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CSL Ltd. Investor Presentation 2020

Aug 18, 2020

17854_rns_2020-08-18_724cb106-2c1e-4f08-a799-bcaece1ca833.pdf

Investor Presentation

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For immediate release 19 August 2020

RESULTS PRESENTATION FOR THE FULL YEAR ENDED 30 JUNE 2020

Melbourne, Australia – CSL (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 briefing will be webcast and can be accessed at https://csl.webcastcloud.com/account/register.

Authorised for lodgment by:

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Fiona Mead Company Secretary

For further information, please contact:

Investors:

Media:

Mark Dehring VP Investor Relations P: +61 3 9389 3407 E: [email protected]

Jemimah Brennan

Head of Communications, Asia Pacific

P: +61 412 635 483 E: [email protected]

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CSL Limited 2020 Full Year Results 19[th] August, 2020

Paul Perreault David Lamont CEO and MD CFO

FORWARD LOOKING STATEMENTS

Legal Notice

The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL Limited and its related bodies corporate (CSL) financial results and estimates, business prospects and products in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. 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, and CSL’s ability to protect its patents and other intellectual property. The statements being made in this presentation do not constitute an offer to sell, or solicitation of an offer to buy, any securities of CSL.

No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including CSL). In particular, no representation, warranty or assurance (express or implied) is given in relation to any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from the forward looking statements and the assumptions on which the forward looking statements are based.

Subject to any continuing obligations under applicable law or any relevant listing rules of the Australian Securities Exchange, CSL disclaims any obligation or undertaking to disseminate any updates or revisions to any forward looking statements in these materials to reflect any change in expectations in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in these materials shall under any circumstances create an implication that there has been no change in the affairs of CSL since the date of these materials.

Trademarks

Except where otherwise noted, brand names designated by a ™ or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.

2

A strong year for CSL with revenue up 9%[1] and profit after tax up 17%[1] reflecting:

FY20 Revenue Performance[1] A strong year for CSL

  • Strong growth in immunoglobulin portfolio

  • Successful evolution of Haemophilia portfolio, driven by IDELVION[®]

  • Transitioned to own distribution model in China

  • Seqirus delivers on product differentiation strategy with strong profit growth

CSL Behring

  • PRIVIGEN[®] +20%

  • HIZENTRA[®] +34%

  • ALBUMIN[®] (36%) (GSP impact)

  • IDELVION[®] +25%

  • AFSTYLA[®] +21%

  • HAEGARDA[® ] +12%

  • KCENTRA[®] +12%

  • ZEMAIRA[®] +20%

Seqirus

  • Seasonal influenza sales +21%

  • FLUAD[®] :

  • Preferred recommendations in UK and Australia

  • QIV launched in Australia and approved in USA & EU

  • FLUCELVAX[®] launched EU

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3 Driven by Our Promise
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TM
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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.

CSL Behring Sales FY20

Therapy Sales
$m
Change1
%
Immunoglobulins 4,014 22%
- IVIG 2,699 16%
- SCIG 1,315 34%
Albumin 640 (36%)
Haemophilia 1,122 8%
- Recombinants 659 18%
- Plasma 463 (3%)
Specialty 1,697 10%
- Peri-Operative Bleeding 788 10%
- Other Specialty 909 9%
Other2 188 (1%)
Total 7,661 8%

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19%
29%
US$7.7B
8%
13%
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16%
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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. Includes Hyperimmunes

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Immunoglobulins

Sales up 22%[1]

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20% growth[1]

  • CIDP indication in the US and EU

  • Expansion of SID usage

  • Continued growth in PID

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34% growth[1]

  • Clear market leader

  • New patient starts in PID

  • Orphan exclusivity for CIDP in the US

Market

  • Global Ig demand remains strong

Market Demand Drivers

  • Increased disease awareness & improved diagnosis

  • Increased usage for chronic therapies

  • CIDP indication

  • Expanding usage for SID

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.

5

Albumin

Sales down 36%[1]

  • Volume up 16% globally, excluding China:

  • Europe up 24%

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Transitioned to Good Supply Practices (GSP) license in China

  • North America up 6%

  • Emerging markets, excluding China, up 28%

    • Successful transition of business model
  • Pricing pressure in some markets

  • China:

  • One-off financial impact from GSP in line with previous guidance

  • Market volume demand outlook mid to high single digits

  • Helps build brand and expand coverage to lower tier cities and hospitals

  • No impact to patient supply

  • Competitive environment

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.

