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CSL Ltd. Interim / Quarterly Report 2023

Feb 13, 2023

17854_rns_2023-02-13_4d9e3f55-f79e-455f-9482-0eb4ca1452ed.pdf

Interim / Quarterly Report

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For immediate release

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14 February 2023

Half Year Profit of US$1.62 Billion[1,2] Ig franchise growing strongly CSL Vifor progressing well

CSL delivered a net profit after tax of $1.62 billion[2] for the first half of financial year 2023, steady at CC[3] . This included one-off costs associated with the acquisition of Vifor Pharma. Underlying profit (NPATA[4] attributable to CSL shareholders) was $1.82 billion[2] , up 10% at CC[3] . Revenue was up 25% at CC[3]

  • Strong growth in immunoglobulin and albumin sales

  • Record levels of plasma collections

  • Strong growth in market leading haemophilia B product IDELVION[® ] and key specialty product KCENTRA[®]

  • Strong performance by influenza vaccines business, CSL Seqirus

  • Licence agreement for late-stage self-amplifying mRNA vaccine technology

  • Successful closure of Vifor acquisition

  • ~15% revenue growth[5]

  • Integration well underway and cost synergies on track

  • HEMGENIX[®] approved by FDA, the first gene therapy for haemophilia B

  • NPATA[4] earnings per share $3.77[2]

  • Interim dividend[6] of US$1.07 per share

  • Converted to Australian currency, the interim dividend is approximately A$1.55 per share, up 9%

  • Guidance reaffirmed – FY23 NPATA[2,4] anticipated to be in the range of approximately $2.7 billion to $2.8 billion[2] at CC[3]

CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.62 billion[2] for the 6 months ended 31 December 2022, steady on a constant currency basis. Underlying profit (NPATA[4] ) was $1.82 billion[2] , up 10% on a constant currency basis.

Mr Paul Perreault, CSL’s Chief Executive Officer and Managing Director said, “CSL delivered a solid performance in the first half of the financial year demonstrating the strong fundamentals of the company and the disciplined execution of our patient focused strategy.

“Our focused investment across our business units underpinned our resilience throughout the pandemic, and as we emerge from it we are starting to deliver positive momentum behind our sustainable growth agenda.

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“CSL’s largest franchise, the immunoglobulin portfolio, grew strongly, up 19%[3] , driven by the significant increase in plasma supply and the increased patient demand for our leading Ig products.

“The increased plasma supply also drove our albumin growth by 11%[3] .

“Plasma collections growth was impressive - up 36% for the period. This acceleration in plasma collections underpins our ability to manufacture our plasma products going forward which is excellent news for patient care”, Mr Perreault said.

“Our leading recombinant haemophilia B product IDELVION[®] , increased sales by 22%[3] with its compelling clinical profile driving patient demand and market share. KCENTRA[®] , our perioperative bleeding product, grew 8%[3] as hospital demand returned to pre-pandemic levels.

“Our vaccines business, CSL Seqirus, delivered another strong performance with revenue up 9%[3] . This was achieved against a backdrop of reduced rates of immunisation. This highlights the strength of CSL Seqirus strategy and its high value differentiated product portfolio.

“During the period, we successfully completed the acquisition of Vifor Pharma and CSL Vifor contributed 5 months of earnings towards our first half result. I am confident that CSL Vifor will add value to CSL’s shareholders and towards the sustainability of CSL’s growth.

“We were also pleased to receive FDA approval for HEMGENIX[®] , the first and only one-time gene therapy for appropriate adults with haemophilia B. This has been a great achievement for our people and the patients we serve,” Mr Perreault concluded.

