CSL Ltd. — Investor Presentation 2014

Dec 2, 2014

R&D Briefing December 3, 2014

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

owned by and/or licensed to CSL or its affiliates.

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Agenda December 2014 R&D Briefing

• Welcome

• Introduction & Highlights

• Protein Science Research

Mark Dehring Andrew Cuthbertson Andrew Nash

• Immunoglobulins & Specialty Products

• Clinical Development

• Commercial Opportunities

Charmaine Gittleson Bob Repella

• Q&A

Break

• Coagulation/Haemophilia

• Clinical Development

Charmaine Gittleson

• Commercial Opportunities

Bob Repella

• 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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CSL R&D Strategy

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Breakthrough
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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• Maintain commitment

• 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

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Leveraging Global Capabilities

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•
>1,100 scientists globally
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Building Global Recombinant Capabilities

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Lengnau rCOAG
Manufacturing
Facility
Broadmeadows Biotech
Manufacturing Facility
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R&D Investment

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 Global R&D Portfolio

December 2013

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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 [®] Japan
Hizentra [®] CIDP
Privigen [®] CIDP
Hizentra [®] biweekly
Fibrinogen New CSL830 Kcentra [TM] US
Voncento [®] EU
Indications C1-INH subcut Surgery
Market PCC New Fibrinogen Kcentra [TM ] US
Development Indications Aortic EU Zemaira [®] EU Bleeding
Novel Plasma
Proteins
Rec Coagulation CSL650
Factors rvWF-FP CSL689 rVIIa-FP CSL627 rVIII-SC
Partnered Vaccine Partnered Vaccine Partnered Vaccine
CSL654 rIX-FP
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:
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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 2014

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Hizentra [®] EU
Flex Dosing
CSL689 CSL654
rVIIa-FP Def rIX-FP
Beriplex [ ®] Kcentra [TM]
Japan Surgery US
CSL312 CSL112
Zemaira [®] EU
Anti-FXIIa Apo AI
CSL334 Beriplex [®] Quad Flu
ASLAN NOACsDaiichi Vaccine 18+
Trivalent Flu
5-9 yrs
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 Global R&D Portfolio

December 2014

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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 [®] Japan
Hizentra [®] CIDP
Privigen [ ®] CIDP
Beriplex [®]
Market Japan Hizentra [®] biweekly
Fibrinogen New CSL830
Development Voncento [®] EU
Indications C1-INH subcut
Kcentra [TM] US
PCC New Beriplex [®] NOACs Fibrinogen
Indications Daiichi Aortic EU Zemaira [®] EU Bleeding /Surgery
Novel Plasma
Proteins
Rec Coagulation CSL650 CSL689 rVIIa-FP CSL689 rVIIa-FP CSL627 rVIII-SC CSL654 rIX-FP
Factors rvWF-FP Congen Def Inhibitors
Partnered Vaccine Partnered Vaccine Partnered Vaccine
New Product Programs Programs Programs
Development P. gingivalis/POD CSL362 IL-3R
OH-CRC/Sanofi FXIIa Antagonist Janssen
Discovery CSL324 G-CSFR CSL112
Projects reconstituted HDL
CSL346 VEGFB
CAM3001 Quadrivalent
CSL334 IL-13R GM-CSFR –AZ Flu Vaccine
Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Core Capabilities:
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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

Protein Science Research

CSL’s Global Research Capability

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• Hub & spoke model

• Single coordinated project portfolio

• Research excellence in therapeutic proteins

• • Plasma and recombinant manufacturing platforms

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Bio21 - Research Hub

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

• 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

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CSL Research Project Portfolio

Some examples from the CSL Research Project Portfolio

Priority	Immunoglobulins	Haemophilia	Specialty Products	Breakthrough Medicines
High	Ig Formulations	FVIII half-life ext.	Beriplex NOACs	CSL312 HAE/Throm
			Reversal	CSL362 SLE*
Medium				_P.ging_vaccine / mAb*
				CSL334 Asthma*
Lower	Ig Biomarkers		Haptoglobin / Hemopexin

*** Partnered project**

Current products

• new indications, new formulations, MOA, Biomarkers

New product candidates

• novel protein-based therapeutics and vaccines, plasma and recombinant

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Plasma and Recombinant Proteins

