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CSL Ltd. — Investor Presentation 2023
Oct 15, 2023
17854_rns_2023-10-15_51dd0911-d845-4f6c-b1f0-59b926625014.pdf
Investor Presentation
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16 October 2023
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CSL Capital Markets Day
CSL Limited (ASX:CSL; USOTC:CSLLY) will today hold its Capital Markets Day in Sydney, Australia.
Please find attached the presentation materials including a news release outlining the highlights of the day.
The briefing for investors and analysts will commence at 9:15am Australian Eastern Daylight Time.
The briefing will be webcast on the Company website at www.csl.com in the ‘Investors’ section under Presentations.
An archived copy of the webcast will be uploaded to the site later in the day.
Authorised for lodgement by:
Fiona Mead Company Secretary
For further information, please contact:
Investors: Bernard Ronchi Director, Investor Relations CSL Limited
P: +61 3 9389 3470 E: [email protected]
Stephen McKeon Director, Investor Relations CSL Limited P: +61 402 231 696 E: [email protected]
Media:
Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected]
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CSL Limited Capital Markets Day
16 October, 2023
IMPORTANT NOTICE AND DISCLAIMER
This presentation contains summary information about CSL Limited (ACN 051 588 348) and its related bodies corporate (together, CSL ) and CSL's activities as at the date of this presentation. It is information given in summary form only and does not purport to be complete. It should be read in conjunction with CSL's other periodic corporate reports and continuous disclosure announcements filed with the Australian Securities Exchange ( ASX ), available at www.asx.com.au This presentation is for information purposes only and is not a prospectus or product disclosure statement, financial product or investment advice or a recommendation to acquire CSL shares or other securities.
Legal Notice
No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of CSL or its directors, employees or agents, nor any other person, accepts liability for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability from fault or negligence on the part of CSL or its directors, employees, contractors or agents.
This presentation contains forward-looking statements in relation to CSL, including statements regarding CSL's intent, belief, goals, objectives, initiatives, commitments or current expectations with respect to CSL's business and operations, market conditions, results of operations and financial conditions, products in research, risk management practices, climate change and other environmental and energy transition scenarios. Forward-looking statements can generally be identified by the use of words such as "forecast", "estimate", "plan", "will", "anticipate", "may", "believe", "should", "expect", “project,” "intend", "outlook", "target", "assume" and "guidance" and other similar expressions.
The forward-looking statements are based on CSL's good faith assumptions as to the financial, market, risk, regulatory and other relevant environments that will exist and affect CSL's business and operations in the future. CSL does not give any assurance that the assumptions will prove to be correct. The forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors, many of which are beyond the control of CSL, that could cause the actual results, performances or achievements of CSL to be materially different to future results, performances or achievements expressed or implied by the statements . Factors that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions or divestitures; research collaborations; litigation or government investigations, advances in environmental protection processes, uncertainty and disruption caused by the COVID-19 pandemic and CSL’s ability to protect its patents and other intellectual property.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as at the date of the presentation. Except as required by applicable laws or regulations, CSL does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in assumptions on which any such statement is based.
TRADEMARKS
Except where otherwise noted, brand names designated by a ™or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.
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BUSINESS USE
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Agenda
| 9:00 – 9:15 | Registration/Coffee | |
|---|---|---|
| Welcome | Mark Dehring | |
| Strategic Overview | Paul McKenzie | |
| CSL Seqirus | Ken Lim | |
| CSL Vifor | Hervé Gisserot | |
| Q&A | ||
| 10:40 – 11:00 | Break | |
| CSL Behring | Andy Schmeltz | |
| Q&A | ||
| 12:30 – 13:30 | Lunch | |
| Information & Digital | Mark Hill | |
| Finance & Sustainability | Joy Linton | |
| Research & Development | Bill Mezzanotte | |
| Q&A | ||
| Concluding Remarks | Paul McKenzie | |
| 16:00 – 18:00 | Refreshments – Marble Bar | CSL Team |
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Strategic Overview
Paul McKenzie CEO & Managing Director
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Leading Positions in Large, Growing Markets
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Global #1
in plasma protein therapies ~$38 billion industry
Global #2
in influenza vaccines ~$7 billion industry
Global #1 in iron ~$5 billion industry
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5
Positioned for Annual Double-Digit Earnings Growth
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Leading positions in high growth markets
-
Significant unmet need
-
Durable products driven by continued innovation and embedded know how
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Robust R&D Portfolio
-
Near-to-mid-term launches
-
Longer-term opportunities across platforms and therapeutic areas
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Yield & capacity expansion
-
Yield enhancement across plasma and manufacturing platforms
-
Investing in Ig and cell capacity
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Disciplined capital allocation for growth
-
R&D, CapEx and value-creating BD
-
• Partnerships across the value chain with leading companies
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Strategic Focus Areas
5
4 Attract, engage, 3 Invest in develop and new digital retain next technologies generation 2 Deliver our to drive leaders R&D pipeline business within our performance investment Realise COGS 1 envelope efficiencies, driving CSL Behring gross Drive top-line margin to growth across pre-pandemic our core levels and franchises beyond
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Management Team
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Andy Schmeltz
EVP, CSL Behring United States
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Joy Linton
Chief Financial Officer
Australia
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Stephen Marlow
SVP and General Manager CSL Seqirus Australia
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Mark Hill
Chief Digital Information Officer United States
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Hervé Gisserot
SVP and General Manager CSL Vifor Switzerland
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Elizabeth Walker
EVP, Chief Human Resources Officer United States
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Bill Mezzanotte
EVP, Head Research & Development United States
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Kate Priestman
Chief Corporate & External Affairs Officer United Kingdom
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Ken Lim
EVP, Chief Strategy Officer Australia
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Greg Boss
EVP Legal and General Counsel United States
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CSL Seqirus
Ken Lim Chief Strategy Officer, CSL
CSL Seqirus growth linked directly to differentiation strategy and core capabilities
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CSL Seqirus historic growth
Seasonal Influenza Revenue (US$'M)
1,500
23% CAGR
1,000
500
-
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23
Non-differentiated Differentiated
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Cornerstones for Success
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Real World Differentiation
Evidence Strategy
Platform
Focus on Scaled
Innovation Manufacturing
Platforms
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CSL Seqirus’s focus within its 4 strategic pillars drives its near and long-term success
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1. CONTINUED GROWTH IN INFLUENZA
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Opportunities in both new and existing markets to increase our global footprint
3. GROW BEYOND INFLUENZA
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Leverage core competence of respiratory vaccines
2. BROADEN OUR PANDEMIC BUSINESS
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Multi-pathogen pandemic capability
MANUFACTURING TECHNOLOGY
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Common technologies and yield investments to underpin our growth
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Influenza still has significant unmet need, particularly in paediatric and older adult populations
Seasonal Influenza Burden
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Deaths
12k – 52k
Hospitalisations
140-170k
Infections/Illness
9-41M
US Data: 2010-2020
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Hospitalisation Rate Across Ages
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70
Hosp. rate
60
50
40
30
20
10
0
<5 5-9 10-19 20-34 35-44 45-54 55-64 ≥65
Patient Age (years)
Rate
(per 10,000)
Hospitalisation
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https://www.cdc.gov/flu/about/burden/ Accessed 8/8/23 Glezen WP, et al. Am Rev Respir Dis. 1987;136(3):550-555.
Putri, Wayan C.W.S. et al , Economic burden of seasonal influenza in the United States , Vaccine. 2018 Jun 22;36(27):3960-3966. Found at: https://pubmed.ncbi.nlm.nih.gov/29801998/ (Accessed September 2020
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In influenza, Seqirus will grow the market through differentiation despite lower immunisation rates
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Historic Trend (US)
Expectations
-
Immunisation rates will return over time
-
Annualisation of COVID-19 boosters will reduce vaccine fatigue
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COVID-19
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- CSL Seqirus growth will outpace the market through differentiation and advocacy efforts
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2009
H1N1
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Current Northern Hemisphere 2023/24 season to date (early, in progress)
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On track to our pre-season commitments
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Flawless supply season
Source: www.cdc.gov
-
Positioned to support in-season opportunities if they arise
-
N.B. we’re still early in the season
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CSL Seqirus focused on continuous innovation to reduce the burden of influenza
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Multiple
Differentiators
Differentiated
aH5N1c
QIVc
Undifferentiated
aQIVc
aTIV
aQIV
TIVe
sa-mRNA
aH5N1
QIVe Development Status: Development Status:
• QIVc: 6-month+ age extension • aQIVc: Phase III
• aQIV: Advanced Real-World Evidence • sa-mRNA flu: Pre-clinical
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sa-mRNA technology differentiates
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CSL Seqirus COVID-19 vaccine candidate
Differentiators of sa-mRNA Technology
Accelerating to market
Superior response to Omicron strain 1 as a booster in adults vs. approved booster (Phase III)
-
Licensing and collaboration agreement with Arcturus Therapeutics Inc.