CSL Behring

  • Immunoglobulins +19%[3]

  • Albumin +11%[3]

  • IDELVION[® ] +22%[3]

  • KCENTRA[® ] +8%[3]

  • Plasma collected +36%

CSL Seqirus

  • Seasonal influenza vaccines +9%[3]

  • US Centers for Disease Control and Prevention adopted the Advisory Committee on Immunisation Practices recommendation that FLUAD[®] be a preferentially recommended seasonal vaccine option for adults aged 65+ years

  • Fill and finish capacity expansion completed at Holly Springs and Liverpool

  • Building works well advanced for the new A$800m cell-culture facility in Melbourne

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CSL Vifor

  • Acquisition of Vifor Pharma Ltd completed 9 August 2022

  • Provides CSL with leadership across an attractive portfolio focused on renal disease and diseases of iron deficiency

  • ~15% revenue growth[5]

  • Integration well advanced and cost synergies on track

Innovation & Development

  • HEMGENIX[®] approved by the FDA in the US, and recommended for approval in Europe by CHMP - the first gene therapy for haemophilia B

  • New state-of-the-art research and development center opened in Marburg, Germany

  • CSL112 (ApoA-1) Phase III study (AEGIS-II) last patient enrolled

  • Licence agreement for late-stage self-amplifying mRNA vaccine technology

  • Adjuvanted Cell Culture Influenza Vaccine (aQIVc) on track to go into Phase 3

  • License agreement for enhanced thrombus dissolving drug candidate

  • Cicada Innovations appointed to oversee and manage new start-up incubator to be located at CSL’s new global corporate headquarters

People & Culture

  • New CEO & Managing Director announced, Paul McKenzie, effective from 6 March 2023

Efficiency

  • 8 new plasma collection centres opened

  • Commenced roll-out of new RIKA plasmapheresis devices

  • Continued adoption of technology by plasma donors

  • Additional base fractionation capacity completed and approved at Broadmeadows and Marburg facilities

  • Continued investment in yield initiatives

Sustainability

  • Carbon emissions reduction targets set:

  • Targeting a reduction of 40% absolute Scope 1 & 2 emissions by 2030 against a baseline of the average annual emission across FY19-21

  • Intend to ensure suppliers who contribute 67% of Scope 3 emissions set Scope 1 & 2 reduction targets by 2030 aligned with science-based targets initiative

  • New global corporate headquarters has been awarded a five-star rating from the Green Building Council of Australia

  • Marburg facility procures 100% of its electricity from renewable sources

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OUTLOOK (at FY22 exchange rates)

Commenting on CSL’s outlook, Mr. Perreault said, “Given the challenges we have faced over the pandemic, I am proud of the way CSL has responded and continued to execute on our patient focused strategy.

“The strong growth we have seen in plasma collections and our immunoglobulins franchise is expected to continue.

“We are looking forward to launching HEMGENIX[® ] in the US, an exciting, ground breaking, new therapy that will change people’s lives. The rest of our R&D pipeline is in great shape and we look forward to bringing more innovative therapies to patients in the future.

“Seqirus continues to perform strongly and will deliver another profitable year. Consistent with the seasonal nature of the business we anticipate, however, a loss in the second half of the year.

“The integration of CSL Vifor is well advanced and we will focus on driving organic growth and efficiencies across the product portfolio and deliver on our synergy objectives.

“CSL’s underlying profit, NPATA[4] , for FY23 is re-affirmed and anticipated to be in the range of approximately $2.7 billion to $2.8 billion at constant currency”, Mr Perreault concluded.

In compiling the company’s financial forecasts for FY23, a number of key variables that may have a significant impact on guidance have been identified and these have been included in the endnote[7] .

FURTHER INFORMATION

Additional details about CSL’s results are included in the company’s 4D statement, investor presentation slides and webcast, all of which can be found on CSL’s website www.csl.com A glossary of medical terms can also be found on the website.

