... How long is it?
Thirty-five.
Thirty-five minutes?
Yeah.
Oh, welcome.
All right, I think we'll get started. Welcome everyone. I'm Dan Kim with the Wells Fargo Biotech Research Team, and really happy to be here with Kiniksa. We have Sanj Patel, CEO and Chairman, John Paolini, Chief Medical Officer, and Ross Moat, Chief Commercial Officer. Thanks for joining. Maybe to start, spend a couple of minutes talking about the Kiniksa story and where things stand today, and then we'll go into more specific questions.
Thanks, Dan. My name's Sanj Patel. I think I'll start. First of all, please note that we will be making forward-looking statements today that are subject to risks and uncertainties. Please refer to our SEC filings for risk factors. So thanks for having me here, first of all, to yourself and the Wells Fargo team, and best to Eva, and congratulations are here in order for her, so that's great. Yeah, so Kiniksa is very much a growth-oriented company. We are massively focused on value creation, and the company has only been around for just over nine, nine and a half years. But since that time, since starting essentially with a blank, blank piece of paper, we have developed now a commercialized product called ARCALYST, which is doing rather well.
Just over four years now since the launch of that product, and what you'll see is that has grown tremendously over the last four and a half years. In fact, just recently, we reported our Q2 earnings, and during our last guidance, and basically, it showed we had $156.8 million in revenue in Q2, and we, in fact, reguided, for the year, saying that now we'll be somewhere between $625 and $640 million for the full year in 2025. So clearly, four years plus out, we've got a tremendous trajectory, but there's an awful lot more still to be done in ARCALYST and as Ross, I'm sure will talk about, our commercialization efforts are really just beginning. And we're looking forward to really expanding into that market.
We have said most recently that our penetration is around only 15% so far into the target patient population of multiple recurrences. We've got a lot to do there, and we're very excited about that and continuing that effort. On top of that, we have a very strong development pipeline. We're very excited about KPL-387. This is potentially a monthly liquid formulation, potential for an auto-injector, also targeted at recurrent pericarditis. This program Phase 2/Phase 3 study. we are recruiting Phase 2/Phase 3 study, and we look forward to having data Phase 2 portion in the second half of next year. We have said that we expect to be on the market with that product in the 2028-2029 timeframe.
Beyond that, we have additional development programs. 1161 is a potentially quarterly antibody that's focused also, targeting IL-1 alpha and beta. So there's an awful lot going on, but it's also a lot of excitement with the company, and again, very much focused on value creation. So excited to be here and talk about it.
Very nice. So maybe provide an overview of the ARCALYST launch so far. You know, talk about the latest Q2 update, and what are sort of the buckets of growth for ARCALYST in, let's say, next, say, twelve to eighteen months?
Yeah, maybe I'll ask Ross to jump in, but we've only just been launched since April of 2021, so I know we both, Ross and I, agree there's an awful lot more to do there with ARCALYST, but it's been a tremendous growth so far.
Yeah. Thank you, Sanj, and thanks, Dan. It's been a good story so far. We launched in Q2, first day of Q2 in 2021, as the first and only approved therapy in recurrent pericarditis, and achieved, you know, a very broad label with the FDA, which for recurrent pericarditis, agnostic to the number of flares patients have suffered from, at the time of being eligible for ARCALYST or consideration for ARCALYST. So since the time of launch, things have grown pretty nicely, and as Sanj said earlier, in Q2 of this year, we were at $156.8 million in net revenue, and we increased our guidance for full year 2025 from $590 million to $605 million, up to $625 million-$640 million.
So you can see that we've grown pretty nicely throughout the last four or so years. But very much to Sanj's point, we're around 15% penetrated into the two-plus recurrence group. That's a group of 14 thousand patients, which is really our target group, if you like. They're the patients that have suffered the highest burden of the disease. They've had the disease for the longest. We think there's a very clear call to action. It's very closely associated with the patient population in the Phase 3 RHAPSODY study. But on top of that, there's also patients earlier on in the disease on their first recurrence. So it's still recurrent pericarditis patients, still covered within the label, and what we have seen over time is that more and more patients within that group are getting prescribed ARCALYST as well.
In fact, out of all of the patients that are prescribed ARCALYST or are actively on ARCALYST at the end of Q2, about 20% of those patients were prescribed it when they were on their first recurrence, and around 80% are two or more recurrences, so we're pleased that as physicians get more and more experience with both ARCALYST but also with the understanding and education, the recurrent pericarditis, I think, is becoming more and more understood as a disease which is mediated by interleukin-1 alpha and beta, and really, you know, focusing on those two key cytokines, as ARCALYST does, is the way to address this population.
