email: [email protected] Email: [email protected]

Media: Jimmy Baker Communications Phone: +61 450 909 211 Email: [email protected]

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Danielle, Living with Primary Immunodeficiency

R&D Investor Briefing November 3, 2022

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 and risk management practices. 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, 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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Inauguration of R&D innovation hub in Marburg, Germany 13 September 2022

Introduction

William Mezzanotte MD

Executive Vice President, Head of R&D Chief Medical Officer

CSL

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01 Welcome 05 Development
Mark Dehring Steve Pascoe
Agenda 02 Introduction, FY22 06 Commercial
Retrospective & Highlights,
Bill Campbell
Combined CSL Portfolio
Bill Mezzanotte
03 Research 07 Looking toward
Andrew Nash FY23 & Summary
Bill Mezzanotte
04 Vaccines 08 Q&A
Jon Edelman Panel
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Dates are all Calendar Years unless otherwise noted

R&D – Supporting CSL’s 2030 Strategy

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• Technology
• Operational
• Excellence
• Plasma
• Products • Capital Project Execution • Recombinants
•
• Delivery • Partnerships Cell & Gene Therapy
• Services • Preventative Vaccines
•
• Iron Therapy
Technology
• Yield
• Immunology
• Haematology
• Transplant • Business
• Respiratory Model
• Cardiovascular • Connected
& Metabolic Healthcare
• Influenza/ • New
Viral Disease Capabilities
• Nephrology/Dialysis
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R&D Highlights – FY22

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Cardiovascular & Metabolic

Immunology

• CSL112 (ApoA - 1)

Garadacimab (Anti-FXIIa) HAE
Phase III study enrolment completed (Last Patient In)
80% enrolment achieved
3rd interim analysis completed
FDA confirmed Fast Track Eligibility
- CSL346 (Anti ~~-~~ VEGF ~~-~~ B) DKD Phase II POC study completed
EMA Orphan Drug Designation granted
BERINERT[®] SC HAE submitted to JP PMDA

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HIZENTRA[®]

Respiratory

Phase II SSc study enrolment completed (Last Patient Last Visit)
EU approval to expand SID indications
Garadacimab (Anti ~~-~~ FXIIa) IPF Phase II study initiated

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Vaccines

Haematology

CSL888 (Haptoglobin) SAH US Orphan Drug Designation granted
aQIVc (cell antigen + MF59[®] ) Phase II study complete
FLUCELVAX[®] Quadrivalent
Etranacogene dezaparvovec
US & Argentina approval 6M+ indication
Primary endpoint achieved in (Haem B gene therapy) HOPE-B study
AU 2yr+ extension
MAA (EU) & BLA (US) submitted
- NZ 9yr+ extension approval
FLUAD[®] Quadrivalent
KCENTRA[®] Trauma
- Adults 50-64yr Phase III study enrolment completed
FDA approval to proceed with Phase III
IDELVION[®] Haem B China CTA filed
AUDENZ  MDV US approval, triggering full ownership transfer of HS to CSL Seqirus

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Partnerships & Alliances

A joint venture founded by CSL, WEHI, & University of Melbourne secured State Government funding to create a biotech start ~~-~~ up incubator in CSL’s new global headquarters, under construction, in Melbourne

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R&D Capacity Expansion

Melbourne: New AU HQ and R&D facilities under construction to house ~800 employees; on track for completion early 2023
Marburg: New R&D Campus to accommodate ~500 employees set to open Sep 2022
Boston: New CSL Seqirus facility in Waltham to be operational in 2022; will host ~300 employees supporting CSL’s R&D portfolio including sa ~~-~~ mRNA technology platform

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Transplant

CSL964 (AAT) prevention of GvHD ~~–~~ MODULAATE Phase III study Part 2 initiated

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Commitment to Research and Development

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$1,156
$1,001
$922
$832
$702
17-18 18-19 19-20 20-21 21-22
R&D investment ~10-11% global revenue
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New Product Development
activities focus on innovative new
therapies for life-threatening diseases
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Market Development strategies seek to bring therapies to new markets and new indications

Life Cycle Management ensures continuous improvement of existing products

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Investment reported in US$ millions; Includes R&D for CSL Behring and CSL Seqirus

Expanding R&D’s Global Footprint

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Tullamarine, AU

Marburg, DE

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Waltham, MA, US

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Melbourne, AU

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Our CSL R&D Footprint - Key Global R&D Locations

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Notable Regional Regulatory Action *

1 July 2021 – 30 June 2022

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SID
fo r the p re ve ntio n o f influe nza
in p e rso ns 6m o s o f ag e +
MMN, MG, LEMS, SPS
fo r the p re ve ntio n o f influe nza
in p e rso ns 6 m o s
o f ag e +
fo r the p re ve ntio n o f influe nza
in p e rso ns 6m o s o f ag e +
Beriate [®] Haemocomplettan [® ] P
Aleviate [®]
vWD prophylaxis
Beriate [®]
CIDP / SID
Albumin (human) [®]
CIDP / SID
Beriplast [®] P
Haemocomplettan [® ] P CIDP
Beriplast [®] P Beriate [®]
Beriplex [®] fo r the p re ve ntio n o f influe nza
in p e rso ns 9 yrs o f ag e +
CIDP
350 0 IU
Beriplast [®] P
for the prevention of influenza
in p e rso ns 2 yrs o f ag e +
fo r the p re ve ntio n o f influe nza in p e rso ns 6m o s o f ag e + fo r the p re ve ntio n o f influe nza in p e rso ns 65 yrs o f ag e +
Excludes CSL Vifor
New Initial Marketing Authorization Approvals New Line Extensions / Indications Approvals
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* Excludes CSL Vifor
10
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Recent CSL News Aligned with R&D Strategy

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Strengthen Our
Core Competencies
Build Strategically
and Scientifically in
our TAs
Explore Disruptive
Innovation
Expand into
Complementary
Disease Areas and
Platforms
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Embrace the External Environment

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Strengthen sa-mRNA
License to TS23 from capabilities through
Translational Sciences partnership with
Haematology Arcturus Therapeutics
Expanded R&D Advance of Internal
Infrastructure & Portfolio across
Incubator Therapeutic Areas
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Global Leadership in Nephrology Empowered by Unique Partnership with Fresenius Medical Care

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STRONG PHARMA EXPERTISE

Development for commercialisation
Clinical development
Manufacturing, regulatory and market access

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GLOBAL LEADER IN DIALYSIS
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~350,000 >54 million >4,200
Kidney disease dialysis Clinics
patients treatments p.a. []
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GLOBAL LEADERSHIP IN NEPHROLOGY THROUGH:

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Close collaboration Access to patient data &
on global scale faster clinical trial
execution
Disease
Insight and
Expertise
Improving outcomes Attractive partner
via treatment algorithms for innovation
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Source: *Fresenius Medical Care Factsheet 2020

Supporting Chronic Kidney Disease Patients Along Their Journey

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Chronic Kidney
Dialysis
Disease
Treatment
Treatment
Prevent Kidney
Transplant
Damage
CSL Immunology
CSL112 Clazakizumab Clazakizumab
Portfolio
Sparsentan INS-3001 SNF472
13
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R&D Portfolio – FY21

Phase I

Phase II

Phase III

Registration/ Post-Registration

Anumigilimab (CSL324) HIZENTRA[®] Garadacimab HAEGARDA[®] AUDENZ™ Anti-G-CSFR mAb(HS) (SSc) Anti-FXIIa mAb(HAE) (HAE) Adjuvanted Monovalent Influenza A (H5N1) Vaccine CSL730 Garadacimab HIZENTRA[®] HIZENTRA[®] rFcMultimer Anti-FXIIa mAb(ILD/IPF) (DM) (SCIg) 20% Liquid AFLURIA[®] QUAD Egg-based Influenza CSL889 PRIVIGEN[®] Vaccine CSL346 Etranacogene Hemopexin (SCD) Anti-VEGF-B mAb Dezaparvovec (IVIg) 10% Liquid FLUAD[®] Trivalent (DKD) (Haem B) CSL787 AFSTYLA[®] Adjuvanted Influenza Vaccine Nebulised Ig rFVIII (HaemA) Adjuvanted Cell Culture KCENTRA[®] Influenza Vaccine 4F-PCC (Trauma) FLUAD[®] Quadrivalent Trabikibart (CSL311) IDELVION[®] (aQIVc) Adjuvanted Influenza Anti-Beta Common mAb CSL1 1 2 rFIX-FP (Haem B) Vaccine Mavrilimumab apoA-I (AMI) Eblasakimab (CSL334) ZEMAIRA[®] /RESPREEZA[®] FLUCELVAX[®] Anti-GM-CSFR mAb (GCA, Anti-IL-13R mAb(AD) COVID) Clazakizumab Alpha-1 Antitrypsin Quadrivalent Cell-based InfluenzaVaccine Anti-IL-6 mAb(AMR) FOCLIVIA[®] /AFLUNOV[®] Adjuvanted Egg-based PANVAX[®] CSL964 Influenza A (H5N1) Vaccine Egg-based Influenza Alpha-1Antitrypsin Vaccine (Treatment of GvHD) CSL964 Alpha 1Antitrypsin (Prevention of GvHD)

Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Vaccines Outlicensed Programs Partnered Projects