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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Group Results

Half year ended December
US$ Millions
Sales
Other Revenue / Income
Total Revenue / Income
Earnings before Interest, Tax, Depreciation
& Amortisation
Depreciation/Amortisation/Impairment
Other acquisition adjustments
Earnings before Interest and Tax8
Net Interest Expense
Tax Expense8
NPATA4
Acquired intangible assets amortisation
Other acquisition adjustments
Income tax on the above adjustments
Net Profit After Tax
NPATA attributable to:
-
Shareholders of CSL Limited
-
Non-controlling interest
NPAT attributable to:
-
Shareholders of CSL Limited
-
Non-controlling interest
NPATA4earnings per share2
Interim Dividend (US$)
Dec
2021
Reported
Dec
2022
Reported
Dec
2022
at CC2,3
Change
%
5,808
6,943
233
241
6,041
7,184
7,325
26%
250
7%
7,575
25%
2,479
2,516
(264)
(293)
17
2,231
184
2,407
(70)
(171)
(384)
(359)
2,690
9%
(301)
190
2,579
16%
(167)
(398)
1,777
1,877
2,014
13%
0
(88)
(17)
(184)
35
(96)
(190)
37
1,760
1,640
1,766
-
1,777
1,877
1,777
1,818
59
1,760
1,640
1,760
1,623
17
3.89
1.04
3.77
1.07
2,014
1,957
10%
58
1,766
1,753
-
13
4.06
4%
3%

5

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  • 1 All figures are expressed in US dollars unless otherwise stated

  • 2 Attributable to CSL shareholders

  • 3 Constant currency (CC) removes the impact of exchange rate movements, facilitating the comparability of operational performance. For further detail refer to CSL’s Financial Statements for the Half Year ended December 2022 (Directors Report)

  • 4 Statutory net profit after tax (NPAT) before amortisation and impairment of acquired intellectual property, business acquisition and integration costs and other acquisition accounting adjustments

  • 5 Five months 1H22 (pre CSL ownership and unaudited) v five months 1H23

  • 6 For shareholders with an Australian registered address, the interim dividend of US$1.07 per share (approximately A$1.55) will be paid on 5 April 2023. For shareholders with a New Zealand registered address the final dividend of US$1.07 per share (approximately NZ$1.70) will be paid on 5 April 2023. The exchange rates will be fixed at the record date of 10 March 2023. All other shareholders will be paid in US$. CSL also offers shareholder the opportunity to receive dividend payments in US$ by direct credit to a US bank account.

  • 7 Key variables that could cause actual results to differ materially include: the success and timing 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; ability to collect plasma; 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 and divestitures; research collaborations; litigation or government investigations; and CSL’s ability to protect its patents and other intellectual property.

  • 8 Underlying results are adjusted to exclude impairment and amortisation of acquired intellectual property ($88 million), business acquisition and integrations costs and other acquisition accounting adjustments.

  • ® Trademarks of CSL Limited or its affiliates.

General disclaimer

Non-IFRS

There are references to IFRS (International Financial Reporting Standards) and non-IFRS financial information in this document report. 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.

6

For immediate release

14 February 2023

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Results Presentation for the Half-year ended 31 December 2022

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]

CSL Limited 2023 Half Year Results 14 February 2023

Joy Linton CFO

Paul Perreault

CEO and Managing Director

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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CEO Overview Paul Perreault CEO & Managing Director Paul McKenzie Incoming CEO

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3

1H23 Performance

Ig franchise growing strongly CSL Vifor progressing well

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CSL Behring

  • Ig franchise growing strongly

  • Record levels of plasma collections

CSL Vifor

  • Successful acquisition closure

  • ~5 months financial contribution

CSL Seqirus

  • Strong sales growth driven by differentiated products

  • Licence agreement for latestage self amplifying mRNA vaccine technology

R&D

  • Gene therapy HEMGENIX[®] approved

  • Multiple late stage programs

$7.18b +25%[1] REVENUE

$1.62b[2] 0%[1] NPAT

Incl. one-off costs associated with Vifor acquisition

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$1.82b [2]
+10% [1]
NPATA [3]
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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. Attributable to the shareholders of CSL Limited

3. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and acquisition accounting related adjustments.