In fact, in the ACC Concise Clinical Guidance fairly recently, they also, you know, shared information and guidance out there to the cardiovascular community that addressing the autoinflammatory phenotype of recurrent pericarditis with interleukin-1 alpha and beta prior to corticosteroids, which in the past was all the... how physicians really dealt with this disease through lack of really having anything else, is the thing to focus on. So it's very much kind of establishing what we've been trying to say since the time of launch and really ramping up the education. Now, since launch, we've seen that the prescriber base has increased substantially and continues to do so at quite a rapid clip up until the end of Q2, which is our last reported.
In fact, in Q2 of this year, we had the highest number of patient enrollments, new patient enrollments prescribed ARCALYST, ever, since the time of our launch. And the number of prescribers were greater. An additional prescribers within that quarter were more than three hundred, taking our total prescriber count to more than three thousand four hundred and seventy-five. So, you know, being at this stage of the launch for four-plus years, out from the launch, being at 15% penetrated, seeing the prescribing group grow very nicely, just goes to show that there is a significant opportunity left. We feel like we're still very much in the infancy of what we want to try to achieve, for this disease and the number of patients involved.
Awesome. So double clicking on the prescriber base, you know, there was a significant expansion in Q2 relative to Q1. What were some of the drivers for that, and how should we think about growth in the prescriber base going forward?
Yeah. Thank you. So it's really to do with education and the understanding that across the U.S., the way that recurrent pericarditis patients generally go into the healthcare system is through a wide range of cardiologists or sometimes rheumatologists. So the patient group is pretty widely dispersed. Having said that, there has been, more recently, an advent, and in part through our support, through initiatives, for example, with the American Heart Association's Addressing Recurrent Pericarditis initiative, of more centers of excellence or pericardial disease centers, people that are really focusing on how to treat this disease and kind of leading the way in the treatment to try to get patients diagnosed earlier. Because one thing we do see in this disease space is that patients often get underdiagnosed and misdiagnosed.
In fact, on average, they receive 2.7 misdiagnoses before they get to the recurrent pericarditis diagnosis. So that kind of advent of key centers is potentially important for the future and is more of a, you know, a change in landscape type of approach, which could benefit patients in the future.
But to go back kind of historically, we've really been focusing on trying to understand where the patients enter into the healthcare system, which physicians they go to see, and educating those physicians around the disease and trying to separate it from just seeing it as another pericarditis, you know, flare or episode, and actually seeing this as a distinct disease of recurrent pericarditis, addressing it differently to what they would have used in the first index episode, of just NSAIDs and colchicine, and utilizing the ACC guidance now around using interleukin-1 alpha and beta, for those patients. And, you know, given the ... You know, there are 30,000 or so cardiologists and rheumatologists around the country, and we've got, you know, 3,475 or so that have prescribed ARCALYST launch date.
Again, goes to show the work that we've got ahead, but it's more education. It's being very focused on our field team for the strategy that we have and the targeting that they have and the reach and frequency of educating physicians. We're also very focused on a digital approach, so we can go, you know, far and wide and educate through different channels and different means. We have been focusing on AI and how that can help us to kind of work much smarter in approaching the marketplace. We focus on not only healthcare professional education, but patient education and patient community supports through the patient advocacy groups that look after recurrent pericarditis, so it's really a multifaceted approach to our whole commercialization.
Great. So, you know, there was a patient bolus reported earlier in the year. I think it was related to Medicare Part D. How should we think about Medicare Part D as a variable for the remainder of the year? You know, is this bolus of patients still on treatment, and should we expect their ARCALYST usage to be any different from, you know, the rest of patients on drugs?
Yes. Thank you. So it's something that we did speak about in the, I think, our Q1 earnings call as well. Mentioned it a little bit at the Q2 earnings call as well. With the change in landscape around the Inflation Reduction Act and the impact that's had upon the Medicare Part D patients, ultimately, you know, being in a situation where historically, as a manufacturer, we cannot support the buying down the copay for Medicare Part D patients.
So there were some patients that were not able to afford, since the time of our launch through to, you know, January 1 of this year, they couldn't afford the copays to go onto therapy, and we have, you know, a PAP program, a patient assistance program, where we provide free goods to eligible patients to try and make sure that they get onto treatment. Now, with the changes at the start of this year associated with the Inflation Reduction Act, that put into place a cap to the copays, the annual copays for Medicare Part D patients, made it much more affordable for patients to be on therapy.