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R&D Portfolio – FY22

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Registration/
Phase I Phase II Phase III Post-Registration
Anumigilimab (CSL324) HIZENTRA [®] Garadacimab HAEGARDA [®] AUDENZ™
Anti-G-CSFR mAb(HS) (SSc) Anti-FXIIa mAb(HAE) (HAE) Adjuvanted Monovalent
Influenza A (H5N1) Vaccine
CSL730 Garadacimab HIZENTRA [®] HIZENTRA [®]
rFcMultimer Anti-FXIIa mAb(ILD/IPF) (DM) (SCIg) 20% Liquid AFLURIA [®] QUAD
Egg-based Influenza
CSL889 PRIVIGEN [®] Vaccine
CSL346 KCENTRA [®]
Hemopexin (SCD) Anti-VEGF-B mAb 4F-PCC (Trauma) (IVIg) 10% Liquid
FLUAD [®] Trivalent
(DKD)
CSL787 AFSTYLA [®] Adjuvanted Influenza
CSL1 1 2 Vaccine
Nebulised Ig rFVIII (HaemA)
Clazakizumab apoA-I (AMI)
Anti-IL-6 mAb(ESKD) FLUAD [®] Quadrivalent
Trabikibart (CSL311) IDELVION [®]
Anti-Beta Common mAb Adjuvanted Cell Culture Anti-IL-6 mAb(AMR) Clazakizumab rFIX-FP (Haem B) Adjuvanted InfluenzaVaccine
Influenza Vaccine
(aQIVc) CSL964 Etranacogene FLUCELVAX [®]
Alpha-1Antitrypsin Dezaparvovec Quadrivalent
(Haem B) Cell-based InfluenzaVaccine
Mavrilimumab (Treatment of GvHD)
Anti-GM-CSFR mAb (GCA,
COVID) CSL964 ZEMAIRA [®] /RESPREEZA [®] PANVAX [®]
Alpha 1Antitrypsin Alpha-1 Antitrypsin Egg-based InfluenzaVaccine
(Prevention of GvHD)
Eblasakimab (CSL334)
FOCLIVIA [®] /AFLUNOV [®]
Anti-IL-13R mAb(AD)
Adjuvanted Egg-based
Influenza A (H5N1) Vaccine
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Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Vaccines Outlicensed Programs Partnered Projects

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Combined CSL & CSL Vifor R&D Portfolio – FY22

Registration/Post-Registration

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|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|Phase|I|Phase|II|Phase III|Registration/Post-Registration|
|Anumigilimab|(CSL324)|HIZENTRA|[®]|Garadacimab|INJECTAFER|[®]|HAEGARDA|[®]|FLUAD|[®]|Quadrivalent|
|Anti-G-CSFR mAb(HS)|(SSc)|Anti-FXIIa mAb(HAE)|(Ferric carboxymaltose)|(HAE)|Adjuvanted Influenza|
|(HF-ID)|Vaccine|
|CSL730|TS23|HIZENTRA|[®]|HIZENTRA|[®]|
|rFcMultimer|α2AP mAb (PE)|(DM)|Sparsentan|(SCIg) 20% Liquid|FLUCELVAX|[®]|
|Dual ETA & AT1 antagonist|Quadrivalent|
|Cell-based InfluenzaVaccine|
|CSL889|Garadacimab|KCENTRA|[®]|(FSGS)|PRIVIGEN|[®]|
|Hemopexin (SCD)|Anti-FXIIa mAb(ILD/IPF)|4F-PCC (Trauma)|(IVIg) 10% Liquid|PANVAX|[®]|
|Sparsentan|
|Egg-based Influenza Vaccine|
|CSL787|Clazakizumab|CSL1 1|2|Dual ETA & AT1 antagonist|AFSTYLA|[®]|
|(IgAN)|rFVIII (HaemA)|
|Nebulised Ig|Anti-IL-6 mAb(ESKD)|apoA-I (AMI)|
|FERINJECT|[®]|
|Trabikibart|(CSL311)|Adjuvanted Cell Culture|Clazakizumab|SNF472|IDELVION|[®]|Ferric carboxymaltose|
|Anti-Beta Common mAb|Influenza Vaccine|Anti-IL-6 mAb(AMR)|Calcification inhibitor|rFIX-FP (Haem B)|(ID)|
|(aQIVc)|(CUA-ESKD)|
|INS-3001|CSL964|Etranacogene|KORSUVA||/KAPRUVIA|[®]|
|Calcification inhibitor|Mavrilimumab|Alpha-1Antitrypsin|SNF472|Dezaparvovec|KOR. agonist|
|(PAD, AVS)|Anti-GM-CSFR mAb|(Treatment of GvHD)|Calcification inhibitor|(Haem B)|(CKD-aP)|
|(PAD-ESKD)|
|(GCA, COVID)|
|CSL964|ZEMAIRA|[®]|/RESPREEZA|[®]|RAYALDEE|[®]|
|Eblasakimab|(CSL334)|Alpha 1Antitrypsin|ARCT-154|Alpha-1 Antitrypsin|Oral ext. release calcifediol|
|(Prevention of GvHD)|COVID-19 Vaccine|(SHPT)|
|Anti-IL-13R mAb(AD)|
|FOCLIVIA|[®]|/AFLUNOV|[®]|
|Adjuvanted Egg-based|TAVNEOS|[®]|
|VAMIFEPORT|Influenza A (H5N1) Vaccine|
|Oral C5a receptor inhibitor|
|Ferroportin inhibitor|
|(AAV)|
|(SCD)|AUDENZ™|
|Adjuvanted Monovalent|VELPHORO|[®]|
|Influenza A (H5N1) Vaccine|
|Sucroferric oxyhydroxide|
| Transaction with Arcturus Therapeutics is subject to|(Serum Phosporous control in|
|AFLURIA|[®]|QUAD|
|customary regulatory clearances before closing|CKD)|
|Egg-based Influenza|
|Vaccine|
|VELTASSA|[®]|
|Immunology|Haematology|Respiratory|Cardiovascular & Metabolic|Transplant|FLUAD|[®]|Trivalent|Oral potassium binder|
|(HK)|
|Adjuvanted Influenza|
|Vaccines|CSL Vifor|Outlicensed Programs|Partnered Projects|Vaccine|

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Research

Pipeline Building Through External Innovator Engagement

Andrew Nash PhD Senior Vice President, Research Chief Scientific Officer CSL

CSL External Innovator Engagement

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Creating investable opportunities

Early discovery/ Stage 0 portfolio
Research Acceleration Initiative (RAI)
WEHI / CSL Centre for Biologic Therapies

Direct investment

VC / accelerator investment
Investment in start-ups

Developing innovation ecosystem

People & skills / Infrastructure & technology
Bio21 Global Research Hub
Biotech Incubator partnership
CSL Melbourne & Tullamarine facilities

Research External Innovation Strategy

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Parkville
Bern
Marburg
Pasadena
Global
Philadelphia
Research site
locations
Partnerships
WEHI
with Global funding Research
Uni. Melbourne
universities, & collaboration Acceleration
SCRI
MRIs, hospitals, initiatives Initiative (RAI)
Uni. Zurich
biotechs
CSL
Research
Pipeline
Partnerships Brandon Capital
Scouting &
with StartX
disruptive
incubators, Science Center
technology
accelerators & Biopôle
reviews
venture funders BaseLaunch
Partnering
conference
attendance &
sponsorship
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Abbreviations: MRI – Medical Research Institute; SCRI – Seattle Children’s Research Institute; VC – Venture Capital

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CSL External Innovator Engagement

External collaboration and engagement delivers a robust and on-strategy Stage 0 portfolio

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Research
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CSL Research Acceleration Initiative Seeking Expressions of Interest from Research Organisations

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Phase l
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Launch
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Enter Enter Enter
Research Development Phase I FIH
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Abbreviations: FIH – First-in-Human; SG – Stage Gate; Tox – Toxicology

CSL External Innovator Engagement

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Stage 0 Collaborations

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Novel targets / therapeutics
Platforms, models, biomarkers, tools, etc.
Direct engagement with local CSL scientists
Products enter through RAI

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Abbreviations: RAI – Research Acceleration Initiative

CSL External Innovator Engagement

Stage 0 Portfolio

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TA Classification of Stage 0 Projects
(%)
15%
22%
15%
18%
15%
15%
Total = 33 projects
Immunology Haematology Respiratory
Cardiovascular
Transplant Platform/ non-TA-aligned
& Metabolic
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An iCa-L peptide antagonist for familial HCM
Results preventive approach
Prof. Livia Hool
Hypercontractility
Metabolic activity
60
Cardiac fibrosis
50
Cardiac hypertrophy
40 Better Left ventricular outflow
tract (LVOT) parameters
30
Scr. Mutants 1-4 4 peptides tested
WT cTnI-G203S
2 selected
Fractional shortening (%)
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Abbreviations: HCM - Hypertrophic Cardiomyopathy; TA – Therapeutic Area; WT – Wild Type

CSL External Innovator Engagement

Biotech Incubator Partnership

Space for up to 40 start-ups

1,400m[2] wet lab space (214 benches)
$95m project housed across two floors located at CSL’s new global corporate headquarters
Run by independent, experienced operator
Lab space, office space, suites, meeting rooms including board room, co-working spaces & event spaces
Target launch date early 2024
Expressions of interest: [email protected]

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1,700m[2] office space (143 desks)

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Support Services Community & Education
& Coordination Network
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CSL External Innovator Engagement

Biotechnology Key Ingredients for a Successful Incubator Incubator Co-location with global, industry anchor Location in well-established hub of science & technology Affordable wet-lab & office space Access to support services & state-of-the-art equipment / facilities Facilitated introductions to investors (access to capital) Mentoring, commercialization, education & programming Proximity to Central Business District Proximity to public transport

[email protected]

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CSL External Innovator Engagement Cicada Innovations Appointed as Incubator Operator

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Australia’s Flagship Deep Tech Incubator

20 years experience in developing ventures
Sydney based incubator supports deep tech innovators with: - cutting edge labs & offices - training & mentoring
connection to investors, partners, policy makers

Two Decades of Impact

326+ Start-ups incubated $1.5B Collectively raised by start-ups $1.3B In exits from 6 deep tech ventures 500+ Patents & trademarks filed 1,000’s Jobs created & people trained

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Garadacimab (Discovery – Development – Medicine)

Garadacimab potently inhibits αFXIIa, shutting down multiple biological pathways

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FXI → FXIa FXIIa - Auto-activation FXII +FXIIa/β FXII
Haemostasis
Macrophage / fibroblast biology
Thrombosis
PK → KAL βFXIIa Plasminogen
Fibroblast/
HK → BK→ BR2 C1qr,s → C1qr,s Plasmin endothelial cell/immune cells
Vasodilation Complement Fibrinolysis Mitogenesis
activation Inflammation
Vascular leakage / HAE
Fibrosis
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* Feedback loops removed for simplicity

