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For immediate release

20 October 2020

CSL’s Annual R&D Investor Briefing 2020

CSL Limited (ASX:CSL; USOTC:CSLLY) – CSL will hold its annual Research and Development briefing today; the presentation is attached for the information of investors.

Amongst other achievements, CSL is pleased to highlight the following :

Its work across a number of programs across our R&D platforms to prevent and treat COVID-19.
CSL’s AEGIS-II Phase 3 study of CSL112 (ApoA-1) for treatment of acute coronary syndrome has now resumed following a COVID related pause. More than 10,000 people have been enrolled to date.
Results from Phase 2 clinical trials for Garadacimab, a treatment in hereditary angioedema (HAE), met its primary end points with a statistically significant reduction in HAE attacks.
US Food & Drug Administration approval for an expanded label indication for Haegarda, to now include patients of 6 years and older.
The aquisition of Clazakizumab (CSL300), an anti-interleukin-6 monoclonal antibody in the IMAGINE Phase 3 trial for the treatment of chronic active antibody-mediated rejection, the leading cause of long-term rejection in kidney transplant recipients.

Shareholders can access the briefing through CSL’s website at CSL.com

Approved for Release

Fiona Mead Company Secretary

For further information, please contact:

Investors:

Mark Dehring Head of Investor Relations Phone: +61 393 893 407 Email: [email protected]

Media:

Christina Hickie

Senior Manager, Communications Phone: +61 429 609 762 Email: [email protected]

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R&D Investor Briefing 2020

20[th] October 2020

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Forward looking statements

Legal Notice

The information in this presentation is current as of the date of this presentation, and includes forward looking statements about CSL Limited and its related bodies corporate’s (CSL) financial results and estimates, business prospects and product candidates in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Factors that could cause actual results to differ materially include: the success of R&D activities, decisions by regulatory authorities regarding product registration and label claims; competitive developments; marketing challenges; 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 secure intellectual property protection. The statements made in this presentation should not be construed as an offer to sell, or solicitation of an offer to buy, any securities of CSL. No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including CSL), including in relation to any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from the forward looking statements and the assumptions on which such statements are based. Subject to any continuing obligations under applicable law or any relevant listing rules of the Australian Securities Exchange, CSL does not undertake to disseminate updates or revisions to any forward looking statements in these materials to reflect any change in expectations in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in these materials shall create an implication that there has been no change in the affairs of CSL since the date of these materials.

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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Introduction William Mezzanotte MD Executive Vice President, Head of Research and Development and CMO CSL Behring

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Agenda

Topic	Presenter
Welcome	Mark Dehring
Introduction and Highlights	Bill Mezzanotte
Research - Protein Therapies, Gene Therapies & Vaccines	Andrew Nash
Immunology Highlights & COVID-19 Response	Mittie Doyle
Commercial	Bill Campbell
Transplant Highlights	Laurie Lee
Summary	Bill Mezzanotte
Q&A	Panel
Close

Global Research and Development Footprint

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King of Prussia US Amsterdam Netherlands
Liverpool UK
Kankakee US
Marburg Germany
London UK
Cambridge US Siena Italy Tokyo Japan
Pasadena US
Bern Switzerland
Summit US Wuhan China Shanghai China
Holly Springs US
 CSL Behring
 Seqirus
Melbourne Australia
> 1,700 scientists globally
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Key Global Research Partnerships for Early Innovation Access

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Commitment to Research and Development

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922
832
702
667
614
15-16 16-17 17-18 18-19 19-20
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New Product Development activities focus on innovative new therapies for life-threatening diseases

Market Development strategies seek to bring therapies to new markets and new indications

Life Cycle Management ensures continuous improvement of existing products

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

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R&D investment ~10-11% global revenue
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Focus Through Our Therapeutic Areas and Platforms

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R&D Portfolio – December 2019

Registration/ Research Pre-Clinical Phase I Phase II Phase III Post-Registration DiscoveryProjects CSL510 CSL730 Garadacimab HIZENTRA[®] PRIVIGEN[®] Modified Fibrinogen rFc Multimer Anti-FXIIa (HAE) mAb (DM) (PID) JP DiscoveryProjects CSL787 CSL324 HIZENTRA[®] CSL112 CSL830 Nebulised Ig Anti-G-CSFR mAb (SSc) ApoA-1 (ACS) C1-INH Subcut EU DiscoveryProjects aQIVc CSL200 PRIVIGEN[®] Clazakizumab PRIVIGEN[®] Adjuvanted Cell Culture CAL-H (SCD) (SSc) Anti-IL-6 (AMR) mAb (CIDP) US, JP Influenza Vaccine DiscoveryProjects CSL889 HAEGARDA[®] CSL842 HIZENTRA[®] P. Gingivalis Hemopexin (SCD) Japan C1-INH (rAMR) (CIDP) US, JP Periodontal Disease DiscoveryProjects Garadacimab CSL630 CSL964 AAT HAEGARDA[®] Anti-FXIIa (Thrombosis) pdFVIII Ruide (GvHD Treatment) US CSL311 Mavrilimumab CSL964 AAT IDELVION[®] Anti-Beta Common mAb Anti-GM-CSFR mAb (GvHD Prevention) CSL346 FLUCELVAX[® ] QIV AFSTYLA[®] Anti-VEGF-B mAb 6M+ CSL334 / ASLAN004 KCENTRA[®] (Anti-IL-13R) Japan ZEMAIRA[®] / RESPREEZA[®] AAT AFLURIA[®] QIV 6M+ US, AU FLUAD[® ] QIV 65yrs+ US,EU,CA AUDENZ™ Adjuvanted Monovalent Haematology Respiratory Cardiovascular & Metabolic Influenza A (H5N1) Vaccine

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

R&D Portfolio Highlights - FY20

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Immunology

HIZENTRA[®] Phase III DM study initiated
HAEGARDA[®] Phase III HAE study in Japan initiated
HAEGARDA[®] paediatric approval in US
PRIVIGEN[®] approved for PID, SID & CIDP in Japan
Garadacimab (Anti-FXIIa) Phase II HAE study results presented at EAACI Congress; FDA granted orphan drug designation (ODD)

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Respiratory

CSL311 (Anti-Beta Common) Phase I study in mild asthmatic patients initiated

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Cardiovascular and Metabolic

CSL112 (ApoA-1) Phase III study (AEGIS-II) >9500 patients recruited
CSL112 (ApoA-1) AEGIS-II first futility analysis conducted; trial to continue as planned

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Acquisitions & Alliances

Alliance with Seattle Children’s Research Institute to develop WAS & XLA stem cell gene therapies for PID
Agreed to acquire exclusive global license rights to AMT-061 ( EtranaDez ) for haemophilia B*
Acquisition of Vitaeris Inc. and Clazakizumab
Transaction with uniQure is subject to customary regulatory clearances before closing
FDA granted HIZENTRA[®] ODD for CIDP

