For the second quarter of 2012, Tysabri global in-market net sales increased by 2% to $395.5 million from $389.0 million for the same period of 2011, and units sold increased by 10%. This reflects the 16% growth in U.S. in-market net sales of Tysabri offset by the 11% decrease in ROW in-market net sales, which were negatively impacted by the $16.3 million revenue reserve in Italy, and unfavorable foreign currency movements.
For the first half of 2012, Tysabri global in-market net sales increased by 8% to $794.5 million from $738.4 million for the first half of 2011, while units sold increased by 14%. This reflects the 17% increase in U.S. in-market net sales of Tysabri, offset by the 1% decrease in ROW in-market net sales, which were negatively impacted by the $32.8 million revenue reserve in Italy, and unfavorable foreign currency movements.
Tysabri was developed and is being marketed in collaboration with Biogen Idec, Inc. (Biogen Idec). In general, subject to certain limitations imposed by the parties, Elan shares with Biogen Idec most of the development and commercialization costs for Tysabri. Biogen Idec is responsible for manufacturing the product. In the United States, Elan purchases Tysabri from Biogen Idec and is responsible for distribution. Consequently, Elan records as revenue the net sales of Tysabri in the U.S. market. Elan purchases product from Biogen Idec at a price that includes the cost of manufacturing, plus Biogen Idec’s gross margin on Tysabri, and this cost, together with royalties payable to other third parties, is included in cost of sales.
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.