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CSL Ltd. — Investor Presentation 2003
Aug 3, 2003
17854_rns_2003-08-03_b18e6f7f-5dd3-48ad-befb-8e39b85493cc.pdf
Investor Presentation
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4 August 2003
Mr James Gerraty Manager Listings Australian Stock Exchange Limited 530 Collins Street MELBOURNE VIC 3000
Dear Mr Gerraty
CSL advises that its Managing Director, Dr Brian McNamee, will be making a presentation to financial analysts at 3.30 p.m. today relating to the future supply of plasma products by CSL to the National Blood Authority.
The presentation materials are available to any interested parties on the Company's website at www.csl.com.au under the heading "Plasma Fractionation Agreement Update" and are also herewith attached for general information purposes only.
Yours sincerely
Peter Turvey COMPANY SECRETARY


CSL Bioplasma and the Plasma Fractionation Agreement


The Stephen Review (March 2001)
Safe, adequate, secure and affordable supply of blood and blood products for Australia
- Safety and quality Review:
- Management and governance
- System wide decision making processes
- Self sufficiency
- Role of the National Fractionator

Key recommendations for plasma products
- Reaffirmation of the policy of Self Sufficiency ۰
- Voluntary donors
- Products provided free to all patients
- Establish a National Blood Authority $\bullet$
- Provide national management and oversight
- Ensure efficiency and equity
- Retention of CSL as the National Fractionator $\bullet$
- New PFA beyond June 2004
- Policy development through transparent evidence-based processes


2003 Update
- Governments move forward with implementation $\bullet$ of key Stephen recommendations
- National Blood Agreement $\bullet$ - Commonwealth, States, Territories
- National Blood Authority Established $\bullet$ $-1$ July 2003

PFA Update
- Governments considering a range of complex ۰ issues
- roll out of national arrangements
- transition to NBA
- Expectation of a new agreement similar to the PFA ۰
- CSL NBA actively engaged in discussions to ۰ ensure continuity of supply into the future

"Proud record...one of the safest and secure blood systems in the world"
Safe system
- Voluntary donor system
- Comprehensive screening ARCBS/CSL
- World leading plant
- Chromatographic based production
- Segregation of chromatographic gels
- Full traceability from donation to patient
- Safe, high quality products
- Highly responsive system
- $-$ Policy
- $-$ R&D capability
Safety

Safety
Category one BSE risk country

Australia, New Zealand, Singapore, Norway
Canada, India, Pakistan, Sweden, USA
Austria, Albania, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, San Marino, Slovak Republic, Slovenia, Spain, Switzerland, Turkey
United Kingdom, Portugal
Source: Geographic BSE Risk (GBR) rating - World Health Organisation
Note: list excludes nations from Africa, South and Central America and the Pacific Islands.
Increased Rick

Security
Australia's interests are safeguarded
Dedicated capacity
- Shield against supply crises
- Certainty of supply
- Security of supply chain ۰
- TGA as the determining regulator ۰
- Planning and preparedness for unforeseen events ۰
- CSL governance
Extensive range of products from Australian donor plasma
Adequacy
| CSL Product | Use | ||
|---|---|---|---|
| Intragam P | Immunodeficiency | ||
| Albumex | Burns, shock | ||
| Normal Immunoglobulin | Prevention of infections | ||
| Hepatitis B Immunoglobulin | Prophylaxis for specific diseases | ||
| Tetanus Immunoglobulin | |||
| Zoster Immunoglobulin | |||
| Cytomegalovirus Immunoglobulin | |||
| $Rh(D)$ immunoglobulin | Rh negative pregnancy | ||
| Biostate | Haemophilia A and von Willebrand's Disease |
||
| MonoFIX-VF | Haemophilia B | ||
| Prothrombinex-HT | Multiple factor deficiency | ||
| Thrombotrol-VF | Antithrombin III deficiency |