• Capabilities from discovery to market

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Phase III / launch manufacturing
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Manufacturing CLD Lab
Target
Patient
Protein Engineering Lab
Phase I / II manufacturing
Market
Animal models of disease
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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 1/2 extension in Haem B extension in Haem B
albumin (CSL654)
patients compared to Benefix
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
Market
0.01
0.005
0 1 2 3 4 5 6 7 8
Days after administration
Faxtor IX antigen (IU/mL)
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CSL654 T1/2 extension in Haem B 1/2 extension in Haem B extension in Haem B patients compared to Benefix

CSL654 T1/2 extension in Haem B dogs compared to Benefix

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500L fed batch fermentation
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CSL312 (FXIIa antagonist mAb)

Contact activation

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(intrinsic) pathway
Damaged
surface
FXII FXIIa C1-INH X
PK KALFXI FXIa
FIX HK BKetc.
BK Receptor 2.
Fibrinogen Fibrin
Vasodilation
Haemostasis
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Hereditary Angioedema (HAE I, II, III)

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HAE attack
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Current therapeutic strategy

• On demand treatment with:

• plasma derived C1-Inhibitor (Berinert)

• small molecule kalikrein inhibitor

• small molecule BR2 inhibitor

• Prophylaxis limited by convenience issues

• • subQ Berinert

Opportunity

• Improve clinical outcomes and patient

• QoL by enabling prophylaxis

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CSL312 (FXIIa antagonist mAb)

Generation & characterisation of a human FXIIa antagonist mAb

• screening of human Ab (Fab) phage display library

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• mAb 3F7 shows complete inhibition of FXIIa

• affinity matured 3F7 ( = CSL312 ) shows further specificity improvements

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CSL312 – Hereditary Angioedema

CSL312 inhibits vascular leakage in ACEI treated C1-INH null mice

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0.5

ACEI 0.4
0.3
0.2
0.1
Basal 0.0
ACEI - + - +
WT KO
3F7/ACEI 0.6 ***
0.4
0.2
BM4/ACEI
0.0
KO mice
Colon
Basal ACEI 3F7/ACEI BM4/ACEI
OD @ 620 nm
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CSL312 – Hereditary Angioedema

CSL312 inhibits Factor XIIa activity in human plasma

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Healthy Donors (n=10) HAE Type I (n=2 pts)
3 4
HAE #1 + Dex
3
HAE #2 + Dex
2
2
1
1
HAE #1 - Dex
HAE #2 - Dex
0 0
VR115 (ug/mL) VR115 (ug/mL)
00.0050.0140.04 0.120.37 1.1 3.3 10 30 00.0050.014 0.04 0.12 0.37 1.1 3.3 10 30
Factor XIIa activity (OD 405) Factor XIIa activity (OD 405)
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Current status

• CSL312 has progressed into product development and toxicology

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Haptoglobin (Hp) / Hemopexin (Hx)

Red blood cell lysis and inflammation / tissue damage

• In pathological settings RBC lyse to release haemoglobin (Hb)

• Haemoglobin is further oxidised leading to the release of heme

• Free Hb and heme are toxic and contribute to disease pathology

• NO scavenging

• reactive oxygen species, oxidative stress

• activation of inflammatory pathways (heme / TLR4)

• Acute phase proteins Hp and Hx sequester and dispose of free Hb and heme

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• Hp and Hx are significantly depleted in acute and chronic disease

Opportunity for replacement therapy

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Haptoglobin (Hp) / Hemopexin (Hx)

Sickle Cell Disease

• Mutation in b-Hb gene, aggregation of b-Hb, sickle-shaped RBC

• Obstruct microvasculature, prone to lysis and release of Hb / heme

Diverse manifestations

• Acute chest syndrome, severe pain, pulmonary hypertension, stroke,

• splenic infarction, sepsis and renal failure

Aetiology

• Chronic low level and acute higher level exposure to Hb and heme

• Vasoconstriction, vascular damage / local inflammation Vaso-occlusive crisis

• mechanical and heme induced obstruction of capillaries

• Hp is absent and Hx significantly depleted in SCD patients

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Haptoglobin (Hp) / Hemopexin (Hx)

Hx therapy normalises blood pressure in SCD mice

• a

• Transgenic mice that express human -globlin and b-globin incorporating the sickle mutation (HbS), no expression of mouse Hb genes

• 0.7mg Hx, 2x per week for 4 weeks from 1 month of age

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Vinchi et al ., Circulation 2013

