Thank you. Good morning, everyone. I'm Paul Choi. I'm a biotech analyst here at Goldman Sachs. It's my pleasure to welcome Kiniksa for our first session this morning on the second day of the conference. I'm required to read off certain disclosures which will primarily relate to investment banking relationships that Goldman Sachs may have with firms, companies presenting here at the conference. These relationships include investment banking, 1% or more ownership, and other relationships. These relationships are available through our disclosures available on our research portal website, available to you as clients of the firm. I'm prepared to read them out loud. However, they are, again, available on our research portal. With that, we'll continue. With Kiniksa, to my immediate left is Ross Moat, Head of Commercial, and my far left, John Paolini, Chief Medical Officer.
Maybe what we'll do is, either let Ross or John maybe kick it off a little bit with an overview of Kiniksa, just sort of where the company's background and sort of core, core focus is, and then we'll get into some more substantive Q&A after that.
Wonderful. Yeah, I'm happy to do that. Thank you very much for hosting us today, Paul, and the Goldman Sachs team. We're happy to be here. We will be providing some forward-looking statements today, which are subject to risks and uncertainties, full copies of which can be seen in our SEC filings and on our webpage. I'm here joined with Dr. John Paolini, our Chief Medical Officer. I'm Ross Mangano, the Chief Commercial Officer. Maybe just to provide a quick, you know, corporate overview to begin with, as you know, Paul, we are a growth-orientated, well-capitalized organization. We are focused on addressing unmet needs, particularly within the cardiovascular space. We're a commercial-stage organization with a good portfolio in the clinical stages as well. ARCALYST, which was approved in 2021, has been growing nicely since the time of our launch.
In 2025, in fact, our Q1 earnings call this year, we increased our revenue guidance for this year to between $590 million and $605 million. So ARCALYST is really performing pretty well so far, but we're very excited about the opportunity we have ahead, and I'm sure we'll go into more details in the subsequent questions. We also have an advancing clinical portfolio. In particular, a fairly recent announcement of just last week is with KPL-387, which is into the clinic in recurrent pericarditis. This is a monoclonal antibody, which has the potential for a liquid formulation, potential for an autoinjector, and potentially to be a monthly preparation. An exciting new treatment for recurrent pericarditis patients.
and that's initiating in a phase 2/3 clinical study in the mid-2025 timeframe, with data readout for the phase 2 portion of that study in the second half of 2026. We're pleased with how that's advancing. We also have KPL-1161, which is an even longer acting, interleukin-1 alpha beta inhibitor, and again, a monoclonal antibody, which has undisclosed indications so far, but we're advancing that in through IND-enabling studies. With that, maybe I'm happy to take a pause and we go into the questions that you have.
Sure. Sounds good, Ross. Maybe talking a little bit about the last quarter and maybe the interquarter trends to date here. One of the things you noted on the first quarter earnings call was the impact of the Medicare Part D redesign, excuse me.
Some other companies have commented on this, that this has been a tailwind for their franchise. Seems to have had a similar effect on yours. Can you maybe just talk about, you know, how has this helped in the ARCALYST, Medicare-eligible population? Are they going through their coverage and donut holes quicker than they have in the past? Any just sort of comments or color there would be helpful.
Yeah, thank you. Yes, we did talk about that a little bit at the Q1 earnings call, and that's really associated with the IRA and the Medicare Part D redesign associated with that, which essentially increased the affordability for patients, for Medicare Part D patients, with a cap on the co-pays, an annual cap of $2,000, and the ability to spread the costs throughout the year as well. We did note that Q1 had pretty significant growth versus Q4 of last year, and that was driven really by three key factors. One was an increase in prescriber base. We saw, you know, an increase in around 300 prescribers, new prescribers to ARCALYST in recurrent pericarditis, taking our total to around 3,150 or more. That was actually one of the largest growths that we've had, quarter to date.
