CSL Ltd. — Investor Presentation 2013

Dec 4, 2013

R&D Briefing December 5, 2013

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’s 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 or its affiliates.

Agenda December 2013 R&D Briefing

• Welcome

• Introduction & Highlights

• Protein Science

Mark Dehring Andrew Cuthbertson Andrew Nash

• Immunoglobulins & Specialty Products

• Clinical Development

• Commercial Opportunities

Russell Basser Lutz Bonacker

• Q&A

Break

• Coagulation/Haemophilia

• Clinical Development

Russell Basser

• Commercial Opportunities

Lutz Bonacker

• Breakthrough Medicines & Licensing

• Summary

Andrew Cuthbertson Andrew Cuthbertson

• Q&A

3

Introduction and Highlights

CSL Protein Therapeutics Technical Platform

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Breakthrough
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
Plasma
Recombinant
Fractionation Technology
Protein Science
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5

CSL R&D Strategy

• Maintain commitment

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Breakthrough
Medicines
Specialty
Immunoglobulins
Products
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Haemophilia Products

• to extracting maximum value from existing assets and supporting and improving current products

• Develop new protein-based therapies for treating serious illnesses focusing on products that align with our technical and commercial capabilities

6

Leveraging Global Capabilities

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7

R&D Investment

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8

 Global R&D Portfolio 

December 2012

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Research Pre-clinical Phase I Phase II Phase III Registration Commercial/
Phase IV
CLINICAL DEVELOPMENT REGISTRATION / POST LAUNCH
Immunoglobulins
Haemophilia
Specialty
Products
Life Cycle Influenza
Management Vaccine
Hizentra [®] CIDP Privigen [®] CIDP Hizentra [®] US/EU
Biostate [®] EU
Fibrinogen New Zemaira [®] EU Berinert [®] Self
Berinert [®] subcut
Indications Beriplex [®] US Admin
Fibrinogen Aortic
Market PCC New Surgery EU
Development Indications
Novel Plasma
Proteins
rvWF-FP
CSL627 rVIII-SC
CSL654 rIX-FP
Rec Coagulation
Factors CSL689 rVIIa-FP
Partnered Vaccine Partnered Vaccine Partnered Vaccine Partnered Vaccine
Programs Programs Programs Programs
P. gingivalis/POD CSL324 G-CSFR CSL362 IL-3R CSL112
OH-CRC/Sanofi reconstituted HDL
CAM3001
Discovery CSL346 VEGFB
New Product Projects GM-CSFR –AZ
Development CSL334 IL-13R
Core Capabilities: Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
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*Partnered Projects

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

Progress through Stage Gates in 2013

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Privigen [® ]
rvWF-FP rVIIa-FP rVIII-SC
CIDP
Hizentra [®]
Anti-FXIIa Beriplex [®] Zemaira [®] EU Japan
Japan
Hizentra [®]
Berinert [®] Kcentra [TM]
Bi-weekly
s.c. Surgery US
Voncento™
EU
CSL112
FXIII
Japan
CSL362
Janssen Kcentra [TM]
Bleeding US
IAT
Berinert [®] EU
programs
S-T prophy
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10

Protein Science

CSL’s Global Research Capability

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• ~130 of 1000 scientists dedicated to research

• Hub & spoke model

• Single coordinated project portfolio

• Research excellence in therapeutic proteins

• Plasma and recombinant manufacturing platforms

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12

Bio21 - Research Hub

• Located within world class university, medical research and hospital precinct in Parkville

• Technical expertise

• protein engineering, molecular biology, cell biology, models of disease, genomics / bioinformatics

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• Improved access to

• high quality staff

• cutting edge technologies

• ideas / innovations / collaborations

• patients and patient samples

• Model for Biotech / Pharma Research

• decentralisation into high quality academic

  • research hubs

13

CSL Research Key Objectives

Deliver new development Scientific support opportunities to SG2 beyond SG2

Assess new product opportunities and emerging threats

Resolve critical scientific issues

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Add value to the existing
CSL product portfolio:
- yield improvements
- improved formulations
- new indications
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14

Innovation in Key Areas of CSL’s Business

Immunoglobulins

• PID - convenience

• Non-PID – efficacy / convenience

Haemophilia

• convenience / quality of life

Specialty Products

• product specific but.....

