Csl Limited · ASX:CSL

Csl — Investor Day (October 2024)

84 slides from Csl's investor day presentation, Oct 22, 2024

  1. Slide 1: Research & Development Investor Briefing

    For immediate release 22 October 2024 Research & Development Investor Briefing For personal use only 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 Compa

  2. Slide 2: R&D Investor Briefing, October 22, 2024

    Zahra, Living with Hereditary Angioedema For personal use only R&D Investor Briefing October 22, 2024

  3. Slide 3: Important Notice and Disclaimer

    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 comple

  4. Slide 4: Introduction

    For personal use only William Mezzanotte MD, MPH Introduction Executive Vice President Head of R&D CSL

  5. Slide 5: Welcome and Agenda

    01 Welcome 05 Vaccines Development Chris Cooper Jon Edelman MD For personal use only Head Investor Relations Senior Vice President Vaccines Innovation Unit Agenda 02 Introduction & Portfolio Highlights 07 Innovation & Sustainability Deirdre BeVard Bill Mezzanotte MD, MPH Senior Vice President Execut

  6. Slide 6: Key Takeaways

    Key Takeaways For personal use only • 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-sta

  7. Slide 7: Key Submissions and Approvals

    Key Submissions and Approvals For personal use only 6

  8. Slide 8: R&D Portfolio Highlights – FY24

    R&D Portfolio Highlights – FY24 Cardiovascular Haematology Respiratory & Metabolic For personal use only • CSL112 (ApoA-1) AMI Phase III top line results • IDELVION® China Phase III first patient in • Trabikibart (Anti-Beta Common) ASTH Phase I • Clazakizumab (ESKD) • Vamifeport (SCD) last patient o

  9. Slide 9: R&D Investment Allocations

    R&D Investment Allocations For personal use only R&D Financial Stewardship • Active Portfolio Management • Strategic Partnerships • Productivity Gains • Gated spend in development and in large trials (futility analyses) 8

  10. Slide 10: Streamlining Our Therapeutic Areas and Platforms

    Streamlining Our Therapeutic Areas and Platforms For personal use only 9

  11. Slide 11: Plasma Proteins & Immunoglobulins

    For personal use only Douglas Lee PhD Plasma Proteins & Immunoglobulins Senior Vice President Plasma Product Development CSL

  12. Slide 12: Focus on Immunoglobulins and Plasma Product Development

    Focus on Immunoglobulins (Ig) and Plasma Product Development For personal use only 11

  13. Slide 13: Ig Yield Maximisation Strategy

    Ig Yield Maximisation Strategy* For personal use only 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 improveme

  14. Slide 14: Horizons 1 & 2 – Meeting Patients' Future Ig Needs

    Horizons 1 & 2 – Meeting Patients’ Future Ig Needs For personal use only 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 Horizon

  15. Slide 15: Horizons 1 & 2 - A Purposeful, Collaborative Regulatory Path

    Horizons 1 & 2 - A Purposeful, Collaborative Regulatory Path For personal use only • Partner with Health Authorities (HAs) by Horizon 2 providing robust analytical programs & non- clinical data packages • Leverage state-of-the-art analytics to deliver Horizon 1 robust process control strategies • Li

  16. Slide 16: Improving Patient Options – HIZENTRA Pre-Filled Syringe

    Improving Patient Options – HIZENTRA® Pre-Filled Syringe (PFS) Fast, simple and convenient for patients For personal use only • First & only PFS available for patients using SCIg • Ease of Use - no vial transfer or preparation needed • Convenience – patients can self-administer • Flexible – patients

  17. Slide 17: Nebulised IgG (CSL787)

    Nebulised IgG (CSL787) For personal use only 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 technolog

  18. Slide 18: New Products from Plasma

    New Products from Plasma For personal use only 17

  19. Slide 19: Optimising RiaSTAP (CSL511) & Hemopexin (CSL889)

    Optimising RiaSTAP® (CSL511) & Hemopexin (CSL889) For personal use only RiaSTAP® (CSL511) Hemopexin (CSL889) • Introduction of 2nd virus reduction step • New plasma protein characterised • Established GMP-ready commercial facility for new by CSL Research CSL511 manufacturing process & validated impr

  20. Slide 20: Plasma Innovation Platform Strategy Group

    Plasma Innovation Platform Strategy Group (PSG) Enterprise Collaboration for Innovation For personal use only 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 • Optimi

  21. Slide 21: Plasma Product Development: Continuous Innovation

    Plasma Product Development: Continuous Innovation For personal use only • 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 Innovation