-
• Finalising clinical programs
-
• Studying emerging variants
-
Regulatory submissions
2 Lower dose of mRNA
Global Launches Anticipated in 2024 - 2026
Duration of protection up 3 to 12 months
^ Links to online publications: https://www.medrxiv.org/content/10.1101/2023.07.13.23292597v1.full.pdf
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Japan EU UK US
(via Meiji Seika)
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https://ir.arcturusrx.com/news-releases/news-release-details/study-shows-novel-sa-mrnavaccines-offer-robust-broad-enduring
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BUSINESS USE
New Flu Cell Culture facility in Australia to meet growing demand and pandemic protection
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Project is on target for schedule and budget, with first production in Q1 2026 Cell culture manufacturing Anti-venom production Fill/Finish facilities
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Key Takeaways
- CSL Seqirus is well positioned to continue its success in influenza:
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-
Capacity development well advanced to support aQIVc launch
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Continuous innovation will enable CSL Seqirus to outpace market growth:
-
aQIVc setting new standard of care
-
sa-mRNA
-
sa-mRNA technology will differentiate CSL Seqirus vaccine in COVID-19
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CSL Vifor
Hervé Gisserot General Manager, CSL Vifor
FY23 – a solid result with 11 months contribution[1]
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Iron Therapy Nephrology
Dialysis Non-Dialysis
3
4
5
(Ex-US)
6
7
In Market products
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In Market products
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~14% revenue growth[2] EPS accretive
Integration and cost synergies on track
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FY23 Revenue By Therapy Group $m [1]
Total: $1,989m
3%, Other, $73
7%, Non Dialysis,
$136
51%,
Iron,
$1,009
39%,
Dialysis,
$771
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1. Acquired 9[th] August 2022 ~approximately 11 months contribution
2. Eleven months FY22 pre CSL ownership and unaudited versus eleven months FY23 at constant currency
3. Licensed from F. Hoffman-La Roche AG., 4. Licensed from Pfizer Inc., 5. Licensed from ChemoCentryx, Inc., 6. Licensed from OPKO Health, Inc., 7. Licensed from Cara Therapeutics, Inc.
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2
0
CSL Vifor’s strategic framework will set the foundations to drive sustainable, profitable growth
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Maximize Unlock revenue upside in Deliver successful launches
Ferinject® / Injectafer® Patient Blood Management and pipeline progress to
growth opportunities across CSL strengthen renal disease
position
Lean and efficient
operations to compete in the new environment
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Iron market: Unique conditions enabling us to drive long-term value
• Market development Continued market growth due to untapped potential
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Follow-on Competition
- Limited number of follow-on products
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Innovation
- No breakthrough innovation
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• Pricing dynamics Strong price competition ?
1. Kassebaum NJ. The Global Burden of Anaemia. Hematol Oncol Clin North Am. 2016;30(2):247-308
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Iron market: Unique conditions enabling us to drive long-term value
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Market Experience
• Market development Continued market growth due to untapped potential
Follow-on Competition
- Limited number of follow on products
Innovation
- No breakthrough innovation
• Pricing dynamics Strong price competition
- Kassebaum NJ. The Global Burden of Anemia. Hematol Oncol Clin North Am. 2016;30(2):247-308
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Relentless focus on Ferinject[®] / Injectafer[®] growth
GROWTH
NEW COMPETITIVE LANDSCAPE
GEOGRAPHIC & MARKET EXPANSION
LCM & SCIENTIFIC EXCELLENCE
-
Tendering excellence
-
Non-clinical differentiation
-
Cost of goods improvement
-
Investment in RWE/RWD
-
New launch markets
-
New presentations / formulation
-
New indications
-
Maximizing value of •
-
partnerships Non-Biologic Complex Drug characterisation
SIGNIFICANT UNTAPPED MARKET POTENTIAL
RWE = Real World Evidence; RWD = Real World Data
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Patient Blood Management addresses a global health issue
- Benefits For patients: • Improved outcomes • Increased safety
Health Problem Patient Blood Management Benefits Critical need to reduce whole blood Evidence-based approach to preserve For patients: transfusions patient’s own blood • Improved outcomes • Avoidable adverse outcomes • Three Pillars of PBM Increased safety • Wastage of scarce blood supply • Reduced risk of complications • Inefficient healthcare spend 01 Detect & manage and infections anaemia/iron deficiency For Health Systems: Due to: • Preserve blood for high-value usage 02 • Insufficient screening of iron deficiency Minimize blood loss • Decrease overall cost of care • Suboptimal intra-operative haemostasis • Improve Quality Indicators & KPIs 03 Optimize patient tolerance of post-op anaemia
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Repeated Demonstrations of Patient & Health System Benefits when PBM is fully implemented
Benefits for health systems Decrease overall cost of care
Benefits for patients
Decrease overall cost of care Improved patient outcomes Length Mortality Infection AMI/stroke of stay Western Australia $18.1 m blood product Activity based cost Patient Blood cost savings over the savings between 28% 21% 31% 15% Management six-year study period ~ $80 m – $100 m Program[1] In-Hospital Length Adv. Events[] of stay Mayo Clinics[2] 22% reduction in Savings of $7 m in N=400,998 admissions Jan 2010 allogenic transfusions transfusion related 1.5% 15% costs through December 2017 at two Absolute risk integrated hospital campuses 49% reduction in RBC Savings of $2.1 m in Across 5 John transfusions orders blood acquisition Hopkins Hospitals[3] costs – ROI 400% University Hospital 40% reduction in Savings of $12.44 m* of Zurich[4] RBC transfusions in blood acquisition N=213,882 patients discharged costs over 4 years
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N=213,882 patients discharged between 2012 and 2017 were included in this retrospective study
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Countries calling on PBM implementation leading to addressable market of $4-5B across range of specialties
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World Health UK, Germany, 2021 Italy, 2016 Romania, 2018
Organization, 2021 2015: NICE guidelines PBM PBM guidelines PBM guidelines
2022: Preop anaemia Recommendations
Policy Brief on “The
management in
urgent need to Russia, 2022
CQUIN
implement PBM” Setting up MoH
working group to
develop PBM standard
Portugal,
2018: Pilot PBM project
in 8 hospitals China, 2022
2022: Decree requiring
PBM guidelines
PBM implementation
Africa, 2022
Mexico 2020 Dakar Declaration on
PBM guidelines the future of surgeries
in Africa
Spain, 2019 Australia, 2012 – 2019
PBM related KPIs intro- Guidelines, National
duced in certain regions Implementation
Strategy &
establishment of PBM
France, 2022
Advisory Committee
PBM guidelines
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TOTAL addressable market[1] $4b to $5b[2] Estimates include EU5, US, Japan & Switzerland
1. Consisting therapeutic areas where we can address PBM in Pillar 1, Pillar 2 and Pillar 3. Areas of potential significant growth include Cardiothoracic Surgery, Orthopaedic Surgery, Major Vascular Surgery, Oncologic Surgery, Gynecologic & Obstetric Surgery, Transplant Surgery and possibly Trauma
2. Internal calculation. Potential PBM market size estimate based on number of addressable patients. Market sizing estimate assumes price erosion across all classes
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CSL is uniquely positioned in PBM to translate evidencebased medicine into evidence-based practice
Pre-surgery
During surgery
Post-surgery
Benefits of PBM
Diagnosing & treating iron-deficiency (anaemia)
Optimizing hemoglobin and erythropoiesis to avoid complication during and post surgery
Optimizing coagulation
Using factor concentrates to minimize need for allogenic blood products
Ensuring optimal & fast recovery
Managing anaemia & irondeficiency and post-operative bleeding & clot stability
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1
CSL
Portfolio
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1. Rights for PBM currently reside with Pfizer (licensor) – asset is part of VFMCRP (distribution limited to US dialysis and non-hospital market)
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Realising the market opportunity through integrated Go to Market operating model
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RWD/RWE DIRECT ENGAGEMENT
Indication expansion & Shape Medical Practice
evidence generation through supporting
supporting PBM benefits policies
Build Influence
Scientific & Global &
Medical National
Leadership Policy Makers
Build Brand Assist Health
IMPLEMENTATION Position & Systems to DATA SERVICES &
Leadership Change
TOOLBOX PROTOCOLS
Compelling combined Support for Key Accounts
Behring & Vifor Portfolio to Implement PBM
Offering
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BUSINESS USE
Strengthen renal disease position along the full spectrum of kidney disease
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Prevent Kidney Chronic kidney Dialysis
Damage disease treatment Treatment
Preserving renal function Manage complications Manage complications
CKD Dialysis
Vadadustat [1]
(Ex-US) Managing transplant patients (including complications)
Sparsentan (EU, ANZ)
CSL964 Clazakizumab
Nephrology &
Multiple potential early- (GvHD prevention and (Ab-mediated rejection
Transplant TA stage assets treatment) and ESKD)
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1. Currently in regulatory assessment by the U.S. FDA. Based on standard NDA resubmission review timelines, our partner Akebia Therapeutics expects a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date at the end of October 2024.