• efficacy / convenience

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Efficacy
Cost Convenience
Drivers of
innovation in
healthcare
(CSL)
Supply Safety
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Breakthrough Medicines

• efficacy

15

Plasma Proteins

• Capabilities from discovery to market

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Plasma collection Plasma fractionation
Electron microscopy of CSL112
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Completed Phase IIa - Strong increase in cholesterol efflux capacity

16

Recombinant Proteins

• Capabilities from discovery to market

Phase III / launch manufacturing

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Manufacturing CLD Lab
Protein Engineering Lab
Patient
Phase I / II manufacturing
Animal models of disease
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17

CSL654 (rIX-FP) – Discovery to Development

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CSL654 manufacturing CHO clones
Factor IX fused to human
CSL654 T1/2 extension in Haem B
albumin (CSL654) Bio21
patients compared to Benefix
Marburg
King of Prussia
Mean values and fitted curves
1 CSL654 100 IU/kg (n=3)
0.50 BeneFIX® 100 IU/kg (n=2)
0.20
0.10
0.05
0.02
0.01
0.005 Parkville
0 1 2 3 4 5 6 7 8
Days after administration
Marburg
CSL654 T1/2 extension in Haem B
dogs compared to Benefix 500L fed batch fermentation
Faxtor IX antigen (IU/mL)
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18

Research Publications

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19

Plasma and Recombinant Synergies

Plasma therapeutics expertise / new recombinant therapies

• Recombinant coagulation factors

• CSL654 / rIX-FP, CSL689 / rVIIa-FP, CSL627 / rVIII-SingleChain

• CSL650 / rvWF-FP

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20

CSL650 (rvWF-FP)

• vWF-FP expressed in CHO cells forms multimers and demonstrates an extended half-life

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Rat PK study
4000
pd vWF
3000
rvWF
rvWF-FP
2000
1000
0
0 120 240 360 480 1440
time [minutes]
Animal Half-life
extension
VWF k.o. 4x
mouse
rat 5x
rabbit 4x
SHP Day 3 Day 7 Day 13 Day 18 Day 24 Day 29 SHP
vWF:Ag [mIU/mL]
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21

FXIIa Antagonists

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Auto-activation pathways Mitogenesis
+FXIIa/β
FXIIa
Berinert
PK → KAL Kalbitor βFXIIa
Icatibant
Berinert
Fibroblast/
FXI → FXIa HK → BK→ BR2 C1qr,s → C1qr,s endothelial cell
Vasodilation, Complement
Hemostasis
vascular permeability activation
Thrombosis HAE Transplantation IPF
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22

FXIIa Antagonist mAb - HAE

Percutaneous anaphylaxis, a mouse model of HAE • anti-FXIIa mAb 3F7 inhibits edema

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120 *** Ctrl
100
80
60
40
20 3F7
0
0.5 0.5 0.2 0.1 0.05 mg
BM4
3F7
% of PBS
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23

FXIIa Antagonist mAb - Thrombosis

• Extracorporeal membrane oxygenation (ECMO)

• Heparin coated circuits and heparin infusion are required to prevent thrombosis

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• Bleeding is the most frequent complication

• intracerebral hemorrhage (particularly new

• borns)

• pulmonary hemorrhage

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• bleeding into chest cavity following cardiac

• surgery etc.

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need for thromboprotection without increasing bleeding risk

• In certain circumstances inhibition of FXIIa prevents thrombosis without increased bleeding risk

FXIIa Antagonist mAb - Thrombosis

ECMO-rabbit model

• anti-FXIIa mAb 3F7 prevents fibrin deposition with no increased risk of bleeding

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25

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CSL362 for the Treatment of SLE
CSL362
•
Proposed role for pDC’s in SLE
CD123 / IL-3R a
TLR7/9
Complement-dependent
activation
cell cytotoxicity
CSL362 targets and
TLR7/9
CD8+
activation kills pDC’spDC Cytotoxicity
T cell
Dying cell
Dying cell
IFN a
RNA/DNA
Immune complex
Autoantibodies
Phagocytosis
Plasma
B cell
CD4+ Presentation of
T cell autoantigens
T cell help
26
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CSL362 for the Treatment of SLE (Lupus)

• a CSL362 prevents IFN production in blood from normal donors and SLE patients

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Healthy controls Healthy controls SLE patients SLE patients Healthy SLE
1000 100 IFI44L
IFIT1
IFIT3
IRF7
100
ISIG5
10 MX1
MX2
10
OAS1
OAS2
SERPING1
1 1 XAF1
CSL362 10ug/ml - - + - - +
CpG 1uM - + + - + +
n = 5 n = 3
Mean +/- SEM Mean +/- SEM
Unstimulated CSL362 10ug/ml + CpG 1uMCpG 1uM Unstimulated CSL362 10ug/ml + CpG 1uMCpG 1uM
IFNa concentration pg/ml (Log10)
IFNa concentration pg/ml (Log10) conc. (pg/ml) conc. (pg/ml)
a a
IFN IFN
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27

CSL Research and Protein Science

• High quality research capability to generate new development opportunities and address key scientific issues

• Expertise to identify and progress opportunities using both plasma and recombinant protein platforms

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Efficacy
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Cost Convenience Drivers of innovation in healthcare (CSL) Supply Safety

• Global coordination of research capability to target highest priority projects

• Portfolio of early stage projects to progress through CSL Stage Gate 2 and beyond

