CSL Ltd. — Investor Presentation 2012

Dec 5, 2012

R&D Briefing December 6, 2012

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.

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Agenda December 2012 R&D Briefing

• Welcome

• Introduction & Highlights

Mark Dehring Andrew Cuthbertson

• Immunoglobulins & Specialty Products

• Clinical Development

Russell Basser

• Commercial Opportunities

Lutz Bonacker

• Q&A

• Break

• Coagulation/Haemophilia

• Introduction & Technical Approach

• Clinical Development

• Commercial Opportunities

Andrew Cuthbertson Russell Basser Lutz Bonacker

• Breakthrough Medicines & Licensing

• Summary

Andrew Cuthbertson Andrew Cuthbertson

• Q&A

3

Introduction and Highlights

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

5

Immunoglobulins Strategy

Maintaining leadership position through focus on:

• Patient convenience

• Yield

• Label

Immunoglobulins

• Formulation science

• Specialty Igs

6

Specialty Products Strategy

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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

7

Haemophilia Strategy

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

• Scientific and product innovation

• Patient benefit

Haemophilia Products

8

Breakthrough Medicines Strategy

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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

Optimising value of IP portfolio and assets

• Partner high opportunity products

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Leveraging Global Capabilities

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Global project management

Recombinant protein manufacturing capabilities

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R&D Investment

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� Global R&D Portfolio �

December 2011

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Immunoglobulins
Haemophilia
Specialty Products
Influenza Vaccine
Fibrinogen Fibrinogen Privigen®CIDP EU Biostate® EU Hizentra® US
New Indications Aortic Surgery
Zemaira® EU Berinert ® Hizentra® EU
PCC Self Admin FXIII US
Beriplex ® US
New Indications
Riastap® US
Riastap® EU
Novel Plasma CSL689 rVIIa-FP
Proteins CSL654 rIX-FP
rvWF-FP CSL627 rVIII-SC
Rec Coagulation
Factors
Partnered Vaccine Partnered Vaccine Partnered Vaccine Partnered Vaccine
Programs Programs Programs Programs
P gingivalis POD CSL112 CAM3001
CRC-OHS/Sanofi * reconstituted HDL GM-CSFR - AZ
CSL362 IL-3R
CSL324 G-CSFR
VEGFB
Discovery
Projects 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 2012

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Hizentra
rVIIa-FP Hizentra CIDP
Canada, EU
Berinert
rVIII-SC rIX-FP
Self Admin
Fibrinogen
CSL362
Aortic EU
Hizentra
Berinert
Japan
Subcut
Privigen CIDP
CSL112 EU
Biostate EU
Beriplex US
Bleeding
13
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� Global R&D Portfolio �

December 2012

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Immunoglobulins
Haemophilia
Specialty Products
Influenza Vaccine
Hizentra® CIDP Privigen® CIDP Hizentra® US/EU
EU
Biostate® EU
Fibrinogen Berinert ®
New Indications Zemaira® EU Beriplex® US Self Admin
PCC Fibrinogen
Berinert® SC
New Indications Aortic EU
Novel Plasma
Proteins
rvWF-FP CSL627 rVIII-SC CSL654 rIX-FP
Rec Coagulation CSL689 rVIIa-FP
Factors
Partnered Vaccine Partnered Vaccine Partnered Vaccine Partnered Vaccine
Programs Programs Programs Programs
P gingivalis POD
CRC-OHS/Sanofi * CSL324 G-CSFR CSL362 IL-3R CAM3001
GM-CSFR - AZ
Discovery C SL346 VEGFB CSL112
Projects
reconstituted HDL
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

Immunoglobulins

Immunoglobulins

Maintaining leadership position through focus on:

• Patient convenience

• Yield

• Label

Immunoglobulins

• Formulation science

• Specialty Igs

Key Focus

• Hizentra[®]

• Privigen[®]

