CSL Ltd. — Interim / Quarterly Report 2021

Feb 17, 2021

For immediate release 18 February 2021

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RESULTS PRESENTATION FOR THE HALF YEAR ENDED 31 DECEMBER 2020

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 Interim 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 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: mark.dehring@csl.com.au

Christina Hickie

Senior Manager, Communications P: +61 429 609 762 E: Christina.Hickie@csl.com.au

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CSL Limited 2021 Half Year Results 18[th] February, 2021

Paul Perreault John Levy CEO and MD Interim 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.

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Highlights[1]

Revenue up 15% with net profit after tax up 44%

CSL Behring

Seqirus

• EBIT +24%

• EBIT +112%

• HIZENTRA[® ] +19%

• Seasonal influenza vaccines +44%

• Gross margin up strongly

• ALBUMIN +93%

• HAEGARDA[®] +16%

• Next generation influenza vaccine manufacturing facility to be constructed in Australia

• COVID-19 vaccine manufacturing

Critical operations maintained during COVID-19 pandemic

• The COVID-19 pandemic has tempered the performance of CSL Behring whilst boosting the performance of Seqirus

• Plasma collections continue to be challenging however multiple initiatives driving improvement

• CSL is well placed to emerge strongly when the COVID-19 crisis recedes

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3 Driven by Our Promise TM 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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CSL Behring Sales up 11%[1]

Therapy	Sales $m	Change1 %
Immunoglobulins	2,157	7%
- IVIG	1,403	2%
- SCIG	754	19%
Albumin	546	93%
Haemophilia	563	1%
- Recombinants	336	5%
- Plasma	227	(5%)
Specialty	899	3%
- Peri-Operative Bleeding	431	3%
- Other Specialty	468	3%
Other2	91	(12%)
Total	4,256	11%

Region[1]

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2%
ROW
79% 7%
Asia Pac
15%
US$4.3B
North
America 5%
11% 50%
4%
EU
28%
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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 7%[1]

• Growth continues to be driven by chronic indications - PID, SID, CIDP

• Strong growth in HIZENTRA[®] +19%[1] driven by:

• −Preference for home treatment and innovation:

Market

• Global Ig demand remains strong

• Flexible dosing

• Pre-filled syringes

  • COVID-19 intensifying supply tightness

• Expanded indications

• Continued uptake for CIDP in US:

• −Orphan exclusivity

   - Customer fulfilment process implemented to ensure equitable distribution
  

• −60% of targeted physicians have now adopted HIZENTRA[®] to treat CIDP

• Modest growth in PRIVIGEN[®]

  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 up 93%[1]

• China:

• −Sales normalised following successful transition to GSP

• −Maintained market leadership

• −COVID-19 reduced hospital operations:

  • Now returned to ~90% of ‘normal’

Potential growth drivers

• Preference for albumin over artificial colloids

• −Increasingly competitive environment

• −Market volume demand outlook mid to high single digits

  • Increased utilization in liver cirrhosis

• Other major markets:

• −Strong growth in EU and emerging markets, US flat

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 1%[1]

• IDELVION[®] +6%[1]

• −Compelling clinical profile continuing to drive patient demand

• AFSTYLA[®] sales flat[1]

• −Competitive market

• HUMATE[®] +6%[1]

• Market leader in the US for vWF

Growth tempered by reduced doctor visits during COVID-19 pandemic

• Demand for BERIATE[®] & HAEMATE[®] continues to decline due to competitive pressure

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 3%[1]

HAE

Hospital Products

ALPHA-1 -7%

• HAEGARDA[®] +16%[1]

• KCENTRA[®] +6%[1]

  • ZEMAIRA[®]

• −New patients and patient switches

• −New launches in EU & Australia exceeding expectations

• BERINERT[®] flat

• Wound healing -26%[1]

• RIASTAP[®] flat

Growth tempered by reduced elective procedures and trauma during COVID-19 pandemic

decline in US following supply interruption

• RESPREEZA[®]

very strong growth in EU following successful launches. Self administration proving very attractive

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

CHALLENGES

• Plasma collections adversely impacted by COVID-19

• Stimulus packages in the US

• Collection volumes:

• −Dec 20 ~80% v Dec 19

• Additional collection costs incurred

INITIATIVES

• Enhanced targeted marketing initiatives to increase collections

• Adoption of new technology

• Satisfy donors with a positive experience

• Roll out of COVID-19 vaccine to increase mobility

• Plasma hold period reduced from 60 to 45 days

• Utilisation of available finished goods inventory

• Industry leader in new collection centres:

• −17 new centres opened in 1H21

• −12 new centres to be opened in 2H21

• −The largest and most efficient centres in industry

• As volumes recover, cost per litre of plasma reduces

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Plasma Collections

Initiatives driving donor growth

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DONORS PER WEEK
Annual tax
season drop
Holiday
Season
Pandemic and
lockdowns begin
Initiatives launched
JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV DEC
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Seqirus Revenue Revenue up 38%[1]

Region[1]

Therapy	Sales $m	Change1 %
QIV	669	31%	Seasonal
TIV	22	(28%)	Influenza
			vaccines
Adjuvanted	563	70%	+44%
Other / In-licence	86	5%
Total Product Sales Pandemic	1,340 77	40% 4%
Other Income Total Revenue	8 1,425	83% 38%

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17%
9%
Asia Pac
6%
EU
US$1.4B
64% 21%
38% North 38%
America
72%
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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

• Significant growth in seasonal influenza vaccines

• Record number of doses NH 20/21 >100m

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• Ongoing portfolio shift to differentiated products

• FLUCELVAX[®] & FLUAD[®]

• Re-launch of business in Germany

• FLUAD[®] QIV launched in the US

• Provided support for COVID-19 vaccines and supply of MF59

COVID-19 pandemic Driving high demand for influenza vaccines

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R&D Highlights

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Immunology

• HIZENTRA[®] 5-, 10- & 20-mL pre-filled syringes launched in US

• PRIVIGEN[®] for CIDP launched in Japan

• PRIVIGEN[®] label update approved in EU

• HAEGARDA[®] US FDA approval for HAE in patients 6+years

• HAEGARDA[®] received ODD in Japan

• Garadacimab Phase I study in Japan initiated

• CSL324 (anti-G-CSFR) Phase 1 in Japan initiated

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Hematology

• uniQure announced data from Phase III trial of EtranaDez

• CSL889 Hemopexin ODD approved in EU and US

• CSL889 Hemopexin (SCD) fast track designation approved by US FDA

• IDELVION[®] 21 day extended dosing option approved in Japan

• Recombinant FIX approved in Mexico as IDELVIAN

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Respiratory

• Nebulised Ig Phase 1 study initiated

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Cardiovascular & Metabolic

• CSL112 (ApoA-1) Phase III study (AEGIS-II) >11,500 patients enrolled, successful completion of first futility analysis

• CSL346 (Anti-VEG-B) diabetic kidney disease Phase II study initiated

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Transplant

• Last patient dosed in Part 1 of CSL964 for prevention of GvHD study

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Influenza Vaccines

• Commencement of aQIVc Phase 2 study

• Pre-clinical assessment of mRNA technology for influenza

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R&D: COVID-19 Response

• Re-prioritisation of R&D projects:

• COVID-19 vaccine collaborations:

  • University of Queensland UQ 451 – significant scale up to support Australian and international populations

• Redeployment and recruitment of personnel

• Paused and recommenced clinical trials

• Oxford University / AstraZeneca AZD 1222

• Pivot mabs and plasma products into ARDS

• Extensive re-tooling of facilities

• CoVIg-19 Plasma Alliance - hyperimmune

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At CSL’s facility in Broadmeadows, bulk concentrated vaccine is frozen and stored in CryoVaults.

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.