Given the fact we've been on the market for four years, I think shows the trajectory that we're on, and what we still have left to do. That was kind of one lever. Another lever was increased durations of therapy, which we saw grow from an average of around 27 months to now an average of around 30 months, in total average duration of therapy on ARCALYST. Thirdly, as you mentioned, the Medicare Part D redesign did enable, you know, a kind of a one-time bolus of patients who were previously on free goods. Obviously, they've had treatment already before switching over onto commercial drugs. It's not as if they are necessarily new patients, or in the main, they're not new patients to ARCALYST, but they transitioned across from free goods to commercial.
and that's associated with the redesign and the increased affordability for those patients to go onto commercial therapy. We were pleased with that and thought it added, you know, meaningfully to the Q1 numbers. Quite how that plays out through the rest of the year is somewhat uncertain. As I say, these patients.
The first year of the redesign, so.
It's the first year of the redesign.
Absolutely. You know, there is a grace period for these patients. There are, you know, levers for whether these patients kind of pay their bills or not with their payers under this new, this new redesign. I think one element is those patients that transitioned across, will they act like kind of other patient cohorts that we see or not? In time, we'll tell on that one. Additionally, for new patients coming into the funnel, the Medicare Part D patients, again, we need to see how that kind of plays out under this new, new program where the co-pay, you know, will be a maximum of $2,000 regardless of when they start throughout the year.
Obviously, as you get further through the year, if they're spreading their costs evenly over the remaining months of the year, the monthly payments kind of ramp up as.
As the year goes on. Having said that, these patients may also be on other therapies, and remember, this cap covers all of their Medicare Part D patients.
Yeah, on that.
There's, there's some kind of uncertainties there that we'll have to see how it plays out.
Yeah. I think one of the questions is, is that because of the lower $2,000 cap, whether there's just been a pull forward of that, I think, in the front half of the year, and now patients are just paying their minimal co-pay on the forward here for both your drug and other drugs. I'm also curious, as you think about, you talked a little bit about the increase in duration, but has there been any other observable changes in patient behavior, you know, over the last, call it, 12 months, in terms of, beyond duration, any, you know, time to restarts and things like that, and people coming on, off drug, but then on drug, what, quicker? Any color there you can provide on patient behavior?
Yeah, thank you. I think there have been certainly changes and things have evolved over time. I think not least just the fact that, you know, since ARCALYST being on the market, I think the viewpoint of both, from both healthcare professionals and patients has been changing towards this disease, primarily, you know, understanding it in greater detail as a, as a generally a multi-year chronic disease for most patients. And we, I think we've seen that, you know, kind of play through in the treatment duration of ARCALYST as well. The total duration of treatment has been growing quite rapidly, really, since the time of our launch. If you remember, in the early days, we anticipated that maybe, you know, the duration would be 6-9 months, and it kind of grew to 12 months, 18 months. Now we're at 30 months.
As an average total treatment duration. The initial treatment period has grown somewhat as well. The median for the initial treatment period is around 17 months now. The restart rate is still about the same. It's been around 45% of all patients who stop therapy do come back onto therapy. Those patients generally come back on within around an eight-week timeframe.
Which makes sense when you think about the washout period and the pharmacodynamics of the drug. If you still have underlying autoinflammation ongoing and you withdraw the drug, which is helping to prevent recurrences, it would make sense that within around an eight-week time period is when patients, you know, start to suffer symptomatology again if there is underlying autoinflammation ongoing. The good news is they can go back onto drug, you know, very, very easily usually. Usually, there's a payer approval in place. Often, the patient has drug on hand, or they just get their next fill, and can go back onto therapy. What we are starting to see is that as patients come back onto therapy, now we've got patients, you know, we're four years out from launch. We've got patients who have stopped and started multiple times now.
So we, rather than providing, you know, precise information on all of those kind of restarts and so on, we just aggregate it up as a total duration of therapy, taking out all the stop time periods.
Mm-hmm.
That's what gets you to around the 30 months.
