Incyte Corporation (Nasdaq: INCY) today reported 2013 fourth-quarter and year-end financial results, including revenue from Jakafi ® (ruxolitinib), which is approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with intermediate or high-risk myelofibrosis (MF). The Company also provided 2014 financial guidance and highlighted multiple achievements in its clinical programs, including agreement with the FDA for a Special Protocol Assessment (SPA) for a registration trial of ruxolitinib in patients with advanced or metastatic pancreatic cancer.
“I have great confidence that Incyte is well-positioned to continue to grow as a successful biopharmaceutical company focused on oncology,” stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. “Jakafi continues to perform well in myelofibrosis, and we believe it will offer substantial growth in a second blood cancer, polycythemia vera. Additionally, we’re encouraged by data from the RECAP Phase II trial suggesting that JAK inhibition may extend and improve patient outcomes in pancreatic cancer and possibly in other solid tumors.”
“Beyond our JAK programs, we have a clinical pipeline that includes oral inhibitors of IDO1 and PI3K-delta, and the recent announcement regarding our clinical trial collaboration with Merck is an important step to furthering our understanding of the role of our oral IDO1 inhibitor in the rapidly evolving field of immunotherapy.”
2013 Fourth-Quarter and Full-Year Financial ResultsNet Loss / Income Quarter Ended December 31, 2013 Net loss for the quarter ended December 31, 2013, was $42.9 million, or $0.26 per basic and diluted share, as compared to net income of $18.8 million, or $0.14 per basic and diluted share, for the same period in 2012. Included in the net loss for the quarter ended December 31, 2013, was a one-time charge of $17.9 million, or $0.11 per basic and diluted share, related to the repurchase of $117.3 million face amount of the Company’s 4.75% Convertible Senior Notes due 2015 (2015 Notes) as described below. Excluding this one-time charge, the net loss for the quarter was $0.15 per basic and diluted share. The table at the end of this press release includes a reconciliation of GAAP to Non-GAAP basic and diluted net loss per share.