Abbreviations: BK - Bradykinin; B2R – B2 Receptor; C1-INH – C1 Inhibitor; HAE – Hereditary Angioedema; HMWK – High Molecular Weight Kininogen; KAL – Kallikrein; PK – Plasma Kallikrein; PPK - Plasma Pre-kallikrein

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Garadacimab (Discovery – Development – Medicine)

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External Partners
Uni. Würzburg: FXII / thrombosis, data & IP
FXIIa Antagonist mAb – thrombosis, ECMO
Proof of concept Human FXIIa blocking
with Infestin mAb / Garadacimab
Renné, T. et al,.(2005) J. Exp. Med. 202(2):271-281
98.94% Previous R&D Investor Day
Mean Reduction
Initial focus on thrombosis
HAE as target indication
CSL  global leader in
FXIIa therapeutics
Placebo Garadacimab
200mg
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Abbreviations: ECMO – Extra Corporeal Membrane Oxygenation; IP – Intellectual Property; HAE – Hereditary Angioedema; mAb – Monoclonal Antibody

CIDP is a Complex Autoimmune Disease

Role of IgG autoantibodies in disease onset & progression is unclear
Response to FcRn inhibitors dependant on the central role of IgG autoantibodies in disease pathology

Plasma half-life

FcRn Inhibitors

FcR γ Disease Cellular mech. Complement

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FcRn
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Global decrease in circulating IgG

10-40% of normal
Safety?
Variable efficacy?
residual IgG - IgM & IgA

Autoantibody e.g., ITP / anti-platelet Ab, MG / anti-AChR Ab

CSL IVIG

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CSL Development CSL730 Ph I

CSL Research FcRn inhibitors, dual FcR γ / FcRn, Complement inhibitors

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Abbreviations: Ab – Antibody; Anti-AChR - Anti-acetylcholine Receptor; FcRn -Neonatal Fc Receptor; IgA – Immunoglobulin A; IgG – Immunoglobulin G; IgM – Immunoglobulin GM; ITP - Immune Thrombocytopenia; MG – Myasthenia Gravis

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Jon Edelman MD

Vaccines

Vice President, Clinical Development Interim Head, CSL Seqirus Vaccines Innovation Unit CSL

Targeting Unmet Need in Influenza & Beyond

Influenza Vaccines are Inconsistently Effective Season to Season

US CDC Seasonal Flu Vaccines Effectiveness

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70
60
60 56
52
49
48
50 47
40
39
38
40
35
29
30
19
20
10
0
Percent Effective
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Flu Season

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Source: CDC Seasonal Flu Vaccine Effectiveness Studies | CDC https://www.cdc.gov/flu/vaccines-work/effectiveness-studies Abbreviations: CDC – Centre for Disease Control & Prevention

Recommended Vaccine Viruses May Not Match with Circulating Flu

WHO continually isolate and characterize influenza viruses in circulation in humans
WHO Collaborating Centers determine the antigenic relatedness of these strains
Viruses are mapped to enable the selection of a candidate vaccine virus (CVV) for each flu subtype for each flu season

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Antigenic Distance
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Prior to 2016, all CVVs were grown in eggs

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Antigenic Distance
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Abbreviations: WHO – World Health Organisation

Recommended Vaccine Viruses May Not Match with Circulating Flu

In 2012, the CVV that WHO chose was antigenically distant from the majority of circulating H3N2 viruses

EGG VACCINE VIRUSES

A/Victoria A/Texas

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Abbreviations: CVV – Candidate Vaccine Virus; WHO – World Health Organisation

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Antigenic Distance

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Frequency of H3N2 Egg-adaptation Mismatch over Time

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Adaptation of viruses grown in eggs results in poorer antigenic match to circulating viruses compared to viruses grown in cells

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Since 2016, WHO makes separate cell and egg seed seasonal strain recommendations

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Wild-type A/H3N2 Collection Date

Egg-based CVV Cell-based CVV

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Source: Rajaram, S. et al. , (2020) Int. J. Environ. Res. Public Health 17(15): 5423. doi:10.3390 / ijerph17155423

Cell-based Vaccines are Designed to Provide a Better Match to WHO-selected Flu Virus Strains

Cell-Based Vaccine

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Circulating
Egg-Based
Strains
Vaccine
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Real World Evidence – Showing Benefit of Cell-based Influenza Vaccines to Reduce Strain Mismatch

Flucelvax[®] QUADRIVALENT - Benefit of Cell Culture

Comparator Study Season Age Group Outcome*	Comparator Study Season Age Group Outcome*	Comparator Study Season Age Group Outcome*		% rVE (95%CI)	% rVE (95%CI)

QIV Boikos (2020) 2017/18 ≥4 GP				3	6 (26, 45)
QIV Divino (2020) 2017/18 4-64 Hospitalizatio		n		1	4 (9, 20)
QIV Boikos (2021) 2018/19 ≥4 Hospitalized o ED/GP		r			8 (7, 9)
QIV Krishnarajah (2021) 2018/19 4-64 Hospitalizatio		n			7 (0.1, 13)

QIV CORE (2021) 2019/20 ≥4 Hospitalized o ED/GP		r		1	7 (16, 19)
QIV HEOR (2021) 2019/20 4-64 Hospitalizatio		n			5 (1, 10)

-10 Favours Comparator	-10		10

*Outcomes due to influenza or pneumonia

2017/18 was the first season a cell-based seed (H3N2) was included in FLUCELVAX[® ] QUADRIVALENT. The outcomes reported in these publications contain information not included in the Prescribing Information. These studies provide data across 3 US influenza seasons with different study designs, outcomes, and study limitations comparing the relative vaccine effectiveness (rVE) of FLUCELVAX[® ] QUADRIVALENT compared to traditional, egg-based influenza vaccines. In seasons where egg adaptation occurs, studies suggest FLUCELVAX[® ] QUADRIVALENT has the potential to be more effective than traditional, egg-based vaccines.

Source: Boikos, C. et al ., (2020) CID 73:816-823; CORE (2021): Presented at ECCMID 2021,; HEOR (2021): Manuscript pending; RWE studies from across 4 US influenza seasons with different study designs, outcomes, and study limitations assessed the relative vaccine effectiveness of FLUAD compared to a high-dose influenza vaccine.

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Immunosenescence and Comorbidities Contribute to Higher Mortality in Older Adults

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Influenza Mortality Rate during the 2019-2020 flu
season in the United States, by age group
0-4 years
1.8
5-17 years
0.3
18-49 years
1.6
50-64 years
9.1
65+ years
22.1
0 5 10 15 20 25
Rate per 100,000 population
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Source: CDC [(National Center for Immunization and Respiratory Diseases (NCIRD)] © Statista 2022; United States: CDC [(National Center for Immunization and Respiratory Diseases (NCIRD)] 2019-2020 Abbreviations: CDC – Centre for Disease Control & Prevention

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Adjuvanted Vaccines Increase the Immune Response in Vulnerable Individuals

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Circulating
Strains
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MF59[®] Adjuvanted Egg-Based Vaccine

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Real World Evidence – Benefit of MF59[® ] Adjuvanted Influenza Vaccine

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FLUAD
Comparator Study Benefit of MF59 Season Outcome [® ] Adjuvanted Influenza Vaccine % rVE (95%CI)
Hospitalized
TIV Boikos (2020) 2017/18 8 (4, 10)
or ED/GP
Hospitalized
TIV Pelton (2020) 2017/18 11 (2, 19)
or ED
TIV Pelton (2020) 2017/18 GP 25 (17, 32)
Hospitalized
TIV Boikos (2020) 2018/19 26 (18, 32)
or ED/GP
Hospitalized
QIV Boikos (2020) 2017/18 18 (16, 21)
or ED/GP
Hospitalized
QIV Pelton (2020) 2017/18 9 (1, 16)
or ED
QIV Pelton (2020) 2017/18 GP 36 (31, 41)
Hospitalized
QIV Boikos (2020) 2018/19 28 (26, 30)
or ED/GP
Hospitalized
QIV CORE 2021 2019/20 28 (24, 31)
or ED/GP
Hospitalized
HD-TIV Boikos (2020) 2017/18 8 (2, 13)
or ED/GP
Hospitalized
HD-TIV Pelton (2020) 2017/18 3 (-3, 9)
or ED
HD-TIV Pelton (2020) 2017/18 GP 17 (11, 22)
Hospitalized
HD-TIV Boikos (2020) 2018/19 7 (3, 11)
or ED/GP
Hospitalized
HD-TIV Pelton (2021) 2018/19 7 (3, 10)
or ED
HD-TIV Pelton (2021) 2018/19 GP 2 (-4, 7)
Hospitalized
HD-TIV CORE 2021 2019/20 14 (11, 17)
or ED/GP
Hospitalized
HD-TIV HEOR 2021 2019/20 3 (-3, 9)
or ED
-10 10 30 50
Favours Comparator
Favours FLUAD
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Source: Boikos, C. et al ., (2020) CID 73:816-823; Pelton, S.I. et al. , (2020) Vaccines 8:446; Pelton, S.I. et al., (2021) Vaccine 39:2396-2407; CORE (2021): Presented at ECCMID 2021,; HEOR (2021): Manuscript pending; RWE studies from across 4 US influenza seasons with different study designs, outcomes, and study limitations assessed the relative vaccine effectiveness of FLUAD compared to a high-dose influenza vaccine. Abbreviations: CI - Confidence Interval; ED - Emergency Department; GP - General Practitioner; (r)VE - (relative) Vaccine Effectiveness; TIV /QIV – standard dose Trivalent/ Quadrivalent Vaccine; HD - High Dose

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Higher Doses of Antigen Can Increase Immune Response in Older Adults

