Outside of the United States, Biogen Idec is responsible for distribution and Elan records as revenue its share of the profit or loss on these sales of Tysabri, plus Elan’s directly-incurred expenses on these sales, which are primarily comprised of royalties that Elan incurs and are payable by Elan to third parties and are reimbursed by the collaboration.
Tysabri – U.S.
At the end of September 2012, approximately 32,900 patients were on commercial therapy, which represents an increase of 3% over the approximately 31,900 patients who were on therapy at the end of June 2012 and 12% over the approximately 29,400 patients who were on therapy at the end of September 2011.
In the U.S. market, Elan recorded net sales of $230.5 million for the third quarter of 2012, an increase of 17% over net sales of $197.1 million in the same period of 2011, principally reflecting a 10% increase in units sold, along with the impact of price increases. Almost all of these sales are for the multiple sclerosis (MS) indication.
Tysabri – ROW
At the end of September 2012, approximately 37,400 patients, principally in the European Union, were on commercial therapy, an increase of 3% over the approximately 36,300 patients (revised) who were on therapy at the end of June 2012 and 13% over the approximately 33,200 patients (revised) who were on therapy at the end of September 2011.
ROW in-market net sales decreased in the third quarter of 2012 to $173.3 million, from $195.5 million for the same period of 2011. While units sold increased by 7%, ROW in-market net sales were negatively impacted by the $14.2 million revenue reserve in Italy, and foreign currency movements, including the 12% decrease in the average dollar-euro exchange rate from the third quarter of 2011 to the third quarter of 2012.