CSL Ltd. — Investor Presentation 2016

Mar 13, 2016

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14 March 2016

Australian Securities Exchange

Seqirus Presentation to Investors/Analysts

Please see attached presentation to investors/analysts given by:

• Gordon Naylor, President, Seqirus

• Russell Basser, SVP R&D, Seqirus

• Brent MacGregor, SVP Commercial Operations, Seqirus

during a site tour of the Seqirus influenza vaccine manufacturing facility at Liverpool, England on Friday, 11 March 2016. An investor/analyst visit to the Seqirus influenza vaccine manufacturing facility at Holly Springs, USA will also take place on Monday, 14 March 2016.

Edward Bailey Company Secretary

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INVESTOR / ANALYST SITE TOUR

11[th] March 2016 LIVERPOOL

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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 including Seqirus (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.

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INTRODUCTION Gordon Naylor, President

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The global burden of seasonal influenza remains high

Each year, influenza related illness:

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• Attacks 5%–10% of adults and 20-30% of children globally[1 ]

• Causes 3 million – 5 million cases of severe illness[1 ]

• Causes up to 500,000 deaths annually[1 ]

• All countries are affected

• Significant economic costs: Medical care and lost labour in the US alone costs up to USD $17bn annually

Northern hemisphere Influenza peak: November–March

Tropics Year-round activity

Southern hemisphere Influenza peak: April–September

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4 1. Influenza. World Health Organization Web site 2014. http://www.who.int/mediacentre/factsheets/fs211/en/;

Industry Overview

• ~$6b global market including prepandemic

• Seasonal market growing at low single-digits pa

• Distinct but related segments, with different competitive and growth characteristics

Commodity

Seasonal (~$4b) Premium Reservation fees

PrePandemic (<$2b)

Pre-pandemic stockpiles Pandemic

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Seqirus Today

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CORPORATE FUNCTION OPERATIONAL BUSINESSES

GLOBAL

• Influenza

CSL R&D

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AUSTRALIA/NZ

• In-licensing

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• Contract logistics

• Immunohaematology

• Products of national significance: Q-fever vaccine and anti-venoms

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6

Seqirus Manufacturing Sites & Commercial presence

 ~1900 employees

 Capacity Northern Hemisphere ~130mds*(projected QIV)

*Assumption is QIV, ~34 weeks of NH campaign (@ 7 day / week operation)

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Liverpool
Egg-based manuf
Marburg
MF59 manuf
Holly Springs
Cell-based manuf
Parkville
Egg-based manuf
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Highlights

World’s no. 2 influenza vaccine provider in sales with operations in more than 20 countries.

State-of-the art manufacturing

Liverpool: Manufacture of eggbased influenza vaccine

Holly Springs: Largest cell culture derived flu vaccine facility in the world, incl MF59 (adjuvant) production & pre-filled syringe capacity

Marburg: MF59 production

Parkville: Manufacturing of eggbased influenza vaccine

World’s only manufacturer of Q- Fever vaccine, and a manufacturer of antivenoms for human use since the 1930s.

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President
GORDON NAYLOR
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Leadership Team

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SVP Commercial
Operations SVP Business VP Human
BRENT Services SVP Operations Resources
MACGREGOR KEN LIM STEVE MARLOW TANYA KENNEDY
SVP R&D VP Quality VP Finance Global Head Legal
RUSSELL BASSER VAS MAVROGENIS HELEN GEARING JOHN MINARDO
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Integration & Turnaround Update

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Novartis
(NVS)
NVS Vaccines
(sold to GSK)
NVS
Flu
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• Acquisition was a carve out from a carve out

• Integration progressing well:

• Transaction closed on 31 July 2015

• Combined leadership team and organisation re-design

• New global headquarters in Maidenhead, UK

Included:

• Most manufacturing assets, commercial footprint & people

• Major project underway to establish IT platform, including greenfield SAP

Not included:

• IT systems & infrastructure

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Success Plan

Complete integration

• Remaining elements of organisational design

• IT

Improved focus / efficiency

Step down in R&D

• COGS, speed to market, quality, customers, Government

• Reduction in spend as complete clinical development programs

• Bring pipeline to market

Launch new products

Innovation

• Shift to differentiated products

• Enhanced profitability facilitates margin expansion while funding innovation

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SEQIRUS RESEARCH & DEVELOPMENT Russell Basser, SVP R&D

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Seqirus Influenza Vaccine Platform

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High-risk
Standard risk populations
Seasonal Adjuvanted
Seasonal
Pandemic
Egg based Cell culture
Influenza Science
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The difference between epidemic vs pandemic influenza

ANTIGENIC SHIFT

ANTIGENIC DRIFT

Small mutations New strain Epidemic Pandemic (yearly) (occasionally) May vary season to season SH vs NH

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Identification and preparation of seasonal influenza vaccine strains (1)

