BioCentury
ARTICLE | Financial News

Celgene provides apremilast update, reports earnings

January 31, 2014 3:00 AM UTC

Celgene Corp. (NASDAQ:CELG) disclosed in its 4Q13 and 2013 earnings that FDA accepted for review an application for Otezla apremilast to treat moderate to severe psoriasis. The PDUFA date is Sept. 23. The biotech also said it submitted an MAA to EMA for Otezla to treat moderate to severe psoriasis and psoriatic arthritis. Celgene expects an opinion from EMA's CHMP by year end. An NDA for the oral phosphodiesterase-4 (PDE-4) inhibitor is already under FDA review to treat psoriatic arthritis, with a March 21 PDUFA date.

Celgene reported 4Q13 adjusted diluted EPS of $1.51, missing by $0.03 the Street's estimate of $1.54 and up 14% from $1.32 in 4Q12. Revenues for the quarter rose 21% to $1.8 billion, beating the Street's estimate of $1.7 billion. For the year, Celgene reported adjusted diluted EPS of $5.96, up from $4.91 in 2013 but missing the Street's estimate of $5.99. Revenues increased 18% to $6.49 billion from $5.51 billion in 2012, slightly above the Street's $6.46 billion estimate. The figures are in line with preliminary numbers reported by the biotech earlier this month (see BioCentury Extra, Jan. 13). ...