CSL Ltd. — Investor Presentation 2024

Oct 21, 2024

For immediate release

22 October 2024

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Research & Development Investor Briefing

CSL Limited (ASX:CSL; USOTC:CSLLY) is holding its 2024 Research & Development Investor Briefing today commencing at 9.00am Australian Eastern Daylight Time.

This 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 today.

The presentation materials are attached for the information of investors and can also be accessed in the ‘Investors’ section of the Company website at www.csl.com.

Authorised by Fiona Mead Company Secretary

For further information, please contact:

Investors: Bernard Ronchi Director, Investor Relations CSL Limited P: +61 431 060 964 E: bernard.ronchi@csl.com.au

Media:

Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: jimmy.baker@csl.com.au

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Zahra, Living with Hereditary Angioedema

R&D Investor Briefing October 22, 2024

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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2

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Introduction

William Mezzanotte MD, MPH Executive Vice President Head of R&D CSL

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01 Welcome 05 Vaccines Development
Chris Cooper Jon Edelman MD
Head Investor Relations Senior Vice President
Vaccines Innovation Unit
Agenda 02 Introduction & Portfolio 07 Innovation & Sustainability
Highlights Deirdre BeVard
Bill Mezzanotte MD, MPH Senior Vice President
Executive Vice President R&D Strategic Operations
Head of R&D
03 Plasma Products & 08 Looking Forward
Immunoglobulins & Summary
Douglas Lee PhD Bill Mezzanotte
Senior Vice President
Plasma Product Development
04 Therapeutic Development 09 Q&A
Marie-Pierre Hellio MD, PhD Panel
Senior Vice President
Strategic Development
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Dates are all Calendar Years unless otherwise noted

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Key Takeaways

• R&D continues to invest and innovate (SID, Nebulised Ig, Horizons 1 & 2, sa-mRNA) in our core Ig, plasma & vaccine platforms to support future growth

• We are relentlessly focused on rapid advancement of our research & early development programs towards late-stage development & registration

• HEMGENIX [®] , KOSTAIVE [®] , RiaSTAP [®] & garadacimab are all advancing toward registration & approval for key indications in key regions

• We have experienced a few late-stage setbacks (KCENTRA[®] Trauma, HIZENTRA[®] DM, clazakizumab AbMR), however each of these products have promising follow-on indications which we are actively pursuing

• We have exciting, novel Phase II (e.g. Vamifeport, Hemopexin) and Phase III programs (e.g. aTIVc, CSL964, clazakizumab, HIZENTRA[®] POTS) to add incremental value to patients & CSL

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Key Submissions and Approvals

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R&D Portfolio Highlights – FY24

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Cardiovascular & Metabolic

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Haematology

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Respiratory

• CSL112 (ApoA ~~-~~ 1) AMI Phase III top line results

• Clazakizumab (ESKD)

• Phase IIb complete

• Phase III first patient in

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Immunology

• Garadacimab (Anti-FXIIa) HAE

• EU, US & JP submissions

• HIZENTRA[ ®] DM Phase III enrolment complete

• HIZENTRA[ ®] PFS 50mL

• US Launch

• EU submission

• Anumigilimab (Anti-G-CSFR) HS Phase II study first patient in*

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Horizon 2

• Ongoing pre ~~-~~ clinical studies with pilot plant materials

• IDELVION[® ] China Phase III first patient in

• Vamifeport (SCD) last patient out

• CSL889 (Hemopexin) SCD Phase I top line results

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Nephrology & Transplant

• Clazakizumab (Anti ~~-~~ IL ~~-~~ 6) ca ~~-~~ AbMR Phase III study 200 patients enrolled*

• CSL964 (Treatment of aGvHD) Phase III top line results

• FILSPARI[® ] (sparsentan) (IgAN) EU CMA

• VELPHORO[®] China launch

• VELTASSA[ ® ]

• AU Launch

• US & EU paediatric approval

• Trabikibart (Anti ~~-~~ Beta Common) ASTH Phase I study complete

• Garadacimab (Anti ~~-~~ FXIIa) IPF/ILD Phase IIa study complete

• CSL787 (Neb Ig) Phase I study complete

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Vaccines

• aQIVc (Adjuvanted Cell-based Quadrivalent Influenza Vaccine) Phase III study 50yr+ first patient in

• KOSTAIVE[®] sa-mRNA (COVID)

  • JP approval

  • US[†] & EU submissions

• CSL406 sa-mRNA (H5N1) Flu Phase I first patient in

• CSL400 sa-mRNA Quad Flu Phase I first patient in

• Transition of QIV to TIV in US

• Ongoing HA engagement

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• Program stopped;[†] Delayed to FY25

Abbreviations: AU – Australia; aGvHD acute Graft versus Host Disease; ca-AbMR - Chronic Active Antibody-Mediated Rejection; DM – Dermatomyositis; ESKD – End Stage Kidney Disease; EU – Europe; HA – Health Authority; HAE – Hereditary Angioedema; HS – Hidradenitis Suppurativa; IgAN - IgA Nephropathy; ILD – Interstitial Lung Disease; IPF - Idiopathic Pulmonary Fibrosis; JP – Japan; Neb Ig - Nebulised Ig; PFS – Pre-Filled Syringe; sa-mRNA – Self-Amplifying messenger RNA; RNA – Ribonucleic Acid; SCD – Sickle Cell Disease; US – United States

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R&D Investment Allocations

R&D Financial Stewardship

• Active Portfolio Management

• Strategic Partnerships

• Productivity Gains

• Gated spend in development and in large trials (futility analyses)

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Streamlining Our Therapeutic Areas and Platforms

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Plasma Proteins & Immunoglobulins