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Innovation to Drive Growth

• Efficient and competitive cost structure

• Ig yield improvements

• Product differentiation

• Patient convenience

• Clinical Use and Indications

• Clinical efficacy

  • Expansion into Neurology

  • Alzheimer’s Disease opportunity

  • Prevention of vertical transmission of CMV by Cytogam[®]

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Cytogam [®]

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The only registered CMV immunoglobulin in the US indicated for the prevention of CMV disease associated with transplantation

• CMV infection is the leading known cause of birth abnormalities in developed countries

• Partnership with US National Institutes of Health (NIH) to determine efficacy of CMV immunoglobulin in preventing mother to baby transmission

• Large multi-site clinical trial screening >150,000 women commenced December 2011

• CSL donating Cytogam[®]

• Primary analysis expected 2016

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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

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Global Introductions Continue

• Launched in US since 2010

• Broad approvals in EU and Canada

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• Japan Phase III licensing study complete

• supports safety and efficacy of Hizentra[®] for PID

• new drug application submitted to PMDA in Sept 12

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Alternate schedules for Hizentra[®]

• Hizentra[®] is indicated weekly for patients with PID

• Enhancing patient options through provision of additional schedules

• Efficacy expected to be maintained

• Safety not expected to be different

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Chronic Inflammatory Polyneuropathy (CIDP)

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• A chronic peripheral nerve disease with progressive muscle weakness and loss of sensation, usually occuring in elderly patients • Most common chronic autoimmune neuropathy

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Potential benefits of Hizentra[®] in Patients with CIDP

Current maintenance therapies

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Oral IVIG Plasma steroids Exchange Adverse Less convenience Invasive therapy effects with long term us e Levels show peak s Limited availability & troughs Short term efficacy Hospital visits

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Hizentra[®]

• Avoids drawbacks of i.v. route

• Reduced volume

• • Increases patient autonomy

• • Less systemic side effects

• • More stable IgG levels

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The PATH Trial: Hizentra[®] in CIDP

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• 150 patients

• • 2 doses vs placebo

• • Study approved by FDA, EMA, PMDA

• • Recruiting in US & EU

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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

Building Capacity to Address Patient Needs Globally

• Privigen approved broadly in US, Europe, South America

• New Ig manufacturing facility in Broadmeadows

Strengthening Presence in Neurology Market

• Phase III study in CIDP completed in Europe

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• Study shows treatment with Privigen[®] improved function in patients with chronic CIDP

• Dossier submitted to EMA in May 12

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Privigen[®] in CIDP: Rate of Response

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100
90
80
70
60
50
40
77%
30
47%
61%
20
10
0
Total IVIg pretreated IVIg untreated
Responder rate (%)
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Specialty Products

Specialty Products

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Leveraging high quality,
broad product portfolio
through:
•
New markets
•
Novel indications
•
Novel modes of
Specialty
administration
Products
Key Focus
•
Beriplex [®]
•
Fibrinogen
•
Zemaira [®]
•
Berinert [®]
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Leveraging high quality, broad product portfolio through: • New markets

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Beriplex[®]

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• Prothrombin Complex Concentrate = PCC

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

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Seeking approval for use of Beriplex[®] to reverse the effects of vitamin K antagonists for:

• Bleeding related to over-anticoagulation

• Patients needing surgery

• 2 large randomised, controlled clinical trials

• Bleeding study completed

• Surgical study recruitment completed

BLA submitted in US for acute bleeding

• Accepted for standard review

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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

• Aim to complete recruitment end 2013

US

• Coagulopathic bleeding related to complex cardiac surgery

• In dialogue with FDA

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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

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Seeking to broaden commercial reach through launch in EU, Canada, Brazil

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

• Increase diagnosis and treatment

Anticipating pivotal efficacy data early 2013

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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 or facial attacks of hereditary angioedema (HAE) in adults and adolescents

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What Happens to Patients?

