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CSL Ltd. — Investor Presentation 2025
Aug 18, 2025
17854_rns_2025-08-18_dd9730cc-01db-488a-b3f7-fd9c8d76d997.pdf
Investor Presentation
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19 August, 2025 Melbourne, Australia
Results Presentation
for the full year ended 30 June 2025
CSL Limited (ASX:CSL; USOTC:CSLLY)
Please find attached the slides for the presentation on the full year results that will be given by the Chief Executive Officer and Chief Financial Officer shortly. The live briefing will be webcast and can be viewed at https://edge.media-server.com/mmc/p/eaiq47e2/
Please note that this link will expire after the webcast concludes.
A recording of the webcast will be made available later in the day at: https://investors.csl.com/investors/financial-results-and-information
Authorised for lodgement by:
Fiona Mead
Company Secretary
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Investor Relations Media Relations
Chris Cooper
Brett Foley
Head, Investor Relations Communications CSL Limited CSL Limited P: +61 455 022 740 P: +61 461 464 708 E: [email protected] E: [email protected] CSL Limited | ABN 99 051 588 348 | 655 Elizabeth Street, Melbourne VIC 3000
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ASX Announcement
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Paul McKenzie Joy Linton Chief Executive Officer Chief Financial Officer & Managing Director
2025 Full Year Results 19 August 2025
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2 Driven by Our Promise
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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.
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 or otherwise of CSL’s research and development activities; factors affecting CSL’s ability to successfully market and sell new and existing products, including decisions by regulatory authorities regarding approval of CSL’s products and regarding label claims, competitive developments affecting CSL’s products, and trade buying patterns; factors affecting CSL’s ability to collect plasma, and difficulties or delays in manufacturing; legislation or regulations affecting the manufacturing, distribution, pricing, or reimbursement of CSL’s products, market access for CSL’s products, environmental protection matters, or tax; litigation or government investigations; fluctuations in interest and currency exchange rates; acquisitions or divestitures; and CSL’s ability to protects 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 McKenzie CEO & Managing Director
Driven by Our Promise
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Agenda
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Introduction
FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Agenda
Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Strong performance in FY25[1]
Revenue +5% Leverage 1.8x NPATA[2,3] +14% FCF[6] +58% NPAT[3] +17% Dividend[6] +12%*
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$15,558m
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Revenue Growth [1]
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CSL Behring +6%
CSL Seqirus +2%
CSL Vifor +8%
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- Final Dividend
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Major initiatives announced to drive further value creation
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Transformation initiatives
-
Distinctive Portfolio Development & Commercialisation operating model
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Targeting annual pre-tax savings >$500m by the end of FY28
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Disciplined reinvestment of savings in high priority growth opportunities
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Intent to demerge CSL Seqirus
- Substantial ASX-listed entity in FY26
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Capital management
- Multi-year share buyback reintroduced in FY26
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Agenda
Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Revenue $11,158m +6%[1]
| Therapy Revenue ($m) Change1 Ig 6,064 +7% Albumin 1,297 +7% Haemophilia 1,488 +13% Hereditary Angioedema 760 +4% Peri-Operative Bleeding 913 (10%) 8 |
