Perfect. Thank you. Good morning. My name is Peter Lawson, and welcome to Barclays Global Healthcare Conference in Miami. First off, you know, if you have need to ask questions, I'll be on Bloomberg. Do remember me or my associates, and we'll try and get questions answered for you. Really pleased to have with me up on stage, the CFO from Deciphera, Tucker Kelly, and Jen Larson, SVP of Finance and Investor Relations. So thank you so much, and welcome. Great, thank you for having us today, Peter. We appreciate you guys hosting the conference down in South Beach again this year. Perfect. I'm glad you could come again. I guess I'd love to start talking just initially about revenues and then GIST and CSF-1R, et cetera. But I guess first question would be around revenues. Kind of what are the key drivers for 2024 that we should be thinking about, those that continue, those that dissipate through the year, kind of the puts and takes that we should be thinking about? Sure. So for folks that aren't as familiar with Deciphera, I'll give you a little bit of quick background. Peter's talking about QINLOCK, or ripretinib, which is our first approved product. It's approved, currently in the U.S. and 40 countries around the world for gastrointestinal stromal tumor, or GIST. So we got approval in the U.S. back in 2020, and we've been marketing it, with our own direct sales force since then, and then beginning in 2022, we launched in Europe following EMA approval at the end of 2021. So we began our marketing there commercially ourselves and working with a growing number of distributors and partners around the world to get access for QINLOCK in the fourth-line setting to GIST patients. So we had a great 2023. We had $163 million in total revenue. Year-over-year product revenue in the fourth quarter was about 42% growth. We'll talk a little bit more about some of the dynamics in the U.S. in particular as to what's creating that increase in revenue. We penetrated relatively quickly the fourth line setting, and over time, that had led to increasing average treatment duration that was building between 2021 and 2022. And then in 2023, we started to see some off-label utilization that we can touch on coming from a couple of parts of the business. And in addition, as I mentioned, we started to launch in Europe back in 2022, first in Germany as well as France, under an early access program, and we've been slowly getting pricing and reimbursement in different jurisdictions. So at the end of last year, for instance, we got approval and began to market in Italy in the fourth quarter, and we'll have more we can touch on for 2024, where we expect continued geographic expansion and concurrent revenue growth coming out of Europe from our own direct sales, as well as then through distributors and other places. So for instance, in January, we announced that we'd signed up Genesis Pharma as our distribution partner in Central and Eastern Europe, which provides access to a large number of patients that have an approval but don't yet have access and reimbursement in those territories. So we're continuing to look to expand the utility in the labeled indication in fourth-line GIST. We'll talk about some of the off-label dynamics that we think are happening in earlier lines of GIST, and then touch on our clinical effort to try and get a label expansion in a portion of second-line GIST. Perfect. Thank you. So Germany and France, you know, some of the first international territories you opened, how penetrated are those, and, you know, how should we be thinking about those as the year unfolds? Sure. So, we launched in Germany in early 2022. We'd actually already been selling under an early access program in France before that, even before approval for, for a while. And so, what I would say is, in Germany, you know, we have full market access. We don't think we are fully penetrated yet. It's a fairly, diffuse, prescribing, situation in Germany. A lot of community oncologists, less concentrated. And so, you know, our commercial team has been working hard to get awareness, and uptake for the product for patients who are eligible, and we'll be continuing to do that. So in Europe, you know, we haven't been seeing off-label utilization. We really think it's all still, you know, penetrating the initial fourth line on label indication. In France, we're again still selling in an early access program, which gives us the ability to commercialize before we finalize price with the French authorities, but it doesn't give us full access. So, you know, we continue to work with the French authorities to get to a final negotiated price, and at that point, we'll have true full market access and have, we think, additional growth that will come from from that status being being changed. So those are two of the largest markets in Europe. Germany is certainly always the highest priced market, and we're really pleased with the price that we were able to secure in Germany of over EUR 18,000 a month before the mandatory discount. But we think there's a lot of strong margin gathering that we can get through the rest of the countries in Europe. And so we're working really hard to get access and