Previous Statements by INCY
» Incyte's Management Present at Barclays Capital 2012 Global Healthcare Conference (Transcript)
» Incyte Corporation's CEO Discusses Q4 2011 Results - Earnings Call Transcript
» Incyte CEO Presents at 30th Annual JP Morgan Healthcare Conference (Transcript)
» Incyte CEO Discusses Q3 2011 - Earnings Call Transcript
Paul will begin with a brief overview of the quarter, Pat will update you on the product launch of Jakafi, and Dave will describe our first quarter 2012 financial results. Prior to opening up the call for Q&A, Paul will close with a summary of some of our other programs.Before beginning, we’d like to remind you that some of the statements made during the call today are forward-looking statements including statements regarding our expectations for the launch and commercialization of Jakafi as well as our development plans in other indications. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our Form 10-K for the year ended December 31, 2011, and from time to time in our SEC documents. Paul? Paul Friedman, M.D. Good morning, everyone. The launch of Jakafi for patients with intermediate- or high-risk myelofibrosis is going well. During the first quarter we recognized $19.3 million in net sales of Jakafi and we shipped 25.1 to our specialty pharmacies. Jakafi is an important advance for patients who suffer from this progressive and life threatening disease. Given the compelling benefits it provides in terms of spleen reduction and symptom improvement, the encouraging survival data recently published in the New England Journal and the fact that this is the first FDA approved treatment for patients with MF, it’s not surprising to me that interest in Jakafi is high. Additionally, last week our partner Novartis received recommendation by the Committee for Medicinal Products for Human Use, the CHMP, for approval of ruxolitinib, the treatment of disease related splenomegaly or symptoms in adult patients with primary post-polycythemia vera or post-essential thrombocythemia myelofibrosis. We look forward to seeing patients and physicians outside the US have access to the drug.
The positive CHMP opinion means that Incyte has earned a $40 million payment from Novartis and will earn a second payment of $60 million once Novartis receives reimbursement and pricing approval in specific EU countries. In the EU, the European Commission generally follows the recommendations of the CHMP and the decision will be applicable to all 27 EU member states.In addition to the ongoing extensions of our Phase II and Phase III trials in MF, Incyte and Novartis are conducting a global pivotal Phase III trial called RESPONSE in patients with advance polycythemia vera and we continue to expect the RESPONSE study to be completed in 2013 with our goal being to obtain FDA approval of the SNDA in 2014. There are also a number of ongoing investigator-sponsored trials in leukemias and in lymphoma, and then there is the Incyte-sponsored trial in pancreatic cancer with that expected from that trial in 2013. So for now, I’ll turn the call over to Pat and then to Dave. Patricia Andrews As Paul said, the launch is going well. Our launch tracking surveys, as well as feedback from our field force, suggest that physicians who have tried Jakafi are impressed by how quickly the product works and how dramatically it improves the debilitating symptoms and splenomegaly that affects so many patients with MF. In the near- to mid-term, we remain confident that this positive initial experience will lead to a steady increase in the use of Jakafi in patients with severe or moderate symptoms and/or splenomegaly. Longer term, as we build awareness of the benefits of Jakafi and the burdensome progressive and life-threatening nature of MF, we expect that use of the product will gradually expand to include intermediate or high-risk MF patients with any degree of symptoms and/or splenomegaly. While it’s still early on in the product launch, I’d like to describe a couple of factors that we think drove our first quarter sales and why we continue to believe that our launch will build gradually. First, since we’ve launched Jakafi in November, we’ve conducted a series of market research surveys with hematologist-oncologists that are remarkably consistent with positive feedback from the field, as well as our own prelaunch market research. Read the rest of this transcript for free on seekingalpha.com