Highlights Major Brands • PRIVIGEN®/ INTRAGAM®+8%, HIZENTRA®+6% • Six months of Medicare Part D Reform – ~($100 million) impact • Robust demand across all core indications • Solid growth driven by China • IDELVION®remains standard of care, +10% – Leadership position in US, key EU markets and Japan • Increased uptake of HEMGENIX®in US and Europe • First sales of ANDEMBRY®in US and other key markets • HAEGARDA®stable • KCENTRA® (16%) – Sequential growth in second half • Progress on label expansions for KCENTRA® and RiaStap® |
|
|---|---|---|
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Revenue $2,166m +2%[1]
| Therapy Revenue ($m) Change1 Egg Based 116 (17%) Cell Culture 474 (12%) Adjuvanted Egg 901 (14%) Pre-Pandemic 197 +235% Pandemic 179 +3% Other (inc in-license) 299 +69% |
Highlights Major Brands • Revenue impacted by decline in US vaccination rates • Momentum in US paediatric segment • Received preferential recommendation for FLUAD®in Germany and France for 60+ • Positive ACIP universal influenza recommendation • Seasonal influenza business expected to stabilise in FY26 • Award of over 90% of H5 avian flu contracts globally • Reservation agreements in place with 20 countries • Includes revenue from COVID vaccine distribution partner in Japan |
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Revenue $2,234m +8%[1]
| Revenue $2,234m +8%1 | |
|---|---|
| Therapy Revenue ($m) Change1 Iron 1,034 +1% Nephrology Dialysis 871 +10% Nephrology Non-Dialysis 267 +34% |
Highlights Major Brands |
| • Global volume growth • Impacted by generic competition in EU • Increased FERINJECT®sales in China |
|
| • VELPHORO® – Strong growth from inclusion in TDAPA • MIRCERA® – Market leader in US • KAPRUVIA® – Strong performance in European markets b a |
|
| • TAVNEOS® – Excellent uptake in all launch markets • FILSPARI® – Successful launches in Germany, Austria and Switzerland c d |
a. Licensed from F. Hoffman-La Roche AG; b. Licensed from Pfizer Inc.; c. Rights to EU, AUS&NZ and certain other countries licensed from Travere Therapeutics, Inc. .; d. Rights to EU, UK, Japan and certain other countries licensed from ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, Inc.
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1
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Agenda
Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Financials
Joy Linton CFO
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Driven by Our Promise
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NPATA[2,3]
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$3,303m
$84m FX
$3,219m
$2,907m
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FY24 NPATA FY25 NPATA @CC
| FY24 | FY25 | Change | |
|---|---|---|---|
| Rep | @CC | %1 | |
| NPATA | $2,907m | $3,303m | +14% |
| Acquired intellectual property amortisation |
($301m) | ($364m) | |
| Other acquisition and disposal adjustments |
($84m) | $30m | |
| Tax | $61m | $57m | |
| NPATA Attributable to NCI | $131m | $191m | |
| NPAT | $2,714m | $3,217m | +19% |
| NPAT Attributable to NCI | ($72m) | ($131m) | |
| NPATto CSL shareholders | $2,642m | $3,086m | +17% |
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CSL Group Financial Highlights
| US$ Millions | FY24 Rep |
FY25 Rep |
FY25 at CC 1 |
Change % 1 |
|---|---|---|---|---|
| Total Revenue | 14,800 | 15,558 | 15,587 | 5% |
| Gross Profit4 | 8,006 | 8,443 | 8,509 | 6% |
| GP %4 | 54.1% | 54.3% | 54.6% | |
| Sales & Marketing4 | (1,556) | (1,616) | (1,619) | (4%) |
| Operating Result4 | 6,450 | 6,827 | 6,890 | 7% |
| R&D4 G&A4 |
(1,428) (825) |
(1,359) (1,000) |
(1,358) (945) |
5% (15%) |
| Net Interest Expense | (437) | (410) | (409) | 6% |
| NPATA3 ETR % |
2,907 19.2% |
3,219 15.9% |
3,303 16.4% |
14% |
| ROIC | 10.5% | 11.5% | ||
| Cashflow From Ops | 2,764 | 3,561 | 29%y | |
| Free Cashflow | 1,819 | 2,866 | 58%y | |
| Capex | (847) | (636) | 25%y | |
| NPATA EPS3($) DPS ($) |
6.02 2.64 |
6.65 2.92 |
10%y 11%y |
- Y. At reported currency
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Capital Expenditure for Property, Plant & Equipment
R&D
-
Prioritising growth opportunities
-
FY26 guidance: ~US$1.35b
G&A
-
FY25 in line with guidance
-
FY26 guidance: ~US$1.0b
Finance
- Balance Sheet continued to de-lever in FY25
Tax
- FY26 guidance: 18-20% (excl. FX)
Cashflow
-
Cashflow from Operations: strong improvement driven by growth in business and working capital management
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Strong increase in free cashflow due to continued reduction in capex
Capex
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FY26 guidance: ~$800m +/- $100m
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Expanding Ig capacity in US over mid-term
