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CSL Ltd. Interim / Quarterly Report 2024

Feb 12, 2024

17854_rns_2024-02-12_343d6d72-e804-451e-8e6d-490ab50bd022.pdf

Interim / Quarterly Report

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For immediate release

13 February 2024

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Results Presentation for the Half-year ended 31 December 2023

Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY)

Please find attached the slides for the presentation on the half year results that will be given by the Chief Executive Officer and the Chief Financial Officer shortly.

The briefing will be webcast and can be accessed in the “Investor” section of CSL’s website (www.CSL.com).

Authorised for lodgement by:

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Fiona Mead Company Secretary

For further information, please contact:

Investors: Media: Bernard Ronchi Jimmy Baker Investor Relations Communications CSL Limited CSL Limited P: +61 3 9389 3470 P: +61 450 909 211 E: [email protected] E: [email protected]

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CSL Limited 2024 Half Year Results 13 February 2024

Paul McKenzie Joy Linton CEO & Managing Director CFO

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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2

01

CEO Overview Paul McKenzie CEO & Managing Director

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3

Strong performance[1] Revenue +11%, NPATA[2,3] +13%, NPAT +20%

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Revenue
CSL Behring CSL Seqirus
by Segment
Solid performance in a
Strong growth across the
challenging season
portfolio especially Ig
• FLUAD [®] +14%

• Regulatory approval for world first sa-mRNA
Ig +23%, KCENTRA [®] +12%,
COVID vaccine
HAEGARDA [®] +9% Seqirus
• +2% • aQIVc phase 3 - last patient enrolled Jan
Gross margin recovery underway
2024

Good progress with plasma initiatives Behring $8,053m
• Garadacimab filed +14%
CSL Vifor
Vifor
nc [4] Well prepared for
transitioning Iron market
• Successful TAVNEOS [®] EU launch

Strong patient conversion to MIRCERA [®]
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1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail..

2. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and unwind of the inventory fair value uplift 3. Attributable to the shareholders of CSL Limited

4.Not comparable

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4

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Revenue up 14%[1]

Revenue Change1 Major
Therapy $m % Performance Brands
Strong growth across all geographies
Ig 2,757 23%
PRIVIGEN®/ INTRAGAM®+27%, HIZENTRA +18%
Significant patient demand in core indications
HIZENTRA®50mlpre-filled syringelaunch inthe US
Strong growth in emerging markets
Albumin 613 8% Solid growth in US and EU
Competition remains strong in China
IDELVION®remains the standard of care, +7%
Haemophilia 662 8%
Market leader in key markets
Significant HCP and patient interest in HEMGENIX®
KCENTRA®+12%

Continues to be the gold standard for warfarin reversal
Specialty 976 6% HAEGARDA®+9%

Strong EU performance

Continue to add new patients
Other2 230 (16%) COVID-19 vaccine supply contract in prior period
Total 5,238 14%

1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail. 2. Includes HPV royalties & Hyperimmunes

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5

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Plasma Highlights

  • Underlying fundamentals of plasma collection remain strong

  • 10% reduction in CPL[1]

  • Expanding geographic footprint of plasma collection network

  • RIKA

  • Currently >30 centres converted

  • Roll out plan over next 18 months

  • Individualised Nomogram filed with the FDA

  • Gross margin recovery underway

1. US only and average over the periods.

Benefits of RIKA Plasma Donation System

  • Fewer donor deferrals; reduced donation time by ~30%

  • Individualised Nomogram will improve average donation yield by ~10%

  • Reduced biohazard disposable waste by 10-15%

  • Improved productivity

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6

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Revenue up 2%[1]

Current Season Dynamics

  • Reduced rates of immunisation

  • • Competitive price pressures • Overburdened healthcare system

Revenue
$m
Change1%
Performance
Major Brands
Egg Based
123
0%

Revenue growth in the northern hemisphere
influenza market in a challenging season

Heightened recognition of benefits of differentiated
product portfolio

Continued FLUAD® preferential recommendation in
the UK

First season following US ACIP preferred
recommendation for FLUAD®in 65+
Cell Culture
529
(13%)
Adjuvanted Egg
988
14%
In License
65
(23%)

Transition to single dose Gardasil vaccine program
Pandemic
85
9%
Other Income
14
67%
Total
1,804
2%

1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.