4

Revenue up 11%1
Revenue Change1
Therapy $m % Performance
Major Brands
Product supply improving in post COVID environment
IG 2,227 19% Strong growth across all geographies especially EU and emerging
markets
Albumin 585 11% Strong growth in US & EU driven by improved supply
Albumin growth in China constrained by COVID
Strong performance by IDELVION® due to:
Haemophilia 611 12%
Higher patient demand with increased in-person doctor visits

Increased utilisation in Japan
Specialty 915 5% KCENTRA® continues to gain market share in the US as hospital
demand returns to pre-pandemic levels
Other2 218 (31%) COVID-19 vaccine supply contract substantially completed in FY22
Total 4,556 11%

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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2. Includes HPV royalties & Hyperimmunes & COVID vaccines

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Operational Highlights

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Plasma Collections

  • Strong increase in plasma collected +36% with levels now 10% above pre-pandemic

  • Mexico border re-opened with collections recovering strongly

  • 7 new centers in US and 1 in Germany

  • Continued adoption of technology

  • CSL Plasma donor app – downloads >2.5m

  • Online health questionnaire

  • RIKA program commenced

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Manufacturing

  • Broadmeadows and Marburg base fractionation facilities completed and opened

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  • Continued investment in yield initiatives

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Revenue up 9%[1]

Revenue Change[1 ] $m %

Performance

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Major Brands

Revenue
$m
Change1
%
Performance
Major Brands
Egg Based
123
(33%)
Cell Culture
599
28%
Adjuvanted Egg
845
7%

9% revenue growth in seasonal influenza
vaccines against a backdrop of reduced rates
of immunisation

110 million doses distributed in NH

US seasonal influenza vaccines >$1 billion for
the second year running

Continue to benefit from differentiated
product portfolio
Other / In License
86
17%
TOTAL Product Sales
1,653
9%
Pandemic
76
1%
Other Income
9
(13%)
Total
1,738
9%

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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Operational Highlights

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Seasonal influenza products

  • 6 months+ age indication for FLUCELVAX[®] now approved in the US, Argentina, Canada & Taiwan with Australia and New Zealand under evaluation

  • FLUAD included as a preferentially recommended seasonal vaccine option for adults aged 65+ years in the US

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COVID-19

  • Contract completed for the manufacture ~50 million doses of Astra Zeneca’s COVID vaccine in Australia

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Pandemic influenza

  • Awarded BARDA task order for the manufacture of H5N8 clinical material and Phase 2 clinical study

  • Supplied AFLUNOV[®] pre-pandemic stockpile (H5N1) to Singapore

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Manufacturing

  • Additional fill and finish capacity completed at Holly Springs and Liverpool

  • Building works well advanced for the new A$800m cell-culture facility in Melbourne

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~5 months revenue contribution[1]

~15% revenue growth[2] Integration and cost synergies on track

Revenue $m Major Brands

Highlights

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• US Heart Failure label variation submitted – response
Iron 427
expected in Feb 23
• Agreement with large US kidney care provider for ESA
portfolio effective Dec 22
• Korsuva [® ] / Kapruvia [®] approved in Australia, Canada, Singapore
Dialysis 377
and Switzerland.
• Long-term exclusive licensing agreement signed for Korsuva [®]
in China
Non Dialysis 55
• Tavneos [®] approved in Great Britain, Switzerland, UAE
All Other 30
Total 889
Nephrology
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2. Five months 1H22 pre CSL ownership and unaudited v v five months 1H23

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1. Acquired 9[th] August 2022 ~approximately 5 months contribution

