Investor R&D Briefing December 1, 2016

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Global

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 or access; 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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Global

Agenda

Welcome
Introduction & Highlights
Research & Early Development
Immunoglobulins & Specialty Products • Clinical Development
Commercial Opportunities

Mark Dehring Andrew Cuthbertson Andrew Nash

Charmaine Gittleson Bob Repella

Q&A

- Break -

Coagulation/Haemophilia
Clinical Development
Commercial Opportunities

Charmaine Gittleson Bob Repella

Breakthrough Medicines
CSL112 Clinical Development
CSL112 Commercial Opportunities
Seqirus R&D
Summary

Charmaine Gittleson Bob Repella Russell Basser Andrew Cuthbertson

Q&A

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Introduction and Highlights
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Global

Commitment to Research & Development

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Global

Past Launches from the R&D Portfolio

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 VIVAGLOBIN[® ] PRIVIGEN[® ] Ig IsoLo[® ] HIZENTRA[® ] RHOPHYLAC[® ] RESPREEZA[®] (EU) ZEMAIRA[®] (US) BERINERT[®] (US) KCENTRA[®] (US) BERIPLEX[®] (EU) RIASTAP[® ] (US) CORIFACT[® ] (US) VONCENTO[®] (EU) IDELVION[® ] AFSTYLA[® ] AFLURIA[®] QIV AFLURIA[® ] FLUCELVAX[® ] QIV H1N1 GARDASIL[® ] FLUAD[®] US

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First major market launch of new product

Global Leveraging Global Capabilities

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>1,400 scientists globally

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Global

R&D Portfolio – December 2015

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Research Pre-clinical Phase I Phase II Phase III Registration Commercial/
Phase IV
CLINICAL DEVELOPMENT REGISTRATION / POST LAUNCH
Immunoglobulins
Haemophilia
Life Cycle
Specialty
Management [# ] Products
Influenza
Vaccine
HIZENTRA [®] CIDP
C1-INH New PRIVIGEN [®]
Market Indications Japan
Development Fibrinogen New BERIPLEX [®] KCENTRA [®] US
Indications Japan Bleeding / Surgery
PCC New CSL830 RESPREEZA [® ]
Indications C1-INH subcut EU/US
Ig Formulations
Rec Coagulation CSL689 rVIIa-FP CSL689 rVIIa-FP CSL654 rIX-FP
Factors Congen Def Inhibitors
Partnered Vaccine Partnered Vaccine Partnered Vaccine CSL627 rVIII-SC
Programs Programs Programs
New Product
P. gingivalis/POD CSL334 IL-13R CSL362 IL-3R
Development
OH-CRC ASLAN AML Janssen
CSL312
CSL112
Discovery Anti-FXIIa
reconstituted HDL
Projects
CSL324 G-CSFR
CAM3001 Quadrivalent
CSL346 VEGFB GM-CSFR –AZ Flu Vaccine
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Core Capabilities:

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Immunoglobulins
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Haemophilia
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Specialty Products
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Breakthrough Medicines
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Vaccines & IP
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*Partnered Projects

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LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

Global

Progress Through Stage Gates in 2016

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PRIVIGEN [®] PRIVIGEN [®]
Japan IsoLo
CSL640 Hizentra [®] IDELVION [®]
rIX-FP subct IIM US
CSL626 D’D3 IDELVION [®]
LA rVIII AFSTYLA [®] EU
Japan
IDELVION [®]
Haptoglobin/ CSL842 C1-INH
AFSTYLA [®] Japan
Hemopexin Transplant
EU
AFSTYLA [®]
Next Gen Ig US
Formulations CSL830
CSL312 C1-INH subcut AFLURIA [®] QIV
Novel Anti-FXIIa 18+ US & AUS
KCENTRA [® ]
Strategies CSL324 Japan FLUAD [® ] TIV
Clinical GCSFR 65+ US
Applications AFLURIA [®] QIV FLUCELVAX [®]
5-17 US, AUS QIV 4+ US
Discovery
Projects
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Global

R&D Portfolio – December 2016

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Commercial/
Research Pre-clinical Phase I Phase II Phase III Registration
Phase IV
CLINICAL DEVELOPMENT REGISTRATION / POST LAUNCH
Immunoglobulins
Haemophilia
Life Cycle
Specialty
Management [# ] Products
Influenza
Vaccine
HIZENTRA [®] CIDP
C1-INH New PRIVIGEN [®] PRIVIGEN [®]
Indications Japan CIDP US
Market
Development Fibrinogen New Hizentra [®] KCENTRA [®] VONCENTO [®]
Formulations IIM Japan VWD EU
PCC New Haptoglobin/ CSL842 C1-INH CSL830 RESPREEZA [® ]
Indications Hemopexin Transplant C1-INH subcut EU/US
Next Gen
Ig Formulations
Rec Coagulation CSL626 D’D3 CSL689 rVIIa-FP CSL689 rVIIa-FP AFSTYLA [®] IDELVION [®]
Factors LA rVIII Congen Def Inhibitors Europe US, EU, Japan
CSL640 AFSTYLA [®]
New Product rIX-FP subct US
Development P. gingivalis/POD CSL334 IL-13R Mavri AFLURIA [®] QIV AFLURIA [®] QIV
OH-CRC ASLAN GM-CSFR – AZ 5-17 US, AUS 18+ US & AUS
Discovery CSL312 CSL362 IL-3R FLUAD [® ] TIV
Projects Anti-FXIIa AML Janssen 65+ US
CSL346 CSL324 CSL112 FLUCELVAX [®]
VEGFB G-CSFR apo-AI QIV 4+ US
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Core Capabilities:

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Immunoglobulins
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Haemophilia
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Specialty Products
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Breakthrough Medicines
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Vaccines & IP
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*Partnered Projects

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LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

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CSL Behring R&D Strategy and Focus
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Global

CSL Protein Therapeutics Technical Platform

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Breakthrough
Medicines
Immunoglobulins Specialty
Products
Haemophilia
Products
Plasma Recombinant
Fractionation Technology
Protein Science
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Research & Early Development
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Global

CSL’s Global Research Capability

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• Coordinated global project portfolio

Specialty Breakthrough Haemophilia Products Medicines

Immunoglobulins

Hub (Bio21, Melbourne) & spoke model
Bio21 expansion to increase pre-clinical research
Research excellence in therapeutic proteins
Plasma and recombinant manufacturing platforms

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Haemophilia

Research Strategy

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Novel Strategies –
Coag Factor
Maximising Value
Addressing
and Performance
Inhibitors
of Existing Assets
Novel Strategies –
Non-Coag Factor
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Major focus on patient Quality of Life
Extract maximum value and performance from existing assets
Develop new protein-based therapies and strategies for treating congenital and acquired bleeding disorders

o LA FVIII

o Novel delivery technologies

o Bispecific Abs

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Haemophilia

FVIII Half-Life Extension

Short FVIII half-life, improved half life = improved prophylaxis
FVIII half-life regulated by VWF
Target VWF half-life while minimising thrombosis risk
• CSL626 = VWF D’D3 fragment fused to human albumin