There was a bolus of patients that switched over from free goods at the end of last year to paid therapy at the beginning of this year, and that provided some tailwind into the year on the kind of commercial side, I guess. Now, while that was a one-time bolus, and that will not repeat, that was a kind of a federal, you know, change in policy. What we have seen, you know, more recently or since that is the Medicare Part D patients have gone on to commercial therapy at a higher rate than what we've seen historically. So that's also kind of provided some help where those patients can kind of get straight through onto commercial therapy now.
So we're pleased to have seen that. But the bolus has happened. That was only, you know, one time at the start of this year. Now, as things progress throughout the rest of the year, the way that the Medicare Part D copays work is that it's capped at $2,000 for each individual patient through the year. That can be spread on a monthly basis. So through the rest of the year, as each month goes by, you know, if they choose to spread the payments, obviously the payments go up. So it could be a case that, you know, theoretically, the patients, those patients may not, you know, be able to afford it, and as the copays kind of go up through the year, even though it's capped at $2,000.
But on the other side of that, you know, patients may be on many other therapies, and this is not a $2,000 limit for one therapy. It's across the board of all their medications. So if they've already hit the cap, then they'll have zero extra payments to make through the rest of the month. So it's. You know, time will tell how all of that, those kind of dynamics, shape out.
Makes sense. So can you provide a bit more color on the average total duration of ARCALYST? In the latest update, you know, you mentioned an average of thirty months total duration. What's driving the increase? How often do patients restart treatment? And, you know, based on natural history studies, how much more upside is there on treatment duration?
Yeah, maybe I'll address that one as well. So, what we're seeing in the commercial setting since the time of launch, and we've updated this periodically as we just see the data evolve over time as more and more patients are on for longer periods of therapy is that at the end of Q2 of this year, the average treatment duration was 30 months in totality across aggregated from all of the patient groups. That's broken down into the average time for the first treatment instance is around 17 months.
And then what happens, and what we've seen very clearly from the clinical side, is when patients go off therapy or trial stop, if the underlying disease is still active and the autoinflammation is still ongoing, symptomology comes back pretty quickly. So patients generally restart if symptomology comes back quite rapidly within the first eight weeks usually of a cessation, which makes sense given the washout time of the drug and how active the disease can be. And around 45% of all patients that stop therapy after the average of 17 months go back onto therapy, but of course, some patients just stay on continuously for much longer. And that's what gets you to the 30 months as the average duration of therapy that we've seen so far.
Now, the natural history shows us that the patients that have had two or more recurrences of recurrent pericarditis patients have a median of three years of disease duration, but those patients often go out much longer. And there is, you know, five years around a third of the patients are still suffering from the disease, and at eight years, a quarter of the patients are still suffering from the disease. So we know that this is a multi-year chronic disease. Now, whether the commercial setting and that thirty months that I talked about will continue to grow, and we will see over time as the data builds and evolves, but that's certainly the picture from the natural history.
And it's probably worth noting as well that that natural history data and the three months is the median. Sorry, the three years is the median. We don't know what the average is because that particular data set stops at eight years. So it, it's an evolving picture, we continue to report it as we see.
Got it. So, you know, how are you thinking about patients in first recurrence and, you know, how much upside are you expecting from these patients? What's going to be your strategy to tackle this patient population?
So we promote ARCALYST for recurrent pericarditis. We promote it very much to the label, which is broad, as I said earlier, is agnostic to the number of recurrences a patient has suffered from. It makes sense that, you know, earlier on in the launch, towards the beginning of the launch, a lot of the patients were in the two-plus recurrences. Some of the most severe patients have been suffering for the longest. And that picture has evolved a little bit over time, with more and more patients being treated earlier on in the disease. And I think some of that comes down to increased familiarity. I think one thing to bear in mind is that cardiologists have historically not had the best prescribing experience with biologics.
And through, you know, the limited experiences that they've had in this realm in the past, in other disease cardiovascular disease spaces, often is met with payer hurdles, declines, rejections, having to do appeals and various other things. So you're working against a backdrop that's not particularly positive over prescribing a biologic. So this is different in terms of it's a rare disease space. Obviously, the efficacy and the safety results are very robust. The payer approval rates are very high, greater than 90%. And payers generally, you know, appreciate the value proposition that's brought by ARCALYST. So over time, as physicians have had more and more experience, they understand how to prescribe the drug. They see their patients get onto drug.