Douglas Lee PhD Senior Vice President Plasma Product Development CSL

Focus on Immunoglobulins (Ig) and Plasma Product Development

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Ig Yield Maximisation Strategy*

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•
•
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Horizon 1

• Continuous Improvement: Yield and capacity improvement initiatives focusing on current PRIVIGEN[®] & HIZENTRA[®] process

Horizon 2

• Industry Leadership: Proprietary and industry disruptive Ig process providing for greater yield improvements

• Illustrative only. Subject to success and timing of R&D activities and decisions of HAs

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Horizons 1 & 2 – Meeting Patients’ Future Ig Needs

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Horizon 1 - Gaining with our Current Processes

• Target maximising yields with minimal changes to current process

• Leverage process analytics to identify new opportunities for improvement

• Reduce regulatory complexity

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Horizon 2 - The Future of Ig Processing

• Novel proprietary process - high Ig yields

• Complements current process

• Provide product comparable to current PRIVIGEN[®] & HIZENTRA[®] products

• Safety

• Purity

• Quality

FY25 R&D Deliverables

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• Complete toxicology package

• Process robustness package

• Health Agency interactions

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• Smaller footprint

• Requires new regulatory filing

• Multi-year phased introduction

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Horizons 1 & 2 - A Purposeful, Collaborative Regulatory Path

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• Partner with Health Authorities (HAs) by providing robust analytical programs & nonclinical data packages

• Leverage state-of-the-art analytics to deliver robust process control strategies

• Listen to HAs to understand their potential concerns early in development process and address them proactively

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IgPro
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Protinus

Horizon 2

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Horizon 1
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HAs
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Improving Patient Options – HIZENTRA[®] Pre-Filled Syringe (PFS)

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Fast, simple and convenient for patients

• First & only PFS available for patients using SCIg

• Ease of Use - no vial transfer or preparation needed

• Convenience – patients can self-administer

• Flexible – patients can tailor treatment to their schedules & needs

• Fewer supplies may reduce steps, effort, and product waste

• Less risk of contamination or breakage

• Available in multiple volumes to fit patients’ individual needs*

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• 1g/5mL, 2g/10mL, 4g/20mL, 10g/50mL

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• Not all PFS options will launch in every affiliate Abbreviations: SCIg – Subcutaneous Immunoglobulin

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Nebulised IgG (CSL787)

CSL787 combines advanced plasma-based therapy with cutting-edge delivery technology

• Unique formulation designed for lung delivery

• State-of-the-art nebuliser to deliver this new product

• Innovative combination of IgG composition & inhalation technology

• Maintains IgG molecular integrity to ensure IgG retains natural binding properties

• Provides appropriate physicochemical properties of the nebulised particle for effective drug delivery

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New Products from Plasma

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Optimising RiaSTAP[®] (CSL511) & Hemopexin (CSL889)

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RiaSTAP[®] (CSL511)

• Introduction of 2[nd] virus reduction step

• Established GMP-ready commercial facility for new CSL511 manufacturing process & validated improved process

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• Process changes submitted as Type II variation for RiaSTAP[®] & Haemocomplettan[®] P

• First commercial manufacturing campaign completed confirming robustness of process

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CSL511 Process EU Approved – Sep 2024

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Hemopexin (CSL889)

• New plasma protein characterised by CSL Research

• Phase II manufacturing in progress

• State-of-the-art proprietary process with small operational footprint

• Current development focused on final commercial process for Phase III clinical study materials

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Plasma Innovation Platform Strategy Group (PSG) Enterprise Collaboration for Innovation

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Re-imagining plasma donation through a progressive lens of digitisation, science, and regulatory policy to provide for the needs of our donors & patients while driving value for CSL

• Optimise plasma protein

• • Drive breakthrough collection allowing for yield

• innovation, unconstrained by R&D growth

• industry norms • Drive development

• • PSG champions for delivery strategies to improve donor

• teams, removing roadblocks safety & experience

• CSL

• & managing relevant cross- I&T •

• Plasma Help CSL to improve the

• organisational stakeholders donor experience

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Plasma Product Development: Continuous Innovation

• Building on a Legacy of Innovation: Strong Foundation for Future Growth in Plasma Products

• Immunoglobulins: Vital for Patients and Key to CSL’s Future Growth with New Innovation Opportunities

• Novel Technological Innovations: Cutting-Edge Technologies for Existing Products

• Our R&D Efforts: Demonstrating Our Commitment to Patients & Donors

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Therapeutic Development

Marie-Pierre Hellio MD, PhD Senior Vice President Strategic Development CSL

Pete, Living with Haemophilia B

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Immunoglobulin Replacement and Immunomodulation

IVIg & SCIg Usage

Immuno-replacement

Immuno-modulation

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PID & SID
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Autoimmune
Diseases
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Abbreviations: IVIg – Intravenous Immunoglobulin; PID – Primary Immune Deficiency; SCIg – Subcutaneous Immunoglobulin; SID – Secondary Immune Deficiency

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HIZENTRA[®] in Secondary Immune Deficiency (SID)

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Significant unmet needs persist in SID

• Hematologic cancer & therapy reduces B-cells & antibodies

• Leading to SID and serious or recurrent infections

• Infections major cause of death among CLL & MM patients

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New approaches required

• Infection prevention by IgRT well documented

• Supported by clinical guidelines worldwide & non-US indications

• Placebo use complicates randomised trials in patients with high unmet need

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Sustainable development

• Actively discussing novel data generation approaches with HAs

• New clinical development avenues

Abbreviations: CLL –Chronic Lymphocytic Leukaemia; IgRT– Immunoglobulin Replacement Therapy; MM – Multiple Myeloma