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Segment Financial Highlights
CSL Behring
| US$ millions reported | FY24 | FY25 | Change % at CC 1 |
|---|---|---|---|
| Sales | 10,334 | 10,930 | 6% |
| Other Revenue Total Revenue Gross Profit4 GP %4 Sales & Marketing4 |
274 10,608 5,275 49.7% (903) |
228 11,158 5,641 51.0%1 (937) |
(16%) 6% 8% (4%) |
| Operating Result | 4,372 | 4,704 | 9% |
| Operating Segment %4 | 41.2% | 42.2% |
Add Rika + INomi benefits
Continued Gross Margin Improvements
-
Optimise donor fees
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• RIKA and I-Nomi
CPL Reduction
-
Network efficiencies
-
ANDEMBRY[®]
New Products ASP Mix Shift
-
HEMGENIX[®]
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• HIZENTRA[®] PFS Change to ANDEMBRY
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HIZENTRA[®] v PRIVIGEN[®]
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• Geographic mix
Ig Yield Improvements
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Horizon 1
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Increased volume
Scale & Efficiency Measures
-
Variable v fixed costs
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• Manufacturing efficiencies
Excludes potential benefits of Horizon 2 initiatives
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Illustrative only
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Segment Financial Highlights
CSL Seqirus
| CSL Seqirus | |||
|---|---|---|---|
| US$ millions reported | FY24 | FY25 | Change % at CC 1 |
| Sales | 1,896 | 1,906 | - |
| Other Revenue | 232 | 260 | 11% |
| Total Revenue | 2,128 | 2,166 | 2% |
| Gross Profit4 | 1,318 | 1,257 | (5%) |
| GP %4 | 61.9% | 58.1%1 | |
| Sales & Marketing | (196) | (230) | (19%) |
| Operating Result4 | 1,122 | 1,027 | (9%) |
| Operating Segment %4 | 52.7% | 47.4% |
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CSL Vifor
| CSL Vifor | |||
|---|---|---|---|
| US$ millions reported | FY24 | FY25 | Change % at CC 1 |
| Sales | 2,029 | 2,199 | 8% |
| Other Revenue | 35 | 35 | - |
| Total Revenue | 2,064 | 2,234 | 8% |
| Gross Profit4 | 1,413 | 1,545 | 9% |
| GP %4 | 68.5% | 69.2%1 | |
| Sales & Marketing | (457) | (449) | 2% |
| Operating Result4 | 956 | 1,096 | 14% |
| Operating Segment %4 | 46.3% | 49.1% |
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Share buyback reintroduced
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US$b Net Debt/EBITDA
11.0 2.7 x 3.0
2.2 x
2.5
1.8 x
10.0 2.0
1.5
9.0 1.0
0.5
8.0 0.0
FY23 FY24 FY25
Net Debt Net Debt/EBITDA
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-
Strong cash flow has significantly de-levered the Balance Sheet
-
Sufficient capacity to support investment in growth opportunities
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Multi-year, on-market share buyback as part of refreshed capital management strategy - A$750m (~US$500m) in FY26, expected to progressively increase over the medium-term
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Target leverage range of 1.5x – 2.0x from FY26
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Agenda
Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Strategic transformation to deliver value
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Reduce
non-clinical
fixed cost
in R&D
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Operating model complexity has increased with growth, against a volatile macro environment
Clear opportunity to improve R&D and commercial productivity and build on our operational efficiencies
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Annual pre-tax savings of >$500m by the end of FY28*
A refocused CSL will…
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Direct savings to
Distinctive accelerate clinical pipeline
operating model and priority programs
Closure of 22
Up to 15%
Optimised R&D expenditure headcount underperforming
reduction plasma centres Be lean and agile
Footprint from 11 sites to 6 in FY26
Faster time-to-market
Streamline corporate
functions and drive
One-off pre-tax restructuring costs
additional revenue
$700-770m ($400-450m cash) in FY26
growth opportunities
Disciplined reinvestment
of savings in high priority Simplify decision making
growth opportunities
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*The initiatives are expected to drive annualised cost savings of $500-550 million progressively over the next three years, with the majority achieved by the end of Financial Year 2027.