Financials John Levy Interim CFO

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Financial Highlights Net Profit After Tax

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$1,248 m
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+45% $1,810m reported FX$16m $1,794 m @CC[1] +44% @CC[1]

GSP China License

• Transition complete - sales of albumin normalised

Seqirus

• COVID -19 driving strong demand

• Growth of differentiated products

• Manufacturing efficiencies

COVID-19

• Vaccine response

• Opex savings

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

US$ Millions	1H20 Reported	1H21 Reported	1H21 at CC	1	Change %
Total Revenue	4,911	5,739	5,653		15%1
Gross Profit	2,842	3,472	3,423		20%1
GP margin	57.9%	60.5%	60.6%
EBIT	1,632	2,358	2,321		42%1
EBIT margin	33.2%	41.1%	41.1%
NPAT	1,248	1,810	1,794		44%1
Cashflow from Operations	1,238	2,321			87%
Capex	704	609			(13%)
EPS ($)	2.75	3.98	3.95		44%1
DPS ($)	0.95	1.04			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

US$ Millions	1H20 Reported	1H21 Reported	Change % at CC 1	Change % at CC 1
Sales	3,768	4,256	11%
Other Revenue	125	59	(54%)
Total Revenue	3,893	4,315	9%
Gross Profit	2,278	2,539	10%
GP margin	58.5%	58.8%
EBIT	1,289	1,665	24%

Seqirus

Seqirus
US$ Millions	1H20 Reported	1H21 Reported	Change % at CC 1
Sales	941	1,340	40%
Other Revenue	77	85	7%
Total Revenue	1,018	1,425	38%
Gross Profit	564	933	64%
GP margin	55.4%	65.5%
EBIT	343	693	112%

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

US$ Millions	1H20 Reported	1H21 Reported	Change $m	@ CC %	1
Research & Development	446	427	(24)	(5%)
Sales & Marketing	435	415	(25)	(6%)
General & Admin	329	273	(58)	(18%)
Finance (Net)	71	107	7	9%
Tax	313	441	136	43%
ETR %	20%	20%

R&D

• COVID-19 vaccine cost recovery

• Portfolio prioritisation

• • FY21 R&D ~10-11% of

• revenue

Sales & Marketing

• COVID-19 related cost savings

General & Admin

• Cost control initiatives

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

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Outlook 2H21[1]

FY21 result will be heavily skewed to the first half

2H21 CONSIDERATIONS

Seqirus

• ~80% of sales in 1H, with COGS falling more evenly over the year giving rise to a loss in 2H, consistent with seasonality

Behring

• Albumin sales now more normalised after the transition to the new business model in China

• Reduced plasma collections in COVID-19 environment leading to constrained sales and elevated COGS

Expenses

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FY21 [1] Outlook
Guidance
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• R&D investment uplift following portfolio re-prioritization in the first half. FY21 R&D expense ~10-11% of revenue, in line with guidance

• SG&A expected to grow as COVID-19 recedes & social mobility improves

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

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Outlook[1]

FUTURE / MID TERM CONSIDERATIONS

• Underlying IG demand expected to remain strong

• FY22 IG & albumin sales reliant on current plasma collections and cycle times

• Collections expected to improve with CSL plasma initiatives and COVID-19 vaccine rollout

• As the COVID 19 pandemic recedes and social mobility increases, growth in doctor visits, elective and emergency procedures are expected – leading to growth in product demand

• Multiple large, late stage R&D programs are underway providing potential new growth opportunities

“CSL is well placed to emerge strongly when the COVID-19 crisis recedes”

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

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CSL Contacts

Mark Dehring VP Investor Relations  +61 3 9389 3407

 mark.dehring@csl.com.au

Bernard Ronchi

Associate Director, Investor Relations  +61 3 9389 3470

• bernard.ronchi@csl.com.au

Stephen McKeon Associate Director, Investor Relations

• +61 3 9389 6798

• stephen.mckeon@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

Summary NPAT
Reportednetprofit after tax	$1,810.0m
Translation currency effect (a)	$ (15.8m)
Transaction currency effect (b)	$ (4.1m)
Foreign Currency (gains) & losses (c)	$ 4.3m
Constant currency net profit after tax *	$1,794.4m

a) Translation Currency Effect $(15.8m)

Average Exchange rates used for calculation in major currencies (6 months to Dec 20/Dec 19) were as follows: USD/EUR (0.85/0.90); USD/AUD (1.40/1.46); USD/CHF (0.92/0.99); USD/CNY (6.83/7.02).

b) Transaction Currency Effect $(4.1m)

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 $4.3m

Foreign currency gains recorded during the period.

Summary Sales

Summary Sales
Reported sales	$5,596.1m
Currency effect	$ (84.0m)
Constant currency sales*	$5,512.1m

• 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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