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CSL Vifor key value catalysts will drive growth into the medium - long term
Near-term
-
Ferinject[®] reimbursement in China
-
Injectafer[®] Heart Failure US launch
Mid-term
-
Maximize strategic partnerships
-
PBM revenue upside
-
CSL 300
-
Long-term • Nephrology / Transplant pipeline
-
BD opportunities
-
Launches Kapruvia[® ] / Korsuva[®] , Tavneos[® ] & Sparsentan
-
Collaboration with Behring / Seqirus
Cost Synergies
Indications / Geographic expansion
R&D Opportunities
1. CUA = Calcific Uremic Arteriolopathy
2. PAD-ESKD = Peripheral Arterial Disease - End Stage Kidney Disease
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Thank You / Questions
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CSL Behring
Andy Schmeltz EVP, CSL Behring
CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION
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DONOR.
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EMPLOYEE.
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PATIENT.
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CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
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PLASMA COLLECTION MANUFACTURING COMMERCIALISATION
Grow
Plasma
Volume
Reduce
Plasma
Acquisition
Cost
EMPLOYEE. PATIENT.
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CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING
COMMERCIALISATION
Grow Improve Plasma Ig and Volume Albumin Yield Reduce Plasma Acquisition Cost
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PATIENT.
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CSL Behring: Driving Sustainable, Profitable Growth
Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING
COMMERCIALISATION
Grow Improve Plasma Ig and Volume Albumin Yield Reduce Plasma Acquisition Cost
Grow Key Medicines and Deliver Successful Launches
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37
CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING Grow Improve Plasma Ig and Volume Albumin Yield Reduce Plasma Acquisition Cost
COMMERCIALISATION Grow Key Medicines and Deliver Successful Launches
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38
Snapshot of CSL Plasma’s Industry-Leading Collection Network
-
USA Germany Hungary
-
Key figures
-
Note: CSL Plasma also operates five centres in China. • 322 centres U.S. • 15 centres EU
-
•
-
39 12 centres opened in last year
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39
Global Plasma Collections Back on Track
-22% in FY21 | +24% in FY22 | +31% in FY23
FY21 FY22 FY23
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FY24
Source: Global Donor Management Systems
40
Leading the Way in Plasma Growth & Efficiency
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Sourcing
Optimizing
Sufficient
Costs
Volume
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41
Multiple Levers to Support Collections Growth, Enabled by Digital Transformation
-
Optimize mix of qualified and new donors
-
Focus on donor and market segmentation
-
• Leverage personalized messaging and incentives RETENTION
-
FREQUENCY • Deliver best-in-class service
-
• Apply technology to guide fee setting
-
• Personalize experience via app
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NEW LAPSED DONORS
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-
Increase awareness across different media
-
Drive first-time donation with differentiated fees
-
• Digitize pre-registration and appointments
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42
Clear Path to Driving Cost Per Litre (CPL) Efficiencies
COVID disruption led to
However, we have turned the corner. Further CPL reductions over coming 4 years
1 - 3 YEARS
Higher donor fees to drive collections
Lower centre output and unfavourable cost absorption
Higher labor wage rates
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----- Start of picture text -----
01 Optimizing Fee
Structures
----- End of picture text -----
-
02 Focus on centre-level Labor Productivity
-
03 Continued Rollout of Rika Plasma Donation System
2 - 4 Years
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Individualized 04
Nomogram
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Improved Centre 05 Productivity and Cost Absorption
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43
U.S. FDA Nomogram: Important Lever to Optimize Donations and Drive Plasma Yield
Collection Target: Weight & Hematocrit Launched in August 2023
Collection Target: Collection Target: Weight Weight, Hematocrit & Height Currently at most centres Anticipated launch in FY25, pending Terumo approval
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44
Benefits of Rika Plasma Donation System
Currently deployed in ~15 centres Roll-out schedule to be agreed with Terumo by December 2023
Donor Experience
Donor Safety
Fewer donor Improper deferrals; reduced collection volume donation time by due to employee ~30% error reduced by 85%
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Sustainable Growth
Individualized Nomogram will improve average donation yield by ~10%
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Sustainability
Reduced biohazard disposable waste by 10-15%
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Source: Global Donor Management System
45
Leading the Way in Plasma Growth & Efficiency
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Sourcing
Sufficient
Volume
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-
Digital Transformation
-
Rika Plasma Donation System
-
Nomogram A & I
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Optimizing
Costs
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-
Enhanced Scheduling
-
Donor Fee Strategy
-
Fleet Optimization
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46
CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION Grow Improve Grow Key Plasma Ig and Medicines and Volume Albumin Deliver Successful Yield Launches Reduce Plasma Acquisition Cost
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47
Global Manufacturing Presence
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Bern, Broadmeadows, Switzerland Australia
Marburg, Germany
-
Core products: • Core products : • Core products: immunoglobulins & immunoglobulins & Human Albumin albumin albumin Behring, coagulation factors, critical care
-
Specialty products:
-
• • Specialty products: coagulation factors, Specialty products: anti-D-hyperimmune critical care, CSL312 hyperimmunes
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Kankakee, Illinois, U.S.
Wuhan,
China
-
•
-
Core products: Core products: albumin, albumin, fractionation for immunoglobulins intermediate pastes
Specialty products: alpha1-proteinase inhibitor
- Toll plasma services for Australia, New Zealand, Hong Kong, Malaysia & Taiwan
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48
Ig Yield Maximisation Strategy[1]
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1. Illustrative only
Subject to the success and timing of research and development activities and the decisions of regulatory authorities
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Yield Improvements
Horizon 1
-
Process changes within regulatory filing
-
Data analytics and plasma allocation
-
Operational excellence
Horizon 2
-
Proprietary process improvements with some manufacturing retooling
-
Will require regulatory approval
-
• Targeted at litres producing Ig & Albumin only
-
Pilot work underway
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49
Operational Excellence
CSL Operating System Delivering Value Across Six Areas
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Productivity Service
Reliability
Engagement
Quality
Sustainability
Example Value
Reduction in cycle Increase level of On Reduction in time and increased Time In Full inventory capacity Delivery to markets
Increase in Reduction in More efficient schedule Repeat Deviations environmental adherence & write offs footprint
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50
CapEx Investments are Providing Capacity for Growth
CSL expects CapEx investment needs to reduce as major projects are now coming online
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Annual CapEx Spend
New Capacity Online
30%
CSL Plasma Centers at Start of FY
Reduction in
IG Production CapEx Spend
COVID Dip
330
303
277
237
206
180
Marburg / Marburg
148 External Filling Fractionation
127
Broadmeadows Kankakee Bern Broadmeadows Broadmeadows
IG Bulk Fractionation Ig Bulk Albumin Bulk Fractionation
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24
51
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CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION Grow Improve Grow Key Plasma Ig and Medicines and Volume Albumin Deliver Successful Yield Launches Reduce Plasma Acquisition Cost
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52
Strong CSL Behring Portfolio with Compelling Growth Drivers
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FY23 Global Revenue
$9.3B/+12% [1,2]
50%
13%
7%
30%
IG Haemophilia HAE Others
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Source:
-
1 FY23 Growth percentages shown at constant currency 2 Includes HPV royalties & Ig Hyperimmunes
-
3 Haemophilia includes Afstyla (Hem-A), Idelvion (Hem-B), Hemgenix (Hem-B), and other coagulation products.
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Immunoglobins (Ig)
-
PRIVIGEN[® ] has >1 Million patient years of therapy
-
HIZENTRA[®] , >10 years as worldwide market leader
Haemophilia[3]
-
IDELVION[® ] is the #1 Factor IX prescribed for prophylaxis
-
HEMGENIX[®] now launched in US
Hereditary Angioedema (HAE)
-
HAEGARDA[®] offers proven effectiveness of C1-inhibitor replacement
-
garadacimab to provide patients with the most efficacious and convenient LTP[*] therapy
-
Long term prophylaxis (LTP)
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Ig Usage Trends by Country Shows Significant Opportunity, Particularly Beyond US and Australia
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Ig Consumption per Capita (gms/100K)
327
303
240
153
138
117
101
96
51
25
17
2
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-
US, Australia and Canada are the leading countries for per capita Ig utilization
-
• Disease prevalence is consistent globally
-
• Clear opportunity to grow Ig subject to adequate supply
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54
Behring Ig Growth Opportunities Span Current and New Indications
- 7 Major Markets: Ig Market Volume by Indication (FY23)
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IVIG SCIG
25%
73%
18%
4%
5%
5%
1%
19% 13%
29%
8%
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Abbreviations: primary immunodeficiency (PID), secondary immune deficiency (SID), chronic immune thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis (MG)
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-
Ig demand across core indications continues to grow: ‒ Ig replacement in PID, SID
-
‒ Ig as an immunomodulator in MG, CIDP, ITP
-
Multiple levers to sustain and expand leadership:
-
Real-world experience (RWE) and data generation
-
Launch of HIZENTRA pre-filled syringe offerings; 5ml, 10ml, 20ml, 50ml
-
‒ Exploring multiple additional indications including dermatomyositis (DM)
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55
PRIVIGEN[®] and HIZENTRA[® ] : Compelling Offerings for Patients
Privigen[®]
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Hizentra[®]
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-
Standard of care IVIg with proven protection through reliable Ig restoration
- Market leading SCIg offering personalized treatment options to patients
-
15+ years in PID and ITP; 10+ years in CIDP
-
Demonstrated to improve motor function in CIDP:
-
Supported by PRIMA and PATH studies
-
1.1M patient years' experience across indications
-
Recommended for CIDP maintenance treatment in Peripheral Nerve Society (PNS) treatment guidelines[1]
-
Proven long-term protection with 5+ years of RWE in CIDP
-
Expanding into dermatomyositis (DM) as the first-and-only SCIg
Abbreviations: primary immunodeficiency (PI), chronic immune thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP)
1Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force—Second revision. Eur J Neurol. 2021;1‐28. https://doi.org/10.1111/ene.14959.
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56
Behring Ig Portfolio to Outpace Market Growth
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Projected Global Ig Market Volume [ ]
IVIg
30+%
share
FY23 FY28
SCIg
50+%
share
FY23 FY28
CSL Behring Rest of Market
Volume
Volume
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Ig Market
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5-Yr Vol
6-8% high single-digits
CAGR
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-
Improving Ig market supply, strong underlying demand and improved diagnosis rates in PID
-
PRIVIGEN® (IVIg) and HIZENTRA® (SCIG) leadership in core indications while expanding to new areas of unmet need
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57
Haemophilia B
Disease Overview and Unmet Needs
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Haemophilia B: A rare genetic bleeding disorder
It results from the ~38K people [2] ~20K people
absence or deficiency of Diagnosed with Treated with Factor
coagulation Factor IX Haemophilia B IX therapies
(FIX) [1] worldwide in 2021 [[2]]
•
Infusion Burden
Significant unmet
•
Durable Protection/ Stable FIX level
need persists despite •
Treatment options for patients with inhibitors
treatment advances •
Psychological and Social Impact
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[1] National Bleeding Disorders Foundation [2] WFH Annual Survey 2021
PdFIX: Plasma-derived Factor IX; SArFIX: Short-acting recombinant Factor IX; LArFIX: Long-acting recombinant Factor IX
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58
IDELVION[®] and HEMGENIX[®] : Leading Through Innovation
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Idelvion
-
Well established standard of care
-
Provides highest factor levels for the longest period of time of any FIX replacement therapy
-
Offers personalized dosing options of up to 21days*
-
Safe and well tolerated with low incidence of adverse reactions
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Hemgenix[®]
-
Provides greater bleed protection vs prophy
-
63% patients reported zero bleeds in the 7 to 18-month period following infusion[[1}]
-
Eliminates routine prophylaxis
-
96% of people discontinued Factor IX prophylaxis and remained prophy-free[[1}]]
-
Sustains FIX levels projected to last 15+ years for majority of patients[[2]]
-
Safe and well tolerated with no treatment related SAE’s
*Where 21-day dosing is approved
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[1] HOPE-B trial [2] Jinesh Shah, factor IX activity following etranacogene dezaparvovec gene therapy in the treatment of haemophilia B Hongseok Kim, Krupa Sivamurthy, Paul E. Monahan & Michael Fries (2023) Comprehensive analysis and prediction of long-term durability of , Current Medical Research and Opinion, 39:2, 227-237, DOI: 10.1080/03007995.2022.2133492Add durability modelling publication reference
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59
Behring Haemophilia B Portfolio to Outpace Market Growth
Projected Global Haemophilia B Market Revenue[*]
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35-40% share FY23 FY28 CSL Behring Rest of Market
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Haem B
Market
5-Yr Rev
4-6% high single-digits
CAGR
•
Haemophilia B market expected to grow
due the launch of advanced therapies
including gene therapy (GT)
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- Targeting the right patients for IDELVION® and HEMGENIX® will maximize success for CSL Haemophilia B portfolio
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60
Hereditary Angioedema (HAE)
Disease Overview and Unmet Needs
- HAE results from missing or low levels of a protein called C1 esterase inhibitor (C1-INH) and can cause attacks of swelling, and often pain, in specific parts of the body.
Hereditary Angioedema: A rare genetic disorder
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32%
51%
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1/40,000-50,000 ~12K treated
50% Chance of passing it on to a child
50% increase in patients getting prophylaxis treatment between 2016 and 2023
patients in major markets
-
Laryngeal attacks that block the airway are potentially life threatening
-
Delayed diagnosis
Significant unmet • Treatment burden need persists despite • Lack of immediate acting prophylaxis treatments treatment advances
- Psychological and Social Impact
Prophy patient share
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61
HAEGARDA[®] and Garadacimab
Best in Class Prophylactic Efficacy
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Haegarda[®]
-
Addresses the root cause of HAE by replacing missing or dysfunctional C1-INH
-
Reduces the median frequency of HAE attacks by 95%*
-
Reduces the median frequency of rescue medication by >99%*
-
99% of US patient days were attack free for up to 2.7 yrs.+
*pivotal Phase 3 study results, + Longhurst H, Cicardi M, Craig T, Bork K, Grattan C, Baker J, COMPACT Investigators et al. Prevention of hereditary angioedema attacks with a subcutaneous C1 inhibitor. N Engl J Med. 2017;376:1131– 1140. doi: 10.1056/NEJMoa1613627.
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Garadacimab
-
First Factor XIIa therapy for HAE prevention working at the top of the cascade
-
One dose, once a month, in less than 15 seconds via prefilled pen
-
99% median reduction in attacks and rescue medication use per month vs placebo*
-
62% of patients (12 years of age +) were completely attack-free over 6-months*
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62
Behring HAE Portfolio to Outpace Market Growth
Projected Global HAE Market Revenue
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----- Start of picture text -----
30+%
share
Revenue
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FY23 FY24 FY25 FY26 FY27 FY28
CSL Behring All Others
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garadacimab
HAE Market
5-Yr Rev
4-6% high single-digits
CAGR
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-
Improved diagnosis rates and new prophylaxis therapies will drive market growth
-
CSL portfolio addresses the needs of patients with effective on-demand treatment (BERINERT[®] ) and prophylaxis therapy (HAEGARDA[®] )
-
HAEGARDA[®] /BERINERT[®] will continue to be preferred by patients who value natural C1 replacement for its strong efficacy, safety profile and track record
-
Garadacimab – potential best-in-class therapy for HAE prophylaxis
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63
Portfolio Enabled by Additional In-line Growth Drivers
FY23 Global Revenue $9.3B/+12%[1,2]
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Hereditary Angioedema (HAE)
Haemophilia [3]
7%
13%
OTHER
30%
50%
Immunoglobins (Ig)
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-
CSL sustained market leadership
-
• Leverage data generation and real-world
-
(11% in FY23) experience in expanded indications • Growth in treatment settings with high unmet needs
-
• Potential expanded indication in trauma
-
(10% in FY23) (Ph3)
-
Launch 4/5gram in US market
-
• Potential indications for acute graft-vs-
-
(24% in FY23) host disease
Source:
-
1 FY23 Growth percentages shown at constant currency 2 Includes HPV royalties & Ig Hyperimmunes
-
3 Haemophilia includes Afstyla (Hem-A), Idelvion (Hem-B), Hemgenix (Hem-B), and other coagulation products.
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64
CSL Behring: Driving Sustainable, Profitable Growth
Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING
COMMERCIALISATION
Grow Improve Plasma Ig and Volume Albumin Yield Reduce Plasma Acquisition Cost
Grow Key Medicines and Deliver Successful Launches
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65
CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION Improve Grow Key 1 Ig and Medicines and Albumin Deliver Successful Deploy Rika , Yield Launches Nomogram A/I, digital transformation and operational excellence
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66
CSL Behring: Driving Sustainable, Profitable Growth Working together from Donor to Patient
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----- Start of picture text -----
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION
Grow Key
1 2
Medicines and
Deliver Successful
Deploy Rika, Deliver Horizon 1 yield
Launches
Nomogram A/I, improvements; advance
digital transformation Horizon 2
and operational
excellence
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67
CSL Behring: Driving Sustainable, Profitable Growth
Working together from Donor to Patient
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----- Start of picture text -----
PLASMA COLLECTION MANUFACTURING COMMERCIALISATION
1 2 3
Deploy Rika , Deliver Horizon 1 yield Outpace market
Nomogram A/I , improvements ; advance growth in Ig ,
digital transformation Horizon 2 Haemophilia B and
and operational HAE
excellence
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68
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Thank You / Questions
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69
Information and Digital
Mark Hill
CDIO
We are selective in choosing digital opportunities with the
greatest potential to differentiate our business
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1
2
3
Our focus areas include:
-
Interactions with donors
-
The acceleration of science in pursuit of new therapies
-
Scaling the enterprise
Under these focus areas lies a massive injection of information and automation
Anchored in a mission to keep our company and its data safe and secure
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Pitch Deck
71 71
Value drivers for information and digital
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Differentiation Integration
Automation
Information
Cybersecurity
Making donations Unified and easier, while standard business ensuring uptime process workflows and resiliency of that drive our plasma centers. continuous productivity and Merging biological operational and computer leverage. science for pipeline growth.
Self-healing processes that reduce cycle time and improve the employee experience.
Making data the Maintaining connective tissue acceptable levels of risk of our enterprise by keeping technology ecosystem for current, employing real-time data cybersecurity flows. measures, establishing business continuity, and meeting regulatory requirements.
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72
Fusion of business and technology
Plasma: Making donations easier, creating a more positive donor experience, and bring in more donors
PLASMA
R&D
Enterprise
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Digital Experience
Data
Artificial Intelligence
Innovation
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73
Fusion of business and technology
R&D: Merging biological and computer science for pipeline growth
Plasma
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----- Start of picture text -----
R&D
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Enterprise
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----- Start of picture text -----
Scientific Insights
Accelerating the
pace of discovery.
Operational Excellence
Integrating our R&D
systems and processes
across businesses.
Data
The connective tissue across
R&D, driving science at scale
74
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Fusion of business and technology
Enterprise: Capabilities for business performance and operational leverage
CSL Enterprise
Information
Real-time data flows that drive insights and seamless ecosystem connections.
Plasma
R&D
ENTERPRISE
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CSL
Automation
Self-healing processes that reduce cycle time and drive productivity at scale.
Behring B Seqirus S Vifor V Current State
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Integration
Unified and standard workflows to drive efficiencies and employee experience.
Target State
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75
Our Generative AI framework focuses on broad productivity, business outcomes and long-term value innovation
Focus Area 3: Breakthrough Innovation
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----- Start of picture text -----
Create game-changing outcomes and
differentiated assets (IP)
3
Focus Area 2: Select Use Cases
Prioritize a list of business cases
2
where we can drive value
Focus Area 1: Productivity Boom
Make as many people as
1
productive and effective as possible
# of users
Foundation
Policy, education,
Foundation
experimentation zone, catalyst
partners, governance
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Illustrative use cases
3 Accelerate time to trial
3 Improve pharmacovigilance reporting
2 Improve patient experience
2 Improve tenders
2 Optimize inventory management 2 Improve the donor experience 1 Improve enterprise search 1 CSL GPT
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76
Cybersecurity remains the biggest risk in digital transformation
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Shifting regulatory requirements and geopolitical threats
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Generative AI risks:
- Data leakage
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Generative AI
-
Hallucination (generating inaccurate responses)
-
Making cyber criminals more efficient and effective
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Cyber risk due to use of new technology/solutions and partners
- Future capacity shortages (future phases of AI will require 100x more capacity than today)
Maintain an acceptable level of risk by keeping technology current, employing cybersecurity measures, establishing business continuity management and meeting regulatory requirements
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77
Takeaways
We see digitalization as a mechanism of scale , accelerating our business growth at less physical cost.
Fusion of business and technology are potential differentiators of our business in the donor experience, the speed of science, and enterprise leverage (extending our moat).
A massive infusion of automation and information are the new table stakes for keeping pace with industry and our ecosystem of partners.
Generative AI is a potential leapfrog opportunity , but also difficult to harness because the speed of innovation is faster than anything we have seen.
. Never forget our commitment to safety and security
. It is the most exciting time to be at the intersection of CSL and Digitalization
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Finance and Sustainability
Joy Linton
CFO
Disciplined Management of Capital
Growing Cash Earnings
-
Maintain strong balance Returns to shareholders Re-invest in the Business Capital structure sheet • Dividend growth in line • R&D investment of 10 -11% • Annual Review • Net debt / EBITDA target with NPATA growth of revenue • Excess capital returned to ratio of less than 2.0x • Circa 40-45% payout • BD – selective investment shareholders
-
• Maintain investment in R&D assets • Steady improvement in
-
grade credit rating • Capex ROIC fuelled by double digit earnings growth ‐ Growth ~70% Partnering approach •
-
‐ Maintenance ~30% Long term valuation creation
-
• Capabilities, competencies, Adjacencies
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80
Capital Expenditure[1]
Key Points
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Capex US$m % of Revenue
1,400 14%
~30% 13%
1,200
12%
1,000 11%
10%
800
9%
600
8%
7%
400
6%
200
5%
- 4%
Maint Growth % of Rev