Flu surveillance WHO Collaborating Seqirus WHO Strain isolated Centre & typed Antigenic & WHO National genetic New Influenza Centres analysis Strain WHO Reassort virus Collaborating → seed Centre Strain selection - SH (Sept), NH (Feb) Strains chosen Seeds selected Reagents made

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WHO
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& release

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Year round
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~18 weeks

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Adaptation of virus for growth in eggs (reassortment)

Seasonal strain

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Selection based on
 seasonal HA and NA
 high growth properties
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High growth donor strain

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The difference between Trivalent (TIV) & Quadrivalent (QIV) Influenza Vaccine

Trivalent vaccine = two A strains + “dominant” B strain Quadrivalent vaccine = two A strains + two B strains

WHO Influenza Collaborating Centres

• select strains for vaccine twice per year – SH (Sept), NH (Feb)

• determine likely dominant B strains

Type A influenza Type B influenza 2 circulating strains (H1N1, H3N2) 2 circulating strains (B/Victoria, B/Yamagata) One maybe dominant One tends to be dominant Can cause significant clinical disease Tends to cause milder disease Infects humans, other species (birds, pigs, etc) Limited to humans

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Egg vs cell culture manufacturing of influenza vaccine

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EGG-DERIVED
• Process well established &
understood
Virus Filling, • Long track record of safety &
Seed Virus harvested, Further
strains propagation in concentrated purification final efficacy
embryonated testing and
selected and inactivated and formulation • Efficient
hens’ eggs release
Seed strains Detergents to
selected for split whole Purification
influenza A virus
CELL CULTURE
• Closed system, antibiotic-free
• Remove reliance on eggs
• Potential efficiency gains
Virus Filling, •
Seed Virus harvested, Further Potentially greater scalability
propagation final
strains in concentrated purification testing and • Potentially faster from start
selected and inactivated and formulation
cells release • Potentially better strain match
Sterile closed-system bioreactors,
antibiotic-free vaccine production
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Benefits of MF59 Adjuvant in seasonal and pandemic influenza vaccines

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FLUAD™ MF59 Improved efficacy Antigen Sparing Cross-reactivity Pediatrics - efficacy 86% vs 43% non-adj.[1 ] Improved breadth of immune Especially pandemic vaccine Elderly - ↓ hospitalization by 25%[2 ] response

Extensive Safety Data

• Fluad™ licensed in 30 countries (1st approved Italy 1997)

• 100 million doses of MF59 adjuvanted vaccines distributed

• 76 million seasonal Fluad™ (elderly)

• ~25 million H1N1 pandemic (incl pregnant women / young children)

• Data in ~120,000 subjects from clinical studies

1. Vesikari et al, N Engl J Med. 2011;365:1406-16.

2. Iob et al, Epidemiol Infect. 2005;133:687–693; Mannino et al, Am J Epidemiol. 2012;176:527–53; Van Buynder et al, Vaccine 2013;31:6122-8.

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Key R&D Influenza Vaccine Programs

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Currently approved for 18+ yrs in US
TIV
4+ under review in US Paediatric (4+yrs) under review
Link to QIV program
Cell culture QIV Under review in US Target 4+ years
Long standing approval in EU
TIV Approved Approved 6M-2 yrs, 65+ yrs Canada
Approved 65+ yrs US 2015
Phase III completed Age 6M to ≤6yrs – filing Q1 2017
Adjuvanted QIV
Phase III Age ≥65yrs – pivotal study to commence 2016
QIV Under review in US & AUS Age ≥18yrs
QIV Phase III completed Age ≥ 5yrs – 18yrs
QIV Phase III Age ≥ 6mo - <5yrs – pivotal study to commence 2016
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Why Adjuvanted Vaccines Targeting age groups at high risk

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Age-related hospitalizations and TIV efficacy rates

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100 Vaccine (TIV) efficacy [1-3 ] Hospitalization rate [4 ] 70
60
80
50
60
40
30
40
20
20
10
0 0
<5 5–9 10–19 20–34 35–44 45–54 55–64 ≥65
Vaccine efficacy (%) (events per 100,000)
Influenza-related hospitalization rate
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Patient age (years)

1. Nichol KL, et al. Vaccine. 2003;21:1769-1775; 2. Goodwin K, et al. Vaccine. 2006;24:1159-1169; 3. GrubeckLoebenstein B, et al. Nat Med. 1998;4:870; 4. Glezen WP, et al. Am Rev Respir Dis. 1987;136:550-555.