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Circulating
Strains Higher Dose
Egg-Based Vaccine
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Preferentially Recommended by CDC Over Standard-dose Influenza Vaccines

For persons 65 years and older:

Adjuvanted egg-based vaccine
Higher dose egg-based vaccine
Recombinant-based vaccine

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aQIVc - Combining Adjuvant & Cell Technologies & Boosting the Dose of Each to Improve Vaccine Effectiveness

3 Proven Flu Vaccine Technologies

~~Circulating~~ Strains

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High Dose MF59[®] Adjuvanted Cell-Based Vaccine

Phase III – NH 2023

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Continued Focus on Next Generation mRNA Vaccines

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Next Generation mRNA Technology: Self-amplifying mRNA

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Antigen Gene
Antigen
Replicase Genes Antigen Gene
Replicase
Antigen
Complex
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Advantages over conventional mRNA vaccines

Lower dose to achieve comparable antigen levels with potential for better tolerability
Ability to entrain multiple antigens in one sa-mRNA
More complete activation of immune system

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Source: Bloom, K. et al. , (2021) Gene Ther. 28: 117–129. https://doi.org/10.1038/s41434-020-00204-y

Abbreviations: CSE - Conserved Sequence Element; mRNA – Messenger RNA; RNA - Ribonucleic Acid; sa-mRNA – self-amplifying mRNA; UTR - Untranslated Region

Engaged Immune System = More Protection

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Humoral
Serum Mucosal
antibodies antibodies
(IgG) (IgA)
Protect Prevent
Lungs Infection
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Cellular
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Amplify Reduce
Humoral Viral
Activate
Response Spread
Immune
Memory
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Abbreviations:: IgA – Immunoglobulin A; IgG – Immunoglobulin G

sa-mRNA Bicistronic Vaccines Co-express HA & NA

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sa-mRNA mono and bicistronic HA/NA vaccine
NA
HA
5’UTR NSP1 NSP2 NSP3 NSP4 HA 3’UTR PolyA
SGP
Replicase Genes
Influenza
virus 5’UTR NSP1 NSP2 NSP3 NSP4 NA 3’UTR PolyA
SGP
Replicase Genes
5’UTR NSP1 NSP2 NSP3 NSP4 HA NA 3’UTR PolyA
SGP SGP
Replicase Genes
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Haemagglutinin (HA) & Neuraminidase (NA) are two viral surface proteins

HA –main antigen in most licensed influenza vaccines
NA – more highly conserved than HA
sa-mRNA monocistronic strategy expresses HA or NA antigens
sa-mRNA bicistronic strategy co-expresses HA & NA antigens

Source: Chang, C. et al ., (2022) Mol. Ther. Meth. & Clin. Dev . (27): 195-205 Abbreviations: NSP - Non-structural Protein; RNA - Ribonucleic Acid; SGP - Sub Genomic Promoter; UTR - Untranslated Region

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Protection of Ferrets from Influenza Infection by sa-mRNA HA-NA Vaccines

H1 Dose:

N1 5.0 µ g H1N1 0.5 µ g

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1 [st] IM/Prime 2 [nd] IM/Boost Challenge Evaluate
Day 1 22 50 54
Nose
Lung
8 8
6 6 •
4 4
2 2 •
0 0
Dose (µg) Dose (µg) Dose ( Dose (µg) µg)
H1-N1 5.0H1-N1 0.5H1 5.0N1 5.0 PBS H1-N1 5.0H1-N1 0.5H1 5.0N1 5.0 PBS
GMT GMT
log10 TCID50/gr log10 TCID50/gr
Virus Recovered
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Vaccine and challenging viruses A/Netherland/602/2009 (H1N1)

Full protection of lung with mono- & bivalent HA-NA sa-mRNA vaccines
Near complete protection with bivalent HA-NA at 1/10[th] dose of HA alone

Source: Chang, C. et al. , (2022) Mol. Ther. Meth. & Clin. Dev . (27):195-205 Abbreviations: IM - Intramuscular

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Robust Anti-HA and Anti-NA Neutralizing Antibody Against Seasonal Strains by Quadrivalent sa-mRNA HA-NA Vaccines

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1 [st] IM/Prime 2 [nd] IM/Boost
Day 1 22 43
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H1N1 H1N1
Dose:
H3N2 H3N2
100 ng
10 ng
Bvic Bvic
1 ng
Byam Byam
Mono Quad
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Both monovalent and quadrivalent bicistronic sa-mRNA vaccines

Raised neutralizing antibodies against HA and NA in a dose dependent manner
Doses as low as 1 ng were effective in generating measurable neutralization of each viral subtype

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mRNA Phase I – initiating 2023

Source: Chang, C. et al. , (2022) Mol. Ther. Meth. & Clin. Dev . (27):195-205 Abbreviations: IM - Intramuscular

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Collaboration with Arcturus Therapeutics* - COVID-19 & More Topline data from ongoing Phase I/II/III study evaluating ARCT-154 (Arcturus’ sa-mRNA vaccine candidate against COVID-19 disease caused by SARS-CoV-2 virus)

Evaluation of vaccine efficacy demonstrated study met primary endpoint of prevention of virologically confirmed COVID-19 disease
19,000 adult subjects enrolled in Ph I/II/III registrational study
95% efficacy overall for prevention of severe COVID-19 disease including related deaths
16,000 subjects enrolled in Ph III placebocontrolled efficacy portion of study
Study conducted when Delta & Omicron variants were dominant in Vietnam
55% efficacy overall for preventing symptomatic COVID-19 disease
Incidence of unsolicited adverse events with ARCT154 similar to placebo; No reported cases of myocarditis or pericarditis

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Phase I/II/III – Ongoing

ARCT-154 to advance into pivotal booster trial in major markets
Transaction with Arcturus Therapeutics is subject to customary regulatory clearances before closing Source: Arcturus Therapeutics News Release April 2022 https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-announces-self-amplifying-covid-19-mrna-vaccine

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Arcturus Therapeutics Complements CSL Seqirus’ Long-term Strategy in Vaccines

Benefits from Arcturus Therapeutics Collaboration*

Faster clinical development with higher probability of success Application to additional pathogens, including those with pandemic potential

Access to an established manufacturing network Access to LNP & lipid library with application across vaccines

Transaction with Arcturus Therapeutics is subject to customary regulatory clearances before closing Abbreviations: LNP – Lipid nanoparticle

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Future offerings of our Vaccine Programs Across the Spectrum of Need in Influenza and Beyond

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Cell-based QIVc

Maximise coverage, reduce force of infection in all ages

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Adjuvanted cell aQIVc

High efficacy, well tolerated, for at risk populations

Next generation mRNA Efficacy, tolerability, speed of response Flexibility for flu and beyond

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Source: https://www.cdc.gov/flu/about/burden/2019-2020.html

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Steve Pascoe MD

Development Key Program Updates

Senior Vice President, Clinical & Therapeutic Area Strategy CSL

CSL112 Apolipoprotein A-I (Human) - AEGIS-II

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18,000 Acute Myocardial Screening Randomisation Infarction (AMI)

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1 ° Endpoint : MACE MACE Follow Up
D90 D180 D365
CSL112
Placebo
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Recruitment on track for LPI December 2022
Launch on track for Q4 2025

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Phase III – Ongoing

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CSL112
particles
ABCA1
Intracellular transporter
cholesterol
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Garadacimab - Disruptive Innovation to Improve Treatment Options for HAE Patients

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Phase III - Double-blind, placebo-controlled, randomised clinical study evaluating efficacy & safety of SC Garadacimab for the prophylaxis of HAE Attacks

Differentiated, Patient-Focused Profile

Primary & key secondary efficacy endpoints achieved with high degree of statistical significance & clinically meaningful differences vs. placebo
Differentiated profile
Convenient administration (AI): Quick (<15 sec) & easy delivery
Study results to be presented at upcoming congress & published in peer-reviewed journal
True once-monthly treatment dosing
Favorable safety & tolerability profile

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Global submissions targeted 2023

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Abbreviations: AI – Autoinjector; HAE – Hereditary Angioedema; SC – Subcutaneous

Pulmonary Embolism Affects Millions Worldwide and Remains a Major Cause of Death

Submassive PE (sPE)

Acute cardiovascular disorder where thrombus (blood clot) obstructs lung blood flow
Causes acute strain of the right side of heart (RV:LV) w/o haemodynamic instability
Mortality: 7% (≤30 days)
SOC is anticoagulation only
Current treatment with recombinant tissue plasminogen activator has unacceptable major bleeding risk (~6%)
There is need for safer, effective treatment that dissolves thrombi and does not cause serious bleeding

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Before

After

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Source : PIOPED Investigators (1990), Chest 97(3); 528-533. https://doi.org/10.1378/chest.97.3.528 Abbreviations: RV – Right ventricular; LV – Left ventricular; SOC – Standard of Care

TS23 is a Novel, Proposed Safe, Effective Therapy for Dissolving Thrombosis with Minimal Bleeding Risk

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Thrombus Dissolution Pathway

TS23 - first-in-class, therapeutic mAb targeting alpha-2-antiplasmin (α2AP)
α2AP blocks dissolution of acute cardiovascular thrombi
α2AP inactivation allows endogenous (local) plasmin activity normally generated in a thrombus to dissolve it, thereby avoiding a systemic lytic state & associated bleeding risk

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endogenous Thrombus
uPA tPA TS23 α 2AP
Plasminogen Plasmin
Dissolved thrombus
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TS23 - safe and effective in Phase I HV
Dose related inactivation α2AP (up to 95%)
Thrombus dissolution ex vivo and inc. D-dimers in vivo

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Phase II – Q4 2022
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Source: Singh, S. et al ., (2017) Circulation 135(11):1011-1020. doi: 10.1161/CIRCULATIONAHA.116.024421. Abbreviations: HV – Healthy volunteers; mAb – Monoclonal Antibody; tPA - tissue Plasminogen Activator; uPA – urokinase plasminogen activator

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TS23 dissolves experimental pulmonary emboli
without increasing bleeding