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CSL Research on Hp / Hx

• Swiss government funding since 2011

• Collaborators: University of Zurich, University of Torino, FDA CBER

• Processes for purification of Hp and Hpx from plasma developed

• Initial pre-clinical proof-of-concept data generated in vitro and in vivo

• Planning to progress into product development during 2015

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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

• Hizentra[® ]

• 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

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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

Benefits of Hizentra[®] : Steady-State Kinetics

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Headache will typically
occur here (Ig-peak-levels
in plasma)
Wear-off effect & potential infections
will occur here (Ig- trough-level)
Total IgG mg/100 mL
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Pharmacokinetic Profile of IVIG vs. SCIG

• [1]

• SCIG weekly dosing results in steady IgG levels (no peaks, no troughs)

• • Patients report less wear off effect switching from IVIG to Hizentra[® ][2]

1.Data shown for a patient with X-linked agammaglobulinemia who received a single infusion of 5% IVIG (30 g followed by 16% SCIG (12 g) every 7 days. 2. Igarashi A. Clin Ther . 2014 Sep 15

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Hizentra[®] Schedules Beyond Biweekly

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Individualised dosing strategies for patient protection

• More optionality, better management of dosing holiday

• Approved by EMA

• Under FDA review

31

Data on file CSL Behring

*Hizentra[®] pharmacometric modeling and simulation

Strengthening Presence in Neurology

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• Chronic Inflammatory Demyelinating Polyneuropathy

• across

• Increased use of Privigen[®] Europe and Canada in patients with CIDP

• Hizentra[®] CIDP orphan designation in the US

• Ongoing progress in Hizentra[®] Path study

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Path Phase III Study Design

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IgG dependency Test

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Path Study Progress

• 60 patients completed

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• 114 / 174 randomised

• Expect to close recruitment in late 2015

• Last patient completing late 2016

• FDA and EMA submissions Q3/4 2017

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Commercial Opportunities and Activities

Global Immunoglobulin Market

2013/14 Sales (USD)

• Ig volume continues to grow globally

• Increased competition particularly in SCIg

• CSL is well positioned

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CSL
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~ $8b

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Sources: Company annual reports / earnings releases, CSL Estimates of Target Markets

CSL’s Immunoglobulin Portfolio

2013/14 Sales (USD)

• Increased presence in neurology in Europe

• Maximise patient convenience

• Geographical expansion

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Hyper
IG
SCIG
IVIG
$2,320m
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Immunoglobulins: Progress Achieved

Increased presence in neurology Maximise patient convenience

• Privigen[®] CIDP launched in Europe and Canada • Ongoing development of Hizentra[®] in CIDP • Additional indications under evaluation

• Individualised therapy from daily to bi-weekly • Further activities ongoing

Geographical expansion

• Hizentra[®] biweekly approved in major regions

• • Hizentra[®] flexible dosing in EU

• • Hizentra[®] registered in 39 countries

• • Privigen[®] registered in 66 countries

38

Individualised Therapy

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Patient
Enhanced
Weekly
Options
Preference Outcomes
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Advantages of individualised therapy with Hizentra[® ]

• Dosing flexibility provides more freedom to patients, allowing them to manage their condition based upon their specific needs and lifestyle

• All dosing options with Hizentra[®] result in steady-state IgG levels, avoiding the monthly IVIG wear-off effects

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Specialty Products

Specialty Products

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Specialty
Products
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Leveraging high quality, broad product portfolio through:

• New markets

• Novel indications

• Novel modes of administration

Key Focus

• Beriplex[® / ] Kcentra™

• Berinert[® ]

• Zemaira[® ]

• Fibrinogen

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Kcentra™ (Beriplex[®] )

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• Prothrombin Complex Concentrate = PCC

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

Kcentra™ launched in April in the US as a first in class therapy to reverse the effects of vitamin K antagonists (e.g. Warfarin) for:

• Bleeding related to over-anticoagulation

• Patients needing urgent surgery

• Included in treatment guidelines

Clinical Program commenced in Japan to register Beriplex[®] for vitamin K antagonist reversal

• PMDA submission Q1 2016

42

Kcentra™ (Beriplex[®] )

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• Potential clinical application for new oral anticoagulant reversal?