  22. Slide 22: Therapeutic Development

    Pete, Living with Haemophilia B For personal use only Marie-Pierre Hellio MD, PhD Therapeutic Development Senior Vice President Strategic Development CSL

  23. Slide 23: Immunoglobulin Replacement and Immunomodulation

    Immunoglobulin Replacement and Immunomodulation IVIg & SCIg Usage For personal use only Immuno-replacement Immuno-modulation Autoimmune PID & SID Diseases Abbreviations: IVIg – Intravenous Immunoglobulin; PID – Primary Immune Deficiency; SCIg – Subcutaneous Immunoglobulin; SID – Secondary Immune Def

  24. Slide 24: HIZENTRA in Secondary Immune Deficiency (SID)

    HIZENTRA® in Secondary Immune Deficiency (SID) Significant unmet needs persist in SID For personal use only • Hematologic cancer & therapy reduces B-cells & antibodies  Leading to SID and serious or recurrent infections • Infections major cause of death among CLL & MM patients New approaches requir

  25. Slide 25: HIZENTRA in Post-COVID POTS

    HIZENTRA® in Post-COVID POTS – a Debilitating “Long COVID” Disease For personal use only Postural Orthostatic Tachycardia Syndrome (POTS) • Dysregulation of autonomic nervous system • Symptoms include lightheadedness, palpitations, fatigue, "brain fog“, GI dysfunction • No approved therapies; only s

  26. Slide 26: HIZENTRA Phase III Study in Post-COVID POTS

    HIZENTRA® Phase III Study in Patients with Post-COVID POTS For personal use only • 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 intol

  27. Slide 27: HIZENTRA Phase III Study in Dermatomyositis

    HIZENTRA® Phase III Study in Patients with Dermatomyositis For personal use only • 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* a

  28. Slide 28: Nebulised IgG (CSL787) in Non-Cystic Fibrosis Bronchiectasis

    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 For personal use only severe and frequent exacerbations Current estimates suggest ~1M 12% mortality at 1-year follow-up patients in

  29. Slide 29: CSL787 - Nebulised IgG in NCFB

    CSL787 - Nebulised IgG in Non-Cystic Fibrosis Bronchiectasis CSL787 combines advanced plasma-based therapy with cutting-edge delivery technology For personal use only Phase I in healthy subjects & subjects with mild NCFB • Included subjects with mild NCFB with largely preserved lung function & teste

  30. Slide 30: Garadacimab - Disruptive Innovation for HAE Patients

    Garadacimab - Disruptive Innovation to Improve Treatment Options for HAE Patients For personal use only Phase III study evaluating efficacy & safety of SC Garadacimab for prophylaxis of HAE Attacks • Primary & key secondary efficacy endpoints Differentiated, Patient-Focused Profile achieved with hig

  31. Slide 31: Phase III Study of SC Garadacimab for HAE Attacks

    Phase III Study Evaluating Efficacy and Safety of SC Garadacimab for Prophylaxis of HAE Attacks For personal use only 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

  32. Slide 32: Fibrinogen - Coagulation Factor Critical for Clot Stability

    Fibrinogen - Coagulation Factor Critical for Clot Stability AFD (hypofibrinogenemia) - known risk factor for haemorrhage in many perioperative surgical settings, including cardiovascular surgery, obstetrics, & trauma For personal use only 1st 50% of patients experience low • Blood transfusions assoc

  33. Slide 33: RiaSTAP Phase III Study – Comparison to SoC

    RiaSTAP® Phase III Study – Comparison to SoC Patients with pseudomyxoma peritonei (PMP) undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy For personal use only • Single centre study • Non-inferiority comparison between RiaSTAP® & cryoprecipitate (SoC) EU Phase III First

  34. Slide 34: KCENTRA - Trauma and PCC Trial

    KCENTRA® - Trauma and PCC Trial Enrolling and dosing patients (with highest risk of mortality) in hospitals according to clinical trial For personal use only standards is challenging, impacting both feasibility & sample size • First patient enrolled in March 2023 • More than 1400 patients enrolled a

  35. Slide 35: KCENTRA Opportunities

    KCENTRA® Opportunities Expanding use of CSL’s Four-Factor Prothrombin Complex Concentrate (4F-PCC) For personal use only DOACs: a leading factor in reducing morbidity & mortality in atrial fibrillation patients Perioperative Coagulopathy • Increased Surgical Bleeding: Leads to more allogeneic blood

  36. Slide 36: Graft versus Host Disease (GvHD)

    Graft versus Host Disease (GvHD) Frequent Post-Transplantation Complication with High Morbidity and Mortality For personal use only 3 Clinical Manifestations • Up to 50% of patients develop GvHD after allogeneic HSCT despite current prophylactic regimens • Of those who develop acute GvHD, only 50% r

