Tysabri – ROW
At the end of December 2012, approximately 38,400 patients, principally in the European Union, were on commercial therapy, an increase of 3% over the approximately 37,400 patients who were on therapy at the end of September 2012 and 13% over the approximately 34,100 patients (revised) who were on therapy at the end of December 2011.
ROW in-market net sales increased 4% in the fourth quarter of 2012 to $189.8 million, from $183.2 million for the same period of 2011 principally reflecting a 13% increase in units sold, offset by unfavorable price and foreign currency movements, including the 4% decrease in the average dollar-euro exchange rate from the fourth quarter of 2011 to the fourth quarter of 2012.
For the full-year 2012, ROW in-market net sales decreased by 2% to $745.1 million, from $764.1 million in 2011. This principally reflects a 13% increase in units sold, offset by a $50.2 million increase in the Italian revenue reserve, along with unfavorable price and foreign currency movements, including the 8% decrease in the average dollar-euro exchange rate from the full-year 2011 to the full-year 2012.
The revenue reserve for Italy relates to a notification received by Biogen Idec from the Italian National Medicines Agency during the fourth quarter of 2011, stating that sales of Tysabri had exceeded a limit established by the agency in 2007. Biogen Idec filed an appeal in December 2011 seeking a ruling that Biogen Idec’s interpretation is valid and that the position of the agency is unenforceable. As a result of this dispute, Biogen Idec deferred $17.0 million of revenue recognized on in-market net sales of Tysabri in Italy during the fourth quarter of 2012, having previously deferred $47.0 million of revenue in Italy during the first nine months of 2012 and $13.8 million during the fourth quarter of 2011. Elan expects that Biogen Idec will continue to defer a portion of in-market revenues on future sales of Tysabri for Italy until the matter is resolved. As a consequence of this deferral of in-market net sales by Biogen Idec, Elan has deferred $8.1 million of revenue in the fourth quarter of 2012 related to these sales, $30.6 million in the full-year 2012 and $37.5 million to date, reflecting the operating and accounting arrangements between the companies. This matter has resulted in the deferral of approximately $22 million of Adjusted EBITDA for the full year 2012.