• Recurrent episodes of swelling, sometime with a rash

• Unpredictable and occur anywhere in the body

• • Life-threatening if laryngeal swelling

• Attacks caused by stress, infection, menstruation, some drugs, unknown causes

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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 or facial attacks of hereditary angioedema (HAE) in adults and adolescents

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US and European approved label expansion for self administration of HAE

• As part of US label expansion Berinert[®] now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks

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Overcoming Challenges in Long-term Prophylaxis of HAE Attacks

Current prophylactic therapies

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Oral androgens

• Limited by adverse effects, especially in women and children

Intravenous C1-INH

• Inconvenience and risks of repeated i.v. administration

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High concentration subcutaneous (sc) Berinert[®]

• Avoids drawbacks of i.v.

• Low volume for s.c. administration

• Builds on well-established safety profile

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Berinert[®] Subcutaneous Prophylaxis Program

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• Study ongoing in US and Germany - due to complete 1H

• Safety and 2013

• pharmacokinetic • Select safe and efficacious dosing for clinical efficacy trial

• study - due to commence 2H 2013

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Commercial Opportunities and Activities

Immunoglobulins

The Immunoglobulin Market is attractive

The 2012 IG market is a > $6 B opportunity

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CSL
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• Market includes IVIG, SCIG and Hyperimmunes

• Growing Market

• CSL is well positioned

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CSL’s Immunoglobulin Portfolio

• Globalise portfolio

• Expand into neurology

• Increase convenience

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Specific
IG
SCIG
Privigen
IVIG
Other
$US1,722M
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Ig Portfolio Positioning

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First and only Proline-stabilised IVIG

• High purity 10% liquid IVIG

• Optimal dimer formulation throughout shelf life for improved tolerability

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First and only 20% Proline-stabilised SCIG

• Low administration volume increases efficiency

• –

• Convenient few sites & fast infusion

Lyophilised IVIG

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• Long track record of safety & reliability

• Broad indications

• Reconstitution options

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Globalise Portfolio

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Privigen & Hizentra
(PL)
Privigen & Hizentra
(HU)
Privigen (BR) Privigen (TW)
Privigen & Hizentra
(CZ) Privigen (TR) Privigen (MY) Privigen (SG)
Privigen (MX) Privigen (RU) Hizentra (BR) Hizentra (TR)
Hizentra (AR) Privigen (HK) Hizentra (JAP) Hizentra (MX)
2012 2013 2014 2015
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• Privigen[®] currently registered in 55 countries

• • Hizentra[®] currently registered in 33 countries

• • Continue global launches for Privigen[®] and Hizentra[®]

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Expand into Neurology

Hizentra 20% CIDP (EU)

Privigen 10% CIDP (EU, CH, CAN)

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(EU, CH, CAN)
Hizentra 20%
CIDP (US)
2012 2013 2014 2015 2016+
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• Strengthen presence in neurological segment

• Launch Privigen[®] in CIDP in the EU

• Develop Hizentra[®] in CIDP in the US, the EU and RoW

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Increase Convenience

Privigen 40g Presentation (US, CH, EU)

Hizentra Convenience Initiatives

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Hizentra 10g
(US, EU)
2012 2013 2014 2015
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• Increase dosing flexibility

• Differentiate through convenience launches:

• 10 g vial Hizentra[®]

• 40 g vial Privigen[®]

• Ongoing convenience initiatives

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Sanitize your hands

Gather your supplies

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Write in your journal

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Start infusion

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Clean surface

Inspect each vial

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of Hizentra

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Prepare syringe

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Infusion Steps 4 preparation steps per vial

Prepare syringe

Reducing number of vials increases convenience

(continued)

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Prepare syringe (continued)

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Prepare injection site(s)

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Insert Sub-Q needle(s)

Cytogam [®]

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The only registered CMV immunoglobulin in the US indicated for the prevention of CMV disease associated with transplantation

Center for Disease Control[1] :

• CMV is the most common viral infection that infants are born with in the United States

Potential Opportunity

Assuming Screening at week 23 95% screening uptake

• About 1 in 150 children is born with congenital CMV infection

• About 1 in 750 children in the US is born with or develops permanent problems due to congenital CMV infection