  37. Slide 37: Alpha-1 Antitrypsin for Acute GvHD Treatment

    Alpha-1 Antitrypsin (AAT) for Acute GvHD Treatment Study: BMT-CTN 1705 Collaboration with Blood & Marrow Transplant Clinical Trials Network For personal use only BMT CTN (NHLBI/NCI) Primary Endpoint: Overall (complete or partial) response to aGVHD treatment at Day 28 Phase III Results Public Present

  38. Slide 38: Clazakizumab in Chronic Antibody Mediated Rejection

    Clazakizumab in Chronic Antibody Mediated Rejection (AbMR) For personal use only Largest placebo-controlled • Futility analysis enabled clear decision to terminate study based on study conducted in AbMR eGFR First Health Authority  Study unlikely to meet ultimate primary efficacy outcome (time to a

  39. Slide 39: Clazakizumab in Patients with ESKD on Dialysis

    Clazakizumab in Patients with End Stage Kidney Disease (ESKD) on Dialysis For personal use only Reduction of hsCRP with canakinumab leads to Dialysis is the most common treatment modality in reduced MACE and CV mortality2 ESKD • Very high unmet need - 188 deaths per 1,000 patients Placebo annually1

  40. Slide 40: Phase III Study of Clazakizumab in ESKD Patients

    Phase III Study of Clazakizumab to Evaluate Cardiovascular Events in ESKD Patients For personal use only • 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 • Phase IIb p

  41. Slide 41: Launching FILSPARI for IgA Nephropathy

    Unlocking New Horizons: Launching FILSPARI® for Treatment of IgA Nephropathy (IgAN) For personal use only Developed in partnership with Travere Most prevalent type of primary Therapeutics, a US biotechnology company glomerulonephritis worldwide & major cause of kidney failure1,2, affecting 3.5 in 10

  42. Slide 42: FILSPARI Significantly Reduced Proteinuria in PROTECT Study

    FILSPARI® Significantly Reduced Proteinuria Over 110 Weeks in Phase III (PROTECT) Study in Adults with Primary IgAN For personal use only Primary Endpoint met at 36-week interim analysis, with a between group relative reduction in proteinuria of 41% (P<0.0001) 41 Abbreviations: BL, baseline; CI, con

  43. Slide 43: Vamifeport (CSL624) for Hereditary Haemochromatosis

    Vamifeport (CSL624) for Hereditary Haemochromotosis (HH) For personal use only Genetic disorder characterised by increased intestinal absorption of iron leading to iron overload and eventually causing end organ damage High unmet need in patients refractory from or phlebotomy intolerance due to ~150-

  44. Slide 44: Sickle Cell Disease – A Complex Systemic Disease

    Sickle Cell Disease (SCD) – A Complex Systemic Disease Genetic disorders associated with hereditary haemolytic anaemia or vaso-occlusive crisis (VOC) with For personal use only rigid red cells & adhesive blood cells occluding circulation ~120k ~40-50% Role of Hemopexin in SCD diagnosed patients in U

  45. Slide 45: Hemopexin (CSL889) for Acute VOCs in Sickle Cell Disease

    Hemopexin (CSL889) for Acute VOCs in Sickle Cell Disease For personal use only 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

  46. Slide 46: HEMGENIX for Treatment of Haemophilia B

    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 For personal use only • After 36 months of follow up:  mean FIX levels remained elevated & sustain

  47. Slide 47: A Robust Pipeline for the Future

    A Robust Pipeline for the Future Developing a robust portfolio of therapeutic area opportunities across our platform capabilities For personal use only 21 TA balanced Leveraging all programs in clinical across R&D portfolio Platforms development 46

  48. Slide 48: Targeting Unmet Need in Influenza & COVID

    For personal use only Vaccines Development Jon Edelman MD Senior Vice President Vaccines Innovation Unit Targeting Unmet Need in Influenza & COVID CSL

  49. Slide 49: Progress and Challenges in Influenza

    Progress and Challenges in Influenza Continue to Inform CSL R&D Efforts in Vaccines For personal use only Over the past we have seen positive impacts of influenza vaccination: However, scientific challenges remain: • Avoidance of morbidity • Inconsistent effectiveness of standard vaccines • Extincti

  50. Slide 50: Influenza Vaccines Have Evolved with Circulating Viruses

    Influenza Vaccines Have Evolved to Keep Up with Changes in Circulating Viruses For personal use only 49

