CSL Ltd. — Interim / Quarterly Report 2017

Feb 14, 2017

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CSL Limited 2017 Half Year Results 15 February 2017

CEO – Paul Perreault CFO – David Lamont

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Legal Notice
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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; 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 or its affiliates.

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2

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Strategic Objectives
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Growth
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Efficiency
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Influenza
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Innovation
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People & Culture
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Maximize portfolio value & deliver new product launches

Be the most efficient, highest quality plasma player

Deliver on influenza strategy

Pursue new opportunities to diversify portfolio and enhance growth Create a culture that attracts, retains and develops the best talent

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Operational Highlights Growth
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CSL Behring

• Product sales up 18% @ constant currency[1]

• Strong take-up of Idelvion[®]

• Afstyla[®] approved by EC

• CSL 830 (Haegarda[®] ) – BLA accepted by US FDA

• CSL 112 – positive results from phase 2b trial

• Three new monoclonal antibodies enter phase 1 trials

• License agreement with Momenta to develop Fc multimer proteins

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

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Operational Highlights Growth
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Seqirus

• Afluria[®] Quadrivalent approved by US FDA

• Fluad[®] launched in the US

• First to market in US for seasonal influenza vaccines

Capital Management

• New US$550 million private placement completed

• New A$500 million share buy-back[1] underway

• ~11% complete[2]

1 CSL reserves the right to suspend or terminate buy-back at any time

2 As at 21 December 2016

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Sales Highlights Growth
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IMMUNOGLOBULINS
sales $1,426m +22% [1]
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HAEMOPHILIA
sales $514m +2% [1]
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SPECIALTY
sales $590m +25% [1]
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ALBUMIN
sales $433m +19% [1]
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SEQIRUS
revenue $620m +14% [1]
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Drivers

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Commentary

• Focussed sales & marketing efforts

• • CIDP indication in Europe

• • New patients, increasing home treatment

• Strong patient penetration of Idelvion[®] in US & EU

• • Transition from Helixate[®]

• • Restructured & fully established sales force

• • Increasing awareness and diagnosis of HAE

• • Enhanced sales & marketing efforts in China

• • Solid growth in Turkey & Brazil

• • More normal influenza season

• • Zostavax* public launch in Australia

• * Zostavax is a registered trademark of Merck & Co. Inc

• 1 Growth shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

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Growth
Market Share Growth
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M grams
US IG Market
80
70
60
50
40
30
20
10
0
2011 2012 2013 2014 2015 2016
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Hizentra[®]

• SCIG leadership

• CIDP indication anticipated in 2018

Privigen[®]

• EU label expansion - CIDP

Commercial Operations

• Enhanced capabilities, skills & focus

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7 Source: PPTA & CSL

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IG – Strategic Imperatives Growth
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US Plasma Collection Centres Efficiency
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centres
600
400
200
0
2012 2013 2014 2015 2016
Source: PPTA & CSL
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CSL leading growth

Growth

• CSL has opened approx. 70 centres in the last 3 years

Efficiency

• Collection centres take 2-3 years to be optimised

• Single integrated platform

• Donor payments increasing

• Plasma market tight

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Influenza
Seqirus
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Seqirus on track

• Organisational redesign

• Integrated processes

• Culture change

• •

• Full-year impact of product Deliver on Holly Springs launches - Step change in output

• • Flucelvax® QIV - Drive efficiency
• • Afluria® QIV • Optimise product portfolio
• • Fluad® - Fluad® growth

• • Optimise R&D spend - TIV to QIV

• • New information systems • Fill and finish facility at

• • Exit transitional services Liverpool agreements

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Innovation
Diversifying the Portfolio
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R&D Investment FY16 - $614m