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HIZENTRA[®] in Post-COVID POTS – a Debilitating “Long COVID” Disease

Postural Orthostatic Tachycardia Syndrome (POTS)

• Dysregulation of autonomic nervous system

• Symptoms include lightheadedness, palpitations, fatigue, "brain fog“, GI dysfunction

• No approved therapies; only symptomatic treatments available

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COVID-19 has dramatically changed POTS epidemiology

• Post-COVID sequalae experienced by 2-14% of patients[1]

• Mostly in younger women with no prior comorbidities[1]

• Disability similar to COPD & heart failure limiting employment & ADLs[2]

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IgG is a promising potential treatment for post-COVID POTS

• Aetiology hypothesised to be immune dysregulation & autoantibodies[3]

Abbreviations: ADLs – Activities of Daily Living; COPD – Chronic Obstructive Pulmonary Disease; GI- Gastrointestinal Sources : 1. Ormiston C.K. et.al. , (2022) Heart Rhythm 19(11):1880-1889; 2. Benrud-Larson, L.M. et al. , (2002) Mayo Clin Proc 77(6):531-537; 3. Wallukat, G. et al. , (2021) J Trans Autoimm 4

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HIZENTRA[®] Phase III Study in Patients with Post-COVID POTS

• Adult patients (n=177) with post-COVID POTS

• Primary Endpoint: Proportion of patients not meeting POTS diagnostic criteria

• Key Secondary Endpoints: Absolute HR change, COMPASS 31 total, COMPASS 31 orthostatic intolerance symptoms

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Phase III First Patient In – Aug 2024

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Abbreviations: COMPASS - Composite Autonomic Symptom Score; HR – Heart Rate

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HIZENTRA[®] Phase III Study in Patients with Dermatomyositis

• 134 treatment-experienced adult patients with dermatomyositis enrolled & reached primary endpoint

• Primary endpoint: responder rate (%) of HIZENTRA[®] recipients vs. placebo

• Responder defined by TIS of ≥ 20 points* at 2 timepoints up to week 25 & completed 24 weeks of randomised treatment without use of rescue corticosteroid treatment

• Study did not meet primary efficacy endpoint

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• HIZENTRA[®] response rate within expected range; unexpected high response rate in placebo group

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• No new safety findings

• Plans to terminate study are underway

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Phase III Study Completed

• Minimum TIS improvement threshold

• Abbreviations: TIS – Total Improvement Score

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Nebulised IgG (CSL787) in Non-Cystic Fibrosis Bronchiectasis (NCFB)

High unmet need in NCFB for patients with limited treatment response to Standard of Care who suffer severe and frequent exacerbations

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Current estimates suggest ~1M 12% mortality at 1-year follow-up
patients in US, EU, & JP diagnosed after hospitalisation due to an
with NCFB exacerbation [1]
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Sources : 1. Scioscia, G., et.al ., (2022) Archivos de Bronconeumologia 58(11): 773-775

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CSL787 - Nebulised IgG in Non-Cystic Fibrosis Bronchiectasis

CSL787 combines advanced plasma-based therapy with cutting-edge delivery technology

Phase I in healthy subjects & subjects with mild NCFB

• Included subjects with mild NCFB with largely preserved lung function & tested positive for presence of ≥ 1 of 6 types bacteria (including pseudomonas aeruginosa)

• Antibacterial effects observed following 15 days of once daily dosing in all 18 treated subjects with 3 active doses

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Phase II First Patient In – Q1 2025

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Garadacimab - Disruptive Innovation to Improve Treatment Options for HAE Patients

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Phase III study evaluating efficacy & safety of SC Garadacimab for prophylaxis of HAE Attacks

• Primary & key secondary efficacy endpoints achieved with high degree of statistical significance & clinically meaningful differences vs. placebo

• Pivotal data releases at AAAAI2023 and primary results published in The Lancet journal[1]

Differentiated, Patient-Focused Profile

• Differentiated profile

• Autoinjector - Convenient administration

• Once-monthly treatment dosing

• Favorable safety & tolerability profile

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EU, US, JP Expected Approvals - 1H 2025 Phase III Paeds Study Completion – Q4 2025

Abbreviations: AAAAI – American Academy of Allergy, Asthma & Immunology; AI – Autoinjector; HAE – Hereditary Angioedema; SC – Subcutaneous Sources: 1. Craig, T.J. et al ., (2023) Lancet 401:1079–1090

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Phase III Study Evaluating Efficacy and Safety of SC Garadacimab for Prophylaxis of HAE Attacks

• Durable efficacy, providing sustained protection from HAE attacks over median exposure of 13.8 months • ≥94% reduction in number of attacks vs. run-in - sustained throughout OLE

• 85% patients had ≥90% attack reduction vs. run-in; 60% patients attack-free

• 88% patients attack-free at end of observation period (months 13–15)

• Favourable long-term safety profile

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Hereditary angioedema attack reduction vs.
run-in period
Time to first hereditary angioedema attack
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Mean and median number of monthly attacks
during 6-month treatment period
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Abbreviations: OLE – Open Label Extension Sources: Craig, T.J. et al ., (2023) Lancet 401:1079–1090

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Fibrinogen - Coagulation Factor Critical for Clot Stability

AFD (hypofibrinogenemia) - known risk factor for haemorrhage in many perioperative surgical settings, including cardiovascular surgery, obstetrics, & trauma

1[st]

coagulation factor to drop to critically low levels in acute bleeding situations[1]

50% of patients experience low levels during complex cardiac surgery[2]

• Blood transfusions associated with increased morbidity, mortality, & hospital costs[5,6]