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Haematology

CSL200 (Gene Therapy) in SCD Phase I study initiated
FDA granted CSL200 fast track designation
CSL889 (Hemopexin) Phase I SCD study initiated
CSL889 (Hemopexin) ODD approved in EU & US for SCD

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Transplant

AAT for prevention of GvHD Phase III study enrolment into Cohort 2 completed
FDA granted AAT ODD for GvHD treatment & prevention
Clazakizumab AMR study initiated
FDA granted Clazakizumab ODD and fast track designation for CABMR

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Influenza Vaccines

Adjuvanted quadrivalent influenza vaccine, FLUAD[®] TETRA , approval in EU and FLUAD[®] QUADRIVALENT in US
US FDA approval of AUDENZ™- adjuvanted, cell-based influenza A (H5N1) pandemic vaccine
aQIVc (cell antigen + MF59[®] ) new product development commenced

Key Past Launches from R&D Portfolio

AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)	AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)	AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)	AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)	AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)	AFLURIA®QIV FLUCELVAX® FLUAD®(US) FLUCELVAX® QIV (US) FLUAD®(UK) FLUCELVAX® QIV 9yrs+ (EU, CA) IDELVION® AFSTYLA® IDELVION® 21-Day (EU)^ IDELVION® 21-Day (JP) 2015 2016 2017 2018 2019 2020 PRIVIGEN® CIDP (US) HIZENTRA® CIDP (JP) Ig IsoLo® HIZENTRA® CIDP PRIVIGEN® CIDP (JP) HAEGARDA®(US) RESPREEZA®(EU) AFLURIA® QIV 6M+ (AU) PRIVIGEN® PID/SID (JP) FLUAD® QIV (US) FLUAD® QIV (EU)
Ig IsoLo®	PRIVIG HAEGAR	EN® CIDP (US) DA®(US)	HIZENTRA® CIDP	HIZENTRA® CIDP (JP) PRIVIGEN® CIDP (JP)	PRIVIGEN® PID/SID (JP)
IDE	LVION® AFSTYLA®			IDE 21-	LVION® Day (EU)^ IDELV 21-Day
RESPREE	ZA®(EU)
AFLURIA®QI FLUCELV FLUAD	V AX® ®(US)	FLU QIV ( FLUA	CELVAX® US) D®(UK) AFLU	FLUCELVAX® QIV 9yrs+ (EU, CA RIA® QIV 6M+ (AU)	) FLUAD® QIV ( FLUAD® QI

Timelines shown by calendar year

^ Expanded label for dosing every 21 days for patients ≥12 years in age, depending on individual patient and efficacy (and jurisdiction)

Notable Regional Regulatory Action

1 July 2019 – 1 October 2020

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CSL889
65yrs+ 6mo+ (treatment SCD)
Garadacimab (Bk-AE) 65yrs+
CSL889 (treatment SCD)
21d dosing CSL964 (prevention GvHD) Human Albumin 20%
CSL964 (treatment GvHD) Extension to register in
Clazakizumab (CABMR) Paediatric Indication 11 countries 1) 21d dosing^
2) 3500 IU
1) PID/SID Indication
2) CIDP Indication
CIDP Indication
CIDP Indication 1) 21d dosing
2) 3500 IU
For MMN/SID
CIDP Indication
2000 IU/3000 IU
CIDP Indication
1) 21d dosing
2) 3500 IU
New Initial Marketing CIDP Indication
Authorization Approvals
New Line Extensions/ CIDP Indication
Indications Approvals
9yrs+
Orphan Drug Designation
*----- End of picture text -----

On-going Activities

Bk-AE: bradykinin-mediated angioedema
** SCD: Sickle Cell Disease
*** GvHD: Graft-versus-Host Disease
**** CABMR: Chronic Antibody-Mediated Rejection
^ Every 21 days in patients ≥12 years of age, depending on individual patient and efficacy (and jurisdiction)

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Expanded label for Expanded label for dosing Labeling update for
enhanced administration every 21 days in patients ≥12 expanded populations
parameters years of age
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R&D Portfolio Progression in 2020

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Pre-Clinical/ Registration/
Phase I Phase II Phase III Post-Registration
CSL888 CSL346 Garadacimab PRIVIGEN [®]
Haptoglobin(SAH) Anti-VEGF-B mAb Anti-FXIIa mAb(HAE) (PID) JP
CSL787 Garadacimab HAEGARDA [®] IDELVION [®]
NebulisedIg Anti-FXIIa mAb (ARDS) Japan rFIX-FP (HaemB)
21d dosing
CSL311 aQIVc
Anti-Beta Common mAb MF59 [®] plus FLUCELVAX [®] QIV 9yrs+
FLUCELVAX [®] antigen AU
CSL040
Novel Complement FLUAD [®] QIV 65yrs+
Inhibitor EU, US
SA-mRNA Influenza AUDENZ™
Vaccine Adjuvanted Monovalent
Influenza A (H5N1) Vaccine
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Calendar Year 2020

Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Influenza Vaccines COVID

CSL112 ApoA-1

All countries and sites reactivated
Japan now active and enrolling well
1[st] futility analysis in 2020 passed

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Screening Randomisation
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17,000 AMI subjects ≥18yrs of age with Acute Coronary Syndrome

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CSL112
particles
ABCA1 transporter
Intracellular
cholesterol
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1 ° Endpoint : MACE MACE Follow Up
D90 D180 D365
6g CSL112
Placebo
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AMI – Acute Myocardial Infarction MACE - major adverse cardiac events