Great. I'm also curious, you talked about the prescriber base last quarter as well. Just where is this traction coming from? Is it still primarily in cardiology-focused academic centers, or is it more in the community practice? I'm just curious how the blend of prescribers has evolved over time as well.
Yeah, so it's continued to grow very well. So we've got more than 3,150 total prescribers now. Out of that group, we've got around 26% or around 820 prescribers who have written for two or more patients. So that's continued to grow kind of really pretty nicely every single quarter since launch. And when you overlay that, sorry, excuse me, when you overlay that with the total number of potential prescribers that are out there, you know, there's around 25,000 cardiologists and.
Mm-hmm.
More rheumatologists as well. It shows that there's still an awful lot of people that could be switched onto prescribing. Bear in mind that these patients are, you know, pretty widely spread throughout the U.S., and there has been, you know, somewhat of a change in the treatment landscape with the evolution of more centers of excellence popping up, really taking a keen interest in pericardial diseases per se. That's kind of maybe increased some throughput at those centers. Generally, patients are pretty widely spread, so there's a lot more physicians to.
Okay.
To switch on for this disease.
You mentioned what you think the prescriber base is of about roughly 25,000 physicians out there. I guess just where are you in terms of, apologies for the sports metaphor, but what inning are you in in terms of targeting that and at least hitting your call points at least once with that sort of initial target base of prescribers? You talked about, you know, 3,000+ already writing scripts, but just in terms of at least hitting the call points, where are you now?
Yeah, thank you. We just haven't provided much of the details around the metrics of our kind of commercial team and the call points and call rates and that type of thing. Maybe suffice to say that we are, you know, incredibly targeted and well-disciplined as an organization. We spent an awful lot of time, in fact, prior to the launch, and of course, we've learned a huge amount since launch as well, to really understand the nuances of where patients present, which physicians, whether it's cardiologists, rheumatologists, and how that interlink works, and really kind of mapping where we believe the patients are.
We have done a lot of work to make sure that we are very well targeted from both our field force perspective and where we cover and what our call rate needs to be on the highest deciles, if you like.
Mm-hmm.
Of doctors that are out there, but also working very smartly with the kind of the long tail of physicians who may only see, I don't know, call it one patient per year. It is still very important to reach those doctors. We find ways of doing that. If it is not through the field team, we focus very much on digital marketing and NPP type of promotion, non-personal promotion, to make sure we get messages out to as many people as we possibly can.
Yep. I'll let you get a sip. In the meantime, my question is, you've talked about this duration of treatment increasing continually as the drug has been on the marketplace, to what seems to be more like a maintenance treatment. I'm just curious, how is ARCALYST thought of as an acute treatment versus steroids, let's say, in the emergency room or cardiologist's office? Is it resonating 'cause it's symptomatic relief and that's what's driving the maintenance, or just maybe help us understand how the patients are continuing to stay on drug here?
Yeah, it's a really great question. It's one of the key things that we've been focused on since the time of our launch in that, historically, I think recurrent pericarditis was seen as kind of different individual flares, and physicians would be focused on treating the individual flares of the disease. I think the mindset is now, and as the data has evolved, has really now come through to an understanding that this is a chronic multi-year disease in most patients, and particularly for those patients that suffer two or more incidences, then the disease is a median of three years. A third of the patients are still suffering after five years. A quarter of the patients are still suffering after eight years. This disease really persists substantially for many, many patients.
Now, physicians were used to really try the individual flares and kind of improve symptoms associated with the disease. NSAIDs and colchicine have always been a mainstay, particularly of an index episode of pericarditis. As it gets through to, for those patients that continue to suffer recurrent pericarditis, often corticosteroids were utilized. Often, you know, knowing the corticosteroids with the toxicity effects and it being incredibly difficult to take patients off steroids without them reflaring again, and even elongating the disease, there's now been, you know, more of a movement to, okay, this is a multi-year disease, and ARCALYST has been designed to be treated throughout the duration of the disease. It has really two key parts to the label. One is dramatic relief and the pain improvement and the reduction of inflammation markers.