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1. Capital Expenditure for Property, Plant & Equipment - net of disposals
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-
Significant investment continued during COVID years providing capacity to meet future demand
-
Mid term capex needs reduced following natural run off of intensive program
-
Capacity enhanced through yield initiatives and accessing CMO’s for new capabilities - pushing out future capex needs
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Key Capital Projects - Completion Timeline
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FY24 FY25 FY26 FY27 FY28 FY29 FY30
2023 2024 2025 2026 2027 2028 2029 2030
Rika Device Rollout
Technology
Veeva (Quality, PhV)
Broadmeadows: Mod 3 – Frac + CSL112
Base Frac
Future Base Frac – delayed need with Yield initiatives
Ig Yield Initiatives – Horizon 1
Ig Yield Initiatives – Horizon 2
Future IG Modules – delayed need with Yield & optimization initiatives
Bulk &
Zemaira 4/5g DP - TFS
Finishing
Broadmeadows Albumin Expansion 2
CSL 112 – Broadmeadows + Bern
Zemaira Bulk (+CSL964) Expansion
Plasma Centers (Continuous)
Other
Hemgenix – Second CMO
Seqirus Tullamarine Flu Cell Line 3
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82
ROIC Outlook
Earnings expansion fuelled by:
-
Differentiated product portfolios
-
Drive IG growth
-
New product launches
-
CSL Behring gross margin recovery
Steady improvement[1] in ROIC fuelled by double digit earnings growth
-
Continued growth in CSL Seqirus
-
CSL Vifor strategy realisation
Continues to exclude potential CSL112 upside
- 1.ROIC is expected to modestly soften in FY24, driven by the timing mismatch between the raising of funds to acquire Vifor Pharma and the payment of consideration
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Continued active management of inventory
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8,000 CPL 200.0
7,500
180.0
7,000
6,500 160.0
6,000 140.0
5,500 Plasma Volumes
120.0
5,000
4,500 100.0
4,000
80.0
3,500
3,000 60.0
2017 2018 2019 2020 2021 2022 2023
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$m Inventory % of revenue
6,000 100%
5,000 80%
4,000
60%
3,000
40%
2,000
20%
1,000
0 0%
2017 2018 2019 2020 2021 2022 2023
Finished Goods Work in Progress Raw Materials Inventory % Revenue
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Increase in plasma volumes and CPL have accentuated the value of inventory
Key Challenges
-
Balancing inventory build versus fulfilling patient demand
-
IG on EMA short supply list until June 2024
-
Most ex-US markets require increased levels of safety stock
-
Plasma collection costs remain high, although downward trending
-
Inventory driven by higher CPL
Outlook
-
Balancing inventory build versus fulfilling patient demand remains
-
Pre pandemic, months of cover ~2.5x – 3.0x
-
FY25 target ~2.0x
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Strong Balance Sheet
Strong liquidity and competitive access to debt capital across multiple markets
US$m
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2,000
1,800
1,600
1,400
1,200
1,000
800
600
400
200
-
Private Placement 144A QDI Bank Debt KfW Other Borrowings
FY24 FY25 FY26 FY27 FY28 FY29 FY30 FY31 FY32 FY33 FY35 FY38 FY42 FY52 FY62
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Debt is strongly weighted towards long tenors at fixed rates
-
Net Debt / EBITDA 2.5x, expected to be ~2.0x by end FY24
-
Business focus for further debt reduction to ensure credit ratings maintained
-
70% of debt fixed with average tenor of 8.9 years
-
Weighted average cost of debt FY23 4.11% versus FY22 3.38%
Flexibility to continue access to deep and diverse capital pools
- Successful US 144 A program creates funding optionality in largest liquidity market (average tenor 18 years)
Stable investment grade credit rating
-
S&P: A- (on negative watch)
-
Moody’s: A3
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As at 30 June 2023
85
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Sustainability
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Sustainability Pillars
ENVIRONMENT
-
Reduce Carbon Emissions
-
Reduce Waste & Emissions in the supply chain
(E)
delivering on our promises to preserve a healthier plant
- Environmental considerations embedded in strategy
SOCIAL
- Donor Experience
(S)
- Patient & Public Health Leader
providing better care for brighter days ahead
- Access to Our Therapies
SUSTAINABLE WORKFORCE
- Employee Engagement
(W)
-
Diversity, Equity & Inclusion
-
• Giving
it’s the people behind our promise that makes us different
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Ongoing
targeted
Diagnostic Ambitions Benefits
efforts
/ Baseline / Targets Roadmap Execution realization
In
In progress Completed Aligned Aligned In progress
progress
In progress Completed In progress In progress Next step Next steps
In progress Completed In progress In progress Next step Next Steps
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GOVERNANCE (G)
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87
Key Sustainability Indicators and Highlights
Environment
SBTi 1.5⁰[C]
100%
Renewable Electricity (RE) across all our major European manufacturing sites, with Australia to follow in Jan 2025. Evaluating promising RE options for our US based manufacturing sites.
Committed to be aligned with SBTi 1.5 ⁰C Submitted to SBTi for validation in 2023
5-star Green Star
190+
by Design rating given to new Melbourne, AUS Headquarter from the Green Building Council of Australia; representing excellence in sustainable building practices.
Suppliers engaged setting their own SBTi aligned targets (Scope 3)
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Social
94%
475
of plasma donors are regulatory inspections of willing to donate again and our manufacturing 91% are willing to refer a facilities and plasma friend to donate plasma at collection centers with no their CSL plasma center impact to licenses
Approved Reflect RAP
>US $1B CSL’s Reflect investment into research Action Plan and development US $13.7M supporting product access across the world Data as at 30 June 2023
CSL’s Reflect Reconciliation Action Plan launched in September 2023
Workforce
59%
Female Employees
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44%
Female representation
at board level
45%
of people managers
are women
Data as at 30 June 2023
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Research & Development
Bill Mezzanotte Executive Vice President, Head of R&D
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ONE CSL R&D
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90
Focus Through Our Therapeutic Areas and Platforms
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New: Nephrology
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91
Enhancing R&D’s Global Capabilities
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Melbourne, Australia
-
New Global Headquarters and Centre for R&D in Melbourne Biomedical Precinct
-
~40,000 m2 including:
-
18 stories for >850 employees
-
9 levels of world-class laboratories & facilities
-
Australia’s first-of-its-kind biotech incubator
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Marburg, Germany
-
New R&D Campus
-
• ~40,000 m2 for >500 R&D employees including:
-
7,400m2 laboratory space
-
10,300m2 working space
-
state-of-the-art vivarium
-
Collaborative laboratory space
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Waltham, USA
-
R&D centre supporting sa-mRNA technology for seasonal & pandemic influenza vaccines
-
~13,000 m2 including:
-
5,000m2 laboratory space
-
Biosafety level 3 laboratory (BSL-3)
-
Collaborative laboratory space
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92
CSL R&D Portfolio – FY23
PhaseI
PhaseII
Phase III
Anumigilimab (CSL324) HIZENTRA[®] HIZENTRA[®] INJECTAFER[®] Anti-G-CSFR mAb(HS) (SSc) (DM) (Ferric carboxymaltose) (HF-ID) CSL730 CSL301 Garadacimab rFc Multimer α2AP mAb (PE) Anti-FXIIa mAb(HAE) FILSPARI ( Sparsentan) Dual ETA & AT1 antagonist CSL889 Garadacimab KCENTRA[®] (FSGS) Hemopexin(SCD) Anti-FXIIa mAb(ILD/IPF) 4F-PCC (Trauma) FILSPARI ( Sparsentan) CSL787 Clazakizumab CSL1 1 2 Dual ETA & AT1 antagonist (IgAN) NebulisedIg Anti-IL-6 mAb(ESKD) apoA-I(AMI) Trabikibart (CSL311) SQ036 (aQIVc) Clazakizumab SNF472 Anti-Beta Common mAb Adjuvanted Cell-based Anti-IL-6 mAb(ca-AbMR) Calcification inhibitor Quadrivalent Influenza (CUA-ESKD) INS-3001 Vaccine CSL964 Calcification inhibitor Alpha-1Antitrypsin SNF472 (PAD, AVS) Mavrilimumab (Treatment of aGvHD) Calcification inhibitor Anti-GM-CSFR mAb (PAD-ESKD) (GCA, COVID) CSL964 Alpha 1Antitrypsin ARCT154 Eblasakimab (CSL334) (Prevention of aGvHD) sa-mRNA Vaccine Anti-IL-13R mAb(AD) (COVID) VAMIFEPORT Ferroportin inhibitor (SCD)
Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant Vaccines CSL Vifor Outlicensed Programs Partnered Projects
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Registration/Post-Registration
HAEGARDA[®] (HAE)
FLUAD[®] Quadrivalent Adjuvanted Egg-based Influenza Vaccine
HIZENTRA[®] (SCIg) 20% Liquid PRIVIGEN[®] (IVIg) 10% Liquid AFSTYLA[®] rFVIII (HaemA)
FLUCELVAX[®] Quadrivalent Cell-based Influenza Vaccine
PANVAX[®] Egg-based Influenza Vaccine FERINJECT[®] Ferric carboxymaltose (ID)
IDELVION[®] Ferric carboxymaltose rFIX-FP (HaemB) (ID) HEMGENIX[®] KORSUVA[® ] /KAPRUVIA[®] (Haem B) KOR. agonist (CKD-aP) ZEMAIRA[®] /RESPREEZA[®] Alpha-1 Antitrypsin RAYALDEE[®] Oral ext. release calcifediol FOCLIVIA[®] /AFLUNOV[®] (SHPT) Adjuvanted Egg-based Influenza A (H5N1) Vaccine TAVNEOS[®] Oral C5a receptor inhibitor AUDENZ™ (AAV) Adjuvanted Cell-based Monovalent Influenza A VELPHORO[[®]] (H5N1) Vaccine
VELPHORO[[®]] (H5N1) Vaccine Sucroferric oxyhydroxide AFLURIA[®] QUAD (Serum P control in CKD) Egg-based Influenza Vaccine VELTASSA[®] FLUAD[[®]] Trivalent Oral potassium binder Adjuvanted Egg-based (HK)
FLUAD[[®]] Trivalent Adjuvanted Egg-based Influenza Vaccine
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93
CSL R&D Portfolio – FY23 Transitions
Phase I
PhaseII
Phase III
Registration/Post-Registration
HAEGARDA[[®]][[/]] BERINERT FLUAD[[®]] Quadrivalent (HAE) Adjuvanted Egg-based Influenza Vaccine
Anumigilimab (CSL324) CSL301 HIZENTRA[®] INJECTAFER[®] HAEGARDA[[®]][[/]] BERINERT FLUAD[[®]] Quadrivalent Anti-G-CSFR mAb(HS) α2AP mAb (PE) (DM) (Ferric carboxymaltose) (HAE) Adjuvanted Egg-based (HF-ID) Influenza Vaccine CSL730 Garadacimab Garadacimab HIZENTRA[®] rFcMultimer Anti-FXIIa mAb(ILD/IPF) Anti-FXIIa mAb(HAE) FILSPARI ( Sparsentan) (SCIg) 20% Liquid FLUCELVAX[®] Quadrivalent CSL889 Dual ETA & AT1 antagonist Cell-based Influenza Vaccine Hemopexin(SCD) Clazakizumab KCENTRA[®] (FSGS) PRIVIGEN[®] (IVIg) 10% Liquid CSL787 Anti-IL-6 mAb(ESKD) 4F-PCC (Trauma) FILSPARI ( Sparsentan) Egg-based Influenza Vaccine PANVAX[®] NebulisedIg HIZENTRA[®] CSL1 1 2 Dual ETA & AT1 antagonist AFSTYLA[®] (IgAN) rFVIII (HaemA) (SSc) apoA-I(AMI) Trabikibart (CSL311) FERINJECT[®] Anti-Beta Common mAb SQ036 (aQIVc) Clazakizumab SNF472 IDELVION[®] Ferric carboxymaltose Adjuvanted Cell-based Anti-IL-6 mAb(ca-AbMR) Calcification inhibitor rFIX-FP (HaemB) (ID) Anumigilimab (CSL324) Quadrivalent Influenza (CUA-ESKD) Anti-G-CSFR mAb Vaccine CSL964 HEMGENIX[®] KORSUVA[® ] /KAPRUVIA[®] (CAP ARDS) Alpha-1Antitrypsin SNF472 (Haem B) KOR. agonist CSL040 Mavrilimumab (Treatment of aGvHD) Calcification inhibitor (CKD-aP) Complement R1 Inhibitor Anti-GM-CSFR mAb (PAD-ESKD) ZEMAIRA[®] /RESPREEZA[®] (GCA, COVID) CSL964 Alpha-1 Antitrypsin RAYALDEE[®] SQ009 Alpha 1Antitrypsin ARCT154 Oral ext. release calcifediol Cell-based Influenza (H2N3) Vaccine Eblasakimab Anti-IL-13R mAb(AD) (CSL334) (Prevention of aGvHD) sa-mRNA Vaccine (COVID) FOCLIVIA Adjuvanted Egg-based[®] /AFLUNOV[®] (SHPT) Influenza A (H5N1) Vaccine SQ012 TAVNEOS[®] sa-mRNA Influenza (H5N1) VAMIFEPORT Oral C5a receptor inhibitor Vaccine Ferroportin inhibitor AUDENZ™ (AAV) (SCD) Adjuvanted Cell-based ARCT2138 Monovalent Influenza A VELPHORO[®] sa-mRNA Quadrivalent (H5N1) Vaccine Influenza Vaccine Sucroferric oxyhydroxide AFLURIA[®] QUAD (Serum P control in CKD) LASN01 Egg-based Influenza Vaccine Anti-IL-11R mAb VELTASSA[®] (IPF,TED) FLUAD[®] Trivalent Oral potassium binder INS-3001 Adjuvanted Egg-based (HK) Calcification inhibitor Influenza Vaccine (PAD, AVS) C1 Inhibitor Immunology Haematology Respiratory Cardiovascular & Metabolic Transplant (AIS) Vaccines CSL Vifor Outlicensed Programs Partnered Projects
94
CSL R&D Portfolio – FY24
PhaseI
PhaseII
Phase III
Registration/Post-Registration
CSL889 Anumigilimab (CSL324) HIZENTRA[®] HAEGARDA[®] FILSPARI ( Sparsentan) AUDENZ™ Hemopexin(SCD) Anti-G-CSFR mAb(HS) (DM) (HAE) Dual ETA & AT1 antagonist Adjuvanted Cell-based (IgAN) Monovalent Influenza A Anumigilimab (CSL324) VAMIFEPORT KCENTRA[®] HIZENTRA[®] (H5N1) Vaccine Anti-G-CSFR mAb Ferroportin inhibitor 4F-PCC (Trauma) (SCIg) 20% Liquid KORSUVA[® ] /KAPRUVIA[®] FOCLIVIA[®] /AFLUNOV[®] (CAP ARDS) (SCD) KOR. agonist Adjuvanted Egg-based CSL1 1 2 PRIVIGEN[®] (CKD-aP) Influenza A (H5N1) Vaccine Trabikibart (CSL311) CSL301 apoA-I(AMI) (IVIg) 10% Liquid Anti-Beta Common mAb α2AP mAb (PE) RAYALDEE[®] FLUAD[®] Trivalent SNF472 Garadacimab Oral ext. release calcifediol Adjuvanted Egg-based CSL787 Garadacimab Calcification inhibitor Anti-FXIIa mAb(HAE) (SHPT) Influenza Vaccine NebulisedIg Anti-FXIIa mAb(ILD/IPF) (CUA-ESKD) AFSTYLA[®] TAVNEOS[®] FLUAD[®] Quadrivalent C1 Inhibitor Clazakizumab FILSPARI ( Sparsentan) rFVIII (HaemA) Oral C5a receptor inhibitor Adjuvanted Egg-basedInfluenza Vaccine (AIS) Dual ETA & AT1 antagonist (AAV) Anti-IL-6 mAb(ESKD) (FSGS) IDELVION[®] FLUCELVAX[®] CSL040 Mavrilimumab rFIX-FP (HaemB) VELPHORO[®] Quadrivalent Complement R1 Inhibitor Clazakizumab Sucroferric oxyhydroxide Cell-based Influenza Vaccine Anti-GM-CSFR mAb Anti-IL-6 mAb(ca-AbMR) HEMGENIX[®] (Serum P control in CKD) SQ009 (GCA, COVID) (Haem B) ARCT154 Cell-based Influenza CSL964 VELTASSA[®] sa-mRNA Vaccine (H2N3) Vaccine Eblasakimab (CSL334) Alpha 1Antitrypsin ZEMAIRA[®] /RESPREEZA[®] Oral potassium binder (COVID) Anti-IL-13R mAb(AD) (Treatment of aGvHD) Alpha 1 Antitrypsin (HK) SQ012 sa-mRNA Influenza INJECTAFER[®] (H5N1) Vaccine CSL964 (Ferric carboxymaltose) Alpha 1Antitrypsin (HF-ID) (Prevention of aGvHD) ARCT2138 sa-mRNA Quadrivalent Influenza Vaccine SQ036 (aQIVc)
SQ036 (aQIVc) Adjuvanted Cell-based Quadrivalent Influenza Vaccine
LASN01 Anti-IL-11R mAb (IPF,TED)
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| Immunology | Haematology | Respiratory | Cardiovascular & Metabolic | Nephrology & Transplant |
|---|---|---|---|---|
| Vaccines | CSL Vifor | Outlicensed Programs | Partnered Projects |
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95
R&D Focus
Investments Coming to Fruition
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Deliver a Promising Portfolio
Strengthen our Core Platforms
-
CSL112
-
Flu Cell Culture yield
-
Garadacimab HAE
-
Iron evidence &
-
Clazakizumab ca-AbMR
-
optimisation
-
KCENTRA[®] Trauma
-
Patient Blood Management
-
CSL964 aGvHD
-
Sparsentan
-
Ig yield
-
sa-mRNA for COVID (near term) & Influenza (medium term)
-
aQIVc
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Ig Yield Horizon 2
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Horizon 2
Manufacturing
Enhancement
Product
Comparability
Performance
Assessment
Iterative Health Authority
Engagement
LABORATORY SCALE PILOT SCALE STABILITY FILING
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Significant Target Launch Dates
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FY23 FY24 - FY27
HEMGENIX [®] HIZENTRA [®] VELPHORO [® ] CSL964 AAT
Etranacogene SCIg 20% Liquid (DM) Sucroferric oxyhydroxide (aGvHD Treatment)
dezaparvovec (Haem B) (Serum P control in CKD)
China
BERINERT [® ] SC HIZENTRA [®] KORSUVA [® ] /KAPRUVIA [®] CSL964 AAT
C1 Esterase Inhibitor SCIg 20% Liquid (50mL KORAgonist (CKD-aP) (aGvHD Prevention)
(HAE) Japan PFS)
INJECTAFER [® ] Garadacimab Clazakizumab SQ036 (aQIVc)
Ferric carboxymaltose Anti-FXIIa (HAE) Anti-IL-6 (ca-AbMR) Adjuvanted Cell-based
(HF-ID) US Quadrivalent Influenza Vaccine
FERINJECT [® ] CSL112 Sparsentan ARCT154
Ferric carboxymaltose ApoA-1 (AMI) Dual ETA & AT1 antagonist sa-mRNA Vaccine
(ID) China (IgAN) EU (COVID)
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| Immunology | Haematology | Cardiovascular & Metabolic | Nephrology & Transplant |
|---|---|---|---|
| Vaccines | CSL Vifor | Outlicensed Programs | Partnered Project |
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Forward-Looking 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 approval
-
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
-
• ARCT154 sa-mRNA (COVID)
-
JP approval
-
US & EU submissions
-
-
SQ012 sa-mRNA (H5N1) Flu Phase I first patient in
-
ARCT2138 sa-mRNA Quad Flu Phase I first patient in
-
Ongoing HA engagement
