CSL Ltd. — Investor Presentation 2004

Dec 15, 2004

TIMETABLE

REGISTRATION - COFFEE (9am) WELCOME AND HOUSEKEEPING TNTRODUCTION and PORTFOLIO OVERVIEW (950am) BREAK PLASMA R&D PHDL (1150am) WRAP UP

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CSL Limited R&D BRIEFING DECEMBER 16, 2004

Dr. Andrew Girkbertson Dr. Jeff Davies Dr. Russell Basser

R3D - IN735MB0T Obj3CTM3

Sistain a highly profitable plasma $\hat{u}$ business

1. Identify and develop novel products where we have Intellectual Property and insight.

Leverage our investment through partnering.

$\mathcal{E}_{\mathcal{A}}$

1. Contribute as part of a fully integrated, specialist biopharmaceutical company.

R3D Conpetitive Aclychicce Key competitive advantages - specialist focus - effective scale - attractive academic partner - CSL recruits high calibre scientists Impact of ZLB-Behring Times and the contract of the contract of the contract of the contract of the contract of the contract of the - global capability E centres of excellence aligned with mantfacturing - synergies achieved

GOMMSREINT DRYSAL BARSCREEN RED

Centres of Excellence

ZLB Behring

CSL Group

o Noval profem product davalonnant Operations Support

O Biotzchrology Recombinant proteins

• Cameración de la cintenación
• $\bullet$ Vacamology

o Life evele induceanant plasme products C Operations Support

• $\circ$ Emmunology
• $\circ$ Hanophill
• O Wound Healing
• C Specialty products
• ORTIGER
• O Marbure, Cermany
• C Bann, SWITZGNOM

CSL Bioplasma

• o Life evele management plasma products Operations Support
• O NEW EURIFICCTION technologies

O Breadingadows, Australia

ODE OF ACTION

3 Key Areas

Allah

• O Parkville, Australia
• O Manouno, Germany
• C. Bern, Switzerland

R3D Staff and Budget

$\sim$ 500 staff ~A5140M

Enregrated R&D Portfolio Management

PharmaPlan

Strategy & Investment

Naw Opportunities

Relatification Evaluation Testing

Project Management Project Review

Commercial

Experience of the Community Community

Operations Exchange Strategy

Performance

Analytical Deal Making

R&D POR TFOLIO December 2004: Novel Profein Product Development

I

HPV Prophylaxis

· HPV Therapy

ISCOMATRIX 220W 2304 PDangule ·Chlanydia

Preclinical Evaluation Topical Eye Delivery · GROS PERIMADS!

R&D PORTFOLIO December 2004: Plastice Proclement

Inmunoglobulins

Coagulation factors

Specialty Products

HPV Vaccine Update

Merck webcast Dec 14, 2004 15

hitp://www.merck.com/newsroom/webcast/

ESCOMATREX® Adjuvant Technology New Milestones

HCV: started safety study in chronically infected pattents (Chiron)

Ō.

$\sigma$

O BSO1: publication of clinical ininumogenicity data*. Started advanced disease study. Commitment to start definitive MRD study in 2005 (LICR)

Chlamydia: new collaboration (Aventis Pastaur)

Dengue: NIH preclinical/clinical grants (Hawait Blotech)

Proceedings of the National Academy of Science (USA) 101:10697, 2004

ZLB Behring Plasing Product R3D

J377 Daviss Head of R&D Integration Global Director of Plasma Product R&D, ZLB Benthe

ZLB Banning R&D has a Rey role in delivering on?

a broad product portfolio with continuing innovation.

development of high quality, high yielding efficient manufacturing processes.

registrations to expand marketing reach.