~~Fibrinogen~~

10-25% 50% of patients require fibrinogen higher need for ≥5 units RBC supplementation with when fibrinogen levels fall cryoprecipitate during below[4] complex cardiac surgery in US[3]

CSL’s Patient Blood Management (PBM) vision:

• Reduce perioperative bleeding

• Reduce need for blood transfusions

• Improve patient outcomes and cost effectiveness

Abbreviations: RBC – Red Blood Cell

Sources: ; 1. Franchini, M. et al. , (2012) Blood Trans 10(1): 23–27; 2. Nishi, T. et al ., (2020) Gen Thor Cardio Surg 68: 335–341; 3. D’Agostino, R.S. et al. , (2019) Ann Thor Surg 107:24; 4. Karkouti, K. et al. , (2013) Anesth Analg 117:14–22; 5. Mehaffey, J.H. et al ., (2018) J Thor Cardio Surg 155(3):875-88; 6. Koch, C.G. et al ., (2006) Ann Thor Surg 81(5):1650-7.

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RiaSTAP[®] Phase III Study – Comparison to SoC

Patients with pseudomyxoma peritonei (PMP) undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

• Single centre study

• Non-inferiority comparison between RiaSTAP[®] & cryoprecipitate (SoC)

EU Phase III First Patient In – Oct 2024 FDA Filing – 1H 2025

Abbreviations: SoC – standard of care

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KCENTRA[®] - Trauma and PCC Trial

Enrolling and dosing patients (with highest risk of mortality) in hospitals according to clinical trial standards is challenging, impacting both feasibility & sample size

• First patient enrolled in March 2023

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• More than 1400 patients enrolled across 84 sites in 3 countries (US, UK, AU)

• No major safety or tolerability concerns with KCENTRA[®]

• Lower than expected mortality in the trial with sample size implications

• Highlights the importance of early KCENTRA[®] administration to target patients with highest risk of mortality

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Abbreviations: ED – Emergency Department; PCC - Prothrombin Complex Concentrate

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KCENTRA[®] Opportunities Expanding use of CSL’s Four-Factor Prothrombin Complex Concentrate (4F-PCC)

Perioperative Coagulopathy

DOACs: a leading factor in reducing morbidity & mortality in atrial fibrillation patients

• Increased Surgical Bleeding : Leads to more allogeneic blood transfusions, higher morbidity, mortality, & costs

• Coagulation Factor Concentrates : Use in PBM protocols reduces transfusions & mortality

>15m

patients globally on DOACs for treatment of AFib or VTE

~2-4%

acute major bleeding is most common side effect of DOACs

• PCC Usage : Growing use in various surgeries, including cardiac, liver transplant, & trauma

• PCC is part of international guidelines for perioperative bleeding treatment

7-20% all-cause mortality within 30d of major DOAC-related bleeding

Current treatments include:

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•
•
•
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• Specific antidotes

• • 4F-PCC (off-label use) • Fresh frozen plasma

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Phase III Clinical Studies in discussion with HAs

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Abbreviations: AFib – Atrial Fibrillation; DOAC – Direct Oral Anti-Coagulant; VTE – Venous Thromboembolism

Sources: Spahn, D.R. & Goodnough, L.T. (2013) Lancet 381(9880):1855–65; Raphael, J. et al., ( 2019) Anesth. Analg. 129(5):1209-1221. Erdoes, G. et al., ( 2021) Anaesthesia 76(3):381-392; Kietaibl, S. et al., (2023) Eur. J. Anaesthesiol. 40(4):226-304; National Blood Clot Alliance.

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Graft versus Host Disease (GvHD) Frequent Post-Transplantation Complication with High Morbidity and Mortality

Clinical Manifestations[3]

• 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[1 ] (termed “steroidrefractory”)

• Severity of acute GvHD varies: Grades III & IV are most severe

• Mortality associated with grade III and grade IV one year after transplant is 75% & 95%, respectively[2]

Abbreviations: HSCT – Haematopoietic Stem Cell Transplant

Sources: 1. Ferrara, J. & Chaudry, M. (2018) Blood Adv . 2(22):3411-3417; 2. Hill, L. et al ., (2018) Ther Adv Hematol. 9(1):21-46; 3. Zeiser, R. & Blazar, B.R. (2017) N Engl J Med .377(22):2167-2179

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Alpha-1 Antitrypsin (AAT) for Acute GvHD Treatment Study: BMT-CTN 1705

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Collaboration with Blood & Marrow Transplant Clinical Trials Network

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BMT CTN (NHLBI/NCI)

Primary Endpoint: Overall (complete or partial) response to aGVHD treatment at Day 28 Phase III Results Public Presentation – 1H 2025

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Abbreviations:[.] CR – Complete response; PR – Partial response.

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*Corticosteroids (CS) = Methylprednisolone starting dose equivalent to prednisone 2 mg/kg/day. (Tapering at discretion of treating physician)

Clazakizumab in Chronic Antibody Mediated Rejection (AbMR)

• Futility analysis enabled clear decision to terminate study based on eGFR

• Study unlikely to meet ultimate primary efficacy outcome (time to composite all-cause allograft loss or irreversible loss of allograft function) upon completion

• Results disappointing & unexpected given Phase II eGFR data

• Full data disclosure planned at American Society of Nephrology October 2024

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Largest placebo-controlled study conducted in AbMR

First Health Authority agreement on surrogate endpoint Leadership and trust with academic & regulatory stakeholders

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Abbreviations: eGFR – estimated Glomerular Filtration Rate

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Clazakizumab in Patients with End Stage Kidney Disease (ESKD) on Dialysis

Dialysis is the most common treatment modality in ESKD

• Very high unmet need - 188 deaths per 1,000 patients annually[1]

• Mortality primarily caused by CV disease is higher than in most common cancers

• Currently no proven treatments to reduce CV events in dialysis

Role of inflammation

• Inflammation common in dialysis and strongly associated with mortality and morbidity, central role of IL-6

• Strong science supporting link between IL-6 and CV events

Reduction of hsCRP with canakinumab leads to reduced MACE and CV mortality[2]

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Placebo
Canakinumab hsCRP≥2.0 mg/L
Canakinumab hsCRP<2.0 mg/L
Follow-up (Years)
Cumulative Incidence
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Abbreviations: CV – Cardiovascular; ESKD – End Stage Kidney Disease

Sources: 1. United States Renal Data System (USRDS) 2023 Annual Report; 2. Reproduced from: 2. Ridker et al., Lancet 2018; 391: 319–28.