New Product Development accounted for two thirds of R&D in FY16

• ~7% of sales

Protein Science focus

• Plasma based

• Recombinant technology

Three new monoclonal antibodies into Phase I trials

CSL Behring free cash flow funding future growth in Biotech

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Near Term Products Innovation
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2016	2017	2018	2019	2020	2021
PRIVIGEN®	PRIVIGEN®	HIZENTRA®	HIZENTRA®
IsoLo	CIDP US	CIDP US/EU	CIDP Japan
			PRIVIGEN®
			Japan PID/SID
IDELVION® US	AFSTYLA®				CSL689 rVIIa-FP
IDELVION® EU	EU/Japan				Prophylaxis
					CSL689 rVIIa-FP
IDELVION® Japan					On Demand
AFSTYLA® US
	CSL830	CSL830
	HAEGARDATM US	EU
	KCENTRA®
	Japan
AFLURIA® QIV	AFLURIA® QIV	AFLURIA® QIV	AFLURIA® QIV
18+ US & AUS	5-17yr US	6m-5yr US	6m-5yr AUS
FLUAD® TIV	AFLURIA® QIV	FLUAD® QIV	QIV
65+ US	5-17yr AUS	6m-5yrs US	EU
FLUCELVAX®
QIV 4+ US

Core Capabilities:

• Calendar Years

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Immunoglobulins
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Haemophilia
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Specialty Products
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Vaccines & IP
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Innovation
R&D Update
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Collaboration and License Agreement with Momenta for recombinant Fc mimetic molecules

• Neurological indications treated by Ig are mediated by the Fc portion of Ig molecule

• M230 is a trimeric Fc construct and a selective immunomodulator of Fc receptors

• Plan to start Phase I clinical trial this year

• Research collaboration for additional Fc multimer proteins

Investment in the newly established A$230 million Biomedical Translation Fund

• Largest life sciences fund in Australia, managed by Brandon Capital Partners

Launch of A$25 million CSL Centenary Fellowships

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Global Workforce People &
Culture
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Financials CFO – David Lamont

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Financial Highlights Growth
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Revenue $3.7 billion, up 17% (up 18% @CC[1] ) EBIT $1,095 million

• Underlying[2] EBIT up 38% @CC NPAT $806 million

• Underlying NPAT up 36% @CC EPS $1.77

• Underlying EPS up 39% @CC Interim dividend increased to $0.64

1 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability of operational performance. See end note for further detail. 2 Underlying excludes from PCP financials the one-off items relating to the Novartis influenza vaccines business (NVS-IV), which was acquired on 31 July 2015.

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Margin Development Growth
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%
50 EBITDA
Margin
40
30
20
10
0
1H11 2H11 1H12 2H12 1H13 2H13 1H14 2H14 1H15 2H15 1H16 2H16 1H17
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1H17

• Sales growth, especially specialty products

• Seqirus – turnaround progress

Outlook[1]

• Margin to continue to benefit from transition to rCOAGs

• Portfolio mix benefits, especially with specialty product growth

• Ongoing Seqirus turnaround activity

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

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Debt Maturity Profile Efficiency
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$m Private Placement Bank Debt New Private Placement
800 New US$550m private placement
•
Completed October 2016
•
Weighted average fixed rate of 3.0%
600
•
Average life of 12.5 years
New bank debt facility
•
400 A$350m with maturity of 3 years
Total debt portfolio
•
Weighted average rate of ~2.5%
200 Liquidity
•
Total liquidity $1,581m
•
Total undrawn facilities $697m
0
•
Cash $884m
FY17 FY18 FY20 FY21 FY22 FY23 FY24 FY25 FY26 FY27 FY28 FY29 FY30 FY31 FY32
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• Weighted average fixed rate of 3.0%

• A$350m with maturity of 3 years

• Total debt portfolio

• Weighted average rate of ~2.5%

• Liquidity

• Total undrawn facilities $697m

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Notable Items
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Change in presentation of Financial Statements