R&D Portfolio – October 2020

Registration/ Post-Registration

Research Pre-Clinical Phase I Phase II Phase III Post-Registration Gene Therapy CSL888 CSL324 HIZENTRA[®] HIZENTRA[®] PRIVIGEN[®] Treatments Haptoglobin(SAH) Anti-G-CSFR mAb(HS) (SSc) (DM) (PID) JP PID CSL510 CSL730 CSL630 HAEGARDA[®] IDELVION[®] DiscoveryProjects Modified Fibrinogen rFcMultimer pdFVIII Ruide Japan rFIX-FP (HaemB) CSL040 CSL889 CSL346 Garadacimab AFSTYLA[®] DiscoveryProjects Novel Complement Hemopexin(SCD) Anti-VEGF-B mAb Anti-FXIIa mAb(HAE) rFVIII (HaemA) Inhibitor (DKD) CSL200 EtranaDez* ZEMAIRA[®] /RESPREEZA[®] DiscoveryProjects SA-mRNA Influenza CAL-H(SCD) Garadacimab Etranacogene Alpha1-Proteinase Vaccine Anti-FXIIa mAb(ILD/IPF) dezaparvovec Inhibitor CSL787 DiscoveryProjects LASN01 NebulisedIg Garadacimab KCENTRA[®] AFLURIA[®] QUAD Anti-IL-11R Anti-FXIIa mAb(ARDS) 4F-PCC (Trauma) Egg-based Influenza CSL311 Vaccine DiscoveryProjects P. Gingivalis Anti-Beta Common mAb Adjuvanted Cell Culture CSL112 (Periodontal Disease) Influenza Vaccine ApoA-1(ACS) FLUCELVAX[®] UQ/CSL V451 (aQIVc) Quadrivalent (aCoV2) Clazakizumab Cell-based Influenza Vaccine Mavrilimumab Anti-IL-6 mAb(AMR) CSL334/ASLAN004 Anti-GM-CSFR mAb FLUAD[®] Quadrivalent Anti-IL-13R mAb(AD) CSL964 Adjuvanted Influenza Alpha-1Antitrypsin Vaccine (Treatment of GvHD) AUDENZ™ CSL964 Adjuvanted Monovalent Alpha-1Antitrypsin Influenza A (H5N1) Vaccine (Prevention of GvHD) * Transaction with uniQure is subject to customary regulatory COVID-19 clearances before closing Hyperimmune Therapy Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Influenza Vaccines COVID Outlicensed Programs Partnered Projects

Transaction with uniQure is subject to customary regulatory clearances before closing

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Research

Protein Therapies Gene Therapies Vaccines Andrew Nash PhD

Senior Vice President, Research and CSO

CSL Behring

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CSL Research

Global team exploiting internal and external expertise and 4 drug discovery platforms to deliver innovative development opportunities across CSL therapeutic areas
Expertise and track record in plasma and recombinant protein drug discovery, influenza vaccines and building capability in cell and gene therapy
Expertise and depth of talent across 6 TAs

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CSL Behring Research

Melbourne

Bio21 Institute, University of Melbourne

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CSL Behring Research Marburg

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CSL Behring Research Bern

Swiss Inst. for Translational & Entrepreneurial Medicine, University of Bern

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CSL Behring Research US Pasadena, KOP

Seqirus Research Boston

CSL Behring Research – Sourcing Innovation

Research External Innovation Strategy - the competition for innovation

Walter and Eliza Hall Institute (WEHI) Bioinformatics Alliance Seattle Children’s Institute Gene Therapy Alliance

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Strategic
Partnerships
(universities, Research Acceleration Initiatives
MRIs, hospitals)
AU, EU, US
Global Funding &
Research site collaboration
locations initiatives
Research
Pipeline
Partnering
BIO USA Funding &
conference
collaboration
BIO EU attendance &
initiatives
Biotechgate sponsorship MRCF/BTF
AusBiotech Biotech Biopole Life Sciences Hub
partnerships Baselaunch
& licensing
Biosana Pharma
Elektrofi
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Research Acceleration Initiatives AU, EU, US Source of 48% new external collaborations FY19-20 CSL has option to exclusively license

Growing the Development Portfolio

Platforms Candidates Plasma proteins CSL888 CSL889 CSL787 CSL312 CSL324 Recombinant CSL346 proteins CSL311 CSL040 CSL362 SCD GT WAS GT Gene therapy XLA GT

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Indications PID & SID Neutrophilic dermatoses ANCA vasculitis SLE COPD Asthma ARDS Pulmonary fibrosis Thrombotic conditions SCD crisis Acute bleeding Ab graft rejection Delayed graft function GvHD Diabetic co-morbidities … and others

ASLAN004 Atopic dermatitis LASN01 Fibrosis & oncology P.ging vaccine Periodontal disease

Collaboration Delivers Innovation

Collaboration leads to the discovery that BTN2A1 is required for the activation of γδ T cells

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Antagonist and agonist monoclonal antibodies for use in autoimmune disease and immuno-oncology

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Source: Rigau, M. et al., (2020) Science 367(642)

Targeting Complement Regulation

Complement Pathways

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C1INH
Anti-C2
C1INH
CSL040
solCR1
Anti-C5
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Potential indications

Chronic Indications, Classical/Lectin Pathway (Anti-C2 mAb)

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Acute Indications, Classical/Lectin Pathway (CSL040)

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Cyclic Acute ex vivo Pathway (CSL040)

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Alternative Pathway needing chronic inhibitor (CSL040)

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Source: Trouw, L.A. et al., (2017) Nat. Rev. Rheumatol. 13(9);538-547

CSL040 Complement Receptor 1 Inhibitor

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CR1 Truncation Mutant, rCR1(1392) / CSL040
SP LHR-A LHR-B LHR-C LHR-D rCR1(1971) / TP-10
1 42 489 939 1392 1971
SP LHR-A LHR-B LHR-C rCR1(1392) = CSL040
1 42 489 939 1392
56 252 410 447 509 578 702 860 897 959 1028 1152 1310 1481 1504 1534 1540 1605 1763 1908
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Haemolytic complement inhibition assays (human serum)

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Inhibitor	IC50Classical	IC50Alternative
rCR1(1971)	253pM	2587pM
rCR1(1392)	104pM	709pM

rCR1(1392) has 2-3 fold increased potency in vitro as compared to rCR1(1971) / TP-10

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CSL040 Complement Receptor 1 Inhibitor

Renal Ischemia-reperfusion Injury (IRI) Mouse Model

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C57BL/6
Remove
right kidney Sacrifice at
24 hrs
Inject treatment or vehicle Clamp blood supply to Unclamp
left kidney for 20' (reperfuse)
i.v. 60 mg/kg CSL040
1 hr pre-IRI and 3 hr later
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CSL040 inhibits complement activity, leukocyte infiltration and renal damage in IRI model
Pharm/Tox and product development to commence mid-2021

Garadacimab

Global leaders in FXII biology – new opportunities for Garadacimab

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- Auto-activation +FXIIa/β
FXI → FXIa FXIIa FXII FXII
Hemostasis
PK → KAL βFXIIa Plasminogen
Fibroblast/
HK → BK→ BR2 C1qr,s → C1qr,s Plasmin endothelial cell/immune cells
Vasodilation Complement Fibrinolysis Mitogenesis
activation Inflammation
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Beyond Hereditary Angioedema

New opportunities in fibrotic disease, cardiovascular disease, inflammatory disease
Feedback loops removed for simplicity

Garadacimab

Pulmonary Fibrosis

Garadacimab reduces fibrosis in the mouse bleomycin model of IPF

Garadacimab from D0 Garadacimab from D5

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Phase II to commence H2 2021

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Translation
to human disease
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Plasma FXII levels are higher in IPF patients with progressive disease