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Phase III Study of Clazakizumab to Evaluate Cardiovascular Events in ESKD Patients

• Phase IIb/III combined dose ranging (Phase IIb) and CV outcome trial (Phase III)

• To demonstrate that IL-6 antagonism with clazakizumab will reduce CV events in dialysis patients

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• Phase IIb part completed; primary data reported at European Renal Association Meeting & published in Nature Medicine

• Clazakizumab at low doses associated with dramatic improvement of key inflammatory biomarker predictors of CV risk and was well tolerated

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Phase III Last Patient In - H1 2026

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Abbreviations: CRP – C-reactive Protein; CV – Cardiovascular; ESKD – End Stage Kidney Disease Source: 1. Chertow, G.M. et al., (2024) Nat Med 30: 2328-2336

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Unlocking New Horizons: Launching FILSPARI[®] for Treatment of IgA Nephropathy (IgAN)

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Developed in partnership with Travere Therapeutics, a US biotechnology company

Most prevalent type of primary Therapeutics, a US biotechnology company glomerulonephritis worldwide & major cause of kidney failure[1,2] , affecting 3.5 in 10,000 people[,3] Detected in 19–51% of kidney biopsies performed in glomerular diseases in EU and frequently diagnosed during 3[rd] & 4[th] decade of life Novel, non-immunosuppressive, dual endothelin angiotensin Despite good understanding of pathophysiology receptor antagonist (DEARA)* & potential therapeutic targets, no nonwith high selectivity for endothelin immunosuppressive therapies are approved for A receptor (ETAR) & angiotensin II treatment of IgAN[†,1,4,5] subtype 1 receptor (AT1R)

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

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

Sources: 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. Barratt, J. & Feehally, J. (2005) J Am Soc Nephrol. 16: 2088–97; 5. Tarpeyo US PI 2021 (accessed July 2022)

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FILSPARI[®] Significantly Reduced Proteinuria Over 110 Weeks in Phase III (PROTECT) Study in Adults with Primary IgAN

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Primary Endpoint met at 36-week interim analysis, with a between group relative reduction in proteinuria of 41% (P<0.0001)

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Abbreviations: BL, baseline; CI, confidence interval; LS, least squares; UP/C, urine protein-creatinine ratio. Sources: 1. Heerspink, H.J.L. et al ., (2023) Lancet 401;1584–94; 2. Rovin, B.H. et al., (2023) Lancet 402:2077–90.

41

Vamifeport (CSL624) for Hereditary Haemochromotosis (HH)

Genetic disorder characterised by increased intestinal absorption of iron leading to iron overload and eventually causing end organ damage

~150-200k

~20%

subjects are nonresponders or intolerant to phlebotomy

diagnosed symptomatic patients in US

~10%

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High unmet need in patients refractory from or phlebotomy intolerance due to lack of approved therapies

Iron removal by phlebotomy is poorly tolerated or contraindicated in refractory patients; restoring regulation of iron could be effective

subjects have high disease & treatment burden requiring better pharmacological options Phase II – In planning stage

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Vamifeport (from CSL Vifor acquisition) mimics effects of hepcidin on ferroportin (FPN), restoring normal regulation of iron & preventing excessive iron absorption

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Sources: EASL Clinical Practice Guidelines on haemochromatosis. J Hepatol. 2022, 77:479-502.

42

Sickle Cell Disease (SCD) – A Complex Systemic Disease

Genetic disorders associated with hereditary haemolytic anaemia or vaso-occlusive crisis (VOC) with rigid red cells & adhesive blood cells occluding circulation

~120k diagnosed patients in US

~40-50% poor efficacy of current prophylaxis treatment options

~~No pharmacological treatment exists for~~ treatment of VOC

Current Treatment Options

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• Non-opioid analgesics & opioids

• Gene therapy adoption is expected to be limited

Role of Hemopexin in SCD

• Heme toxicity major component of SCD

• Vaso-occlusive crisis (VOC) & hemolytic anemia most common manifestations of SCD

• VOC can result in severe daily pain, ultimately potential organ failure & reduced life expectancy

• Hemopexin - natural heme scavenger with potential to reverse VOC

Demonstrating effectiveness in reducing/eliminating VOCs & associated complications will transform treatment paradigm

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Hemopexin (CSL889) for Acute VOCs in Sickle Cell Disease

Phase II Study to Evaluate Efficacy & Safety of CSL889 in Patients with SCD Experiencing VOC

Phase I Study in Adult Patients with Sickle Cell Disease

• CSL889 well tolerated at all dose levels

• No serious adverse events attributed to CSL889

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Phase II First Patient In – Q1 2025

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HEMGENIX[®] for Treatment of Haemophilia B

HEMGENIX[®] has consistently favourable safety profile, with no treatment-related SAEs reported, and no new safety events reported through 3 years post-treatment

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• After 36 months of follow up:

• mean FIX levels remained elevated & sustained consistent with 24-month data showing ongoing durable effect[1]

• 94% of participants did not require continued prophylaxis

• 46% of participants received no FIX infusion over 3-year period

• 48-month analysis confirmed:

• sustained Factor IX activity levels at 37.4%, with superior bleed protection compared to FIX prophylaxis,

• decrease of exogenous Factor IX consumption by 96%

• No serious adverse events (AE) related to treatment

• Overall safety profile remained favorable & consistent with previous observations

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Registration/Launch/Post Registration Studies – Ongoing Phase III JP Last Patient In – Achieved Oct 2024

• One patient died (prophylaxis free); one patient who remained on prophylaxis withdrew consent for efficacy assessment

• Source: 1. Pipe S.W. et al., (2023) N Engl J Med 388(8):706-718.