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7

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Operational Highlights

Seasonal influenza products

  • FLUCELVAX[®] 6-month+ age extension approved in UK, Australia and New Zealand

  • FLUAD[®]

  • 50-year+ age extension approved in the EU.

  • Received preferential recommendation in Canada for the 65+ population

Product Innovation

  • Phase III clinical study commenced for aQIVc

  • Regulatory approval for world first sa-mRNA COVID vaccine

  • Japanese approval for ARCT154

  • R&D development program beyond influenza

  • Phase 1 trial for sa-mRNA for seasonal and pandemic influenza

Pandemic influenza

  • UK Advance Purchase Agreement awarded solely to CSL Seqirus

  • Selected by BARDA for delivery of H5N8 A/Astrakhan antigen to the U.S. government for preparedness against potential avian flu outbreak in humans

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Revenue1$m
Major Brands
Highlights
Iron 505

China FERINJECT® inclusion in the National Reimbursement
Drug List

Well prepared for a transitioning iron market

US step edit pressure
Nephrology Dialysis
399

MIRCERA®

Strong ESA performance in the U.S., as patients
convert

KAPRUVIA®

Approved in multiple emerging markets

Strong performance in Germany, France and Austria

VELPHORO®

US inventory adjustment

China approval and inclusion in the National
Reimbursement Drug List
2
3
4
Non-Dialysis
90

Strong TAVNEOS®performance in all EU launch markets, with
regulatory approval obtained in South Korea

Paediatric indication of VELTASSA®in US Oct-23, EU Jan-24
5
All Other 17
Total
1,011
  1. The prior comparable period included only 5 months revenue following the acquisition of Vifor Pharma in August 2022 .

2. Licensed from F. Hoffman-La Roche AG; 3. Licensed from Pfizer Inc.; 4. Licensed from Cara Therapeutics, Inc.;5. Ex-US rights licensed from ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, Inc.

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9

02

Pipeline Bill Mezzanotte EVP & Head of R&D

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10

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

Objective: to evaluate the efficacy and safety of CSL112 on reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), or stroke

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Treatment period Follow-up period (1 year)
(4 weekly infusions)
6 g CSL112 (n=9,112)
18,219 MI patients
from
49 Countries
Placebo (n=9,107)
Infusion: 1 2 3 4
Visit: 1 2 3 4 5 6 7 8 9 10 11
Study day: 1 8 15 22 29 60 90 180 270 365
Within 5 days of
arriving for evaluation All infusions given within
and treatment of MI 30 days of the first infusion
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Randomization

Primary Endpoint at 90 days

Time to first occurrence of any component of the composite endpoint of CV death, MI, or stroke from time of randomization through 90 days

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

  • Objective: to evaluate the efficacy and safety of CSL112 on reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), or stroke

  • For the primary efficacy endpoint at 90 days, the trial did not meet the threshold for statistical significance

  • There are no plans for a near-term regulatory filing

  • Additional analyses are ongoing to understand the complete data and determine next steps

  • Study results will be presented at the American College of Cardiology (ACC) Scientific Sessions, 6 April 2024, and published in a peer-reviewed journal

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Recent Late-Phase R&D Highlights

  • Clazakizumab for reduction of cardiovascular events in patients with End-Stage Kidney Disease (ESKD)

  • Well-characterized link of inflammation and cardiovascular morbidity and mortality in patients with ESKD

  • Positive phase 2b data; Phase 3 prepared to start 2Q 2024

  • Garadacimab for Hereditary Angioedema

  • High efficacy, Favorable safety and tolerability; patient-friendly presentation and regimen

  • Global submissions and regulatory review underway; First approval expected 4Q 2024

  • HIZENTRA[® ] for Dermatomyositis

  • 5-year mortality rate 10-30%, high comorbidity; Better treatments needed

  • Enrolment complete for phase 3; Data expected 3Q 2024

• Adjuvanted, cell-based Quadrivalent Influenza Vaccine (aQIVc)

  • aQIVc combines benefits of MF59® adjuvant, higher antigen dose and cell-derived antigen to increased influenza protection via heightened immune response

  • Phase III Immunogenicity study (50 years+) enrolment completed ahead of schedule; Data expected 4Q 2024

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13

03

Financials Joy Linton CFO

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14

NPATA[1]