90
60

60
40
20 30
0 0
Control TPA TS23 Control TPA TS23
Bleeding (Hgb loss)
Embolism Dissolution (%)
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Haematology

Etranacogene Dezaparvovec Gene Therapy (AAV5-Padua FIX) for Treatment of Haemophilia B

Improvement in ABR of Specific Bleed Types

Key Results from Phase III HOPE-B Trial

Pivotal Phase III study (HOPE-B) showed superiority (annual bleeding rate, ABR) compared to standard of care
Stable & durable FIX expression to near normal levels demonstrated following treatment:
At 18 months steady-state, total number of annual bleeds decreased by 64% compared
24 month data are comparable

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Launch – US & EU Q1 2023

One-sided p-value ≤0.025 for post-treatment/lead-in <1 is regarded as statistically significant Source: Clinical trial AMT-061-02 2-year Clinical Study Report

Abbreviations: ABR – Annual Bleeding Rate; AJBR – Annualised Joint Bleeding Rate; aPTT – Activated Partial Thromboplastin Time; ASBR – Annualised Spontaneous Bleeding Rate

Etranacogene dezaparvovec reduced ABR by 64% and demonstrated superiority to prophylaxis*

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Uncontaminated Central Laboratory One-Stage (aPTT-based) FIX
Activity during Post-treatment Period
Number of Visit (Weeks)
Subjects with 54 43 49 51 47 46 48 46 44 46 51 48 45 51 47 45 51 50 50 50 50
Data
One-Stage aPTT Factor IX Activity (%)
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Haematology

Etranacogene Dezaparvovec Gene Therapy (AAV5-Padua FIX) for Treatment of Haemophilia B

Etranacogene dezaparvovec is a result of CSL’s ongoing commitment to further develop treatments for haemophilia B that address unmet medical needs

AAV5 vector gene therapy with key differentiating factors:

Predicted Cumulative Proportion Of Participants With Factor IX Activity Levels

Single dose gene therapy not requiring concomitant steroid therapy
Effective in a broad set of patients
Steady state FIX activity levels without peaks & troughs associated with prophylactic FIX infusions
Improved quality of life, return to normal physical activities, & freedom from routine infusions
ICER draft report on etranacogene dezaparvovec estimates durability at 23 years

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N=1000 16.9%
14.1%
12.2%
10.8%
8.9%
7.0%
5.5%
4.7%
3.7%
2.1% [2.7%]
[1.4%]
0% 0% 0% 0% 0% 0% 0% [0.1%] [0.2% 0.2% 0.2% 0.3% 0.7% 0.9%]
0 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5
Years since 6-month post-infusion
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Source: Shah, J., et al. (2022) Curr Med Res Opin. 25: 1-11. doi: 10.1080/03007995.2022.2133492. Abbreviations: AAV5 - Adeno-associated virus 5; ICER - Institute for Clinical and Economic Review; NAb – Neutralising Antibodies

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Clazakizumab in AMR

50% of All Kidney Transplants Fail by Year 10; AMR Implicated in 57-63% of Graft Losses

IL-6 induces donor-specific antibodies (DSAs) leading to renal tissue damage

Chronic AMR:

Graft loss leads to low quality of life, dialysis, retransplantation and/or death; high resource burden
No approved treatments; clazakizumab would be firstline treatment

Anti-inflammatory and immune modulatory effects of IL-6 blockade:

Reduces plasmablasts & proinflammatory T cells
Increases Treg cells
Decreases DSA production
Reduces IL-6 production in activated ECs and subsequent reduction in vasculopathy

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IL-6 Clazakizumab
Donor Specific
Antibodies
IL-6 Producing
Plasma Cell
Plasmablast
Germinal Center IL-6 Clazakizumab
CD4+ Tfh Bcl-6+
CXCR5+ Naïve B-cell CD4+ Th17
cell
T naïve cell
HLA Class III
DSA Activates IL-6 Normal EC
Production in EC
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Source: Adapted from Jordan, S. et al ., (2017) Transplantation. 101 (1): 32-44. Abbreviations: AMR – Antibody-Mediated Rejection; EC – Endothelial Cells; HLA - Human Leukocyte Antigen; DSA – Donor Specific Antibodies

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Clazakizumab Stabilizes Kidney Function & Improves Histologic Evidence of Rejection

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Results from Phase II randomized, placebocontrolled trial in late AMR

Clazakizumab slows eGFR decline by 60% after 12 weeks (model-based prediction)[1]
In 51 week biopsies, clazakizumab decreased molecular AMR and “all rejection” scores

**Mean eGFR Slopes (Solid Lines) In Relation To Treatment In Part A[*]**

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Clazakizumab Placebo
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Part A: Mean eGFR decline in Clazakizumab group was slower compared with placebo

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Source: 1. Doberer, K. et al. , (2021) J Am Soc Nephrol. 32: 708-722. Abbreviations: AMR – Antibody-Mediated Rejection; eGFR - estimated Glomerular Filtration Rate

IMAGINE Clazakizumab for chronic AMR treatment study

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Treatment Phase: Day 1 to Week 260
Dosing with Clazakizumab 12.5 mg SC injection, Q4W (until graft loss or death): N=175
V2: Day 1 V68: Wk 260 Follow-up
V1 BL Assessments EOS Assessments (monthly)
Screening
Day -42 to -1
Dosing with Placebo 1 mL SC injection, Q4W (until graft loss or death): N=175
V2: Day 1 V68: Wk 260 Follow-up
BL Assessments EOS Assessments (monthly)
• Interim Analysis #2: 200 subjects • Final Analysis: 350 subjects
• Change from baseline in mean eGFR at Week 52 • Event driven (all-cause composite allograft loss, eGFR decrease)
• Full approval globally – 2032 Launch
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Conditional Approval US - 2025

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Abbreviations: BL – Baseline; eGFR - estimated Glomerular Filtration Rate; EOS - End of Study; Q4W – every 4 weeks; SC – Subcutaneous

Clazakizumab in Dialysis

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Dialysis is the most common treatment modality in ESKD

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350k
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>550k

>370k

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≃ 130k new cases annually
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≃ 80k new cases annually
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≃ 40k new cases annually
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Very High Unmet Need 160 deaths per 1,000 patients annually

Currently no proven treatments to reduce CV events in dialysis

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Role of inflammation

Inflammation common in dialysis and strongly associated with CV events, central role of IL-6
Strong science supporting link between IL-6 and CV events

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Abbreviations: CV – Cardiovascular; ESKD – End Stage Kidney Disease

CLAZAKIZUMAB in Dialysis

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To demonstrate that IL-6 antagonism with clazakizumab will reduce CV events in dialysis patients
An “Operationally Seamless” Phase IIb/III combined dose ranging (Phase IIb) and CV outcome trial (Phase III)
Novel design to shorten development timeline received favorable feedback from FDA, EMA, PMDA
Leverage Fresenius Medical Care study sites

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Clazakizumab low dose IV Q4w (n=30) Clazakizumab TBD mg IV Q4w (n=1095)
Clazakizumab medium dose IV Q4w (n=30)
Clazakizumab high dose IV Q4w (n=30)
Placebo IV Q4w (n=30) Placebo IV Q4w (n=1095)
Dose
Phase IIb Phase III
Evaluation
Phase IIb/III – FPI Oct 2022
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Abbreviations: CV – Cardiovascular; EMA – European Medicines Agency; FDA – Food & Drug Administration; FPI – First Patient In; PMDA – Pharmaceuticals & Medical Devices Agency; Q4w – every 4 weeks; TBD – To be determined

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Haematology

KCENTRA[®] in Trauma

Trauma is the leading cause of morbidity and mortality in the US*

Haemorrhage is the most common, preventable cause of early death following Trauma

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Through early administration in the Emergency Department, KCENTRA[®] is intended to restore effective haemostasis, stop bleeding quickly, and improve survival of Trauma patients with AMB

~880k

patients suffer traumatic injury annually in US

~85%

of haemorrhagic deaths occur within 6 hours

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Data from preclinical and clinical studies[1-3] support use of KCENTRA[®] in trauma resuscitation

35-40%

of Trauma patients experience life threatening Acute Major Bleeding (AMB)

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Trauma and 4-F PCC Phase III Study

KCENTRA[®] + Standard of Care vs. Standard of Care
Primary endpoint: 6-hr all-cause mortality

*Among children, adolescents and young adults 1-44 years old.

Source: 1. Ghosh, S. et al ., (2021) https://doi.org/10.1371/journal.pone.0258192.; 2. Zeeshan, M. et al ., (2019) J Trauma Acute Care Surg. 87(2): 274-281.; 3. Joseph, B. et al ., (2014) World J Surg 38(8): 1875-8. Abbreviations: 4-F PCC- Four-Factor Prothrombin Complex Concentrate

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Haematology

KCENTRA[®] Large Simple Study

KCENTRA[®]

Multimodal therapy containing multiple clotting factors that may be safe & effective in achieving haemostasis in patients with traumatic injury & confirmed or suspected acute major bleeding
Enrollment starts: Feb 2023
Study ends: Jul 2026
Up to 8,000 subjects

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KCENTRA [®]
Up to Day 30
Screening
in ED Study Design observation for
secondary endpoints
Placebo
Standard of Care Treatment
Patient arrives Primary Endpoint: End of Subject
at ED 6-hour mortality Participation
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Phase III – initiating Q1 2023

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Abbreviations: ED – Emergency Department

Sparsentan for IgA nephropathy and Focal Segmental Glomeruloscelrosis (FSGS)

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IgA nephropathy is the most prevalent type of primary glomerulonephritis worldwide and a major cause of kidney failure[1,2]

The incidence of FSGS is estimated to be:[4] 0.1/100,000/year in children 0.8/100,000/year in adults

Despite having a good understanding of the pathophysiology and potential therapeutic targets, no non-immunosuppressive therapies are approved for the treatment of IgA nephropathy[†,1,5,6]

IgA nephropathy affects 3.5 in 10,000 people*,3

The number of patients affected by the condition is estimated and assessed on the basis of data from the EU, Iceland, Liechtenstein, Norway, and the UK. This represents a population of 519,200,000 (Eurostat)[3] ;

† Only one FDA-approved product, delayed-release budesonide, is indicated for the treatment of patients with primary IgAN at risk of rapid disease progression, approved by FDA on December 15, 2021, positive opinion for market authorization in Europe May 2022.[7]

Source: 1. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group (2021) Kidney Int. 100(4S): S1–S276; 2. Yeo, S.C. et al., (2018) Pediatr Nephrol. 33: 763–77; 3. EU/3/20/2336: Orphan designation for the treatment of primary IgA nephropathy. Available at: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202336 (accessed: July 2022); 4. McGrogan, A. et al., (2011) Nephrol Dial Transplant 26:414–430; 5. Barratt, J. & Feehally, J. (2005) J Am Soc Nephrol. 16: 2088–97; 6. Tarpeyo US PI 2021 (accessed July 2022)

Abbreviations: EU - European Union; FDA - Food & Drug Administration; IgA - Immunoglobulin A; IgA – IgA Nephropathy

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Sparsentan is a Novel Dual Endothelin Angiotensin Receptor Antagonist in Development for IgAN & FSGS*

Sparsentan is being developed in partnership with Travere Therapeutics, a US biotechnology company. CSL Vifor territories include EU, AU & NZ.