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A Robust Pipeline for the Future

Developing a robust portfolio of therapeutic area opportunities across our platform capabilities

21

programs in clinical development

TA balanced across R&D portfolio

Leveraging all Platforms

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Vaccines Development Targeting Unmet Need in Influenza & COVID

Jon Edelman MD Senior Vice President Vaccines Innovation Unit CSL

Progress and Challenges in Influenza Continue to Inform CSL R&D Efforts in Vaccines

Over the past we have seen positive impacts of influenza vaccination:

However, scientific challenges remain:

• Avoidance of morbidity

• Extinction of B Yamagata

• Inconsistent effectiveness of standard vaccines

• Highly pathogenic avian influenza H5N1

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Influenza Vaccines Have Evolved to Keep Up with Changes in Circulating Viruses

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Transition From Quadrivalent Influenza Vaccines (QIV) to Trivalent Influenza Vaccines (TIV)

As CSL transitions to TIV formulations, we are committed to maintaining the protection, safety, reliability, and value of our differentiated seasonal influenza vaccine portfolio

CSL Seqirus played key role in shaping landscape to ensure smooth transition to TIV

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CSL’s NH24/25 vaccines in US are all TIV Transitioning ROW to TIV over next year

• US FDA - All TIV released Jul 24 for NH24/25

 UK MHRA - approved on Jul 24 for NH25/26

 EU EMA – on track for approval by NH25/26

 ROW – anticipate transition by SH26

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Worldwide Spread of H5 Avian Influenza Now Affecting Dairy Cows

Cumulative weekly avian flu reports in FAO EMPRES-I database from 01 Aug 23 to 30 Jul 24[1]

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Abbreviations: FAO EMPRES-I Food and Agriculture Organization of the United Nations Emergency Prevention System-i; Source: 1. FAO EMPRES-I Global Animal Disease Information System [Accessed 30 July 2024]

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Pandemic Strategy - Innovation at Industrial Scale As an Expert, Responsive and Proven Partner to 30 Governments

Cell-Culture Technology MF59[®] Adjuvant Greater match & effectiveness Dose sparing Next gen technology today, at Breadth of protection scale & speed 300mds+ safety database

sa-mRNA (future) Potential for higher effectiveness, durability multi pathogen, speed, dose sparing (vs mRNA)

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

PrePan PrePan
H5Nx H9Nz
Selected technology partnerships
- Pre-pandemic stockpiles afford ability to
Global access for governments to MF59 [®] (MF59 [®] & investment in cell-based capacity, R&D
combine with different pandemic antigens of
adjuvanted, cell & egg-based APA’s / pandemic
concern, permitting dose-sparing and further
vaccine for population wide coverage
reach of early supply.
MF59 [®] adjuvant can be used in other products
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Abbreviations: MDS – Minimum Data Set

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CSL Seqirus Pandemic Portfolio

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

First avian influenza
vaccination program:

®
FINLAND
H5N8 zoonotic vaccines offers protection against the current H5N1 clade 2.3.4.4b
H5N8
H5N8 H5N8 & H5N1
MF59 [®] adj, egg
Alum adj, egg MF59 [®] adj, cell
Mar 2024 - MHRA Approval
Oct 2023 - TGA approval Under review with FDA
Apr 2024 - EMA approval
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• In EU and UK, approved as CELLDEMIC[®] (zoonotic ), INCELLIPAN[®] (pandemic )

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Sources: 1. FOCLIVIA[ ®] SmPC. 2. Panvax[®] Approved Product Information. 3. AUDENZ[®] PI. 4. AFLUNOV[®] SmPC. 5. Panvax[®] H5N8 pre-pandemic Approved Product Information. 6. Zoonotic Influenza Vaccine H5N8 SmPC. 7. CSL Seqirus Press Release 29th May 2024. 8. Clinicaltrials.gov

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Influenza-related Mortality in US is Rising Post-COVID

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Source: CDC MMWR – Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report

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Renewed Efforts to Increase Influenza Vaccinations A Key Public Health Priority

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CSL’s Three-Pronged Approach to Improving Current Egg-based Vaccine Technology

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1. Adjuvant
•
Boost & broaden response
2. Cell-based
•
Exact match to target
3. Optimised Dose
•
Further increase response
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Abbreviations: CVV – Candidate Vaccine Virus; WHO – World Health Organisation

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CSL’s Three-Pronged Approach to Improving Current Egg-based Vaccine Technology

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

1. Adjuvant
•
Boost & broaden response
2. Cell-based
•
Exact match to target
3. Optimised Dose
•
Further increase response
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Abbreviations: CVV – Candidate Vaccine Virus; WHO – World Health Organisation

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MF59[®] Adjuvant Offers an Enhancement for Egg-based Vaccines

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Adjuvant MF59[®]

Immune boosting impact of MF59 [®] adjuvant

Abbreviations: QIV - Quadrivalent Influenza Vaccine; TIV - Trivalent Influenza Vaccine