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20

Future directions for influenza vaccine innovation

Alternate routes of delivery

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Universal vaccine

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Novel sources of antigens

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Universal flu vaccine - target conserved parts of virus Goal to find ‘Achilles heel/s’ present in all flu viruses

RAISE BROADLY NEUTRALISING ANTIBODIES

Hemagglutinin (main vaccine component)

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Variable Seasonal Epitopes Conserved Broad Epitope

Very few conserved regions

Broadly Neutralizing Antibodies To Conserved Regions

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2
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1

RAISE Conserved internal Flu replicates in cell BROADLY proteins NEUTRALISING IMMUNE Virus CELLS infects cell

3 Immune cells destroy infected cells containing conserved regions

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SEQIRUS COMMERCIAL Brent MacGregor, SVP Commercial Operations

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Influenza causes significant hospitalizations each year

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In the US there has been modest growth of vaccination rates despite 2010 universal recommendation

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100
90
80
70
60
50 46.2 46.2 47.1
45
43
41.8
40
30
20
10
0
2009-10 2010-11 2011-12 2012-13 2013-14 2014-15
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Source: National Immunization Survey-Flu (NIS-Flu) and Behavioral Risk Factor Surveillance System (BRFSS), http://www.cdc.gov/flu/fluvaxview/coverage-1415estimates.htm. Accessed November 19, 2015.

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Our commercial focus for the coming years will be around five key drivers of growth

1		Launch Fluad 65+ in the US market in the elderly segment first, followed by the pediatric segment
2		Maintain our TIV offer in the near-term while launching our QIV offer
3		Grow our Rapivab business as a convenient intravenous offer in the hospital-setting emergency department
4		Focus our efforts on our key markets in the near-term: US, Europe, Australia
5		Optimise our pandemic and pre-pandemic enterprise to reinforce our reputation as a partner-of-choice in pandemic preparedness

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Seqirus provides a differentiated portfolio of vaccines and treatment for influenza that we will continue to improve

Brand	Age Indication Today	Planned Future Age Indication	Target Offer
	65+ years	6 mths-6 years 65+years	QIV
	18+ years	4+ years	QIV
	18+ years	6mths+	QIV
	18+ years	5+ years	I.V.
	4+ years	4+ years	TIV
	6mths+	6mths+	TIV

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Our product strategy: adjuvanted QIV product in Pediatric and Elderly and egg or cell-based QIV for the general population

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Fluad
Pediatric
(aQIV) Expected greater efficacy in vulnerable
6m - 6y
populations compared to non-adjuvanted
influenza vaccines
Fluad
(aQIV)
65y+
Afluria QIV
Flexibility of manufacturing platforms in
Flucelvax
US and Australia
QIV
General population
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While the US and European markets are transitioning to QIV, this transition has taken longer than originally expected

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80%
2013 Seqirus projections of
70% TIV market decline versus
actual decline for the US
60%
50%
40%
30%
20%
10%
0%
2013-14 2014-15 2015-16
Projections TIV Actual TIV
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• Seqirus volume market share stable in 2015/16

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Rapivab™ (peramivir injection) is an effective complement to our Flu vaccines portfolio

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• Approved in the US Dec 2014

• Niche indication for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 48 hrs

• Single, rapid IV administration

• Stable at room temp. for 5 years

Treatment of adults patients with influenza Tamiflu (75mg twice daily) Rapivab (600mg IV) No further injections required

~20% of patients prescribed a course of oral multi-dose antiviral adhere to only 2 of the 5 days[1-4 ]

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In pandemic preparedness, Seqirus is a leading global player with a strong track record

Leading pandemic assets and capabilities

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Reservation fees
Pre-
Pandemic
(<$2b)
Pre-pandemic
stockpiles
Pandemic
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Production capabilities with global manufacturing network with different technologies. Holly Springs specifically designed for rapid scale-up of production in a pandemic situation

Strong worldwide reputation and track record built through fast response and significant value capture in the 2009 flu pandemic and, more recently, in the H7N9 threat

Unique product offering due to MF59 adjuvant, enhances efficacy and production efficiency, which maximizes population coverage and has made us a preferred pandemic supplier to governments

Key government contracts around the world

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In Australia and NZ, Seqirus augments its core flu vaccine with a comprehensive In-Licensed Vaccine & Pharmaceutical Portfolio

Vaccine Partners Products Pharma Partners Products

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Gardasil, RotaTeq, Varivax, Vaqta, Pneumovax23, Zostavax, MMRII, H-B-VaxII

Rabipur Menjugate Jespect

Palexia Tramal Caldolor Versatis Fuicidin BenPen Burinex

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Vivotif Oral Dukoral

Tetrabenazine

ADT Booster

Grazax Mitizax Jext

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IN SUMMARY Gordon Naylor

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On track to meet our growth targets over the next few years

• Integration is going well

• Fluad will drive a material increase in defensible value in our primary market

• Migration to QIV in key markets will increase value per dose across much of the sales volume

• Deep operational and scientific capabilities will deliver a nimble, efficient supply chain

• Rapivab is a useful complementary product

• The proven cell culture platform provides strategic optionality

• We see interesting potential Innovation pathways for the future

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Holly Springs

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Liverpool

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Parkville

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