28

Immunoglobulins

Immunoglobulins

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Immunoglobulins
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Maintaining leadership position through focus on:

• Patient convenience

• Yield

• Label

• Formulation science

• Specialty Igs

Key Focus

• Privigen[®]

• Hizentra[®]

30

Privigen[®]

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The first and only 10% liquid intravenous immunoglobulin (IVIg) therapy that is proline stabilised with room temperature storage up to 36 months

Strengthening Presence in Neurology Market

• Phase III study showed treatment with Privigen[®] improved function in patients with CIDP

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• EMA approval for treatment of patients with CIDP in April 2013

Building Capacity to Address Patient Needs Globally

• New Ig manufacturing facility in Broadmeadows

31

Hizentra[®]

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The first 20% high concentration low volume SCIG for convenient self administration providing steady-state Ig levels and an established long-term safety record with chronic administration

Global Rollout

• Launched in US since 2010

• Broad approvals in EU and Canada

• Approval in Japan for PID and SID in Sept 2013

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• First SCIg therapy approved for use in Japan

The PATH Trial: Hizentra[®] in CIDP

• 2 doses vs placebo

• Ongoing in US, EU & Japan

• Recruitment estimated to be

• completed by end 2014

32

Hizentra[®] Schedules

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US administration options expanded to include dosing once every two weeks (biweekly) in Sept 2013

• FDA and EU approval of biweekly dosing based on principles of pharmacometrics and pharmacokinetic modelling of clinical trial data from registration program Simulation of SCIG q1W & q2W PK

Simulation of SCIG q1W & q2W PK

Pharmacometrics Clinical Biostatistics Pharmacology

33

From Landersdorfer et al, Postgrad Med 2013

Commercial Opportunities and Activities

Global Immunoglobulin Market

2012/13 Sales

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CSL
$US 7+ B
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• Market includes IVIG, SCIG and Hyperimmunes

• Growing, but competitive, market

• CSL is well positioned:

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• X

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• X

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• x

35

CSL’s Immunoglobulin Portfolio

2012/13 Sales

• Globalise portfolio

• Expand into neurology

• Increase convenience

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Specific
IG
Hizentra [®]
Privigen [®]
IVIG
Other
$US 2,081 M
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36

Immunoglobulins: Progress Achieved

Globalise portfolio

• Hizentra[®] PID in Japan – first and only SCIG product in Japan

• Privigen[®] currently registered in 61 countries

• Hizentra[®] currently registered in 38 countries

Expand into neurology

• Privigen[®] CIDP launched in Q2 2013

• Ongoing Development of Hizentra[®] in CIDP

• Further options under evaluation

Increase convenience

• Privigen[®] 40 g launched in Q2 2013

• Hizentra[®] 10 g launched in Q3 2013

• Hizentra[®] Bi-weekly launched in Q3 2013

• Further activities ongoing

37

Benefits of SCIg: Steady-State, Convenience

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1600
1400
1200
Intravenous Ig
1000
800
Subcutaneous Ig
600
400
0 2 4 6 8 10 12 14 16 18 20 22
Days
Total IgG (mg/dL)
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Representative graph for illustration only
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SCIG:

• Steady-state IgG levels[1]

• Self-administration[2]

• Flexibility in infusing[3]

• Low risk of systemic adverse events[4]

• True s.c administration profile

• Less infusions per month

• No change in safety profile

• Convenient

• No adjuncts required

• Gardulf A, et al. Lancet . 1991;338:162-166.

38

1.Berger M. Clin Immunol. 2004;112:1-7. 2.Shapiro RS. J Clin Immunol. 2013;33(s2):S95-S98.

1. Younger EM, et al. J Infusion Nurs . 2013;36(1):1-11.

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New Advances for Patients

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Biweekly 10g (50mL) Vial
• •
Approval US: Sept 25, 2013 Approval US: Jun 12, 2013
• Available US: Sept 25, 2013 • Available US: Oct 15, 2013
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IVIg patients who:

• Have considered SCIg but felt weekly infusions were too frequent

Patients relying on caregivers who:

• Want steady state and convenience of in-home infusions but find it difficult to fit weekly infusions into everyone’s schedules

Weekly SCIG patients who:

• Are on a 10% SCIg, and want to infuse less frequently without increasing the volume per infusion

• Are on Hizentra[®] and want to infuse less frequently

39

Specialty Products

Specialty Products

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Specialty
Products
41
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Leveraging high quality, broad product portfolio through:

• New markets

• Novel indications

• Novel modes of administration

• Key Focus

• Beriplex[® / ] Kcentra[TM]

• Fibrinogen

• Zemaira[®]

• Berinert[®]

Kcentra[TM] (Beriplex[®] )

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• Prothrombin Complex Concentrate = PCC

• vitamin K-dependent coagulation factors (FII, FVII, FIX, FX)

Seeking approval for use of Kcentra[TM] to reverse the effects of vitamin K antagonists (e.g. Warfarin) for:

• Bleeding related to over-anticoagulation

• Patients needing surgery

FDA approval for urgent Warfarin reversal in patients with acute major bleeding in April 2013

• Kcentra[TM] launched in April as a first in class therapy

42

Kcentra[TM] (Beriplex[®] )

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• 

• Kcentra approved by FDA in April for bleeding indication

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43

Kcentra[TM] Surgical Study Design

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Kcentra + Vitamin K
R
A
N
D
O
Subjects on
M
VKA in need
I
of surgery
S
Plasma + Vitamin K
E
D
1:1
INR Haemostatic Safety Virus
efficacy (SAEs) testing
30 min End of surgery 45 days 90 days
end of infusion
44
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Kcentra[TM] to reverse VKA prior to surgery

• All patients had reversal of blood thinning test (INR) to normal prior to surgery

• Those given Kcentra[TM] had less bleeding during subsequent surgery

% of subjects Difference Kcentra – Kcentra Plasma plasma (%) (N = 87) (N = 81) “Effective” 78 61 P <0.05 bleedin control g (90%) (75%)

45

Kcentra[TM] Surgical Study Conclusions

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Kcentra[TM] was:

• superior to plasma for control of bleeding

• superior to plasma for rapid reduction in INR

• as safe as plasma (safer with regard to some effects)

FDA granted priority review

• Action date 14 December 2013

46

Fibrinogen

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The first and only treatment approved by the US FDA for acute bleeding episodes in patients with congenital fibrinogen deficiency

Europe

• Peri-/post-operative control of coagulopathic bleeding

• REPLACE Phase III study

• 200 subjects – recruitment commenced Jan 2012

• Lower bleeding rate than in pilot study – longer to recruit

US

• Coagulopathic bleeding related to complex cardiac surgery

• Ongoing dialogue with FDA

• Aim to commence Phase II study in 2014

47

Zemaira[®]

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Zemaira is the first highly purified alpha-1 augmentation therapy approved by the FDA for chronic augmentation and maintenance therapy of adults with Alpha-1 and emphysema

Seeking to broaden commercial reach through:

• Launch in EU, Canada, Brazil

• EU requires demonstration of a clinical outcome (disease modification)

• Increase diagnosis and treatment

• Broaden label in US

48

Alpha-1-antitrypsin Deficiency

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• Chronic obstructive pulmonary disease (COPD) or emphysema

• Cirrhosis and liver failure less commonly

• Under-diagnosed

• Lung disease usually presents in 30-40’s

49

RAPID Study Design

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R EXTENSION STUDY
Zemaira weekly iv
A
N
D
Zemaria weekly iv
O
M
180 subjects
I
Placebo
S
E
D
1:1 baseline 12 months 24 months 36 months 48 months
CT scan
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50

2

RAPID Study Data

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Physiologically Adjusted Lung Density (TLC)

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Placebo Zemaira
0.0
-1.45
-1.0
-2.0
-2.90
-3.0 -2.19
-3.97
-4.0
-5.03
-5.0
-4.38
-6.0 -5.35
-7.0 RAPID Trial RAPID Extension Trial -6.32
-8.0
0 12 24 36 48
Month of Treatment
Change From Baseline (g/L)
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Zemaira[®] slows damage to lung tissue

• Efficacy supplement submitted to FDA late Nov 2013

• MAA submitted to EMA early Dec 2013

51

Berinert[®]

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Plasma derived, pasteurised & nanofiltered concentrate of C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adults and adolescents

• US and European approved label expansion for self administration of HAE in 2012

• EMA approval for short term prophylaxis in adults and children in April 2013

• Phase I/II high concentration, subcutaneous prophylaxis study complete

52

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• Dose-ranging study • Assess safety, PK/PD

• • 18 HAE patients with infrequent attacks Phase II • Clinically relevant blood levels achieved

• Clinical efficacy study • Double-blind, placebo-controlled • 72 HAE patients with frequent attacks

Phase III

• Long-term safety and efficacy • Re-randomised, open-label, 1 year

• • Patients completing efficacy study

53

Commercial Opportunities and Activities

CSL’s Specialty Products Portfolio

2012/13 Sales

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Wound Healing
Other Specialty Products Tachocomb [®]
Beriplast [®]
Kybernin [®]
Berinert [®]
Zemaira [®]
Streptase [®]
Fibrogammin [®]
Beriplex [®] Perioperative Bleeding
$US719 M
Riastap [®]
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• Increase clinical data set

• Add indications

• Expand regionally

55

Blood Components vs. Concentrates

FFP

Fibrinogen concentration at ≈2.3g / L Not virus inactivated Frozen, requires time (<50 minutes) to thaw