**A further ~$100 million cash impact is expected in Financial Year 2027
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Agenda
Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus
Outlook and FY26 Guidance Q&A
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Intention to demerge CSL Seqirus to CSL shareholders
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CSL Seqirus to be demerged, creating an ASX listed global vaccine leader
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Company to be chaired by Mr Gordon Naylor
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The demerger will be subject to third party consents, regulatory approvals and CSL will conduct a voluntary shareholder vote
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Targeting completion before the end of financial year 2026
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Strong strategic rationale to enhance shareholder value
Reduces complexity, making businesses more agile and efficient to manage
Reinvigorates focus on core differentiating capabilities
Enables acceleration of transformation and efficiency projects
Autonomy to set strategic direction and capital allocation
Capitalise on potential opportunities that may arise in dynamic markets
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Two global leaders in healthcare
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Global #1 in ~$38bn plasma protein therapies industry
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Global #2 in ~$7bn influenza vaccine industry with ~~-~~
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attractive long term fundamentals
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Global #1 in ~$5bn iron industry
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~~-~~
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Leading manufacturer of plasma derived therapies, ~~- -~~
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utilising a best in class, global network of plasma centers
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Highly differentiated and market leading portfolio
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Strong and differentiated clinical pipeline
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• Deep Australian heritage, including supply of products of national significance
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Leading market positions in rare diseases
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Long track record of delivering value to shareholders
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$13.4bn $5.8bn
FY25 Revenue FY25 Operating Result
FY25 Revenue by Therapy Group
IG
5%
8% Haemophilia
8% Albumin
6% 45% Peri-Operative Bleeding
HAE
7%
Iron
10%
Nephrology
11%
Other
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$2.2bn $1.0bn
FY25 Revenue FY25 Operating Result
FY25 Revenue by Therapy Group
22% Cell Culture
31%
Adjuvanted
Egg Based
Other
5%
42%
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Note:
- Operating result does not include allocation of group costs.
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- **Other comprises: In License, Pre-Pandemic, Pandemic Res Fees and Other Income.
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Introduction
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FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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Outlook
CSL Behring
CSL Seqirus
-
Seasonal influenza revenue to stabilise
-
Robust patient demand across multiple areas of high unmet need
-
Substantially lower contribution from avian influenza and COVID-19
-
HIZENTRA[®] to grow strongly
-
Leverage differentiated portfolio
-
PRIVIGEN[®] impacted by tender losses in UK and Mexico
-
Significant geographic launch opportunities (Germany, France, Korea)
-
Building on positive ANDEMBRY[®] launch momentum
CSL Group
-
Horizon 1 and 2 yield initiatives progressing to plan
-
Reduce fixed cost in R&D and drive pipeline productivity
-
Consistent annual increases in Gross Margin through mid-term
-
Embed distinctive Portfolio Development & Commercialisation model
CSL Vifor
-
Optimise activities across plasma network
-
Well-positioned for iron competition
-
Streamline corporate costs
-
Nephrology launch momentum
-
Recommence multi-year share buyback
-
• Potential sectoral tariffs unlikely to impact strategic initiatives
-
Commercial and medical integration with CSL Behring
Notes:
-
Group revenue guidance excluding an incremental ~$100m IRA Part D reform impact ~ 5 – 6% @CC[1]
-
-24 NPATA guidance excluding an incremental -$85m post-tax impact from Part D Reform ~ 10 – 13% @CC[1,3 ] ~$3.54 - $3.64b @ CC[1,3]
-
FY26 FX impact estimated to be a tailwind of ~$60m if current rates remain unchanged for the remainder of the Financial Year
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FY26 Guidance[7]
Revenue Growth ~ 4 - 5% @CC[1] NPATA Growth
(excl. restructuring cost[5] ) ~ 7 – 10% @CC[1,3] to ~$3.45 – $3.55b @CC[1,3]
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Agenda
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Introduction FY25 Business Performance Financials Strategic Transformation Intent to Demerge CSL Seqirus Outlook and FY26 Guidance Q&A
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25
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CSL Contacts
Chris Cooper Investor Relations +61 455 022 740 [email protected] Bernard Ronchi Investor Relations +61 431 060 964 [email protected] Jimmy Baker Investor Relations +61 450 909 211 [email protected]
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 year (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 year (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 transparency and comparability of a financial report . 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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Summary NPAT attributable to members of parent entity
| of parent entity | |
|---|---|
| Reportednetprofit after tax | $3,002m |
| Currency effect | $84m |
| Constant currency net profit after tax* | $3,086m |
Average exchange rates for major currencies for full year ended 30 June 2025/ 30 June 2024 include: USD/EUR (0.92/0.92), USD/AUD (1.55/1.52), USD/CHF (0.87/0.89), USD/CNY (7.21/7.22) and USD/GBP (0.77/0.79).
