CSL Ltd. — Interim / Quarterly Report 2020

Feb 11, 2020

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For immediate release 12 February 2020

RESULTS PRESENTATION FOR THE HALF YEAR ENDED 31 DECEMBER 2019

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 Chief Financial Officer shortly.

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

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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: mark.dehring@csl.com.au

Jemimah Brennan

Head of Communications, Asia Pacific P: +61 412 635 483 E: jemimah.brennan@csl.com.au

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CSL Limited

2020 Half Year Results 12 February 2020

Paul Perreault, CEO and MD David Lamont, CFO

LEGAL NOTICE

Forward looking statements

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. CSL Group is also involved in multiple litigations in the ordinary course of business. 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.

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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.

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1H20 Performance

A strong half year for CSL with revenue up 11%[1] and net profit after tax up 11%[1] reflecting:

• Strong growth in immunoglobulin portfolio

• Transition to own distribution model in China progressing well

• Continued evolution of the haemophilia portfolio

• Strong performance from Seqirus

CSL BEHRING

• PRIVIGEN[® ] +28%[1]

• HIZENTRA[® ] +37%[1]

• ALBUMIN -33%[1] (GSP IMPACT)

• AFSTYLA[®] +30%[1]

• IDELVION[®] +21%[1]

• ZEMAIRA[® ] +31%[1]

SEQIRUS

• Seasonal influenza +16%[1]

• FLUCELVAX[®] launched in EU

• FLUAD[®] preferred recommendations in UK & Australia

• Positive real world effectiveness evidence continuing

• Commenced aQIVc development

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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 1H20

Therapy	Sales $m	Change1 %
Immunoglobulins	1,985	26%
- IVIG	1,361	21%
- SCIG	624	37%
Albumin	278	(33%)
Haemophilia	550	4%
- Recombinants	314	13%
- Plasma	236	(5%)
Specialty	851	7%
- Peri-Operative Bleeding	411	11%
- Other Specialty	440	3%
Other2	104	5%
Total	3,768	10%

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REGION [1]
26%
ROW
32%
(incl. GSP) Asia Pac 17%
North
US$3.8b America
10%
Europe
15%
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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 26%[1]

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• 28% growth[1]

• Growth drivers

• CIDP indication

• Competitor supply challenges

• Tender markets

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• 37% growth[1]

• Growth drivers

• New patient starts in PID

• CIDP indication

• Competitor supply challenges

• Mix shift

• Convenience

Industry

• Global Ig demand exceeding supply

Demand drivers

• Increased disease awareness & improved diagnosis

• Increased usage for chronic therapies

• CIDP indication

• Expanding usage for SID

Lyophilised Ig phased out

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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Albumin Sales down 33%[1]

• Double digit sales growth in Europe & Emerging Markets

• US sales up 5%[1]

Transition to Good Supply Practices (GSP) license in China

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• China sales impacted by one-off transition to new distribution model

Benefits

• Transition progressing well with sales commenced under new model

• Sales impact consistent with previous guidance

• No impact on supply to patients

• Strong underlying growth in China continues

• Achieved Chinese regulatory approval for AlbuRx[®] from Kankakee

• Improved participation in value chain

• Ability to work directly with clinicians

• Reduces reliance on 3rd parties

• CSL becomes a Tier 1 distributor

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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Haemophilia

Sales up 4%[1]

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• 21% growth[1]

• Strong growth in US

• Highest rates of switches globally

• 30% growth[1]

• Strong growth in US

• Patient retention and ongoing switches driving growth

Plasma Coagulation Factors

• Modest growth in VWF in US

• Tender variability

• Competitive pressures

HELIXATE[®] phased out

Recombinant Coags +13%[1]

PD Coags -5%[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.

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Specialty Products Sales up 7%[1]

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3%
Peri-
11% Other
Operative
US$851m Specialty
Bleeding
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• Continued patient growth

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• Capacity improvement in place

• New launches planned

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• Modest growth

• Wound Return of competitor •

• Healing Sales normalised

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• 31% growth

• Supply normalised

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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Seqirus Revenue 1H20 Revenue up 9%[1]

Sales $m % Change1	Sales $m % Change1
QIV 507 21%
TIV 30 (50%)
Adjuvanted 325 21%
Other / In-licence 80 (31%)
Total Product Sales 941 9%
Pandemic 72 14%
Other Income 5
Total Revenue 1,018 9%

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REGION [1]
60%
Seasonal
Influenza
ROW
vaccines 5%
+16% [1]
Asia Pac
US$1,018m North
America 10%
25% Europe
9%
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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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Seqirus – Operating Highlights

FLUCELVAX[®]

• All strains manufactured using cell-specific seed for NH 2019/20 season

• Launched in EU (9 years+)

FLUAD[®]

• Retention of preferred recommendations in UK and Australia

• QIV approved in Australia

FLUCELVAX[®]

• To launch in Australia SH21

aQIV

• To launch in Australia SH20

• US & EU registration anticipated in CY2020

• US launch NH20/21; EU launch anticipated NH21/22

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Seqirus – Operating Highlights

• US FDA approval of AUDENZ[TM] - world’s first adjuvanted, cell-based influenza A (H5N1) pandemic vaccine

