Highlights 2005-2006
CSL Behring Report
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CSL Behring this year consolidated the momentum from the integration of Aventis Behring in 2004 with sales reaching $2.4 billion and further improvements achieved in business efficiency. Sales revenue was 11% ahead of the previous year (10% in constant currency) with strong performance across our product portfolio.

The strong demand for Factor VIII contributed to sales growth of 10% in our Helixate® recombinant product. The sales growth of plasma-derived Factor VIII and von Willebrand Factor products has been helped by the increasing awareness of von Willebrand Disease and Immune Tolerance Therapy (ITT) treatment protocols.

Immunoglobulin sales grew over the previous year with continued strong demand in the US market driving global growth. We successfully launched Liquid Sandoglobulin in Europe with strong sales in England, France and Denmark. Vivaglobin® (immunoglobulin for subcutaneous injection) received US Food and Drug Administration (FDA) approval midway through the year and has been launched in the United States for the treatment of Primary Immune Deficiency. Vivaglobin® offers patients the flexibility of treating themselves in the convenience of their own homes, with approval from their doctors.

CSL Behring achieved strong growth in the number of patients being treated with Zemaira® for genetically-linked emphysema and the recent FDA approval of our expanded manufacturing capacity has significantly increased the potential for greater patient numbers.

In Japan, self-sufficiency initiatives and flat demand for plasma therapeutics are slowly eroding sales opportunities. However, CSL Behring’s specialty products in surgical sealants and for critical care provide a base for us to compete in this market.

CSL Behring’s financial performance has continued to exceed expectations as a result of strong demand across CSL Behring’s product portfolio. This is reflected in a 28% increase in earnings before interest and tax over the previous year. Product margins have improved from additional manufacturing volumes, higher prices, integration benefits, and from operating efficiencies compensating for the discount allocated to inventory arising from the purchase of Aventis Behring. Market demand and improved supply chain management have produced strong cash flows from operations.

Strong US demand for intravenous immunoglobulin is also driving the demand for plasma to manufacture our products. CSL Behring is well placed to meet growth opportunities through its own plasma collection centres and plasma purchased from US and European Blood Banks.

Our research and development projects have made good progress this year. The clinical trial for a chromatographic, high-yielding liquid immunoglobulin for intravenous administration has been completed and filings are planned for late 2006 with the FDA, European and Canadian regulatory agencies. A surgical study for Humate®/Haemate® (plasma-derived Factor VIII) has been completed and the file supplement for this indication has been submitted to the FDA. A multi-centre clinical trial in Hereditary Angiodema is in progress with the aim of broad registration of Berinert® (C-1 Esterase Inhibitor) for treatment of this painful and sometimes life-threatening condition. A clinical trial will also be completed in 2006 evaluating the use of Beriplex® (prothrombin complex) for treatment of coagulation factor deficiencies associated with Warfarin therapy.

To meet projected demand for immunoglobulin, work has commenced on a large-scale chromatographic purification plant at our Bern facility. The Bern project includes a state-of-the-art filling suite for immunoglobulin. At our Marburg plant, we have started work on a new filling suite for coagulation factor products. Additional works are being undertaken to expand our capacity for coagulation and acute care products.

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Laboratory technician, Thomas Rein, carries out a Real Time PCR quantitative virus detection assay used to determine that biological materials are virus free.