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Von Willebrand Factor
D’ D3 Albumin
D’ D3 Albumin
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AFSTYLA[®] bound to CSL626 should have an increased half life (by accessing the FcRn salvage pathway)

+ AFSTYLA[®]

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Haemophilia

FVIII Half-Life Extension

CSL626 extends the half-life of co-administered AFSTYLA[®] in NHPs

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AFSTYLA[®] HAEMATE[®] P pd VWF + AFSTYLA[®] CSL626 dose 1 + AFSTYLA[®] CSL626 dose 2 + AFSTYLA[®] CSL626 dose 3 + AFSTYLA[®] CSL626 dose 1

4-5 fold increase in AFSTYLA[®] half-life
GLP toxicology studies in progress
Phase I planned to commence H1, 2018

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Immunoglobulins Research Strategy

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Optimising the
Value of our
Products
Anticipating
Translating Ig
Disruptive
Mechanisms
Innovation
Defining New
Indications
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Formulation and purification processes
Opportunities for new technologies / molecules
Mechanism driven product design and indication selection
Identifying new indications for IV/SCIG

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Immunoglobulins

Immunoglobulin Mimetics

Immunoglobulin functional domains

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Fab region
•Immune
deficiencies
recombinant multimerised Fc
Fc region
•Autoimmune
conditions
Improved target binding
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Immunoglobulins Immunoglobulin Mimetics

CSL777 proof-of-concept in CAbIA model of arthritis

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6
6
5
5
4
PBS 4
3
3

2 IVIG
2
CSL777
1 1
0 0
6 7 8 9 10 11 12 13 14 PBS IVIG CSL777
Day of experiment
Clinical score
Mean clinical score (d7-14)
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200 mg/kg CSL777 or 2 g/kg IVIG, i.p. at day 6
CSL777  significantly reduced clinical score (*P < 0.05) and joint cell infiltrate
GLP toxicology planned to commence in 2H, 2017

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Breakthrough Medicines Research Strategy

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Breakthrough
Medicines
Specialty
Immunoglobulins Products
Haemophilia
Products
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Leveraging clinical and technical insight in developing novel proteinbased therapies

o Significant unmet need

o Multiple indications

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Breakthrough Medicines

Portfolio – Late Preclinical / Clinical

Portfolio of preclinical and early-mid stage clinical opportunities consistent with CSL commercial objectives
Delivery of high quality candidates for clinical development

Research Pharm / tox Phase I Phase II CSL362* (anti-IL-3R) CSL324 (anti-G-CSFR)

CSL312 (anti-FXIIa) CSL346 (anti-VEGF-B)

*Partnered with Janssen Biotech

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Breakthrough Medicines CSL324 – Chronic & Acute Inflammation

Targeting the G-CSF receptor represents a novel approach to the treatment of neutrophil mediated pathologies
Efficacy in multiple animal models of inflammatory disease

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G-CSF G-CSF Bone Marrow neutrophils

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inflamed tissues

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Breakthrough Medicines CSL324 – Chronic & Acute Inflammation

Anti-G-CSFR mAb reverses development of arthritis

Mouse CAbIA model

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‡ P < 0.001
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GLP toxicology completed, CSL324 safe and well tolerated
Phase I commenced July 2016, Phase II H1 2018

Source: Campbell et al ., J. Immunol. (in press)

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Breakthrough Medicines

CSL312 – HAE and Thrombosis

Targeting FXIIa represents a novel approach to the treatment of hereditary angioedema and contact activated thrombosis
Efficacy in multiple animal models and translational studies

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Auto-activation
FXIIa -
FXI → FXIa PK → KAL βFXIIa
→ thrombin HK → BK→ BR2 C1qr,s → C1qr,s
Haemostasis Vasodilation, Complement
vascular permeability activation
Thrombosis HAE
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Breakthrough Medicines CSL312 – HAE and Thrombosis

Anti-FXIIa antibody prevents FXIIa mediated vascular leakage

Mouse model incorporating a mutant (HAE type III) human FXIIa Tg

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Human HAE type III
FXII gene in
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(7mg/kg)
Tg Off On On
Mouse HAE wild
type FXII gene out
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+ anti-FXIIa mAb

GLP toxicology completed, CSL312 safe and well tolerated
Phase I commenced Nov 2016, Phase II H1 2018

Source: Bjorkquist et al. , J Clin Invest. 2015

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Breakthrough Medicines

CSL312 – HAE and Thrombosis

Anti-FXIIa antibody prevents foreign surface activated thrombosis without increasing bleeding risk

• Rabbit ECMO model

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Source: Larsson et al., Sci Transl Med, 2014

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Breakthrough Medicines

CSL346 – Diabetes / Diabetic Complications

VEGF-B controls tissue uptake of fatty acids via regulation of endothelial fatty acids transport

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VEGF-B
VEGFR-1
NRP-1
Fatty
acids
PGC-1a
FATP3/4
Tissue Endothelium
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Increased VEGF-B leads to lipid accumulation in tissues and lipotoxicity

diabetes and diabetic complications

Inhibition of VEGF-B signalling may represent a novel therapeutic strategy for diabetes and associated complications
CSL346: mAb targeting VEGF-B

Sources: Hagberg et al ., Nature 2010. Hagberg et al ., Nature 2012

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Breakthrough Medicines

CSL346 – Diabetes / Diabetic Complications

Anti-VEGF-B antibody prevents development of nephropathy in db/db//BLKS mice

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GLP toxicology studies in progress
Phase I planned to commence in 2H, 2017

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Global

Strong Research Portfolio

Expanding capacity and capability across global research sites
Innovating in key areas of business strength

Immunoglobulins Haemophilia

Specialty Products

Developing new opportunities in important areas of unmet medical need o Three novel mAbs entering the clinic in 12-18 month timeframe

Breakthrough Medicines

• Creating a sustainable pipeline for future growth

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Immunoglobulins
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Immunoglobulins

Breakthrough Medicines Specialty Immunoglobulins Products Haemophilia Products

Maintaining leadership position through focus on:

o New Indications

o Geographic expansion

o Delivery options

Key Focus

o HIZENTRA[® ] o PRIVIGEN[® ]

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Immunoglobulins Progress in Neurology

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Progressive weakness and impaired sensory function in the legs and arms
New cases per year ~1-2 per 100,000 people
Occurs at any age, in both genders, more common in young adults and in men
Course varies widely among individuals. Left untreated, 30% of CIDP patients will progress to wheelchair dependence
IVIG as first line therapy

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Immunoglobulins PATH Program – Phase III Study[1]

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N=276 N=245 N=207
N=172
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Largest placebo controlled study in CIDP

• Data base locked

HIZENTRA[®] CIDP FDA submission mid 2017 and EMA submission 2H 2017

Source: 1. Von Schaik et al. Trials 016 Jul 25;17(1):345

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Immunoglobulins

PATH Supports Efficacy of PRIVIGEN [®] in CIDP

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73% PATH subjects responded with improvement in INCAT score
PATH and PRIMA represent largest CIDP cohort studied
FDA submission sBLA November 2016