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FXII expression is higher in the IPF lung

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IPF – Idiopathic Pulmonary Fibrosis

Gene Therapy

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AMT-061 (EtranaDez) gene therapy (GT) for the treatment of Haemophilia B

AAV5 vector encoding FIX Padua variant

May be clinically effective in patients with pre-existing Abs

Phase IIb mean FIX activity at 52 weeks 41%

Phase III study in progress

Upon deal completion, which is subject to customary regulatory clearances, CSL will have exclusive global rights to supply

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Direct delivery Cell-based delivery
Treatment or Treatment or
missing gene missing gene
Patient stem
cells removed
The treatment from the body The treatment
gene is added and cultured gene is added to
to a vector such a harmless
as an adeno lentivirus
associated virus
(AAV)
…which in turn
…which is
introduces it to
delivered
the isolated
directly stem cells
to the patient
by injection
The stem cells,
are returned to
the patient
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Seattle Children’s Research Institute (SCRI) – world leading preclinical & clinical experience with Lentivirus based GT

Alliance consolidates and extends CSL GT capability Wiskott Aldrich Syndrome (WAS)

CSL LVV and Select+ tech.
Ph I/II expected to commence H22022

XLA

SCRI LVV
Ph I/II expected to commence H22022

FIX – Factor IX

XLA - X-linked agammaglobulinemia LVV – Lentiviral vector Abs - Antibodies

Fc Mimetics and Anti-FcRn mAbs

IVIg & SCIg Usage

ImmunoImmunoreplacement modulation

Responds to Antibody Fc γ mimetics mediated & / or anti-FcRn

Ig vs. anti-FcRn

Ig supplementation long term persistence vs. immune safety of response suppression

Novel Applications for IgFc Mimetics

Surrogate CSL730 is effective in a model of glomerulonephritis*

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Disease induced by administration and cross-linking of antibodies directed against the kidney glomerular basement membrane

CSL730 Clinical Development

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CSL / Momenta
partnership
+ -
+ -
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Phase I (moved to subcutaneous administration)

IVIg – Intravenous Immunoglobulin SCIg – Subcutaneous Immunoglobulin

CSL – COVID-19 Vaccines

	UQ/CSL V451	AZD1222
Partners Vaccine Format CSL Responsibility Current Status	Ph I ongoing, FSI Ph II/III Dec 2020 University of Queensland, Coalition for Epidemic Preparedness Innovations (CEPI) Recombinant virus spike protein (molecular clamp technology) formulated with MF59® adjuvant Vaccine manufacture, clinical trials, supply	Phase III ongoing AstraZeneca Adenovirus vector designed to express spike protein of COVID-19 virus_in situ_ Vaccine manufacture

FSI – First subject in

CSL – COVID-19 Vaccines

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Classical Platforms Next-Gen Platforms
AZD1222
7 8
4
13 6
UQ/CSL V451 subunit vaccine
2
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Candidates in clinical development - 42 Candidates in pre-clinical development - 151

plus 2 live replicating viral vectors

In Clinical Development

Source: van Riel, D & de Wit, E., (2020) Nature Materials 19; 810-812

CSL – Production of UQ/CSL V451

CSL Biotech. Manufacturing Facility, Broadmeadows

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2000L Cell Culture
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Harvest by Depth Drug Drug Product Filling, to be Filtration Substance Formulated with MF59[®]

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Vaccination

Process scaled up and industrialised from Ph I as required
Production, Fill/Finish for Ph II/III underway
Same manufacturing platform technology to be used for AZD1222

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Immunology & COVID-19 Response Mittie Doyle MD Vice President, R&D Immunology CSL Behring

Christal: a nurse living with chronic inflammatory demyelinating polyneuropathy (CIDP)

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1. FOUNDERS

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2. MEMBERS

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CONTRIBUTORS

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SUPPORTERS

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Collaborative Hyperimmune Ig Trial in COVID- 19

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Placebo + Remdesivir
Screen 500 Randomize
Day 1 Patients 1:1
H-Ig + Remdesivir
Anti-COVID-19 Hyperimmune
Globulin (H-Ig) will be provided Day 0 Day 7 Day 28
by four manufacturers
H-IG Administration Primary Endpoint Secondary Endpoint /
End of Study
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Phase III enrolling
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Hyperimmune Program for Australia

Convalescent plasma collected by the Australian Red Cross Lifeblood
CSLB has manufactured a clinical batch ready for clinical testing
A single centre, Phase I, study of the Australian H-Ig product in 24 healthy volunteers
Leverage global H-Ig data

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Phase I to commence H2 2020

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Potential Benefits of Blocking Factor XIIa in COVID-19

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Primary Drivers of ARDS in COVID-19

Inflammation

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•
Thrombosis
Thrombosis Vasodilation, Complement Cytokine
• vascular permeability activation production
Vascular Permeability
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ARDS – Acute Respiratory Distress Syndrome

Garadacimab in COVID-19

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Garadacimab + Supportive Care
Screening Dosing Primary endpoint
Day -2 to 1
1:1
Day 1 Day 2 Day 7 Day 14 Day 21 Day 28
ICF
Placebo + Supportive Care
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Population - 124 patients with severe COVID-19 complications
• Primary objective - prevent progression to intra-tracheal intubation or death

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Phase II ongoing
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Garadacimab in HAE: The Vanguard Program

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Phase II Study Phase III Study Design

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Autosomal dominant genetic condition 1 in 10,000 – 50,000 people

Unregulated protein cascade → elevated levels of bradykinin → fluid release into tissues → swelling in specific parts of body

Unpredictable onset, severity and attack location, lasts for 2-5 days

HAE – Hereditary Angioedema

Garadacimab and Factor XIIa in HAE

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Garadacimab
Vascular Permeability
Angiodema
Landelumab
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Monthly SC Garadacimab Markedly Reduces Mean HAE Attack Rate (Phase II Study Results) Primary Endpoint

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5
4.24
88.68% 98.94% 90.50% (2.74–5.75)
4 Mean Reduction Mean Reduction Mean Reduction
3
Mean Reduction in HAE Attacks per Month vs Placebo
2
1 0.48 0.40
(-0.33–1.29) 0.05
(-0.07–0.88)
(-0.06–0.15)
0
Garadacimab 75 mg Garadacimab 200 mg Garadacimab 600 mg Placebo
q4w (n=9) q4w (n=8) q4w (n=7) q4w (n=8)
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Source: Craig, T., (2020) European Academy of Allergy and Clinical Immunology Congress

Mean percentage reduction in HAE attacks vs Placebo

95% CI values are given in brackets

HAE - hereditary angioedema; q4w - every 4 weeks; TP1 - Treatment Period 1

VANGUARD

Garadacimab Pivotal Phase III Study

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Double-Blind, Placebo-Controlled, n=60

