For the fourth quarter of 2012, Tysabri global in-market net sales increased by 14% to $432.8 million from $379.6 million for the same period of 2011 and units sold increased by 15%. For the full-year 2012, Tysabri global in-market net sales increased by 8% to $1,631.1 million from $1,510.6 million for the full-year 2011, while units sold increased by 13%.
Tysabri was developed in collaboration with Biogen Idec, Inc. (Biogen Idec). Until the Tysabri Transaction closes, Tysabri continues to be marketed in collaboration with Biogen Idec and, 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.
Tysabri – U.S.At the end of December 2012, approximately 33,400 patients were on commercial therapy, which represents an increase of 2% over the approximately 32,900 patients who were on therapy at the end of September 2012 and 11% over the approximately 30,000 patients who were on therapy at the end of December 2011. In the U.S. market, Elan recorded net sales of $243.0 million for the fourth quarter of 2012, an increase of 24% over net sales of $196.4 million in the same period of 2011, principally reflecting a 17% increase in units sold, along with the impact of price increases. For the full year, Elan recorded net sales of $886.0 million, an increase of 19% over full year 2011, reflecting a 13% increase in units sold, along with price increases. Almost all of these sales are for the multiple sclerosis (MS) indication.