Source: 1. Leger, JM et al. J Peripher Nerv Syst 2013 Jun;18(2):130-40

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Immunoglobulins Expanding on Successful CIDP Experience

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Neurology Idiopathic Inflammatory Myopathies

Rheumatology • Auto-immune pathology Systemic Sclerosis

Muscle, skin and inner organ fibrosis • Evidence of efficacy of immunoglobulins

• Expand on our commitment to rare diseases

Rigorous review of science and prioritisation
Commence study in idiopathic inflammatory myopathies 2H 2017

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Immunoglobulins IVIG and Haemolysis[1 ]

New generation IVIG products are associated with low, but relevant, risk of haemolysis

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Red blood cell haemolysis has been noted when IVIG > 2g/kg is administered to patients with blood groups A, B or AB

• Due to isoagglutinins

Regulatory release specifications for maximum IVIG isoagglutinin titre are ≤1:64[2]
All Ig products manufactured by CSLB already meet these standards

Sources: 1. Bellac CL, et al. Transfusion. 2015;55(Suppl 2):S13–S22. 2. European Pharmacopea

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PRIVIGEN[®] Isoagglutinin Levels Lowered to Immunoglobulins Reduce IVIG Associated Haemolysis Risk[1 ]

Methods to Reduce Isoagglutinin Levels

Donor screening

Cold ethanol fractioning

fractioning The levels of isoagglutinins can be Cohn method includes a reduced by 1 titre step[2] precipitation step that with exclusion of ~5% of reduces isoagglutinin donors[3] levels[2]

Immunoaffinity chromatography (IAC)

Isoagglutinin levels in PRIVIGEN[®] can be reduced by 2–3 titre steps, or 75–88%[4-6]

PRIVIGEN[®] median isoagglutinin titres are now 1:8 for anti-A and 1:4 for anti-B

Sources: 1. CSL Behring. Data on File. 2. Romberg V, et al. Transfusion. 2015;55(Suppl 2):S105–S109. 3. Siani B, et al. Transfusion. 2015;55(Suppl 2):S95–S97. 4. Gerber S, et al. Manuscript submitted. 5. Hoefferer L, et al. Transfusion. 2015;55(Suppl 2):S117–S121. 6. Hubsch AP, et al. [Poster]. 2016 AAAAI, LA, CA.

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Immunoglobulins Reduction in PRIVIGEN[®] Haemolysis

CSL Behring proactively introduced an isoagglutinin reduction strategy that reflects our strong commitment to continue to deliver safe and effective therapies to patients

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• PRIVIGEN[®] IsoLo[®] approved in US, Europe, Canada, Australia, Switzerland and other selected countries

Source: ENCePP: Privigen PASS. Available at: http://www.encepp.eu/encepp/viewResource.htm?id=6515. Accessed 14 April 2016

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Commercial Market Overview
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Global

Plasma-proteins Therapeutics Market

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Immunoglobulin
$9.0B
Haemophilia
$10.8B
Total Global
Market Value:
~$27.0B
Specialty
Albumin $3.4B
$3.8B
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Sources: Company 3Q 2016 reports/financial schedules, MRB global Coagulation Factors Concentrate Market 2015 & 2016, MRB WW Plasma Fractionation Market 2015 interim report, CSL Actuals FY16

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Global Key Segment Opportunities

Ig Specialty Haegarda[TM ] Coag

Deliver Innovation Demonstrate Leadership Drive Growth

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Commercial Opportunities and Activities

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Immunoglobulins Global Market

Global market volume growth projected at 5-7% in 2017

Hyper $0.9B

Demand driven by medical education and brand promotion
Growing patient acceptance of subcutaneous delivery in developed and emerging markets
Evidence-based opportunities for future indications

Total Global Market Value: ~$9.0B IVIG $6.9B

Sources: Company 3Q 2016 reports, Markets and Markets Plasma Fractionation Report 2016, based on 2015 data, CSL Actuals FY16

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Immunoglobulins

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US $M
US $2,457M
2,500
SCIG
2,000
1,500
1,000 IVIG
500
Hyper
0
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Global revenue +7%
CIDP & SID indications in the EU
Reliability of supply
Geographic and market expansion
Introduction of PRIVIGEN[®] IsoLo[® ]
Global revenue +31%
Significant increase in new patient starts in US and EU
Patient preference for at home treatment

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Jun 16
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Reported sales for the 12-month period

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Immunoglobulins

More proline in food than in HIZENTRA[®]

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Proline, Average weekly
1,975 1,836 1,055 1,450 1,458 dose proline 1,997 325 361 4,295
mg
in HIZENTRA [® ]
1.45g
~25 X
Average weekly
dose proline
in food
36.5g
cheese eggs spinach steak
2 chicken and skin) (in water)
1 cup frozen
1 tub yoghurt 12g 2 slices provolone 1 cup scrambled 1 turkey wing (meat and skin) drumsticks (meat 1 3oz can tuna 5 serves broccoli 1 9oz piece sirloin
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http://www.nutritionvalue.org/foods_by_Proline_content_page_1.html HIZENTRA[®] dose 1 X 50ml vial (10g) – average weekly adult dose

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Immunoglobulins

Global Ig Franchise: Strategic Imperatives

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Category
Leadership
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Immunoglobulins CSL Behring Ig Franchise Vision

CSL Behring is the world renowned leader in Ig therapy delivering innovations that enhance patients’ lives

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Specialty Products
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Specialty

Breakthrough Medicines Immunoglobulins Specialty Products Haemophilia Products

Leveraging high quality broad product portfolio through:

o New markets

o Novel indications

o Novel modes of administration

Key Focus

o HAEGARDA[TM] /BERINERT[®] o BERIPLEX[®] /KCENTRA[® ] o ZEMAIRA[®] /RESPREEZA[® ]

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Specialty

Clinical Presentation of Hereditary Angioedema (HAE)

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Specialty

**QOL* Negatively Impacted by HAE**

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Work Productivity Activity Impairment (WPAI)[1 ]

•QOL – Quality of Life Source: 1. Lumry WR, et al. Allergy Asthma Proc 2010; 31(5):407–14.