reimbursement, you know, in the other large markets and territories, while still respecting what we think is really the strong clinical benefit for the product and, and really focusing on getting good value for QINLOCK, that we think patients get from the benefit of the therapy. Perfect. Thank you. Next major markets we should be thinking about, whether they're in Europe or further afield? Yeah. So, you know, we just launched in Italy at the end of last year, so certainly continuing that launch in the first part of this year. There are oftentimes individual jurisdictions within a country that, you know, have additional hoops you need to jump through, but we've gotten now to most of the large ones. But the next ones after that, I think, would really be Spain, as we're focused on, as well as then looking at areas like the Benelux region, or the Nordic regions as well. We've not yet gotten agreement with NICE on price in the U.K., or England and Wales, and so we'll continue to have conversations there to again get what we think is fair value for the clinical benefit of the product. But that's obviously one of the other larger markets that we're not yet commercial in in Europe. Gotcha. Thank you... Is there anything else needed for, for NICE? Any other studies? No, it's, you know, it's—I know it's a challenge for a lot of sponsors and issuers to come to agreement. They're very firm on their view of cost, benefit, and price, and in a constrained healthcare system, so which we understand and appreciate, and yet we feel very strongly about the incredible data that we put up with QINLOCK. It's a very innovative product. It has survival benefit, PFS benefit, randomized controlled trial. So, you know, we feel like the clinical benefits and economic benefits of helping these patients is something that should be better reflected in the price. And so we'll continue to have discussions with NICE and find ways in which to have that conversation to hopefully get to a resolution at some point. Gotcha. Thank you. The updated NCCN guidelines, kind of how did that drive durability or treatment, duration of treatment? And kind of how should we think about that as how, how long does that benefit last to revenues as a driver? Sure. So I'd like to interpret the NCCN guidelines, just in terms of the duration question, Peter. So what we know is that in the fourth line setting, we see typically in the clinical study, about 6.5 months of PFS, 6.3. In practice, what we've said in the commercial settings, we do know we have a number of really good long responders. And so these patients, they can be out even years. So it's a smaller portion of the patient population in the fourth line setting, but it does allow, over time, the average treatment duration to increase. And that's what we've been seeing in the U.S., to the point where now we think we're probably in the 7.5-month range. We think at peak, we could be at eight to 8.5 months of average treatment duration as those long responders contribute to an increasing average. You know, in the second-line setting, it depends a little bit. So what we know from the INTRIGUE study, which was our all-comer second-line trial, was that there, the overall PFS was very similar to sunitinib. It was about 8.3 months. But that in certain patient populations, it was either significantly higher or lower than that. And so for instance, in the exon 11 primary and 17, 18 secondary mutations, those patients had a 14.2-month PFS. And what we think is, in practice, when we get an approved label expansion there, that we think patients, like it was in the fourth line, will have a higher average treatment duration than we had PFS in the clinical study. So we think that could be up to about 20 months of duration of treatment. But, you know, for an unselected non eleven, seventeen, eighteen, you know, it may be closer to that eight or somewhere different. So, you know, that will be something as we talk about some off-label utilization NCCN guidelines, that is harder to gauge in terms of how will that impact the revenue curve and the treatment duration. But maybe, Jen, if you want to talk about the NCCN guidelines? Sure. Yeah, no, we're really pleased to see QINLOCK listed in the NCCN guidelines, and as a reminder, it was listed for patients who are intolerant of sunitinib. And so what we've said, and what we've seen in the past few quarters is that we have a very strong fourth line business. As when we launched, as Tucker mentioned, we think we penetrated very quickly. So when we saw consistent quarters year-over-year since launch, then being listed in the NCCN guidelines, we started to see what we attributed to earlier line usage. We do have some visibility into what lines of therapy and where QINLOCK is being used, but not perfect visibility. So the biggest sort of test that we have for that is really the consistency of the baseline, fourth line business that we had previously, and then the uptick that we've seen, which we do believe is coming both from being listed in the NCCN guidelines, and expect that that will continue. But also just the overall awareness based on the data that was presented after the INTRIGUE study and the data that