6

Haemophilia

Sales up 8%[1]

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  • 25% growth[1]

  • Differentiated product

  • Strong growth in US, Japan and Switzerland

  • Approval of 21-day dosing in EU, Switzerland and Japan

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  • 21% growth[1]

  • • Double digit growth in nearly all launched markets

  • • Patient retention strategies and ongoing switches in competitive environment

Plasma Derived Coagulation Factors

  • Modest growth in HUMATE [® ] /HAEMATE [®] (vWF)

  • pdVIII competitive pressures

  • • MONONINE [®] to IDELVION [®] switches

Recombinant Coags +18%[1]

PD Coags (3%)[1]

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.

7

Specialty Products

Sales increased by 10%[1]

• 12%[1] growth • 12%[1] growth • Deeper • Capacity expansion penetration into broad hospital • New launches in EU segment 9% and Canada 10% US$1,697m • • Maintained 10%[1 ] growth global leadership position • 20%[1] growth • 5% growth • Supply normalised • Wound 9% decline healing • Return of competitor

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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Plasma Collections

Continue to grow plasma collection network

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40 new centres opened in the United States

ALL CENTERS REMAIN OPEN

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277 centres:

✓ 261 United States

✓ 8 Germany

  • ✓ 3 Hungary

  • ✓ 5 China

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Plan to open 20 - 30

new centres in FY21

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Plasma Collections

COVID-19 Impact

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Mitigation

Challenge

  • Plasma collections adversely impacted

• Collection centres designated ‘essential critical infrastructure’

  • FY20 plasma collection volume down ~5% v FY19

• FDA approved inventory hold reduction from 60 to 45 days

  • Utilisation of available finished goods inventory

  • Additional collection costs incurred

  • Potential to accelerate plasma collections

  • Enhanced marketing initiatives to increase collections

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Protecting Staff and Donors

Actions

  • Pre-assessment of potential donors

  • Re-direction of donors to sister centers if needed

  • Plasma designed social distancing

  • Enhanced cleaning & disinfectant procedures

  • ‘Safe passage’ letters provided to staff, donors and key vendors

  • Investing in new centres

10

Seqirus Revenue FY20 Revenue up 11%[1]

Therapy Sales
$m
Change1
%
QIV 542 27%
TIV 31 (53%)
Adjuvanted 379 30%
Other / In-licence 184 (11%)
Total Product Sales 1,136 14%
Pandemic 145 11%
Other Income 16 (64%)
Total Revenue 1,297 11%

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57%
Seasonal
Influenza 19%
vaccines
+21%
US$1.3B
11%
18%
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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.

11

Seqirus

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Operating Highlights

  • Strong result driven by ongoing product differentiation

  • Critical operations maintained during COVID pandemic

  • Real world evidence continues to demonstrate the potential for improved effectiveness of FLUCELVAX[®] & FLUAD[®]

  • Progression on fill and finish expansion projects

Looking Forward

  • COVID-19 driving demand:

  • ─ Increased supply into the US of up to ~60m doses for NH20/21

  • Fill & finish expansion:

  • ─ Liverpool operational from NH 21/22

  • ─ Holly Springs operational from NH 22/23

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Seqirus

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Operating Highlights

FLUCELVAX[®]

  • All strains manufactured using cellspecific seed for NH 2019/20 season

  • Launched in EU (9 years+)

FLUAD[®]

  • Ongoing preferred recommendations in UK and Australia

  • 65+ QIV launched in Australia; approved in US, EU and UK

Looking Forward

FLUCELVAX[®] :

  • Expanded paediatric in US and EU 2021

  • aQIVc to commence clinical trials NH20/21

  • FLUAD QIV[® ] : • US NH20/21 and EU NH21/22 launches

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AFLURIA[®]

  • QIV approved in Argentina and Germany

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R&D Highlights

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Immunology

  • HIZENTRA[®] Phase III DM study initiated

  • PRIVIGEN[®] Phase II SSc study initiated

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Hematology

  • CSL200 in SCD Phase I study initiated

  • CSL889 Hemopexin Phase I SCD study initiated

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Transplant

  • AAT for prevention of GvHD Phase III study enrolment into Cohort 2 completed

  • CSL acquired Vitaeris Inc. and Clazakizumab

  • HAEGARDA[®] Phase III HAE study in Japan initiated

  • PRIVIGEN[®] approved for PID & SID in Japan

  • Garadacimab Phase II HAE study results presented at EAACI Congress

  • FDA granted HIZENTRA[®] orphan drug exclusivity for CIDP; PRIVIGEN[® ] ODD and fast track designation for SSc

  • Alliance with Seattle Children’s Research Institute to develop stem cell gene therapies for PID ~~–~~ WAS and XLA

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Respiratory

  • CSL311 (Anti ~~-~~ Beta Common) Phase I study in mild asthmatic patients initiated

  • FDA granted CSL200 fast track designation

  • CSL889 Hemopexin ODD approved in EU for SCD

  • CSL agreed to acquire exclusive global license ~~-~~

  • rights to adeno associated virus gene therapy program, AMT ~~-~~ 061 EtranaDez for hemophilia B*