Number of Patients: 25 thousand

Total market (volume): ~ 1,000 kg

Total U.S. Market: ~ $US 300-500 M

1) http://www.cdc.gov/cmv/trends-stats.html

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Specialty Products

Specialty Products

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Wound Healing
Other Specialty Products Tachocomb
Beriplast
Kybernin
Berinert
Zemaira
Fibrogammin
Streptase
Beriplex
Perioperative Bleeding
$US618 M Riastap
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• Increase clinical data set

• Add indications

• Expand regionally

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Beriplex[®]

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In the US 3.8 M patients are on warfarin[1] with a major bleeding rate of 3.1-3.6%[2] per year

• In US launch in warfarin reversal indication

• US surgical indication: Patients requiring emergency surgery needing urgent reversal of warfarin

• Understand the use in Factor Xa inhibitor reversal

• Include in perioperative bleeding management algorithm

• 2) Connolly et al NJEM 2009, Patel et al NEJM 2011, Granger et al NEJM 2011

1) IMS data July 2012

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Blood Products vs. Concentrates

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FFP
Fibrinogen concentration at ≈2.3g / L
Not virus inactivated
Frozen, requires time (<50 minutes) to thaw
Red Blood Cells
Need to be matched to blood type
Not virus inactivated
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Platelets Short shelf life (5 days) Risk of bacterial contamination

Cryo

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• Frozen, require time to thaw

• Pooled from 10 bags of FFP in the blood bank

• Average Fibrinogen concentration ≈ 6g /L

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

• Obtain WEU & US acquired label

• Initiate acquired label expansion

• Generate, publish & communicate

• data

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Bring

to Europe

Pivotal trial objective: Zemaira slows the progression of emphysema Demonstration of a clinical outcome (disease modification)

• Publish data in 2013:

• American Thoracic Society

• European Respiratory Society

• Recognition in treatment guidelines

• Demonstrate economic benefit

• Reimbursement

• Enhanced testing & diagnosis

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Berinert[®]

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Berinert treats the fundamental cause of HAE symptoms by providing C1INH deficient patients with the missing human protein[1. ] Berinert has demonstrated that it provides fast relief of pain and swelling within 30 minutes[2]

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• Obtain Prophylaxis indication

• Increase convenience with s.c. treatment option

• Continue geographical expansion

• Continuous Life Cycle Management to improve product profile

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

• 2) Craig et al. J Allergy Clin Immunol 2009

52

Berinert[®] - Current Life Cycle Activities

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•
Low-volume, high
Product
concentration, formulation
improvement
•
Short-term prophylaxis,
Expand 2013 (EU/Can)
indication • Further initiatives ongoing
New
method of • Prophylaxis Indication
use with s.c. formulation
53
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Q&A

Break

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

57

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
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Improved molecular stability

Opportunity for Extended Dosing Interval

58

rIX-FP (CSL654)

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rIX-FP (CSL654) Clinical Program

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PUP
study
Phase Phase 1/2 Phase 2/3 Phase 3
Paediatric
1 PK PK
PK Long-term safety Long-term safety
Extension
safety 7d prophylaxis 7-14d prophylaxis
On-demand On-demand
Surgical prophylaxis
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Compared with in market rFIX

• 5.3-fold longer half-life (92hrs)

• ~ 45% higher incremental recovery

• ~7-fold larger AUC

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• ~7-fold slower clearance

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Efficacy of rIX-FP in Phase 1/2 Trial

• 13 subjects treated weekly for up to 48 weeks

• �

• previously on prophylaxis no increase in weekly FIX consumption

• �

• switched from on-demand to weekly prophylaxis >90% reduction in bleeding rate

• Subjects treated on-demand (85 bleeds)

• 88% of episodes controlled by a single injection (the rest by only one additional injection)

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rIX-FP (CSL654) Safety Data

• Excellent safety profile in completed studies

• Well tolerated

• No inhibitors

• No adverse events related to CSL654

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rIX-FP (CSL654) Further Development