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Abbreviations: ca-AbMR - Chronic Active Antibody-Mediated Rejection; ESKD – End Stage Kidney Disease; EU – Europe; HA – Health Authority; HAE – Hereditary Angioedema; IgAN - IgA Nephropathy; ILD – Interstitial Lung Disease; IPF - Idiopathic Pulmonary Fibrosis; JP – Japan; Neb Ig - Nebulised Ig; PFS – Pre-Filled Syringe; samRNA – Self-Amplifying messenger RNA; RNA – Ribonucleic Acid; SCD – Sickle Cell Disease; US – United States
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99
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Thank You / Questions
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100
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Concluding Remarks
Paul McKenzie CEO & Managing Director
Financial Outlook
FY24 Guidance
| FY24 Guidance | |
|---|---|
| Revenue | Growth of 9-11% @CC_RE-AFFIRMED_ |
| NPATA | Growth of 13-17% @CC |
| $2.9 - $3.0 billion @CC_RE-AFFIRMED_ | |
| Capex | Down 30% |
| Operating efficiency | G&A ~5% of revenue |
| Balance sheet | Circa 2x net debt / EBITDA |
Outlook
| Outlook | |
|---|---|
| CSL Behring gross margin | Recovering to pre-covid margin in 3-5 years |
| ROIC | Steady improvement1 in ROIC fuelled by double digit earnings |
| growth |
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1.ROIC is expected to modestly soften in FY24, driven by the timing mismatch between the raising of funds to acquire Vifor Pharma and the payment of consideration
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Strategic Positioning
-
Growing global markets with significant unmet patient need
-
Best in class, durable products driven by continued innovation
-
Scaled manufacturing platforms underpinned by embedded know how
Near Term / Recent Activity
Near Term / Recent Activity Market Opportunities Outpacing industry growth Industry volume growth 6-8% p.a. Ig yield initiatives underway (Horizon 1 & 2) US/Canada/Aust Ig consumption 2-3x that of Immunoglobulins EU Hizentra for dermatomyositis Disease prevalence consistent globally New technologies aQIVc and sa-mRNA Recovery in vaccination rates Vaccines COVID vaccine – preparation for global licensure Ongoing portfolio differentiation Flu cell culture yield improvement Heart Failure label expansion for Injectafer in US 30% of population has iron deficiency; of which Iron 50% have iron deficiency anaemia Approval of Ferinject in China Patient Blood Management strategy
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R&D Programs – Near Term Milestones
| Opportunity | FY24 | |
|---|---|---|
| Garadacimab (HAE) | Potentially best in class treatment option for HAE patients |
EU, US & JP submissions |
| Clazakizumab (ca-AbMR) | AbMR is leading cause of transplant failure | Phase III study - 200 pts enrolled |
| KCENTRA® (Trauma) | Trauma is leading cause of morbidity & | Phase III study tracking towards 2000 |
| mortality in US | patients enrolled for interim analysis | |
| CSL112 ApoA-1 (AMI) | Potentially transform treatment of AMI | |
| patients at high-risk of recurrent | Phase III top line results | |
| cardiovascular events | ||
| Sparsentan (IgAN) | IgAN is major cause of kidney failure | EU approval |
| aQIVc | Potential to set standard of care for patients 50yr+ |
Phase III study 50yr+ first patient in |
| sa-mRNA | Efficacy, tolerability, durability & flexibility | Japan approval (COVID) |
| for flu and beyond | Phase I study first patient in (Flu) | |
| Ig Yield initiatives | Horizon 1 | Implementation of first improvements |
| Horizon 2 | Ongoing pilot plant activities |
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Positioned for Annual Double-Digit Earnings Growth
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Leading positions in high growth markets
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Significant unmet need
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Durable products driven by continued innovation and embedded know how
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Robust R&D Portfolio
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Near-to-mid-term launches
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Longer-term opportunities across platforms and therapeutic areas
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Yield & capacity expansion
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Yield enhancement across plasma and manufacturing platforms
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Investing in Ig and cell capacity
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Disciplined capital allocation for growth
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R&D, CapEx and value-creating BD
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• Partnerships across the value chain with leading companies
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CSL Contacts
Mark Dehring VP Investor Relations +61 3 9389 3407 [email protected]
Bernard Ronchi Investor Relations +61 3 9389 3470 [email protected]
Stephen McKeon Investor Relations +61 3 9389 6798 [email protected]
NEWS RELEASE
For immediate release
16 October 2023
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CSL well-positioned to deliver sustainable, profitable growth
SYDNEY, Australia – 16 October 2023 – CSL Limited will today hold its inaugural Capital Markets Day to brief investors on its strategies to deliver annual double-digit earnings growth underpinning a steady improvement in return on invested capital (ROIC)[1] .
“CSL has leading positions in growing global markets with significant unmet need. Our three business units – CSL Behring, CSL Seqirus and CSL Vifor – are supported by best-in-class products and an innovative pipeline focused on new therapies and new indications. Our embedded know-how in scaled manufacturing platforms is driving efficiencies, yield improvements and productivity. By serving significant unmet patient needs and adding value to healthcare systems, we can deliver sustainable and profitable growth to support more innovation and research, and generate returns for our shareholders,” said Dr Paul McKenzie, CSL’s Chief Executive Officer and Managing Director.
Strategic highlights:
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CSL’s market-leading plasma-based therapies, influenza vaccines and iron provide opportunities in growing global markets with significant unmet patient need, driven by innovation.
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Demand for immunoglobulin (Ig) remains strong, presenting substantial growth prospects.
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CSL Behring has a clear pathway to pre-COVID gross margins by optimising its donor payments, introducing new plasma collections technology and maximising Ig yield manufacturing.
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CSL Seqirus is well positioned to outpace broader market growth through its differentiated innovation portfolio and continued investment in scalable manufacturing technologies.
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CSL Vifor will continue to grow its leading iron franchise through market expansion and life cycle management.
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By combining the expertise and product offering from CSL Behring and CSL Vifor, CSL is well-positioned to translate the World Health Organisation guidelines for Patient Blood Management to improve patient outcomes and minimise healthcare costs.
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CSL has a range of R&D programmes nearing trial conclusion, which if successful and approved, will deliver additional growth.
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CSL’s advances in digital and artificial intelligence technologies help reduce the time to collect plasma, discover new compounds, and conduct clinical trials.
CSL reaffirms guidance for FY24 with revenue growth of 9-11 per cent at constant currency and NPATA growth of 13-17 per cent at constant currency.
FURTHER INFORMATION
Additional details about CSL’s Capital Markets Day can be found on CSL’s website www.csl.com A glossary of medical terms can also be found on the website.
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For further information, please contact:
Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected]
- 1 ROIC is expected to modestly soften in FY24, driven by the timing mismatch between the raising of funds to acquire Vifor Pharma and the payment of consideration.
2