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Red Blood Cells

Need to be matched to blood type Not virus inactivated

Platelets

Short shelf life (5 days) Risk of bacterial contamination

Cryo

• Frozen, require time to thaw

• Pooled from 10 bags of FFP in the blood bank

• Average Fibrinogen concentration ≈ 6g /L

Concentrated, virus inactivated, room temperature storage, Fibrinogen concentration 20g / L

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56

Kcentra[TM]

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Kcentra[TM] , Prothrombin Complex Concentrate (Human), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g. warfarin) therapy in adult patients with acute major bleeding

2013

Apr May Jun Jul Aug Sep Oct Nov Dec First New 1,000 Surgical Sale Technology IU Indication Add-On Vial Action Payment Size Date Approval Action Date Pivotal Manuscript Published

57

Kcentra[TM] Awarded New Technology Add-On Payment

Medical Community Support for Kcentra NTAP

Centers for Medicare and Medicaid Services (CMS) approved a new technology add-on payment (NTAP) for Kcentra

“AABB strongly believes that Kcentra provides a significant improvement in care for patients in life-threatening circumstances …….” . Letter of support from AABB to CMS dated June 25, 2013

“…Kcentra represents a substantial improvement compared to existing therapeutic technologies (i.e. plasma therapy). ….”

Letter of support from the American Society of Hematology to CMS dated June 24, 2013.

Riastap[®]

trial with global impact, Europe, Japan, Canada

• Obtain US acquired bleeding label

• Initiate acquired label expansion

• Central role of fibrinogen in severe bleeding discussed in scientific literature[1]

• Early intervention with concentrates further recommended in guidelines[2,3] and transfer into local algorithms[4]

1Davenport and Brohi Critical Carre 2013, 17:190

• 2Spahn et al. Critical Care 2013 Apr 19;17(2):R76

• 3Kozek-Langenecker et al. Eur J Anaesthesiol 2013; 30:270–382

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• 4Nardi et al. Journal of Anesthesiology and Clinical Science 2013

59

Zemaira[® ] and the RAPID results

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The first and only proven disease-modifying A1-PI therapy shown to slow damage to lung tissue and delay the progression of emphysema

RAPID data

• Data rollout initiated at ATS

• Will provide clinical differentiation supporting preferred formulary placement

Targeted to be:

• First and only A1-PI with pan EU approval

• First and only A1-PI that will have clinical efficacy data in package insert

• Will allow sales rep promotion

• May expand market to convince A1-PI

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• “non-believer” physicians

60

Berinert[®]

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Berinert treats the fundamental cause of HAE symptoms by providing C1-Inhibitor deficient patients with the missing human protein[1 ] Berinert has demonstrated that it provides fast relief of pain and swelling within 30 minutes[2]

• Obtain Prophylaxis indication

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• Increase convenience with s.c. treatment option

• Continuous Life Cycle Management to improve product profile

• Self administration, nano-filtration, and most recently “short term prophylaxis” approval in EU

• Continue geographical expansion

61

1) Agostini et al. J Allergy Clin Immunol. 2004

2) Craig et al. J Allergy Clin Immunol 2009

Berinert[®] Key Features

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----- Start of picture text -----

•Efficacy: Almost no
redosing required to treat
attacks
Product
•Early onset of relief
Advantages
•Excellent Safety and
tolerability
• Control of product supply
Manufact- - own plasma collection
uring centers and
manufacturing sites
• s.c. prophylaxis
Life Cycle • Low Volume formulation
Management • Further LCM indications
under evaluation
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62

HAE Therapeutic Segments

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----- Start of picture text -----

Current Developments
Berinert (C1
Inhibitor)
Acute
Bradykinin/Kallikrein
antagonist
Steroids
C1 Inhibitor i.v. Berinert s.c.
Prophylaxis
FXIIa MAb (longer
half life)
Kallikrein Inhibitors
(longer half life)
Segments
HAE Therapeutic
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63

Q&A

Break

R&D Briefing December 5, 2013

Haemophilia Products

Haemophilia

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

• Scientific and product innovation

• Patient benefit

Key Focus

Haemophilia Products

• Long acting rIX-FP

• Long acting rVIIa-FP

• rVIII-Single Chain

• Research into long acting rvWF-FP

3

Innovation to Drive Growth

driver of innovation

• Albumin fusion technology

• rIX-FP, rVIIa-FP, rvWF-FP

• Factor VIII

• biobetter rVIII-SingleChain

Scientific Edge

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Improved Precise
half life, rAlbumin engineering
extended as fusion of specially
dosing platform designed
interval linker
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High vWF affinity Improved molecular stability

Opportunity for Extended Dosing Interval

4

rIX-FP (CSL654)

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5

rIX-FP (CSL654) Global Clinical Program

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PUP
study
Phase I Phase I/II Phase II/III Phase III
Paediatric
PK PK PK
safety Long-term safety Long-term safety
Extension
7d prophylaxis 7-14d prophylaxis
On-demand On-demand
Surgical prophylaxis
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6

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Compared with in market rFIX

• 5.3-fold longer half-life (92hrs)