  51. Slide 51: Transition From QIV to TIV

    Transition From Quadrivalent Influenza Vaccines (QIV) to Trivalent Influenza Vaccines (TIV) For personal use only As CSL transitions to TIV formulations, we are committed to maintaining the protection, safety, reliability, and value of our differentiated seasonal influenza vaccine portfolio  US FDA

  52. Slide 52: Worldwide Spread of H5 Avian Influenza

    Worldwide Spread of H5 Avian Influenza Now Affecting Dairy Cows For personal use only Cumulative weekly avian flu reports in FAO EMPRES-I database from 01 Aug 23 to 30 Jul 241 51 Abbreviations: FAO EMPRES-I Food and Agriculture Organization of the United Nations Emergency Prevention System-i; Source

  53. Slide 53: Pandemic Strategy - Innovation at Industrial Scale

    Pandemic Strategy - Innovation at Industrial Scale As an Expert, Responsive and Proven Partner to 30 Governments For personal use only sa-mRNA (future) Cell-Culture Technology MF59® Adjuvant Potential for higher Greater match & effectiveness Dose sparing effectiveness, durability Next gen technology

  54. Slide 54: CSL Seqirus Pandemic Portfolio

    CSL Seqirus Pandemic Portfolio For personal use only First avian influenza vaccination program: ®* * FINLAND H5N8 zoonotic vaccines offers protection against the current H5N1 clade 2.3.4.4b H5N8 & H5N1 H5N8 H5N8 MF59® adj, cell MF59® adj, egg Alum adj, egg Mar 2024 - MHRA Approval Oct 2023 - TGA app

  55. Slide 55: Influenza-related Mortality in US is Rising Post-COVID

    Influenza-related Mortality in US is Rising Post-COVID For personal use only Source: CDC MMWR – Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report 54

  56. Slide 56: Renewed Efforts to Increase Influenza Vaccinations

    Renewed Efforts to Increase Influenza Vaccinations A Key Public Health Priority For personal use only 55

  57. Slide 57: Three-Pronged Approach to Improving Egg-based Vaccine Technology

    CSL’s Three-Pronged Approach to Improving Current Egg-based Vaccine Technology For personal use only 1. Adjuvant • Boost & broaden response 2. Cell-based • Exact match to target 3. Optimised Dose • Further increase response Abbreviations: CVV – Candidate Vaccine Virus; WHO – World Health Organisatio

  58. Slide 58: Three-Pronged Approach to Improving Egg-based Vaccine Technology

    CSL’s Three-Pronged Approach to Improving Current Egg-based Vaccine Technology For personal use only 1. Adjuvant • Boost & broaden response 2. Cell-based • Exact match to target 3. Optimised Dose • Further increase response Abbreviations: CVV – Candidate Vaccine Virus; WHO – World Health Organisatio

  59. Slide 59: MF59 Adjuvant Offers an Enhancement for Egg-based Vaccines

    MF59® Adjuvant Offers an Enhancement for Egg-based Vaccines For personal use only Adjuvant MF59® Immune boosting impact of MF59® adjuvant Abbreviations: QIV - Quadrivalent Influenza Vaccine; TIV - Trivalent Influenza Vaccine 58

  60. Slide 60: Real World Evidence: Cell-Based Vaccine Improved rVE

    Real World Evidence: Cell-Based Vaccine Showed Improved rVE versus Egg-Based Vaccines Across 4 NH Seasons For personal use only Cell Cell Technology provides an exact antigenic match to recommended viral strain 59

  61. Slide 61: aTIVc Combines Two Proven Vaccine Technologies

    aTIVc Combines Two Proven Vaccine Technologies and an Optimised Dose of Antigen For personal use only Abbreviations: aTIVc - adjuvanted trivalent cell-based influenza vaccine 60

  62. Slide 62: aTIVc – Phase II Data Support Combining Three Technologies

    aTIVc – Phase II Data Support the Advantages of Combining These Three Technologies For personal use only * aQIVc data will support registration of aTIVc 61

  63. Slide 63: Phase III Immunogenicity & Safety Study in Adults ≥ 50 Years

    Phase III (V201_03) Immunogenicity & Safety Study in Adult Subjects ≥ 50 years For personal use only Phase III Data Readout – 1H 2025 Abbreviations: aQIV- adjuvanted quadrivalent influenza vaccine; aQIVc - adjuvanted cell-based quadrivalent influenza vaccine; QIVr - recombinant quadrivalent influenz

  64. Slide 64: Conventional mRNA Vaccines – Limitations Remain

    Conventional mRNA Vaccines – While Promising, Limitations Remain For personal use only 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) Influen