• Alignment with internal reporting

• Expands revenue disclosure on face of P&L

• New segment disclosure – including gross profit

Expenses

• Phasing of R&D skewed towards 2H

• Borrowing costs up in line with debt levels

• Tax - product mix shift giving rise to higher 1H ETR

• anticipate ~20 to 22% ETR for FY17

Seqirus

• Gross profit skewed to 1H in line with northern hemisphere influenza vaccine sales

• Indicative Seqirus sales 75% / 25% - 1H / 2H. Costs even over year

• 1H16 includes only 5 months NVS-IV financials (acquired 31 July 2015)

  • Impacts expenses but July is typically a low sales month

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Outlook for FY17 [1] Growth
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NPAT growth[2] ~ 18-20% @ CC[3] EPS growth to exceed NPAT growth

Outlook for remainder of FY17

• Continued strong demand for plasma therapy products

• Ongoing growth in rCOAGs sales contribution

Uneven profit profile between 1H and 2H arising from –

• Competitor product supply returning

• Seasonality of the Seqirus business

• Timing of expenses, particularly research and development

• Momenta agreement

• Timing of payments from partners

Near term R&D highlights

• Planning for CSL 112 (apoA-I) Phase III continuing

• • Haegarda[®] approval anticipated in 1H FY18

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

2 Excludes one-off gains and costs (net $90m) relating to the acquisition of NVS-IV from FY16

3 Constant Currency (CC) removes the impact of exchange rates movements to facilitate comparability

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20

Financial Appendix

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Group Results
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roup Results
Half year ended December US$ Millions	Dec 2015 Reported Dec 2015 Underlying2 Dec 2016 Reported Dec 2016 at CC1 Underlying2 Change %
Sales Other Revenue / Income Total Revenue / Income	3,031 105 3,136 3,031 105 3,136 3,553 123 3,677 3,563 127 3,690 17.6% 17.7%
Earnings before Interest, Tax, Depreciation & Amortisation Depreciation/Amortisation Earnings before Interest and Tax Gain on Acquisition Net Interest Expense Tax Expense Net Profit after Tax NVS-IV one-off (gain)/costs3 Underlying Net Profit after Tax Interim Dividend EPS	848 917 1,226 1,254 36.8% (102) 746 (102) 815 (131) 1,095 (133) 1,121 37.6% 176 (27) (176) - (27) (181) - (38) (251) - (39) (255)
	719 607 806 827 36.2% (112) - -
	607 607 806 827 36.2%
	0.58 1.55 0.58 1.31 0.64 1.77 1.81 10.3% 38.6%

1 Constant Currency (CC) removes the impact of exchange rate movements to facilitate comparability of operational performance. 2 Underlying excludes from 1H16 financials the one off items relating to the Novartis influenza vaccines business (NVS-IV), which was acquired on 31 July 2015 3 NVS-IV one-off comprises gain on acquisition of $176m & one-off costs of $64m (@NPAT line).

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CSL Behring Sales
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Half year ended December US$ Millions	Dec 2015 Dec 2016 Dec 2016 CC1 Change %
Immunoglobulins Albumin Haemophilia - Recombinants - Plasma Specialty Total Product Sales Other sales (mainly plasma) Total Sales	1,181 376 203 306 466 1,426 433 232 282 590 1,442 447 233 287 584 22% 19% 15% (6%) 25%
	2,532 2,963 2,992 18%
	5 2,537 13 2,976 13 3,006

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

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FY17 Financial Guidance
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	CSL GROUP	CSL GROUP
Full year ended June US$ Millions	FY16 Actual	FY17 Guidance1
Reported Net Profit after Tax NVS-IV one-offs3 Underlying NPAT	1,242 (90) 1,152	~18-20% growth @CC2
FX Impact4 ~(50M)

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 Comprises gain on acquisition ~$176.1m & one off acquisition related costs of $86.6m (@NPAT line) 4 Assumes current rates remain steady for the remainder of the year

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Notes - 1
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(#) 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 (foreign currency effect). The sum of translation currency effect, transaction currency effect and foreign currency effect is the amount by which reported net profit is adjusted to calculate the result at constant currency.