• Enrolment of Phase 2/3 study due to be completed early 2013

• Paediatric study has commenced

• �

• Prolonged half life exploring treatment intervals longer than every second week

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rVIIa-FP (CSL689)

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Development of rVIIa-FP (CSL689)

• Phase 1 in 40 healthy volunteers

• First-in-man dose escalation study in healthy volunteers completed

• No SAEs, one related mild AE

• Pivotal Phase 2/3 Trial in Hemophilia A & B patients with Inhibitors

• Dose finding, Safety and Efficacy on-demand therapy

• Completed discussions with PEI

• Briefing documents to FDA / EMA

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66

Phase 1 Study of rVIIa-FP in Healthy Volunteers

Lines represent different doses of CSL689 (no placebo)

Half-life 3-4 fold longer t ~~h~~ an rFVIIa

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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 hemophilia

• Glanzmann's thrombasthenia

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68

rVIII-SingleChain (CSL627)

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69

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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70

rVIII-SingleChain: high affinity for vWF

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Binding to plasma-derived (pd) VWF Comparison of VWF affinity constants
250
20
18
200
16
14
150
12
10
8
100
6
4
50
2
Single chain rFVIII (CSL627)
0
Full length rFVIII
rVIII-SingleChain Full length rFVIII
0
(CSL627)
0 500 1,000 1,500
Relative units
Affinity constant (1/(nm)
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Surface plasmon resonance (SPR) analysis Time (s) CSL Behring. Data on file

71

rVIII-SingleChain : PK profiles in rodents

PK in haemophilia A mice

PK in rats

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5 6,000
5,000
4
200 IU/kg FVIII:C
100 IU/kg FVIII:C 4,000 n=3/timepoint
3 geometric means ± SD
n=5/timepoint
3,000
geometric means ± SD
2
2,000
1
1,000
0 0
0 20 40 60 80 0 120 240 360 480
Time (hrs) Time (min)
CSL627
Full-length rFVIII
FVIII:Ag (mIU/mL)
FVIII:C plasma level (IU/mL)
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CSL627 has ~ 50% increase in terminal half-life compared to full-length rFVIII

72

rVIII-SingleChain Phase 1/3 Study Design

Interim analysis Planned Dec 2012

Part 1 Part 2 CSL627 & Octagog alfa CSL627 repeat-dose, on-demand or single-dose PK (n=30) 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) Study entry

• Part 1 due to complete enrolment 2012

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• Part 3 to commence early 2013

73

Recombinant Coagulation Portfolio Summary

Target Launch Dates

CSL654 (rIX-FP)

2015

• Pivotal Phase II/III study commenced

• P h ase I data demonstrate >5x half life extension

• O r phan drug status granted by US FDA

• CSL627 (rVIII-SingleChain)

2016

  - Phase I/III trial commenced

• Early clinical data support potential half life extension

• CSL689 (rVIIa-FP)

• Initial pharmacokinetic data shows a 3-4x half life extension

• 2017+ • Orphan drug status granted by US FDA

• CSL650 (rVWF-FP)

  • Candidate pre-clinical molecule shows a 5x half life extension

74

Commercial Opportunities and Activities

Coagulation Sales

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Helixate
pd Coag
$US1,058M
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• Launch rIX-FP in 2015

• Launch rVIII-SingleChain as bio-better in 2016

• Grow pd FVIII

76

Coagulation: Total Market Size Key Market Segments and Products

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•
Beriate
•
Helixate
•
Factor X P Hem A
~ $5B
FX P
~ $3M
pd ITT
management • Biostate
~ $300M
Inhibitor bleed
•
Haemate P
treatment
Target
~ $1B
Segments
•
Mononine
VWD Hem B • Berinin
•
Biostate
~$500M ~$700M
•
Haemate P
77
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CSL Market Estimate 2012

Coagulation: Key Market Segments and Products.