| Summary NPATA2attributable to | ||
|---|---|---|
| members of the parent entity | US$m | |
| Reported net profit after tax | 3,002 | |
| Amortisation of acquired intellectual property | 295 | |
| Net gain on business disposals | (30) | |
| Income tax credit on above adjustments | (48) | |
| NPATA2 attributable to members of the parent entity |
3,219 | |
| Currency effect attributable to members of the parent entity |
84 | |
| Constant Currency# NPATA2 attributable to members of the parent entity |
3,303 |
Summary Revenue
| Summary Revenue | |
|---|---|
| Reported revenue | $15,558m |
| Currency effect | $29m |
| Constant currency revenue* | $15,587m |
-
*Constant currency net profit after tax and constant currency sales have not
-
been audited or reviewed in accordance with Australian Auditing Standards.
Footnotes
-
Percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail
-
NPATA is defined as the statutory NPAT before impairment and amortisation of acquired IP and non-recurring items from business acquisition and disposals
-
Attributable to the shareholders of CSL Limited
-
Underlying results have been adjusted to exclude impairment and amortisation of acquired IP and non-recurring items from business acquisition and disposals
-
Pre-tax restructuring costs $700-770m in FY26
-
Reported FX rates
-
Does not incorporate the impact of the potential CSL Seqirus demerger
NPATA to NPAT FY26 outlook
| NPATA (excl. restructuring costs) to NPAT adjustments, attributable to: |
Group | CSL shareholders (post tax) |
CSL shareholders (post tax) |
|
|---|---|---|---|---|
| FY26 Outlook | FY25 at CC |
FY26 outlook |
FY25 at CC |
|
| Restructuring costs | 700-770 | 560-630 | ||
| Income tax on restructuring costs | (140)-(150) | |||
| Amortisation of acquired intellectual property |
370+/- 10% | 364 | 260 +/- 10% | 251 |
| Net gain on disposal | - | (30) | - | (33) |
| Income tax on above adjustments | (60) +/- 10% | (57) | - | - |
| Total | 900 +/- 10% | 277 | 850 +/- 7% | 217 |
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Appendix
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Appendix A CSL Behring – Key Products
| CSL Behring | Therapy Group | Sales $m | Change1% |
|---|---|---|---|
| Privigen | IVIG | 3,904 | 8% |
| Hizentra | SCIG | 2,078 | 6% |
| Albumin | Albumin | 1,297 | 7% |
| Idelvion Kcentra |
Haemophilia Peri-operative bleeding |
853 592 |
10% (16%) |
| Haegarda | HAE | 490 | - |
| Berinert | HAE | 248 | 3% |
| Haemocomplettan | Peri-operative bleeding |
242 | 6% |
| Humate | Haemophilia | 202 | 10% |
| Haemate | Haemophilia | 138 | 18% |
| Hemgenix | Haemophilia | 92 | 189% |
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FY25 Revenue By Therapy Group $m
| IVIG | $3,986 | 36% | ||
| SCIG | $2,078 | 19% | ||
| CSL | Haemophilia | $1,488 | 13% | |
| Behring | ||||
| Albumin | $1,297 | 12% | ||
| Peri-Operative Bleeding | $913 | 8% | ||
| HAE | $760 | 7% | ||
| Other | $636 | 5% |
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Appendix B CSL Seqirus & CSL Vifor – Key Products
FY25 Revenue By Therapy Group $m
| Sales | Change | |||