  65. Slide 65: Self-amplifying mRNA Vaccine Technology

    Self-amplifying mRNA Vaccine Technology For personal use only Antigen Gene Antigen Replicase Genes Antigen Gene Replicase Antigen Complex Potential Advantages over Conventional mRNA Vaccines Superior Immune Durable Immune Broad Immune Lower mRNA dose Response Response Response High potential for Inc

  66. Slide 66: KOSTAIVE (sa-mRNA) - Clinical Efficacy Against COVID-19

    KOSTAIVE® (sa-mRNA) - Clinical Efficacy Against COVID-19 • Primary Endpoint met: VE against COVID-19 of any severity is 56.6%* For personal use only • Key Secondary Endpoint met: VE against severe COVID-19 is 93.3%† * Predefined success criteria for primary endpoint: Lower Limit of 95% confidence in

  67. Slide 67: KOSTAIVE - More Durable Post-booster Response

    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 For personal use only over 12 months post-booster in both young (18-49 years) & older (≥50 years) adults 66 Source: Oda, Y

  68. Slide 68: KOSTAIVE - Broader Post-booster Response

    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 For personal use only a conventional mRNA vaccine over 12 months post-booster 67 Source: Oda, Y., et al., (2024) Lancet I

  69. Slide 69: KOSTAIVE - First Approved sa-mRNA Vaccine Against COVID-19

    KOSTAIVE® - First Approved sa-mRNA Vaccine Against COVID-19 For personal use only • Approved in Japan October 2024 • Under review in EMA • US filing with updated formulation anticipated 2025 68

  70. Slide 70: Innovation & Sustainability

    For personal use only Deirdre BeVard Senior Vice President Innovation & Sustainability R&D Strategic Operations CSL

  71. Slide 71: Delivering on Our Promise

    Delivering on Our Promise For personal use only 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 70

  72. Slide 72: Digital Advances in Product Development

    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 For personal use only Scalable Technology Platforms Maximising Experimental Throughput Da

  73. Slide 73: CSL R&D External Engagement for Innovation

    CSL R&D External Engagement for Innovation Driving strategic partnering to amplify our research capabilities and advance our pipeline For personal use only 72

  74. Slide 74: Collaboration Leads to Innovative Growth and Patient Impact

    Collaboration Leads to Innovative Growth and Patient Impact For personal use only CSL and uniQure awarded 2023 Prix Galien USA Award in the category of Best Product for Rare/Orphan Diseases for HEMGENIX® 73

  75. Slide 75: CSL's Sustainability Strategy

    CSL’s Sustainability Strategy For personal use only 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. 74

  76. Slide 76: Partnerships Help Us Advocate for Patients

    Partnerships Help Us Advocate for Patients CSL actively works with organisations to develop programs & activities for patients For personal use only We partner to improve and expand educational and outreach efforts about these diseases and the importance of plasma donation 75

  77. Slide 77: Clazakizumab AbMR: Prioritising Patient Perspectives

    Clazakizumab AbMR: Prioritising Patient Perspectives CSL is committed to addressing the unmet needs of patients living with transplantation For personal use only CSL’s clazakizumab AbMR team utilised unique patient-focused efforts to recruit patients in the Phase III IMAGINE study including publishi

  78. Slide 78: Garadacimab Paediatric Trial: Empowering Patient Participation

    Garadacimab Paediatric Trial: Empowering Patient Participation Gathering patient insights into clinical development designs to help patients take For personal use only control of their care and treatment Meet our Clinical Companions from Empath Labs; helping our youngest clinical trial participants

  79. Slide 79: Delivering on Our Promise

    Delivering on Our Promise For personal use only 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 78

  80. Slide 80: Summary

    Stacy, Living with Primary Immunodeficiency For personal use only William Mezzanotte MD, MPH Summary Executive Vice President Head of R&D CSL

  81. Slide 81: CSL R&D Portfolio – FY25

    CSL R&D Portfolio – FY25 For personal use only 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

  82. Slide 82: Forward-Looking Portfolio Highlights – FY25

    Forward-Looking Portfolio Highlights – FY25 For personal use only Abbreviations: AFD – Acquired Fibrinogen Deficiency; aGvHD – Acute Graft versus Host Disease; aTIVc- Adjuvanted Cell-Based Trivalent Influenza Vaccine; aQIV – 81 Adjuvanted Quadrivalent Influenza Vaccine; ESKD – End Stage Kidney Disea

  83. Slide 83: Key Takeaways

    Key Takeaways For personal use only • 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-sta

  84. Slide 84: Thank You / Questions

    For personal use only Thank You / Questions 83

CSL — Investor Day (October 2024) on 6ix