Key Value Drivers for R&D Enfregrafion

R&D alignment with optimised manufacturing Z hetworks

• Immunology (Bern) - Haemophilia, Specialty products (Marburg) - Alpha-1-Proteinase inhibitor (Kankakee)

R&D alignment with Commercial Operations

R&D Integration is Well Advanced

o R&D restructure completed

8 Key project decisions made

6 Financial targets on track

6 Global management systems established

Réid Supports a Major Global Product POMEROITO

Broad portfolio of products - Global Sales Reach

Benefits of Integration for Key Products

· Camitan P · Gamna Vann · Ventminure

· Rickform

ATHE D

EVATE

GAFTGA Albritticia OGTS

Carinune /

· Rhophylac

* ZLE-Abumin / Human Aisikh

Opercritonal Centres of Excellence

Increased IVIG output from Bern

OF Current supply of IVIG Will be net by improved manufacturing efficiencies.

$\circ$

FDA requirements for processing Kankakee Fr IItIIII paste now met and manufacturing commenced.

Major synegy Droiegrach Deie

R3D portfolio Dzcznber 2004; Plastice Products

Emminedobilhs Liquid IVIG products STIDEL TENCORS TO Anti D for ITP

Gotochichton Gotors VOITWII IE DRAME SCHSCARE (Haemate/Humate NexGen) Anti-coaculant reversal (Beriplex P, EU)

onal la de la B A-DL process Rathogen Safety Wound Healthe Fibrin Szakia (Beriplest reconstitution and dalivery)

Profense Malbrors CI esterase hinbro: (Berinert P for USA) Alokka (421

Strengthening Our IVIG Portfolio

Sandoglobulin @ (Lyophilised, IV)

Sandoglobulin © Liquid (226,EV)

Chromatographic (10%DV)

Opaning Naw Markais for Loc

Vivaglobin^TM

TELESCOPE

- Subcutaneous IgG: 16%

- For treatment of immunodeficiency

- Well tolerated

- Hone therepy/self infusion (weekly)

Improving clicqnosis of immunocleficiency

The Jeffrey Modell Diagnostic Genter for Primary 8 Ummunoclaficiancias en The Children's Fosphel of Philedaphie Chrondrographic IVIC State of the art gualty with manufacturing efficiency

. In house Swiss and Australian technology o Liquid, 10% ready to use 6 Comprehensive pathogen safety data O Pitchyfeld and punity

Ic(G portfoliot Tinelines and inilestones

Siberrenzors IGG (EU)

Sibelitaaseis Re(G (US)

12% Liquid IVIG (EU)

12% Liquid IVIC (US)

Chrometographic Liquid Livie

· Approved October 2004

· BLA submitted October 2004

· Approved, Switzerland, UK. · MRP submission Dec 04

• Clinical commenced Sept 04

· Clinicals commenced -Sapt 04 PID, ENEXOZA ETE

2005

201074

2003

Naurology and Ininunoglobulins

Expansion of label claims

- "Applying for GBS indication in the USA

Supporting education in emerging markets

MG in Natirological Disacses

Exploring new indications

Hemolytic disease of the newborn (HDN) High product purity allows for IV or IM COMMISTRATION Liquid product Yield over 3 times Rhesogam US approval received in February 2004 Registration expanded to 16 EU countries in 2004

Anti D for IIP submissions Q1 05

Designation

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HaengteP/Hungte P; VWF-FVIIII conc. Superior product features

on Willebrand's Disease: 1-2% of population. Under diagnosed

onWillebrand factor: initiates formation of hemostatic plug, stabilises FVII

High MW multimers · Injoorrant for efficacy

Content of HMW-VWF - NHP=100%

100 $93.6$ 90 松腔 80 70 werklik
No 60 50 40 30 IMM-VWF, 20 10 Haemate^® Products

· High collagen binding Pa measure of vWF activity

WF:CB per Unit FVIII:C

Hungte P/Hoeingte P NexGen Hippoved Formulation, use in surgery

Enpreved formulation

• 2 fold reduction in volume - Therease convenience - Retains high MW multimers and activity - To be introduced in 2005...