• ~ 45% higher incremental recovery

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• ~7-fold larger AUC

• ~7-fold slower clearance

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7

rIX-FP (CSL654) Efficacy in Phase I/II Study

• Annualised spontaneous bleeding during the study vs previous 12 months

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(n=10) (n=3) (n=4)
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8

rIX-FP (CSL654) Clinical Development

• Excellent safety profile

• Well tolerated

• No inhibitors

• No adverse events related to CSL654

• All patients now enrolled in Phase II/III and Paediatric studies

• Dossier submission now planned early 2015

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9

rVIIa-FP (CSL689)

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10

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Time

• Half-life = 8.5 hrs (vs rFVIIa ~2-3hrs)

• Well tolerated, no serious adverse events

11

rVIIa-FP (CSL689) Global Clinical Program

• Pivotal Phase II/III trial in haemophilia A & B patients with inhibitors

• Dose finding, safety & efficacy on-demand therapy

• Ongoing discussions with regulatory agencies (FDA, PEI, PMDA)

• Anticipate commencing in 2014

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12

Potential of rVIIa-FP (CSL689)

• For patients with inhibitors

• Single dose for treatment of bleeding

• Prevention of bleeding in patients undergoing surgery

• Prophylaxis

Other indications

• Congenital Factor VII deficiency

• Acquired haemophilia

• Glanzmann's thrombasthenia

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13

rVIII-SingleChain (CSL627)

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14

rVIII-SingleChain: approach for improved FVIII

• FVIII’s physiological partner in plasma is von Willebrand factor (vWF)

• FVIII/vWF complex is important role in the physiological activity and clearance of FVIII

• Aim - improve binding to vWF

• FVIII is an unstable molecule in the manufacturing environment

• Potential for dissociation and loss of procoagulant activity of FVIII

• Aim - improve molecular stability

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Me [++]
A1 A2 A3 C1 C2
rVIII-SingleChain
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15

rVIII-SingleChain Phase I/III Study Design

		Part 2 CSL627 repeat-dose, on-demand or prophylaxis (n=30) Part 3 CSL627 repeat-dose, on-demand or prophylaxis (n=78 evaluable subjects) Single-dose PK rVIII-SingleChain (n≥13) Surgical sub-study Includes patients from Parts 2 & 3 (n=5 with ≥10 major surgeries) Interim analysis
Part 1 CSL627 & Octagog alfa single-dose PK (n=30)		Part 2 CSL627 repeat-dose, on-demand or prophylaxis (n=30)
tudy entry

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• Part 1 completed enrolment Q1 2013

• • Part 3 commenced Q2 2013 – now scheduled to complete early 2014

16

CSL627 PK Supports Dosing Twice-Weekly

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Product Time to 2% Time to 1%
(hr) (hr)
rVIII-SingleChain 78.0 91.9
Octocog alpha 65.2 77.2
Data presented are mean values. n=22
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17

CSL627 PK Evaluation: Area Under the Curve

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30
25
20
15
10
5
0
1
AUC0-last AUC0-∞
Dose-normalised AUC (IUhr/mL)
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rVIII-SingleChain Octocog alpha

*Dose-normalised baseline-corrected FVIII activity AUC0-last and AUC0-∞ in plasma following a single intravenous administration of rVIII-SingleChain or Octocog alpha. FVIII activity determined by chromogenic assay and normalised by individual dose to 50 IU/kg. Data presented are mean ±SD n=27

18

rVIII-SingleChain Phase I/III Study

• Results to Date

• Very well tolerated

• No inhibitors

• All bleeding events effectively treated

• Last patient now to be enrolled early 2014

• recruitment challenges

• Dossier submission now planned early 2015

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19

Commercial Opportunities and Activities

Coagulation Sales

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----- Start of picture text -----

2012/13
Helixate [®]
Pd Coag
$US1,090M
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• Broad portfolio presence

• Growing pd portfolio

• Helixate[®]

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pd Coag
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• for recombinant pipeline

21

Coagulation: Key Market Segments and Products

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----- Start of picture text -----

• Beriate [®]
•
Helixate [®]
NexGen/FS/81
•
Factor X P [®] Hem A •
rVIII-Single
FX P ~ $5.2B Chain
~ $2M
pd ITT •
Voncento [®]
management
•
rVIIa-FP Inhibitor bleed ~ $0.4B • Haemate P [®]
treatment
Target
~ $1B
Segments
•
Mononine [®]
•
Voncento [®]
VWD Hem B • Berinin [®]
• Haemate P [®] ~$0.5B ~$0.9 B • rIX-FP
• rvWF-FP
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22

CSL Market Estimate 2013

Coagulation: Factors with Market Impact

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Product Choice Treatment Options Diagnosis rIX-FP

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rVIIa-FP rVIII-SingleChain

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23

Coagulation: Factors with Market Impact

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----- Start of picture text -----