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Specialty

Phase III Study Positive

Phase III COMPACT Study

C1-INH (SC), CSL830, a low volume self-administered, subcutaneous C1-inhibitor preparation, is well tolerated and efficacious for preventing attacks in patients with HAE[1 ]

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Source: 1. Zuraw et al. Oral Presentation American College of Allergy Asthma and immunology. Manuscript submitted

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Specialty

HAEGARDA[TM] demonstrates efficacy in HAE Prophylaxis

• Primary endpoint met:

o 40 IU/kg reduced attack rate 88.6% (median, p<0.001) o 60 IU/kg reduced attack rate 95.1% (median, p<0.001)

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5
p<0.001 p<0.001
4
HAE attacks
3
per month,
LS mean
2
(95% CI)
1
3.6 1.2 4.0
0.5
0
High-volume 40 IU/kg Low-volume 60 IU/kg
Placebo CSL830 Placebo CSL830
N=44 N=43 N=42 N=43
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Specialty

HAEGARDA[TM] Reduces Attack Severity

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Specialty

Notable Responder Rate with HAEGARDA[TM ]

• FDA definition of a responder is a subject with ≥ 50% reduction of attacks

Indirect Cross-study Comparison

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100
KEY:
90
≥ 50%
80
≥ 70%
70
≥ 90%
60
50
40
COMPACT
30 lower bound 95% CI >33%
20
10
0
≥ 40 IU/kg 40 IU/kg 60 IU/kg Cinryze [1 ]
1000 IU
% Responder relative to Placebo
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Source: 1. Zuraw BL, et al: Results of a randomized double-blind placebo controlled study of nanofiltered C1-inhibitor for the treatment of HAE attacks. American College of Allergy, Asthma & Immunology; Dallas, Texas 2007

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Specialty

HAEGARDA[TM] Safe and Well-tolerated

Adverse Events in Study Safety Population

n (%)	40 IU/kg CSL830 N=43	60 IU/kg CSL830 N=43	Combined placebo N=86
Patients reporting ≥1 AE	29 (67.4)	30 (69.8)	57 (66.3)
Adverse drug reactions, number of patients (%)
Injection site reactions*	12 (27.9)	15 (34.9)	21 (24.4)
Nasopharyngitis	1 (2.3)	8 (18.6)	6 (7.0)
Hypersensitivity**	2 (4.7)	3 (7.0)	1 (1.2)
Dizziness	4 (9.3)	0	1 (1.2)

• Injection site reactions were the most commonly reported AEs

• 95% of injection site reactions were mild, most occurred and resolved within 24 h after injection

• No injection site reactions were serious or led to discontinuation of treatment

*Injection site reactions include: injection site bruising, coldness, erythema, and similar

**Hypersensitivity includes: pruritus, rash, and urticaria

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Specialty

Summary and Program Progress

COMPACT trial demonstrated dose-dependent efficacy of HAEGARDA™ for the prevention of HAE attacks

o Reduction in median attack rate: 89–95%

o Response rate (≥50% relative attack reduction): 76–90%

o 60 IU/kg consistently showed higher efficacy

BLA accepted by FDA 30 August 2016
Submission to EU anticipated early 2017

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Specialty

Transplant – Overview of Unmet Need

Increasing global demand for organ transplantation associated with limited supply[1 ]

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AGR: 5.3%
AGR: 1.7%
AGR: 1.5%
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Source: 1. OPTN Database May 2016 (Note: Deceased donors may donate multiple organ)

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Specialty

CSL Therapies in Transplantation

Normal Kidney

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HLA reduction /
Desensitisation /
Improve viability
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Transplant
Cellular Early AMR Late AMR
Rejection <12 mo >12 mo
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Rejected Kidney
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Delayed or Primary
Graft (Dys) Function
September26 , 2001
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Specialty

Renal Transplantation

• Lack of donors, organ unsuitability

Long-term graft survival still poor, graft loss after 1 year is 5% per year[1 ]

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Kidney Wait
List
~100,000 [2 ]
Cross Match +
Standard Kidney Sensitised
Transplant Kidney Transplant (hi PRA)
~17,500/year 300/year >25,000
Acute AMR Late AMR Acute AMR Many Never
5-10% (1 yr) 25% 20-40% Transplanted
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AMR – Antibody Mediated Rejection

Sources: 1. Lamb, KE et al, Am J Transplant 2011 Mar;11(3):450-62. 2. OPTN Database May 2016 (Note: Deceased donors may donate multiple organ)

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Specialty

C1 Inhibition in Refractory AMR*

Patients treated with BERINERT[®] demonstrated an improvement in renal function (GFR - glomerular filtration rate)

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Refractory AMR (acute or late) patients who have not responded to 3 months standard of care
Source: Viglietti et al. Am J Transplant 2016 May;16(5):1596-603

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Specialty

CSL Therapies in Transplantation

Program will test ability to increase donor compatibility and improve long and short-term graft survival
First program of C1 inhibition in renal transplant in 2H 2017, pending regulatory interactions
Ongoing interactions with high quality collaborators and regulators which will inform further CSL sponsored programs

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Commercial Opportunities and Activities

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Specialty

Global Market

Orphan/rare diseases
Unmet medical need
Often under or misdiagnosed
Awareness and education
Significant patient value

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Other
~$0.3B
Acquired
Bleed
~$0.7B
Total Global
Market Value:
~$3.4B
HAE
AATD
~$1.6B
~$0.8B
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Sources: Company annual reports/financial schedules, based on 3Q 2016 data, MRB WW Plasma Fractionation Market 2016 interim report, CSL Actuals FY16

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Specialty

CSL’s Global Performance

KCENTRA[®] /BERIPLEX[®] usage growing across multiple specialties
BERINERT[®] geographic and market expansion continues
Launch of RESPREEZA[®] in EU
EU growth of HAEMOCOMPLETTAN[®] P

CSL FY16 Sales $983M Acquired Bleeding AATD Other HAE

Key Brands:

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Specialty

Reimbursement Status – RESPREEZA[® ]

AATD market in Europe approximately ~$200M
Majority of treated patients are in Germany and France
RESPREEZA[®] differentiation:
Indicated for maintenance treatment, and to slow the progression of emphysema in adults
Highly purified formulation provides lower volume for faster infusion speed

Reimbursement Reimbursement Achieved Pendin g Czech Rep Austria France Belgium Germany Denmark Greece Finland Italy Norway Portugal Poland Slovakia Sweden Spain United Kingdom Switzerland

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Specialty

HAEGARDA[TM] Value Proposition

Most effective in preventing HAE attacks

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C1 Individualised Sub-Q
Inhibitor Dosing Administration
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Specialty

Key Primary Market Research Findings – HAE

HCP

Patients

HAEGARDA[TM] has two key perceived advantages over current options:
More efficacious in reducing frequency of HAE attacks
Only subcutaneous agent for HAE prophylaxis
The core value proposition HAEGARDA[TM] offers is greater efficacy (reduced number of attacks) with prophylaxis therapy
Subcutaneous administration is a life-transforming advantage, but secondary to efficacy
All physicians noted that efficacy is their primary goal when recommending prophylactic therapy

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Specialty

HAE Franchise

Revenue Potential of $0.75M – $1B p.a.