Reversal Effects of Beriplex[ ® ] on Edoxaban* in Healthy Volunteers

Key: BD=bleeding duration ETP=endogenous thrombin potential PT=prothrombin time

• 50IU/kg Beriplex[®] dose reversed the anticoagulant effect of edoxaban

Clinical Trial Registration —URL: http://www.clinicaltrials.gov. Unique identifier: NCT02047565. (Zahir H. Circulation . 2015;131:00-00. Published online November 17, 2014) * Edoxaban - Daiichi Sankyo Pharma Development, Edison, NJ

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Berinert [®]

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

• Post marketing safety studies completed

• No antibody generation

• No increased thrombo-embolic risk

44

CSL830 (Subcutaneous C1-INH)

Plasma derived, pasteurised & nanofiltered highly concentrated C1 Esterase Inhibitor indicated for subcutaneous administration in the prophylaxis of hereditary angioedema (HAE) in adults and adolescents

• Patients with frequent attacks (50 to <100/year):

• Treat acute attack, loss of life quality

• High frequency attacks (>100/year)

• Prophylaxis with intravenous C1 Esterase Inhibitor

• Limited by venous access, break though attacks in some patients[1 ]

45

Zuraw B. Allergy, Asthma & Clinical Immunology 2010, 6 :23[1 ]

Vulnerable Period (time <40% C1-INH activity) SC CSL830 maintains trough levels above “protective” C1 levels

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(a) 1000 IU IV pdC1-INH (b) 3000 IU SC CSL830
150
Peak Trough Ratio Peak Trough Ratio
63.9 29.4 2.2 60.3 42.9 1.4
100
50
0
0 5 10 15 20 25 30 0 5 10 15 20 25 30
Time (days) Time (days)
C1-INH functional activity (%)
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Data on file CSL Behring Submitted for publication

CSL830 Clinical Program

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Phase II
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• Dose-ranging study • Safety

• • PK/PD • 18 HAE patients with infrequent attacks

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Phase III
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• Clinical efficacy study • Efficacy

• • PK • Safety

Phase IIIb

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Long-term safety
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Completed

Ongoing

Commencing Dec 14

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www.clinicaltrials.gov

CSL830 Phase II COMPACT Study Results

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Primary Endpoint
Protective Level
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Modified from Zuraw et al; EEACI 2014

CSL830 Phase III Study Design

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*Pbo = Placebo Modified from Zuraw et al; EEACI 2014

CSL830 COMPACT Program Progress

• 84/100 patients randomised

• Last Patient visit Q4 2015

• Long term Safety study to commence Dec 2014

• Submission to FDA Q2/3 2016

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50

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 use through approval in EMA in 2015

• Completed RAPID trial in 2013

• Under review with EMA

51

Zemaira[®] Biochemical Efficacy

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Study CE1226_2002 RAPID Study
Equivalence to Prolastin [® ]
30 30
Zemaira [®]
Placebo
20 20
11 µM 11 µM
10 10
CE1226 60 mg/kg
Prolastin 60 mg/kg
0 0
1 2 3 4 5 6 7 8 9 10 11 BL 3 6 9 12 15 18 21 24
Weeks Months
Serum API (µM) ±SD
Serum API (µM) ±SD
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52

www.clinicaltrials.gov

Zemaira[®] Continues to Slow the Rate of Lung Density Decline Over 4 Years

Estimated Rate of Decline in Physiologically Adjusted P15 at TLC

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RAPID Study RAPID Extension (Dec 2013)
N=97 N=97
0
Annual Rate of Decline
-1
-1.37 g/L/Year
-2
-3 Annual Rate of Decline
Annual Rate of Decline -1.08 g/L/Year
-2.06 g/L/Year
-4
-5
-6 Early Start Group (n=50) Annual Rate of Decline
-1.31 g/L/Year
Delayed Start Group (n=47)
-7
0 12 24 36 48
Months
from Baseline
Estimated Decline
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www.clinicaltrials.gov

53

Commercial Opportunities and Activities

Select Specialty Products – Global Markets

• Rare diseases

• Unmet medical need

• High value

• Increasing awareness

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HAE
~$900m
PCC Target Alpha-1
~$300m segments ~$750m
Fibrinogen
~$250m
~$2.2b
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55

Sources: Company annual reports / earnings releases, CSL Estimates of Target Markets

CSL’s Specialty Products Portfolio

2013/14 Sales (USD)

Other Specialty Products

Peri-Operative Bleeding

• Increase demand

• Geographical expansion

• Education and diagnosis

$848m

56

Kcentra™

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Kcentra™, Prothrombin Complex Concentrate (Human), is the first nonactivated 4-factor PCC approved in the U.S. for the urgent reversal of vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or needing an urgent surgery or other invasive procedure