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R&D Highlights – 1H23

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Immunology

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Respiratory

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Transplant

  • Garadacimab (Anti-FXIIa) HAE

  • Phase III study data announced

  • Global submissions started

  • BERINERT[®] SC HAE JP PMDA launch

  • Garadacimab (Anti ~~-~~ FXIIa) IPF Phase II study enrolment complete

  • CSL787 (Neb Ig) Phase I study enrolment complete

  • CSL964 (AAT) treatment of GvHD ~~–~~ Phase III study last patient in

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  • Anumigilimab (CSL324; G-CSFR antagonist) Phase Ib study complete

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Haematology

  • CSL889 (Hemopexin) Phase I study last patient out

  • HEMGENIX[®] (Etranacogene dezaparvovec)

  • US Launch

  • EU launch

  • HOPE-B extension study 24-month data showed durable protection & sustained FIX activity

  • KCENTRA[®] Trauma Phase III study first patient in

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Cardiovascular & Metabolic

  • CSL112 (ApoA ~~-~~ 1) Phase III study enrolment complete

  • Clazakizumab (ESKD) Phase IIb/III study first patient in

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Vaccines

  • aQIVc (cell antigen + MF59®) Phase IIb study results available

  • ARCT-154 COVID vaccine, preparing for global submissions

  • INS-3001 (AVS) Phase I study first patient in

  • FERINJECT[®] (ferric carboxymaltose) ID China approval

  • INJECTAFER[® ] (ferric carboxymaltose) ID-HF Phase III data available

  • KORSUVA[® ] /KAPRUVIA[®] (difelikefalin) multiple country approvals

  • SNF472 CUA

  • Phase III study complete

  • Top Line Data

  • Sparsentan (IgAN) CMA EU submitted

  • VELPHORO[®] (sucroferric oxyhydroxide) China approval

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Points covered in green indicate items spoken to at the 1H23 results briefing

Abbreviations: aQIVc – Adjuvanted Cell Culture Quadrivalent Influenza Vaccine; AVS – Aortic Valve Stenosis; CMA – Conditional Marketing Authorisation; CUA - Calcific Uremic Arteriolopathy; ESKD – End Stage Kidney Disease; EU – Europe; FIX – Factor IX; G-CSFR - Granulocyte Colony-Stimulating Factor Receptor; GvHD – Graft versus Host Disease; HAE – Hereditary Angioedema; HF – Heart Failure; ID – Iron Deficiency; IgAN - IgA Nephropathy; IPF - Idiopathic Pulmonary Fibrosis; JP – Japan; Neb Ig - Nebulised Ig; SC – Subcutaneous; SCD – Sickle Cell Disease; US – United States

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Significant Target Launch Dates[1]

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

FY23 FY24 - FY27
HEMGENIX [®] Garadacimab CSL112 FERINJECT [® ]
Etranacogene Anti-FXIIa (HAE) ApoA-1 (AMI) Ferric carboxymaltose
dezaparvovec (Haem B) (ID) China
BERINERT [® ] SC HIZENTRA [®] Adjuvanted Cell Culture Sparsentan
C1 Esterase Inhibitor SCIg 20% Liquid (DM) Influenza Vaccine Dual ETA & AT1 antagonist
(HAE) Japan (aQIVc) (IgAN) EU
INJECTAFER [® ] Clazakizumab ARCT-154 COVID Sparsentan
Ferric carboxymaltose Anti-IL-6 (AMR) Vaccine Dual ETA & AT1 antagonist
(ID-HF) US (FSGS) EU
CSL964 AAT SNF472
(GvHD Treatment) Calcification inhibitor
(CUA)
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Immunology Haematology Cardiovascular & Metabolic Transplant Vaccines CSL Vifor Partnered Projects

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11

1. Launch subject to clinical completion, submission and regulatory approval

Financials Joy Linton CFO

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12

NPATA[3]

$1,777m
1H22
NPATA
+10%
$1,818m
$138m
1H23
NPATA
@ CC
$1,957m
FX
1H23 NPATA @ CC1
$1,957m
Acquired intangible assets amortisation
($96m)
Other acquisition adjustments
($190m)
Tax on adjustments
$37m
NPATA Attributable to NCI2
$58m
1H23 NPAT @ CC
$1,766m
NPAT Attributable to NCI2
($13m)
1H23 NPAT @ CC1
$1,753m

1. Attributable to the shareholders of CSL Limited.

2. Non-Controlling Interest

13

3. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and acquisition accounting related adjustments.