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•
Beriate
•
Helixate
NexGen/FS/81
•
• Factor X P Hem A rVIII-Single
Chain
~ $5B
FX P
~ $ 3M
pd ITT
management • Biostate
•
rVIIa-FP ~ $300M
Inhibitor bleed
•
Haemate P
treatment
Target
~ $1B
Segments
•
Mononine
•
Biostate EU
VWD Hem B • Berinin
• Haemate P/ ~$500M ~$700M
•
rIX-FP
•
rVWF-FP
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78
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CSL Market Estimate 2012

Recombinant Coagulation Portfolio

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2012/13
&
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• Differentiate recombinant albumin fusion platform and launch rIX-FP

• Differentiate and launch rVIII-SingleChain

• Strong support for Helixate and growth of rVIII-SingleChain

79

rIX-FP (CSL654) & rVIIa-FP (CSL689)

Scientific Edge

Improved half life, extended dosing interval

Recombinant Albumin as fusion partner

Specifically designed linker

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80

rIX-FP: The Scientific Edge

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Phase 1 data rIX-FP [1] rFIX- PEGylated [2] rFIX-Fc fusion [3]
–
(CSL Behring
Albumin Fusion)
Half life
x 5.3 x 5 ~ x3
extension vs
rFIX
•
Half life supports dosing every 2+ weeks
1 Santagostino et al, Blood. 2012; 120 (12): 2405 – 2411
2 Negrier et al., Blood 2011, 118(10): 2695-2701
3 Shapiro et al., Blood 2012, 119(3): 666-672
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81

rVIIa-FP: The Scientific Edge

T/2 extension

Half life vs rFVIIa

rVIIa-FP (CSL Behring-Albumin Fusion) Phase 1 being analysed

x 3-4

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• The only half life extension technology currently in clinical development which enhances the duration of effect of native rFVIIa

• Half life supports single dose management of bleeding events and may enable prophylactic use

82

rVIII-SingleChain (CSL627)

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Commercial
Scientific Edge
Edge
Improved Improved
High VWF
financial molecular
affinity
contribution stability
Opportunity for Extended
Dosing Interval
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Me [++]
A1 A2 B A3 C1 C2
Covalent bond
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83

Presenting Data: Active Scientific Presence

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30
25
20
15
10
5
0
Albumin Fusion rVIIa-FP rVIII-SingleChain rIX-FP
Technology
Abstract/Poster Publication
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84

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)

• CSL362 (anti-IL-3R mAb)

• CSL346 (anti-VEGF-B mAb)

86

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

• Global Phase 2b development program to initiate mid-2013

• Potential to address significant gap in acute coronary syndrome

87

� CSL362 (anti-IL-3R mAb)

• Initial indication: Acute myeloid leukaemia

• Enhanced recruitment of tumour killing NK cells

• Targeting patients in remission with high risk of relapse

• Phase I trial in progress at

• 4 sites

• Other high quality

• opportunities in autoimmunity eg. SLE

CSL362 - Improved killing of patient leukaemia cells with autologous NK cells

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88

CSL346 (anti-VEGF-B mAb)

• Type 2 Diabetes

• Fat accumulation within tissues leads to insulin resistance

  • and failure to control blood glucose

• Most patients progress to insulin dependence

• VEGF-B controls fat uptake into tissues

• Blockade of VEGF-B signalling in rodents prevents insulin resistance and preserves islet cell function

• Humanised mAb in development

• single agent and in combination with

  • existing therapies

CSL346 treatment preserves � cell insulin production in diabetic mice

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89

Licensing and Collaborations

Licensing

Breakthrough Breakthrough Medicines Medicines

Specialty Immunoglobulins Specialty Immunoglobulins Products Products

Haemophilia Products Haemophilia Products

Optimising value of IP Portfolio and assets

• Partner high opportunity products

• GARDASIL[®]

• Mavrilimumab (GMCSFR� - Medi/AZ)

• Periodontal disease (Sanofi)

• Continue broad licensing strategy for ISCOMATRIX[®] adjuvant

91

GARDASIL[® ]