we've been able to show in the 11, 17, and 18 population. So we do think that 2024 will remain a growth year for QINLOCK, partially for the reasons that Tucker mentioned earlier, and also with some earlier line usage as well. Gotcha. Perfect. Thank you so much. Do you think that it's hard to pick between the two, maybe, but the NCCN guidelines, do you think that's the biggest part of that driver or? Yeah, it's tough for us to tell. We think it's both. We think that there's sort of a, an additional awareness now with the publication. We published in Nature Medicine very recently. That's brought awareness, but certainly the NCCN guidelines and having that availability has also been helpful. Now, that's something that we can't and don't promote to. It's off-label, so it's very important, and that's the other reason why we've initiated the INSIGHT study for additional work on 11, 17, and 18 patients to be able to get the label to be able to promote to it. Gotcha. That kind of off-label use, so do you think it's potentially you've penetrated that or there's further growth there? I'm just curious on how that kind of curve looks over time. Yeah, I mean, we, again, tough for us to tell, but we do think that there's, you know, additional space in earlier lines, certainly. Remains to be seen whether or not that will continue with just, without the label, with just sort of the listing in the NCCN and the additional awareness. But we do expect that 2024 would continue to be a growth year with some, some normal variability quarter to quarter with some seasonality. Gotcha. What we said, Peter, is that, you know, we think at peak, that the inclusion of the approved label for this eleven, seventeen, eighteen population second line could double the business in the U.S. for QINLOCK. So we think the fourth line on its own, at peak, could be $175 million-$200 million, and that with an approved label and being able to promote to it, we think that we could basically double that and have a $375 million-$400 million business in the U.S. And that's not a TAM or a total addressable market. That's what we think we can actually generate at peak. So we think there's a lot of room for the brand to grow with an approved label and our ability to market and promote awareness to it. That doesn't include, obviously, as Jen was mentioning, the NCCN inclusion for patients who are intolerant of sunitinib. And then again, that is based on the full results of the INTRIGUE study, not the sub-patient population. You know, we showed that 8.3 to eight months of PFS and a safety profile where the grade 3+ adverse events that were treatment-related were actually double in sunitinib arm than what they were in the QINLOCK arm. So, you know, the safety tolerability is a feature of the product that we get a lot of really positive feedback from physicians and patients on. As you know, sunitinib is not a well-tolerated or well-loved drug for patients or physicians to utilize. So, we were pleased to see that the committee had decided to update the guidelines to provide that as an option for physicians who decide that they think their patients could be intolerant to sunitinib and choose to write off-label for ripretinib. But that's outside of that $40 million peak number that we've talked about in the U.S. for QINLOCK, including the subpopulation. Gotcha. I, I know in the past you've talked about that business being essentially profitable, the sales business. Does that continue to be profitable as you kind of expand into different territories? And I guess, what, what does that mean? What do you have to strip out to get to profitability? Yeah, we've been thinking hard about where we're investing and where we're expanding into additional markets. You know, certainly as a standalone today, given the revenue that QINLOCK is bringing in, both in the U.S. and ex-U.S., with the investment that we have, it is, on a standalone basis, a profitable accretive to the business overall. Yeah. We don't break it out, obviously, it's not a GAAP-based measure, but if you look at the $163 million we did in the U.S. last year, and you think about what we, you know, spend in SG&A, you know, obviously, not everything in SG&A is related to the commercial business, and there's some costs that are associated with the commercial business that are embedded in R&D. But as Jen mentioned, you know, we look at it, we do think it's accretive, not just in the U.S., but even in Europe. And that's, I think, something that's quite different than a lot of U.S. companies that decide to stand up infrastructure in Europe. Oftentimes, people will go in, and they'll put in a large organization right at the outset. They'll put territory managers in all the key countries, and have a number of years where they're really investing at a high level and, and not getting the return on revenue. Because, again, once you get approvals, we talked about, you've got to get market access and reimbursement, and that takes some time. So for us, we took a different approach. We really were very targeted about how we put in place our infrastructure, and we built kind of the core team for pricing and reimbursement, for market access, and for sales