1 1 1
NPATA
$1,818m
$2,017m
1H23 NPATA
1H24 NPATA @CC
3
FX $39m
$2,056m
1H23
Rep
1H24
@ CC3
NPATA
$1,818m2
$2,056m2
Acquired intangible assets
amortisation
($88m)
($129m)
One-off acquisition adjustments
($184m)
($49m)
Tax
$35m
$31m4
NPATA Attributable to NCI5
$59m
$53m
NPAT
$1,640m
$1,962m
NPAT Attributable to NCI5
($17m)
($20m)
NPAT
$1,623m2
$1,942m2

1. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and unwind of the inventory fair value uplift 2. Attributable to the shareholders of CSL Limited.. 1H23 includes ~5 months of CSL Vifor contribution

3. Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group

4.Tax attributable to amortisation of acquired intellectual property $24m. Tax attributable to one-off acquisition adjustments (including unwind of the inventory fair value uplift) $7m 5. Non-Controlling Interest

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15

CSL Group Financial Highlights

US$ Millions 1H23
Rep
1H24
Rep
1H24
at CC
1
Change
%
1
Total Revenue 7,184 8,053 7,954 11%
Gross Profit3 4,042 4,494 4,491 11%
GP %3 56.3% 55.8% 56.5%
Sales & Marketing 683 707 696 2%
Operating Result3 3,359 3,787 3,796 13%
R&D3 593 669 661 11%
G&A3 360 323 335 (7%)
Finance (Net) 171 234 226 32%
NPATA2 1,818 2,017 2,056 13%
ETR % 16.0% 19.2% 18.1%
Cashflow From Ops 980 1,069 9%4
NPATA EPS2($) 3.77 4.18 11%4
DPS ($) 1.07 1.19 11%4

1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail

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R&D

Growth in line with sales Anticipate FY24 within 10-11% of revenue

G&A

Favourable FX differences

Efficiencies driven by centralisation of Enabling Functions

Finance

Higher interest rates

Tax

Higher ETR due to geographic profit mix and increased UK tax rate

Cashflow from Operations

Increase in cash earnings from growth in sales

2. Attributable to the shareholders of CSL Limited.

3. Underlying results have been adjusted to exclude impairment and amortisation of acquired IP, business acquisition and transaction costs and unwind of the inventory fair value uplift

  • 4.At reported currency

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16

CSL Group 1H24 by Segment

US$ millions reported CSL
Behring
CSL
Seqirus
CSL
Vifor
CSL
Group
CSL
Group
Change
% at CC
1
Change
% at CC
1
Sales 5,093 1,705 1,006
7,804
11%
Other Revenue 145 99 5 249 2%
Total Revenue 5,238 1,804 1,011 8,053 11%
Gross Profit2 2,617 1,207 670 4,494 11%
Reported GP %2 50.0% 66.9% 66.3% 55.8%
Sales & Marketing 396 89 222 707 (2%)
Operating Result 2,221 1,118 448 3,787 13%
Operating Segment %2 42.4% 62.0% 44.3%
47.0%

1. Percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.

2. Underlying results have been adjusted to exclude impairment and amortisation of acquired IP, business acquisition and transaction costs and unwind of the inventory fair value uplift

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17

04

CEO Overview Paul McKenzie CEO & Managing Director

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Outlook[1]

CSL Vifor

CSL Behring

CSL Seqirus

  • • •

  • Underlying patient Progression of Well positioned for iron demand for Ig in core global registrations competition indications remain for next• Nephrology launch

  • strong generation mRNA momentum

  • COVID vaccine

  • 2H growth expected •

  • for HEMGENIX[®] ~85% of sales in 1H,

  • • with expenses Plasma and falling more evenly

  • yield initiatives over the year

  • ongoing giving rise to a loss

  • • Gross margin in 2H, consistent

  • recovery underway with seasonality

  • Unlock value across CSL commercial and operations e.g. patient blood management with CSL Behring

  • 1 For forward looking statements, refer to Legal Notice on page 2

  • 2 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability. See end note for further detail

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FY24 Guidance Reaffirmed

Revenue Growth ~ 9 – 11% @CC[2 ]

NPATA Growth

~ 13 – 17% @CC[2,3 ] to ~$2.9 – $3.0b @CC[2,4]

  • 3 % growth rates exclude the one-off gain from the sale of property in FY23 (NPATA $44m)