Ig franchise growing strongly

CSL Group Financial Highlights

Includes ~5 months of Vifor financials

US$ Millions
Total Revenue
1H22
Rep
6,041
1H23
Rep
7,184
1H23
at CC
7,575
1 Change
%
1
25%
Gross Profit3
GP %3
3,448
57.1%
4,052
56.4%
4,275
56.4%
24%
Sales & Marketing
Operating Result3
431
3,017
669
3,383
712
3,563
65%
18%
R&D 486 577 606 25%
G&A3 300 400 378 26%
Finance (Net) 70 171 167 139%
NPATA2 1,777 1,818 1,957 10%
ETR % 17.8% 16.0%
Cashflow From Ops4
NPATA EPS2 ($)
DPS ($)4
1,427
3.89
1.04
981
3.77
1.07
4.06 (31%)
4%
3%

R&D

Projects within cardiovascular, haematology and immunology

S&M

HEMGENIX[®] commercial activities

G&A

5 months of CSL Vifor

Finance

Acquisition of Vifor and higher interest rates

Tax

Lower ETR due to geographic profit mix and lower Vifor ETR

Cashflow from Operations Strong growth in plasma collections

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. 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 other acquisition related adjustments 4.At reported currency

14

CSL Group

1H23 by Segment

US$ Millions CSL
Behring
CSL
Seqirus
Total Change
% at CC
1
CSL
Vifor

3
CSL
Group
Change
% at CC
1
Sales 4,414 1,653 6,067 10% 876 6,943 26%
Other Revenue 142 85 227 1% 13 241 7%
Total Revenue 4,556 1,738 6,294 10% 889 7,184 25%
Gross Profit4 2,238 1,198 3,436 5% 615 4,052 24%
GP %2,4 50.3% 65.9% 54.6% 69.7% 56.4%
Sales & Marketing 363 90 453 12% 215 669 65%
Operating Result 1,875 1,108 2,983 4% 400 3,383 18%
Segment %2,4 42.3% 60.7% 47.4% 44.6% 47.0%
Operating Result adjusted for
non recurring COVID vaccine
8%

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. Percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail. 3. Acquired 9[th] August 2022 ~approximately 5 months contribution

4.Underlying results have been adjusted to exclude impairment and amortisation of acquired IP, business acquisition and transaction costs and other acquisition related adjustments

15

CSL Behring Gross Margin

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$195.00 59.0%
$190.00
57.0%
Total
$185.00 US
Onset of CPL 55.0%
$180.00 COVID-19
impact
$175.00 53.0%
$170.00 51.0%
Gross
$165.00
Approx. 9-12 Margin 49.0%
$160.00 month inventory
cycle time
47.0%
$155.00
$150.00 45.0%
Dec-20 Dec-21 Dec-22
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  • Higher plasma collection costs in COVID environment

  • Inflationary pressures

  • Long inventory cycle

  • 9-12 month lag to gross margin impact

  • Continuous focus on improving collection efficiency

Gross margin expected to improve over the medium term

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Foreign Currency Impact

Volatility in world currency markets

1H23 $138m NPATA headwind - largely driven by strong USD

Realised losses:

  • USD/CNY

  • • GBP/USD

Unrealised losses:

  • USD/EUR

  • Emerging market currencies against USD

Full year FX impact is estimated to be $175m unfavourable, assuming FX rates remain steady for the balance of the financial year

Currency Average Rates

1H22 1H23 % change
USD/EUR 0.86 0.99 15.1%
USD/CHF 0.92 0.97 5.4%
USD/GBP 0.73 0.85 16.4%
USD/CNY 6.44 6.97 8.2%
USD/AUD 1.36 1.49 9.6%