The patients report back, you know, generally speaking, very positive outcomes of being on the drug. The compliance is very good. The duration has been growing since the time of launch. So that's a positive feedback cycle that physicians are kind of getting from their patients and how well they're being looked after on ARCALYST, and that goes into encouraging them not only to identify and prescribe for future patients, but also to maybe use earlier on in the disease course, having more confidence in how to do that, also around peer-to-peer education of the success that they're having. So all of these elements are very important, and, you know, we think the opportunity here is very significant.
In totality, there's 40,000 patients in any given year suffering from recurrent pericarditis, and as we said, around the 15% penetration number that we've said, that's just for the two-plus recurrence group, so we've got a lot more work to do, but we've been making reasonable progress so far.
Got it. Maybe one more question on ARCALYST before moving to 387 and 1161. So, you know, what's the rationale for ARCALYST in cardiac sarcoidosis? You know, what do you hope to learn from your collaboration with Mayo Clinic and Hopkins? And, you know, could this serve as a proof of concept for your other pipeline programs?
Yeah, thanks for the question. So as you know, cardiac sarcoidosis is an inflammatory disease of the myocardium. And so, you know, we've been very interested in, you know, cardiac inflammation, and we started with the pericardium, but we have great interest in inflammation of the myocardium as well, the heart muscle. And so cardiac sarcoidosis is one of those important diseases. And there has already been some early information that blockade of the IL-1 pathway could reduce inflammation in this disease, which is, you know, which is quite debilitating. So we're very excited to be working with the Mayo Clinic and with Johns Hopkins on this clinical trial that actually looking at myocardial inflammation directly with PET/CT imaging.
And so the idea is to take patients who have cardiac sarcoidosis that is refractory to other therapies, and they have, you know, their myocardium is lighting up with inflammation, and to see if treatment with rilonacept, ARCALYST, would decrease that inflammation. So that's a very exciting study over six months, led by, and we're happy to collaborate with Mayo and Hopkins on that. And I think it would provide important information, you know, not only about the management of that disease, but also by helping us understand myocardial inflammation more help us, you know, kind of understand general approaches to myocardial inflammation more broadly.
And, you know, hopefully that, you know, is something that we'll learn from and be able to do better for patients.
Thanks. Maybe shifting gears to three eighty-seven. You know, you recently announced this new program in development for recurrent pericarditis. How should we think about differentiation from ARCALYST?
You want to start?
Yeah. Yeah, I mean, look, we're very excited about the program. It's obviously potentially a monthly liquid formulation with potential for an auto-injector. So obviously that is an important, exciting potential treatment option for patients. Obviously, the data will be the data, so we're excited to see that in the second half of next year. But certainly, as far as, you know, there's potential there for potentially more convenient dosing. Obviously, we're very excited to see the efficacy and the safety of that program.
But I do think, you know, and maybe Ross can talk a little bit about the market research that we've just released as part of an SEC filing just yesterday, which show that there really does seem to be interest in both physicians and patients and healthcare providers for a potential target, you know, profile as KPL-387. I think that's quite exciting, but maybe, Ross, you want to elaborate? Yeah, there was some research that we put on the corporate deck as well, on one of the slides around KPL-387, and ultimately testing the target product profile that we aim for, for KPL-387, which is a highly efficacious potential monthly formulation in an auto-injector.
Ultimately, what that market research showed us is that firstly, the physicians, the vast majority of physicians believe that the introduction of KPL-387 into the market would expand the use of interleukin-1 alpha and beta across the recurrent pericarditis population and expand the market, the addressable market, if you like. Additionally, when you break it down into both healthcare professional and patient viewpoints on the target profile of KPL-387, around 75% of patients, when they look at the target profile of KPL-387, commercially available drug and other clinical programs that are in the public domain, they greatly preferred and favored the KPL-387 profile.
Around 70% of those patients also said that the utilization of KPL-387, if indeed it comes through the clinical trials and makes it onto market, would aid them in a longer duration of treatments, being a monthly auto-injector drug, as well as fewer missed doses and better compliance. So that was really the highlights, I guess, of the patient feedback. Then the healthcare professional feedback was that 92% of healthcare professionals said that they are highly likely to prescribe the profile of KPL-387 as their treatment for recurrent pericarditis, if indeed the target product profile is hit. That's for new patients.