Sparsentan has been shown to reduce proteinuria in Immunoglobulin A nephropathy (IgAN) and in FSGS

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IgAN: Mean Change in Proteinuria from Baseline at
Week 361
ET-1 Sparsentan IRB -15.1%
Ang II
SPAR -49.8%
ETAR
Mesangial cells -0% -10% -20% -30% -40% -50% -60%
Podocytes
Other renal
cell types AT1R FSGS: Partial Response Endpoint at Week 36 [2]
50
40
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50
40
30
20 42.0%
26.0%
10
0
Sparsentan Irbesartan
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IgAN Conditional approval – H2 2023 FSGS Submission – Q4 2023

Sparsentan is an investigational compound for treatment of primary or genetic FSGS and IgAN. It is not approved by any regulatory agency.

Source: 1. Travere Therapeutics press release: https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-positive-topline-interim-results (accessed May 2022); 2. Travere Therapeutics press release. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-achievement-interim-proteinuria (accessed July 2022) Figure © 2022 Travere Therapeutics, Inc. All rights reserved. Abbreviations: Ang II - Angiotensin II; AT1R - Angiotensin II Receptor Type 1; ETAR - Endothelin Receptor Type A; ET-1 - Endothelin 1; IgAN - Immunoglobulin A Nephropathy

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Key Research with FERINJECT[®] / INJECTAFER[®] in Heart Failure (HF)

	HEART-FID1	FAIR-HF22
POPULATION	Patients (N=3014) with HFrEF and ID	Patients (N=1200) with full HF spectrum and ID
INTERVENTION	Ferric Carboxymaltose	Ferric Carboxymaltose
PRIMARY ENDPOINT	Treatment response over 12 months for incidence of death, hospitalisation for HF and change in 6MWT over 6 months	Composite of recurrent hospitalisations for HF and CV death after ≥12 months of follow-up
SPONSOR	American Regent, a Daichii Sankyo Company	University Hospital Hamburg, Germany
DATA AVAILABILITY	Q2 2023	Q1 2024

Source: 1. https://clinicaltrials.gov/ct2/show/NCT03036462; 2 . Kalra, P.R. et al., (2022) Heart 0:1–7. doi:10.1136/heartjnl-2022-321304 Abbreviations: CV – Cardiovascular; HF - Heart failure; HFrEF - Heart Failure with Reduced Ejection Fraction; ID - Iron Deficiency; 6MWT - 6-minute Walk Test

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SNF472 - Calciphylaxis/Calcific Uremic Arteriolopathy (CUA): Orphan Disease with High Morbidity and Mortality

Extreme form of vascular calcification in skin arterioles affecting mostly patients with end stage renal disease

No approved treatments; standard of care limited to palliative options
Characterized by intensely painful ischemic/necrotic wounds
Rapid disease progression leads to extreme pain, infection and death

~10k

~55% 1-year mortality[2]

patients in US & Europe[1]

SNF472 blocks hydroxyapatite (HAP) surfaces, the final common pathway of vascular calcification

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Source: 1. Company market research: survey conducted with 100 practicing nephrologists and dialysis clinicians in December 2017. Figure extrapolated from US prevalence, National kidney foundation – ESRD in the US, European Renal Association – European Dialysis and Transplant Association (2016 Annual Report). US + Europe prevalence estimated at 9.8K; 2. Weenig, R.H. et al ., (2007) J Amer Acad Derm. 56(4): 569-579; Nigwekar, S. U. et al. , (2018) N Engl J Med. 378: 17041714; 3. Shetty, M. et al. , (2018) Cleveland Clin J Med. 85(8): 584-585. doi: https://doi.org/10.3949/ccjm.85a.18009.

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Phase II in CUA: Wounds and Pain Improved During SNF472 Treatment

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Total BWAT Pain VAS Wound - QoL
-8.1 ( P < 0.001 ) -23.6 ( P = 0.015 ) -0.9 ( P = 0.003 )
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Abbreviations: . BWAT - Bates-Jensen Wound Assessment Tool; VAS - Visual Analog Scale; QoL - Quality of Life; Range of possible values: Total BWAT, 13–65; Pain VAS, 0–100; Wound QoL 0-4.

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CALCIPHYX – Phase III Pivotal Study in CUA Design and Alternate Primary Endpoints Agreed to by FDA/EMA

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Other endpoints. Total BWAT. Wound image assessment. Wound Quality of Life

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Alternate Primary Endpoints:
Wound healing (BWAT-CUA) and pain (VAS)
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N = 66
SNF472 SNF472
Screening 7.0 mg/kg 7.0 mg/kg
Selection criteria: Dialysis 3x/week + SOC Dialysis 3x/week + SOC Safety
follow-up
Haemodialysis
SNF472
≥ 1 CUA ulcerated
Placebo
lesion Pain VAS ≥50 7.0 mg/kg
Dialysis 3x/week + SOC Dialysis 3x/week + SOC
0 Week 12 Week 24 Week 28
Randomisation
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Phase III – Top Line Data 1H 2023

Abbreviations: . BWAT - Bates-Jensen Wound Assessment Tool; CUA - Calcific Uremic Arteriolopathy; EMA – European Medicines Agency; FDA – Food & Drug Administration; QoL - Quality of Life; SOC - Standard of Care; VAS - Visual Analog Scale

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Patients and Public Health: Our Promise

Aidan and his mother, Amy, Living with Primary Immunodeficiency

Expanding late-stage portfolio
High unmet need
Many CSL products entering Phase III & market

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Logan, Living Haemophillia B

Commercial

Bill Campbell Executive Vice President Chief Commercial Officer CSL Behring

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Performance

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FY22
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Commercial

Highlights

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Global revenue $8.4Bn

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Delivering on our promise to patients during time of uncertainty
Investment in infrastructure, technology & market conditioning to support growth

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Immunology

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Despite supply constrained environment, PRIVIGEN[®] & HIZENTRA[®] remained market leaders
Continued CIDP expansion

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Haemophilia

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Maintained IDELVION[®] leadership in key markets
Successful launches in France and Argentina
Etranacogene dezaparvovec (Haem B gene therapy) market readiness

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Specialty

Strong growth from HAEGARDA and KCENTRA[®]
Zemaira / Respreeza supply challenges behind us

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Abbreviations: CIDP - Chronic inflammatory demyelinating polyneuropathy

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Targeted Protein Therapeutic Market Continues to Grow

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2022
2017
Albumin
$4.6
Albumin
$3.9
5-Year CAGR:
Specialty
Total Market: 8%
Specialty $5.3 Haemophilia
Haemophilia
$12.2
$3.6 Total Global $10.8 Ig: 14% Total Global
Market Value:
Market Value:
~$27.6B
Specialty: 10%
~$37.9B
Haemophilia: 3%
Immunoglobulin
Albumin: 4%
$9.3
Immunoglobulin
$15.9
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Source: CSL Actuals FY17 and FY22; Market based on internal TA forecast models, competitor annual reports, situation analysis, CI reports 2022 Market: Immunoglobulins market include Hyperimmunes; Haemophilia market include Factor XIII and non-factor(Hemlibra); Specialty includes AAT, HAE, Fibrinogen, PCC, ATT markets Abbreviations: CAGR – Compound Annual Growth Rate

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Immunoglobulin Market

Market Dynamics

Global Ig Volume by Indication

Growth limited by COVID constrained plasma collections
Underlying Ig demand remains robust
FY22 CSL Plasma collections increased 24% YOY
Investment in plasma collection centers during COVID
Leading indicators of disease diagnosis returning to pre-covid levels

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Other
PID
21%
28%
MG
5% $15.9B
ITP
5%
SID
CIDP
16%
25%
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Source: Data on file for 2021

Abbreviations: CIDP - Chronic Inflammatory Demyelinating Polyneuropathy; ITP - Idiopathic Thrombocytopenic Purpura; MG – Myasthenia Gravis; PID – Primary Immune Deficiency; SID –Secondary Immune Deficiency: YOY – Year on Year

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Infection rates leading to a PID diagnosis at ~70% of preCOVID levels

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BRONCHITIS EAR INFECTION PNEUMONIA SINUS INFECTION
30
25
•
20 Lead indicators declined starting
March 2020
15 •
Trough level in Mar-21
•
10 PID patient diagnosis continuing
to increase in recent months
5
0
MAT Dx Visits (in Millions)
0
2
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19 Dec-19 Jan- Feb-20 Mar-20 Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21 Jul-21 Aug-21 Sep-21 Oct-21 Nov-21 Dec-21 Jan-22 Feb-22 Mar-22 Apr-22 May-22 Jun-22
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“ Patients will return to a normal pre-Covid life and have the same risks and exposures, plus the immune system will need practice.” – Immunologist

