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CSL Ltd. AGM Information 2007

Oct 16, 2007

17854_rns_2007-10-16_6a14be02-48b8-446c-9489-bbf5bfe48d18.pdf

AGM Information

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17 October 2007

To: The Manager Companies Company Announcements Office Australian Stock Exchange Limited

Dear Sir/Madam

CHAIRMAN’S ADDRESS AND MANAGING DIRECTOR’S PRESENTATION

Please find attached copies of the Chairman’s Address and Managing Director’s presentation slides to be presented at CSL’s Annual General Meeting which commences at 10.00 a.m. today.

Yours faithfully,

Peter Turvey

COMPANY SECRETARY

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CSL LIMITED CHAIRMAN’s ADDRESS ANNUAL GENERAL MEETING 17 OCTOBER 2007

I am very pleased to be able to report that the strong trading performance of our plasma products business and successful Australian and international launches of the GARDASIL vaccine against cervical cancer have combined to deliver an excellent result for CSL.

CSL Group net profit after tax from continuing operations increased 54% on the previous year to $539 million. Group sales revenue grew 11% to $3.2 billion.

Our plasma products business continues to expand with ongoing demand for immunoglobulins, growth in sales of plasma-derived Factor VIII, and strong gains in price and volume for our critical care medicines.

In addition, two significant achievements for the plasma product business occurred during the year, the first being FDA approval of Privigen for the US market. Privigen is the first proline-stabilised liquid intravenous immunoglobulin that is ready for immediate use, requiring no refrigeration or reconstitution. The second significant achievement was an extension of our agreement with Bayer from 2009 to 2017 for the supply of Helixate recombinant Factor VIII.

Turning to progress achieved with the cervical cancer vaccine, GARDASIL, which was developed in collaboration with our partner, Merck & Co Inc, this product has now been approved in 85 countries and launched in 66 of those countries. This is quite a remarkable achievement by Merck. CSL has received royalty payments of $86m from Merck this year on global sales of GARDASIL. The Company also successfully launched GARDASIL in Australia with the Commonwealth Government approving a free national immunisation programme.

CSL’s acquisition of Zenyth Therapeutics Limited in November 2006 has strengthened our research interests in the development of products based on recombinant monoclonal antibody technology, adding a portfolio that fits well with our research into cancer, immunology and inflammation.

In March this year, we filed a Biologics Licence Application with the US FDA for registration of CSL’s influenza vaccine in the US and this application has just recently been approved. We anticipate selling our first influenza vaccine in the US during the course of the upcoming winter season.

Work to expand CSL’s influenza vaccine manufacturing plant in Melbourne is on track to deliver extra capacity in 2008 and to support our growth opportunities in other international markets.

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BUSINESS REPORTS

Let me now briefly comment on our business activities which include the operations of CSL Behring, CSL Bioplasma, CSL Biotherapies, and our global research and development programs.

CSL Behring sales revenue increased 8% on the previous financial year to $2.6 billion. Earnings before interest and tax grew 48% with strong demand across the entire product portfolio.

CSL Behring is a global leader in plasma therapeutics, strong in products to treat immune deficiency, critical care conditions and haemophilia. The business has substantial markets in the US, Europe and Japan, manufactures products in the US, Switzerland and Germany, and has regional sales offices throughout the world.

CSL Behring operates a plasma collection business through ZLB Plasma, the largest collector of human blood plasma in the world. To ensure our ability to meet expected future global demand for immunoglobulin, ZLB Plasma significantly increased plasma collections this year. Together with plasma purchased from US and European Blood Banks, these increased collections will expand our future growth prospects.

CSL Bioplasma increased sales revenue 10% to $211 million this year through growth in plasma volumes for fractionation, increased demand for plasma products in Australia and across the Asia Pacific region, and continued strong demand for commercial albumin in Asia. CSL Bioplasma has also expanded its operations in Asia having successfully negotiated to fractionate plasma from Taiwan, reinforcing its position in the Asia Pacific region as the plasma fractionator of choice and the leading supplier of commercial plasma products.

CSL Bioplasma’s continued role as Australia’s national fractionator was confirmed this year in a review of Australia’s fractionation services which endorsed the integrity and benefits of Australia’s existing system.

CSL Biotherapies sales revenue grew to $317 million – up 49% on the previous year. This growth was underpinned by strong sales of the GARDASIL vaccine in Australia and an expanding international influenza vaccine business.

A national immunisation campaign against cervical cancer began in April this year, funded by the Commonwealth Government. The program offers free vaccination with GARDASIL for girls and women from 12 to 26 years of age. Approximately 1.7 million Australians will be eligible for free vaccination during the first two years of this program.

As already mentioned, the continued growth of our international influenza vaccine business and particularly planned entry into the US market are

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underpinned by the work in progress to significantly increase vaccine production at our Melbourne plant.

Research and development investment increased 18% this year to $191 million. Our focus is protein-based medicines purified from human plasma, made from traditional sources (as with influenza vaccines), or produced using recombinant DNA technology.