Then additionally, for existing patients that are on other therapies, that they were willing to look at a transition from other therapies onto KPL-387, particularly if the patient requested or desired a change to the type of profile of KPL-387. Maybe that links to the clinical study that we also announced yesterday for KPL-387 as a transition program.
... So do you want to maybe talk a little bit about the, you know, where we are in the program and what the development program looks like?
Absolutely. Sure. Yeah. So this as we were discussing that KPL-387 is a monoclonal antibody inhibitor, the IL-1 R1, so it binds to IL-1 R1, so the receptor. And so prevents binding of both alpha and beta, IL-1 alpha and beta, blocks signal propagation. And so in that sense, provides a mechanism for long-term control of the pathway. We've worked our way through the phase 1 study and have demonstrated that subcutaneous administration of the 300 milligram dose stays above the target concentration that we believe is important for efficacy for, you know, 57 days.
And that sets up, you know, the concept of potential monthly dosing. And so that's what we're testing currently Phase 2 program that we've announced previously, which is a dose-focusing study, where we're testing a number of different dosing regimens with KPL-387 to affirm whether or not and confirm, you know, whether this monthly dosing profile, you know, would move forward. The centerpiece of the program, though, is the pivotal clinical trial, so the Phase 3 clinical trial, which is a randomized withdrawal clinical trial that draws many of the parallels from the prior experience that we've had from RHAPSODY, which was, you know, highly successful scientifically.
And so we've built upon that, you know, to, let's say, modernize that into the, you know, into the current era and to optimize outcomes for, you know, a once-monthly drug. In addition to provide kind of a totality of the dosing experience, since those first two trials are focused on patient, you know, initiation of the drug, you know, in a novel setting, you know, whether in patients who are failing NSAIDs, colchicine, corticosteroids, depending on the study and the mixture. We wanted to make sure that we have data for the totality of the potential clinical situations where one would initiate drug.
And so, of course, the other thing is to look at how patients could transition to KPL-387 monotherapy from existing therapies, whether it's NSAIDs, colchicine, corticosteroids, rilonacept, anakinra, you know, whatever that is, to work through the mechanics of dosing and administration. Then the final piece of the package, of course, are the long-term extensions, and of which there are three from each of the different trial elements. And that provides the long-term safety information that's so critical, you know, for the program, because, as Ross mentioned, you know, the goal is to treat patients for the duration of the disease and to provide them continuous treatment over the long term.
And so that kind of long-term safety data, similar to the kind of data that we generated with the prior program, you know, will ultimately come together into... It's designed to come together in a total package. So that's the totality of the development program. And in terms of some of the more granular aspects, we anticipate data Phase 2 dose-focusing portion in the second half of 2026. And as Sanj just mentioned, we aim to be on the market in the 2028-2029 time frame.
So sorry, that was a lot, but I figured that it's a comprehensive package, and that's our approach to generating the kind of data that brings confidence to patients and physicians.
Yeah, I do think it's important to know that the Phase 2/ Phase 3 portion is really the, the registrational part, and this transition to KPL-387 monotherapy study is really more of a sort of study that will help physicians. Yeah. And patients help as when the drug's hopefully on the market. But it's really the Phase 2/ Phase 3 that are the core registrational study.
Very nice. So can you maybe walk us through sort of PK/PD data available so far for three eighty-seven, and, you know, was the safety consistent with expectations for an IL-1 receptor inhibitor?
Sure. So a little bit on the on the PK. So that's the Phase 1 program.
So we began the program from the beginning with the understanding that, you know, a meaningful therapy for patients that we were trying to develop to, you know, maintain and extend our leadership in the space, was about subcutaneous dosing and monthly administration. And so we tuned the study to that. So the backbone of the dose escalation was built around subcutaneous administration. We were focused on the 300 milligram dose level as the likely monthly dose, but we, of course, you know, went higher than that in order to provide safety, you know, exposure coverage. And then we also ran a parallel arm with intravenous administration. We went up to a gram intravenous in order to provide, you know, again, much higher headroom and much longer durations of therapy.
In addition, we had a multiple ascending dose mechanism, which involved you know, treating for 12 weeks in healthy volunteers. So that's a fairly substantial package in over 100 patients. And we've shared some of those data on our website primarily focusing on the 300 mg dose level subcutaneous, which is the one of greatest interest. And in those healthy volunteers, as I mentioned, it sits above what we believe to be the target plasma or serum concentration. It sits above that for you know, for 57 days. So if you think about monthly administration being essentially every 28 days, that provides a reasonable buffer of coverage to enable you know, monthly dosing in Phase 2 setting.