But very, very importantly, and what we hear is actually, you know, one of the most important things for both physicians and, and particularly for patients is the prevention of future recurrences.
These patients are often terrified of suffering future recurrences, not knowing when it's gonna happen, not knowing, you know, how the cadence and the severity of future recurrences, you know, really limiting their ability to travel, their ability to do things that they may, may want to be doing. That quality of life element has been very important to patients. I think that's really where ARCALYST fits in very nicely, that it is used for the treatment for the prevention of future or the reduction of the risk of future recurrences happening for these patients. With the knowledge that this is a multi-year disease, the fact that ARCALYST has now been used as an average for 30 months, I think bodes well. There are still questions of, you know, when do you, when do you stop treatments?
That is somewhat of a, you know, kind of informed by baseline characteristics, but also is a little bit of trial and error of not.
Mm-hmm.
Fully knowing or having a very robust way to understand whether the patient is through the disease or not. Sometimes when physicians and patients decide to trial a stop of ARCALYST, it's thinking that hopefully they're through the disease, but you don't really fully know until you stop therapy, you withdraw ARCALYST, and you see whether the patient flares again.
Yep. I'm curious, as you gather more data and more patient experiences over the past few years, are patients primarily still going on after two-plus flares or recurrences, or are you starting to see more of the patients come after their first recurrence? Just curious how the sort of patient history or patient mix has evolved.
Yeah, so we've certainly seen more and more patients in NSAIDs come on, on their first recurrence, if you like. So we've stated that we have around, if you take all the recurrent pericarditis patients, and when we've done research with those patients and with the physicians as well to ask what stage were the patients at when they were prescribed ARCALYST, around 15% of all those patients were started when they were on their first recurrence and 85% on two or more recurrences. I think that shows that there's been, you know, ARCALYST, as people become more and more comfortable with it, and it's the only FDA-approved therapy for recurrent pericarditis, more and more people have become very comfortable with prescribing the drug, how to prescribe it, getting patients onto therapy, doing the prior authorization, and so on.
I think that's led to greater confidence of prescribing it earlier on in the disease. I think the incredibly important point is one way of looking at it is how many flares does a patient have. Actually, ARCALYST is the, the label is agnostic to the number of flares.
Mm-hmm.
A patient has suffered. As long as it's recurrent pericarditis, a physician can use it for those patients under the label. Probably the more apt way of looking at it is what line of therapy is ARCALYST prescribed in. Generally, what we've seen in both the literature, which has really been coming out more and more since the time of launch, and in prescriber behavior, is that ARCALYST has now really been used before corticosteroids, I think to an increasing level as people become more and more familiar. Generally, after NSAIDs and colchicine, which are used for an index episode, physicians more and more come into ARCALYST as the next line in therapy.
Okay. One of the things the company has talked about is shifting manufacturing of ARCALYST to a third party, I think Samsung Biologics specifically. Can you maybe walk us through the rationale behind your diversification of sort of manufacturing plans? And then secondly, just given that, you know, policy considerations and foreign manufacturing is so topical these days, just sort of what the potential impact to you from a maybe from a margin perspective, you know, or roughly might be from having a foreign-manufactured ARCALYST?
Yeah, thank you, Paul. This is really something that we've had planned under the license agreement with since the beginning stages with ARCALYST. We, tech transfer was triggered in 2023. We've been working on the technology transfer for some time with Regeneron support. Right now, ARCALYST is manufactured in the United States under Regeneron. That would, you know, if you think about tariffs and so on, obviously, ARCALYST right now would not be subject to any, you know, potential tariffs. Of course, there's uncertainty there of exactly what things, you know, may look like in the future.
As we go through the technology transfer, which is to South Korea, we expect at some point in the future, as drug kind of comes in, of course, not knowing really what the tariffs may look like, if they exist at all, if they're extended to pharmaceuticals or anything in the future. If indeed it is extended to pharmaceuticals and there's a tariff on bringing, you know, drug in from South Korea, we expect that to be immaterial to our gross margins. We import in drug substance from South Korea too.