Run-in Period

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Up to 1 month~13 weeks 1-2 months~13 weeks 6 months
200 mg Garadacimab
N=36 once monthly SC
3:2
≥12 years of age type Baseline attack rate
1 or 2 HAE ≥1 attack/month
N=24 Placebo
once monthly SC
200 mg
Garadacimab
Randomization will be stratified by:
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• Age (≤17 years and >17 years)
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Phase III to commence H1 2021

Disease severity
Subjects will receive 400 mg loading dose as first dose (2 × 200 mg)

HAE in Japan

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No ethnic differences worldwide* Prevalence ~1/50,000, 2,400 estimated patients in Japan; HAE type 1 (85%), type 2 (15%)

No drugs approved for long-term prophylaxis Investigating both Garadacimab and HAEGARDA[®] for long term prophylaxis

Source: Zuraw, B. (2010) World Allergy Organ J 3(9 Suppl); S25-8

Investigating HAEGARDA[®] for HAE in Japan

Open-label, single-arm Phase III study in ≥ 8 patients with HAE1+2

Twice-weekly subcutaneous administration of 60 IU/kg HAEGARDA[®]
Primary Endpoint: HAE attack rate during treatment vs during Run-in period

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Follow-up
Screening Run-in period Treatment period period
Up to 4 weeks Up to 8 weeks 16 weeks 2 w
End of
To confirm the
Screening study
60 IU/kg HAEGARDA [®]
attack rate
visit
≥2 attacks in
consecutive 4wks
≥1 attack(s) in 1 [st] 2wks
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Phase III ongoing

Dermatomyositis – a Severe Autoimmune Disease

Incidence 11 per 1,000,000
Prevalence rate 14 per 100,000
Increases with age (peak ages 70-79)*

Presents with proximal weakness, characteristic rash and systemic manifestations

Mortality rate 10-30% (5y), high comorbidity

Current treatment: corticosteroids and azathioprine, other immunosuppressives: no approved disease-modifying anti-rheumatic drugs (DMARDs)

High unmet need for long-term treatments without systemic side effects

Source: Svensson J, et al., (2017) Clin Exp Rheumatol . 35(3):512-515

RECLAIIM Phase III Study of HIZENTRA[®] in Adults with Dermatomyositis

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Weeks 1 to 53

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Active DM w/without Steroid rescue if worsening occurs
Muscle Weakness
A HIZENTRA [®] 0.5 g/kg HIZENTRA [®] 0.5 g/kg
Forced Steroid taper starting at Week 17 if clinically relevant improvement met
B Placebo HIZENTRA [®] 0.5 g/kg
Up to 2 months Weeks 1 to 25 Weeks 25 to 53 Week 56
Primary endpoint:
TIS responder status
Phase III ongoing
Screening
Telephone Call
Randomization Safety Follow-up
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Commercial Bill Campbell

Executive Vice President and Chief Commercial Officer CSL Behring

John, a police officer, and his daughter, Emma, are both living with bleeding disorders.

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FY20 Highlights

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Sales of $7.7Bn; increased by 8%[1]

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Strong underlying demand across the portfolio

Balanced regional & key market growth

New products contributing significantly to growth

Ig growth well above market

Continuing to invest in foundational tools for future growth

Successful transition of business model in China

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

FY20: Strong Performance Across the Portfolio

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in 20% growth[1]

revenue YoY; Continued growth[2] in PID, CIDP

New launches in

EU, APAC and Canada;

in 12% growth[1]

revenue YoY

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in revenue YoY and 34% growth[1] clear SCIg market leader[2] globally

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in 21% growth[1] revenue YoY;

Growth[3] in nearly all launched markets

Transitioned

to GSP in China; in 11% growth[1] revenue YoY ex-China

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25% growth[1] in revenue YoY;

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in 12% growth[1] revenue YoY; Further in US penetration[2]

in Market leadership[2] 20% growth several key markets, including US, Germany, Japan, Switzerland and Italy revenue YoY; approval of 4&5 gr vials

in 20% growth[1] revenue YoY; approval of

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

Targeted Protein Therapeutic Market

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Albumin
$4.1B
Immunoglobulins
$12.8B
Total Global
Market Value
Haemophilia ~$33.5B
$11.9B
Specialty
$4.7B
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Source: Analyst Reports, Company Annual Reports, data on file; Haemophilia mkt includes Inhibitor mkt

Haemophilia Sales increased by 8%[1]

FY20 Sales

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$1,122
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Plasma

Coagulation Factors

Transformational product
Leadership position in several key markets[2]
Approval of 21-day dosing in EU[^] CH, JP & CA
Patient retention strategies and ongoing switches in competitive environment
New market launches
Modest growth in HUMATE[®] /HAEMATE[®] (vWF)
pdVIII competitive pressures

Ig Haemophilia Specialty Albumin Other

Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.
MONONINE[®] to IDELVION[®] switches
Data on file
^ Expanded label for dosing every 21 days for patients ≥12 years in age, depending on individual patient and efficacy (and jurisdiction)

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AFSTYLA[®] Share of rFVIII Prophylaxis – Growing Steadily

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Patient Share (%)
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®
AFSTYLA rFVIII Prophylaxis Patient Share by Country
12%
11%
10%
9%
8%
6%
5%
5%
4% 4%
3%
2% 2%
2%
0%
Q3 16 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
Germany Italy Japan Spain Switzerland US France Launched markets Avg.
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Source : Data on file. Data only available for 7MM, BR, CH and AR through Q2’20; Launched markets include DE, IT, JP, ES, CH, US, and FR 7MM refers to US, DE, FR, IT, UK, ES & JP

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IDELVION[®] Share of rFIX Prophylaxis – Significant Shares

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®
70% IDELVION rFIX Prophylaxis Patient Share by Country
59%
60%
58%
57%
50%
44%
43%
40% 41%
30%
29%
20%
10%
0%
Q1 16 Q2 16 Q3 16 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
Germany Italy Japan Switzerland UK US Launched markets Avg.
Patient Share (%)
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Source : Data on file. Only available for 7MM, BR, CH and AR through Q2’20; Launched markets include DE, IT, JP, CH, UK, and US 7MM refers to US, DE, FR, IT, UK, ES & JP

Immunoglobulin Market

Global Ig Volume by Indication

Market Dynamics

Market growth above historical rates
Growth in PID & CIDP
Expanding usage for SID
Market supply tightness pre-COVID-19
COVID-19: Impact on plasma collection
Shifting preference to SCIg and home administration

Source: Data on file

Immunoglobulins[1]

Sales increased by 22%[2]