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Real World Evidence: Cell-Based Vaccine Showed Improved rVE versus Egg-Based Vaccines Across 4 NH Seasons

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Cell

Cell Technology provides an exact antigenic match to recommended viral strain

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aTIVc Combines Two Proven Vaccine Technologies and an Optimised Dose of Antigen

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Abbreviations: aTIVc - adjuvanted trivalent cell-based influenza vaccine

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aTIVc – Phase II Data Support the Advantages of Combining These Three Technologies

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• aQIVc data will support registration of aTIVc

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Phase III (V201_03) Immunogenicity & Safety Study in Adult Subjects ≥ 50 years

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Phase III Data Readout – 1H 2025

Abbreviations: aQIV- adjuvanted quadrivalent influenza vaccine; aQIVc - adjuvanted cell-based quadrivalent influenza vaccine; QIVr - recombinant quadrivalent influenza vaccine

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Conventional mRNA Vaccines – While Promising, Limitations Remain

COVID-19

• Significant reactogenicity

• Waning effectiveness over time

• Frequent boosting required to maintain protection

RSV

• Lower efficacy compared to protein-based vaccines (with or without adjuvant)

Influenza

• Higher reactogenicity than current influenza vaccines

• Inconsistent immunogenicity against B-strains

• Inconsistent efficacy in older adults

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Abbreviations: RSV – Respiratory Syncytial Virus

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Self-amplifying mRNA Vaccine Technology

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

Antigen Gene
Antigen
Replicase Genes Antigen Gene
Replicase
Antigen
Complex
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Potential Advantages over Conventional mRNA Vaccines

Superior Immune Response Increased clinical protection

Durable Immune Response Less frequent boosters

Broad Immune Response Protection against antigenic escape viruses

Lower mRNA dose

High potential for development of combined vaccines

Abbreviations: CSE - Conserved Sequence Element; mRNA – Messenger RNA; RNA - Ribonucleic Acid; sa-mRNA – self-amplifying mRNA; UTR - Untranslated Region Source: Bloom, K. et al. , (2021) Gene Ther. 28: 117–129.

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KOSTAIVE[® ] (sa-mRNA) - Clinical Efficacy Against COVID-19

• Primary Endpoint met: VE against COVID-19 of any severity is 56.6%*

• Key Secondary Endpoint met: VE against severe COVID-19 is 93.3%[†]

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• Predefined success criteria for primary endpoint: Lower Limit of 95% confidence interval exceeds 30%

• Predefined success criteria for key secondary endpoint: Lower Limit of 96% confidence interval exceeds 0%

• Figures show data for virologically-confirmed COVID-19 from 7 days after second dose up to Day 92. Abbreviations: VE – Vaccine Effectiveness

Source : Reproduced from Hồ, N.T., et al. (2024) Nat Commun 15(4081)

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KOSTAIVE[®] - More Durable Post-booster Response at 12 Months than a Leading mRNA Vaccine

KOSTAIVE[®] (ARCT-154) induced higher immune response compared to conventional mRNA vaccine over 12 months post-booster in both young (18-49 years) & older (≥50 years) adults

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Source: Oda, Y., et al ., (2024) Lancet Infectious Diseases, Published online

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KOSTAIVE[®] - Broader Post-booster Response at 12 Months than a Leading mRNA Vaccine

KOSTAIVE[®] (ARCT-154) induces higher immune response to evolving variants of concern compared to a conventional mRNA vaccine over 12 months post-booster

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Source: Oda, Y., et al ., (2024) Lancet Infectious Diseases, Published online

KOSTAIVE[®] - First Approved sa-mRNA Vaccine Against COVID-19

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• Approved in Japan October 2024

• Under review in EMA

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• US filing with updated formulation anticipated 2025

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Deirdre BeVard Senior Vice President R&D Strategic Operations CSL

Innovation & Sustainability

Delivering on Our Promise

More than a century ago, CSL made a promise to protect the health of those stricken with a range of serious medical conditions. Today, that promise has never been stronger

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70

Digital Advances in Product Development

Autonomous labs linked with AI-powered data analysis, enable a new era of automated, more efficient & effective Product Development across all of our scientific platforms

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Scalable Technology Platforms

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Data Reproducibility & Robustness

Maximising Experimental Throughput

Accelerated Analysis & Reporting

Process development, formulation and drug product development all benefit from these advances which are applicable to all our scientific platforms

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71

CSL R&D External Engagement for Innovation

Driving strategic partnering to amplify our research capabilities and advance our pipeline

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Collaboration Leads to Innovative Growth and Patient Impact

CSL and uniQure awarded 2023 Prix Galien USA Award in the category of Best Product for Rare/Orphan Diseases for HEMGENIX[®]

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CSL’s Sustainability Strategy

CSL’s Sustainability Vision CSL is committed to a healthier world .

Its vision is a sustainable future for its employees, communities, patients and donors, inspired by innovative science and a values-driven culture.

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Partnerships Help Us Advocate for Patients

CSL actively works with organisations to develop programs & activities for patients We partner to improve and expand educational and outreach efforts about these diseases and the importance of plasma donation

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Clazakizumab AbMR: Prioritising Patient Perspectives

CSL is committed to addressing the unmet needs of patients living with transplantation

CSL’s clazakizumab AbMR team utilised unique patient-focused efforts to recruit patients in the Phase III IMAGINE study including publishing a peerreviewed paper during study recruitment which uniquely included a patient commentary as a call to action for all transplant providers to consider clinical trials as an option for patients in their care.

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Berger, M., et al., (2024) 108(5): 1109-1114.