The only Southern Hemisphere manufacturer of influenza vaccine, CSL is continuing to work closely with public health authorities and the Australian Department of Health on a bird flu vaccine against the H5N1 virus. We recently filed for the registration of an H5N1 influenza vaccine with Australia’s Therapeutic Good Administration.

CSL scientists continue to work on new product development and life-cycle management projects – and are always interested in looking at early stage new product opportunities. Strong relationships are encouraged and maintained with academic and corporate research partners.

Our acquisition of Zenyth Therapeutics Limited and integration of Zenyth scientists into a new research team in the Bio21 Institute at the University of Melbourne has strengthened CSL’s capacity to develop new products based on recombinant monoclonal antibody technology.

DIVIDEND

“The Board has declared a final dividend of 55 cents per share franked at 50% taking the full year dividend to $1.04c. Dividend cheques were mailed to shareholders on 12[th] October.

OUTLOOK

At the end of the first quarter of the current financial year, I am pleased to advise that the company is performing consistent with our expectations.

When preparing the company’s financial forecasts for 2007/08 there were several key variables. These included royalties on GARDASIL sales by Merck, foreign exchange movements, tax rate changes in jurisdictions where CSL operates and movements in price and volume of core plasma products.

At the time of announcing our full year’s result in August we indicated an expectation for strong growth in fiscal 2008 and a net profit after tax of between $670 and $700 million, using the 2006/07 exchange rates. This of course is still subject to the variables mentioned.

Shareholders should also note, however, the recent movements in foreign currency exchange rates. The Australian dollar for instance is at a 24 year high against the US dollar. It needs to be recognised that about 90% of our earnings are now generated offshore.

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When consolidating net profit of our international businesses for financial reporting purposes there are non cash implications of notionally translating their foreign currency earnings into Australian dollars as exchange rates move from one financial reporting period to another. Given translation for reporting purposes does not reflect a cash flow, CSL does not consider it appropriate or economic to hedge these earnings.

Whilst recognising exchange rates continually move, we estimate that if recent exchange rates prevail until the end of this financial year there will be an adverse impact of approximately $65m to net profit after tax, which is consistent with the sensitivity table already provided to investors during the August results briefing.

OUR THANKS TO MANAGEMENT AND STAFF

“CSL’s strong trading performance is underpinned by the skills and commitment of thousands of people in many countries – people involved in research, manufacturing, sales, business development, and a range of other tasks and services that combine to bring us success by delivering life-saving medicines to an international community.

“Your Board of Directors congratulates management and staff around the world for everything that we have achieved in another successful year.

Elizabeth Alexander, AM Chairman

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Key Operational Highlights

  • Strong global demand for plasma therapies continues

  • Successful first full year of GARDASIL[®] rollout by Merck

  • Commonwealth Government funding of GARDASIL[®] in Australia

  • Extension of Helixate[®] supply agreement to 2017

  • Privigen™(10% liquid IVIG) approved by US FDA

  • Acquisition of CytoGam[®]

  • Acquisition of Zenyth Therapeutics Ltd completed

  • License and option agreement with Wyeth for ISCOMATRIX[®] adjuvant technology & expansion of existing Merck agreement

Recent

  • US FDA marketing approval for Afluria[®]

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Net Profit After Tax

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$M 600
$521m
+48% Sanofi
500
Settlement
400
$351m
300
200 Aventis
contingent
Provision
100
Reported Reported
NPAT NPAT
$117m $539m
0
Jun 06 Jun 07
NPAT for the 12 month period
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Sales – Geographic Breadth

Global Sales $3.2bn

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Australia
13%
Asia
North America
8%
38%
Rest of
World
4%
Europe
37%
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Sales – By Business Unit

CSL Biotherapies $317m

CSL Bioplasma $211m

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CSL Behring $2,645m

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CSL Behring – Therapy Group

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US$2.1bn
+13%
Other
Immuno-
globulins
Wound H
Critical Care
Pd Coag
Rec Coag
Jun 06 Jun 07
Sales for the 12 month period
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CSL Behring - Strong EBITDA Margin

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31%
15%
Inventory
Discount
2004 2005 2006 2007
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Sales – By Business Unit

CSL Biotherapies $317m

CSL Bioplasma $211m

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CSL Behring $2,645m

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GARDASIL[®] Australia

  • $100m in sales

  • Strong start to school based program

  • 18 to 26 year old GP based catch-up program

  • commenced July 2007

Influenza Vaccine

  • US FDA marketing approval for Afluria[®]

  • Launch anticipated October 2007

  • Significant phase IV studies required by US FDA

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Sales – By Business Unit

CSL Bioplasma $211m CSL Biotherapies $317m

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CSL Behring $2,645m

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R&D Investment

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$Am
FY2008
~$220m
200 $191
New Product Development
150
100 Market development
50 Life Cycle Management
0
FY2005 FY2006 FY2007
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Growth Strategy

  • Novel Biotech products

  • ISCOMATRIX[®] Novel plasma products

  • adjuvant

  • Market Development

  • Influenza vaccine

  • Advanced IG products

  • Global Specialty

  • Biopharmaceutical

  • HPV royalties

  • GARDASIL[®]

  • (Aust)

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