  • *The transaction with uniQure is subject to customary regulatory clearances before closing

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Cardiovascular & Metabolic

  • CSL112 (ApoA ~~-~~ 1) Phase III study (AEGIS ~~-~~ II) >9500 patients recruited

  • CSL112 AEGIS ~~-~~ II first futility analysis conducted; trial to continue as planned

  • Clazakizumab AMR study initiated

  • FDA granted Clazakizumab ODD and fast track designation

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Influenza Vaccines

  • First cell ~~-~~ based quadrivalent seasonal influenza vaccine, FLUCELVAX® TETRA, approval in Europe

  • US FDA approval of AUDENZTM ~~-~~ adjuvanted, cell ~~-~~ based influenza A (H5N1) pandemic vaccine

  • aQIVc (cell antigen + MF59) new product development commenced

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PREVENTION TREATMENT

COVID-19 Response

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||||||||
|---|---|---|---|---|---|---|
|Therapeutic|Vaccines|Hyperimmunes|Monoclonal|
|Options|Polyclonal|Antibodies|
|Antibodies|
|Collaborators|•|University of|•|Hyperimmunes|•|Academic clinical|
|Queensland|researchers|
|‐|
|Alliance with Takeda|
|•|Coalition for|and others|
|Epidemic|‐|
|Australian program|
|Preparedness|
|•|
|Innovations (CEPI)|Polyclonal: SAB|
|Therapeutics|
|Update|•|Partnership formed|•|Clinical manufacture|•|FPI achieved for first|
|to accelerate the|underway|mAb offering (CSL312)|
|development,|
|•|Clinical trial start|•|CSL324 IND|
|manufacture and|
|targeted for this|submitted June 20;|
|distribution of|
|quarter|FPI expected in 3Q20|
|vaccine|
|•|Vaccine to be|
|available in 2021 if|
|successful|

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PEOPLE

COVID-19 Summary

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  • Employees encouraged and supported to work remotely

  • Flexible and robust IT systems facilitate ongoing productivity

  • • Development of strict protocols to ensure the safety of our employees and donors

INNOVATION

COVID-19 presents some challenges however we remained focussed on strategy execution and continue to invest for growth.

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  • Focussed response leveraging the Company capabilities:

  • • Prevention ~~–~~ vaccine collaboration • Treatment:

  • Hyperimmune ~~–~~ Global, Australia and SAB

  • Pivoting Mabs and plasma products into ARDS patients

  • Paused clinical trials to recommence in FY21

  • • Products are used to treat serious rare diseases and often used chronically • Demand remains strong across the portfolio • Especially strong for IG & influenza vaccines

  • • Increased preference for home treatment driving HIZENTRA[®] demand • Recognised as an ‘essential’ business • All plasma centres remain open

DEMAND

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SUPPLY

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  • CSL Behring & Seqirus manufacturing facilities operational

  • Plasma collections adversely impacted by COVID ~~-~~ 19 pandemic

  • • Multiple initiatives underway to ensure patient supply of therapies

BALANCE SHEET

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  • Ongoing conservative approach to liquidity and leverage

  • Raised US$750 million via private placement, bolstering existing strong capital position

  • • Net debt to EBITDA 1.5x. Available liquidity $3.1 billion

  • • Credit ratings S&P A ~~-~~ , Moody’s A3

16

.

Financials David Lamont CFO

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Financial Highlights Net Profit After Tax

  • $2,247m

  • +17% @CC[1] GSP China Transition

  • @CC[1] FX$144m • Albumin sales reduction in line with guidance

  • • Profit effect in line with historical CSL Behring margin

  • +10%

  • reported Other Income • One-off $30m benefit

  • New lease standard • Balance sheet gross up

  • • P&L impact immaterial

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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Financial Highlights

CSL Group

Full year ended June
US$ Millions
FY19
Reported
FY20
Reported
FY20
at CC
1
FY20
at CC
1
Change
%
Total Revenue 8,539 9,151 9,295 9%1
Gross Profit 4,777 5,226 5,338 12%1
GP margin 56.0% 57.1% 57.4%
EBIT 2,504 2,717 2,877 15%1
EBIT margin 29.3% 29.7% 31.0%
NPAT 1,919 2,103 2,247 17%1
Cashflow from Operations 1,644 2,488 51%
ROIC 24.3% 21.6%
EPS ($) 4.24 4.63 4.95 17%1
DPS ($) 1.85 2.02 9%

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

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Financial Highlights

Segments

CSL Behring

Seqirus

US$
Millions
FY19
Reported
FY20
Reported
Change
% at CC
1
Change
% at CC
1
Sales 7,187 7,661 8%
Other
Revenue
156 193 24%
Total
Revenue
7,343 7,854 9%
Gross Profit 4,195 4,540 11%
GP margin 57.1% 57.8%
EBIT 2,351 2,451 11%
EBIT margin 32.0% 31.2%
Seqirus
US$
Millions
FY19
Reported
FY20
Reported
Change
% at CC
1
Sales 1,018 1,136 14%
Other
Revenue
178 161 (7%)
Total
Revenue
1,196 1,297 11%
Gross Profit 582 686 17%
GP margin 48.7% 52.9%
EBIT 153 265 74%
EBIT margin 12.8% 20.4%

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.