|---|---|---|---|---|
| CSL Seqirus | Therapy Group | $m | 1% | |
| Fluad | Adjuvanted | 901 | (14%) | |
| Flucelvax Afluria |
Cell culture Egg-based |
474 111 |
(12%) (21%) |
|
| Sales | Change1 |
|||
| CSL Vifor | Therapy Group | $m | % | |
| Ferinject/Injectafer | Iron | 766 | - | |
| Mircera | Nephrology: Dialysis | 567 | (8%) | |
| Velphoro Venofer |
Nephrology: Dialysis Iron |
258 172 |
137% (2%) |
|
| Veltassa | Nephrology: Non Dialysis | 144 | 4% | |
| Tavneos | Nephrology: Non Dialysis | 112 | 86% | |
| Maltofer | Iron | 91 | 11% |
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Cell Culture $474 22% Adjuvanted $901 42% Egg Based $116 5% CSL Seqirus Pre-Pandemic $197 9% Pandemic $179 8% Other (inc in-license) $299 14% Iron $1,034 46% Nephrology: Dialysis $871 39% CSL Vifor Nephrology: Non Dialysis $267 12% Other $62 3%
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For more information visit www.CSL.com
R&D Portfolio Highlights – FY25
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Immunoglobulins
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Cardiovascular & Renal
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Vaccines
-
Clazakizumab (ESKD)
-
HIZENTRA[®] PFS 50mL
-
Enrolment ongoing
-
JP submission complete
-
FDA Phase III DAP submitted
-
EU approval complete
- FILSPARI[®] (Sparsentan) IgAN Full EU approval complete
-
Horizon 2
-
Toxicology package complete
-
Process robustness package complete
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Haematology
Transplant & Immunology
-
HEMGENIX[® ] Japan Phase III last patient in complete
-
ANDEMBRY[®] (Garadacimab; Anti ~~-~~ FXIIa) HAE
-
AFSTYLA[® ] China Phase III first patient in • AU, JP, EU, UK, Switzerland & US approved complete
-
CSL964 in aGvHD
-
RiaSTAP[®] AFD
-
Treatment Data presented at TCT Feb 25
-
Phase III first patient in complete
-
Phase 3 prevention study futility passed
-
US submission complete
-
Improved fibrinogen manufacturing process EU approval received
-
CSL403 (aTIVc)
-
UK & EU submissions complete
-
QIV to TIV Transition US, EU, UK approval complete
-
KOSTAIVE[®] sa-mRNA (COVID)
-
JP launch – EU marketing authorization - UK submission
Discontinued Programs
-
KCENTRA[® ] Trauma
-
HIZENTRA[® ] Dermatomyositis
-
HIZENTRA[® ] POTS
-
Clazakizumab AbMR
-
CSL889 (Hemopexin) VOC in SCD Phase II first patient in (July)
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Abbreviations: AFD – Acquired Fibrinogen Deficiency; aTIVc - Adjuvanted Cell-based Trivalent Influenza Vaccine; DAP – Diversity Action Plan; EU – Europe; FDA – Food & Drug Administration; HA – Health Authorities; HAE – Hereditary Angioedema; JP – Japan; IgAN – Immunoglobulin A Nephropathy; PFS – Pre-Filled Syringe; POTS - Postural Orthostatic Tachycardia Syndrome; PK – Pharmacokinetic; PR – Prolonged Release; QIV – Quadrivalent Influenza Vaccine; RNA – Ribonucleic Acid; sa-mRNA – SelfAmplifying messenger RNA; TCT - Transplantation and Cellular Therapy; TIV- Trivalent Influenza Vaccine; UK - United Kingdom; US – United States; VOC – Vaso-occlusive Crisis.
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