That's a good example.
To the U.S., not finished product. So we believe that any such tariffs would be likely to be levied on drug substance. We should have an immaterial impact to Kiniksa's margins.
Okay. With the fill and finish still to be done in the U.S.
That's correct.
Okay. Great. I wanna maybe bring John into the conversation and talk a little bit about 387 here. He's been very patient. As you think about 387 and the properties that it has versus ARCALYST, could you maybe compare and contrast sort of the key properties and sort of what you think the incremental benefits might be with 387 as you advance it through the clinic?
Yeah, no, no, thanks for that, Paul, and thanks for having us. Yeah, we're very excited about the KPL-387 program. As Ross had mentioned, that is a monoclonal antibody in a liquid formulation with subcutaneous administration. The prospect, or the possibility of having a single injection with a monthly dosing interval profile, is something that, you know, could provide really a nice option for patients and physicians in the treatment of this disease. I think as we think about that, you know, as Ross mentioned, with the growing understanding of the duration of the disease being, you know, a median of three years, as you start to think about, you know, how patients might wish to treat the disease, having a monthly profile, if we're successful with that, you know, could really be beneficial to them.
I think the way we view this is that physicians and patients should have a range of options available to them, and then each option, if you will, has to present itself and speak for itself in terms of those attributes. We are very excited about this program, which is just starting, scheduled to start in the middle of this year for the phase two-three program that we recently announced. We can go through that.
Great. Apart from a potentially more convenient dosing interval, are there any other properties of 387 that might translate either from an efficacy or a safety perspective at this point?
Right. Certainly, ARCALYST has set the bar, in terms of what a highly efficacious approach to blocking the IL-1 pathway, you know, can do. Again, we point out that it's important to block both IL-1 alpha and IL-1 beta in order to maximize the inhibition of the mechanism, and to make sure that, you know, the kinds of treatment response and reduction in risk of recurrence, you know, to have that maintained. That is a very high bar, if you will. I think, you know, I wouldn't sell short the importance of the dosing interval. I think at this point, it remains to be seen exactly what the efficacy of KPL-387, you know, will be. We're certainly well-positioned to do the appropriate testing and experiments in order to see what kind of efficacy and safety profile KPL-387 will bring.
At this point, I think, you know, we know what that profile would need to look like in order for it to be successful for patients.
You recently laid out in a press release the sort of tri-trial parameters, and maybe you could remind the audience of how you're thinking about advancing it through the clinic, sort of what key metrics matter from a trial design and pivotal endpoint perspective.
Sure. No, thanks for that. Yeah, so we've previously mentioned that our phase one data that had shown that subcutaneous dosing could support a monthly profile. Recently, we shared a little bit more of the specifics that the 300 mg subcutaneous dose, which can be delivered in phase two in a single injection, provides extensive exposures above the target threshold for, you know, 56 days plus, therefore supporting a paradigm of monthly dosing. As we thought about the phase two-three program, as you would expect, we drew upon our extensive trial design experience with Rhapsody exactly, which, for others, is the phase three program that supported the sBLA for ARCALYST back in 2021. We took a lot of those learnings forward as we thought about how to design this program.
Of course, with the goal of speed to bring this to patients as quickly as humanly possible, the approach that we took is a phase two-three program design. That's taking a phase two dose-focusing portion, a phase three pivotal portion, two long-term extensions, all in overlapping format, but all integrated into a single protocol. That is scheduled to start in the mid-portion of this year. Maybe a little bit more detail. The dose-focusing portion, patients who are experiencing acute pericarditis episode despite oral therapies, you know, are brought into the trial and randomized in a one-to-one-to-one-to-one ratio across four different dosing levels of KPL-387, with that primary efficacy endpoint of time to treatment response, and that's a 24-week treatment period.