  • 4 NPATA to NPAT adjustments are estimated to be:

  • Amortisation of acquired intellectual property. FY24 estimate $320m (pre-tax), $270m (post tax)

  • CSL Vifor integration costs and the unwind of inventory fair value uplift. FY24 estimate $85m (pre-tax), $70m (post-tax)

  • FY24 FX impact expected to be a headwind of ~$85M if current rates remain unchanged for the remainder of the financial year

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19

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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]

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Notes

Summary NPAT attributable to members
of parent entity
Reportednetprofit after tax $1,901m
Currency effect $41m
Constant currency net profit after tax* $1,942m

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group. This is done in three parts: a) by converting the current year net profit of entities in the group that have reporting currencies other than US Dollars, at the rates that were applicable to the prior comparable period (translation currency effect); b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior comparable period (transaction currency effect); and c) by adjusting for current year foreign currency gains and losses. The sum of translation currency effect, transaction currency effect and foreign currency gains and losses is the amount by which reported net profit is adjusted to calculate the operational result.

Average exchange rates for major currencies for half year ended 31 December 2023/ 31 December 2022 include: USD/EUR (0.92/0.99), USD/AUD (1.53/1.49), USD/CHF (0.89/0.97), USD/CNY (7.24/6.97) and USD/GBP (0.80/0.85).

Summary NPATA1 attributable to
members of the parent entity US$m
Reported net profit after tax 1,901
Amortisation of acquired intellectual property 102
Unwind of inventory fair value uplift 21
Acquisition and integration costs 19
Income tax credit on above adjustments (26)
NPATA1attributable to members of the parent
entity
2,017
Currency effect attributable to members
of the parent entity
39
Constant Currency# NPATA1attributable to
members of the parent entity
2,056
Summary Revenue
Reported revenue
$8,053m
Currency effect
($99m)
Constant currency revenue*
$7,954m
*Constant currency net profit after tax and
constant currency sales have not been audited or
reviewed in accordance with Australian Auditing
Standards.

General Disclaimer Non-IFRS

There are references to IFRS (International Financial Reporting Standards) and non-IFRS financial information in this document. Non-IFRS financial measures are financial measures other than those defined or specified under any relevant accounting standard and may not be directly comparable with other companies’ information. Non-IFRS financial measures are used to enhance the comparability of information between reporting periods, and enable further insight and a different perspective into the financial performance. Non-IFRS financial information should be considered in addition to, and is not intended to be a substitute for, IFRS financial information and measures. Non-IFRS financial measures are not subject to audit or review.

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1. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and unwind of the inventory fair value uplift

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Appendix

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22

Appendix A CSL Behring – Key Products

CSL BEHRING Therapy Group Sales $m Change1%
Privigen IVIG 1,768 35%
Hizentra SCIG 945 18%
Albumin Albumin 613 8%
Idelvion Haemophilia 390 7%
Kcentra Specialty 366 12%
Haegarda Specialty 245 9%
Berinert Specialty 120 (7%)
Haemocomplettan Specialty 115 0%
Humate Haemophilia 97 8%
Haemate Haemophilia 58 16%

1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail

HY24 Revenue By Therapy Group $m

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4%,
9%
Other,
Other
$242
Specialty
$450
10%, 35%
Peri-Operative IVIG
Bleeding, $1,812
$526
4%,
Plasma,
$205
8%
Recombinants
$445
12%,
18%,
Albumin, $613
SCIG,
$945
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23

Appendix B CSL Vifor & CSL Seqirus – Key Products

CSL SEQIRUS Therapy Group Sales $m Change1%
Fluad Adjuvanted 988 14%
Flucelvax Cell culture 529 (13%)
Afluria Egg-based 123 9%
CSL VIFOR Therapy Group Sales $m
Ferinject / Injectafer Iron 376
Mircera Dialysis 313
Venofer Iron 82
Veltassa Non Dialysis 66
Velphoro Dialysis 46
Maltofer Iron 46

1. Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.

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HY24 Revenue By Therapy Group $m
0% Other
5%, Pandemic, $85
Income $14
4%, In License, $65
29%,
Cell Culture,
7%, Egg Based,
$529
$123
55% ,
Adjuvanted,
$988
9%, Non Dialysis, 2%, Other, $17
$90
50%,
Iron,
$505
39%,
Dialysis,
$399
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