and marketing, as well as a very nimble G&A function there to help support the group. And then we've been building on that incrementally as we've gotten access to reimbursement. So, you know, we don't have KAMs or key account managers in the Netherlands or Spain yet because we don't yet have kind of full access and reimbursement, but we try and time it so that we make those investments concurrent with when we get, you know, revenue for it. So, you know, there, we did $11 million in revenue in the fourth quarter in our international business most, which is out of Europe. And, you know, we've got in total roughly about 40 people in Europe, including some G&A folks. So, it's a very efficient business and something we think is not only good for QINLOCK, but will set up great for us to launch vimseltinib and provides the substrate for us to potentially, you know, find other products from the outside that we could bring in, either on a global or U.S. and European basis or even on a regional basis. And, you know, they've done a great job of getting quick access to reimbursement and exceptional pricing for QINLOCK, and we think we've built a really strategic asset in our team in Europe. Got you. So that would be, if you potentially brought something in, it would kind of be very synergistic with the sales force, the touch points that they have. That's how you kind of think about that? Ideally, sure, and we'll talk about the INTRIGUE, that actually just really more by serendipity than anything else, is a perfect fit for it. It caused the same call point, 78% overlap, and allows us to leverage that infrastructure. That's a pretty special fit. I don't think we would expect nearly all products to have that kind of homology and overlap. But so yeah, certainly the things that have the most overlap, whether it be a sarcoma or calling on a similar set of physicians, just got the most efficiency. But a lot of the basic infrastructure, whether it's operations, logistics, or, you know, your 3PLs, your access and reimbursement teams, you know, those are all things that can be leveraged across. So we do think that there may be opportunities, even if it's not, you know, a hand-in-glove fit with QINLOCK, to make modest investments to grow our commercial presence, if there is a product that would be a, a good fit, and we think the economics work out for, someone like us to commercialize it. Gotcha. Perfect. Thank you. Just on the, not minutiae, but the kind of 1Q numbers, you were kind of talking about all the guidance about seasonality. What does that mean? Does that mean kind of flat? Does it mean a year-over-year decline or quarter-over-quarter decline, we should- Sure, yeah. So, as we noted, 2024, we do expect to be a growth year overall for QINLOCK, but we have seen in the past, and we would expect to continue to see some level of seasonality where there's, you know, reset in some of the, the free pricing program and so on. And so in—from Q4 of last year to Q1, there was a, you know, about a 4%-5% decrease, and we would expect to there to be something similar this year, even with an overall growth year for QINLOCK. Got you. Perfect. Thank you. Insight, so your phase III study for the 11, 17, 18 mutation. How's that rolling? Kind of where are you for that? And kind of, I guess the second question around that, whether the NCCN guidelines kind of reduces the need to run that study, essentially. Yeah, no, INSIGHT is the confirmatory trial that we're running to try and validate the subpopulation analysis that we saw in the INTRIGUE trial. So it's a small compact study. It's 54 patients, randomized 2:1, QINLOCK against sunitinib in second-line patients who've progressed on imatinib. And we're prescreening those patients to have, using ctDNA, the exon 11 primary and exon 17, 18 secondary mutations. And so we're very pleased with the pace of activation of sites, of prescreening and enrollment. We haven't had any issues there. We started this study at the end of last year, and we're actively continuing to bring on new sites around the world, and actively prescreen and enroll patients. So, so far, we're really pleased with how it's going. You know, the prescreening with the ctDNA is just one small step. It's a blood test with a fairly quick turnaround in order to be able to prequalify patients so they could then go into the normal screening process. And so far, again, we've been really pleased with how that's progressed, and it's in line with our expectations. So, we think it's important, as Jen mentioned earlier, to get the INSIGHT study enrolled and read out. We feel really strong about the likelihood of success there, given the incredible data we put up in INTRIGUE there. We had a 44% to zero response rate. We had a 14.2-month PFS versus 1.6, which is the first restaging scan for sunitinib. And again, the tolerability and safety profile continuing to be better than that of sunitinib. So, you know, we had a hazard ratio in that sub-analysis of 0.22, and what we said is we could double that and still have a positive study in INSIGHT. So it really is about execution, getting these patients, finding them, and putting them on trial. We haven't provided any