HAEGARDA[TM ]

BERINERT[® ]

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Most effective in preventing HAE attacks Most effective in stopping HAE attacks
C1 Individualised Sub-Q C1 Individualised IV
Inhibitor Dosing Administration Inhibitor Dosing Infusion
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PK data to reinforce consistent levels for Sub-Q

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Q&A
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Break
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Investor R&D Briefing December 1, 2016

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Haemophilia Products
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Haemophilia

Breakthrough Medicines

Immunoglobulins Specialty Products

• Supporting and enhancing plasma products and developing novel recombinant portfolio with focus on:

o Scientific and product innovation o Patient benefit

Key Focus

Haemophilia Products

o IDELVION[®] (rIX-FP)

AFSTYLA[®] (rVIII-Single Chain)
o Long acting rVIIa-FP

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Haemophilia Global Approvals Ongoing

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Achieved 2016 Anticipated 2017
Australia
Canada Hong Kong
EU Israel
Japan New Zealand
Switzerland Taiwan
USA
Australia
EU (positive opinion Nov 2016)
Canada
Japan
USA
New Zealand
Switzerland
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Haemophilia

Low AsBR on IDELVION[®] Extended Regimens

AsBR Extension Study 7-Day Regimen (n=19) 10-Day Regimen (n=7) 14-Day Regimen (n=21) 21-Day Regimen (n=10) Adults Median (IQR) 0.85 (0,2.9) 0 (0,0) 0 (0,0) 0 (0,0) Estimated Mean AsBR (95% CI) 1.91 (1.09-3.36) 0.31 (0.4-0.7) 0.88 (0.47-1.65) 0.45 (0.07-0.98) Duration 309 650 491 442 7-Day Regimen (n=20) 10-Day Regimen (n=6) 14-Day Regimen (n=8) Not tested <12 years Median (IQR) 0 (0,5.6) 0 (0-3,06) 1.16 (0-2.63) Estimated Mean AsBR (95% CI) 0.7 (0.3-1.6) 2.12 (0.56-8.02) 1.19 (0.56-2.54) Duration 415 501 483	AsBR Extension Study 7-Day Regimen (n=19) 10-Day Regimen (n=7) 14-Day Regimen (n=21) 21-Day Regimen (n=10) Adults Median (IQR) 0.85 (0,2.9) 0 (0,0) 0 (0,0) 0 (0,0) Estimated Mean AsBR (95% CI) 1.91 (1.09-3.36) 0.31 (0.4-0.7) 0.88 (0.47-1.65) 0.45 (0.07-0.98) Duration 309 650 491 442 7-Day Regimen (n=20) 10-Day Regimen (n=6) 14-Day Regimen (n=8) Not tested <12 years Median (IQR) 0 (0,5.6) 0 (0-3,06) 1.16 (0-2.63) Estimated Mean AsBR (95% CI) 0.7 (0.3-1.6) 2.12 (0.56-8.02) 1.19 (0.56-2.54) Duration 415 501 483
<12 years	Median (IQR) 0 (0,5.6) 0 (0-3,06) 1.16 (0-2.63)
	Estimated Mean AsBR (95% CI) 0.7 (0.3-1.6) 2.12 (0.56-8.02) 1.19 (0.56-2.54)
	Duration 415 501 483

AsBR, annualised spontaneous bleeding rate; CI, confidence interval; IQR, interquartile range † Assuming Poisson distribution

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Haemophilia rVIIa-FP (CSL689)

rFVIIa Linker rAlbumin

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Haemophilia

Clinical Programs

Congenital Haemophilia A or B with Inhibitors (CHwI)

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Phase III
Prophylaxis
Surgery
(PLANNED)
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COMPLETED ONGOING

Congenital Haemophilia Factor VII Deficiency

COMPLETED

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EXTENSION
PLANNED
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Haemophilia

CHwI Preliminary Efficacy Data

rVIIa-FP is efficacious and safe in treating bleeding events

o 47 bleeds in 10 subjects

o 77% of bleeds controlled with 1 infusion

o 100% of bleeds controlled with 2 infusions

o No thrombo-embolic adverse events experienced

• NOVOSEVEN[ ®]

o 10% of bleeds controlled with 1 infusion

o 27% of bleeds controlled with 2 infusions (published data*)

*S.R. Lentz et al. Journal of Thrombosis and Haemostasis , 12: 1244–1253
CSL689 was not studied head to head with NOVOSEVEN [®]

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Haemophilia

Congenital Factor VII Deficiency

Phase I study confirms rVIIa-FP has measurable FVIIa levels up to 48 hrs
Supports testing once to twice weekly dosing in Phase II
Phase II to commence 2H 2017

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rVIIa-FP 100 µg/kg
N=3
rVIIa-FP 300 µg/kg
N=3
pdFVII 30 IU/kg N=2
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Commercial Opportunities and Activities

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Haemophilia

Global Market

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VWD
$0.5B
Hem B
$1.4B
Total Global
Inhibitor Market Value:
Bleed
Therapy ~$10.8B
Hem A
$2.2B
$6.7B
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Trend toward recombinants in developed markets
75% of patients with bleeding disorders are under/un-treated
Launches of multiple longer-acting products in Hem-A space
Payers contemplating active category management
Rapid transition of Hem-B category

Sources: Company 3Q 2016 reports/financial schedules, based on 2016 data, MRB global Coagulation Factors Concentrate Market 2015 & 2016, Hemophilia World, December 2013, Vol 20. No 3, CSL Actuals FY16

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Haemophilia

Global Portfolio

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CSL FY16 Sales $1B

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Recombinant
Plasma
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Haemophilia Recombinant Coagulation Launches

Revenue Potential of $0.7 – $1B p.a. in 4-5 years

		US	EU	Japan
•	Unique albumin fusion
	protein
•	New SOC for haemophilia B	Launched	Launched	Launched
•	Increased protection and
	convenience
•	Unique single chain design
•	Longer acting (2-3x weekly dosing)	Launched	Q1’17	Q1’18
•	Increased vWF affinity

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Haemophilia

Evolution of IDELVION[®] Promotion

Single Dose:

IDELVION[®] maintains high trough levels (>5%) for protection from bleeds between treatments

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Steady-State:

IDELVION[®] delivers steady-state mean FIX levels of 21% with 7-day prophylaxis (patients <12 years) and 13% with 14-day prophylaxis (patients ≥12 years)

**Baseline-corrected FIX activity[*1 ]**

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*After administration of a single infusion of IDELVION. Data from Phase 1 clinical study.

Santagostino E, Negrier C, Klamroth R, et al. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood . doi:10.1182/blood-2012-05-429688.

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Haemophilia Conversions to IDELVION[® ]

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3%
5%
10%
B ENEFIXeneFix [® ]
A LPROLIXlprolix [®]
M ONONINEononine [®]
10%
A LPHANINElphanine [®]
52%
R IXUBISixubis [® ]
I XINITYxinity [®]
19%
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Source: My Source weekly reporting as of October 25. Based on data from U.S. Hub Services Provider

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Haemophilia Conversions to AFSTYLA[® ]

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17%
22%
A DVATEdvate [® ]
A DYNOVATEdynovate [® ]
6%
E LOCTATEloctate [®]
H ELIXATE FSelixate FS [®]
6% 5%
K OGENATE FSogenate FS [®]
R ECOMBINATEecombinate [® ]
5%
Unknown
39%
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Source: My Source weekly reporting as of October 25. Based on data from U.S. Hub Services Provider

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Breakthrough Medicines
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Breakthrough Medicines

Leveraging clinical and technical insight in developing novel proteinbased therapies

Breakthrough Medicines

Specialty Immunoglobulins Products

o Significant unmet need o Multiple indications

Key Focus

o CSL112 (Apo AI)

Haemophilia Products

o CSL324 (anti-G-CSFR mAb) o CSL346 (anti-VEGFB mAb) o CSL312 (anti-FXIIa mAb)