• Developing use in surgery (US)

Merket leeder in WVF concentrate

Wound Healing- Fibrin sealants For szaltne lzakaeks associatza with sureteal preczelnes

· Beriplast Combiset (fibrin sealant)

• Lyophilised fibrinogen and thrombin - Combiset registered in EU and Japan Key market is Japan Improved reconstitution and delivery systems to be introduced in 2005

TachoComb® (Nycom2e); Another mode of delivery

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o TachoComb® (Collagen/fibrinogen/thrombin)

• Sealing and prevention of fistulae Sealing and prevention of air leaks in pulmonary surgery Anastomosis protection Sealing of perforations of the eardrum Sealing of dura mater defects
• Manufactured using ZLB Behring fibrinogen and thrombin - Distributed by ZLB Behring in Japan

C1 Inhibitor Deficiency

HAE RHIGHS

Healthy subjects

FRIGHTCHY ANGIOSCRIKC Encloiances if in 50,000, Ave: 1 ciricek per month. Can be faral.

Berinert P (C1 esterase inhibitor)

Registered in Germany, Japan, Austria, Hungary and Switzerland, Argentina

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Clinical trial design for treatment of acute episodes under davalopmant

Competition - Dyax/Genzyme: kallikrein inhibitior Jerini: bradykinin receptor antagonist É Pharming: transquite C1 esterase inhibitor F

Competitive advantage of Berineri Prhalf life and multifactorial $(0010)$

The Barbon Containst and the second contact of the second of the second second second second second second second second second second second second second second second second second second second second second second se

Incidence: 1: 6000 (under diagnosed) Dose: 60mg per kg once per week

Deficiency leads to emphysema later in life with significant lifestyle impacts

ZLB Behring has recently entered the US market

Zznatra: Superior Profile

Volume.

• 5 Zemaira: Purity, rapid reconstitution, low
• O Market base growing o Phase IV trials planned in 2005 o Validation of new facility in Kankakee near completion with FDA approval expected second half 2005

A track record of safe plasma products and reputation for leading safety standards

Virus Safety

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Viral Inactivation processes dealing with both enveloped and non-enveloped viruses

• Pasteupisation - Nanofifration
• SD technology
• Low of treatment
• Enterging viruses (e.g West Nile, 54RS) frice five red by These processes.

A track record of safe plasma products and reputation for leading safety standards

Prion Safety

o State of the art in-house technology for measuring capability of processes to eliminate prions should they be present in plasma.

o First company to get FDA approved label claim for
capability of process to eliminate prions

Complementary laboratories maintaining state of the art virology and prion technologies.

Plasina Products Portfolio Suminary

• Key R&D integration tasks completed and forecast savings delivered

6 The major manufacturing synergy project completed

6 Key R&D milestones for ongoing programs met

New infilefives underway

AHDE - Two Major Clinical Davalopmant Obbortuntrias

De Rússell Basser Global Clinical Director, New Product Development

A-IDL = Reconstituted high-density lipoprotein

H

HSL = Tood cholestero!"

791 : 1

ALDE a synthesized lipoprotein particle chemically and biologically resembling native HDL

Manufactured from discarded fraction of plasing

The six of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the

DIE DE LA PARA

plasma

discarded marrion

ADOAI Drotein

FEDT:

PHDL is safe & biologically active in

humans

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TEST

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Clinical trials in over 150 people Very well tolerated No serious or unpredicted side-effects Biological activity demonstrated

PHDL is a potent biological conpound

• Extensive scientific work shows rHDL is active
• anti-inflammatory - sucks cholesterol from vessel walls ("reverse cholesterol transport") - increases blood flow (vasodilator) - anti-oxidant A blood thinning (antigotgulant)

PROGRESS WITH PHOL FOR STROKE

O Preclinical stroke work progressing - publication of Italian research results - Australian paper submitted o Trial in stroke patients commenced Nov 04 - safety and pharmacology Preparing for phase 2 study – effeci of rHDL on size of stroke (by Magnetic Resonance scan)

Contract Contract Contract Contract Contract Contract Contract

What is ACS?

