Incyte Corporation's CEO Discusses Q4 2011 Results - Earnings Call Transcript

Incyte Corporation's CEO Discusses Q4 2011 Results - Earnings Call Transcript
By Seeking Alpha ,

Incyte Corporation (

INCY

)

Q4 2011 Earnings Conference Call

February 15, 2012, 08:30 AM ET

Executives

Pamela Murphy - Vice President, Investor Relations and Corporate Communications

Paul Friedman - President and Chief Executive Officer

Patricia Andrews - Executive Vice President and Chief Commercial Officer

David Hastings - Executive Vice President, Chief Financial Officer

Richard Levy - Executive Vice President, Chief Drug Development and Medical Officer

Analysts

Matthew Roden – UBS

Ying Wang - Barclays Capital

Eric Schmidt - Cowen and Company

Salveen Richter – Collins Stewart

Brian Abrahams - Wells Fargo

Cory Kasimov - JP Morgan

Thomas Russo - Robert W. Baird

Rachel McMinn - Bank of America Merrill Lynch

Ian Somaiya - Piper Jaffray

Thomas Wei - Jefferies & Co

Yogesh – Goldman Sachs

David Friedman - Morgan Stanley

David Crumpler[ph] – Morningstar

Presentation

Operator

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Greetings ladies and gentlemen and welcome to the Incyte Corporation Fourth Quarter 2011 and year-end financial results call. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ms. Pamela Murphy, Vice President, Investor Relations and Communications. Thank you Ms. Murphy, you may begin.

Pamela Murphy

Good morning and welcome to Incyte’s fourth quarter 2011 conference call. With me today are Paul Friedman, Incyte’s President and Chief Executive Officer; Pat Andrews, Executive Vice President, Chief Commercial Officer; Dave Hastings, Executive Vice President and Chief Financial Officer; and Rich Levy, Executive Vice President, Chief Drug Development and Medical Officer. Paul will begin with brief overview of the quarter, Pat will update you on the product launch of Jakafi, and Dave will describe our fourth quarter results and 2012 financial guidance.

Prior to opening up the call for the Q&A, Paul will close with the summary of some of our other programs.

Before beginning, we would 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 for other indications and our 2012 financial guidance. 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-Q for the quarter ended September 30, 2011 and from time-to-time in our SEC documents. Paul

Paul Friedman

Good morning everyone. The approval on the launch of Jakafi for myelofibrosis represents a major accomplishment for Incyte and an important advance for patients who suffer from this debilitating disease. Given the compelling benefits Jakafi provides, the encouraging survival trend that was described at ASH and the fact that this is the first FDA approved treatment for patients with MF, as well as the first commercially available JAK1 and JAK2 inhibitor not surprising to me that interest in Jakafi is high and that the launch has been going well.

Since approval, on November 16 and beginning on November 22 through December 31, we were able to recognize $2 million as net sales in 2011 based on $4.9 million of Jakafi that we shipped to our specialty pharmacies. Dave is going to walk you through this with more detail in a moment.

I would like to take a minute to describe why I believe Jakafi is going to be a successful product. First, there is no existing therapy that does what Jakafi does for these patients. Drug truly works, can make a meaningful difference and how a patient with myelofibrosis feels and gets through daily activities. It’s well tolerated. And the associated side effects that are seen are generally well managed. Second, once physicians have experience with the drug, more often first with their more ill MF patients and they see how effective Jakafi is, I believe they want to use Jakafi in the majority of their intermediate or high-risk MF patients. And we believe this represents about 80% to 90% of all MF patients.

I can tell you that we have gotten back from the field even in these early days multiple testaments to what I just said about the physicians and patients and the responses that they are getting through the drug. Now these two risk groups, intermediate or high-risk, encompass anyone over the age of 65 or anyone who has or has ever had any of the following: anemia, constitutional symptoms, or elevated white blood cell or blast counts, as well as anyone who has or ever had a platelet count of less than 100,000. So you can see in this group why the overwhelming majority of the total MF population fits in to these two risk categories.

Now, third reason for my optimism is about Jakafi’s commercial potential is that we have received a broad descriptive label from the FDA with no restriction on baseline platelet count, nor is the label limited to patients with splenomegaly or specific symptoms of MF. And this gives me further confidence that overtime the benefits of Jakafi will be viewed as appropriate for most patients with MF.

Myelofibrosis should be just the beginning. The JAK pathway is involved in the growth and survival of numerous other cancers and our plans, as well as those of our partner in Novartis involve advancing into other myeloproliferative neoplasms, hematologic cancers and solid tumors either in separate studies or collaboratively. In particular, in addition to the ongoing extensions of our Phase II/III trials in MF, there is a pivotal Phase III response trial in patients with advanced polycythemia and there are also trials in leukemias, lymphomas and in pancreatic cancer.

Regarding the PV pivotal study response, our proposal to amend the entry criteria and reduce the size of the study was accepted by the FDA under our existing SPA. The trial design now involves 200 patients randomized 1:1, ruxolitinib versus best available therapy, and we continue to expect the study to be completed in 2013 with our goal being to obtain FDA approval of the sNDA in 2014.

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