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Breakthrough Medicines

Medical Need: Cardiovascular Disease (CVD)

In 2012, CVDs are the leading cause of death globally (31%)
~7.4 million were due to coronary heart disease
~6.7 million were due to stroke[1 ]
In the European Union, coronary heart disease, is the single most common cause of death

o 681,000 deaths each year

ACS patients experience a high rate of recurrent cardiovascular events in the sub-acute period

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CSL112 Infusions
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Sources: 1. http://www.who.int/mediacentre/factsheets/fs317/en/ 2. Nichols et al, 2012 Figure adapted from the PLATO Trial. Wallentin et al. N Engl J Med 2009;361:1045-57

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Breakthrough Medicines

Development of Atherosclerosis

Cholesterol Influx and Efflux Imbalance

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Cholesterol efflux
Cholesterol influx
ApoA-I
LDL
Lipid-poor
preβHDL
LDL retention
and oxidative
modification
ABCA1 transporter
Macrophage
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ABCA1=ATP-binding cassette transporter 1; HDL=high-density lipoprotein; LDL=low-density lipoprotein.

Sources: 1. Curtiss LK, et al. Arterioscler Thromb Vasc Biol . 2006;26:12-19. 2. Linton MF, et al. The role of lipids and lipoproteins in atherosclerosis. In: De Groot LJ, et al, eds. Endotext [Internet]. Dartmouth, MA: MDText.com, Inc.; 2000. http://www.ncbi.nlm.nih.gov/books/NBK343489. Accessed May 24, 2016.

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Breakthrough Medicines Cholesterol Efflux With CSL112

Removal of Cholesterol From Unstable Plaque

Upon infusion, CSL112 immediately produces a significant increase in circulating lipid-poor apoA-I particles…

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CSL112
particles
ABCA1
transporters
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Breakthrough Medicines Cholesterol Efflux With CSL112

Removal of Cholesterol From Unstable Plaque

…accompanied by a marked increase in ABCA1-dependent cholesterol efflux capacity

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CSL112
particles
CSL112
particles
ABCA1 transporter
ABCA1
transporters
Intracellular cholesterol
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CSL112 holds the potential to rapidly stabilise plaque and reduce the high rate of early recurrent cardiovascular events

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Breakthrough Medicines

AEGIS-I

The Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Human ApoA-I, After Acute Myocardial Infarction: The A poA-I E vent reducin G in I schemic S yndromes I Trial (AEGIS-I)

Infusion of aopA-I (CSL112) in addition to standard of care in subjects following ACS can safely and rapidly elevate cholesterol efflux capacity

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Source: Gibson, M et al. Circulation. 2016;134 – In press

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Breakthrough Medicines AEGIS-I Primary Endpoint Met

	CSL112 2g N=415	CSL112 6g N=416	Placebo N=413
Liver
Confirmed elevated markers of liver injury	4 (1.0%)	2 (0.5%)	0 (0.0%)

Kidney
Confirmed elevated markers of kidney injury	0 (0.0%)	3 (0.7%)	1 (0.2%)

Percentages are based on the number of subjects with data
A hepatic endpoint of interest is defined as any subject recording one of the two following results: ALT > 3x ULN, Total bilirubin > 2x ULN, confirmed by a consecutive repeat test after at least 24 hours but within 1 week of the original test
A renal event is defined as a serum creatinine increase of ≥ 1.5X the baseline value, confirmed by a repeat test after at least 24 hours but within 1 week, or the need for renal replacement therapy

Source: Gibson, M et al. Circulation. 2016;134 – In press

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Breakthrough Medicines

Proof of Mechanism Demonstrated

• Cholesterol efflux capacity increased after Infusion of CSL112 in AMI patients

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5
4.5
4
4.30
3.5
3.67
3
2.5
2 2.45
1.5 1.87
1
0.5 0.94
0.82
0
Total Cholesterol Efflux Capacity ABCA1-Dependent Cholesterol
(%/4h) Efflux Capacity (%/4h)
KEY Placebo 2g CSL112 6g CSL112
Infusion
st
Fold Elevation at Peak After 1
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AMI- acute myocardial infarction Fold elevation at peak compared with baseline All analyses were performed using patients with available data.

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Breakthrough Medicines

AEGIS-I Exploratory Endpoint (MACE)

Major Cardiovascular Events (MACE) collected to inform Phase III

o Comprised cardiovascular death, non-fatal myocardial infarction, stroke, hospitalisation for unstable angina

Low event rate was expected in this study population

o Study not powered to detect an efficacy signal

Data available in Circulation , 2016*

*American Heart Association. Heart Disease and Stroke Statistics—2016 Update. Circulation . 2015;132:000-000. DOI: 10.1161/CIR.0000000000000350

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Breakthrough Medicines

AEGIS-I Summary

AEGIS-I study positive
Four weekly infusions of CSL112 following MI was feasible and did not have any safety concerns
CSL112 rapidly elevates cholesterol efflux in a dose dependent fashion in the acute MI setting
Based on the current assessment of the data, the 6g dose is recommended for further study in Phase III

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Breakthrough Medicines Proposed Phase III Study Design

A Phase III, Multicenter, Double-blind, Randomised, Placebocontrolled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

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Double-blind, 1:1 randomisation

4 weekly infusions

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CSL112 6g

Placebo

All subjects followed for 6 months

Primary endpoint: Time-to-first occurrence of any component of the composite MACE, ie, CV death, MI, or stroke, from the time of randomisation through 90 days
Enriched Study Population: Multi-vessel disease + ≥65 years of age or previous MI or peripheral artery disease or diabetes mellitus

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Breakthrough Medicines AEGIS Planning for Phase III x

Regulatory agency consultations have commenced
Results of safety study in moderate renal impaired ACS patients anticipated 2H 2017
Study planned to start Dec 2017 / early 2018, pending outcome of above activities
Study likely to run over a 3-4 year period

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Commercial Opportunities and Activities

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Breakthrough Medicines

CSL112: Apo-A1 HDL

Unmet Medical Need:

Approximately 20% of patients that survive a heart attack will experience a recurrent CV event within one year
About half of these will occur in the first month post index event

Potential Clinical Benefit:

Significant reduction in early, recurrent CV events (CV death, Recurrent MI, stroke) in high-risk ACS patients

MOA:

Rapidly removes cholesterol from atherosclerotic lesions/plaque via significantly enhanced cholesterol efflux

Source: WHO 2013 Update; CDC Heart Disease Fact Sheet August 2014

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Breakthrough Medicines CSL112 Commercial Opportunity

Uncontested sub-acute market space

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PLATO STUDY [1] SWEDISH REGISTRY STUDY [2]
20
Chronic
12 15 Phase
Chronic
10 Phase
Statins
8 10 PCSK9i
Statins
CETPi
PCSK9i
6
CETPi
CSL CSL
4
112 5 112
2 Sub-acute Sub-acute
Phase Phase
0 0
0 30 60 90 180 360 0 30 60 90 180 360
Days Days
Vascular death, MI, or stroke (%)
Vascular death, MI, or stroke (%)
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Sources: 1. Figure adapted from Wallentin L, et al. N Engl J Med. 2009;361:1045-1057. 2. Figure adapted from Jernberg T, et al. Eur Heart J . 2015;36:1163-1170.