Product
Choice
Treatment
Options
Diagnosis
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Identification of patients with bleeding disorders is still ongoing[1)]

24

1) WFH Global Survey 2011

Coagulation: Factors with Market Impact

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• On Demand

• • Episodic, fewer infusions

• Addresses bleed

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• Treatment Prophylaxis

• Options • Regular, more infusions

• • Avoids bleeds

WFH/ISTH recommendation: “Prophylaxis prevents bleeding and joint destruction and should be the goal of therapy to preserve normal musculoskeletal function. (Level 2)”[1) ]

25

1) WFH Guidelines for the Management of Hemophilia, 2nd edition

Coagulation: Factors with Market Impact

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Product Choice Effective Safe Low inhibitor risk Fewer needlesticks

26

rIX-FP (CSL654)

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• Effective Safe Low inhibitor Fewer risk needlesticks

• • Bleeding • Recombinant events Albumin as • Specifically • T/2 at 92h effectively fusion partner designed • Supports treated • Well linker dosing every

• • Successful tolerated, • Recombinant 2+ weeks prophylaxis locally and Albumin as • Approx. 80 maintained systemically fusion partner fewer needle to date

• • Access to site sticks p.a. of bleed

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----- Start of picture text -----

• Approx. 80
fewer needle
sticks p.a.
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27

rVIIa-FP (CSL689)

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----- Start of picture text -----

Effective Safe Low inhibitor
• Effective in • Recombinant risk
range of Albumin as
• Specifically
animal fusion partner
designed
models
• Well tolerated flexible linker
locally and • Recombinant
systemically Albumin as
to date
fusion partner
• Native FVIIa
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Fewer
needlesticks
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• T/2 at 8.5h

• Supports on demand and prophylactic therapy options

28

rVIII-SingleChain (CSL627)

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----- Start of picture text -----

Effective Safe Opportunity
for low
• •
Bleeding Well
inhibitor risk
events tolerated
•
effectively locally and High binding
treated systemically affinity to
• Improved to date VWF
molecular • No inhibitors
stability to date
•
Access to
site of bleed
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Fewer
needlesticks
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----- Start of picture text -----

•
Time to 1%
FVIII level
supports 2x
per week
dosing
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• Up to 52 fewer needle sticks p.a.

29

Presenting Data: Active Scientific Presence

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----- Start of picture text -----

40
35
30
25
20
15
10
5
0
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Abstracts / Poster / Presentations Publications
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30

Breakthrough Medicines

Breakthrough Medicines

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----- Start of picture text -----

Breakthrough
Medicines
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Leveraging clinical and technical insight in developing novel protein-based therapies

• Significant unmet need

• Multiple indications

Key Focus

• CSL112 (Apo AI)

• CSL346 (anti-VEGF-B mAb)

• FXII Antagonist

32

CSL112 (Apolipoprotein A-I)

• CSL112 is natural apolipoprotein A-I (apoA-I) the chief protein component of HDL

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• Rapidly and robustly enhances capacity of plasma to promote cholesterol efflux

• Potential to address significant gap in acute coronary syndrome

• Cholesterol removal from atherosclerotic plaque and its proposed removal by CSL112 demonstrated in Phase IIa study

33

CSL112 Mechanism of Action

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----- Start of picture text -----

Unesterified cholesterol
HDL3 HDL2
CSL112 LCAT LCAT
Cholesterol esters
HDL-VS
ApoA-I
Phospholipid
ABCA1
ABCG1
SRB1
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• Global Phase IIb clinical program to initiate early 2014

34

Modified from Kingwell & Chapman. Circulation 2013;128:1112-21

Licensing and Collaborations

Licensing

Breakthrough Breakthrough Medicines Medicines

Specialty ImmunoglobulinsImmunoglobulins ProductsSpecialty Products

Haemophilia Products Haemophilia Products

Optimising value of IP Portfolio and assets

• Partner high opportunity products

• GARDASIL[®]

• Mavrilimumab (GMCSFRa - Medi/AZ)

• Periodontal disease (Sanofi)

• CSL362 (Janssen)

• Continue broad licensing strategy for ISCOMATRIX[®] adjuvant

36

GARDASIL[®]

• Impact of Australian HPV Vaccination Program

• 93% reduction in genital warts in females less than 21 years

• 82% reduction in genital warts in heterosexual males less than 21 years

• 48% less high grade pre-cancers in women vaccinated in catch-up program (12-17 years in 2007)

• Long term protection

• Follow up studies up to 8 years demonstrate no break through disease

• V503: 9-Valent HPV Vaccine

• Merck’s 2nd generation HPV vaccine

• BLA Dec 2013 for 2015 launch

• Phase III data: prevented 97% cervical, vaginal and vulvar precancers caused by additional 5 types

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37

Gardasil is a registered trademark of Merck and Co., Inc.

a CSL362 (anti-IL-3R mAb)