Meets evolving clinical need
Adequacy
- Redeveloped product range based on "superior" chromatography
- Continued improvements in viral safety
- World's best IVIG $\bullet$
- driver of plasma requirements from ARCBS
- yield optimised to meet increasing clinical need
- Customised products ۰
- Biostate vWF
- 250 IU minidose Rh D
- Thrombotrol-VF
- Guaranteed production capacity

Intragam P is a world leading IVIG
Adequacy
| Manufacturer | Product | Eorm | Specific Viral Inactivation Steps enveloped viruses only |
non-enveloped and enveloped viruses |
|---|---|---|---|---|
| CSL | Intragam P | liquid | Low pH | Pasteurisation er for de la segunda de la companya de la companya de la companya de la companya de la companya de la companya La companya de la companya de la companya de la companya de la companya de la companya de la companya de la co |
| ZLB | Sandoglobulin NF | powder | Low pH | Nanofiltration |
| Baxter | Gammagard S/D | powder | Solvent det | |
| Aventis Behring | Gammar-P I.V. | powder | X | Pasteurisation |
| Bayer | Gamimune N S/D | liquid | Solvent det Low pH |
Source: "Comparison Chart of Intravenous Immuno Globulins" Blood Diagnostics Inc

Basis of the price arrangements in the original Agreement
Affordability
The pricing objectives in the negotiation of the original PFA were:
- Recovery of costs with fair margin
- Prices competitive with international benchmarks

Model adopted with:
- individual product prices
- mechanisms to encourage efficiency
- mechanisms to encourage continued investment in products and processes
- encouragement of regional relationships

The Agreement has mechanisms to deliver efficiency benefits and continued investment
Affordability
- Two tier pricing: - All production beyond fixed volumes must be supplied at significantly lower, second tier prices
- All growth is at second tier prices
- Productivity: - Mechanism to share productivity gains with Government
- Investment: - Ensuring highest quality product range is rewarded
- Prices for new products to be based on PBS-like mechanisms

Affordability must be assessed relative to the appropriate comparator
Affordability
National Fractionator:
- Medical-marketing support, logistics, planning
- Low volume, niche products
- Scale limitations
- Commercial restrictions
Superior Product Range:
- Extensive product range
- Premium products
- Continued investment in R&D
Appropriate Comparators:
- Developed nations
- Self sufficiency model
- Similar scale

Affordability
Fractionation Economics
Industry Revenue by Product Other 23% IVIG 36% pdFIX $4%$ pdFVII 17% Albumin 20%
Source: "The Worldwide Plasma Fractions Market" MRB May 2002
Recovered plasma is by-product of ٠ producing fresh blood products
- Strict joint products most products can be extracted from the same unit of plasma without affecting the yield of others
- Plasma cost is allocated across all products
- Fractionation cost is driven by the quantity and range of products, plant scale, batch scale

Comparison of Liquid IVIG Prices

Sources: "Eurodata" MRB Mar 2002, "The Plasma Fractions Market in the United States" MRB June 2002 "The Plasma Fractions Market in Asia and the Pacific" MRB Jan 2002, CSL market intelligence
.© /} Innovative · Dedicated · Caring

Comparison of Factor VIII prices

Sources: "Eurodata" MRB Mar 2002, "The Plasma Fractions Market in the United States" MRB June 2002 "The Plasma Fractions Market in Asia and the Pacific" MRB Jan 2002, CSL market intelligence

CSL's prices compare well, even to the US market

Annual savings of obtaining Australian plasma product requirements at actual prices rather than US commercial prices (with US prices adjusted downward to compensate for plasma cost)
Sources: "Eurodata" MRB Mar 2002. "The Plasma Fractions Market in the United States" MRB June 2002 "The Plasma Fractions Market in Asia and the Pacific" MRB Jan 2002, CSL market intelligence


Conclusion
CSL' view:
- Australia remains committed to the policy of self sufficiency, and retention of a National Fractionator
- CSL provides good value for money
- broad responsibilities
- high quality products
- regulatory compliance
- basket of products
- dedicated capacity / preparedness