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

• US Executive Order, calling for modernisation of influenza vaccines

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R&D Highlights

Immunology and Neurology	•HIZENTRA® granted Orphan Drug Exclusivity for CIDP •HIZENTRA® Dermatomyositis (DM) Phase III Study initiated •Garadacimab (Anti-FXIIa) in Hereditary Angioedema (HAE) Phase II double blind period complete
•CSL200 (CAL-H) in Sickle Cell Disease (SCD) Phase I Study initiated •CSL889 Hemopexin in SCD Phase I Study initiated Haematology and Thrombosis
Respiratory	•CSL311 (Anti-Beta Common) Phase I study commenced •Approval of convenient single-vial dosing for ZEMAIRA®(Alpha1-Proteinase Inhibitor) in the US
•CSL112 (ApoA-1) Phase III study (AEGIS-II) progressing well with >7000 patients recruited Cardiovascular and Metabolic
Transplant	•CSL964 Alpha-1 Antitrypsin (AAT) for prevention of Graft versus Host Disease (GvHD) after Transplantation of Allogenic Hematopoietic Cell Transplantation (HCT) Phase III study actively recruiting and on track
Influenza Vaccines	•First cell-based quadrivalent seasonal influenza vaccine, FLUCELVAX® TETRA, approved in Europe •AFLURIA® QUAD (quadrivalent influenza vaccine) granted expanded indication for use in children 6M+ in Australia •aQIVc (MF59 plus FLUCELVAX® antigen) new product development commenced

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Financials David Lamont, CFO

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Financial Highlights Net Profit After Tax

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+11%
$1,292m
@CC [1]
@CC [1]
FX $44m
$1,248m
$1,161m $1,161m
1H19
1H19 1H20
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GSP transition in China

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•
Financial impact split
evenly 1H v 2H
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Other income
•
One-off benefit $30m
New Lease Standard
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• 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

Half year ended Dec	1H19	1H20	1H20	Change
US$ Millions	Reported	Reported	at CC1	%
Total Revenue	4,505	4,911	4,980	11%1
Gross Profit	2,623	2,842	2,891	10%1
GP margin	58.2%	57.9%	58.0%
EBIT	1,553	1,632	1,679	8%1
NPAT	1,161	1,248	1,292	11%1
Cashflow from Operations	535	1,245		133%
Capex	539	685		27%
EPS ($)	2.56	2.75	2.85	11%1
DPS ($)	0.85	0.95		12%

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

Segments

CSL BEHRING

US$ Millions	1H19 Reported	1H20 Reported	Change % at CC1
Sales	3,468	3,768	10%
Other Revenue	88	125	42%
Total Revenue	3,556	3,893	11%
Gross Profit	2,117	2,278	10%
GP margin	59.5%	58.5%
EBIT	1,249	1,289	7%

SEQIRUS

US$ Millions	1H19 Reported	1H20 Reported	Change % at CC1
Sales	874	941	9%
Other Revenue	75	77	4%
Total Revenue	949	1,018	9%
Gross Profit	506	564	10%
GP margin	53.3%	55.4%
EBIT	304	343	13%

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

Reported Expenses

	1H20	Change	at CC1
	$m	$m	%
Research & Development	446	61	16	CSL 112
Sales & Marketing	435	18	4	Down 1%1 on trailing period
General & Admin	329	63	24	Facilities expansion & new technology
				Staff up 10% on pcp
Finance (Net)	71	(24)	(26)	FX unfavourable $35m pcp AASB 16 - $13m
Tax	313	19	6

1. Constant currency removes the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail.

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Guidance Upgraded – FY20 growth 10-13%[1,2]

Strong growth in 2H20 compared to pcp

Business expectations 2H20

• Continued strong demand for CSL’s therapies

• One-off effect on albumin sales arising from transition to new distributor model in China

• Seqirus seasonality (loss making 2H)

FY20 NPAT

• ~$2,110m to $2,170m @CC[2,3]

• Includes impact of China GSP transition

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~8-16%
@CC [2]
2H 2H
Implicit 2H
growth on
pcp
1H 1H
FY19 FY20
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FY19
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Guidance [2]
~$2,110m -
$2,170m
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• 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 Full year FX impact expected to be $70 million unfavourable assuming exchange rates remain steady for the remainder of the financial year

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Strategy

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• Technology
• Process
Improvement
• Operational
Excellence
•• ProductsDelivery • Capital Project Growth Platforms: • Plasma
• Services Execution • Recombinants
• Technology • Cell & Gene Therapy
• Influenza Vaccines
• Immunology
& Neurology
• Haematology
& Thrombosis • Connected
• Transplant Healthcare
• Respiratory • New
• Cardiovascular Capabilities
& Metabolic
• Influenza
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CSL Limited Contact Mark Dehring VP Investor Relations

• +61 3 9389 3407

• mark.dehring@csl.com.au

Bernard Ronchi Senior Manager, Investor Relations

• +61 3 9389 3470

• bernard.ronchi@csl.com.au

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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

Reported net profit after tax $1,248.0m Translation currency effect (a) $ 3.0m Transaction currency effect (b) $ 22.4m Foreign Currency (gains) & losses (c) $ 18.1m Constant currency net profit after tax * $ 1,291.5m

a) Translation Currency Effect $3.0m

Average Exchange rates used for calculation in major currencies (six months to Dec 19/Dec 18) were as follows: USD/EUR (0.90/0.86); USD/CHF (0.99/0.99).

b) Transaction Currency Effect $22.4m

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 $18.1m

Foreign currency gains recorded during the period.

Summary Sales Reported sales $4,709.4m Currency effect $ 67.8m Constant currency sales* $ 4,777.2m

• 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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