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Breakthrough Medicines

CSL112 – Market Development Activities

Third-party Payers

Payer perspective on key Phase 3 design variables

Access and Reimbursement

HEOR endpoints / HTA / Value demonstration

Product Labeling

Claims prioritisation and treatment guidelines placement

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Seqirus R&D
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Seqirus Influenza Vaccine Platform

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At-risk populations Standard risk
Adjuvanted seasonal Seasonal
TIV → QIV QIV
Pandemic
Egg based Cell culture
Influenza Science
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TIV = trivalent influenza vaccine (3 strains) QIV = quadrivalent influenza vaccine (4 strains)

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Influenza Changes Constantly

Antigenic drift

Antigenic shift

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Small mutations

New strain

Epidemic Yearly seasonal vaccine 3-4 circulating strains (2 “A”, 1 or 2 “B” strains) May vary season to season, SH vs NH

Pandemic Occasional vaccine Single strain

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Programs at Time of Acquisition

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Registration
& Launch
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Post
Registration
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Phase 3
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Fluad™ QIV 6m-5yrs Efficacy on-going

Fluad™ TIV 65yrs+ Submitted USA

Flucelvax[®] QIV 4yrs+ Submitted USA

Afluria[®] QIV 5-17yrs On-going

Afluria[®] QIV 18yrs+ Submitted USA, AUS

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Delivery of all Milestones during Integration

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Registration
& Launch
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Post
Registration
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Phase 3
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Fluad™ QIV 6m-5yrs Fluad™ TIV 65yrs+ Fluad™ TIV 65yrs+ Efficacy complete Submitted UK Approval USA Fluad™ QIV 65yrs+ Efficacy start Flucelvax[®] QIV 2yrs+ Flucelvax[[®]] QIV 4yrs+ Efficacy start Approval USA Afluria[®] QIV 6m-4yrs Afluria[®] QIV 5-17yrs Afluria[[®]] QIV 18yrs+ Safety & Immuno start Submitted USA, AUS Approval USA, AUS

Flucelvax[[®]] QIV 4yrs+ Approval USA Afluria[[®]] QIV 18yrs+ Approval USA, AUS

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Differentiated Product Portfolio - Current and Future Indications

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Planned Future Age
Brand Age Indication Today Target Offer
Indication
6 months to 2years 6 months to 5 years
QIV
65 years + 65 years +
4 years + 2 years + QIV
18 years + 6 months + QIV
6 months + TIV
4 years +
TIV
Pandemic preparedness
FOCLIVIA
18 years + 5 years + i.v.
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FLUAD™

Differentiated (MF-59 adjuvanted) influenza vaccine for vulnerable populations

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Why FLUAD™?

Age-related hospitalisations and TIV efficacy rates

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10 0 Vaccine (TIV) Hospitalization rate [4 ] 70 • MF59 adjuvant strengthens and
efficacy [1-3 ]
potentially broadens the
60
80
immune response
50
•
>100 million doses of MF59
60
40
adjuvanted vaccines distributed
30
40 – excellent safety
20 •
Developing QIV for at risk
20
10 paediatric and elderly age
0 0 groups
<5 5–9 10–19 20–34 35–44 45–54 55–64 ≥65
Patient age (years)
(%)
efficacy
Vaccine
(events per 100,000)
Influenza-related hospitalization rate
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MF59 adjuvant strengthens and potentially broadens the immune response
100 million doses of MF59 adjuvanted vaccines distributed

1. Nichol KL, et al. Vaccine. 2003;21:1769-1775; 2. Goodwin K, et al. Vaccine. 2006;24:1159-1169; 3. Grubeck-Loebenstein B, et al. Nat Med. 1998;4:870; 4. Glezen WP, et al. Am Rev Respir Dis. 1987;136:550555.

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FLUCELVAX[® ]

Developing a cell culture-derived QIV for the general population in global markets

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Cell-culture offers potential benefits over egg-derived influenza vaccine

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EGG-DERIVED
• Process well established and understood
•
Long track record of safety and efficacy
Virus • Efficient
Seed Virus harvested, Filling, final
propagation in Further purification
strains concentrated testing and
embryonated and formulation
selected and inactivated release
hens’ eggs
Seed strains
Detergents to
selected for Purification
split whole virus
influenza A
CELL CULTURE
•
Removes reliance on eggs
•
Potential to increase capacity
• substantial process improvements
• greater scalability
•
Virus Improvements in seed selection
strains Seed propagation in Virus harvested, concentrated Further purification Filling, final testing and • Enhanced responsiveness, ie in a
mammalian and formulation
selected cells and inactivated release pandemic
Sterile closed-system bioreactors, antibiotic-free
vaccine production
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AFLURIA[® ]

Developing an egg-derived QIV for the general population in global markets

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Reduced fever rate with Afluria[®] QIV in children

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Comparison with Historical Fever Rates
5 - 8 years age group
Afluria (NHF-04-05)
Afluria (USF-06-29)
Historical TIV
Afluria (USF-07-36)
Afluria TIV (Pooled)
Afluria TIV (USF-10-69) ↑ TDOC (H3N2+B)
Fluzone (USF-07-36)
Fluzone (USF-10-69) Comparator TIV/QIV
Fluarix (QIV-13-02)
Afluria QIV (QIV-13-02) ↑ TDOC (all strains)
0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 22% 24%
Fever Rate
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* Pooled estimate from studies NHF-04-05, USF-10-69, USF-07-36
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In-depth scientific investigations  manufacturing changes
Comprehensive clinical program  fever rates now equivalent to comparable marketed QIV

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Longer Term 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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Milestones Expected for 2017

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Registration Post
Phase 3
& Launch Registration
Fluad™ QIV 6m-5yrs Fluad™ TIV 65yrs+
Submission USA Approval UK
QIV
Submission EU
Afluria [®] QIV 6m-4yrs
Afluria [®] QIV 6m-4yrs
Safety & Immuno
Submitted USA, AUS
complete
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Summary
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Global

R&D Portfolio – December 2016

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Commercial/
Research Pre-clinical Phase I Phase II Phase III Registration
Phase IV
CLINICAL DEVELOPMENT REGISTRATION / POST LAUNCH
Immunoglobulins
Haemophilia
Life Cycle
Specialty
Management [# ] Products
Influenza
Vaccine
HIZENTRA [®] CIDP
C1-INH New PRIVIGEN [®] PRIVIGEN [®]
Indications Japan CIDP US
Market
Development Fibrinogen New Hizentra [®] KCENTRA [®] VONCENTO [®]
Formulations IIM Japan VWD EU
PCC New Haptoglobin/ CSL842 C1-INH CSL830 RESPREEZA [® ]
Indications Hemopexin Transplant C1-INH subcut EU/US
Next Gen
Ig Formulations
Rec Coagulation CSL626 D’D3 CSL689 rVIIa-FP CSL689 rVIIa-FP AFSTYLA [®] IDELVION [®]
Factors LA rVIII Congen Def Inhibitors Europe US, EU, Japan
CSL640 AFSTYLA [®]
New Product rIX-FP subct US
Development P. gingivalis/POD CSL334 IL-13R CAM3001 AFLURIA [®] QIV AFLURIA [®] QIV
OH-CRC ASLAN GM-CSFR – AZ 5-17 US, AUS 18+ US & AUS
Discovery CSL312 CSL362 IL-3R FLUAD [® ] TIV
Projects Anti-FXIIa AML Janssen 65+ US
CSL346 CSL324 CSL112 FLUCELVAX [®]
VEGFB G-CSFR apo-AI QIV 4+ US
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Core Capabilities:

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Immunoglobulins
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Haemophilia
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Specialty Products
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Breakthrough Medicines
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Vaccines & IP
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*Partnered Projects

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LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

Global

Expected Progress in next 12 Months

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HIZENTRA [® ] PRIVIGEN [® ]
Ig Mimetic
CSL689 CIDP US/EU CIDP US
Congen Def
CSL830
EU
AFSTYLA [® ]
CSL842 C1-INH
EU
Transplant
AFSTYLA [®]
Japan
CSL830
CSL346 CSL112
HAEGARDA [TM ] US
Anti-VEGFB apoA-I
KCENTRA [® ]
Japan
FLUAD [®] QIV
6m-5yrs US
QIV
EU
AFLURIA [®] QIV
6m-5yr US, AUS
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Global

Significant Target Launch Dates

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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
EU/Japan Prophylaxis
IDELVION [®] EU
CSL689 rVIIa-FP
On Demand
IDELVION [® ] Japan
AFSTYLA [® ] US
CSL830 CSL830
HAEGARDA [TM] US EU
KCENTRA [®]
Japan
AFLURIA [®] QIV AFLURIA [®] QIV AFLURIA [®] QIV AFLURIA [®] QIV
18+ US & AUS 6-17yr US 6m-5yr US 6m-5yr AUS
FLUAD [® ] TIV AFLURIA [®] QIV QIV
65+ US 6-17yr AUS EU
FLUCELVAX [®] FLUAD [®] QIV
QIV 4+ US 6m-5yrs US
Core Capabilities: Immunoglobulins Haemophilia Specialty Products Vaccines & IP
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Calendar Years

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Global

2016 Highlights

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Immunoglobulins
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PRIVIGEN[®] IsoLo[®] approved in major markets
HIZENTRA[® ] CIDP Phase III study (PATH) completed

• PATH supports efficacy of PRIVIGEN[®] in CIDP

Specialty Products

C1-INH subcut (CSL830) Phase III (COMPACT) completed
COMPACT demonstrates efficacy of CSL830 in HAE prophylaxis
• CSL830 BLA accepted for review by US FDA

Haemophilia

IDELVION[®] registered in major markets • IDELVION[®] is a new standard of care for haemophilia B • AFSTYLA[®] registered in US; positive opinion in EU; submitted in JPN • AFSTYLA[® ] unique single chain design results in longer acting product
CSL112 (Apo A-1) Phase IIb study (AEGIS-I) completed
Breakthrough • CSL112 (Apo A-1) Phase IIb study (AEGIS-I) completed CSL112 safely and rapidly elevates cholesterol efflux capacity
Medicines • Anti-GCSFR and anti-FXIIa mAbs Phase I studies commenced

Licensing & Vaccines

AFLURIA[®] QIV registered in US & AUS in 18+ yrs • FLUAD[®] TIV registered in US in 65+ yrs • FLUCELVAX[®] QIV registered in US in 4+ yrs

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R&D Briefing

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Global

Further Information

Presentation Playback

A webcast of the presentation can be accessed in the investors section of the CSL website. Contact: [email protected]

Investor Relations:

Mark Dehring Head of Investor Relations CSL Limited Phone: +613 9389 3407 Email: [email protected]

Media:

Jemimah Pentland Head of Asia Pacific Communications CSL Limited Phone: +613 9389 3473 Mobile: +614 1263 5483 Email: [email protected]

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AI assistant

CSL Ltd. — Investor Presentation 2016

17854_rns_2016-11-30_06ebf20f-6d09-4633-9f68-fed151b2539f.pdf

Global

Legal Notice

Forward looking statements

Trademarks

Global

Agenda

- Break -

Global

Commitment to Research & Development

Global

Past Launches from the R&D Portfolio

Global Leveraging Global Capabilities

Global

R&D Portfolio – December 2015

Core Capabilities:

LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

Global

Progress Through Stage Gates in 2016

Global

R&D Portfolio – December 2016

Core Capabilities:

LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

Global

CSL Protein Therapeutics Technical Platform

Global

CSL’s Global Research Capability

• Coordinated global project portfolio

Haemophilia

Research Strategy

Haemophilia

FVIII Half-Life Extension

+ AFSTYLA[®]

Haemophilia

FVIII Half-Life Extension

Immunoglobulins Research Strategy

Immunoglobulins

Immunoglobulin Mimetics

Immunoglobulin functional domains

Immunoglobulins Immunoglobulin Mimetics

CSL777 proof-of-concept in CAbIA model of arthritis

Breakthrough Medicines

Portfolio – Late Preclinical / Clinical

Anti-G-CSFR mAb reverses development of arthritis

Breakthrough Medicines

CSL312 – HAE and Thrombosis

Breakthrough Medicines CSL312 – HAE and Thrombosis

Breakthrough Medicines

CSL312 – HAE and Thrombosis

• Rabbit ECMO model

Breakthrough Medicines

CSL346 – Diabetes / Diabetic Complications

VEGF-B controls tissue uptake of fatty acids via regulation of endothelial fatty acids transport

Breakthrough Medicines

CSL346 – Diabetes / Diabetic Complications

Anti-VEGF-B antibody prevents development of nephropathy in db/db//BLKS mice

Global

Strong Research Portfolio

• Creating a sustainable pipeline for future growth

Immunoglobulins

Immunoglobulins Progress in Neurology

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunoglobulins PATH Program – Phase III Study[1]

• Data base locked

Immunoglobulins

PATH Supports Efficacy of PRIVIGEN [®] in CIDP

Immunoglobulins Expanding on Successful CIDP Experience

• Expand on our commitment to rare diseases

Immunoglobulins IVIG and Haemolysis[1 ]

• Due to isoagglutinins

PRIVIGEN[®] Isoagglutinin Levels Lowered to Immunoglobulins Reduce IVIG Associated Haemolysis Risk[1 ]

Methods to Reduce Isoagglutinin Levels

Immunoglobulins Reduction in PRIVIGEN[®] Haemolysis

• PRIVIGEN[®] IsoLo[®] approved in US, Europe, Canada, Australia, Switzerland and other selected countries

Global

Plasma-proteins Therapeutics Market

Global Key Segment Opportunities

Immunoglobulins Global Market

CSL Ltd. Investor Presentation 2016

**QOL* Negatively Impacted by HAE**