$\sum$

Myocardial infarction & unstable angina $\sim$ 1.7M clinical episodes per yr in USA $\sum$ o "Vuinerable patient"

• generalised process in all coronary blood VESSES
• risk of a further clinical event despite CUMPENT TRECTMENT (te new inforction, inscited intervention, surgery, death)
• 10:% at 1yr, 15-20% at 2yrs

What happens in ACS?

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Underlying problem is atherosclerosis - hardening and narrowing of the coronary arteries - starts from childhood - related to genes, environment, various medical CONCITIONS ACS occurs when a clot forms on ruptured segment of unstigble atheroma (plaque) - blocks blood supply to area of heart myscle - results in chest pain with or without permanent damace

ACS: What's happening in the blood
vessel?

Libby, Nature 2002

Inflammetion is inportant in atherona 2 ACS

PLUTO AND BEYOND . THE SKEPTICAL ENVIRONMENTALIST REPLIES

AEREAIEN Inflammations Link to Heart Attacks

Extreme Lasens Rent a Rain Forest When Whales Walked

Current treatnent of AGS

Tractinents dined at

• maintaining blood flow in the affected blood vessel
• Imiting damage to heart
• reducing the chance of further clot formation

• delaying further progression (growth) of plague

• multiple drugs

aspírin, beta blocker, AGE inhibitor, statin – early procedure to look at plumbing (blood vessels) keep open with stent (metal mesh) 2

Why is CSL interested in ACS?

• Information in animals & humans that rHDL has properties that are beneficial
• reverse cholesterol transport
• anti-inflammatory
• anti-oxidant

$\mathbf{\Omega}$

• calms chronically irritated endothelial (lining) cells
• Intellectual property, product supply and formulation Strenchis

The concept of rHDL for ACS

. infusion of rHDL provides rapid stabilisation of plaque - rapid removal of fat from blood vessel - rapid reduction in inflammation of the coronary arteries

=> rHDL will take the blood vessels back in time to a more stable and less aggravated state => much less chance of further clinical problems

Product Concept to be Tested in Genedian Gantra

o New diagnostic technology: able to conduct a Phase 2 clinical study · Identified high quality cardiology group In Ganada

High Quality Clinical Trial Opportunity,

· Study based on intravascular ultrasound (IVUS) neasure of plaque and blood vessel Wall Thickness

6 Montreal Heart Institute (MHI) - Dr Jean-Claude Tardif is Director of Research

• one of two state-of-art IVUS groups = network of cardiology investigators in Ganacla

• high quality clinical trial infrastructure

What is IVUS?

Intravascular ultrasonography

Plaque

SOF

Schoenhagen et al, Glev Glin J Med. 2008

Guidewire

shadow

IVUS shows details otherwise missed

Nissen, Am J Cardiol 2002

When night we expect to flick

o shrinkage of plaque reduction in the languion TELESCOPE

=> will give confidence their giving rHDL to patients with ACS is likely to provide clinical

Sunnary of HBL projects

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· Stroke indication progressing as planned - phase 2 trial planned to commence 2006

AGS provides a complimentary opportunity - phase 2 trial to commence first half 2005 - phase 2 results in 2006

Excinple of ch Barlier Stage Opportunity

Sighificant work by Australian researchers: Professor Doug Coster, Finders Medical Centre • Applying biotechnology to treating serious eye diseases

Topical Delivery of Reconbinant Antibodies for Treating Eye Disease

o US Patent Issued

o Continuing to evaluate in preclinical experiments

R3D Highlights from 2004

Merck HPV clinical trial progress $\circ$ ZLB Behring integration advanced with 2000 Financial trapgets on track 2-3 paste registered in Bern 0 Vivaglobin s.c. approval EU, US submitted Py o First stroke patients treated and ACS indication for rHDL O Naw Galaaydig ISGOMATRIX® collaboration With Avenits Topical dalivary for eye disease parant issued