CSL gets US FDA closeout letter and reports positive results for FY2012

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Related tags: Ethylene glycol, Food and drug administration

CSL gets US FDA closeout letter and reports positive results for FY2012
CSL Group has resolved the manufacturing problems it faced over the last 12 months to finish fiscal 2012 with higher revenue and profits.

Revenue for the 12 month period ended June 30 was A$A4.4bn ($4.6bn), up 12 per cent on fiscal 2011, while net profit increased 4.5 per cent to A$983m. The firm’s business units –CSL Biotherapies and CSL Behring – saw revenues grow 10 per cent to $813m and 11 per cent to A$3.6bn, respectively.

The Biotherapies unit’s growth – driven by higher immunoglobulin, albumin and haemophilia product sales – was achieved in parallel with work to address manufacturing deficiencies that earned its vaccines plant in Victoria a US Food and Drug Administration (FDA) warning letter​ last June.

CSL spokeswoman Sharon McHale confirmed that the problems have now been resolved, telling in-Pharmatechnologist.com that: “the FDA has closed out the Warning Letter issued to CSL Biotherapies[earlier this month.]”

McHale added that a second manufacturing problem relating to contamination of products by ethylene glycol – which saw Australia’s TGA quarantine 140 batches of human albumin for testing – has also been successfully resolved in fiscal 2012.

CEO departure   

News of CSL’s 2012 performance follows a few weeks after the firm announced that longstanding CEO – Brian McNamee – is to step down in July next year to be replaced by Paul Perreault, currently President of CSL Behring.

Despite his imminent departure McNamee was upbeat about CSL’s prospects for fiscal 2013.

 “Looking into 2013 we anticipate trading conditions to be similar to those of fiscal 2012with global demand tempered by ongoing economic pressures. Our global sales reach, our extensive portfolio and our research and development programs are well supported by a solid balance sheet."


McNamee also touched on CSL’s ongoing restructuring activities, which saw it start integrating its Australian plasma operations with CSL Behring. The plan is to set up a single plasma group that will include its facility in Broadmedows, Victoria in a bid to boost efficiency.

As part of an ongoing focus on productivity we are reorganising operations to better align our plasma fractionation activities into one seamless international operation​.”

The firm also announced that it will start reporting its results in US dollars from now on.

Related topics: Markets & Regulations, QA/QC

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