Incyte Corporation (NASDAQ:INCY) Q3 2023 Earnings Call Transcript

And just having to go through one step because most patients will have, in fact, use topical steroids when they have AD, so that makes it much easier. In terms of contracting and concessions, there’s always a negotiation, of course, with the PBMs and the payers over rebates and fees and so forth. So it might cost us a little bit more on the rebate and but in fact, then the co-pays generally go down. And most importantly, what we’re really trying to achieve is volume. And then I suppose your last question is the negotiations with payers always continues. We don’t really have to have any further negotiations unless we choose to until 2025 for Opzelura. But there’s always the – there’s always a chance that we come back and decide to do something slightly different in terms of getting in terms of making access easier for patients.

Most of the contracts that we have in place currently in fact, allow plans to step up and change their step therapy from two to one and so forth.

Operator: Thank you. Next question today is coming from David Lebowitz from Citi. Your line is now live.

David Lebowitz: Thank you very much for taking my question. Would you be able to give us insight on the current – I guess, rate of the number of tubes per patient in AD and vitiligo you were expecting? Have there been changes in expectations and where you think stand right now?

Barry Flannelly: Sure. So in terms of AD, I think we had it on the slide, it’s around two. We’ve been saying that for a while. We expect two tubes per patient for atopic dermatitis on average. Obviously, some patients we’ll get a lot more than that. In vitiligo, we need some more time really to evaluate exactly in the real world how patients will receive will see Opzelura for vitiligo. So patients who have – might just apply the drug to the face, for example, or apply it all over their body, it varies. But we’ll continue to track the number of tubes for vitiligo, but obviously, with our data so far, long-term extension data, patient can use it safely for years, and continue to get benefit. So we’ll update you when we have more information as we gather more data as we have more use in vitiligo.

Operator: Thank you. Next question is coming from Jessica Fye from JPMorgan. Your line is now live.

Jessica Fye: Great. Good morning. Thanks for taking my question. Curious if you’ll be in a position to provide Opzelura sales guidance for 2024. And with respect to your BET, what you’ll be looking for in the upcoming [indiscernible] results?

Christiana Stamoulis: So Jess, I’ll take the first part of the question regarding the Opzelura guidance. As we’ve shared with you in the past, in order to provide guidance, we want to have a few quarters of real world experience with Opzelura, especially for vitiligo, given that a disease in new market. And be able to see how in the real world utilization is how many tubes on average vitiligo patients use, and also how quickly and at what rate in active patients can get in to see their physicians and get on therapy. So we are still very early in the launch of Vitiligo, and we continue to monitor the progress and I want to say a few more quarters before we are in a position to provide guidance.

Steven Stein: And then in terms of your question related to BET inhibition in myelofibrosis, the competitor ongoing first-line study, which you allude to is what we consider a pretty standard first-line study in about 440 patients, the primary endpoint spleen volume reduction of 35% or greater and already communicated, it has to be an end in terms of the secondary endpoint of heading total symptom score, 50% improvement or above versus the competitor racks in that situation. For our own BET inhibitor, as I said earlier, both monotherapy data, we’ve really shown spleen reduction, symptom response and some hemoglobin responses and then the ongoing combo work showing the same. And we’ll have to see how that data plays out versus what the competitor delivers in their first-line study in terms of our registration efforts, and we’ll communicate further about that at the ASH meeting coming up in December. Thanks.

Operator: Thank you. Next question is coming from Marc Frahm from TD Cowen. Your line is now live.

Marc Frahm: Hi. Thanks for taking my questions. Maybe first to start on the commercial side to follow up on one of the prior questions. Just Barry, on a blended basis, given this is a pretty large plan that you’re moving up the formulary, but on a blended overall basis for the franchise, should we expect gross-to-net to kind of incrementally increase in 2024 versus the full-year 2023, given that move?

Barry Flannelly: Mark, I’m [indiscernible] sure, to be honest with you, we’ll have to see what the volume is and what the improvement in co-pays is to see how it affects our gross-to-net. But anyway, we’ll see, but there’s always a chance that we could actually benefit a great deal from net sales by making it much easier for patients to be able to access our drug.

Operator: Thank you. Next question is coming from Vikram Purohit from Morgan Stanley. Your line is now live.

Gospel Enyindah-Asonye: Good morning. This is Gospel on for Vikram. We have two questions for Jakafi. I mean due to the recent approval of GSK for Ojjaara. The first one is what portion of MF patients using Jakafi do you estimate are using a sub optimal dose due to anemia. And in this patient population have you seen an increased rate of discontinuations as prescribers and patients potentially move towards Ojjaara. And secondly, have you observed a decrease in Jakafi new patient starts in MF since Ojjaara was approved. Thank you.

Barry Flannelly: Well, Gospel, the most important thing is that – so – Ojjaara only got approved on September 15. It really only launched in the last week of the year. I’d be surprised that there was actually any sales, except for stocking sales in the quarter. So anyway, so I can’t imagine that would affect any part of us yet. Now what percent of patients might be receiving a suboptimal dose. What we’ve only said before, I believe, is that the number of patients who are at steady state on 5-milligram twice a day dose or something like that is only about 5% of our patients. I believe those patients are actually getting benefit, but that’s the most. And just like in our clinical trials, cover one trial, I mean, only one patient discontinued for anemia.

So we don’t believe that that’s a big part of it. And like I said before, about the benefits that Jakafi provides the MF patients, whether they’re anemic or non-anemic it’s overall survival, it’s symptom control, it’s spleen control. So far, we don’t really see – we don’t really anticipate an impact by momelotinib certainly in the third quarter.