And after that's done, patients may be eligible to continue on, receiving treatment with additional durations of exposures for 24, for an additional 24 months. Once the phase, once the dose-focusing portion, you know, is completed, then the pivotal portion can begin in an overlapping fashion. That's a classic randomized withdrawal program with a run-in period, the duration of which is blinded, followed by a randomized withdrawal period, which is event-driven. Again, when that portion of the study is closed, patients can continue into a long-term extension. That entire package, the way it's designed, as I mentioned, with starting in the middle of this year, the phase two data would be expected in the second half of 2026.
In terms of the overall program timelines, you know, Sanj has mentioned that, in previous meetings, that we wanna bring this forward to patients in the 2027, 2028, I'm sorry, we wanna bring this to patients in the 2028, 2029 timeframe. As we think about the timelines going forward, you know, we've engaged with the FDA. We are on track to begin the program, and we're excited to move forward.
Great. Maybe one question on the trial design is, I think in Rhapsody, before the dose-focus portion of it, the analogous portion there, there was a bit of a taper period off their existing therapies or background therapies. Is that the case here as well too?
Right. The goal of, we believe that.
The steroid taper, I think it was. Yeah.
Yeah. No, that's perfect. We believe that the way, because of the mechanism of the disease, that targeted immunomodulation of the IL-1 pathway is sufficient for the managing of the disease. And those learnings, which we had from the Rhapsody program, are carried forward into this program even as early as the phase two program, where the goal is to demonstrate the efficacy of KPL-387 as a monotherapy. In the phase two program, patients initiate therapy and then are tapered off their standard oral therapies, and that carries forward into the phase three program as well, where there's a broader list of prior therapies that patients can come in on. Again, the goal is to achieve monotherapy with KPL-387 throughout the program.
One follow-up question I have is on the eligible population here. You had a pretty well-defined patient population for Rhapsody. Are the inclusion or exclusion criteria basically the same here for this phase 2-3 study? Or are you thinking about possibly a more expansive population that might allow you down the road to tackle a broader patient set?
Right. First, in terms of inclusion-exclusion criteria, one thing to note is that clinicaltrials.gov is a very, is our, is a very excellent resource, if you will, for updates of our clinical trials. In fact, the trial is, in fact, posted on clinicaltrials.gov right now, and it does have the inclusion-exclusion criteria, at least the top-level ones, for the patients. It's also important to note that a lot of times the inclusion-exclusion criteria are a little bit more about the efficient running of the clinical trial. If you look at the ARCALYST label, what you see is that, you know, we had the inclusion criteria that we did, but the label itself is very broad. As Ross mentioned, for example, it's agnostic to the, you know, number of recurrences. It just says, you know, recurrent pericarditis. It's agnostic to prior treatment.
It's agnostic to the etiology of the original disease. Those learnings are carried forward into this program as well, where we target the specific populations that are necessary for the execution of the trial and, shall we say, the robustness of the endpoints of the trial, with the ultimate understanding that the biology speaks to that broad population as you've described. In that sense, patients entering the trial who have recurrent pericarditis of any etiology except for the forbidden etiologies, as you might expect, you know, cancer and certain infections, you know, can enter the trial.
The idea of the acutely symptomatic patient entering the trial is there in order to be able to demonstrate that first part of the label that Ross mentioned, which is, you know, the treatment of the disease, meaning the reduction in pain and the reduction of inflammation and the control of the manifestations of the disease. In that upfront portion, that's an important part of it. Ultimately, for the demonstration of the reduction in risk of recurrence, that's where the randomized withdrawal portion comes in and the demonstration of the recurrence of the disease, you know, as the drug washes out with the introduction of the placebo. The rescue of the patient, once they've had a recurrence that meets bailout criteria and demonstrating that that patient goes back under control, is really part of that totality.
I think we have the right patient population that's in the trial
and the patient attributes, if you will, that support the robust endpoints of the trial.