guidance as to, you know, when we'll reach full enrollment or read out the study, or just too early in the enrollment phase to do that. You know, our practice typically is that we have line of sight to full enrollment. We'll be able to guide to that and say, "Hey, we think based on where we are today, that we'll get to full enrollment in X quarter or X half," and then try and narrow that as we get closer. Similarly, as an event-driven study, you know, like we have had in a couple of our trials in the past, that's a little bit more difficult to predict because you don't know when the events will occur, but we'll do our best to, again, provide guidance to the street to say, "Here's, here's what we think based on the current event rate, you know, we would likely have top-line results available from the study." But we're, we're just a little too early now to be able to predict either full enrollment or top-line readout. Got you. Okay, perfect. Thank you. I guess there's no yet kind of a sense of expectations of when we could see that initial data. What about, you know, sNDA? Any sense there? I'm sorry, on? For the SNDA. Oh, no, again, that'll all be on the critical path, get enrolled, get readout, and then file the sNDA. So I guess what I can say qualitatively is, you know, there's a lot of enthusiasm for the study amongst investigators and patients, again, based on the strength of that data and the real desire of clinicians to try and, you know, have a much more targeted approach in GIST, which, you know, historically has been very much a kind of a road pattern of imatinib frontline, sunitinib second line, regorafenib third line, and now QINLOCK since 2020 in the fourth line. And, you know, we've known that there's genetic variation amongst the patients. It's a very polyclonal disease. These patients have multiple tumors that can, even within individual patients, the different tumors can have different mutational statuses. So you know, the ability to use a new technology like ctDNA that they're already using in other parts of solid tumor oncology to try and better target the drug therapy for their patients, I think is really exciting for them and something that they're both clinically excited about, excited about for their patients and also, you know, for the field to really improve the treatment of GIST by getting more targeted therapies to the right patients. And you know, that's really what we showed in the INTRIGUE sub-analysis that, you know, now for the first time, we think there's a rationale for doing this testing, which we think will change the paradigm and allow patients to get better outcomes by using the right drug at the right time. Got you. Thank you. And then on the CSF-1R, the, where you got additional data in 2Q, just what should we expect to see in that data set? Sure. So, the CSF-1R program, this is vimseltinib. We've reported out the phase III MOTION study at the end of October last year and are moving for the NDA submission in the second quarter and the MAA in the third quarter. We will have additional data updates, first from the MOTION trial itself. At the top-line readout, we provided the key, the first primary endpoint, which was a RECIST response at week 25, and we also provided two of the six key secondary endpoints. All six key secondary endpoints that we have in the study were statistically significant and clinically meaningful. We presented in the first two of those, the top-line readout. One of those is response by tumor volume score. This is a volumetric way of actually measuring the tumor that is better in tenosynovial giant cell tumors than RECIST, just given the nature of the way these, these tumors grow. And again, there, we had a 67% response rate at week 25 versus zero for placebo. And then thirdly, we presented range of motion data. So pain, suffering, quality of life measures, patient-reported outcomes are really important in this disease. It's not a fatal disease, but one where there's high morbidity. So we presented on range of motion with a 5x improvement over placebo. And then in the second quarter, we'll have... This is all from part one of the MOTION study, the blinded period. What we'll have in the second quarter is, additional detail on the other secondary endpoints, so kind of more fulsome disclosure than we provided at the top line. And then later this year, we'll also have data coming out on the phase I/II study. So, obviously, the registration trial is the key one for, approval in the U.S. and around the world, but we think not only the underlying supportive data that would be part of any submission is helpful, but it as well, that, you know, showing over time how patients do, when treated with themselves in both safety and efficacy. So our last disclosure was at CTOS last year. We had patients out, over four years in the, in the phase I portion of the study, average or median treatment duration there going out to 24 months. So, and in the phase I and phase II Cohort A, we had just less than half the patients still on study. So there we think we'll have a really nice update with some additional time on study for these patients to again show continuing safety profile, which has remained