In terms of safety and tolerability, you know, this is a mechanism which is, you know, highly well-studied for, you know, almost twenty years now. And so it's understood that targeted inhibition of the IL-1 pathway provides really selective and targeted immunomodulation, which is really substantially different from broad immunosuppression. And so when we think about the safety profile that we've seen with this mechanism as a whole, you know, what you get is injection site reactions that you would expect from, you know, an injectable biologic. And then, you know, in terms of the infectious disease profile, it's a modest increase in upper respiratory tract infections. So that's the history and the backdrop. What we've seen in the Phase 1 study, we haven't shared, you know, a lot of data other than to say...
You know, we, of course, share it with the regulatory authorities, but, in the public domain, to say that it's been well-tolerated and that the safety profile is consistent with what we've seen with IL-1 inhibition in the past.
... Makes sense. So, you know, can you maybe touch on what other indications would make the most sense for three eighty-seven, based on the mechanism and, you know, the Phase 1 data available?
Yes, John, what would that be?
So, you know, we're obviously. There's incredible power that comes from, you know, if KPL-387 is successful for robust blockade of the IL-1 pathway delivered, you know, over monthly therapy. And so as we've talked about why that's so important in recurrent pericarditis, because of the long duration of the disease and thinking about this as treating for a disease duration rather than treating individual flares. So that really unlocks, you know, potential in other autoinflammatory diseases of, you know, long duration. And so, without going into any great specifics, you know, we're, you know, really thinking about it with that lens of how we can make life better for patients who are suffering from chronic, you know, autoinflammatory diseases.
We obviously have an interest in the cardiac side of things, you know, predominantly, but, you know, we're always open to thinking about, you know, where we can make lives better for patients. I don't know, Sanj, do you want to say more than that?
No, I think that's right. I think we also, in regards to 1161-
Yeah
-which is a potentially quarterly IL-1 alpha and beta inhibitor. I mean, that's certainly an area, that molecule, that we certainly are looking very, very closely at where would the indication be. You know, and, and it's not obvious that it would be RP, and there are certainly other ways of blocking the IL-1 mechanism that I think we're focused on. So I would just say watch this space, but we're giving it a lot of thought. And certainly, the work that we're doing with Hopkins and on cardiac sarcoidosis is going to be important. And there's other external proofs of validation that are, that are going on with other partners that are working in this space. We'll be watching very carefully. So, you know, being a fast mover is not always a bad thing when it comes to the quarterly molecule.
You mentioned 1161 , which is in early development. So, you know, what are the benefits of an Fc modified IL-1 antagonist versus just an IL- 1 antagonist? And, you know, what's the target dose profile for that program?
Sure. So a little bit about 1161. So it also targets the IL-1 receptor. So in that sense blocks signaling of both IL-1 alpha and IL-1 beta. With it, the concept of, as you mentioned, Fc modification, is really about how monoclonal antibodies are cleared, you know, from the body. And so what that does is it alters the clearance rate so that these drugs can actually stay in circulation, you know, for longer, and thus you get, you know, potentially longer durations of action. So the target profile is, you know, to enable potentially quarterly dosing.
The reason why that could be, you know, important is, as you think about, you know, some diseases that might be either genetically based or might be lifelong, you know, the idea of quarterly dosing, you know, is very appealing when it comes to a profile that, you know, is good for patients who are trying to control their disease over, you know, even potentially longer durations. As Sanj mentioned, you know, our thought process is wide open, if you will, as we look at, you know, many of the different literature precedents in the space about where IL-1 is involved in certain of these autoinflammatory diseases, but you know, we're...
As you said, watch this space, 'cause we continue that work, but we are moving 1161 forward in its preclinical space, and doing IND-enabling studies at this time.
All right, we're about to hit time, but maybe one last question. Big picture, you know, previously, you shared that you expect to remain cash flow positive on an annual basis. How are you thinking about balancing this with pursuing the new indication opportunities for, you know, 387 and 1161?
Yeah, I mean, I think as Mark would say, our CFO, you know, certainly our intention is to be cash flow positive on an annual basis. That includes our development programs as well as our efforts on the commercialization. You know, the ARCALYST has done very well. The cash flow has been very solid and, you know, we continue to crack on and execute, and we're very, very mindful of our capital allocation, and I think it's just hopefully going to get better from here on.
Awesome. Well, Sanj, John, Ross, thanks so much for joining us today.
Smashing. Thank you.
Thank you very much.