We know that IL-1 has been validated as a target from an efficacy perspective, but just curious maybe more at a theoretical level from the longer exposure, continual exposure to it, to 387, just what are the theoretical, I guess, safety risks that could happen with the longer or more continuous exposure here?
Sure. So it's always a, it's always a benefit risk, and the ARCALYST program demonstrated that complete pathway inhibition, you know, of, of IL-1 alpha and IL-1 beta is, is very well tolerated. The, you know, we carry in the, in the label, for ARCALYST, the potential risks of, you know, of course, the injection site reactions that are, you know, of course, in the, in the near term with the injection of the drug, but in terms of the, the longer term, in terms of infections, you know, which usually manifest themselves in terms of upper respiratory tract infections. But it's important to note that this is a targeted immunomodulator.
When you think about that in the context of other options that previously had been available to patients, which were corticosteroids, which provided broad-based immunosuppression, you know, I think what the program, the previous program has shown is what the profile of a targeted immunomodulator could be. As we roll forward and think about the KPL-387 program, where the difference is instead of targeting the cytokine and trapping the cytokine, which is what ARCALYST does, to targeting the receptor, which is what KPL-387 does, you know, our expectation is that, you know, mechanistically, these would be, you know, fairly similar. Of course, as with any program, it's necessary to, you know, go through the program, you know, in its totality in order to demonstrate.
the safety profile and the benefit risk. As I mentioned, the reason why we've described such a robust program of, you know, over 160+ patients, with not only these two studies, but also the two long-term extensions, you know, really provides a robust platform to collect the kind of safety data and benefit risk data that will help inform physicians as they're making that choice with their patients.
Great. We're running close on time, so I maybe wanna end on one more question, which is just as you think about lifecycle management for the category, you have 387 in the clinic now. You've also talked briefly about 1161 as another asset. Just, you know, how are you thinking about lifecycle management here and transitioning from a partnered asset where you, with ARCALYST in the case of ARCALYST with Regeneron versus these proprietary assets and just positioning all your evolving portfolio?
Mm-hmm. Maybe I'll say a little bit about, you know, kind of from the scientific perspective and then turn it over to Ross. Just to mention a little bit about 1161, which Ross mentioned in his introductory remarks. This is an extended half-life IL-1 pathway inhibitor, again, blocking IL-1 alpha and IL-1 beta, and it does that with FC modifications. That is an option for us as we think about, you know, a range of chronic diseases that, you know, are mediated through the IL-1 pathway, so not necessarily restricted to recurrent pericarditis. I think what we have to do as that program moves forward is really think about, you know, what is the best place for diseases that, you know, would potentially benefit from management with a quarterly drug.
You know, Ross, I don't know if you wanna comment a bit more about the interface of the other assets.
Yeah, absolutely. Thank you. Yeah, in some way, we're excited by the future. I think, you know, as market leaders within recurrent pericarditis, it's upon us to make sure we continue to innovate and provide treatment options for patients suffering what's a really debilitating disease. ARCALYST has got incredibly strong efficacy and is a very well-tolerated drug, as John has taken us through. We believe ARCALYST has a huge potential ahead as well. As a reminder, at the end of 2024, we were around 13% penetrated into just the 14,000. That's a 2+ recurrence thousand population. That tells us that there's significant room left for us to continue.
To grow, ARCALYST in recurrent pericarditis. At the same time, as I said, you know, upfront, we are, you know, a well-capitalized, growth-orientated organization. We are planning for the future. We want to make sure that we dominate this disease space and continue to provide the options that, that patients need. KPL-387 is a wholly owned, independently developed drug that we're very excited about. And then KPL-1161 is kind of behind it, not necessarily in recurrent pericarditis, but has optionalities. Maybe just to finish, you know, the organization was profitable in Q1 of 2025 thanks to the growing ARCALYST revenues, which added to our cash balances of around $268 million. We are well-capitalized and very excited about the future that we have.
Great. My thanks to Ross and John for joining us, and we'll end it on that note. Thank you very much.
Thank you.
Thank you very much.
Appreciate it.