The U.S. Food and Drug Administration has approved the use of CSL Ltd.'s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older. Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children's vaccines available is an important step in responding to the H1N1 outbreak. The company's 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company's seasonal flu vaccine. The expanded approval also covers the company's seasonal flu vaccine. The approval was based on a study of the company's seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

CSL Ltd. provided earnings guidance for the fiscal year 2010. For the year, the company expects net profit after tax to be between $1.16 billion and $1.26 billion at 2008/09 exchange rates.

CSL Biotherapies Inc. and its parent company, CSL Ltd. have reached an agreement with Merck & Co. Inc. on rights to market and distribute Afluria(R) in the United States under an exclusive, six-year agreement effective September 3, 2009. Afluria, a CSL product, is a non-adjuvanted trivalent seasonal influenza vaccine sold in two different formulations: thimerosal-free, pre-filled syringes, and in multi-dose vials. Merck will have the exclusive right to sell and distribute Afluria in the United States beginning with the 2010/11 seasonal influenza season. The manufacture, filling and packaging of Afluria will continue and will not change with this agreement; CSL Ltd. will retain the Afluria license.