Source: Data on File – Represents US market only Abbreviations: PID - Primary Immune Deficiency

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 HIZENTRA[®] , >10 years as worldwide market leader

Immuno lobulins g

 75% of targeted physicians using HIZENTRA[®] to treat CIDP

FY22 Sales: $4,024M[1]

Down 3%[2]

 >50% of HIZENTRA[®] starts in the US are newly diagnosed patients

 Increased preference for home treatment as a result of the pandemic

Patient focused supply continuity strategy executed

 PRIVIGEN[®] patient share[4 ] in US up +3% YOY

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 PRIVIGEN[® ] maintained market leadership in key global markets

“We see a lot more PID patients. It seems to have gone up even into July and August…. I think its a combination of diagnosis and patients realizing the value of prophylaxis...” Immunologist

Source:

1 Excludes Ig hyperimmunes

2 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

3 Combination updated Peripheral Nerve Society (PNS) treatment guidelines, PATH extension data

4 Date on file – Represents US market in core indications; PID, CIDP, SID

Abbreviations: CIDP - Chronic inflammatory demyelinating polyneuropathy; YOY – Year on Year

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# 1 Ig ~~Proven~~ Patients report favorable treatment Prescribed for PID and the Long-term protection with experience with HIZENTRA[®] only SCIg approved for use in >10 yrs. of real-world CIDP[1] experience

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>3.5 New Personalized treatment Years of clinical efficacy and option with prefilled tolerability evidence syringes

Online Harris Poll survey, sponsored by CSL Behring LLC, of 104 U.S. adults with PI who ever received IVIg (n=65), SCIg in glass vials (n=65), and/or SCIg in prefilled syringes (n=33)

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Source:[1 ] Data on File – Represents US market only Abbreviations: CIDP - Chronic inflammatory demyelinating polyneuropathy; PID – Primary Immune Deficiency

HIZENTRA[® ] Sustained Market Leadership: US

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Patients
HIZENTRA
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Patient Growth: All Indications

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CIDP Patients
HIZENTRA
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CIDP Patient Growth

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Source Represents US market only Abbreviations: CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

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Haemophilia

IDELVION[®] +20%[1] YOY revenue growth
Standard of care in Haemophilia B with compelling clinical profile

FY22 Sales: $1,166M

Up 8%[1]

Market leadership[2] in key markets, including US, Germany, Italy, Spain, Switzerland and Japan
Strong launches during pandemic
AFSTYLA[®] holding patient share in competitive Haem A segment

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pdFVIII maintained market leadership globally in vWD with 55% patient share[2,3]
HUMATE[®] revenue growth of +4%[1] YOY

Source:

1 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. 2 Data on file

3 Includes HUMATE®/HAEMATE® and VONCENTO®

4 Date on file – Represents US market in core indications; PID, CIDP, SID Abbreviations: vWD – von Willebrand Disease; YOY – Year on Year

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IDELVION[® ] - Maintaining Market Leadership

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rFIX Prophylaxis Patient Share
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Based on data from US, JP, DE, IT, ES, CH and UK where IDELVION[®] is reimbursed and commercially available Source: Data on file

IDELVION[®] - Market Shares Within Key Markets

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Market Share (Patients) %
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Source: Data on file

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Gene Therapy in Haem B: Patients' unmet needs include achieving greater freedom from the burden of the disease

Durable Protection: Patients crave more durable treatments, to help protect them from the spontaneous bleeds and joint damage.

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Psychological and Social Impact: Patients face anxiety, depression, and social issues as a part of managing their Haem B. Patients experience challenges with living a “normal” life.

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Haem B Patient
Unmet Needs
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Infusion Burden: Patients report feeling like managing their Haem B is time-consuming and restricts their ability from living their life.

“I want more freedom from my infusions so that I can spend time living life to the fullest […] I don’t want to receive injections anymore ” (Patient)

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Specialty Products

KCENTRA[®] +18%[1] YOY revenue growth; exceeded pre-pandemic levels
Remains the gold standard for warfarin reversal in the US

FY22 Sales: $1,792M

Up 3%[1]

Substantial growth opportunities, with FFP still used in ~40% of patients[2 ] in the US
HAEGARDA[®] +5%[1] YOY revenue growth
Launches in EU and Australia exceeding expectations

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Treatment paradigm shifts further from on-demand to long-term prophylaxis
Pipeline expansion opportunity with Garadacimab
ZEMAIRA[®] / RESPREEZA[®] supply challenges behind us

Source:

1 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

2 Data on file

Abbreviations: FFP – Fresh Frozen Plasma; YOY – Year on Year

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KCENTRA[®] - Growth in the US

US Clinical practice guidelines recommend KCENTRA[®] over FFP to reverse the effects of Warfarin*

~1.4M patients on warfarin, with ~18k new patient starts per month[1]
Growth drivers: Superior efficacy data versus fresh frozen plasma and penetration within hospital systems

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Warfarin Urgent/Major Bleed Reversal Shares KCENTRA [®] Demand KCENTRA® Source of Business by Segment
FY 21/22
80.00%
70.00%
60.00% 23%
50.00%
40.00%
49%
30.00%
20.00%
10.00% 28%
0.00%
Warfarin DOAC No Prior AC
KCENTRA ® FFP Others
Source:
Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 FY15 FY16 FY17 FY18 FY19 FY20 FY21 FY22
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All data represents US market only

Neurocritical Care Society, Society of Critical Care Medicine, American College of Cardiology, American College of Chest Physicians, American Society of Gastrointestinal Endoscopy, American College of Surgeons 1 Data on file – represents US market only

Abbreviations: DOAC - Direct-acting Oral Anticoagulants; FFP – Fresh Frozen Plasma; YOY – Year on Year

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HAEGARDA[®] / BERINERT[®] SC

Patient Growth Amidst Increased Competition

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Regional Progress

US: New patient growth in competitive market
EU: Recent launches exceeding expectations
Australia achieved +70% patient share[1,2] within a year of launch
Three additional launches planned by end of 2022

HAEGARDA® / BERINERT SC® Patients[1]

Source:

1 Data on file

2 Patient share in the non-steroidal prophylaxis segment Abbreviations: SC – Subcutaneous

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HAEGARDA[®] /BERINERT[®] SC Efficacy Drives Potential

Proven Record Of High Efficacy And Safety[2]

HAE Market Share (Patients) by Regimen[1]

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 Prophylaxis segment continues to grow; reducing patients on acute therapy to ~55%

 >50% of HAEGARDA[®] patients have been on therapy for more than a year

 Continue to see patients switch back from competing products to the benefits of HAEGARDA[®] /Berinert[®] SC[1]

Source:

1 Data on file – Represents US, DE & ES. Includes all HAE markets, split on long term prophylaxis vs. on-demand

2 In the clinical trial, 95% median reduction in number of attacks in patients receiving 60 IU/kg of HAEGARDA® vs placebo, and a >99% median reduction in rescue medication use in patients receiving 60 IU/kg of HAEGARDA® vs placebo. Abbreviations: SC – Subcutaneous

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Commercial Summary

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Executing on Long-Range plan

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Pivoted from COVID constrained approach to demand generation Anticipate strong growth in FY23

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Preparing for transformational new launches Sustained track record of delivering long-term growth

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Summary

Michael, Living with Haemophilia B

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William Mezzanotte MD

Executive Vice President, Head of R&D Chief Medical Officer

CSL

Combined CSL & CSL Vifor R&D Portfolio – FY22

Registration/Post-Registration

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101

Forward-Looking Portfolio Highlights – FY23

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Immunology

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Respiratory

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Vaccines

Garadacimab (Anti-FXIIa) HAE
Phase III study data announced
Global submissions started
Anumigilimab (CSL324; G-CSFR antagonist) Phase Ib study last patient out
BERINERT[®] SC HAE JP PMDA approval

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Haematology

CSL889 (Hemopexin) Phase I study last patient out
Etranacogene dezaparvovec US & EU launch
KCENTRA[®] Trauma Phase II study first patient in
Garadacimab (Anti ~~-~~ FXIIa) IPF Phase II study enrolment complete
CSL787 (Neb Ig) Phase I study enrolment complete

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Cardiovascular

& Metabolic

CSL112 (ApoA ~~-~~ 1) Phase III study enrolment complete
Clazakizumab (ESKD) Phase IIb/III study first patient in

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Transplant

CSL964 (AAT) treatment of GvHD ~~–~~ Phase III study last patient in
aQIVc (cell antigen + MF59[®] ) Phase IIb study results available
ARCT-154 COVID vaccine global submissions started

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INS-3001 (AVS) Phase I study first patient in
FERINJECT[®] (ferric carboxymaltose) ID China approval
INJECTAFER[® ] (ferric carboxymaltose) HF-ID Phase III data available
KORSUVA  /KAPRUVIA[®] (difelikefalin) multiple country approvals
SNF472 CUA Phase III Top Line Data
Sparsentan (IgAN) CMA EU
VELPHORO[®] (sucroferric oxyhydroxide) China approval
Vamifeport (SCD) Phase IIa study recruitment complete

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102

R&D Strategic Investments Coming to Fruition

Continued improvements in manufacturing processes

Strengthen Our Core Competencies

• Progression of our clinical internal portfolio

Plasma – CSL112, KCENTRA[®] , AAT (GvHD), HIZENTRA[®] , CSL787 & CSL889
MAb – CSL730, Clazakizumab, Anumigilimab
Vaccines – aQIVc+

Build Strategically and Scientifically in our TAs

Small molecules – SNF472, Sparsentan
Exciting near-term launches for disruptive new therapies
Etranacogene dezaparvovec

Explore Disruptive Innovation

Garadacimab
Embracing the External Environment
New Research Partnerships

Expand into Complementary Disease Areas and Platforms

Biotech Incubator

• Strategic Additions in Complementary Platforms and Therapy Areas

Translational Sciences – Thrombosis reduction – Haematology
Arcturus – next generation mRNA technology

Embrace the External Environment

CSL Vifor – Strengthen our CardioRenal Portfolio, New Core Competency in Nanomedicines/Iron
Leading Commercial expertise to bring these therapies to patients

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103

Leah, Living with Hereditary Angioedema

Panel Q&A Session

FINAL: 02 November 22 CONFIDENTIAL

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Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL’s three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead

MELBOURNE, Australia and KING OF PRUSSIA, Pennsylvania – 03/02 November

22 -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is wellpositioned to meet the current and future needs of patients and public health. CSL revealed progress and plans in advancing assets that have the potential to disrupt current standards of care in its areas of focus (immunology, haematology, respiratory, cardiovascular and metabolic, transplant, nephrology, vaccines) using its strategic scientific platforms (plasma protein technology, recombinant technology, cell and gene therapy, and sa-mRNA, adjuvanted, cell-based and egg-based vaccines).