Sustain momentum in US

Key tactics

• Surgical indication and launch

• Hospital account expansion

• Pivotal publication in Lancet

• Broad customer education

Geographical expansion[1]

Life cycle management

• Eastern Europe

• Japan

• Improved virus filtration

• New 1000IU vial

57

1) Beriplex[®]

Berinert[® ]

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Berinert treats the fundamental cause of HAE symptoms by providing C1Inhibitor deficient patients with the missing human protein[1 ]

Berinert has demonstrated that it provides fast relief of pain and swelling within 30 minutes[2 ]

Geographical expansion

Patient care and convenience

• Asia

• Latin America

• Russia

• Short term prophylaxis in Europe

• Self-administration education and expansion

58

Agostini et al. J Allergy Clin Immunol. 2004[1] Craig et al. J Allergy Clin Immunol 2009[2]

Berinert[®] Key Features

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Improved •Low volume formulation
patient
convenience
New method
of use • subQ prophylaxis
New • Explore new indications
Indications (e.g. Transplantation)
59
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Zemaira[®]

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Indicated in the US for chronic augmentation and maintenance therapy in adults with alpha-1 deficiency and clinical evidence of emphysema Has been shown to slow the progression of emphysema as measured by CT lung density

DNA1 is the first and only test to confirm known and unknown variants of alpha-1 proteinase inhibitor

Increased diagnosis

Geographical expansion

• Approximately 100K patients in US

• 10% of patients diagnosed

• Established DNA test 1

• EU registration process ongoing

• Launched in Brazil

• Dossier submitted in Mexico

Continued investment

RAPID data

• Expand US sales force

• Explore new formulations

• Publish in high impact journal

• Medical Affairs education

60

Q&A

Break

R&D Briefing December 3, 2014

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

65

Innovation to Drive Growth

Patient benefit primary driver of innovation

• Albumin fusion technology

• rIX-FP, rVIIa-FP, rvWF-FP

• Factor VIII

• Innovative SingleChain design

Scientific Edge

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

Precise
Improved
engineering
half life, rAlbumin
of
extended as fusion
specially
dosing platform
designed
interval
linker
----- End of picture text -----

Strong vWF binding Greater molecular integrity and stability Opportunity for Extended Dosing Interval

66

PROLONG-9FP Clinical Development Program: rIX-FP

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www.clinicaltrials.gov

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Compared with in market rFIX

• 5.3-fold longer half-life (92hrs)

• ~ 45% higher incremental recovery

• ~7-fold larger AUC

• ~7-fold slower clearance

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PROLONG-9FP Clinical Development Program: rIX-FP

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Phase III
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• Phase I/II • Phase II/III Pediatric

• PK • PK Long-term • Long-term

• safety safety

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Phase I
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• PK

• PK

• Long-term safety

• Safety

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• Weekly prophylaxis

• 7,10 and14-day prophylaxis

• 7,10 and14-day Extension prophylaxis

• • PUP On-demand treatment

• • Surgical Surgery prophylaxis

• On-demand • PUP On-demand treatment treatment • Surgical prophylaxis Completed Completed Completed Completed Ongoing

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www.clinicaltrials.gov

69

PROLONG-9FP Clinical Results Summary

• Excellent safety profile

• Well tolerated

• No inhibitors

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• No adverse events related to CSL654

• Meets all criteria for registration

• Effectively treats bleeding episodes

• Offers benefit for prophylaxis

• Effective in 7-day, 10-day and 14-day regimens

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FIX Activity: rIX-FP vs. rFIXFc

rIX-FP shows higher activity at the 240 hour time point

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Paired comparison: Mean (SD) Plasma FIX activity-time Profiles
1001 0 0 after 50 IU/kg in 12 yo and older
rIX-FP (n=12) rIX-FP (n=12)
previous FIX (n=12)
previous FIX [] (n=12)
rFIX (n=22) 50 IU/kg
rFIXFc (n=22) 10 1 0
rFIX (n=22)
50 IU/kg
rFIXFc (n=22)
3%
1 1 1%
*With baseline correction Hours post dose 0 24 48 72 96 120 144 168 192 216 240 264 288 312 336 360 384
Hours post dose
plasma-derived and recombinant products Hours post dose
Plasma FIX activity-time profiles in ≥12-year olds
Plasma FIX activity (IU/dL, %)

Plasma FIX activity (IU/dL)
Plasma FIX activity (IU/dL)
Plasma FIX activity (IU/dL)
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Powell et al. N Engl J Med 2013; CSL Behring. Data on file.