very good over the years, as well as then increasing average treatment duration. We think that goes a lot to kind of what the commercial opportunity looks like and the ability of these patients to get, you know, sustained benefit over time on vimseltinib for their TGCT. Got you. What's the length of follow-up we could see? So it depends on the data cut date, so it won't be maybe quite a year, depending on when we present. But it'll be a, you know, a good substantial increase over the prior year's disclosure. Perfect. Thank you so much. Just on the competitive landscape in TGCT, I guess Abbisko keeps on coming up. Just the differentiation of your molecule versus theirs? ... Yeah, so, you know, we sort of monitor the competition. We feel really good about our position. We think, vimseltinib is best in class, and we're much further ahead. So we've obviously got the NDA coming up, and we have a broader, larger development program. We've treated a few hundred patients now with TGCT and have a very well-characterized drug from a safety and efficacy standpoint. And importantly, we've got that in a broad-based international population. Abbisko, for those who don't know, is a Chinese-based company that's got some earlier data. They're currently running later-stage studies, but all their data to date has been in non-Western populations. And so, you know, we have seen in other development programs there can be some variability based on that. So we'll be eager to see as they move forward and mature that data set, how it evolves from a safety and efficacy standpoint, and also how it looks as they potentially broaden it into a larger number of subjects outside of China. Okay. Anything on the preclinical side or mechanism action that- No, there's nothing about it why it would have a particularly differentiated profile better than vimseltinib. That's why, again, ultimately, it's the clinical data, but no, there's nothing in the preclinical profile of note, and that's why, you know, looking at it in a larger patient population, a more diverse patient population, you know, will be key. Again, we feel really good about our position with vimseltinib and our ability to move into the TGCT market with a best-in-class agent and with our highly effective field force that's got this great overlap and call point with these docs. So, we feel good about our clinical profile and our ability to commercialize this in the U.S. very effectively. Gotcha. And the... Abbisko running kind of additional trials. Does that affect the commercialization for you? Does it kind of draw patients into a clinical trial versus commercial drug? No, those were not commercial yet, so it's hard to speak to that. But no, I wouldn't think so. Yeah, the size of these trials and the size of the patient populations aren't such that you think there would be, you know, any kind of reduction in, you know, any kind of material reduction in your sales opportunity for that. And so, no, I wouldn't expect that to be a problem. Gotcha. Okay, perfect. And then how do you view the market? Do you view it, do you grow it beyond pexidartinib, but you steal market share there? What's the dynamics we should think about? Yeah. So pexidartinib being the only approved agent, in the U.S., it was not approved ex-U.S. It's a, it's a challenging drug, pexidartinib. We do get a lot of questions around sort of the total market opportunity that we see versus what PEX is doing today. And PEX has, a black box, and a REMS program attached to it, so it's, it's challenging for patients, it's challenging for doctors to prescribe. You need to be registered in order to be able to do so. Pexidartinib does about $35 million-ish, in the U.S., so nothing approved outside the U.S. What we see, though, is there in our claims data that we've both, done externally and then brought in-house to be able to analyze further, we see 1,400 patients, on an annual basis, seeing oncologists today seeking treatment for TGCT. Those 1,400 patients, though, aren't all receiving pexidartinib. In fact, only half of them are getting any sort of TKI. And so half of the 1,400, at 700, only about 25% of those patients are actually getting pexidartinib today. So when you do that math out of pexidartinib WAC price at that level of patients over their duration of therapy, that gets to their $35 million-ish. Whereas we feel, as Tucker said, with a better, you know, best-in-class, agent and a better, you know, better-tolerated drug, that we have the ability to, you know, switch drugs from pexidartinib. Others are using off-label imatinib. It's not very effective, but it is better tolerated than pexidartinib. And that's only sort of what we see in the claims data that we're currently seeing those medical oncologists that are the overlap that we've been talking about with GIST. That doesn't include, you know, the prevalent pool of patients that we see, patients that are seeing surgical oncologists as well as, you know, our surgeons, and do it using other treatment. And then, of course, there's also the opportunity ex-U.S. as well. There's no agent there. Perfect. Thank you so much. Really enjoyed the conversation. Thank you very much. It was a pleasure.