Among the highlights presented were the following:

Late-Stage Development Includes Disruptive Innovation and New Additions to the CSL Portfolio

Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). If approved, etranacogene dezaparvovec would be the first-ever gene therapy treatment option for the haemophilia B community. The regulatory filings are supported by results from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The multi-year clinical development program for etranacogene dezaparvovec was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials has transitioned to CSL after acquiring global rights to commercialize the investigational treatment.
Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. CSL aims to begin filing for approval with global regulatory authorities next calendar year. Garadacimab was discovered and optimised by scientists at CSL’s Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility.

FINAL: 02 November 22 CONFIDENTIAL

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CSL Vifor brings a leading portfolio of therapies in nephrology, dialysis and iron deficiency. New late-stage assets to the pipeline include Sparsentan for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) and SNF472 for calciphylaxis and calcific uremic arteriolopathy (CUA).

R&D Portfolio Progress Across Areas of Focus and Scientific Platforms

Clazakizumab, an anti-IL6 monoclonal antibody, intended for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients continues to progress in the Phase III IMAGINE trial. This is CSL’s leading program for clazakizumab, which will also be investigated in a Phase IIb/III study for improvement of cardiovascular (CV) outcomes in dialysis patients. CSL plans to engage Fresenius Medical Care dialysis centres in the study.
AEGIS-II, a Phase II, multicenter, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112, compared to placebo, in reducing the risk of major adverse CV events (MACE) in patients following a heart attack, will enrol the last patient by the end of 2022, with completion of the trial expected towards the end of 2023.
CSL is advancing the Phase IIb study for its adjuvanted, cell-based high-dose quadrivalent influenza vaccine (aQIVc). This study will help CSL further build the body of clinical evidence to support the optimal formulation for when the company moves into the Phase III immunogenicity and safety study for aQIVc.
Published results from the preclinical studies of CSL’s self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines, indicate a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). CSL’s sa-mRNA candidate is expected to enter clinical trials in 2023.

Recently Announced

Collaboration and license agreement with Arcturus Therapeutics aims to accelerate next-generation mRNA capabilities in influenza, pandemic preparedness and other selected respiratory viral pathogens -- including a near term COVID-19 vaccine that has recently reported interim results from a large Phase III efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favourable safety profile.
A strategic option and license agreement with Translational Sciences to license TS23, a first-in-class anti-α2-antiplasmin monoclonal antibody. TS23 is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS). The treatment candidate is soon to be evaluated in the US in the NAIL-IT Phase II study, which has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with sub-massive (intermediate risk) PE.

“CSL is on the leading-edge of innovation in areas we know well and we have strategically and methodically built a pipeline that has never been more robust with

FINAL: 02 November 22 CONFIDENTIAL

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diverse sources of innovation, from in-house and external sources, that include the disruptive scientific platforms of gene therapy and sa-mRNA,” said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, and Chief Medical Officer for CSL. “Our enhanced capabilities across all of our scientific platforms and therapeutic focus areas will help us in our relentless pursuit to deliver on our promise to help patients lead full lives, protect public health and sustainably grow our business in the decades ahead, while providing promising futures for our employees.”

In fiscal year 2021-2022, CSL invested approximately $1.16 billion in R&D. This includes growing CSL R&D’s footprint in Melbourne, Australia; Marburg, Germany; throughout Switzerland and Waltham, Massachusetts – helping to create an integrated global organization that can conveniently collaborate with institutions everywhere -- offering scientists a wide array of opportunities for professional development and enhancing access to external innovation.

Advancing External Innovation: The Biotechnology Incubator at CSL’s Global Headquarters in Melbourne, Australia Names Its Operator

CSL, WEHI and The University of Melbourne have appointed Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL’s new global headquarters currently under construction in the Melbourne Biomedical Precinct. The appointment follows the project partners joining forces to create an incubator for biotech start-up companies, with the Victorian Government’s landmark Breakthrough Victoria Fund providing funding to support the AU$95 million project. It will be Australia’s first and only incubator that is co-located with a leading biopharmaceutical company and will have space for up to 40 start-ups.

“Incubator residents will be working in an innovation-driven environment alongside a large and focused CSL R&D team, enabling opportunities for peer-collaboration, learning and sharing of ideas,” said Dr. Andrew Nash, CSL’s Chief Scientific Officer and Senior Vice President, Research. “The strong collaboration between CSL, the University of Melbourne, WEHI, Breakthrough Victoria and now Cicada Innovations has been critical to bring the incubator to fruition and reflects CSL’s values and desire to deliver on our promise to patients worldwide.”

For more about the incubator, https://www.csl.com/news/2022/20221103-cicadainnovations-to-operate-new-biotech-incubator.

For more on CSL’s R&D Investor Briefing, please visit https://www.csl.com/.

About CSL

CSL Limited (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs more than 30,000 people. Our unique combination of

FINAL: 02 November 22 CONFIDENTIAL

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commercial strength, R&D focus, and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.

For more information visit www.csl.com.

Media Contacts:

Greg Healy Email: [email protected] +1 610 906 4564

In Australia:

Jimmy Baker Email: [email protected] +61 450 909 211

Kim O’Donohue Email: [email protected] +61 449 884 603

In Europe:

Jasmin Joller Email: [email protected]

AI assistant

CSL Ltd. — Investor Presentation 2022

17854_rns_2022-11-02_015944b5-8ebe-4330-97e7-1256ec3e929a.pdf

CSL Highlights Progress Across Strong R&D Pipeline

Important Notice and Disclaimer

Legal Notice

Trademarks

R&D – Supporting CSL’s 2030 Strategy

R&D Highlights – FY22

Cardiovascular & Metabolic

Immunology

• CSL112 (ApoA ~~-~~ 1)

Respiratory

Vaccines

Haematology

Partnerships & Alliances

R&D Capacity Expansion

Transplant

Commitment to Research and Development

Expanding R&D’s Global Footprint

Our CSL R&D Footprint - Key Global R&D Locations

Notable Regional Regulatory Action *

Recent CSL News Aligned with R&D Strategy

Global Leadership in Nephrology Empowered by Unique Partnership with Fresenius Medical Care

STRONG PHARMA EXPERTISE

GLOBAL LEADERSHIP IN NEPHROLOGY THROUGH:

Supporting Chronic Kidney Disease Patients Along Their Journey

R&D Portfolio – FY21

R&D Portfolio – FY22

Combined CSL & CSL Vifor R&D Portfolio – FY22

Research

CSL External Innovator Engagement

Creating investable opportunities

Direct investment

Developing innovation ecosystem

Research External Innovation Strategy

CSL External Innovator Engagement

CSL External Innovator Engagement

Stage 0 Collaborations

CSL External Innovator Engagement

Stage 0 Portfolio

CSL External Innovator Engagement

Biotech Incubator Partnership

Space for up to 40 start-ups

CSL External Innovator Engagement

Australia’s Flagship Deep Tech Incubator

Two Decades of Impact

Garadacimab (Discovery – Development – Medicine)

Garadacimab potently inhibits αFXIIa, shutting down multiple biological pathways

* Feedback loops removed for simplicity

Garadacimab (Discovery – Development – Medicine)

CIDP is a Complex Autoimmune Disease

Plasma half-life

FcRn Inhibitors

Vaccines

Influenza Vaccines are Inconsistently Effective Season to Season

US CDC Seasonal Flu Vaccines Effectiveness

Flu Season

Recommended Vaccine Viruses May Not Match with Circulating Flu

Recommended Vaccine Viruses May Not Match with Circulating Flu

EGG VACCINE VIRUSES

Frequency of H3N2 Egg-adaptation Mismatch over Time

Wild-type A/H3N2 Collection Date

Cell-based Vaccines are Designed to Provide a Better Match to WHO-selected Flu Virus Strains

Real World Evidence – Showing Benefit of Cell-based Influenza Vaccines to Reduce Strain Mismatch

Flucelvax[®] QUADRIVALENT - Benefit of Cell Culture

Immunosenescence and Comorbidities Contribute to Higher Mortality in Older Adults

Adjuvanted Vaccines Increase the Immune Response in Vulnerable Individuals

Real World Evidence – Benefit of MF59[® ] Adjuvanted Influenza Vaccine

Higher Doses of Antigen Can Increase Immune Response in Older Adults

Preferentially Recommended by CDC Over Standard-dose Influenza Vaccines

aQIVc - Combining Adjuvant & Cell Technologies & Boosting the Dose of Each to Improve Vaccine Effectiveness

3 Proven Flu Vaccine Technologies

High Dose MF59[®] Adjuvanted Cell-Based Vaccine

Next Generation mRNA Technology: Self-amplifying mRNA

Advantages over conventional mRNA vaccines

Engaged Immune System = More Protection

sa-mRNA Bicistronic Vaccines Co-express HA & NA

Haemagglutinin (HA) & Neuraminidase (NA) are two viral surface proteins

Protection of Ferrets from Influenza Infection by sa-mRNA HA-NA Vaccines

CSL Ltd. Investor Presentation 2022

• CSL112 (ApoA - 1)

**Mean eGFR Slopes (Solid Lines) In Relation To Treatment In Part A[*]**