71

rIX-FP (CSL654) Clinical Development

• All patients now in extension study

• Dossier submission for adult and paediatric indications

• FDA Dec 2014

• EMA Q2 2015

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rVIIa-FP (CSL689)

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rFVIIa Linker rAlbumin

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

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rVIIa-FP Clinical Development Program

Congenital Factor VII Deficiency

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Phase II/III
Phase I
Prophylaxis Extension
PK
On-demand
safety
Pediatrics
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• Phase I PK/PD study in congenital FVII deficiency patients

• PK and safety in patients

• To commence December 2014

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75

rVIIa-FP Clinical Development Program

Congenital Haemophilia with Inhibitors

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

Phase II/III
Phase I PK Phase III
PK Long-term safety Prophylaxis
safety On-demand Surgery
Pediatrics
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• Pivotal Phase II/III trial in haemophilia A & B patients with inhibitors

• Dose finding, safety & efficacy on-demand therapy

• To commence first half 2015

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rVIII-SingleChain (CSL627)

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

Me [++ ]
A1 A2 A3 C1 C2
rVIII-SingleChain
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AFFINITY Clinical Development Program: rVIII-SingleChain

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Phase I/III 1001
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• PK

• Long-term safety

• On-demand treatment

• Long-term prophylaxis

• Surgical prophylaxis

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Phase III
• Pediatric
Extension
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Completed Ongoing Ongoing
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www.clinicaltrials.gov

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CSL627 PK Evaluation: Area Under the Curve

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

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

*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

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www.clinicaltrials.gov CSL Behring. Data on file.

CSL627 PK Evaluation: Clearance and t 1/2

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*Dose-normalised baseline-corrected FVIII activity Clearance and half-life 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. n=27

80

CSL Behring. Data on file.

CSL627 PK Supports Dosing Twice-Weekly

Product Time Time to 2% to 1% (hr) (hr) rVIII78.0 91.9 Sin leChain g Octocog 65.2 77.2 al ha p Data presented are mean values. n=22

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CSL Behring. Data on file.

rVIII-SingleChain Phase I/III Study

• Very well tolerated

• No inhibitors

• All bleeding events effectively treated

• All surgeries successfully treated

• Pivotal study primary endpoint reached

• US dossier submission first half 2015

• EMA dossier submission Q4 2015

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Commercial Opportunities and Activities

Coagulation: Key Market Segments (USD)

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

• [®]
Beriate
•
Helixate [®]
Hem A ~$5.4b [1]
•
rVIII-Single
Chain
•
Haemate P [®]
•
rVIIa-FP
Inhibitor
Hem B
bleed
treatment Target
~$0.9b [1]
~$1.4b [1] segments • Mononine [®]
•
Berinin [®]
• rIX-FP
•
Voncento [®]
VWD
•
Haemate P [®]
~$0.5b [1]
• rvWF-FP
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84

Sources: Company annual reports / earnings releases, CSL Estimates of Target Markets

Global Haemophilia Market (USD)

• Trend toward recombinants

• in major markets

• New longer-acting competition

• Pd highly competitive tender markets

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Plasma derived
Recombinant
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$8.2b

85

Sources: Company annual reports / earnings releases, CSL Estimates of Target Markets

CSL Coagulation Sales 2013/14 (USD)

• Broad portfolio presence

• Growth in developed and emerging markets

• Helixate[®] for recombinant pipeline

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pd Coag
pdCoag Helixate [® ]
$1,064m
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rVIII-SingleChain (CSL627)

Single chain design with most of B-domain deleted Covalent link between heavy and light chains

Single Chain Design

Potential Differentiated Profile

• Binds strongly to vWF

• Greater molecular integrity and stability

• Improved PK profile

• Effective bleeding control

• Favorable tolerability profile

• Low potential for inhibitors

• Longer lasting therapeutic effect

• • Twice-weekly dosing

87

rIX-FP (CSL654)

Unique recombinant albumin fusion protein molecule Enhanced pharmacokinetic profile including five-fold half-life extension, seven fold increase in AUC* and higher trough levels

Attributes of Albumin

Potential Differentiated Profile

• Natural protein

• Transports natural components

• Not associated with immune response

• Long half-life

• Effective bleeding control

• Favorable tolerability profile

• Minimising the potential for immunologic response

• Dosing interval 7 to 14 days

88

• Santagostino E et al. Blood 120: 2405-2411 (2012)