Summary NPAT adjusted for currency effects Reported net profit after tax $805.5m Translation currency effect (a) $(4.3m) Transaction currency effect (b) $3.1m Foreign Currency losses (c) $22.2m Constant currency net profit after tax * $826.5m

a) Translation Currency Effect NPAT $(4.3m)

Average Exchange rates used for calculation in major currencies (six months to Dec 16/Dec 15) were as follows: USD/EUR (0.91/0.91); USD/CHF (0.99/0.97).

b) Transaction Currency Effect NPAT $3.1m

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 Effect NPAT $22.2m

Foreign currency losses during the period as recorded in the financial statements.

Summary Sales Reported sales $3,553.4m Currency effect $9.0m Constant currency sales (Group) $3,562.4m

• Constant currency net profit after tax and sales have not been audited or reviewed in accordance with Australian Auditing Standards.

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25

Business Unit Appendix

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CSL Behring
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Product Sales up 18% @CC

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$M
$2,963m
3,000
$2,532m
2,500
2,000 Immunoglobulins
1,500
Haemophilia
1,000
Specialty
500
Albumin
0
Dec 15 Dec 16
Reported sales for the 6 month period
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Immunoglobulins
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Sales up 22% @CC
$M
Highlights
1,500 $1,426m IVIG – Privigen [®] up 34%
•
acute segment
$1,181m SCIG
•
•
Operational capacity
•
1,000
•
•
IVIG
500
SCIG – Hizentra [[®]] up 14%
•
pharmacies
0 Hyper IG • New market entrant
Dec 15 Dec 16
Reported sales for the 6 month period
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• Market growth in hospital segment and nonacute segment

• Focussed sales and marketing efforts

• Operational capacity

• Competitor supply constraints

• Successful launch in Turkey

• CIDP indication in Europe continuing to underpin strong growth

SCIG – Hizentra[[®]] up 14%

• New patients, increasing home treatment and selective partnering with key speciality pharmacies

• New market entrant

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Haemophilia
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Sales up 2% @CC

$M

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600
$509m $514m
400
rCOAGs
200
pd COAGS
0
Dec 15 Dec 16
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Highlights

rCOAGs up 15%

• Strong uptake of Idelvion[®] in US and EU

• Growth offset to some extent by decline in Helixate[®]

pdCOAGs down 6%

• Phasing of Russian tender

• Lower share of Polish tender

• Volatility in surgical and ITT usage

Reported sales for the 6 month period

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Specialty
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Sales up 25% @CC $M

Highlights

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$590m
600
Kcentra [[® ]]
•
$466m
Acquired force
Bleeding •
400
Berinert [[® ]]
•
HAE
HAE
200 •
AATD Beriplast [®]
Other •
0
Dec 15 Dec 16
Reported sales for the 6 month period
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Kcentra[[® ]] / Beriplex[®]

• Restructured and fully established sales force

• Deeper penetration into hospital market

Berinert[[® ]] P

• Increasing awareness and diagnosis of HAE

• Competitor product supply disruption

• Strong increase in Japan

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Albumin
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Sales up 19% @CC
$M
500
$433m
400 $376m
300
200
100
0
Dec 15 Dec 16
Reported sales for the 6 month period
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Highlights

China

• 35% sales growth

• Enhanced sales, marketing and distribution efforts

• Expanded market access into Tier 2 & 3 cities and new hospital listings

Solid sales growth in Turkey and Brazil

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Seqirus
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$M Revenue up 14% @CC
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Highlights

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800
$620m
600
$532m
400 Influenza
200
Pharma
& vaccines
0
Dec 15 Dec 16
Reported sales for the 6 month period
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• Influenza revenue $464 million

• Flucelvax[®] QIV launched in US

• Afluria[®] QIV approved in US and Australia

• First to market in US for influenza vaccines

• Zostavax* launched in public market in Australia

* Zostavax is a registered trademark of Merck & Co. Inc

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32