And your specific question was with respect to whether we may enjoy priority review with the application? So it’s too soon for us to comment on that. And certainly the FDA will make that determination as to whether or not the application qualifies for priority review. As you may remember, the ENLIVEN study and the application for pexidartinib was reviewed by FDA with priority review status. So that certainly is the precedent, if you will, in this disease. So we’re looking forward to our ongoing and continued productive dialog with the FDA as we prepare to file here in the second quarter. And we’ll, of course, make appropriate disclosures at the right time in terms of whether that is a priority review or a regular review at the FDA’s discretion.
And then in terms of the European review process, that as you may remember, is a lengthier process. So we would expect that, that will take potentially longer than the FDA review. But as we get into our further dialog with the EMA, we may be able to better cast a timeline as to when we might expect action on the application once it gets filed. But we remain super excited about the profile of the drug. The MOTION data are very clear and compelling, and we’re looking forward to delivering our second potential approved medicine to patients.
Reni Benjamin: Right. And then if I could just have a follow-up regarding vimseltinib and what could ultimately be involved in prelaunch activities. Is this something that we should just be — just given the overlap think that Dan mentioned in the call, is this something that could just be as easy as kind of dropping it into the bag of sales and they’re sort of off and running or are there significant prelaunch activities that need to be conducted you know given this market.
SteveHoerter: Yes, I’ll ask Dan to comment on the pre-launch activities, but you’re right, Ren, we believe there’s 70% to 80% overlap in terms of the prescriber base. So a really meaningful opportunity, both in the U.S. as well as in Europe, for meaningful synergy with our existing commercial organization. Dan, do you want to comment further on the pre-launch activities?
DanMartin: Yes, absolutely. Thanks, Ren, for the question. So we think that investment in market development or pre-launch activities is really important. Our focus will be on disease education, largely to make sure that all potential treaters of TGCT are thoroughly educated on how common TGCT is, and the burden that these patients deal with. This is a really debilitating disease, it’s something that isn’t a lethal disease, of course, but it is one that can be very locally aggressive. And really have a significant impact on how patients feel and function. And we want to really paint that patient picture, bring that to light, raise that awareness. So certainly that, coupled with our med affairs organization and you know data from our studies, all of this will be part of making sure that prior to launch, physicians appropriately so know the information that they need.
And then, as Steve mentioned, at launch, yes, we think there’s tremendous synergy, we think we’re really uniquely positioned to take advantage of both the opportunity in GIST with QINLOCK and the opportunity in TGCT, with Vimseltinib.
Reni Benjamin: Terrific. Thanks for taking the questions, guys. Good luck.
Operator: [Operator Instructions] Our next question comes from Peter Lawson with Barclays. You may proceed.
Peter Lawson: Great. Thank you so much. Thanks for taking the questions. I guess two. Firstly, just on the seasonality and how we should think about that for the U.S. versus ex- U.S., as investors model out 2024 revenues. And then just moving into GVHD, just your thoughts on differentiation as well around safety and potentially efficacy versus an antibody and the ability to combine with other regimens in that GVHD space. Thank you.
SteveHoerter: Hi, Peter. Thanks for the two questions. So I’ll ask Dan and Margarida, to comment on expectations for the year broadly in 2024 and our expectation of the usual seasonality patterns. And then I’ll ask Matt to take your second question with respect to Vimseltinib and GVHD. Dan, you want to go first?
DanMartin: Sure, absolutely. Hi Peter, good morning. Thanks for the question. So as we noted on the call, we feel really excited and pleased with the progress that we’ve made. I’ll speak to the U.S. specifically, in the fourth quarter, delivering $35.3 million in net product revenue, which was a 38% year-over-year increase for the full year 2023, $121.5 million, which was a 25% year-over-year increase. So we feel really pleased with that. And as we look to 2024, we think some of the core drivers of our recent success will continue to be the core drivers of what we expect to be another record year for QINLOCK. Specifically strength in our core business, increasing average duration of therapy, and then, as noted earlier, contribution from unpromoted earlier line use.
So when we take a step back and look at the year as a whole, those are sort of the themes and the reason for our excitement. As we think about just the quarter-to-quarter pattern, we wanted to note that we would expect a pattern similar to past years, which reflects some seasonality dynamics, specifically as it relates to Q1, very common in the industry, to see a strong quarterly buying pattern at the end of the year that can potentially impact Q1, as well as some early in the year sort of post-holiday demand seasonality or demand softness. Of course, the other factor that we’ve noted in the past and would expect this year to also play out true to form is the Pap dynamic, which we typically see a lower PAP percentage in the early part of the year with a gradual increase throughout the year.
So those are some of the moving parts that we wanted to note. Margarida?
Margarida Duarte: Sure. So regarding ex-U.S., let me start by saying that we are delighted with the launch, how it’s going, and the strong revenue growth from last quarter, which was driven by strong performance in existing markets, but also the contribution from the launch in Italy. So I would say that as we continue to successfully advance our price and reimbursement and launch in new markets, we expect QINLOCK to continue to grow in International. It is always difficult to predict when new markets will open given the different reimbursement processes and different timelines in each market. But assuming we get there, I expect this to happen more toward the second part of 2024. So another thing to note is that while we expect future growth, we cannot exclude quarter-over-quarter variability.
So we have seen this in the past and we may see this again in the future. So, I would say all in all, geographic expansion is a key focus for us in 2024. QINLOCK is well positioned for growth. And the recent deal with GENESIS for Central and Eastern Europe is also a good example of the type of transactions that you can expect from us in the future.
SteveHoerter: Great. Thanks Margarida. Matt, do you want to take the vimseltinib question?
MattSherman: Yes. So hi Peter. Yes, so in regards to your question about Vimseltinib in TGC — I’m sorry, in graft versus host disease, and really to be able to differentiate this, we do remain very excited about our plan to initiate our proof-of-concept study in the second half of this year. And also we have a very large database of safety based on Vimseltinib in TGCT, both from the MOTION Phase 3 study as well as from the Phase 1/2 study. And GVHD is a chronic disease and particularly with the skin and joint involvement there can be severe limitations of patients mobility. And the antibody therapy would have to be given intravenously every two weeks. So for a chronic disease such as GVHD, that’s a pretty significant burden on patient.
So one of the major features of using vimseltinib as an oral agent will be to combine with other oral therapies as you know, the standard of care now consists primarily of oral agents, whether it’s a JAK2 kinase inhibitor or Fura-2 inhibitor and in fact on steroids as well too. And so our ability to differentiate from an antibody, pretty significant with vimseltinib in our Phase 2 study.
Peter Lawson: Got you. Thank you. Is there any way from, I guess, preclinical data to see any differentiation of an oral drug versus an antibody. If you think that could drive differences in efficacy or durability or safety?
MattSherman: Yes, I think most of the preclinical data just speaks to the role of the macrophage in the profibrotic manifestations of the disease. And that’s particularly important in several organs, as I mentioned, particularly the skin, because these patients can have pretty severe sclerotic skin lesions, and even joint contractions and also particularly in the lungs as well too. And fibrosis has been a major organ that — is currently is not a satisfactory treatments current regimens for GVHD. So the role of macrophages inhibiting macrophages in those particular organs could really be a benefit for vimseltinib in this disease.
Peter Lawson: Great. Thanks so much.
Operator: Thank you. I would now like to turn the call back over to Steve Hoerter for any closing remarks.
Steve Hoerter: Yes. Thank you for joining us on today’s call, and thanks for your support. We look forward to keeping you updated on our continued progress here at Deciphera during the course of the year. Hope you have a great day.
Operator: Thank you for your participation. You may now disconnect.