Coagulation: Growth Drivers

Increased diagnosis

• Estimated 1 in 1,000 people have inherited blood disorders

• 75% inadequate or no care; disorder not diagnosed

Awareness of benefits of prophylaxis

• Publications and presentations

• Benefits of long/longer acting products

Growth in • Hemophilia B – long acting rIX-FP • recombinant Hemophilia A – longer acting rVIII-SingleChain • market Inhibitors – long acting rVIIa-FP

CSL leadership

• Strong heritage in therapeutic category

• Understanding of physician and patient community

• • Robust pipeline of recombinant products

89

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Breakthrough Medicines

Breakthrough Medicines

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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

91

CSL112 (Apolipoprotein A-I)

• Reduction of early recurrent cardiovascular events represents a substantial unmet medical need

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• Recurrent CV events occur early, are associated with high mortality and are inadequately addressed by available therapies

Figure adapted from PLATO Trial, Kohli P et al. Circulation 2013;127:673-680

92

92

CSL112

• Novel Mechanism of Action for Early Reduction of Recurrent CV Events

• Produces an immediate and robust increase in the efflux of cholesterol from cells, including lipid-rich macrophages in coronary arteries

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• Expected to rapidly stabilise plaque and reduce the incidence of early recurrent cardiovascular events

93

CSL112 AHA Presentations Nov 18, 2014

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may rapidly stabilise plaque at risk of rupture

Mechanism of HDL Remodeling Induced by CSL112

• Prebeta-1 HDL levels correlate strongly with ABCA1 mediated cholesterol efflux

• Infusion of CSL112 rapidly produces large increases in prebeta-1 HDL

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CSL112 Enhances Cholesterol Efflux In Patients with Low HDL Function

• CAD* patients have impaired ability to efflux cholesterol from cells

• CSL112 caused strong and quantitatively similar elevation in cholesterol efflux in patients with coronary artery disease and healthy subjects

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*Coronary artery disease

CSL112 AHA announcement of Phase 2b start

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Randomisation
N = 1200
Four Weekly Infusions
High dose (6 gms) Low Dose (2 gms) Placebo
N = 400 N = 400 N = 400
Administrated in acute MI setting
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Primary endpoint: liver and renal safety

To be followed by Phase 3 morbidity/mortality trial Target indication Reduction of early atherothrombotic events in acute MI patients at high risk of recurrent events

95

Licensing and Collaborations

Licensing

Breakthrough Breakthrough Medicines Medicines

Specialty Immunoglobulins Immunoglobulins Products Specialty 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)

• CSL334 (ASLAN)

• ISCOMATRIX[®] adjuvant

97

GARDASIL[®]

• Impact of Australia’s HPV Vaccination Program

Genital warts

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

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

• Rates of treatment for genital warts in private hospitals have also declined

• Cervical disease

• Current Australian cervical screening program data show that rates of high grade cervical disease are declining in both the <20 year old age group and in women aged 20–24 years

HPV Prevalence

• Substantial fall in vaccine-targeted HPV types in vaccinated women

• Also lower prevalence of vaccine-targeted types in unvaccinated women, suggesting herd immunity

98

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

GARDASIL[®]

• 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

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

• US - BLA Dec 2013 for 2015 launch

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• Australia - Submitted registration package to TGA June 2014

99

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

a Mavrilimumab (GM-CSFR mAb)

Phase IIb (EARTH EXPLORER 1) study:

• 326 patients with moderate-to-severe RA and an inadequate response to at least one disease-modifying anti-rheumatic drug

• Dosing (30, 100, 150mg) every 2 weeks for 24 weeks

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• Co-primary endpoints

• Mean change from baseline in DAS28-CRP at Week 12

• ACR20 response rate at Week 24

• Other endpoints

• Multiple disease activity parameters

• Safety and tolerability profile

• Patients eligible to enter openlabel extension (OLE) study

100

Mavrilimumab

Phase IIb study met DAS28-CRP co-primary endpoint:

• At Week 12, a statistically significant difference in DAS28-CRP was seen for all doses of mavrilimumab versus placebo

• Sustained at Week 24 versus placebo

• A significantly greater percentage of mavrilimumab-treated patients met the ACR20 co-primary endpoint versus placebo for all doses

***p<0.001, mavrilimumab versus placebo

101

Mavrilimumab

Phase IIb study conclusions:

• Study met both co-primary endpoints at all mavrilimumab doses

• All secondary endpoints (including ACR50, ACR70 response) achieved statistical significance for the 150 mg dose

• Rapid (after one week of initiation of treatment) and sustained improvement in multiple symptoms of RA observed in patients receiving mavrilimumab

• Improvements demonstrated in patient-reported outcomes (pain, health-related quality of life, physical function, fatigue)

• An acceptable safety and tolerability profile, with no apparent safety signals, demonstrated over the 24-week study period

102

a CSL362 (anti-IL-3R mAb)

• Initial indication: Acute myeloid leukaemia

• Enhanced recruitment of tumour killing NK cells

• Phase I study in progress

• Other high quality opportunities in autoimmunity eg. SLE

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• Partnership with Janssen Biotech, Inc

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Summary

 Global R&D Portfolio

December 2014

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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
Life Cycle Specialty
Management [# ] Products
Influenza
Vaccine
Hizentra [®] Japan
Hizentra [®] CIDP
Privigen [ ®] CIDP
Beriplex [®]
Market Japan Hizentra [®] biweekly
Fibrinogen New CSL830
Development Voncento [®] EU
Indications C1-INH subcut
Kcentra [TM] US
PCC New Beriplex [®] NOACs Fibrinogen
Indications Daiichi Aortic EU Zemaira [®] EU Bleeding /Surgery
Novel Plasma
Proteins
Rec Coagulation CSL650 CSL689 rVIIa-FP CSL689 rVIIa-FP CSL627 rVIII-SC CSL654 rIX-FP
Factors rvWF-FP Congen Def Inhibitors
Partnered Vaccine Partnered Vaccine Partnered Vaccine
New Product Programs Programs Programs
Development P. gingivalis/POD CSL362 IL-3R
OH-CRC/Sanofi FXIIa Antagonist Janssen
Discovery CSL324 G-CSFR CSL112
Projects reconstituted HDL
CSL346 VEGFB
CAM3001 Quadrivalent
CSL334 IL-13R GM-CSFR –AZ Flu Vaccine
Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Core Capabilities:
----- End of picture text -----*

*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

105

Expected Progress in next 12 Months

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

Privigen Privigen Hizentra US
MG Japan Flex Dosing
Haptoglobin/ rVIIa-FP rIX-FP
Hemopexin Inhibitors US Approval
rIX-FP
EMA Dossier
CSL12
rVIII-SC
Anti-FXIIa
BLA Dossier
CSL324
CSL830
G-CSFR Zemaira [®] EU
C1-INH s.c.
CSL334 CSL362
Beriplex [® ]
ASLAN Janssen
Japan
QIV
18+ years
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106

 Significant Target Launch Dates

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

2014 2015 2016 2017 2018 2019
Voncento™ Voncento™ CSL654 CSL654 CSL689 rVIIa-FP
Haem A EU V WD EU rIX-FP US rIX-FP Japan Congen Def
CSL654 CSL627 rFVIII
rIX-FP EU EU/Japan
CSL627
rFVIII-SC US
Kcentra [TM] Zemaira [®] CSL830 C1-INH
Surgical EU SubCut
Beriplex [® ]
Japan
Fibrinogen EU
Aortic Surgery
Hizentra [® ] Hizentra®
Japan CIDP
Privigen [® ]
Japan PID/SID
Quadrivalent Flu
Vaccine 18+
----- End of picture text -----

Immunoglobulins Haemophilia Specialty Products Vaccines & IP Core Capabilities:

• Calendar Years

107

2014 Highlights

Immunoglobulins

Specialty Products

Haemophilia

Breakthrough Medicines

Licensing & Vaccines

• Hizentra[®] flexible dosing registration in EU

• Hizentra[® ] CIDP orphan drug designation • Ongoing global Privigen CIDP registrations

• Kcentra[TM] registration for surgical indication in US • Berinert[®] s.c. Pivotal Phase III rapid recruitment • Commencement of Beriplex[TM] Japan Phase III study

• rIX-FP Phase III efficacy data supports 7-14 day dosing • rVIII-SingleChain Phase I/III supports twice-weekly dosing • rVIIa-FP congenital deficiency Phase I/II commenced

• Commencement of CSL112 (Apo A-1) Phase IIb study • Anti-FXIIa mAb progressed into product development

• Quadrivalent Flu (QIV-01) study 18+ yrs fully recruited • Mavrilimumab positive additional Phase II data

108

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