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FY20 Sales
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$4,014
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Increased disease awareness & improved diagnosis in chronic therapies (PID & CIDP)
Expansion of SID usage
Launched PID/SID in Japan
Market leader
Increased preference for home administration
Orphan exclusivity for CIDP in the US

Ig Haemophilia Specialty Albumin Other

Continued CIDP launches
Excludes Ig hyperimmunes
Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.
Includes Privigen[®] , Sandoglobulin[®] / Carimune[®] and Intragam[®]

HIZENTRA[®] : Continued Strong Performance in SCIg Segment

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80%
70%
62%
61% 59% 60% 61% 60% 60% 60% 61%
58% 57% 57% 58% 57%
60%
50%
40%
30%
20%
10%
0%
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
®
Hizentra (CSLB) Competitor A Competitor B Competitor C Competitor D Competitor E
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Source: Data on file 7MM refers to US, DE, FR, IT, UK, ES & JP

CSL Behring Well-Positioned in CIDP

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40%
35%
30%
25%
20%
15%
10%
5%
0%
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
CSLB Competitor A Competitor B Competitor C Competitor D
Patient Share (Total 7MM)
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Source: Data on file 7MM refers to US, DE, FR, IT, UK, ES & JP

Specialty Products Sales increased by 10%[1]

FY20 Sales

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$1,697
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Ig Haemophilia Specialty Albumin Other

Peri-Operative Bleeding +10%[1]

Other Specialty +9%[1]

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

HAEGARDA[®] Continues to Deliver in the US

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HAEGARDA [®]
reduced HAE attacks
by 95%
Rescue medication
use was reduced by
>99% [†‡1]
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Prophylactic market grew by 25%[1]**

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Finished with most patients on HAEGARDA[®] since launch[1]

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Almost 25% of all new patients came from newest product launch[1]

Median reduction in number of attacks in patients receiving 60 IU/kg of HAEGARDA[®] vs placebo.
Median reduction in rescue medication use in patients receiving 60 IU/kg of HAEGARDA[®] vs placebo.
The World Allergy Organization (WAO) guidelines for the management of HAE state that patients should have HAE rescue medication available at all times.
** Prophylactic non- steroids patient market
Data on file – represents US market only

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Finished with Most Patients on HAEGARDA[®] Since Launch

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Q3 17 Q4 17 Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20
®
HAEGARDA Patients
Patients
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Source : Data on file – represents US market only

KCENTRA[® ] : OAC Market & KCENTRA[®] Utilization

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

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Oral Anticoagulant (OAC) Market FY 19/20 Warfarin Urgent/Major Bleed Reversal Shares
Total: 6.9M Patients
Other 80%
2%
70%
Warfarin/ 60%
Product B
Coumadin
25% 50%
27%
40%
Product A 30%
46%
20%
10%
0%
®
Warfarin/ Coumadin Product A Product B Other KCENTRA FFP Others
Source: Data on file Source: Data on file + LRx Q4 2019
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Kcentra [®] Utilization MAT CY Q4’19
Total: 246M IUs
Warfarin
Reversals
34%
All Other
66%
Warfarin Reversals All Other
Indicated for warfarin reversal. Not promoted in other areas
Source: CSL Internal data + Data on file+ LRx
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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

FFP – Fresh frozen plasma

Successful Transition of Business Model in China

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----- Start of picture text -----

Obtained the GSP [1] license
Recruited and transferred all employees
to GSP [1] Entity
Completed
Implemented IT systems, interfaces & training
in ~1 Year
Developed and changed business processes for
new affiliate
Established direct relationships with hospitals
and key distributors
No impact to patient supply
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Good Supply Practices (GSP)

Strong underlying demand Executing on strategies across the portfolio Commercial Summary Balanced regional & key New products contributing market growth significantly to growth Aligned therapeutic area Remain flexible and agile teams and strategy managing through COVID-19

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Transplant Laurie Lee MD Vice President, R&D Transplant CSL Behring

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Improve Outcomes for Transplant Recipients

Unmet needs in hematopoietic stem cell (HSCT) & solid organ transplantation

Before & During Transplantation Lack of organs & optimally matched cells

Shortage of available organs & organ discard
Donor-recipient mismatch
Consequences of ischemiareperfusion injury
After Transplantation
Inadequate long-term Need for less toxic post patient and graft survival transplantation regimens
• • Graft-versus-Host Disease Patients are at risk for (GvHD) is major risk to patient infection, malignancy and survival post-HSCT other comorbidities

• Antibody-Mediated Rejection (AMR) is leading cause of long-term graft loss in kidney transplant recipients

Scientific focus:

Anti-inflammatory & immune modulation

Three Ongoing Late-Phase Transplant Programs

Inadequate long-term patient and graft survival

Graft-versus-Host Disease (GvHD)

Antibody-Mediated Rejection (AMR)

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Phase III

AAT (CSL964) treatment study in collaboration with BMT CTN (NHLBI/NCI)

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Phase II/III AAT (CSL964) MODULAATE prevention study

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Phase III

Clazakizumab (CSL300) IMAGINE trial

Interleukin 6 Blockade Modifying AntibodyMediated Graft Injury and Estimated Glomerular Filtration Rate (eGFR) Decline

GvHD: Frequent Post-Transplantation Complication with High Morbidity and Mortality

Clinical Manifestations

Up to 50% of patients develop GvHD after allogeneic HSCT despite current prophylactic regimens

Of those who develop acute GvHD, only 50% respond to treatment*(termed “steroid-refractory”)

Severity of acute GvHD varies: grades III and IV are the most severe

Mortality associated with grade III and grade IV one year after transplant is 75% and 95%, respectively**

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Skin GI Liver
Early Early Early
Advanced Advanced Advanced
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•
Upper GI: nausea, Cholestatic jaundice •
vomiting Hyperbilirubinemia
Maculopapular rash
Lower GI: profuse watery diarrhoea; bloody diarrhoea or ileus
Ferrara, J. & Chaudry, M. (2018) Blood Adv . 2(22):3411-3417

** Hill, L. et al., (2018) Ther Adv Hematol. 9(1):21-46

Source: Zeiser, R. & Blazar, B.R. (2017) N Engl J Med .377(22):2167-2179

Potential Mechanisms of AAT in GvHD

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----- Start of picture text -----

Pre-Clinical Data
AAT
1 • Protease inhibition protects
DAMPs
2 tissue
Conditioning
regimen, Tissue Activation and
chemo-therapy damage Chemokines proliferation of
or radiation Teff cells •
Reduces pro-inflammatory
PAMPs APC Naïve T cell 3 cytokine secretion
Cytokine storm:
AAT TNF-IL-6, IL-32α, IL-1β Acute GvHD • Decreases CD8+ effector
Teff End-organ damage:
Skin, liver, gut
IL-10 memory cells
•
Inhibits neutrophil migration
AAT
to sites of inflammation
AAT
Treg IL-8
•
Promotion Promotes release of
Inhibition anti-inflammatory cytokine
Neutrophil
IL-10
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Source: Adapted from Blazar, B. R., et al., (2012). Nat Rev Immunol 12(6): 443-458