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Garadacimab Paediatric Trial: Empowering Patient Participation

Gathering patient insights into clinical development designs to help patients take control of their care and treatment

Meet our Clinical Companions from Empath Labs; helping our youngest clinical trial participants by providing a tool to engage, educate, and retain paediatric clinical trial participants while creating world class experiences for caregivers and sites.

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CSL is the first company to use Clinical Companions in a clinical trial

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Delivering on Our Promise

Our efforts to forge a healthier future for patients have been made possible through embracing the evolution of medicine, listening to patient voices and collaborating with purpose

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Stacy, Living with Primary Immunodeficiency

Summary

William Mezzanotte MD, MPH Executive Vice President Head of R&D CSL

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CSL R&D Portfolio – FY25

Phase I

Phase II

Phase III

Registration/Post-Registration

Anumigilimab Horizon 2 HIZENTRA[®] HIZENTRA[®] FILSPARI[ ®] ( Sparsentan) AUDENZ[ ®] /CELLDEMIC[®] Anti-G-CSFR mAb Ig Yield (SCIg) 20% Liquid (SCIg) 20% Liquid Dual ETA & AT1 antagonist Adjuvanted Cell-based (SCD) (CLL) (IgAN) Monovalent Influenza A CSL787 PRIVIGEN[®] (H5N1) Vaccine CSL040 NebulisedIg HIZENTRA[®] (IVIg) 10% Liquid KORSUVA[ ® ] /KAPRUVIA[®] FOCLIVIA[®] /AFLUNOV[®] Complement R1 Inhibitor (SCIg) 20% Liquid KOR. agonist Adjuvanted Egg-based Hemopexin (POTS) ZEMAIRA[®] /RESPREEZA[®] (CKD-aP) Influenza A (H5N1) Vaccine CSL405 Cell-based Influenza (H2N3) Vaccine (VOC in SCD) Fibrinogen Concentrate RiaSTAP[®] Alpha 1 Antitrypsin Oral ext. release calcifediol RAYALDEE[®] FLUAD[®] Trivalent* Vamifeport (AFD) HAEGARDA[®] (SHPT) Adjuvanted Egg-based CSL406 Ferroportin inhibitor C1 Inhibitor (HAE) Influenza Vaccine sa-mRNA Influenza (HH) Clazakizumab TAVNEOS[®] (H5N1) Vaccine CSL400 (TIV) Anti-α2AP mAb (sPE) CSL301 Anti-IL-6 mAb (ESKD) CSL964 Anti-FXIIa mAb(HAE) Garadacimab Oral C5a receptor inhibitor(AAV) Cell-based Influenza Vaccine FLUCELVAX[®] Trivalent sa-mRNA Trivalent Influenza Alpha 1Antitrypsin AFSTYLA[®] VELPHORO[®] KOSTAIVE[® ] Vaccine CSL525 (SNF472) (Treatment of aGvHD) rFVIII (HaemA) Sucroferric oxyhydroxide sa-mRNA Vaccine Calcification inhibitor (Serum P control in CKD) (COVID) LASN01 (CUA-ESKD) CSL964 IDELVION[®] Alpha 1Antitrypsin Anti-IL-11R mAb rFIX-FP (HaemB) VELTASSA[®] Eblasakimab (CSL334) (Prevention of aGvHD) (IPF,TED) Anti-IL-13R mAb(AD) Oral potassium binder FLUAD[[®]] Trivalent Efficacy HEMGENIX[ ®] * (HK) Adjuvanted Egg-based (Haem B)

FLUAD[[®]] Trivalent Efficacy Adjuvanted Egg-based Influenza Vaccine

CSL403 (aTIVc) Adjuvanted Cell-based Trivalent Influenza Vaccine

• Ongoing Post-Marketing Studies

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Immunoglobulins	Haematology	Cardiovascular & Renal	Transplant & Immunology
Vaccines	Outlicensed Programs	Partnered Projects

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Forward-Looking Portfolio Highlights – FY25

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Abbreviations: AFD – Acquired Fibrinogen Deficiency; aGvHD – Acute Graft versus Host Disease; aTIVc- Adjuvanted Cell-Based Trivalent Influenza Vaccine; aQIV – Adjuvanted Quadrivalent Influenza Vaccine; ESKD – End Stage Kidney Disease; EU – Europe; HA – Health Authorities; HAE – Hereditary Angioedema; JP – Japan; IgAN – Immunoglobulin A Nephropathy; MACE - Major Adverse Cardiac Events; Neb Ig - Nebulised Ig; PFS – Pre-Filled Syringe; POTS - Postural Orthostatic Tachycardia Syndrome; sa-mRNA – Self-Amplifying messenger RNA; RNA – Ribonucleic Acid; SCD – Sickle Cell Disease; US – United States; VOC – Vaso-occlusive Crisis

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Key Takeaways

• R&D continues to invest and innovate (SID, Nebulised Ig, Horizons 1 & 2, sa-mRNA) in our core Ig, plasma & vaccine platforms to support future growth

• We are relentlessly focused on rapid advancement of our research & early development programs towards late-stage development & registration

• HEMGENIX [®] , KOSTAIVE [®] , RiaSTAP [®] & garadacimab all advancing toward registration & approval for key indications in key regions

• We have experienced a few late-stage setbacks (KCENTRA[®] Trauma, HIZENTRA[®] DM, clazakizumab AbMR), however each of these products have promising follow-on indications which we are actively pursuing

• We have exciting, novel Phase II (e.g. Vamifeport, Hemopexin) and Phase III programs (e.g. aTIVc, CSL964, clazakizumab, HIZENTRA[®] POTS) to add incremental value to patients & CSL

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Thank You / Questions

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