• Impact of Australian HPV Vaccination Program

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

• Adolescent male funding

• Extension to Australian NIP to include 12-13 yr males, with 2 year catch up for Year 9 males, from 2013

• Long term protection

• No break through disease 6 yrs post immunisation

• V503: 9-Valent HPV Vaccine

• Merck’s 2nd generation HPV vaccine

• Anticipated global filing Dec 2013 for 2015 launch

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92

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

� Mavrilimumab (GM-CSFR )

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Phase II EARTH Study completed

• 264 subjects with moderate-to-severe RA

• bi-weekly dosing for 12weeks (10, 30, 50, 100mg)

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• Primary endpoint

• DAS28-CRP decrease >1.2 at wk12

• Secondary endpoints

• DAS28-CRP remission

• ACR20/50/70 & HAQ-DI

• Safety profile

Outcomes

• rapid (2 weeks) and significant clinical effect compared with placebo

• excellent safety profile over 3 months of dosing

Current clinical activity

• Two ongoing Phase II studies

• mavrilimumab in subjects with moderate to severe RA(NCT01706926)

• mavrilimumab vs. anti-TNF in subjects with RA (NCT01715896)

ISCOMATRIX[®] Adjuvant Partnering Activities

• Major partners continue to advance vaccine development programs

• Merck Research Laboratories initiated Dengue clinical study

• Strong neutralising antibodies against all 4 serotypes in NHPs even at low antigen doses

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10000
1000
100
10
1
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Months
Microneut. Titers
50
Geometric Mean
LiCor
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Saline / IMX 20 ug DEN4-80E / IMX 20 ug DEN4-80E / Alhydrogel LAV (10e5 pfu)

Vaccination of all DEN-80E groups

Challenge of mid dose (20 mg) DEN-80E groups

LAV given at 0 and 6 months (not challenged)

94

IMX = ISCOMATRIX[®] Adjuvant

Summary

� Global R&D Portfolio �

December 2012

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

Immunoglobulins
Haemophilia
Specialty Products
Influenza Vaccine
Hizentra® CIDP Privigen® CIDP Hizentra® US/EU
Biostate® EU
Fibrinogen Berinert ®
New Indications Zemaira® EU Beriplex® US Self Admin
PCC Fibrinogen
Berinert® SC
New Indications Aortic EU
Novel Plasma
Proteins
rvWF-FP CSL627 rVIII-SC CSL654 rIX-FP
Rec Coagulation CSL689 rVIIa-FP
Factors
Partnered Vaccine Partnered Vaccine Partnered Vaccine Partnered Vaccine
Programs Programs Programs Programs
P gingivalis POD
CRC-OHS/Sanofi * CSL324 G-CSFR CSL362 IL-3R CAM3001
GM-CSFR - AZ
Discovery C SL346 VEGFB CSL112
Projects
reconstituted HDL
CSL334 IL-13R
Core Capabilities Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
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96

*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

Expected Progress in next 12 Months

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rVWF-FP rVIIa-FP Zemaira EU
Beriplex Beriplex
P gingivalis
Japan Surgery US
Partnered vaccine Privigen CIDP
programs EU
Berinert EU
rVIII-SC
Prophylaxis
Berinert Beriplex
SC Bleeding US
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97

� Significant Short-Midterm Target Launch Dates

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2016
2013 2014 2015 2016 2017
CSL654 CSL627 CSL689
rIX-FP rFVIII rVIIa-FP
Berinert®
Beriplex® US Beriplex® US SubCut EU Berinert®
Bleeding Surgical SubCut US
Fibrinogen EU
Aortic Surgery
Zemaira®
EU
Privigen® CIDP Hizentra® Hizentra®
EU Japan CIDP
Core Capabilities Immunoglobulins Haemophilia Specialty Products Breakthrough Medicines Vaccines & IP
Partnered Projects
Calendar Years
98
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Q&A

For website and printed version

Mavrilimumab

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Safety profile - Most Common Adverse events (≥3%)

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101

Mavrilimumab

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– Safety profile serious adverse events

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102