20

Financial Highlights

Reported Expenses

FY20 Change @ CC Change @ CC 1
$m $m %
Research &
Development
922 101 12
Sales & Marketing 896 39 5
General & Admin 692 48 8
Finance (Net) 144 (28) (17)
Tax 470 72 17
ETR % 18.3%

R&D

  • CSL112 phase III trial

  • CSL200 SCD gene therapy trial initiated

  • COVID-19 response

Finance (Net)

  • AASB16 adoption - $26m

  • YoY variation in Swiss debt costs $41m

Tax

  • Increase in-line with profit increase

  • FY21 ETR rate ~20-22%

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

21

Inventory Management[1]

Flexibility in the supply chain

$M

Key Insights

  • Continue to produce for demand

  • Inventory as a percentage of revenue steady

  • Seqirus inventory mix impacted by strain notification

1 Reported numbers

22

Capital Expenditure[1]

Investment to support demand

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$M Capex
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$B Sales
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Key Projects

  • Significant new manufacturing capacity

  • Additional plasma collection centers

  • ERP systems completed

  • Lengnau facility

  • −Thermo Fisher lease −Accelerates optimisation of facility capability

  • FY21 ~ $1.6 billion

1 Reported numbers

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Key Capital Projects

Completion Timeline

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FY20 FY21 FY22 FY23 FY24 FY25
ERP Systems
Tech
Enterprise Process Management
Kankakee
Marburg
Base Frac
Broadmeadows
Other Base Frac Modules
Bern IG
Bulk &
IG Modules
Finishing
Berinert / C1 Precipitate Capacity Increase
Lengnau
Other Plasma Centers (Continuous)
CSL 112
Fill & Finish – Liverpool
Seqirus Fill & Finish – Holly Springs
Biotech Facility
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Outlook for FY21[1]

Demand

  • Continued strong demand for plasma and recombinant products

  • Seqirus’ product differentiation and COVID-19 expected to drive strong demand for influenza vaccines

  • Albumin sales to normalize following GSP transition

Plasma Collections

  • COVID-19 restrictions expected to restrain plasma collections

  • Additional plasma collection costs

FY21[1] Outlook

Revenue Growth ~6 - 10% @CC[2]

  • Multiple initiatives underway to mitigate impact

R&D

  • COVID-19 response and new growth initiatives to drive uplift in investment towards the top end of prior guidance range[3]

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

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

  • 3 Previously provided R&D investment guidance of ~10-11% of revenue

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CSL Contacts

Mark Dehring VP Investor Relations  +61 3 9389 3407

Bernard Ronchi

Senior Manager, Investor Relations  +61 3 9389 3470

Stephen McKeon Associate Director, Investor Relations

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CSL Strategy and Values

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

Strategic
Overview
Patient Superior
Innovation Integrity Collaboration
Core Focus Performance
Values
We deliver on We turn innovative We walk the talk We are stronger We take pride in
our promise thinking into together our results
to patients solutions
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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.

Summary NPAT

Summary NPAT
Reportednetprofit after tax $2,102.5m
Translation currency effect (a) $ (1.0m)
Transaction currency effect (b) $ 60.1m
Foreign Currency (gains) & losses (c) $ 85.4m
Constant currency net profit after tax * $2,247.0m

a) Translation Currency Effect $(1.0m)

Average Exchange rates used for calculation in major currencies (Twelve months to June 20/June 19) were as follows: USD/EUR (0.90/0.87); USD/CHF (0.98/0.99).

b) Transaction Currency Effect $60.1m

Transaction currency effect is calculated by reference to the applicable prior year exchange rates. The calculation takes into account the timing of sales both internally within the CSL Group (ie from a manufacturer to a distributor) and externally (ie to the final customer) and the relevant exchange rates applicable to each transaction.

c) Foreign Currency Loss $85.4m

Foreign currency gains recorded during the period.

Summary Sales

Summary Sales
Reported sales $8,796.6m
Currency effect $ 141.2m
Constant currency sales* $ 8,937.8m
  • Constant currency net profit after tax and constant currency sales have not been audited or reviewed in accordance with Australian Auditing Standards.

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