Incyte's CEO Presents At Morgan Stanley Healthcare Conference (Transcript)

Incyte Corporation (INCY)

Morgan Stanley Healthcare Conference Call

September 12, 2012 10:55 am ET

Executives

Paul A. Friedman – President and Chief Executive Officer

David C. Hastings – Executive Vice President, Chief Financial Officer

Analysts

David Friedman – Morgan Stanley & Co. LLC

Presentation

David Friedman – Morgan Stanley & Co. LLC

All right. I think we will get started here and thanks everyone for joining us. I’m Dave Friedman, one of the Biotech Analyst. And in terms of personal and research disclosures, you can look at morganstanley.com/disclosure. And I’m joined happily up here by the team from Incyte on the far side Dave Hastings, Chief Financial Officer and then on the near side Paul Friedman, and the relation President and CEO.

And we’d look for this to be as interactive as possible, so anyone should please feel free to raise your hand and shout out, and we’ll make sure we can get your questions asked. So thank you both again for joining us and I think we can just jump right in. You guys relatively recently have had a drug approved for a rare blood diseases, and so maybe you can just talk about the drug, the approval and how the commercial roll out has gone so far.

Paul A. Friedman

Sure. So the drug is JAKAFI, generic name ruxolitinib. It is an inhibitor of two kinases, in a family of kinases known as Janus associated kinase. They are JAK1, JAK2, JAK3 and Tyk2, were all related and a family of enzymes. Our compound inhibits JAK1, and JAK2, but not JAK3, and inhibits Tyk2 to a significantly less degree than JAK1 and JAK2.

Drug has worked extremely well in myeloproliferative neoplasm called myelofibrosis of which there were about 18,000 known patients in the United States. It treats the very debilitating symptoms of the disease and also as part of that shrinks the very large spleens that many of these patients get. There is accumulating data that shows that the drug may well prolong survival, although we don’t have that in the label. And the drug was approved for use in intermediate and high-risk patients which comprise about 85% of that 18,000, and without any restriction on platelet count, despite the fact that we had only studied patients with platelet counts above 100,000 in our Phase III studies.

So the approval was towards the end of last year, and our revenue is growing in a steady and sustained way. And we are getting reports back from the field and from physicians that they are seeing pretty dramatic effects which is the same thing we saw in the Phase III studies.

I’m sure you don’t want to get more specific about some aspects of that, but in general that’s kind of the story.

David Friedman – Morgan Stanley & Co. LLC

Great. And so, maybe if we can just jump into the types of patients that have come on drug to date and it’s only been a couple of quarters. But if you can talk about just in the general sense the types of patients that you saw coming on drug in the first couple of months versus the contrast of the types of people you’ve seen come on drug in the past couple of months.

Paul A. Friedman

Sure, but I think that is important to note. So the beauty of the label was we did not get a restriction for platelet count. The difficulty with the label that we’re dealing with aggressively is that without a limitation on platelet count, we saw in the beginning of our launch a very high proportion of the sicker patients who are too sick to get into our clinical trials that is patients with platelet counts less than 100,000. I mean over 60% of the patients who came in early in launch had platelet count in that range.

The two doses in the label are 15 milligrams and 20 milligrams twice a day, which were quite well for people who have platelet counts above 100,000 and we are challenging for people with platelet counts below 100,000. Because one of the major reversible side effects of using the drug are myelosuppression both decrease in platelet count and decrease in red count, although that latter is a somewhat transient phenomenon because there are recovery mechanisms that occur while you are still on the drug. So the platelet count early on can go down, it goes down below a certain level patients have to discontinue the drug.

And we have – since launched on a very nice study in low platelet count patients where we start them on a lower dose 5 milligrams twice a day and work up and we are finding that almost all of them can get to 10 milligrams BID and at that does they are getting essentially the same results on spleen reduction symptom relief that the less sick patients get at the higher doses and we put that in – we send that to the FDA for an update on the label and when requested we are obviously explaining that to physicians who might start a patient with low platelet count on the drug.

But as you might expect those patients were sick, much significantly sicker than the patients that we are currently seeing coming to the group of people who are now getting the drug and who we studied in Phase III. So some of them died, some of them can't tolerate the higher doses, so early on the discontinuation rate was higher. It seems to be modulating.

Read the rest of this transcript for free on seekingalpha.com

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