Clinical Response to AAT in Patients with Steroid-Refractory acute GvHD (SR-aGvHD)

Prospective, open label, Phase II study of i.v. AAT in SR-aGvHD*

40 subjects, steroid-refractory acute GvHD
AAT twice weekly x 4 weeks at 60mg/kg
Overall response rate (ORR) (CR + PR): at d28 = 65%; CR at d28=35%
Sustained response at d60 of 73%

Second smaller study (n=12) had consistent findings**

Overall Response Rate (ORR)

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Days after initiation of AAT
% response
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Treg Fold Change

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Magenau, J.M. et al., (2018) Blood . 131(12):1372-1379
** Marcondes, A.M. et al., (2016) BBMT 22(9): 1596-1601

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Figure 1. ORR. The percentage of patients who experienced an overall response (primary end point) as defined by the sum of patients with SR-aGvHD achieving complete response (CR) and partial response (PR) after initiation of AAT. NR, nonresponder; Prog, progression.

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AAT for GvHD Treatment Study: BMT CTN 1705 Collaboration opportunity with Blood and Marrow Transplant Clinical Trials Network BMT CTN (NHLBI/NCI)

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AAT IV (120mg/kg)
Twice weekly (x 8 doses)
+ CS
Primary If Response:
Acute GvHD Endpoint AAT or
Randomization (1:1) Placebo
(De Novo)
Day 28 once weekly
CR+PR (x 4 doses)
Placebo IV (albumin)
Twice weekly (x 8 doses)
+ CS
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Enrollment Treatment

Maintenance

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Phase III ongoing

BMT CTN (NHLBI/NCI)

MODULAATE

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AAT GvHD Prevention Phase II/III Study

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Part 1: Part 2:
Dose Finding – Open Label Randomized Double Blind Placebo Controlled
3 ascending cohorts Cohort 4
(n=15) for each cohort Selected dose from Part 1
(n=260, 1:1; AAT: Placebo)
HSCT Adults & adolescents
AAT/Placebo
HSCT
Day
-5 -3 -1 0 7 14 21 28 35 42 49 56 63 70 77 84 91 100 120 150 180 270 365
MTX
CNI
Primary Endpoint:
Phase II/III ongoing Proportion of acute Graft-versus-Host
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Primary Endpoint: Proportion of acute Graft-versus-Host Disease-free survival at 180 days post-HSCT

Solid Organ Transplantation

Transplants by Organ Type (US - 2015)

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500,000 patients are living with a transplanted kidney*

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Other
3%
Lung
7%
Heart
9%
Liver Kidney
23% 58%
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Scientific Registry of Transplant Recipients (SRTR) and European Renal Association – European Dialysis and Transplant Association (ERA-EDTA)

Antibody-Mediated Rejection (AMR) is a Leading Cause of Long-Term Graft Loss

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Source: Sellarés et al., (2012) Am J Transplant . 12:388-99

Source: Halloran et al., (2015) J Am Soc Hephrol . 26:1711-1720

IL-6 Plays a Key Role in the Development of AMR

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

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

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

Source: Adapted from Jordan, S. et al., (2017) Transplantation. 101 (1): 32-44

IMAGINE

Clazakizumab for chronic AMR treatment study

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Treatment Phase: Day 1 to Week 260

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Dosing with Clazakizumab 12.5 mg SC injection, Q4W (until graft loss or death): N=175
V2 V68 Follow-up
Day 1 Wk 260
V1 BL EOS (monthly)
assessments assessments
Screening
Day -42 to -1
Dosing with Placebo 1 mL SC injection, Q4W (until graft loss or death): N=l75
V2 V68 Follow-up
Day 1 BL Wk EOS 260 (monthly)
assessments assessments
Day 1 (BL) Last Dose 5 Months
Randomization Week 256 (V67) After Last Dose
1 [st] Dose of Study Drug
Week 52
•
• Subjects continue in study
Interim analysis: 200 subjects
•
• Event driven final analysis
Change from baseline in mean eGFR at Week 52
• Expedited Approval • Time to All-Cause Graft Loss
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Phase III ongoing

Improve Outcomes for Transplant Recipients

Unmet needs in hematopoietic stem cell (HSCT) & solid organ transplantation

Before & During Transplantation After Transplantation Lack of organs & optimally Inadequate long-term Need for less toxic post matched cells patient and graft survival transplantation regimens
• Shortage of available organs &  Graft-versus-Host Disease  Patients are at risk for organ discard (GvHD) is major risk to patient infection, malignancy and
• survival post-HSCT other comorbidities Donor-recipient mismatch
•  Antibody-Mediated Rejection Consequences of ischemia(AMR) is leading cause of
reperfusion injury long-term graft loss in kidney transplant recipients

Scientific focus:

Anti-inflammatory & immune modulation

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Summary William Mezzanotte MD Executive Vice President, Head of Research and Development and CMO CSL Behring

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R&D Portfolio – October 2020

Registration/ Research Pre-Clinical Phase I Phase II Phase III Post-Registration Gene Therapy CSL888 CSL324 HIZENTRA[®] HIZENTRA[®] PRIVIGEN[®] Treatments Haptoglobin(SAH) Anti-G-CSFR mAb(HS) (SSc) (DM) (PID) JP PID CSL510 CSL730 CSL630 HAEGARDA[®] IDELVION[®] DiscoveryProjects Modified Fibrinogen rFcMultimer pdFVIII Ruide Japan rFIX-FP (HaemB) CSL040 CSL889 CSL346 Garadacimab AFSTYLA[®] DiscoveryProjects Novel Complement Hemopexin(SCD) Anti-VEGF-B mAb Anti-FXIIa mAb(HAE) rFVIII (HaemA) Inhibitor (DKD) CSL200 EtranaDez* ZEMAIRA[®] /RESPREEZA[®] DiscoveryProjects SA-mRNA Influenza CAL-H(SCD) Garadacimab Etranacogene Alpha1-Proteinase Vaccine Anti-FXIIa mAb(ILD/IPF) dezaparvovec Inhibitor CSL787 DiscoveryProjects LASN01 NebulisedIg Garadacimab KCENTRA[®] AFLURIA[®] QUAD Anti-IL-11R Anti-FXIIa mAb(ARDS) 4F-PCC (Trauma) Egg-based Influenza CSL311 Vaccine DiscoveryProjects P. Gingivalis Anti-Beta Common mAb Adjuvanted Cell Culture CSL112 (Periodontal Disease) Influenza Vaccine ApoA-1(ACS) FLUCELVAX[®] UQ/CSL V451 (aQIVc) Quadrivalent (aCoV2) Clazakizumab Cell-based Influenza Vaccine Mavrilimumab Anti-IL-6 mAb(AMR) CSL334/ASLAN004 Anti-GM-CSFR mAb FLUAD[®] Quadrivalent Anti-IL-13R mAb(AD) CSL964 Adjuvanted Influenza Alpha-1Antitrypsin Vaccine (Treatment of GvHD) AUDENZ™ CSL964 Adjuvanted Monovalent Alpha-1Antitrypsin Influenza A (H5N1) Vaccine (Prevention of GvHD) * Transaction with uniQure is subject to customary regulatory COVID-19 clearances before closing Hyperimmune Therapy Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Influenza Vaccines COVID Outlicensed Programs Partnered Projects