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FY23 Outlook

Guidance Re-affirmed

2H23 Considerations

CSL Behring

  • Strong plasma collections and Ig growth expected to continue

  • Gene therapy HEMGENIX[®] US commercialisation

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FY23[1] Result Skewed to 1H

CSL Seqirus

  • Seasonal business with less than 20% of total annual sales in 2H

Revenue

28 - 30% growth @ CC[1]

NPATA[2,3]

CSL Vifor

  • Continued integration and delivering on synergy objectives.

~$2,700 - $2,800m @CC[1] 13 - 18% growth

R&D portfolio progressing

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. Attributable to the shareholders of CSL Limited

3. NPATA is defined as the statutory net profit after tax before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and acquisition accounting related adjustments

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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

(#) 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.

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.

Summary NPAT attributable to members of parent entity

Reported net profit after tax $1,623.2m Currency effect $ 130.2m Constant currency net profit after tax* $1,753.4m

Average exchange rates for major currencies for half year ended 31 December 2022/31 December 2021 include: USD/EUR (0.99/0.86), USD/AUD (1.49/1.36), USD/CHF (0.97/0.92), USD/CNY (6.97/6.44) and USD/GBP (0.85/0.73).

Summary NPATA1 attributable to members of
the parent entity
Reported net profit after tax
US$m
1,623.2
Amortisation of acquired intellectual property 63.7
Acquisition accounting adjustments 76.1
Acquisition and integration costs
Income tax credit on above adjustments
NPATA1 attributable to members of the
84.1
(28.8)
1,818.3
parent entity
Currency effect attributable to members of the 138.4
parent entity
Constant Currency# NPATA1 attributable to
members of the parent entity
1,956.7

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Summary Revenue
Reported revenue $7,183.5m
Currency effect $ 391.6m
Constant currency revenue* $7,575.1m
  • Constant currency net profit after tax and constant currency sales have not been audited or reviewed in accordance with Australian Auditing Standards.

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 acquisition accounting related adjustments

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Appendix

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Appendix A CSL Behring - Key Products

Therapy Sales Change1
CSL BEHRING Group $m %
Privigen IVIG 1,306 22%
Hizentra SCIG 801 17%
Albumin Albumin 585 11%
Idelvion Haemophilia 363 22%
Kcentra Specialty 325 8%
Haegarda Specialty 224 1%
Berinert Specialty 131 4%
Haemocomplettan Specialty 112 9%
Humate Haemophilia 90 10%
Haemate Haemophilia 52 (3%)

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1H23 Revenue
By Therapy Group
$m
4%,
10% Other,
Other $218
Specialty
$436 31%
IVIG
11%,
$1,424
Peri-Operative
Bleeding,
$479
4%,
Plasma,
$192
9%
Recombinants
$419
18%,
13%, SCIG,
Albumin, $585 $803
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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

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1H23 Revenue By Therapy Group

Appendix B CSL Vifor & CSL Seqirus – Key Products

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$m
4%, 1%,
Pandemic, Other,
5%, 7%,
$76 $9
In-Licence, Egg Based,
$86 $123
34%,
Cell Culture,
$599
49% ,
Adjuvanted,
$845
4%,
6%,
Other,
Non Dialysis, $30
$55
48%,
Iron,
$427
42%,
Dialysis,
$377
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Therapy Sales Change1
CSL SEQIRUS Group $m %
Fluad Adjuvanted 845 7%
Flucelvax
Afluria
Cell culture
Egg-based
599
113
28%
(34%)
CSL VIFOR
Ferinject / Injectafer
Therapy
Group
Iron
Sales
$m
315
Mircera Dialysis 258
Velphoro
Venofer
Dialysis
Iron
77
74
Veltassa Non Dialysis 49
Maltofer Iron 36

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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