• Initial indication: Acute myeloid leukaemia

• Enhanced recruitment of tumour killing NK cells

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• Phase I trial in progress

• Other high quality opportunities in autoimmunity eg. SLE

• Agreement with Janssen Biotech, Inc

• Exclusive worldwide license to develop and commercialise CSL362

• Collaborative research program to support the use of CSL362 in other indications

38

ISCOMATRIX[®] Adjuvant

Merck Research Laboratories

• Dengue Phase 1 fully enrolled

• Long lived antibodies in pre exposed NHPs

Novavax

• H5N1

• WVC 2013

• H7N9

• NEJM Nov 2013

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----- Start of picture text -----

100
VLP 45mcg
80
Low-dose IMX
60 5mcg
Low-dose IMX
40 15mcg
Med-dsoe IMX Med-dose IMX
20 5 mcg
5mcg
Med-dose IMX
0 15mcg
)
10
FRNT Titre (Log
% Subjects seroconversion
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IMX = ISCOMATRIX[®] adjuvant

39

Summary

 Global R&D Portfolio 

December 2013

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----- Start of picture text -----

Research Pre-clinical Phase I Phase II Phase III Registration Commercial/
Phase IV
CLINICAL DEVELOPMENT REGISTRATION / POST LAUNCH
Immunoglobulins
Haemophilia
Specialty
Products
Life Cycle Influenza
Management Vaccine
Hizentra [®] Japan
Hizentra [®] CIDP
Privigen [®] CIDP
Hizentra [®] biweekly
Fibrinogen New Kcentra [TM] US
Berinert [®] subcut Voncento [®] EU
Indications Surgery
Market PCC New Fibrinogen Kcentra [TM] US
Development Indications Aortic EU Zemaira [®] EU Bleeding
Novel Plasma
Proteins
Rec Coagulation CSL689 rVIIa-FP CSL627 rVIII-SC
rvWF-FP
Factors
CSL654 rIX-FP
Partnered Vaccine Partnered Vaccine Partnered Vaccine
Programs Programs Programs
P. gingivalis/POD CSL362 IL-3R
OH-CRC/Sanofi Janssen
Discovery CSL324 G-CSFR CSL112
Projects reconstituted HDL
CSL346 VEGFB
New Product FXIIa Antagonist CAM3001
GM-CSFR –AZ
Development CSL334 IL-13R
Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Core Capabilities:
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

Expected Progress in next 12 Months

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----- Start of picture text -----

rVIIa-FP Zemaira [®] EU
Kcentra [TM]
CSL112
Surgery US
Fibrinogen
Anti-FXIIa
Aortic US Beriplex [®]
Japan
Berinert [®]
s.c.
Fibrinogen
Aortic Japan
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42

 Significant Target Launch Dates

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----- Start of picture text -----

2013 2014 2015 2016 2017 2018
Voncento™ CSL654 CSL689
EU rIX-FP rVIIa-FP
CSL627
rFVIII
Kcentra [TM] Kcentra [TM] Fibrinogen EU Berinert®
Bleeding Surgical Aortic Surgery SubCut
Berinert® EU Zemaira® Beriplex ®
ST Prophylaxis EU Japan
Privigen® CIDP Hizentra® Hizentra®
EU Japan CIDP
Hizentra®
Biweekly
Immunoglobulins Haemophilia Specialty Products
Core Capabilities:
----- End of picture text -----

• Calendar Years

• Based on estimated first approval

43

2013 Highlights

Immunoglobulins Specialty Products Haemophilia

• Privigen[®] CIDP registration in EU

• Hizentra[®] BiWeekly registration in US and EU

• Hizentra[®] registration in Japan

• Kcentra[TM] registration for bleeding indication in US

• Zemaira[® ] efficacy data submitted in EU and US

• Berinert s.c. Pivotal Phase III commenced

• rIX-FP pivotal Phase III enrolment complete

• rIX-FP preliminary data demonstrates efficacy

• rVIII-SingleChain Phase I/III supports twice-weekly dosing

• Breakthrough CSL112 (reconstituted HDL) Phase IIa data supports Medicines mechanism of action and further development • CSL362 (IL-3Ra mAb) partnership with Janssen Licensing

• CSL112 (reconstituted HDL) Phase IIa data supports

• mechanism of action and further development

44

Q&A

Further Information

Presentation Playback

A playback of the Research and Development presentations will be available for a period of two weeks following the R&D Briefing. Investors wishing to listen to these presentations should contact CSL Investor Relations to arrange access. Contact: maria.pikos@csl.com.au

Investor Relations:

Mark Dehring Head of Investor Relations Phone: +61 3 9389 2818 Email: mark.dehring@csl.com.au

Media:

Sharon McHale Senior Director Public Affairs CSL Limited Phone: +613 9389 1506 Mobile: +614 0997 8314 Email: sharon.mchale@csl.com.au