Transaction with uniQure is subject to customary regulatory clearances before closing

Significant Target Launch Dates

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2019 2020 2021 2022 2023-2025
HIZENTRA [®] CIDP PRIVIGEN [®] PID FLUCELVAX [®] QUAD HAEGARDA [®] CSL510
Japan Japan 9yrs+ AU Japan Modified Fibrinogen
PRIVIGEN [® ] CIDP IDELVION [®] UQ/CSL V451^ EtranaDez CSL112
Japan 21 Day Dosing (aCov2) Etranacogene ApoA-1 (ACS)
dezaparvovec
AFLURIA [®] QIV FLUAD [®] QIV Garadacimab
6m+ (AUS) 65yrs+ US, EU Anti-FXIIa (HAE)
FLUCELVAX [®] QIV HIZENTRA [®]
9yrs+ EU (DM)
Clazakizumab
Anti-IL-6 (AMR)
CSL964 AAT
(GvHD Treatment)
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Timelines shown by calendar year

Transaction with uniQure is subject to customary regulatory clearances before closing
^ Provisional Approval

clearances before closing Provisional Approval
Immunology	Haematology	Respiratory	Cardiovascular & Metabolic	Transplant
Influenza Vaccines	COVID	Outlicensed Programs	Partnered Projects

R&D Portfolio Highlights – FY21

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Transplant

CSL964 (AAT) for prevention of GvHD - complete Part 1, adaptive phase of study, and advance to confirmatory Part 2

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Immunology

Garadacimab (Anti-FXIIa) initiate Phase III study
HAEGARDA[®] complete Phase III HAE study in Japan
CSL324 (Anti-G-CSFR) initiate PK/Ethnicity study for SC formulation and inclusion of Japan

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Cardiovascular and Metabolic

CSL112 (ApoA-1) Phase III study (AEGIS-II) complete 2[nd] futility analysis (if applicable)
CSL346 (Anti-VEGF-B) initiate Phase II study for DKD

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Respiratory

CSL311 (Anti-Beta Common) advance Phase I study in mild asthmatic patients
Garadacimab (Anti-FXIIa) initiate Phase II ILD/IPF study
CSL787 (NebIg) initiate Phase I study

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Haematology

KCENTRA[® ] initiate Phase III study for treatment of massive haemorrhage associated with severe traumatic injury
EtranaDez* US Approval

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Influenza Vaccines

FLUCELVAX[®] Quadrivalent EU & CA approvals in 2+yrs indication
FLUCELVAX[®] Quadrivalent US & CA submissions 6mons+ indication
aQIVc (cell antigen + MF59[®] ) initiate Phase II safety & immunogenicity study in adults 50+yrs

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COVID

COVID-19 Hyperimmune Therapy Phase III First Patient In
Garadacimab (Anti-FXIIa) complete Phase II study
UQ/CSL V451 Phase II/III First Patient In
Transaction with uniQure is subject to customary regulatory clearances before closing

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Panel Q&A Session

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AI assistant

CSL Ltd. — Investor Presentation 2020

17854_rns_2020-10-19_c32cb7f5-f5c0-41c3-add1-730a8a098669.pdf

For immediate release

CSL’s Annual R&D Investor Briefing 2020

Approved for Release

For further information, please contact:

Forward looking statements

Trademarks

Agenda

Global Research and Development Footprint

Key Global Research Partnerships for Early Innovation Access

Commitment to Research and Development

Focus Through Our Therapeutic Areas and Platforms

R&D Portfolio – December 2019

R&D Portfolio Highlights - FY20

Immunology

Respiratory

Cardiovascular and Metabolic

Acquisitions & Alliances

Haematology

Transplant

Influenza Vaccines

Key Past Launches from R&D Portfolio

Notable Regional Regulatory Action

1 July 2019 – 1 October 2020

On-going Activities

R&D Portfolio Progression in 2020

CSL112 ApoA-1

R&D Portfolio – October 2020

Research

CSL Research

CSL Behring Research

Melbourne

CSL Behring Research Bern

CSL Behring Research – Sourcing Innovation

Growing the Development Portfolio

Collaboration Delivers Innovation

Targeting Complement Regulation

Complement Pathways

Potential indications

CSL040 Complement Receptor 1 Inhibitor

Haemolytic complement inhibition assays (human serum)

CSL040 Complement Receptor 1 Inhibitor

Garadacimab

Global leaders in FXII biology – new opportunities for Garadacimab

Beyond Hereditary Angioedema

Garadacimab

Pulmonary Fibrosis

Plasma FXII levels are higher in IPF patients with progressive disease

FXII expression is higher in the IPF lung

Gene Therapy

XLA

Fc Mimetics and Anti-FcRn mAbs

IVIg & SCIg Usage

Ig vs. anti-FcRn

CSL730 Clinical Development

CSL – COVID-19 Vaccines

CSL – COVID-19 Vaccines

In Clinical Development

CSL – Production of UQ/CSL V451

1. FOUNDERS

2. MEMBERS

Collaborative Hyperimmune Ig Trial in COVID- 19

Hyperimmune Program for Australia

Potential Benefits of Blocking Factor XIIa in COVID-19

Garadacimab in COVID-19

Garadacimab in HAE: The Vanguard Program

Garadacimab and Factor XIIa in HAE

Monthly SC Garadacimab Markedly Reduces Mean HAE Attack Rate (Phase II Study Results) Primary Endpoint

VANGUARD

Garadacimab Pivotal Phase III Study

Double-Blind, Placebo-Controlled, n=60

Run-in Period

HAE in Japan

Investigating HAEGARDA[®] for HAE in Japan

Open-label, single-arm Phase III study in ≥ 8 patients with HAE1+2

Dermatomyositis – a Severe Autoimmune Disease

RECLAIIM Phase III Study of HIZENTRA[®] in Adults with Dermatomyositis

Weeks 1 to 53

CSL Ltd. Investor Presentation 2020